National Coverage Analysis (NCA) Tracking Sheet

Microvolt T-wave Alternans

CAG-00293N

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 proposed 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.

We have received a formal and complete request to open this NCD and to provide standard national coverage for this technology.  It is the requestor’s perception that coverage varies across local contractor jurisdictions.  In accordance with Section 1862(l) of the Social Security Act, we have opened a national coverage analysis to determine if there is sufficient evidence that MTWA testing is reasonable and necessary for the diagnosis and treatment of Medicare patients.

National Coverage Determinations

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Cambridge Heart, Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/07/2005
Expected NCA Completion Date
03/21/2006
Public Comment Period
07/07/2005 - 08/07/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/21/2005
Proposed Decision Memo Public Comment Period
12/21/2005 - 01/21/2006
Decision Memo Released
03/21/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Stuart Caplan, RN, MAS
Lead Medical Officers
James Rollins, MD, MSHA, PhD

Medicare Benefit Category Determination Date

Actions Taken

July 5, 2005

CMS meets with the requestor.

July 7, 2005

CMS is opening an NCD to evaluate the use of MTWA testing in the Medicare population. CMS begins a national coverage determination review in response to an external request. We are interested in all public comments on its use. A 30-day public comment period opens. Instructions on submitting comments can be found at: https://www.cms.hhs.gov/coverage/8h.asp

August 5, 2005

Public comment period closes. CMS completes the posting of public comments to the coverage website. 28 comments received.

December 21, 2005

CMS is posting its Proposed Decision Memorandum for a 30 day public comment period.

March 21, 2006

CMS is posting its Final Decision Memorandum.