HHS Issues New Advisory Opinion Regarding the Scope of Immunity Under the Public Readiness and Emergency Preparedness Act

On October 23, 2020, the U.S. Health and Human Services general counsel’s office issued an advisory opinion on two frequently arising questions concerning the Public Readiness and Emergency Preparedness (PREP) Act.¹ Who is a “program planner” under the PREP Act and the Secretary’s declaration? What is the scope of the declaration provision limiting PREP Act coverage to activities authorized by an “authority having jurisdiction”? This advisory opinion “re-emphasizes the breadth of PREP Act immunity” and takes the position that it is not limited to entities “that are part of a government response to the COVID-19 pandemic.”²

On the first question, the advisory opinion states that a “program planner” can include any entity, including a “public or private corporation,” that is carrying out “certain functions, including “supervising or administering a program …” to administer, dispense, or distribute covered countermeasures “in accordance with” the declaration, including by “supplying technical or scientific advice or assistance or providing a facility to administer or use a covered countermeasure.” It explains that “in short, any individual or organization can potentially be a program planner and receive PREP Act coverage.” Companies that are, for instance, involved with planning programs to provide COVID-19 diagnostic tests to their employees, or involved with other programs to provide COVID-19 countermeasures to employees, customers, or others, should consider whether they may be eligible for PREP Act immunity as “program planners.”

On the second question, the advisory opinion explains that the declaration extends PREP Act immunity only to activities that are related to either federal agreements or “activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction” regarding the provision of covered countermeasures. The advisory opinion states that “[p]ublic-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 the Declaration. But to obtain such authorization, a covered person must follow that public-health guidance.”

In other words, an entity “must comply with the public-health guidance issued by an Authority Having Jurisdiction over the person’s activity or location in order to qualify for PREP Act immunity.” The advisory opinion may lead to a complex analysis when there are conflicts among federal, state, and/or local guidance or requirements regarding the same activities. The advisory opinion states that if one “authority takes precedence, a covered person must follow the guidance of the Authority Having Jurisdiction that takes precedence in order to obtain PREP Act coverage.” Which authority “takes precedence” may require a nuanced consideration of the legal force and intent of the particular authorities at issue.

For instance, while federal law generally takes precedence over conflicting state or local law, a local order may “take precedence” over a federal guidance that is nonbinding or not intended to displace state authorities. The advisory opinion gives as an example the Centers for Disease Control and Prevention (CDC) guidance concerning schools, which states that it is “meant to supplement — not replace” state and local requirements, stating “if there were a conflict between that CDC guidance” and a state or local rule or regulation “with which schools must comply, a covered person must rely on guidance of the latter jurisdiction, and not CDC’s guidance, as the basis for PREP Act coverage.”

The advisory opinion clarifies that an entity need not have been specifically authorized or ordered by any agency to undertake particular activities to obtain PREP Act coverage; it is enough that a governmental authority has generally authorized or recommended the activities. However, the advisory opinion’s analysis regarding the effect of conflicts between governmental authorities reinforces the importance of close attention to applicable regulations, orders, and guidances issued by all levels of government.

The advisory opinion also addresses the question whether PREP Act immunity is limited to “provision of a countermeasure to a recipient” or if it can also apply to decisions not to provide medical countermeasures. The advisory opinion disagrees with Casabianca v. Mount Sinai Medical Center,³ which held that PREP Act immunity was not available to a healthcare provider that did not provide a vaccine to the plaintiff because he was not in a priority population. In the advisory opinion, HHS states that Casabianca “was wrong”; PREP Act coverage also includes “management and operation” of programs to provide countermeasures, including decisions on “prioritization” of recipients where there are shortages, provided that those decisions “follow[] CDC directions.” Several recent decisions have followed Casabianca in concluding that “the PREP Act applies to action, not inaction.”⁴ The advisory opinion’s contrary position could be significant, at least in situations where entities are facing shortages in the availability of covered countermeasures, and their decisions on prioritization follow applicable agency guidances. This issue is likely to continue to arise and calls for careful consideration in business planning.

¹ 42 U.S.C. § 247d-6d

² Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act (Oct. 23, 2020), available at https://www.hhs.gov/sites/default/files/advisory-opinion-20-04-hhs-ogc-public-readiness-emergency-preparedness-act.pdf.

³ 1014 N.Y. Slip. Op. 33583(U), 2014 WL 10413521 (N.Y. Sup. Dec. 12, 2014)

⁴ Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074 (D. Kan. Aug. 19, 2020); see also, e.g., Sherod v. Comprehensive Healthcare Management Services, LLC, 2020 WL 6140474 (W.D. Pa. Oct. 16, 2020).