Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Heartburn. 
Treatment: LINX Procedure (code 43284). 

The insurer denied: LINX Procedure (code 43284). 
The denial is overturned. 

The patient is an adult male with BMI (body mass index) of 21. He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease), with symptoms of heartburn and coughing of 10-years duration. He has been treated with prescription medications (Dexilant) with refractory symptoms. He has no reported symptoms of dysphagia. The patient has been evaluated for this condition with the following:
EGD (esophagogastroduodenoscopy) showed a small hiatal hernia. There was significant esophagitis without dysplasia/metaplasia.
pH (potential of hydrogen) study that showed elevated DeMeester scores on each of the three days of the study (53, 18, 51) (normal greater than 14.7). 
Esophageal motility testing showed normal esophageal peristalsis with 90% normal contractility.
Esophagram showed no hiatal hernia and normal esophageal motility during the study.
The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease). The health plan rationale for denial is that the LINX procedure is considered to be investigational by the Plan. The denial is being appealed.

The health plan should cover the requested LINX procedure.

Based on the submitted clinical records and the body of published peer reviewed literature, the health plan should cover the requested LINX procedure as a medically appropriate treatment of GERD (gastroesophageal reflux disease). This patient with GERD (gastroesophageal reflux disease) who has successfully completed a comprehensive evaluation that establishes the diagnosis of pathologic esophageal acid exposure, preserved esophageal motility and no alternative diagnosis. 
The LINX procedure is medically appropriate and is likely to be more beneficial for the patient's condition or disease. 

The LINX procedure is a minimally invasive procedure for the treatment of GERD (gastroesophageal reflux disease), 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 NCT00776997 (10) and NCT01624506 (13), which provide the necessary long term follow up regarding LINX. These studies 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 (Gastroesophageal Reflux Disease) in selected patients.
LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use since 2012. Since the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to 5-years post implantation. The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device. 
The American Society of General Surgeons has released a position statement that supports the inclusion of the LINX procedure into the armamentarium of treatment options for appropriately selected patients with GERD (gastroesophageal reflux disease). 
The patient has symptoms of chronic GERD (gastroesophageal reflux disease). He has been appropriately evaluated with pH study, motility testing, esophagram, and upper endoscopy. There is confirmed pathologic esophageal acid exposure based on objective pH testing. Standard of care treatment options include ongoing medicinal treatment, laparoscopic Nissen fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure. 
There are not equally effective treatments for GERD (gastroesophageal reflux disease) as in this case.