TO TOMMY THOMPSON SUPPORTING
CONTINUED COVERAGE OF CLINICAL TRIALS BY MEDICARE
(February 11, 2002)
February 11, 2002
The Honorable Tommy
Secretary, Department of Health & Human Services
200 Independence Avenue, S.W.
Room 615-F - HHH Bldg.
Washington, D.C. 20201
Dear Secretary Thompson:
It has come to our attention that the Centers for Medicare and Medicaid
Services (CMS) may be considering a significant retreat from standards
of quality cancer care for Medicare beneficiaries by denying coverage
for routine patient care costs for beneficiaries who enroll in cancer
clinical trials. This reversal of CMS policy would be devastating for
beneficiaries with cancer and would engender the strongest opposition
from cancer patient advocates across the nation, including the members
of the Cancer Leadership Council, listed below.
As announced by the Medicare program in the fall of 2000, current policy
makes clear that patients enrolled in clinical trials continue to be entitled
to reimbursement for their routine patient care costs, such as physician
and hospital charges. These routine charges are not research costs but
rather patient care costs, and there is no justification for not covering
them. After almost a decade of discussion, including various bipartisan
legislative proposals to clarify the policy, the Medicare program finally
agreed that routine patient care costs were a program responsibility even
when rendered in the context of a clinical trial. A decision by the Department
to return to a state of uncertainty about the coverage policy -- or worse
yet, to clearly state a noncoverage position -- would be unacceptable.
Although cancer is predominantly a disease of the elderly, Medicare beneficiaries
have been significantly under-represented in cancer clinical trials, at
least in part because of the historical uncertainty about coverage of
patient costs. This under-representation in clinical trials has substantial
implications for the applicability of research results to senior citizens.
The September 2000 policy clarification was an important step forward
in integrating Medicare beneficiaries into the cancer clinical trial system,
which is an essential component of quality cancer care in this country.
It would be most unfortunate if the Medicare program sought now to retrench
from its earlier enlightened action and return to denials of coverage
for routine patient care just because the beneficiary accesses care in
the context of a clinical trial.
Significantly, the current policy was developed in consultation not only
with Medicare officials but also with experts from the National Institutes
of Health, the Food and Drug Administration, and the Agency for Healthcare
Research and Quality. In addition, the Medicare coverage decision in 2000
was an outgrowth of strong bipartisan support for coverage of these costs
by Members of Congress as influential and diverse as Democratic Senators
Edward Kennedy and Jay Rockefeller, former Republican Senator Connie Mack,
and Republican Representatives Nancy Johnson and Deborah Pryce. We believe
they would be as concerned as the cancer community if the agency reversed
its enlightened decision to clarify coverage of these important entitlements.
During his campaign and since taking office, President Bush has declared
his intention to continue the fight against cancer. Clinical trials are
critical to any further advances in this fight. Since our nation's seniors
are the population most affected by cancer, rescinding an existing benefit
that holds so much promise for them is unacceptable. We urge you and the
Department to reject any suggestion of retreat from the position set forth
in the September 2000 coverage decision. Medicare beneficiaries should
have the same right as every other American to participate in cancer clinical
trials without the threat of random denials of health care to which they
are otherwise clearly entitled.
for Lung Cancer Advocacy, Support, and Education
American Cancer Society
American Society of Clinical Oncology
Cancer Care, Inc.
Cancer Research Foundation of America
The Children's Cause, Inc.
Coalition of National Cancer Cooperative Groups
Colorectal Cancer Network
Foundation for the Children's Oncology Group
Kidney Cancer Association
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
Multiple Myeloma Research Foundation
National Coalition for Cancer Survivorship
National Patient Advocate Foundation
National Prostate Cancer Coalition
North American Brain Tumor Coalition
Oncology Nursing Society
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
US TOO! International, Inc.
The Wellness Community
Y-ME National Breast Cancer Organization
cc: The Honorable
Nancy L. Johnson
The Honorable Deborah Pryce
The Honorable Edward M. Kennedy
The Honorable John D. Rockefeller
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