Latest Review Date: August 2024                     

Category: Surgery   

POLICY:

For dates of service on or after October 7, 2024:

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
    • Gastroesophageal reflux disease (GERD)
      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, not including nicotine replacement therapy* (NRT) for a minimum of 6 weeks prior to surgery.
• Initial bariatric surgery is considered investigational for all other indications, including when the above criteria are not met, due to the lack of clinical evidence demonstrating an impact on improved health outcomes

  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, not including nicotine replacement therapy (NRT) for a minimum of 6 weeks prior to surgery.
• Revision or conversion surgery is considered investigational when performed for inadequate weight loss due to documentation of individual noncompliance with prescribed postoperative nutrition and exercise.

Revision bariatric surgery is considered investigational for all other indications, including when the above criteria are not met, due to the lack of clinical evidence demonstrating an impact on improved health outcomes

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 also be submitted:

1.    Initial Procedure

• Documentation requirements described in Patient Selection criteria (section I) must be included in the prior authorization; AND
• Documentation that the patient is a never-smoker OR has abstained from smoking, use of smokeless tobacco and/or nicotine products (not including nicotine replacement therapy (NRT)) for a minimum of 6 weeks prior to surgery.

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 (not including nicotine replacement therapy (NRT)) for a minimum of 6 weeks prior to surgery.

For dates of service July 31, 2023 through October 6, 2024:

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 investigational 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).

*Nicotine: A highly addictive chemical compound present in a tobacco plant. All tobacco and non-tobacco nicotine (NTN) products contain nicotine. Examples of nicotine products include cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (e.g., dip, snuff, snus, chewing tobacco), hookah tobacco, e-cigarettes, and vape pens.

*Nicotine Replacement Therapy (NRT): Products designed to help individuals quit smoking by delivering small amounts of nicotine to the brain without the toxic chemicals found in cigarette smoke. Examples include skin patches, gum, and lozenges.

KEY POINTS:

Summary of Evidence

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. Initial guidelines for bariatric surgery focused on BMI with a later expansion to include comorbid conditions. Several new guidelines and treatment algorithms have been released that include bariatric surgery as an effective option in those with type 2 diabetes, a BMI of 30-34.9 kg/m², and inadequate glycemic control. The vast majority of published literature on bariatric surgery addresses the effectiveness of one procedure or compares effectiveness of various procedures. Criteria exists in guidelines and treatment algorithms for restrictive procedures, combined restrictive/malabsorptive procedures, endoluminal procedures, and reoperation/revisions. Pediatric and general guidelines detail treatment specific to the pediatric population.

The Swedish Obese Subjects (SOS) study, a case-control study with respect to outcomes from bariatric surgery, reported statistically significant long-term weight loss after different types of bariatric surgery (banding and gastric bypass) as compared to controls (non-surgical management). The study matched subjects at baseline on 18 variables, including gender, age, height, and weight. At eight years of follow-up, among 251 surgically treated patients, the average weight loss was 20 kg (or 16 percent of body weight) as compared to no change in the control group of 232 medically treated patients. Weight loss in the operated group ranged from 4.4-35kg. The SOS study, the only carefully-controlled trial with long-term results, also demonstrated that there was approximately 8-9 kg more sustained weight loss in gastric bypass as compared to VBG. Their results provided strong evidence of the superiority of surgical treatment for the patients that were enrolled (37–57-year-olds with an average BMI of about 41kg/m2). In the Swedish Obesity Study (SOS), ten-year follow-up of 1,006 post-bariatric surgery patients aged 37 to 57 years showed that the two-year incidence rates of diabetes, hypertension, and low high-density lipoprotein (HDL) were statistically significantly higher in the control group (diabetes 16% vs. 0.5%, hypertension 23% vs. 6.0%, and elevated HDLs 16% vs. 5.0%).

Müller-Stich et al published results of a meta-analysis in 2015 on use of surgery compared to medical treatment to treat T2DM in non-severely obese patients.  A systematic literature search identified RCTs and nonrandomized comparative observational clinical studies (OCS) evaluating surgical versus medical T2DM treatment in patients with BMI < 35kg/m 2. Study follow-up ranged from 12 to 36 months. T2DM remission was the primary outcome of included studies. Additional outcomes included glycemic control, change in BMI, HbA1C level, remission of comorbidities, and safety. Random effects meta-analyses were calculated and presented as weighted odds ratio (OR) or mean difference (MD) with 95% confidence intervals (95% CI).

