Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease).
Treatment: LINX Reflux Management System.
The insurer denied the LINX Reflux Management System.
The denial is overturned.

The patient is a male with severe GERD (gastroesophageal reflux disease) refractory to high dose PPIs (proton pump inhibitors). He has a small hiatal hernia, a +(plus) Demeester score, normal manometry and normal gastric emptying study. His provider is requesting treatment with LINX reflux management system. The plan denied it as it considers it investigational.

Yes, the health plan should cover the LINX procedure.
As reported by The American Journal of Gastroenterology Guidelines for the diagnosis and management of gastroesophageal reflux disease, "Gastroesophageal reflux disease (GERD) is arguably the most common disease encountered by the gastroenterologist. It is equally likely that the primary care providers will find that complaints related to reflux disease constitute a large proportion of their practice. The following guideline will provide an overview of GERD [Gastroesophageal reflux disease] and its presentation, and recommendations for the approach to diagnosis and management of this common and important disease. Sphincter augmentation using the LINX Reflux system constructed of titanium beads has shown efficacy up to 4 years in the reduction of the amount of pathologic esophageal acid exposure in a small number of subjects (99). This device has been approved by the FDA [United States Food and Drug Administration] based on a clinical study in 100 GERD [gastroesophageal reflux disease] patients. This study found that performance of LINX resulted in consistent symptom relief and pH control with markedly fewer side effects than traditional laparoscopic fundoplication in well-selected patients." (Katz et al).

The FDA (United States Food and Drug Administration) approved the LINX Reflux system but this approval was based on a required five-year follow-up of the 100 patients from the investigational device exemption (IDE) pivotal study to evaluate safety and efficacy of the device over the long term. This long-term evaluation has since been completed.

According to the Society of American Gastrointestinal and Endoscopic Surgeons, based on the available evidence, the LINX device should be provided as an available option for the management of GERD (gastroesophageal reflux disease) that is refractory to standard medical treatments, and that has not yet progressed to end-stage reflux disease with associated complications. Additionally, the American Society of General Surgeons have indicated that based on currently available information, the LINX procedure is supported as a mechanism for controlling GERD (gastroesophageal reflux disease). It has been shown to have a positive effect on health outcomes and is supported by reliable medical literature.

As reported by Reynolds et al, "Magnetic sphincter augmentation (MSA) of the gastroesophageal junction with the LINX Reflux Management System is an alternative to fundoplication for gastroesophageal reflux disease (GERD) that was approved by the U.S. Food and Drug Administration (FDA).  MSA (Magnetic sphincter augmentation) with LINX is a safe and effective alternative to fundoplication for treatment of GERD [gastroesophageal reflux disease]."

According to a study by Ganz et al, "Based on results from year 2 of a 5-year trial, the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD [gastroesophageal reflux disease]."

The Linx Reflux Management System in a patient with GERD (gastroesophageal reflux disease) refractory to medical therapy is supported by medical literature and is accepted by the medical community as being safe and effective, and as it is generally accepted standards of medical practice; clinically appropriate and has been demonstrated through scientific evidence to be effective in improving health outcomes. Therefore, the requested LINX is clinically appropriate, accepted standard of care and medically appropriate, and the health plan should cover it.

Yes, the LINX procedure is more beneficial.
As above, it is as effective and with less side effects than a Nissen funduplication, and is a safe and effective alternative to a more invasive Nissen funduplication.