Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastric Reflux
Treatment: Outpatient Linx Procedure
The insurer denied the outpatient Linx procedure.
The denial is overturned.

The patient is an adult female with chronic GERD (gastroesophageal reflux disease), manifested by heartburn, cough, chest pain, and regurgitation. She has failed PPIs (proton pump inhibitors) and Histamine Type-2 (H2) blockers, as well as lifestyle and diet modification. She has a small hiatal hernia, abnormal potential hydrogen (pH) study and normal manometry. The medical doctor is requesting treatment with LINX. 

The health plan should cover the requested health service. 

As reported by The American Journal of Gastroenterology Guidelines for the diagnosis and management of 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 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 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, 
2013). 

The FDA 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. 

In an article by Saino, et al (2015), entitled "Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement," the LINX device enabled restoration of the anti-reflux barrier without extensive anatomical disruption. There were no significant or new safety issues identified during the long-term follow-up. This article also stated that the device provided clinical benefits, such as objective evidence of reduced acid exposure along with symptomatic improvement, increased patient satisfaction, and elimination of PPI use. 

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 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. It has been shown to have a positive effect on health outcomes and is supported by reliable medical literature. 

The LINX Reflux Management System in a patient with GERD 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 a generally accepted standard of medical community practice, clinically appropriate and has been demonstrated through scientific evidence to be effective in improving health outcomes. Therefore, the health plan should cover the proposed treatment.