Smoking cessation

Nolan and Warner (2015) authored a narrative review to discuss the current evidence for nicotine replacement therapy’s (NRT)efficacy and safety in patients scheduled for surgical treatment and other invasive procedures. Noting the lack of human trials, the authors stated that although available data are limited, there is no evidence from human studies that NRT increases the risk of healing-related or cardiovascular complications. Clinical trials of tobacco use interventions that include NRT have found either no effect or a reduction in complications. Authors concluded that given the benefits of smoking abstinence to both perioperative outcomes and long-term health and the efficacy of NRT in achieving and maintaining abstinence, any policies that prohibit the use of NRT in surgical patients should be reexamined.

In 2020, Stefan et al reported on a retrospective study (n=147,506). Researchers analyzed the association between nicotine replacement therapy (within 2 days of admission) and inpatient complications and outcomes. In the propensity-matched analysis, there was no association between receipt of NRT and in-hospital complications (OR, 0.99; 95% CI, 0.93-1.05), mortality (OR, 0.84; 95% CI, 0.68-1.04), all-cause 30-day readmissions (OR, 1.02; 95% CI, 0.97-1.07), or 30-day readmission for wound complications (OR, 0.96; 95% CI, 0.86-1.07). Authors concluded that this demonstrates that perioperative NRT is not associated with adverse outcomes after surgery. These results strengthen the evidence that NRT should be prescribed routinely in the perioperative period.

In 2023, Ashour et al published [online ahead of print] abstract information on a completed systematic review focusing on vaping exclusively. We are awaiting full-text availability of the findings, but the following conclusions are noted: Despite limited objective data, the recommendation is that e-cigarettes be treated as tobacco cigarettes; hence, vaping should be stopped in the perioperative period to decrease the incidence of wound healing complications. Vaping can significantly increase the risk of complications after surgery in ways comparable to smoking regular cigarettes. No matter the method of consumption, nicotine can greatly disrupt the body’s healing processes by negatively affecting:

Wound healing and scarring;

• The effectiveness of certain post-operative medications;
• The risk of infections after surgery;
• The body’s ability to deliver oxygen to vital organs and tissues; and
• The survival of healthy tissue, leading to an increased risk of necrosis.

Practice Guidelines and Position Statements

An update of the joint guidelines on support for bariatric surgery were published by the AACE, the Obesity Society, the American Society for Metabolic and Bariatric Surgery (ASMBS), Obesity Medicine Association, and American Society of Anesthesiologists. Recommendations on the following questions are summarized below.
“Which individuals should be offered bariatric surgery?”

• "Individuals with the following comorbidities and BMI≥35 kg/m2 may also be considered for a bariatric procedure, though the strength of evidence is more variable; obesity-hypoventilation syndrome and Pickwickian syndrome after a careful evaluation of operative risk; idiopathic intracranial hypertension; GERD [gastroesophageal reflux disease]; severe venous stasis disease; impaired mobility due to obesity, and considerably impaired quality of life."
• "Bariatric procedures should be considered to achieve optimal outcomes regarding health and quality of life when the amount of weight loss needed to prevent or treat clinically significant obesity-related complications cannot be obtained using only structured lifestyle change with medical therapy."

The 2023, the American Diabetes Association (ADA) “Standards of Care in Diabetes” published the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Recommendations included the following: Metabolic surgery may be considered as an option to treat type 2 diabetes in adults with BMI 30.0–34.9 kg/m² who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. “A” recommendation

American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) (2022)

• Metabolic Surgery (MBS) is recommended in patients with T2D and BMI  30 kg/m².
• Obesity definitions using BMI thresholds do not apply similarly to all populations. Clinical obesity in the Asian population is recognized in individuals with BMI 25 kg/m^2. Access to MBS should not be denied solely based on traditional BMI risk zones.

While the updated ASMBS statement endorses SADI-S as an appropriate metabolic bariatric surgical procedure, it states that studies of long-term safety and efficacy are still needed.

The World Health Organization defines the terms overweight and obesity based on BMI thresholds. In its consensus panel statement of 1991, the NIH stated that the “risk for morbidity linked with obesity is proportional to the degree of overweight.” In the Asian population the prevalence of diabetes and cardiovascular disease is higher at a lower BMI than in the non-Asian population. Thus, BMI risk zones should be adjusted to define obesity at a BMI threshold of 25–27.5 kg/m² in this population. Therefore, in certain populations, access to MBS should not be denied solely based on traditional BMI thresholds.

