title: Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions.
abstract: BACKGROUND
  There is a paucity of data on the adequacy of the resources and tools used by the Centers for Medicaid and Medicare Services (CMS) in making national coverage determinations about services for beneficiaries. The objective of this study was to determine the extent to which clinical trials relied on by the CMS are applicable to Medicare beneficiaries.
  
  
  METHODS
  We performed a meta-analysis of data on 40 009 individuals from all 141 trials included in the technology assessments for the 6 cardiovascular disease meetings of the CMS advisory panel and compared them with the demographics of the Medicare population.
  
  
  RESULTS
  Medicare beneficiaries differ significantly from the cardiovascular clinical trial participants used to inform Medicare coverage decisions. Clinical trial participants, compared with beneficiaries, are more likely to be younger (60.1 vs 74.7 years), male (75.4% vs 41.8%), and non-US residents (60% vs 0%). The clinical trials, moreover, rarely included outcome stratification by age, sex, and race.
  
  
  CONCLUSIONS
  Participants in cardiovascular studies relied on by the CMS for coverage determinations differ substantially from the Medicare population. Data frequently are not available on relevant subgroup populations. Suggestions are made that address the need for data more relevant to Medicare beneficiaries by increasing enrollment of, and reporting on, women and elderly individuals in clinical trials and use of relevant data for coverage decisions.
authors.affiliation: University of California at San Francisco School of Medicine, San Francisco, CA 94143-0124, USA.
authors.forename: Sanket S
authors.initials: SS
authors.lastname: Dhruva
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D026683:Advisory Committees; D000368:Aged; D002318:Cardiovascular Diseases / Q000191:economics / Q000628:therapy*; D014487:Centers for Medicare and Medicaid Services, U.S.; D003657:Decision Making; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D019458:Insurance Coverage / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D008297:Male; D006278:Medicare / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D008875:Middle Aged; D018579:Patient Selection; D014481:United States