[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