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National Coverage Analysis (NCA) Tracking Sheet

Leadless Pacemakers

CAG-00448N

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Issue

CMS is initiating an NCA to establish a national coverage determination (NCD) for coverage of leadless cardiac pacemakers.

Conventional pacing systems consist of a pacemaker containing the electronics and battery typically implanted in a subcutaneous pocket in the chest. One or more leads are threaded from the device pocket through veins into the heart and conduct the pacing therapy to the desired pacing site. The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead, eliminating an important source of complications associated with traditional pacing systems while providing similar benefits. The scope of this NCA does not include conventional pacemakers.

CMS is soliciting public comment relevant to this NCA. We are particularly interested in comments that include scientific evidence.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Physicians' Services
Prosthetic Devices

Requestor Information

Requestor NameRequestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
05/18/2016
Expected NCA Completion Date
02/12/2017
Public Comment Period
05/18/2016 - 06/17/2016
Proposed Decision Memo Released
11/14/2016
Proposed Decision Memo Public Comment Period
11/14/2016 - 12/14/2016
Decision Memo Released
01/18/2017
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton, MHS
David Dolan, MBA
David.dolan@cms.hhs.gov
410-786-3365
Lead Medical Officers
Jyme Schafer, MD, MPH

Actions Taken

May 18, 2016

CMS initiates this national coverage analysis for Leadless Pacemakers. 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 clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

November 14, 2016

January 18, 2017
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