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Telemedicine: Understanding the FDA's role in recent regulatory and enforcement actions

Serra J. Schlanger (sschlanger@hpm.com) is a Senior Associate and Rachael Hunt (rhunt@hpm.com) is an Associate at Hyman, Phelps & McNamara PC in Washington, DC.

Interest in and use of telemedicine services appears to be dramatically increasing. According to researchers, telehealth visits by members of one private US health plan rose by 52% annually from 2005 to 2014, and soared by 261% from 2015 to 2017.[1] As more people seek to use telemedicine services, there has been an increased focus on what constitutes the appropriate use of these services. In addition, increased utilization has also increased the potential risk for fraud and abuse. In 2017, the Department of Health and Human Services Office of Inspector General (OIG) added Medicaid telehealth payment audits to its Work Plan.[2]

Many discussions of the risks related to telemedicine focus on state-regulated practice of medicine issues and healthcare fraud and abuse concerns that typically fall under the purview of the Centers for Medicare & Medicaid Services (CMS); however, recent regulatory and enforcement actions have also been undertaken by the U.S. Food and Drug Administration (FDA or the Agency). This article will provide an overview of the FDA’s enforcement authority and discuss two examples of how the Agency has recently exercised that authority over telemedicine-related activities. This article will not discuss the FDA’s authority to regulate products used to provide digital health services (e.g., clinical decision support software, mobile medical apps).

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