aremanagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing...

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INSIDE THIS ISSUE C are M anagement Vol. 20, No. 4 AUGUST/SEPTEMBER 2014 join/renew ACCM online at academyCCM.org or use the application on page 31 SPECIAL SECTIONS: 18 PharmaFacts for Case Managers Approvals, warnings and the latest information on clinical trials—timely drug information case managers can use. 24 LitScan for Case Managers The latest in medical literature and report abstracts for case managers. DEPARTMENTS: 2 Diabetes Diabetes 3 News from CCMC CCMC Announces New Board Members and Officers 4 News from CDMS Value on Investment 5 News from URAC Monitoring Quality and Effectiveness of Patient Care Coordination 30 How to Contact Us 30 ACCM Membership Benefits 31 Membership Application CONTINUING EDUCATION ARTICLES: 8 How Payers Are Managing Complex and Chronic Care, Part II CE By Susan Philip, MPP, and Sophie Miller, MPH In the June/July issue, we reported on disease management and complex case management programs in California. You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs. This article is a continuation of the previous Part I with information on the programs themselves. 12 Family Caregivers and Case Managers Working Together to Coordinate Care CE By Carol Levine As case managers are well aware, “patient and family engagement” has become one of the most popular terms in the new health care lexicon. What the phrase actually means, however, is not so clear. Case managers are at the front lines of nurturing that engagement for improved patient care. 16 CE Exam CE Members: Take exam online or print and mail. Nonmembers: Join ACCM to earn CE credits. OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

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Page 1: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

I N S I D E T H I S I S S U E

CareManagementVol 20 No 4 AUGUSTSEPTEMBER 2014

joinrenew ACCM online at

academyCCMorg

or use the application on page 31

SPECIAL SECTIONS

18 PharmaFacts for Case Managers Approvals warnings and the latest information on clinical trialsmdashtimely drug information case managers can use

24 LitScan for Case ManagersThe latest in medical literature and report abstracts for case managers

DEPARTMENTS

2 Diabetes Diabetes

3 News from CCMC CCMC Announces New Board Members and

Officers

4 News from CDMS Value on Investment

5 News from URAC Monitoring Quality and Effectiveness of Patient

Care Coordination

30 How to Contact Us

30 ACCM Membership Benefits

31 Membership Application

CONTINUING EDUCATION ARTICLES

8 How Payers Are Managing Complex and Chronic Care Part II CE

By Susan Philip MPP and Sophie Miller MPH

In the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I with information on the programs themselves

12 Family Caregivers and Case Managers Working Together to Coordinate Care CE

By Carol Levine

As case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular terms in the new health care lexicon What the phrase actually means however is not so clear Case managers are at the front lines of nurturing that engagement for improved patient care

16 CE Exam CE

Members Take exam online or print and mail

Nonmembers Join ACCM to earn CE credits

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2 CareManagement AugustSeptember 2014

Editor-in-Chief

Gary S Wolfe rn ccm

Editorial Board

Barbara Aubry rn cpc chcqm faihcq

Catherine M Mullahy rn bs ccrn ccm

Patrice V Sminkey rn

Deborah Smith rnc mn

Adele Webb rn phd aacrn cpnap faan

Executive Editor

Jennifer Maybin ma els

Certified Case Manager News Editor

Jennifer Maybin ma els

Art Director

Laura D Campbell

Production Director

Laura D Campbell

Circulation Manager

Robin Lane Ventura

Member Services Coordinator

Kathy Lynch

Senior VP Finance amp Administration

Jacqueline Abel

Publisher President

Howard Mason rph ms

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents are copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

Subscription rates $120 per year for ACCM members $150 for institutions

Opinions expressed in articles are those of the authors and do not necessarily reflect the opinions of the editors or the publisher or the Academy of Certified Case Managers One or two copies of articles for personal or internal use may be made at no charge For copying beyond that number contact Copyright Clearance Center Inc 222 Rosewood Dr Danvers MA 01923 Tel 978-750-8400

CareManagement is indexed in the CINAHLreg Database and Cumulative Index to Nursing amp Allied Health Literaturetrade Print Index and in RNdextrade

FROM THE EDITOR-IN-CHIEF

Gary S Wolfe

Diabetes is in the news again with the Food and Drug Administrationrsquos (FDA) approval of inhaled insulin

Afrezza Data just released from the National Diabetes Statistic Report 2014 paints a worsening picture of diabetesbull Prevalence In 2012 291 million

Americans or 93 of the population had diabetesndash In 2010 the figures were 258

million and 83 The prevalence rate for adults aged 20 and older in 2012 was 123 compared to 113 in 2010

bull Undiagnosed Of the 291 million 210 million were diagnosed and 81 million were undiagnosedndashIn 2010 the figures were 188 million and 70 million

bull Prevalence Among Seniors The percentage of Americans aged 65 and older with diabetes remains high at 259 or 118 million seniors (diagnosed and undiagnosed)ndashThe rate was 269 in 2010

bull New Cases The incidence of diabetes in 2012 was 17 million new diagnosesyear in 2010 it was 19 million

bull Prediabetes In 2012 86 million Americans aged 20 and older had prediabetes this is up from 79 million in 2010ndashThe percentage is up slightly from 35 in 2010 to 37 in 2012mdashand is now at 51 among those age 65 and older

bull Deaths Diabetes remains the seventh leading cause of death in the United States in 2012 with 69071 death certificates listing it as the underlying cause of death and a total of 234051 death certificates listing diabetes as an underlying or contributing cause of death

The rising cost of diabetes is staggering

According to the American Diabetes Association using the latest available data on cost the total estimated cost of diagnosed diabetes in 2012 was $245 billion including $176 billion in direct medical costs and $69 billion in reduced productivity

The largest components of medical expenditures arebull Hospital inpatient care (43 of the total

medical cost)bull Prescription medications to

treat complications of diabetes (18)bull Antidiabetic agents and diabetes

supplies (12)bull Physician office visits (9)bull Nursingresidential facility stays (8)

People with diagnosed diabetes incur average medical expenditures of about $13700 per year of which about $7900 is attributed to diabetes People with diagnosed diabetes on average have medical expenditures approximately 23 times higher than what expenditures would be in the absence of diabetes

For the cost categories analyzed care for people with diagnosed diabetes accounts for more than 1 in 5 health care dollars in the US and more than half of that expenditure is directly attributable to diabetes

Indirect costs includebull Increased absenteeism ($5 billion) bull Reduced productivity while at work

($208 billion) for the employed population

bull Reduced productivity for those not in the labor force ($27 billion)

bull Inability to work as a result of disease-related disability ($216 billion)

bull Lost productive capacity due to early mortality ($185 billion)

Diabetes

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

continues on page 28

THE COMMISSION FOR CASE MANAGER CERTIFICATION

NEWS FROM

CCMC Announces New Board Members and Officers

The Commission for Case Manager Certification (the Commission) installed a new slate of officers for 2014-

2015 With new elements of health care reform rolling out these officers will oversee the Commissionrsquos work as case managers take a center-stage role in care coordination and team-based care The Commission with more than 35000 board-certified case managers is the oldest and largest nationally accredited organization certifying case managers These volunteer leaders bring knowledge commitment and diverse academic and professional experience to their leadership roles Working with the

Commissionrsquos executive team board of commissioners and volunteers they will advocate for professional case management excellence through certification education and advocacy programs and services In addition this year the Commission fields its Role amp Functions Study and revises the Code of Professional Conduct for Case Managers two of the most important efforts to guide the principles and practice of case management The CCMreg certification (CCM) and the CMLearning Networkreg host education programs and resources such as the Case Management Body of Knowledgetrade that support the Commissionrsquos work

Jo Carter BSN RN CCM is the Commissionrsquos newly elected chair Carter is associate vice president of network services for Paradigm Management Services LLC Concord CA and is responsible for managing the firmrsquos national networks of work-ersrsquo compensation catastrophic nurse case managers and physicians She is a member of the first class to take the Commissionrsquos CCM examination and previously served as the Commissionrsquos chair and on the Commissionrsquos Executive Committee She holds a bachelorrsquos degree in nursing from the Medical College of Virginia and has served on the Executive Committee

--

continues on page 28

4 CareManagement AugustSeptember 2014

NEWS FROM

CERTIFICATION OF DISABILITY MANAGEMENT SPECIALISTS COMMISSION

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks

A comprehensive flexible employee wellness program that has multiple levels of leadership backing will

yield a significant return on investment (ROI) say experts in workplace health and productivity

Past winners of the C Everett Koop National Health Award attest to the financial rewards of effective wellness programs 2013 winner Dell Inc net-ted an ROI of 21 for the ldquoWell at Dellrdquo health improvement program which incorporates lifestyle coaching onsite fitness centers annual health screen-ings and quarterly wellness challenges The Nebraska state government a win-ner in 2012 saw an ROI of $270 for every dollar spent on a wellness pro-gram that includes health risk assess-ments biometric screenings health coaching and online resources

Programs that promote the overall well-being of employees pay bigger long-term dividends than those that nar-rowly focus on reducing insurance and disability management costs and absen-teeism says Ron Z Goetzel PhD presi-dent and CEO of The Health Project which established the Koop awards

ldquoA lot of employers are now pay-ing attention to outcomes of interest beyond ROIrdquo says Goetzel who is also a vice president at Truven Health Analytics in Bethesda MD ldquoA new metric that is gaining traction is value on investment Employers want to have workers who are healthy productive and engaged in what they are doing They want to have a healthy company culture in which employees feel appreci-ated and rewarded for their efforts and they feel like part of a community that

has common interests and goalsrdquo A ldquomyopic focus on health care

costsrdquo misses other important outcomes such as talent acquisition and retention productivity and performance agrees Henry Albrecht CEO of Limeade a wellness consulting and management firm in Bellevue WA ldquoIf you develop the reputation that you are committed to the well-being of your workforce it will help you attract and retain peoplerdquo Albrecht says ldquoThe average spend-ing on attracting and retaining talent dwarfs the spending on any sort of well-ness programrdquo

Well-Designed ProgramsWell-designed programs require lead-ership commitment Goetzel says ldquoLeaders must lsquowalk the talkrsquo and actu-ally support the program with money give employees time to participate in it provide facilities such as on-site health clinics and fitness centers and have pol-icies that support healthful lifestylesrdquo

To establish health-promoting protocols Goetzel suggests employers use the Centers for Disease Control and Preventionrsquos Worksite Health ScoreCard This checklist includes 125 items ranging from creating a worker relaxation area to posting signs that encourage employees to take the stairs

Employers should avoid ldquoperverse incentivesrdquo such as those that reward overweight or prediabetic employees for entering a disease management program Albrecht says ldquoThis is unfair to people whorsquove been running mara-thons for yearsrdquo he observes ldquoAt the same time treating people like theyrsquore a bundle of health risks and trying to single out the weak and expensive with

clinically focused programs only alien-ates all employees Itrsquos better to take a positive inclusive engaging approachrdquo

The most effective wellness initia-tives are built around evidence-based best practices according to Jessica Grossmeier PhD vice president of research for StayWell a health manage-ment firm in St Paul MN Such prac-tices she says include the followingbull Securing leadership support and

participation at all levels of the organization

bull Making sure workplace policies align with the wellness programrsquos goals

bull Taking the time to explain the pro-gram before implementing

bull Ensuring that any financial incen-tives comply with Health Insurance Portability and Accountability Act guidelines and serve simply to initiate behavior change rather than being the focus of the broader wellness program

bull Establishing a ldquowellness champion networkrdquo of employees who build sup-port for the program

bull Providing a comprehensive menu of options that appeals to all employees and acknowledges diverse learning styles and preferences for delivery

bull Integrating components of the pro-gram so that employees can find what they need such as by having a Web portal serve as a single point of access to information

bull Regularly assessing whether all aspects of the program are operat-ing as intended and generating the desired outcomes

Financial ReturnsWellness best practices produce

continues on page 28

AugustSeptember 2014 CareManagement 5

Monitoring Quality and Effectiveness of Patient Care Coordination Programs in Clinical and Managed Care Office Settings By Bonnie Zickgraf BSN RN CRRN

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

W ith its broad-based governance structure and an inclusive standards development process URAC ensures that all stakeholders are represented in establishing meaningful

quality measures for the entire industryAccreditation is an evaluative rigorous transparent and

comprehensive process in which healthcare organizations undergo an examination of their systems practices and performance by an impartial external accrediting body Accreditation verifies that the reviewed organizations are conducting business in a manner that meets predetermined criteria and is consistent with national standards

URAC accredits many types of healthcare organizations based on their functions URACrsquos accreditation programs provide these organizations with a range of services from organizational review of health plan standards to boosting quality within a single functional area such as case manage-ment or credentialing

With the implementation of the Patient Protection and Affordable Care Act (PPACA) Case Management has assumed an increasingly important role in improving the quality and efficiency of health care in addition to preventing chronic disease and improving public health PPACA men-tions the requirement of ldquocase managementrdquo 10 times ldquocare managementrdquo 21 times and ldquocare coordinationrdquo 20 times1

The URAC Case Management Accreditation program pro-vides an essential set of standards and performance measures that address the increased demand for excellence in coordi-nating care for improving consumer engagement achieving optimal healthcare outcomes and managing care transitions

My job as an Accreditation Reviewer for URAC is rather unique and quite interesting since I have a front row view of our healthcare system transforming as it continues to improve access to quality healthcare services I am privileged to have

the opportunity to assist URACrsquos clients as they maneuver through the current maze of healthcare reform and emerge as stronger more patient-centered organizations by adhering to and being empowered by industry recognized standards

URACrsquos philosophy towards accreditation incorporates an educational approach When I visit clients to perform accredi-tation reviews I am often referred to as a surveyor or an auditor but in reality my job is that of an educator helping to improve and recognize the value URACrsquos clients bring to the healthcare industry one organization and often one person at a time I find that my position as a reviewer is very similar to those in the industry who coordinate patient care But my ldquopatientsrdquo are organizations My role is to help organizations learn how to implement and optimize the industry standards that will propel them to achieve successful outcomes

Consumer safety is at the heart of all standard sets devel-oped by URAC A committee of experts representing diverse interests in the healthcare community develop URAC stan-dards These experts include industry leaders and subject mat-ter experts including physicians pharmacists and other provid-ers patients employers and regulators When new standards are developed experts from that particular area of healthcare delivery participate on the committee URAC always circulates draft standards for public comment so that the public may provide input in the standards development process

URAC care management standards are developed to ensure the quality and effectiveness of patient care coordina-tion in a clinical or managed care office setting URACrsquos stan-dard requirements when clarified in policies and consistently implemented can improve the quality and effectiveness of patient care coordination for any organization For example URAC standard CM 4 Internal Performance Monitoring2 describes the need for internal performance monitoring of patient care coordination programs includingbull The use of evidence-based or clinical practice guidelinesbull The systematic evaluation of performance goals of the

programbull Quality committee or governing body oversightbull Analysis (with potential revision) of guidelines used for

admission and discharge criteria of patientsbull The monitoring and adjusting of the case manager work

load (caseload guidelines)See sidebar for 5 quality review checklists that may be

Bonnie Zickgraf BSN RN CRRN is an Accreditation Reviewer with URAC In addition to six yearsrsquo experience supporting multiple accreditation programs including Health and Workers Compensation Utilization Management Health Plan Case Management Disease Management and Independent Review Organizations Ms Zickgraf has twenty years of experience as a Registered Nurse her clinical nursing experience includes psychiatric medical-surgical and ICU nursing and over eighteen years of leadership experience within the managed care industry

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 2: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

2 CareManagement AugustSeptember 2014

Editor-in-Chief

Gary S Wolfe rn ccm

Editorial Board

Barbara Aubry rn cpc chcqm faihcq

Catherine M Mullahy rn bs ccrn ccm

Patrice V Sminkey rn

Deborah Smith rnc mn

Adele Webb rn phd aacrn cpnap faan

Executive Editor

Jennifer Maybin ma els

Certified Case Manager News Editor

Jennifer Maybin ma els

Art Director

Laura D Campbell

Production Director

Laura D Campbell

Circulation Manager

Robin Lane Ventura

Member Services Coordinator

Kathy Lynch

Senior VP Finance amp Administration

Jacqueline Abel

Publisher President

Howard Mason rph ms

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents are copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

Subscription rates $120 per year for ACCM members $150 for institutions

Opinions expressed in articles are those of the authors and do not necessarily reflect the opinions of the editors or the publisher or the Academy of Certified Case Managers One or two copies of articles for personal or internal use may be made at no charge For copying beyond that number contact Copyright Clearance Center Inc 222 Rosewood Dr Danvers MA 01923 Tel 978-750-8400

CareManagement is indexed in the CINAHLreg Database and Cumulative Index to Nursing amp Allied Health Literaturetrade Print Index and in RNdextrade

FROM THE EDITOR-IN-CHIEF

Gary S Wolfe

Diabetes is in the news again with the Food and Drug Administrationrsquos (FDA) approval of inhaled insulin

Afrezza Data just released from the National Diabetes Statistic Report 2014 paints a worsening picture of diabetesbull Prevalence In 2012 291 million

