MMS Info Session PROs, PROMs, and PRO-PMs: Demystifying

MMS Info Session PROs, PROMs, and PRO-PMs: Demystifying Terminology and Best Practices around Patient-Reported Data March 24, 2021 Presenters: Chuck Amos, NQF Teresa Brown, NQF Brenna Rabel, Battelle

Info Session Goals Part of a larger effort to engage stakeholders and the public in quality measure development. Additional activities the MMS team leads: Annual public webinars on high-priority CMS topics Outreach via our stakeholder listserv and the CMS MMS listserv MMS website updates and maintenance Development and promotion of emerging tools and resources MACRA-specific education and outreach 1 2

Agenda Considerations for developing and testing PRO-PMs – Brenna Rabel, MPH, Senior Social Scientist and MMS Stakeholder Engagement Task Lead, Battelle Patient-Reported Outcomes: Best Practices on Selection and Data Collection – Chuck Amos, MBA, Director, Quality Innovation, National Quality Forum – Teresa Brown, MHA, MA, Senior Manager, Quality Measurement, National Quality Forum 3 04/07/2024

Presentation Objectives By the end of this presentation, you will be familiar with: – The relationship between PROs, PROMs, and PRO-PMs – The value and potential uses of patient-reported outcomes – Challenges associated with developing PRO-PMs – Lessons learned from NQF’s work on implementing PROMs in clinical settings and implications for future measure development 4 04/07/2024

Why are PRO-PMs a CMS Priority? PRO-PMs help CMS deliver on the promise of patient voice in value-based payment while also being outcome-driven CMS prioritizes PRO-PM measures because they – Are inherently patient-centered – Evaluate progress on outcomes that are meaningful to patients (e.g., quality of life, functional status, pain) – Lead to better outcomes – Improve delivery of patient-centered care 5 04/07/2024

Considerations for developing and testing PRO-PMs Brenna Rabel, MPH, Senior Social Scientist and MMS Stakeholder Engagement Task Lead, Battelle 6 04/07/2024

Defining Terms 7 04/07/2024

PRO, PROM, PRO-PM Examples PRO – Functional Status after Knee Replacement Surgery Health-related quality of life Symptoms and symptoms burden (pain, fatigue) Experience with care Health behaviors (smoking, diet) PROM – Patient-Reported Outcomes Measurement Information System (PROMIS) – Medicare Health Outcomes Survey (HOS) – Focus on Therapeutic Outcomes (FOTO) PRO-PM – Functional Status Assessment for total Knee Replacement (eCQM) – Back Pain After Lumbar Discectomy/Laminotomy 8 04/07/2024

PRO-PM – Example Functional Status Assessment for Total Knee Replacement (eCQM) Percentage of patients 18 years of age and older who received an elective primary total knee arthroplasty (TKA) and completed a functional status assessment within 90 days prior to the surgery and in the 270-365 days after the surgery. Numerator Patients with patient-reported functional status assessment results (i.e., VR-12, PROMIS-10 Global Health, Knee Injury and Osteoarthritis Outcome Score [KOOS], KOOS Jr.) in the 90 days prior to or on the day of the primary TKA procedure, and in the 270 - 365 days after the TKA procedure Denominator 9 Patients 19 years of age and older who had a primary total knee arthroplasty (TKA) in the year prior to the measurement period and who had an outpatient encounter during the measurement period Denominator Exclusions Patients with two or more fractures indicating trauma at the time of the total knee arthroplasty or patients with severe cognitive impairment that overlaps the measurement period. Exclude patients whose hospice care overlaps the measurement period 04/07/2024

Unique Considerations when Evaluating PRO-PM The measure developer should evaluate outcome measures, including those based on PROs against standard criteria in the same way that all measures under development must be evaluated. Unique Considerations that apply to evaluating PRO-PM include: – Importance The measures must be patient-centered. Patients must be involved in identifying the PROs used for performance measurements – Feasibility Minimize burden to respondents. Illness may complicate accessibility issues. Consider language literacy and cultural issues. 10 04/07/2024

