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CMS Policy Sets Boundaries On Transcatheter Valve Procedure

Final Coverage Plan Includes Compromise, But Maintains Evidence Development, Other Restrictions

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.

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...

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