The undersigned cancer patient, provider, and
research organizations are writing regarding the
reconsideration of the Medicare coverage policy
on clinical trials. Many of us were involved in
the decade-long legislative effort that ended
with the issuance in June 2000 of an Executive
Memorandum directing Medicare to pay for routine
patient care costs in clinical trials. We
applauded that action and the National Coverage
Decision that implemented the policy.
We welcome the reconsideration of the clinical
trials coverage decision if it presents the
opportunity to refine the policy. However, we do
not support any movement to restrict or reduce
the current scope of coverage of clinical trials.
Impact of National Coverage Decision
Prior to the National Coverage Decision, Medicare
beneficiaries were clearly underrepresented in
clinical trials. A study of the clinical trials
in one large cancer cooperative group concluded
that only 25% of the patients enrolled in those
trials were patients age 65 or older, even though
that population represented 63% of all patients
with cancer. This study confirmed anecdotal
reports regarding the limited participation of
seniors in clinical trials. [footnote 1]
A follow-up study in that same cancer cooperative
group found older patient population in trials
had increased to 38% of trial enrollees in the
period from 2001 to 2003, from the pre-coverage
policy level of 25%. [footnote 2] This is an
important but inadequate improvement, and it
suggests that additional efforts must be made to
boost clinical trials participation by seniors.
With the reimbursement issue for seniors
significantly addressed by the National Coverage
Decision, cancer organizations are attempting to
address other barriers to trials enrollment by
educating providers and patients regarding
participation of seniors in trials and enhancing
overall consumer awareness of the benefits of
participation in trials. [footnote 3] Any
retrenchment in the coverage standards would
threaten the progress that has been made to date
and undermine our additional efforts to enhance
senior participation.
Refinements in the National Coverage Decision
Although participation by seniors overall has
been enhanced since the coverage decision, one
population of seniors has not benefited as
significantly. The cancer cooperative group
study identifies those seniors without
supplemental insurance policies as a population
that participates in trials at a less robust rate
than seniors overall. This population most
likely includes seniors who are enrolled in
Medicare managed care plans and who do not
ordinarily purchase supplemental coverage. Those
beneficiaries’ claims for clinical trials are
processed as fee-for-service claims subject to
20% coinsurance. Because these managed care
enrollees do not routinely have supplemental
coverage and are probably unable to pay the
coinsurance for their clinical trial care out-of-
pocket, they must forego clinical trials
enrollment. The conclusions of the study authors
regarding the experience of Medicare managed care
enrollees are consistent with reports from other
clinical trial sponsors regarding the lack of
participation of this group of seniors due to
economic barriers.
We understand that the Centers for Medicare &
Medicaid Services (CMS) has the ability to adjust
payments to managed care plans to reflect the
costs that may be associated with the National
Coverage Decision on routine patient care costs
in clinical trials. This adjustment is necessary
to ensure that beneficiaries will have access to
clinical trials according to the terms of their
managed care plans and not as fee-for-service
claims with 20% copayment. We urge CMS to
address this issue immediately. This will only
become a more significant issue if efforts to
boost enrollment in Medicare managed care plans
is successful.
**********
We appreciate the opportunity to comment on the
initiation of the process for reconsidering the
coverage decision on clinical trials, and we look
forward to the issuance of a decision memo in
early 2007. We consider the Medicare clinical
trials policy a work-in-progress and recommend
that no major changes be made in the scope of the
policy. The coverage policy has addressed the
reimbursement obstacle to clinical trials for
many Medicare beneficiaries, and cancer
organizations have redoubled their efforts to
remove additional barriers to clinical trials
participation. We urge CMS to use the
reconsideration process to address implementation
issues related to the coverage policy but not as
an opportunity to restrict Medicare
beneficiaries’ payment for routine patient care
costs in trials.
Sincerely,
Cancer Leadership Council
American Psychosocial Oncology Society
American Society of Clinical Oncology
American Society for Therapeutic Radiology &
Oncology
Association of American Cancer Institutes
Bladder Cancer Advocacy Network
C3: Colorectal Cancer Coalition
Cancer Care
Cancer Research and Prevention Foundation
International Myeloma Foundation
Lance Armstrong Foundation
The Leukemia & Lymphoma Society
The Lung Cancer Alliance
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
National Prostate Cancer Coalition
North American Brain Tumor Coalition
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Sarcoma Foundation of America
The Susan G. Komen Breast Cancer Foundation
Us TOO International Prostate Cancer Education
and Support Network
Y-ME National Breast Cancer Organization
cc: Leslye K. Fitterman, Ph.D.
Foonote 1: Laura F. Hutchins, et al.,
Underrepresentation of Patients 65 Years of
Age or Older in Cancer-Treatment Trials, 341
N. Eng. J. Med. 2061 (1999).
Footnote 2: Joseph M. Unger, et al., Impact of
the Year 2000 Medicare Policy Change on Older
Patient Enrollment to Cancer Clinical Trials,
24 J. Clin. Onc. 141 (2006)
Footnote 3: We believe the "Medicare and You"
handbook might be used more effectively to
educate Medicare beneficiaries regarding
Medicare policy on clinical trials coverage
and clinical trials enrollment opportunities,
and we would like to collaborate with the
agency in exploring this idea.
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