Medical Policy: 02.01.23 

Original Effective Date: July 2001 

Reviewed: October 2020 

Revised: October 2020 



This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.


This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.



Gastroesophageal Reflux Disease (GERD)

More than 60 million people in United States suffer from a weakening or inappropriate relaxation of the lower esophageal sphincter, which allows movement of stomach contents into the lower esophagus, a condition known as gastroesophageal reflux disease (GERD). This has generated interest in creating minimally invasive transesophageal therapeutic alternatives to open or laparoscopic fundoplication or chronic medical therapy. The available FDA approved minimally invasive endoscopic treatments are based on a variety of technologies that involve improving the function of the lower esophageal sphincter. Three types of procedures have been investigated including Transesophageal endoscopic gastroplasty including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency (RF) energy, and injection/implantation of prosthetic devices or bulking agents.


There are multiple therapies and surgical interventions being studied for the treatment of gastroesophageal and laryngopharyngeal reflux disease. Non-surgical treatments continue to be first-line treatment for all reflux disease. Treatment GERD generally involves a stepwise approach. The goals are to control symptoms, to heal esophagitis, and to prevent recurrent esophagitis or other complications. The treatment is based on lifestyle modification and control of gastric acid secretion.


The definition of refractory gastroesophageal reflux disease (GERD) is controversial. According to most experts, patients with GERD who exhibit partial or lack of response to proton pump inhibitor (PPI) twice daily are considered to have failed PPI therapy. GERD in these patients is termed refractory GERD. However, we suggest that lack of satisfactory symptomatic response to PPI once a day should be considered a failure of PPI therapy.


Surgical Techniques

Transesophageal endoscopic gastroplasty (gastroplication or fundoplication) is an outpatient procedure. During this procedure, suture(s) are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux. Currently, four endoscopic suturing devices have received FDA 510(k) marketing clearance for use in the treatment of GERD:

  • The EndoCinch™ (CR Bard, Murray Hill, NJ) is a suture technique for partial-thickness plication intended to improve the function of the sphincter near the gastroesophageal junction.
  • NDO Plicator™ (Ethicon Endo-Surgery, Chicago, IL) is an endoluminal therapy intended for full thickness plication to restore the valvular mechanism of the gastroesophageal junction
  • Transoral Incisionless Fundoplication (TIF) ® with the EsophyX® device is a less invasive procedure performed to construct an antireflux valve and tighten the lower esophageal sphincter. The intended outcomes include creating a sufficient reflux barrier and improving the integrity of the gastroesophageal junction.
  • Medigus Ultrasonic Surgical Endostapler (MUSE™) The Medigus SRS Endoscopic Stapling System (MUSE, Medigus LTD) is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create anterior partial fundiplication for treatment of symptomatic chronic GERD in patients who require and respond to pharmacologic therapy
  • GERDx™ (G-SURG) is an endoscopic full-thickness plication device that uses hydraulic elements for controlling. This device does not have FDA approval at this time. 


Radiofrequency Ablation (e.g. Stratta)

Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. This technique has also been referred to as the Stretta® (Mederi Therapeutics, Greenwich, CT) procedure. Specifically, radiofrequency energy is applied through 4 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.


Submucosal injection or implantation of a prosthetic or bulking agent to enhance the volume of the lower esophageal sphincter. In one procedure, a biocompatible liquid polymer is injected into the lower esophageal sphincter. On contact with the tissue, the polymer precipitates into a spongy mass. The mechanism of action in reducing reflux is not precisely known. One polymer, Enteryx™, received FDA approval in 2003 through the premarket approval process for the treatment of symptomatic GERD. However, in September 2005, Boston Scientific Corporation issued a recall of Enteryx™ due to the device polymerizing shortly after injection into a spongy material that cannot be removed. Serious adverse events involved unrecognized transmural injections of Enteryx™ into structures surrounding the esophagus, potentially resulting in serious injury or death.


Another bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), is being evaluated. Durasphere® is a bulking agent approved for treatment of urinary and fecal incontinence. Use of this product for esophageal reflux would be considered off-label use. The website of Carbon Medical Technologies states that Durasphere GR is an investigational device in the United States "intended to treat problems associated with GERD."


