The ACC, in collaboration with the Heart Rhythm Society (HRS) and Society for Cardiac Angiography and Interventions (SCAI), submitted comments to the Centers for Medicare and Medicaid Services (CMS) recommending changes to its draft national coverage determination for use of leadless pacemakers. The societies critiqued the proposed coverage of patients in studies approved by the U.S. Food and Drug Administration (FDA) as too narrow. Instead, coverage was recommended for patients who fit FDA-approved indications using FDA-approved devices. This approach would allow access to patients who would benefit from technology already deemed safe and effective by the FDA while long-term post-approval studies are completed.

Comments from the presidents of HRS and SCAI and ACC President Richard A. Chazal, MD, FACC, called for collaborative work to ensure that patients are able to receive the most innovative treatment possible. “Physicians and patients should be able to thoroughly consider all available therapies that are appropriate, discuss the known risks and benefits at the current life cycle of the technology, and then make a documented decision on how to proceed. We encourage CMS and the vendor community to work together with societies to develop a robust and minimally burdensome mechanism to capture data needed to answer these questions without restricting access to this important new technology.”

CMS will consider public comments before issuing a final decision memorandum by Feb. 12, 2017.

Keywords: Pacemaker, Artificial, Medicaid, Centers for Medicare and Medicaid Services, U.S., United States Food and Drug Administration

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