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Primary Care Clinic Application for Improved Patient Care Projects The Healthy Living Program at the Salt Lake County Health Department works with primary care clinics to improve patient care and clinical practices to prevent and manage hypertension, high cholesterol, and diabetes. The overall goal of this funding opportunity is to improve hypertension control rates (NQF 18) and diabetes control rates (NQF 59) as well as other appropriate measures related to blood pressure, cholesterol, diabetes, and prediabetes. This funding opportunity is from January 1 st through December 31 st 20 . Projects need to be implemented by July 15 th 20 for reimbursement and outcome evaluation needs to be turned in by January 15 th 20 in order to have a full year of data. Please read the following application instructions and funding requirements for more detail. Application Instructions All clinics that offer primary care services in Salt Lake County are eligible to apply. Priority areas for the Healthy Living Program are Glendale, Rose Park, West Valley, South Salt Lake, Midvale, Kearns, Taylorsville, and Magna. Clinic can apply for a maximum of $3,000. Clinic CANNOT choose activities that are already implemented in the clinic. Application will be accepted on a first come, first served basis until funds are exhausted. Once submitted, application will only be approved after a staff member from the Healthy Living Program meets with the clinic to finalize project activities. Clinic must fully implement the projects by July 15 th to receive reimbursement. Funding CAN pay for the time spent on planning, implementing, disseminating, and evaluating the projects. Funding CANNOT pay for research, equipment, incentives, or direct services such as patient care, co-pay fees, medication, or individual patient education. Funding Requirements Submit a timeline of project planning, implementation, and evaluation within 30 days of application approval. o Project baseline data within 30 days of approved application o Project planning within 60 days of approved application o Project implementation completed by July 15 th o Project outcome evaluation completed by January 15 th of the following year Conduct a staff meeting discussing chosen IPCP activities that clinic will be focusing on. Submit required reporting documentation by July 15 th . This includes dates of trainings completed, successes and barriers for process improvements, and copies of policies and workflows implemented. Participate in at least 75% of learning collaborative meetings led by the Healthy Living Program. Refer patients to the Living Well classes (required project). http://livingwell.utah.gov/docs/bhpguide/BHP_Guide.pdf (Provider Guide) Communicate regularly with assigned Healthy Living staff member including a kick-off meeting, mid-point meeting, and wrap-up meeting. Be available for follow-up data requests for up to 5 years. Submit at least one success story of how a project(s) has improved your clinic. Read the Leavitt Partners white paper “Driving Improvements in Utah’s Health Outcomes: the community health worker solution” 19 19 20

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Page 1: Primary Care Clinic Application for Improved Patient Care ... · home blood pressure machine lending library, providing regular free walk-in blood pressure check opportunities for

Primary Care Clinic Application for Improved Patient Care Projects

The Healthy Living Program at the Salt Lake County Health Department works with primary care clinics to improve patient care and clinical practices to prevent and manage hypertension, high cholesterol, and diabetes. The overall goal of this funding opportunity is to improve hypertension control rates (NQF 18) and diabetes control rates (NQF 59) as well as other appropriate measures related to bloodpressure, cholesterol, diabetes, and prediabetes. This funding opportunity is from January 1st throughDecember 31st 20 . Projects need to be implemented by July 15th 20 for reimbursementand outcome evaluation needs to be turned in by January 15th 20 in order to have a full year ofdata. Please read the following application instructions and funding requirements for more detail.

Application Instructions • All clinics that offer primary care services in Salt Lake County are eligible to apply.• Priority areas for the Healthy Living Program are Glendale, Rose Park, West Valley, South Salt

Lake, Midvale, Kearns, Taylorsville, and Magna.• Clinic can apply for a maximum of $3,000.• Clinic CANNOT choose activities that are already implemented in the clinic.• Application will be accepted on a first come, first served basis until funds are exhausted.• Once submitted, application will only be approved after a staff member from the Healthy Living

Program meets with the clinic to finalize project activities.• Clinic must fully implement the projects by July 15th to receive reimbursement.• Funding CAN pay for the time spent on planning, implementing, disseminating, and evaluating

the projects. Funding CANNOT pay for research, equipment, incentives, or direct services suchas patient care, co-pay fees, medication, or individual patient education.

