Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)
Treatment: Reflux Management System (LINX)
The insurer denied: Reflux Management System (LINX)
The denial is overturned.

This patient is an adult female (body mass index [BMI] 31 kilograms per meter squared [kg/m2]) who sought surgical evaluation for the symptoms of throat clearing and globus sensation of five-years duration. Symptoms also include frequent cough and regurgitation. The records indicate that the patient is treated for dyspepsia with acid suppressing medications (Dexilant) but does have breakthrough symptoms. There is no reported dysphagia. The patient has been evaluated by an ear, nose and throat (ENT) physician who attributed the symptoms to 
reflux. The patient has also completed a gastroenterology evaluation. The patient has been evaluated for this condition with:
-Upper endoscopy showed no esophagitis and no hiatal hernia. The esophagus was described as normal.
- Contrast upper gastrointestinal (UGI) study showed a small hiatal hernia and no dysmotility. Gastroesophageal reflux was noted during the study.
- Potential of hydrogen (pH) testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a DeMeester score of 22.9 (normal less than [<] 14.7). 
- Esophageal motility testing showed normal esophageal peristalsis. There was no hiatal hernia noted on manometry testing. There was no Chicago Classification abnormality identified.
- Gastric emptying study was normal.
The treating surgeon has proposed the LINX procedure as treatment of gastroesophageal reflux disease. The health plan determination is that the Plan considers LINX to be unproven for the treatment of gastroesophageal reflux disease.

The requested LINX (43284) is medically necessary for this patient.

This treatment is medically necessary for the treatment of pathologic esophageal acid exposure and is not unproven in this case. This treatment is in accordance with generally accepted standards of medical practice, is clinically appropriate and considered effective for the condition being treated. It is not for the convenience of anyone and is the most appropriate care that can be safely provided to this patient. There are randomized controlled trials cited in the references below that support the safety and efficacy of the proposed LINX procedure for this patient (Bell 2019, Bell 2020).
The proposed LINX has been granted Food and Drug Administration (FDA) approval since 2012. It is not the subject of phase I, II or III clinical trials. Based on the volume and quality of 
the peer-reviewed literature cited below, the safety, effectiveness, and effect on health outcomes has been established. Reliable evidence shows that the LINX procedure is safe and effective for the treatment of gastroesophageal reflux disease as is documented to exist in this case. LINX is a 
proven effective therapy for the condition of gastroesophageal reflux disease and is generally recognized by the medical community as effective and appropriate for the specific diagnosis of this patient. This patient has symptomatic gastroesophageal reflux disease. She has completed evaluation with potential of hydrogen (pH) testing, esophagogastroduodenoscopy (EGD), contrast upper gastrointestinal (UGI) study, and esophageal motility testing. These studies confirm that there is pathologic esophageal acid exposure and no alternative diagnosis or contraindication to application of the LINX device. The patient has been appropriately evaluated with esophagogastroduodenoscopy (EGD) that showed a 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 noted on potential of hydrogen (pH) testing.