Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD)

Treatment magnetic collar around the esophagus and upper stomach

The insurer denied coverage for magnetic collar around the esophagus and upper stomach

The denial is overturned

This is a patient has a history of gastroesophageal reflux disease (GERD), hypertension, asthma, and cardiomyopathy. She presented to the Gastroenterologist's (GI) office for a follow up visit for epigastric pain and GERD. The patient reported 7 out of 10 chronic epigastric pain, burning, and a pressure like sensation. The most recent endoscopy revealed mild grade A reflux esophagitis. The Linx procedure is requested to treat GERD.  

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 (Torax Medical, St. Paul, MN [Minnesota, USA [United States of America) 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 [Proton Pump Inhibitors), with minimal side effects and no safety issues. [2] The Linx system is intended for use in GERD patients with abnormal pH (potential of hydrogen) testing who continue to have chronic symptoms despite anti-reflux 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.

This patient presented with persistent epigastric pain. Symptoms are not controlled with famotidine and Omeprazole.. Pathology demonstrated gastritis and esophagitis. A pH study demonstrated abnormal reflux events and an elevated DeMeester score of 44.6. An upper GI study demonstrate reflux and a small hiatal hernia. Linx obtained Food and Drug Administration (FDA) approval and has been demonstrated to be safe and effective in patients with GERD. The referenced peer reviewed literature clearly indicates that the Linx is medically necessary. 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the magnetic collar around the esophagus and upper stomach is substantiated. The insurer's denial is overturned