Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: Procedure code 43284, LINX Reflux Management System

The insurer denied coverage for procedure code 43284, LINX Reflux Management System

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 (Torax Medical, St. Paul, MN, USA) 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 proton pump inhibitors (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 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 is an adult male patient with a history of GERD. The patient presented with persistent reflux. Symptoms are not controlled despite the use of pantoprazole and famotidine. An esophagogastroduodenoscopy (EGD) demonstrated duodenal erosions. A pH (acid or alkaline ) study demonstrated abnormal reflux events and an elevated DeMeester score of 22.5. An upper gastrointestinal (GI) study demonstrated reflux. LINX obtained Food and Drug Administration (FDA) approval in 2012 and has been demonstrated to be safe and effective in patients with GERD. 

The requested procedure is necessary and is likely to be more beneficial than other standard treatments.

Peer reviewed literature does support a result of improvement in health outcomes with the requested procedure. 

The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for the requested procedure.  It is the best available treatment for this patient at this time.

In summary, the denial of procedure code 43284, LINX Reflux Management System and coverage for the requested service/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.