LIABILITY UNDER THE ACAWHAT VASCULAR CLINICIANS

NEED TO KNOW!

Russ Nassof, JD2016

Program• The Business of Medicine• Background• Solution• Affordable Care Act (ACA)• Problems• Why Should We Care?• The Legal Stuff• Importance of Product, Practice, and People• Liability Minimization

The Business of Medicine

The Business of Medicine• DO NO HARM (Clinician) versus• MAKE $$$$ (Lawyers)

The Business of MedicineAll too often… Brings the Bad News!

The Business of MedicineAll too often… Never Invited to Lunch!

The Business of MedicineAll too often… Invited AFTER the Adverse Event

The Business of MedicineAll too often… How We Feel At the End of the Day!

The Business of Medicine

The Solution:

The Business of Medicine

•Creating an Accountable Care Org. (ACO)•Personnel Shortages•Technology•Population Health Management•Physician-Hospital Relations•PATIENT SATISFACTION•Care for the uninsured•PATIENT SAFETY AND QUALITY•GOVERNMENT MANDATES•HEALTHCARE REFORM IMPLEMENTATION•FINANCIAL CHALLENGES*

*http://www.ache.org/pubs/research/ceoissues.cfm. Accessed 2/18/16

Where did This Come From???

Pronovost and Prevention

The Problem with Zero

What is Preventable = Moving Target

•Umschied – ”As many as 33% of all cases of CLABSI and almost 50% of SSI and VAP were not preventable.”*Preventability and Liability

•When Nothing was Preventable there was No Liability

• *Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14.

• *Umac

Why?

The Background

And Today- even adverse events such as falls are deemed to be preventable and the list grows every year…

The Problem• Regulating Healthcare vs Clinical Practice?

The Solution?• Fee for Service vs. Pay for Performance

• 2001- NQF and the “Never Events”-29 events

• Terminology is problematic but caught on with payors, regulators, PSOs, state health organizations, etc.

• Serious, largely preventable patient safety incidents that should not occur with appropriate preventive measures (includes contaminated device injury/illness/death)

• List has grown slowly from inception

The Solution?• Fee for Service vs. Pay for Performance

• 2008- Center for Medicare/Medicaid Services (CMS)- “To encourage hospitals to prevent certain HACs not POA.”*

• Deficit Reduction Act (DRA)- Hospitals will no longer receive the differential (enhanced payment) when the sole reason for the differential was REASONABLY PREVENTABLE through adherence to evidence based guidelines.*

• POA conditions become critical• 11 conditions included (some overlap with NQF “Never Events” list)• Includes Vascular Catheter-associated Infections, catheter-associated

urinary tract infections, falls, and pressure ulcers (stages III and IV)**

*https://www.fojp.com/sites/default/files/infocusFall10.pdf. Accessed 2/20/16**https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitalacqcond/hospital-acquired_conditions.html. Accessed 2/20/16

The Solution?

The ACA• Fee for Service vs. Pay for Performance

• 2010- Patient Protection and Affordable Care Act(ACA)-ObamaCare

• 16.4 million newly insured with 8 million enrolled in a marketplace plan*

• Uninsured fell from 18% to 9.2% as of 8/15**

• Financial rewards/penalties based on quality measure attainment established by CMS (including HAIs)

• New Goal- 30% of direct payments to doctors, hospitals, and other providers will be through alternative payment models

*http://www.hhs.gov/healthcare/fact-and-features/fact-sheets/aca-is-working/index.html. Accessed 2/20/16**http://www.dailykos.com/story/2015/11/5/1445323/-CDC-Uninsured-rate-lowest-ever. Accessed 2/20/16

The ACA• Fee for Service vs. Pay for Performance✓ More changes to CMS payments

I. Hospital Readmissions Reduction ProgramII. Hospital Acquired Conditions (HACs)III. Hospital Value Based Purchasing IV. Hospital Inpatient Quality Reporting Program

✓ ALL 4 PROGRAMS WORK IN TANDEM TO INCENTIVIZE IMPROVED PATIENT OUTCOMES/SATISFACTION WITH LOWER COST

The ACA• Why Should We Care about the ACA?

