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UnitedHealthcare® Commercial Medical Policy Bariatric Surgery Policy Number: 2022T0362HH Effective Date: May 1, 2022 Instructions for Use Table of Contents Page Related Commercial Policies Coverage Rationale ....................................................................... 1 • Minimally Invasive Procedures for Gastroesophageal Documentation Requirements ...................................................... 2 Reflux Disease (GERD) and Achalasia Definitions ...................................................................................... 3 • Obstructive and Central Sleep Apnea Treatment Applicable Codes .......................................................................... 4 • Robotic-Assisted Surgery Policy, Professional Description of Services ................................................................. 6 Benefit Considerations .................................................................. 9 Community Plan Policy Clinical Evidence............................................................................ 9 • Bariatric Surgery U.S. Food and Drug Administration............................................ 51 References ................................................................................... 53 Medicare Advantage Coverage Summary Policy History/Revision Information ........................................... 63 • Obesity: Treatment of Obesity, Non-Surgical and Instructions for Use...................................................................... 64 Surgical (Bariatric Surgery) Coverage Rationale See Benefit Considerations The following bariatric surgical procedures are proven and medically necessary for treating obesity: Biliopancreatic diversion/Biliopancreatic diversion with duodenal switch Gastric bypass (includes robotic-assisted gastric bypass) Adjustable gastric banding (using open or laparoscopic approaches) for individuals > 18 years of age. Refer to the U.S. Food and Drug Administration (FDA) section for additional information Sleeve Gastrectomy (Vertical Sleeve Gastrectomy) Vertical banded gastroplasty In adults, bariatric surgery using one of the procedures identified above for treating obesity is proven and medically necessary when all of the following criteria are met: Class III obesity; or Class II obesity in the presence of one or more of the following co-morbidities: o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or o History of coronary artery disease with a surgical intervention such as coronary artery bypass or percutaneous transluminal coronary angioplasty; or o History of cardiomyopathy; or o Obstructive Sleep Apnea (OSA) confirmed on polysomnography with an AHI or RDI of >30 and The individual must also meet the following criteria: o Both of the following: Completion of a preoperative evaluation that includes a detailed weight history along with dietary and physical activity patterns; and Bariatric Surgery Page 1 of 64 UnitedHealthcare Commercial Medical Policy Effective 05/01/2022 Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc. Psychosocial-behavioral evaluation by an individual who is professionally recognized as part of a behavioral health discipline to provide screening and identification of risk factors or potential postoperative challenges that may contribute to a poor postoperative outcome or o Participation in a multi-disciplinary surgical preparatory regimen In Adolescents, the bariatric surgical procedures identified above are proven and medically necessary for treating obesity when all of the following criteria are met: Class III obesity; or Class II obesity in the presence of one or more of the following co-morbidities: o Type 2 diabetes; or o Poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or o Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of >30 and The individual must also receive an evaluation at, or in consultation with, a multidisciplinary center focused on the surgical treatment of severe childhood obesity. This may include adolescent centers that have received accreditation by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) or can demonstrate similar programmatic components. Revisional Bariatric Surgery using one of the procedures identified above is proven and medically necessary when due to a Technical Failure or Major Complication from the initial bariatric procedure. The following procedures are unproven and not medically necessary for treating obesity due to insufficient evidence of efficacy: Revisional Bariatric Surgery for any other indication than those listed above Bariatric surgery as the primary treatment for any condition other than obesity Bariatric interventions for the treatment of obesity including but not limited to: o Bariatric artery embolization (BAE) o Gastric electrical stimulation with an implantable gastric stimulator (IGS) o Intragastric balloon o Laparoscopic greater curvature plication, also known as total gastric vertical plication o Mini-gastric bypass (MGB)/Laparoscopic mini-gastric bypass (LMGBP) o Single-Anastomosis Duodenal Switch (also known as duodenal switch with single anastomosis, or stomach intestinal pylorus sparing surgery [SIPS]) ® o Stomach aspiration therapy (AspireAssist ) ® ® o Transoral endoscopic surgery (includes TransPyloric Shuttle (TPS ) Device, endoscopic sleeve gastroplasty) o Vagus Nerve Blocking (VBLOC®) Gastrointestinal liners (EndoBarrier®) are investigational, unproven and not medically necessary for treating obesity due to lack of U.S. Food and Drug Administration (FDA) approval, and insufficient evidence of efficacy. Documentation Requirements Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested. Bariatric Surgery Page 2 of 64 UnitedHealthcare Commercial Medical Policy Effective 05/01/2022 Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc. CPT Codes* Required Clinical Information Bariatric