Linx Reflux Management System denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a LINX procedure. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollee’s gastroesophageal reflux disease (GERD). Magnetic sphincter augmentation (MSA) is performed using the LINX Reflux Management System, a device that treats GERD by augmenting the lower esophageal sphincter using magnets. Status post MSA, nearly all patients will cease PPIs and only 10-15% of patients will restart PPIs at mid-term follow-up. One long-term study revealed freedom from long-term GERD medications in 79% of MSA patients. Additionally, MSA has demonstrated reduced distal esophageal acid exposure, which correlates with improvement in heartburn and regurgitation symptoms.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for LINX reflux management system. The request for LINX reflux management system is supported in this case. The records indicate that the patient presents with evidence of increased esophageal reflux and persistent symptoms of gastroesophageal reflux disease (GERD). The patient has failed treatment with medical therapy at standard doses. LINX is effective for the treatment of GERD. The standard surgical alternative, Nissen fundoplication, can be associated with complications in patients who become pregnant and limitation of vomiting, which can become an issue during pregnancy. Notably, LINX is not associated with vomiting limitations. In this patient of childbearing age and in whom future pregnancy is possible, LINX is more appropriate than Nissen fundoplication.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the LINX Reflux Management System for treatment of the enrollee’s 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.

Nature of Statutory Criteria/Case Summary:An enrollee has requested authorization and coverage for the LINX Reflux Management System or the treatment of the enrollee’s 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.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Linx Reflux Management System, then check the rights and deadlines that apply to your plan.