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Washington Roundup, May 2012

Executive Summary

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.

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Medical Device Market & Industry Briefs, March 2012

Brief summaries of recent medtech market and industry developments. This month we cover new scrutiny of metal-on-metal hip implants, new developments in reimbursement for carotid artery stenting, and a new report on shifting hospital purchasing patterns.

Superiority Standard? Groups Bristle At CMS’ Transcatheter Valve Trial Proposal

Some worry that a provision in CMS’ proposed national coverage decision for transcatheter aortic valve replacement devices, which restricts coverage for off-label indications to trials designed to show superiority, signals the agency’s intent to play a more active role in dictating trial designs.

Cardiologists Push Back On Proposed Transcatheter Valve Credentialing Proposals

Clinicians say some of the procedural experience requirements proposed by CMS and societies as prerequisites for conducting transcatheter aortic valve replacements might overly limit access to the technology. ACC has made some revisions to its proposal in response.

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