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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 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 oftrials 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 CANCERCLINICAL 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.