Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary's March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests approved for diagnostic purposes by the Food and Drug Administration (FDA).
The Advisory Opinion concluded that the PREP Act makes clear that state and local governments cannot prevent "qualified persons" from ordering or administering covered countermeasures, including COVID-19 tests, because:
- The Secretary's March 10, 2020 declaration allows the Secretary to designate a "qualified person" to order or administer COVID-19 tests even when such individuals are not licensed to do so under state law;
- The PREP Act expressly preempts state and local requirements that would prevent a "qualified person" from ordering or administering a COVID-19 test; and
- The PREP Act explicitly provides that courts do not have subject matter jurisdiction to review the Secretary's decision identifying certain individuals as "qualified persons" pursuant to the Secretary's March 10, 2020 declaration.
As a result, any action by state or local authorities that would prevent licensed pharmacists from ordering or administering a diagnostic COVID-19 test that has been approved by the FDA is expressly preempted by federal law.
We suspect that, in putting this Advisory Opinion into effect, HHS will promptly direct state Boards of Pharmacy from taking any action that would prevent local pharmacies from suspending COVID-19 testing on the basis that pharmacists are not authorized to order or administer such tests, as HHS will take the position those local requirements are preempted by federal law. Because pharmacists are often the easiest and first point-of-contact for many individuals, providing all pharmacists nationwide with the ability to order and administer COVID-19 tests may help ease the access and time delays that have been seen with COVID-19 testing.
To review the entirety of Advisory Opinion 20-02, click here.
Originally published 21 May 2020
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