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:

• Too few seniors participate in clinical trials. About one percent of seniors participate in clinical trials, despite the fact that the elderly bear the majority of the disease burden experienced nationally. For example, 63 percent of cancer patients are older than 65, but they constitute only 33 percent of those enrolled in clinical trials. The disparity is greater for breast cancer patients - elderly women make up 44 percent of breast cancer patients, but only 1.6 percent of women over the age of 65 are in clinical trials for the disease. Scientists believe that higher participation in clinical trials could lead to faster development of therapies, as it often takes between three and five years to enroll enough participants in a clinical trial to make the results scientifically valid and statistically meaningful.

• Current Medicare reimbursement policies often discourage seniors from 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.

• Increased participation is likely to have significant rewards. Striking progress made in treating and curing pediatric cancers was largely possible because of widespread participation in clinical trials. For decades now, well over 50 percent of pediatric cancer patients were enrolled in clinical trials, and today, 75 percent of cancers in children are curable. Experts believe that coverage of all clinical trials - not just those for cancer - is critically important to ensuring new breakthroughs in diagnostics, treatments, and cures for many of the most devastating diseases afflicting millions of Americans of all ages.

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:

• Revise Medicare program guidance to explicitly authorize payment for routine patient care costs associated with clinical trials. This week, the Health Care Financing Administration (HCFA) will inform all claims processing contractors that Medicare will immediately begin to reimburse for the routine patient care costs as well as costs due to medical complications associated with participation in a clinical trial, removing this barrier to participation.

• Launch activities to increase beneficiary awareness of the new coverage option. HHS will launch an effort to educate beneficiaries and providers about this policy change, including adding information on clinical trial coverage to the Medicare handbook and posting information on their website.

• Establish a tracking system for Medicare payments. Before the end of the fiscal year, HCFA will implement a system to track spending in trials for which Medicare contributes financial support.

• Ensure that the information gained from important clinical trials is used to inform coverage decisions. Beginning this summer, HCFA and the National Institutes of Health (NIH) will work with researchers prior to the beginning of a clinical trial in order to structure the trial to produce information necessary to inform subsequent Medicare coverage decisions when the therapies or devices under review have significant implications for the Medicare program.

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

• 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, Congresswoman Johnson, Congressman Cardin, and Congressman Bentsen in advocating for Medicare coverage for certain types of 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.

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