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This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-03

Original Effective Date: 06/15/01

Reviewed: 02/27/14

Revised: 03/15/14

Subject: Minimally Invasive Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

   

Previous Information

DESCRIPTION:

Gastroesophageal reflux (GER) is the reflux of gastric contents into the esophagus. Gastroesophageal reflux disease (GERD) is related to incompetence of the lower esophageal sphincter. GERD occurs when chronic GER leads to pathological changes in the esophagus, such as esophagitis, esophageal stricture, ulceration, and erosion.

Endoscopic gastroplasty, also referred to as gastroplication, is a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy for the treatment of GERD. Endoscopic gastroplasty is an outpatient procedure that takes about 30 – 55 minutes and does not require general anesthesia. With endoscopic gastroplasty, sutures are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter in order to decrease reflux. The Bard® EndoCinch™ is a device that has been approved by the U.S. Food and Drug Administration (FDA) for use in endoscopic suturing, and has been investigated as a device used in endoscopic gastroplasty.

Transoral incisionless fundoplication (TIF) is a minimally invasive procedure performed under general anesthesia using the EsophyX surgical device (Endogastric Solutions, Inc.). The TIF procedure is referred to as a Natural Orifice Surgery (NOS) procedure because the EsophyX device is introduced into the body through the mouth, rather than through an abdominal incision, and is advanced into the esophagus under visualization of a video camera.

Other devices used for this purpose include the Plicator™ and the StomaphyX™.

Radiofrequency energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. This technique has also been referred to as the Stretta procedure. Radiofrequency energy is applied through four 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.

Enteryx™ is a liquid polymer that is endoscopically injected into the lower esophageal sphincter region for the treatment of GERD. On contact with the tissue, the polymer precipitates into a spongy mass. The mechanism of action in reducing reflux is not precisely known. Enteryx™ received FDA approval in 2003 through the PMA process for the treatment of symptomatic gastroesophageal reflux disease. However, on September 23, 2005, 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 death or serious injury.

Polymethylmethacrylate (PMMA) microbead implantation involves the implantation of microscopic spheres of PMMA into the submucosa 1 or 2 cm proximal to the squamocolumnar junction. The purpose is to increase tissue thickness at the gastroesophageal junction, thereby narrowing the lower esophageal sphincter (LES) and reducing GERD. The process is performed under intravenous sedation.

A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms despite maximum medical therapy. One such device is the LINX™ Reflux Management System (Torax Medical), which is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (e.g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging (MRI) is needed for another condition.

POSITION STATEMENT:

  1. Transesophageal endoscopic gastroplasty (i.e., the EndoCinch procedure or NDO Plicator procedure) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of transesophageal endoscopic gastroplasty as a treatment of gastroesophageal reflux disease. Minimal data are available in peer-reviewed journals to permit conclusions about the effects of transesophageal endoscopic gastroplasty on GERD.
  2. Transoral incisionless fundoplication (TIF) using devices such as the Esophyx, for the treatment GERD is considered experimental or investigational as there is insufficient published long-term clinical evidence supporting the effects of this therapy on health outcomes.
  3. Transesophageal radiofrequency to create submucosal thermal lesion of the gastroesophageal junction (i.e., the Stretta procedure) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction as a treatment of gastroesophageal reflux disease. There are only a few case series and clinical trials, both having variable outcomes, to permit conclusions about the effects of transesophageal endoscopic gastroplasty on GERD. Additional comparative and longer-term efficacy and safety data are needed.

NOTE: Curon Medical, Inc, the maker of the Stretta device, declared bankruptcy in 2006. Further searches indicate that Curon Medical filed for Chapter 7 bankruptcy and ceased operations. Several years ago, Mederi Therapeutics, Inc. (Greenwich, CT) purchased the Stretta device.

  1. Endoscopic submucosal implantation of a biocompatible polymer (i.e., Enteryx) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of endoscopic submucosal injection of a biocompatible polymer as a treatment of gastroesophageal reflux disease. There is inadequate data to determine whether or not injection of a polymer is at least as good as the established alternative of medical therapy.

NOTE: Endoscopic liquid polymer injection, Enteryx (Boston Scientific), was recalled 09/23/05 and is no longer available on the market.