Americans or 93 of the population had diabetesndash In 2010 the figures were 258

million and 83 The prevalence rate for adults aged 20 and older in 2012 was 123 compared to 113 in 2010

bull Undiagnosed Of the 291 million 210 million were diagnosed and 81 million were undiagnosedndashIn 2010 the figures were 188 million and 70 million

bull Prevalence Among Seniors The percentage of Americans aged 65 and older with diabetes remains high at 259 or 118 million seniors (diagnosed and undiagnosed)ndashThe rate was 269 in 2010

bull New Cases The incidence of diabetes in 2012 was 17 million new diagnosesyear in 2010 it was 19 million

bull Prediabetes In 2012 86 million Americans aged 20 and older had prediabetes this is up from 79 million in 2010ndashThe percentage is up slightly from 35 in 2010 to 37 in 2012mdashand is now at 51 among those age 65 and older

bull Deaths Diabetes remains the seventh leading cause of death in the United States in 2012 with 69071 death certificates listing it as the underlying cause of death and a total of 234051 death certificates listing diabetes as an underlying or contributing cause of death

The rising cost of diabetes is staggering

According to the American Diabetes Association using the latest available data on cost the total estimated cost of diagnosed diabetes in 2012 was $245 billion including $176 billion in direct medical costs and $69 billion in reduced productivity

The largest components of medical expenditures arebull Hospital inpatient care (43 of the total

medical cost)bull Prescription medications to

treat complications of diabetes (18)bull Antidiabetic agents and diabetes

supplies (12)bull Physician office visits (9)bull Nursingresidential facility stays (8)

People with diagnosed diabetes incur average medical expenditures of about $13700 per year of which about $7900 is attributed to diabetes People with diagnosed diabetes on average have medical expenditures approximately 23 times higher than what expenditures would be in the absence of diabetes

For the cost categories analyzed care for people with diagnosed diabetes accounts for more than 1 in 5 health care dollars in the US and more than half of that expenditure is directly attributable to diabetes

Indirect costs includebull Increased absenteeism ($5 billion) bull Reduced productivity while at work

($208 billion) for the employed population

bull Reduced productivity for those not in the labor force ($27 billion)

bull Inability to work as a result of disease-related disability ($216 billion)

bull Lost productive capacity due to early mortality ($185 billion)

Diabetes

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

continues on page 28

THE COMMISSION FOR CASE MANAGER CERTIFICATION

NEWS FROM

CCMC Announces New Board Members and Officers

The Commission for Case Manager Certification (the Commission) installed a new slate of officers for 2014-

2015 With new elements of health care reform rolling out these officers will oversee the Commissionrsquos work as case managers take a center-stage role in care coordination and team-based care The Commission with more than 35000 board-certified case managers is the oldest and largest nationally accredited organization certifying case managers These volunteer leaders bring knowledge commitment and diverse academic and professional experience to their leadership roles Working with the

Commissionrsquos executive team board of commissioners and volunteers they will advocate for professional case management excellence through certification education and advocacy programs and services In addition this year the Commission fields its Role amp Functions Study and revises the Code of Professional Conduct for Case Managers two of the most important efforts to guide the principles and practice of case management The CCMreg certification (CCM) and the CMLearning Networkreg host education programs and resources such as the Case Management Body of Knowledgetrade that support the Commissionrsquos work

Jo Carter BSN RN CCM is the Commissionrsquos newly elected chair Carter is associate vice president of network services for Paradigm Management Services LLC Concord CA and is responsible for managing the firmrsquos national networks of work-ersrsquo compensation catastrophic nurse case managers and physicians She is a member of the first class to take the Commissionrsquos CCM examination and previously served as the Commissionrsquos chair and on the Commissionrsquos Executive Committee She holds a bachelorrsquos degree in nursing from the Medical College of Virginia and has served on the Executive Committee

--

continues on page 28

4 CareManagement AugustSeptember 2014

NEWS FROM

CERTIFICATION OF DISABILITY MANAGEMENT SPECIALISTS COMMISSION

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks

A comprehensive flexible employee wellness program that has multiple levels of leadership backing will

yield a significant return on investment (ROI) say experts in workplace health and productivity

Past winners of the C Everett Koop National Health Award attest to the financial rewards of effective wellness programs 2013 winner Dell Inc net-ted an ROI of 21 for the ldquoWell at Dellrdquo health improvement program which incorporates lifestyle coaching onsite fitness centers annual health screen-ings and quarterly wellness challenges The Nebraska state government a win-ner in 2012 saw an ROI of $270 for every dollar spent on a wellness pro-gram that includes health risk assess-ments biometric screenings health coaching and online resources

Programs that promote the overall well-being of employees pay bigger long-term dividends than those that nar-rowly focus on reducing insurance and disability management costs and absen-teeism says Ron Z Goetzel PhD presi-dent and CEO of The Health Project which established the Koop awards

ldquoA lot of employers are now pay-ing attention to outcomes of interest beyond ROIrdquo says Goetzel who is also a vice president at Truven Health Analytics in Bethesda MD ldquoA new metric that is gaining traction is value on investment Employers want to have workers who are healthy productive and engaged in what they are doing They want to have a healthy company culture in which employees feel appreci-ated and rewarded for their efforts and they feel like part of a community that

has common interests and goalsrdquo A ldquomyopic focus on health care

costsrdquo misses other important outcomes such as talent acquisition and retention productivity and performance agrees Henry Albrecht CEO of Limeade a wellness consulting and management firm in Bellevue WA ldquoIf you develop the reputation that you are committed to the well-being of your workforce it will help you attract and retain peoplerdquo Albrecht says ldquoThe average spend-ing on attracting and retaining talent dwarfs the spending on any sort of well-ness programrdquo

Well-Designed ProgramsWell-designed programs require lead-ership commitment Goetzel says ldquoLeaders must lsquowalk the talkrsquo and actu-ally support the program with money give employees time to participate in it provide facilities such as on-site health clinics and fitness centers and have pol-icies that support healthful lifestylesrdquo

To establish health-promoting protocols Goetzel suggests employers use the Centers for Disease Control and Preventionrsquos Worksite Health ScoreCard This checklist includes 125 items ranging from creating a worker relaxation area to posting signs that encourage employees to take the stairs

Employers should avoid ldquoperverse incentivesrdquo such as those that reward overweight or prediabetic employees for entering a disease management program Albrecht says ldquoThis is unfair to people whorsquove been running mara-thons for yearsrdquo he observes ldquoAt the same time treating people like theyrsquore a bundle of health risks and trying to single out the weak and expensive with

clinically focused programs only alien-ates all employees Itrsquos better to take a positive inclusive engaging approachrdquo

The most effective wellness initia-tives are built around evidence-based best practices according to Jessica Grossmeier PhD vice president of research for StayWell a health manage-ment firm in St Paul MN Such prac-tices she says include the followingbull Securing leadership support and

participation at all levels of the organization

bull Making sure workplace policies align with the wellness programrsquos goals

bull Taking the time to explain the pro-gram before implementing

bull Ensuring that any financial incen-tives comply with Health Insurance Portability and Accountability Act guidelines and serve simply to initiate behavior change rather than being the focus of the broader wellness program

bull Establishing a ldquowellness champion networkrdquo of employees who build sup-port for the program

bull Providing a comprehensive menu of options that appeals to all employees and acknowledges diverse learning styles and preferences for delivery

bull Integrating components of the pro-gram so that employees can find what they need such as by having a Web portal serve as a single point of access to information

bull Regularly assessing whether all aspects of the program are operat-ing as intended and generating the desired outcomes

Financial ReturnsWellness best practices produce

continues on page 28

AugustSeptember 2014 CareManagement 5

Monitoring Quality and Effectiveness of Patient Care Coordination Programs in Clinical and Managed Care Office Settings By Bonnie Zickgraf BSN RN CRRN

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

W ith its broad-based governance structure and an inclusive standards development process URAC ensures that all stakeholders are represented in establishing meaningful

quality measures for the entire industryAccreditation is an evaluative rigorous transparent and

comprehensive process in which healthcare organizations undergo an examination of their systems practices and performance by an impartial external accrediting body Accreditation verifies that the reviewed organizations are conducting business in a manner that meets predetermined criteria and is consistent with national standards

URAC accredits many types of healthcare organizations based on their functions URACrsquos accreditation programs provide these organizations with a range of services from organizational review of health plan standards to boosting quality within a single functional area such as case manage-ment or credentialing

With the implementation of the Patient Protection and Affordable Care Act (PPACA) Case Management has assumed an increasingly important role in improving the quality and efficiency of health care in addition to preventing chronic disease and improving public health PPACA men-tions the requirement of ldquocase managementrdquo 10 times ldquocare managementrdquo 21 times and ldquocare coordinationrdquo 20 times1

The URAC Case Management Accreditation program pro-vides an essential set of standards and performance measures that address the increased demand for excellence in coordi-nating care for improving consumer engagement achieving optimal healthcare outcomes and managing care transitions

My job as an Accreditation Reviewer for URAC is rather unique and quite interesting since I have a front row view of our healthcare system transforming as it continues to improve access to quality healthcare services I am privileged to have

the opportunity to assist URACrsquos clients as they maneuver through the current maze of healthcare reform and emerge as stronger more patient-centered organizations by adhering to and being empowered by industry recognized standards

URACrsquos philosophy towards accreditation incorporates an educational approach When I visit clients to perform accredi-tation reviews I am often referred to as a surveyor or an auditor but in reality my job is that of an educator helping to improve and recognize the value URACrsquos clients bring to the healthcare industry one organization and often one person at a time I find that my position as a reviewer is very similar to those in the industry who coordinate patient care But my ldquopatientsrdquo are organizations My role is to help organizations learn how to implement and optimize the industry standards that will propel them to achieve successful outcomes

Consumer safety is at the heart of all standard sets devel-oped by URAC A committee of experts representing diverse interests in the healthcare community develop URAC stan-dards These experts include industry leaders and subject mat-ter experts including physicians pharmacists and other provid-ers patients employers and regulators When new standards are developed experts from that particular area of healthcare delivery participate on the committee URAC always circulates draft standards for public comment so that the public may provide input in the standards development process

URAC care management standards are developed to ensure the quality and effectiveness of patient care coordina-tion in a clinical or managed care office setting URACrsquos stan-dard requirements when clarified in policies and consistently implemented can improve the quality and effectiveness of patient care coordination for any organization For example URAC standard CM 4 Internal Performance Monitoring2 describes the need for internal performance monitoring of patient care coordination programs includingbull The use of evidence-based or clinical practice guidelinesbull The systematic evaluation of performance goals of the

programbull Quality committee or governing body oversightbull Analysis (with potential revision) of guidelines used for

admission and discharge criteria of patientsbull The monitoring and adjusting of the case manager work

load (caseload guidelines)See sidebar for 5 quality review checklists that may be

Bonnie Zickgraf BSN RN CRRN is an Accreditation Reviewer with URAC In addition to six yearsrsquo experience supporting multiple accreditation programs including Health and Workers Compensation Utilization Management Health Plan Case Management Disease Management and Independent Review Organizations Ms Zickgraf has twenty years of experience as a Registered Nurse her clinical nursing experience includes psychiatric medical-surgical and ICU nursing and over eighteen years of leadership experience within the managed care industry

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 3: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

THE COMMISSION FOR CASE MANAGER CERTIFICATION

NEWS FROM

CCMC Announces New Board Members and Officers

The Commission for Case Manager Certification (the Commission) installed a new slate of officers for 2014-

2015 With new elements of health care reform rolling out these officers will oversee the Commissionrsquos work as case managers take a center-stage role in care coordination and team-based care The Commission with more than 35000 board-certified case managers is the oldest and largest nationally accredited organization certifying case managers These volunteer leaders bring knowledge commitment and diverse academic and professional experience to their leadership roles Working with the

Commissionrsquos executive team board of commissioners and volunteers they will advocate for professional case management excellence through certification education and advocacy programs and services In addition this year the Commission fields its Role amp Functions Study and revises the Code of Professional Conduct for Case Managers two of the most important efforts to guide the principles and practice of case management The CCMreg certification (CCM) and the CMLearning Networkreg host education programs and resources such as the Case Management Body of Knowledgetrade that support the Commissionrsquos work

Jo Carter BSN RN CCM is the Commissionrsquos newly elected chair Carter is associate vice president of network services for Paradigm Management Services LLC Concord CA and is responsible for managing the firmrsquos national networks of work-ersrsquo compensation catastrophic nurse case managers and physicians She is a member of the first class to take the Commissionrsquos CCM examination and previously served as the Commissionrsquos chair and on the Commissionrsquos Executive Committee She holds a bachelorrsquos degree in nursing from the Medical College of Virginia and has served on the Executive Committee

--

continues on page 28

4 CareManagement AugustSeptember 2014

NEWS FROM

CERTIFICATION OF DISABILITY MANAGEMENT SPECIALISTS COMMISSION

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks

A comprehensive flexible employee wellness program that has multiple levels of leadership backing will

yield a significant return on investment (ROI) say experts in workplace health and productivity

Past winners of the C Everett Koop National Health Award attest to the financial rewards of effective wellness programs 2013 winner Dell Inc net-ted an ROI of 21 for the ldquoWell at Dellrdquo health improvement program which incorporates lifestyle coaching onsite fitness centers annual health screen-ings and quarterly wellness challenges The Nebraska state government a win-ner in 2012 saw an ROI of $270 for every dollar spent on a wellness pro-gram that includes health risk assess-ments biometric screenings health coaching and online resources

Programs that promote the overall well-being of employees pay bigger long-term dividends than those that nar-rowly focus on reducing insurance and disability management costs and absen-teeism says Ron Z Goetzel PhD presi-dent and CEO of The Health Project which established the Koop awards

ldquoA lot of employers are now pay-ing attention to outcomes of interest beyond ROIrdquo says Goetzel who is also a vice president at Truven Health Analytics in Bethesda MD ldquoA new metric that is gaining traction is value on investment Employers want to have workers who are healthy productive and engaged in what they are doing They want to have a healthy company culture in which employees feel appreci-ated and rewarded for their efforts and they feel like part of a community that

has common interests and goalsrdquo A ldquomyopic focus on health care

costsrdquo misses other important outcomes such as talent acquisition and retention productivity and performance agrees Henry Albrecht CEO of Limeade a wellness consulting and management firm in Bellevue WA ldquoIf you develop the reputation that you are committed to the well-being of your workforce it will help you attract and retain peoplerdquo Albrecht says ldquoThe average spend-ing on attracting and retaining talent dwarfs the spending on any sort of well-ness programrdquo

Well-Designed ProgramsWell-designed programs require lead-ership commitment Goetzel says ldquoLeaders must lsquowalk the talkrsquo and actu-ally support the program with money give employees time to participate in it provide facilities such as on-site health clinics and fitness centers and have pol-icies that support healthful lifestylesrdquo

To establish health-promoting protocols Goetzel suggests employers use the Centers for Disease Control and Preventionrsquos Worksite Health ScoreCard This checklist includes 125 items ranging from creating a worker relaxation area to posting signs that encourage employees to take the stairs

Employers should avoid ldquoperverse incentivesrdquo such as those that reward overweight or prediabetic employees for entering a disease management program Albrecht says ldquoThis is unfair to people whorsquove been running mara-thons for yearsrdquo he observes ldquoAt the same time treating people like theyrsquore a bundle of health risks and trying to single out the weak and expensive with

clinically focused programs only alien-ates all employees Itrsquos better to take a positive inclusive engaging approachrdquo

The most effective wellness initia-tives are built around evidence-based best practices according to Jessica Grossmeier PhD vice president of research for StayWell a health manage-ment firm in St Paul MN Such prac-tices she says include the followingbull Securing leadership support and

participation at all levels of the organization

bull Making sure workplace policies align with the wellness programrsquos goals

bull Taking the time to explain the pro-gram before implementing

bull Ensuring that any financial incen-tives comply with Health Insurance Portability and Accountability Act guidelines and serve simply to initiate behavior change rather than being the focus of the broader wellness program

bull Establishing a ldquowellness champion networkrdquo of employees who build sup-port for the program

bull Providing a comprehensive menu of options that appeals to all employees and acknowledges diverse learning styles and preferences for delivery

bull Integrating components of the pro-gram so that employees can find what they need such as by having a Web portal serve as a single point of access to information

bull Regularly assessing whether all aspects of the program are operat-ing as intended and generating the desired outcomes

Financial ReturnsWellness best practices produce

continues on page 28

AugustSeptember 2014 CareManagement 5

Monitoring Quality and Effectiveness of Patient Care Coordination Programs in Clinical and Managed Care Office Settings By Bonnie Zickgraf BSN RN CRRN

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

W ith its broad-based governance structure and an inclusive standards development process URAC ensures that all stakeholders are represented in establishing meaningful

quality measures for the entire industryAccreditation is an evaluative rigorous transparent and

comprehensive process in which healthcare organizations undergo an examination of their systems practices and performance by an impartial external accrediting body Accreditation verifies that the reviewed organizations are conducting business in a manner that meets predetermined criteria and is consistent with national standards

URAC accredits many types of healthcare organizations based on their functions URACrsquos accreditation programs provide these organizations with a range of services from organizational review of health plan standards to boosting quality within a single functional area such as case manage-ment or credentialing

With the implementation of the Patient Protection and Affordable Care Act (PPACA) Case Management has assumed an increasingly important role in improving the quality and efficiency of health care in addition to preventing chronic disease and improving public health PPACA men-tions the requirement of ldquocase managementrdquo 10 times ldquocare managementrdquo 21 times and ldquocare coordinationrdquo 20 times1

