On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity to certain individuals and entities arising from the manufacturing, distribution, administration or use of medical countermeasures (e.g., therapeutics and vaccines) against COVID-19.
According to HHS, the new Secretary of HHS “has determined that there is an urgent need to expand the pool of available COVID-19 vaccinators in order to respond effectively to the pandemic.” Accordingly, the Fifth Amendment to the PREP Act Declaration expands the pool of eligible vaccinators in two ways:
- Vaccination Across State Lines:
The Fifth Amendment authorizes any healthcare professional or other individual holding an active license or certification permitting the individual to prescribe, dispense, or administer vaccines under the law of any state to prescribe, dispense, and administer COVID-19 vaccines that are covered by the PREP Act in any jurisdiction (i.e., any other state) where the PREP Act applies in connection with vaccination efforts by federal, state and local agencies in that state. The foregoing permission does not apply to any individual whose license or certification has been restricted, suspended, surrendered, or revoked, or who is on the Office of Inspector General’s (OIG) list of excluded individuals and entities. In order to engage in cross-border vaccination practices and receive protection under the PREP Act, an individual must complete the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules, and providers not currently practicing must document their competency as observed by a currently-practicing professional with experience in vaccinations.
- Vaccination by Retired/Inactive/Lapsed Licensees:
The Fifth Amendment expands the categories of “Qualified Persons” authorized under the PREP Act to prescribe, dispense, and administer COVID-19 vaccines to newly include retired and inactive physicians, advanced practice registered nurses, registered nurses, and practical nurses as long as (i) such individuals held an active state license or certification within the last five years, (ii) such license or certification was active and in good standing prior to becoming inactive, expired, or lapsed, (iii) such license or certification was not revoked or surrendered under suspension/disciplinary/investigation or following an arrest, and (iv) such individual is not on the OIG’s list of excluded individuals and entities.
It is important to note that this second provision of the Fifth Amendment does not include physician assistants.
According to HHS, this expansion of eligible vaccinators under the Fifth Amendment “achieves two purposes:” it provides liability protections under the PREP Act for additional Qualified Persons to administer COVID-19 vaccines, and “any State law that would otherwise prohibit the healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines is preempted.”