Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD [gastro esophageal reflux disease]

Treatment: stomach surgery (procedure code 43284), placement of esophageal sphincter augmentation device

The insurer denied coverage for stomach surgery (procedure code 43284), placement of esophageal sphincter augmentation device.

The denial is upheld.

This is the case of an adult female with a history of gastroesophageal reflux disease (GERD) without esophagitis, hernia, Barrett's esophagus without dysplasia, chronic diarrhea, depression, and migraine. Diagnostic workup showed a DeMeester score of 9.5 and 1-2 centimeter (cm) hiatal hernia. The patient reports that proton pump inhibitor medication has not helped her symptoms. Approval for the Linx procedure is requested.

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.

 According to the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the safety and effectiveness of the Linx device has not been validated in patients with symptoms of dysphagia more than once per week within the last 3 months, esophageal stricture or gross esophageal anatomic abnormalities, esophageal or gastric varices, morbid obesity. 

This is an adult female patient with a history of GERD. Symptoms are no longer controlled with pantoprazole. An esophagogastroduodenoscopy [EGD] demonstrated a 3-cm hiatal hernia. Pathology did not demonstrate Goblet cells or dysplasia. A potential of Hydrogen [pH] study demonstrated abnormal reflux events and an elevated DeMeester score of 40.4. Linx obtained FDA [Food and Drug Administration] approval and has been demonstrated to be safe and effective in patients with GERD. However, the large hiatal hernia is a contraindication for the procedure. Per provided clinical documentation, Linx is not considered medically necessary for this patient. 

The requested procedure is not likely to be more beneficial than any other existing standard health service.

The carrier's denial of stomach surgery (procedure code 43284); placement of esophageal sphincter augmentation device should be upheld.