BlueCross BlueShield of Tennessee Medical Policy Manual

Minimally Invasive Procedures for Weight Loss

DESCRIPTION

Minimally invasive procedures involving a variety of gastrointestinal devices and techniques are being investigated for individuals who are morbidly obese, have diabetes and/or as a primary bariatric procedure. They are also used as a revision procedure (i.e., to remedy large gastric stoma or large gastric pouches) and for those who have regained weight following weight loss surgery. Endoluminal (also called endosurgical, endoscopic, or natural orifice) bariatric procedures access the stomach through the mouth without skin incisions. Examples of endoluminal bariatric devices or procedures include a duodenojejunal sleeve or liner, intragastric balloons and/or gastric plication procedures.

The implantable duodenojejunal sleeve or liner (e.g., the EndoBarrier® Gastrointestinal Liner) is an impermeable fluoropolymer tube that will allow partially digested food leaving the stomach to move through the gastrointestinal tract without mixing with digestive enzymes or allowing nutrients to be absorbed. Under general anesthesia, the liner is deployed through a catheter, anchored within the duodenum and left in place. The device can be removed endoscopically by using the liner drawstrings to collapse and retract the anchor barbs.

Intragastric balloons [e.g. Silimed™, ReShape Duo™, BioEnterics® Intragastric Balloon (BIB) or Obalon System] are placed in the stomach using an endoscope or swallowed to act as a space-occupying device. They are either a single balloon or two connected balloons that once in place, are filled with saline or air. Complications include problems with erosion and migration, and long term weight loss is variable.

Gastric plication procedures, also known as endoscopic gastroplasty procedures include several restrictive suturing or stapling techniques that do not leave devices behind.  In one the greater curve plication or total vertical gastric plication of the stomach is accessed endoscopically and numerous pleats or imbrications are created to reduce the volume of the gastric cavity. The pleats are sutured or stapled in place (e.g. EndoCinch™, StomaphyX™, EsophyX™, NDO Plicator™). Another, the Transoral Gastric Volume Reduction (TGVR) is a relatively new restrictive procedure that works by sewing the sides of the stomach to create a feeling of fullness. The Primary Obesity Surgery Endolumenal (POSE™) procedure is for those who have not had weight loss surgery in the past and are seeking more conservative weight loss results. It reduces the size of the stomach by creating folds and anchoring them in place with sutures.

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The published evidence from peer-reviewed literature on minimally invasive bariatric surgery procedures is insufficient to form conclusions on their impact on health outcomes. While the short-term weight loss is similar to gastric bypass, the complications rates, especially nutritional complications, may be higher. Therefore, these procedures remain investigational.

SOURCES

American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic and Bariatric Surgery. (March 2013) Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient - 2013 update. Retrieved July 21, 2015 from: http://www.guideline.gov/content.aspx. (NCG#010217)

American Society for Gastrointestinal Endoscopy/ American Society for Metabolic and Bariatric Surgery Task Force on Endoscopic Bariatric Therapy. (2011). A pathway to endoscopic bariatric therapies. Gastrointestinal Endoscopy, 74 (5), 943-953.

American Society for Metabolic and Bariatric Surgery. (2009). Position statement on emerging endosurgical interventions for the treatment of obesity, Surgery for Obesity and Related Diseases. 5 (2009), 297-298.

American Society for Metabolic and Bariatric Surgery. (2011). Policy statement on gastric plication. Retrieved November 25, 2013 from: https://s3.amazonaws.com/publicASMBS/GuidelinesStatements/PolicyStatment/Rev_Gastric+Plication+Statement_10.06.11.pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2016) Bariatric Surgery. (7.01.47) Retrieved March 20, 2016 from: BlueWeb. (135 articles and/or guidelines reviewed)

Bolton, J., Gill, R., Al-Jahdali, A., Byrns, S., Shi, X., Birch, D. and Karmali, S., (2012) Endoscopic revision (StomaphyX) versus formal surgical revision (Gastric Bypass) for failed vertical band gastroplasty. Journal of Obesity. Vol. 2013, Article ID 108507. (Level 4 evidence)

California Technology Assessment Forum. (May 2015). Controversies in obesity management. May 26, 2015. Retrieved July 21, 2015 from: http://www.ctaf.org/. (477 articles and/or guidelines reviewed)

Center for Medicare and Medicaid Services. CMS.gov (1987) National Coverage Determination (NCD) for gastric balloon for treatment of obesity (100.11). Retrieved March 20, 2016 from: https://www.cms.gov.

