Medical Policy Bariatric Surgery

Transcription

1 Medical Policy Bariatric Surgery Document Number: 001 Commercial MassHealth and Qualified Health Plans Authorization required X X Notification within 24 hours of service or next business day No notification or authorization Not covered Overview The purpose of this document is to describe the guidelines Neighborhood Health Plan (NHP) utilizes to determine medical appropriateness for bariatric surgeries. The treating specialist must request prior authorization for bariatric surgery. Coverage Guidelines NHP covers bariatric surgery for the treatment of severe obesity when such surgery is authorized prior to the procedure and meets medical necessity criteria. Based upon a review of current medical literature and local practices, authorization of bariatric surgical procedures is limited to: 1. Gastric bypass using Roux-en-Y short limb with a gastric restriction procedure; 2. Gastric bypass using biliopancreatic diversion (BPD) with duodenal switch (DS) and limited gastric resection 3. Laparoscopic sleeve gastrectomy 4. Laparoscopic adjustable gastric banding 5. Vertical-banded gastroplasty Bariatric Surgery - Initial Procedure NHP covers medically necessary bariatric surgery when all of the following criteria are met for adults greater than or equal to 18 years of age: 1. At the start of the bariatric program assessment, the BMI is greater than or equal to 40 or the BMI is greater than or equal to 35 in conjunction with one or more of the following comorbidities: a. Coronary heart disease; b. Type 2 diabetes mellitus; c. Obstructive sleep apnea; d. Obesity hypoventilation syndrome; e. Pseudotumor cerebri; f. Obesity related cardiomyopathy; g. Nonalcoholic steatohepatitis (NASH); or h. Presence of 3 or more of the following CV risk factors: i. Hypertension (SBP>140 or DBP >90 or taking antihypertensive agents); ii. Low HDL cholesterol (<35 mg/dl); iii. Elevated LDL cholesterol (>160 mg/dl); iv. Impaired glucose intolerance (FPG 110 to 125 mg/dl); Bariatric Surgery -001 Page 1 of 6

2 v. Family history of premature CHD (MI or sudden death at or before 55 years of age in father or other male first-degree relative, or at or before 65 years of age in mother or other female first degree relative); or vi. Age > 45 in men and >55 in women; 2. There is documented failure of repeated and sustained recent weight loss attempts through nonsurgical, physician-supervised methods, such as diet, exercise, behavior modification programs, and pharmaceutical interventions; 3. Metabolic causes of obesity such as thyroid and adrenal disease have been considered and ruled out or adequately treated; 4. The member must be enrolled in a comprehensive program that provides pre-op and post-op evaluation and treatment, including (at a minimum) medical, nutritional, and psychological/behavioral management; the management must occur for a period of months in order to assess and clearly demonstrate the member s suitability for the procedure. 5. The member must have an informed understanding of pre-operative and post-operative dietary management, and have demonstrated the commitment to fully participate with and adhere to advice and management preoperatively, post-operatively and for the required and long- term follow-up in order to promote a successful outcome; 6. If the member is a smoker, there must be documentation of formal smoking cessation counselling and advice with goal to achieve smoking cessation for 6 weeks prior to surgery; 7. The absence of any unmanaged major psychiatric disorder or substance abuse problem that might impede the ability of the member to participate effectively in treatment; 8. The member must not be pregnant or breast-feeding and must be willing to use secure birth control methods during the period of rapid weight loss; 9. The member understands the risks and benefits of surgery including complication rates and the potential for inadequate weight loss. NHP covers medically necessary bariatric surgery when all of the following criteria are met for adolescents who have completed bone growth, generally greater than or equal to 15 years of age: 1. The BMI is greater than or equal to 35 in conjunction with one or more of the following comorbidities: a. Poorly controlled Type 2 diabetes mellitus despite optimal medication management; b. Moderate to severe obstructive sleep apnea with AHI 15; c. Obesity hypoventilation syndrome; d. Pseudotumor cerebri; 2. There is documented failure of repeated and sustained recent weight loss attempts through nonsurgical, physician-supervised methods, such as diet, exercise, behavior modification programs and pharmaceutical interventions; 3. Metabolic causes of obesity such as thyroid and adrenal disease have been considered and ruled out or adequately treated; 4. The member must be enrolled in a comprehensive pediatric bariatric program that provides pre-op and post-op evaluation and treatment with (at a minimum) pediatricians, and pediatric-focused nutrition and psychological/behavioral management; the management must occur for a period of months in order to assess and clearly demonstrate the member s suitability for the procedure. 5. The member must have an informed understanding of pre-operative and post-operative dietary management and have demonstrated the commitment to fully participate with and adhere to advice and management preoperatively, post-operatively and for the required and long term follow-up in order to promote a successful outcome; 6. If the member is a smoker, there must be documentation of formal smoking cessation counselling and advice with goal to achieve smoking cessation for 6 weeks prior to surgery 7. The absence of any unmanaged major psychiatric disorder or substance abuse problem that might impede the ability of the member to participate effectively in treatment; 8. The member must not be pregnant or breast-feeding and must be willing to use secure birth control methods during the period of rapid weight loss; Bariatric Surgery -001 Page 2 of 6