The URAC Case Management Accreditation program pro-vides an essential set of standards and performance measures that address the increased demand for excellence in coordi-nating care for improving consumer engagement achieving optimal healthcare outcomes and managing care transitions

My job as an Accreditation Reviewer for URAC is rather unique and quite interesting since I have a front row view of our healthcare system transforming as it continues to improve access to quality healthcare services I am privileged to have

the opportunity to assist URACrsquos clients as they maneuver through the current maze of healthcare reform and emerge as stronger more patient-centered organizations by adhering to and being empowered by industry recognized standards

URACrsquos philosophy towards accreditation incorporates an educational approach When I visit clients to perform accredi-tation reviews I am often referred to as a surveyor or an auditor but in reality my job is that of an educator helping to improve and recognize the value URACrsquos clients bring to the healthcare industry one organization and often one person at a time I find that my position as a reviewer is very similar to those in the industry who coordinate patient care But my ldquopatientsrdquo are organizations My role is to help organizations learn how to implement and optimize the industry standards that will propel them to achieve successful outcomes

Consumer safety is at the heart of all standard sets devel-oped by URAC A committee of experts representing diverse interests in the healthcare community develop URAC stan-dards These experts include industry leaders and subject mat-ter experts including physicians pharmacists and other provid-ers patients employers and regulators When new standards are developed experts from that particular area of healthcare delivery participate on the committee URAC always circulates draft standards for public comment so that the public may provide input in the standards development process

URAC care management standards are developed to ensure the quality and effectiveness of patient care coordina-tion in a clinical or managed care office setting URACrsquos stan-dard requirements when clarified in policies and consistently implemented can improve the quality and effectiveness of patient care coordination for any organization For example URAC standard CM 4 Internal Performance Monitoring2 describes the need for internal performance monitoring of patient care coordination programs includingbull The use of evidence-based or clinical practice guidelinesbull The systematic evaluation of performance goals of the

programbull Quality committee or governing body oversightbull Analysis (with potential revision) of guidelines used for

admission and discharge criteria of patientsbull The monitoring and adjusting of the case manager work

load (caseload guidelines)See sidebar for 5 quality review checklists that may be

Bonnie Zickgraf BSN RN CRRN is an Accreditation Reviewer with URAC In addition to six yearsrsquo experience supporting multiple accreditation programs including Health and Workers Compensation Utilization Management Health Plan Case Management Disease Management and Independent Review Organizations Ms Zickgraf has twenty years of experience as a Registered Nurse her clinical nursing experience includes psychiatric medical-surgical and ICU nursing and over eighteen years of leadership experience within the managed care industry

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 4: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

4 CareManagement AugustSeptember 2014

NEWS FROM

CERTIFICATION OF DISABILITY MANAGEMENT SPECIALISTS COMMISSION

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks

A comprehensive flexible employee wellness program that has multiple levels of leadership backing will

yield a significant return on investment (ROI) say experts in workplace health and productivity

Past winners of the C Everett Koop National Health Award attest to the financial rewards of effective wellness programs 2013 winner Dell Inc net-ted an ROI of 21 for the ldquoWell at Dellrdquo health improvement program which incorporates lifestyle coaching onsite fitness centers annual health screen-ings and quarterly wellness challenges The Nebraska state government a win-ner in 2012 saw an ROI of $270 for every dollar spent on a wellness pro-gram that includes health risk assess-ments biometric screenings health coaching and online resources

Programs that promote the overall well-being of employees pay bigger long-term dividends than those that nar-rowly focus on reducing insurance and disability management costs and absen-teeism says Ron Z Goetzel PhD presi-dent and CEO of The Health Project which established the Koop awards

ldquoA lot of employers are now pay-ing attention to outcomes of interest beyond ROIrdquo says Goetzel who is also a vice president at Truven Health Analytics in Bethesda MD ldquoA new metric that is gaining traction is value on investment Employers want to have workers who are healthy productive and engaged in what they are doing They want to have a healthy company culture in which employees feel appreci-ated and rewarded for their efforts and they feel like part of a community that

has common interests and goalsrdquo A ldquomyopic focus on health care

costsrdquo misses other important outcomes such as talent acquisition and retention productivity and performance agrees Henry Albrecht CEO of Limeade a wellness consulting and management firm in Bellevue WA ldquoIf you develop the reputation that you are committed to the well-being of your workforce it will help you attract and retain peoplerdquo Albrecht says ldquoThe average spend-ing on attracting and retaining talent dwarfs the spending on any sort of well-ness programrdquo

Well-Designed ProgramsWell-designed programs require lead-ership commitment Goetzel says ldquoLeaders must lsquowalk the talkrsquo and actu-ally support the program with money give employees time to participate in it provide facilities such as on-site health clinics and fitness centers and have pol-icies that support healthful lifestylesrdquo

To establish health-promoting protocols Goetzel suggests employers use the Centers for Disease Control and Preventionrsquos Worksite Health ScoreCard This checklist includes 125 items ranging from creating a worker relaxation area to posting signs that encourage employees to take the stairs

Employers should avoid ldquoperverse incentivesrdquo such as those that reward overweight or prediabetic employees for entering a disease management program Albrecht says ldquoThis is unfair to people whorsquove been running mara-thons for yearsrdquo he observes ldquoAt the same time treating people like theyrsquore a bundle of health risks and trying to single out the weak and expensive with

clinically focused programs only alien-ates all employees Itrsquos better to take a positive inclusive engaging approachrdquo

The most effective wellness initia-tives are built around evidence-based best practices according to Jessica Grossmeier PhD vice president of research for StayWell a health manage-ment firm in St Paul MN Such prac-tices she says include the followingbull Securing leadership support and

participation at all levels of the organization

bull Making sure workplace policies align with the wellness programrsquos goals

bull Taking the time to explain the pro-gram before implementing

bull Ensuring that any financial incen-tives comply with Health Insurance Portability and Accountability Act guidelines and serve simply to initiate behavior change rather than being the focus of the broader wellness program

bull Establishing a ldquowellness champion networkrdquo of employees who build sup-port for the program

bull Providing a comprehensive menu of options that appeals to all employees and acknowledges diverse learning styles and preferences for delivery

bull Integrating components of the pro-gram so that employees can find what they need such as by having a Web portal serve as a single point of access to information

bull Regularly assessing whether all aspects of the program are operat-ing as intended and generating the desired outcomes

Financial ReturnsWellness best practices produce

continues on page 28

AugustSeptember 2014 CareManagement 5

Monitoring Quality and Effectiveness of Patient Care Coordination Programs in Clinical and Managed Care Office Settings By Bonnie Zickgraf BSN RN CRRN

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

W ith its broad-based governance structure and an inclusive standards development process URAC ensures that all stakeholders are represented in establishing meaningful

quality measures for the entire industryAccreditation is an evaluative rigorous transparent and

comprehensive process in which healthcare organizations undergo an examination of their systems practices and performance by an impartial external accrediting body Accreditation verifies that the reviewed organizations are conducting business in a manner that meets predetermined criteria and is consistent with national standards

URAC accredits many types of healthcare organizations based on their functions URACrsquos accreditation programs provide these organizations with a range of services from organizational review of health plan standards to boosting quality within a single functional area such as case manage-ment or credentialing

With the implementation of the Patient Protection and Affordable Care Act (PPACA) Case Management has assumed an increasingly important role in improving the quality and efficiency of health care in addition to preventing chronic disease and improving public health PPACA men-tions the requirement of ldquocase managementrdquo 10 times ldquocare managementrdquo 21 times and ldquocare coordinationrdquo 20 times1

The URAC Case Management Accreditation program pro-vides an essential set of standards and performance measures that address the increased demand for excellence in coordi-nating care for improving consumer engagement achieving optimal healthcare outcomes and managing care transitions

My job as an Accreditation Reviewer for URAC is rather unique and quite interesting since I have a front row view of our healthcare system transforming as it continues to improve access to quality healthcare services I am privileged to have

the opportunity to assist URACrsquos clients as they maneuver through the current maze of healthcare reform and emerge as stronger more patient-centered organizations by adhering to and being empowered by industry recognized standards

URACrsquos philosophy towards accreditation incorporates an educational approach When I visit clients to perform accredi-tation reviews I am often referred to as a surveyor or an auditor but in reality my job is that of an educator helping to improve and recognize the value URACrsquos clients bring to the healthcare industry one organization and often one person at a time I find that my position as a reviewer is very similar to those in the industry who coordinate patient care But my ldquopatientsrdquo are organizations My role is to help organizations learn how to implement and optimize the industry standards that will propel them to achieve successful outcomes

Consumer safety is at the heart of all standard sets devel-oped by URAC A committee of experts representing diverse interests in the healthcare community develop URAC stan-dards These experts include industry leaders and subject mat-ter experts including physicians pharmacists and other provid-ers patients employers and regulators When new standards are developed experts from that particular area of healthcare delivery participate on the committee URAC always circulates draft standards for public comment so that the public may provide input in the standards development process

URAC care management standards are developed to ensure the quality and effectiveness of patient care coordina-tion in a clinical or managed care office setting URACrsquos stan-dard requirements when clarified in policies and consistently implemented can improve the quality and effectiveness of patient care coordination for any organization For example URAC standard CM 4 Internal Performance Monitoring2 describes the need for internal performance monitoring of patient care coordination programs includingbull The use of evidence-based or clinical practice guidelinesbull The systematic evaluation of performance goals of the

programbull Quality committee or governing body oversightbull Analysis (with potential revision) of guidelines used for

admission and discharge criteria of patientsbull The monitoring and adjusting of the case manager work

load (caseload guidelines)See sidebar for 5 quality review checklists that may be

Bonnie Zickgraf BSN RN CRRN is an Accreditation Reviewer with URAC In addition to six yearsrsquo experience supporting multiple accreditation programs including Health and Workers Compensation Utilization Management Health Plan Case Management Disease Management and Independent Review Organizations Ms Zickgraf has twenty years of experience as a Registered Nurse her clinical nursing experience includes psychiatric medical-surgical and ICU nursing and over eighteen years of leadership experience within the managed care industry

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 5: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 5

Monitoring Quality and Effectiveness of Patient Care Coordination Programs in Clinical and Managed Care Office Settings By Bonnie Zickgraf BSN RN CRRN

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

W ith its broad-based governance structure and an inclusive standards development process URAC ensures that all stakeholders are represented in establishing meaningful

quality measures for the entire industryAccreditation is an evaluative rigorous transparent and

comprehensive process in which healthcare organizations undergo an examination of their systems practices and performance by an impartial external accrediting body Accreditation verifies that the reviewed organizations are conducting business in a manner that meets predetermined criteria and is consistent with national standards

URAC accredits many types of healthcare organizations based on their functions URACrsquos accreditation programs provide these organizations with a range of services from organizational review of health plan standards to boosting quality within a single functional area such as case manage-ment or credentialing

With the implementation of the Patient Protection and Affordable Care Act (PPACA) Case Management has assumed an increasingly important role in improving the quality and efficiency of health care in addition to preventing chronic disease and improving public health PPACA men-tions the requirement of ldquocase managementrdquo 10 times ldquocare managementrdquo 21 times and ldquocare coordinationrdquo 20 times1

The URAC Case Management Accreditation program pro-vides an essential set of standards and performance measures that address the increased demand for excellence in coordi-nating care for improving consumer engagement achieving optimal healthcare outcomes and managing care transitions

My job as an Accreditation Reviewer for URAC is rather unique and quite interesting since I have a front row view of our healthcare system transforming as it continues to improve access to quality healthcare services I am privileged to have

the opportunity to assist URACrsquos clients as they maneuver through the current maze of healthcare reform and emerge as stronger more patient-centered organizations by adhering to and being empowered by industry recognized standards

URACrsquos philosophy towards accreditation incorporates an educational approach When I visit clients to perform accredi-tation reviews I am often referred to as a surveyor or an auditor but in reality my job is that of an educator helping to improve and recognize the value URACrsquos clients bring to the healthcare industry one organization and often one person at a time I find that my position as a reviewer is very similar to those in the industry who coordinate patient care But my ldquopatientsrdquo are organizations My role is to help organizations learn how to implement and optimize the industry standards that will propel them to achieve successful outcomes

Consumer safety is at the heart of all standard sets devel-oped by URAC A committee of experts representing diverse interests in the healthcare community develop URAC stan-dards These experts include industry leaders and subject mat-ter experts including physicians pharmacists and other provid-ers patients employers and regulators When new standards are developed experts from that particular area of healthcare delivery participate on the committee URAC always circulates draft standards for public comment so that the public may provide input in the standards development process

URAC care management standards are developed to ensure the quality and effectiveness of patient care coordina-tion in a clinical or managed care office setting URACrsquos stan-dard requirements when clarified in policies and consistently implemented can improve the quality and effectiveness of patient care coordination for any organization For example URAC standard CM 4 Internal Performance Monitoring2 describes the need for internal performance monitoring of patient care coordination programs includingbull The use of evidence-based or clinical practice guidelinesbull The systematic evaluation of performance goals of the

programbull Quality committee or governing body oversightbull Analysis (with potential revision) of guidelines used for

admission and discharge criteria of patientsbull The monitoring and adjusting of the case manager work

load (caseload guidelines)See sidebar for 5 quality review checklists that may be

Bonnie Zickgraf BSN RN CRRN is an Accreditation Reviewer with URAC In addition to six yearsrsquo experience supporting multiple accreditation programs including Health and Workers Compensation Utilization Management Health Plan Case Management Disease Management and Independent Review Organizations Ms Zickgraf has twenty years of experience as a Registered Nurse her clinical nursing experience includes psychiatric medical-surgical and ICU nursing and over eighteen years of leadership experience within the managed care industry

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

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7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

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CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 6: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

6 CareManagement AugustSeptember 2014

Analyzing the use of evidence-based or clinical practice guidelines3

Is there a listing of all the evidence- based or clinical guidelines used at our organization

Does our organization have a policy on the use of such guide-lines and if so what is our policy

Has the Medical Director or other senior clinician(s) approved our policy as written

How often does our organization review and revise the policy

Do we share our policy with clinical staff and how do they access this

Do providers with expertise in their specialty area contribute to our clinical guidelines

Do we audit the use of evidence based medicine in our clinical setting If so how

Are results of these audits shared with the provider case man-ager or care coordinator for improving performance in the use of evidence based andor clinical practice guidelines

Do our policies support proactive (rather than reactive) patient care coordination activities

CHECKLIST 1

Evaluation of performance goals of the care coordination program

What are the current specific performance goals of our care coordination program

Are program goals based onbull improving our performance bull andor by contracted deliverables bull andor by any regulatory compliance requirementsbull andor on patient clinical outcomes

Are we measuring what we really need to measure bull Too many or too few goals

Did we seek input from patients providers and care coordina-tors to help determine our goals

Is each goal clearly defined for 2014 and use clearly-stated measures bull Do we all understand them

What strategies must we take to reach each performance goal bull Do we have resources to get there

Are individual performance goals contributing toward the over-all performance improvement goals of the organization

How do we audit our performance bull Who does itbull Volume frequency bull Collection of results

Are any patient outcomes measured bull If so what are they how are they measured and what were

the outcomes for last year

How do our performance goals compare from last year to now bull Do we track and trend results

Are our goals transparent and proudly displayed for our patients consumers on our website or in a newsletter

CHECKLIST 2

5 Checklists for Internal Performance Monitoring

useful to assist with internal performance monitoring in both clinical and managed care operations

Mandatory clinical and nonclinical standards and mea-sures (some required by state and or federal law) are available within URACrsquos proprietary Internet platform that accredited and ldquoin-processrdquo organizations use for documentation and policy uploads URAC also provides self-assessments tools to aid prospective clients review the capability and readiness of their computer systems for the implementation of the requisite standards and measurements In addition URAC offers organi-zational gap analyses to assist organizations find the best-accred-itation programs to fit their organizationrsquos mission and goals

from the 32 accreditation and certification programs offered The measure of success for any patient care coordina-

tion program is exhibited through consistently monitoring of quality and effectiveness This article examined only one of the URAC standards that addresses patient care coordination activities in the clinical managed care or insurance office settings Imagine what the rest of the URAC standards could do to help an organization become a recognized leader in providing patient care

ldquoTo measure is to knowrdquo and ldquoIf you cannot measure it you cannot improve itrdquo3

ndash Lord Kelvin (Sir William Thomson)

References continued on page 29

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

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CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 7: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 7

Analysis of admission and discharge criteria for the care coordination program

Does our care coordination program set criteria for admission and discharge

What are the current admission criteria into the care coordina-tion program bull Must it be revised

What are the current discharge criteria for discharge out of our program bull Are revisions needed

Is our program voluntary bull Opt-in or opt-out bull Regulated by any laws or contracts

Do we offer care management 247365 and do our patients know about it

Is this criteria written in policy and procedures bull Who has access to this information

What patients are admitted to our care coordination program bull All ages all diagnoses bull Catastrophic or high acuity patients bull Chronically-ill only bull Focused populations

When are they admitted to our care coordination program bull At the time of first encounter bull Upon referral from an outside source bull Internally- referredbull Self- referrals