Center for Medicare and Medicaid Services. CMS.gov (1987) National Coverage Determination (NCD) for bariatric surgery for treatment of morbid obesity (100.1). Retrieved March 20, 2016 from: https://www.cms.gov

de Moura, E. G., Martins, B. C., Lopes, G. S., Orso, I. R., de Oliverira, S. L., Galvao Neto, M. P., et al. (2012). Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technology & Therapeutics, 14 (12), 183-189. (Level 2 evidence - Industry sponsored)

ECRI Institute. Health Technology Assessment Information Service™.(2016, March) Health Technology Forecast. Intragastric balloons for treating obesity. Retrieved March 20, 2016 from ECRI Institute. (65 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Assessment Information Service™.(2015, September) Product Brief.  Orbera® intragastric balloon system (Apollo Endosurgery, Inc.) for treating obesity. Retrieved March 20, 2016 from ECRI Institute. (69 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Assessment Information Service™.(2015, December) Product Brief. OverStitch endoscopic suturing system (Apollo Endosurgery, Inc.) for placing full-thickness surgical sutures. Retrieved March 20, 2016 from ECRI Institute. (69 articles and/or guidelines reviewed)

Espinet-Coll, E., Nebreda-Durán, J. Gómez-Valero, J. Muñoz-Navas, M., Pujol-Gebelli, J. Vila-Lolo, C. et. al., (2012) Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig (Spanish Journal of Gastroenterology) 2012; 104 (2): 72-87. (meta-analysis)

Gersin, K., Keller, J., Stefanidis, D., Simms, C., Abraham, D., Deal, S., et al. (2007). Duodenal-jejunal bypass sleeve: A totally endoscopic device for the treatment of morbid obesity. Surgical Innovation, 14 (4), 275-278.

Gersin, K., Rothstein, R., Rosenthal, R., Stefanidis, D., Deal, S., Kuwada, T., et al. (2010). Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointestinal Endoscopy, 71 (6), 976-982. (Level 2 evidence - Industry sponsored)

National Institute for Health and Clinical Excellence. (2012, November). Laparoscopic gastric plication for the treatment of severe obesity. Retrieved November 25, 2013 from http://guidance.nice.org.uk.

Ramos, A., Neto, M, Galvao, M., Evangelista, L., Campos, J., & Ferraz, A. (2010). Laparoscopic greater curvature plication: Initial results of an alternative restrictive bariatric procedure. Obesity Surgery, 2010 (20), 913-918. (Level 4 evidence - Industry supported)

Rodriquez, L., Reves, E., Fagalde, P., Oltra, M. S., Saba, J., Aylwin, C. G., et al. (2009). Pilot clinical: Study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes. Diabetes Technology & Therapeutics, 11 (11), 725-732. (Level 2 evidence - Industry sponsored)

Ryou, M., Ryan, M., & Thompson, C. (2011). Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointestinal Endoscopy Clinics of North America, 21 (2), 315-333.

Schouten ,R., Rijs, C., Bouvy, N., Hameeteman, W., Koek, G., Janssen, I., Greve, J., et al. (2010). A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Annals of Surgery, 251 (2), 236-243. (Level 2 evidence - Industry sponsored)

Society of American Gastrointestinal and Endoscopic Surgeons. (2009) Position statement on endoluminal therapies for gastrointestinal diseases. Retrieved March 20, 2016 from: http://www.sagescms.org.

Stylopoulos, N., & Aguirre, V. (2009). Mechanisms of bariatric surgery and implications for the development of endoluminal therapies for obesity. Gastrointestinal Endoscopy, 70 (6), 1167-1175.

U. S. Food and Drug Administration. (2007. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071553. Retrieved November 25, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071553.pdf.

U. S. Food and Drug Administration. (2012, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120147. Retrieved November 25, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf12/k120147.pdf.

Verdam, F., Schouten, R., Greve, J., Koek, G., & Bouvy, N. (2012). An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. Journal of Obesity, 2012 (epub).

Winifred S. Hayes, Inc. Clinical Research Response. (2015, October) Obera intragastric balloon system (Apollo Endosurgery Inc.). Retrieved March 20, 2016 from: www.Hayesinc.com/subscriber. 

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, March) Intragastric balloons for the treatment of obesity. Retrieved March 20, 2016 from: www.Hayesinc.com/subscriber. (62 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  9/9/2012

MOST RECENT REVIEW DATE:  5/26/2016

ID_BT

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