Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Treatment: Esophageal sphincter augmentation device
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.  
Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is medically necessary and is likely to be more beneficial than any standard treatment or treatments for the patient'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.
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 Society of American Gastrointestinal and Endoscopic Surgeons (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. At baseline, the median GERD-HRQL scores were 27 in patients not taking proton pump inhibitors (PPIs) and 11 in patients on PPIs; five years after device placement this score decreased to four. 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 five 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 five-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. [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.    
The patient has symptoms of chronic GERD.  He has been appropriately evaluated with pH study, motility testing 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 the motility testing.  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.