When are patients discharged from our care coordination pro-gram bull Upon discharge from our hospital bull Upon workersrsquo compensation adjuster request bull At point of fullest recovery for the level of care offered bull At end of life bull At maximum medical improvement or no further impact from

coordination of care efforts bull Upon physician orders bull By patient request

How often do we review our admission and discharge criteria

Who has input bull Medical or clinical director(s) bull Health plans bull Patients bull Case managers or care coordinators bull Regulated by any laws or contracts

Who ultimately approves our admission and discharge criteria for our program

Is this criteria ever adjusted bull When and why

Is our criteria for admission and discharge to our care coordina-tion program ever advertised made public marketed or com-municated in any way

Do we disclose admission and discharge criteria to patients bull Are patient welcome packets offered on admission with patient

rights and responsibilities contact numbers etc

Is transition of care a requirement in your care coordination program bull Required with each change of level of care from one practice

setting to another 4 or upon discharge

CHECKLIST 4

Committee andor governing body oversight of the care management program

Are performance results for each goal reported to appropriate channels for further oversight direction and review bull How often

Is acknowledgement or feedback ever received from the over-sight body

Is feedback provided back to individual contributors on a rou-tine basis about oversight review

Does the oversight body review approve and evaluate the effectiveness of our overall care coordination program as demonstrated by our performance goals and quality measures

Have they approved our goals for this year and provided feed-back about our performance from last year

CHECKLIST 3

INSIDE THE CASE MANAGEMENT STANDARDS

A URAC COLUMN EXCLUSIVE TO CAREMANAGEMENT

continued on page 29

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 8: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

8 CareManagement AugustSeptember 2014

How Payers Are Managing Complex and Chronic Care Part II

By Susan Philip MPP and Sophie Miller MPH

IntroductionIn the JuneJuly issue we reported on disease management and complex case management programs in California You will recall that commercial payers and MediCal managed care plans were surveyed to determine how they are designing these programs This article is a continuation of the previous Part I

Key Differences for Medicare and Medi-Cal ProgramsBoth Medicare and Medi-Cal popula-tions would benefit from improved chronic disease care A study from the Chronic Condition Data Warehouse which contains Medicare fee-for-service data found that 50 of beneficiaries have one or more chronic conditions and a quarter of beneficiaries in the cohort suffered from diabetes8 Also recent studies show that chronic condi-tions account for much of the growth in Medicare spending from 1987 to 20069

Nationwide more than half of all adult Medicaid enrollees have a chronic or disabling condition10 In addition to the high prevalence of chronic conditions nonelderly Medicaid adults often have comorbid conditions and complex care needs10 States adopt care management programs such as DM and CCM to both improve quality and reduce costs for

Medicaid enrollees11

Many aspects of Medicare and Medi-Cal DM and CCM programs are similar to those in commercial pro-grams There are a few key differences however stemming from the makeup of the patient populations and the admin-istration of the programs

MedicareThis discussion focuses on payers with Medicare Advantage contracts20 Some Medicare payers use an external vendor such as Alere while other payers con-duct their DM and CCM in-house One payer stated that the reason for con-ducting their DM and CCM functions internally was that it was fundamental to their mission as a social HMO to pro-vide high-level ldquocustomer intimacyrdquo

Identification and Stratification ProcessesOne payer described the process they use to identify and stratify Medicare members They examine the disease stage to determine which program would be most helpful Newly diag-nosed CHF patients may not yet need a DM program to manage their care and patients with end-stage disease may benefit more from palliative care than from DM This payer also uses senior-specific information that could impact health status for CCM eligibility such as loss of a caregiver or spouse or an unstable living situation The payer also considers the memberrsquos ability to par-ticipate in a program Can the member communicate via phone Is the member able to use a bathroom scale

Targeted ConditionsMedicare DM programs target slightly different conditions compared to the ldquobig fiverdquo conditions addressed by com-mercial programs One payer reported that asthma management was not offered as part of their Medicare pro-grams since asthma does not affect a large majority of seniors (ie it is either well-managed or a patient manifests a higher-acuity pulmonary condition that requires management) Another Medicare payer indicated that they do not operate a diabetes management program under DM since an elderly person with diabetes that is not well managed would likely qualify for the CCM program that is not condition-specific This payer said that given their frail elderly population their DM pro-grams tend to be more intensivemdashmore frequent contact by case managers more time spent on the phone with case managers greater use of devices such as telemonitoring devicesmdashthan tradi-tional DM programs

Health AssessmentsTwo payers viewed health assessments as particularly important for their Medicare populations and require that all seniors receive one One of these payers reported that 70 of seniors who were asked to complete the health assessment did so These payers include a discussion of end-of-life care and advance care planning in their health assessments and members are asked to consider their end-of-life goals and plans One payer noted that doctorsrsquo

Susan Philip MPP and Sophie Miller MPH are health care and management con-sultants with Booz Allen Hamilton Booz Allen Hamilton founded in 1915 has 96 years of experience in strategy management and technol-ogy consulting for the public and private sectors

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 9: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 9

reticence to discuss this topic is a bar-rier to effective and appropriate care for their Medicare population All Medicare payers involved in this study reported that they discuss palliative and hospice care with patients since hospice is a benefit covered under Medicare for terminally ill patients

Outreach and Engagement StrategiesThere are important differences in outreach to and engagement of the Medicare population These frail and elderly patients often have more intensive needs than the non-Medicare population however they may be easier to reach via phone One payer uses Masterrsquos degreendashlevel social workers or gerontologists in addition to nurses to conduct an initial health assessment upon enrollment This payer reported that all members receive phone calls from a nurse and the frequency of this outreach is tailored to the patientrsquos care management plan

In general payers reported that Medicare patients were more likely to engage with their case managers over the phone compared to commercial members Payers speculated that com-pared to the commercial population Medicare members may have more time to speak on the phone may be more accustomed to phone conversa-tions than their younger counterparts and may have a more positive view of health plans Several payers provided anecdotes of the bonds that Medicare patients developed with their care man-agers especially in CCM programs While this relationship building could result in the patient being enrolled in the program longer than necessary it also helps to ensure that the patient

stays on track in meeting care goalsIn addition to traditional low-tech

outreach methods one payer talked about wanting to integrate social media into the case management programs of their Medicare members They are developing a strategy to expand their phone services to include newer tech-nology-driven interfaces with members

Medi-CalThe majority of Medi-Cal managed care plans included in this survey reported using an internal group to deliver their DM and CCM programs Health Net is the only Medi-Cal managed care plan to use a DMO McKesson

Targeted ConditionsMajor differences in Medi-Cal DM and CCM program design and delivery stem from differences in disease prevalence and demographics Studies indicate that asthma disproportionately affects low-income individuals as a result Medi-Cal spends $400 million treating this one condition One payer identified asthma as the most common condition in their Medi-Cal DM programs

Under the Medi-Cal program men-tal health is administered separately or carved out While CCM and DM pro-grams usually do not comprehensively address mental health needs payers reported that their care outreach teams have talking points around depression and can help refer patients to appropri-ate services They said that care coor-dination with the county for mental health care is a challenge as the con-tracting mental health providers do not have any obligation or mechanism to provide health information back to the Medi-Cal managed care plan

Patient EngagementMedi-Cal managed care plans face particular challenges in patient engage-ment Medi-Cal patients often move frequently lack phones or have out-dated and incomplete information in their records12 Additionally despite efforts by counties to minimize the rate at which individuals lose and regain coverage over short time periods many enrollees do lose their Medi-Cal cover-age which leads to associated gaps in care This complicates patient engage-ment as patients may not spend enough time in a plan to connect with and trust their case managers

In addition to the traditional patient engagement tools payers use specialized engagement methods to reach their Medi-Cal populations One payer conducts outreach through com-munity resource centers in the larger counties such as Los Angeles and Fresno Nonlicensed staff members contact patients and inform them that outreach is underway and that they should expect a phone call from a health coach Another payer encourages patients to remain engaged in their health by sending them newsletters and educational pamphlets even after their graduation from programs

Program Metrics and EvaluationPayers regularly evaluate their DM and CCM programs to help improve their understanding of the factors that might increase engagement rates improve integration with providers improve performance and demonstrate to pub-lic programs and private purchasers the value of DM and CCM programs Payers reported evaluating their programs every 12 to 18 months They use a range

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

There are important differences in outreach to and engagement of the Medicare population

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 10: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

10 CareManagement AugustSeptember 2014

of evaluation toolsbull HEDIS measures All payers use the

Healthcare Effectiveness Data and Information Set (HEDIS) perfor-mance measures established by NCQA Payers use these scores to measure performance internally and to report to commercial purchasers and public programs such as Medicare and Medi-Cal HEDIS measures cover a variety of chronic and acute conditions

bull Surveys Payers conduct their own evaluations such as plan-administered patient satisfaction surveys to assess a programrsquos patient engagement rates One payer representative stated that her plan asks its CCM graduates to evaluate their case managers This evaluation helps assess case manag-ersrsquo abilities to deliver holistic care empower the patient with the necessary tools for self-management and provide care that is culturally competent

bull Financial analysis Self-insured employers and purchasers ask payers to validate that DM programs help con-trol costs mdash for example by requesting a return on investment analysis or a rate of return per dollar spent Payers conduct financial calculations of the program cost and the cost offsets that result in reduced use such as avoided emergency department visits or reduced inpatient admissions

Evaluation metrics provide a basis for payers to select a DMO and to develop contract provisions For example contracts may include per-formance guarantees that are tied to HEDIS scores DMOs that cannot dem-onstrate improvement or consistently high thresholds of performance may not receive incentives available from the payer and consistently low performance may lead to contract termination Payers

have become more sophisticated at using outcome measures as part of their performance guarantees For example instead of rewarding the volume of calls placed or the number of patients reached the focus has shifted to patient engagement rates and improved quality as demonstrated by HEDIS scores

The Centers for Medicare amp Medicaid Services (CMS) and the California Department of Health Care Services under Medicare and Medicaid rules and regulations require payers to conduct chronic condition management for Medicare Advantage and Medi-Cal managed care plan members Payers are therefore required to demonstrate com-pliance during the contracting phase and during audits Medi-Cal managed care plans are evaluated based on HEDIS scores and contract renewal depends not only on the program design but also on high HEDIS scores

Effects of Health ReformThe ACA includes several provisions to improve population health and health outcomes and to lower costs Several ACA provisions pertain spe-cifically to chronic condition care and management13

bull Alignment of financial incentives to promote primary care and chronic condition management through enhanced reimbursements and grant making Under the Medicaid Incentives for Prevention of Chronic Diseases program California applied for and received a grant to encourage Medi-Cal members to quit smoking and to better manage their diabetes through phone counseling

bull Specific reporting requirements for payers ldquowith respect to payer or cover-age benefits and health care provider

reimbursement structures that improve health outcomes through the implementation of activities such as quality reporting effective case man-agement care coordination chronic disease management and medication and care compliance initiativesrdquo

bull Coverage standards under essential health benefits (EHBs) which are specific categories of benefits to be covered by qualified health plans sold in the exchange and by plans in the small group and nongroup insurance markets outside the exchange begin-ning in 2014 EHBs include coverage of ldquoprevention and wellness services and chronic disease managementrdquo

New Federal ProgramsThe ACA also includes incentives to improve health care delivery and care coordination and to reform payment by focusing on the value of services (includ-ing outcomes and quality) rather than the volume of services Medicare provid-ers can be eligible to receive financial rewards or face financial penalties under several federal programs created by the ACA the Pioneer Accountable Care Organization initiative Medicare Shared Savings Program and the Hospital Readmission Reduction Program These programs are driving the market to create formalized relationships between providers and payers to collectively account for the consequences of mis-managed care Medicare Advantage payers also have additional incentives to improve population health manage-ment such as bonus payments tied to new quality indicators including smok-ing cessation medication adherence and body mass index management

Increased scrutiny on a payerrsquos med-ical loss ratio (MLR) or the proportion

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Payers have become more sophisticated at using outcome measures as part of their performance guarantees

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 11: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

of premium dollars they spend on medical claims or quality improvement activities has also placed pressure on payers to demonstrate that DM and CCM programs are not administrative programs but are programs essential for health care delivery and management Payers argue that robust DM and CCM programs are essential to comply with the ACArsquos MLR requirements13

Payers generally agreed that the current environment under health care reform creates additional motivation and pressures to evaluate restructure and redesign their DM and CCM programs Two payers that recently changed their DM strategy from separate condition- specific programs to holistic approaches were motivated in part because of the ACArsquos incentives to improve care coordi-nation and management

Accountable Care at the Delivery LevelThe current environment under health reform provides further motivation to consider mechanisms to better integrate disease management and complex case management at the care delivery level Payers developing ACO strategies stated that the new risk-based or shared- sav-ings arrangements with providers help to address the issue that providers are typically not financially compensated for time spent on care coordination and management Thus providers in ACO arrangements have the incentive to be activated and engaged partners In addition providers that choose to enter an ACO relationship will typically have the health information technol-ogy infrastructure patient engagement expertise and analytic capabilities to conduct care management directly

Payers in ACO arrangements were asked if they delegate their DM or CCM functions to the provider These payers were reluctant to completely delegate and have a hands-off approach to these functions One payer representa-tive stated that he would characterize the payerrsquos relationship with the ACO

provider partner as ldquocoordinating DM and CCM functions rather than delegat-ing themrdquo He described their payerrsquos care coordinators as being embedded with the provider group to conduct case management as an integrated member of the physicianrsquos team

Payers stated repeatedly that they were reluctant to delegate these func-tions because they are still responsible for meeting NCQA standards and very few providers have the scale and capa-bility to conduct the data analysis and predictive modeling activities necessary to reliably identify patients eligible for DM and CCM In addition few provid-ers have large-scale outreach and enroll-ment capabilities such as the ability to conduct mass telephone outreach Payers believe they can constructively partner with providers to give them the tools needed to better understand their panel risk-mix and use trends and to identify patients who are at high risk for condition deterioration The drive toward better integration with the physi-cian and the movement to provide care management closer to the point of care is the future direction of DM and CCM

Key ConsiderationsTo better meet the needs of the growing population of Californians with mul-tiple chronic conditions payers might consider fine-tuning their care manage-ment programs tobull Use analytic tools to better identify the

population that would most benefit from these programmatic interventions

bull Adjust the program design to engage and activate the patient by experi-menting with a wide range of toolsmdashincluding low-touch technological solutions such as mobile applica-tions and text messaging and high-touch in-person coaching or case management

bull Leverage changes in the market resulting from health reform activi-ties to better integrate DM and CCM programs with the treating provider

or primary care provider This would include using contracting arrange-ments to better align financial incen-tives and outcome measurement and experimenting with a wide range of provider engagement tools such as operational health information exchanges provider portals and the embedding of care managers

DM and CCM program development and delivery continues to be dynamic Despite mixed success in the ability of these programs to bend the cost curve and to improve outcomes payers and public and private purchasers agree that fragmented and uncoordinated care is not an option CE

References8 Schneider K OrsquoDonnell B Dean D Prevalence of multiple chronic conditions in the United Statesrsquo Medicare populationrdquo Health Qual Life Outcomes 20097(82)1477

9 Thorpe K Ogden L Galactionova K Chronic conditions account for rise in Medicare spending from 1987 to 2000 Health Aff 201029(4)718-724

10 The Role of Medicaid for Adults with Chronic Illnesses Washington DC Kaiser Family Foundation 2012

11 Williams C Medicaid Disease Management Issues and Promises Washington DC Kaiser Family Foundation 2004

12 McRea D The Impact of Asthma on Vulnerable Populations Lexington KY Council of State Governments 2006

13 Affordable Care Act

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

AugustSeptember 2014 CareManagement 11

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 12: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

12 CareManagement AugustSeptember 2014

Family Caregivers and Case Managers Working Together to Coordinate CareBy Carol Levine

A s case managers are well aware ldquopatient and family engagementrdquo has become one of the most popular

terms in the new health care lexicon What the phrase actually means however is not so clear As Humpty Dumpty explained in Through the Looking Glass ldquoWhen I use a word it means just what I choose it to meanmdashneither more nor lessrdquo From their dif-ferent perspectives proponents claim that patient and family engagement will prevent hospital readmissions improve satisfaction survey scores or gain mar-ket share A physician may see engage-ment as a way to ensure adherence to a medication regimen An administrator may see it as a way to prevent medical errors A policy maker may see it as a way to control costs All good things but heavy burdens to place on sick patients and their families For their part case managers know how hard it is to make this catch phrase a reality

Most patients and families havenrsquot heard the term and donrsquot know what engagement means They do not typically see themselves as ldquopassiverdquo or ldquononcompliantrdquo disparaging terms often applied to people who do not fol-low every aspect of professionalsrsquo advice Patients and family caregivers exist on a continuum of engagement from unin-volved or only marginally involved to

very actively involved some might say over-involved

The reasons people are on the lower end of the engagement spectrum are complex Most people are not indifferent to their health Some however lack the skills experience and confidence to navigate a complex health care system Some learn better with visual rather than written or oral presentations of information Others feel that they have no control over what happens to them in hospitals or doctorsrsquo offices Their history of prior unsatisfactory encounters may limit their ability to become engaged in the current episode Patients and families bring to the health care system not only medical problems but often social and economic problems that they perceive to demand more immediate attention than yet another doctor visit All these barriers can and must be addressed for true engagement

