On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP Act (Guidance). The Guidance clarifies that immunity from liability under the PREP Act extends to licensed pharmacists who order and administer COVID-19 tests, including serology tests, authorized by FDA. Apart from providing specifics regarding the scope of PREP Act coverage with respect to pharmacy activity, more generally, the Guidance offers insight into how HHS interprets PREP Act coverage under the HHS Declaration for Medical Countermeasures Against COVID-19, of March 17, 2020 (COVID-19 Declaration). Further, the Guidance demonstrates how obtaining an official statement, such as a guidance document, from a government agency responsible for public health and/or incident response, can help bolster PREP Act liability protection.

PREP Act coverage limitation regarding “means of distribution”

Although the PREP Act is commonly understood, in its simplest terms, to provide a defense of liability immunity to Covered Persons engaging in Recommended Activities involving Covered Countermeasures, there is an often overlooked provision that may override, and potentially negate, the liability protection that would otherwise apply. Under the PREP Act, HHS is granted the authority to limit immunity from liability “to covered countermeasures obtained through a particular means of distribution” specified in the declaration.[1] In the COVID-19 Declaration, HHS chose to exercise that authority by including Section VII of the Declaration, which states:

I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

(a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or

(b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency.

This element of the liability immunity defense is easily established under Section VII(a) to the extent that there is a federal contract or other federal agreement under which the activity is performed. However, without such a contract or agreement, PREP Act immunity may depend upon the ability to show, under Section VII(b), that the Recommended Activities are “related to” activities “authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency.” The Authority Having Jurisdiction is broadly (and somewhat cryptically) defined to mean: “the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.” The potential ambiguity in the language of Section VII(b) and the definition of an Authority Having Jurisdiction has made it difficult, in some cases, to assess whether the PREP Act would provide immunity from liability in specific cases. In at least one instance, HHS has read Section VII(b) to mean that a governmental authority must authorize, control, or direct the distribution.

Federal agencies as authorities having jurisdiction

Notably, in support of its conclusion that licensed pharmacists will be immune from liability under the PREP Act for ordering, administering and using FDA-authorized COVID-19 tests under Section VII(b) of the Declaration, the Guidance announces that HHS OASH is an “Authority Having Jurisdiction” under the Declaration. This statement is significant, because it indicates that federal authorities other than OASH that perform public health or incident response functions, such the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Assistant Secretary for Preparedness and Response (ASPR), should also be considered "Authorit[ies] Having Jurisdiction.” Along these lines, the Guidance states that OASH, in issuing the Guidance, is “authorizing” licensed pharmacists to order and administer FDA-authorized COVID-19 tests, as Covered Persons, and concludes that the pharmacists “may receive immunity under the PREP Act.” This suggests that CDC, FDA, ASPR, and perhaps other federal agencies, may have similar authority to issue pronouncements that “authorize” Covered Persons to use Covered Countermeasures in accordance with Section VII(b) of the Declaration.

To assess the PREP Act coverage for COVID-19 Covered Countermeasures for which there is not an underlying federal contract or other agreement, it is important to consider whether the distribution or other activity for which liability may attach is related to activities authorized by an Authority Having Jurisdiction. Obtaining written authorization from a public health or incident response agency with jurisdiction at the federal level may, therefore, provide a higher degree of assurance of PREP Act coverage.

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