Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal/Gastroesophageal Reflux Disease/GERD
Treatment: Surgical Services (All)
The health plan denied the requested LINX service.
The health plan's determination is overturned.

This is a patient with a history of asthma and gastroesophageal reflux disease (GERD) who is presently on a proton pump inhibitor (PPI) daily with occasional breakthrough. Reflux monitoring showed a Demeester score of 38.0. An esophagogastroduodenoscopy (EGD) revealed no esophagitis and a small hiatal hernia. High resolution esophageal motility study showed no Chicago class abnormalities. The patient's body mass index (BMI) is 24.96. A LINX procedure has been recommended.
At issue is whether the proposed health service or treatment of the LINX Reflux Management System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I overturn, in whole, the health plan's determination regarding the proposed health service or treatment.

Yes. The proposed health service or treatment LINX Reflux Management System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The LINX device was approved by the Food and Drug Administration (FDA) in early 2012 and is currently the only medical device approved by the FDA to be safe and effective for the treatment of gastroesophageal reflux disease (GERD). Ganz and colleagues, in a single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, concluded that exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Post approval studies to monitor safety of the device during clinical use have been done. LINX is indicated for patients with GERD as defined as abnormal potential hydrogen (pH) testing and who are seeking an alternative to acid suppression therapy (i.e., PPIs) in the management of their disease.
The procedure is a minimally invasive procedure that restores their esophageal sphincter without side effects. Advantages of the LINX procedure over the traditional fundoplication while still reducing reflux symptoms, acid exposure, and dependence on medications include: 1. anatomy is left as intact and undisturbed as possible while still accomplishing sphincter reconstruction that is safe and effective (fundus wrap is invasive and a permanent modification); 2. fundoplication may not allow the patient to vomit or vent their stomach (LINX trials indicate that these patients are able to vomit and belch); 3. failures after the Nissen fundoplication usually occur within 2 years after the procedure (2 year reoperation rates are up to 15% with over 27% cumulative failure rates at 10 years.) After several years of clinical application, the LINX device has been shown to not only be effective for the management of GERD but also be as effective as fundoplication. With respect to safety, the most common complication of MSA is dysphagia. This often resolved without intervention, but esophageal dilation or device explanation are occasionally necessary. Not fully appreciated in earlier reviews, erosion of the device into the esophagus appears to be the most significant complication of the device after extended follow-up. While very rare, the potentially severe consequences of this phenomenon suggest that the device should be used with some restraint and that patients should be made aware of this potential morbidity. Fortunately, in the few cases of device erosion described in the literature reviewed, the LINX device was easily and safely removed.