Can wearable devices be prescribed for clinical use?
Can fitness trackers, wireless blood pressure cuffs, wireless scales, etc. be prescribed to a patient? Can providers be reimbursed for "remote monitoring" of the data when used for treatment plan decisions?
Answer (1)
Full disclaimer, this is not a definitive answer: it appears that some wearables can be prescribed to a patient under certain conditions using CPT codes 99453, 99454, 99457, and 99458. Under CMS rules, the use of these devices would fall under Remote Patient Monitoring ("RPM") under specific conditions:
- The device must meet the FDA's definition of a "medical device" under 201(h). FDA clearance or registration is not necessary, but it is appropriate.
- The device must upload data automatically to the provider (patient-entered data does not qualify)
- The data collection and management must be medically and reasonably necessary, that is, relevant to the treatment of the patient's condition
- The device must collect and transmit data in an accurate and reliable manner
In other words, specific device functions that fall under the FDA's "medical device" definition, such as afib detection, or FDA-cleared devices such as Continuous Glucose Monitors, should be able to be prescribed. However, other functionality that may not meet the "medical device" definition, such as steps and calories, would have a harder time qualifying - for now.
For more information, see:
https://www.foley.com/insights/publications/2020/12/2021-remote-patient-monitoring-cms-final-rule/
https://www.100plus.com/resource/cpt-code-99453-remote-patient-monitoring-guide/