Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD)
Treatment: LINX Reflux Management System (LINX) Procedure
The insurer denied the LINX procedure.
The health plan's determination is overturned.

This patient is a female who sought a surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The surgical history and physical (H&P) states that the patient has had symptoms of heartburn that are refractory to antisecretory therapy. There is no reported dysphagia. The patient was evaluated due to ongoing symptoms.
An esophagram showed a small sliding hiatal hernia and normal esophageal motility. There was moderate gastroesophageal reflux to the level of the aortic arch. The esophagogastroduodenoscopy (EGD) showed a medium sized hiatal hernia. The esophagus was anatomically normal.  potential hydrogen (pH) testing while off acid suppressing therapy showed pathologic esophageal acid exposure with a DeMeester score of 29.1 (normal less than (<) 14.7) An esophageal motility study showed normal esophageal peristalsis. There was no manometrically detected hiatal hernia. The treating surgeon has proposed the LINX reflux management system (LINX) procedure as treatment of GERD.

Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is likely to be more beneficial than standard treatment for this patient's condition of GERD.
The LINX procedure is a minimally invasive procedure for the treatment of GERD and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure. There has been completion of ongoing clinical trials National Clinical Trial (NCT)00776997 and NCT01624506 that provide the necessary long term follow up regarding the LINX procedure. These studies, in conjunction with previously published data, support the long-term safety and efficacy of the LINX procedure and reinforce that this procedure has withstood appropriate scrutiny and should be included in the armamentarium of proven-effective therapy for the treatment of GERD in selected patients.
The LINX procedure is a Magnetic Sphincter Augmentation (MSA) that has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use. LINX is not subject to review and approval by any institutional review board for the proposed use. LINX is not the subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trials set forth in the FDA regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication).

The patient has symptoms of chronic GERD (heartburn, but no dysphagia). The symptoms are refractory to medicinal therapy. She has been appropriately evaluated with EGD that showed a moderate-sized hiatal hernia without mention of esophagitis. There is no contraindicating esophageal motor condition based on the esophageal motility study. There is confirmed pathologic esophageal acid exposure with elevated esophageal acid exposure (composite DeMeester score of 29, normal is less than (<) 14.7). The esophagram also showed significant gastroesophageal reflux. Finally, the patient does not have specific precaution to implantation of the LINX device 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, she is not pregnant and does not plan to become pregnant and she is not morbidly obese.
 
The health plan's determination is overturned in whole.