  1. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds is considered experimental or investigational, as there is insufficient clinical evidence to support the use of endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds as a treatment of gastroesophageal reflux disease. There is insufficient peer-reviewed literature to permit conclusions about the effects of endoscopic submucosal implantation of polymethylmethacrylate beads on GERD.
  2. Magnetic sphincter augmentation (e.g., LINX™ Reflux Management System) for the treatment of gastroesophageal reflux disease (GERD) is considered experimental or investigational. The clinical evidence published in the peer-reviewed literature is insufficient to permit conclusions concerning the effect of this procedure on net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

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 (investigational) [Stretta]

Coding Notes:

Transesophageal endoscopic gastroplasty no longer has a specific code and would most likely be reported with code 43499 (unlisted procedure, esophagus). The procedure might be reported along with a laparoscopic paraesophageal hernia repair (codes 43281 and 43282).

Endoscopic submucosal injection of a bulking agent would most likely be coded using 43201.

The following CPT procedure codes would be considered experimental or investigational when performed for transendoscopic treatments of GERD:

43201

Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43212

Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and 19guide wire passage, when performed)

43236

Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43241

Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or the jejunum as appropriate; with transendoscopic intraluminal tube or catheter placement

43266

Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and postdilation and guide wire passage, when performed)

43499

Unlisted procedure, esophagus

There is no specific CPT or HCPCS code for magnetic sphincter augmentation (e.g., the LINX system). It would likely be reported with the unlisted laparoscopy procedure, esophagus code 43289.

ICD-9 Diagnoses Codes That Support Medical Necessity:

All diagnoses for minimally invasive procedures for the treatment of GERD are considered experimental or investigational.

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT and PROGRAM EXCEPTIONS.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Noncovered Procedures - Endoscopic Treatment of Gastroesophageal Reflux Disease (GERD) (L32485) located at fcso.com.

DEFINITIONS:

Dysphagia: Difficulty in swallowing.

Gastroesophageal junction: The lower part of the esophagus that connects to the stomach

Nissen fundoplication: A surgical procedure in which the upper portion of the stomach is wrapped around the lower end of the esophagus and sutured in place as a treatment for GERD.

Odynophagia: Pain produced by swallowing

Proton pump inhibitor (PPI): Any of a group of drugs (e.g., omeprazole) that inhibit the activity of proton pumps and are used to inhibit gastric acid secretion in the treatment of ulcers and gastroesophageal reflux disease.

RELATED GUIDELINES:

Endoscopic Radiofrequency Ablation or Cryosurgical Ablation for Barrett’s Esophagus, 01-91000-10

OTHER:

Other names used to report minimally invasive procedures for treating gastroesophageal reflux disease:

• Bard Endoscopic Suturing System (BESS)

• EndoCinch, Treatment for Gastroesophageal Reflux Disease

• EndoLuminal Gastroplication

• Endoscopic Gastroplasty or Gastroplication

• Enteryx

• EsophyX

• Gastroesophageal Reflux Disease (GERD), Endoscopic Gastroplasty

• Gastroplasty or Gastroplication, Endoscopic

• Gatekeeper hydrocel prosthesis

• Implantable magnetic esophageal ring for GERD

• Laparoscopic implantation of magnetic esophageal ring

• LINX Reflux Management System

• Magnetic esophageal ring to GERD

• Magnetic sphincter augmentation (MSA)

• Mechanical sphincter augmentation (MSA)

• NDO Plicator™ Procedure

• Plexiglas microspheres

REFERENCES:

