Latest Review Date: December 2023                     

Category: Surgery     

POLICY:

For dates of service on or after July 31, 2023:

I. Patient Selection Criteria: Initial Procedure

The surgical treatment of morbid obesity may be considered medically necessary 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) at initial evaluation 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; OR
    • BMI 30 kg/m²-34.9 kg/m² with type 2 diabetes mellitus, with inadequate glycemic control (HbA1c ≥8%) 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 at least 6 months of ongoing adherence to recommended behavior and nutrition modifications; AND
  • Compliance with recommended strategies to address identified personal barriers to making and continuing needed life changes; 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; AND
• Patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for a minimum of 6 weeks prior to 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 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, prolonged GERD causing esophagitis); 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 OR a BMI 30 kg/m² – 34.9 kg/m² with type 2 diabetes mellitus and inadequate glycemic control. (HbA1c ≥8%); AND
    • Evaluation by a mental health professional indicates any barriers to successful reoperation have been identified and addressed. AND
    • Patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for a minimum of 6 weeks prior to surgery.
• 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 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 (SG)
  • 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 investigational 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] single anastomosis duodeno-ileal bypass with sleeve gastrectomy [SADI-S])
  • Laproscopic gastric plication
  • Bariatric surgery (any procedure) for patients with a BMI < 30 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, Spatz3 Adjustable Gastric Balloon)
  • 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. AND
• Documentation that the patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy for a minimum of 6 weeks prior to surgery.

DESCRIPTION OF PROCEDURE OR SERVICE

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.

Despite limitations of BMI to accurately risk stratify patients with obesity for their future health risk, it is the most feasible and widely used criteria to identify and classify patients with overweight or obesity. The World Health Organization defines the terms overweight and obesity based on BMI thresholds. In certain ethnic populations the prevalence of diabetes and cardiovascular disease is higher at a lower BMI. Thus, BMI risk zones are adjusted to define obesity at a lower BMI threshold in certain populations.

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 and Spatz3® adjustable intragastric balloon (IGB). 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). The procedure utilizes the Apollo ESG, Apollo ESG Sx, Apollo REVISE, and Apollo REVISE systems that contain the OverStitch™ Endoscopic Suturing device.
  • Transpyloric Shuttle (TPS): is intended to treat obesity by slowing gastric emptying. The device consists 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).

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

POLICY HISTORY

Reviewed and posted July 1, 2021.

Reviewed and posted January 3, 2022

September 2022: Policy Statement updated to include additions to the Initial Procedure and Reoperation criteria. Policy Statement updated to include criteria pertaining to smoking status. Policy on draft September 16, 2022 through October 30, 2022.

December 2022: 2023 Annual coding update. Added CPT codes 43290 and 43291 to Current Coding section effective 1/1/2023.

June 2023: Updates to Description, Documentation Submission. Policy Statement updated to include criteria pertaining to use of smokeless tobacco and/or nicotine products, and/or nicotine replacement therapy. Policy Statement updated to include BMI 30kg/m² with type 2 diabetes with inadequate glycemic control. Policy Investigational list updated to include: Bariatric surgery (any procedure) BMI < 30 kg/m², and Spatz3 Adjustable Gastric Balloon. Policy on draft June 16, 2023 through July 30, 2023.

December 2023: 2024 Annual Coding Update. Added CPT code 0813T to the Current Coding section effective 2/19/2024.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.