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Morbid obesity is associated with a reduction in life expectancy and significant comorbid medical conditions. Surgical intervention is considered a form of risk reduction in morbidly obese patients with serious medical problems. The decision to undergo surgical intervention is shared by the physician and patient and is based on factors such as the patient's present weight, weight loss history, physical and mental readiness, patient expectations and motivation, all of which are determined by a qualified team of professionals with integrated knowledge of medicine, surgery, psychiatry, nutrition and exercise.

Bariatric surgeries may be generally categorized as follows:

• Restrictive procedures
  • Adjustable gastric banding: A gastric band is placed around the exterior of the stomach. The band is attached to a reservoir that is implanted subcutaneously in the rectus sheath. The reservoir is injected with saline to alter the diameter of the gastric band. The stoma of the stomach can then be progressively narrowed to induce weight loss or expanded if complications develop. This procedure is most often performed laparoscopically but may be performed via an open incision.
  • Sleeve gastrectomy: The majority of the greater curvature of the stomach is removed and a tubular stomach is created. Sleeve gastrectomy can be performed as a standalone procedure or in combination with a malabsorptive procedure (e.g. biliopancreatic diversion with duodenal switch).
  • Mini-gastric bypass: A modification of the gastric bypass in which the stomach is divided using a laparoscopic approach. Instead of creating a Roux-en-Y connection, however, the jejunum is connected directly to the stomach.
  • Vertical banded gastroplasty: The stomach is divided vertically, with a band stapled around the top portion of the stomach. This creates a small pouch with an opening (stoma) at the distal end to allow food to pass from the pouch to the stomach and into the small intestines.
  • Laparoscopic gastric plication: This procedure is similar to the sleeve gastrectomy, but instead of transecting the stomach, gastric volume is reduced through a reversible plication of the greater curvature of the stomach.
• Combined restrictive/malabsorptive procedures
  • Biliopancreatic diversion with duodenal switch: The procedure is a combination of the sleeve gastrectomy and a long intestinal bypass, with the pylorus (the ring of muscle that connects the stomach with the duodenum) and the most proximal portion of the duodenum left intact.
  • Roux-en-Y Gastric bypass (RYGB): Through an open or laparoscopic approach, a small stomach pouch is created, and the remaining stomach remnant stapled off from the pouch. The intestine is divided into two limbs. The pouch is anastomosed to a Roux limb of jejunum. The pancreaticobiliary limb, consisting of stomach remnant, duodenum, and proximal jejunum, is anastomosed more distally to the Roux limb. This technique restricts food intake and reduces caloric absorption.
  • Long limb gastric bypass: A variation of the Roux-en-Y procedure, the pancreaticobiliary limb is again anastomosed to the Roux limb, but at a more distal location in the ileum.
  • Stomach intestinal pylorus-sparing [SIPS or single anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S)] involves an open or laparoscopic sleeve gastrectomy along with a simplified 1-loop duodenal switch.  This procedure may also be referred to as a one-anastomosis duodenal switch.
• Endoluminal procedures (list may not be all-inclusive)
  • AspireAssist® Weight Loss Therapy System: consists of a gastronomy tube and a "gravity" flow director system through which patients aspirate gastric contents directly into the toilet about 20 to 30 minutes after consumption of a meal. The system was FDA-approved in June 2016 and is intended for adults who are at least 22 years old and have a BMI of 35.0-55.0 kg/m² who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. It is intended for long-term use in conjunction with lifestyle therapy and continuous medical monitoring.
  • Duodenal-jejunal sleeve: These devices are designed to block absorption from the proximal small intestine. No devices currently have FDA approval.
  • Intragastric balloon: Several devices have been approved by the FDA including the Obalon Balloon System, Orbera® Managed Weight Loss System and ReShape™ Duo. These devices may be placed in the stomach via endoscope or swallowing to occupy space and induce satiety.
  • Primary Obesity Surgery, Endoluminal (POSE):  an endoscopic gastroplasty that uses tissue anchors to reduce the size of the stomach and its ability to stretch to accommodate a meal. The procedure uses the g-Cath EZ™ Suture Anchor Delivery Catheter to create a durable fold in the stomach.
  • StomaphyX™:  an endoscopic revision procedure following Roux-en-Y surgery in patients who have regained weight due to a stretched stomach pouch or enlarged stomach outlet.
  • OverStitch™: an endoscopic revision procedure in patients who have gained significant weight. The procedure is performed using a flexible endoscope and specialized device that allow sutures to be placed through the endoscope. Stitches are placed around the stomach outlet to reduce the diameter.This is frequently referred to as transoral outlet reduction (TORe).
  • Transpyloric Shuttle (TPS): is intended to treat obesity by slowing gastric emptying. The device consist of a large spherical bulb connected to a smaller cylindrical bulb by a flexible tether. A clinician endoscopically places the device in the patient’s stomach, where it self-positions across the pylorus to slow gastric emptying. The device is temporary and intended for endoscopic removal after 12 months. The FDA granted premarket approval (PMA) for the TPS device in April 2019.
• Reoperation 
  • Conversion: A second bariatric procedure that changes the bariatric approach from the index procedure to a different type of procedure (e.g., sleeve gastrectomy or adjustable gastric band converted to RYGB. Note: This is not to the same as an intraoperative conversion (e.g., converting from laparoscopic approach to an open procedure). 
  • Revision: A procedure that corrects or modifies anatomy of a previous bariatric procedure to improve the intended outcome or correct a complication. These procedures also address device manipulation (e.g., gastric pouch resizing, re-sleeve gastrectomy, limb length adjustments in RYGB and gastric band replacement).

