Cardiac pacemakers are self-contained, battery-operated units that have one or more wire leads that are placed in one or more heart chambers and send electrical stimulation to the heart. In general, these devices are implanted to treat symptoms related to abnormal heart rate and/or rhythm, most commonly symptomatic bradycardia.
Section 20.8 of the Medicare National Coverage Determinations (NCD) Manual establishes conditions of coverage for permanent single-chamber and dual-chamber cardiac pacemakers. CMS received an external joint request from the Heart Rhythm Society and the American College of Cardiology for reconsideration of dual-chamber pacemaker coverage. CMS is opening this national coverage analysis to reconsider coverage indications for single-chamber and dual-chamber cardiac pacemakers. The scope of this reconsideration does not include biventricular pacemakers, pacemakers that stimulate more than two chambers, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors.
CMS initiates this national coverage analysis for reconsideration of Section 20.8 of the NCD Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.
CMS considers all public comments and is particularly interested in comments that include clinical studies and other scientific evidence.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.