Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions

Of interest in this study were the coverage decisions made by the Centers for Medicare and Medicaid Services (CMS). Specifically, a review of the data used in cardiovascular technology assessment (TA) was conducted to ascertain how such data pertained to the population of Medicare beneficiaries.

Data was gathered from six CMS advisory panel meetings where cardiovascular products or services were reviewed. The resultant sample of 141 peer-reviewed publications included 40,009 patients and was compared to the population of Medicare beneficiaries on demographic and health factors.

Key Findings:

  • Patients in the cardiovascular TAs were significantly younger at an average age of 60.1 years than were Medicare beneficiaries who were on average 70.8 years of age.
  • As compared to the Medicare beneficiary population that was mostly female, the majority of patients in clinical trials were male.
  • The majority of studies reviewed were located outside of the United States, with Europe a common location.
  • Many of the Medicare beneficiaries had comorbid conditions, whereas the patients in clinical trials were healthier.

Decisions about coverage for Medicare beneficiaries should be grounded in findings from clinical trials with patients similar in attributes to the actual population of Medicare beneficiaries.