Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Gastroesophageal reflux disease (GERD)
Treatment: LINX Implantable Magnetic Esophageal Ring
The insurer denied the LINX Implantable Magnetic Esophageal Ring.
The determination is overturned.

This is a male patient who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The records indicate that he has been treated with anti-acid medications (Nexium), but has refractory symptoms. He has been evaluated for his complaints with the following diagnostics.
An esophagogastroduodenoscopy (EGD) showed Grade B esophagitis at the gastroesophageal junction. There was a 2 centimeter (cm) hiatal hernia. A contrast upper gastrointestinal (UGI) study was performed and showed a small hiatal hernia
Manometry testing showed adequately preserved motility. There was normal distal contractile integral. There was no manometrically detected hiatal hernia.
Potential hydrogen (pH) testing confirmed pathologic esophageal acid exposure with a DeMeester score of 76.3 (normal less than 14.7).
The treating surgeon has proposed the LINX procedure as treatment of chronic GERD. At issue is whether the LINX Implantable Magnetic Esophageal Ring is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is likely to be more beneficial for this patient compared with alternative surgical and non-surgical therapy.
This patient has GERD. There is pathologic esophageal acid exposure as documented by the objective pH testing that confirmed an elevated DeMeester score while off acid suppressing therapy. The patient has been appropriately evaluated with endoscopy and motility studies that confirm the absence of a precluding hiatal hernia and no alternative diagnosis or motor abnormality of the esophagus. An antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic Nissen fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure.
There are not equally effective treatments for GERD as in this case. LINX offers improved esophageal acid reduction compared to ongoing medication usage. LINX also offers similar reduction in esophageal acid exposure compared to surgical fundoplication, but with an improved risk profile. The ability to belch and vomit are preserved with LINX compared to fundoplication. For these reasons the LINX procedure is likely to be more beneficial for this patient compared with alternative, standard therapy.
The LINX procedure, approved by the Food and Drug Administration (FDA) in 2012, has demonstrated long term efficacy to support that it is as safe and effective as alternative therapy such as traditional fundoplication with improved risk exposure. Therefore, this procedure has been shown to be safe and effective for a patient such as this. This therapy is likely to be more beneficial for this patient compared with alternative surgical and non-surgical therapy.
Listed contraindications or precautions to implantation of the LINX device (per the manufacturer) include conditions such as scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age less than 21. In this case, none of these contraindications exist and the patient is appropriate for this intervention.