Some companies, like Edwards Lifesciences, have been savvy about using CED to align FDA and CMS requirements. Edwards received FDA approval for its Transcatheter Aortic Valve Replacement (TAVR) procedure in November 2011, and several U.S. hospitals had been part of testing the procedure in clinical trials for the past five years. In a statement to DOTmed News, Edwards said: "As a general matter, device manufacturers today are increasingly expected to not only provide robust clinical data to support the safety and efficacy of new therapies, but also to demonstrate the impact to patients' quality of life as well as the overall value of the device."

Williams said manufacturers don't want to go through the FDA review process only to get to CMS and have them ask for more data. In addition, he said that CMS is receptive to this, opening up NCDs earlier and sometimes before FDA approval, "encouraging enhanced coordination between the two entities."


Avalere said in an official statement that this could also be a pathway for getting new products onto the market faster.

CMS will release final CED guidelines in early 2013. They are expected to stick by the most recent draft.

Back to HCB News

More Industry Headlines