The Centers for Medicare and Medicaid Services said on Sept. 30 that it is soliciting comments on a proposal to cover laparoscopic sleeve gastrectomy for Medicare patients.
Currently, that procedure is not covered by the federal health program. In its solicitation, the agency said it is asking the public "whether there is adequate evidence, including clinical trials, for evaluating health outcomes of laparoscopic sleeve gastrectomy (LSG) for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination."
LSG is a procedure in which the vast majority of the stomach is removed, leaving a tube or sleeve. It may be a first step before a gastric bypass, or it may be the primary procedure. It is an option for patients with a very high body mass index (BMI) who cannot tolerate a bypass procedure. Postoperatively, patients do not experience dumping or malabsorption of nutrients. However, if weight is regained, the decision about what to do next is not easy (World J. Gastroenterol. 2008;14:821-7).
Medicare has covered three bariatric procedures since 2006: open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch.
The procedures are reimbursed only for Medicare beneficiaries who have a BMI of 35 kg/m2 or greater; who have at least one obesity-related comorbidity, such as cardiovascular disease, chronic obstructive pulmonary disease, or type 2 diabetes mellitus; and who have not been successfully treated otherwise.
In order to be covered, the procedures must be performed at facilities certified either by the American College of Surgeons (ACS) as a level I bariatric surgery center or by the American Society for Metabolic and Bariatric Surgery as a bariatric surgery center of excellence (BSCOE).
Open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, and open adjustable gastric banding are among the bariatric procedures that are not currently covered.
A recent observational study presented at the annual meeting of the American Surgical Association found that at 1 year after surgery, LSG was associated with morbidity and effectiveness rates that fell between those of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y bypass procedures.
The absolute reduction in BMI at 1 year was smallest in the laparoscopic adjustable gastric banding group at about 6, greatest with open or laparoscopic Roux-en-Y gastric bypass at about 15, and intermediate at close to 12 with LSG.
The study, based on prospective, longitudinal, standardized data from 109 hospitals, was the first to come out of the ACS Bariatric Surgery Center Network accreditation program. Additional years of follow-up are planned, according to Dr. Matthew M. Hutter, an ACS Fellow with Massachusetts General Hospital, Boston.
Dr. Hutter reported no financial conflicts.
CMS will seek public comment until Oct. 30. The agency plans to issue a proposed decision by March 30, 2012, and to make a final decision by June 30.