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ESA Stakeholders May Find Clues About Medicare Revisions In Device NCDs

Executive Summary

Pharma stakeholders could face an uphill battle convincing CMS to revise its recent final Medicare national coverage determination for the use of erythropoiesis-stimulating agents for non-renal indications, unless they can cite newly available published data, CMS' history of NCD reconsiderations suggests

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Medicare ESA coverage to re-open?

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)...

Private Payers’ ESA Policies Will Differ From Medicare NCD – Amgen

Commercial insurers are unlikely to follow CMS' recent national coverage determination on erythropoiesis-stimulating agents for non-renal disease uses, Amgen is predicting

Medicare ESA Coverage Will Not Experiment With Clinical Trial Approach

CMS has abandoned the idea of limiting some uses of erythropoiesis-stimulating agents to a research trial setting, despite receiving public comments that the "coverage with evidence development" approach may be acceptable in some circumstances

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