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Medical Policy: 07.01.17
Original Effective Date: September 1995
Reviewed: October 2011
Revised: September 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Obesity is the most frequent form of malnutrition in the developed world and it is increasing. Morbid obesity (i.e., obesity with secondary serious or debilitating progressive disease) is generally associated with a body mass index (BMI) of ≥40 kg/m² (i.e. weight/height squared). Morbid obesity has a significant impact on cardiac risk factors, incidence of diabetes, obstructive sleep apnea, debilitating arthritis of weight bearing joints, infertility, psychosocial and economic problems and various types of cancers, etc.
The first treatment of morbid obesity is dietary and lifestyle changes. When conservative treatment fails, a few patients may require a surgical approach. The National Institutes for Health defines potential candidates for surgery as those with a BMI of 40 kg/m² or more or a BMI between 35 kg/m² and 39.9 kg/m² and a serious obesity-related health problem such as type 2 diabetes, coronary heart disease, or severe sleep apnea. Additionally, persons should have acceptable operative risks, the ability to participate in treatment and long-term follow-up, and possess an understanding of the surgical procedure and necessary life style changes.
Surgery for morbid obesity, also known as bariatric surgery is based on intestinal malabsorption and gastric reduction. Surgery is considered successful if weight loss is maintained at greater than or equal to 50% of excess body weight for more than 10 years.
Several different gastric reduction and intestinal malabsorption procedures are listed below:
Gastric reduction (gastric restrictive) procedures:
- Vertical-banded gastroplasty
- Adjustable gastric banding
- Gastric bypass (Roux-en-Y gastroenterostomy); this can be done by both open or laparoscopic approach
- Mini-gastric bypass (laparoscopic)
- Sleeve gastrectomy; performed as a stand-alone procedure or in combination with malabsorptive procedures
Malabsorptive Procedures:
- Biliopancreatic bypass (Scopinaro Procedure)
- Biliopancreatic bypass with duodenal switch
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Prior Approval:
Prior approval is recommended for this service. Submit a prior approval now. 
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Policy:
The following surgical procedures for the treatment of morbid obesity may be considered medically necessary when the criteria listed below are met:
- Vertical-banded gastroplasty
- Gastric bypass (Roux-en-Y gastroenterostomy) with short Roux limb equal to or less than 150 cm; this can be done by either open or laparoscopic approach
- Biliopancreatic bypass (i.e., the Scopinaro procedure) with duodenal switch; this can be done by either open or laparoscopic approach
- Sleeve gastrectomy, either as a stand-alone procedure or in combination with malabsorptive procedures
General Criteria for Coverage:
- Patient is at least 18 years old
And
- The patient must have documentation in the medical record of failure to sustain weight loss within the two years preceding surgery and documentation of the health care provider’s monitoring of the patient’s progress toward a goal of weight loss.
And
- The patient must be a motivated individual with acceptable operative risk and must be evaluated by a licensed mental health provider to determine the patient's willingness to comply with pre and postoperative treatment plans, and a strategy to ensure cooperation with follow-up must be documented.
And, in addition to the general requirements above, the patient must also meet one of the following weight criteria:
- BMI of 40kg/m² for at least 3 years
- BMI of ≥ 50 kg/m² for biliopancreatic bypass (i.e., the Scopinaro procedure) with duodenal switch
Or
- BMI of greater than 35kg/m² in conjunction with one of the following:
- Hypertension requiring medication for at least one year
- Diabetes Mellitus type 2 requiring medication for at least one year
- Obstructive sleep apnea, confirmed by sleep study, which does not respond to conservative treatment
- Documented cardiovascular disease
- Hypoventilation of obesity (Pickwickian syndrome)
Adjustable gastric banding (Lap-Band® System) may be considered medically necessary for patients meeting the above general criteria and
- BMI ≥ 40 kg/m2 for at least 3 years
Or
- BMI ≥ 30 kg/m2 in conjunction with one of the following:
- Hypertension requiring medication for at least one year
- Diabetes Mellitus type 2 requiring medication for at least one year
- Obstructive sleep apnea, confirmed by sleep study, which does not respond to conservative treatment
- Documented cardiovascular disease
- Hypoventilation of obesity (Pickwickian syndrome)
Revision surgery to address perioperative or late complications of a bariatric procedure may be considered medically necessary. Such complications include, but are not limited to:
- Staple-line failure
- Obstruction
- Stricture
- Non-absorption resulting in hypoglycemia or malnutrition
- Weight loss of 20% or more below ideal body weight
The following surgical procedures for the treatment of obesity are considered investigational:
- Mini-gastric bypass (laparoscopic)
- Biliopancreatic bypass (Scopinaro Procedure)
- Long-limb ( > 150 cm) gastric bypass
Endoscopic procedures, including but not limited to the StomaphyXTM device, to treat weight gain after bariatric surgery due to large gastric stoma or large gastric pouches are considered investigational.
