Laparoscopic and Endoscopic Therapies for Gastroesophageal Reflux (GERD)

BlueCross BlueShield of Tennessee Medical Policy Manual

DESCRIPTION

Due in part to the prevalence of gastroesophageal reflux disease (GERD), there has been interest in developing a minimally invasive alternative to the standard treatments of open or laparoscopic fundoplication (Nissen) or chronic pharmaceutical therapy. This policy addresses several different types of emerging minimally invasive procedures.

Standard treatments for gastroesophageal reflux (GERD) are not addressed in this policy.

Transesophageal endoscopic gastroplasty, also referred to as gastroplication, fundoplication, and transoral incisionless fundoplication (TIF), is a procedure where sutures are placed in the lower esophageal sphincter. The sutures are proposed to strengthen and lengthen the sphincter to decrease reflux. Products approved for marketing by the FDA include EsophyX® and Medigus SRS Endoscopic Stapling System (MUSE).
Radiofrequency energy has been proposed as a treatment option to produce submucosal thermal lesions at the gastroesophageal junction (e.g., Stretta™). The mechanism of action of the thermal lesions is not precisely known but may be related to ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissue tightening effect related to heat-induced collagen contraction.
Submucosal implantation of a prosthesis (e.g., Gatekeeper™ Reflux Repair System) or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) to enhance the volume of the lower esophageal sphincter has also been proposed.
A ringed magnetic bead sphincter augmentation device (e.g., LINX® Reflux Management System) placed laparoscopically has been proposed as a treatment for GERD. The magnetic attraction between the beads purportedly helps the Lower Esophageal Sphincter (LES) resist opening to gastric pressures, preventing reflux from the stomach into the esophagus. Swallowing forces temporary breaks in the magnetic bond, allowing food and liquid to pass normally into the stomach. Magnetic attraction closes the LES immediately after swallowing, purportedly restoring the barrier to reflux.

POLICY

Transoral incisionless fundoplication (e.g., EsophyX; MUSE) for the treatment of gastroesophageal reflux disease is considered investigational.
Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (i.e., Stretta® procedure) for the treatment of gastroesophageal reflux disease is considered investigational.
Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) for the treatment of gastroesophageal reflux disease is considered investigational.
Laparoscopic insertion of interlinked magnetic beads (e.g., LINX® Reflux Management System) for the treatment of gastroesophageal reflux disease is considered investigational.

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

There remains a lack of high-quality evidence to support the procedures addressed within this policy. There is a need for large randomized controlled trials with long-term outcomes comparing these procedures to currently accepted treatments.

SOURCES

Ajmera, K., Thaimuriyil, N., & Shah, N. (2022). Recent Advances in the endoscopic management of gastro-esophageal reflux disorder: a review of literature. Cureus, 14 (6), e26218. doi: 10.7759/cureus.26218. (Level 5 evidence)

American College of Gastroenterology. (2022, January). Guidelines for the diagnosis and management of gastroesophageal reflux disease. Retrieved September 8, 2022 from https://journals.lww.com/ajg/fulltext/2022/01000/acg_clinical_guideline_for_the_diagnosis_and.14.aspx.

American Gastroenterology Association. (2016, April). Technology coverage statement on minimally invasive surgical options for gastroesophageal reflux disease. Retrieved October 3, 2023 from https://www.endogastricsolutions.com/2016/06/american-gastroenterological-association-releases-technology-coverage-statement-on-minimally-invasive-surgical-options-for-gerd/.

American Society for Gastrointestinal Endoscopy. (2015). Guideline: The role of endoscopy in the management of GERD. Retrieved March 2, 2017 from http://www.giejournal.org.

American Society of General Surgeons. (2014). LINX statement of support from ASGS. Retrieved December 11, 2019 from https://theasgs.org.

American Society of General Surgeons. (2019). Position statement: transoral fundoplication. Retrieved December 11, 2019 from https://theasgs.org.

Asti, E., Bonitta, G., Lovece, A., Lazzari, V., & Bonavina, L. (2016). Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation. Medicine, 95 (30), e4366. (Level 3 evidence)

Bell, R., Lipham, J., Louie, B., Williams, V., Luketich, J., Hill, M., et al. (2019). Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointestinal Endoscopy, 89 (1), 14-22. Abstract retrieved December 10, 2019 from PubMed database.