The American Association of Clinical Endocrinology (2022) notes that persons with BMI 30 to 34.9 kg/m² and T2D with inadequate glycemic control despite optimal lifestyle and medical therapy should be considered for a bariatric procedure.

In 2013, the Institute for Clinical Systems Improvement (ICSI) published health care guidelines on the prevention and management of obesity in adults. The following was included in the current indications for bariatric surgery:

• BMI >35 kg/m² with significant comorbidity (diabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease, gastroesophageal reflux, and pseudotumor cerebri)

The American Gastroenterological Association (AGA) Institute Clinical Practice Updates Committee has published Best Practice Advice. Statements presented were developed from expert review of existing literature combined with extensive discussion and expert opinion to provide practical advice. Formal rating of the quality of evidence or strength of recommendations was not the intent of this clinical practice update. The best practice advice recommendation important to this policy states the following: “In patients with proven GERD, Roux-en-Y gastric bypass is an effective primary anti-reflux intervention in obese patients, and a salvage option in non-obese patients, while sleeve gastrectomy has potential to worsen GERD.” (Best Practice Advice)

In 2008, the Endocrine Society published recommendations on the prevention and treatment of pediatric obesity. In 2017, the Society sponsored an update of these guidelines by the Pediatric Endocrine Society and the European Society of Endocrinology. These guidelines recommended the following:

“We suggest that bariatric surgery be considered only under the following conditions:

• The child has attained Tanner 4 or 5 pubertal development and final or near-final adult height.
• The child has a BMI > 40 kg/m² or has BMI above 35 kg/m² and significant, extreme comorbidities.
• Extreme obesity and comorbidities persist, despite compliance with a formal program of lifestyle modification, with or without a trial of pharmacotherapy.
• Psychological evaluation confirms the stability and competence of the family unit.
• There is access to an experienced surgeon in a pediatric bariatric surgery center of excellence that provides the necessary infrastructure for individual care, including a team capable of long-term follow-up of the metabolic and psychosocial needs of the individual and family.
• The individual demonstrates the ability to adhere to the principles of healthy dietary and activity habits.

We recommend against bariatric surgery for preadolescent children, for pregnant or breast-feeding adolescents (and those planning to become pregnant within 2 yr of surgery) and in any individual who has not mastered the principles of healthy dietary and activity habits and/or has an unresolved substance abuse, eating disorder, or untreated psychiatric disorder.”

In 2019, the American Academy of Pediatrics (AAP) published a report outlining the current evidence regarding adolescent bariatric surgery that provided recommendations for practitioners and policy makers. Within this report, AAP listed indications for adolescent metabolic and bariatric surgery that reflected 2018 ASMBS recommendations. Additionally, the AAP report noted that generally accepted contraindications to bariatric surgery included: "a medically correctable cause of obesity, untreated or poorly controlled substance abuse, concurrent or planned pregnancy, current eating disorder, or inability to adhere to postoperative recommendations and mandatory lifestyle changes."

In 2023, the AAP published their first evidence-based clinical practice guideline for the evaluation and treatment of children and adolescents (ages 2 to 18 years) with obesity. The recommendations put forth in the guideline are based on evidence from RCTs and comparative effectiveness trials, along with high-quality longitudinal and epidemiologic studies gathered in a systematic review process described in their methodology. The AAP's recommendation related to bariatric surgery is below:

• "Pediatricians and other PHCPs [pediatric health care providers] should offer referral for adolescents 13 years and older with severe obesity (BMI ≥ 120% of the 95th percentile for age and sex) for evaluation for metabolic and bariatric surgery to local or regional comprehensive multidisciplinary pediatric metabolic and bariatric surgery centers (Grade C Evidence Quality)."

In 2024, The National Comprehensive Cancer Network (NCCN) published guidelines on smoking cessation. The guideline states the following: Nicotine replacement therapy (NRT) is not a contraindication to surgery. There is no evidence that NRT degrades the wound-healing benefits of abstinence from smoking in humans. NRT offers benefits over continued smoking. NRT typically provides less nicotine than cigarettes, and nearly doubles the chance of smoking abstinence.