The Gatekeeper Reflux Repair System (Medtronic, Shoreview, MN) utilizes 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.


Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.


Barrett's Esophagus

Barrett's esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD).


Stages of Barrett’s Esophagus

  1. Normal, healthy esophagus
  2. Esophagus damaged by prolonged acid exposure
  3. Barrett's esophagus tissue
  4. Dysplastic Barrett's esophagus
  5. Esophageal adenocarcinoma


The current management of Barrett's esophagus includes treatment of GERD, and surveillance endoscopy to detect progression to high-grade dysplasia or adenocarcinoma. The findings of low-grade dysplasia typically warrants only follow-up and surveillance biopsies, whereas the findings of high-grade dysplasia or early-stage adenocarcinoma warrants mucosal ablation or resection, either endoscopic mucosal resection or esophagectomy.


At this time, key gastroenterological societies (American Gastroenterological Association and American Society of Gastrointestinal Endoscopy) do not have any guidelines or position statements endorsing laser ablation, argon plasma ablation or electrocoagulation as a treatment for Barrett's esophagus. Current literature consists primarily of uncontrolled studies with small group sizes, with only a limited number of randomized controlled trials comparing treatments for Barrett's esophagus. While these endoscopic techniques are promising in terms of treating Barrett's esophagus, few long-term results are available.  In 2010, the National Institute for Health and Clinical Excellence (NICE) issued a clinical guideline for "Ablative therapy for the treatment of Barrett's esophagus." For ablative therapies, they concluded to "not use argon plasma coagulation, laser ablation or multipolar electrocoagulation alone, or in combination with each other, unless part of a clinical trial." The authors of a Cochrane review in 2010 concluded that ablative therapies have a role in the management of Barrett's esophagus, however; "more clinical trial data and in particular randomized controlled trials are required to assess whether or not the cancer risk is reduced in routine clinical practice."  Most studies of endoscopic therapy have only limited follow-up information of a relatively small number of patients. Thus, the durability of these technologies beyond 1–2 years remains unclear. Short-term and long-term safety issues are unresolved, but serious adverse events led to the voluntary withdrawal of Enteryx by the manufacturer in September 2005 and suspension of the Gatekeeper clinical program in late 2005. While newer devices and improvements in endoscopic antireflux techniques may yield better and more durable treatment outcomes, current data suggest that there are no definite indications for endoscopic therapy for GERD at this time. Both practitioners and patients need to be aware of the limitations in the evidence that exist with these devices at present.


Confocal Laser Endomicroscopy (CLE)

Confocal laser endomicroscopy (CLE) is a device that allows in vivo microscopic imaging of cells during endoscopy. For patients undergoing screening or surveillance multiple studies have evaluated the diagnostic accuracy of CLE. While the reported sensitivity and specificity in these studies is high, it may not be sufficiently high to replace biopsy and histopathologic analysis. Several RCTs and a meta-analysis of RCTs and observational studies suggest that CLE has high accuracy for identifying dysplasia in patients with BE. The sensitivity of CLE in these studies was higher than for white-light endoscopy alone, but the specificity was not consistently higher. There are limited data comparing standard protocols using random biopsies to protocols using CLE and targeted biopsies, so data are inconclusive regarding the potential for CLE to reduce the number of biopsies in patients with BE undergoing surveillance without compromising diagnostic accuracy.


Molecular and Biomarker Testing

Pathfinder Barretts, now called BarreGEN molecular testing

The patented PathFinderTG®/BarreGEN™ test is a molecular test intended to be used adjunctively when a definitive pathologic diagnosis cannot be made, because of inadequate specimen or equivocal histologic or cytologic findings. RedPath Integrated Pathology (Pittsburgh, PA), the test provider, states that PathFinderTG® produces mutational profiles to help physicians resolve complex diagnostic dilemmas inpatients who are at risk of cancer.


The evidence reviewed does not demonstrate that PathFinderTG® testing for prognosis of Barrett esophagus adds value to current prognostic assessments.


