Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease/GERD
Treatment: LINX Procedure
The health plan denied: LINX Procedure
The determination is: Upheld

The patient is a male (body mass index [BMI] 30.1) who sought surgical evaluation for symptoms of choking and reported dysphagia with the sensation of food sticking in the proximal esophagus. He is prescribed Proton-pump inhibitor (PPI) medication for symptom control (Dexilant), but he has refractory symptoms. He has used Protonix and famotidine in the past for reflux symptoms. The patient was evaluated with the following diagnostics.
An esophagram showed normal esophageal motility. There was no hiatal hernia and no reflux noted during the study. There was an oropharyngeal diverticulum. An esophagogastroduodenoscopy (EGD) identified grade A esophagitis at the gastroesophageal junction and no hiatal hernia. Potential hydrogen (pH) testing was performed while off acid suppressing medication and showed a DeMeester score of 26.8 (normal less than 14.7) over 4-days of study. Esophageal manometry testing was unable to be completed due to patient intolerance. A computed tomography (CT) scan identified multiple enlarged cervical lymph nodes.
The treating surgeon has proposed the LINX procedure as treatment of gastroesophageal reflux disease (GERD). The health plan has denied this treatment based on the contention that LINX is experimental/investigational.
The health plan's determination regarding the proposed health service or treatment is upheld in whole.
No. Based on the submitted clinical documentation, it cannot be said that the proposed LINX procedure will be more beneficial than any standard treatment for the insured's life threatening or disabling condition or disease.
This patient's primary symptoms per the surgical consultation are choking and reported dysphagia with the sensation of food sticking in the proximal esophagus. The surgical consultation specifically does not indicate symptoms of heartburn or regurgitation. The CT scan identified multiple enlarged cervical lymph nodes. The etiology of these CT findings is not included in the submitted review material. The esophagram does not assess the esophageal motility, and the patient did not tolerate the esophageal motility study. Consequently, there is no objective assessment of esophageal function in this patient with the primary complaint of dysphagia.
While LINX is a proven therapy for the specific group of patients with proven pathologic esophageal acid exposure, preserved esophageal motility, and no contraindication to application of the LINX device, in this case the patient does have specific contraindications to implantation of the LINX device.
The manufacturer listed precautions/contraindications to LINX include conditions such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture, or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age less than 21.
In this case, the patient has the primary complaint of dysphagia, and he has not had an objective assessment of esophageal motor function. Additionally, he has the CT finding of multiple enlarged cervical lymph nodes, the etiology of which is uncertain based on the submitted medical records. Therefore, LINX is not known to be more beneficial for this patient's condition.