Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: Linx Reflux Management System.

The insurer denied coverage for Linx Reflux Management System.
The denial is overturned.

This is the case of a patient with a history of gastroesophageal reflux disease (GERD). He has significant daily heartburn despite medication and progressively worsening regurgitation requiring bed wedge. The regurgitation occurs nightly and causes him loss of sleep, lack of vitality the next day and is impacting his work. He also has chronic cough, throat clearing, and globus sensation. Prior testing with an esophagogastroduodenoscopy (EGD) showed reflux esophagitis. Barium swallow and esophageal manometry were normal. 48-hour ambulatory pH (potential of hydrogen) study was abnormal with 1 of the 2 days DeMeester score of 20.8 with good symptoms associated probability. The recommendation is for laparoscopic implantation of the Linx Reflux Management System.

Gastroesophageal reflux disease (GERD) results from incompetency of the lower esophageal sphincter (LES) that allows the contents of the stomach to reflux into the esophagus, airways, and mouth. The Linx Reflux Management System was developed to provide a permanent solution to GERD by augmenting the sphincter barrier with a standardized, reproducible laparoscopic procedure that does not alter gastric anatomy and is easily reversible. [1] The Linx Reflux Management System is a permanent, drug-free treatment for GERD that consists of a small band of magnetized titanium beads that are wrapped around the LES. This is performed under sedation using a laparoscopic technique. This band helps prevent gastric acids from pushing back up into the esophagus from the stomach yet also safely allows the LES to open when required to allow for easy swallowing. Sphincter augmentation with the Linx Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. [2] The Linx system is intended for use in GERD patients with abnormal pH testing who continue to have chronic symptoms despite antireflux therapy. [3] Linx Reflux Management System should be considered a safe and efficacious alternative to the more technically difficult and infrequently used Nissen fundoplication, with lower complication rates as well as the unique option for easy removal.  This procedure should be considered a standard of care option for the treatment of GERD.

The patient presented with persistent heartburn and regurgitation. Symptoms are not controlled with proton pump inhibitors. An esophagram demonstrated no reflux and no hiatal hernia. A pH study demonstrated abnormal reflux events and an elevated DeMeester score of 20.8. Linx obtained Food and Drug Administration (FDA) approval and has been demonstrated to be safe and effective in patients with GERD. Per provided clinical documentation, Linx is likely to be more beneficial than standard medical management. 

The carrier's denial of Linx Reflux Management System should be overturned.