Transplant Experts Urge Caution As CMS Weighs Expanded LVAD Coverage
This article was originally published in The Gray Sheet
Executive Summary
Groups representing artificial heart transplant providers and researchers are advising CMS to make sure there is adequate clinical evidence before the agency expands Medicare coverage for left ventricular assist devices as a destination therapy for New York Heart Association Class IIIB patients
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Thoratec Unloads Dx Equipment Unit To Danaher To Help Fund VAD Efforts
Thoratec's divestiture of hospital and home diagnostic equipment maker International Technidyne Corp. to Danaher for up to $136 million will allow greater focus on the firm's core ventricular assist device business
Thoratec Unloads Dx Equipment Unit To Danaher To Help Fund VAD Efforts
Thoratec's divestiture of hospital and home diagnostic equipment maker International Technidyne Corp. to Danaher for up to $136 million will allow greater focus on the firm's core ventricular assist device business
Medicare In Brief
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