CMS Measure Development Education & Outreach

1. MACRA Info Session #3 CMS Measure Development Education & Outreach • Building a Business Case Presenters: Brenna Rabel, Battelle Matt Humphrey, RELI January 23, 2019 2:00-3:00pm EST

2. 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

3. MACRA Info Session #3 CMS Measure Development Education & Outreach Agenda: Overview of business cases for measure development Components of the business case template Examples

4. MACRA Info Session #3 What is a Business Case? • Documentation of all anticipated impacts of a quality measure (both positive and negative) • Resources required • Lives saved • Costs reduced • Complications prevented • Patient experience enhanced • Implementation challenges expected • Enables decision-making by demonstrating that the anticipated benefits outweigh costs and burden of collection and implementation

5. MACRA Info Session #3 Objectives of the Business Case • Explain why the measure is needed (e.g., opportunities for improvement, gaps in existing measure landscape) • Show how it will further CMS aims and objectives • Describe the strength of the evidence supporting the measured process/outcome • Illustrate why it is the best balance of direct and indirect cost, benefits, and risks • Describe all realistic and affordable costs • Demonstrate sufficient capacity • within the system to implement the • measure

6. MACRA Info Session #3 Why Build a Business Case? • Helps establish measure importance • Aligns with NQF endorsement requirements • Can be submitted to the Measure Applications Partnership (MAP) committee during Pre-Rulemaking to inform their recommendation • Provides justification for continued investment in measure development • Enables CMS decision-making about continued use in CMS programs (for implemented measures)

7. MACRA Info Session #3 Timing • For measures under development, business case should be made early, drawing from information collected during conceptualization • For measures in use, an updated business case can inform whether measure performance aligns with anticipated impacts • At every point, the business case should include analysis of existing related measures

8. MACRA Info Session #3 Business Case Template: Executive Summary • Frames the business case by explaining, at a high level

9. MACRA Info Session #3 Current Performance • Establish a baseline for the measure • Report relevant morbidity and mortality statistics • Review the literature for supplementary information • Describe any disparities • Describe performance by subgroup • Consider drivers of the issue or quality gap

10. MACRA Info Session #3 Measure Impact on Care • Describe linkages and steps between measure focus and expected improvements to care provided. For example: • Illustrate how a measure focused on reducing opioid overuse could improve or help routinize medication reconciliation processes at healthcare facilities • Describe evidence linking the measured process (confirming documentation of an advance care plan) to the desired outcome (patient-led care planning)

11. MACRA Info Session #3 Metrics to Consider: Improving Care • When demonstrating how the measure will improve care, consider • Clinical performance gaps • Benefits of the process (e.g., how the process leads to better outcomes) • Lives saved • Patient experience or trust in the healthcare system • Reduced disparities

12. MACRA Info Session #3 Measure Impact on Health Outcomes • Describe the linkages and steps between the measure focus and anticipated health outcomes • For outcome measures: provide evidence that connects the measured outcome to improved health (e.g., describing how the measure will reduce negative health impacts of opioid overuse) • For process measures: provide evidence that the measured process will lead to improved outcomes (e.g., demonstrating that medication reconciliation at discharge will reduce unnecessary opioid prescribing, which may reduce opioid-related morbidity and mortality

13. MACRA Info Session #3 Metrics to Consider: Improving Health • When demonstrating how the measure will improve health, consider • Incidence and prevalence of condition or treatment • How the measure will minimize morbidity and mortality, or hospital readmissions, or reduce average length of stay • Impact on other health outcomes or quality of life • Expected improvement

14. MACRA Info Session #3 Evidence Supporting the Measure • Clinical practice guidelines • ECRI Guidelines Trust (previously the National Guideline Clearinghouse) stores information about the strength of underlying evidence • Direct evidence • Directly demonstrates the link between the measure focus and the desired outcome • Indirect evidence • Requires that an inference be made about the evidence and the conclusion to be drawn from it

15. MACRA Info Session #3 Measure Impact on Healthcare Costs • Describe if and how the measure will impact healthcare costs • Savings by preventing complications or unnecessary healthcare • Efficiencies created by implementing • a new clinical process • Savings by improving population • health

16. MACRA Info Session #3 Influencing Factors • Describe factors that may influence measure adoption or outcomes resulting from the measure • Legislation and regulation • Endorsements • Stakeholder feedback • Competitive market pressures • Data infrastructure

17. MACRA Info Session #3 Influencing Factors • Describe potential feasibility challenges that might impact successful measure implementation • Does the measure rely on specific technology, and if so, are there risks or gaps associated with it? • Consider capacity and readiness within the healthcare system to implement the measure • Availability of data elements (e.g., are electronic clinical quality measure data elements likely to be stored in easily extractable fields?) • Workflow or technology implications (e.g., need for training on a new infection prevention protocol)

