Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease (GERD). 
Treatment: Esophageal sphincter augmentation device (Procedure code 43284) and inpatient stay. 

The insurer denied coverage for the esophageal sphincter augmentation device (Procedure code 43284) and inpatient stay.  The denial is upheld. 

This is a male patient with a diagnosis of gastroesophageal reflux disease (GERD), Barrett's esophagus, irritable bowel syndrome and constipation. Per a telemedicine visit with a thoracic surgeon, this was an evaluation as a second opinion. The patient has had Barrett's esophagus and reflux, and has been worked up with endoscopy which showed a small hiatal hernia. The patient's potential of hydrogen (pH) study in the past showed a DeMeester score of 17 while he was on high dose proton pump inhibitor (PPI) therapy. The patient's motility study was normal. The patient's computed tomography (CT) scan of the abdomen showed a moderate to large amount of stool throughout the colon. The patient was seen by a surgeon who recommended Linx, but another surgeon recommended a partial fundoplication. The patient underwent an application for the Linx procedure through his insurance company but initially got denied. The patient was still experiencing persistent GERD symptomatology that has been limiting to his nutritional maintenance and activities of daily living. A follow-up esophagram showed mild GERD. 

Regarding the Linx procedure, there is scientific evidence in peer reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the Food and Drug Administration (FDA). It has been recognized by Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and American Society of General Surgeons (ASGS) as an option for treating GERD. There are long term results out to 5 years with improvement in the health outcomes for patients undergoing the Linx procedure. 

Based on the review of the medical record and literature, it appears that this patient should be a good candidate for the esophageal sphincter augmentation device given the fact that the patient has reflux with a DeMeester score of 17 on ambulatory pH monitoring with a small hiatal hernia. As per UpToDate, eligible patients for the procedure include those with all of the following: Typical GERD symptoms; Abnormal pH study; Partial response to daily PPI therapy; Absence of a large hiatal hernia (>3 centimeters) or severe esophagitis. 

Review of a Televisit with the thoracic surgeon for an opinion regarding treatment of GERD raises an issue regarding a diagnosis of Barrett's esophagus.  It lists "reviewed problems" Barrett's esophagus, onset approximately 2 years prior to the Televisit. A letter notes the patient's history of Barrett's esophagus and reflux. Note that the esophagogastroduodenoscopy (EGD) /biopsy were negative.  The data regarding Barrett's esophagus as a diagnosis are inconsistent. This patient does have indications based upon his condition for an anti-reflux procedure with significant reflux and symptoms which correlated with pH study. However, while literature supports the use of this procedure in a patient with a DeMeester score 17, given the contradictory data provided regarding Barrett's esophagus, further evaluation and clarification of the presence or absence of Barrett's is required prior to the Linx procedure. At this time it cannot be said that this procedure is likely to be more beneficial than any other standard procedure given the question of Barrett's. 

The carrier's denial of the requested esophageal sphincter augmentation device (Procedure code 43284) and inpatient stay should be upheld.