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National Coverage Analysis (NCA) Tracking Sheet for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3)

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.

Inpatient Hospital Services
Physicians' Services
Prosthetic Devices
Requestor Name(s)Bruce L. Wilkoff, MD FRS; Immediate Past President, Heart Rhythm Society; William A. Zoghbi, MD, FACC; President, American College of Cardiology
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated01/24/2013
Expected NCA Completion Date08/27/2013
Public Comment Period01/24/2013 - 02/23/2013
Proposed Decision Memo Released05/29/2013
Proposed Decision Memo Public Comment Period: 05/29/2013 - 06/28/2013 
Decision Memo Released08/13/2013
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Joseph Chin, MD, MS

January 24, 2013

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.

May 29, 2013

May 30, 2013

The correct due date for the final decision memo is August, 27, 2013 and the correct ending date for the comment period is June 28, 2013. We apologize for any inconvenience.

August 13, 2013

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