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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for laparoscopic anti-reflux surgery utilizing the LINX Reflux Management System.Findings: Two out of three physician reviewers found that the requested laparoscopic anti-reflux surgery utilizing the LINX Reflux Management System is not likely to be more beneficial than any available standard treatment for the patients medical condition.Researchers conducted a controlled clinical trial and concluded 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 PPIs, with minimal side effects and no safety issues. They concluded that patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. The LINX Reflux Management System received U.S. Food and Drug Administration (FDA) Premarket Approval on 3/22/12. The FDA approval states that the device is indicated for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.Researchers performed a study in order to construct an evidence and experience-based consensus regarding appropriate preoperative evaluation for antireflux surgery. They noted that while antireflux surgery may be an excellent option for some patients, proper patient selection is critical to achieve excellent outcomes. They found that 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. They stated that each testing modality has a specific role in the diagnosis and workup of GERD, and no single test alone can provide the entire clinical picture. The results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. They concluded that upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery.In this case, the submitted documentation supports that the patient has gastroesophageal reflux, the symptoms of which have at least partially benefited from unspecified acid suppression treatment. As such, the patient cannot be considered refractory to medical therapy. The submitted records do not support LINX implantation in lieu of maximized medical therapy, improved lifestyle, and a diet aimed at GERD management. While LINX implantation may be medically appropriate in selected patients with GERD, the patients available records do not support at this time that LINX implantation is appropriate in lieu of conventional medical management, nor that the patients pre-operative assessment has been appropriately completed to warrant the risks of surgical augmentation of his lower esophageal sphincter. Accordingly, the requested laparoscopic anti-reflux surgery utilizing the LINX Reflux Management System is not likely to be more beneficial than any available standard treatment for the patients medical condition.Final Result: The reviewers determined that the requested services are not likely to be more beneficial than any available standard treatment for the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine, with subspecialty certification in gastroenterology, and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and are knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.