CMS Quality Programs, Coverage, and Evidence

1. CMS Quality Programs, Coverage, and Evidence Patrick Conway, M.D., MSc CMS Chief Medical Officer and Director, Center for Clinical Standards and Quality December 10, 2012

2. Objectives • Summary of CMS Quality Programs • Coverage – coverage with evidence development • Guidelines and Evidence implementation

3. Size and Scope of CMS Responsibilities • CMS is the largest purchaser of health care in the world (approx $800B per year) • Combined, Medicare and Medicaid pay approximately one-third of national health expenditures. • CMS programs currently provide health care coverage to roughly 105 million beneficiaries in Medicare, Medicaid and CHIP (Children’s Health Insurance Program); or roughly 1 in every 3 Americans. • The Medicare program alone pays out over $1.5 billion in benefit payments per day. • Through various contractors, CMS processes over 1.2 billion fee-for-service claims and answers about 75 million inquiries annually. • Millions of consumers will receive health care coverage through new health insurance programs authorized in the Affordable Care Act.

4. Our Aims Better Health for the Population Better Care for Individuals Lower Cost Through Improvement

5. Center for Clinical Standards and QualityLevers for Safety, Quality & Value Over 425 federal FTE’s, $1.3 billion and approximately 10K contractors focused on improving quality across the nation Contemporary Quality Improvement: Quality Improvement Organizations Quality Measurement and Public Reporting: Hospital Inpatient Quality Reporting Program Incentives: Hospital Value Based Purchasing, ESRD, physician value modifier Regulation: Conditions of Participation (Hospitals, 15 other provider types) and Survey and Certification Coverage Decisions: Coverage with evidence development, coverage for Preventative Services 5

6. Goals of CMS Quality Programs • Improvement aimed at achieving better care and better health • Focus on patient-centered outcome measures whenever possible • Engage physicians, other clinicians, and providers in helping shape and improve the quality programs • Foster shared accountability in a health care system that achieves better outcomes for patients • Align programs to maximize improvement and minimize burden

7. CMS has a variety of quality reporting and performance programs * Denotes that the program did not meet the statutory inclusion criteria for pre-rulemaking, but was included to foster alignment of program measures.

8. National Quality Strategy promotes better health, better healthcare, and lower costs • Six priorities: • Making care safer by reducing harm caused in the delivery of care. • Ensuring that each person and family are engaged as partners in their care. • Promoting effective communication and coordination of care. • Promoting the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease. • Working with communities to promote wide use of best practices to enable healthy living. • Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.

9. CMS framework for measurement maps to the six National Quality Strategy priorities Care coordination • Transition of care measures • Admission and readmission measures • Other measures of care coordination Population/ community health Clinical quality of care • HHS primary care and CV quality measures • Prevention measures • Setting-specific measures • Specialty-specific measures • Measures should be patient-centered and outcome-oriented whenever possible • Measure concepts in each of the six domains that are common across providers and settings can form a core set of measures • Measures that assess health of the community • Measures that reduce health disparities • Access to care and equitability measures Person- and Caregiver- centered experience and outcomes Efficiency and cost reduction Safety • Spend per beneficiary measures • Episode cost measures • Quality to cost measures • CAHPS or equivalent measures for each settings • Functional outcomes • Health care acquired conditions and infections • All cause harm Greatest commonality of measure concepts across domains

10. Quality can be measured and improved at multiple levels Community • Population-based denominator • Multiple ways to define denominator, e.g., county, HRR • Applicable to all providers • Three levels of measurement critical to achieving three aims of National Quality Strategy • Measure concepts should “roll up” to align quality improvement objectives at all levels • Patient-centric, outcomes oriented measures preferred at all three levels • The “five domains” can be measured at each of the three levels Practice setting • Denominator based on practice setting, e.g., hospital, group practice Increasing individual accountability Increasing commonality among providers Individual physician • Denominator bound by patients cared for • Applies to all physicians • Greatest component of a physician’s total performance

11. CMS Vision for Quality Measurement • Align measures with the National Quality Strategy and Six Measure Domains • Implement measures that fill critical gaps within the 6 domains • Align measures across CMS programs whenever possible • Parsimonious sets of measures; core sets of measures • Removal of measures that are no longer appropriate (e.g., topped out) • Major aim of measurement is improvement over time

12. 7 Value-Based Purchasing • Goal isto reward providers and health systems that deliver better outcomes in health and health care at lower cost to the beneficiaries and communities they serve. • Hospital VBP, ESRD, and Physician Value-Modifier • Five Principles • Define the end goal, not the process for achieving it • All providers’ incentives must be aligned • Right measures must be developed and implemented in rapid cycle • CMS must actively support quality improvement • Clinical community and patients must be actively engaged • VanLare JM, Conway PH. Value-Based Purchasing – National Programs to Move from Volume to Value. NEJM July 26, 2012

13. Coverage Topics • Coverage with Evidence Development (CED) Updates • Guidance • MEDCAC • List of coverage topics

14. National Bioeconomy Blueprint http://www.whitehouse.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_april_2012.pdf

15. Coverage with Evidence DevelopmentCurrent Status • MEDCAC (May 16, 2012) on review of CED • Support for CED • Input given on how to best frame guidance and next stage of CED • Transcript on the coverage home page • Published draft guidance document on November 29, 2012 http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=23 • Welcome comments

16. CED MEDCAC information is available on the CMS website Proposals for the Physician Quality Reporting System (PQRS)http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=63&

17. List of Potential Coverage Topics • CMS requested public comment on items or services that may be misused, underused, or overused • Public responded • November 27th CMS posted the list online • http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=19&McdName=Potential+NCD+Topics&mcdtypename=Potential+National+Coverage+Determination+&MCDIndexType=2&bc=AAAEAAAAAAAA&

18. The “3T’s” Road Map to Transforming U.S. Health Care Improved health care quality & value & population health Basic biomedical science Clinical efficacy knowledge Clinical effectiveness knowledge T1 T2 T3 Key T1 activity to test what care works Clinical efficacy research Key T2 activities to test who benefits from promising care Outcomes research Comparative effectiveness Research Health services research Key T3 activities to test how to deliver high-quality care reliably and in all settings Quality Measurement and Improvement Implementation of Interventions and health care system redesign Scaling and spread of effective interventions Research in above domains Source: JAMA, May 21, 2008: D. Dougherty and P.H. Conway, pp. 2319-2321. The “3T’s Roadmap to Transform U.S. Health Care: The ‘How’ of High-Quality Care.”

19. Rapid Evidence Adoption

20. Quality and Evidence • Quality measurement needs to based on strong evidence • Quality data infrastructure can be built in manner for systematic measurement and improvement • Coverage policy can determine appropriateness based on the evidence and be utilized to develop more evidence when needed • Guidelines can support transformation but likely need to be thought of and implemented in much more dynamic manner • Evidence can and should be shared with patients in shared decision-making model that meets individual patient needs whenever possible

21. Contact Information Dr. Patrick Conway, M.D., M.Sc. CMS Chief Medical Officer and Director, Center for Clinical Standards and Quality 410-786-6841patrick.conway@cms.hhs.gov