THE WHITE HOUSE
Office of the Press Secretary
PRESIDENT CLINTON TAKES NEW ACTION TO ENCOURAGE PARTICIPATION IN CLINICAL TRIALS Medicare Will Reimburse For All Routine Patient Care Costs For Those in Clinical Trials
Today, President Clinton will issue 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, and to take additional action to promote the participation of Medicare beneficiaries in clinical trials for all diseases. These actions, strongly advocated by the Vice President and initiated through his leadership, 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. With the fast pace of medical advancement and continuing efforts to make evidence based medical decisions, clinical trials serve as the first step towards providing new clinical innovations to the forefront of medical practice. President Clinton's announcement builds on legislation sponsored by Senator Rockefeller, Senator Mack, Representative Jo hnson, Representative Cardin, and Representative Bentsen and the President will thank them for their exceptional leadership on this issue.
ACTION IS NECESSARY TO INCREASE THE PARTICIPATION OF SENIORS IN CLINICAL TRIALS. Today, the President highlighted that:
participating in clinical trials. Because clinical trial investigators cannot guarantee that Medicare will pay for the care associated with participation in their clinical trial, seniors considering whether to enter these trials must assume that they may be responsible for costs simply because they are participating in a clinical trial. In addition, investigators and research centers are often reluctant to recruit them because of the uncertainty of Medicare reimbursement.
PRESIDENT CLINTON DIRECTS HHS TO TAKE NEW ACTION TO ENCOURAGE PARTICIPATION IN CLINICAL TRIALS. Today, President Clinton will issue an Executive Memorandum that directs HHS to:
--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.
PRESIDENT CLINTON PRAISED THE BROAD BIPARTISAN SUPPORT FOR CANCER CLINICAL TRIAL COVERAGE IN MEDICARE AND CALLED FOR EXTENSION TO ALL PRIVATE PLANS. The President singled out the longstanding commitment of the Vice President, Senator Rockefeller, Senator Mack, Representative Johnson, Representative Cardin and Representative Bentsen in advocating for Medicare coverage for cancer clinical trials. Their support for this policy, in addition to the recently released Institute of Medicine report, made a significant contribution towards this policy revision. The President also called on the Congress to extend similar enforceable provisions to all private plans for all types of clinical trials, underscoring that the Norwood-Dingell Patients' Bill of Rights legislation that is now stalled in the Congress has such provisions.
LONGSTANDING COMMITMENT OF THE CLINTON-GORE ADMINISTRATION TO PROMOTING BIOMEDICAL RESEARCH. Today's announcement underscores the longstanding commitment of President Clinton and Vice President Gore to promoting biomedical research and removing barriers to participation in clinical trials providing access to cutting-edge treatment for Americans with diseases such as cancer, heart disease, Alzheimer's, Parkinsons, and diabetes. Since the beginning of the Clinton-Gore Administration, funding for NIH has increased by $7.3 billion - an increase of 73 percent. Last year, NIH received $2.3 billion, a 15 percent increase over FY 1999 funding levels, to build on the Administration's commitment to biomedical research. As a result, NIH now supports the highest levels of research ever on nearly all types of disease and health conditions, making new breakthroughs possible in vaccine development and use and the treatment of chronic and acute disease. President Clinton recently announced that HHS is taking new steps to strengthen federal oversight and increase the accountability of researchers conducting clinical trials with human subjects in order to protect the safety of individuals participating in all clinical trials. Actions include: issuing new guidelines stating that investigators must obtain new informed consent from participants after any event related to their clinical trial that may affect their willingness to participate, and proposing new civil monetary penalties of up to $250,000 per individual and $1 million per institution to promote compliance with current regulations. Finally, President Clinton signed an Executive Order prohibiting every civilian federal department and agency from using genetic information in any hiring or promotion action, removing any fear of repercussion in the workplace and making individuals at risk of hereditary diseases more likely to participate in clinical trials.