CMS Coverage Decision Based on FDA Parallel Review Program
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
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