Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for laparoscopy implantation of the LINX Reflux Management System. Findings:  The physician reviewer found that the patient is with gastroesophageal reflux disease (GERD). The patient also has asthma per the patient history questionnaire.  The provider progress note reported a history of reflux, heartburn, and lower gastrointestinal bleeding. Abdominal ultrasound  was normal.  Endoscopy with biopsies showed gastritis but was otherwise normal.  Bravo pH study showed elevated acid exposure. Esophagram  was normal. Per the provider note, the patient does not want to be on medication for acid reflux long-term. The patient has requested authorization and coverage for the laparoscopic implantation of the LINX Reflux Management System for treatment of GERD. The Health Plan has denied the requested procedure as investigational for treatment of the patients GERD. There is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other standard surgical anti-reflux procedures. One evidence review 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 one 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 since the U.S. Food and Drug Administrations (FDA) approval. A peer-reviewed journal published a letter stating that there are 11 reports of endoscopically-confirmed LINX erosion through the esophagus in the publically-accessible FDA adverse events database. Additionally, LINX is associated with severe dysphagia requiring endoscopic intervention. The available peer-reviewed literature does not definitively support the conclusion that LINX is likely to be more beneficial in this case than standard treatment of surgical fundoplication. Moreover, the American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. Based on the available literature and relevant clinical guidelines, laparoscopic implantation of the LINX Reflux Management System for treatment of this patients GERD is not likely to be more effective than other treatment options.Final Result: The reviewers determined that the requested procedure is 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 reviewers  number 1,2 & 3 are 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.