Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is overturned.

This is a male patient (body mass index (BMI) 27.5 kilograms per square meter (kg/m2)) who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The surgical history and physical states that the patient has had symptoms of heartburn for many years. He also has symptoms of globus, shortness of breath and voice hoarseness. He has occasional regurgitation. He has been treated with Nexium, Dexilant, and Protonix. Despite this, he continues to have breakthrough symptoms. He denies dysphagia. He was diagnosed with osteopenia due to chronic use of proton pump inhibitor (PPI) medications. The patient was evaluated due to ongoing symptoms.
An esophagogastroduodenoscopy (EGD) showed no hiatal hernia. There was no esophagitis. The actual EGD report states that the esophagus was normal with no evidence of erosive esophagitis, mass, stricture, or Barrett's.
Potential hydrogen (pH) testing showed pathologic esophageal acid exposure with a DeMeester score of 36.8 (normal less than 14.7) An esophagram showed a small hiatal hernia. There was gastroesophageal reflux during the study. Esophageal motility showed 10 percent (%) of swallows had failed peristalsis. The manometric diagnosis was that of normal esophageal motility.
The treating surgeon has proposed the LINX procedure as treatment of GERD. At issue is whether the LINX procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Yes. 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, globus, shortness of breath and voice hoarseness, regurgitation, but no dysphagia). He has been appropriately evaluated with an esophagogastroduodenoscopy (EGD) that showed no hiatal hernia without mention of 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 36.8, normal is less than 14.7). Finally, 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.
Therefore, based on the status of peer reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA approval, the LINX procedure is likely to be more beneficial than standard therapy in this case.
Based on the submitted history and diagnostic test results, an Anti-reflux procedure is warranted in this case. 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, there is an absence of equally effective alternative therapy.