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Clinical Trials--Private Insurance

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(September 12, 2000)

September 12, 2000

The Honorable J. Dennis Hastert
Speaker of the House
H-232 The Capitol
Washington, D.C. 20510

Dear Mr. Speaker:

As representatives of the cancer patient, survivor, provider and research communities, the undersigned organizations are writing to thank you for your commitment to pass a Patients' Bill of Rights this year. The cancer community has a well-known interest in the clinical trials provision. As negotiations continue, we urge your support for a strong provision that includes access to those trials privately sponsored by the pharmaceutical, biotechnology and medical device industries.

Privately-funded trials are among those most sought after by people with cancer because they feature the exciting new technologies that may offer the most hope of extending survival or improving quality of life. Their quality cannot be questioned as they are under review by the Food and Drug Administration (FDA).

It is worth noting that the Health Care Financing Administration (HCFA) has just issued a proposed National Coverage Decision that extends coverage of clinical trials under Medicare not only to government-sponsored research but also to trials by industry that proceed under an investigational exemption from FDA. This administrative decision was reached after the President issued an Executive Memorandum instructing that Medicare cover such trials, both those publicly funded and those funded by the private sector. If this scope of coverage is available for Medicare beneficiaries, we believe it unquestionably is appropriate for those enrolled in private health plans.

If the universe of privately-sponsored clinical trials is omitted from coverage, the Congress will have done only half of the job that is needed to address the concerns of cancer patients—and others with serious or life-threatening diseases—about access to potentially life-extending clinical trials. As you proceed with deliberations over the Patients' Bill of Rights, your support for this critical enhancement will be greatly appreciated.

Cancer Leadership Council

Alliance for Lung Cancer Advocacy, Support, and Education
American Cancer Society
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 Alliance of Breast Cancer Organizations
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

Patients' Bill of Rights Conferees

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