Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD). 
Treatment: Transoral incisionless fundoplication (and associated services). 

The insurer denied the Transoral incisionless fundoplication (and associated services). 
The denial is upheld. 

This patient is a male with gastroesophageal reflux disease (GERD) for seven (x7) years. He has been on proton pump inhibitors (PPI) therapy up to twice daily with an H2 (histamine 2) blocker. He is on Dexilant. Esophagogastroduodenoscopy (EGD) showed a two centimeter hiatal hernia with biopsies showing marked acute inflammation while on proton pump inhibitor therapy. 

No, the proposed transoral incisionless fundoplication is not medically necessary. 
The TEMPO trial (transoral incisionless fundoplication EsophyX vs Medical PPI Open Label Trial) (Trad KS et al) was a multicenter randomized study comparing the efficacy of the transoral incisionless fundoplication  (TIF) procedure against maximal dose proton pump inhibitor (PPI) therapy. In this trial the transoral incisionless fundoplication (TIF) patients had elimination of troublesome regurgitation in 97% of patients versus 50% of patients on proton pump inhibitor (PPI) therapy, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11). However, in the study transoral incisionless fundoplication (TIF) was not better than proton pump inhibitors at eliminating heartburn, healing of reflux esophagitis, and normalizing distal esophageal acid exposure. Medium term follow up is available for three years (Muls V et al) and long term follow up is available for eight years (Chimukangara M et al). 

Laparoscopic Nissen fundoplication (LNF) is considered standard of care in patients with medically refractory gastroesophageal reflux disease (GERD). There has been no direct comparison of transoral incisionless fundoplication (TIF) versus laparoscopic Nissen fundoplication (LNF). In a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of transoral incisionless fundoplication (TIF) versus laparoscopic Nissen fundoplication (LNF) in patients with gastroesophageal reflux disease (GERD), seven trials comprising 1128 patients were included. Transoral incisionless fundoplication had highest probability of increasing patients' health-related quality of life (0.96), followed by laparoscopic Nissen fundoplication (0.66), a sham procedure (0.35), and proton pump inhibitors (0.042). Laparoscopic Nissen fundoplication had the highest probability of increasing percent time at potential hydrogen (pH) less than (<) four _tmplitem="1600" (0.99), followed by proton pump inhibitors (0.64), transoral incisionless fundoplication (0.32), and the sham procedure (0.05). Laparoscopic Nissen fundoplication also had the highest probability of increasing lower esophageal sphincter (LES) pressure (0.78), followed by transoral incisionless fundoplication (0.72) and proton pump inhibitors (0.01). Patients who underwent the sham procedure had the highest probability for persistent esophagitis (0.74), followed by those receiving transoral incisionless fundoplication (0.69), laparoscopic Nissen fundoplication (0.38), and proton pump inhibitors (0.19). The authors concluded: "TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, we do not recommend it as a long-term alternative to PPI or LNF treatment of GERD." (Richter JE et al). 

Direct comparison studies / randomized studies are needed to compare transoral incisionless fundoplication versus laparoscopic Nissen fundoplication. 

The American College of Gastroenterology issued the following statement in their latest guidelines in the diagnosis and management of gastroesophageal reflux disease (GERD): "The usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy (Strong recommendation, moderate level of evidence)." 

Direct comparison studies / randomized studies are needed to compare transoral incisionless fundoplication (TIF) vs laparoscopic Nissen fundoplication (LNF). 

The American College of Gastroenterology issued the following statement in their latest guidelines in the diagnosis and management of GERD: "The usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy (Strong recommendation, moderate level of evidence)."