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Sapien Valve Reimbursement Begins Taking Shape, But Key Questions Remain

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifescience’s proactive reimbursement strategy for its market-pending Sapien transcatheter aortic valve appears to be progressing as planned, but questions remain about how Medicare coverage policies could ultimately affect adoption of the closely- watched technology.

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TAVR Gets Love, MitraClip Gets None In Medicare Inpatient Proposal

CMS proposes to grant new hospital inpatient payment categories for transcatheter valve replacements, a potential boon to Edwards’ and Medtronic’s devices. But the Medicare agency continues to stand firm against upgrading payment levels for Abbott’s MitraClip percutaneous mitral valve repair procedure.

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.

CMS Policy Sets Boundaries On Transcatheter Valve Procedure

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.

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