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Medicare Will Reimburse For All Routine Patient Care Costs For Those
in Clinical Trials
THE WHITE HOUSE Office of the Press Secretary
For Immediate Release
June 7, 2000
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:
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
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
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.