Medical Affairs Policy

Transcription

1 Service: Bariatric Surgery PUM Medical Affairs Policy Medical Policy Committee Approval 03/17/17 Effective Date 07/01/17 Prior Authorization Needed Yes Note: Many member health plans have a specific exclusion for bariatric surgery. Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, medical.policies@wpsic.com. Description: There is scientific evidence that bariatric surgery can be safe and effective in allowing individuals with severe obesity to lose substantial weight and improve their weight-related comorbidities, provided those patients are appropriately selected and participate in a comprehensive weight management program which includes appropriate medical, nutritional, and psychological care. Traditionally bariatric procedures have been classified as restrictive, malabsorptive, or both. Restrictive procedures (lap band, sleeve gastrectomy, vertical sleeve gastrectomy) reduce the volume of the stomach. Malabsorptive procedures (Roux-en-Y, gastric bypass, biliopancreatic diversion [BPD]) divert the flow of the nutrients/food and reduce the absorptive surface of the GI tract. These GI procedures cause weight loss by mechanisms involving complex neurohormonal pathways. Metabolic surgery (manipulation of a normal organ or organ system to achieve a metabolic goal) alters the gut-brain-adipose communication, potentially resulting in significant and sustainable weight reduction, improvement/remission of diabetes, obstructive sleep apnea, hypertension, dyslipidemia, and decreased mortality. Indications of Coverage: I. Gastric bypass, laparoscopic adjustable gastric banding, laparoscopic or open Roux-en-Y, biliopancreatic diversion (BPD), and Laparoscopic sleeve Page 1 of 11

2 gastrectomy are considered medically necessary when all the following criteria are met: A. Age 18 and over, with a body mass index (BMI) greater than 40 OR Age 18 and over, with a BMI greater than 35 with one of the following comorbid conditions: 1. Coronary artery disease with evidence of previous CABG or PCI (percutaneous coronary intervention), or obesity-related cardiomyopathy 2. Diabetes Mellitus 3. Hypertension: difficult to control (defined as hypertensive despite a maximum dose of 3 antihypertensive agents) while compliant with medical therapy 4. Sleep apnea that requires Positive Airway Pressure (PAP) treatment (e.g. Obstructive Sleep Apnea or Obesity Hypoventilation Syndrome diagnosed by a sleep medicine specialist) 5. Pseudotumor cerebri 6. Degenerative joint disease with prior total joint arthroplasty or documentation of need for joint replacement 7. Metabolic syndrome 8. Gastro-Esophageal Reflux Disease (GERD) B. Documentation of complete history and physical (including evaluation and treatment of obesity related comorbidities, BMI history, history of previous weight loss attempts, and evaluation of surgical risks. Cardiac, pulmonary, endocrine, and GI evaluation is obtained as indicated. Note: For a member with COPD, documentation includes surgery recommended in consultation with the member s treating pulmonologist. C. Nutritional evaluation: (by a Registered Dietician) that includes all the following: 1. Minimum of three visits within the past 12 months Page 2 of 11

3 2. Initial clinical nutrition evaluation (may include micronutrients) 3. Instruction for post-surgery diet 4. Documentation that there is a reasonable expectation based on the evaluation and adherence to the pre-surgical program, that the member will be able to comply with the post-surgical diet plan. D. Documentation of a psychological evaluation that assesses appropriateness for surgery, issues related to addiction, and ability to comply with the pre-and postoperative program. If the member is receiving treatment for an active behavioral health disorder, clearance from the treating provider is required with documentation that the patient s psychiatric illness has been optimally treated. E. Documentation that, within the past 12 months, there has been at least six months (three consecutive) of participation in a professionally supervised multidisciplinary weight loss program. Documentation must consist of actual progress notes for the dates of participation in the program. This documentation must include weight data as well as documentation that diet, exercise, and behavior modification were addressed. Participation which is summarized in the form of a letter is not acceptable. Appropriate documentation is: 1. Dated progress notes from one of the professionals (physician, dietician, or weight-loss professional) supervising diet, exercise, and behavior modification at least once every four to eight weeks during the six-month period with clear evidence that weight reduction management was the primary service provided to the patient on that date. F. Surgery must be performed by a credentialed bariatric surgeon. Note: Repeat bariatric surgery requires physician review (when it is not an exclusion of the policy or health plan). II. Bariatric surgery on an individual under 18 years of age requires physician review. Services must be performed in a pediatric bariatric surgery center of excellence that provides the necessary infrastructure for patient care, including a team capable of longterm follow-up of the metabolic and psychosocial needs of the patient and family, and treatment must be consistent with the recommendations in the Endocrine Society Clinical Practice Guideline published in the Journal of Clinical Endocrinology and Metabolism available at click here. Page 3 of 11

