Medicare Coverage For Leadless Pacemakers
The Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination for leadless pacemakers. Responding to comments submitted by the ACC, in collaboration with the Heart Rhythm Society and the Society for Cardiac Angiography and Interventions, CMS finalized coverage that includes leadless pacemakers implanted in accordance with U.S. Food and Drug Administration (FDA)-approved label indications in prospective longitudinal studies. This builds on the initial proposal to cover leadless pacemaker implantation only for patients enrolled in FDA-approved clinical studies. Effectively, coverage was expanded from only post-approval studies to allow access to appropriate patients who are not at trial sites, if they are tracked prospectively in accordance with the coverage determination. Some of this can be done through claims data. CMS will issue claims processing instructions and additional guidance in the coming months.