MACRA Info Session 4 CMS Measure Development Education

MACRA Info Session #4 CMS Measure Development Education & Outreach Patient-Reported Outcomes in Performance Measurement Presenters: Brenna Rabel, MPH Nicole Brennan, Dr. PH February 13, 2019 2: 00 -3: 00 pm EST

Vision and Goals: MACRA Info Sessions CMS Measure Development Education & Outreach • An ongoing process to engage the public in quality measure development. • Elicit feedback that will help CMS design resources that can help all of those interested in healthcare quality improvement better understand the goals of quality measurement. • Education • Outreach • Dedicated Websites • Measure Development Roadmaps • Listserv opportunities 1

MACRA Info Session #4 CMS Measure Development Education & Outreach 1. 2. 3. 4. 5. 6. 7. Agenda: Key definitions Background Benefits and challenges Special considerations (conceptualization to testing) Conclusion References Discussion 2

MACRA Info Session #4 Key Definitions Patient-Reported Outcome (PRO) • Any report of a patient’s health status that comes directly from the patient without interpretation of the patient’s response by a clinician or other clinical staff PRO measure (PROM) • A patient-level assessment of health status, typically using a questionnaire/tool to elicit information directly from respondents • Examples: PROMIS-10, VR-12, PHQ-9, Visual Analog Scale (VAS) for Pain PRO performance measure (PRO-PM) • A performance measure that is based on patient-reported outcome data aggregated for an accountable healthcare entity 3

MACRA Info Session #4 Example • PRO: Patient’s experience of back pain • PROM: Patient’s assessment of their back pain collected via the Visual Analog Pain Scale • PRO-PM: Average change (pre-op to one year post-op) in back pain for adults who had a lumbar spine fusion surgery 4

MACRA Info Session #4 Background • PROMs are already common in clinical trials • Increasing interest in comparative effectiveness research, routine clinical practice, and EHR systems • Represent a key part of CMS’s Meaningful Measures Framework 5

MACRA Info Session #4 Benefits of PROs in Performance Measurement Patient self-reported symptoms and health status are associated with use of medical services (e. g. , emergency department visits and hospitalizations), costs, and survival. The process of self reporting can itself improve symptom management, quality of life, communication, and satisfaction with care. Symptoms and functional status impairment are more common than serious complications (e. g. , hospitalizations and death). Patients selecting treatment or providers may have an interest in outcomes based on previous reports of patients like themselves. 6

MACRA Info Session #4 Challenges of PROs in Performance Measurement There is an absence of widespread use of specific PROMs in most clinical settings (with the exception of post-acute care) There is a limited understanding in the patient-reported outcome methodology community (e. g. , psychometricians) about PRO-PMs Conversely, there is a limited understanding in the measure development community about PROM development Low response rates—especially for long-term outcomes—can impede testing and implementation 7

MACRA Info Session #4 Considerations for Conceptualization 8

MACRA Info Session #4 Conceptualization of a PRO-PM (1/2) • Consider whether the outcome or condition of interest lends itself to patient-reporting • Information should be knowable by patients (ex. , symptoms) • Outcomes and analysis results should be important and meaningful to patients • Measured outcomes should be sensitive to changes in clinical practice 9

MACRA Info Session #4 Conceptualization of a PRO-PM (2/2) • Conduct a thorough environmental scan • Identify PROMs that may serve as the basis for your performance measure • Consider whether they are validated, and for what population/clinical environment • Consider barriers to feasibility, such as patterns of use and how information from the PROMs are collected and stored • Determine whether to use a global or conditionspecific tool • Compile a list of related or competing measures 10

MACRA Info Session #4 Final Considerations for Conceptualization • Rate the evidence supporting the selected tool • Determine whether the tool is in use and validated for your target population/setting • Consider whether the tool is suitable for use in performance measurement • Think through potential feasibility and implementation burden 11

MACRA Info Session #4 Considerations for Specification 12

MACRA Info Session #4 Specification (1/2) • Target population (e. g. , patients 18 years of age or older who have undergone lumbar surgery) • Outcome type (e. g. , average change, percent improvement, percent of patients who experience improvement) • Timing (e. g. , within one month prior to surgery and between 270 -365 days following surgery) • Risk-adjustment 13