4 Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. B. If used for a condition/diagnosis other than is listed in the Indications of Coverage, deny as experimental, investigational, and unproven to affect health outcomes. C. If used for a condition/diagnosis that is listed in the Indications of Coverage but the criteria are not met, deny as not medically necessary. D. Bariatric surgery for the management and treatment of GERD, gallbladder disease, or diabetes, osteoarthritis, gallstones, urinary stress incontinence, or gastroparesis without meeting all the above criteria, is considered experimental or investigational as there is insufficient peer-reviewed medical literature documenting the effectiveness of these procedures for the management of these conditions. E. Bariatric surgery for treatment of non-alcoholic steatohepatitis with advanced fibrosis, Non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH) with or without meeting all the above criteria, is considered experimental, investigational, and unproven to affect health outcomes. Results regarding postoperative outcomes are conflicting. F. Routine cholecystectomy (removal of the gallbladder) at the time of bariatric surgery, without documentation of preoperative identification of gallbladder disease is considered incidental to the bariatric surgery. G. The following bariatric procedures are considered experimental or investigational as there is insufficient peer-reviewed medical literature documenting the effectiveness of these procedures over standard bariatric procedures: 1. Intragastric balloon (e.g. Orbera Intragastric Balloon System, Reshape Integrated Dual Balloon System) 2. Gastric plication 3. Electrical neuromodulation, Gastric electrical stimulation with an implantable gastric stimulator (IGS) 4. Vagal blockade / Vagus Nerve Blocking (VNB) (e.g. Maestro Rechargeable System) 5. Endoluminal vertical gastroplasty Page 4 of 11

5 6. Implantable gastric pacing 7. Endoscopic gastrointestinal bypass device 8. Mini-gastric bypass or Laparoscopic Mini-gastric bypass 9. Gastrointestinal liners-endoscopic gastrointestinal bypass devices (EGIBD) (EndoBarrier ) 10. Transoral Endoscopic Surgery 11. Restorative Obesity Surgery, endoluminal (ROSE) procedure 12. Aspire Assist (Aspiration Therapy) device 13. Vertical Banded Gastroplasty H. Bariatric surgery is considered not medically necessary if any of the following conditions are documented: 1. Current drug abuse/alcohol abuse within the last three months 2. Terminal disease 3. Chronic obstructive pulmonary disease unless surgery is recommended in consultation with the member s treating pulmonologist 4. Active untreated eating disorder or untreated psychiatric disorder 5. Cognitive impairment that would interfere with patient s ability to comply with the post-operative treatment plan Documentation Required: Office notes Psychological evaluation report X-rays (if applicable) Page 5 of 11

6 References: 1. Andrews R, Lim R, Surgical Management of Severe Obesity. UpToDate Last updated Jan 31, American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE). AACE/ACE position statement on the prevention, diagnosis and treatment of obesity (1998 revision). Jacksonville, FL: AACE; Available at: Accessed: 5 Jan American Society for Bariatric Surgery. Guidelines for granting privileges in bariatric surgery. Revised October Available at: Accessed: 5 Jan American Society for Bariatric Surgery. Rationale for the surgical treatment of morbid obesity. Updated November 3, Available at: Accessed: 5 Jan Anthone GJ. The duodenal switch operation for morbid obesity. Surg Clin North Am Aug; 85(4): Anthone GJ, Lord RV, DeMeester TR, Crookes PF. The duodenal switch operation for the treatment of morbid obesity. Ann Surg Oct; 238(4): BlueCross BlueShield Association (BCBSA) Technology Evaluation Center (TEC). Laparoscopic Adjustable Gastric Banding for Morbid Obesity. TEC Assessment Program. Vol. 21, No. 13. Chicago, IL: BCBSA; Feb Available at: Accessed: 5 Jan Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA Oct 13; 292(14): Buchwald H; Consensus Conference Panel. Consensus conference statement bariatric surgery for morbid obesity: health implications for patients, health professionals, and third-party payers. Surg Obes Relat Dis May Jun; 1(3): Center for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD): Bariatric Surgery for Treatment of Morbid Obesity. NCD Baltimore, MD. Effective date: 02/12/09, 09/24/13. Available at: Accessed: 5 Jan 11. Page 6 of 11

