Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: laparoscopic esophageal sphincter augmentation

The insurer denied coverage for laparoscopic esophageal sphincter augmentation

The denial is upheld

This is an adult who is being evaluated for symptomatic Gastroesophageal Reflux Disease (GERD). This is a review for the LINX Procedure. Thoracic Follow-up on 01/12/2023 confirmed diagnosis of Barrett's Esophagus. Diagnostic testing including Pathology confirms Barrett's Esophagus.

According to the documentation submitted, this is a patient with a history of Gastroesophageal Reflux Disease (GERD). The patient had a physician follow up for gastroesophageal reflux disease and small hiatal hernia. The note stated that potential hydrogen (pH) examination off medical therapy showed a DeMeester score of 209.8. Esophagram a year ago showed a small hiatal hernia and recent endoscopy confirmed a small area of Barrett's esophagus. The physician stated that the LINX device in addition to the fundoplication has now become standard of care.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

This patient is being evaluated for symptomatic Gastroesophageal Reflux Disease. Thoracic follow-up confirmed diagnosis of Barrett's Esophagus. Diagnostic testing including Pathology confirms Barrett's Esophagus. 

The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus as documented for this patient. Therefore, the scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

As per LINX Website and Food and Drug Administration (FDA) Contraindications: General Precautions: The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include explantation and/or replacement. The use of the LINX device in patients with a hiatal hernia larger than 3 centimeters (cm) should include hiatal hernia repair to reduce the hernia to less than 3 cm. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm. The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification) esophagitis. 

Laparoscopic esophageal sphincter augmentation surgery does have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is not a good candidate laparoscopic esophageal sphincter augmentation surgery.

Laparoscopic esophageal sphincter augmentation surgery is not the best available treatment for this patient at this time. This patient is not a candidate having documented Barrett's Esophagus.     

The adverse risks are increased over standard treatment/services.     

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

In summary, the denial of laparoscopic esophageal sphincter augmentation surgery and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.