Feds' ESA proposal draws howls of protest

June 25, 2007

Yet another group has come out against CMS for its proposal to withdraw coverage of erythropoiesis-stimulating agents (ESAs) for many uses.

Yet another group has come out against CMS for its proposal to withdraw coverage of erythropoiesis-stimulating agents (ESAs) for many uses. The Washington Legal Foundation (WLF) called CMS' proposal "arbitrary and capricious." In explanation, WLF said the FDA has approved the antianemia agents for many indications. Yet CMS did its own risk-benefit analysis and is proposing to stop covering the products for some indications that the agency has already approved. "Never before has the federal government threatened to deny coverage for FDA-approved uses of a drug or biologic," noted WLF chief counsel Richard Samp. In addition to WLF, Amgen and Ortho Biotech, which produce ESAs, have criticized CMS' proposal. In another development, the National Patient Advocate Foundation (NPAF) has joined the chorus of critics against CMS' proposal. NPAF represents cancer and other chronically ill patients.

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