Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease. 
Treatment: Surgery (transoral fundoplication using the EsophyX - procedure code 43210). 

The insurer denied: Surgery (transoral fundoplication using the EsophyX - procedure code 43210). 
The denial is overturned. 

This patient is an adult female who sought surgical evaluation for the condition of recurrent gastroesophageal reflux disease associated with heartburn, regurgitation, and nausea. She has a complex past surgical history that includes a hiatal hernia repair and Nissen fundoplication. The symptoms are partially controlled with medicinal therapy (omeprazole, sucralfate, Dexilant). The patient has been evaluated for this condition with: Recent esophagogastroduodenoscopy showed grade B esophagitis and a large sliding hiatal hernia. Upper gastrointestinal study (UGI) that showed no hiatal hernia. There was reflux during the study. Potential of hydrogen (pH) study confirmed abnormal esophageal acid exposure with a DeMeester score of 30 (normal less than [<] 14.7). Esophageal manometry testing showed that 60% of swallows were peristaltic and 40% had failed peristalsis. There was a 3.7-centimeter manometrically detected hiatal hernia. There were large peristatic breaks with frequent failed peristalsis. - A gastric emptying study showed normal gastric emptying. The treating surgeon has proposed the transoral incisionless fundoplication (TIF) procedure as treatment of recurrent and refractory gastroesophageal reflux disease (GERD). 

The health plan rationale for denial is that the transoral incisionless fundoplication (TIF) procedure is considered to be investigational by the Plan and therefore not medically appropriate. 

The health plan should cover the proposed treatment. 

In this case, the transoral incisionless fundoplication (TIF) procedure is medically appropriate and would be expected to be health beneficial for the condition being treated. In this case, the patient has the diagnosis of recurrent and refractory gastroesophageal reflux disease. She continues to have reflux symptoms despite prior surgical and ongoing medicinal treatment. There is proven pathological esophageal acid exposure based on potential of hydrogen (pH) testing, image confirmation of reflux, and no contraindicating anatomic abnormality. 

In 2016, Trad published the results of the TEMPO trial. This was a multicenter randomized study at seven United States community hospitals that compared transoral incisionless fundoplication to maximal dose proton pump inhibitor (PPI) therapy in partial responders to proton pump inhibitor therapy. At six-month follow up, troublesome regurgitation was eliminated in 97% of transoral incisionless fundoplication patients versus 50% of proton pump inhibitor patients and 90% of transoral incisionless fundoplication patients had completely stopped proton pump inhibitor use. Follow up endoscopy was performed at six-months and complete healing or reduction in reflux esophagitis was achieved in 90% of transoral incisionless fundoplication patients versus 38% of medicinally treated patients. The median total Reflux Symptom Index score in the transoral incisionless fundoplication group decreased significantly from 23 on proton pump inhibitors before the procedure to three off proton pump inhibitors at six-month follow up. Longer term follow up has been reported to three-years. 

Based on the volume of peer-reviewed clinical data, Food and Drug Administration (FDA) approval of the procedure, and affirmative society statement from the American Gastroenterology Association and the Society of American Gastrointestinal Surgeons (SAGES), the transoral incisionless fundoplication procedure is medically appropriate.  The submitted records indicate that this patient is an appropriate candidate and has none of the listed contraindications for transoral incisionless fundoplication.