Funding Requirements • Submit a timeline of project planning, implementation, and evaluation within 30 days of

application approval.o Project baseline data within 30 days of approved applicationo Project planning within 60 days of approved applicationo Project implementation completed by July 15th

o Project outcome evaluation completed by January 15th of the following year• Conduct a staff meeting discussing chosen IPCP activities that clinic will be focusing on.• Submit required reporting documentation by July 15th. This includes dates of trainings

completed, successes and barriers for process improvements, and copies of policies andworkflows implemented.

• Participate in at least 75% of learning collaborative meetings led by the Healthy Living Program.• Refer patients to the Living Well classes (required project).

http://livingwell.utah.gov/docs/bhpguide/BHP_Guide.pdf (Provider Guide)• Communicate regularly with assigned Healthy Living staff member including a kick-off meeting,

mid-point meeting, and wrap-up meeting.• Be available for follow-up data requests for up to 5 years.• Submit at least one success story of how a project(s) has improved your clinic.• Read the Leavitt Partners white paper “Driving Improvements in Utah’s Health Outcomes: the

community health worker solution”

19 1920

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Clinic Information

Name of Clinic:

Clinic Address:

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Applicant Name:

Applicant Job Title and Role in Application Projects:

Applicant Phone Number:

Applicant Email:

Names and Roles of Other Staff Who Will Be Involved:

Select what project your clinic commits to working on. Follow the instructions for how many activities you need to choose in each category per section topic.

Referral to Living Well Classes (REQUIRED) - $500 ** If choosing the “National Diabetes Prevention Program” Project, you are exempt from this requirement

• Required: Designate a “Referral Champion” Have providers and appropriate clinical staff learn about the classes offered through

Living Well website that can benefit their patients Have providers and appropriate clinical staff register for and use the Living Well patient

referral program or another referral method that works for your organization Pull a registry report to identify patients who have been diagnosed with specific chronic

diseases (such as arthritis or diabetes) and refer them to the Living Well self-management and physical activity programs

Establish a policy with workflow to routinely query registry for newly diagnosed patientswith specific chronic conditions (such as arthritis or diabetes) and refer them to theLiving Well self-management and physical activity programs through the bi-directionalphysician portal

• Choose at least 1 additional activity:� Track and set goals to increase patient referrals to the Living Well classes � Turn on an EHR alert or manual alert to remind physicians to refer patients to classes � Implement an algorithm or automatic process that identifies and suggests appropriate

referrals to the physician and/or sends information to the patient about classes � Provide information about Living Well classes to patients identified with specific chronic

conditions (such as arthritis or diabetes) � Invite SLCoHD to conduct a Lunch and Learn to educate your staff about Health

Department programs available to patients (tobacco cessation, Asthma Home Visitation Program, etc.) and how to refer into the programs

� Participate in a Lunch and Learn, presented by SLCoHD, in an effort to reduce the misuse and abuse of prescription opioids. Focusing on the controlled substance data base and best practices for prescribing opioids

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Incorporating Community Health Workers (CHWs) - $750 • Choose one of the following projects

� Incorporate CHWs into your clinic. Possible activities include: • Hire a CHW• Reach out to 1-2 community organizations with a CHW to establish a

relationship for patient referral to their CHW• Create a workflow process to refer patients to a community organization with

a CHW for patient chronic disease management• Create and implement a bidirectional referral policy with a community

organization that uses CHWs• Evaluation – Number of patients referred to CHWs; Description of CHW

impact in clinic� Training and improve utilization of current CHWs in your clinic. Possible activities

include: • Invite SLCoHD to conduct an initial training on either correct blood pressure

measurement, cholesterol, diabetes or diabetes prevention for employedCHWs

• Implement a policy to conduct a yearly training for CHW staff to review bloodpressure, cholesterol, diabetes, and diabetes prevention

• Have CHWs complete the Core Skills Training offered by the Utah Departmentof Health

• Create a workflow process to have CHW identify and follow-up with patientswith a chronic condition routinely by pulling a patient list through anEHR/patient database query

• Join one of the Utah CHW Coalition workgroups to support and promote thework of CHWs in Utah. Attend 75% of meetings

• Evaluation – Number of patients contacted by CHWs; Report ofoutcomes/patient impact

