Appeal type: Experimental/Investigational
Decision: Upheld

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

This patient sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). Her symptoms include bloating and regurgitation. She is treated with twice daily Pantoprazole for reflux symptoms, but has breakthrough symptoms. The patient has had a prior arcuate ligament repair (presumably for celiac artery compression syndrome). The patient was evaluated with the following diagnostics.
An esophagram showed reflux to the level of the clavicles, a small hiatal hernia and delayed gastric emptying consistent with gastroparesis (a gastric emptying study was requested to further evaluate this condition to assess for the possibility of vagal nerve injury per the surgical note).
An esophagogastroduodenoscopy (EGD) identified a normal esophagus, gastroesophageal junction and stomach. There was no metaplasia on biopsy.
Potential hydrogen (pH) testing was performed while off acid suppressing medication and showed a DeMeester score of 36.2 (normal less than [<] 14.7).
Esophageal manometry testing showed normal peristaltic pressures. All swallows were peristaltic and distal contractile integral was normal.
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.

Based on the current evidence-based literature and the patient-specific objective clinical evaluation submitted in this case, it cannot be said that the LINX procedure is likely to be more beneficial than any standard treatment for the insured's reported condition of GERD.
The records indicate that this patient has had a prior arcuate ligament repair (presumably for celiac artery compression syndrome). An esophagram showed reflux to the level of the clavicles, a small hiatal hernia and delayed gastric emptying consistent with gastroparesis. The surgical note states that a gastric emptying study was requested to further evaluate this condition to assess for the possibility of vagal nerve injury. However, the records do not include the results of this gastric emptying study. A diagnosis of gastroparesis would confound the diagnostic results of the pH study and would be an alternative diagnosis that would preclude application of the LINX magnetic sphincter augmentation device.
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 in specific clinical circumstances. 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.
However, in this case, the patient does have a specific contraindication to implantation of the LINX device as she has had prior gastric surgery and possibly has the diagnosis of gastroparesis.
Specific precautions/contraindications per the manufacturer to implantation of the LINX device 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:
1)	Scleroderma
2)	Suspected or confirmed esophageal or gastric cancer
3)	Prior esophageal or gastric surgery or endoscopic intervention
4)	Distal esophageal motility less than 35 millimeters of mercury (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 lower esophageal sphincter (LES)
5)	Symptoms of dysphagia more than once per week within the last 3 months
6)	Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, hiatal hernia, etc.)
7)	Esophageal or gastric varices
8)	Lactating, pregnant or plan to become pregnant
9)	Morbid obesity (BMI greater than [>] 35)
10)	Age less than (<) 21

While the body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation for the diagnosis of GERD in specific clinical circumstances, LINX is not a proven therapy in the setting of prior arcuate ligament surgery, possible vagal nerve injury or possible gastroparesis.
While LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the United States (U.S.) Food and Drug Administration (FDA) to be lawfully marketed for the treatment of GERD since 2012 and is not subject to review and approval by any institutional review board for the proposed use. The listed indications and applications for LINX do not include use after prior esophagogastric surgery (arcuate ligament surgery) or possible alternative diagnoses such as gastroparesis.