6. What types of devices can be used for RPM?
Regarding the device requirements for CPT 99453 and 99454, CMS has specified that any such device must:
• Meet the definition of "medical device" stated in section 201(h) of the Federal Food, Drug and Cosmetic Act
• Automatically upload patient physiologic data (i.e., data are not self-recorded and/or self-reported by the patient)
• Be capable of generating and transmitting either (a) daily recordings of the beneficiary's physiologic data, or (b) an alert if the beneficiary's values fall outside pre-determined parameters.
• 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.
• Be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient's health status in order to develop and manage a plan of treatment.