Working with Pharmacists - $750 • Required:

Research the effectiveness of patient medication adherence when CollaborativePractice Agreements and Medication Therapy Management (MTM) is conducted with apharmacist

Establish 1-2 relationships with a pharmacist and discuss the benefits of collaborativepractice agreements (CPAs)

Establish a CPA with a pharmacist for MTM with patients on hypertension, cholesterolor diabetes related medications

Evaluation – Number of patients reached by MTM in clinic; Patient outcomes/Impacttracked through testimonials and disease management improvements in electronichealth records

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Hypertension - $1000 • Required:

Designate a “Hypertension Control Champion” Apply for the Utah Million Hearts “Excellence in Blood Pressure Measurement and

Control Award.” The award application is open Feb 1- Mar 15. Evaluation - NQF18 baseline and outcome report; # of patients in registries and

receiving follow-up, when applicable• Choose at least 1 training:

� Have all providers watch the Million Hearts AOBP measurement webinar and the Million Hearts “Hiding in Plain Sight” video

� Conduct annual and new hire staff trainings on correct blood pressure measurement � Conduct annual assessment of BP measurement techniques and accurate BP

documentation • Choose at least 3 process improvements:

� Implement alerts in the EHR for elevated blood pressure and/or provide a visual alert to notify Provider of elevated blood pressures

� Pull reports and create registries of patients with high BP readings and patients diagnosed with hypertension to identify those with undiagnosed hypertension and then provide follow-up workflow process

� Implement evidence-based algorithms (clinical criteria) to identify patients with potentially undiagnosed HTN

� Adopt and improve utilization of dashboards for hypertension management � Improve self-monitored blood pressure tied to clinical support through implementing a

home blood pressure machine lending library, providing regular free walk-in blood pressure check opportunities for patients, or another method

� Encourage patient participation of home blood pressure self-monitoring. Provide patient education on correct blood pressure measurement techniques, documentation, medication adherence, and follow-up care

� Regularly utilize team huddles to provide updates on BP goals, identify gaps in care, and plan on how to best manage patients with uncontrolled hypertension

� Establish relationships (including CPAs) and work with pharmacies to provide MTM and reduce out of pocket costs for patients taking medication for hypertension

� Provide educational materials, through a patient portal or handout, on diet, physical activity, medication adherence, etc. for high blood pressure

� Pull reports and create registries of patients diagnosed with hypertension that are also smokers and provide follow-up including offering a referral to the Utah Tobacco Quit Line and other resources

� Create and implement a quality improvement project to build upon existing hypertension work in your clinic (if selected, you don’t need to choose another process improvement)

• Choose at least 2 policies:� Implement a policy for annual and new hire blood pressure measurement training � Implement a policy for identifying undiagnosed hypertension by regularly pulling reports

from the EHR of patients who have had high BP readings in the past year with workflow process to contact patients for follow up care

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� Implement a policy for correctly diagnosing hypertension through AOBP, SMBP, and/or 24-hour ambulatory monitoring

� Implement a policy to provide an after-visit summary to all patients with an elevated blood pressure, including recommendations and education for blood pressure care and a blood pressure tracking log

� Implement a policy on clear procedures for team coordination and communication to ensure accurate blood pressure measurement and hypertension management (can include using front office staff to contact patients to confirm upcoming appointments and provide preparation instructions for correct blood pressure measurement)

� Implement another policy not mentioned related to blood pressure and/or hypertension

Cholesterol - $750 • Required:

Designate a “Cholesterol Champion” Evaluation – Appropriate cholesterol measure baseline and outcome reports (based on

activities and clinic such as CQM 438); # of patients in applicable registries and thosereceiving follow-up

• Choose at least 1 training:� Have all providers read the 2018 ACC/AHA Guideline on the Management of Blood

Cholesterol � Have all providers complete the AMA Medication Adherence Patient Care Module

(.5CME available) • Choose at least 2 process improvements:

� Pull reports and create registries of patients who meet the ACC guidelines, that have not completed the ASCVD risk assessment, and flag them in the EHR for follow up

� Pull reports and create registries to identify patients who have been diagnosed with high cholesterol

� Implement alerts in the EHR to flag/identify patients with cholesterol levels out of normal range