7 11. Center for Medicare and Medicaid Services (CMS). National Coverage Analysis (NCA): Surgery for Diabetes. CAG-00397N. Proposed Decision Memo. Nov 17, Available at: Accessed: 9 Jan Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev Apr 15 ;( 2):CD Fobi M, Lee H, Igwe D Jr, Felahy B, James E, Stanczyk M, et al. Prophylactic cholecystectomy with gastric bypass operation: incidence of gallbladder disease. Obes Surg Jun; 12(3): Franz MJ, VanWormer JJ, Crain AL, Boucher JL, Histon T, Caplan W, Bowman JD, Pronk NP. 15. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc Oct; 107(10): Garb J, Welch G, Zagarins S, Kuhn J, Romanelli J. Bariatric surgery for the treatment of morbid obesity: a meta-analysis of weight loss outcomes for laparoscopic adjustable gastric banding and laparoscopic gastric bypass. Obes Surg Oct; 19(10): Livingston EH. Complications of bariatric surgery. Surg Clin North Am Aug; 85(4):853-68, vii. 18. Mason EE, Renquist KE. Gallbladder management in obesity surgery. Obes Surg Apr; 12(2): National Institutes of Health, National Heart, Lung and Blood Institute, Expert Panel on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. Executive Summary. Bethesda, MD: National Institutes of Health; September Available at: Accessed: 5 Jan O Brien PE, Dixon JB. A rational approach to cholelithiasis in bariatric surgery: its application to the laparoscopically placed gastric band. Arch Surg Aug; 138(8): O Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium term weight loss after bariatric operations. Obes Surg. 2006; 16(8): Page 7 of 11

8 22. O'Rourke RW, Andrus J, Diggs BS, Scholz M, McConnell DB, Deveney CW. Perioperative morbidity associated with bariatric surgery: an academic center experience. Arch Surg Mar; 141(3): Parikh MS, Laker S, Weiner H, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic bariatric procedures. Am Coll Surg Feb; 202(2): Epub 2005 Dec Shekelle PG, Morton SC, Maglione MA, Suttorp M, Tu W, Li Z, et al. Pharmacological and surgical treatment of obesity. Evidence Report/Technology Assessment No Rockville, MD: Agency for Healthcare Research and Quality; 2004 Jul. Available at: Accessed: 5 Jan Sreenarasimhaiah J. Prevention or surgical treatment of gallstones in patients undergoing gastric bypass surgery for obesity. Curr Treat Options Gastroenterol Apr; 7(2): Strain GW, Gagner M, Pomp A, Dakin G, Inabnet WB, Hsieh J, Heacock L, Christos P. Comparison of weight loss and body composition changes with four surgical procedures. Surg Obes Relat Dis Sep-Oct; 5(5): Tice JA. California Technology Assessment Forum. Duodenal Switch Procedure for the Treatment of Morbid Obesity. 2004, Feb. Available at: Accessed: 5 Jan Villegas L, Schneider B, Provost D, Chang C, Scott D, Sims T, et al. Is routine cholecystectomy required during laparoscopic gastric bypass? Obes Surg Jan; 14(1): Wisconsin Physicians Service Medicare Local Coverage Determination (LCD): Bariatric Surgery for Morbid Obesity (L32904). Available at: Accessed 22 Feb Mechanick J, Youdim A, Jones D, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-2013 update: cosponsored by the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic and Bariatric Surgery. Available at Accessed 21 Feb 14 Page 8 of 11