• Focus on improving patient outcomes• Improved outcomes will result from reduction in vascular catheter

related adverse events• Reduction in vascular catheter adverse events will result from

selection of the right product for the right patient at the right time• Government will penalize those failing to achieve improved

outcomes and will reward those that are successful• Bottom Line- INCREASED SCRUTINY OF VASCULAR CLINICIAN

PRACTICE

The ACA• Changes to CMS

I. Hospital Readmission Reduction Program• Penalties (3% in 2015) on hospitals that have excess readmissions

(above the national average) for • Cardiac- AMI/Heart Failure• Pulmonary-Pneumonia/COPD• Orthopedic-Total Hip/Knee Arthroplasty• Potential for more to be added-CABG/percutaneous coronary intervention

• Some allowances now made for demographics, comorbidities, patient frailties (risk adjustment)*

* The Advisory Board Company, Healthcare Industry Committee, Hospital Readmissions Reduction Program, C-Suite Cheat Sheet Series, August 2013. Accessed 2/21/16

The ACA• Changes to CMS

II. Hospital Acquired Conditions• Penalties (1%) on hospitals in the top 25% for the following HACs

(among others)• CENTRAL VENOUS CATHETER BLOODSTREAM INFECTIONS• Pressure ulcer rate• Postop. hip fracture rate• Postop. sepsis rate• Postop. pulmonary embolism or DVT• Catheter-associated urinary tract infection (CAUTI)• C.difficile/MRSA/SSIs of colon, abdomen coming in ‘16/’17*

*The Advisory Board Company, Healthcare Industry Committee. Hospital-Acquired Condition Reduction Program. C-Suite Cheat Series. August 2013. Accessed 2/21/16.

The Affordable Care ActHospital Acquired Condition (HAC) Program

Domain 1(AHRQ Measure)

Weighted 25%

This measure consists of:• Pressure ulcer• Iatrogenic pneumothorax• Central venous catheter-related blood

stream infection rate• Hip fracture rate• Postoperative PE/DVT rate• Sepsis rate• Wound dehiscence rate• Accidental puncture

Domain 2(CDC Measure)

Weighted 75%

2015 (measures):CLABSICAUTI

2016Surgical Site Infection (Colon Surgery and Abdominal Hysterectomy)

2017 (2 additional measures):MRSAC Diff

Association of American Medical Colleges presentation. https://s3.amazonnaws.com/public-inspection, federalregister.gov/2013-18956. Accessed 2/20/16.www.stratishealth.org/documents/HAC_fact_sheet.pdf. Accessed 2/20/16

Performance Period July 1, 2012 – June 30, 2014 Performance Period January 1, 2013 – December 31, 2014

100%

The ACA• Changes to CMS

III. Value Based Purchasing (VBP)• The Name…DOES NOT SAY IT ALL• Penalties- Up to 2%• Incentives- Up to 2%• Budget Neutral for CMS- Hospitals pay on the front end and then

either receive the $$ back, lose the $$, or receive a bonus $$ based upon a Total Performance Score (TPS)*

* http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/index.html?redirect=/hospital-value-based-purchasing/. Accessed 2/20/16

Value Based PurchasingThe ACA

Improvement (self)

Hospitals will be assessed on how much their current performance

changes from their own baseline period performance

Achievement (others)

Hospitals measured based on how much their current performance differs from all other hospitals’ baseline period performance

Total Performance Score (TPS)*

vsvs

*http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/index.html?redirect=/hospital-value-based-purchasing/. Accessed 2/21/16

The ACA• Changes to CMS

IV. Value Based Purchasing (VBP)• Domains/Scoring (‘13) 2017

• Clinical Process- 70% 5%• Patient Satisfaction- 30% 25%• Outcomes -0% 25%• Safety-CLABSI- 0% 20% • Efficiency-0% 25%*

*http://www.stratishealth.org/documents/FY2017-VBP-fact-sheet.pdf. Accessed 2/19/16*https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets-items/2015-10-26.html Accessed 2/19/16

Percent of CMS Dollars at Stake by FY 2017

6%plus any deductions under the deficit reduction act and other regulations*

*The Advisory Board Company, Healthcare Industry Committee, Hospital Value-Based Purchasing. C-Suite Cheat Sheet Series. August 2013.-accessed 2/20/16**The Advisory Board Company, Healthcare Industry Committee, Hospital Readmissions Reduction Program. C- Suite Cheat Sheet Series. August 2013.- accessed 2/20/16***The Advisory Board Company, Healthcare Industry Committee, Hospital-Acquired Condition Reduction Program. C-Suite Cheat Sheet Series. August 2013. Accessed 2/20/16

•Value Based Purchasing+/-2%

•Readmission Reduction Program 3%

•Healthcare Acquired Condition Program 1%

The ACA• So what does 6% amount to anyway???

