Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Issue under review: LINX procedure
The health plan denied LINX procedure.

Determination:
The health plan's denial is upheld.

This patient is an adultwoman (BMI 37 kg/m2) who sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease).  She has been treated for this condition with Omeprazole with refractory symptoms. She is reported to not have symptoms of dysphagia.  The surgical consultation states that there is a history of Barrett's without dysplasia per EGD (esophagogastroduodenoscopy).  This consult records her height and weight as:  64 inches and 214 lbs.

Evaluation includes:

EGD showed mild esophagitis and no hiatal hernia.  The submitted pathology report does not identify Barrett's metaplasia.

pH testing records that the DeMeester score on this study was 33.6 (normal < 14.7). There was strong symptom correlation for heartburn.  The study was positive for elevated esophageal acid exposure on each of the two days of the study.

Esophageal motility study showed 50% fragmented contractions and 10% ineffective contractions.  Esophageal propagation was reported to be normal.  There was no manometric hiatal hernia.  

The treating surgeon has proposed the LINX procedure as treatment of GERD.   

Based on the submitted clinical material and the published literature and manufacturer selection criteria for LINX, the proposed LINX is not known to be more beneficial than any standard treatment for the patient's condition/disease.  

LINX is not proven therapy in this case based on published literature and manufacturer selection criteria.  LINX is not known to be health beneficial for this patient's condition of GERD in the setting of class II obesity with a body mass index > 35 kg/m2.  Additionally, this patient is reported to have a history of Barrett's metaplasia per endoscopy, though this is not confirmed based on EGD.  The most recent records date (nearly two years ago) that document her height, weight and Body Mass Index.

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 motility and no alternative diagnosis, in this case the records indicate a history of class II obesity and a possible history of Barrett's esophageal 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.   

Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include: Scleroderma, Suspected or confirmed esophageal or gastric cancer, Prior esophageal or gastric surgery or endoscopic intervention, Distal esophageal motility less than 35 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 LES (lower esophageal sphincter) Symptoms of dysphagia more than once per week within the last 3 months. Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, hiatal hernia, etc.) Esophageal or gastric varices, Lactating, pregnant or plan to become pregnant, Morbid obesity (BMI >35) Age < 21

This patient has class II obesity and a possible history of Barrett's metaplasia.  The device manufacturer criteria were initially limited to use of LINX in patient without any of the list precautions/contraindications.  For these reasons, the proposed LINX is not known to be beneficial and would be considered experimental/investigational in this case.