Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  GERD
Issue under review:  LINX procedure

Determination:
The health plan should cover the LINX procedure.

The studies of LINX, 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 has been approved by the U.S. 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).

The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device.  At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs, and 11 in patients on PPIs; five years after device placement this score decreased to 4.  All patients used PPIs at baseline; this value decreased to 15.3% at five years.  Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years.  All patients reported the ability to belch and vomit if needed.  The study concluded that MSA with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications.  No new safety risks emerged over a 5-year follow-up period.  These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD.  This study provides the five-year conclusion of the clinical trial NCT00776997.  

The FDA-required five-year follow up 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 is an observational study designed to collect data about anti-reflux surgical treatment options in clinical practice.  This study also tracked the clinical course of patients.  One-year data showed that both MSA and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates.

The patient has symptoms of chronic GERD.  He has been appropriately evaluated with pH study, motility testing, esophagram, and upper endoscopy.  There is confirmed pathologic esophageal acid exposure based on objective pH testing.  There is no contraindicating esophageal motor condition based on the motility testing or esophagram.  Finally, the patient does not have specific contraindication to implantation of the LINX device such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age < 21.

Therefore, based on the status of peer reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA approval, the LINX procedure is medically appropriate in this case and is likely to be health beneficial for his proven condition of GERD.  LINX should not be considered to be experimental or investigational for appropriately selected patients as in this case.