3 9. The member has the cognitive, social, and emotional development to support their independent role in the decision-making process; 10. There are strong supports in place for a long-term successful outcome; 11. The member/family/supports understand the risks and benefits of surgery including complication rates and the potential for inadequate weight loss; Bariatric Surgery Correction/Conversion Procedures NHP covers medically necessary corrective surgery for symptomatic and significant complications from bariatric surgery when: 1. Symptoms are due to an anatomical abnormality including but not limited to the following: a. Anastomotic stenosis or lumen stricture not amenable to endoscopy; b. Anastomotic or staple line leak; c. Ulcerations not amenable to conservative therapy; d. Fistula; e. Band erosion, slippage, or stricture that cannot be corrected with non-surgical band manipulation; or f. Intractable vomiting not amenable to medical management and requiring such treatment as: repeated intravenous hydration, TPN and/or feeding tube. NHP covers medically necessary conversion surgery for symptomatic and significant complications from bariatric surgery when 1-7 are met: 1. Symptoms are due to an anatomical abnormality including but not limited to the following: a. Anastomotic stenosis or lumen stricture not amenable to endoscopy; b. Anastomotic or staple line leak; c. Fistula; d. Band erosion, slippage, or stricture that cannot be corrected with non-surgical band manipulation; or e. Intractable vomiting not amenable to medical management and requiring such treatment as: repeated intravenous hydration, TPN and/or feeding tube. 2. Met medical necessity criteria for initial bariatric surgery listed above; 3. Has had regular follow up by a bariatric program; 4. Remains compliant with prescribed exercise and nutrition; 5. Has had sustained and consistent weight loss commensurate with the length of time since initial surgery 1 ; 6. Understands the higher risks of reoperative bariatric surgery compared with a primary procedure; 7. The request is for one of the following conversion surgeries: a. Gastric bypass procedure when the initial procedure was a sleeve gastrectomy. b. A sleeve gastrectomy or a gastric bypass with a gastric restriction procedure when the initial procedure was an adjustable gastric band placement. c. Gastric bypass using Roux-en Y short limb when the initial procedure was vertical-banded gastroplasty. Note: NHP requires clear documentation of compliance with prescribed exercise, diet, and follow up. Note: The conversion surgery may be simultaneous to any surgical treatment of a complication, or delayed to allow healing. NHP covers medically necessary conversion/corrective surgery for lack of weight loss or for inconsistent weight loss when all of the following are met: 1. Lack of weight loss or inconsistent weight loss is due directly to an anatomical disruption of the initial procedure (e.g. gastric fistula formation after a Roux-en-Y short limb with a gastric resection), and not due to dietary noncompliance: 2. Has had sustained and consistent weight loss commensurate with the length of time since initial surgery and the development of the anatomical disruption 1 ; 1 In general most of the weight loss occurs in the first year after bariatric surgery. Reported two year weight loss percentages are: 40% for vertical-banded gastroplasty, 40-50% for adjustable gastric band, 60% for sleeve gastrectomy, and 70-75% for gastric bypass procedures. Bariatric Surgery -001 Page 3 of 6

