BlueCross BlueShield of Tennessee Medical Policy Manual

Bariatric Surgery for Morbid Obesity

Does not apply to the State of TN Member Contract.
Does not apply to TRH Health Plans, please refer to the TRH Health Plans' Member EOC.
Does not apply to SymbionARC Management Services, Inc. Welfare Benefit Plan.
Does not apply to CoverTN, AccessTN and CoverKids.

DESCRIPTION

Morbid obesity is a condition of persistent and uncontrollable weight gain that constitutes a present or potential threat to life. Morbid obesity has empirically been defined as more than 100 lbs. (45.4 kg) or 100% over ideal body weight. The American Association of Clinical Endocrinologists, The Obesity Society and American Society for Metabolic & Bariatric Surgery (AACE/TOS/ASMB) guideline defines obesity as a body mass index (BMI; weight in kg/[height in meters]2) greater than or equal to 30 kg/m2 in an overall classification as follows:

Surgery for morbid obesity, termed bariatric surgery, falls into the following categories:

See Additional Information for brief descriptions of the various bariatric procedures.

Refer to the Bariatric Surgery Precertification Request Form

It is highly recommended that physicians utilize the Bariatric Surgery Precertification Request Form in order to simplify and speed up the pre-bariatric surgery review and approval process.

POLICY

See also:  

MEDICAL APPROPRIATENESS

NOTE: If any of the above (Interview/evaluation, Minnesota Multiphasic Personality Inventory, the Eating Disorder Inventory or the EAT-26) provides a suggestion of cognitive slippage or psychosis, a projective test (e.g., Thematic Apperception Test (TAT) or the Rorschach test) is required.

IMPORTANT REMINDERS

This medical policy does not apply to the State of TN Member Contract.

This medical policy does not apply to TRH Health Plans, please refer to the TRH Health Plans' Member EOC.

This medical policy does not apply to SymbionARC Management Services, Inc. Welfare Benefit Plan.

This medical policy does not apply to CoverTN, AccessTN and CoverKids.

ADDITIONAL INFORMATION

The cost of bariatric surgery for the treatment of morbid obesity may or may not be covered by insurance.

Well-designed clinical trials, addressing other procedures (e.g., cholecystectomy, liver biopsy) performed at the same time as bariatric surgery, are not available. As always, each separate procedure must independently be determined to be clinically appropriate to be considered medically necessary.

National Institutes of Health clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: Evidence report addresses the initial goal of weight loss as, “there is strong and consistent evidence from randomized trials that overweight and obese patients in well-designed programs can achieve a weight loss of as much as 10 percent of baseline weight.” They also report “randomized trials suggest that weight loss at the rate of 1 to 2 lb/week (calorie deficit of 500 to 1,000 kcal/day) commonly occurs for up to 6 months.”

American Society for Bariatric Surgery and the Society of American Gastrointestinal Endoscopic Surgeons guideline for laparoscopic and conventional surgical treatment of morbid obesity addresses peri-operative and long-term management considerations. The guideline states, “The overall care of patients undergoing bariatric surgery (weight reduction surgery) requires programs which address both perioperative care and long-term management….Patients should have a clear understanding of expected benefits, risk, and long term consequences of surgical treatment…Patients require appropriate lifelong follow-up with nutritional counseling and biochemical surveillance. Surgeons need to be aware of the needs of severely obese patients in terms of facilities, supplemental equipment, staff and procedures, and should plan the personal time, specialized staff and/or multi-disciplinary referral system as required. This multi-disciplinary approach includes medical management of co-morbidities, dietary instruction, exercise training, specialized nursing care and psychological assistance as needed. Post-operative management of co-morbidities should be directed by the practitioner familiar with the operation performed and the changes created.

A single center feasibility trial of the safety and efficacy of the ValenTx Endo Bypass system in obese individuals was completed September 2010. This single trial of 12 individuals was conducted in Monterrey, Mexico. The lack of randomized controlled trials and studies provide little evidence of the safety and efficacy to support the use of this implantable sleeve (e.g., the Endo Bypass System) technology for the treatment of morbid obesity.

Because of the lack of randomized controlled trials and studies there is no evidence of safety and efficacy to support the use of the laparoscopic greater curve plication (LGCP) (i.e., total vertical gastric plication, gastric imbrication, gastric pleat) technology for the treatment of morbid obesity.

