Obesity Device Makers Debate Merits Of CMS Gastric Sleeve Coverage Proposal
This article was originally published in The Gray Sheet
Allergan and Johnson & Johnson have differing responses to the Medicare agency’s proposal to require clinical trial participation in return for coverage of a laparoscopic sleeve gastrectomy procedure to treat obesity.
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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.
The findings come from two studies, including the randomized STAMPEDE trial, funded by Johnson & Johnson and the National Institutes of Health, comparing medical therapy with two forms of surgical treatment – gastric bypass or sleeve gastrectomy.
CMS is taking comments through Jan. 6 on implementation of CED policies as part of national coverage determinations, how CED impacts Medicare beneficiaries and how new approaches might maximize benefits.