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.
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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.
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.
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.