HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering FDA-Approved COVID-19 Tests

On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act¹(PREP Act) preempts any state or local law that prohibits a pharmacist from ordering and administering authorized COVID-19 tests.

We previously reported that the PREP Act permits the Secretary of HHS to declare that certain “qualified persons” are immune from liability (i.e., loss sounding in tort or contract) for taking certain “covered countermeasures” that are necessary to combat a public-health emergency such as COVID-19. On March 10, 2020, Secretary of HHS Alex Azar issued such a declaration (Declaration).

As we reported, on April 8, 2020, the Office of the Assistant Secretary for Health (OASH) issued guidance authorizing licensed pharmacists to order and administer COVID-19 tests that the Food and Drug Administration (FDA) had authorized. Secretary Azar’s stated rationale in promulgating this guidance was to expand access to testing for those in need.

And as we recounted here, on April 14, 2020, OGC issued an advisory opinion specifying that PREP Act immunity may extend beyond actual “qualified persons” and approved “countermeasures”—even though they are technically not covered by the PREP Act—if one could have reasonably believed the persons or countermeasures were covered.

Since then, OGC has been asked whether, under the PREP Act, licensed pharmacists may order and administer COVID-19 tests even in states that prohibit licensed pharmacists from doing so. The May 19 Advisory Opinion addresses that question and concludes that under the PREP Act, state and local authorities may not prohibit or effectively prohibit “qualified persons” from ordering and administering covered countermeasures.²HHS proffered three reasons in support of this conclusion:

1. Secretary Azar’s Declaration designated licensed pharmacists as “qualified persons” for purposes of administering FDA-authorized COVID-19 tests—even if they are not authorized to do so under state licensing laws.
2. Under the PREP Act, state or local laws that prohibit a qualified person from ordering and administering a covered countermeasure are expressly preempted.³
3. State and local governments are barred from filing a lawsuit in state or federal court challenging the Secretary’s designation of persons authorized to order and administer covered countermeasures.

By including such sweeping provisions, Congress made clear that the Secretary has virtually unreviewable authority to immunize and designate a “qualified person” to use a “covered countermeasure.” As such, during the effective period of the PREP Act Declaration, states and political subdivisions cannot “establish, enforce, or continue in effect” any legal requirement that prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests.

We will continue to monitor COVID-19-related developments under the PREP Act, and encourage pharmacists and other health care providers seeking immunity under the PREP Act to reach out to Seyfarth’s health care team with questions about whether such immunity applies to them and their efforts to combat this epidemic.

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1. See 42 U.S.C. § 247d-6d.
2. The Advisory Opinion is nonbinding on HHS and the federal courts, and does not have the force or effect of law.
3. See 42 U.S.C. § 247d-6d(b)(8). Importantly, however, the PREP Act does not preempt all state and local laws to the extent such laws do not differ from or conflict with the PREP Act or any declaration issued thereunder with respect to COVID-19 tests.