Bariatric surgery is considered investigational as a cure for type 2 diabetes mellitus.
Subsequent bariatric procedures, including revisions, in patients who regain weight due to failure to comply with lifestyle or dietary modifications are considered not medically necessary.
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Procedure Codes and Billing Guidelines:
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Selected References:
- Deitel M. Overview of Operations for Morbid Obesity. World Journal of Surgery 1998; 22:913-918.
- Lonroth H. Laparoscopic Gastric Bypass. Obesity Surgery 1998; 563-565.
- National Institute of Health (NIH) Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults.
- Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Guidelines for Laparoscopic and Conventional Surgical Treatment of Morbid Obesity. Accessed at www.sages.org
- Monteforte MH, Turkelson CM Meta-Analysis Bariatric Surgery for Morbid Obesity. Obesity Surgery 2000; 10:391-401.
- Scopinaro N et al. Biliopancreatic Diversion. World Journal of Surgery 1998; 22:936-946.
- Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obesity Surgery 2002; 12:564-568.
- Doherty C, Maher JW, Heishusen DS, Long-term data indicate a progressive loss in efficacy of adjustable silicone gastric banding for the surgical treatment of morbid obesity. Surgery 2002; 132:724-728.
- Pontiroli AE et al. Laparoscopic adjustable gastric banding for the treatment of morbid (grade 3) obesity and its metabolic complications: A three year study. The Journal of Clinical Endocrinology And Metabolism 2002; 87(8):3555-3561.
- Livingston EH. Obesity and its surgical management. The American Journal of Surgery 2002;184:103-113.
- American Gastroenterological Association Medical Position Statement on obesity. Gastroenterology 2002;123:879-881.
- Fisher BL, Schauer P. Medical and surgical options in the treatment of severe obesity. The American Journal of Surgery 184(2002) 9S-16S.
- Guidance on the use of surgery to aid weight reduction for people with morbid obesity. Technology Appraisal No. 46. National Institute for Clinical Excellence, July 2002.
- Blue Cross Blue Shield Association Technology Evaluation Center. (2005). Newer Techniques in Bariatric Surgery for Morbid Obesity: Laparoscopic Adjustable Gastric Banding, Biliopancreatic Diversion, and Long-Limb Gastric Bypass. TEC Evaluations 20:5.
- Tice JA. Laparoscopic gastric banding for the Treatment of Morbid Obesity. California Technology Assessment Forum. June 2004.
- Institute for Clinical Systems Improvement. Gastric Restrictive Surgery for Clinically Severe Obesity in Adults. Technology Assessment Report #14. May 2005.
- Holloway J. The Lap-Band is an effective tool for weight loss even in the United States. Am J Surg. 2004 Dec; 188(6):659-62.
- ECRI. Laparoscopic Bariatric Surgery for Morbid Obesity. Windows on Medical Technology. Evidence report. May 2005.
- Jan J. Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Gastric Bypass for Morbid Obesity: A Single-Institution Comparison Study of Early Results. J Gastrointest Surg. 2005 Jan; 9(1):30-9.
- Buchwald H, Avidor Y, Braunwald E et al. Bariatric surgery : a systematic review and meta-analysis. JAMA 2004, Oct. 13; 292(14):1724-37.
- Ponce J, Paynter S, Fromm R. Laparoscopic Adjustable Gastric Banding: 1,014 Consecutive Cases. J Am Coll Surg. 2005 Oct.;201(4):529-35.
- Bowne WB, Julliard K, Castro AE et al. Laparoscopic Gastric Bypass is Superior to Adjustable Gastric Band in Super Morbidly Obese Patients. Arch Surg. 2006; 141:683-689.
- Encinosa WE, Bernard Dm, Chen CC et al. Healthcare Utilization and Outcomes after Bariatric Surgery. Med Care 2006; 44:706-12.
- Ren CJ. Controversies in bariatric surgery: evidence-based discussions on laparoscopic adjustable gastric banding. J Gastrointets Surg. 2004; 8:396-397.
- Holeczy P, Novak P, Kralova A. 30% Complications with Adjustable gastric Banding; What Did We Do Wrong? Obes Surg. 2001; 11:748-751.
- Shapiro K, Patel S, Abdo Z et al. Laparoscopic adjustable banding: is there a learning curve? Surg endosc. 2004; 18:48-50.
- Suter M, Calmes JM, Paroz A et al. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg. 2006;16(7):829-35.
- Sarker S, Meyers J, Serot J et al. Three-year follow-up weight loss results for patients undergoing laparoscopic adjustable gastric banding at a major university medical center: does the weight loss persist> Am J Surg. 2006;191(3):372-6.
