Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD).

Treatment: procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus

The insurer denied coverage for procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus.

The denial is upheld.

This is a patient with a history of gastroesophageal reflux disease (GERD). The patient had symptoms of regurgitation, globus sensation, and dysphagia to hard meats. The patient has been taking omeprazole but continued to have symptoms when the dosage was decreased. An esophagogastroduodenoscopy (EGD) demonstrated LA Grade B (mucosal fold) esophagitis and small gastric ulcers. A pH (potential of hydrogen) study demonstrated abnormal reflux events and an elevated DeMeester score of 81.6. Linx obtained Food and Drug Administration (FDA) approval has been demonstrated to be safe and effective in patients with GERD. However, there is no indication as to how often the patient experiences dysphagia. Per provided clinical documentation, Linx is not considered medically necessary for this patient. The requested procedure is not indicated for this patient based on the provided clinical information. 

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 (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 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.

Linx is not intended for use in patients with allergies to metals. It is also not intended for patients with defibrillators, pacemakers, or metallic implants. Contraindications of Linx implantation include a history of dysphagia, previous upper abdominal surgery, previous anti-reflux procedures, large sliding hiatal hernias (> [greater than] 3 cm [centimeters]), or those with Barrett's esophagus.[4-6] 

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 (Schatzki's ring, obstructive lesions, etc.), esophageal or gastric varices, morbid obesity, or age <  [less than]  21. [5] 

This not the best available treatment. While the risks are not increased this procedure is not likely to be more beneficial than any other patient.

The carrier's denial of procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus should be upheld.