Regulatory Focus™ > News Articles > CMS Coverage Decision Based on FDA Parallel Review Program

CMS Coverage Decision Based on FDA Parallel Review Program

Posted 02 May 2012 | By Alexander Gaffney, RAC 

A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA).

"This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medical device industry," wrote CMS Acting Administration Marilyn Tavenner.

TAVR, used to treat patients with a damaged aortic heart valve, is being hailed by CMS as a minimally-invasive procedure that will benefit patients who are unable to undergo open heart surgery.

Under CMS's decision, any TAVR devices that receive pre-market approval from FDA and meet additional treatment criteria will be eligible for reimbursement.


Read more:

CMS - CMS to cover new technology for Medicare patients with heart valve damage

CMS - National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

CMS - Decision Summary

CardioSource - CMS Releases Official National Coverage Determination of TAVR

Forbes - CMS Issues National Coverage Decision for TAVR

Med Page Today - Medicare to Pay for TAVI

Modern Healthcare - Medicare to cover heart-valve procedure

FDA - FDA, CMS launch pilot program for voluntary parallel review of innovative devices


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