4 3. Met medical necessity criteria as listed for an initial bariatric surgery; 4. Has had regular follow up by a bariatric program; 5. Remains compliant with prescribed exercise and nutrition; 6. Currently meets medical necessity criteria for initial bariatric surgery; 7. Understands the higher risks of re-operative bariatric surgery compared with a primary procedure; 8. The request for surgery is one of the following: a. Gastric bypass procedure when the initial procedure was a sleeve gastrectomy. b. A sleeve gastrectomy or a gastric bypass with a gastric restriction procedure when the initial procedure was an adjustable gastric band placement. c. Gastric bypass using Roux-en -Y short limb when the initial procedure was vertical-banded gastroplasty. d. Repair of a fistula when the initial procedure was a Roux-en-Y short limb with a gastric restriction procedure. Note: NHP requires clear documentation of compliance with prescribed exercise, diet, and follow up NHP covers medically necessary sleeve gastrectomy as a planned stage procedure for a BMI of at least 45 with medical condition(s) felt to pose a high risk for an initial gastric bypass procedure when all of the following are met: 1. Met medical necessity criteria for initial bariatric surgery; 2. Has had regular follow up by a bariatric program; 3. Remains compliant with prescribed exercise and nutrition; 4. Lost the prerequisite weight in order to decrease complications of gastric bypass and the weight loss has plateaued; 5. Currently meets medical necessity criteria for initial bariatric surgery; and 6. The current request is for conversion surgery for a gastric bypass procedure. Note: NHP requires clear documentation of compliance with prescribed exercise, diet, and follow up. Exclusions NHP does not provide coverage for the following bariatric surgeries: 1. Gastric plication; 2. Jejunoileal bypass; 3. Biliopancreatic diversion without duodenal switch; 4. Long limb gastric bypass; 5. Horizontal gastric partitioning/gastroplasty; 6. Gastric wrapping; 7. Mini-gastric bypass; 8. Garren-Edwards gastric bubble; 9. Gastric Electric stimulation (gastric pacemaker);and 10. Endoscopic bariatric procedures/devices including, but not limited to: a. ROSE procedure b. StomaphyX endoluminal fastener and delivery system c. EndoCinch suturing system. 11. Conversion of a vertical-banded gastroplasty to either a sleeve gastrectomy or a biliopancreatic diversion with duodenal switch due to unacceptably high complication rates in clinical studies. Definitions Bariatric surgery: Non-cosmetic, surgical procedures used in the treatment of morbid obesity. Body Mass Index (BMI): is calculated by dividing the patient s weight, in kilograms, by height, in meters, squared. Conversion Surgery: A surgery that changes one type of procedure to a different type of procedure. Corrective Surgery: Surgical procedures addressing complications or an incomplete treatment effect of a prior surgery, without changing the type of procedure. May include reversal procedures that restore the original anatomy. Bariatric Surgery -001 Page 4 of 6

5 Related Policies: Bariatric Surgery Provider Payment Guideline Effective September 2015: Smoking cessation counselling added and references updated. September 2014: Reoperation, revision, and surgery to criteria Added. February 2014: Annual Review February 2013: Gastric placation added to excluded procedures, specified adolescent criteria added. January 2012: Modified age requirement for bariatric surgeries, Removed specific requirements for laparoscopic Sleeve surgery. September 2002: Policy Effective References: 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. : A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. JACC, 2014; 63: American Association of Clinical Endocrinologists/ The Obesity Society/American Society for Bariatric Surgery, Clinical Practice Guidelines for the Perioperative Nutritional,Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient 2013 Update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surgery for Obesity and Related Diseases, 2013, 9: American Society for Metabolic & Bariatric Surgery (2011) ASMBS policy statement on gastric plication. Surgery for Obesity and Related Diseases, 2011, 7: 262 American Society for Metabolic & Bariatric Surgery (2012) ASMBS position statement: bariatric surgery in class 1 obesity (BMI kg/m 2 ). Surgery for Obesity and Related Diseases, 2013, 9: e1 e10 American Society for Metabolic & Bariatric Surgery (2011) Updated position statement on sleeve gastrectomy as a bariatric procedure. Surgery for Obesity and Related Diseases, 2012, 8: e21-e26 American Society for Metabolic & Bariatric Surgery (2012) Pediatric committee best practice guidelines. Surgery for Obesity and Related Diseases, 2012, 8: 1-7. American Society for Metabolic & Bariatric Surgery: Systematic review on reoperative bariatric surgery. American Society for Metabolic and Bariatric revision Task Force. Surgery for Obesity and Related Diseases. Published online, Feb 2014, in press. Available on line at; SystematicReviewReoperativeBarSurg-Feb2014.pdf. Accessed 6/4/2015. Birkmeyer, John D., et al. Surgical skill and complication rates after bariatric surgery. New England Journal of Medicine. 2013; 369: Brethhauer, SA et al. Systemic Review of sleeve gastrectomy as staging and primary bariatric procedure. Surgery for Obesity and Related Diseases, 2009: 5; Buchwald H. Ikramuddin S. Laparoscopic adjustable gastric banding in bariatric surgery: an overview of the LAP-BAND. Introduction. American Journal of Surgery. 2002; 184(6B):1S-3S Centers for Medicare and Medicaid Services. National coverage determination (NCD) for Bariatric Surgery for Treatment of Morbid Obesity (100.1). at: Accessed 6/2015 Chang, SH, et al. The Effectiveness and Risks of Bariatric Surgery: An Updated Systematic Review and Meta-analysis, JAMA Surgery 2014; 149: Colquitt, JL., Picot, J., et al. Surgery for obesity (review). Cochrane Database of Systematic Reviews; 2014, August 8. Bariatric Surgery -001 Page 5 of 6

