Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 57-year-old male enrollee has requested reimbursement for CPT 43210 esophagogastroduodenoscopy with transoral incisionless fundoplication performed on 4/23/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials. However, the conclusions are contradictory. A non-blinded multicenter randomized crossover study (TEMPO) showed improvement in regurgitation in 97% of TIF patients versus 50% of proton pump inhibitor patients at six months, with similar normalization in esophageal acid exposure; at three years, after all control patients had TIF, total esophageal pH less than 4 time improved from 10.5% to 7.8% and esophagitis healed in 86% and 71% had stopped proton pump inhibitor; at five years, 86% reported resolution of regurgitation, 80% reported resolution of atypical symptoms, and 34% remained on proton pump inhibitor. One large randomized trial by Witteman and colleagues included 60 patients and found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% (less than the proton pump inhibitor group) in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors in 61%. The study concluded that no long-term objective reflux control was achieved. A recent systematic review and meta-analysis by McCarty and colleagues concluded, aFuture controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication.a Another recent systematic review and meta-analysis by Huang and colleagues concluded, aLong-term results showed decreased efficacy with time. Patients often resume proton pump inhibitors at reduced doses in the near future.a The current medical literature has not definitively established that TIF will be able to control acid reflux over the long-term, especially in comparison with conventional methods, such as Nissen fundoplication. The 2013 American College of Gastroenterology guidelines for treatment of gastroesophageal reflux disease noted, aThe usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence).a In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery. SAGES concluded, aFurther studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety.a These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF. Therefore, CPT 43210 esophagogastroduodenoscopy with transoral incisionless fundoplication performed on 4/23/21 was not likely to have been more beneficial than other available standard therapy.