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 past medical history of long standing gastroesophageal reflux disease (GERD), and he was seen in a telemedicine visit for a surgical evaluation to manage his reflux disease. The patient was advised to undergo the Linx procedure as opposed to a fundoplication. The patient returned to the office in a telemedicine visit after an esophagram which confirmed acid reflux. This review is requested to determine the medical necessity of the Linx procedure, and if it is an approvable procedure. 

As per Moore et al. (2016), "Few absolute contraindications to an anti-reflux exist except the presence of esophageal cancer or Barrett's mucosa with untreated high-grade dysplasia. A long-term outcome 5-year follow-up study evaluating anti-reflux surgery in patients with Barrett's esophagus that included patients with low-grade dysplasia, short and long-segment Barrett's showed reflux symptoms were absent in 67 of 85 patients (79%) after surgery [21]. In regards to resolution of Barrett's, low-grade dysplasia regressed to nondysplastic Barrett's in 7 of 16 (44%), and intestinal metaplasia regressed to cardiac mucosa in 9 of 63 (14%). High-grade dysplasia and adenocarcinoma were prevented in all 97 patients [21]." 

As per DeMeester (2017), "Patients with severe gastroesophageal reflux disease (GERD) have several surgical options to manage their reflux burden. Nissen fundoplication, which prevents transient lower esophageal sphincter relaxations, involves a 360-degree wrap around the lower esophageal sphincter, whereas a Toupet fundoplication involves a 180-degree wrap. Both procedures have associated side effects, mainly persistent dysphagia (approximately 2% incidence), postprandial bloating (35%-40% incidence), and the inability to belch or vomit. Efforts to augment the function or competency of a failing sphincter easily and without side effects or the need for extensive alteration of the anatomy have led to the development of several sphincter augmentation devices." 

As there is conflicting documentation regarding the patient's Barrett's esophagus diagnosis, it needs to be clearly demonstrated whether the patient has Barrett's esophagus diagnosis, and supported by documentation. If the patient does not have Barrett's esophagus, then the Linx procedure is an option. However, if the patient does have Barrett's esophagus, then the Linx procedure would not be appropriate. It cannot be stated that this is likely to be more beneficial than any other standard treatment in this clinical scenario. 

The requested esophageal sphincter augmentation device (Procedure code 43284) is not the best available treatment for this patient at this time, since there is conflicting documentation. 

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