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Medical Policy: 02.01.23
Original Effective Date: July 2001
Reviewed: August 2011
Revised: December 2010
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.
Description:
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, three 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.
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.
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Prior Approval:
Not applicable
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Policy:
Transesophageal endoscopic gastroplasty is considered investigational as a treatment of gastroesophageal reflux disease (e.g., Endocinch™, NDO Plicator™, 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.
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. A number of these devices (e.g., EndoCinch™, NDO Plicator™, Gatekeeper, Enteryx™) are no longer marketed or actively evaluated due to lack of efficacy and/or safety issues. For procedures that are still in development, high-quality data from large randomized controlled trials are needed to compare endoscopic procedures with both sham controls and with the currently accepted treatments for GERD, namely drug therapy and laparoscopic fundoplication. 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.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 43257 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum, as appropriate; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease
- 43201 esophagoscopy, rigid or flexible; with direct submucosal injection(s), any substance
- 43219 esophagoscopy, rigid or flexible; with insertion of plastic tube or stent
- 43499 unlisted procedure, esophagus
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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. [cited YYYY Mon DD]. Available: http://www.guideline.gov.
- 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]. Also available: http//www.ecri.org.
- ECRI Institute. Stretta Procedure for Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute; 2009 May 18. 11p. [ECRI hotline response]. Also available: http//www.ecri.org.
- ECRI Institute. Endoscopic Esophageal Fundoplication (EsophyX) for treatment of Gastroesophageal Reflux Disease. Plymouth Meeting (PA): ECRI Institute; 2010 May 25. 8p. [ECRI hotline response]. Also available: http//www.ecri.org
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Policy History:
Date Reason Action
December 2010 Interim review Revised
EsophyX®
August 2011 Annual review Policy renewed
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of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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