Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease (GERD)  Printer-Friendly Version
Medical Policy: 02.01.23
Original Effective Date: July 2001
Reviewed: June 2008
Revised: September 2008
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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;
- The StrettaTM procedure employs radiofrequency energy to the gastroesophageal tissues, which is thought to ultimately lengthen and strengthen the sphincter due to scarring caused by thermal changes.
- The EndoCinchTM device uses plication of the tissues near the gastroesophageal junction to improve the function of the sphincter. However, recent studies show poor duration of efficacy.
- The injection of a synthetic polymer substance used as a bulking agent or placement of a prosthesis to improve the function of the gastroesophageal sphincter. One synthetic polymer product, marketed under the trade name Enteryx® was recently withdrawn from the market by the manufacturer and the FDA has advised physicians not to use this treatment.
- Full-Thickness suture plicator: The NDO Full-thickness Plicator (NDO surgical, Mansfield, MA) is an endoluminal therapy. As opposed to Endocinch, the NDO plicator takes full-thickness bites, achieving a serosa-to-serosa placation that resores the valvular mechanism of the GE junction. The FDA approved the system in 2003.
- Additional systems and devices have been developed and some have been approved by the FDA. Others may still be in development or in clinical trials. However, well designed randomly controlled double blinded studies demonstrating short and long term safety and effectiveness for any of these devices is not available.
Policy:
Effective September 1, 2008 All transesophageal endoscopic therapies for GERD are considered investigational.
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- CPT code 43257 Stretta ™ procedure.
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- 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.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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