Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease (GERD) and Barrett's esophagus
Treatment: LINX Reflux Management System, Pre-service
The insurer denied the LINX Reflux Management System, Pre-service.
The denial is upheld. 

This patient is a man.  He has a BMI (body mass index) of 34.4 kg/m2 (kilograms per meters squared).  He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) with Barrett's metaplasia without dysplasia and a 3-4 cm (centimeter) hiatal hernia.  The surgical H&P (history and physical) also describes the diagnosis of Barrett's based on endoscopic biopsy.  He has been treated with Pantoprazole for years with only partial response.

The patient was evaluated due to ongoing symptoms with the following:

A pH (potential of hydrogen) study identified a composite DeMeester score of 53.5 over 48-hours (45.8 on Day 1, Day 2 not included with the review material (normal less than [<] 14.7)).

EGD (esophagogastroduodenoscopy) showed a 3-cm hiatal hernia and Barrett's esophagus.

EGD showed distal esophagitis.  The pathology report documents the diagnosis of Barrett's metaplasia without dysplasia.

Esophageal motility was aborted due to inability to pass the manometry catheter.

Barium swallow showed no hiatal hernia and normal appearing esophageal motility.

The treating surgeon has proposed the LINX procedure as treatment of GERD with Barrett's metaplasia.  The health plan has denied this treatment based on the contention that LINX is experimental/investigational.

No, the health plan should not cover the LINX Reflux Management System.

LINX is not medically appropriate in this case, based on published literature.  LINX is not known to be health beneficial for this patient's condition of GERD in the setting of biopsy-proven 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, 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 [Los Angeles] classification) esophagitis.  This patient has a history of Barrett's as detailed in the EGD biopsy 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 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) 4) Symptoms of dysphagia more than once per week within the last 3 months 5) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.) 6) Esophageal or gastric varices 7) Lactating, pregnant or plan to become pregnant 8) Morbid obesity (BMI greater than [>] 35) 9) Age < 21

This patient has Barrett's metaplasia.  For this reason, the proposed LINX is not known to be beneficial and is not medically appropriate.

No, the LINX system is not likely to be more beneficial.

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 in such a clinical scenario.  Therefore, based on the status of peer-reviewed literature and the case specific details of this case, the LINX procedure is not consistent with the diagnosis and is not compatible with the standards of acceptable medical practice in the United States.

Evidence-based alternative standard therapy for this patient would include laparoscopic crural closure/repair and fundoplication.  Radiofrequency ablation of the intestinal metaplasia has also been considered in this case.