National Coverage Analysis (NCA) Tracking Sheet

AlloMap® Molecular Expression Testing For Detection of Rejection of Cardiac Allografts

CAG-00455N

Issue

CMS received a complete, formal request to establish a national coverage determination to non-cover AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts.

AlloMap® Molecular Expression (AlloMap®) Testing is an FDA-approved In Vitro Diagnostic Multivariate Index Assay (IVDMIA) test service performed in a single laboratory, assessing the gene expression profile of ribonucleic acid (RNA) isolated from peripheral blood mononuclear cells (PBMC). AlloMap Testing is intended to give physicians information on the risk of acute cellular rejection in their patients following heart transplant.

CMS is soliciting public comment relevant to the request.

National Coverage Determinations

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Marc Halushka MD, PhD, Department of Pathology, Johns Hopkins Medical Institutions View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/16/2020
Expected NCA Completion Date
01/14/2021
Public Comment Period
Proposed Decision Memo Due Date
Proposed Decision Memo Released
10/16/2020
Proposed Decision Memo Public Comment Period
10/16/2020 - 11/15/2020
Decision Memo Released
04/13/2021
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Heather Hostetler, J.D.
Heather.Hostetler@cms.hhs.gov
410-786-4515
Lead Medical Officers
Joseph Hutter, MD, MA

Medicare Benefit Category Determination Date

Actions Taken

October 16, 2020

CMS initiates this national coverage analysis and posts the proposed decision memorandum. The 30-day public comment period on the proposed decision begins with this posting date, and ends after 30 calendar days. CMS considers all public comments.

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

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

November 6, 2020

The benefit category and the Expected NCA Completion Date have been edited.

April 13, 2021