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, endoscopically-placed gastrostomy tube with an aspiration device, 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.
Endoscopically-placed gastrostomy tube with an aspiration device (e.g. AspireAssist®) is similar to a percutaneous endoscopic gastrostomy (PEG) tube, with a detachable external device through which patients partially drain their gastric contents into a toilet after a meal. The device is readily reversible and intended for long-term duration of use.
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™, and NDO Plicator™). The StomaphyX™ procedure is also used as a revision procedure for individuals who have had the Roux-en-Y gastric bypass surgery and have regained weight. 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.The ROSE (restorative obesity surgery endoluminal) procedure is another example of a minimally invasive bariatric procedure. This incisionless surgery reduces stomach volume and stoma diameter, which is designed to increase restriction and encourage weight loss in gastric bypass patients.
Minimally invasive procedures (i.e., implantable duodenojejunal sleeve, intragastric balloons, restorative obesity surgery endoluminal procedure, endoscopically-placed gastrostomy tube with an aspiration device and/or gastric plication procedures) for weight loss are considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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 complication rates, especially nutritional complications, may be higher. Long-term safety data is either not available or conflicting.
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 www.asmbs.org.
American Society for Metabolic and Bariatric Surgery. (2015). Position statement on intragastric balloon therapy endorsed by SAGES. Retrieved January 18, 2017 from https://asmbs.org.
American Society for Metabolic and Bariatric Surgery. (2016). Position statement on single-anastomosis duodenal switch. Retrieved January 18, 2017 from https://asmbs.org
BlueCross BlueShield Association. Evidence Positioning System. (2:2018). Bariatric Surgery (7.01.47). Retrieved October 2, 2018 from https://www.evidencepositioningsystem.com/ (143 articles and/or guidelines reviewed)
Bolton, J., Gill, R., Al-Jahdali, A., Byrns, S., Shi, X., Birch, D. & 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.
Centers for Medicare and Medicaid Services. CMS.gov NCD forbariatric surgery for treatment of morbid obesity (100.1). Retrieved January 17, 2017 from https://www.cms.gov.
Centers for Medicare and Medicaid Services. CMS.gov. NCD forgastric balloon for treatment of obesity (100.11). Retrieved January 17, 2017 from https://www.cms.gov.
Dakin, G., Eid, G., Mikami, D., Pryor, A., Chand, B. and ASMBS Emerging Technology and Procedures Committee. (2013, May-June). Endoluminal revision of gastric bypass for weight regain—a systematic review. Surgery of Obesity Related Disorders, 9 (3), 335-42. Abstract retrieved September 29, 2017 from PubMed database.
de Moura, E. G., Martins, B. C., Lopes, G. S., Orso, I. R., de Oliveira, S. L., Galva˜o 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)
Deb, S., Voller, L., Palisch, C., Ceja, O., Turner, W., Rivas, H., et al. (2016). Influence of weight loss attempts on bariatric surgery outcomes. The American Journal of Surgery, 82 (10), 916-920. Abstract retrieved January 18, 2017 from PubMed database.
ECRI Institute. Health Technology Assessment Information Service™. (2016, March). 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™. (2013, April). Endoluminal sleeve (EndoBarrier) for preoperative weight loss or treating obesity. Retrieved November 25, 2013 from ECRI Institute. (31 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. Spanish Journal of Gastroenterology, 104 (2), 72-87. (Level 1 evidence)
Gaillard, M., Tranchart, H., Lainas, P., Ferretti, S., Perlemuter, G., & Dagher, I. (2016). Single-port laparoscopic sleeve gastrectomy as a routine procedure in 1000 patients. Surgery for Obesity and Related Diseases, 12 (7), 1270-1277. Abstract retrieved January 18, 2017 from PubMed database.
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)
Koehestanie, P., de Jonge, C., Berends, F., Janssen, I., Bouvy, N., and Greve, J. (2014). The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Annals of Surgery, 260(6), 984-82. Abstract retrieved September 29, 2017 from PubMed database.
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.
Rodriquez, L., Reyes, 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)
Schouten, R., Rijs, C., Bouvy, N., Hameeteman, W., Koek, G., Janssen, I., 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)
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.
Thompson, C., Dayyeh, B., Kushner, R., Sullivan, S., Schorr, A., Amaro, A., et al. (2017). Percutaneous gastrostomy device for the treatment of class II and class III obesity: results of a randomized controlled trial. The American Journal of Gastroenterology, 112, 447-457. (Level 2 evidence)
U. S. Food and Drug Administration. (2007. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071553 (Plicator™). Retrieved November 25, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2012, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120147 (ACE Stapler™). Retrieved November 25, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2016, June). Center for Devices and Radiological Health. Pre-market approval decisions for P150024 (AspireAssist®). Retrieved September 29, 2017 from http://www.fda.gov.
Vanguri, P., Brengman, M., Oiticica, C., Wickham, E., Bean, M., & Lanning, D. (2014). Laparoscopic gastric plication in the morbidly obese adolescent patient. Seminars in Pediatric Surgery, 23 (1), 24-30. (Level 5 evidence)
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 ahead of print)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, March). Intragastric balloons for the treatment of obesity. Retrieved March 20, 2016 from www.Hayesinc.com/subscribers. (62 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 9/9/2012
MOST RECENT REVIEW DATE: 11/8/2018
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.
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