Yet all too often it is profession-als not patients and families who are not engaged Some professionals make quick judgments about patients and families based on external character-istics previous experience time con-straints or other factors Engagement should be a two-way street but profes-sionals often do not offer timely consis-tent and understandable information to patients and families Rushed hos-pital discharges inadequately coordi-nated care teams confusing and con-flicting follow-up instructions missing informationmdashall lead to poor outcomes

that are casually and often erroneously attributed to ldquolack of patient and family engagementrdquo

Case Managersrsquo Critical RoleOften it is up to case managers to clar-ify consult and actually engagemdashthat is have conversations withmdashpatients and families Case managers are the mediators between clinicians and patients and families They can find out what patients and families actually understand not just what they have been told This realistic assessment is essential for setting up a care plan that is feasible in the particular circum-stances facing the patient and family It is also the basis for coordinating care once the plan is in place This article will discuss both aspects of working with family caregivers

Case managers perhaps more than many other professionals know how essential family caregiver involvement is to a successful care plan although they may not realize how difficult the plan may be to implement in a specific circumstance Many discussions of care planning assume a patient who is independent able to ldquoself-managerdquo and not cognitively impaired But the real-ity is often quite different Even such an idealized patient may be temporar-ily unable to function independently after a hospitalization A recent report identified a ldquopost-hospital syndromerdquo similar to post-traumatic stress disorder which is caused by the trauma of hospi-talization itself1 Most people who are

Carol Levine directs the Families and Health Care Project at the United Hospital Fund in New York City

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

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CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 13: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 13

hospitalized or who need ongoing care management have multiple chronic conditions that affect not only their health but also their ability to function at home Without assistance usually provided by family members they will be at further risk of poor outcomes rehospitalization and eventual nursing home placement

The best-laid care plans fall apart when one key partnermdashthe family care-givermdashcannot do the job If family care-givers are not involved in planning they may not understand what is expected of them They may have no opportunity to point out barriers to implementing the plan Here are a few examples bull A case manager may work hard to set

up an appointment for a consultation with a specialist but the family care-giver has to coordinate all the steps it takes to get the person ready for the visit arrange transportation and take time off from work to accompany the patient Any misstep in this chain of events can mean a missed appoint-ment and a potentially worsening medical condition

bull A case manager has ordered durable medical equipment and it has been delivered But the family caregiver doesnrsquot know how to assemble or operate it and puts it away rather than letting the case manager know about the problem The caregiver is hesitant to reveal this problem fearing that he or she will be shamed and blamed

In these as in the many other examples the case manager can both anticipate problems and respond to them when they occur The trust that has been built in the care planning pro-cess will be essential in this process

Building Patient and Family Caregiver Engagement Into the Care PlanWhile most descriptions of care plan-ning include the patient the family care-giver is not always explicitly mentioned Changes are underway largely driven by the proliferation of transitional care

programs that are aimed at reducing hospital readmissions and the resulting financial penalties In their initial stages these programs largely did not include family caregivers as essential partners2 But as the developers gained experience in working with patients with multiple chronic illnesses and disabilities they recognized the gap and in response integrated new ways of involving family caregivers

Recently the United Hospital Fund (UHF) and Boston University Medical Center (BUMC) collaborated on one such effort BUMC developed Project RED (Re-Engineered Discharge) in 2007 and it has been adopted by over 500 hospitals nationally The first addition to the RED Toolkit since its inception is Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo created by UHF and BUMC (See the box on Resources for links) While it is aimed primarily at hospital discharges Project RED has also been successfully used in a skilled nursing facility to reduce hospital readmissions3 The principles and key features of Tool 7 can be adapted to any setting in which family caregivers play an important role in follow-up care

The toolmdashas well as all UHF work in this areamdashis based on a broad defini-tion of family caregiver who can be a member of a biological family spouse partner or friendmdashanyone who pro-vides or manages care for a person with chronic illness or disabilities The fam-ily caregiver may but need not live with the patient Sometimes there are several family caregivers they may take turns in providing care or they may have dif-ferent roles and responsibilities

The Project RED tool has five steps to guide practitionersStep 1 Identify the Family Caregiver Sometimes on admission clinicians will have identified the person who is going to be responsible for the patientrsquos follow-up care and that information

will be readily available to the case manager Often however there is no name or information is incomplete for example failing to note the personrsquos relationship to the patient or contact information Sometimes vague terms like ldquonext of kinrdquo or ldquoemergency con-tactrdquo are used If there is a designated health care proxy it may be assumedmdashincorrectlymdashthat that person is also going to be managing the care at home

Identifying the family caregiver early in the episode of care is critical because everything that follows depends on the information being up-to-date and accurate Talking about a care plan with a family member who is only visiting from out-of-state and will have no role in the ongoing care is not going to be helpful Assuming that a daughter rather than a son will take over can be a mistake If a person has been listed as the primary contact it is important to verify what that person should be contacted about that person may simply be the family member who is easy to reach and not a decision-maker (such as a power of attorney) or a person who will provide or organize

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Project REDrsquos Tool 7 ldquoUnderstanding and Enhancing the Role of Family Caregivers in the Re-Engineered Dischargerdquo

United Hospital Fundrsquos Next Step in Care family caregiver assessment guides for providers ldquoWhat Do You Need as a Family Caregiverrdquo and an overall guide to caregiver assessment

ldquoFour Questions About Engaging Family Caregiversrdquo

For more information about HIPAA see Carol Levine ldquoHIPAA What It Protects and What It Permitsrdquo Care Management Journal 201319(1)11-15 and the Next Step in Care provider guide

RESOURCES

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 14: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

14 CareManagement JuneJuly 201414 CareManagement AugustSeptember 2014

care going forward And if no one has been listed then the first order of business is to find out who will play that role If there is no one willing and able to do the job alternate sources of support have to be investigated

Many family caregivers do not iden-tify themselves as caregivers they think of themselves solely as daughters hus-bands partners or friends And many patients do not see themselves as need-ing ldquohelprdquo of any kind They may fear losing independence or burdening their families So it is important to use neu-tral language in opening discussions for example asking a patient ldquoWho arranges your pill boxrdquo rather than ldquoWho helps you take your medicinesrdquo And to a family caregiver who ada-mantly says that she is not and never will be a caregiver just ask ldquoWhat do you do as a daughter to help your Momrdquo

Since communication is essential to these discussions asking about the personrsquos language preference is impor-tant If the patient or the family care-giver does not feel comfortable speak-ing English then a trained interpreter should be requested Asking a staff member or another family member particularly a child to translate is not a good option because of the possibil-ity of misunderstandings or hesitation about disclosing bad news

Step 2 Assess the Family Caregiverrsquos NeedsMaking the family caregiver part of the team means recognizing that partnerrsquos strengths and limitations There will certainly have been an assessment of the patientrsquos needs but that alone does not tell what the family caregiver can and cannot do and what his or her own

needs are That requires a separate step best accomplished by a guided self-assessment This is a technique that combines both a professional assess-ment and the caregiverrsquos own assess-ment so that there is room for discus-sion questions and clarification

Some professionals are wary of opening a discussion of caregiver needs because they feel that ldquocaregivers donrsquot know what they needrdquo Or they may feel that once a need is identified it will be up to them to make sure it is addressed These concerns are real but most care-givers accept limitations once they are explained and are grateful that they are even seen as having needs of their own They do not generally have professional expertise but they do know their own lives and what is important to them

There are many caregiver assessment tools available Some are short and some take hours Most focus on long-term stress and burden The United Hospital Fundrsquos Next Step in Care website has a guide to caregiver assessment and a three-part tool to assist a caregiver to assess his or her own needs (See the Resource box) The results of the caregiver assessment should be documented and shared with other members of the care team The assessment may contain information that will be helpful for ongoing care and planning and in communications with care partners in other facilities If case management is ongoing the assessment should be repeated at regular intervals

Step 3 Integrate the Family Caregiverrsquos Needs Into the Care PlanUsing the patient and family caregiver assessments as basic starting points

some options for a care plan can be developed Sometimes what is totally clear to a clinicianmdashfor example this patient is going to need rehab in a skilled nursing facility (SNF)mdashis not so obvious to or desired by patients and families And sometimes there is no clearly preferable option either a SNF rehab program or home care with physical therapy would be clinically acceptable

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available By the way the nursing home is 50 miles awayrdquo If a case manager is brought into the discussion early on these options can be discussed with the patient and family so that if a decision has to be made quickly there will have been basic information about preferences such as location which is a major concern for patients and families and often a factor in the success of the transition

Home care might be an option for many patients but either they donrsquot know about it or reject it out of hand saying ldquoI donrsquot want strangers in my houserdquo On the other hand some patients and family caregivers have unrealistic expectations of the type and level of home care services they might receive A neighbor may have an aide every day for 8 hours paid for by Medicaid a Medicare patient will be eligible for only a few hours of aide ser-vices two to three times a week for a few weeks and then only if he or she needs what is termed skilled nursing care

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

Patients and family caregivers frequently complain that they are not consulted on these post-hospital discharges a nurse simply says ldquoYour mother is going to a nursing home tomorrow Yoursquore lucky because there is a bed available

By the way the nursing home is 50 miles awayrdquo

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 15: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

JuneJuly 2014 CareManagement 15

It is hard for patients and families to understand how these different public programs work Itrsquos the case managerrsquos often unpleasant job to apprise them of the realities of the health care system

Step 4 Share Family Caregiver Information With the Next Setting of CareThe wealth of information collected by a care manager should be shared with the providers who will be following the patient on an ongoing basis That may mean coordinating with other care managers for example at a health plan or medical practice Building good relationships with these providers will also lead to sharing of their informa-tion so that everyone has a better idea of what is working out well what needs to be changed and what needs may be foreseeable Sharing information with providers who are directly involved in the health care of a patient is permitted under HIPAA

Step 5 Provide Telephone Reinforcement of the Care PlanPatient and family caregivers value having a person they feel understands their situation someone they can trust Following up with regular phone calls is not just a job requirement it is a way of reinforcing trust Patients and family caregivers get many phone calls from hospital or SNF staff who just ask ldquoHow are you doingrdquo but do nothing to address any problems that may arise Patients and family caregivers may resent these calls and even ignore them even though they have important questions and concerns Because of the trusting relationship that has been developed the case managerrsquos calls should be welcome opportunities for discussion

At times it may be necessary and advisable to call the patient and fam-ily caregiver separately Each may have things to say that they would prefer not to share with the other The case man-ager has to sort out these differences and find appropriate resolutions

Care Coordination The Family Caregiverrsquos RoleA large part of case management is care coordination Case managers have professional training to take on this demanding role They bring specific skills and resources to the job The role of family caregivers in care coordina-tion however is less well recognized The Agency for Healthcare Quality and Research (AHRQ) surveyed the litera-ture on care coordination and found more than 40 definitions that depended on the setting provider goal of the pro-gram and other factors4 Only a few of these definitions mostly those related to pediatrics explicitly recognized the role of the family in coordinating care even though this is a major activity for family caregivers In a national survey only 3 of family members reported having a care coordinator from a pub-lic or private insurance program or a private care manager5

Because care coordination is such an important part of family caregiving UHF created with the assistance of an advisory group of professionals two Next Step in care guides one for profes-sionals and the second for family care-givers (See Resource box for links)

The care manager can assist patients and family caregivers bybull Building rapportbull Explaining how the system worksbull Explaining the boundaries of scope

and length of involvement (since most professional care coordination is time-limited)

bull Ensuring that the patient family caregiver and health care providers (including other professional care coordinators) are working from the same understanding of the patientrsquos needs and the plan of care

bull Preparing the patient and family caregiver to take on additional care coordination duties when the care managerrsquos services end

Remember that this is often a time of reorganization for the family roles

may shift and new stressors may arise that take a toll on the family system While the case managerrsquos job is to coor-dinate services a family memberrsquos job is to coordinate life A skilled and com-passionate case manager can make that job easier and by doing so serve the patientrsquos needs as well CE

References1 Krumholz HM Post-hospital syndromemdashan acquired transient condition of generalized risk N Engl J Med 2013368(2)100-102

2 Gibson MJ Kelly K Kaplan AK Family Caregiving and Transitional cCare A Critical Review San Francisco Family Caregiver Alliance October 2012 httpscaregiverorgsitescaregiverorgfilespdfsFamilyCGing_andTransCare_CR_FINAL10292012pdf Accessed June 17 2014

3 Berkowitz RE Fang Z Helfand BKI et al Project ReEngineered Discharge (RED) lowers hospital readmissions of patients discharged from a skilled nursing facility J Am Med Directors Assoc 201314736-740

4 Agency for Healthcare Quality and Research Closing the Quality Gap A Critical Analysis of Quality Improvement Strategies Volume 7 Care Coordination Rockville MD AHRQ June 2007 wwwahrqgovresearchfindingsevidence-based-reportscaregappdf Accessed June 17 2014

5 Reinhard S Levine C Samis S Home Alone Family Caregivers Providing Complex Chronic Care Washington DC AARP Public Policy Institute and United Hospital Fund 2013 wwwuhfnycorgpublications880853 Accessed June 17 2014

CE for CCM amp CDMS Approved for 2 hours of CCM CDMS and nursing education credit Exclusively for ACCM Members

AugustSeptember 2014 CareManagement 15

Take this exam online gt

NEW CE exams may be taken online Click the link below to take the test online and then immediately print your certificate after successfully completing the test Members only benefit Exams expire November 30 2014

ndash or print complete and mail the exam on the following pages

You must be an ACCM member to take the exam click here to join ACCM

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 16: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

16 CareManagement December 2013January 2014

Exam 1 Exam 2

16 CareManagement AugustSeptember 2014

1 According to a recent study what percentage of Medicare beneficiaries have one or more chronic conditionsa 20 b 30 c 40 d 50

2 States adapt care management programs such as disease management and complex case management to both improve quality and reduce costs for Medicaid enrolleesa True b False

3 In frail elderly populations disease management programs tend to be more intensive ndash more frequent contact by the case manager more time spent on the phone greater use of telemonitoring devicesmdashthan tradi-tional disease management programsa True b False

4 Some of the differences in outreach and engagement between Medicare and non-Medicare enrollees includea The Medicare population has more intensive needsb The Medicare population may be easier to reach by phonec Medicare patients are more likely to engage with their case manager

over the phoned All of the above

5 Major differences in payer disease management and complex case man-agement programsrsquo design and delivery stem from differences in disease prevalence and demographicsa True b False

6 How much does Medi-Cal spend on treating asthma annuallya $350 million c $400 millionb $375 million d $425 million

7 Medi-Cal managed care plans face particular challenges in patient engagement includinga Lack of phoneb Outdated or incomplete address informationc Gaps in care because of Medi-Cal coverage lossd All of the above

8 Payers use a range of evaluation tools for their disease management and complex case management programs includinga HEDIS measures b Surveys c Financial analysisd All of the above

9 The Affordable Care Act contains several provisions pertaining specifically to chronic condition case management includinga Alignment of financial incentivesb Specific reporting requirementsc Coverage standardsd All of the above

10 Payers feel that robust disease management and complex case manage-ment programs are essential to comply with the Affordable Care Actrsquos medical loss ratio requirementsa True b False

1 Proponents claim that patient and family engagement willa Prevent hospital readmissionsb Improve satisfaction survey scores or gain market sharec Prevent medical errorsd All of the above

2 Patient and family caregivers exist on a continuum of engage-ment from involved to only marginally involved to very actively involveda True b False

3 Some of the reasons people are on the lower end of the engage-ment spectrum includea Lack of skills c Lack of confidenceb Lack of experience d All of the above

4 Engagement is a one-way street where professionals offer timely consistent and understandable information to patients and fam-ilya True b False

5 Family caregiver involvement is essential to a successful care plana True b False

6 A family caregiver may bea A biological family member c A partnerb A spouse d A friende All of the above

7 Which of the following steps are critical in engaging the patient and family caregiver in a care plana Identify the family caregiverb Assess the family caregiverrsquos needsc Integrate the family caregiverrsquos needs into the care pland All of the above

8 It is important to explain the meaning of activities to the patient and family caregiver so they understand terms in the plana True b False

9 Follow-up telephone calls to the patient and family caregiver not only reinforce the care plan but also help build trusta True b False

10 The case manager can assist the patient and family caregiver bya Building rapportb Explaining how the system worksc Explaining the boundaries of scope and length of involvementd Preparing the patient and family caregiver to assume additional

care coordination dutiese All of the above

Family Caregivers and Case Management Working Together to Coordinate Care Objectives

How Payers Are Managing Complex and Chronic Care Part II

CE for CCM amp CDMS Contact Hours for RNs Exclusively for ACCM Members

NEW CE exams may be taken online Click the links below to take the test online and then immediately print your certificate after success-fully completing the test Or print complete and mail the exam on the next page Members only benefit Exams expire November 30 2014

Take this exam gtTake this exam gt

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

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JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

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q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

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ACCMAcademy of Certified Case Managers

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Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 17: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

December 2013January 2014 CareManagement 17AugustSeptember 2014 CareManagement 17

Exam 1 How Payers Are Managing Complex and Chronic CareObjectives 1 Describe two challenges faced by the case manager in patient engagement

2 State two types of evaluation tools used to evaluate patient engagement

3 Define two key considerations to meet the needs of a growing population with multiple chronic conditions

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Exam 2 Family Caregivers and Case Management Working Together to Coordinate Care ObjectivesObjectives 1 Define three steps of building patient and family caregiver engagement into the care plan

