BlueCross BlueShield of Tennessee Medical Policy Manual

Laparoscopic and 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 alternative to the standard treatments of open or laparoscopic fundoplication (Nissen) or chronic pharmaceutical therapy. The standard treatments are not a part of this policy. In this policy several different types of emerging outpatient procedures have been reviewed:

  1. Transesophageal endoscopic gastroplasty [gastroplication, fundoplication or transoral incisionless fundoplication (TIF)] is a procedure where 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 the FDA has given a 510(k) designation (e.g. EndoCinch™, The Plicator™ System and the EsophyX™).

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

  3. Injection or implantation of a prosthetic device or bulking agent to enhance the lower esophagealsphincter. This can be done with a polymer gel (e.g. Enteryx™), or an expandable polyacrylonitrile-based hydrogel (e.g. the Gatekeeper™ Reflux Repair System). Endoscopic submucosal implantations of polymethylmethacrylate (PMMA) beads or pyrolytic carbon-coated zirconium oxide spheres (Durasphere®) have also been used.

  4. More recently a ringed magnetic bead sphincter augmentation device (e.g. LINX® Reflux Management System) placed laparoscopically has been proposed as a treatment for GERD. The magnetic attraction between the beads helps the Lower Esophageal Sphincter (LES) resist opening to gastric pressures, preventing reflux from the stomach into the esophagus. Swallowing forces temporarily break the magnetic bond, allowing food and liquid to pass normally into the stomach. Magnetic attraction closes the LES immediately after swallowing, restoring the barrier to reflux.

POLICY

See also:  Natural Orifice Transluminal Endoscopic Surgery

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 safety concerns. For those devices and procedures that are still being developed uniformity in diagnosis and large randomized controlled trials are needed to compare these procedures to currently accepted treatments such as drug therapy and 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 College of Gastroenterology. (2013).Guideline for the diagnosis and treatment of gastroesophageal reflux disease. Retrieved March 17, 2014 from www.guideline.gov.

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. (11:2013). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved August 27, 2014 from BlueWeb. (52 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2014). Magnetic Esophageal Ring to Treat Gastroesophageal Reflux (7.01.137). Retrieved October 1, 2014 from BlueWeb. (9 articles and/or guidelines reviewed)

Bonavina, L., DeMeester, T., Fockens, P., Dunn, D., Saino, G., Bona, D., et al. (2010). Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: One- and 2-year results of a feasibility trial. Annals of Surgery, 252 (2), 857-862. (Level 4 Evidence - Industry sponsored)

Bonavina, L., Saina, G., Lipham, J. C., DeMeester, T. R., (2013). LINX®  Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux. Therapeutic Advances in Gastroenterology, 6(4) 216-268. (Level 2 evidence)

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/.

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2013, September). Magnetic sphincter augmentation (LINX® reflux management system) for treating gastroesophageal reflux disease. Retrieved August 28, 2014 from ECRI Institute. (53 articles and/or guidelines reviewed)

Ganz, R., Peter, J., Horgan, S., Bemelman, W., Dunst, C.., Edmundowicz, S., et al. (2013). Esophageal sphincter device for gastroesophageal reflux disease. New England Journal of Medicine, 368 98), 719 – 727. (Level 4 Evidence - Industry  supported)

Katz, P. O. MD, et al. (2013, February), Guidelines for the diagnosis and management of gastroesophageal disease. American Journal of Gastroenterology, 108:308 – 328. (184 articles and/or guidelines reviewed)

Lipham, J. C., Demeester, T. R., Ganz, R. A., Bonavina, L., Saino, G., Dunn, D. H., et al. (2012). The LINX® reflux management system: Confirmed safety and efficacy now at 4 years. Surgical Endoscopy, 26, 2944-2949. (Level 4 Evidence - Industry sponsored)

National Institute for Health and Clinical Excellence (NICE). (2012, September). Laparoscopic insertion of a magnetic bead band for gastro-esophageal reflux disease. Retrieved August 28, 2014 from http://www.nice.org.uk/Guidance.

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.

Society of American Gastrointestinal and Endoscopic Surgeons. (2013, May). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System. Retrieved September 3, 21014 from  http://www.sages.org.

U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. National Coverage Analyses. (June, 1987). NCD for Implantation of anti-gastroesophageal reflux device (100.9). Retrieved August 28, 2014 from http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?

U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. Local Coverage Determination. (April, 2010). LCD for endoscopic treatment of GERD (L30473). Retrieved August 28, 2014 from http://www.cms.gov/medicarecoveragedatabase/details/lcddetails.aspx?

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.

U. S. Food and Drug Administration. (2012, March). Medical devices. PMA Pre-Market Approval Database. P100049. Retrieved September 2, 2014 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=22472.

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 .

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:  11/20/2014

ID_BA

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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