Esoguard a biomarker-based, non-endoscopic method for detecting Barrett’s esophagus using methylated DNA retrieved via a swallowed balloon-based, esophageal sampling device. This test uses next-generation sequencing (NGS) of bisulfate converted DNA to detect the presence of Vimentin (mVIM) and CyclinA1 (mCCNA1) methylation signatures at 31 sites within those genes, to purportedly identify individuals with Barrett’s esophagus.  


Esophageal String Test is designed to allow frequent, quantitative monitoring of individuals with eosinophilic esophagitis. A capsule containing a yard-long string is swallowed after one end of the string is taped to the individual’s cheek. The string passes through the gastrointestinal tract (stretching through the esophagus, stomach and the upper region of the small intestine) and becomes coated with digestive secretions. It is then removed and analyzed for eosinophil-derived protein biomarkers that may indicate inflammation (eg, active eosinophilic esophagitis).


TissueCypher Barrett's Esophagus Assay is intended for individuals with diagnoses at the early end of the Barrett’s spectrum (nondysplastic [ND], indefinite for dysplasia [IND] or low-grade dysplasia [LGD]) and combines analysis of multiple protein-based biomarkers with tissue structure information from endoscopic biopsies to predict the risk of progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in individuals with Barrett’s esophagus. 


The evidence review does not demonstrate that biomarker testing for prognosis of Barrett esophagus adds value to current prognostic assessments for disease diagnosis or progression status at this time.


Practice Guidelines and Position Statements

American College of Gastroenterology

Guidelines released by the American College of Gastroenterology in 2013 state that the usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical.


The American Gastroenterological Association

In 2018 the guideline “Endoscopic eradication therapy for patients with Barrett’s esophagus-associated dysplasia and intramucosal cancer” was published:

  1. In BE patients with LGD and HGD being considered for EET, we suggest confirmation of diagnosis by at least 1 expert GI pathologist or panel of pathologists compared with review by a single pathologist. Strength of Recommendation: Conditional Quality of Evidence: Low
  2. (a) In BE patients with LGD, we suggest EET compared with surveillance; however, patients who place a high value on avoiding adverse events related to EET may choose surveillance as the preferred option. Strength of Recommendation: Conditional Moderate
    (b) In BE patients with confirmed HGD, we recommend EET compared with surveillance. Strength of Recommendation: Strong Quality of Evidence: Moderate
  3. In BE patients with HGD/IMC, we recommend against surgery compared with EET. Strength of Recommendation: Strong Quality of Evidence: Very low quality Evidence
  4. In BE patients referred for EET, we recommend endoscopic resection of all visible lesions compared with no endoscopic resection of visible lesions. Strength of Recommendation: Strong Moderate
  5. In BE patients with visible lesions who undergo endoscopic resection, we suggest ablation of the remaining Barrett’s segment compared with no ablation. Strength of Recommendation: Conditional Quality of Evidence: Low
  6. In BE patients with dysplasia and IMC referred for EET, we recommend against routine complete endoscopic resection of entire Barrett’s segment compared with endoscopic resection of visible lesion followed by ablation of remaining Barrett’s segment. Strength of Recommendation: Strong Quality of Evidence: Very low
  7. In BE patients with dysplasia and IMC who have achieved CE-IM after EET, we suggest surveillance endoscopy versus no surveillance. Strength of Recommendation: Conditional Quality of Evidence: Very low 


National Comprehensive Cancer Network (NCCN) Guidelines

NCCN guidelines for esophageal cancer indicate resection is the preferred treatment choice for Barrett’s esophagus but ablative therapy such as RFA is listed as an alternative option to resection for Barrett’s esophagus with high-grade dysplasia. NCCN guidelines state that, for primary treatment, endoscopic mucosal resection or ablative therapy may be appropriate for Barrett’s esophagus associated with Tis (HGD or carcinoma in-situ). Patients with superficial T1a disease should have ablation (preferred) or esophagectomy performed following mucosal resection. For post-treatment surveillance, the guidelines state that ablation of residual flat or recurrent high-grade and low-grade dysplasia using RFA or cryoablation should be considered. Ablation of non-dysplastic Barrett’s esophagus is not recommended.


