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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the LINX Reflux Management System for treatment of the enrollees gastroesophageal reflux disease (GERD). Findings:  2/3 of the physician reviewers found that in the medical literature, colleagues noted that sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on proton pump inhibitors, with minimal side effects. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. The LINX device has also received U.S. Food and Drug Administration (FDA) premarket approval for patients with diagnosed GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. Two post-approval studies are designed to evaluate the long-term effectiveness of the device and incidence of adverse events. Appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD, it is critical to document the presence of abnormal distal esophageal acid exposure, especially when anti-reflux surgery is considered, and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. The patient has undergone some of this pre-operative assessment. However, while this patient may report dyspeptic-sounding symptoms, the available records do not support a diagnosis of refractory acid reflux as the patients pH recording demonstrated normal DeMeester scores off acid suppression therapy. Since this patient does not meet the accepted indications for the device, the requested LINX Reflux Management System is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: 2/3 of 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 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.