CMS Policy Sets Boundaries On Transcatheter Valve Procedure

Article preview from "The Gray Sheet"-  May 7, 2012

New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.

CMS Policy Sets Boundaries On Transcatheter Valve Procedure

Article preview from "The Gray Sheet"-  May 7, 2012

A national Medicare coverage policy is now set for transcatheter aortic valve replacement, stabilizing the reimbursement environment for the new procedure, but also establishing a level of payer 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. CMS' reimbursement approach to the revolutionary technology may provide a window into how the agency will address future high-profile, early-stage technologies in an era of heightened concerns over costs and evidence.

The coverage decision is also one of the first to be completed under a 2010 memorandum of understanding between CMS and FDA allowing for enhanced data-sharing between the two agencies.

CMS finalized its coverage-with-evidence-development determination for transcatheter aortic valve replacement (TAVR) May 1, tweaking a February proposal in response to input from physicians and device companies.

 

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