National Institute for Health and Care Excellence (NICE)

The National Institute for Health and Care Excellence (NICE) issued updated interventional procedure guidance in 2013 on endoscopic radiofrequency treatment for GERD, concluding: "The evidence on the safety of endoscopic radiofrequency ablation for gastro-esophageal reflux disease is adequate in the short and medium term but there is uncertainty about longer term outcomes. With regard to efficacy, there is evidence of symptomatic relief but objective evidence on reduction of reflux is inconclusive. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research." The reviewing committee noted "concern on the part of some specialists about the possibility that symptoms may improve as a result of denervation caused by the procedure; if that were the case then failure to recognize and treat reflux might lead to complications in the long term."


Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

SAGES considers RF treatment an appropriate therapy for patients being treated for GERD who are 18 years of age or older; who have had symptoms of heartburn, regurgitation, or both for six months or more; and who have been partially or completely responsive to anti-secretory pharmacologic therapy.


The SAGES Technology and Value Assessment Committee (TVAC) updated its safety and effectiveness analysis of the LINX Reflux Management System. Review of published studies suggests that magnetic sphincter augmentation is safe with no reported deaths and a 0.1% rate of intra/perioperative complications. Long-term efficacy of LINX appears good for typical GERD symptoms with reduced acid exposure, improved GERD symptoms, and freedom from PPI in 85-88% at 3-5 years. Dysphagia resolves in most patients and the incidence is roughly 10% at 1 year and 4% at 3 years. The need for endoscopic dilation ranges from 6-12% and the primary reason for explantation appears to be persistent dysphagia with a rate in larger series from 3-6%. Erosion appear to be rare, with one case reported in the 1st 1,000 patients, one additional published case report, a large series reporting 2 erosions, and several additional reports in the FDA MAUDE dataset (true number unknown, as multiple entries in this dataset may be made for each patient). Based on very limited literature, erosion can be successfully treated with explantation.


The American Gastroenterological Association (AGA)

The 2008 Medical Position Statement of the American Gastroenterological Association makes no recommendation for or against “the use of currently commercially available endoluminal ant reflux procedures in the management of patients with an esophageal syndrome” based on insufficient evidence.


ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus includes the following recommendations:

  1. For patients with confirmed low-grade dysplasia and without life-limiting comorbidity, endoscopic therapy is considered as the preferred treatmentmodality, although endoscopic surveillance every 12 months is an acceptable alternative (strong recommendation, moderate level of evidence).
  2. Patients with BE and confirmed high-grade dysplasia should be managed with endoscopic therapy unless they have life-limiting comorbidity (strong recommendation, high level of evidence).


American Society for Gastrointestinal Endoscopy (ASGE)

In the American Society for Gastrointestinal Endoscopy (ASGE) technology status evaluation report, confocal laser endomicroscopy is considered an emerging technology with the potential to significantly reduce the number of biopsies in Barrett's esophagus and irritable bowel disorder. Confocal laser endomicroscopy can provide surrogate real-time histological information of the bile duct and within the pancreatic cysts. ASGE concluded, "Before the technology can be widely accepted, many further studies are needed to determine its clinical efficacy and evaluate its cost-effectiveness and its utilization in both academic and community settings."


American Society of Gastrointestinal Endoscopy (ASGE)

In high-grade dysplasia, abnormal changes are seen in many of the cells and there is an abnormal growth pattern of the cells. Low-grade dysplasia means that there are some abnormal changes seen in the tissue sample but the changes do not involve most of the cells, and the growth pattern of the cells is still normal. “Indefinite for dysplasia” simply means that the pathologist is not certain whether changes seen in the tissue are caused by dysplasia. Other conditions, such as inflammation or swelling of the esophageal lining, can make cells appear dysplastic when they may not be.


Prior Approval:

Not applicable



Gastroesophageal Reflux Disease

Endoscopic Gastroplasty

Transesophageal endoscopic gastroplasty is considered investigational as a treatment of gastroesophageal reflux disease (e.g., Endocinch™, NDO Plicator™, Medigus Ultrasonic Surgical Endostapler (MUSE™ System) or EsophysX™/EsophyX2 HD procedures). This includes transoral incisionless fundoplication.


Stretta Procedure

Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (i.e., the Stretta procedure) is considered investigational as a treatment of gastroesophageal reflux disease.


