Oscar Bariatric Surgery (Adolescents) (CG009) Form

Morbid (clinically severe) obesity

Morbid (clinically severe) obesity is a condition in which body fat accumulates to a level that can cause or inhibit the treatment of life-threatening medical comorbidities. Initial treatment steps include a regimented plan of diet and lifestyle changes, often designed and supervised by a team of healthcare professionals.

Morbidly obese patients who have failed traditional treatment methods and are being treated for associated high-risk conditions including diabetes, hypertension, or obstructive sleep apnea, may be candidates for bariatric surgery.

Bariatric surgery procedures attempt to reduce fat tissue accumulation through restrictive or malabsorptive approaches and can often be performed as open or laparoscopic surgery.

Restrictive surgeries

Restrictive surgeries function by decreasing the effective size of the stomach, creating a sensation of early satiety and preventing the patient from intaking large meals.

Malabsorptive procedures

Malabsorptive procedures function by rearranging the flow of food through the digestive system to decrease overall digestion/absorption of calories. Some procedures combine restrictive and malabsorptive approaches.

Additionally, a comprehensive post-operative plan of diet, exercise, and behavioral modification is critical in achieving durable weight loss outcomes, where success is defined reduction in excess body weight by 50% and returning to within 30% of a patient's ideal body weight.

Treatment plans and surgical options differ for adults and adolescents [see CG008: Bariatric Surgery (Adults) for patients 18 years or older]. Bariatric surgery always requires prior authorization.

Definitions

• Body Mass Index (BMI) relates body weight to height, defined as body mass divided by body height squared in units of kg/m2 and is used to risk-stratify patients.
• Class I Obesity is defined as a BMI of 30 - 34.9.
• Class II Obesity is defined as a BMI 35 - 39.9.
• Class III Obesity is defined as a BMI ≥40.
• Bariatric is a term referring to the treatment of obesity.
• Open Surgery refers to a procedure where a large incision allows for direct visualization and access to intra-abdominal organs.
• Laparoscopic Surgery or minimally invasive surgery refers to a procedure often consisting of multiple small incisions allowing the use of a small camera (laparoscope) and several thin instruments.
• Bariatric Surgery is surgery on the stomach and/or intestines to assist with weight loss in patients with severe or extreme obesity (Classes II and III). It can be done via restrictive procedures, malabsorptive procedures, or a combination of the two.

Types of Bariatric Surgery Procedures

Restrictive Procedures

• Decrease digestive capacity, promote early satiety, and decrease the speed at which food moves through the digestive system.
• Sleeve Gastrectomy (SG) is where the greater curvature of the stomach is resected, resulting in a tube or sleeve-like shape to restrict capacity. This can be performed via open incision or laparoscopically. It can also be combined with malabsorptive surgery in a sequential 2-stage procedure or at a later date if adequate weight loss is not obtained.

Malabsorptive Procedures

• Reduce digestion and absorption of calories through re-arrangement of the digestive system:
• Gastric Bypass (Roux-en-Y Gastric Bypass [RYGB]) combines restrictive and malabsorptive features. The stomach is divided into either a horizontal or vertical plane similar to banded gastropathy (restrictive). The Roux-en-Y procedure then takes the small intestine and creates a "Y" shape, where the two legs of the "Y" allow a portion of food to pass through undigested while retaining a limited digestive capacity for the remaining food (malabsorptive). A gastric bypass can be performed via open incision or laparoscopically. Expected weight loss at two years is approximately 70%.

Other Surgical Information

• Repair refers to a procedure or operation performed to correct and/or treat a complication of a prior surgery.
• Conversion is when a prior procedure is converted to a new one—e.g., when there are complications or inadequate weight loss with the primary surgery such as sleeve gastrectomy conversion to Roux-en-Y gastric bypass.
• Revision refers to a procedure or operation performed due to failure of desired outcome of prior surgery or to reverse/adjust a prior surgery. It does not result in a new procedure, unlike conversion.

Clinical Indications

Procedures & Length of Stay

The Plan considers the following procedures, settings, and goal lengths of stay for the treatment of morbid obesity in adolescents (ages 13-17) medically necessary when criteria are met:

• Roux-en-Y gastric bypass (<150cm)
  • Open - 2 days inpatient admission
  • Laparoscopic - Ambulatory, which may include an overnight stay
• Sleeve gastrectomy
  • Open - 1 day inpatient admission
  • Laparoscopic - Ambulatory, which may include an overnight stay

An inpatient admission for a higher level of care with a laparoscopic approach may be considered medically necessary when the member meets MCG Ambulatory Surgery Exception Criteria (CG-AEC)i.

