Clinton: Medicare to reimburse research study care providers

President Clinton issued an Executive Memorandum directing 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. The order also directs Medicare to take additional action to promote the participation of Medicare beneficiaries in clinical trials for all diseases. These actions follow a recent Institute of Medicine report recommending policy changes to encourage greater use of clinical trials by older Americans and the completion of a review of administration policy.

The memorandum was issued because of low senior participation in clinical trials. "Today, America's seniors are badly under-represented in clinical trials, yet, they bear the heaviest share of illness," said the president. "More than half of our cancer patients are over 65, but only a third of those in clinical trials are seniors. For breast cancer, the statistics are even worse."

The Executive Memorandum directs the Department of Health and Human Services to:

•Â Revise Medicare program guidance to explicitly authorize payment for routine patient care costs associated with clinical trials.

•Â Launch activities to increase beneficiary awareness of the new coverage option.

•Â Establish a tracking system for Medicare payments.

•Â Ensure that the information gained from important clinical trials is used to inform coverage decisions.

•Â Review the feasibility and advisability of taking additional action to promote research on issues of importance to the Medicare population within 90 days.

•Â Develop a registry of ongoing clinical trials receiving Medicare reimbursement.

"As America ages, we must provide all our seniors affordable, quality healthcare, and we should be using our cutting-edge science to meet that challenge," said the president. "Simply put, the more seniors we enroll in trials, the faster we'll be able to use these advances to save American lives. We've done this successfully with cancer in children. For decades now, more than half of all the children with cancer have joined clinical trials, giving us a wealth of evidence about how the disease works and how best to fight it. Now we can cure three-quarters of childhood cancers. …We should be doing the same for Americans of every age." PR