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National Coverage Analysis (NCA) Tracking Sheet for Cardiac Pacemakers (CAG-00063R2)

The language in CIM 65-6 does not accurately reflect the program’s intent with respect to the medical necessity for cardiac pacemakers. The present language speaks to “the medical necessity, or lack thereof, for pacemaker implantation….” However, the Medicare program denies coverage for devices or procedures that are either experimental or have proven harmful or not useful. In the case of cardiac pacemakers, the procedure used to implant the device is neither experimental nor routinely harmful. However, indications for the use of a pacemaker other than those outlined in CIM 65-6 may not have sufficient scientific evidence to support the use of the device for the new indication and therefore be considered experimental and noncovered. We are opening this NCD to solicit public comment and determine the appropriateness of modifying CIM 65-6 to remove the surgical procedure as the experimental part of the coverage determination.

Inpatient Hospital Services
Physicians' Services
Prosthetic Devices
Requestor Name(s)Internally generated
Formal Request Accepted and Review Initiated10/24/2003
Expected NCA Completion Date03/12/2004
Public Comment Period11/23/2003 - N/A
Decision Memo Released03/12/2004
Lead Analyst(s)
  • Anthony Norris
Lead Medical Officer(s)
  • Lori Paserchia, MD

October 24, 2003

CMS is opening the national coverage determination to solicit input as to the appropriateness of modifying CIM 65-6 to remove the reference to implantation as the experimental or covered entity.

March 12, 2004

Decision Memorandum posted which announces CMS's intent to modify CIM 65-6 to remove the surgical procedure as the experimental part of the coverage determination.
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