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Cancer Doctors Across America 'Stunned' at Government's Ruling Restricting Anemia Management Protocols for Cancer Patients, Call Ruling 'Interference' in Practice of Medicine

Limited Coverage Under Medicare Creates Two-Tiered System of Cancer Care in America; Cancer Patients on Medicare Face Avoidable Blood Transfusions

HOUSTON, Sept. 25 /PRNewswire-USNewswire/ -- US Oncology, the nation's leading oncology network representing over 1,100 oncologists across the country, today expressed "deep concern" over a letter released yesterday by the Centers for Medicare and Medicaid Services (CMS) -- the agency which manages the nation's Medicare program. US Oncology believes that this new government policy outlined in the letter severely interferes with cancer doctors' treatment protocols, creates a two-tiered system of cancer care in America, and potentially forces many cancer patients already undergoing chemotherapy treatment to undergo avoidable blood transfusions.

"CMS has reversed over 15 years of clinical experience in the treatment of Medicare patients with ESAs without offering appropriate scientific evidence to support such a drastic change" said Dan Cohen, US Oncology Senior Vice President of Government Relations & Public Policy. "This action ignores the substantial scientific evidence submitted during the course of the CMS review, and dramatically alters the standard of care for Medicare cancer patients"

ESAs are regarded as an integral drug as part of treatment protocols in cancer patients undergoing radiation and chemotherapy. ESAs, which are an injectable biologic, increase oxygen-carrying blood in patients who are anemia deficient due to chemotherapy treatments by naturally stimulating the body to produce more red blood cells. The alternative to ESAs are blood transfusions, which more cumbersome and carry various health risks, and could measurably reduce the nation's blood supply due to this policy, according to recent estimates.

Further highlighting the issue, the U.S. Food & Drug Administration (FDA) recently found ESAs safe and effective for hemoglobin levels up to 12 grams/dcl, while CMS will now only reimburse for ESAs for beneficiaries with hemoglobin levels up to 10 grams/dcl.

The letter, issued by Dr. Barry Straube, the chief medical officer of CMS, was addressed to the American Society of Hematology, US Oncology and the American Society of Clinical Oncology, and outlined limitations on coverage of erythropoietin stimulating agents (ESAs) for cancer patients. CMS stated that they would only reconsider amending the cancer National Coverage Determination (NCD) for ESAs if evidence is submitted within 30 days to challenge the ruling.

Physicians representing US Oncology expressed "serious concern" over this ruling, following an extensive presentation of clinical evidence initially challenging the CMS decision in July, and providing detailed evidence seeking a reconsideration of the policy. US Oncology, due to its size and reporting protocols is regarded as having some of the most accurate clinical data, provided their findings in several meetings and letters to officials within CMS.

US Oncology maintains that "CMS' decision is based on misinterpretation of current scientific data, and should be immediately revised. We have provided comprehensive, science-based answers to the questions posed by CMS," said Cohen. "The new policy overlooks that evidence, and will interfere with doctors' patient protocols and clinical judgment, thereby jeopardizing patient care."

US Oncology also believes that the new policy will create "two-tiers" of cancer treatment in America. Patients with private insurance will continue to receive appropriate ESA treatment based on universal clinical protocols developed and refined over more than two decades based on a trove of clinical outcomes data.

Under the new policy, Medicare beneficiaries risk dropping to hemoglobin levels oncologists regard as inappropriately low levels, and as a result, will risk being forced to undergo blood transfusions.

"Medicare beneficiaries who are battling cancer are already fighting for their lives. They should not have to also be battling Medicare coverage policy for treatments that their personal oncologists regard as necessary," concluded Cohen.

US Oncology, headquartered in Houston, TX, is one of the nation's largest cancer treatment and research networks. US Oncology provides extensive services and support to its affiliated cancer care sites nationwide to help them expand their offering of the most advanced treatments and technologies, build integrated community-based cancer care centers, improve their therapeutic drug management programs and participate in many of the new cancer-related research studies. US Oncology is affiliated with 1,122 physicians operating in 442 locations, including 90 radiation oncology facilities in 38 states.

SOURCE US Oncology
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