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Medicare Coverage ~ Clinical Trials
Clinical trials are research studies designed to evaluate the safety and effectiveness of medical care. They are key to understanding the appropriate use of medical interventions of all types and informing payers about what services to cover. Previously, Medicare has not paid for items and services related to clinical trials because of their experimental nature. As a result, only a very small percentage of American seniors participate in clinical trials, although the elderly bear a disproportionate burden of disease in the United States.
On June 7, 2000, the President of the United States issued an executive memorandum directing the Secretary of Health and Human Services to "explicitly authorize [Medicare] payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials." In keeping with the President's directive, CMS is engaged in defining the routine costs of clinical trials and identifing the clinical trials for which payment for such routine costs should be made.
To find out more about Medicare coverage of clinical trials, click on the links below:
- Proposed National Coverage Decision
- Final National Coverage Decision
- Program Memorandum
- Provider Bulletin
- Federal Register Notice Announcing 10/20/00 Meeting
- Federal Register Notice Announcing 11/20/00 Meeting
(Also see our Quick Reference Guide for other links to Clinical Trials information.)
Questions can be sent via E-mail or regular mail to:
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Clinical Trial Policy
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard, C1-09-06
Baltimore, MD 21244
