Medtronic plc announced that the U.S. Centers for Medicare and Medicaid Services (CMS) will cover leadless cardiac pacemakers, as outlined in the agency's final National Coverage Determination (NCD). This decision will provide Medicare patient access to leadless pacemakers, consistent with the FDA-approved labeling for the devices, through Medicare's policy of Coverage with Evidence Development (CED). CED is a Medicare policy through which additional evidence must be collected as a condition of coverage. The leadless pacemaker decision will provide coverage for leadless pacemakers when procedures are performed in FDA-approved studies of leadless pacemakers and prospective longitudinal studies approved by CMS. Under the policy, Medtronic will seek coverage of the existing FDA-approved Micra Post-Approval Study (PAS) as a well as a new study being finalized to track longitudinal data on Micra patients in the Medicare population. Coverage for Micra will become effective upon approval of these studies by CMS.