Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    A procedure being used to treat esophageal reflux is Transoral Fundoplication using the Esophyx, Stomaphyx, or other like systems; this procedure is not covered.

2)    For use of radiofrequency thermal destruction therapy for GERD, see BI327.

Transoral Fundoplication is considered experimental and investigational, as there is insufficient peer review evidence to support the effectiveness, especially for long term.

Codes Used In This BI:

C9724          Endoscopic full-thickness placation in the gastric cardia using endoscopic

                    application system (EPS); includes endoscopy (code deleted 1/1/16)

43210           EGD with esophagogastric fundoplasty

CPT code 43210 is not covered.

1.     In March 2007, the FDA granted 510(k) premarketing clearance to the Stomaphyx (EndoGastric Solutions, Inc.), an endoluminal fastener and delivery system used to tighten esophageal tissue. The FDA clearance indicated that the Stomaphyx is substantially equivalent to EndoCinch. In September 2007, the FDA granted 510(k) premarketing clearance to the Esophyx System with Serosa Fuse Fastener (EndoGastric Solutions, Inc.) as being substantially equivalent to the Stomaphyx and EndoCinch devices.  The Esophyx System is designed to perform a Transoral incision less fundoplication procedure using to reconstruct a valve at the gastro esophageal junction through Transoral delivery of multiple fasteners. Cadiere, et al. (2008) reported on the outcome of a short-term, uncontrolled study of the Esophyx system for treating GERD. Eighty-six patients with chronic GERD treated with proton pump inhibitors were enrolled. Exclusion criteria included an irreducible hiatal hernia greater than 2 cm.  At 12 months, 73% of study subjects had 50% or greater improvement in GERD health-related quality of life scores, and eighty-one percent of study subjects discontinued PPI use. However, less than half (37%) of study subjects had normalization of esophageal acid exposure. Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. The investigators reported that other adverse events were mild and transient.

2.     In a retrospective study, Bergman and co-workers (2008) examined the safety and effectiveness of the Esophyx system in patients with GERD who had undergone endoluminal fundoplication with the device.  At follow-up, proton pump inhibitor (PPI) usage was elicited and 2 validated questionnaires were administered measuring GERD health-related quality of life (range of 0 to 50) and symptom severity (range of 0 to 72).  In limited preliminary evaluation, the initial North American experience with endoluminal fundoplication using the Esophyx device is that it appears to be safe and provides moderate effectiveness in treating the symptoms of GERD.  Moreover, the authors stated that further studies comparing this technique with conventional medical and surgical therapies are necessary.

3.     Some evidence comparing Esophyx with PPIs shows outcomes at least as good as PPI alone, but there are no good comparisons of Esophyx to laparoscopic fundoplication, which would be considered standard of care.  Furthermore, the long term effectiveness of Esophyx is unknown.  Transoral fundoplication is not more cost effective than PPIs or laparoscopic fundoplication.

4.     According to Clinical Trials.gov, there are at least two studies currently active to evaluate the effectiveness of this technology.

5.     Witteman compared Transoral fundoplication to continued PPI therapy in patients controlled on PPIs in a randomized trial.  Although fundoplication resulted in improved GERD related quality of life and produced a short-term improvement in the reflux barrier in some patients, no long-term objective reflux control was achieved.  Furthermore, 61% of patients resumed PPI therapy after fundoplication.

1.     Cadière GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a Transoral device for the treatment of GERD: A feasibility study. Surg Endosc. 2008; 22(2):333-342.

2.     U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). EndoGastric Solutions Stomaphyx endoluminal fastener and delivery system. Summary of Safety and Effectiveness Information. 510(k) No. K062875. Rockville, MD: FDA; March 3, 2007.

3.     U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). EndoGastric Solutions (EGS) Esophyx System with Serosa Fuse Fastener and accessories. 510(k) Summary. 510(k) No. K071651. Rockville, MD: FDA; September 14, 2007.

4.     Bergman S, Mikami DJ, Hazey JW, et al. Endoluminal fundoplication with Esophyx: The initial North American experience. Surg Innov. 2008; 15(3):166-170.

5.     Von Renteln D, Schiefke I, Fuchs KH, et al. Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: A multicenter study (with video). Gastrointest Endosc. 2008; 68(5):833-844.

6.     Pace F, Costamagna G, Penagini R, et al. Review article: Endoscopic antireflux procedures - an unfulfilled promise? Aliment Pharmacol Ther. 2008; 27(5):375-384.

7.     National Institute for Health and Clinical Excellence (NICE). Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. Interventional Procedure Guidance 292. London, UK: NICE; March 2009

8.     Hayes Medical Technology Directory.  Endoscopic therapy for gastro esophageal reflux disease.  Published 30 July 2015.  Accessed 3 August 2015.

9.     Witteman BP et al.  Randomized controlled trial of Transoral incision less fundoplication vs. proton pump inhibitors for treatment of gastro esophageal reflux disease.  Am J Gastroenterology.  2015 Apr; 110(4): 531-542.

Addendum:

Effective 01/01/2017:  Removed HCPCS Code C9724 from Claim Statement section.  This code was deleted effective 1/1/16.