12:00 AM
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Aug 06, 2007
 |  BioCentury  |  Regulation

CMS a careful wordsmith

The Centers for Medicare & Medicaid Services narrowed the scope of how it will cover ESAs to treat anemia in cancer and related neoplastic conditions. Whether last week's change in policy is consistent with FDA's labels and the Medicare statute is another question entirely, but CMS looks to have carefully worded the document to avoid the appearance of stepping into FDA's turf.

In its final National Coverage Decision (NCD), effective July 30, CMS announced it would not reimburse the use of erythropoiesis stimulating agents for chemotherapy-induced anemia unless a patient's hemoglobin (Hb) level dips below 10 g/dL or hematocrit value falls below 30%. The product would be covered for four weeks after the initial ESA dose, but not thereafter if Hb rises above 10 g/dL and not longer than eight weeks after the final dose of myelosuppressive chemotherapy.

The policy is clearly more restrictive than the FDA-approved labeling for the drugs, which is to maintain the lowest Hb level sufficient to avoid the need for a blood transfusion without exceeding 12 g/dL. Thus, although FDA has approved ESAs for patients with Hb of 10-12 g/dL, CMS would not reimburse such use...

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