• Readmissions- $161,240 (average penalty ‘15)• VBP- $91,873 (average penalty ‘15)• HACs- $541,896 (average penalty ’15)• Total = $795,009 (average penalty ‘15)• But if you were a poor performer the total could be as high as

$8,570,333 !!!!!!!!!!(2015)*

*https://www.ahd.com/state.html. Accessed 2/21/16The Advisory Board Pay for Performance File-https://www.advisory.com/research/health-care-industry-committee/members/resources/2014/p4p-impact-file. Accessed 2/21/16

The ACA• More Changes to CMS

• Hospital Inpatient Quality Reporting Program

• Financial incentive (up to 2%) for reporting quality of services so as to provide consumers with data to make more informed decisions re care (Hospital Compare)*

• HAC Reduction Program results available on Hospital Compare

• Includes HAIs- CLABSI, CAUTI, SSIs, MRSA, C.diff as well as other adverse events**

• Uses CDC NHSN definitions and provides hospitals with tools to perform self-assessments

• As of 1/1/15 CLABSI/CAUTI reporting includes ALL medical and surgical beds- not JUST ICUs.

*https://www/cms/gov/medicare/quality-initiatives-patient-assessment-instruments/hospitalqualityinits/hospitalrhqdapu.html. Accessed 2/18/16** http://www.qualityreportingcenter.com/wp-content/uploads/2015/01/IQR_FY-2016-Reference-Checklist.pdf. Accessed 2/18/16

The ACA

• Health Information Technology for Economic and Clinical Health (HITECH)-2009

• HITECH is a separate act with funding to enhance the widespread adoption of electronic health record (EHR) usage*

• Adoption will assist in facilitating compliance with regulatory/data reporting requirements for adverse events

• Advantages but many risks…

*https://www.healthit.gov/policy-researchers-implementers/health-it-legislation. Accessed 2.22.16

GoalsAffordable Care Act

•CMS readmission penalties3

•Non payment of Healthcare Acquired Conditions (HACs)1

•Value-based purchasing2

Regulatory Requirements

•Reportable quality metrics2,3,4

•Measured patient outcomes2,4

•Patient satisfaction reporting2,4

Provider Opportunities in Changing Landscape

•Reduce Readmissions•Reduce HAIs•Improve Patient Satisfaction•Improve Patient Outcomes•Use Evidence Based Medicine/Practice

1 – Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Number 161, Tuesday, August, 19, 2008. Accessed October 7, 20142 – Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011. Accessed October 7, 20143 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011. Accessed October 7, 20144 – Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011. Accessed October 7, 20145 - https://innovation.cms.gov/initiatives/bundled-payments/ Accessed 11/5/15

More Problems…Non-clinicians who know nothing about infection prevention have assumed that all infections must be preventable and are somehow the result of a lapse in patient care.

“The patient in the next bed is highly infectious. Thank God for these curtains.”

More Problems…• Are these preventable HAI sources?

• Overpopulation of hospitals

• Multi-drug resistance

• Visitor hygiene/illnesses

• Patients own immune system condition

• Physical proximity of patients

• Increasingly invasive procedures

• Use of antibiotics

• Endogenous infections

• Multiplicity of HAI origins today often makes it difficult to identify precise HAI source!

More Problems…

•Contaminated environment – source of many pathogens “facilities are dirty” BUT•Evidence lacking – difficult to precisely link infection with exact environmental source and transmission event ..however

•Data on Outbreaks – Successful interruption after interventions eliminating potential environmental sources

The Problem of HAI Sources

More Problems…

•Increasingly complex•Increasingly lengthy- UTI criteria in APIC Elimination Guide is 6 pages long•Increased confusion-forum questions•Increased liability exposure

NHSN HAI Definitions

More Problems…

•Healthcare-associated Infection (HAI)•Must be contracted in healthcare setting*

•Must not be present on admission (POA)*

•POA-2 days prior/2 days after…*

OR REBUTTABLE PRESUMPTION?

