Medical policy: Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease (Formerly Procedures for the Treatment of Gastroesophageal Reflux Disease)

Policy number: MP 2.053

Effective date: 11/1/2026

Policy

Transoral incisionless fundoplication (e.g., EsophyX, MUSE, GERDX) is considered investigational as a treatment of gastroesophageal reflux disease. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (i.e., Stretta procedure) is considered investigational as a treatment of gastroesophageal reflux disease. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) is considered investigational as a treatment of gastroesophageal reflux disease. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-references

• MP 1.145 Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease
• MP 1.118 Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus

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

Gastroesophageal reflux disease (GERD) is a common disorder characterized by heartburn and other symptoms related to reflux of stomach acid into the esophagus. Nearly all individuals experience such symptoms at some point in their lives; a smaller number have chronic symptoms and are at risk for complications of GERD. The prevalence of GERD has been estimated to be approximately 20% in the United States.

Pathophysiology

The pathophysiology of GERD involves excessive exposure to stomach acid, which occurs for several reasons. There can be an incompetent barrier between the esophagus and stomach, either due to dysfunction of the lower esophageal sphincter or incompetence of the diaphragm. Another mechanism is abnormally slow clearance of stomach acid. In this situation, delayed clearance leads to an increased reservoir of stomach acid and a greater tendency to reflux.

In addition to troubling symptoms, some patients will have a more serious disease, which results in complications such as erosive esophagitis, dysphagia, Barrett esophagus, and esophageal carcinoma. Pulmonary complications may result from aspiration of stomach acid into the lungs and can include asthma, pulmonary fibrosis, and bronchitis, or symptoms of chronic hoarseness, cough, and sore throat.

Treatment

Guidelines on the management of GERD emphasize initial medical management. Weight loss, smoking cessation, head of the bed elevation, and elimination of food triggers are all recommended in recent practice guidelines. Proton pump inhibitors have been shown to be the most effective medical treatment. In a Cochrane systematic review, van Pinxteren et al (2010) reported that proton pump inhibitors demonstrated superiority to H₂-receptor agonists and prokinetics in both network meta-analyses and direct comparisons.

Surgical treatment

The most common surgical procedure used for GERD remains laparoscopic Nissen fundoplication; however, the utilization of this procedure steadily declined between 2009 and 2013 with the advancement of novel nonmedical (endoscopic and surgical) techniques. Fundoplication involves wrapping a portion of the gastric fundus around the distal esophagus to increase lower esophageal sphincter pressure. If a hiatal hernia is present, the procedure also restores the position of the lower esophageal sphincter to the correct location. Laparoscopic fundoplication was introduced in 1991 and has been rapidly adopted because it avoids complications associated with an open procedure.

Although fundoplication results in a high proportion of patients reporting symptom relief, complications can occur and sometimes require conversion to an open procedure. Patients who have relief of symptoms of GERD after fundoplication may have dysphagia or gas-bloat syndrome (excessive gastrointestinal gas).

Other treatment options

Due in part to the high prevalence of GERD, there has been interest in creating a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. This type of procedure may be considered natural orifice transluminal surgery. Three types of procedures have been investigated.

• Transesophageal endoscopic gastroplasty (gastroplication, transoral incisionless fundoplication) can be performed as an outpatient procedure. During this procedure, the fundus of the stomach is folded and then held in place with staples or fasteners that are deployed by the device. The endoscopic procedure is designed to recreate a valve and barrier to reflux.
• Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction (this technique has also been referred to as the Stretta procedure.) Specifically, radiofrequency energy is applied through four electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction. 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 and fibrosis.
• Submucosal injection or implantation of a prosthetic or bulking agent to enhance the volume of the lower esophageal sphincter has also been investigated. One bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere), is being evaluated. The Gatekeeper™ Reflux Repair System (Medtronic) uses a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis is implanted into the esophageal submucosa, and with time, the prosthesis absorbs water and expands, creating bulk in the region of implantation. However, as the only identified RCT was terminated early due to lack of efficacy and it was voluntarily withdrawn by the manufacturer. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

Regulatory status

The EsophyX^® (EndoGastric Solutions) is a transesophageal (or transoral) incisionless fundoplication (TIF) device that was originally cleared for marketing by FDA through the 510(k) process in 2007 and has subsequently undergone 2 evolutions: Generation 2=EsophyX2 iterations (E2-Plus, HD) and Generation 3=Z iterations (EZ/ZR, Z+). Some of the key Regulatory Status changes are summarized herein. In 2007, EsophyX^® (EndoGastric Solutions) was cleared for marketing by the FDA through the 510(k) process for full-thickness plication. In 2016, EsophyX^® Z Device with SerosaFuse Fasteners was cleared for marketing by FDA through the 510(k) process (K160960) for use in transoral tissue approximation, full-thickness plication, ligation in the gastrointestinal tract, narrowing the gastroesophageal junction, and reduction of hiatal hernias of 2 cm or less in patients with symptomatic chronic GERD. In June 2017, EsophyX2 HD and the third-generation EsophyX Z Devices with SerosaFuse fasteners and accessories were cleared for marketing by FDA through the 510(k) process (K171307) for expanded indications, including patients who require and respond to pharmacologic therapy and patients with hiatal hernias larger than 2 cm when a laparoscopic hiatal hernia repair reduces a hernia to 2 cm or less. An additional FDA 510(k) clearance (K172811) occurred in October 2017 for new product specification iterations of EsophyX2 HD and EsophyX Z Devices. This clearance allows for "a moderate increase in the upper limit of the temporary Tissue Mold clamping pressure occurring during each fastener deployment”. A 2024 FDA 510(k) clearance (K240879) updated instructions for use and other device labeling. FDA product code: ODE.

