The Doctor’s Advocate | First Quarter 2021
Government Relations Report

PREP Act Liability Protections for COVID-19: Countermeasures and Vaccine Administration

Remi Stone, JD, Regional Director, Government Relations, The Doctors Company

In 2005, Congress passed and the president signed into law the Public Readiness and Emergency Preparedness Act (PREP Act). The act facilitates the development and implementation of medical countermeasures during a federally declared emergency by limiting liability for those who administer the countermeasures.

The PREP Act provides “liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving ‘willful misconduct’ as defined in the PREP Act.”^1(p1) 

The PREP Act protections shield manufacturers and distributors of covered countermeasures and program planners (that is, state and local governments and employees, along with others who supervise and administer programs that dispense, distribute, provide, or use a covered countermeasure). Importantly, the act includes “qualified persons” who are licensed healthcare professionals and other persons who are authorized to prescribe, administer, or dispense covered countermeasures.

Until the advent of the COVID-19 pandemic, the law and its broad application were relatively obscure. On March 17, 2020, then U.S. Department of Health and Human Services (HHS) Secretary Alex Azar issued a declaration under the act to provide limited immunity for covered persons implementing countermeasures necessary to combat the virus. In our current pandemic circumstances, covered countermeasures include any antiviral, biologic, diagnostic, devices, drugs, respirators, or vaccines to prevent, diagnose, treat, mitigate, or cure COVID-19 and its mutations.

Since the March declaration, an advisory opinion and four amendments to the declaration have been issued to clarify the act’s limited liability umbrella. Clarifications range from the use of telehealth to respirators. A recent amendment corresponds with the rollout of the vaccines. Among its clarifying directives is immunity for providers who administer the COVID-19 vaccine.

On December 3, 2020, then Secretary Azar declared that liability protections will be afforded to covered persons who “manufacture, test, develop, distribute, administer, or use” the COVID-19 vaccine.^1(p23) The liability protections were triggered when the vaccine was defined as an approved covered countermeasure. In addition, the scope of the PREP Act was clarified to acknowledge that situations exist when not administering a covered countermeasure is appropriate and can fall within the act’s liability protections.^1(p24)

For purposes of administering the COVID-19 vaccine, the amended declaration includes in its definition of covered persons those who are authorized under law to “prescribe, administer, deliver, distribute or dispense” the vaccine and includes pharmacists who meet specific training requirements.^1(p17)

Recognizing the important role that telehealth plays in patient care and facilitating public health mitigation strategies, the December 3 amendment provided clarity to “help maximize the utility of telehealth” by detailing the nature of telehealth service providers within its covered persons definition.^1(p9)

The amendment makes clear that the PREP Act’s limited liability protections include authorized healthcare providers, who may administer covered countermeasure care via telehealth technologies to patients in a state other than the state in which the healthcare provider is licensed, as long as the provider is complying with the legal requirements in the provider’s home state that are necessary for practicing telehealth. In addition, it preempts “any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth.”^1(p9)

Interestingly, the HHS advisory opinion states that the PREP Act preempts state and local laws, too. While the advisory opinion is currently untested, it may negate state tort laws that would allow a person to sue a provider who delivers care covered under the act during the pandemic, unless the provider acts with willful misconduct.

Patients can seek compensation through a fund that runs in tandem with the PREP Act. The Countermeasures Injury Compensation Program allows individuals who are seriously injured or killed by the administration of a covered countermeasure to seek compensation, regardless of whether the injury or death was the result of willful misconduct.

In general, liability protections became effective February 4, 2020, and continue through the final day of the federal declaration of emergency or October 1, 2024, whichever occurs first. Manufacturers are granted an additional 12 months for the disposal of countermeasures. Liability protections for respiratory protective devices became effective March 27, 2020, and liability protections for COVID-19 vaccine countermeasures began on December 3, 2020.

In response to the limited scope of the PREP Act, The Doctors Company has continuously advocated at national and state levels for liability protections for healthcare providers during the pandemic.

Learn More

To learn about the liability protections enacted in your state, visit our Legislative, Regulatory, and Judicial Advocacy page.

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