America has one of the highest per capita healthcare spending in the western world. 1

Unfortunately, increased spending has not correlated with better outcomes, and the troubling trend of rising costs and poor outcomes is particularly pronounced in the area of chronic conditions. Diabetes prevalence is the fastest growing (expected to double by 2030) followed by stroke, hypertension, and heart disease.2

America’s costly chronic disease problem has forced us to reevaluate the way we pay for care, measure quality, and manage chronic conditions.

PERFORMANCE AND VALUE BASED PAYMENTS AND PATIENT REPORTED OUTCOMES

With the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Center for Medicare and Medicaid Services (CMS) defined a path forward with value-based payments as an alternative to the failing fee for service model. To support this transition to the Merit-Based Incentive Payment System (MIPS) and alternative payment models (APM), such as the oncology care model, CMS deemed Patient Reported Outcomes Measures “a key priority” in the interest of measuring patient and caregiver experience. 3

The New Dataset: Patient Reported Outcomes

Patient-reported outcomes (PROs), broadly defined, are any report of health status that comes directly from the patient, without interpretation of the patient’s response by a clinician or other third party. Though some players have raised concerns about subjectivity in PROs, PROs are undeniably relevant for many activities, including but not limited to helping patients and clinicians make informed decisions about health care, tracking the progress and effectiveness of clinical trials, and improving the quality of health care services.

Applications of PROs• Shared decision making inputs

• Quality measures to improve healthcare services

• Measures of effectiveness in clinical trials, as outlined by FDA guidelines

• Real world insights to improve access to care

There’s a growing body of research to support the validity of Patient Reported Outcomes Measures (PROMs) - standardized or structured questionnaires that translate patient report into quantitative data that enables comparison of patient groups or providers. Well-established examples of PROMs include the nine-item Patient Health Questionnaire (PHQ-9) for depression and the Patient Reported Outcome Measurement Information System (PROMIS) assessments for physical, mental, and social health. PROs become more valuable when measured systematically according to these validated scales, with promising applications in surgical practice,

4,5 clinical trials, 6 and other healthcare settings.

7

That said, three major challenges must be addressed. First, the FDA’s 2009 guidelines set a high bar for reliability, construct validity, and ability to detect change, so the development and validation of PRO instruments to support product development and labeling claims requires a high level of expertise in this relatively new and evolving field.8 Second, PROs have yet to be widely adopted in clinical use, so even the existing validated scales may feel new and unfamiliar to many of our healthcare system’s key players. Finally, patients must be able and willing to provide accurate responses. A balance must be struck between conditions that establish trust and make the patient comfortable sharing - e.g. a relationship or warm rapport - and conditions that make PROs reliable - e.g. a standardized methodology.

BEYOND CLINIC DOORS

In their Quality Measure Development Plan (2016), CMS noted that PROMs “may not be specific to a care setting” and “remote monitoring technologies such as telehealth and smartphone applications might be leveraged to engage patients in collecting PROMs”.9 Pack Health’s digital health coaching platform is one such patient engagement solution. As both a consumer service and an industry partner, Pack Health leverages PROs beyond clinic doors to support early intervention, risk stratification, and activation of patients and their care teams.

Pack Health has developed a system with over 70 touchpoints and over 100 PROs collected per patient per quarter, in which validated scales such as:

• PROMIS Global-10 for physical and mental health,

• the Comprehensive Score for Financial Toxicity (CoST),

• the Patient Health Questionnaire 2 (PHQ-2),

• Perceived Stress Scale (PSS-4)

and others are administered with personalized digital health coaching and concierge support.

Patient ReportedOutcomesHbA1c

Weight

Diabetesdistress

Adherence

Lifestyle

Navigating Healthcare

ERVisits

Out of pocketcosts

Physical

Mental

Financial

EyeexamFoot

exam

WEL

LBEING BEHAVIORS

CO

ND

ITIO

N M

ANAGEMENT

QUALITY

UTI

LIZ

AT

ION

PROs collected by Pack Health for Type 2 Diabetes include:

We collect patient reported outcomes within 5 key areas:

• Wellbeing: We measure physical, mental, and financial wellbeing according to validated scales such as PROMIS, PSS, and CoST.