Brief description of the various bariatric procedures:

Biliopancreatic bypass procedure (i.e., Scopinaro procedure): Consist of subtotal gastrectomy using a long Roux-en-Y procedure to divert the biliopancreatic juices into the distal ileum.

Biliopancreatic bypass with duodenal switch: It is essentially a variant of the biliopancreatic bypass. Instead of performing a distal gastrectomy, a “sleeve” gastrectomy is performed along the vertical axis of the stomach. The sleeve gastrectomy decreases the volume of the stomach and the parietal cell mass.

Gastric bypass using the Roux-en-Y anastomosis: Restricts the size of the stomach by stapling shut 90% of the lower stomach. The proximal intestinal anatomy is re-arranged, thereby bypassing the duodenum.

Gastric banding: Involves placing a gastric band around the outside of the stomach. The stomach is not entered.

Implantable sleeve: This device used in a study, is a 120 centimeter sleeve that is anchored to a cuff or to an artificial stoma at the gastroesophageal junction.

Laparoscopic greater curve plication (LGCP) (i.e., total vertical gastric plication, gastric imbrication, gastric pleat): A sleeve is created by suturing rather than removing stomach tissue therefore preserving its natural nutrient absorption capabilities.

Mini gastric bypass: Uses the laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass. Instead of creating a Roux-en-Y anastomosis, the jejunum is anastomosed incontinuity directly to the stomach, similar to a Billroth II procedure. The unique aspect of the procedure is not based on the laparoscopic approach, but rather the type of anastomosis used.

Sleeve gastrectomy: A form of unbanded gastroplasty involving subtotal gastric resection for creation of a long lesser curve-based gastric conduit. It has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss, to be then followed by subsequent surgical procedures to convert the sleeve gastrectomy to an intestinal bypass.

Vertical banded gastroplasty (VBG): Restricts the size of the stomach using a stapling technique. There is no rearrangement of the intestinal anatomy.

SOURCES

Adams, T. D., Gress, R. E., Sherman, C. S., Halverson, R. C., Simper, S. C., Rosamond, W. D., et al. (2007). Long-term mortality after gastric bypass surgery. The New England Journal of Medicine, 357 (8), 753-761. (Level 1 Evidence - Independent study)

Agency for Healthcare Research & Quality. (2008, November). Evidence report/technology assessment No.169: Bariatric surgery in women of reproductive age: Special concerns for pregnancy. (Publication No. 08-E013). Retrieved October 26, 2010 from http://www.ahrq.gov/downloads/pub/evidence/pdf/bariatricrep/barirep.pdf.

Agency for Healthcare Research and Quality. (2004, July). Evidence report/technology assessment No.103: Pharmacological and surgical treatment of obesity. (Publication No. 04-E028-2). Retrieved October 26, 2010 from http://www.ahrq.gov/downloads/pub/evidence/pdf/obespharm/obespharm.pdf.

American Association of Clinical Endocrinologist. (1998, September/October). AACE/ACE position statement on the prevention, diagnosis, and treatment of obesity (1998 revision). Retrieved October 26, 2010 from http://www.aace.com/pub/pdf/guidelines/obesityguide.pdf.

American Association of Clinical Endocrinologist. (2008, July/August). American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Retrieved October 26, 2010 from http://www.aace.com/pub/pdf/guidelines/Bariatric.pdf.

American College of Obstetricians and Gynecologists. (2009, June). ACOG practice bulletin number 105: Bariatric surgery and pregnancy. Retrieved October 26, 2010 from http://mail.ny.acog.org/website/SMIPodcast/BariatricSurgery.pdf.

American Society for Metabolic and Bariatric Surgery. (2004, October). Suggestions for the pre-surgical psychological assessment of bariatric surgery candidates. Retrieved October 26, 2010 from http://www.asbs.org/html/pdf/PsychPreSurgicalAssessment.pdf.

American Society for Metabolic and Bariatric Surgery. (2007). ASMBS position statement on prophylactic measures to reduce the risk of venous thromboembolism in bariatric surgery patients. Retrieved October 26, 2010 from http://www.asbs.org/Newsite07/resources/vte_statement.pdf.

American Society for Metabolic and Bariatric Surgery. (2008, February). Bariatric surgery: Postoperative concerns. Retrieved October 26, 2010 from http://www.asbs.org/html/pdf/asbs_bspc.pdf.

