Summary Of Evidence

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Analysis of Evidence

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The sleeve gastrectomy (SG) is a surgical procedure performed in either an open or laparoscopic manner. The surgery involves excision of the lateral aspect of the stomach, leaving a much reduced, tubular stomach. When performed laparoscopically, the term laparoscopic sleeve gastrectomy (LSG) is used. Presently, LSG is being used as a stand-alone approach to bariatric surgery. By reducing gastric capacity, there is both short- and long-term weight loss. A stand-alone SG is sometimes referred to as an isolated SG. There are variations in the detail and technique for the SG procedure itself. LSG has been gaining popularity over the last few years with increased experience among surgeons and the procedure has taken its place among other bariatric surgical procedures for extreme obesity. Unlike some bariatric surgical procedures, this technique is irreversible.

Obesity, defined as a body mass index (BMI) ≥ 30kg/m²,  is recognized as an important risk factor for morbidity and mortality associated with a number of chronic diseases, such as heart disease and diabetes (Flegal, 2010). The Centers for Disease Control and Prevention (CDC) reported that obesity rates in the United States 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 National Institutes of Health (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 Centers for Medicare and Medicaid Services (CMS) has recognized the importance of screening and treating obesity and recently provided Medicare coverage for intensive behavioral therapy for obesity. CMS also has allowed national coverage for some bariatric surgical procedures for Class II and Class III obesity:

• 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) or gastric reduction duodenal switch (BPD/GRDS).

LSG was specifically not approved under past National Coverage Determinations (NCDs). Recently, under a national coverage analysis (Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity CAG-00250R2) CMS has made the decision to allow discretion for stand-alone LSG coverage to be at the local contractor level. Open SG is specifically not covered in the CMS NCD.

Palmetto GBA is concerned that there are no randomized controlled trials (RCTs) that specifically evaluated adults ≥ 61 years, few large scale trials on stand-alone LSG and few, if any, long-term trials. Palmetto GBA medical directors have also discussed the surgery with subject matter experts in our jurisdiction. Given the strengths and limitations of the evidence, Palmetto GBA will cover laparoscopic sleeve gastrectomy only when ALL of the following criteria are met:

• Patient has a BMI ≥ 35.0 kg/m² (Class II or Class III obesity)
• Patient has at least 1 co-morbidity related to obesity, and,
• Active participation within the last 12 months prior to bariatric surgery in a weight-management program that is supervised by a physician or other health care professionals. The weight-management program must include monthly documentation of ALL of the following components:
  
  • weight
  • current dietary regimen
  • physical activity (e.g., exercise program)

Physician-supervised programs consisting exclusively of pharmacological management are not sufficient to meet this requirement.

• A thorough multidisciplinary evaluation within the previous 6 months which includes ALL of the following:
  
  • an evaluation by a bariatric surgeon recommending surgical treatment, including a description of the proposed procedure(s)
  • a primary care provider referral
  • evaluation for bariatric surgery by a mental health provider including a statement regarding motivation and ability to follow post-surgical requirements
  • a nutritional evaluation by a physician or registered dietician
• For dates of service prior to September 24, 2013, LSG shall be furnished in a CMS approved bariatric facility.
• For dates of service on or after September 24, 2013 facility certification shall no longer be required for coverage of covered bariatric procedures.
• For a patient with age greater than 61 years: In recognition of both the need to provide obesity treatment and the potential for increased risk and decreased benefit in older patients, Palmetto will cover laparoscopic sleeve gastrectomy if, in addition to the criteria established above, the following are met:

1. In addition to the nutritional and psychological evaluation previously outlined in this local coverage determination (LCD), there must be evidence documented in the patient's medical record that the patient is able to personally understand the nature and potential complications of surgery and has the capacity to follow the postoperative care and nutritional requirements, and the patient must sign the informed consent personally.

2. Indications for surgery in this age group will include at least 1 of the following serious comorbidities:

• Diabetes Mellitus   
• Hypertension not well controlled with a single medication   
• Hyperlipidemia requiring more than 1 medication to manage   
• Joint Disease requiring surgical intervention 
• Gastroesophageal Reflux Disease (GERD) refractory to a 2 month trial of appropriate treatment and medications   
• Obstructive Sleep Apnea requiring CPAP, OR
• Potential organ transplant candidacy at a United Network for Organ Sharing (UNOS)-certified center whereby a BMI ≥ 35 is required.

3. Contraindications include:

• Dementia to the extent that self-care is precluded (including exercise and nutritional care)
• Requirement for Home Oxygen therapy
• Organ failure unless the patient is a transplant candidate to replace the failing organ at an UNOS certified-center.

The information above must be documented in the patient's medical record and available on request.