- O’Brien PE, McPhail T, Chaston TB et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16(8):1032-40.
- Ledoux S, Msika S, Moussa F et al. Comparison of nutritional consequences of conventional therapy of obesity, adjustable gastric banding, and gastric bypass. Obes Surg. 2006;16(8):1041-9.
- Ballantyne GH, Farkas D, Laker S et al. Short-term changes in insulin resistance following weight loss surgery for morbid obesity: laparoscopic adjustable gastric banding versus laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006;16(9):1189-97.
- Frezza EE, Barton A, Herbert H et al. Laparoscopic sleeve gastrectomy with endoscopic guidance in morbid obesity. Surg Obes Relat Dis 2008 Apr 11 [E-pub ahead of print]
- Frezza EE, Barton A, Herbert H et al. Laparoscopic sleeve gastrectomy with endoscopic guidance in morbid obesity. Surg Obes Relat Dis 2008 Apr 11 [E-pub ahead of print].
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Assessment Program. Laparoscopic Adjustable Gastric Banding for Morbid Obesity. Vol. 21. No. 13. February 2007.
- Karamanakos SN, Vagenas K, Kalfarentzos F et al. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double-blind study. Ann Surg 2008 Mar;247(3);401-7.
- Bult MJ, van Dalen T, Muller AF. Surgical treatment of obesity. Eur J Endocrinol. 2008 Feb;158(2):135-45.
- ECRI Institute. Safety and Efficacy of StomaphyX Device for Gastric Pouch Reduction after Gastric Bypass Surgery. Plymouth Meeting (PA):ECRI Institute; 2008 Feb 11. 4p. [ECRI hotline response]. Also available: http://www.ecri.org.
- ECRI Institute. Bariatric surgery for the treatment of type II diabetes mellitus in patients with BMI <35. Plymouth Meeting (PA):ECRI Institute; 2009 July 22. 4p. [ECRI hotline response]. Also available: http://www.ecri.org.
- Longitudinal Assessment of Baritric Surgery (LABS) Consortium, Flum DR, Belle, SH, King WC et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54.
- Marceau P, Biron S, Hould FS, et al. Duodenal switch improved standard biliopancreatic diversion: a retrospective study. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):43-7.
- Jacobs M, Bisland W, Gomez E, et al. Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. Surg Endosc. 2009 Aug 19. [Epub ahead of print]
- Karamanakos SN, Vagenas K, Kalfarentzos F et al Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double-blind study. Ann Surg 2008 Mar; 247(3):401-7.
- Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009 Jul-Aug; 5(4):469-75.
- Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg 2010 May;20(5):535-40.
- Genco A, Cipriano M, Materia A et al. Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study. Surg Endosc 2009 Aug;23(8):1849-53.
- Kueper MA, Kramer KM, Kirschnial A et al. Laparoscopic sleeve gastrectomy: standardized technique of a potential stand-alone bariatric procedure in morbidly obese patients. Worl J Surg 2008 Jul;32(7):1462-5.
- Berrington de Gonzalez A, Hartge P, Cerhan JR et al. Body-Mass Index and Mortality among 1.46 Million White Adults. N Engl J Med. 2010 Dec 2; 363(23):2211-9.
- Beddingfield F. LAP-BAND® Adjustable Gastric Banding System: PMA Supplement. Retrieved March 7, 2011 from United States Food and Drug Administration web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm234224.htm
- Walsh J. Sleeve gastrectomy as a stand-alone bariatric procedure for obesity. California Technology Assessment Forum (San Francisco, CA). October 13, 2010. Available at: http://www.ctaf.org/content/assessment/detail/1210
- Sovik TT, Aasheim ET, Taha O et al. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011;155:281-91.
- Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 2010; 252(2):319-24.
- Chouillard EK, Karaa A, Elkhoury M et al. Laparoscopic Roux-en Y gastric bypass versus laparoscopic sleeve gastrectomy for morbid obesity: a case-control study. Surg Obes Relat Dis 2011 Mar 8 [Epub ahead of print].
- Emerging Technologies and Clinical Issues Committees of the ASMBS. American Society for Metabolic and Bariatric Surgery Position Statement on emerging endosurgical interventions for treatment of obesity. Surg Obes Rel Dis 2009; 5(3):297-8. Available online at: http://www.asmbs.org/Newsite07/resources/emerging_tech_position.pdf. Last accessed July 2011.
- ECRI Institute. Emerging Technology Evidence Report: Laparoscopic sleeve gastrectomy for obesity. Plymouth Meeting (PA): ECRI Institute; 2011 October 7, 2011. Available at: http://www.ecri.org. Last accessed October 2011.
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Policy History:
Date Reason Action
October 2010 Annual review Policy revised
March 2011 Interim review Policy revised
September 2011 Interim review Policy revised
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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