CMS Obesity Coverage Proposal Includes Sunset Deadlines For CED Studies
This article was originally published in The Pink Sheet Daily
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.
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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.
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.
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