2 State the meaning of ldquopatient and family engagementrdquo

3 Describe three ways the care manager can assist patients and family caregivers

Please indicate your answer to the exam questions on page 18 by filling in the letter

1 _____ 2 _____ 3 _____ 4 _____ 5 _____ 6 _____ 7 _____ 8 _____ 9 _____ 10 _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high)

Exam 1 Exam 2

1 The objectives were met 1 2 3 4 5 1 2 3 4 5

2 The article was clear and well organized 1 2 3 4 5 1 2 3 4 5

3 The topic was both relevant and interesting to me 1 2 3 4 5 1 2 3 4 5

4 The amount and depth of the material was adequate 1 2 3 4 5 1 2 3 4 5

5 The quality and amount of the graphics were effective 1 2 3 4 5 1 2 3 4 5

6 I would recommend this article 1 2 3 4 5 1 2 3 4 5

7 This has been an effective way to present continuing education 1 2 3 4 5 1 2 3 4 5

8 Additional comments _______________________________________________________________________________________________________________

Please print Certificantrsquos Name ___________________________________________________ CCM ID __________________________________________________

Email Address ___________________________________________________ CDMS ID _________________________________________________

Mailing Address ___________________________________________________ RN ID ___________________________________________________

___________________________________________________ ACCM Membership ______________________________________

___________________________________________________ ACCM Expiration Date ___________________________________

CE contact hours applied for CCM RN CDM

CE exams cannot be processed without above information

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability Management Specialists Commission Provider 00059431 Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing Provider CEP 8083 Exams are for ACCM members only ACCM members must indicate their membership number and membership expiration date in the space provided on the answer sheet Exams cannot be processed without this information To receive credit for either exam you must score 80 or above Exams expire November 30 2014

Please note Exams may be taken online at wwwacademyCCMorg Click the link in the journal take the exam and immediately print your certificate after successfully completing the test Mailed exams should be sent to Academy of Certified Case Managers 1574 Coburg Road 225 Eugene Oregon 97401 Please allow 4 to 6 weeks for processing of mailed exams

This CE exam is protected by US Copyright law ACCM members are permitted to make one copy for the purpose of exam submission Multiple copies are not permitted

If you are not an ACCM member and wish to become one please use the application found on page 30 and submit it with this exam and dues I f you have lost or misplaced your membership information please print the exam and mail it to the address above with a check in the amount of $500

made payable to ACCM your exam will be processed and your membership number and expiration date will be emailed to you

Exclusively for ACCM Members CareManagement Vol 20 No 4 AUGUSTSEPTEMBER 2014

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 18: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

18 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

New Approvals

Afrezza (Insulin human) Inhalation Powder

Indications and UseAfrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus

Limitations of UseAfrezza is not a substitute for long-acting insulin Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus It is not recommended for the treatment of diabetic ketoacidosis The safety and efficacy of Afrezza in patients who smoke has not been established The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking

Dosage and Administrationbull Afrezza should only be administered via oral inhalation using

the Afrezza Inhaler Afrezza is administered using a single inha-lation per cartridge

bull Administer at the beginning of the mealbull Dosage adjustment may be needed when switching from another insulin to Afrezza

Starting Mealtime Dosebull Insulin-naiumlve Individuals Start on 4 units of Afrezza at each

mealbull Individuals Using Subcutaneous Mealtime (Prandial) Insulin

Determine the appropriate Afrezza dose for each meal by con-verting from the injected dose using Figure 1

bull Individuals Using Subcutaneous Pre-mixed Insulin Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day Convert each estimated injected mealtime dose to an appropriate Afrezza dose using Figure 1 Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose

Figure 1 Mealtime Afrezza Dose Conversion Table

Mealtime Dose Adjustmentbull Adjust the dosage of Afrezza based on the individualrsquos metabolic

needs blood glucose monitoring results and glycemic control goal

bull Dosage adjustments may be needed with changes in physical activity changes in meal patterns (ie macronutrient content or timing of food intake) changes in renal or hepatic function or during acute illness

bull Carefully monitor blood glucose control in patients requiring high doses of Afrezza If in these patients blood glucose control is not achieved with increased Afrezza doses consider use of subcutaneous mealtime insulin

Afrezza Administration for Doses Exceeding 8 unitsFor Afrezza doses exceeding 8 units inhalations from multiple cartridges are necessary To achieve the required total mealtime dose patients should use a combination of 4-unit and 8-unit car-tridges Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1 For doses above 24 units combina-tions of different multiple cartridges can be used

Dosage Adjustment Due to Drug InteractionsDosage adjustment may be needed when Afrezza is coadminis-tered with certain drugs

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 19: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

December 2013January 2014 CareManagement 19AugustSeptember 2014 CareManagement 19

PharmaFacts for Case Managers

Lung Function Assessment Prior to AdministrationAfrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza perform a medical history physical examination and spirometry (FEV1) in all patients to identify potential lung disease

Important Administration Instructionsbull See Patient Instructions for Use for complete administration

instructions with illustrationsbull Keep the inhaler level and white mouthpiece on top and purple

base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down held with the mouthpiece pointing down shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs the cartridge should be replaced before use

Dosage Forms and StrengthsAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single use cartridges to be administered via oral inhala-tion with the Afrezza Inhaler only

ContraindicationsAfrezza is contraindicated in patients with the followingbull During episodes of hypoglycemiabull Chronic lung disease such as asthma or chronic obstructive

pulmonary disease (COPD) because of the risk of acute bron-chospasm

bull Hypersensitivity to regular human insulin or any of the Afrezza excipients

Warnings and Precautions

BLACK BOX WARNING

Acute Bronchospasm in Patients with Chronic Lung Diseasebull Because of the risk of acute bronchospasm Afrezza is contrain-

dicated in patients with chronic lung disease such as asthma or COPD

bull Before initiating therapy with Afrezza evaluate all patients with a medical history physical examination and spirometry (FEV1) to identify potential underlying lung disease

bull Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD In a study of patients with asthma bronchoconstriction and wheezing following Afrezza dosing was reported in 29 (5 out of 17) and 0 (0 out of 13) of patients with and without a diagnosis of asthma respectively In this study a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma In a study of patients with COPD (n = 8) a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of Afrezza The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established

Changes in Insulin RegimenGlucose monitoring is essential for patients receiving insulin ther-apy Changes in insulin strength manufacturer type or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia These changes should be made under close medical supervision and the frequency of blood glu-cose monitoring should be increased Concomitant oral antidia-betic treatment may need to be adjusted

HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins including Afrezza Severe hypoglycemia can cause seizures may be life-threatening or cause death Hypoglycemia can impair concentration ability and reaction time this may place an individual and others at risk in situations where these abilities are important (eg driving or operating other machinery)

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation Afrezza has a dis-tinct time action profile which impacts the timing of hypoglyce-mia Hypoglycemia can happen suddenly and symptoms may dif-fer across individuals and change over time in the same individual Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease in patients using certain medications] or in patients who experience recurrent hypoglycemia Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg macronutrient content or timing of meals) changes in level of physical activity or changes to co-administered medication Patients with renal or hepatic impairment may be at higher risk of hypoglycemia

Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and manage hypoglycemia Self-monitoring of blood glucose plays an essen-tial role in the prevention and management of hypoglycemia In patients at higher risk for hypoglycemia and patients who have

WARNING RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASEbullAcutebronchospasmhasbeenobservedinpatientswithasthmaandCOPDusingAfrezzabullAfrezza iscontraindicatedinpatientswithchroniclungdiseasesuchasasthmaorCOPDbullBeforeinitiatingAfrezzaperformadetailedmedicalhistoryphysicalexaminationandspirometry(FEV1)toidentifypotentiallungdiseaseinallpatients

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

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Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

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JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

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ACCMAcademy of Certified Case Managers

Membership Application

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Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

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Page 20: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

20 CareManagement AugustSeptember 2014

PharmaFacts for Case Managers

reduced symptomatic awareness of hypoglycemia increased fre-quency of blood glucose monitoring is recommended

Decline in Pulmonary FunctionAfrezza causes a decline in lung function over time as measured by FEV1 In clinical trials excluding patients with chronic lung disease and lasting up to 2 years Afrezza-treated patients experienced a small [40 mL (95 CI -80 -1)] but greater FEV1 decline than comparator-treated patients The FEV1 decline was noted within the first 3 months and persisted for the entire duration of therapy (up to 2 years of observation) In this population the annual rate of FEV1 decline did not appear to worsen with increased duration of use The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes

Assess pulmonary function (eg spirometry) at baseline after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms In patients who have a decline of ge 20 in FEV1 from baseline consider discontinuing Afrezza Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing broncho-spasm breathing difficulties or persistent or recurring cough If symptoms persist discontinue Afrezza

Lung CancerIn clinical trials two cases of lung cancer one in controlled trials and one in uncontrolled trials (2 cases in 2750 patient-years of exposure) were observed in participants exposed to Afrezza while no cases of lung cancer were observed in comparators (0 cases in 2169 patient-years of exposure) In both cases a prior history of heavy tobacco use was identified as a risk factor for lung cancer Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to Afrezza and were reported by investigators after clinical trial completion These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors In patients with active lung cancer a prior history of lung cancer or in patients at risk for lung cancer consider whether the benefits of Afrezza use outweigh this potential risk

Diabetic KetoacidosisIn clinical trials enrolling subjects with type 1 diabetes diabetic ketoacidosis (DKA) was more common in subjects receiving Afrezza (043 n = 13) than in subjects receiving comparators (014 n = 3) In patients at risk for DKA such as those with an acute illness or infection increase the frequency of glucose moni-

toring and consider delivery of insulin using an alternate route of administration if indicated

Hypersensitivity ReactionsSevere life-threatening generalized allergy including anaphylaxis can occur with insulin products including Afrezza If hypersen-sitivity reactions occur discontinue Afrezza treat per standard of care and monitor until symptoms and signs resolve Afrezza is contraindicated in patients who have had hypersensitivity reac-tions to Afrezza or any of its excipients

HypokalemiaAll insulin products including Afrezza cause a shift in potas-sium from the extracellular to intracellular space possibly leading to hypokalemia Untreated hypokalemia may cause respiratory paralysis ventricular arrhythmia and death Monitor potassium levels in patients at risk for hypokalemia (eg patients using potas-sium-lowering medications patients taking medications sensitive to serum potassium concentrations and patients receiving intrave-nously administered insulin)

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma AgonistsThiazolidinediones (TZDs) which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists can cause dose-related fluid retention particularly when used in combination with insu-lin Fluid retention may lead to or exacerbate heart failure Patients treated with insulin including Afrezza and a PPAR-gamma ago-nist should be observed for signs and symptoms of heart failure If heart failure develops it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR- gamma agonist must be considered

Adverse Reactionsbull Acute bronchospasm in patients with chronic lung disease bull Hypoglycemiabull Decline in pulmonary functionbull Lung cancerbull Diabetic ketoacidosisbull Hypersensitivity reactions

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying designs the incidence of adverse reactions reported in one clinical trial may not be easily compared to the incidence reported in another clinical trial and may not reflect what is observed in clinical practice

The data described below reflect exposure of 3017 patients to Afrezza and include 1026 patients with type 1 diabetes and 1991

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 21: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 21

PharmaFacts for Case Managers

patients with type 2 diabetes The mean exposure duration was 817 months for the overall population and 816 months and 818 months for type 1 and 2 diabetes patients respectively In the overall population 1874 were exposed to Afrezza for 6 months and 724 for greater than one year 620 and 1254 patients with type 1 and type 2 diabetes respectively were exposed to Afrezza for up to 6 months 238 and 486 patients with type 1 and type 2 diabe-tes respectively were exposed to Afrezza for greater than one year (median exposure = 18 years) Afrezza was studied in placebo and active-controlled trials (n = 3 and n = 10 respectively)

The mean age of the population was 502 years and 20 patients were older than 75 years of age 508 of the population were men 826 were White 18 were Asian and 49 were Black or African American 97 were Hispanic At baseline the type 1 diabetes population had diabetes for an average of 166 years and had a mean HbA1c of 83 and the type 2 diabetes population had diabetes for an average of 107 years and had a mean HbA1c of 88 At baseline 334 of the population reported peripheral neuropathy 320 reported retinopathy and 196 had a history of cardiovascular disease

Table 1 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of controlled trials in type 2 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on placebo andor comparator and occurred in at least 2 of patients treated with Afrezza

Table 1 Common Adverse Reactions in Patients with Type 2 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Placebo (n = 290)

Afrezza (n = 1991)

Nonplacebo comparators (n = 1363)

Cough 197 256 54

Throat pain or irritation 38 44 09

Headache 28 31 18

Diarrhea 14 27 22

Productive cough 10 22 09

Fatigue 07 20 06

Nausea 03 20 10

Carrier particle without insulin was used as placebo

Table 2 shows common adverse reactions excluding hypogly-cemia associated with the use of Afrezza in the pool of active-con-trolled trials in type 1 diabetes patients These adverse reactions were not present at baseline occurred more commonly on Afrezza than on comparator and occurred in at least 2 of patients treated with Afrezza

Table 2 Common Adverse Reactions in Patients with Type 1 Diabetes Mellitus (excluding Hypoglycemia) Treated with Afrezza

Subcutaneous Insulin (n = 835)

Afrezza (n = 1026)

Cough 49 294

Throat pain or irritation 19 55

Headache 28 47

Pulmonary function test decreased 10 28

Bronchitis 20 25

Urinary tract infection 19 23

HypoglycemiaHypoglycemia is the most commonly observed adverse reaction in patients using insulin including Afrezza The incidence of severe and non-severe hypoglycemia of Afrezza versus placebo in patients with type 2 diabetes is shown in Table 3 A hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery after treatment for hypoglycemia

Table 3 Incidence of Severe and Nonsevere Hypoglycemia in a Placebo-Controlled Study of Patients With Type 2 Diabetes

Placebo (n = 176)

Afrezza (n = 177)

Severe Hypoglycemia 17 51

Nonsevere Hypoglycemia 30 67

CoughApproximately 27 of patients treated with Afrezza reported cough compared to approximately 52 of patients treated with comparator In clinical trials cough was the most common reason for discontinu-ation of Afrezza therapy (28 of Afrezza-treated patients)

Pulmonary Function DeclineIn clinical trials lasting up to 2 years excluding patients with chronic lung disease patients treated with Afrezza had a 40 mL (95 CI -80 -1) greater decline from baseline in forced expiratory volume in one second (FEV1) compared to patients treated with comparator anti-diabetes treatments The decline occurred during the first 3 months of therapy and persisted over 2 years A decline in FEV1 of ge 15 occurred in 6 of Afrezza-treated subjects com-pared to 3 of comparator-treated subjects

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 22: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

22 CareManagement JuneJuly 2014

Weight GainWeight gain may occur with some insulin therapies including Afrezza Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria In a clinical trial of patients with type 2 diabetes there was a mean 049 kg weight gain among Afrezza-treated patients compared with a mean 113 kg weight loss among placebo-treated patients

Antibody ProductionIncreases in anti-insulin antibody concentrations have been observed in patients treated with Afrezza Increases in anti-insulin antibodies are observed more frequently with Afrezza than with subcutaneously injected mealtime insulins Presence of antibody did not correlate with reduced efficacy as measured by HbA1c and fasting plasma glucose or specific adverse reactions

Drug InteractionsDrugs That May Increase the Risk of HypoglycemiaThe risk of hypoglycemia associated with Afrezza use may be increased with antidiabetic agents ACE inhibitors angiotensin II receptor blocking agents disopyramide fibrates fluoxetine monoamine oxidase inhibitors pentoxifylline pramlintide pro-poxyphene salicylates somatostatin analogs (eg octreotide) and sulfonamide antibiotics Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Decrease the Blood Glucose Lowering Effect of AfrezzaThe glucose lowering effect of Afrezza may be decreased when co-administered with atypical antipsychotics (eg olanzapine and clozapine) corticosteroids danazol diuretics estrogens glucagon isoniazid niacin oral contraceptives phenothiazines progesto-gens (eg in oral contraceptives) protease inhibitors somatropin sympathomimetic agents (eg albuterol epinephrine terbutaline) and thyroid hormones Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co-admin-istered with these drugs

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Afrezza

The glucose lowering effect of Afrezza may be increased or decreased when co- administered with alcohol beta-blockers clonidine and lithium salts Pentamidine may cause hypoglyce-mia which may sometimes be followed by hyperglycemia Dose adjustment and increased frequency of glucose monitoring may be required when Afrezza is co- administered with these drugs

Drugs That May Affect Hypoglycemia Signs and SymptomsThe signs and symptoms of hypoglycemia may be blunted when beta-blockers clonidine guanethidine and reserpine are co-administered with Afrezza

Use in Specific PopulationsPregnancy Teratogenic Effects Pregnancy Category CAfrezza has not been studied in pregnant women Afrezza should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus

Pediatric UseAfrezza has not been studied in patients younger than 18 years of age

Geriatric UseIn the Afrezza clinical studies 381 patients were 65 years of age or older of which 20 were 75 years of age or older No overall dif-ferences in safety or effectiveness were observed between patients over 65 and younger patients

Pharmacokineticpharmacodynamic studies to assess the effect of age have not been conducted

Hepatic ImpairmentThe effect of hepatic impairment on the pharmacokinetics of Afrezza has not been studied Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with hepatic impairment

