LCD L35080: Select Minimally Invasive GERD Procedures

Indications:

EsophyX™ is a device for performing transoral incisionless fundoplication surgery (TIF) for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevent acid reflux. Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, Enteryx® or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. Coverage is not available for LINX® Reflux Management System, which is not a true endoluminal treatment but is also not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.

Currently, these procedures other than TIF are considered non-covered due to the fact that current peer-reviewed literature does not support the long-term efficacy and long-term safety of the services. Claims will be denied as "not proven effective."

Limitations:

For TIF, Coverage is not extended to:

• any patient who has recurrent symptoms or other evidence of failure following a prior TIF. These procedures (repeat TIF) would be considered investigational at this time.

• any patient with a hiatal hernia greater than 2 cm, except where the hernia has been reduced to 2 cm or less by a successful laparoscopic hernia reduction procedure prior to the TIF procedure. (Based on (FDA) approval).

• any GERD patients with BMI > 35, esophagitis LA grade >B, Barrett’s esophagus > 2 cm, and presence of achalasia or esophageal ulcer or has not been on an appropriate trial of proton pump inhibitors.

Summary of evidence for TIF:

As noted above, transoral incisionless fundoplication surgery is a method for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevents acid reflux.

Anti-Reflux Surgery Supplement to Endogastric Solutions TIF ESOPHYX Reconsideration Request NGS MAC, April 2017. This is not a peer-reviewed publication but a summary of what the procedure is and a summary of selective publications. Thus, this is not a peer-reviewed publication indexed in the U.S. National Library of Medicine of the National Institutes of Health and thus not valid as supportive literature.

Hakansson B., Montgomery M., Cadiere G, et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Alimentary Pharmacology and Therapeutics. 2015 John Wiley & Sons Ltd. This publication is indexed in the U.S. National Library of Medicine of the National Institutes. The study was blinded and divided equally into TIF and sham procedures. While the follow up period was only six (6) months, the time (average days) in remission offered by the TIF procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P Stefanidis G, Viazis N, Kotsikoros N. Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy. Diseases of the Esophagus (2017) 30, 1–8. This publication is indexed in the U.S. National Library of Medicine of the National Institutes of Health. The study initially had 45 patients who had the TIF procedure and were followed for a mean of 59 months (range 36–75). Only one patient had a complication during surgery and thus was excluded. The 44 patients all had follow-up upper endoscopy at 6 months, 1 year, and 3–5 years postoperatively. Seventy-two point seven percent that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (none PPI usage). Six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for Technology Coverage Statement on Minimally Invasive Surgical Options for Gastroesophageal Reflux Disease April 2016. This is a position paper from the American Gastrological Association based on its reviews of TIF publications. It is strongly supportive.