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Case Detail


Proposed Restrictions on Medicare/Medicaid Coverage for ESAs
(Regulatory Proceeding)
On June 11, 2007, WLF filed comments with the federal Centers for Medicare and Medicaid Services (CMS), objecting to CMS's proposal to deny Medicare/Medicaid coverage for many uses of Erythropoiesis Stimulating Agents (ESAs), even uses that are FDA-approved. ESAs are a class of drugs approved by FDA for treating numerous types of cancer. Although ESAs are widely used, FDA has required them to be labeled with "black box" warnings that remind doctors of health concerns associated with their use. WLF argued that so long as FDA continues to conclude that the benefits of ESAs outweigh the risks, the Social Security Act prohibits CMS from second-guessing that conclusion by denying coverage for FDA-approved uses. WLF also argued that CMS's decision to deny coverage is bad for public health because it denies many patients access to the drugs their physicians believe are medically necessary.
Case Status:
Awaiting CMS response.
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