The Medigus SRS Endoscopic Stapling System (MUSE, Medigus) was cleared for marketing by FDA through the 510(k) process in 2012 (K120299) and 2014 (K132151). MUSE is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create anterior partial fundoplication for treatment of symptomatic chronic GERD in patients who require and respond to pharmacologic therapy. FDA product code: ODE.

The GERDX-System (K233240) was cleared through the 510(k) process in 2024 (K233240). The device is intended for endoscopic full-thickness plication for chronic GERD in individuals who require and respond to pharmacological therapy. FDA product code: ODE. The manufacturer website includes a description for use in presence of a hiatal hernia up to 3 cm in size. The device is clinically, biologically, and technologically identical to the NDO Surgical Endoscopic Plication System (K071553) which was approved by the FDA in 2003 and has since been removed from the market due to risk of complications. Technological details of the GERDX-System have been improved from the predicate device to improve safety.

In 2000, the CSM Stretta^® System was cleared for marketing by FDA through the 510(k) process for general use in the electrosurgical coagulation of tissue and was specifically intended for use in the treatment of GERD. In 2010, Mederi Therapeutics began manufacturing the Stretta^® device. Mederi was acquired by Respiratory Technology Corporation in 2018. FDA product code: GEI.

DurasphereÒ is a bulking agent approved for treatment of urinary and fecal incontinence (see evidence review MP 4.012). Use of this product for esophageal reflux would be considered off-label use. The website of Carbon Medical Technologies states that the Durasphere^® GR product is “intended to treat problems associated with GERD” but is considered an investigational device in the United States.

Rationale

Summary of evidence

For individuals who have GERD and a hiatal hernia of 2 cm or less that is not controlled by PPIs who receive TIF (e.g., EsophyX), the evidence includes 2 RCTs comparing TIF with PPI therapy, nonrandomized studies comparing TIF with fundoplication, and case series with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The highest quality RCT (RESPECT) was sham-controlled that compared TIF with PPI therapy while the other RCT (TEMPO) compared TIF with maximum PPI therapy. Both trials found a significant benefit of TIF on the primary outcome measure in about 65% of patients. The sham-controlled trial reported improvement in 45% of the sham-controlled group and no benefit on secondary subjective outcome measures. The nonblinded RCT found significant improvements in subjective measures but no difference in objective outcome measures compared with PPI therapy. Together, these trial results would suggest a strong placebo effect of the surgery and a modest benefit of TIF in patients whose symptoms were not controlled by PPIs. For these patients, the most appropriate comparator would be laparoscopic fundoplication. Studies comparing TIF with fundoplication have limitations that include earlier TIF procedures and unbalanced groups at baseline and are inadequate to determine relative efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD and a hiatal hernia of 3 cm or less that is controlled by PPIs who receive TIF (e.g., EsophyX), the evidence includes 2 RCTs and observational studies with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. A sham-controlled trial found that the time to resume PPI therapy was longer following TIF and the remission rate was higher, indicating that TIF is more effective than no therapy. The nonblinded RCT found a benefit of TIF compared with continued PPI therapy for subjective measures, but not for the objective measures of pH normalization and esophagitis. In addition, a single-center, double-blind RCT in individuals with GERD (using GERDX) and a hiatal hernia of 3 cm or less found improved subjective outcomes to 12 months, but objective measures such as esophageal pH control were not significantly improved. These results raise questions about a possible placebo effect for the procedure. Also, observational studies have indicated a loss of treatment effectiveness over time. Adverse events associated with the procedure (e.g., perforation) may be severe. At present, the available evidence does not support the use of this intervention in patients whose symptoms are adequately controlled by medical therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive endoscopic radiofrequency energy (e.g., Stretta), the evidence includes 2 meta-analyses a network meta-analysis, 6 small RCTs, 2 nonrandomized comparative studies, and observational studies with longer-term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCTs reported some improvements in symptoms and quality of life following treatment with radiofrequency energy compared with sham controls. However, objective measures of GERD and a meta-analysis of 4 RCTs found no significant improvements in outcomes, raising questions about the mechanism of the symptom relief. Symptom relief and clinical success is reported to be lower than after fundoplication, and reoperations and other severe adverse events greater. Larger RCTs with longer follow-up, preferably compared with fundoplication, are needed to define the risks and benefits of this procedure better. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive esophageal bulking agents, the evidence includes case series. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. High-quality data from large RCTs are needed to compare bulking procedures with both sham controls and with the currently accepted treatments for GERD (i.e., drug therapy, laparoscopic fundoplication). Well-designed trials should use standardized outcome measures to examine whether subjective improvement (e.g., discontinuation of medication therapy, GERD Health-Related Quality of Life scores) is supported by objective improvement (e.g., esophageal acid exposure). The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

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 policies 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 for transesophageal endoscopic therapies for gastroesophageal reflux disease

References

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