Renal ImpairmentThe effect of renal impairment on the pharmacokinetics of Afrezza has not been studied Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure Frequent glucose monitoring and dose adjustment may be necessary for Afrezza in patients with renal impairment

Clinical StudiesOverview of Clinical Studies of Afrezza for Diabetes MellitusAfrezza has been studied in adults with type 1 diabetes in com-bination with basal insulin The efficacy of Afrezza in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin Afrezza has been studied in adults with type 2 diabetes in combination with oral antidiabetic drugs The efficacy of Afrezza in type 2 diabetes patients was compared to placebo inhalation

Type 1 DiabetesPatients with inadequately controlled type 1 diabetes participated in a 24-week open-label active-controlled study to evaluate the glucose lowering effect of mealtime Afrezza used in combination with a basal insulin Following a 4-week basal insulin optimiza-tion period 344 patients were randomized to Afrezza (n = 174) or insulin aspart (n = 170) administered at each meal of the day Mealtime insulin doses were titrated to glycemic goals for the first 12 weeks and kept stable for the last 12 weeks of the study At Week 24 treatment with basal insulin and mealtime Afrezza pro-

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

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Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

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Page 23: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

JuneJuly 2014 CareManagement 23

vided a mean reduction in HbA1c that met the pre- specified non-inferiority margin of 04 Afrezza provided less HbA1c reduction than insulin aspart and the difference was statistically significant More subjects in the insulin aspart group achieved the HbA1c target of le 7 (Table 4)

Table 4 Results at Week 24 in an Active-Controlled Study of Mealtime AFREZZA plus Basal Insulin in Adults With Type 1 Diabetes

Efficacy Parameter

Afrezza + Basal Insulin (n = 174)

Insulin Aspart + Basal Insulin (n = 170)

HbA1c ()

Baseline (adjusted meana) 794 792

Change from baseline (aadjusted meanab)

-021 -040

Difference from insulin aspart (adjusted meanab)

019 (002 036)

Percentage of patients achieving HbA1c le 7c

138 271

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1539 1516

Change from baseline at (adjusted meana b)

-253 102

Difference from insulin aspart (adjusted meana b) (95 CI)

-354 (-563 -146)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks were available from 131 (75 ) and 150 (88 ) subjects randomized to the AFREZZA and insulin aspart groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

Type 2 DiabetesA total of 479 adult patients with type 2 diabetes inadequately con-trolled on optimalmaximally tolerated doses of metformin only or 2 or more oral antidiabetic (OAD) agents participated in a 24-week double-blind placebo-controlled study Following a 6- week run-in period 353 patients were randomized to Afrezza (n = 177) or an inhaled placebo powder without insulin (n = 176) Insulin doses were titrated for the first 12 weeks and kept stable for the last 12 weeks of the study OADs doses were kept stable At Week 24 treat-ment with Afrezza plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group (Table 5)

Table 5 Results at Week 24 in a Placebo-Controlled Study of AFREZZA in Adults with Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Agents

Efficacy Parameter

Afrezza + Oral Anti-Diabetic Agents (n = 177)

Placebo + Oral Anti-Diabetic Agents (n = 176)

HbA1c ()

Baseline (adjusted meana) 825 827

Change from baseline (adjusted meanab)

-082 -042

Difference from placebo (adjusted meanab) (95 CI)

-040 (-057 -023)

Percentage () of patients achieving HbA1C le7c

322 153

Fasting Plasma Glucose (mgdL)

Baseline (adjusted meana) 1759 1752

Change from baseline (adjusted meanab)

-112 -38

Difference from placebo (adjusted meanab) (95 CI)

-74 (-180 32)

a Adjusted mean was obtained using a Mixed Model Repeated Measures (MMRM) approach with HbA1c or FPG as the dependent variable and treatment visit region basal insulin stratum and treatment by visit interaction as fixed factors and corresponding baseline as a covariate An autoregression (1) [AR(1)] covari-ance structure was used

b Data at 24 weeks without rescue therapy were available from 139 (79) and 129 (73) subjects randomized to the AFREZZA and placebo groups respectively

c The percentage was calculated based on the number of patients randomized to the trial

How SuppliedStorage And HandlingAfrezza (insulin human) Inhalation Powder is available as 4-unit and 8-unit single-use cartridges Three cartridges are contained in a single cavity of a blister strip Each card contains 5 blister strips sep-arated by perforations for a total of 15 cartridges For convenience the perforation allows users to remove a single strip containing 3 cartridges Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package)

The cartridges are color-coded blue for 4 units and green for 8 units Each cartridge is marked with ldquoAfrezzardquo and ldquo4 unitsrdquo or ldquo8 unitsrdquo

The Afrezza Inhaler is individually packaged in a translucent overwrap The inhaler is fully assembled with a removable mouth-piece cover The Afrezza Inhaler can be used for up to 15 days from the date of first use After 15 days of use the inhaler must be discarded and replaced with a new inhaler

StorageNot in Use Refrigerated Storage 2deg-8degC (36deg-46degF)

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 24: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

24 CareManagement AugustSeptember 2014

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to

case managers in an easy-to-read format Each abstract includes information to locate the full-text article

if there is an interest This member benefit is designed to assist case managers in keeping current with clinical

breakthroughs in a time-effective manner

LitScan

Hepatology 2014 Jun 27 doi 101002hep27281 [Epub ahead of print]

Relationship of vitamin D status with advanced liver fibrosis and response to hepatitis C virus therapy a meta-analysis

Garciacutea-Aacutelvarez M Pineda-Tenor D Jimeacutenez-Sousa MA Fernaacutendez-Rodriacuteguez A Guzmaacuten-Fulgencio M Resino S

BACKGROUND AND AIMS There is growing evidence that vita-min D is related to chronic hepatitis C (CHC) pathogenicity We analysed the relationship of vitamin D status with advanced liver fibrosis (ALF) in CHC treatment-naiumlve patients and sustained virologic response (SVR) in CHC patients on pegylated interferon alpha plus ribavirin (pegIFNαribavirin) therapy METHODS We performed a meta-analysis of all eligible studies published to date (April 2014) in PubMed SCOPUS LILACS and the Cochrane Library assessing plasmaserum vitamin D levels related to ALF andor SVR Pooled odds ratios were estimated by either fixed or random effects models RESULTS Fourteen studies were selected from the literature search 7 for ALF (1083 patients) and 11 for SVR (2672 patients) For liver fibrosis low vitamin D status was related to a diagnosis of ALF with the cut-offs of 10 ngmL (OR = 237 [95 CI = 120 472]) and 30 ngmL (OR = 222 [95 CI = 124 397]) being significant and a near-significance for 20 ngmL (OR = 144 [95 CI = 099 212]) Regarding SVR a significant heterogeneity among studies was found (P lt 0001) and we only found a significant association with SVR for a vitamin D cut-off of 20 ngmL (OR = 053 [95 CI = 031 091]) When meta-analysis was performed excluding the outliers significant pooled ORs were found for all patients [10 ngmL (OR = 048 [95 CI = 034 067]) and 20 ngmL (OR = 058 [95 CI = 045 076]) and GT14 patients [10 ngmL (OR = 053 [95 CI = 034 081]) and 20 ngmL (OR = 054 [95 CI = 039 074]) CONCLUSIONS Low vitamin D status in CHC patients is associated with a higher like-lihood of having ALF and lower odds of achieving SVR following pegIFNαribavirin therapy

Am J Respir Crit Care Med 2014 May 1189(9)1052-64 doi 101164rccm201401-0058OC

Outcomes associated with corticosteroid dosage in critically ill patients with acute exacerbations of chronic obstructive pulmonary diseaseKiser TH Allen RR Valuck RJ Moss M Vandivier RW

RATIONALE Studies evaluating corticosteroid (CS) dosing for patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) have largely excluded patients admitted directly to the intensive care unit (ICU) and none have evaluated the effect of CS dosing regimens on mortal-ity OBJECTIVES To examine the effectiveness and safety of lower- versus high-dose CS in patients admitted to the ICU with an AECOPD METHODS This pharmacoepidemiologic cohort study evaluated ICU patients with AECOPD admitted to one of 473 hospitals and treated with CS within the first 2 days between January 1 2003 and December 31 2008 Patients were grouped into lower-dose (methylprednisolone le 240 mgd) or high-dose (methylprednisolone gt 240 mgd) groups based on CS dosage on hospital Day 1 or 2 The primary outcome was hospital mortality MEASUREMENTS AND MAIN RESULTS A total of 17239 patients were included 6156 (36) were in the lower-dose and 11083 (64) in the high-dose CS group After propensity score matching and adjustment for unbalanced covariates lower-dose CS was not associated with a significant reduction in mortality (odds ratio 085 95 confidence interval [CI] 071-101 P = 006) but it was associated with reduced hospital (-044 d 95 CI -067 to -021 P lt 001) and ICU (-031 d 95 CI -046 to -016 P lt 001) length-of-stay hospital costs (-$2559 95 CI -$4508 to -$609 P = 001) length of invasive ventilation (-029 d 95 CI -052 to -006 P = 001) need for insulin therapy (227 vs 251 P lt 001) and fungal infections (33 vs 44 P lt 001) CONCLUSIONS Two-thirds of patients admit-ted to the ICU with an AECOPD are treated with high doses of CS that are associated with worse outcomes and more frequent adverse effects Lower dosage strategies should be encouraged for patients admitted to the ICU and the optimum dose should be determined through clinical trials

F O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 25: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 25

AIDS 2014 Jun 28 [Epub ahead of print]

Osteoporosis and fractures in HIVhepatitis C virus coinfection a systematic review and meta-analysis

Dong HV Corteacutes YI Shiau S Yin MT

OBJECTIVE There is growing evidence that fracture risk is increased in individuals with HIV andor hepatitis C virus (HCV) infection We systematically reviewed the literature to determine whether prevalence of osteoporosis and incidence of fracture is increased in HIVHCV-coinfected individuals DESIGN A systematic review and meta-analysis METHODS A search was performed of Medline Scopus and the Cochrane Library databases as well as of abstracts from annual retroviral liver and bone meetings (up to 2013) for studies with bone mineral density (BMD) or bone fracture data for HIVHCV-coinfected individuals Osteoporosis odds ratios (ORs) and fracture incidence rate ratios (IRRs) were estimated from studies with data on HIV-monoinfected or HIVHCV-uninfected compari-son groups RESULTS Of 15 included studies nine reported BMD data and six reported fracture data For HIVHCV-coinfected the estimated osteoporosis prevalence was 22 [95 confidence interval (95 CI) 12-31] and the crude OR for osteoporosis compared with HIV-monoinfected was 163 (95 CI 127-211) The pooled IRR of overall fracture risk for HIVHCV-coinfected individuals was 177 (95 CI 144-218) compared with HIV-monoinfected and 295 (95 CI 217-401) compared with uninfected individuals In addi-tion to HIVHCV-coinfection older age lower BMI smoking alco-hol and substance use were significant predictors of osteoporosis and fractures across studies CONCLUSION HIVHCV coinfection is associated with a greater risk of osteoporosis and fracture than HIV monoinfection fracture risk is even greater than uninfected controls These data suggest that HIVHCV-coinfected individuals should be targeted for fracture prevention through risk factor modi-fication at all ages and DXA screening at age 50

AIDS Res Hum Retroviruses 2014 Jun 22 [Epub ahead of print]

Habitual nutrient intake in HIV-infected youth and associations with HIV-related factors

Ziegler T McComsey G Frediani J Millson E Tangpricha V Eckard AR

BACKGROUND Few studies have evaluated habitual nutri-ent intake among HIV-infected youth in the United States even

though diet may influence disease progression and risk of co-morbidities This study determined micro- and macronutrient intake in HIV-infected youth METHODS HIV-infected subjects and healthy controls 1-25 years old were prospectively enrolled Nutrient intake was assessed via 24-hour dietary recalls performed every 3 months for one year and compared to Dietary Reference Intakes (DRIs) and Acceptable Macronutrient Distribution Ranges (AMDRs) RESULTS Subjects with ge 2 food recalls were analyzed (175 HIV+ and 43 healthy controls) Groups were similar in age race sex body mass index and kilocalorie intake In both groups intake of several micronutrients was below the DRI In addition HIV+ subjects had lower percent DRI than controls for vitamins A D E pantothenic acid magnesium calcium folate and potas-sium HIV+ subjectsrsquo percent caloric intake from fat was above the AMDR and was higher than controls Caloric intake was negatively correlated with current and nadir CD4 count Zinc riboflavin and magnesium percent DRI were positively associated with cur-rent CD4 count In HIV+ subjects not on antiretroviral therapy HIV-1 RNA levels were negatively correlated with protein intake CONCLUSIONS HIV+ youth have inadequate intake of several essential nutrients and poorer dietary intake compared to controls Intake of some nutrients was associated with HIV-related fac-tors Further investigation is warranted to determine the impact of dietary intake of specific nutrients on HIV progression and chronic complication risk in this population

Hypertension 2014 Jun 30 pii HYPERTENSIONAHA11302973 [Epub ahead of print]

Renal arteriolar injury by salt intake contributes to salt memory for the development of hypertension

Oguchi H Sasamura H Shinoda K et al

ABSTRACT The role of salt intake in the development of hyper-tension is prominent but its mechanism has not been fully eluci-dated Our aim was to examine the effect of transient salt intake during the prehypertensive period in hypertensive model animals Dahl salt-sensitive rats and spontaneously hypertensive rats were fed from 6 to 14 weeks with low-salt (012 NaCl) normal-salt (08 NaCl) high-salt (7 NaCl) or high-sodiumnormal-chloride diet and returned to normal-salt diet for 3 months Rats in the high-salt group saw elevations in blood pressure (BP) not only during the treatment period but also for the 3 months after returning to normal-salt diet We named this phenomenon salt memory Renal arteriolar injury was found in the high-salt group at the end of experiment Dahl salt-sensitive rats were fed from 6 to 14 weeks with high-salt diet with angiotensin receptor blocker vasodilator calcium channel blocker and calcium channel

LitScanF O R C A S E M A N A G E R S

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 26: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

26 CareManagement AugustSeptember 2014

blocker+angiotensin receptor blocker and returned to normal-salt diet Although BP was suppressed to control levels by vasodilator or calcium channel blocker elevated renal angiotensin II and renal arteriolar injury were observed and salt memory did not disap-pear because of sustained renal arteriolar injury Calcium channel blocker+angiotensin receptor blocker suppressed renal arteriolar injury resulting in the disappearance of salt memory Cross-transplantation of kidneys from Dahl salt-sensitive rats on high salt to control rats caused increase of BP whereas control kidneys caused reduction in BP of hypertensive rats inducing the central role of the kidney These results suggest that renal arteriolar injury through BP and renal angiotensin II elevation plays important roles in the development of salt memory for hypertension

Lung Cancer 2014 Jun 6 pii S0169-5002(14)00256-6 doi 101016jlungcan201406001 [Epub ahead of print]

Aggressive therapy for patients with non-small cell lung carcinoma and synchronous brain-only oligometastatic disease is associated with long-term survival

Gray PJ Mak RH Yeap BY et al

OBJECTIVES Optimal therapy for patients with non-small cell lung carcinoma (NSCLC) presenting with synchronous brain-only oligometastases (SBO) is not well defined We sought to analyze the effect of differing therapeutic paradigms in this subpopula-tion MATERIALS AND METHODS We retrospectively analyzed NSCLC patients with 1-4 SBO diagnosed between 12000 and 12011 at our institution Patients with T0 tumors or documented Karnofsky Performance Status lt 70 were excluded Aggressive thoracic therapy (ATT) was defined as resection of the primary disease or chemoradiotherapy whose total radiation dose exceeded 45Gy Cox proportional hazards and competing risks models were used to analyze factors affecting survival and first recurrence in the brain RESULTS Sixty-six patients were included Median follow-up was 319 months Intrathoracic disease extent included 9 stage I 10 stage II and 47 stage III patients Thirty-eight patients received ATT 28 did not Patients receiving ATT were younger (median age 55 vs 605 years P = 0027) but were otherwise similar to those who did not Receipt of ATT was associated with prolonged median overall survival (OS) (264 vs 105 months P lt 0001) with actuarial 2-year rates of 54 vs 26 ATT remained associated with OS after controlling for age thoracic stage performance status and initial brain therapy (HR 040 P = 0009) On multivariate analysis the risk of first failure in the brain was associated with receipt of ATT (HR 362 P = 0032) and initial combined modality brain therapy (HR 034 P = 0046) CONCLUSION Aggressive management of thoracic disease in NSCLC patients with SBO is associated with

improved survival Careful management of brain disease remains important especially for those treated aggressively

PLoS One 2014 Jul 19(7)e100164

The adherence to initial processes of care in elderly patients with acute venous thromboembolism

