Medical Policy: 02.01.23
Original Effective Date: July 2001
Reviewed: October 2015
Revised: October 2015
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.
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. The following technologies have been investigated:
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
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 22005, 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.
Radiofrequency Ablation for 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).
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.
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 histolopathologic 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.
The patented PathFinderTG® 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.
In 2011, the American Gastroenterological Association published a position statement on the management of Barrett esophagus. For patients with Barrett esophagus who are undergoing surveillance, the guideline developers recommend:
- Endoscopic evaluation be performed using white light endoscopy (strong recommendation, moderate-quality evidence).
- 4-quadrant biopsy specimens be taken every 2 cm (strong recommendation, moderate-quality evidence).
- Specific biopsy specimens of any mucosal irregularities be submitted separately to the pathologist (strong recommendation, moderate-quality evidence).
The guideline developers suggest against requiring chromoendoscopy or advanced imaging techniques for the routine surveillance of patients with Barrett esophagus at this time.
National Comprehensive Cancer Network 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.
The Society of American Gastrointestinal and Endoscopic Surgeons (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.
At this time, the key gastroenterological societies (American College of Gastroenterology, 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 (Li, 2008). In 2010, the National Institute for Health and Clinical Excellence (NICE) issued a clinical guideline for "Ablative therapy for the treatment of Barrett's oesophagus." 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."
The American Gastroenterological Association (AGA) published a medical position statement on the use of Endoscopic Therapy for Gastroesophageal Reflux Disease in 2006. This document states:
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.
Updated 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 therapy. (Conditional recommendation, moderate level of evidence)
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™ procedures).
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.
Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., biocompatible liquid polymer, polymethylmethacrylate beads, zirconium oxide spheres) is considered investigational as a treatment of gastroesophageal reflux disease.
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 two physicians.
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.
Argon plasma coagulation, electrocoagulation and laser ablation are considered investigational for the treatment of Barrett's esophagus.
Magnetic esophageal ring implant (LINX) for the treatment of GERD is investigational because the safety and/or effectiveness of this service cannot be established.
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 testing using the PathFinderTG® system is considered investigational for all indications.
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.
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
- C9724 Endoscopic full-thickness plication in the gastric cardia using endoscopic plication system (EPS); includes endoscopy
- 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)
- 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)
- 0392T Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band)
- 0393T Removal of esophageal sphincter augmentation device
- 43289 Unlisted laparoscopy procedure, esophagus
- 43210 Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed
- 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 ClearinghouseExternal Site (NGC) [website]. Rockville (MD): 2008 May.
- ECRI Institute. Stretta Procedure for Gastroesophageal Reflux Disease[Windows on Medical Technology].2008.ECRI InstituteExternal Site.
- ECRI Institute. Endoluminal Gastroplication (EndoCinch) for Gastroesophageal Reflux Disease. [Windows of Medical Technology].2008. ECRI InstituteExternal Site.
- 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 InstituteExternal Site; 2009 May 14. 11p. [ECRI hotline response].
- ECRI Institute. Stretta Procedure for Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2009 May 18. 11p. [ECRI hotline response].
- ECRI Institute. Endoscopic Esophageal Fundoplication (EsophyX) for treatment of Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2010 May 25. 8p. [ECRI hotline response].
- American Society of General Surgeons. Position statementExternal Site: Transoral fundoplication. 2011. Accessed July 30, 2012.
- ECRI Institute/ Stretta System (Mederi Therapeutics, Inc.) for Treating Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2012 June.
- Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux DiseaseExternal Site: 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 ExcellenceExternal Site (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 GastroenterolExternal Site 2013; 108(10):1672.
- Society of American Gastrointestinal and Endoscopic SurgeonsExternal Site. 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.
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.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.