Apovian, C. M. (2010). Overweight in older children and adolescents: Treatment or prevention? Archives of Disease in Childhood, 95 (1), 1-2.

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2011). Bariatric surgery (7.01.47). Retrieved June 30, 2011 from BlueWeb. (109 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. September 2007.

Brethauer, S. A., Harris, J. L., Kroh, M., & Schauer, P. R. (2011). Laparoscopic gastric placation for treatment of severe obesity. Surgery for Obesity and Related Diseases, 7 (1), 15-22. (Level 4 Evidence - Industry sponsored)

Buchwald, H., & Consensus Conference Panel. (2005). Consensus conference statement bariatric surgery for morbid obesity: Health implications for patients, health professionals, and third-party payers. Surgery for Obesity and Related Diseases, 1 (3), 371-381.

Cariani, B., Agostinelli, L., Leuratti, L., Giorgini, E., Biondi, P., & Amenta, E. (2010). Bariatric revisionary surgery for failed or complicated vertical banded gastroplasty (VBG): Comparison of VBG reoperation (re-VBG) versus Roux-en-Y gastric bypass-on-VBG (RYGB-on-VBG). Journal of Obesity, 2010 (206249), 1-6.

Christou, N., & Efhimiou, E. (2009). Five-year outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in a comprehensive bariatric surgery program in Canada. Canadian Journal of Surgery, 52 (6), e249-e258. (Level 1 Evidence - Industry sponsored)

Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery. (2010). Updated position statement on sleeve gastrectomy as a bariatric procedure. Surgery for Obesity and Related Diseases, 6 (1), 1-5.

Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Bariatric surgery for treatment of morbid obesity (NCD 100.1, p. 2-47, 2-48). Ingenix.

Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Gastric balloon for treatment of obesity (NCD 100.11, p. 2-50). Ingenix.

Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Intestinal by-pass surgery (NCD 100.8, p. 2-49). Ingenix.

Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Surgery for diabetes (NCD 100.14, p. 2-50, 2-51). Ingenix.

Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Treatment of obesity (NCD 40.5, p. 2-34). Ingenix.

D’Hondt, M., Vanneste, S., Pottel, H., Devriendt, D., Van Rooy, F., & Vansteenkiste, F. (2011). Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surgical Endoscopy, no pages. (Level 2 Evidence - Independent study)

Dixon, J. B., O’Brien, P. E., Playfair, J., Chapman, L., Schachter, L. M., Skinner, S., et al. (2007). Adjustable gastric banding and conventional therapy for type 2 diabetes: A randomized controlled trial. JAMA, 299 (3), 316-323. (Level 2 Evidence - Industry sponsored)

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2010, September). Laparoscopic sleeve gastrectomy for obesity. Retrieved October 5, 2010 from ECRI Institute. (50 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Evidence Reports. (2005, May). Laparoscopic bariatric surgery for morbid obesity. Retrieved June 29, 2005 from ECRI Institute. (116 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Health Technology Assessment. (2007, August). Bariatric surgery in pediatric patients. Retrieved September 26, 2007 from ECRI institute. (137 articles and/or guidelines reviewed)

Flum, D. l., Salem, L., Elrod, J., A., Dellinger, E. P., Cheadle, A., & Chan, L. (2005). Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA, 294 (15), 1903-1908. (Level 2 Evidence - Independent study)

Folli, F., Pontiroli, A. E., & Schwesinger, W. H. (2007). Metabolic aspects of bariatric surgery. The Medical Clinics of North America, 91 (3), 393-414.

Fontana, M. A., & Wohgemuth, S. D. (2010). The surgical treatment of metabolic disease and morbid obesity. Gastroenterology Clinics of North America, 39 (1), 125-133.

Fried, M., Dolezalova, K., & Sramkova, P. (2011). Adjustable gastric banding outcomes with and without gastrogastric imbrications sutures: A randomized controlled trial. Surgery for Obesity and Related Diseases, 7 (1), 23-31. (Level 2 Evidence - Industry sponsored)

Greenwald, D. (2010). Preoperative gastrointestinal assessment before bariatric surgery. Gastroenterology Clinics of North America, 39 (1), 81-86.

Hussain, A., Mahmood, H., & El Hasani, S. (2009). Can Roux-en-Y gastric bypass provide a lifelong solution for diabetes mellitus? Canadian Journal of Surgery, 52 (6), e269-e275.