Length of Stay (LOS) Extensions

Subject to medical necessity review, the Plan may consider extensions for hospital admission under the following circumstances:

• Patients <18 years old
• In the presence of complex comorbidities (COPD, renal disease, heart failure)
• Conversion from laparoscopic to open procedure
• Complications in the peri- or post-operative phases, such as anastomotic leak, thromboembolic disease (DVT or pulmonary embolism), wound infection, suture line bleeding, pneumonia, respiratory failure, evisceration, or splenic injury
• Clear liquid diet not tolerated during the post-operative phase
• Failure to meet general discharge criteria as per MCG guidelines

Criteria for Medically Necessary Procedures

Procedures are considered medically necessary when ALL of the following criteria are met:

1. The end of provided text without specific criteria listed.

1. Both patient and parental/guardian informed consent with appropriate explanation of risks, benefits, and alternatives;
2. Adolescent aged 13-17 years who has achieved physical maturity, defined as 95% of the predicted adult stature based on bone age; or
3. The presence of obesity with severe comorbidities as meeting ONE of the following criteria:
   • BMI ≥ 40 or BMI ≥ 140% of the 95th percentile for age; or
   • BMI ≥ 35 or BMI ≥120% of the 95th percentile for age, and any ONE of the following comorbidities:
     1. Type 2 diabetes mellitus; or
     2. Moderate to severe sleep apnea (AHI > 15); or
     3. Pseudotumor cerebri; or
     4. Severe Non-Alcoholic Steatohepatitis (NASH); or
   • BMI ≥30 or BMI ≥95% to <120% of the 95th percentile for age, see Class I Obesity section below; and
4. Failure to achieve and maintain successful long-term weight loss via non-surgical therapy; and
5. The proposed bariatric surgery includes a comprehensive pre- and post-operative plan to evaluate nutritional status, overall health, and any specific surgical risks:
   • Preoperative evaluation to rule out and treat any other reversible causes of weight gain/obesity, which may include routine lab testing, screenings, and risk evaluations such as:
     1. Fasting blood glucose, fasting lipid panel, complete blood count (CBC), lipid/kidney function testing (Complete Metabolic Panel), blood typing, coagulation studies (PT/PTT/INR); or
     2. Nutrient deficiency screening (vitamin B12, iron, folate) and formal nutrition evaluation by a registered dietician or nutritionist; or
     3. Cardiopulmonary risk evaluation - to assess as part of standard pre-operative clearance with EKG, Chest X-Ray, and echocardiogram as appropriate based on medical comorbidities; or
     4. Endocrine evaluation - Hemoglobin A1c if diabetic, serum TSH if indicated at risk, and appropriate workup of endocrine abnormalities such as Cushing’s disease for suspected reversible causes of obesity as part of history and physical
   • Smoking cessation counseling, if applicable; and
6. Psycho-social behavioral evaluation performed by a licensed adolescent psychologist to specifically assess for ALL of the following:
   • The member’s emotional maturity; and
   • The member’s ability to succeed and adhere to postoperative recommendations and long-term follow up; and
   • Any major mental health disorders that would contraindicate surgery and/or negatively impact patient compliance with postoperative follow-up care and adherence to nutrition guidelines; and
   • No current substance abuse has been identified; and
   • Members who have any of the following conditions must also have formal, documented preoperative clearance by a licensed psychiatrist:
     1. A history of schizophrenia, borderline personality disorder, suicidal ideation, severe depression; or
     2. Who are currently under the care of a psychologist/psychiatrist; or
     3. Who are on psychotropic medications, as necessary in order to exclude; or members who are unable to provide informed consent or who are unable to comply with the pre- and post-operative regimen.

Members with Class I Obesity (BMI 30-34.9 or BMI ≥95% to <120% of the 95th percentile for age)

Please review member plan coverage documents (e.g., Evidence of Coverage) as coverage indications may vary. A recent joint statement by international diabetes organizations concluded that the current scientific evidence supports a benefit to metabolic surgery in some patients with Class I obesity (BMI 30 - 34.9) who have poorly controlled type 2 diabetes despite optimal medical therapy. In 2018, The American Society for Metabolic and Bariatric Surgery Pediatric Committee states metabolic and bariatric surgery should be offered to adolescents with obesity to reverse comorbidities and achieve overall wellness. However, they also acknowledge continued knowledge limitations related to this population, as most evidence for obesity class I with comorbid conditions are for the patient population 18-65 age group. As a result, the Plan will consider the medical necessity of bariatric surgery in members with a BMI of 30 - 34.9 who continue to have poorly controlled comorbidities despite adherence to optimal medical therapy on a case-by-case basis.

