Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease).

Treatment: procedure code 43284, surgery to place an esophageal sphincter augmentation device.

The insurer denied coverage for procedure code 43284, surgery to place an esophageal sphincter augmentation device.

The denial is overturned.

According to the documentation submitted this is the case of male who has a history of GERD. According to the telemedicine visit with the thoracic surgeon, the patient takes Nexium, Carafate and famotidine with little relief of GERD symptoms. The surgeon noted that endoscopy showed a small hiatal hernia. Pathology showed no evidence of Barrett's esophagus. Further workup included pH (potential of hydrogen) study which showed a Demeester score of 17 while on high dose acid suppressive therapy. Manometry showed normal motility. Esophagram showed gastroesophageal reflux disease with very small hiatal hernia. Unfortunately, the patient has been denied a robotic assisted lap LINX procedure with hiatal hernia repair.

The esophageal pH and impedance monitoring study showed a Demeester score of 17.3. The impression was abnormal acid reflux study for such high dose PPI (proton pump inhibitor) blocker.  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 with improvement in the health outcomes for patients undergoing the Linx procedure. In terms of the actual literature one can find numerous even recent articles that document the efficacy of the Linx. For example, Ayazi et al. reported on the "Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients" 

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 17 with symptom associated probability of 100%. Thus, the patient does have indications based upon his condition with persistent symptoms. 

The reviewer does believe that in this case scenario the LINX is a good available treatment for this patient as this patient has GERD with a Demeester score of 17 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 for 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 especially for this patient. 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 than the standard fundoplication.

The LINX should not be considered investigational. The LINX should be considered as good as a treatment modality as the gold standard which is fundoplication for this patient. Denial for the procedure in this case is therefore overturned.

The carrier's denial of procedure code 43284, surgery to place an esophageal sphincter augmentation device should be overturned.