National Coverage Analysis (NCA) Tracking Sheet

Implantable Cardioverter Defibrillators (ICDs)



An ICD is implanted in a patient’s chest to monitor heart rhythm and deliver an electrical shock when a life-threatening ventricular arrhythmia is detected. CMS currently covers ICDs for several indications listed in CIM 35-85. CMS has received a request to expand these indications to include patients with a prior myocardial infarction and an ejection fraction of less than 30% without requiring evidence of arrhythmias. CMS will review the current policy and consider the requested indications.

Benefit Category

Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Guidant Corporation N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
07/01/2002 - N/A
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
JoAnna Baldwin
Lead Medical Officers
Joe Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

May 30, 2002

Request received and tracking sheet posted.

June 10, 2002

Benefit category determination under review.

July 1, 2002

This device was determined by the Center for Medicare Management to fall within the Prosthetic Device benefit category.

July 16, 2002

Medtronic Inc. submitted a request for coverage similar to the current request and will be subsumed within that request.

August 26, 2002

The due date will be extended to allow time for the requestor to provide additional information. CMS is also awaiting publication of updated guidelines for pacemaker and antiarrhythmia devices from the American College of Cardiology.

September 27, 2002

CMS has met with the requestor and with the ACC. Additional information in being provided by the requestor. The due date will be extended 60 days to review this information.

October 30, 2002

In the above "issue" section, CMS announced that it would review the current policy (CIM 35-85) and consider the requestor's new indications for ICDs. To clarify, CMS' intention was to review all past and present indications and we have been reviewing current evidence on all indications and receiving public comments on the same. Any additional comments on any indication in the current policy or any proposed indication continues to be welcomed.

November 14, 2002

CMS has received input from cardiology experts and professional associations indicating that uncertainty remains regarding how to identify patients who are likely to benefit from ICD therapy. Many experts have indicated that currently available evidence does not clearly support the practice of implanting ICDs in all patients who meet the MADIT II criteria. Therefore, CMS has decided to further explore this issue by convening a meeting of the Medicare Coverage Advisory Committee (MCAC). This forum will provide an opportunity for further public discussion of the published evidence, and for consideration of other evidence that may help define patient characteristics of those likely to benefit from ICD therapy. CMS is currently in the process of scheduling the MCAC meeting and will post information concerning the meeting when it becomes available.

January 14, 2003

The MCAC is scheduled for February 12, 2003 at the Baltimore Convention Center in Baltimore, MD. Please see the Federal Register Notice [PDF, 95KB] for more information.

Due date is 60 days after the MCAC signs the minutes from the meeting

[Date entered in Expected Completion Date field is an approximation.]

February 3, 2003

Materials [PDF, 146KB] prepared by CMS for the panel members, including evidence summaries and tables, are now posted on our web site.

February 4, 2003

Guidant Corporation has prepared a background document that was distributed to the MCAC panelists in preparation for the upcoming meeting. Guidant has made this document available on their web site at

February 6, 2003

The MCAC meeting agenda and panel roster are now available on our web site.

February 11, 2003

An updated CMS summary of evidence [PDF, 146 KB] including the conclusions from our consultant, is available on our website.

February 26, 2003

At the MCAC meeting on 2/12/03, Guidant presented new data from EP studies of the control group in the MADIT II trial. The attached letter [PDF, 111KB] to Guidant is a request for the complete MADIT II data set to include the new data presented to the MCAC as well as additional information on criteria used by referring physicians to refer patients into the trial. The current due date will be 60 days after receipt of that information.

[Date entered in Expected Completion Date field is an approximation.]

April 1, 2003

The transcript and minutes from the February 12 MCAC panel meeting are now available.

June 3, 2003

Response to public comment and Agency and Departmental review require a short amount of additional time

June 6, 2003

August 25, 2003

Updated Coverage Issues Manual section 35-85 posted with an effective date of October 1, 2003 for expanded coverage.