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 a history of dysphagia.  The patient has been found to have a Zenker's diverticulum, small hiatal hernia and reflux. The patient's DeMeester score is more than 35.  The patient's manometry was normal in the lower esophageal sphincter.  The patient takes proton-pump inhibitors (PPI) twice a day without improvement of symptoms.  The request for LINX (magnetic sphincter augmentation (MSA)) has been made.

The scientific evidence in peer reviewed literature does support a result of improvement in health outcome.  The literature shows that LINX is safe and effective for patients with small hiatal hernias, no Barrett's esophagus and no Los Angeles (LA) Classification System grade C or D esophagitis.  The LINX is approved by the Food and Drug Administration (FDA) and was not shown to be experimental.  Results of current medical literature show that LINX is an acceptable alternative to the Nissen Fundoplication and may have less side effects.  Patients receiving LINX show cessation of proton-pump inhibitor (PPI) use and preserved ability to belch and vomit when compared to Nissen Fundoplication.  Therefore, there is an improvement in health outcome.

Per Bonavina et al., "This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of [magnetic sphincter augmentation (MSA)] and [Laparoscopic Fundoplication (LF)].  Despite the more severe nature of [gastroesophageal reflux disease (GERD)] in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint."      

As per Nikolic et al., "Although preoperative [ineffective esophageal motility (IEM)] has an influence on [gastroesophageal reflux disease (GERD)] presentation, it has no effect on postoperative outcome after [Laparoscopic Nissen Fundoplication (LNF)]. IEM should not be a cause for avoiding LNF, as is has been shown as the most effective and safe anti-reflux treatment." As per Nikolic et al., "LNF is a safe and effective surgical procedure with low postoperative morbidity rates and efficient GERD-related symptom relief. Persistent Dysphagia (PD) does not represent a relevant clinical issue when LNF is performed in a surgical standardized way."                 

The available peer reviewed literature shows that LINX is as safe and effective as the Nissen Fundoplication.  The LINX preserves the ability to vomit in the patient.  Similar decreases in PPI use, symptom resolution, and ability to belch are seen.  LINX also has a shorter operative time. However, in this case the patient has a history of dysphagia.  The use of LINX in patients with a history of dysphagia is not well-established.  Thus, this patient is not a good candidate for the LINX procedure.   

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.