Unique Considerations when Evaluating PRO-PM Cont. – Scientific Acceptability Specifications must include methods of administration, handling of proxy responses, response rate calculations, and how the responses affect results. Reliability and validity must be established not only for the data measurement instrument (PROM) but also for the derived performance measurement (PRO-PM) – Usability and Use Not only must patients find the results of PRO-PMs useful, but providers must also be able to use the information to improve quality of care. – Psychometrically sound In addition to the usual validity and reliability criteria, cultural and language considerations, and patients’ burden of responding should be considered. 11 04/07/2024

Unique Considerations when Evaluating PRO-PM Cont. – Person-Centered Measures should reflect collaboration and shared decision-making with patients. Patients become more engaged when they can give feedback on outcomes important to them. – Meaningful Measures should capture impact on health-related quality of life, symptom burden, experience with care, and achievement of personal goals. – Amenable to Change Outcomes of interest must be responsive to specific healthcare services or intervention. – Implementable Data collection directly from patients involves challenges of burden to patients, health literacy of patients, cultural competence of providers, and adaptation to computer-based platforms. Evaluation should address how to manage these challenges. 12 04/07/2024

Common Challenges Measure Developers Might Encounter Lack of PRO data in extractable format Insufficient pre- and post- data Increased burden on patients and providers to collect necessary data Complexity of developing a quality measure that allows for multiple tools to be used Ensuring both the PROM and the PRO-PM are adequately validated Blueprint PROM resource for developers: https://www.cms.gov/files/document/blueprint-patient-reported-outcome-m easures.pdf 13 04/07/2024

http://www.qualityforum.org Measure Management System Information Session Patient-Reported Outcomes: Best Practices on Selection and Data Collection March 24, 2021 14

The National Quality Forum: A Unique Role History: Established in 1999, NQF is a nonprofit, nonpartisan, membershipbased organization. Consensus-Based Entity (CBE): NQF brings together public and private sector stakeholders to reach consensus on healthcare performance measurement. The goal is to make healthcare in the U.S. better, safer, and more affordable. For the past 20 years, NQF and our members have been at the forefront of advancing healthcare quality while tackling the healthcare system’s most urgent needs. 15

Background 16

Background: Terminology Concept Definition Example PRO (Patient-reported outcome) PROM (Patient-reported outcome measure) Any information on the outcomes of healthcare obtained directly from patients without modification by clinicians or other healthcare professionals. Any standardized or structured questionnaire regarding the status of a patient’s health condition, health behavior, or experience with health care that comes directly from the patient (i.e., a PRO). The use of a structured, standardized tool such as a PROM will yield quantitative data that enables comparison of patient groups or providers. A performance measure that is based on patientreported outcomes assessed through data often collected through a PROM and then aggregated for an accountable healthcare entity. Symptom: depression PRO-PM (Patient-reported outcome performance measure) Patient Health Questionnaire 9 ( PHQ-9) , a standardized tool to assess depression Percentage of patients with diagnosis of major depression or dysthymia and initial PHQ-9 score 9 with a follow-up PHQ-9 score 5 at 6 months (NQF #0711) 17

Background: NQF’s previous PRO work 2012*: Two NQF-commissioned papers, one on Patient-Level Reported Outcome Data and one on PRO-PMs for Healthcare Accountable Entities 2013*: Final report from NQF Technical Expert Panel (TEP) articulating guiding principles and a detailed pathway of taking a PRO to a PRO-PM, steering to a more person-centered approach 2015: Methodological Issues report updated by Cella, et. al., remaining an essential resource for the field’s understanding of PROs, PROMs, and PRO-PMs 2019*: NQF TEP for PROs: Best Practices on Selection and Data Collection 2021*: Building a Roadmap from Patient-Reported Outcome Measures to Patient-Reported Outcome Performance Measures 18 * This NQF-led work was supported by funding from the Centers for Medicare & Medicaid Services.

