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.
VACCINE LEGAL ISSUES: LIABILITY AND INSURANCE
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:
- Is the activity a covered countermeasure?
- Is the activity recommended?
- Who are covered persons?
- Does the activity fit within the HHS declaration’s limitations on distribution?
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
- establishing a program for vaccination of employees;
- retaining a vendor to administer vaccines to employees; or
- providing the use of a company facility for administration of vaccines.
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:
- Ensuring healthcare professionals can cross state lines to administer vaccines without fear of violation of state licensing or other prohibition.
- Adding qualified personnel to the category of qualified persons covered under the PREP Act to include any federal government employee, contractor, or volunteer who would distribute or dispense the vaccine.
- Further expanding protection to midwives, paramedics, advanced or intermediate emergency medical technicians (EMTs), physician assistants, respiratory therapists, dentists, podiatrists, optometrists, and veterinarians administering COVID-19 vaccines.
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:
- Coordinate the vaccine distribution program with and obtain approval from the Centers for Disease Control and Prevention (CDC) as well as a governmental entity such as a state or local health department.
- Address in vendor arrangements who will administer the vaccines (such as healthcare providers or pharmacies).
- Define the role of the employer as a “program planner” in coordinating the administration of vaccines.
State Law: A Patchwork Approach
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 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.
VACCINE LEGAL ISSUES: ENFORCEMENT
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:
- Uptick in state attorney general and US Department of Justice (DOJ) investigations related to CDC/HHS public health protocol compliance (infection control and prevention).
- Expect broad government scrutiny of vaccine rollout issues to include distribution and supply chain issues.
- Current DOJ COVID-19 task force has focused on criminal scams in misuse of Paycheck Protection Program (PPP) and other COVID-19 relief funds.
- The Federal Trade Commission (FTC) is ramping up attention on vaccine scams related to surveys, vaccine cards, and purchase access issues.
- No immunity for administrative, civil, and criminal enforcement. Healthcare professional licensure and scope of practice have been the subject of potential immunity.
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:
- Create a checklist and confirm all PREP Act requirements and specific HHS declaration COVID-19 requirements.
- Assess and document steps to establish and comply with PREP Act requirements for covered countermeasures and status as a covered person.
- Ensure that the provider can meet the good-faith standard of covered persons engaging in recommended activities for covered countermeasures.
- Determine any actions through authority under jurisdiction that may expand immunity, including for volunteers.
- Investigate all state declarations, orders, and benchmark immunity requirements.
- Assess use of COVID-19 waivers or contract amendments to incorporate PREP Act or other immunity provisions or establish assumption of risk defenses.
- Determine insurer position on whether and how coverage (including duty to defend) is impacted by PREP Act and related immunities.
For more on this topic, check out our liability and insurance program, which is part of our Privatization of the Vaccine Rollout webinar series.