MACRA Info Session #4 Specification (2/2) Specifications for PRO-PMs must also include: • Methods of administration (e. g. , paper vs. electronic, in-office vs. at home via patient portal) • How proxy responses are handled • Response rate calculations • How responses affect results 14

MACRA Info Session #4 Considerations for Testing 15

MACRA Info Session #4 Evaluation/Testing • Same overall requirements as other outcome measures, with additional considerations • Importance • Feasibility • Scientific Acceptability (reliability and validity) • Usability and Use • Harmonization 16

MACRA Info Session #4 Importance Considerations • Must be patient-centered • Patients should be involved in selecting the outcomes and the PROMs for the performance measure • Must demonstrate that the measure can lead to improved outcomes and/or address a performance gap 17

MACRA Info Session #4 Feasibility Considerations • Burden to respondents • Questionnaire length • Timing • In-office assessment vs. online • Accessibility issues • Severity of patient’s condition • Type of illness 18

MACRA Info Session #4 Feasibility Considerations • Burden to clinicians • Workflow changes • Reliance on proprietary tools • IT requirements • Language, literacy, and cultural issues • PROMs available in multiple languages • Age of target population 19

MACRA Info Session #4 Scientific Acceptability Considerations (1/3) • Must be established for both the PROM and for the PRO-PM • Must demonstrate that the PROM tool is psychometrically sound • PRO-PM validity can be demonstrated by testing relationships (e. g. , correlation) with another performance measure or PROM • PRO-PM reliability can be demonstrated using signal-to-noise (or similar) 20

MACRA Info Session #4 Scientific Acceptability Considerations (2/3) • Missing data may be more prevalent with PRO-PMs than with other types of performance measures • Missing responses on a multi-item scale • Missing responses from eligible patients • Missing information because of exclusions • Using proxies to mitigate potential missing responses • Analyses of missing data and response rates are required to demonstrate that potential problems in these areas do not bias the performance measure results 21

MACRA Info Session #4 Scientific Acceptability Considerations (3/3) • PRO-PM reliability and validity should be assessed quantitatively; requires data collection from test sites • Low sample size could jeopardize testing results • Carefully consider likely response rates when selecting sites to participate in testing • Review findings from feasibility testing to inform testing plans 22

MACRA Info Session #4 Usability Considerations • Demonstrate that clinicians can use the measure to improve the quality of the care they provide • Demonstrate that patients can use the information from the measure and find it to be meaningful 23

MACRA Info Session #4 Conclusions PRO-PMs are an important facet of patientcentered care and patient-centered measurement, but they are not appropriate for every condition/outcome. Testing PRO-PMs can be a challenge, but guidance is available to support organizations who want to develop them. 24

MACRA Info Session #4 References • CMS MMS Blueprint – https: //www. cms. gov/Medicare/Quality-Initiatives-Patient. Assessment-Instruments/MMS-Blueprint. html • National Quality Forum—Patient-Reported Outcomes – https: //www. qualityforum. org/Publications/2012/12/Patient. Reported_Outcomes_in_Performance_Measurement. aspx • PCPI “Methods for Developing Patient-Reported Outcome -Based Performance Measures (PRO-PMs)” – https: //doi. org/10. 1016/j. jval. 2015. 02. 018 25

MACRA Info Session #4 Discussion Questions 26

MACRA Info Session #4 Upcoming Info Sessions Planned Upcoming Webinars: • March 6, 2019 – Introducing the Clinical Quality Bundle and Pre-Rulemaking Updates • April 3, 2019 – Why Measures Fail Endorsement, presented by NQF To suggest topics for upcoming Info Sessions, email: MMSsupport@battelle. org 27

MACRA Info Session #4 CMS Measure Development Education & Outreach Contact information: • Battelle Measures Management System Contract Holder Contact: MMSsupport@Battelle. org • CMS Kimberly Rawlings: Kimberly. Rawlings@cms. hhs. gov 28