The patient population in clinical trials used by CMS to make coverage determinations for Medicare beneficiaries differs significantly from the actual Medicare population, researchers reported in a study in the Journal of the American Medical Association.
The study found that participants in CMS cardiovascular disease studies were mostly male, non-U.S. residents under age 65. By contrast, Medicare beneficiaries must be over 65, U.S. residents, and are mostly female. The authors contend that the population disparity likely will increase as U.S. residents live longer.
Researchers called for clinical trials based on age, sex and race in order to strengthen the evidence used by CMS in making coverage decisions, while helping to explore questions about health disparities across specific populations. The study concludes these efforts would lead to better health outcomes for the growing population of Medicare beneficiaries (Dhruva/Redberg, Journal of the American Medical Association, January 2008).