Bell, R.C.W., Freeman, K., Heidrick, R., & Ayazi, S. (2021). Transoral incisionless fundoplication demonstrates durability at up to 9 years. Therapeutic Advances in Gastroenterology, 14 (17562848211004827), doi: 10.1177/17562848211004827). (Level 5 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (1:2023). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved September 18, 2023 from http://www.evidencepositioningsystem.com. (42 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (12:2022). Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux (7.01.137). Retrieved September 18, 2023 from http://www.evidencepositioningsystem.com/. (12 articles and/or guidelines reviewed)

Chen, M.Y., Huang, D.Y., Wu, A., Zhu, Y.B., Zhu, H.P., Lin, L.M., & Cai, X.J. (2017). Efficacy of magnetic sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease in short term: a meta-analysis. Canadian Journal of Gastroenterology and Hepatology, doi: 10.1155/2017/9596342. (Level 2 evidence)

CMS.gov: Center for Medicare & Medicaid Services. Palmetto GBA. (2022, August). Upper gastrointestinal endoscopy and visualization. (LCD ID L34434). Retrieved September 2, 2022 from https://www.cms.gov.

Dughera, L., Rotondano, G., DeCento, M., Cassolino, P, & Cisaro, F. (2014). Durability of Stretta radiofrequency treatment for GERD: results of an 8-year follow-up. Gastroenterology Research and Practice, DOI:10.1155/2014/531907. (Level 2 evidence)

Fass, R., Cahn, F., Scotti, D.J., & Gregory, D.A. (2017). Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surgical Endoscopy, 31 (12), 4865-4882. Abstract retrieved December 10, 2019 from PubMed database.

Gawron, A.J., Bell, R., Dayeh, A., Buckley, B.K., Chang, K., Dunst, C.M., et al. (2020). Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel. Gastrointestinal Endoscopy, 92 (1), 78-87. (Level 5 evidence)

Gerson, L., Stouch, B., & Lobontiu, A. (2018). Transoral incisionless fundoplication (TIF 2.0): a meta-analysis of three randomized, controlled clinical trials. Chirurgia, 113 (2), 173-184. (Level 2 evidence)

Guidozzi, N., Wiggins, T., Ahmed, A.R., Hanna, G.B., & Markar, S.R. (2019). Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Diseases of the Esophagus, 32 (9). Abstract retrieved June 25, 2021 from PubMed database.

Gutierrez, O.I.B., Choi, D., Hejazi, R., Samo, S., Tran, M.N., Chang, K.J., et al. (2023). American foregut society white paper on transoral incisionless fundoplication. Foregut, 0 (0) 1-13. (Level 4 evidence)

Håkansson, B., Montgomery, M., Cadiere, G.B., Rajan, A., des Varannes, S.B., Lerhun, M., et al. (2015). Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Alimentary Pharmacology and Therapeutics, 42, 1261-1270. (Level 2 evidence)

Haseeb, Muhammad., Brown, J.R.G., Hayat, U., Bay, C., Bain, P.A., Jirapinyo, P., et al. (2022). Impact of second-generation transoral incisionless fundoplication on atypical GERD symptoms: a systematic review and meta-analysis. Gastrointestinal Endoscopy, 97 (3), 394-406.Abstract retrieved September 18, 2023.

Huang, X., Chen, S., Zhao, H., Zeng, X., Lian, J, Tseng, Y., & Chen, J. (2017). Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Surgical Endoscopy, 31 (3), 1032-1044. (Level 2 evidence)

Hunter, J., Kahrilas, P., Bell, R., Wilson, E., Trad, K., Dolan, J., et al. (2015). Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology, 148, 324-333. (Level 2 evidence)

Jaruvongvancih, V.K., Matar, R., Relsenauer, J., Janu, P., Mavrelis, P., Ihde, G., et al. (2023). Hiatal hernia repair with transoral incisionless fundoplication versus nissen fundoplication for gastroesophageal reflux disease: a retrospective study. Endoscopy International Open, 11 (1), E11-E18. (Level 4 evidence)

National Institute for Health and Clinical Excellence (NICE). (2023, January). Laparoscopic insertion of a magnetic ring for gastro-esophageal reflux disease. Retrieved September 18, 2023 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (2023, March). Endoluminal gastroplication for gastro-oesphageal reflux disease. Retrieved September 18, 2023 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (NICE). (2013, August). Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. Retrieved January 11, 2018 from http://www.nice.org.