Submucosal Injection

Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., biocompatible liquid polymer, plexiglass implantation/PMMA polymethylmethacrylate beads, zirconium oxide spheres, Durasphere) is considered investigational as a treatment of gastroesophageal reflux disease


Sphincter Devices

Magnetic esophageal ring implant (LINX) for the treatment of GERD is investigational because the safety and/or effectiveness of this service cannot be established.


Reza Band Upper Esophageal Sphincter Assist Device is considered investigational for the treatment of Gastroesophageal Reflux Disease.


GERDx™ (G-SURG) is an endoscopic full-thickness plication device and is considered investigational for the treatment of Gastroesophageal Reflux Disease. This device does not have FDA approval at this time.


Bariatric Surgery

Roux-en-Y Gastric Bypass (RYGBP) (open or laparoscopic) for the treatment of Gastroesophageal Reflux Disease is considered investigational.


Barrett’s Esophagus

Radiofrequency Ablation

Radiofrequency ablation may be considered medically necessary for the treatment of Barrett's esophagus with high-grade dysplasia.


Radiofrequency ablation may be considered medically necessary for the treatment of Barrett's esophagus with low-grade dysplasia when the initial diagnosis of low-grade dysplasia is confirmed by biopsy and diagnosised by a pathologist.


Radiofrequency ablation is considered investigational for treatment of Barrett's esophagus in the absence of dysplasia.



Cryoablation is considered is considered investigational for Barrett's esophagus, with or without dysplasia.


Other Therapies

Argon plasma coagulation, electrocoagulation and laser ablation are considered investigational for the treatment of Barrett's esophagus.


Confocal Laser Endomicroscopy is considered investigational. At this time the evidence is not sufficient to conclude that CLE improves outcomes when used as an adjunct to endoscopy.


Molecular and Biomarker Testing

Molecular testing using the PathFinderTG® system, now called BarreGEN, is considered investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.


Esophageal String Test (0095U) is considered investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.


TissueCypher Barrett's Esophagus Assay (0108U) is considered investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.


EsoGuard (0114U) is considered investigational for all indications. The evidence is insufficient to determine the effects of the technology on health outcomes.


There is insufficient evidence at present to establish the safety and efficacy of these procedures, particularly in the long term. Some of the unresolved issues include questions about the safety and durability of the device/treatment, and lack of consistent improvement in objective measures (esophageal acid exposure) using these devices. Laparoscopic Nissen fundoplication is considered the gold standard surgical intervention for individuals with GERD. Evidence for newer endoluminal and laparoscopic therapies is limited in quality and quantity and concerns remain about the safety and long-term effectiveness of many of these procedures. Well-designed RCTs and comparative studies with longer follow-up time are needed in order to better assess the safety and effectiveness of these interventions. Well-designed trials should use standardized outcome measures to examine whether subjective improvement, such as discontinuation of medication therapy and GERD-HRQL scores, is supported by objective improvement, such as esophageal acid exposure.


In regards to the magnetic esophageal ring implant, the FDA has required a 5-year follow-up on the subjects in the pivotal study, as well as a post-approval study and a randomized trial is in progress that will compare treatment with the magnetic esophageal ring and treatment with double-dose proton pump inhibitors. Randomized comparisons of magnetic sphincter augmentation with Nissen fundoplication are also needed to evaluate the relative risk-benefit of the magnetic esophageal ring versus the current gold standard. All studies available are using historical controls which are invalid for comparitive studies. While several studies provided long-term outcomes, they had limitations, including high dropout rates and noncomparison superiority to current therapy. Moreover, they do not address the critical issues that comparisons of LINX with either fundoplication or comparisons with medical therapy are needed. The safety of the device has been further studied and looks promising but the lack of comparison to current therapy outcomes remains insufficient. A recent systematic review and meta-analysis concluded the validity of many of the primary outcomes was decreased due to their subjective nature and lack of clear medical definition. The long-term implications of reversal of the LINX remain unknown.


There is no evidence that the use of ablation in Barret’s esophagus without dysplasia is necessary in preventing progression to cancer. Surveillance without ablation is recommended.


Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 43257 Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease
  • 43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance
  • 43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance
  • 43206 Esophagoscopy, flexible, transoral; with optical endomicroscopy
  • 43252 Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy
  • 43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance
  • 43499 Unlisted procedure, esophagus
  • 43229 Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
  • 43270 Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
  • 43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed
  • 43285 Removal of esophageal sphincter augmentation device
  • 43999 Unlisted procedure, stomach
  • 43659 Unlisted laparoscopy procedure, stomach
  • 88375 Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session.
  • 84999 Unlisted chemistry procedure (when specified as Pathfinder Barrett's)
  • 43289 Unlisted laparoscopy procedure, esophagus
  • 43210 Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed
  • C9724 Endoscopic full-thickness plication in the gastric cardia using endoscopic plication system (EPS); includes endoscopy
  • E1399 Durable medical equipment, Miscellaneous
  • 0095U Inflammation (eosinophilic esophagitis), ELISA analysis of eotaxin-3 (CCL26 [C-C motif chemokine ligand 26]) and major basic protein (PRG2 [proteoglycan 2, pro eosinophil major basic protein]), specimen obtained by swallowed nylon string, algorithm reported as predictive probability index for active eosinophilic esophagitis
  • 0108U Gastroenterology (Barrett's esophagus), whole slide-digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 protein biomarkers (p16, AMACR, p53, CD68, COX-2, CD45RO, HIF1a, HER-2, K20) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer
  • 0114U Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus
  • 0397T Endoscopic retrograde cholangiopancreatography (ERCP), with optical endomicroscopy (List separately in addition to code for primary procedure)


Selected References:

  • Filipi, CJ et al. Transoral endoscopic suturing for gastroesophageal reflux disease, multicenter trial. Gastrointestinal Endoscopy 2000; vol. 51 #4: part2.
  • Swain, CP Endoscopic suturing. Bailliere's Clinical Gastroenterology 1999; Vol. 13, #1: 97-108. 
  • Carlsson, R. Endoscopic-negative reflux disease. Bailliere's Clinical Gastroenterology 2000; vol.15, #5: 827-837.
  • Emerging Technology List Radio Frequency Energy. Canadian Coordinating Office for Health Technology Assessment; No.12: January 2002
  • TEC Assessment: Transesophageal endoscopic treatments of Gastroesophageal reflux disease (GERD). July 8. 2002 Vol 19, (2).
  • Corley DA, Katz P et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 2003;125(3):970-973.
  • Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc. 2004 Jul;18(7):1038-44. Epub 2004 May 27. 
  • Torquati A, Houston HL, et al. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc. 2004 Oct;18(10):1475-9.
  • Schiefke I, Zabel-Langhenning A, et al. Long term failure of endoscopic gastroplication (EndoCinch). Gut. 2005 Jun;54(6):752-8.
  • DeVault KR, Castell DO, American college of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J gastroenterol. 2005 Jan;100(1):190-200.
  • Yeh RW, Triadafilopoulos G. Endoscopic antireflux therapy: the Stretta procedure. Thorac Surg Clin. 2005 Aug;15(3):395-403. (Abstract Viewed on Line.)
  • Ip S, Bonis P, Tatsoni A et al. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease. Evidence Report/Technology Assessment No. 1. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center) Agency for Healthcare Research and Quality. AHRQ Publication No. 06-EHC003-EF
  • Williams B, Richards W O. Endoluminal therapy for GERD: Where we stand. VOL Contemporary Surgery ©2008 Dowden Health Media. Vol 64, NO 4/APRIL 2008.National Guideline Clearinghouse (NGC). Guideline synthesis: Diagnosis and Management of Gastroesophageal Reflux Disease (GERD). In: National Guideline Clearinghouse (NGC) [website]. Rockville (MD): 2008 May.
  • ECRI Institute. Stretta Procedure for Gastroesophageal Reflux Disease[Windows on Medical Technology].2008.ECRI Institute
  • ECRI Institute. Endoluminal Gastroplication (EndoCinch) for Gastroesophageal Reflux Disease. [Windows of Medical Technology].2008. ECRI Institute
  • Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5.
  • ECRI Institute. Endoluminal Gastroplication (EndoCinch) for Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute 2009 May 14. 11p. [ECRI hotline response].
  • ECRI Institute. Stretta Procedure for Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute 2009 May 18. 11p. [ECRI hotline response].
  • ECRI Institute. Endoscopic Esophageal Fundoplication (EsophyX) for treatment of Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute 2010 May 25. 8p. [ECRI hotline response].
  • American Society of General Surgeons. Position statement Transoral fundoplication. 2011. Accessed July 30, 2012.
  • ECRI Institute/ Stretta System (Mederi Therapeutics, Inc.) for Treating Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute 2012 June.
  • Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease Update. Comparative effectiveness review number 29. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center) Rockville, MD.  September 2011. Accessed July 27, 2012.
  • National Institute for Clinical Excellence (NICE) Endoluminal gastroplication for gastro-oesophageal reflux disease. Interventional Procedure Guidance 404. London, UK; NICE; July 2011.
  • Orman ES, Li N, Shaheen NJ. Efficacy and durability of radiofrequency ablation for Barrett's Esophagus: systematic review and meta-analysis. Clin Gastroenterol Hepatol 2013; 11(10):1245-55.
  •  Ertan A, Zaheer I, Correa AM et al. Photodynamic therapy vs radiofrequency ablation for Barrett's dysplasia: efficacy, safety and cost-comparison. World J Gastroenterol 2013; 19(41):7106-13.
  •  Triadafilopoulos G. Stretta: A valuable endoscopic treatment modality for gastroesophageal reflux disease. World of Gastroenterology. 2014;20(24):7730-7738.
  • Dughera L, Rotondano G, De Cento M, et al. Durability of Stretta Radiofrequency Treatment for GERD: Results of an 8-Year Follow-Up. Gastroenterology Research and Practice. 2014.
  • Noar M, Squires P, Noar E. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surgery Endoscopy. 2014 January.
  • Chadwick G, Groene O, Markar SR et al. Systematic review comparing radiofrequency ablation and complete endoscopic resection in treating dysplastic Barrett's esophagus: a critical assessment of histologic outcomes and adverse events. Gastrointestinal Endoscopy 2014.
  • Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease   Am J Gastroenterol 2013; 108:308–328. Corrigendum. Am J Gastroenterol2013; 108(10):1672.
  • Society of American Gastrointestinal and Endoscopic Surgeons Endoluminal treatments for gastroesophageal reflux disease (GERD) 2013.
  • Sheu EG, A comparative trial of laparoscopic magnetic sphincter augmentation and Nissan fundoplication. Surgical Endoscopy July 2014.
  • National Institute for Health and Care Excellence. IPG461 - Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. 2013.
  • National Institute for Health and Care Excellence. IPG404 - Endoluminal gastroplication for gastrooesophageal reflux disease. 2011.
