COMMENTS ON
DRAFT NATIONAL COVERAGE DECISION ON CLINICAL TRIALS
(September 5, 2000)

September 5, 2000

VIA ELECTRONIC MAIL

Nancy-Ann Min DeParle
Administrator, Health Care Financing Administration
Department Health & Human Services
200 Independence Ave., S.W.
Room 314-G B HHH Bldg.
Washington, D.C. 20201

RE: Medicare Coverage of Clinical Trials

Dear Ms. DeParle:

The Cancer Leadership Council (CLC) includes organizations representing cancer patients, providers and researchers. The CLC has been involved in advocacy for coverage of routine patient care costs in cancer clinical trials for many years and is now gratified that the Health Care Financing Administration (HCFA) has taken the bold and creative step of implementing such coverage through a National Coverage Decision (NCD). We believe that the NCD is relatively straightforward, thorough and persuasive in its rationale. There are, however, several points that we perceive as requiring clarification.

First, we are aware that the intent of the drafters was to extend "deemed" coverage status to privately sponsored trials conducted under an investigational new drug (IND) exemption from the Food and Drug Administration (FDA) as well as to federally funded trials. Unfortunately, however, this result is not consistently conveyed in the NCD. The initial discussion of the trials presumed to be covered leaves the impression that only federally funded trials are eligible for coverage:

"Trials funded by certain Federal agencies, as described below, will be automatically deemed to receive Medicare coverage of routine costs as soon as this NCD takes effect. Other types of trials will be included later as the principal investigators certify that the trials meet criteria developed by a Federal multi-agency group that are based on the desirable characteristics that follow."

Subsequently, the NCD adds that "all trials of patients that are either conducted under an investigational new drug application (IND) or are exempt from having an IND under 21 CFR 312.2(b)(1) would have deemed status."

While we have no doubt that so-called IND trials are intended to qualify automatically for coverage, the inconsistency between the two above statements could result in confusion. In fact, several trade press accounts of the NCD have focused on the initial statement and reported that coverage extends only to federally funded trials. The NCD should be clarified by noting in both instances that IND trials enjoy the same "deemed" coverage status as federally funded trials.

In addition, we have some concern that the NCD's description of trials that are not considered covered may lead to questions about the status of phase I clinical trials in cancer and perhaps other life-threatening diseases. The NCD states, "Trials that are designed exclusively to test such things as toxicity or basic disease biology are excluded from coverage." Because phase I trials are traditionally viewed as solely for the purpose of assessing toxicity by administering the drug to healthy volunteers, this statement could be interpreted as excluding all phase I trials. Such a result would be very problematic for Medicare beneficiaries diagnosed with cancer, as phase I trials are viewed as valid therapeutic options for some patients. (A review article on the "Critical Role of Phase I Clinical Trials in Cancer Treatment," adopted by the American Society of Clinical Oncology and published in the Journal of Clinical Oncology, is attached.) Denying coverage for phase I clinical trials would be contrary to the intent and spirit of the NCD, and the language should be clarified to indicate specifically that phase I trials in cancer patients are to be covered.

Finally, we wish to commend HCFA for its attention to the issue of coverage for beneficiaries enrolled in Medicare+Choice plans. HCFA's proposal is entirely appropriate, as Medicare+Choice enrollees deserve the same access to clinical trials as those enrolled in the traditional Medicare fee-for-service program.

Once again, we thank you and your staff for your efforts in reviewing this very important issue and arriving at a policy that will help to ensure quality cancer care for Medicare beneficiaries.

Cancer Leadership Council

Alliance for Lung Cancer Advocacy, Support, and Education
American Society of Clinical Oncology
Association of American Cancer Institutes
Cancer Care, Inc.
Cancer Research Foundation of America
The Children's Cause, Inc.
Coalition of National Cancer Cooperative Groups
Colorectal Cancer Network
Cure For Lymphoma Foundation
International Myeloma Foundation
Kidney Cancer Association
The Leukemia & Lymphoma Society
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
The Susan G. Komen Breast Cancer Foundation
US-TOO International, Inc.
Y-ME National Breast Cancer Organization

Attachment

cc:
The Honorable William Jefferson Clinton, President of the U.S.
The Honorable Albert Gore, Vice President of the U.S.
The Honorable Donna Shalala, Secretary, HHS
Ruth Kirschstein, M.D., Acting Director, NIH
Jane E. Henney, M.D., Commissioner, FDA
The Honorable Connie Mack
The Honorable John D. Rockefeller
The Honorable Nancy L. Johnson
The Honorable Benjamin L. Cardin
The Honorable Ken Bentsen
The Honorable Henry A. Waxman

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