Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease
Treatment: Outpatient LINX Reflux Management System
The insurer denied Outpatient LINX Reflux Management System.
The denial is Upheld.

The patient is an adult male. He has the diagnosis of refractory GERD (gastroesophageal reflux disease). The patient has failed conventional therapies as per the provider. The provider has requested the provision of the LINX system as treatment for the patient's condition. 

The health plan should not cover the LINX procedure. 

At this time the requested, LINX has shown promising results. However, further studies are needed in order to establish the long-term efficacy, safety, and overall health benefit of this procedure in the patient's setting. Therefore, the requested LINX procedure is experimental/investigational. 
In 2017, Skubleny and colleagues conducted a systematic review and meta-analysis of LINX compared to fundoplication as a treatment for GERD (gastroesophageal reflux disease). The LINX device was found to be statistically better than fundoplication in preserving individuals' ability to belch, Nissen fundoplication, thus comparability between recipients of LINX versus fundoplication remains poorly understood. 
In March 2017, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) conducted an updated Safety and Effectiveness Analysis for the LINX Reflux Management System and concluded: With regards to safety: Safety analyses suggest the LINX procedure was associated with few serious adverse events and no reported mortality. No new patterns of failure or complications have been reported in long-term follow-up. Longer-term follow-up supports the FDA (United States Food and Drug Administration) conclusion that the device is safe. Longer-term follow-up data demonstrates that the LINX Reflux Management System is effective in the management of GERD (gastroesophageal reflux disease). Despite SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) conclusions, controlled studies, preferably prospective and randomized in design, which directly compare LINX with either fundoplication or maximal medical therapy, in those who would be considered candidates for LINX, are warranted.
In 2020, Bell and colleagues published 1-year follow-up data from the above-mentioned randomized clinical trial. Long-term outcomes with sustained robust numbers and a comparator group that is comparable to the interventional arm is warranted. In this study, the PPI (proton pump inhibitor)-only group was not eligible for LINX implantation due to reasonably controlled GERD (gastroesophageal reflux disease) with PPIs (proton pump inhibitors) alone; as such, the PPI (proton pump inhibitor) dose was dropped to the minimum therapeutic dose for the remaining 6 months of the study, likely reducing the therapeutic effect of PPIs (proton pump inhibitor) being achieved in this cohort.
In 2020, Bell and colleagues published 1-year follow-up data from the above-mentioned randomized clinical trial. In this 1-year trial with randomized, cross-over design, implantation of the LINX device was not associated with adverse operative events such as device explants, erosions, or migrations. Long-term outcomes with sustained robust numbers and a comparator group that is comparable to the interventional arm is warranted.
A systematic review included 35 studies composed of 2511 subjects who received the LINX device for refractory GERD (gastroesophageal reflux disease). While PPI (proton pump inhibitor) cessation rates neared 100%, the incidence of dysphagia ranged from 6% to 83% with 8% resulting in dilation. While authors conclude that the LINX device has potential, the study also acknowledged the gap in long-term results. The need for large, long-term, randomized trials with head-to-head comparison of LINX with Nissen fundoplication remain (Schizas, 2020).