• Behaviors: We collect PROs on lifestyle, adherence, and navigation (e.g. barriers to care)

• Utilization: We track key measures such as ER visits and out of pocket costs

• Quality: We track quality measures, e.g. foot and eye exams for type 2 diabetes.

• Condition management: We track clinical outcomes, e.g. HbA1c. weight, and diabetes distress.

THE BIGGER PICTURE

Patient Engagement and Patient Reported Outcomes mean different things to different people, and Pack Health sits at the center of it all.

To date, Pack Health has developed 20+ programs across therapeutic areas in partnership with key industry players including patients, payers, manufacturers, professional associations, and providers. In addition to driving our personalized engagement strategy for patients, our HIPAA-secure digital platform was designed to collect unique and valuable insights on patients’ experiences, attitudes, barriers, and needs. Having selected, collected, and validated PROMs across therapeutic areas for various clients, we’ve learned to leverage our platform, insights, and expertise for a wide range of stakeholder goals.

Mazi Rasulnia PhD(205) 821-1704 mazi@packhealth.com

Dhiren Patel PharmD

(781) 956-3825 dhiren@packhealth.com

OUR CAPABILITIES INCLUDE:

• Consulting on which PROs to collect and how to collect and validate them

• Implementing studies to collect and test PROs

• Performing custom analytics such as hot spot analysis, behavioral phenotyping and modeling utilizing PROs and claims, labs and clinical data

For more information on our consulting and engagement services or to request a case study, contact our team:

Manufacturers

Payers

Providers

Health systems

Nonprofits

Patients

Mazi Rasulnia, PhDPresident

(205) 821-1704 mazi@packhealth.com

ABOUT PACK HEALTHPack Health is a digital health coaching company that helps patients overwhelmed by a diagnosis access the right care and develop the self-management skills to achieve better health and well-being. Our products include:

3613 6th Ave S, Birmingham, AL 35222www.packhea l th .com/ins i gh ts

my

my

my

An all-digital engagement solution for select populations.

A complete health coaching service with dedicated Health Advisors and a digital platform.

OUR LEADERSHIP

Dhiren Patel, PharmDMedical Director

(781) 956-3825 dhiren@packhealth.com

REFERENCES

1. Oracle White Paper. Building the healthcare system of the future. (2017). Retrieved from http://www.oracle.com/us/industries/financial-services/healthcare-system-future-wp-2392577.pdf.

2. A. Gaskel. (2017).The Future of Healthcare (is much like the past). Forbes. Retrieved from https://www.forbes.com/sites/adigaskell/2017/04/10/the-future-of-healthcare-is-much-like-the-past/2/#5f7e40c15c35

3. Centers for Medicare & Medicaid Services. CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Baltimore, MD: Centers for Medicare & Medicaid Services; 2016. Retreived from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based- Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.

4. Papuga MO, Beck CA, Kates SL, Schwarz EM, Maloney MD. Validation of GAITRite and PROMIS as high-throughput physical function outcome measures following ACL reconstruction. J Orthop Res 2014; 32: 793-801.

5. Ho B, Houck JR, Flemister AS, et al. Preoperative PROMIS scores predict postoperative success in foot and ankle patients. Foot Ankle Int 2016; 37: 911-8.

6. Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. Can Med Assoc J. 1986;134(8):889-95.

7. Dawson, J., Doll, H., Fitzpatrick, R., Jenkinson, C., & Carr, A. J. (2010). The routine use of patient reported outcome measures in healthcare settings. Bmj, 340, c186. 8.Food and Drug Administration. (2009). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist, 74(235), 65132-65133. https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf

9. Centers for Medicare & Medicaid Services. CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Baltimore, MD: Centers for Medicare & Medicaid Services; 2016. Retreived from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based- Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.