Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)
Treatment: Procedure code 43284 (LINX Reflux Management System)
The insurer denied coverage for procedure code 43284 (LINX Reflux Management System)
The denial is overturned

This case involves a patient diagnosed with gastroesophageal reflux disease (GERD), obesity, and Peyronie's syndrome who was being recommended for the LINX reflux management system procedure. The upper gastrointestinal (GI) endoscopy report noted a small hiatal hernia with the examination otherwise normal. Records noted the patient did not have esophagitis, was negative for H. (Helicobacter) pylori, and had been counseled on dietary management given that his body mass index was above normal at 30.37. The barium swallow esophagram showed moderate esophageal motility with incomplete esophageal stripping wave with moderate retained esophageal barium. There was a small sliding-type hiatal hernia with moderate mid thoracic gastroesophageal reflux noted during the exam. The patient was recommended for the LINX procedure.  

The LINX procedure was unanimously endorsed by the selected Food and Drug Administration (FDA) advisory panel and approved by the FDA in 2012 using the indication statement, "The LINX Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal hydrogen potential (pH) testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD."

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

Procedure code 43284 (LINX Reflux Management System) has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for procedure code 43284 (LINX Reflux Management System).

Procedure code 43284 (LINX Reflux Management System) is one of the best available treatments for this patient at this time.

The adverse risks are not increased over standard treatment/services.

The requested service is likely to be as beneficial or more beneficial than any of the standard treatments/procedures for this patient.

Current medical literature has noted that the LINX device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. The LINX device, approved for human use in 2012, is a magnetic sphincter augmentation (MSA) device placed at the gastroesophageal junction and functions as an expandable ring which restores pressure of the lower esophageal sphincter. The information provided for this review noted the patient was diagnosed with refractory gastroesophageal reflux disease. While the patient was previously denied coverage for the Linx procedure with claims that medical studies have not shown that the device helps gastroesophageal reflux disease, upon brief research of this procedure and device, the evidence has shown that there are multiple studies showing that the Linx procedure is beneficial in reducing gastroesophageal reflux disease symptoms and is beneficial to improving health.

In summary, the denial of procedure code 43284 (LINX Reflux Management System) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.