Appeal type: Experimental/Investigational
Decision: Overturned

This is a patient with a long history of reflux that is not effectively managed with maximal medical therapy, nor with a prior endoscopic (incisionless) fundoplication. His current potential of hydrogen (pH) testing is markedly abnormal demonstrating gastroesophageal reflux disease (GERD) with a DeMeester score of 26. His upper gastrointestinal (G.I.) study shows normal anatomy with the exception of a small hiatal hernia and several areas of outpouching. The endoscopy otherwise shows no active esophagitis.
The health plan's determination is overturned. The LINX procedure is likely to be more beneficial than standard surgical therapy due to the equivalent effectiveness of these two approaches to GERD treatment and the documented lower risk of adverse events after LINX compared with standard surgical therapy (fundoplication).
Currently, numerous published clinical studies have confirmed that the LINX device reinforces the lower esophageal sphincter, effectively reduces the percent time of esophageal acid exposure, and improves GERD health-related quality of life similar to that of fundoplication. However, the question at hand is whether the LINX device is "more beneficial" than fundoplication. In experienced hands, the operation time for LINX placement is shorter than that of Nissen fundoplication, primarily due to the fact that an extensive dissection of the fundus and re-creation of the angle of His and anti-reflux barrier is not necessary. Postoperative dysphagia has been reported, as with fundoplication, and for the majority of patients, these symptoms appear to be short-lived and resolve with observation or with dilation of the gastroesophageal junction.
When outcomes of patients who underwent the LINX procedure were compared with another group undergoing fundoplication, the number of patients reporting mild gas-bloat was similar between the two groups, but there were no patients with severe gas and bloating in the LINX group compared with significantly more (11%) in the fundoplication group. Nearly 3x more fundoplication patients were unable to belch and about 5x more fundoplication patients were unable to vomit. These findings of superiority, along with the similar anti-reflux efficacy between the device and standard fundoplication, form the justification for LINX being the better surgical option in modern times.
Thus, the plurality of the evidence demonstrates that the device is more beneficial than the alternative surgical option of fundoplication. Data shows that the procedure is similarly effective against reflux but with lower risks of surgical trauma, bleeding risk, risk of postoperative complications such as gas-bloat and inability to vomit. These data are well described by Telem et.al. in the most recent Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) report.

The device is FDA approved and there is good evidence in the peer reviewed literature that it does benefit patients with GERD. This patient has documented medical necessity for effective surgical treatment of GERD, and the alternative (fundoplication) is not proven to be superior to the LINX management system.