  1. American College of Gastroenterology. Practice Guidelines: Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease (01/05)
  2. American College of Gastroenterology, Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol advance online publication (02/19/13).
  3. American Gastroenterological Association Position Statement on the Management of Gastroesophageal Reflux Disease. Gastroenterology 2008;135:1383-1391. (updated 07/26/10)
  4. American Gastroenterological Association Medical Position Statement on the Management of Gastroesophageal Reflux Disease (10/2008).
  5. American Gastroenterological Association Position Statement on the use of Endoscopic Therapy for Gastroesophageal Reflux Disease. Gastroenterology 2006; 131:1313-1314.
  6. American Society for Gastrointestinal Endoscopy (ASGE) Technology Assessment Committee. Endoscopic anti-reflux procedures. Updated 03/01/09.
  7. American Society for Gastrointestinal Endoscopy (ASGE). Role of endoscopy in the management of GERD. Gastrointest Endosc 2007 Aug;66(2):219-24 (reaffirmed 2011).
  8. Bell RC, Freeman KD. Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease. Surg Endosc 2011; 25(6):1975-84.
  9. Blue Cross Blue Shield Association Medical Policy Reference Manual. 2.01.38 Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease, 11/08/12.
  10. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC). Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease. TEC Assessments 2003, Volume 18, No. 20.
  11. Blue Cross and Blue Shield Association Medical Policy Reference Manual, 7.01.137 Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD) (08/08/13).
  12. Bonavina L, Saino G, et al. One Hundred Consecutive Patients Treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center. J Am Coll Surg 2013.
  13. Cadiere GB, Buset M, Muls V et al. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg 2008; 32(8):1676-88.
  14. California Bankruptcy Blog. Curon Medical Inc. of Fremont California shuts down and files for Chapter 7 Bankruptcy (11/17/06).
  15. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Implantation of Anti-Gastroesophageal Reflux Device (100.9) (06/22/87).
  16. Chen YK, Raijman I, Ben-Menachem T, Starpoli AA, Liu J, Pazwash H, Weiland S, Shahrier M, Fortajada E, Saltzman JR, Carr-Locke DL. Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial. Gastrointest Endosc. 2005 May; 61(6): 659-67.
  17. Chen YK. Endoscopic suturing devices for treatment of GERD: too little, too late? Gastrointest Endosc. 2005 Jul; 62(1): 44-7.
  18. ClinicalTrials.gov. Accessed 01/09/14.

a. LINX Reflux Management System (NCT01624506).

b. A Post-Approval Study of the LINX® Reflux Management System (NCT01940185).

c. LINX Reflux Management System Clinical Study Protocol (NCT00776997).