� Adopt and improve utilization of dashboards for patients with high cholesterol � Include cholesterol as a comorbidity that is regularly checked and followed-up on for

patients with hypertension and/or type 2 diabetes � For non-compliant patients establish an action plan and/or a Collaborative Practice

Agreement (CPA) with their pharmacy to assist with cholesterol medication adherence � Provide educational materials through a patient portal or handout on diet, physical

activity, and medication adherence for high cholesterol � Create and implement a quality improvement project to build upon existing cholesterol

work in your clinic (if selected, you don’t need to choose another process improvement) • Choose at least 1 policy:

� Implement a policy to use the American College of Cardiology “ASCVD Risk Estimator” to estimate patient’s 10-year ASCVD risk based on clinical recommendations

� Implement a policy to identify patients currently taking cholesterol medication, assess medication adherence, and provide appropriate follow-up

� Implement another policy not mentioned related to cholesterol

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National Diabetes Prevention Program (National DPP) - $2000 ** If choosing this project you are exempt from the “Referral to Living Well Classes” requirement

• Required training: Set up meeting with SLCoHD to discuss steps to become an NDPP site Designate a National DPP Coordinator Send staff to National DPP Lifestyle Coach training

• Required processes: Apply to become a National DPP site and provider Implement National DPP following the CDC Standards and Operating Procedures Start at least one class within 6 months of application approval Create a sustainability plan for National DPP Develop clinical workflow process for National DPP bi-directional referral

• Required policy: Implement a policy for National DPP bi-directional referral

• Required data collection and evaluation: Use Compass for data collection and evaluation Collect and submit check-in participant surveys at week 16 of the program Collect and submit long-term participant surveys 1 year after completion of the program Report number of patients included in bidirectional referral process

Prediabetes - $750 • Required:

Designate a clinic “prediabetes champion” Evaluation – Number of patients identified with blood glucose/A1C in prediabetic range,

referred, and/or followed-up; Number of patients flagged in EHR, if applicable• Choose at least 1 training:

� Have all providers complete the American Medical Association (AMA) “Preventing Type 2 Diabetes in At-Risk Patients” online training for 1 CME credit

� Invite SLCoHD to conduct a Lunch and Learn to educate your staff about the National Diabetes Prevention Program (National DPP) and importance of identifying and referring patients with prediabetes

• Choose at least 2 process improvements:� Implement alerts in the EHR to flag/identify patients with prediabetes � Create clinical workflow to identify patients with prediabetes, refer to National DPP, and

follow-up with patients with prediabetes during in-office visits OR retrospectively. Retrospective method: every 6-12 months collect a list of patients with prediabetes through EHR/patient database query and refer/follow-up

� Adopt and improve utilization of dashboards for patients with prediabetes � Implement a prediabetes awareness campaign to educate patients about prediabetes

and National DPP (if possible, tailor to underserved patient populations) � Create and implement a quality improvement project to build upon existing prediabetes

work in your clinic (if selected, you don’t need to choose another process improvement)

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• Choose at least 1 policy:� Implement a policy to identify patients with prediabetes, refer to National DPP, and

follow-up with patients with prediabetes during in-office visits and/or retrospectively Retrospective method: every 6-12 months pull a list of patients with prediabetes through EMR/patient database query and refer/follow-up

� Implement a policy to conduct yearly prediabetes staff trainings � Implement another policy not mentioned related to prediabetes

Diabetes - $1000 • Required:

Designate a “Diabetes Management Champion” Evaluation – NQF59 baseline and outcome reports; Number of patients identified with

blood glucose/A1Cs within diabetic range• Choose at least 1 training:

� Watch DSMT Webinar Series (10 videos) � Have all providers and appropriate clinical staff read the diabetes education and