18. MACRA Info Session #3 Resources Required for Implementation • Describe and quantify the resources necessary to implement the measure • Staff time • Costs associated with electronic health record modifications • Other direct and indirect costs

19. MACRA Info Session #3 Costs of Clinical Care • Describe and quantify the resources necessary to implement the changes in care the measure seeks to change • Staff time • Required trainings • New or updated technology requirements • Direct and indirect costs related to workflow changes

20. MACRA Info Session #3 Potential Unintended Consequences • Consider unintended consequences related to • Resource utilization • Provider behavior • Patient satisfaction • Leverage qualitative feedback from clinical experts to anticipate potential consequences of the measure • For implemented measures, look for opportunities to assess this quantitatively

21. MACRA Info Session #3 Description of Model(s) and Formula(s) Used • Explain the methodology for calculating expected costs and resource use (e.g., variables used in a cost model) • Intended to promote transparency in the business case calculations

22. MACRA Info Session #3 Limitations of Analysis • Describe key assumptions and the limitations of those assumptions • Explain weaknesses or gaps in the literature, especially for indirect evidence • Identify data that are missing or limited

23. MACRA Info Session #3 Net Benefit • Report anticipated benefits related to: • Better health through reduction in morbidity and mortality and improvements in quality of life • Better Care through both improvement in the quality of care provided and positive influence on patients’ perception of their care • Affordability through direct and indirect cost savings

24. MACRA Info Session #3 Designing your Business Case • Develop a hypothesis about the measure trajectory (e.g., the effect of the measure over time) • Compile historical and baseline data about similar measures to identify and monitor performance gaps • Apply a testable model to quantify benefits of implementing the measure (e.g., cost savings model) • Re-evaluate after the measure has been implemented

25. MACRA Info Session #3 Business Case Example 1 • Hypothesis - Adopting a higher cost drug, low molecular weight heparin (LMWH) to treat deep vein thrombosis will actually save money based on a published study showing a 1:5 cost savings ratio when compared to the traditional deep vein thrombosis (DVT) treatment

26. MACRA Info Session #3 Business Case Example 1 • Historical and Baseline Data • LMWH costs $50 more per day but can be given in an outpatient setting • This results in reductions in hospitalizations, lab testing, length of stay • Estimated cost savings of $800 per patient

27. MACRA Info Session #3 Business Case Example 1 • Testing • Adoption rate of treatment • Appropriate use of treatment • Cost savings during the measurement period • Findings • Adoption rate was low (29 out of 500 eligible patients in 6 months were on the treatment) • Yielded savings of $22,000, but off protocol use made them negligible

28. MACRA Info Session #3 Business Case Example 1 • Evaluation • The organization would need to see wide adoption of the LMWH treatment to realize positive results in this cost savings model • Misapplication must be avoided to prevent cost increase

29. MACRA Info Session #3 Business Case Example 2 • Hypothesis - Patients with high serum cholesterol levels, specifically those with a history of heart disease, would benefit from proper statin use, which can reduce heart attacks and make them less severe, if used properly

30. MACRA Info Session #3 Business Case Example 2 • Historical and Baseline Data • Improper use of statins is a common problem in the United States • The health system was currently at 53% effective use of the therapy, with an approximate cost of $675 per patient. • Research and literature suggests a 1:2 cost savings ratio.

31. MACRA Info Session #3 Business Case Example 2 • Testing: • Conducted a trial lipid clinic of 800 patients • Monitored statin use, tracked lipid levels, altered dosage, and provided counseling on diet and exercise • Findings: • Improved patient health • Potential 2:1 return on investment

32. MACRA Info Session #3 Business Case Example 2 • Evaluation • Despite encouraging results, the program was not expanded • Return on investment was deemed too long-term and patients benefitting now from the treatment may be patients elsewhere at the time future heart attacks would have occurred

33. MACRA Info Session #3 Building a Business Case: Resources and Templates • The MMS Blueprint contains • A Business Case chapter which describes a business case and development • A Business Case Template and Business Case Form Instructions, which includes detailed instructions for how to compile a business case

34. MACRA Info Session #3 References • CMS MMS Blueprint (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf • Business Case Chapter: Section 3, Chapter 11 • Business Case Form Instructions: Section 4, #2 • Business Case Template: Section 4, #3

35. MACRA Info Session #3 Discussion Questions

36. MACRA Info Session #3 CMS Public Engagement Webinars Planned Upcoming Webinars: • February 13, 2019 – Patient Reported Outcome Measures • March 6, 2019 – Best Practices for Environmental Scanning • Email: MMSsupport@battelle.org

37. MACRA Info Session #3 CMS Measure Development Education & Outreach Contact information: • Battelle Measures Management System Contract Holder: Battelle Contact: MMSsupport@Battelle.org • CMS Kimberly Rawlings: Kimberly.Rawlings@cms.hhs.gov