National Coverage Analysis (NCA) Tracking Sheet

Transmyocardial Revascularization for Severe Angina

CAG-00004N

Issue

Transmyocardial revascularization (TMR) is a surgical technique which uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached by diseased or clogged arteries. This technique is used as a late or last resort for relief of symptoms of severe angina in patients with ischemic heart disease not amenable to direct coronary revascularization interventions, such as angioplasty, stenting or open coronary bypass.

We are reviewing material submitted by several manufacturers of lasers used in this procedure to determine medical effectiveness. We are also reviewing the meetings and findings of the FDA.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Internal N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
12/30/1998
Expected NCA Completion Date
12/30/1998
Public Comment Period
12/30/1998 - 01/29/1999
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
12/30/1998

Contacts

Lead Analysts
JoAnna Baldwin
Lead Medical Officers
Mitch Burken
Vilis Kilpe

Medicare Benefit Category Determination Date

Actions Taken

July 9, 1998

Met with PLC Medical Systems to discuss FDA status and data from clinical trials.

December 30, 1998

Decision Memo  posted.

December 19, 2002

Tracking sheet created as part of the rollout of the Medicare Coverage Database. This record pre-dates the national coverage determination process announced in the Federal Register on April 27, 1999. That redesigned process provided timeframes for addressing coverage issues and a formal public comment period. The dates on this tracking sheet reflect only the date of the decision memorandum.