Reimbursement In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medicare will cover clinical trials of extracorporeal photopheresis in lung transplant recipients. Government Accountability Office reports on GPO oversight. More reimbursement news.
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Washington Roundup, January 2013
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.
CMS Redefines Coverage-With-Evidence-Development In Draft Guidance
The document replaces a 2006 guidance, making substantial changes in response to public comment and six years of experience with the policy. The policy allows for national Medicare coverage under the condition that data be collected on use of the item or service in Medicare beneficiaries.
CMS Obesity Coverage Proposal Includes Sunset Deadlines For CED Studies
Under a proposal, the Medicare agency would cover laparoscopic sleeve gastrectomy as a weight-loss surgery option only for patients enrolled in a qualifying clinical trial. In a new approach, CMS puts end dates on when coverage-with-evidence-development studies need to be approved and completed.