Jakobsen, G. S., Hofso, D., Roislien, J., Sandbu, R., & Hjelmesaeth, J. (2010). Morbidly obese patients -- Who undergoes bariatric surgery? Obesity Surgery, 20 (8), 1142-1148.

Kini, S., Herron, D. M., & Yanagisawa, R. T. (2007). Bariatric surgery for morbid obesity - A cure for metabolic syndrome? The Medical Clinics of North America, 91 (6), 1255-1271.

Leyba, J. L., Aulestia, S. N., & Liopis, S. N. (2011). Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study of 117 patients. Obesity Surgery, 21 (2), 212-216. (Level 2 Evidence - Independent study)

Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum, D. R., Belle, S. H., King, W. C., Wahed, A. S., Berk, P., et al. (2009). Perioperative safety in the longitudinal assessment of bariatric surgery. The New England Journal of Medicine, 361 (5), 445-454. (Level 1 Evidence - Industry sponsored)

Maggard, M. A., Shugarman, L. R., Suttorp, M., Maglione, M., Sugerman, H. J., Livingston, E. H., et al. (2005). Meta-analysis: Surgical treatment of obesity. Annals of Internal Medicine, 142 (7), 547-559. (Level 2 Evidence - Industry sponsored)

National Guideline Clearinghouse. (2008, July). Role of endoscopy in the bariatric surgery patient. Retrieved October 26, 2010 from http://www.guidelines.gov.

National Guideline Clearinghouse. (2010, February). Management of obesity. A national clinical guideline. Retrieved October 26, 2010 from http://www.guidelines.gov.

National Institutes of Health, National Heart, Lung, and Blood Institute, & North American Association for the Study of Obesity. (2000, October). The practical guide identification, evaluation, and treatment of overweight and obesity in adults. Retrieved October 27, 2010 from http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf.

Nilsson, P. M. (2008). Is weight loss beneficial for reduction of morbidity and mortality? What is the controversy about? Diabetes Care, 31 (Suppl. 2), S278-S283.

O’Brien, P. E., Sawyer, S. M., Laurie, C., Brown, W. A., Skinner, S., Veit, F., et al. (2010). Laparoscopic adjustable gastric banding in severely obese adolescents: A randomized trial. JAMA; 303 (6):519-526. (Level 2 Evidence - Industry sponsored)

Ramos, A., Galvao Neto, M., Galvao, M., Evangelista, L. F., Campos, J. M., & Ferraz, A. (2010). Laparoscopic greater curvature plication: Initial results of an alternative restrictive bariatric procedure. Obesity Surgery, 20 (7), 913-918.

Runkel, N., Columbo-Benkmann, M., Huttl, T. P., Tiges, H., Mann, O., Sauerland, S., et al. (2011). Bariatric surgery. Deutsches Arzteblatt International, 108 (20), 341-346.

Saltzman, E., Anderson, W., Apovian, C. M., Boulton, H., Chamberlain, A., Cullum-Dugan, D., et al. (2005). Criteria for patient selection and multidisciplinary evaluation and treatment of the weight loss surgery patient. Obesity Research, 13 (2), 234-243.

Sjostrom, L., Gummesson, A., Sjostrom, C. D., Narbro, K., Peltonen, M., Wedel, H., et al. (2009). Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): A prospective, controlled intervention trial. The Lancet Oncology, 10 (7), 653-662. (Level 1 Evidence - Industry sponsored)

Sjostrom, L., Narbro, K., Sjostrom, C. D., Karason, K., Larsson, B., Wedel, H., et al. (2007). Effects of bariatric surgery on mortality in Swedish obese subjects. The New England Journal of Medicine, 357 (8), 741-752. (Level 1 Evidence - Industry sponsored)

Snow, V., Barry, P., Fitterman, N., Qaseem, A., Weiss, K., Clinical Efficacy Assessment of the American College of Physicians. (2005). Pharmacologic and surgical management of obesity in primary care: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 142 (7), 525-531.

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). (2008, June). SAGES guideline for clinical application of laparoscopic bariatric surgery. Retrieved October 26. 2010 from www.sages.org.

