Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: Linx Reflux Management System.

The insurer denied coverage for Linx Reflux Management System.
The denial is overturned.

According to the documentation submitted this is the case of a male with a history of gastroesophageal reflux disorder (GERD). The patient had had symptomatic reflux at an early age and has been treated with Proton Pump Inhibitor (PPI) for that duration. He has significant daily heartburn despite medication progressively worsening regurgitation requiring bed wedge. The regurgitation is almost nightly and causes him significant loss of sleep as well as vitality the following day at work. His body mass index (BMI) was 24.53. He noted that esophagogastroduodenoscopy (EGD) showed reflux esophagitis. Barium swallow was normal. Esophageal manometry was normal. 48-hour ambulatory pH (potential of hydrogen) study was abnormal with one of the 2 days with Demeester score of 20.8 with normal less than 14 and good symptom associated probability. The plan was laparoscopic Linx placement.

Esophagram showed normal esophagus with normal motility without evidence of hernia or obstruction.

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 for Gastrointestinal Endoscopy) 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. 

This procedure is FDA approved.

It appears that this patient is a reasonably good candidate for this device given the fact that the patient has reflux with a total Demeester score of 13.9 with symptom associated probability of 75.1 with the breakdown of a Demeester score of 0.8 on day 1 but on day 2 was a Demeester score of 20.8. The interpretation was increased acid exposure only on the second day of the study without significant symptom correlation. However, it should be recognized that symptom association is not a strong predictor- rather the acid exposure is more significant. Thus, the patient does have indications based upon his condition with persistent symptoms despite being on PPI therapy and the indication of excess pH on the ambulatory pH study with a Demeester score of 20. 

In this case scenario the Linx may be a good available treatment for this patient as this patient has GERD with a Demeester score of 20 on day 2 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.

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

Therefore, based upon the records the insurer is incorrect in denying requested esophageal sphincter augmentation device as experimental, as the procedure has been established for this type of patient with GERD. To do a fundoplication in this young patient would be too dramatic of an option to help this patient at this time. 

The carrier's denial of Linx Reflux Management System should be overturned.