On March 29, 2012, the Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memorandum regarding the request to include laparoscopic sleeve gastrectomy (LSG) as a treatment for morbid obesity for qualified Medicare beneficiaries.
According to the memo, the panel does not believe there is enough evidence at this time to include laparoscopic sleeve gastrectomy “as a covered use in the Bariatric Surgery for Treatment of Morbid Obesity National Coverage Determination (NCD).”
They go on to say, however, that “new, emerging data suggest that LSG for the treatment of obesity (BMI = or > than 35) may possibly provide health benefits for Medicare beneficiaries” and thus “we propose to cover LSG for the treatment of obesity (BMI = or > 35 kg/m2) for patients with at least one comorbidity when furnished in an approved clinical study under CED (Coverage with Evidence Development).”
The CMS opened the review on September 30, 2011. At that time, the agency requested public comments to determine “whether there is adequate evidence, including clinical trials, for evaluating health outcomes of laparoscopic sleeve gastrectomy for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination.” The initial 30-day public comment period closed on October 30, 2011.
During the initial 30 day comment period, CMS received 180 public comments. 179 of them supported the inclusion of LSG as a covered surgery in the bariatric surgery NCD.
The panel also made mention of the updated position statement of the American Society for Metabolic and Bariatric Surgery (ASMBS) to recognize sleeve gastrectomy “as an acceptable option as a primary bariatric procedure,” but went on to state that while the update had been posted on the ASMBS site it had not yet been published in a peer reviewed journal.
In conducting their review on whether to include laparoscopic sleeve gastrectomy as a planned stand alone procedure for the treatment of morbid obesity, the following question was considered by the panel:
- “Is the evidence sufficient to determine that laparoscopic sleeve gastrectomy improves health outcomes for Medicare beneficiaries who have a BMI equal or greater than 35 kg/m2, at least one comorbidity of obesity and have been previously unsuccessful with medical treatment for obesity?”
While the panel does not believe the evidence is sufficient at this time, they also believe that further studies may yet show that the LSG procedure can provide health benefits to the Medicare population and thus warrant coverage. To this end, they “propose to support the development of further research on the effectiveness of LSG for Medicare beneficiaries who have a BMI = or > 35 kg/m2 and at least one comorbidity only when furnished in a randomized controlled trial under the coverage with evidence development paradigm.”
Sleeve gastrectomy as a primary bariatric procedure is a fairly new practice. The operation involves reducing the size of the stomach in order to restrict food consumption and reduce hunger in order to facilitate weight loss in morbidly obese individuals. For many years, it was performed as the first part of a two-staged duodenal switch procedure in order to reduce risk in some patients – it was the restrictive gastric component to be followed up with a malabsorptive intestinal component at a later time.
Today, the use of sleeve gastrectomy as a stand-alone bariatric procedure is becoming increasingly popular with many surgeons and patients, as it seems to offer many of the benefits associated with other bariatric procedures (weight loss, health improvements, hunger control) without involving a medical implant (gastric band) or intestinal rerouting (gastric bypass). The procedure is now covered by some insurance companies as well, based on evidence gathered from the laparoscopic sleeve gastrectomy studies that have been done to date.
However, much of the available data supporting the use of LSG was excluded by the CMS panel for various reasons, including: small sample sizes (less than 50 study participants), too short of a follow-up period (less than 1 year), observational studies/lack of a control group, studies presented as abstracts or presentations and not published in peer reviewed medical journals, and articles not written in English. Also, the data was very limited on older adults, so the panel had to review evidence on health outcomes in younger populations.
At this time, the CMS is proposing further clinical studies and requesting public comments to the proposed decision. The panel will issue a final determination after consideration of the public comments and any additional evidence.
Source: CMS Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
Related Article: CMS Considers Coverage of Gastric Sleeve