  1. ClinicalTrials.gov. “Evaluation of the Efficacy of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease”; Identifier # NCT00200642 (05/20/08).
  2. Comay D, Adam V, da Silveira EB, Kennedy W, Mayrand S, Barkun AN. The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis. Can J Gastroenterol. 2008 Jun;22(6):552-8.
  3. Corley DA, Katz P, Wo JM, Stefan A, Patti M, Rothstein R, Edmundowicz S, Kline M, Mason R, Wolfe MM. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003 Sep; 125 (3): 668-76.
  4. 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.
  5. ECRI Custom Hotline Response. Endoluminal Gastroplication (Endocinch) for Gastroesophageal Reflux Disease. Plymouth Meeting, PA: ECRI. Updated 04/18/08.
  6. ECRI Emerging Technology Report. Magnetic Sphincter Augmentation (Linx Reflux Management System) for Treating Gastroesophageal Reflux Disease (09/13/13).
  7. ECRI Endoluminal gastroplication [EndoCinch (TM)] for gastroesophageal reflux disease (GERD). Plymouth Meeting, PA: ECRI, 2003:17, (updated 04/18/08).
  8. ECRI Forecast. Boston Scientific recalls Enteryx for acid reflux (10/07/05).
  9. ECRI Stretta System (Mederi Therapeutics, Inc.) for Treating Gastroesophageal Reflux Disease; Hotline Article (06/05/2012).
  10. ECRI The Stretta™ procedure for gastroesophageal reflux disease [GERD]. Plymouth Meeting, PA: ECRI, 2003:32, (updated 04/18/08).
  11. Endogastric Solutions Inc website. Accessed 08/24/12.
  12. Endogastric Solutions press release. “10,000th Patient in the United States Treated with Transoral Incisionless Fundoplication (TIF®) Using EsophyX® Technology from EndoGastric Solutions”, Redwood City, CA, September 6, 2012.
  13. Endogastric Solutions press release. “EndoGastric Solutions Completes Patient Enrollment in Clinical Trial Comparing TIF Procedure to PPI Therapy for the Treatment of GERD”, Redwood City, CA, October 2, 2012.
  14. Falk GW, Fennerty MB, Rothstein RI. AGA Institute medical position statement on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006 Oct; 131(4): 1313-4.
  15. First Coast Service Options (FCSO). Local Medicare Coverage Determination Noncovered Procedures - Endoscopic Treatment of Gastroesophageal Reflux Disease (GERD) (L32485) (01/01/13).
  16. Ganz RA, Peters JH, Horgan S, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med; 368(8):719-27. (2013)
  17. Hailey D. Endoscope-based treatments for gastroesophageal reflux disease. Ottawa: Canadian Coordinating Office for Health Technology Assessment (CCOHTA), 2004.
  18. Hayes, Inc. HAYES Medical Technology Directory. Endoscopic Therapy for Gastroesophageal Reflux Disease. Lansdale, PA: Hayes, Inc. October 2007.
  19. Heidelbaugh J, Nostrant T. Medical and surgical management of gastroesophageal reflux disease. Clin Fam Pract. 2004 Sep; 6(3); 547.
  20. Ip S, Bonis P, Tatsioni A, Raman G, Chew P, Kupelnick B, Fu L, DeVine D, Lau J. Comparative Effectiveness Strategies for Gastroesophageal Reflux Disease. Evidence Report/Technology Assessment No. 1. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract No. 290-02-0022) Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Publication No. 06-EHC003-EF. December 2005.
  21. Ip S, Chung M, Moorthy D, Yu WW, Lee J, Chan JA, Bonis PA, Lau J. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update. Comparative Effectiveness Review No. 29. (Prepared by Tufts Medical Center Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I.) AHRQ Publication No. 11-EHC049-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011.
  22. Lipham, JC, Demeester, TR, Ganz, RA, et al. The LINX reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc; 26: 2944-9. (2012).
  23. Madan AK, Ternovits CA, Tichansky DS. Emerging endoluminal therapies for gastroesophageal reflux disease: adverse events. Am J Surg. 2006 Jul; 192(1): 72-5.
  24. Meier PN. Efficacy of endoscopic antireflux procedures: at least durability for radiofrequency energy delivery. Gastrointest Endosc. 2007 Mar; 65(3): 375-6.
  25. National Digestive Diseases Information Clearinghouse. NIH Publication No. 07–0882, Heartburn, Gastroesophageal Reflux (GER), and Gastroesophageal Reflux Disease (GERD) (05/07).
  26. National Guideline Clearinghouse. Gastroesophageal reflux disease (GERD) (2002; revised 01/07).
  27. National Guideline Clearinghouse. Guideline synthesis: Diagnosis and management of gastroesophageal reflux disease (GERD). Agency for Healthcare Research and Quality (AHRQ); 2008 May (revised 2012 Nov). Accessed 08/21/13.
  28. National Institute for Clinical Excellence (NICE). Endoscopic gastroplication for gastro-oesophageal reflux disease. London, UK: NICE; Feb 2005.
  29. National Institute for Clinical Excellence (NICE). Gastroelectrical stimulation for gastroparesis. London, UK: NICE; February 2005.
  30. Perry K, Banerjee A, Melvin S. Radiofrequency Energy Delivery To The Lower Esophageal Sphincter Reduces Esophageal Acid Exposure And Improves GERD Symptoms: A Systematic Review and Meta-Analysis. Surgical Laparoscopy Endoscopy and Percutaneous Techniques, August 2012; 22(4) 283-288.
  31. Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness publication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005 May; 61(6): 643-9.
  32. Reymunde A, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc. 2007 Mar; 65(3): 361-6.
  33. Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg. 2003 May; 237(5): 638-47; discussion 648-9.
  34. Schilling D, Kiesslich R, Galle PR, Riemann JF. Endoluminal therapy of GERD with a new endoscopic suturing device. Gastrointest Endosc. 2005 Jul; 62(1): 37-43.
  35. Schwartz MP, Wellink H, Gooszen HG, Conchillo JM, Samsom M, Smout AJ. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut. 2007 Jan; 56(1): 20-8.
  36. Shaheen NJ. The rise and fall (and rise?) of endoscopic anti-reflux procedures. Gastroenterology. 2006 Sep; 131(3): 952-4.
  37. Smith CD, DeVault KR, Buchanan M, Introduction of Mechanical Sphincter Augmentation for Gastroesophageal Reflux Disease into Practice: Early Clinical Outcomes and Keys to Successful Adoption. Journal of the American College of Surgeons (2014), doi:10.1016/j.jamcollsurg.2013.12.034.
  38. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Position Statement on Endolumenal Therapies for Gastrointestinal Diseases (11/09).
  39. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Sages Clinical Spotlight. Clinical Spotlight Review (02/2013).
  40. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System, Safety and Effectiveness Analysis LINX® Reflux Management System (Torax Medical, Inc.) Accessed 01/09/14.
  41. Tam WC, Schoeman MN, Zhang Q, Dent J, Rigda R, Utley D, Holloway RH. Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease. Gut. 2003 Apr; 52(4): 479-85.
  42. Trad KS, Turgeon DG, Emir D. Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc. DOI 10.1007/s00464-011-1932-6. Published online 09/30/11.
  43. Trad KS, Turgeon DG, Deljkich E. Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc. 2012 Mar;26(3):650-60. Epub 2011 Sep 30.
  44. The Merck Manual of diagnosis and Therapy, Gastroesophageal Reflux Disease, 1995 – 2001.
  45. University of Michigan Health System (UMHS). Gastroesophageal reflux disease (GERD). Ann Arbor (MI): University of Michigan Health System; 2012 May.
  46. U. S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. 510(K) Summary, CSM Stretta™ System. # K000245. 04/18/00.
  47. U. S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. Summary of Safety and Effectiveness Information, Bard® Endoscopic Suturing System. # K994290. 03/20/00.
  48. U. S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. Summary of Safety and Effectiveness Data, Enteryx™ Procedure Kit. PMA # P020006. 04/22/03.
  49. U.S. Food and Drug Administration (FDA). LINX™ Reflux Management System. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee 2012. Accessed 01/09/14.
  50. Yeh RW, Triadafilopoulos G. Endoscopic antireflux therapy: the Stretta procedure. Thorac Surg Clin. 2005 Aug; 15(3): 395-403.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/27/14.