National Institute for Health and Clinical Excellence. (NICE). (2004, April; last updated January 2012). Endoscopic injection of bulking agents for gastro-oesophageal reflux disease. Retrieved January 11, 2018 from http://www.nice.org.

Richter, J.E., Kumar, A., Lipka, S., Miladinovic, B., & Velanovich, V. (2018). Efficacy of laparoscopic Nissen fundoplication vs transoral incisionless fundoplication or proton pump inhibitors in patients with gastroesophageal reflux disease: a systematic review and network meta-analysis. Gastroenterology, 154 (5), 1298-1308. (Level 2 evidence)

Schizas, D., Mastoraki, A., Papoutsi, E., Giannakoulis, V.G., Tsillimigras, D., Ntourakis, D., et al. (2020). LINX® reflux management system to bridge the “treatment gap” in gastroesophageal reflux disease: A systematic review of 35 studies. The World Journal of Clinical Cases, 8 (2), 294-305. (Level 1 evidence)

Skubleny, D., Switzer, N.J., Dang, J., Gill, R.S., Shi, X., de Gara, C., et al. (2017). LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis. Surgical Endoscopy, 31 (8), 3078-3084. Abstract retrieved December 10, 2019 from PubMed database.

Society of American Gastrointestinal and Endoscopic Surgeons. (2017, March). SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: LINX® Reflux Management System. Retrieved January 9, 2018 from http://www.sages.org.

Society of American Gastrointestinal Endoscopic Surgeons (SAGES). (2017, May). Clinical Spotlight Review: Endoluminal treatments for gastroesophageal reflux disease (GERD). Retrieved January 10, 2018 from https://www.sages.org.

Testoni, S., Hassan, C., Mazzoleni, G., Antonelli, G., Fanti, L., Passaretti, S., et al. (2021). Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endoscopic International Open, 9 (2), E239-E246. (Level 1 evidence)

Toomey, P., Teta, A., Patel, K., Ross, S., Sukharamwala, P., & Rosemurgy, A.S. (2014). Transoral incisionless fundoplication: is it as safe and efficacious as a nissen or toupet fundoplication? The American Surgeon, 80 (9), 860-867. (Level 5 evidence)

Trad, K., Fox, M., Simoni, G., Shughoury, A., Mavrelis, P., Raza, M., et al. (2016). Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surgical endoscopy, DOI 10.1007/s00464-016-5252-8. (Level 3 evidence)

U. S. Food and Drug Administration. (2000, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K000245. Retrieved August 29, 2014 from www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K092400. Retrieved February 15, 2011 from www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2012, March). PMA Pre-Market Approval Database. P100049 (LINX™). Retrieved September 2, 2014 from www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2012, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120299. Retrieved January 11, 2018 from www.accessdta.fda.gov.

Winifred S. Hayes, Inc. Health Technology Brief. (2022, August). Magnetic sphincter augmentation with LINX Reflux Management System (Ethicon, Inc.) for treatment of gastroesophageal reflux disease. Retrieved September 2, 2022 from www.Hayesinc.com/subscribers. (38 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc., Medical Technology Directory. (2017, December; last update search April 2022). Comparative effectiveness review of laparoscopic surgery for gastroesophageal reflux disease refractory to medical therapy. Retrieved September 2, 2022 from www.Hayesinc.com/subscribers. (84 articles and/or guidelines reviewed)

Winifred S. Hayes. Inc., Health Technology Assessment. (2023, May). Transoral Incisionless Fundoplication 2.0 With EsophyX (EndoGastric Solutions Inc.) for Treatment of Gastroesophageal Reflux. Retrieved September 18, 2023 from www.Hayesinc.com/subscribers. (43 articles and/or guidelines reviewed)

Winifred S. Hayes. Inc., Medical Technology Directory. (2017, December; last update search January 2022). Comparative effectiveness review of endoscopic therapy for gastroesophageal reflux disease. Retrieved September 2, 2022 from www.Hayesinc.com/subscribers. (106 articles and/or guidelines reviewed)

Yadlapati, R., Gyawali, C.P., & Pandolfino, J.E. (2022). AGA clinical practice update on the personalized approach to evaluation and management of GERD: expert review. Clinical Gastroenterology and Hepatology, 20 (5), 984-994. (Level 5 evidence)

ORIGINAL EFFECTIVE DATE: 1/1/2001

MOST RECENT REVIEW DATE: 11/9/2023

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