Surgery for Diabetes? CMS Will Look At the Evidence For Coverage
Full article reprinted from "The Gray Sheet" - May 26, 2008
In response to media attention focused on bariatric surgery's potential to send diabetes patients into remission, a skeptical CMS said last week that it would consider whether a new national Medicare coverage policy was needed.
The national coverage analysis, opened May 19, will focus, in particular, on reviewing the evidence of the benefits of bariatric surgery in people with diabetes who are not considered morbidly obese by standard body-mass index (BMI) measures.
A CMS 1tracking sheet announcing the coverage analysis says such evidence is "scant" and cites the American Diabetes Association as urging caution in attributing a benefit.
According to the American Society for Metabolic and Bariatric Surgery, however, more than 30 studies support the effectiveness of bariatric surgery in the treatment of type 2 diabetes.
The procedure's effectiveness in obese individuals has been demonstrated in several recent studies, including a recent 55-patient trial led by John Dixon, Monash University Obesity Research Center, Melbourne, Australia, published in the Jan. 23 Journal of the American Medical Association. That study showed that laparoscopic adjustable gastric banding resulted in remission of type 2 diabetes in 73% of patients at two years ("2The Gray Sheet, Jan. 28, 2008, p. 16).
Arthur Meltzer, who will be CMS' lead analyst for this coverage determination process, told "The Gray Sheet" that he and colleagues will be looking primarily for data on the surgery's use in people with lower BMIs.
Media Reports Sparked Coverage Analysis
Meltzer said CMS decided to take this issue on after reading high-profile accounts of the value of surgery for people with type 2 diabetes in the popular press, including a page-one Washington Post article that ran earlier this month.
Bariatric surgical procedures include gastric bypass and laparoscopic adjustable gastric banding.
A national Medicare coverage policy finalized in February 2006 covers bariatric surgery for the treatment of morbid obesity in beneficiaries who have failed other weight loss treatments and have at least one comorbid condition (3"The Gray Sheet" Feb. 27, 2006, p. 9). The policy does not specifically address bariatric surgery as a diabetes treatment, so coverage in some cases is currently at the discretion of local Medicare contractors.
CMS is requesting public comments on its analysis before June 18. The agency plans to issue proposed decisions by Nov. 19, and finalize a policy in February.
Allergan (Lap-Band) and Johnson & Johnson/ Ethicon (Realize) offer laparoscopic adjustable gastric bands, while various firms make instruments such as staplers used in gastric bypass procedures.
- Sue Darcey
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