I.   Patient Selection Criteria: Initial Procedure

The surgical treatment of morbid obesity may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients who meet ALL the following criteria:

• Meets one of the following:
  • Age 18 years or older; OR
  • Bone age of ≥ 13 years in girls or ≥ 15 years in boys; OR
  • Attainment of 95% of adult height based on estimates of bone age; 
• AND
• Body mass index (BMI) of ONE of the following: 
  • BMI of ≥ 40 kg/m² OR 
  • BMI of 35 kg/m² to < 40 kg/m² with AT LEAST ONE of the following comorbid conditions:
    • Hypertension refractory to standard treatment; OR
    • Cardiovascular disease; OR
    • Type 2 diabetes mellitus; OR 
    • Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) or other related treatment; OR 
    • Obesity-hypoventilation syndrome (OHS); OR
    • Pickwickian syndrome (a combination of OSA and OHS); OR
    • Nonalcoholic fatty liver disease (NAFLD); OR
    • Nonalcoholic steatohepatitis (NASH); OR
    • Pseudotumor cerebri; 
• AND
• Patient has been evaluated by an eligible licensed mental health professional within 12 months prior to the surgery. The mental health professional’s notes must document ALL of the following:
  • Absence of active substance use disorder; AND
  • If a mental health condition is present, it is under successful treatment; AND
  • Patient able to provide informed consent; AND
  • Personal barriers to making and continuing required life changes have been identified, and strategies to overcome those barriers have been recommended; AND
  • Family and social supports have been assessed, and strategies to strengthen those supports have been recommended; 
• AND
• Patient has actively participated in a preoperative program supervised by a physician, physician’s assistant, nurse practitioner/advanced practice nurse, or registered dietician. The supervising medical professional’s notes must document ALL of the following:
  • Correctable endocrine disorders and other medical conditions have been ruled out, or are under successful treatment; AND
  • Medications that may contribute to the patient’s obesity, such as antipsychotic medications, have been identified; AND
  • Patient has demonstrated consistency in adherence to recommended behavior and nutrition modifications; AND
  • Recommended strategies to address identified personal barriers to making and continuing needed life changes have been implemented; 
• AND
• Patient has completed a surgical preparatory program. The surgical preparatory program’s notes must document that the patient has been informed of BOTH of the following:
  • Required appointments with the surgery team the patient will need to attend before and after surgery; AND
  • Life changes patient must make and continue to make, including diet and exercise programs before and after surgery.