6 Dimick, JB., et al. Bariatric Surgery Complications Before vs After Implementation of a National Policy Restricting Coverage to Centers of Excellence: Complications Following Bariatric Procedures. JAMA, 2013; 309: Dixon JB. O'Brien PE. Changes in comorbidities and improvements in quality of life after Lap-Band placement. American Journal of Surgery, 2002; 184(6B):51S-54S Franco, J., Palermo, P., Gangner, M. A review of studies comparing three laparoscopic procedures in bariatric surgery: sleeve gastrectomy, roux-en-y gastric bypass and adjustable gastric banding. Obesity Surgery, 2011; 21: Hayes Medical Technology Directory, Laparoscopic Sleeve Gastrectomy for Super Obesity in Adults, January 22, Accessed 6/2015. Hayes Medical Technology Directory, Revisional surgery for treatment of complications after bariatric surgery. July 24, 2014, Accessed 6/2015. Hayes Medical Technology Directory Roux-en-Y Gastric Bypass for Diabetes in Obese or Severely Obese Patients, August 7, Accessed 6/2015 Hayes Medical Technology Search and Summary. Biliopancreatic Diversion with Duodenal Switch for Treatment of Obesity in Adults, July 17, Accessed 6/2015. Hayes Medical Technology Search and Summary. Preoperative Supervised Weight Loss Prior to Adult Bariatric Surgery, February 5, Accessed 6/2015. Hayes Medical Technology Search and Summary. Roux-en-Y Gastric Bypass for Treatment of Obesity in Children, February 12,2015. Accessed 6/2015 Hayes Medical Technology Search and Summary. Sleeve Gastrectomy for Treatment of Obesity in Children, February 12,2015. Accessed 6/2015. Inge, Krebs, Garcia et. al., Bariatric surgery for severely overweight adolescents: concerns and recommendations. Pediatrics. 2004; 114;217 Kehagias, I., Karamanakos, S., Argentou,M., Kalfarentzo F. Randomized clinical trial of laparoscopic roux-en-y-gastric bypass versus laparoscopic sleeve gastrectomy for the management of patients with BMI < 50 kg/m 2. Obese Surgery, 2011; 21: MassHealth, Guidelines for Medical Necessity Determination for Bariatric Surgery, April 1, 2006, retrieved 2008, 2009, 2010, 2011, 2012, 2013, 2014, Myers JA. Sarker S. Shayani V. Treatment of massive super-obesity with laparoscopic adjustable gastric banding. Surgery for Obesity & Related Diseases. 2006, 2(1):37-40 Pratt JS, Lenders CM, et al. Best practice updates for pediatric/adolescent weight loss surgery. Obesity (Silver Spring). 2009; 17: Puzziferri N, Roshek TB, et al. Long-term Follow-up After Bariatric Surgery:A Systematic Review JAMA. 2014; 312(9): Shimizu, Hideharu, et al. Revisional bariatric surgery for unsuccessful weight loss and complications. Obesity surgery 2013; 23: SAGES Guidelines for Clinical Application of Laparoscopic Bariatric Surgery Surg Obes Relat Dis. 2009; 5(3): Spyropoulos, Charalambos, et al. Revisional bariatric surgery: 13-year experience from a tertiary institution. Archives of Surgery, 2010; 145: 173. MassHealth MCO Contract 2.6D Bariatric Surgery -001 Page 6 of 6