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Medicare ESA coverage to re-open?

Executive Summary

The American Society of Clinical Oncology is asking CMS to re-open its Medicare Part B national coverage determination on the use of erythropoiesis stimulating agents for non-renal disease patients, primarily cancer patients. In an Aug. 30 letter, ASCO asserts that CMS "materially misinterpreted the existing evidence" on ESAs "in several respects." For example, it says, studies supporting FDA approval "did not involve stopping administration of ESAs when the patient's hemoglobin exceeded 10 g/dL," which is the level where CMS said it will cease payment (1"The Pink Sheet" Aug. 6, 2007, p. 21). The NCD is also "inconsistent" with approved labeling and national guidelines, it adds. Amgen, which has had losses for its ESA product Aranesp as a result of the NCD, predicts that a number of stakeholders may look for ways to persuade CMS to take a second look at the topic (2"The Pink Sheet" Aug. 27, 2007, p. 14)...
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