Vaccination Rollout Plans: Considerations to Evaluate Employer Readiness

February 5, 2021 Advisory

On Feb. 2, 2021, the federal government announced new efforts to increase overall weekly vaccine supply to states, tribes and territories to 10.5 million doses nationwide. Included with the efforts is the phase one launch of a federal retail pharmacy program that will distribute approximately 1 million COVID-19 vaccine doses a week directly to pharmacies across the country. While access to vaccinations is still not projected to be widely available to all individuals before the summer months, following the government’s plans to increase vaccine distributions, now is a good time for employers to consider their return-to-work strategies, including workforce vaccination strategies. Employers should stay apprised of the evolving developments in this area as they begin to consider what role, if any, they will take in vaccine distribution to enable employees to get back to their worksites.

Vaccination Strategy: Mandatory or Voluntary?

Employers will first need to consider whether they will mandate that employees be vaccinated prior to their return to the workplace or whether vaccination will be presented to employees as a voluntary option. Employers need to consider several factors in deciding whether to mandate the vaccine. First, most states are following the Advisory Committee on Immunization Practices (ACIP) guidance which recommends prioritizing health care personnel, residents of long-term care facilities, frontline essential workers (including non-health care workers) and individuals age 75 and older in the earlier phases of vaccination. Thus, employers should consider whether they are in an industry that is well suited for employees to have priority access to vaccinations and whether they have a high concentration of employees within the priority roles or in a mix of priority and nonessential roles working side by side or in close proximity of one another. For instance, in businesses designated as essential in state vaccination plans, it may be easier for a critical mass of employees to gain ready access to the vaccine to support consistent application of a business mandate requiring vaccination before the return to work. In other nonessential industries it may be more difficult for workers who do not otherwise satisfy other criteria for early phase vaccination eligibility to access the vaccination in order to satisfy an employer mandate. This will present practical concerns for even-handed application that could be problematic for employers with a vaccination mandate.

In addition to the practical considerations, certain legal considerations may also present operational challenges for mandatory vaccination programs when vaccinations are not yet widely available to all populations. The Equal Employment Opportunity Commission (EEOC) cautions in its guidance that while employers can mandate COVID-19 vaccinations, employers should individually consider each employee’s objection to COVID-19 vaccinations to ensure that a mandate does not discriminate against workers with a disability or those workers who object to the vaccine mandate on the basis of their religion. The EEOC guidance suggests that in circumstances where an employee states an objection on one of these bases to receiving the vaccine, the availability of a reasonable accommodation should be evaluated. Under the Americans with Disabilities Act (ADA) an employer is prohibited from making disability-related inquiries and requiring medical examinations of employees, except under limited circumstances. Under Title VII of the Civil Rights Act of 1964 (Title VII), employers are prohibited from discriminating against employees on the basis of their religion, including their sincerely held religious beliefs which may include objections to vaccines. Additionally, other similar state and local laws also prohibit discrimination based on disability and/or religion.

ADA Vaccination Considerations

The Food and Drug Administration (FDA) recommends that health care providers ask certain questions before administering the COVID-19 vaccine to ensure that there is no medical reason that would prevent a person from receiving the vaccination. For employers this protocol presents the question of whether these pre-screening questions are likely to elicit information about a disability for which ADA considerations may arise. Under the ADA, an employer must be able to demonstrate in its vaccination program that disability-related screening questions are “job-related and consistent with business necessity” if the employer mandates that the employee receive the vaccination as a condition of returning to the worksite. If the employer has a reasonable belief, based on objective evidence, that an employee who cannot be vaccinated because they have refused to answer the screening questions poses a direct threat to the health or safety of themselves or others, then unless the direct threat can be eliminated or reduced through a reasonable accommodation (without undue hardship), the employer can proceed with the employee’s exclusion from the workforce. 

Key to the direct threat analysis is a review of whether there is a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation (i.e. excusing a worker from the vaccination mandate). The “direct threat” analysis is heavily scrutinized by the EEOC, and an employer must engage in an individualized assessment to evaluate the significance of the risk by evaluating:

  • the duration of the risk;
  • the nature and severity of the potential harm;
  • the likelihood that the potential harm will occur; and
  • the imminence of the potential harm.

According to the EEOC, “[t]he prevalence in the workplace of employees who already have received a COVID-19 vaccination and the amount of contact with others, whose vaccination status could be unknown, may impact the undue hardship consideration.” Consideration may be given to whether a role can be performed remotely as a reasonable accommodation. If the position cannot work remotely during the period where vaccination is mandated and no other accommodation can be reasonably provided by the employer without undue hardship, the employer is permitted to exclude the unvaccinated employee from the workplace. However, rather than proceeding straight to termination for such an employee, the employer should engage in an interactive process with the employee to determine if there is a reasonable accommodation that would allow the excluded employee to continue to perform essential job functions without being vaccinated. Other accommodations that may be reasonable include taking leave, working at the jobsite when no other employees are present, or temporarily transferring the employee to an open and vacant position for which the excluded employee is qualified to perform with or without a reasonable accommodation that does not involve potential exposure to other employees or the employer’s customers. Importantly, managers and supervisors should be instructed that it is unlawful to disclose that an employee is receiving a reasonable accommodation or to retaliate against an employee for requesting an accommodation.

