Reed Smith Client Alerts

Covered in this alert:

  • Novel coronavirus declared a U.S. public health emergency
  • Overview of federal public health powers
  • The Emergency Medical Treatment and Active Labor Act (EMTALA), Stark Law, and other federal waivers
  • Overview of state law police powers, including quarantine
  • Relevant rules for disclosure of personal health information
  • FDA emergency authorization for coronavirus diagnostic test
  • Supply chain concerns and 340B pricing limitation

Authors: Scot T. Hasselman Celeste A. Letourneau Joseph W. Metro Lesley C. Reynolds Nicole J. Aiken-Shaban Jessica R. Christensen Rebecca E. Dittrich Arielle R. Lusardi Kristin B. Parker Janine R. Tougas

Since being declared a Public Health Emergency of International Concern by the World Health Organization (WHO) on January 30, 2020, and a public health emergency (PHE) in the United States by the U.S. Department of Health and Human Services (HHS) the next day, novel coronavirus (2019-nCoV, also known as "SARS-CoV-2") has garnered significant public attention. The outbreak of 2019-nCoV was first detected in mainland China in December 2019, and, as of February 11, 2020, 2019-nCoV has infected over 40,000 individuals in at least 25 countries, including five states in the United States. On February 11, 2020, the WHO named the disease caused by 2019-nCoV "COVID-19."1 The detection of a novel coronavirus2 has forced regulatory agencies, health care providers, and others to consider what steps should be taken to track diagnoses, prevent exposure, and otherwise control the public health impact of this virus.

In the United States, the declaration of a PHE empowered HHS to direct funding to: (1) enable the dissemination of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve screening and detection efforts; and (4) support state and local governments in efforts to control the virus.Working parallel to HHS, the Centers for Disease Control and Prevention (CDC) continue to monitor the outbreak closely, and the U.S. Food and Drug Administration (FDA) has already fast-tracked a diagnostic test for the virus through its emergency authorization power.4 The diagnostic test is only one example of the emergency activities we expect to see undertaken as federal and state agencies rush to respond to the 2019-nCoV outbreak.

In this alert, we provide an overview of the powers that enable federal and state governments to respond to a PHE, and the rules and regulations set forth by federal and state agencies regarding which health care providers, suppliers, and facilities may or must comply when a federal PHE has been declared, or an infectious disease outbreak occurs under state law.