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Medicare In Brief

This article was originally published in The Gray Sheet

Executive Summary

LVAD coverage analysis: CMS will consider whether to expand national Medicare coverage for ventricular assist device destination therapy to match recently updated FDA labeling for Thoratec's HeartMate II, the agency said Feb. 22. The coverage analysis was opened in response to a request by Thoratec, which gained PMA approval in January for its next-generation left-ventricular-assist device to keep alive end-stage heart failure patients who are not candidates for transplant (1"The Gray Sheet" Jan. 25, 2010). The FDA-indicated destination therapy population for HeartMate II includes a broader set of heart failure patients and a lower duration requirement for prior failed therapies than what was approved for Thoratec's older-generation HeartMate XVE, the device that formed the basis of the current Medicare destination therapy coverage policy established in 2003. CMS will issue a proposal by August 22 on whether to expand coverage and a final decision by Nov. 20. Comments are due March 24
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