Discussion of PROs: Best Practices on Selection and Data Collection Final Report 19

PROs: Best Practices on Selection and Data Collection NQF convened TEP to elicit recommendations for best practices to address challenges in selecting and collecting PRO data through PROMs PROMs are the building blocks of PRO-PMs, crucial tools for strengthening patient-centered care PROM is defined as any standardized or structured questionnaire regarding the status of a patient’s health condition, health behavior, or experience with health care that comes directly from the patient (i.e., a PRO). Final report provided guidance on selecting PROs that are meaningful to a clinic’s or health system’s population, as well as selecting and implementing related PROMs Included use cases related to burns and trauma, heart failure, and joint replacement 20

Categories of PROs Health-related quality of life (HRQoL) Includes an individual’s perception of their physical and mental health, such as energy or mood Functional status Focusing on daily activities (e.g., eating, transfers, bathing, and dressing) Symptoms and symptom burden Patient perceptions like pain, fatigue, and shortness of breath Health behaviors Individual behaviors that can influence health status (e.g., tobacco use, diet, and exercise) Experience with care Assess patient experience or satisfaction with care 21

Continuum of Specificity When selecting PROMs, it is necessary to understand that they exist on a continuum of specificity, from disease-agnostic PROMs to those designed to measure outcomes related to a certain disease or condition Disease-agnostic PROMs can be used across almost any disease or condition to help understand the wellness or functioning of a patient Disease-specific PROMs are designed to capture data that pertain to a specific disease or condition 22

Best Practices on Selection of Patient-Reported Outcomes 23

Best Practice Recommendations for Selecting PROs Engage patients, family members, and caregivers in the selection process Promote alignment between patients and clinicians Include patient input on goals and priority areas Engage clinical experts, including provider champions Expert opinions can create a foundation that benefits patient engagement Identify clinical goals Assess how well specific outcomes align with a clinic’s goals Build consensus around actionable PROs with feasible workflows Clinicians should focus on PROs that are actionable, e.g., responsive to healthcare interventions Consider the specific barriers and facilitators that exist within the practice or system where the PROs will be implemented 24

Best Practice Recommendations for Selecting PROMs Engage a diverse selection of patients, family members, and caregivers alongside other expert stakeholders Identify PROMs used by others for similar patients, topics, and conditions Select PROMs that best capture outcomes that are most valuable to both patients and clinicians Evaluate various PROM selection criteria systematically and pragmatically Document the selection process: selecting a PROM is an iterative exercise and documenting the process is critical to establishing rationale for the final decision 25

Identified Attributes for Selecting PROMs Covers Desired PROs Psychometric Soundness Person-Centered Meaningful Actionable (i.e., Amenable to Change) Implementable Feasible Recognizes Patient Burden Multiple Languages Available Cost (e.g., proprietary and/or licensing considerations) Current Practices Cross-Setting Data Alignment 26

Best and Promising Practices on Data Collection 27

Achieving Stakeholder Buy-In Identify and engage clinical champions to help ensure clinical adoption and success in improving care Understand that buy-in will follow an adoption curve Learn from peers and peer organizations who are implementing PROMs Increase cross-stakeholder buy-in whenever possible 28

Data Collection Burden Prepare to address barriers raised by real and perceived data collection burden from clinicians or staff Identify inefficient workflows or technological challenges that can exacerbate data collection burden Reduce patient burden by addressing questionnaire length, technological challenges, potential bias, and other factors (e.g., medically complex patients, those with cognitive impairments, those without internet access, etc.) Reduce clinician burden through education, well-designed workflows, and technology 29

Workflow Identify key stakeholders and engage them early in the design process Ensure both patient completion and clinical integration are considered in workflow Utilize technology (e.g., asynchronous data collection via patient portal tools, tablets in waiting room for data collection upon appointment arrival) as much as possible Continuously monitor workflow and staff input for opportunities to improve efficiency 30

Interpretability of Scores Ensure clinicians understand and can discuss each PROM’s scoring and cut-points as easily as they understand a high blood pressure reading or a low-density lipoprotein (LDL) result Provide training to clinicians and staff so results are easily understood and actionable Use the Attribute Grid in the PRO Best Practices report to select PROMs with clear scoring and cut-points 31

Integration into EHRs Understand and develop action plans to address interoperability challenges across different systems, accounting for possible extended timelines for complex data and workflows Select vendors who have PROMs built into systems or can provide the capability to add them Utilize third-party applications as needed to asynchronously provide PROMs to patients via patient portals Store and visualize data in a meaningful way that allows clinicians and patients to track progress over time (e.g., dashboards for trending outcomes) 32

Additional Considerations Resource Availability Population Demographics Return on Investment Patient and Physician Incentives Oversight and Governance of Implementation Activities Ethical and Legal Considerations 33