Stuck AK Meacutean M Limacher A et al

BACKGROUND We aimed to assess whether elderly patients with acute venous thromboembolism (VTE) receive recommended initial processes of care and to identify predictors of process adherence METHODS We prospectively studied in- and outpatients aged ge65 years with acute symptomatic VTE in a multicenter cohort study from nine Swiss university- and non-university hospitals between September 2009 and March 2011 We systematically assessed whether initial processes of care which are recommended by the 2008 American College of Chest Physicians guidelines were performed in each patient We used multivariable logistic models to identify patient factors independently associated with process adherence RESULTS Our cohort comprised 950 patients (mean age 76 years) Of these 86 (645750) received parenteral anticoag-ulation for ge 5 days 54 (405750) had oral anticoagulation started on the first treatment day and 37 (274750) had an international normalized ratio (INR) ge 2 for ge 24 hours before parenteral antico-agulation was discontinued Overall 35 (53153) of patients with cancer received low-molecular-weight heparin monotherapy and 72 (304423) of patients with symptomatic deep vein thrombosis were prescribed compression stockings In multivariate analyses symptomatic pulmonary embolism hospital-acquired VTE and concomitant antiplatelet therapy were associated with a significantly lower anticoagulation-related process adherence CONCLUSIONS Adherence to several recommended processes of care was subop-timal in elderly patients with VTE Quality of care interventions should particularly focus on processes with low adherence such as the prescription of continued low-molecular-weight heparin therapy in patients with cancer and the achievement of an INR ge 2 for ge 24 hours before parenteral anticoagulants are stopped

PLoS One 2014 Jun 309(6)e99978 doi 101371journalpone0099978 eCollection 2014

Comparing benefits from many possible computed tomography lung cancer screening programs extrapolating from the national lung screening trial using comparative modeling

McMahon PM Meza R Plevritis SK et al

LitScanF O R C A S E M A N A G E R S

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 27: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

AugustSeptember 2014 CareManagement 27

BACKGROUND The National Lung Screening Trial (NLST) dem-onstrated that in current and former smokers aged 55 to 74 years with at least 30 pack-years of cigarette smoking history and who had quit smoking no more than 15 years ago 3 annual computed tomography (CT) screens reduced lung cancer-specific mortality by 20 relative to 3 annual chest X-ray screens We compared the benefits achievable with 576 lung cancer screening programs that varied CT screen number and frequency ages of screening and eligibility based on smoking METHODS AND FINDINGS We used five independent microsimulation models with lung cancer natural history parameters previously calibrated to the NLST to simulate life histories of the US cohort born in 1950 under all 576 programs lsquoEfficientrsquo (within model) programs prevented the great-est number of lung cancer deaths compared to no screening for a given number of CT screens Among 120 lsquoconsensus efficientrsquo (identified as efficient across models) programs the average start-ing age was 55 years the stopping age was 80 or 85 years the average minimum pack-years was 27 and the maximum years since quitting was 20 Among consensus efficient programs 11 to 40 of the cohort was screened and 153 to 846 lung cancer deaths were averted per 100000 people In all models annual screening based on age and smoking eligibility in NLST was not efficient continuing screening to age 80 or 85 years was more efficient CONCLUSIONS Consensus results from five models identified a set of efficient screening programs that include annual CT lung cancer screening using criteria like NLST eligibility but extended to older ages Guidelines for screening should also con-sider harms of screening and individual patient characteristics

J Nephrol 2014 Jul 1 [Epub ahead of print]

C reactive protein and long-term risk for chronic kidney disease a historical prospective studyKugler E Cohen E Goldberg E et al

INTRODUCTION C reactive protein (CRP) is an acute phase reactant that primarily produced by hepatocytes yet may be locally expressed in renal tubular cells We assessed the association of CRP and the risk for chronic kidney disease (CKD) development METHODS Historical prospective cohort study was conducted on subjects attending a screening center in Israel since the year 2000 Subjects with an estimated GFR (eGFR) above 60 mLmin173 m2 at baseline were included and high sensitive (hs) CRP levels as well as eGFR were recorded for each visit Follow up continued for at least 5 years for each subject until 2013 Risk for CKD at end of follow up was assessed in relation to mean hs-CRP levels of each subject The confounding effects of other predictors of CKD were examined A logistic regression model treating CRP as a continuous variable was further applied RESULTS Out of 4345 patients 42 (1 ) developed CKD in a mean follow up of

76 plusmn 2 years Elevated levels of CRP were associated with greater risk for CKD (crude OR 417 95 CI 146-1189) The OR for the association of CRP with CKD when controlling for age and gender was 52 (95 CI 17-162) When controlling for established renal risk factors elevated CRP levels remained significantly associated with greater risk for CKD (OR 542 95 CI 176-1668) When applying logistic regression models treating CRP as a continuous variable for patients with diabetes mellitus (DM) hypertension (HTN) or eGFR between 60-90 mLmin173 m2 the predictive role of CRP for CKD was highly significant CONCLUSION Elevated CRP level is an independent risk factor for CKD development In patients with DM HTN or baseline eGFR between 60-90 mlmin173 m2 its predictive role is enhanced

Transplantation 2014 Jul 1598(1)72-8 doi 10109701TP00004432246696037

Role of anti-vimentin antibodies in renal transplantation

Besarani D Cerundolo L Smith JD et al

BACKGROUND The role of non-HLA antibodies in rejection is not clear We investigate whether antibodies to vimentin are made after renal transplantation and if production is associated with interstitial fibrosis and tubular atrophy (IFTA) METHODS In this retrospec-tive study sera from 70 recipients of renal allografts (40 controls 30 IFTA) were studied The biopsy diagnosis of interstitial fibrosis and tubular atrophy (IFTA) was based on random cause-indicating biopsies Sera were collected pretransplant and at 3 monthly inter-vals up to 5 years posttransplant or diagnosis of IFTA and assayed by ELISA for IgM and IgG anti-vimentin antibodies (AVA) and HLA antibodies RESULTS Mean titers of IgM AVA were higher at every year after transplantation compared with pretransplant for both IFTA and controls groups (Plt 0001) There was no difference in the mean level of IgM AVA achieved by IFTA and control groups The mean pretransplant levels of IgG AVA in the IFTA and control group were 182plusmn117 and 110plusmn81 respectively (P = 0001) There was a signif-icant increase between the pretransplant mean levels of IgG AVA and the levels at years 1 to 4 in the IFTA group (years 1-3 P lt 00001 year 4 P = 0003) but not in the controls There was no significant difference between the numbers of IFTA or control patients achiev-ing a positive value (mean+2SD of pretransplant antibody titers) of IgM AVA (50 vs 375 respectively) or IgG AVA (266 vs 125 respectively) There was no association between production of HLA and AVA antibodies CONCLUSION Posttransplant production of IgM AVA is not associated with IFTA The production of IgG AVA by a minority of IFTA patients suggests that in some individuals IgG AVA may be involved in the pathology of IFTA

LitScanF O R C A S E M A N A G E R S

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 28: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

substantial value to employers Grossmeier says citing research conducted by StayWell in 2013 on client BPrsquos wellness program

ldquoResearchers found that strong employee participation at BP has pro-duced a 56 reduction in the average number of lifestyle-related health risks at the population levelrdquo she notes ldquoIn terms of financial savings BP saw its overall health care spending decrease by 35 and realized an estimated $3

return in health care cost savings for each dollar invested in the wellness program

ldquoMany of StayWellrsquos previous studies have also demonstrated how compre-hensive programs can produce savings based on improved productivity while at work and reduced costs associated with workersrsquo compensation and health-related absenteeismrdquo She points out that research conducted by the Health Enhancement Research Organization (HERO) shows that even small employ-ers can successfully implement and realize sizeable returns from compre-hensive wellness programs CM

of the Central Virginia Chapter of Case Management Society of America and on the National Workersrsquo Compensation Advisory Board for the Shepherd Center

Other 20142015 officers arebull Immediate Past-Chair Sue Jensen

PhD RN CCM MSCC associate pro-fessor Grand Valley State University

bull Chair-elect Sandra Zawalski RN BSN CRRN CCM ABDA MSCC director field case management Sedgwick

bull Treasurer Annette Watson RN-BC CCM MBA founder and principal Watson International Consulting

bull Secretary Jane Harkey RN MSW CCM founder and owner of an inde-pendent geriatric care management company

The Commission also elected four new Members at Large representing a range of allied health fields and deliv-ery settings bull Bruce Christopherson MEd

CRC LCPC MAC CCM chief of

rehabilitation services for the Idaho Commission for the Blind amp Visually Impaired

bull Michael J Demoratz PhD LCSW CCM director of special projects at AMADA Senior Care Laguna Woods CA

bull Jeannie L LeDoux RN BSN MBA CCM CPHQ CTT+ clinical educator at MCG Health Seattle WA

bull Charlotte Sortedahl DNP MPH MS RN CCM assistant professor at the University of Wisconsin Eau Claire

ldquoIt is an exciting time for the Commission to serve as a leader in health care at the forefront of case management education and influencerdquo said Patrice Sminkey the Commissionrsquos CEO ldquoCase managers are the hub of care coordination efforts for the medi-cal home and medical neighborhood and they play a critical role in bridging gaps in care transitions ldquoEmployers across the care spectrum need a knowl-edgeable well-prepared workforce to guide patients to the resources they needrdquo she said ldquoAnd board certification validates that case managers have the experience and expertise to meet todayrsquos challenges and are ready to be leaders in a rapidly changing health care environmentrdquo CM

This estimate highlights the substantial burden that diabetes imposes on society Additional components of societal burden omitted from this information include intangibles from pain and suffering resources from care provided by nonpaid caregivers and the burden associated with undiagnosed diabetes

This information points to the need for case managers to be aggressive in identifying patients with diabetes and managing them effectively In part because of changing lifestyles and eating habits type 2 diabetes is seen in many more than just older people In recent years many new medications have been approved including new classes of medications

The FDA has approved MannKindrsquos application for Afrezza a rapid-acting inhaled insulin allowing patients to set aside needles and syringes and use an inhaler Afrezza has been approved for both type 1 and 2 diabetes Afrezza is not the first inhaled insulin to be approved Pfizerrsquos inhaled insulin Exubera was marketed in 2006 and 2007 It is thought that Exubera was taken off the market because of poor marketing Afrezza presents with a different inhaler and several improvements over Exubera In this issue PharmaFacts is devoted to Afrezza Become knowledgeable about Afrezza and consider it to be another medication in the toolbox to help your patients control their diabetes

Gary S Wolfe RN CCM Editor-in-ChiefGSWolfeaolcom

ACCM Improving Case Management Practice through Education

28 CareManagement AugustSeptember 2014

Diabetes continued from page 2

CCMC Announces New Board Members and Officers continued from page 3

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 4

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 29: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

References1 111th Congress of the United States of America The Patient Protection and Affordable Care Act H R 3590 pages 1- 906 January 1 2010

2 URAC Case Management Standards Version 50 Washington DC URAC June 2013

3 Lord Kelvin Quotations httpzapatopinetkelvinquotes Accessed August 1 2014

4 NTOCC The National Transitions of Care Coalition wwwntoccorgAboutUsaspx Accessed August 1 2014

Value on Investment Effective Wellness Programs Improve Productivity and Morale Reduce Risks continued from page 6

AugustSeptember 2014 CareManagement 29

Managing care coordination workload (caseload guidelines)

The aspects or measurements that could should trigger a change in case management caseload guidelines could be

Lower overall quality audit scores for the case management group or a trending downward

Staffing turnovers big swings in case manager staffing (too many case managers leave employment because they feel over-loaded overwhelmed)

The percentage of patient goals not being ldquometrdquo continues to rise or is trending upward for the case management organization

An increase in the number of complaints (to management by the case management employees themselves) about their work-loads and is trending upward

A trend of reactive case management rather than proactive case management style as self-reported by the case management group or as determined by case audit file review

Complaints by case managers or patients of missed preventative or educational opportunities with patients

The volume of documented preventative or educational oppor-tunities with patients is flat or trending lower

The duration of time until cases are opened or closed changes dramatically as seen in monthly reports for the case manage-ment group (opening a case takes longer to open from month-to-month and or never closes a case because they canrsquot get around to closing them)

Failure to ldquotrue-uprdquo case load lists by the case management team can lead to total case numbers higher than actual cases being worked on by the case managers (possibly due to fear of having more cases assigned) cases should be closed when the case meets program closure criteria

Does the care coordination computer program automatically terminate close or remove cases not touched by any staff for the previous 60- 90 days (to true up workload and program statistics)

Total amount of ldquoredrdquo or ldquolaterdquo tasks displayed (missed tasks) as seen on case management employee computer screens increases day after day after day Are case managers ldquobehindrdquo and frus-trated before they even get started for the day

Examine Can any non-clinical staff assist the case manager in any appropriate capacity or do we need to hire more staff

Is there an increase in member complaints of failure to return phone calls timely or never at all

The overall acuity for the total members in the case manage-ment program changes significantly higher or lower (which could permit more or less cases per case manager)

Have the total years of experience of the case management group changed impacting output

Does our organization offer appropriate resources for the case management group Have we asked the case managers what they need to be successful in their care coordination efforts

Note All of the above can be indicators of an ineffective case man-agement program because of the absence of caseload review guide-lines In examining the above responses the accreditation reviewer can determine if the current number of cases assigned to each case manager is still a good number for the reviewed organizationrsquos program(s) or if the case load needs to be revised as needed

In addition

Does our patient documentation computer system allow suf-ficient room to document all elements necessary for our care coordination program

Can we generate data reports from our computer systems to effectively and easily monitor our inputs our outputs and all necessary elements in between (patient encounters assess-ments care plans medications all providersrsquo names and contact information involved in patient care medical records correspondence etc)

Can we print-on-demand patient education materials as needed or send automated hyperlinks to patientrsquos emails or smart phones if requested by patients

CHECKLIST 4

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 30: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

joinrenew ACCM online at wwwacademyCCMorg

REFER A COLLEAGUE TO ACCM

Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs They can join ACCM at wwwacademyCCMorg or by mailing or faxing the Membership Application on the next page to ACCM

Why join ACCM Here are the answers to the most commonly asked questions about ACCM Membership

Q Does membership in ACCM afford me enough CE credits to maintain or my CCMS certification

A If you submit all of the CE home study programs offered in CareManagement you will accumulate 90 CE credits every 5 years

Q Are CE exams available onlineA Yes ACCM members may mail exams or take them online When

taking the exam online you must print your certificate after successfully completing the test This is a members only benefit If mailing the exam is preferred print the exam from the PDF of the issue complete it and mail to the address on the exam form

Q Where can I get my membership certificateA Print your membership certificate instantly from the website or click

here Your membership is good for 1 year based on the time you join or renew

Q How long does it take to process CE examsA Online exams are processed instantly Mailed exams are normally

processed within 4 to 6 weeks

Q Do CE programs expireA Continuing education programs expire in approximately 90 days

Q Is your Website secure for dues paymentA ACCM uses the services of PayPal the nationrsquos premier payment processing organization No financial information is ever transmitted to ACCM

application on next page

HOW TO CONTACT US

Editor-in-Chief Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Executive Editor Jennifer Maybin MA ELS 203-454-1333 ext 3 email jmaybinacademyccmorg

PublisherPresident Howard Mason RPH MS 203-454-1333 ext 1 e-mail hmasonacademyccmorg

Art Director Laura D Campbell 203-256-1515 e-mail lcampbellacademyccmorg

Subscriptions 203-454-1333 Website wwwacademyCCMorg

phone 203-454-1333 fax 203-547-7273 Website wwwacademyccmorg

Executive Vice President Gary S Wolfe RN CCM 831-443-6847 email gwolfeacademyccmorg

Member Services 203-454-1333 ext 3 e-mail hmasonacademyccmorg

Vol 20 No 4 AugustSeptember 2014 CareManagement (ISSN 1531-037X) is published electronically six times a year February April June August October and December and its contents copyrighted by Academy of Certified Case Managers Inc 10 Covlee Dr Westport CT 06880 Tel 203-454-1333 Fax 203-547-7273

ACCMAcademy of Certified Case Managers

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

CareManagement

30 CareManagement AugustSeptember 2014

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 31: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

First Name Middle Name Last Name

Home Address

City State Zip

Telephone Fax e-mail (required)

Certification ID _____________________ (ACCM mailings will be sent to home address)

Practice SettingWhich best describes your practice setting

q IndependentCase Management Company q HMOPPOMCOInsuranceCompanyTPA

q Rehabilitation Facility q Hospital

q Medical GroupIPA q Home CareInfusion

q Hospice q Academic Institution

q Consultant q Other _____________________________

JOIN ACCM TODAYq 1 year $120 (year begins at time of joining)

q Check or money order enclosed made payable to Academy of Certified Case Managers Mail check along with a copy of application to Academy of Certified Case Managers 2740 SW Martin Downs Blvd 330 Palm City FL 34990

q MasterCard q Visa q American Express If using a credit card you may fax application to 203-547-7273

Card ________________________________________ Exp Date ______________ Security Code _______________

Personrsquos Name on Credit Card ____________________________Signature ________________________________

Credit Card Billing Address ______________________________________________________

City ________________________________ State _________ Zip ________________________________________

s

ACCMAcademy of Certified Case Managers

Membership Application

s

joinrenew ACCM online at wwwacademyCCMorg

q I wish to become a member

For office use only__________________Membership __________________ Membership expiration__________________

Do not use this application after December 31 2014

Date

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack
Page 32: areManagement - academyccm.orgacademyccm.org/pdfs/22cm.pdf · are at the front lines of nurturing that engagement for ... case management excellence through certification, ... such

OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

2740 SW Martin Downs Blvd 330 Palm City FL 34990

Tel 203-454-1333 bull Fax 203-547-7273

copy Academy of Certified Case Managers Inc 2014

CareManagement

  • _GoBack