FDA For RPM Equipment

CPT 99453; 99454
Providing Education and Set-up of device: All auxiliary personnel (including clinical staff and non-clinical) may provide education to patients on RPM services and set up of the device under CPT code 99453. The personnel can be either contracted or employed by the billing practitioner. This means that RPM vendors can provide the education and set-up of the device. 16 Days of Monitoring: To bill for initial set-up and continued monitoring, monitoring must occur over at least 16-days of a 30-day period. RPM services can only be billed by one practitioner per 30-day period and cannot be reported for a patient more than once during a 30-day period (even when multiple medical devices are provided to a patient). CPT code 99453 can be billed only once per episode of care which “begin[s] when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals’’.
Definition of Medical Device: Medical devices that digitally collect and transmit a patient’s physiologic data must be reasonable and necessary for the diagnosis or treatment of the patient’s illness or injury or to improve the functioning of a malformed body member. The device must meet the FDA’s definition of medical device 201 of Federal, Food, Drug, and Cosmetic Act; however, it does not have to be FDA-cleared/registered. The devices must digitally (automatically) upload patient physiologic data and cannot be recorded or reported by the patient. Medical devices must be used to collect and transmit reliable and valid physiologic data
that helps describes the patients’ health status to develop and manage a plan of treatment.