Appeal type: Experimental/Investigational
Decision: Overturned

Digestive System/Gastrointestinal
Surgical Services (All)

Diagnosis: Gastroesophageal Reflux Disease
Treatment: LINX procedure
The insurer denied the LINX procedure.
The health plan's determination is overturned. 

This patient is a male (body mass index (BMI) 31 kilograms per meters squared (kg/m2)) who sought surgical evaluation follow up for the condition of gastroesophageal reflux disease (GERD). The surgical history and physical (H&P) states that the patient has had symptoms of heartburn and hoarseness. He has been treated with Omeprazole. Despite this, he continues to have breakthrough symptoms. He denies dysphagia. He was previously evaluated for his reflux symptoms and was found to be an acceptable candidate for LINX magnetic sphincter augmentation but was unable to proceed with surgery due to the onset of the Coronavirus (COVID) pandemic. The patient was evaluated due to ongoing symptoms.
The EGD showed a 3 centimeter (cm) hiatal hernia. There was esophagitis. The potential hydrogen (pH) testing showed pathologic esophageal acid exposure with a composite DeMeester score of 20.1 (normal is less than (<) 14.7). Esophageal motility showed normal esophageal peristalsis and normal distal contractile integral. There was no manometrically detected hiatal hernia. The manometric diagnosis was that of normal esophageal motility.

Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is likely to be more beneficial than standard treatment for the insured's condition of GERD. The patient has symptoms of chronic GERD (heartburn, voice hoarseness, but no dysphagia). He has been appropriately evaluated with EGD that showed esophagitis. There is no contraindicating esophageal motor condition based on the esophageal motility study. There is confirmed pathologic esophageal acid exposure with elevated esophageal acid exposure (composite DeMeester score of 20.1, normal is < 14.7). The patient does not have specific precaution to implantation of the LINX device 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, or morbid obesity.
The LINX procedure is a minimally invasive procedure for the treatment of GERD and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure. There has been completion of ongoing clinical trials, National Clinical Trial (NCT)00776997 and NCT01624506 that provide the necessary long term follow up regarding LINX. These studies, in conjunction with previously published data, support the long-term safety and efficacy of the LINX and reinforce that this procedure has withstood appropriate scrutiny and should be included in the armamentarium of proven-effective therapy for the treatment of GERD in selected patients.
 
Based on the submitted history and diagnostic test results, an antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure. The LINX procedure offers benefits over traditional surgical fundoplication with equivalent reduction in esophageal acid exposure with preservation of the ability to belch/vomit. LINX offers improved symptom control compared to ongoing medicinal therapy with reduction in need for anti-acid medications and reduction in regurgitation. For these reasons, LINX is likely to be more beneficial than any standard treatment for this patient.