Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is upheld.

This patient [body mass index (BMI) 27 kilograms per square meter (kg/m2)] sought surgical evaluation for the condition of heartburn. These symptoms are partially responsive to proton pump inhibitor (PPI) medication (Nexium and Pepcid), but he does have breakthrough symptoms. He has no dysphagia. He has a history of Barrett's esophagitis per the consultation.

He has been evaluated for this condition with:
Esophagogastroduodenoscopy (EGD) that identified esophagitis in the area of the gastroesophageal (GE) junction and no hiatal hernia. The pathology report is not included with the review material.

Esophageal motility showed adequate peristalsis of the esophagus. There was a no manometric hiatal hernia and 100% (percent) of swallows were normally peristaltic.

A potential hydrogen (pH) study identified an elevated esophageal acid exposure with a composite DeMeester score of 68.6 over 48-hours of study (normal [n] less than [<] 14.7). Symptom correlation was strong for heartburn, chest pain and regurgitation.

The treating surgeon has proposed the LINX procedure as treatment of gastroesophageal reflux disease (GERD).

At issue is whether the LINX procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

LINX cannot be said, based on published literature, to be more beneficial than any standard therapy for this for this patient's condition of GERD in the setting of Barrett's metaplasia of the distal esophagus.

While LINX magnetic sphincter augmentation has been shown by scientific evidence to be safe and effective for the condition of GERD with proven elevated esophageal acid exposure, preserved esophageal motility and no contraindication to application of LINX, in this case the records indicate a history of Barrett's metaplasia.

General precautions listed by the manufacturer for LINX implantation include a diagnosis of Barrett's as 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. This patient has a history of Barrett's as detailed in the surgical consultation report.

Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include:
1) Scleroderma 2) Suspected or confirmed esophageal or gastric cancer 3) Prior esophageal or gastric surgery or endoscopic intervention 4) Distal esophageal motility less than 35 millimeters of mercury (mmHg) peristaltic amplitude on wet swallows or < 70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive lower esophageal sphincter (LES) 5) Symptoms of dysphagia more than once per week within the last 3 months 6) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.) 7) Esophageal or gastric varices 8) Lactating, pregnant or plan to become pregnant 9) Morbid obesity (BMI greater than [>] 35) 10) Age < 21.

This patient has a history of Barrett's metaplasia. For this reason, the proposed LINX is not known to be more beneficial than standard alternative therapy.

The body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation for the diagnosis of GERD. However, in this case the records document the diagnosis of Barrett's metaplasia. LINX has not been adequately tested/studied in such a clinical scenario. This diagnosis was an exclusion criterion per existing published literature for the application of LINX.