Religious Freedom Vaccination Considerations

Similar to the ADA, religious accommodations may also be required if an employee objects to the vaccine based on their religion. Under Title VII, employers must provide reasonable accommodations to their employees who indicate they cannot receive the vaccine due to sincerely held religious beliefs, practices or observations. An accommodation on these bases that poses an undue hardship on the employer can be rejected by the employer as unreasonable. In considering accommodation requests based on religion, employers should take note that what is considered a sincerely held religious belief extends beyond “traditional organized and established” religions with which an employer may be more readily familiar. Employers should therefore tread carefully in challenging the sincerity of an employee’s asserted “sincerely held religious belief” and should consult with counsel where the employer has questions or concerns.

Employer-Sponsored COVID-19 Vaccination Programs at the Worksite: Other Considerations

FDA

Employers who are considering sponsoring a COVID-19 vaccination program at the worksite need to ensure that their program is compliant with regulatory requirements including the FDA. Under the FDA, currently the only COVID-19 vaccinations that are available for use are available under emergency use authorization (EUA). Employer vaccination programs that are administered onsite must comply with the requirements of the individual vaccination EUA requirements. While requirements may vary by EUA, generally these include requirements to “ensure that recipients of the vaccine under an EUA are informed, to the extent practicable under the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.” This information is typically provided in a fact sheet given to patients at the time of the vaccine administration. The patient fact sheet also contains information about the manufacture of the vaccine.   

PREP Act

Employers that strictly adhere to the FDA requirements may be eligible for immunity for their administration of the COVID-19 vaccine for “claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a ‘covered countermeasure.’” “Covered countermeasures” include the administration of COVID-19 vaccines authorized under a EUA from the FDA. Employers should consult with counsel to identify the extent to which the employers’ practices satisfy the Public Readiness and Emergency Preparedness (PREP) Act and the Secretary of Health and Human Services’ applicable declarations under the Act, entitling the employer to immunity for actions taken in furtherance of administering COVID-19 vaccinations.

GINA

Other legal considerations that employers should keep in mind in rolling out a workplace vaccination program are the restrictions under Title II of the Genetic Information Nondiscrimination Act (GINA). Under GINA, employers may not use genetic information to make decisions related to the terms, conditions and privileges of employment, or acquire or disclose genetic information outside of narrow circumstances.

An employer may administer a COVID-19 vaccination program onsite for employees, or alternatively require employees to provide proof that they have received COVID-19 vaccinations, without violating Title II of GINA. To do so, however, the actions cannot involve the use of genetic information to make employment decisions, or the acquisition or disclosure of genetic information. Therefore, employers administering worksite COVID-19 vaccination programs should ensure that pre-screening questions used to determine eligibility for the vaccination program do not ask about genetic information, such as family members’ medical histories in violation of GINA. Additionally, employers that allow for employees to obtain their vaccinations outside of the workplace should also ensure that in validating that the vaccination has been taken, employees do not disclose genetic information to the employer that would violate GINA. Where the vaccination is administered at a third-party location by contracted providers, only the minimum necessary information to confirm that the vaccination was taken should be requested by the employer.

CDC Guidance and State and Local Requirements

Employers also need to ensure that their COVID-19 vaccination requirements and programs comply with CDC guidance and state and local public health orders and regulations. State and local requirements may include requirements by jurisdiction to report demographic information about vaccinations administered at an employer’s workplace.

Confidentiality Concerns

Employers must continue to follow general confidentiality principles to keep employee medical and other personal information confidential, including disability and religious accommodation requests concerning the COVID-19 vaccination program. Employers should refrain from posting pictures of their employees receiving the COVID-19 vaccination on their social media or intranet sites unless consent to do so has been provided. In addition, some employers may also need to consider whether they have additional compliance obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rule.

Costs of COVID-19 Vaccination Programs

There is no mandate that an employer pay for the administrative costs related to the COVID-19 vaccines, however, employers should consider the implications if it does not do so. In the case of a mandatory vaccination program, consider whether the administrative cost of the vaccine would take individual employee pay below minimum wage. If so, then this may present wage-related issues that the employer would need to address. In addition, if an employer is mandating vaccinations, the employer will likely have to pay the employee for the time it takes to receive the vaccination. In the event that the vaccination program is voluntary, there is more latitude for an employer to decide to pay the administrative costs for the vaccination. This decision, however, should be evenly applied among similarly situated employees.

Under the Coronavirus Aid, Relief and Economic Security (CARES) Act, an employer’s group health plan is required to include coverage of the COVID-19 vaccination, at no cost to plan participants, during the period of the public health emergency pandemic. This does not include separate administrative costs. Employers administering the vaccine onsite will need to consider how they will structure the vaccine and administrative costs to employees participating in the vaccination program that are either covered or not covered by the employer’s group health plan.  Furthermore, employers that wish to provide incentives to encourage employee vaccination should consult with counsel to confirm that such incentives comply with wellness-plan requirements, especially given the evolving nature of those rules.

Collective Bargaining Agreements

If the employer has employees covered by a collective bargaining agreement, then the employer would need to inform and bargain on matters that impact wages, health and safety, and other mandatory subjects of bargaining.

Key Takeaways

While employers are generally permitted to require employees to receive COVID-19 vaccinations and may sponsor COVID-19 vaccination programs, employers should be careful to ensure that their programs satisfy their obligations under applicable federal, state and local laws and regulations. Employers should consult legal counsel prior to mandating COVID-19 vaccinations or implementing their own vaccination programs.

Armstrong Teasdale attorneys are actively monitoring and providing updates regarding the impact of COVID-19. For additional information, visit Armstrong Teasdale’s COVID-19 Resource Center.

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