Washington Roundup, May 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on the new Medicare coverage policy for transcatheter aortic valve replacement and Medicare latest hospital inpatient payment proposal.

A national Medicare coverage policy is now set for transcatheter aortic valve replacement (TAVR), stabilizing the reimbursement environment for the new procedure, but also establishing a level of payor restrictions that is rare for a technology so early in its life cycle.

The TAVR procedure, an alternative to open heart valve surgery, is being touted as practice-changing by cardiologists and a blockbuster business opportunity for device companies. The Centers for Medicare and...

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