[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