HHS Clarification On PREP Act Impact On State Licensing Laws: What it Means For Pharmacists’ COVID-19 Testing Capabilities

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Background

On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.” In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.

Advisory Opinion 20-02

Numerous pharmacists, pharmacies, and one trade association asked the Office of the General Counsel (OGC) whether the PREP Act preempts state licensing laws that would restrict or prohibit a pharmacist from ordering and administering COVID-19 diagnostic tests. On May 19, 2020, OGC responded to this question in Advisory Opinion 20-02. OGC explained that any state licensing law with differing requirements or requirements in conflict with the April 8th guidance is preempted.

OGC gave three reasons for coming to its conclusion. First, the PREP Act allows the Secretary to designate a “qualified person” to use and administer a covered countermeasure (i.e., the COVID-19 test) even when that person is not authorized to do so under state law. If the Secretary could only allow covered persons to use and administer a covered countermeasure when allowed under state law, the power conferred to the Secretary pursuant to the PREP Act would essentially be meaningless. Second, the PREP Act expressly preempts any state law that prohibits a covered person from ordering and administrating a covered counter measure in accordance with the Secretary’s Order. Finally, Orders under the PREP Act may not be challenged in any United States Court, because Congress divested courts of jurisdiction for such Orders. Thus, to the extent a state licensing law would not allow a pharmacist to order and administer COVID-19 tests or would require a pharmacist to have a separate certification, the state may not enforce such licensing provisions.

It is unclear how this Advisory Opinion would play out from a practical perspective in the event a pharmacist faces claims of malpractice from a patient, or if this will deter state boards of pharmacy from raising disciplinary issues.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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