Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Gastroesophageal Reflux Disease (GERD)

Treatment: LINX procedure

The insurer denied coverage for Linx procedure

The denial is overturned

This is the case of a male who has a history of GERD. According to the thoracic surgeon's note, the patient had previously been seen for consideration for the Linx system. Workup thus far included a Demeester score of 71. Endoscopy showed no evidence of malignancy. Erosive esophagitis was seen. Esophagram showed severe reflux to the level of the clavicles. There was a tiny hiatal hernia. Normal esophageal motility with 92% (percent) of the swallows completely cleared the bolus. The physician discussed treatment options including robotic assisted Linx procedure or robotic assisted fundoplication with hiatal hernia repair. The patient was more interested in the Linx procedure.

There is scientific evidence in peer reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the FDA (Food and Drug Administration). It has been recognized by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) and ASGS (American Society of General Surgeons) as an option for treating GERD. There are long term results out to 5 years with improvement in the health outcomes for patients undergoing the Linx procedure. In terms of the actual literature one can find numerous articles that document the efficacy of the Linx. 

Sterris et al noted "Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons" in Curr Opin Gastroenterol that  "MSA is a safe and efficacious procedure originally approved for patients with medically refractory, uncomplicated gastroesophageal reflux disease. The accumulating body of evidence suggests patients with intestinal metaplasia or hiatal hernias can safely and effectively undergo MSA, whereas further research will be required before MSA is widely used for post-bariatric patients or for patients requiring a transthoracic surgical approach. MSA is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far."

Therefore, the Linx procedure can improve health outcomes and the insurer is wrong to claim that it is investigational as it does improve health outcomes as there is considerable literature to support this. 

This procedure is FDA approved.
It appears that this patient is a good candidate for this device given the fact that the patient has Demeester score of 71 with symptom associated probability of 100% with severe reflux. Thus, the patient does have indications based upon his condition with persistent symptoms. 

The Linx is a good available treatment for this patient as this patient has GERD with a Demeester score of 71 and does require treatment. It is the least invasive and would provide durable results for this patient and as noted by the provider he is a good candidate fort the Linx. There is no reason to do a very invasive procedure such as a Nissan fundoplication when one can get a durable result with the Linx. The Linx offers several advantages over the fundoplication approach; the fundus wrap is extremely invasive and is non-reversible; the fundoplication often leaves the patient with the inability to vomit and vent their stomach. 

The adverse risks are not increased over standard treatment services as this procedure is less invasive that the standard fundoplication.

Thus, the Linx should be considered as good as a treatment modality as the gold standard which is fundoplication for this patient, and the Linx could be as beneficial for this patient as the standard treatment as it is less invasive.

The requested service is likely to be more beneficial than any of the standard treatments/ procedures for this patient.

The carrier's denial of the Linx procedure should be overturned.