*http://www.cdc.gov/nhsn/pdf/pscmanual/protocol-clarification.pdf. Accessed 2/22/16

More Problems…BUT…✓ Many infections are asymptomatic after onset for some time*✓ Colonization/inflammation are not infections*✓ Extensions of infections which are POA are not HAI unless there is a

change of pathogens but this is not applicable to SSIs, VAEs*✓ What about device removal/reinsertion?✓ No consensus on optimal time point for PVC change or if required at all✓ CLABSI- just need a central line and the NHSN definition- no need to

prove a source of infection*✓ PVC infection rate- likely vastly underreported

*http://leg5.state.va.us/reg_agent/frmView.aspx?Viewid=32b11002109-3&typ=40&actno=002109&mime=application.pdf. Accessed 2/20/16

More Problems…• Does anyone other than Chellie DeVries care about Peripheral Lines?• 300 million sold/year• Up to 90% of patients have a PIV• Up to 50% failure rate• PVC infection rate-incidence (up to 2.2%) is low but the numbers

are HUGE• Are PVC infections less problematic than CLABSIs?

The catheter may be different but the pathogens and pathways are the SAME**Helm R. Klausner K. Klemperer,J. Flint L, Huang E. Accepted but Unacceptable: Peripheral IV Catheter Failure, The Art and Science of Infusion Nursing;2015:189-203.

Why Should We Care?• Vascular Clinicians

• Focus of ACA on vascular issues without regard to type/location of catheter

• Penalties/Incentives for vascular catheter-related events

• Increased scrutiny on reporting, adverse event occurrence, improvement, patient satisfaction and outcome

• Product selection could have great impact on outcomes

Why Should We Care?• Vascular Clinicians

• More patients… but not more staff• More responsibility…but not more $$$• More documentation…but no more time• More liability…

• Failure to protect patient from avoidable injury• Failure to prevent infection• Failure to monitor and assess clinical status• Failure to use equipment properly*

*Diehl-Svrjcek B. Dawson B., Duncan L. Infusion Nursing-Aspects of Practice Liability. Journal of Infusion Nursing, 2007: vol. 30, no 5;274-79.

Why Should We Care?Providers/Physicians/Nurses

○ Can always be sued- regardless of merit- and will need to defend and under strict liability can be liable without fault and without negligence

○ Consider having your own Professional Legal Liability (PLL) insurance:✓ “Free Nursing Input”- can lead to lawsuits✓ Good Samaritan Law immunity does not prevent lawsuit filing✓ Some states permit hospital indemnification for nurse

acts/omissions✓ Inexpensive

Why Should We Care?

And the big news is that nurses are STRESSED OUT-Nursing Times✓ 46% worked longer hours than last year

✓ 80% reported short staffing at least weekly

✓ 73% suffered work related stress-physical, mental problems

✓ 37% took more sick leave

✓ 74% felt pressure to come to work sick

✓ 2x the depression rate of general population*

http://www/fiercehealthcare.com/story/survey-nurses-overworked-understaffed-and-stressed/2013-10-01. Accessed 5/5/15

The Legal StuffMedical Malpractice occurs when…

A medical professional does not adhere to the STANDARD OF CARE required of them and their NEGLIGENCE results in harm to their patient*

http://www.pintas.com/medical-malpractice.html. Accessed 2/2016

The Legal StuffNegligence:

✓ Duty- legal duty to exercise reasonable care

✓ Breach- failure to exercise reasonable care

✓ Causation- physical harm caused by the conduct

✓ Damage- physical harm/actual damages

Medical Malpractice is Negligence committed by a medical professional

The Legal StuffThe Standard of Care…

The caution that a reasonable person in SIMILAR CIRCUMSTANCES would exercise in providing care*

YOU ARE ALLOWED TO BE WRONG!YOU ARE ALLOWED TO MAKE MISTAKES!

