Appeal type: Medical necessity
Decision: Upheld

Diagnosis: GERD (gastroesophageal reflux disease)
Treatment: LINX Reflux Management System
The insurer denied the LINX Reflux Management System.
The denial is upheld.

This patient is a woman. She sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) and Barrett's esophagus. She has been treated with medicinal therapy in addition to endoscopic resection and radiofrequency ablation several times.

The patient was evaluated for her symptoms with the following diagnostics:

A pH (potential of hydrogen) study identified a normal esophageal acid exposure over 24-hours of study.

EGD (esophagogastroduodenoscopy) showed a 2-cm (centimeters) hiatal hernia without mention of esophagitis.

Contrast UGI (upper gastrointestinal series) showed mild esophageal dysmotility, a 3.6 x 2.9-cm hiatal hernia and reflux to the distal esophagus.

Motility testing showed 80% (percent) normal peristaltic swallows. There were manometric findings of hiatal hernia.

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 not medically necessary. The denial is being appealed.

No, the requested LINX is not medically necessary.

LINX is not medically necessary in this case based on published literature and manufacturer guidelines for patient selection. LINX is not known to be health beneficial for this patient's condition of GERD in the setting of Barrett's metaplasia of the distal esophagus and prior endoscopic esophageal resection and radiofrequency ablation.

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 and prior esophageal intervention.

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 surgical consultation and has undergone endoscopic resection and radiofrequency ablation.

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 < (less than) 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 3 months 6) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc. [and so forth]) 7) Esophageal or gastric varices 8) Lactating, pregnant or plan to become pregnant 9) Morbid obesity (BMI [body mass index] > [greater than] 35) 10) Age < 21.

This patient has undergone prior endoscopic resection and radiofrequency ablation for the diagnosis of Barrett's metaplasia. For these reasons, the proposed LINX and related inpatient stay is not known to be beneficial and is not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.

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 in the setting of preserved motility and no contraindication to the LINX device. However, in this case the records document the diagnosis of Barrett's metaplasia and prior endoscopic intervention as detailed above. LINX has not been adequately testing 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.