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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.
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:
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.