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COVID-19

Federal PREP Act Liability Protections for COVID-19 Vaccination

February 2, 2021

Overview

Local health departments play a crucial role in prescribing and administering COVID-19 vaccines and in supervising and administering COVID-19 vaccination programs. This new role has raised questions about the liability protections available to local health departments and their employees under the Federal PREP Act.

Question: If a local health department employee administers a COVID-19 vaccine, to what extent are the employee and the health department protected from liability under the Federal PREP Act?

Answer: The Federal PREP Act provides liability protection to local health departments and their employees for “Recommended Activities” associated with “Covered Countermeasures” such as administering FDA-authorized vaccines. The “sole exception” to the PREP Act’s liability protection is for death or injury caused by a Covered Person’s willful misconduct. Absent willful misconduct, an injured party’s only remedy is to seek compensation through the Countermeasures Injury Compensation Program (CICP). Thus, the Federal PREP Act provides liability protection to local health departments and their employees for prescribing and administering FDA-authorized COVID-19 vaccines as well as for supervising and administering COVID-19 vaccination programs.

The federal Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of the U.S. Department of Health and Human Services (HHS) to issue a Declaration of a public health emergency to protect “Covered Persons” from liability for claims relating to “Recommended Activities” involving “Covered Countermeasures.” The HHS Secretary first issued a PREP Act Declaration relating to COVID-19 on March 17, 2020, with amendments issued on April 15, 2020June 8, 2020August 24, 2020December 9, 2020, and February 2, 2021. While the COVID-19 PREP Act Declaration protects a wide variety of individuals and entities from liability associated with activities related to the COVID-19 pandemic, we describe only the most relevant provisions below.

Under the COVID-19 PREP Act Declaration, as amended:

  • Covered Persons include “program planners” and “qualified persons,” as well as their officials, agents, and employees.
    • Program planners include State, local, or tribal governments and their employees who supervise or administer a program relating to “the administration, dispensing, distribution, provision, or use” of a Covered Countermeasure.
    • Qualified persons include “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures” under State law. Specific to the COVID-19 Declaration, qualified persons also include:
      • Persons authorized as part of the public health and medical response of an “Authority Having Jurisdiction” following a declaration of emergency (discussed further below).
      • Licensed pharmacists who order and administer (as well as supervised licensed or registered pharmacy interns who administer) authorized COVID-19 vaccines to persons ages 3 years or older, if they follow Advisory Committee on Immunization Practices (ACIP) vaccine recommendations, complete specified immunization training programs and obtain CPR certification, and comply with recordkeeping requirements and federal requirements relating to COVID-19 vaccine administration,
      • Healthcare providers using telehealth to order or administer Covered Countermeasures in a State other than the State in which they are licensed or permitted to practice, if they comply with applicable requirements of the State in which they are licensed to practice,
      • Healthcare providers who have an active license or certification permitting them to prescribe, dispense, or administer vaccines under any State’s law (or under the Declaration’s pharmacist provision, described above), as well as physicians, advanced practice registered nurses, registered nurses, and practical nurses who have held an active license or certification in any State within the last five years that is currently inactive, expired, or lapsed, who prescribe, dispense, or administer COVID-19 vaccines in any State in connection with a federal, State, Tribal, local, or territorial vaccination effort or an institution where COVID-19 vaccines are administered, as long as the license or certification is not/was not suspended, restricted, revoked, or surrendered while under suspension, discipline, or investigation by any licensing authority, and the individual is not on the Office of Inspector General’s List of Excluded Individuals/Entities. The provider must (1) document completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Module and, (2) for providers not currently practicing, document an observation period by an experienced provider who confirms competency to deliver the relevant COVID-19 vaccines.
  • Covered Countermeasures include vaccines developed and administered to prevent transmission of SARS-CoV-2, as well as any device used to administer the vaccine, as long as the countermeasure has received an appropriate FDA approval/authorization.
  • Recommended Activities include “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.” “Administration of the Covered Countermeasure” is defined broadly in the Declaration to include not only “physical provision of the countermeasures to recipients,” but also “activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures,” as well as management and operation of countermeasure programs or distribution locations.

Furthermore, the Declaration, as amended, preempts any state law that would otherwise prohibit “qualified persons” from prescribing, dispensing, or administering COVID-19 vaccines. This is intended to “enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 vaccination program.”

The Declaration’s liability protections apply to specified distribution channels, including those involving (1) federal agreements or (2) activities authorized in connection with the public health and medical response of an Authority Having Jurisdiction (e.g., a State or local health department) “to prescribe, administer, deliver, distribute, or dispense Covered Countermeasures,” if the agency has declared an emergency to administer and use Covered Countermeasures. For more information about the meaning of “program planner” and “Authority Having Jurisdiction” under the COVID-19 PREP Act Declaration, see the HHS General Counsel’s Advisory Opinion incorporated into the COVID-19 PREP Act Declaration via the December 9 amendment. The COVID-19 PREP Act Declaration also provides liability protections for private distribution channels in specified circumstances.

The current version of the COVID-19 PREP Act Declaration explicitly extends immunity to situations in which a Covered Countermeasure is not administered to certain individuals due to a limited supply. Specifically, the amended Declaration provides that “where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual” can qualify for PREP Act protection under the COVID-19 Declaration if all other requirements are met (emphasis in original).

Although several courts recently declined to apply PREP Act immunity to situations in which Covered Persons allegedly failed to implement appropriate COVID-19 protocols and provide personal protective equipment (PPE) to employees, interpreting the PREP Act as applying only to claims connected to the use of—but not the failure to use—covered countermeasures, these decisions were issued under prior versions of the COVID-19 Declaration that did not include the above-quoted language. It is not entirely clear whether the courts in these cases were interpreting the PREP Act alone or as extended by the COVID-19 Declaration; thus, it is possible that a court could disavow the HHS Secretary’s authority to extend PREP Act immunity to a Covered Person who does not administer a countermeasure, even due to limited supply. See Casabianca v. Mount Sinai Med. Ctr., Inc., 2014 N.Y. Slip Op. 33583 (N.Y.Sup.Ct. 2014) (refusing to apply PREP Act immunity to a Covered Person’s failure to administer an H1N1 vaccine due to a vaccine shortage, even though the decision aligned with federal and state guidance; however, it appears the H1N1 PREP Act Declaration did not include similar language to the COVID-19 Declaration language quoted above).

That said, the HHS Secretary issued an Advisory Opinion on January 8, 2021 distinguishing between situations in which non-use of a Covered Countermeasure results from conscious decision-making and resource allocation (and therefore may qualify for PREP Act immunity), versus situations in which the non-use results from “nonfeasance” (and are less likely to qualify for PREP Act immunity). The Advisory Opinion states:

Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections. There can potentially be other situations where a conscious decision not to use a covered countermeasure could relate to the administration of the countermeasure. In contrast, the failure to purchase any PPE, if not the outcome of some form of decision-making process may not be sufficient to trigger the PREP Act.

The language of the PREP Act itself supports a distinction between allocation which results in non-use by some individuals, on the one hand, and nonfeasance, on the other hand, that also results in non-use.

For general information about the PREP Act, see the Michigan Department of Health and Human Services document, The Public Readiness and Preparedness Act (PREP): What you need to know. Note that state laws may provide additional liability protection to local health departments and/or their employees when performing health department functions.

Network attorneys are available to answer questions on this and other public health topics at no cost to you, and can assist you in using law to advance your public health initiatives. Contact a Network Attorney in your area for more information. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.