HHS Substantially Expands the Scope of PREP Act Immunity for Covered Medical Countermeasures to Combat COVID-19

On December 3, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) significantly expanded the scope of his March 10, 2020, Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID-19 (Declaration).¹ The Declaration provides liability protections to those engaged in medical countermeasures to combat COVID-19. First, recognizing the value of telehealth providers and their increased use during this pandemic, the amendments allow healthcare personnel who are permitted to order and administer a covered countermeasure through telehealth in a state to do so in other states so long as such activities are in compliance with the requirements of the provider’s licensing state. With this change, these healthcare personnel can now qualify as “covered persons” under the Declaration’s liability protections. The Declaration also states that state laws that would prohibit ordering or administering covered countermeasures through telehealth are preempted.  

Second, noting that “COVID-19 is an unprecedented global challenge that requires a whole-of-nation response,” the amendments “extend PREP Act coverage to additional private-distribution channels.” The Declaration already provides immunity to covered persons for recommended activities relating to (1) certain federal contracts or other agreements and (2) certain activities authorized by a public agency for prescribing and distributing covered countermeasures. The new amendments add a third channel and extend these liability protections to a covered countermeasure that combats COVID-19 and is either (a) a drug “licensed, approved, cleared, or authorized by” the Food and Drug Administration or (b) “a respiratory protective device approved by the National Institute for Occupational Safety and Health [NIOSH]… that the Secretary determines to be a priority for use.” This change explicitly extends the Declaration’s activity to private distribution channels “even if there is no federal agreement” in place.

Third, highlighting the nature of this “unprecedented global pandemic,” the amendments clarify “that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005).” Thus, the amendments highlight the importance of “a uniform interpretation of the PREP Act” and underscore that “the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.” 

In addition, the amendments incorporate prior advisory opinions² from the HHS’s Office of General Counsel interpreting the PREP Act and specify that “the Declaration must be construed in accordance with the Advisory Opinions.” 

¹  https://www.sidley.com/en/insights/newsupdates/2020/03/hhs-secretary-azar-announces-certain-protections-from-liability-for-covered 

²  https://www.sidley.com/en/insights/newsupdates/2020/04/hhs-issues-advisory-opinion-and-amendment-to-public-readiness-and-emergency-preparedness-act;   

https://www.sidley.com/en/insights/newsupdates/2020/10/hhs-issues-new-advisory-opinion-regarding-the-scope-of-immunity-under-the-public-readiness