National Coverage Analysis (NCA) Tracking Sheet

Cardiac Pacemakers

CAG-00063R2

Issue

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.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Physicians' Services
Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/24/2003
Expected NCA Completion Date
03/12/2004
Public Comment Period
11/23/2003 - N/A
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
03/12/2004

Contacts

Lead Analysts
Anthony Norris
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

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.