Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease).
Treatment: Surgery (laparoscopic anti-reflux surgery utilizing LINX system(43284).
The insurer denied the Surgery (laparoscopic anti-reflux surgery utilizing LINX system(43284).
The denial is overturned.

The patient is a female with severe GERD (gastroesophageal reflux disease), asthma and chronic cough, refractory to medical therapy with high dose proton pump inhibitors. She has a positive pH (potential of hydrogen) study, normal manometry and significant reflux on imaging. Her provider is requesting treatment with LINX. LINX was denied, as the plan states that it does not have a positive effect on health outcomes.

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.

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, as the patient has GERD (gastroesophageal reflux disease) refractory to medical therapy, based on records and plan language, the requested LINX is not experimental/investigational and is medically appropriate, and should be covered by the health plan.

It is as beneficial as TIF (transoral incisionless funduplication) and laparoscopic Nissen funduplication, and less invasive than the latter.