Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: gastroesophageal reflux disease

Treatment: Linx Reflux Management System and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed

The insurer denied coverage for Linx Reflux Management System and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed

The denial is overturned

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 lower esophageal sphincter (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 proton pump inhibitors (PPIs), with minimal side effects and no safety issues. The LINX system is intended for use in GERD patients with abnormal pH (potential for hydrogen) testing who continue to have chronic symptoms despite antireflux therapy. The 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 is a patient with a history of GERD. The patient presented with persistent heartburn and regurgitation. Symptoms are not controlled with Omeprazole. An Esophagogastroduodenoscopy EGD demonstrated grade B esophagitis. Pathology demonstrated gastritis and esophagitis. A pH study demonstrated abnormal reflux events and an elevated DeMeester score of 86.1. An upper gastrointestinal (GI) study demonstrated a small hiatal hernia. LINX obtained Food and Drug Administration (FDA) approval in 2012 and has been demonstrated to be safe and effective in patients with GERD. As the patient has a small hiatal hernia, cruroplasty would be necessary as well. A one-night observation stay would be appropriate. The requested procedure is medically necessary and is likely to be more beneficial than other standard treatments. 

In summary, the denial of  LINX Reflux Management System (LINX) and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed 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.