Medical policy: Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease

Policy number: MP 1.145

Effective date: 11/1/2026

Policy

Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease is investigational. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-reference

• MP 2.053 Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Description/Background

Gastroesophageal reflux disease (GERD) is defined as reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10% to 20% prevalence in developed countries. The severity of GERD varies widely. Many patients have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other patients have chronic, severe GERD that can lead to complications such as Barrett esophagus and esophageal cancer.

Treatment

For patients with severe disease, chronic treatment with acid blockers is an option. For some patients, medications are not adequate to control symptoms; other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery. A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery.

The LINX™ Reflux Management System (Torax Medical) is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (e.g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.

Regulatory status

In 2012, the LINX™ Reflux Management System (Torax Medical, Shoreview, MN) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for patients diagnosed with gastroesophageal reflux disease (GERD), as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum therapy for the treatment of reflux. FDA initially required 5-year follow-up of 100 patients from the investigational device exemption pivotal study to evaluate safety and efficacy of the device, which was completed in March 2016. FDA product code: LEI.

In March 2018, the FDA approved an update of the LINX^® Reflux Management System precautions statement, stating that the use of the system "in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm and that the LINX Reflux Management System has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm, add a hiatal hernia clinical data summary in the instructions for use, update the instructions for use section to highlight the recommendation to repair a hiatal hernia, if present, at the time of the LINX Reflux Management System implantation, and update the patient information booklet to align with the instructions for use and include 5 year clinical study results."

In February 2024, the FDA revised the labeling for the LINX® Reflux Management System. They removed a precautionary statement about Barrett's Esophagus (BE) from the instructions for use. However, the updated labeling now includes this guidance: "LINX has not been proven to effectively treat BE by causing regression or preventing progression to cancer. Patients with BE who use LINX to manage GERD symptoms should consult their physician about ongoing BE treatment, which may include continued use of proton pump inhibitors (PPIs)."

Rationale

Summary of evidence

For individuals who have GERD who receive magnetic esophageal sphincter augmentation (MSA), the evidence includes 1 RCT comparing MSA to proton pump inhibitor (PPI) therapy, 4 nonrandomized studies comparing MSA to laparoscopic Nissen fundoplication (LNF), laparoscopic Toupet fundoplication (LTF), or anti-reflex mucosectomy (ARM), single-arm cohort studies, and systematic reviews comparing MSA to LNF. Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. An RCT comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and GERD-related quality of life (QOL) at 6 months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. Four non-randomized comparative studies of MSA to laparoscopic fundoplication showed mixed outcomes, with some studies indicating similar improvements in QOL, PPI use, and satisfaction, while others reported no significant differences in symptom improvement but a higher rate of dysphagia in the MSA group, and another study observed transient differences in favor of fundoplication in QOL, with the MSA group having worse QOL scores at final follow-up. Limitations in these comparative studies included a lack of randomization, blinding, heterogeneity in surgical techniques, outdated MSA protocols, imbalanced baseline patient characteristics, and selection bias in treatment choice. In the 2 single-arm, uncontrolled pivotal trials submitted to the FDA with materials for device approval, subjects showed improvements in GERD-health related QOL (GERD-HRQL) scores and reduced PPI use. Similarly, observational comparative studies included in systematic reviews, most often comparing MSA with LNF, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce PPI use after MSA. However, the comparative studies are retrospective and nonrandomized and may be affected by selection bias. Randomized comparisons of MSA with LNF are needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Gastroesophageal reflux (GERD) is a backflow of contents of the stomach into the esophagus that is often the result of incompetence of the lower esophageal sphincter. Gastric juices are acid and therefore produce burning pain in the esophagus. Repeated episodes of reflux may cause esophagitis, peptic esophageal stricture, or esophageal ulcer.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered