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:

REFERENCES:

1.   Alverdy JC, Prachand V. Smoking and postoperative surgical site infection: Where there's smoke, there's fire. JAMA Surg. 2017;152(5):484. doi:10.1001/jamasurg.2016.5706

2.   Armstrong SC, Bolling CF, Michalsky MP, et al. Pediatric metabolic and bariatric surgery: Evidence, barriers, and best practices. Pediatrics. Dec 2019; 144(6).

3.   Ashour O, et. al. The implications of vaping on surgical wound healing: A systematic review [published online ahead of print, 2023 Mar 29]. Surgery. 2023;S0039-6060(23)00092-2

4.   Blonde L, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a diabetes mellitus comprehensive care plan-2022 update [published correction appears in Endocr Pract. 2023 Jan;29(1):80-81]. Endocr Pract. 2022;28(10):923-1049.

5.   Busetto L, Dixon J, De Luca M, Shikora S, Pories W, Angrisani L. Bariatric surgery in class I obesity: a Position Statement from the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Obes Surg. 2014;24(4):487-519. doi:10.1007/s11695-014-1214-1

6.   Center for Disease Control and Prevention, Electronic Nicotine Delivery Systems, Electronic Cigarettes. July 12, 2021. Retrieved from: cdc.gov

7.   Chang S, et.al. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014;149(3):275–287.

8.   Coffin B, Maunoury V, Pattou F, et al. Impact of intragastric balloon before laparoscopic gastric bypass on patients with super obesity: a randomized multicenter study. Obes Surg. 2017;27(4):902-909. doi:10.1007/s11695-016-2383-x

9.   Eisenberg D, et. al., 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for metabolic and bariatric surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356.

10. Fan Chiang YH, Lee YW, Lam F, Liao CC, Chang CC, Lin CS. Smoking increases the risk of postoperative wound complications: A propensity score-matched cohort study. Int Wound J. 2023;20(2):391-402. doi:10.1111/iwj.13887

11. Fitch A, Fox C, Bauerly K, et al. Health Care Guideline: Prevention and management of obesity for children and adolescents. Institute for Clinical Systems Improvement. 2013; https://www.icsi.org/_asset/s935hy/ObesityAdults.pdf.

12. Grønkjær M, Eliasen M, Skov-Ettrup LS, et al. Preoperative smoking status and postoperative complications: a systematic review and meta-analysis. Ann Surg. 2014;259(1):52-71. doi:10.1097/SLA.0b013e3182911913

13. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity [published correction appears in Pediatrics. 2024 Jan 1;153(1):e2023064612. doi: 10.1542/peds.2023-064612]. Pediatrics. 2023;151(2):e2022060640. doi:10.1542/peds.2022-060640

14. Hayes, Inc. Clinical Research Response. OverStitch Endoscopic Suturing System (Apollo Endosurgery Inc.). May 2018. Lansdale, PA.

15. Hayes, Inc. Medical Technology Directory: Intragastric Balloons for Treatment of Obesity. March 2018. Lansdale, PA

16. Kallies K, Rogers AM; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. American Society for Metabolic and Bariatric Surgery updated statement on single-anastomosis duodenal switch. Surg Obes Relat Dis. 2020;16(7):825-830.

17. Liu D, Zhu L, Yang C. The effect of preoperative smoking and smoke cessation on wound healing and infection in post-surgery subjects: A meta-analysis. Int Wound J. 2022 Apr 22. doi: 10.1111/iwj.13815. Online ahead of print.

18. Lopez-Nava G, Sharaiha RZ, Vargas EJ, et al. Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up. Obes Surg. 2017;27:2649–55.

19. MacVicar S, Mocanu V, Jogiat U, et al. Revisional bariatric surgery for gastroesophageal reflux disease: characterizing patient and procedural factors and 30-day outcomes for a retrospective cohort of 4412 patients. Surg Endosc. 2024;38(1):75-84. doi:10.1007/s00464-023-10500-4

20. Madruga-Neto AC, Bernardo WM, de Moura DTH, et al. The effectiveness of endoscopic gastroplasty for obesity treatment according to FDA thresholds: systematic review and meta-analysis based on randomized controlled trials. Obes Surg. 2018 Jun 16. doi: 10.1007/s11695-018-3335-4.

