Obesity, defined as a body mass index (BMI) ≥ 30 kg/m2, is recognized as an important risk factor. The Centers for Disease Control and Prevention (CDC) reported that obesity rates in the U.S. have increased dramatically over the last 30 years, and obesity is now epidemic in the United States (Kahn, 2009). For adults 60 years and older, the prevalence of obesity is about 37% among men and 34% among women (NHANES - National Health and Nutrition Examination Survey). Obesity may be further classified according to the NIH:
- Class I Obesity = BMI 30.0-34.9 kg/m²
- Class II Obesity = BMI 35.0-39.9 kg/m²
- Class III (Extreme) Obesity = BMI ≥ 40.0 kg/m²
The prevalence of Class II and III obesity is about 12% among men and 13% among women aged 60 years and older. (http://www.nhlbi.nih.gov/health/public/heart/obesity/lose_wt/bmi_dis.htm)
In 2006, CMS released a final National Coverage Determination (NCD) on Bariatric Surgery for the Treatment of Morbid Obesity. For Medicare beneficiaries who have a BMI ≥ 35, at least one co-morbidity related to obesity such as cardiovascular disease, chronic obstructive pulmonary disease or type 2 diabetes mellitus, and who have been previously unsuccessful with medical treatment for obesity, the following procedures were determined to be reasonable and necessary:
- open and laparoscopic Roux-en-Y gastric bypass (RYGBP);
- laparoscopic adjustable gastric banding (LAGB); and
- open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS).
In addition, the NCD stipulates that the above bariatric procedures be covered only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (BSCOE). The 2006 NCD specifically non covered open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, laparoscopic sleeve gastrectomy, and open adjustable gastric banding.
On August 22, 2011, we received an informal request for reconsideration of the Bariatric Surgery for the Treatment of Morbid Obesity NCD to review evidence for inclusion of sleeve gastrectomy as a covered procedure. Sleeve gastrectomy is a surgical weight-loss procedure in which the stomach is reduced to about 25% of its original size by surgical removal of a large portion of the stomach. The surgical excision follows the major curve of the stomach. The open edges are then attached together to form a sleeve or tube with a banana shape. The procedure is usually performed laparoscopically and is not reversible.
CMS will review available evidence on the use of laparoscopic sleeve gastrectomy (LSG) for the treatment of morbid obesity. We are particularly interested in receiving evidence speaking to the health outcomes attributable to the use of LSG in the Medicare population. As we are considering coverage under Section 1862(a)(1)(A) and Section 1862(a)(1)(E) of the Social Security Act, we also encourage the submission of comments that would pertain to clinical studies falling under the Coverage with Evidence Development (CED) paradigm.