Effective 8/29/2017

The Centers for Medicare & Medicaid Services (CMS) has signaled its intent to cover leadless pacemakers through Coverage with Evidence Development (CED). Medicare covers leadless pacemakers when procedures are performed in certain FDA approved studies. Medicare will cover, in CMS-approved prospective long-term studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:

  • An associated ongoing FDA approved post-approval study; or
  • Completed an FDA post-approval study (Posted January 18, 2017)

Decision Memo for Leadless Pacemakers (CAG-00448N)