Repair, Removal, Revision, or Conversion Procedures

Please refer to the member’s plan documents for benefits

1. Repair is considered medically necessary when there is documentation of a surgical complication related to the original surgery, including:
   • Fistula
   • Erosion
   • Leakage of suture/staple line
   • Herniated band
   • Obstruction
   • Enlargement of the pouch due to complications of vomiting
     Note: Enlargement of pouch (stretching) is NOT covered if due to overeating, as this is not a surgical complication and is therefore not considered medically necessary.
2. Removal of an adjustable gastric band medically necessary when recommended by the member’s physician.
3. Revision of a primary bariatric surgery is considered medically necessary when ALL of the following criteria are met:
   • The procedure has failed due to dilated gastrojejunal stoma, dilation of the anastomosis site, or dilation of the gastric pouch; and
   • The initial surgery successfully resulted in weight loss; and
   • The member has been compliant with the postoperative plan of diet, exercise, and behavioral modification.
4. Conversion surgery to a sleeve gastrectomy or RYGB is considered medically necessary when there are complications that cannot be corrected or when ALL of the following criteria are met:
   • Meets all medical necessity criteria for bariatric surgery as defined above; and
   • Documented compliance with postoperative plan of diet, exercise, and behavioral modification; and
   • A minimum of 2 years following original surgery with documentation of inadequate weight loss:

5. If the member is requesting conversion surgery from a sleeve gastrectomy to a Roux-en-Y gastric bypass for the indications of Proton Pump Inhibitor (PPI) Refractory Gastroesophageal Reflux Disease (GERD), Barrett's esophagus, or biopsy proven dysplasia, then the following criteria must be met:
   • A biopsy documented Barrett's esophagus with high grade dysplasia (cancer risk 7% per year) confirmed by two separate pathologists refractory to maximal medical and endoscopic therapy; or
   • A biopsy documented Barrett's esophagus with low grade dysplasia (cancer risk 0.7% per year) confirmed by two separate pathologists refractory to maximal medical therapy, including ALL of the following:
     1. At least 3 months of prescription strength anti-secretory agents (e.g., omeprazole, pantoprazole, esomeprazole, etc.,); and
     2. At least 3 months of one of the following (unless contraindicated):
        1. Aspirin, nonsteroidal anti-inflammatory agents, or statins (HMG-CoA reductase inhibitors); and
     3. Failure of endoscopic therapy; or
   • A biopsy proven non-dysplastic or indefinite grade dysplasia confirmed by two separate pathologists that has progressed to biopsy proven dysplasia despite at least 1 year of maximal medical therapy as described above; or
   • PPI Refractory Gastroesophageal Reflux Disease (GERD) by meeting the following indications:
     1. Failure of at least 1 year of single dose prescription strength (not over the counter) anti-secretory treatment (e.g., PPI); and
     2. At least 8 weeks of dual prescription strength anti-secretory treatment (2 different PPIs taken together); and
     3. Biopsy proven erosive disease confirmed by separate two pathologists (e.g., esophagitis Los Angeles (LA) Grade C or D, peptic stricture requiring dilatation, Barrett's esophagus as described above); and
     4. One of the following:
        1. Failure of endoscopic therapy; or
        2. Failure of prior surgical therapy (e.g., surgical fundoplication, hiatal hernia repair, vagotomy).

Experimental or Investigational / Not Medically Necessary Procedures

Although the following may be medically necessary in adults meeting the appropriate criteria, there is a lack of clinical evidence and/or long-term data for the following procedures in morbidly obese adolescents:

• Laparoscopic adjustable gastric banding
• Biliopancreatic diversion with duodenal switch (open or laparoscopic)

The Plan considers the following procedures to be experimental, investigational or unproven as they have either not demonstrated long-term benefit, have unnecessary risks, or have demonstrated inferior outcomes to safer, more appropriate techniques:

• >150cm long limb gastric bypass (except for BPD with DS)
• Air-filled intragastric balloon or liquid-filled intragastric balloons (e.g., Orbera, ReShape)
• Aspiration therapy procedures
• Biliopancreatic Diversion (BPD) without duodenal switch
• Conversion of Gastric Sleeve to Roux-en-Y Gastric Bypass for Gastroparesis
• Gastroplasty (stomach stapling)
• Gastric plication (Laparoscopic)
• Endoscopic sleeve gastroplasty / endoluminal vertical gastroplasty
• Jejunoileal bypass
• Mini gastric bypass/one anastomosis gastric bypass/Billroth II
• Natural orifice transoral surgery (NOTES)
• Open adjustable gastric banding
• Prophylactic mesh placement to prevent incisional hernia after open bariatric surgery
• Silastic ring (Fobi pouch)
• Vagal blockade
• Vertical Banded Gastroplasty (VBG)

Skin Removal Surgery

Excess skin is common after a successful bariatric surgery. Unless MCG criteria is met, skin removal by abdominoplasty and/or panniculectomy is considered a cosmetic and elective procedure that is not medically necessary by the Plan.

General Contraindications

• Medically correctable cause of obesity
• Ongoing substance abuse or substance abuse in preceding 12 months
• Medical, psychological, psychosocial, or cognitive condition that prevents adherence to post-op dietary and medical requirements or impairs decision capacity
• Current or planned pregnancy within 12-18 months
• Inability of patient or parent to comprehend risks, benefits, and alternatives of surgical procedure
• Severe or poorly controlled psychiatric disorder or mental illness, as above
• Bulimia nervosa
• Any advanced stage neoplastic disease
• Diagnosis of inflammatory bowel disease
• Any medical condition requiring critical drug levels, such as in seizure or psychiatric illness, where malabsorption or changes in drug metabolism may result in serious consequences.