The Centers for Medicare & Medicaid Services (CMS) announced on May 18 that it was initiating a national coverage analysis for leadless cardiac pacemakers.
In April, the FDA approved Medtronic’s Micra Transcatheter Pacing System, which is the first commercially available leadless intracardiac transcatheter pacing system in the U.S.
The public can make comments on the leadless pacemakers through June 17, according to CMS. It expects to complete the national coverage analysis by Feb. 16, 2017. CMS will assess the comments and evidence to establish a national coverage determination for coverage of the leadless pacemakers for Medicare and Medicaid patients.
“CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review,” the agency said.