diabetes educators’ handout � Have SLCoHD do a training about DSMES in Utah

• Choose at least 3 process improvements:Pull reports and create registries of patients diagnosed with type 2 diabetes according to stratified care such as patients newly diagnosed with type 2 diabetes, patients at risk for diabetes complications, and patients with complications and comorbidities Implement alerts and/or automated processes in the EHR to help with identification, management, and follow-up for patients with type 2 diabetes Implement alerts and/or automated processes in the EHR to help provide education and/or referral to classes and other preventative services for patients with type 2 diabetes (including DSMES) Adopt and improve utilization of EHR dashboards for diabetes management Implement a workflow to identify patients with type 2 diabetes to be educated on diabetes management education and referral to DSMES (trifold provided by SLCoHD) Implement shared medical appointments and/or group education which includes multiple health care professionals Expand the reach and coordination of the diabetes healthcare team using telehealth (ex., group diabetes education, medical nutrition counseling, primary care digital retinal imaging) Improve collaborative care by working on bi-directional referrals and collaborations with external health care professionals such as CHWs, CDEs, RNs, pharmacists, podiatrists, dentists, eye care professionals, depression care managers, etc. Establish relationships to implement a CPA with pharmacies to provide MTM (medication therapy management) to focus on medication adherence and reduce out of pocket costs for patients taking medication for type 2 diabetes Create and implement a quality improvement project to build upon existing diabetes work in your clinic (if selected, you don’t need to choose another process improvement)

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• Choose at least 2 policies:� Implement a policy to train providers and appropriate clinical staff annually on diabetes

diagnosis, treatment, education and documentation � Implement a policy to identify and provide stratified care according to type 2 diabetes

patient population needs � Implement a policy to identify, refer to DSMES, and follow-up with patients with type 2

diabetes during in-office visits and/or retrospectively (Retrospective method: every 6-12 months pull a list of patients diagnosed with type 2 diabetes through EMR/patient database query and refer/follow-up)

� Implement a policy on clear procedures for team coordination and communication when working with patients with type 2 diabetes, including when to refer to external healthcare professionals

� Implement another policy not mentioned related to type 2 diabetes

Diabetes Self-Management Education (DSMES) - $1000 • Required training:

Set up meeting with SLCoHD to discuss steps to become a DSMES site and provider Gather required documentation to become a DSMES accredited provider through AADE

• Required processes: Become a DSMES site and provider Apply to become an accredited DSMES provider through ADA or AADE If needed, look at scholarship opportunities through Utah Department of Health Begin DSMES course at clinic Obtain 15 continuing education credit hours annually

• Required policy: Implement a policy for DSMES bi-directional referral

• Required data collection and evaluation: Number of patients referred to DSMES program Track behavior change outcomes and AADE7 Self-care behavior impacts (such as

healthy eating, being active, taking medication, monitoring, problem solving, reducingrisk and healthy coping)

Healthy Living - $250 • Choose at least 1 of the following projects:

Become a Healthier Worksite for Employees Fill out Worksite Wellness assessment and/or apply for the Utah Worksite

Wellness Award and choose at least 2 activities to improve in the followingareas: physical activity, nutrition, and/or breastfeeding

Become a Community Partner for Improving Healthy Food Access Choose a project or event that will increase access to healthy food such as

participating in Foodstruction (SLCoHD summer event where you compete andbuild food sculptures that will be donated to the Utah Food Bank), holding ahealthy food drive, creating a community garden, or partnering with a foodpantry, farmer’s market or other organization

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Implement Parks Rx Use Parks Rx America database and your EHR to prescribe physical activity at a

park with walking paths to combat chronic diseases. SLCoHD will train and assistwith implementation

SLCoHD Staff Time in Clinic ** This activity has no money attached to it, but can be chosen if you feel it would benefit your clinic

• Opportunity to pilot a project where SLCoHD staff works consistently (a few hours per month) inyour clinic to help with quality improvement projects during 2019. SLCoHD staff cannot provideany direct services to patients. If you choose this, please have an idea of what this would looklike and we will set up a meeting to move forward.

Total Amount of Chosen Activities (CANNOT exceed $3000) = $_________

By signing below, the clinic agrees to complete the chosen activities and submit the required documentation to [email protected] by July 15, 20 upon approval from SLCoHD staff. The clinic agrees to submit a supplier vendor form, if one is not already on file, in order to receive payment contingent upon ongoing federal government funding for this program. The clinic agrees to contact SLCoHD staff by June 1, 20 if the clinic will not be able to complete the chosen activities by the deadline.

