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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 ...

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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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...Unitedhealthcare commercial medical policy bariatric surgery number thh effective date may instructions for use table of contents page related policies coverage rationale minimally invasive procedures gastroesophageal documentation requirements reflux disease gerd and achalasia definitions obstructive central sleep apnea treatment applicable codes robotic assisted professional description services benefit considerations community plan clinical evidence u s food drug administration references medicare advantage summary history revision information obesity non surgical see the following are proven medically necessary treating biliopancreatic diversion with duodenal switch gastric bypass includes adjustable banding using open or laparoscopic approaches individuals years age refer to fda section additional sleeve gastrectomy vertical banded gastroplasty in adults one identified above is when all criteria met class iii ii presence more co morbidities o type diabetes cardiovascular coronary ...

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