21. Maggard-Gibbons M., et. al. Bariatric surgery for weight loss and glycemic control in non-obese adults with diabetes. JAMA 2013;309(21):2250–2261.

22. Müller-Stich BP, Senft JD, Warschkow R, et al. Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis. Ann Surg. 2015;261(3):421-429.

23. National Comprehensive Cancer Network. Smoking Cessation (Version 1.2024). https://www.nccn.org/professionals/physician_gls/pdf/smoking.pdf

24. Nolan MB, Warner DO. Safety and efficacy of nicotine replacement therapy in the perioperative period: a narrative review. Mayo Clin Proc. 2015;90(11):1553-1561. doi:10.1016/j.mayocp.2015.08.003

25. Saber AA, Shoar S, Almadani MW, et al. Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials. Obes Surg. 2017;27(2):277-287. doi:10.1007/s11695-016-2296-8

26. Sánchez-Pernaute A, Rubio MÁ, Cabrerizo L, Ramos-Levi A, Pérez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015;11(5):1092-1098. doi:10.1016/j.soard.2015.01.024

27. Schauer PR, Bhatt DL, Kashyap SR. Bariatric surgery versus intensive medical therapy for diabetes. N Engl J Med. 2014;371(7):682. doi:10.1056/NEJMc1407393

28. Slater BJ, Collings A, Dirks R, et al. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD). Surg Endosc. 2023;37(2):781-806. doi:10.1007/s00464-022-09817-3

29. Slater BJ, Dirks RC, McKinley SK, et al. SAGES guidelines for the surgical treatment of gastroesophageal reflux (GERD). Surg Endosc. 2021;35(9):4903-4917. doi:10.1007/s00464-021-08625-5

30. Sørensen LT. Wound healing and infection in surgery. The clinical impact of smoking and smoking cessation: a systematic review and meta-analysis. Arch Surg. 2012;147(4):373-383. doi:10.1001/archsurg.2012.5

31. Stefan MS, Pack Q, Shieh MS, et al. The association of nicotine replacement therapy with outcomes among smokers hospitalized for a major surgical procedure. Chest. 2020;157(5):1354-1361. doi:10.1016/j.chest.2019.10.054

32. Sjöström CD, Peltonen M, Wedel H, Sjöström L. Differentiated long-term effects of intentional weight loss on diabetes and hypertension. Hypertension. 2000;36(1):20-25. doi:10.1161/01.hyp.36.1.20

33. Tate CM, Geliebter A. Intragastric balloon treatment for obesity: Review of recent studies. Adv Ther. 2017;34(8):1859-1875. doi:10.1007/s12325-017-0562-3

34. U.S. Food and Drug Administration, Products, Guidance and Regulations. Updated June 3, 2020. Accessed June 7, 2023. https://www.fda.gov/tobacco-products/products-guidance-regulations

35. U.S. Food and Drug Administration. Tobacco, June 29, 2022. Retrieved from: www.fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends

36. van Wezenbeek MR, Smulders JF, de Zoete JP, Luyer MD, van Montfort G, Nienhuijs SW. Long-Term Results of Primary Vertical Banded Gastroplasty. Obes Surg. 2015;25(8):1425-1430. doi:10.1007/s11695-014-1543-0

37. Wong J, An D, Urman RD, et al. Society for Perioperative Assessment and Quality Improvement (SPAQI) Consensus Statement on Perioperative Smoking Cessation. Anesth Analg. 2020;131(3):955-968. doi:10.1213/ANE.0000000000004508

38. Yadlapati R, Gyawali CP, Pandolfino JE; CGIT GERD Consensus Conference Participants. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review [published correction appears in Clin Gastroenterol Hepatol. 2022 Sep;20(9):2156. doi: 10.1016/j.cgh.2022.05.005]. Clin Gastroenterol Hepatol. 2022;20(5):984-994.e1. doi:10.1016/j.cgh.2022.01.025

39. Zhao H, Jiao L. Comparative analysis for the effect of Roux-en-Y gastric bypass vs sleeve gastrectomy in patients with morbid obesity: Evidence from 11 randomized clinical trials (meta-analysis). Int J Surg. 2019;72:216-223. doi:10.1016/j.ijsu.2019.11.013

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.

August 2024: Updates to Description, Documentation Submission, Key Points added, and References added. Policy Statement updated to include Gastroesophageal reflux disease (GERD). Policy on draft August 19, 2024 through October 6, 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.