Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  GERD (gastroesophageal reflux disease).
Treatment:  LINX Procedure.

The insurer denied the LINX Procedure.  The denial is upheld. 

The patient is a male with BMI (body mass index) of 36 kg (kilograms)/m2 (meters squared).  He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) associated with heartburn and regurgitation.  These symptoms are partially responsive to medications (Protonix), which he has been using for the past ten years.  The presence of dysphagia is not detailed in the surgical note.

The patient has been evaluated for this condition with the following:  1) EGD (esophagogastroduodenoscopy) showed erosive esophagitis and a 3-4-cm (centimeter) hiatal hernia.  Biopsy of the distal esophagus identified columnar epithelium with esophagitis and Goblet cells (Barrett's) without dysplasia; 2) A pH (potential of hydrogen) study identified a DeMeester score of 59.5 over 48-hours (normal < 14.7).  There was strong symptom correlation for heartburn; and 3) Esophageal motility that showed normal esophageal function with preserved esophageal peristalsis.  Distal wave amplitude was normal at 76.8 mmHg (millimeters of mercury).  There was no manometric hiatal hernia reported.

The treating surgeon has proposed the LINX procedure as treatment of GERD.  The health plan has denied this treatment based on the contention that LINX is E/I (experimental/investigational), per the denial letter. 

No, the health plan should not cover the LINX Procedure.

No, the LINX Procedure is not likely to be more health beneficial for this patient's condition of GERD than standard treatment.

LINX is not medically appropriate in this case based on published literature.  LINX has not been adequately studied in patients with BMI (body mass index) in excess of 35 kg (kilograms)/m2 (meters squared) or in patients with Barrett's metaplasia of the esophagus.  This patient has a BMI of 36. kg/m2, and he has biopsy proven intestinal metaplasia (Barrett's) of the distal esophagus.
  
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 [Los Angeles] classification) esophagitis.    

Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include the following:  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 mmHg (millimeters of mercury) 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 LES (lower esophageal sphincter), 5) Symptoms of dysphagia more than once per week within the last three months, 6) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc. [et cetera]), 7) Esophageal or gastric varices, 8) Lactating, pregnant or plan to become pregnant, 9) Morbid obesity (BMI >35), or 10) Age < 21 years.

This patient has a BMI greater than 35 kg/m2.  He also carries the diagnosis of Barrett's esophagus based on the endoscopy performed.  LINX has not been adequately tested in such a clinical scenario.  For these reasons, the proposed LINX is not known to be more beneficial than standard therapy (ongoing medical treatment or laparoscopic hiatal hernia repair and fundoplication) and is not medically appropriate in this case.