National Coverage Analysis (NCA) Tracking Sheet

Implantable Defibrillators - Clinical Trials



CMS announced its decision to modify the covered indications for implantable defibrillators in a decision memorandum posted on the CAG website on June 6, 2003. In writing the instructions to implement the expanded coverage, CMS realized that interpretation of the decision memorandum may preclude our intention to allow for coverage of these devices in current and future Category B IDE clinical trials (60 CFR 48417) or in trials defined in CIM 30-1. It was not the intention of CMS to nationally disallow coverage of implantable defibrillators under these circumstances. CMS is reevaluating this language and will issue a decision memorandum addressing this clinical trial issue only. Public comments are welcome in the first 30 days of this process. We request that comments are restricted to this specific discussion.

Benefit Category

Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
09/11/2003 - 10/11/2003
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

August 11, 2003

CMS is opening the national coverage determination for implantable defibrillators to assess potential coverage of the device under Category B IDE clinical trials as set forth in 60 CFR 48417 or under the clinical trial policy outlined in CIM 30-1.

August 25, 2003

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

March 12, 2004

Decision memorandum is now posted which delineates our decision to allow coverage in certain clinical trials.