ACC Submits Comments on CMS Leadless Pacemaker Coverage Determination

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. Read more on