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HHS Advisory Opinion Clarifies PREP Act Preemption Measures and Protection for Pharmacists

May.27.2020

Widespread testing has been considered one of the country’s best ways to help minimize the spread of COVID-19, by allowing for quick identification, isolation, and treatment of infected individuals before further spread the virus.  To this end, the Department of Health and Human Services (HHS) has recognized that pharmacists are uniquely positioned to aid in COVID-19 testing expansion, as they are trusted health care professionals who have established relationships with both their patients and medical providers, and also have the ability to refer patients to hospitals when necessary.  On May 19, 2020, HHS issued an Advisory Opinion (Opinion) on the Public Readiness and Emergency Preparedness (PREP) Act, making it clear that the PREP Act shields pharmacists from liability stemming from ordering and administering FDA-authorized COVID-19 tests. 

HHS had previously issued guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests.  Under this guidance, pharmacists were authorized as “Covered Persons” under the PREP Act, and would thereby receive liability immunity from claims of loss caused by, relating to, or resulting from the administration or use of FDA-authorized COVID-19 tests. However, many states prohibit licensed pharmacists from ordering and administering tests, raising an important question about the PREP Act’s preemption provisions.  HHS’s Opinion clarifies that the PREP Act authorization for pharmacists does, in fact, preempt any conflicting state laws.

First, the Opinion discusses the pharmacists’ status as “Covered Persons.”  For PREP Act purposes, pharmacists fall within the subcategory of “qualified persons.”  A “qualified person” is either (1) a licensed health care professional authorized under state law to prescribe, administer, or dispense a Covered Countermeasure, or (2) one identified as a “qualified person” by the HHS Secretary in the PREP Act declaration.  The Opinion notes that this second category allows the Secretary to “designate someone as a ‘qualified person’ even if that person is not authorized to prescribe, administer, or dispense such countermeasures under state law when that person prescribes, administers, or dispenses the countermeasures in that State.” (emphasis in original).  The Opinion further explains that the HHS Secretary would not immunize anyone under this second category if states or localities could prohibit those persons from administering the Covered Countermeasures in the first place.

Second, the Opinion explores the PREP Act’s preemption provisions.  The applicable statute mandates that during the effective period of the HHS Secretary’s PREP Act declaration, “no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement” if it is “different from, or is in conflict with, any requirement applicable under this section; and relates to the . . . prescribing, dispensing, or administration by qualified persons of the covered countermeasure.”  The Opinion reasons that the PREP Act would not preempt all state and local laws for pharmacists, but only those that differ from or conflict with the PREP Act or the PREP Act declaration.  At a minimum, this provision would be broad enough to preempt any state or local requirement which would otherwise prohibit pharmacists from ordering and administering FDA-approved COVID-19 tests.

It is also important to note that these particular protections for pharmacists only apply for the purposes of ordering and administering COVID-19 tests, and not necessarily for other acts.  Nonetheless, the Opinion should provide assurance to pharmacists concerned that they may be violating state laws by testing individuals for COVID-19.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1 202.624.2910
Email: jfuson@crowell.com
Chalana N. Damron
Counsel – Washington, D.C.
Phone: +1 202.624.2566
Email: cdamron@crowell.com
Mena Gaballah, PharmD
Associate – Washington, D.C.
Phone: +1 202.624.2875
Email: mgaballah@crowell.com
Mariam Sarwar
Associate – Los Angeles
Phone: +1 213.443.5570
Email: msarwar@crowell.com