Two New HHS Advisory Opinions Dramatically Illuminate the Wide Scope of PREP Act Immunity

The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in the fight against COVID-19.[1]

One advisory opinion examines the broad availability of PREP Act immunity in more detail by further discussing (1) the definition of a “program planner” and (2) the activities authorized by an “Authority Having Jurisdiction.” It also provides examples of PREP Act coverage when a program planner follows the public-health guidance of an applicable “Authority Having Jurisdiction”—even as guidance or directives change or conflict with other guidance.

The second advisory opinion analyzes how state laws may or may not be preempted by the PREP Act regarding pharmacists, with an additional section addressing how epinephrine may be a covered countermeasure when used to combat COVID-19.

Through further interpretation of the Act and the Secretary’s Declaration, and by providing key examples, these advisory opinions further demonstrate the wide potential application of PREP Act immunity and preemption across various industries. They explain, for example, how its protections may cover not just health care companies and professionals but also businesses, schools, and even places of worship, in the fight against COVID-19. The advisory opinions and their examples also provide additional direction on what constitutes applicable “guidance” from federal and non-federal sources that may then serve as the basis for PREP Act immunity.

While these PREP Act immunities and coverage were ostensibly already present in the statute and the HHS Secretary’s Declaration, the recent advisory opinions attempt to demystify the contours of that immunity and create predictability in its application. They also break with current court interpretations of the PREP Act and seek to resolve other issues currently making their way through litigation.

1. Advisory Opinion 20-04

In Advisory Opinion 20-04 (AO 20-04), the HHS Office of the General Counsel addresses the scope and meaning of the terms “program planner” and “authority having jurisdiction” under the PREP Act and its implementing Declaration,[2] and re-emphasizes the wide-ranging nature of PREP Act immunity.

According to HHS, the ever-evolving public-health directives issued in response to COVID-19 have led to significant uncertainty, including potential legal risk for public and private individuals and organizations who are battling the pandemic. Enter the PREP Act, which exists, in part, to remove legal uncertainty and risk, and covers a broad array of entities that take reasonable steps to follow public-health guidelines in using covered medical products.

As we previously explained, when an individual or organization meets the requirements of the PREP Act and the Declaration, they “shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”[3]

A. “Program Planners”

Under the PREP Act, the term “covered person” includes the United States or “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees.”[4] The PREP Act broadly defines a “program planner,”[5] and the Secretary’s original Declaration explains that a program planner can be a “private sector employer or community group.”[6] In short, any individual or organization can potentially be a program planner and receive PREP Act coverage. According to AO 20-04, private businesses, public and private transportation providers, public and private schools, and religious organizations are all eligible for immunity under the PREP Act when they act in accordance with its requirements.[7]

B. “Authority Having Jurisdiction”

The Declaration specifies that, for the COVID-19 public-health emergency, “liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to” (1) federal agreements or (2) “[a]ctivities 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.”[8]

Public-health guidance from an applicable Authority Having Jurisdiction that recommends or requires using covered countermeasures in certain circumstances may qualify as authorizations under the PREP Act and Declaration. But to obtain such authorization, a covered person must follow that public-health guidance. If there are conflicts among such guidance, PREP Act coverage will apply to a covered person using a covered countermeasure in accordance with any of the guidance.

AO 20-04 provides the following illustration: If a governor’s order on using face masks preempts a mayor’s order under that state’s law, then the former must be the basis for PREP Act coverage. As another example, the CDC’s guidance for “Preparing for a Safe Return to School” specifies that the guidance is “meant to supplement––not replace––” applicable local health and safety laws. So if there were a conflict between the CDC guidance and any applicable health and safety law, a covered person must rely on the guidance of the latter jurisdiction, and not CDC’s guidance, as the basis for PREP Act coverage.

C. Examples

To illustrate more concretely these PREP Act doctrines, AO 20-04 provides several hypothetical examples of program planners using covered countermeasures according to the guidance of an Authority Having Jurisdiction.

One such example concerns a university that followed the guidance of a local Authority Having Jurisdiction which recommended a lower testing frequency than the state or federal Authorities Having Jurisdiction. Under this hypothetical, the university is immune from suit and liability for loss stemming from such lower testing frequency, assuming that it satisfied all other requirements under the PREP Act.

