Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 65-year-old male with a history of gastroesophageal reflux disease (GERD) who continues to be symptomatic despite high dose Nexium 40mg twice daily. The patient complains of burning and tightness in his throat and chest. Pathology revealed evidence of possible Barretts esophagus. Wireless Bravo pH capsule testing was requested to evaluate his symptoms of esophageal reflux disease, and to tailor his acid reflux therapy based upon the results of the Bravo pH study. At issue is whether the Bravo pH capsule testing is likely to be more beneficial for treatment of the patients condition than any available standard therapy.The wireless Bravo pH monitoring system is now considered the standard of care for the evaluation of patients with suspected or possible gastroesophageal reflux disease (GERD). Compared to the catheter probe monitoring study, it does not cause inconvenience or discomfort, and does not interfere with day-to-day activities during the duration of the monitoring. As such, it has replaced the catheter-based system nationally, and has become the standard of care for the evaluation of suspected GERD.Based upon the studies published in the peer-reviewed journals, Bravo pH monitoring is considered safe and efficacious for the evaluation of patients with GERD or with extraesophageal manifestations of GERD. With this system it is possible to perform 48-hour wireless capsule pH monitoring, a major advance in patient comfort and acceptance, thereby allowing the opportunity to gather an additional day of monitoring. In various studies, comparison of the 24-hour pH probe to the Bravo 48-hour period clearly showed that the 48-hour pH capsule is superior to the 24-hour pH capsule probe. The 48-hour period pH capsule is a physiological measurement of acid reflux. Moreover, unlike the catheter probe system, the wireless capsule does not cause inconvenience and discomfort to the patient, and does not limit day-to-day activities or food intake and therefore, provides more accurate evaluation of the patients underlying GERD. The requested procedure is medically appropriate and necessary for this patient and should be authorized.For the reasons set forth above, I have determined that the requested procedure is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 2:  The patient is a 65-year-old male with chronic throat burning. He was previously treated with high dose PPIs without benefit. An EGD with biopsy showed possible Barretts esophagus. He has requested coverage for wireless Bravo pH capsule testing. This request has been denied by the Health Plan on the basis that the requested procedure is considered experimental/investigational in nature.This patient is an appropriate candidate for the wireless Bravo pH capsule study as he had equivocal endoscopic findings and has reflux symptoms that are refractory to PPI therapy. The wireless Bravo pH capsule study is much more comfortable for the patient and the patient can be monitored while eating a normal diet and experiencing normal activity levels. Furthermore, there is some evidence showing benefit with this 48-hour study compared to traditional 24-hour pH studies. The Bravo pH capsule study is quickly becoming the standard pH study. Catheter-based pH studies are likely to be performed far less often. Accordingly, the requested procedure is clinically indicated and necessary. Based upon the information set forth above, I have determined that the requested procedure is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 3:  The patient is a 65-year-old male with a history of possible Barretts esophagus who continues to be symptomatic with Nexium. A Bravo pH capsule study has been requested to further evaluate the esophagus for the presence of acid. The Health Plan has determined there is insufficient evidence of the efficacy of the procedure to warrant its use in this clinical setting. It is reasonable to measure this patients pH in the esophagus since the patient is symptomatic despite the use of appropriate levels of PPIs. This would distinguish true persistent GERD from functional chest pain or globus sensation. The FDA has approved the use of the Bravo pH capsule device for measuring pH. A search of the medical literature also reveals multiple articles supporting the procedure. A study by Prakash concluded that extending monitoring to two days with a wireless pH monitoring system increases the detection of GERD in a clinically significant proportion of patients with NCCP. In addition, a paper by Tseng found that 48-hour pH testing might increase detection accuracy and sensitivity for AEAE by as much as 22%. Accordingly, the use of the Bravo pH capsule study is medically necessary in this clinical setting. In conclusion, I have determined that the requested procedure is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.