Remote Patient Monitoring in Telehealth: Avoiding Key Compliance Pitfalls and Understanding When FDA Regulation and Oversight Comes Into Play

November 16, 2023 11:15am

Carrie Nixon
Co-Founder and Managing Partner
Nixon Gwilt Law

Carol Yarbrough
Telehealth Business Operations Manager
UCSF Health
Manager, Government Billing & Reimbursement
UCSF Clinical Practice Group at ZSFG

Benjamin M. Zegarelli
Of Counsel
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

  • Overcoming the top billing compliance and reimbursement challenges faced by providers for RPM and remote therapeutic monitoring (RTM)
  • Understanding when a telehealth company is utilizing or marketing a “medical device” regulated by the FDA: what does this additional layer of FDA regulation look like?
  • Assessing when you can utilize the FDAs definition of “device” to qualify for reimbursement without qualifying for FDA oversight and regulation
  • Examining when durable medical equipment (DME) is used in connection with RPM, and the recent governments enforcement priorities with regard to DME
  • Key takeaways to ensure a company’s compliance with data privacy issues when using RPMs or DMEs
  • Identifying and ensuring patients’ rights when utilizing RPM in telehealth