Leadless Pacemakers

CMS covers leadless pacemakers only when implanted within CMS-approved Coverage with Evidence Development (CED) studies, including prospective longitudinal studies that comply with FDA labeling and post-approval study status. Covered studies must meet CMS's scientific integrity standards, address specified research questions (peri/post-procedural complications, long-term outcomes, effects of patient characteristics), be registered publicly, obtain informed consent, comply with human subjects regulations, and submit full protocols and reporting plans to CMS. Leadless pacemakers furnished outside CMS-approved CED studies are non-covered.

"CMS covers leadless pacemaker implantation only when the procedure is performed as part of a CMS-approved Coverage with Evidence Development (CED) study that is FDA-regulated or FDA-approved."

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