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Taking New Action To Encourage Participation In Clincal Trials

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White House at Work


Wednesday, June 7, 2000


"As America ages, we must provide all our seniors affordable, quality health care, and we should be using our cutting-edge science to meet that challenge. Simply put, the more seniors we enroll in trials, the faster we'll be able to use these advances to save American lives."

President Bill Clinton
Wednesday, June 7, 2000

Today, at the White House, President Clinton issued an Executive Memorandum directing Medicare to begin reimbursing providers for the cost of routine patient care associated with participation in clinical trials, and to promote participation by Medicare beneficiaries in clinical trials for all diseases. Today's action, strongly supported by the Vice President, builds on legislation sponsored by Senators Rockefeller and Mack, and Representatives Johnson, Cardin, and Bentsen, whom the President acknowledged for their leadership. The President urged Congress to extend coverage for the cost of participating in clinical trials to seniors in private plans as well by passing a strong, enforceable Patients' Bill of Rights.

More Participation by Seniors In Clinical Trials is Needed. A recent report by the Institute of Medicine recommended policy changes to encourage greater use of clinical trials by older Americans. Today, President Clinton highlighted that:

  • Too few seniors participate in clinical trials – only about one percent – despite the fact that the elderly bear the majority of the disease burden nationally;

  • The uncertainty of Medicare reimbursement often discourages seniors from participating in clinical trials; and

  • Scientists believe that increased participation in clinical trials could lead to faster development of therapies.

Taking Executive Action to Encourage Participation. President Clinton issued an Executive Memorandum that directs the Department of Health and Human Services to:

  • Revise Medicare to immediately begin reimbursing routine patient care costs associated with clinical trials;

  • Increase awareness among Medicare beneficiaries of the new coverage;

  • Establish a tracking system for Medicare payments to clinical trials;

  • Ensure that the information gained from clinical trials is used in coverage decisions; and

  • Review within 90 days additional actions that can be taken to promote research on issues important to seniors.

Urging Congress to Extend Coverage to All Private Plans. The President commended Vice President Gore, Senators Rockefeller and Mack, and Representatives Johnson, Cardin and Bentsen for advocating Medicare coverage for cancer clinical trials, and called on Congress to extend similar coverage to seniors in private plans by passing a strong, enforceable Patients' Bill of Rights. The President pointed out that the Norwood-Dingell legislation, which has been stalled in Congress for six months, contains a provision requiring private insurers to cover the cost of participation in clinical trials.

Building on a Longstanding Commitment to Biomedical Research. Today's action builds on the record of President Clinton and Vice President Gore in promoting biomedical research and removing barriers to participation in clinical trials, including:

  • Increasing funding for the National Institutes of Health by 73 percent since the start of the Administration. As a result, NIH now supports the highest levels of research ever on nearly all types of diseases;

  • Directing HHS to strengthen federal oversight and increase the accountability of researchers conducting clinical trials in order to protect the safety of individuals participating in trials; and

  • Issuing an Executive Order prohibiting every civilian federal department and agency from using genetic information in any hiring or promotion action.

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