Artificial heart CED decision
This article was originally published in The Gray Sheet
Executive Summary
CMS will nationally cover artificial hearts for patients with end-stage heart failure, but only if they are enrolled in an FDA-approved clinical trial that meets specified criteria, the Medicare agency announces May 1 in a coverage-with-evidence-development 1decision. The CED mirrors a February proposal (2"The Gray Sheet" Feb. 11, 2008, p. 8). The trials must address patient or facility characteristics that affect outcomes, average time to device failure, and/or the generalizability of the trial results to a broader population. The decision, which acknowledges the technology's promise, applies to SynCardia Systems' CardioWest temporary total artificial heart, approved in 2004, and Abiomed's AbioCor implantable replacement heart, approved in 2006. Artificial hearts had been explicitly non-covered by CMS since 1986
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