Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

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 there is a lack of support for the services at issue in this clinical setting. There is a lack of long-term data to show the efficacy and durability of the transoral incisionless fundoplication procedure over time in comparison to other therapies. Studies of the transoral incisionless fundoplication procedure are lacking a large sample size with randomization and blinding. The safety and efficacy of the intervention over time has not been proven. The transoral incisionless fundoplication procedure is not more likely to be beneficial for the patient compared to conservative measures, such as therapy with twice-daily proton pump inhibitors, or surgical intervention, such as Nissen fundoplication. The field of endoscopic fundoplication has gained popularity over the past few years, and in an attempt to create a less invasive procedure that mimics anti-reflux surgery with fewer side effects, transoral incisionless fundoplication was developed. Several initial reports on transoral incisionless fundoplication were encouraging and showed effectiveness in reducing typical and atypical gastroesophageal reflux disease symptoms, eliminating daily proton pump inhibitor dependence, as well as in normalizing distal esophageal pH. On the contrary, other early experiences reported substantial failure rates. The available data on the transoral incisionless fundoplication technique are of limited quality and extracted from uncontrolled studies with generally a short follow-up duration. In this case, although the patient has reportedly failed multiple proton pump inhibitors, the medical record documentation does not detail whether or not he has trialed all of the proton pump inhibitors at a maximum twice-daily dose. In a randomized controlled trial by Witteman and colleagues, a total of 60 were included. At six months, gastroesophageal reflux disease symptoms were more improved in the transoral incisionless fundoplication group compared with the proton pump inhibitor group, with a similar improvement of distal esophageal acid exposure compared with baseline. The pH normalization for transoral incisionless fundoplication group and proton pump inhibitor group was 50% and 63%, respectively. The authors concluded, aAlthough transoral incisionless fundoplication resulted in an improved gastroesophageal reflux disease-related quality of life and produced a short-term improvement of the anti-reflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.a The adverse risks associated with the transoral incisionless fundoplication procedure are not substantially increased over other standard services, although this is a surgical intervention and thus carries significantly more risk than therapy with titration of proton pump inhibitor therapy. 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.