YOU ARE NOT ALLOWED TO BE NEGLIGENT!!!http://www.west.net/~smith/negligence.htm. Accessed 2/20/16

The Legal Stuff• Standard of Care (SOC)

• Experts frequently have different opinions as what constitutes the SOC

• Nursing has always been based on some sort of evidence

• SOC IS RARELY 100% EVIDENCED BASED but the more evidence based the stronger the standard

The Legal Stuff• What is Evidence Based Medicine (EBM) or Evidence Based Practice (EBP)?• Problem solving approach to clinical decision making within a

healthcare organization integrating best available scientific and experiential evidence. (Science & Experience)*

• Components- CRITICAL RISK EXPOSURE POINTS• PRODUCTS• PRACTICE • PEOPLE

*http://www.hopkinsmedicine.org/gim/research/method/ebm.html. Accessed 2/20/16

The Legal Stuff-Risk Exposure Point• How does PRODUCT SELECTION fit in with EBM and EBP?• Utilizing products that are Evidenced Based:

• Proven and tested;

• Should reduce adverse events and improve patient outcomes;

• Should reduce variation across the continuum of care

• Should reduce medical malpractice because using EBM/EBP should validate meeting the SOC;

• Supported by industry standards; and

• Should improve patient outcomes which WILL REDUCE COSTS/IMPROVE REIMBURSEMENTS UNDER THE ACA !!!!

The Issue

SOMETIMES

MAYBE?

YES!

NO

Are products the solution to healthcare associated

bloodstream infections?

Product Selection “Oh… They’ve changed our product again”

“We’ve always used this…”

“…it’s how we’ve always done it.”

Liability Mitigation

To Make EBP/EBM the SOC- the next time someone tells you that we’ve changed the product-

tell them- “SHOW ME THE DATA”…

Liability Mitigation• Products may look alike but BE CAREFUL….

Liability Mitigation• Vascular Product Selection to meet PATIENT STANDARD (patient satisfaction):• Which one of these things do I want in my body and why????

• Best Product• Least Intrusive/pain/adverse events• Shortest duration• Product history/market share• Economical

Liability Mitigation• Vascular Product Selection to meet EBM STANDARD (HACs, VBP):

• Clinical evidence (level I,II,III evidence)-DOES IT WORK???• Compliance with standards (which ones?)• Active ingredient (CHG- how much?) and delivery• Product duration/durability (does it last over time and will it crumble?)• Infection prevention capability?• Product Design?• FDA cleared indication (for what?)• Years on the market?/Product success (market share)?• READ THE LABEL- what does it do and how does it do it (how does it

work) and does it meet best practice requirements?• Patient issues-impact/satisfaction• Device issues- stability/securement/removal/application• DOES IT PAY FOR ITSELF (supporting studies)???

The Legal Stuff- Risk Exposure Point• Critical Risk Exposure Point- PRACTICE

• Insertion

• Use and Maintenance

• Adverse Event Response

• Technology

The Legal Stuff• Critical Risk Exposure Point- Practice

The Legal Stuff• Critical Risk Exposure Point- Practice

The Legal Stuff• Critical Risk Exposure Point- Practice

The Legal Stuff• Critical Risk Exposure Point- Practice

The Legal Stuff-Risk Exposure Point• Critical Risk Exposure Point- People

The Legal Stuff• Critical Risk Exposure Point- People

The Legal Stuff• What is the importance of EBM and EBP?

• Will NOT prevent you from getting sued… BUT• Should improve the quality of care provided and• Should decrease your chances of litigation*

*http://www.ampirrg.com/articles/Evidence-based_medicine.pdf.Accessed 2/20/16

Program Summary• Standard of Care (SOC)- the caution that a reasonable person in similar circumstances would exercise in providing care

• To meet the SOC- practice EBM- problem solving approach integrating both scientific and experiential evidence and will include PRODUCTS, PRACTICE AND PEOPLE

• Practicing EBM is a goal of the ACA because it will improve patient outcomes which will:• Reduce Readmissions• Reduce HACs• Improve patient satisfaction and• Improve the bottom line ($$$)

Goals For All Lines

•Significantly Reduce Readmissions•Significantly Reduce HAIs•Increase Patient Satisfaction•Improve Patient Outcomes•Use Evidence Based Medicine/Practice Protocols

Provider Opportunities in Changing Landscape/Goals

1. Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Number 161, Tuesday, August, 19, 2008. Accessed October 7, 2014

2. Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011. Accessed October 7, 20143. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for

Graduate Medical Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011. Accessed October 7, 20144. Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011. Accessed October 7, 2014

Readmission Rates

Peripheral IV

Lines

Surgical Drains

Home Infusion

Arterial Lines

Staff Complianc

e = Kits

CVC Lines &

PICC Lines

Dialysis Patients

LVADs

SSIs

Questions

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