National Coverage Analysis (NCA) Tracking Sheet

Microvolt T-wave Alternans

CAG-00293R

Issue

Microvolt T-wave Alternans (MTWA) testing is a non-invasive diagnostic test that detects minute electrical variability in a portion of the electrocardiogram known as the T-wave. Published articles in peer reviewed medical journals have described a role for this test in the stratification of patients who may be at risk of sudden cardiac death from ventricular arrhythmias.

Medical literature suggests that, within patient groups that may be considered candidates for implantable cardioverter defibrillator (ICD) placement, a negative MTWA test may be useful in identifying low-risk patients who are unlikely to benefit from, and who may experience worse outcomes from, ICD placement. The spectral analysis method and the modified moving average method are different ways to measure MTWA.

Currently, Medicare nationally covers only MTWA using the spectral analysis method. The requestor, GE Healthcare, is asking CMS to reconsider the NCD to broaden national coverage to include the modified moving average method.

National Coverage Determinations

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
GE Healthcare View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/17/2007
Expected NCA Completion Date
05/14/2008
Public Comment Period
08/17/2007 - 09/16/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/14/2008
Proposed Decision Memo Public Comment Period
02/14/2008 - 03/15/2008
Decision Memo Released
05/12/2008
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Lisa Eggleston
Stuart Caplan, RN MAS
Lead Medical Officers
Ross Brechner, MD MS MPH

Medicare Benefit Category Determination Date

Actions Taken

August 17, 2007

CMS opens this reconsideration of the NCD on MTWA testing. The formal request is to add the modified moving average method of determining MTWA to NCD Manual Section 20.30. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

February 14, 2008

The proposed decision memorandum is now available for 30 days of public comment. The comment period will end on March 15, 2008.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/02_publiccoments.asp#TopOfPage.

May 12, 2008