The U.S. Food and Drug Administration (FDA) has requested additional information pertaining to the Apnea Risk Evaluation System (ARES) respiratory effort signal. As a result, the manufacturer of the device, Advanced Brain Monitoring, has temporarily removed the respiratory effort signal from the ARES labeling and will disable its use with the ARES Model 610, according to a letter from Advanced Brain Monitoring.
“This change impacts whether studies performed with this device will continue to be a covered service, and if so, the CPT code to be used to describe a home sleep study with the measurement of respiratory analysis by airflow, oxygen saturation, heart rate, sleep time but not effort,” a letter from product distributor, Watermark Medical, stated. The letter to customers continued, “Watermark has begun contacting payors to determine the proper CPT code to bill and the continued availability of reimbursement, but this will take some time. In the meantime, we advise that you do not submit claims for the ARES while we make these determinations.”
Advanced Brain Monitoring has provided the FDA with information and is working to satisfy the administration’s requests.