BlueCross BlueShield of Tennessee Medical Policy Manual

Transesophageal Endoscopic Therapies for Gastroesophageal Reflux (GERD)

DESCRIPTION

Due in part to the prevalence of gastroesophageal reflux disease (GERD), there has been interest in creating a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. Four different types of procedures have been investigated.

  1. Transesophageal endoscopic gastroplasty (or gastroplication) is an outpatient procedure that takes about 30-35 minutes and does not require general anesthesia. In the procedure, sutures are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux. Currently there are three endoscopic suturing devices for use in the treatment of GERD:

  1. Radiofrequency energy has also been used to produce submucosal thermal lesions at the gastroesophageal junction (e.g., Stretta™). 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.

  2. Implantation of a polymer (e.g., Enteryx™) has also been investigated. Specifically, a biocompatible 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. This polymer, Enteryx™, received FDA approval in 2003 for the treatment of symptomatic gastroesophageal reflux disease. In 2005, the manufacturer initiated a voluntary recall of the procedure kit and the FDA issued notification to physicians to discontinue its use.

  3. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated. The purpose is to increase tissue thickness at the gastroesophageal junction, thereby narrowing the lower esophageal sphincter and reducing gastroesophageal reflux disease.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There is a lack of evidence to support the long term safety and efficacy of these procedures. Some of these devices are no longer being marketed due to lack of efficacy. For those devices and procedures that are still being developed large randomized trials are needed to compare these procedures to currently accepted treatments (e.g drug therapy, laparoscopic fundoplication).

SOURCES

Agency for Healthcare Research and Quality. (2011, September). Comparative effectiveness of management strategies for gastroesophageal reflux disease: an update. Retrieved May 9, 2013 from http://www.effectivehealthcare.ahrq.gov/ehc/products/165/755/CER29-GERD_20110926.pdf.

American Gastroenterological Association Institute. (2008). American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterology, 135, 1383-1391.

American Society for Gastrointestinal Endoscopy. (2012). Appropriate use of GI endoscopy. Retrieved May 9, 2013 from http://www.asge.org/.

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2012). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved May 9, 2013 from BlueWeb. (46 articles and/or guidelines reviewed)

Cadier, G. B., Buset, M., Muls, V., Rajan, A., Rosch, T., Eckardt, A. J., et al. (2008). Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World Journal of Surgery, 32, 1676-1688.

California Technology Assessment Forum. (2004). Endoluminal treatments for gastroesophageal reflux disease. Retrieved may 9, 2013 from http://www.ctaf.org/section/assessment/.

International Pediatric Endosurgery Group (IPEG). (2002). Guidelines for surgical treatment of Pediatric gastroesophageal reflux disease. Retrieved May 9, 2013 from http://www.ipeg.org/education/guidelines/gerd.html.

National Institute for Health and Clinical Excellence. (2011). Endoluminal gastroplication for gastro-oesphageal reflux disease. Retrieved May 9, 2013 from http://www.nice.org.uk/nicemedia/live/11161/55653/55653.pdf.

U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073671. Retrieved February, 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K073671.pdf.

U. S. Food and Drug Administration. (2009, May). Medical devices. Advice for patients with ENTERYX® for gastroesophageal reflux disease (1st advisory). Retrieved September 15, 2009 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064748.htm.

U. S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K092400. Retrieved February 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092400.pdf.

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, October, Archived: Nov 22, 2012). Endoscopic therapy for gastroesophageal reflux disease. Retrieved September 15, 2009 from www.Hayesinc.com/subscribers. (75 articles and/or guidelines reviewed)

Wisconsin Physicians Service Insurance Corporation. (2013, January). Local Coverage Determination (LCD) for endoscopic treatment of GERD (L30473). Retrieved May 9, 2013 from http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=30473&ContrId=268&ver=19&ContrVer=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Tennessee&KeyWord=endoscopic&KeyWordLookUp=Title&KeyWordSearchType=And&from2=search.asp&bc=gAAAABAAAAAAAA%3d%3d&#0.

Witteman, B., Strijkers, R., deVries, E., Toeman, L., Conchillo, J., Hameeteman, W., et al.  (2012). Transoral incisionless fundoplication for treatment of gastroesophageal reflux disease in clinical practice. Surgical Endoscopy. 26 (11), 3307 -3315. (Level 3 Evidence)

ORIGINAL EFFECTIVE DATE:  1/1/2001

MOST RECENT REVIEW DATE:  6/13/2013

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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