  • Liang WT, Yan C, Wang ZG, et al. Early and Midterm Outcome After Laparoscopic Fundoplication and a Minimally Invasive Endoscopic Procedure in Patients with Gastroesophageal Reflux Disease: A Prospective Observational Study. J Laparoendosc Adv Surg Tech A. Aug 2015;25(8):657-661. PMID 26258269
  • 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
  • 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
  • Dunbar KB, Agoston AT, Odze RD, et al. Association of acute gastroesophageal reflux disease with esophageal histological changes. JAMA. doi:10.1001/jama.2016.5657
  • 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. 2016;14(5):671-677.
  • Shaheen, N., Falk, G., Iyer, P., Gerson, L. (2015) ACG Clinical Guideline: Diagnosis and Management of.Barrett’s Esophagus. Am J Gastroenterol (3) November 2015; doi: 10.1038/ajg.2015.322
  • Skubleny D, Switzer NJ, Dang J, Gill RS, Shi X, de Gara C, Birch DW, Wong C, Hutter MM, Karmali S. LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis. Surg Endosc. 2016 Dec 15. [Epub ahead of print]
  • Sangle, N., Taylor, S., Edmond, M., et al. (2015) Overdiagnosis of high-grade dysplasia in Barrett’s esophagus: a multicenter, international study. Modern Pathology 28, 758-765.
  • Welk, G.W. (2017) Current management of low-grade dysplasia in Barrett’s esophagus. Gastroenterology and Hepatology 13, 4 221-225.
  • Endoscopic eradication therapy for patients with Barrett’s esophagus–associated dysplasia and intramucosal cancer
  • Wani, S., et. al. Development of quality indicators for endoscopic eradication therapies in Barrett’s esophagus: the TREAT-BE (Treatment with Resection and Endoscopic Ablation Techniques for Barrett’s Esophagus) Consortium
  • CADTH Rapid Response Report Non-Pharmacological alternatives to proton-punp inhibitors: comparative clinical effectiveness and guidelines. May 11, 2018.
  • National Comprehensive Cancer Network NCCN Esophageal and Esophogastric Junction Cancers Version 2.2018 
  • Kellokumpu, I. et. al. Quality of life following laprascopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastro(2013) 19(24) 3810-3818.
  • Bell, R, Lipham, J, Louie, B, Williams, V, Luketich, J, Hill, M, Richards, W, Dunst, C, 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. 2018.
  • Schwameis, K, Nikolic, M, Morales Castellano, DG, Steindl, A, Macheck, S, Kristo, I, Zorner, B, and Schoppmann, SF. Results of Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease. World J Surg. 2018;42(10):3263-3269.
  • Wani S, Qumseya B, Sultan S, et al. Endoscopic eradication therapy for patients with Barrett's esophagus-associated dysplasia and intramucosal cancer: American Society for Gastrointestinal Endoscopy, Standards of Practice Committee. Gastrointest Endosc. 2018; 87(4):907-931.
  • Guthikonda A, Cotton CC, Madanick RD, et al. Clinical outcomes following recurrence of intestinal metaplasia after successful treatment of Barrett’s esophagus with radiofrequency ablation. Am J Gastroenterol. 2017; 112(1):87-94.
  • McCarty TR, Itidiare M, Njei B, et al. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy. Jul 2018;50(7):708-725. PMID 29625507
  • Viswanath Y, Maguire N, Obuobi RB, et al. Endoscopic day case antireflux radiofrequency (Stretta) therapy improves quality oflife and reduce proton pump inhibitor (PPI) dependency in patients with gastro-oesophageal reflux disease: a prospective study from a UK tertiary centre. Frontline Gastroenterol. 2019 Apr;10(2):113-119.
  • Schizas D, Mastoraki A, Papoutsi E, et al. LINX® reflux management system to bridge the "treatment gap" in gastroesophageal reflux disease: A systematic review of 35 studies. World J Clin Cases. 2020;8(2):294–305
  • ECRI Institute. Custom Product Briefs Guidance. EsophyX (EndoGastric Solutions, Inc.) for treating gastroesophageal reflux disease. Plymouth Meeting, PA. Updated July 2020.
  • 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. 2019 Jan;89(1):14-22.e1.
  • Januszewicz W, Tan WK, Lehovsky K, et al; on behalf of the BEST 1 and BEST2 study investigators. Safety and acceptability of esophageal Cytosponge cell collection device in a pooled analysis of data from individual patients. Clin Gastroenterol Hepatol. 2019;17(4):647-656.
  • Standards of Practice Committee, Wani S, Qumseya B, et al. Endoscopic eradication therapy for patients with Barrett's esophagus-associated dysplasia and intramucosal cancer. Gastrointest Endosc. Apr 2018;87(4):907-931 e909. PMID 29397943.


Policy History:

  • October 2020 - Annual Review, Policy Revised
  • November 2019 - Annual Review, Policy Revised
  • October 2018 - Annual Review, Policy Revised
  • October 2017 - Annual Review, Policy Revised
  • October 2016 - Annual Review, Policy Revised
  • October 2015 - Annual Review, Policy Revised
  • October 2014 - Annual Review, Policy Revised
  • January 2014 - Annual Review, Policy Revised
  • July 2013 - Annual Review, Policy Renewed
  • August 2012 - Annual Review, Policy Renewed
  • August 2011 - Annual Review, Policy Renewed
  • December 2010 - Interim Review, Policy Revised

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.


*CPT® is a registered trademark of the American Medical Association.