Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is upheld.

The patient has symptoms of gastroesophageal reflux. The medical record indicates symptoms of heartburn and things coming up in her throat. She is taking Protonix 40 milligrams (mg) orally twice daily. Her body mass index was 31. An esophagram shows a small hiatal hernia with severe reflux and delayed gastric emptying. A DeMeester score on Bravo study of 36.2 indicates abnormally high esophageal acid exposure. An esophagogastroduodenoscopy demonstrates normal anatomy without Barrett's. She has a history of arcuate ligament surgery in the past. Esophageal peristalsis was normal on a motility study.
At issue in this case is whether the proposed LINX  procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed LINX procedure is not likely to be more beneficial than standard treatment for this patient's condition. Medication therapy and surgical fundoplication are current standard therapies, and the LINX system has not proven to be more beneficial in effectiveness or safety over a significant period of time for this chronic disease. Serious concerns remain regarding the long-term safety of the device from erosion over the longer term, with nearly every author calling for more randomized data.
In Gudozzi's 2019 pooled analysis and systematic review, the authors examined more than 19 studies, but most of them reported 12 months or less of follow up. The authors wrote, "In conclusion, magnetic sphincter augmentation achieves good gastroesophageal reflux disease (GERD) symptomatic control similar to that of fundoplication, with the benefit of less gas bloating. The safety of magnetic sphincter augmentation (MSA) also appears acceptable with only 3.3% of patients requiring device removal. There is an urgent need for randomized data directly comparing fundoplication with MSA for the treatment of GERD to truly evaluate the efficacy of this treatment approach."
This urgent need for more, longer term, and controlled data, remains. The LINX procedure has been studied in primarily cohort studies with limited randomized trials. The data overall suffers from being short term, with industry-funded cohort studies and with limited long term and controlled studies of significant numbers of subjects. Because some of the most significant concerns with the LINX device relate to longer term risks of erosion and complications from an encircling device at the gastroesophageal junction, there is inadequate data to put those concerns to rest. Such opinions of the need for more study are articulated by numerous authors in the published literature.
As Schivas finds in a 2020 meta-analysis of LINX studies, "The findings of our review suggest that MSA has the potential to bridge the treatment gap between maxed-out medical treatment and LF. However, further studies with longer follow-up are needed for a better elucidation of these results."
Similar findings are echoed by Zhuong in a 2021 meta-analysis, with the authors concluding, "MSA was an effective and safe therapy for refractory (r) GERD. Well-designed randomized trials that compare the efficacy of MSA with other therapies are needed."
As such, the LINX procedure is not demonstrated as more beneficial compared to current standard therapies.