Outsourcing operations can offer solutions to a variety of business challenges, particularly with respect to remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) (collectively, RM) and other digital health and telemedicine companies, where services can be furnished by healthcare professionals far from the patient’s location. However, healthcare providers and investors operating in the RM, digital health, and telemedicine space should beware of potential federal and state False Claims Act (FCA) risk in using personnel outside the United States or even in other U.S. states to furnish RM services reimbursed by Federal Health Care Programs (FHCPs). As FHCPs are so highly regulated, and FCA qui tam provisions financially incentivize whistleblowers to file complaints with the government, regardless of the merits of their allegations, improperly structuring outsourcing operations can lead to significant FCA risk.
To comply with FHCP requirements and mitigate FCA risk, parties should ensure that any individual furnishing RM services billed to FHCPs is located in the United States and appropriately licensed to provide services to patients residing outside of the state in compliance with state laws. Further, claims submitted to FHCPs must identify the accurate place of service, as FHCP reimbursement may vary depending on the location in which RM services are furnished. If a company is carving out FHCP data for domestic review while channeling other types of data...
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