CLC Comments on Draft Decision Memorandum on Clinical Trials
(May 09, 2007)

May 9, 2007


RE: CAG-00071R

The undersigned members of the Cancer Leadership Council (CLC) represent cancer patients, providers and researchers throughout the nation. We are writing to express our deep concern over the proposal to change the “deemed status” of IND exempt trials, eliminating their automatic coverage by Medicare under the 2000 National Coverage Determination (NCD) on clinical trials.

Many CLC members have worked for years not just to achieve the Medicare policy on clinical trials but also to obtain passage of state legislation modeled after that policy. We are very disappointed to see that the Centers for Medicare & Medicaid Services (CMS) has deleted an important element of the policy, coverage for IND exempt trials, without offering a satisfactory justification. The Food and Drug Administration (FDA) has made a science-based decision that IND exempt trials do not require the same level of oversight as other trials, and CMS should respect that decision. These trials offer important treatment options for many patients, and they also provide incremental advances in our knowledge of how chemotherapy drugs may be best utilized. It is not insignificant that, as CMS acknowledges, every comment submitted on this topic advocated retaining the automatic coverage of IND exempt trials.

CMS committed to the development of a self-certification process for these trials, but no such process has emerged. We feel that it is not an acceptable response for CMS simply to abandon coverage for IND exempt trials without further consideration of methods for assuring that these trials are appropriately covered – though we firmly believe that FDA’s judgment on this issue should be controlling.

Finally, this category of trial has special – perhaps unique – significance for cancer treatment, and we urge CMS to seriously consider continuing the “deemed” coverage status of IND exempt cancer trials, even if a decision is made to eliminate coverage of other IND exempt trials.


Cancer Leadership Council

American Cancer Society
American Psychosocial Oncology Society
American Society of Clinical Oncology
C3: Colorectal Cancer Coalition
Cancer Care
Cancer Research and Prevention Foundation
Coalition of Cancer Cooperative Groups
International Myeloma Foundation
Kidney Cancer Association
Lance Armstrong Foundation
The Leukemia & Lymphoma Society
The Lung Cancer Alliance
Lymphoma Research Foundation
Multiple Myeloma Research Foundation
National Coalition for Cancer Survivorship
National Lung Cancer Partnership
National Prostate Cancer Coalition
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Sarcoma Foundation of America
Susan G. Komen for the Cure
Us TOO International Prostate Cancer Education and Support Network
Y-ME National Breast Cancer Organization

cc: Leslie Worwalk, Acting CMS Administrator
Leslye Fitterman, Ph.D., Lead Analyst