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 upheld. 

This is a male patient with gastroesophageal reflux disease (GERD).  At an office visit, it was noted that he has a small 2.2 centimeter Zenker's diverticulum. A 13 millimeter barium tablet passed from his mouth to the stomach without delay.  His esophagogram showed a thickened cricopharyngeal bar.  Motility testing confirmed upper esophageal sphincter and lower esophageal sphincter relaxation.  His endoscopy showed no endoscopic abnormality to explain the patient's dysphagia.  A small hiatal hernia was present. His symptoms included dysphagia to certain solid foods.  The attending provider is planning to perform the LINX procedure for the treatment of the patient's GERD.  The esophagogastroduodenoscopy (EGD) showed a 3 centimeter hiatal hernia.  The patient's Bravo testing showed a DeMeester score of 36.4.

AS per Sheu et al., "The LINX device is a safe, well tolerated, and effective therapy for [gastroesophageal reflux disease (GERD)] in the short term. [Magnetic sphincter augmentation (MSA)] should be considered for selected GERD patients without significant anatomic or motility defects. However, the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined."      

As per Skubleny et al., "Magnetic sphincter augmentation appears to be an effective treatment for GERD with short-term outcomes comparable to the more technically challenging and time-consuming Nissen fundoplication. Long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation."                                                    

The scientific evidence available for the LINX device is composed by a large retrospective study and a few prospective studies including small number of patients.  The use of the LINX procedure is not the subject of an ongoing clinical trial for this patient's condition.  The clinical trial and investigation on the safety and effectiveness of the LINX Reflux Management System in the treatment of GERD was completed and is now closed.  There is no other open ongoing trial. However, there is a lack of randomized clinical trials comparing the LINX procedure with the laparoscopic fundoplication which is the current standard of care for the treatment of patients with GERD.  The LINX procedure has not been compared in a well-designed Randomized Controlled Trials (RCT) to the laparoscopic fundoplication.

In this case, the patient has documented dysphagia.  This condition represents a relative contraindication to the LINX procedure as shown in the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommendations and consensus guidelines for the application of the LINX procedure into clinical practice. According to SAGES, "The safety and effectiveness of the LINX device has not been evaluated in patients with dysphagia and hernia of 3 cm [centimeters] or greater." Therefore, this patient is not a good candidate for the LINX procedure. Furthermore, the clinical evidence published in the peer-reviewed literature is insufficient to permit conclusions concerning the effect of this procedure on net health outcomes.  In conclusion, despite early favorable results, the LINX procedure has not been shown to clinically improve the net health outcome of patients with GERD in well-designed comparison with the laparoscopic fundoplication.  The best option for the patient is to undergo a laparoscopic fundoplication.     
  
The LINX procedure (reflux management system) is not 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 upheld.