Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Treatment: LINX Reflux Management System
Based on the submitted clinical records and the body of published peer reviewed literature, the health plan should cover the proposed LINX procedure in this case.

The LINX Reflux Management System is likely to be more beneficial.

Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is medically appropriate and is likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.

The LINX procedure is a minimally invasive procedure for the treatment of GERD, and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure.  There has been completion of ongoing clinical trials NCT00776997 and NCT01624506 that provide the necessary long term follow up regarding LINX.  These studies, in conjunction with previously published data, support the long-term safety and efficacy of the LINX and reinforce that this procedure has withstood appropriate scrutiny and should be included in the armamentarium of proven-effective therapy for the treatment of GERD in selected patients.

LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use since 2012.  LINX is not subject to review and approval by any institutional review board for the proposed use.  LINX is not the subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication) with less incidence of inability to belch or vomit (as can be associated with fundoplication).

Since the SAGES Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to five years post implantation.  The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device... These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. This study provides the 5-year conclusion of the clinical trial NCT00776997. [Ganz et al, 2015]  The FDA-required five-year follow up of 100 patients from the investigational device exemption pivotal study has been completed and supports the safety and efficacy of the procedure.  

Clinical trial NCT01624506 is an Anti-Reflux Surgical Study that... One-year data showed that both MSA and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates.  [Riegler M, et al, 2015]

Reynolds et al... concluded that the results support the use of MSA as first-line therapy in patients with mild to moderate GERD. Finally, The American Society of General Surgeons has released a position statement that supports the inclusion of the LINX procedure into the armamentarium of treatment options for appropriately selected patients with GERD.  

The patient has symptoms of chronic GERD.  She has been appropriately evaluated with pH study, esophagram and upper endoscopy.  There is confirmed pathologic esophageal acid exposure based on objective 48-hour pH testing.  There is no contraindicating esophageal motor condition based on motility testing.  Finally, the patient does not have specific contraindication to implantation of the LINX device.

 LINX should not be considered to be experimental or investigational for appropriately selected patients as in this case.