Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Gastroesophageal Reflux.
Treatment: Linx (a sphincter augmentation device) system and full hospital admission (procedure code 43284).
The insurer denied coverage for Linx system and full hospital admission (procedure code 43284).
The denial is overturned

The patient has chronic gastroesophageal reflux. He was on proton pump inhibitor (PPI) therapy but continued to have symptoms. He had a DeMeester score of 45.5

Position statement from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) noted the implementation of the Linx device requires minimal dissection and relatively few technical steps when compared to Nissen fundoplication and that the Linx device may provide an option currently lacking in clinical practice for patients with medically refractory gastroesophageal reflux disease (GERD) who have not yet progressed to end-stage reflux disease with associated complications. The conclusion was that "on the basis of the available evidence, the Linx device should be an option available to patients and providers for the management of medically refractory GERD."
 
"Our experience has revealed that the Linx device can be placed safely in patients with normal or significantly altered anatomy but requires adherence to several key principles and technical points. This procedure offers a new option that is anatomically and physiologically unique compared to standard fundoplication, and that offers highly effective control of GERD with a less invasive approach." (Kuckelman, J. P., et al.).
 
"Magnetic sphincter augmentation (MSA) with the Linx  Reflux Management System (Torax Medical, Maple Grove, MN) was approved in by the FDA. Numerous studies have shown MSA to be safe and effective in the treatment of GERD and an excellent alternative to the classic Nissen fundoplication. [4, 5] Advantages of MSA over a Nissen fundoplication include improved side-effect profile, minimal disruption of anatomy, and reproducibility. [6] MSA augments the resting lower esophageal sphincter pressure, prevents effacement, and reduces gastric reflux. In contrast to the static nature of a fundoplication, the ability of MSA to open dynamically allows for more physiologic transport of food boluses, vomiting, and belching." (Buckley, F. P., 3rd, et al.,).
 
"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." (Zadeh, J., et al.).   

The Linx device is used in patients who continue to have symptoms of gastroesophageal reflux (GERD), such as heartburn and reflux, despite maximum medical therapy and for patients who would be considered candidates for anti-reflux surgery. The Linx Reflux Management System (a sphincter augmentation device) (Torax Medical, Shoreview, MN) is used, according to the Food and Drug Administration (FDA), "to treat gastroesophageal reflux disease (GERD) in patients who continue to have GERD symptoms despite the use of maximum medical therapy for the treatment of their reflux." After review of the clinical records, medical history, and physical examinations, supporting information, Plan provisions, and relevant guidelines and literature, the Linx is likely to be more beneficial than any other standard health service and the risks are not increase over standard therapies.
                                                  
The carrier's denial of Linx system and full hospital admission (procedure code 43284) should be overturned.