    [Weekly Compilation of Presidential Documents Volume 36, Number 23 (Monday, June 12, 2000)]
    [Pages 1311-1313]
    [Online from the Government Publishing Office, www.gpo.gov]

    <R04>
    Memorandum on Increasing Participation of Medicare Beneficiaries in
    Clinical Trials

    June 7, 2000

     Memorandum for the Secretary of Health and Human Services

    Subject:  Increasing Participation of Medicare Beneficiaries in Clinical
    Trials

        Promoting biomedical research and ensuring that Medicare
    beneficiaries receive the highest quality care possible are longstanding
    priorities of my Administration. Over the past 3 years, with the
    invaluable assistance of the Vice President, my Administration has
    advocated and secured funding for a budget proposal that explicitly
    provides for Medicare coverage of services associated with cancer
    clinical trials, assuring that seniors and disabled persons with cancer
    have access to cutting-edge treatments and helping promote the research
    necessary to find new treatments and cures.
        Research shows that only about 1 percent of American seniors
    participate in clinical trials, although the elderly bear the majority
    of the disease burden in the United States. For example, although 63
    percent of cancer patients are over 65, these older cancer patients
    constitute only 33 percent of all those enrolled in clinical trials. The
    disparity is greater for breast cancer patients--elderly women comprise
    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. These low
    participation rates hinder efforts to develop new therapies, because
    they mean that scientists often need between 3 and 5 years to enroll
    enough participants in a clinical trial to generate scientifically valid
    and statistically meaningful results.
        Experts believe that coverage of all clinical trials--not just those
    for cancer--can lead to breakthroughs in diagnostics, treatments, and
    cures for many of the most devastating diseases afflicting millions of
    Americans of all ages. For example, we have made striking

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    progress in treating and curing pediatric cancers, largely 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.
        One factor contributing to seniors' low participation rate in
    clinical trials is the Medicare program's failure to guarantee Medicare
    payment for the care associated with participation. This uncertainty
    regarding reimbursement often deters patients from participating in
    these trials, and deters physicians and other clinicians from recruiting
    patients, contributing to low participation rates and slowing the
    development of new medical treatments and diagnostic tests that could
    benefit the entire Medicare population.
        Last December, the Institute of Medicine (IOM) issued a report
    entitled ``Extending Medicare Reimbursement in Clinical Trials,'' which
    recommended that Medicare explicitly cover routine patient care costs
    for participants in clinical trials. This and other recommendations by
    IOM, combined with your ongoing efforts to modernize Medicare's process
    to ensure coverage of new technology, prompted a review of Medicare's
    administrative flexibility to independently remove barriers to
    participation in clinical trials. Following this review, you concluded
    that Medicare could exercise its administrative authority to provide
    reimbursement for routine patient care costs associated with clinical
    trials.
        Based on the results of your Department's review and your
    recommendations, as well as our shared commitment to promoting critical
    biomedical research and to assuring that older Americans and millions of
    people with disabilities have access to cutting edge medical treatments,
    I hereby direct the Department of Health and Human Services (HHS) to:
    <bullet>    Revise Medicare program guidance to explicitly authorize
                payment for routine patient care costs associated with
                clinical trials.  The HCFA should inform all claims-
                processing contractors that Medicare will immediately begin
                to reimburse routine patient care costs and costs due to
                medical complications associated with participation in
                clinical trials.
    <bullet>    Launch activities to increase beneficiary awareness of the
                new coverage option. The HHS should educate beneficiaries
                and providers about this policy change, including developing
                an easy-to-read brochure, adding information on clinical
                trial coverage to future Medicare handbooks, and posting
                information on the HHS website.
    <bullet>    Establish a tracking system for Medicare payments.  The HCFA
                should implement a system to track clinical trial spending
                to which Medicare contributes financial support.
    <bullet>    Ensure that the information gained from important clinical
                trials is used to inform Medicare coverage decisions.  The
                HCFA and the National Institutes of Health (NIH) should work
                with researchers prior to clinical trials designed to test
                the efficacy of devices or therapies that have significant
                implications for the Medicare program to structure those
                trials to produce information to inform subsequent Medicare
                coverage decisions.
    <bullet>    Review and report back to me within 90 days on the
                feasibility and advisability of additional actions to
                promote research on issues of importance to the Medicare
                population, including:
    --           as recommended by IOM, supporting certain clinical trials
                of particular importance to the Medicare population,
                including certain health care interventions unique to the
                Medicare population and clinical trials that could lead to
                more effective and/or less costly treatments. HHS should
                review IOM's recommendation to provide additional financial
                support for monitoring and evaluation, device implantation,
                and other non-covered costs for trials researching methods
                of care of particular importance to Medicare beneficiaries;
    --           increasing the participation of seniors in clinical trials.
                Specifically, the NIH should evaluate additional action to

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                increase seniors' participation in clinical trials to ensure
                that researchers can determine the best therapies for older
                as well as younger patients; and
    --           developing a registry of all ongoing clinical trials
                receiving Medicare reimbursement, using the information
                contained in current NIH and FDA clinical trial registries.
                This new registry would provide a comprehensive picture of
                ongoing trials, participation rates, and ways patients can
                access the trials and facilitate the HCFA's ongoing review
                and oversight activities to ensure that only covered
                services are billed and reimbursed.
                                                William J. Clinton