DESCRIPTION
Minimally invasive endoscopic 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 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., ReShape®, ORBERA® 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 individuals drain a portion of their gastric contents after a meal. The device is readily reversible and intended for long-term use.
Endoscopic gastroplasty, also known as endoscopic gastric plication, includes several restrictive suturing or stapling techniques to reduce the size of the stomach (e.g., EndoCinch™, StomaphyX™, NDO Plicator™, Transoral Gastric Volume Reduction (TGVR), Restorative Obesity Surgery Endoluminal (ROSE), and the Primary Obesity Surgery Endolumenal (POSE™).
POLICY
Minimally invasive endoscopic procedures to perform primary bariatric procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches), including, but not limited to the following, are considered investigational:
Implantable duodenojejunal sleeve
Intragastric balloons
Endoscopically-placed gastrostomy tube with an aspiration device
Endoscopic gastroplasty
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 complication rates, especially nutritional complications, may be higher. Long-term safety data is either not available or conflicting.
SOURCES
American Society for Gastrointestinal Endoscopy. (2015). ASGE position statement on endoscopic bariatric therapies in clinical practice. Retrieved September 20, 2019 from https://www.asge.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.
BlueCross BlueShield Association. Evidence Positioning System. (3:2023). Bariatric Surgery (7.01.47). Retrieved June 27, 2023 from https://www.evidencepositioningsystem.com/. (184 articles and/or guidelines reviewed)
Brunaldi, V.O., Jirapinyo, P., de Moura, D.T.H., Okazaki, O, Bernardo, W.M., Neto, G., et al. (2018). Endoscopic treatment of weight regain following roux-en-Y gastric bypass: a systematic review and meta-analysis. Obesity Surgery, 28 (1), 266-276. Abstract retrieved September 20, 2019 from PubMed database.
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.
Cohen, R., Oliveira da Costa, M., Charry, L., & Heins, E. (2019). Endoscopic gastroplasty to treat medically uncontrolled obesity needs more quality data: a systematic review. Surgery for Obesity and Related Diseases: Official Journal of the American Society for Bariatric Surgery, 15 (7), 1219–1224. Abstract retrieved June 28, 2023 from PubMed database.
Gys, B., Plaeke, P., Lamme, B., Lafullarde, T., Komen, N., Beunis, A., & Hubens, G. (2019). Endoscopic gastric plication for morbid obesity: a systematic review and meta-analysis of published data over time. Obesity Surgery, 29 (9), 3021-3029. Abstract retrieved September 20, 2019 from PubMed database.
Hedjoudje, A., Dayyeh, A., Cheskin, L., Adam, A., Neto, M., Badurdeen, D., et al. (2020). Efficacy and safety of endoscopic sleeve gastroplasty: a systematic review and meta-analysis. Clinical Gastroenterology and Hepatology, 18 (5), 1043 – 1053.e4. (Level 1 evidence)
Jung, S.H., Yoon, J.H., Choi, H.S., Nam, S-J., Kim, K.O., Kim, D.H., et al. (2020). Comparative efficacy of bariatric endoscopic procedures in the treatment of morbid obesity: a systematic review and network meta-analysis. Endoscopy, doi: 10.1055/a-1149-1862. [Epub ahead of print]. Abstract retrieved July 28, 2020 from PubMed database.
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. 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.
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, March; last update search March 2022). Intragastric balloons for the treatment of obesity. Retrieved June 27, 2023 from www.Hayesinc.com/subscribers. (62 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 9/9/2012
MOST RECENT REVIEW DATE: 8/10/2023
ID_BA
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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