Another example establishes that inaction (e.g., a pharmacy’s decision not to administer a COVID-19 test) may still be entitled to PREP Act coverage. In this example, a pharmacy’s decision not to give someone a COVID-19 test as a matter of prioritizing resources and pursuant to CDC prioritization rules nevertheless complies with the guidance of an Authority Having Jurisdiction. Therefore, the pharmacy has PREP Act coverage assuming that it has also complied with all other requirements of the PREP Act and Declaration.

In addition, AO 20-04 expressly disagrees with a decision from a New York court addressing a similar situation during the H1N1 emergency in which the court concluded that the PREP Act does not cover a provider that followed vaccine-prioritization guidelines from the CDC and state and local health departments.[9] By failing to interpret the PREP Act consistent with its plain meaning, according to the AO 20-04, “[t]he court was wrong.”

2. Advisory Opinion 20-03

Advisory Opinion 20-03 (AO 20-03) addresses three vaccination-related issues that have arisen under the PREP Act.

First, as we previously reported, the Third Amendment to the Declaration identifies, as qualified persons who are eligible for PREP Act immunity, certain pharmacists and pharmacy interns who are not authorized to order and administer certain childhood vaccines to certain children under state law.[10] The Third Amendment preempts narrower state scope-of-practice laws for pharmacists and pharmacy interns who meet the requirements set forth in the Third Amendment. But the Third Amendment does not affect broader state scope-of-practice laws. Thus, states or their sub-units may not impose any requirement that effectively prohibits activities authorized by the HHS Secretary in a PREP Act declaration. Accordingly, state-licensing laws that are less stringent than those in the Secretary’s Declaration are not preempted because they do not prohibit or effectively prohibit the activity in question––namely, vaccination.

Second, any state or local law requiring a pharmacist to enter into a collaborative-practice agreement (which is a protocol required by some states to administer vaccinations to children of certain ages) would be preempted if that requirement prohibits or effectively prohibits a pharmacist from ordering and administering vaccines.

And third, under the PREP Act, “covered countermeasures” include qualified products “manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device.”[11] Under the Third Amendment, CDC-recommended vaccines satisfy the statutory definition of “covered countermeasures.” According to AO 20-03, epinephrine mitigates or treats a serious or life-threatening condition that, in some rare instances, may be a side effect of vaccine administration. Therefore, epinephrine, when used to counteract a CDC-recommended vaccine reaction, is a “covered countermeasure” subject to PREP Act immunity and preemption.

3. Conclusion

These two advisory opinions underscore the breadth of PREP Act immunity, and provide guidance that demonstrates its expansive application to a broad range of entities (including private businesses, public and private transportation providers, public and private schools, and religious organizations) that take reasonable steps to follow public-health guidelines and directives in using covered medical products.

Many questions remain regarding PREP Act immunity that are making their way through the courts, such as whether the PREP Act provides complete federal preemption and serves as a basis for original federal jurisdiction. These advisory opinions, however, are a step in further providing clarity on what may be a litigation game-changer in the age of the COVID-19 pandemic.

[1] The advisory opinions are nonbinding on HHS and the federal courts, and do not have the force or effect of law.

[2] See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198 (Mar. 17, 2020) (Declaration); 85 Fed. Reg. 21,012 (Apr. 15, 2020) (First Amendment); 85 Fed. Reg. 35,100 (June 8, 2020) (Second Amendment); 85 Fed. Reg. 52,136 (Aug. 24, 2020) (Third Amendment).

[3] 42 U.S.C. § 247d-6d(a)(1).

[4] Id. § 247d-6d(a)(4)(B).

[5] Id. § 247d-6d(i).

[6] See Declaration, 85 Fed. Reg. at 15,199.

[7] The PREP Act provides liability immunity to “covered persons” (defined above) against any claim of loss relating to the manufacture, distribution, administration, or use of “covered countermeasures,” which are medical countermeasures including federally approved drugs used to treat COVID-19 and federally approved devices used to prevent its spread, except for claims involving “willful misconduct” as defined in the PREP Act. For more information about PREP Act requirements, please see our previous coverage here, here, and here.

[8] See Declaration, 85 Fed. Reg. at 15,202.

[9] Casabianca v. Mount Sinai Medical Center, 1014 N.Y. Slip. Op. 33583(U), 2014 WL 10413521 (N.Y. Sup. Dec. 12, 2014).

[10] See Third Declaration, 85 Fed. Reg. at 52,138-39.

[11] See 42 U.S.C. § 247d-6d(i)(7)(A)(ii).