CareDx is one of the leading genomics companies, with a market cap today of $2.5B (here). Their pioneering product, covered by CMS since about 2008, was the ALLOMAP test, a test of WBC activation that can help manage heart transplant recipients. More recently, CareDx has had a major achievement in the commercialization of the AlloSure test, which detects DNA secreted from damaged graft kidneys and helps manage renal transplant rejection.
In a proposed decision memorandum released today, October 16, 2020, CMS announces it plans NOT to do an NCD on the Allomap test. CMS remarks in the procedural history, that an NCD had been requested in January 2013 (!) from Marc Halushka, Johns Hopkins.
CMS concludes that
We believe the proposed decision to continue to allow MACs to determine coverage of AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts is clinically appropriate and in the best interest of beneficiaries....due to the very low number of tests, which are used by << 1 percent of the Medicare population, and the need for careful patient selection, CMS believes that coverage of AlloMap is an appropriate determination made by the Medicare Administrative Contractors (MACs). The MACs are structured to be able to take into account local patient, clinician and institutional factors, which are important when the overall prevalence is low.
CMS proposes this position as a public comment period for 30 days.
See decision here:
Note the "comment" box in the header above.
See the tracking sheet here:
The PDF of the 2013 request letter (84pp with attachments) is online here:
https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id302.pdf
