On Jun. 7, 2000, President Bill Clinton issued an Executive Memorandum that directed the Medicare program to revise its payment policy and immediately begin to explicitly reimburse providers for the cost of routine patient care associated with participation in clinical trials, and to take additional action to promote the participation of Medicare beneficiaries in clinical trials for all diseases.

This action followed an Institute of Medicine report that recommended policy changes to encourage greater use of clinical trials by older Americans.

• The Institute of Medicine’s recommendation that HCFA support certain clinical trials that are of particular importance to the Medicare population. Certain health care interventions are unique to the Medicare population and clinical trials on these issues could lead to more effective or less costly treatments. HHS will review the feasibility and advisability of providing additional financial support for monitoring and evaluation, device implantation, and other non-covered costs for trials of importance to Medicare beneficiaries.
• Taking action to increase the participation of seniors in clinical trials. NIH will evaluate the feasibility and advisability of taking additional action to increase the participation of seniors in clinical trials to ensure that researchers can determine the best therapies for older as well as younger patients.
• Developing a registry of ongoing clinical trials receiving Medicare reimbursement. In addition, HHS will review the feasibility and advisability of using the information contained in current NIH and FDA clinical trial registries to develop a national registry of all clinical trials receiving Medicare reimbursement. This new registry would provide a comprehensive picture of the types of trials ongoing, the participation rates, and how patients can access the trials, in addition to facilitating HCFA’s ongoing review and oversight activities to ensure that only covered services are billed and reimbursed.