Surgery 0312T, 0313T, Medical notes documenting the following, when applicable: 0314T, 0315T, Member height 0316T, 0317T, Member weight 43644, 43645, Detailed weight and body mass index (BMI) history 43647, 43648, Diet history 43659, 43770, Co-morbidities 43771, 43772, Treatments tried, failed, or contraindicated; include the dates and reason for discontinuation (e.g., 43773, 43774, medications, diet, exercise, etc.) 43775, 43842, Psychological evaluation by a licensed behavioral health professional 43843, 43845, Nutritional consult 43846, 43847, Name of the facility where the procedure will be performed 43848, 43860, For subsequent bariatric surgery, also provide the following, when applicable: 43865, 43881, o Previous unsuccessful medical treatment 43882, 43886, o Initial bariatric surgery performed and date and subsequent results or complications that 43887, 43888, require further surgical intervention 64590, 64595 *For code descriptions, refer to the Applicable Codes section. Definitions Adolescent: Individuals 12-21 years of age (Hardin and Hackell [American Academy of Pediatrics], 2017). For the purposes of this policy, adults are considered >18 years of age. Body Mass Index (BMI): A person's weight in kilograms divided by the square of height in meters. BMI can be used as a screening tool but is not diagnostic of the body fatness or health of an individual (Centers for Disease Control and Prevention [CDC], 2017). The National Heart, Lung and Blood Institute’s (NHLBI) Practical Guide Identification, Evaluation and Treatment of Overweight and Obesity in Adults classifies the ranges of BMI in adults as follows: < 18.5 - Underweight 2 18.5 to 24.9 kg/m – Normal Weight 2 25-29.9 kg/m – Overweight 2 30-34.9 kg/m – Obesity Class I 2 35-39.9 kg/m – Obesity Class II 2 >40 kg/m – Extreme Obesity Class III The American Society of Metabolic and Bariatric Surgeons (ASMBS; Pratt et al., 2018), classifies severe obesity in adolescents as follows: th 2 Class II obesity – 120% of the 95 percentile height, or an absolute BMI of 35-39.9 kg/m , whichever is lower* th 2 Class III obesity – 140% of the 95 percentile height, or an absolute BMI of >40 kg/m , whichever is lower *Also as defined by the American Heart Association (Kelly et al., 2013). Multidisciplinary: Combining or involving several academic disciplines or professional specializations in an approach to create a well-trained, safe and effective environment for the complex bariatric patient. Building the multidisciplinary team includes staff such as the bariatric surgeon, obesity medicine specialist, registered dietician, specialized nursing, behavioral health specialist, exercise specialist and support groups (American Society for Metabolic and Bariatric Surgery (ASMBS) textbook of bariatric surgery). Obstructive Sleep Apnea (OSA): The American Academy of Sleep Medicine (AASM) defines OSA as a sleep related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA severity is defined as: Mild for AHI or RDI ≥ 5 and < 15 Bariatric Surgery Page 3 of 64 UnitedHealthcare Commercial Medical Policy Effective 05/01/2022 Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc. Moderate for AHI or RDI ≥ 15 and ≤ 30 Severe for AHI or RDI > 30/hr. For additional information, refer to the Medical Policy titled Obstructive and Central Sleep Apnea Treatment. Revisional Bariatric Surgery: Conversion – A second bariatric procedure that changes the bariatric approach from one procedure to a different type of procedure (e.g., sleeve gastrectomy or adjustable gastric band converted to Roux-en-Y [RYGB]). Note: This is not to the same as an intraoperative conversion (e.g., converting from laparoscopic approach to an open procedure). Corrective – A procedure that corrects or modifies anatomy of a previous bariatric procedure to achieve the original desired 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). Reversal – A procedure that restores original anatomy. (Mirkin, et al. 2021) Technical Failure or Major Complication: Potential issues related to bariatric procedures include but are not limited to the following: Bowel perforation (including adjustable gastric band erosion) Adjustable gastric band migration (slippage) that cannot be corrected with manipulation or adjustment. (Records must demonstrate that manipulation or adjustment to correct band slippage has been attempted.) Leak Obstruction (confirmed by imaging studies) Staple-line failure Mechanical adjustable gastric band failure Uncontrollable reflux related to sleeve gastrectomy Applicable Codes The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply. Coding Clarification: Utilize CPT code 43775 to report laparoscopic sleeve gastrectomy rather than the unlisted CPT code 43659. CPT Code Description 0312T Vagus nerve blocking therapy (morbid obesity); laparoscopic implantation of neurostimulator electrode array, anterior and posterior vagal trunks adjacent to esophagogastric junction (EGJ), with implantation of pulse generator, includes programming 0313T Vagus nerve blocking therapy (morbid obesity); laparoscopic revision or replacement of vagal trunk neurostimulator electrode array, including connection to existing pulse generator 0314T Vagus nerve blocking therapy (morbid obesity); laparoscopic removal of vagal trunk neurostimulator electrode array and pulse generator 0315T Vagus nerve blocking therapy (morbid obesity); removal of pulse generator 0316T Vagus nerve blocking therapy (morbid obesity); replacement of pulse generator 0317T Vagus nerve blocking therapy (morbid obesity); neurostimulator pulse generator electronic analysis, includes reprogramming when performed 43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less) Bariatric Surgery Page 4 of 64 UnitedHealthcare Commercial Medical Policy Effective 05/01/2022 Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
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