Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Surgical Services. 
The insurer denied surgical procedure on esophagus. 
The denial is upheld.

The patient is a male with gastroesophageal reflux disease (GERD). He underwent peroral endoscopic myotomy to address dysphagia due to type II achalasia, with subsequent improvement in dysphagia. He has moderate to severe pain caused by acid reflux, resulting in frequent nocturnal and early morning awakenings, decreased sleep quantity and quality, and occupational impact. Esophagogastroduodenoscopy showed a Hill Grade II valve and patulous lower esophageal sphincter; biopsy of the gastroesophageal junction was negative for intestinal metaplasia. Bravo pH study showed elevated esophageal acid exposure with DeMeester score of 38.1, and symptom association probability of 78.3% for heartburn and chest pain. He has failed high-dose and then simultaneous use of dexlansoprazole, pantoprazole, and famotidine with dietary changes and lifestyle modification; he had no change in symptoms when holding medications for the Bravo pH study. The subject under review is the benefit of the transoral incisionless fundoplication for the treatment of GERD.

The health plan's determination is upheld.

The proposed procedure is not definitively supported as likely to be more beneficial than any standard treatment or treatments for the treatment of gastroesophageal reflux disease in this case. The efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials (Sami, et al). However, the conclusions are contradictory: one large, randomized trial including 60 patients found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors (PPIs) in 61% (Witteman, et al.). The study concluded that no long-term objective reflux control was achieved. 
The Society of American Gastrointestinal and Endoscopic Surgeons reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery; Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) concluded that "further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety (Auyang, et al). Guidelines from the American Society for Gastrointestinal Endoscopy (ASGE) report that the long-term follow-up data for TIF is limited (ASGE Standards of Practice Committee, et al.). These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF (Ashfaq, et al; Bell, et al; Edress, et al).
The use of TIF to treat gastroesophageal reflux disease which develops after peroral endoscopic myotomy (POEM) for the treatment of achalasia has been reported in limited series (Kumta, et al; Tyberg, et al). However, the data is limited, and the conclusion has been that further study is needed (Tyberg, et al; Fass, et al). For these reasons, TIF is not definitively supported as likely to be more beneficial than any standard treatment or treatments for the treatment of gastroesophageal reflux disease in this case.