Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:An enrollee has requested authorization and coverage for the LINX Reflux Management System or the treatment of the enrollees gastroesophageal reflux disease (GERD).Findings:  The physician reviewer found that There is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Sheu and colleagues in Current Opinion in Gastroenterology, concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. Another best evidence review concluded that long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation. Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration approval. One peer reviewed journal published a letter stating that there are 11 reports of endoscopically confirmed LINX erosion through the esophagus in the U.S. Food and Drug Administration (FDA) Adverse Events database. Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention. The currently available peer reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial than standard treatment, surgical fundoplication. The American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. All told, LINX Reflux Management System is not likely to be more efficacious than the available treatment options for treatment of this patients medical condition. Final Result: The reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.