^{Washington, DC – Congressman Edolphus Towns, representing New York’s 10th Congressional District, released two letters.  These request the U.S. Department of  Health and Human Services (HHS) to release all documents related to the formulation of the July 30, 2007 National Coverage Determination (NCD) issued by the Centers for Medicare and Medicaid Services (CMS) on Erythropoiesis Stimulating Agents (ESAs) by September 30, 2007.  The Erythropoiesis Stimulating agents are used to treat the anemia caused by a weakened immune system.} 

^{On September 17, 2007, Congressman Towns sent a letter to HHS requesting documents from HHS, CMS and the Food and Drug Administration (FDA) on the CMS/NCD.  This request for information is to answer multiple questions raised by cancer patient and professional oncology groups about the validity and underlying science used to justify CMS’s flawed NCD policy.  The September 30th deadline has come and gone with no response from HHS.  This prompted Congressman Towns to send a second letter.}

^{The NCD establishes a new, restrictive coverage policy which is narrower than the FDA approved labeling.  The FDA has found ESAs to be safe and effective up to hemoglobin levels of 12 grams per deciliter, while the CMS policy sets a hemoglobin limit below 10 grams per deciliter. The coverage policy is in direct conflict with oncology clinical practice guidelines from the American Society of Clinical Oncology and the American Society of Hematology.}

^{“If CMS chooses to put cost savings over the needs of extremely sick cancer patients then we need to know,” said Congressman Towns. “I have yet to see from CMS a credible rationale for setting the hemoglobin level limit below 10 grams per deciliter and nothing in the FDA letter seems to support the CMS policy that ESAs should only be administered to patients who are below 10 g/dL,” Towns wrote in his October 18th letter.}

^{Dr. David H. Henry, a practicing oncologist and Vice Chairman and Associate Program Director of the Department of Medicine at the Pennsylvania Hospital in Philadelphia, agrees that the CMS policy of withholding ESA treatment at a hemoglobin level of 10 grams per deciliter is flawed.  "CMS' policy simply does not reflect best practices and standard of care for patients with chemotherapy-induced anemia, based on all of the evidence that has been rigorously reviewed by several organizations with experts in this field. "Patients will suffer accordingly as hemoglobin levels are allowed to drift lower before ESA treatment is started, leading to an increase in blood transfusions, and an overall decline in the cancer patient's quality of life", Dr. Henry concluded.}

^{“From this investigation I hope to learn what, if any, deliberations by CMS on the NCD were grounded in sound credible science,” commented Towns.  Release of these letters comes as bipartisan support continues to grow for House Joint Resolution 54 which would formally disapprove of the CMS NCD and force CMS to rescind its flawed policy.}

###

Return to Congressman Towns' website