Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Gastroesophageal reflux disease.
Treatment:  LINX procedure (reflux management system).

The insurer denied coverage for the LINX procedure (reflux management system).  The denial is overturned. 

This is a male patient with a diagnosis of gastroesophageal reflux disease (GERD). The patient is being treated for his condition.  He presented to his provider's office with a small 2.2 centimeter (cm) Zenker's diverticulum with a 13 millimeter (mm) barium tablet passing from mouth to stomach without delay. The patient's esophagram showed a thickened cricopharyngeal bar.  Motility testing confirmed esophageal sphincter and lower esophageal sphincter relaxation.  The provider noted that endoscopy showed no endoscopic esophageal abnormality to explain for the patient's dysphagia; a small hiatal hernia was present. The patient noted his symptoms included dysphagia to certain solid foods. The patient had a Heimlich performed in the past. He takes pantoprazole twice daily. The recommendation was to perform a sphincter augmentation procedure to the lower the esophageal sphincter prior to performing a myotomy of the upper esophageal sphincter.  It was also documented that cutting the muscle to the upper esophageal sphincter with a diverticulotomy without reinforcing the lower esophageal sphincter would place the patient at risk for aspiration pneumonia and Zenker's recurrence. The provider felt that the upper esophageal sphincter was much thickened, and this was likely on the basis of chronic reflux especially with a small hiatal hernia. The provider also noted that the patient needed potential of hydrogen (pH) testing to confirm acid reflux. 

A telemedicine visit was done with the provider where it was noted that the patient complained of dysphagia with increasing bouts of choking.  The patient discussed the risks, benefits, alternatives and indications of the LINX procedure.  A Bravo pH test was to be done. The patient was seen again at a follow-up visit where he continued to indicate his interest in the robotic-assisted LINX (magnetic sphincter augmentation) procedure to treat his condition. The patient's upper gastrointestinal endoscopy showed a 3 centimeter (cm) hiatal hernia, diverticulum at the cricopharyngeus, and a normal stomach; a Bravo pH capsule was placed. The patient's Bravo pH study revealed a DeMeester score of 36.4. The patient's esophagram revealed cricopharyngeal hypertrophy with a moderate size contrast retaining Zenker's diverticulum with no reflux noted with contrast readily passing from the mouth to the stomach without obstruction or delay with normal motility to the esophagus.

As per literature review, there is scientific evidence in peer reviewed literature to support and substantiate the LINX (magnetic sphincter augmentation (MSA)) procedure's 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 the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Society of General Surgeons (ASGS) as an option for treating this patient's condition, GERD.  

In this case scenario, the LINX (magnetic sphincter augmentation (MSA)) may well be the best available treatment for this patient as this patient has GERD with a DeMeester score of 36 and does require treatment. It is the least invasive and would provide durable results for this patient. The LINX procedure offers several advantages over the fundoplication approach; the fundus wrap is extremely invasive and is non-reversible; the fundoplication often leaves the patient with the inability to vomit and vent their stomach

The LINX procedure (reflux management system) is likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of the LINX procedure (reflux management system) should be overturned.