References

1. Warren HF, Reynolds JL, Lipham JC, et al. Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surg Endosc. Aug 2016; 30(8):3289-3296. PMID 26541740
2. Asti E, Bonitta G, Lovece A, et al. Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis. Medicine (Baltimore). Jul 2016;95(30):e4366. PMID 27472725
3. Reynolds JL, Zehetner J, Wu P, et al. Laparoscopic magnetic sphincter augmentation vs laparoscopic nissen fundoplication: a matched-pair analysis of 100 patients. J Am Coll Surg. Jul 2015;221(1):123-128. PMID 26095560
4. Louie BE, Farivar AS, Shultz D, et al. Short-term outcomes using magnetic sphincter augmentation versus Nissen fundoplication for medically resistant gastroesophageal reflux disease. Ann Thorac Surg. Jun 21 2014;98(2):498-504. PMID 24961840
5. Sheu EG, Nau P, Nath B, et al. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. Jul 11 2014;29(3):505-509. PMID 25012804
6. Riegler M, Schoppman SF, Bonavina L, et al. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. May 2015;29(5):1123-1129. PMID 25171881
7. U.S. Food and Drug Administration, Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. LINX™ Reflux Management System. 2012;
8. Bonavina L, DeMeester T, Fockens P, et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. Nov 2010;252(5):857-862. PMID 21037442
9. Lipham JC, DeMeester TR, Ganz RA, et al. The LINX(R) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. Oct 2012;26(10):2944-2949. PMID 22538694
10. Ganz RA, Peters JH, Horgan S, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. Feb 21 2013;368(8):719-727. PMID 23425164
11. Saino G, Bonavina L, Lipham JC, et al. Magnetic sphincter augmentation for gastroesophageal reflux at 5 years: final results of a pilot study show long-term acid reduction and symptom improvement. J Laparoendosc Adv Surg Tech A. Oct 2015;25(10):787-792. PMID 26437027
12. Ganz RA, Edmundowicz SA, Taiganides PA, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. May 2016;14(5):671-677. PMID 26044316
13. Bonavina L, Saino G, Bona D, et al. One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg. Oct 2013;217(4):577-585. PMID 23856355
14. Lipham JC, Taiganides PA, Louie BE, et al. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. Mar 11 2015;28(4):305-311. PMID 24612509
15. Smith CD, DeVault KR, Buchanan M. Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg. Apr 2014;218(4):776-781. PMID 24529809
16. Reynolds JL, Zehetner J, Bildzukewicz N, et al. Magnetic sphincter augmentation with the LINX device for gastroesophageal reflux disease after U.S. Food and Drug Administration approval. Am Surg. Oct 2014;80(10):1034-1038. PMID 25264655
17. Warren HF, Louie BE, Farivar AS, et al. Manometric changes to the lower esophageal sphincter after magnetic sphincter augmentation in patients with chronic gastroesophageal reflux disease. Ann Surg. Jul 26 2016. PMID 27464617
18. Rona KA, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. Aug 23 2016. PMID 27553803
19. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System. 2013
20. ASGE Technology Committee. Magnets in the GI tract. Gastrointest Endosc. Oct 2013;78(4):561-567. PMID 24054738
21. Guidozzi N, Wiggins T, Ahmed AR, et al. Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Dis Esophagus. Nov 13 2019; 32(9). PMID 31069388
22. Aiolfi A, Asti E, Bernardi D, et al. Early results of magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: Systematic review and meta-analysis. Int J Surg. Apr 2018; 52: 82-88. PMID 29471155
23. Bell R, Lipham J, Louie BE, et al. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol. Jul 2020; 18(8): 1736-1743.e2. PMID 31518717
24. Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. Jan 2019; 89(1): 14-22.e1. PMID 30031018
25. Louie BE, Smith CD, Smith CC, et al. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. Aug 2019; 270(2): 302-308. PMID 29697454
26. Ayazi S, Zheng P, Zaidi AH, et al. Magnetic Sphincter Augmentation and Postoperative Dysphagia: Characterization, Clinical Risk Factors, and Management. J Gastrointest Surg. Jan 2020; 24(1): 39-49. PMID 31388888
27. Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. Aug 13, 2020; 10(1): 13753. PMID 32792508
28. American Foregut Society (AFS). American Foregut Surgery Statement on Appropriate Patient Selection and Use of Magnetic Sphincter Augmentation (LINX). n.d
29. Khaitan L, Abu Dayyeh BK, Lipham J, et al. American Foregut Society (AFS) Committee Statement on Combined Magnetic Sphincter Augmentation and Bariatric Surgery. Published April 2021. Accessed September 23, 2025. https://www.americanforegutsociety.org/wp-content/uploads/2021/04/AFS_MSA_Bariatric_Surgery_Final-1.pdf
29. Gottlieb KT, Banerjee S, Barth BA, et al. Magnets in the GI tract. Gastrointest Endosc. Oct 2013; 78(4): 561-7. PMID 24054738218(4): 776-81. PMID 24529809
30. Schizas, D., Mastoraki, A., Papoutsi, et al. (2020). LINX® reflux management system to bridge the "treatment gap" in gastroesophageal reflux disease: A systematic review of 35 studies. World journal of clinical cases, 8(2), 294–305. PMID 32047777
31. Schwaitzberg S, Louie B, Talley N, et al. Surgical Management of Gastroesophageal Reflux in Adults. Last updated October 5, 2021.
32. Zadeh, J., Andreoni, A., Treitl, D., & Ben-David, K. (2018). Spotlight on the Linx™ Reflux Management System for the treatment of gastroesophageal reflux disease: evidence and research. Medical devices (Auckland, N.Z.), 11, 291–300. PMID 30214323Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022;117(1):27-56. PMID 34807007
33. Slater BJ, Collings A, Dirks R, et al. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD) [published online ahead of print, 2022 Dec 18]. Surg Endosc. 2022;10.1007/s00464-022-09817-3. doi:10.1007/s00464-022-09817-3 PMID 36529851
34. Nikolic M, Matic A, Feka J, et al. Expanded Indication for Magnetic Sphincter Augmentation: Outcomes in Weakly Acidic Reflux Compared to Standard GERD Patients. J Gastrointest Surg. 2022;26(3):532-541. PMID: 34590216
35. Yadlapati R, Gyawali CP, Pandolfino JE; CGIT GERD Consensus Conference Participants. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review [published correction appears in Clin Gastroenterol Hepatol. 2022 Sep;20(9):2156. doi: 10.1016/j.cgh.2022.05.005]. Clin Gastroenterol Hepatol. 2022;20(5):984-994.e1. doi:10.1016/j.cgh.2022.01.025
36. Chen JW, Vela MF, Peterson KA, Carlson DA. AGA Clinical Practice Update on the Diagnosis and Management of Extraesophageal Gastroesophageal Reflux Disease: Expert Review. Clin Gastroenterol Hepatol. 2023;21(6):1414-1421.e3 PMID 37061897
37. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.01.137, Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease. November 2024
38. National Institute for Health and Care Excellence. Laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease [IPG749]. Published 2023. Accessed September 23, 2025. https://www.nice.org.uk/guidance/IPG749
39. American Foregut Society (AFS). American Foregut Surgery Statement on Appropriate Patient Selection and Use of Magnetic Sphincter Augmentation (LINX). n.d.; https://www.americanforegutsociety.org/assets/docs/AFS-LINX-Final.pdf. Accessed September 24, 2025.
40. Tadé Y, Newman D, Walters RW, et al. Fundoplication significantly improves objective and subjective reflux outcomes-a meta-analysis. Surg Endosc. Jul 2025; 39(7): 4496-4504. PMID 40442360