Use Case Example 34

Joint Replacement Use Case For joint replacement patients, important and meaningful outcomes largely relate to whether a patient is on the expected trajectory of proper recovery and return to baseline functionality or mobility, including: Abilities post-replacement that were not possible prior to surgery Pain, including joint-specific pain Ability to function as desired Goal attainment Physical function Quality of life Mobility 35

Joint Replacement: Patient Perspective Patient-Reported Outcomes How is the outcome meaningful for the patient? How does the outcome reflect patient goals? Data Collection Using PROMs Is completing the questionnaire burdensome? How ready is the patient to share PRO information digitally? Discussing Outcomes in a Clinical Setting How well will the patient understand the score? What meaningful conversations will this outcome generate between patients and the clinical team? Decision-Making Points What specific results would prompt a patient to contact a provider, for example, if a specific recovery goal is met? 36

Joint Replacement: Provider Perspective Patient-Reported Outcomes PROs in a Clinic Setting Data Collection Using PROMs How is the outcome actionable by the provider? How does the outcome reflect the recovery process? How does this PRO align with overarching strategic goals? What clinical resources will support this PRO? How can the clinic support a digital PROM implementation? How can we ensure the collection is HIPAA compliant? Discussing Outcomes in a Clinical Setting Can a provider meaningfully explain the results to a patient? How well does the provider understand the results? Decision-Making Points Are there timeframes that can be automated for follow-up? What specific results would prompt action to a provider? 37

Future Goals and Considerations 38

Future Goals and Considerations Fully integrating PROM data into decision-making requires more timely calculation of PROM results and ability to interpret them Timely understanding of results may also improve if PROMs are more commonly and better integrated into EHRs There is a need for specific recommendations of PROMs that are best suited for widespread use Additional work is needed to investigate how PROs and PROMs benefit both patients and healthcare organizations and to clarify the financial incentives that could motivate clinics and health systems to adopt PROMs Payers should continue to explore ways to incentivize the adoption of PROMs through accountability and quality programs 39

Current NQF Work: Building a Roadmap from PROMs to PRO-PMs 40

Purpose To identify the attributes of PROMs that have been used by CMS for regulatory purposes and develop a step-by-step guidance for using these PROMs to develop PRO-PMs The current TEP for Building a Roadmap from PROMs to PRO-PMs will: Determine attributes that a PROM must have for use in CMS’ Value-Based Purchasing programs or alternative payment models Consider PROMs used for other purposes (e.g., the Kansas City Cardiomyopathy Questionnaire’s use in Medicare coverage determination) to provide other attributes that might be conducive to PRO-PM development Develop step-by-step guidance for using PROMs to develop PRO-PMs that could meet NQF endorsement criteria 41

Web Meeting Timeline 42

Upcoming Dates Final version of the Environmental Scan will be posted May 18 Interim Report will be posted for public comment in June Technical Guidance will be posted for public comment in September 43

Questions? 44

Contact Information Email: [email protected] NQF phone: (202) 783-1300 PRO Final Report: Patient-Reported Outcomes: Best Practices on Selection and Data Coll ection PRO-PM project page: Building a Roadmap from Patient-Reported Outcome Measures to Patient -Reported Outcome Performance Measures 45

THANK YOU. NATIONAL QUALITY FORUM http://www.qualityforum.org 46

Key Takeaways Discussion What are the main takeaways from NQF’s work with PROMs? – What’s next for patient-driven outcomes measures? – What are the primary challenges, and how can they be mitigated? 47 04/07/2024

Questions 48 04/07/2024

Upcoming Pre-Rulemaking Events Join CMS for the 2021 Pre-Rulemaking Season Kick-off Webinar on March 30, from 1:00–2:30 PM,ET, to learn what’s new with this year’s pre-rulemaking process and CMS quality measurement priorities. Click here to register! CMS is also offering a CMS MERIT Tips & Tricks Session on Thursday, April 8 at 1:00 PM, ET, to review the ins and outs of this new tool for measure submissions. Click here to register! 49 04/07/2024

Upcoming Info Session Upcoming MMS Information Session: – April 21, 2021 – Update on the work of Qualified Clinical Data Registries (QCDRs) 50 04/07/2024

Battelle CMS Brenna Rabel (Stakeholder Engagement Task Lead) Contact: [email protected] Feedback: [email protected] Kim Rawlings (CMS COR) Contact: [email protected] 51 04/07/2024