Medicare will not cover bariatric surgery for beneficiaries who have type 2 diabetes but do not have a body mass index greater than 35 kg/m
“While recent medical reports claimed that bariatric surgery may be helpful for these patients, [the Centers for Medicare and Medicaid Services] did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals,” according to a CMS statement.
Dr. Barry Straube, the agency's director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients whose BMI is less than 35 is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.” The proposal also clarifies that type 2 diabetes is one of the comorbidities that would be acceptable criteria for surgery.
In 2006, the CMS issued a national coverage decision for bariatric surgery in morbid obesity. That decision said that Medicare would cover only three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI greater than 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.
At that time, the agency then asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures to improve diabetes status among obese, overweight, and nonoverweight diabetes patients.
The proposed decision memo is an outcome of that query; the CMS accepted comments on the memo until mid-December. The agency has up to 30 days to issue a final decision memo. (The proposed memo is available online at www.cms.hhs.gov/mcd/index_list.asp?list_type=nca
Dr. Jeffrey Mechanick, who cochaired a bariatric surgery guidelines committee for the American Association of Clinical Endocrinologists, said the CMS was responding to a trend in the medical literature and meeting presentations suggesting that bariatric surgery might be helpful for diabetes patients who are not overweight.
“A lot of surgeons began noticing that after bariatric surgery, patients with diabetes had amelioration of their hyperglycemia,” he said. “At first glance, it seems pretty easy—you lose weight and so your diabetes should be getting better. But they found that a lot of the improvement was independent of weight loss; there was something else.”
The theories included two hypotheses: proximal changes, such as factors in the proximal small bowel, and distal changes, such as glucagonlike protein-1 and other factors made by the small bowel in the distal ileum, said Dr. Mechanick, who is also director of metabolic support in the division of endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine, New York.
He noted that although the CMS currently is not covering the surgery for patients with a BMI under 35, that could change if long-term follow-up data on the procedure became available.
Dr. Philip Schauer, past president of the American Society for Metabolic and Bariatric Surgery, said he was not disappointed with the proposed decision memo. To the contrary, “we in the surgical community were somewhat surprised this came up at all because our organization was not necessarily pushing CMS to address the issue,” said Dr. Schauer, who is director of the Bariatric and Metabolic Institute at the Cleveland Clinic.
“However, there is increasing evidence on bariatric surgery for patients with diabetes and BMI 30–34. When more of this evidence emerges, I think CMS will look at the issue again.”
Dr. Schauer said he was pleased that the agency reaffirmed its support for surgery for diabetes patients with the standard BMI threshold of 35 kg/m
Dr. Schauer was one of four organizers of the Diabetes Surgery Summit held in Rome in 2007 with the goal of developing consensus guidelines for gastrointestinal surgery to treat type 2 diabetes. The guidelines have been completed and were accepted for publication in the Lancet; they will probably appear early in 2009, he said. The guidelines affirm that uncontrolled type 2 diabetes patients with BMIs greater than 35 should be strongly considered for surgical intervention; they also state that for similar patients whose BMIs are less than 35 but greater than 30, surgery may be a reasonable option.
The American Diabetes Association is in agreement with the CMS proposal, a spokeswoman said. She noted that the association has stated that “people with type 2 diabetes and a BMI of 35 or above may be candidates for bariatric surgery.”