GUIDELINE UPDATE INFORMATION:

06/15/01

New Medical Coverage Guideline.

03/15/02

Additions to Non-Covered section/Added CPT code 0008T.

04/15/03

Medical Coverage Guideline Reviewed.

01/01/04

Annual HCPCS coding update.

04/15/04

Review and revision of guideline consisting of updated references and added information regarding endoscopic submucosal biocompatible polymer (investigational).

10/01/04

4th quarter HCPCS coding update consisting of addition of S2215 (investigational).

01/01/05

Annual HCPCS update consisting of addition of 43257 and deletion of 0057T.

04/15/05

Review and revision of guideline consisting of updated references.

01/01/06

Annual HCPCS coding update consisting of the deletion of S2215 and the addition of 0133T.

04/15/06

Review and revision of guideline consisting of updated references.

01/01/07

HCPCS update consisting of the deletion of 0008T.

04/15/07

Review and revision of guideline consisting of updated references.

06/15/07

Reformatted guideline.

07/01/07

HCPCS update consisting of the deletion of 0133T.

03/15/08

Review and revision of guideline consisting of updated references.

03/15/09

Review and revision of guideline consisting of updated references.

05/15/09

Scheduled review; added informational statements relating to Stretta and Enteryx; no change in position statements; references updated.

06/15/10

Scheduled review; position statement unchanged, references updated.

03/15/11

Review Position Statement for Stretta procedure; Position Statement unchanged. References updated.

11/15/11

Revision consisting of the addition of clarification regarding TIF and Esophyx.

11/15/12

Annual review; position statement unchanged; references updated.

11/15/13

Annual review; position statement unchanged; Coding section revised; Program Exceptions section updated; references updated.

01/01/14

Annual HCPCS coding update: added 43212 and 43266; revised 43201, 43236, and 43257.

03/15/14

Revision to add Position Statement regarding magnetic sphincter augmentation procedures; coding and references updated.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: August 1, 2014: 08:21 PM