II.   Patient Selection Criteria: Reoperation

• Revision bariatric surgery OR conversion of one type of bariatric surgery to a different procedure may be considered MEDICALLY NECESSARY AND APPROPRIATE using one of the procedures identified in section III as medically necessary, for EITHER of the following indications:
  • Treatment of surgical complications or technical failures following the original bariatric surgery (e.g., staple line failure, band migration or slippage, pouch dilation, narrowing or constriction of the stoma); OR
  • Inadequate weight loss following the original surgery when ALL the following criteria are met:
    • At least two (2) years have elapsed since the original bariatric surgery; AND
    • Patient has been and continues to be compliant with the required appointments with the surgery team and the required life changes including diet and exercise recommended by the surgery team from the time of surgery up to the present time without any period of non-compliance; AND
    • Patient currently has a BMI ≥ 40 kg/m2 OR a BMI of 35 kg/m2 to < 40 kg/m2 with an obesity related comorbid condition as described in section I; AND
    • Evaluation by a mental health professional indicates any barriers to successful reoperation have been identified and addressed.
• Revision or conversion surgery is considered NOT MEDICALLY NECESSARY when performed for inadequate weight loss due to documentation of  individual noncompliance with prescribed postoperative nutrition and exercise.

III.  Surgical Procedures

• The following surgical procedures may be considered MEDICALLY NECESSARY AND APPROPRIATE in the treatment of morbid obesity when the previous patient selection criteria in section I have been met:
  • Open gastric bypass using a Roux-en-Y anastomosis with an alimentary or Roux limb of ≤ 150 cm
  • Laparoscopic gastric bypass using a Roux-en-Y anastomosis
  • Open or laparoscopic sleeve gastrectomy
  • Open or laparoscopic biliopancreatic diversion (i.e., Scopinaro procedure) with duodenal switch
  • Laparoscopic adjustable gastric banding, (i.e., Lap-Band® and REALIZE Band)
• Any other surgical or minimally invasive procedure is considered EXPERIMENTAL/INVESTIGATIVE as a treatment of morbid obesity including but not limited to the following due to the lack of evidence demonstrating an impact on improved health outcomes:
  • Open or laparoscopic vertical banded gastroplasty
  • Open adjustable gastric banding
  • Gastric bypass using a Billroth II type of anastomosis, known as the mini-gastric bypass one anastomosis gastric bypass (OAGB)
  • Biliopancreatic diversion (i.e., the Scopinaro procedure) without duodenal switch
  • Long limb gastric bypass procedure (i.e., > 150 cm)
  • Single anastomosis duodenal switch (i.e., stomach intestinal pylorus-sparing [SIPS] or single anastomosis duodenoileal bypass with sleeve gastrectomy [SADI-S])
  • Laproscopic gastric plication
  • Bariatric surgery (any procedure) for patients with a BMI < 35 kg/m² including but not limited to solely as a cure for type 2 diabetes mellitus
  • Endoluminal (also called endosurgical, endoscopic, sclerosing endotherapy or natural orifice transluminal endoscopic) procedure as a primary bariatric procedure or as a revision procedure by any method including but not limited to:
  • Aspiration therapy device (e.g., AspireAssist® Weight Loss Therapy System)
  • Duodenal-jejunal sleeve
  • Intragastric balloon therapy (e.g., Obalon, Orbera®, ReShape™ Duo systems)
  • Primary Obesity Surgery, Endoluminal (POSE)
  • StomaphyX™
  • OverStitch™
    
  • Transpyloric Shuttle

Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must be submitted:

1.    Initial Procedure

Documentation requirements described in Patient Selection criteria (section I) must be included in the prior authorization.

2.    Reoperation Procedure 

• Date of previous bariatric surgery or surgeries; AND
• Initial procedure(s) performed; AND
• ONE of the following:
  • Description of surgical complication(s) or technical failure; OR
  • If reoperation due to inadequate weight loss, clinic notes from the past 2 years including ALL of the following:  
    • Patient's current BMI; AND
    • Obesity-related comorbid conditions; AND
    • Record of psychological evaluation for reoperation; AND
    • Copy of the surgery team's standard required appointments after surgery including and documentation of the following at each visit: 
      • Patient's weight;
      • Patient's eating and exercise habits; 
      • Progress toward achieving life changes the patient was instructed to make.

Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-11/Bariatric-Surgery-Comm-Pre-Auth-Request-Form-Med-Policy-IV-19.pdf