The novel coronavirus (2019-nCoV, also known as “SARS-CoV-2”) has been declared a public health emergency (PHE) by the U.S. Department of Health and Human Services (HHS). This designation authorizes 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 virus control efforts.
Reed Smith has prepared a client alert that provides an overview of government PHE regulatory authorities and analyzes federal and state regulations impacting health care providers, suppliers, and facilities when a federal PHE has been declared or an infectious disease outbreak occurs under state law. Among other things, the client alert addresses: Emergency Medical Treatment and Active Labor Act (EMTALA), Stark Law, and other federal waivers; state law police powers, including quarantine; relevant rules for disclosure of personal health information; FDA emergency authorization for coronavirus diagnostic test; and supply chain concerns and 340B pricing implications. Our client alert is available here.