Signature __________________________________________ Date ______________

Approved by Salt Lake County Health Department _______________________________ Date_________

Resources:

Quality Data for Beginners – Using reports and patients lists for quality improvement

Healthinsight.org/bloodpressure – Clinic resources and toolds for blood pressure and hypertension

Million Hearts – Tools and resources for blood pressure and hypertension Cholesterol Tools and Resources – from the American Heart Association

Redesigning the Health Care Team – Clinic guide for diabetes prevention and management

Doihaveprediabetes.org – Resource to provide patients on prediabetes and link to provider resources at the bottom of the page for prediabetes

Definitions:

Automated Office Blood Pressure (AOBP): a blood pressure machine that provides multiple sequential measurements when staff is not present to reduce “white-coat hypertension”

Collaborative Practice Agreement (CPA): a formal practice relationship between a pharmacist and a prescriber. The agreement specifies what functions (in addition to the pharmacist’s typical scope of practice) can be delegated to the pharmacist by the collaborating prescriber. CPA’s increase the efficiencies of team-based care and formalize practice relationships between pharmacists and prescribers.

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Community Health Worker (CHW): The jobs and roles of CHWs are as varied as their titles (promotora, patient advocate, health navigator, peer support specialist, etc.). All CHWs, however, share trust and a connection with their communities. Community Health Workers are trained lay people who provide education and social support, while serving as a liaison with health care providers and social services. CHWs offer interpretation, provide culturally appropriate health information, assist people in receiving the care they need, help overcome barriers, give informal counseling and guidance on health behaviors, and advocate for individual and community health needs.

Diabetes Self-Management Education Support (DSMES): Diabetes Self-Management Education (DSME) is the cornerstone of care for all individuals with diabetes who want to achieve successful health outcomes and avoid complications. The ten-week program is conducted in health care settings, such as physicians’ offices and clinics, pharmacies and hospital outpatient settings. DSME is the active, ongoing process of facilitating the knowledge, skill, and ability necessary for diabetes self-care. The overall objectives of DSME are to support informed decision-making and improved self-care behaviors, encourage effective problem-solving and active collaboration with the healthcare team, and improve clinical outcomes, health status, and quality of life.

Electronic Health Record (EHR): a digital version of a patient’s paper chart; they are real-time, patient centered records that make information available instantly and securely to authorized users

Medication Therapy Management (MTM): a distinct service or group of services that optimize therapeutic outcomes for individual patients. These services are independent of, but can occur in conjunction with, the provision of a medication product. MTM encompasses a broad range of professional activities and responsibilities within the licensed pharmacist’s scope of practice. These services include but are not limited to the following: performing or obtaining necessary assessments of the patient’s health status, formulating a medication treatment plan, selecting, initiating, modifying, or administering medication therapy, monitoring and evaluating the patient’s response to therapy, performing a comprehensive medication review, communicating essential information to the patient’s primary care providers, providing verbal education and training to enhance patient understanding and appropriate use of medications, providing services designed to enhance patient adherence to therapeutic regimens.

National Diabetes Prevention Program (National DPP): The National DPP is a structured, evidence-based, year-long lifestyle change program to prevent or delay onset of type 2 diabetes in adults with prediabetes or at risk of developing type 2 diabetes. The National DPP lifestyle change program is founded on randomized controlled research studies which showed that making realistic behavior changes helped people with prediabetes lose 5% to 7% of their body weight and reduce their risk of developing type 2 diabetes by 58% (71% for people over 60 years old). The program is group-based, facilitated by a trained lifestyle coach, and uses a CDC-approved curriculum. The curriculum supports regular interaction between the lifestyle coach and participants; builds peer support; and focuses on behavior modification through healthy eating, increasing physical activity, and managing stress. The program may be delivered in-person, online, via distance learning, or through a combination of these delivery modes.

NQF18: The measure of the percentage of patients 18-85 years of age who had a diagnosis of Hypertension and whose blood pressure was adequately controlled (<140/90mmHg) during the measurement period.

NQF59: The measure of the percentage of patients 18-75 years of age with diabetes (type 1 and type 2) whose most recent HbA1c level during the measurement year was greater than 9.0% (poor control) or was missing a result, or if an HbA1c test was not done during the measurement year.

2017 PQRS/MIPS Measure #438: Percentage of the following patients-all considered at high risk of cardiovascular events-who were prescribed or were on statin therapy during the measurement period: Adults aged >= 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); OR Adults aged >=21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial or pure hypercholesterolemia; OR Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 mg/dL