Still, C., Benotti, P., Wood, G., Gerhard, G., Petrick, A., Reed, M., et al. (2007). Outcomes of preoperative weight loss in high-risk patients undergoing gastric bypass surgery. Archives of Surgery, 142 (10), 994-998. (Level 1 Evidence - Independent study)

Talebpour, M., & Amoli, B. S. (2007). Laparoscopic total gastric vertical placation in morbid obesity. Journal of Laparoendoscopic & Advanced Surgical Techniques, 17 (6), 793-798. (Level 2 Evidence - Independent study)

Technology Evaluation Center. (2003, September). Special report: The relationship between weight loss and changes in morbidity following bariatric surgery for morbid obesity. (Vol. 18, No. 9). Chicago: BlueCross BlueShield Association. (44 articles and/or guidelines reviewed)

Technology Evaluation Center. (2006, February). Laparoscopic gastric bypass surgery for morbid obesity. (Vol. 20, No. 15). Chicago: BlueCross BlueShield Association. (148 articles and/or guidelines reviewed)

Technology Evaluation Center. (2007, February). Laparoscopic adjustable gastric banding for morbid obesity. (Vol. 21, No. 13). Chicago: BlueCross BlueShield Association. (118 articles and/or guidelines reviewed)

U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. (2010, October). Article for NCD - Bariatric surgery for treatment of morbid obesity (A48897). Retrieved October 26, 2010 from http://www.cms.gov/mcd/viewarticle.asp?article_id=48897&article_version=20&show=all.

U.S. Department of Health and Human Services. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases. (2009, March). Bariatric surgery for severe obesity. Retrieved October 26, 2010 from http://www.win.niddk.nih.gov/publications/PDFs/gasurg12.04bw.pdf.

U.S. Department of Health and Human Services. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases. (2010, January). Longitudinal assessment of bariatric surgery (LABS). Retrieved October 26, 2010 from http://www.win.niddk.nih.gov/publications/PDFs/LABSFactSheet(final).pdf.

U.S. Department of Health and Human Services. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases. (2008, November). Understanding adult obesity. Retrieved October 26, 2010 from http://www.win.niddk.nih.gov/publications/PDFs/understandingobesityrev.pdf.

U.S. Food and Drug Administration. (2007, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. P070009. Retrieved October 30, 2007 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070009b.pdf.

U.S. Food and Drug Administration. (2011, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. P000008/S017. Retrieved August 8, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P000008S017A.pdf.

U.S. Food and Drug Administration. (2011, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K110829. Retrieved October 30, 2007 from http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110829.pdf.

Wadden, T. A., Berkowitz, R. I., Womble, L. G., Sarwer, D. B., Phelan, S., Cato, R. K., et al. (2005). Randomized trial of lifestyle modification and pharmacotherapy for obesity. The New England Journal of Medicine, 353 (20), 2111-2120. (Level 2 Evidence - Industry sponsored)

Wang, Y., & Zhang, C. (2009). Bariatric surgery to correct morbid obesity also ameliorates atherosclerosis in patients with type 2 diabetes mellitus. American Journal of Biomedical Sciences, 1 (1), 56-69.

Winifred S. Hayes. Medical Technology Directory. (2007 June). Open malabsorptive bariatric surgery: Roux-en-Y gastric bypass. Retrieved October 5, 2010 from www.Hayesinc.com/subscribers. (110 articles and/or guidelines reviewed)

Winifred S. Hayes. Medical Technology Directory. (2007, June). Laparoscopic bariatric surgery: Roux-en-Y gastric bypass, vertical banded gastroplasty, and adjustable gastric banding. Retrieved October 5, 2010 from www.Hayesinc.com/subscribers. (93 articles and/or guidelines reviewed)

Winifred S. Hayes. Medical Technology Directory. (2007, June). Malabsorptive bariatric surgery: Open and laparoscopic biliopancreatic diversion. Retrieved October 5, 2010 from www.Hayesinc.com/subscribers. (94 articles and/or guidelines reviewed)

Winifred S. Hayes. Medical Technology Directory. (2007, June). Open restrictive bariatric surgery: Gastroplasty and gastric banding. Retrieved October 5, 2010 from www.Hayesinc.com/subscribers. (85 articles and/or guidelines reviewed)

Winifred S. Hayes. Medical Technology Directory. (2007, June). Pediatric bariatric surgery for morbid obesity. Retrieved October 5, 2010 from www.Hayesinc/com/subscribers. (81 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  12/10/1980

MOST RECENT REVIEW DATE:  2/17/2014

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.