The recent rollout of various COVID-19 vaccines has raised many questions around their availability, distribution, and requirements for employers and other groups, including essential insurance, liability, and enforcement considerations. Here we provide key legal and regulatory perspectives for those organizations providing access to the vaccines and/or mandating vaccination. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease and what employers contemplating the administration of a closed point-of-delivery (POD) vaccination program need to know.
The federal Public Readiness and Emergency Preparedness (PREP) Act offers potentially sweeping and broad protection from liability for a number of specific activities relating to vaccination. Additionally, a number of states have stepped up to enact liability protection for businesses, organizations, and individuals with respect to COVID-19 claims.
Federal Law: The PREP Act
The PREP Act enables the US Health and Human Services (HHS) secretary to issue a declaration to provide federal and state liability immunity to “covered persons” against any claim of “loss” relating to the manufacture, distribution, administration, or use of “covered countermeasures,” except for claims involving “willful misconduct.” In March 2020, an HHS declaration pertaining to COVID-19 was published, making the PREP Act applicable to COVID-19.
To secure the protection of the PREP Act, the following four aspects must be evaluated and met:
In addition to manufacturers and distributors of vaccines, and licensed healthcare professionals who administer the vaccines, program planners, individuals, or entities that supervise or administer a vaccination program also potentially benefit from the protections of the PREP Act. This includes, for example, employers. A private employer may potentially qualify as a “program planner” with respect to COVID-19 vaccination by
A number of amendments have been made to the HHS declaration as a result of the desire to encourage and empower vaccine administration, including those aimed at reducing workforce barriers:
If done properly, a private employer considering the administration of a closed POD vaccination program can receive the protection of the PREP Act. The following considerations should be made by employers before proceeding with formal programs:
Some states have made efforts to provide protection to healthcare providers with respect to the treatment of COVID-19, while others have taken broad action granting immunity from claims related to the virus. The most critical factor for companies, even if they operate in a state without liability protection, is to be able to demonstrate that they have complied with government and OSHA requirements and standards as well as state and local health laws.
State laws differ with respect to whether organizations can mandate vaccines and what exemptions can be available to individuals, including medical, religious, and philosophical exemptions. Resulting legal issues may include everything from ensuring employee benefits plans are not breeched to complying with vaccine storage requirements. It is imperative for companies to look at the laws of the state or states in which they are operating to determine protection.Insurance
Insurance protection for employers with respect to claims by employees varies from state to state and depends on whether vaccination has been mandated and where it occurs. Potential for workers’ compensation protection is a necessary consideration when employers decide whether to offer employee vaccination or make it mandatory. Additionally, commercial general liability (CGL) insurance is another possible area for insurance protection.
Current Enforcement Trends
The federal government has a robust task force that has sought out those misusing COVID-19 relief funds. A selection of enforcement trends to date include the following:
Conducting an Immunity Assessment
It is important for companies to consider how strong and durable immunity will be in the near future and if it will be retracted as some executive orders have been. Organizations should benchmark where they may be on the immunity scale through the following steps:
For more on this topic, check out our liability and insurance program, which is part of our Privatization of the Vaccine Rollout webinar series.