ASCO Applauds CMS For Maintaining Coverage Of Crucial Clinical Trials For Patients With Cancer

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 22 Oct 2007 - 4:00 PDT

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In a major victory for cancer care, the Centers for Medicare & Medicaid Services (CMS) stated yesterday that it would not change its clinical trials coverage policy. The American Society of Clinical Oncology (ASCO) and others in the cancer community have been urging CMS to continue coverage after the agency issued a proposal July 17 that threatened Medicare beneficiaries' access to clinical trials.

The draft proposal would have rescinded automatic Medicare coverage that began in 2000 for clinical trials funded by the federal government or conducted under Food and Drug Administration (FDA) review. The proposal would have required that sponsors or principal investigators self-certify that the clinical trial meets 13 scientific and technical standards set forth by CMS before the agency would approve coverage.

However, in a Decision Memo issued October 17, CMS stated that "after careful consideration, the Agency has decided that no change …is appropriate at this time and therefore, we are not imposing any additional conditions of coverage." CMS acknowledged some of ASCO's concerns with the standards in stating that it "will work with other HHS components in order to avoid imposing duplicative or inconsistent obligations."

"ASCO is pleased that CMS has opted to maintain its current clinical trials coverage policy, which has a record of success in providing improved access to promising new therapies for Medicare beneficiaries," said ASCO President Nancy Davidson, MD, director of the breast cancer program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland.

"Clinical trials make advances in cancer treatment possible. Because the majority of patients with cancer are over age 65, the proposed Medicare policy would have seriously impaired seniors' access to cutting-edge cancer therapies and our ability to advance cancer prevention treatment," Dr. Davidson added.

It is estimated that just 5% of cancer patients participate in clinical trials, in part because of lack of insurance coverage. In a letter to CMS in August, ASCO and others in the cancer community stated that revising the clinical trials coverage policy would be devastating not only to patients with cancer, but also to the clinical research enterprise as a whole. In addition, it would leave the Medicare program without the data it desires on the impact of new treatments on the Medicare-eligible population.

Members of Congress who joined ASCO in expressing their concern include Sens. Benjamin Cardin (D-MD) and Sam Brownback (R-KS), who, along with 15 of their colleagues, sent a letter to CMS calling on the agency to maintain automatic coverage for federally reviewed trials. In the House, Reps. Deborah Pryce (R-OH), Lois Capps (D-CA), Sue Myrick (R-NC), and Steve Israel (D-NY), co-chairs of the House Cancer Caucus, also sent a letter to CMS in opposition to the change in policy.

"We applaud those Members of Congress that stood up to fight for America's seniors, to ensure that they have access to a full range of cancer care," Dr. Davidson said.

The American Society of Clinical Oncology (ASCO) is the world's leading professional organization representing physicians of all oncology subspecialties who care for people with cancer. ASCO's nearly 25,000 members from the United States and abroad set the standard for patient care and lead the efforts to discover more effective cancer treatments, increase funding for clinical and translational research, and, ultimately, improve cancer care for the estimated 10 million people diagnosed with cancer worldwide each year. ASCO publishes the Journal of Clinical Oncology (JCO), the preeminent, peer-reviewed, medical journal on clinical cancer research, and produces People Living With Cancer, a comprehensive consumer website providing oncologist-vetted cancer information to help patients and families make informed health-care decisions.

American Society of Clinical Oncology