9 31. MCG Inpatient & Surgical Care 18 th Edition ORG: S-512 (ISC) Gastric Restrictive Procedure with Gastric Bypass 32. Hayes Search & Summary. Preoperative Supervised Weight Loss Prior to Adult Bariatric Surgery. Publication Date: Feb 05, Hayes Directory. Roux-en-Y Gastric Bypass for Diabetes in Obese or Severely Obese Patients. Publication Date: August 7, 2014 Annual Review Aug 18, Hayes Directory. Roux-en-Y Gastric Bypass for Gastroesophageal Reflux Disease in Obese or Severely Obese Patients. Publication Date: July 10, Annual Review: July 10, Fridley J, Foroozan R, Sherman V, et al. Bariatric surgery for the treatment of idiopathic intracranial hypertension. J Neurosurg 2011 Jan; 114: Su-Hsin C, Stoll C, Song J, et al. The Effectiveness and Risks of Bariatric Surgery. JAMA Surg. Doi: /jamasurg Published online December 18, Schauer P, Bhatt D, Kirwan J, et al. Bariatric Surgery versus Intensive Medical Therapy for Diabetes-3-Year Outcomes. NEJM. DOI: NEJmoal Published online March 31, Hayes Prognosis Overview. Maestro Rechargeable System for Vagal Blocking for Obesity Control (VBLOC) Jan 14, UpToDate. Bariatric procedures for the management of severe obesity: Descriptions. Literature review current through: Dec This topic last updated: July 20, Hayes Search and Summary. Preoperative supervised weight loss prior to adult bariatric surgery. Publication date: February 5, Hayes Clinical Research Response. Orbera intragastric balloon system (Apollo Endosurgery Inc.) Publication date: October 22, UpToDate. Electrical stimulation for gastroparesis. Literature review current through: Jan This topic last updated: Sep 16, MCG 21 st ed. ISC S-512 Gastric Restrictive Procedure with Gastric Bypass Page 9 of 11

10 44. MCG 21 st ed. ISC S-513 Gastric Restrictive Procedure with Gastric Bypass by Laparoscopy 45. MCG 21 st ed. ISC S-515 Gastric Restrictive Procedure without Gastric Bypass by Laparoscopy 46. MCG 21 st ed. ISC S-512 Gastric Restrictive Procedure with Gastric Bypass 47. MCG 21 st ed. ACG: A-0395 Gastric stimulation (electrical) 48. Hayes Search and Summary. Transoral Outlet Reduction (TORe) after Bariatric S Surgery. Jan 12, Hayes MTD Intragastric Balloons for Treatment of Obesity. March 17, Hayes MTD Laparoscopic Sleeve Gastrectomy for Super Obesity in Adults Annual Review sept 15, 2016 Publication Date October 19, Hayes MTD Roux-en-Y Bypass for Gastroesophageal Reflux Disease in Obese or Severely Obese Patients Publication Date July 10, Annual Review May 26, Hayes HTB. Maestro Rechargeable System for Vagal Blocking for Obesity Control (VBLOC) February 4, Hayes MTD Revisional Surgery for treatment of Complications After Bariatric Surgery Publication Date July 24, 2014, Annual Review July 18, Peri-operative management of obstructive sleep apnea. ASMBS. Clinical Issues Committee American Society for Metabolic and Bariatric Surgery. Surgery for Obesity and Related Diseases 8 (2012)e27-e32.Reviewed Oct 2015; no update needed. Available at: Accessed 2/6/ Styne DM, Arslanian SA, Connor EL, et al. Pediatric obesity-assessment, treatment, and prevention: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab [published online January 31, 2017]. doi: /jc Available at: Accessed 2/6/ Ahmad N and Bawazir O. Assessment and preparation of obese adolescents for bariatric surgery. International Journal of Pediatrics and Adolescent Medicine. Vol 3, Issue 2, June 2016, pp47-54 Available at: Page 10 of 11

11 Accessed 2/6/ UpToDate. Medical outcomes following bariatric surgery. Literature review current through Jan2017. Topic Last Updated Jun 16, 2016 WPS / Arise Review History: Implemented 04/04/14, 04/17/15, 07/01/16, 07/01/17 Reviewed 03/07/14, 03/13/15, 03/11/16, 03/17/17 Revised 03/07/14, 03/13/15, 03/11/16, 03/17/17 Developed Medical Policy 03/07/14, 03/13/15, 03/11/16, 03/17/17 Committee Approval Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Approved by the Medical Director Page 11 of 11