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Remote physiological monitoring - Accepted devices?

Brad Posted Tue 25th of June, 2019 00:59:14 AM
Regarding 99457 Remote physiological monitoring - Can smart phones, Holter-Monitors, Fit-Bits be used as measuring devices? Is there a list of accepted remote devices by Medicare/AMA ?
SuperCoder Answered Tue 25th of June, 2019 08:24:02 AM

Hello Brad,

Thank you for your question.

 

Medicare and AMA do not provide any specific list of accepted remote devices for Remote Physiological Monitoring.

Also, for Fitbit device, FDA has not yet provided the final approval.

 

Please find the below articles indicating the FDA approvals for Smartphones and Holter Monitoring.

For Smartphone

https://www.fda.gov/medical-devices/recently-approved-devices/eversense-continuous-glucose-monitoring-system-p160048s006

 

For Holter Monitor

https://www.fda.gov/medical-devices/mobile-medical-applications/examples-pre-market-submissions-include-mmas-cleared-or-approved-fda

 

Note: You are advised to check with your respective payer for coverage determination of these devices.

 

Hope that helps!

Thanks

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