As the COVID-19 pandemic continues to spread and, in some areas, threatens to overwhelm existing health care resources, the first of what is expected to be several COVID-19 vaccines is now available. On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years and older. It is expected that additional vaccines will be approved in the coming weeks or months.

Because of limited supplies of the vaccine, the Centers for Disease Control and Prevention (CDC) has recommended that health care personnel1 and residents of long-term care facilities be the first groups to receive the vaccine. Now that the vaccine is available, health care employers are developing vaccination programs for their workforce and asking whether these programs should be voluntary or mandatory.

Background

The CDC estimates that there are approximately 21 million health care workers in the United States. As of mid-December 2020, there were more than 249,000 confirmed COVID-19 cases and 866 deaths among health care personnel. Currently, there is an insufficient quantity of the Pfizer vaccine to immunize all health care personnel and residents of long-term care facilities.

As a result, health care employers are now faced with making a decision about whether or not to mandate the COVID-19 vaccine for some or all of their employees. Neither the FDA nor the CDC requires that health care personnel receive the COVID-19 vaccine. Indeed, the terms of the EUA require health care providers to give a Fact Sheet to vaccine recipients that reminds the individual it is their "choice" to receive the vaccine.2 The Occupational Safety and Health Organization (OSHA) has also not addressed this topic. However, on December 16, 2020, the EEOC updated its technical assistance publication titled What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws (Guidance) to include a section on COVID-19 vaccinations. The Guidance provides that mandatory vaccine programs for employees are acceptable so long as the employees receive the vaccine from a third party provider that does not have a contract with the employer (or that the employer can establish its vaccine requirements are job-related and consistent with business necessity) and there is a mechanism for accommodating objections to taking the vaccine if based on an employee's disability or sincerely held religious belief. The guidance provided by the EEOC is discussed below.

Mandatory Vaccine Programs - Legal Considerations

Historically, health care employers have been able to mandate that their employees get certain vaccinations. Currently the CDC recommends (but does not require) that health care workers get vaccines for Hepatitis B, Influenza, Measles, Mumps, and Rubella (MMR), Varicella (chickenpox), Meningococcal, and Tetanus, Diptheria, and Pertussis (Tdap). Some states have gone farther and require that health care workers be immunized against specific diseases.3 For example, 18 states currently have some type of influenza vaccination requirements for hospital health care workers. In California, Colorado, Massachusetts, Nebraska, New Hampshire, New York, Rhode Island, and Tennessee, the flu vaccine is mandatory for hospital workers.4 A number of courts have upheld a health care employer's right to mandate the influenza vaccine for health care workers provided that there are exemptions for employees with disabilities or employees who have a religious objection to receiving a vaccine.

In establishing any type of mandatory COVID-19 vaccination program, health care employers are well-advised to take the following legal considerations into account.

Federal Non-Discrimination Law (Americans with Disabilities Act and Title VII)

As noted above, the EEOC updated its COVID-19 technical assistance publication to include a section on vaccinations. Essentially, the EEOC has said all employers can require mandatory vaccines as long the employer: allows employees to receive the vaccine from a third party that does not have a contract with the employer (or establishes that the vaccine requirements are job-related and consistent with business necessity); and follows accommodation requirements under the Americans with Disabilities Act (ADA) and Title VII.

Revised EEOC Guidelines

The main legal restriction on requiring employees to be vaccinated comes from the ADA, which contains strict restrictions on an employer's ability to require employees to undergo a medical examination and make disability-related inquiries. The EEOC stated in its guidance that a vaccine is not a medical examination and that asking employees about whether or not they have been vaccinated is not a disability-related inquiry. (On the latter point, at least one federal court has arguably held to the contrary, holding that inquiring about whether an employee is immune to a disease is a disability-related inquiry).

However, the EEOC also stated that pre-screening questions asked by the employer or a contractor administering the vaccine at the employer's request, "may" implicate the ADA's provision on disability-related inquiries as they are "likely" to elicit information about a disability.5 Thus, if an employer administers the vaccine, or a contractor does so on its behalf, the employer must show that such pre-screening questions are job-related and consistent with business necessity. To meet this standard, an employer must demonstrate that an employee who refuses to answer pre-screening questions, and therefore cannot receive the vaccine, will pose a direct threat to the health or safety of him/herself or others.

Notwithstanding the above, the EEOC identified two scenarios in which an employer can ask such pre-screening questions without making a showing that they are job-related and consistent with business necessity.

  • Voluntary programs:  If an employer offers vaccination to employees on a voluntary basis and the decision to answer the pre-screening questions is also voluntary, this will not pose an issue under the ADA. The employee can choose not to answer the questions, and the only consequence will be that the employee will not receive the vaccine.
  • Vaccine provided by third party.  If the employer mandates that employees receive a COVID vaccine and an employee receives the vaccine from a third party with whom the employer does not have a contract, the ADA restrictions on disability-related inquiries are not implicated. Given this last point, it is permissible for all employers under the ADA to mandate the COVID vaccine (subject to accommodation requests as described below) as long as the employees receive the vaccine from a third party pharmacy or other medical provider with which the employer does not have a contract.

Unlike most employers, health care employers are more likely to have the capability of administering the vaccine program directly to its employees and are also more likely to require the vaccine—at least for patient facing positions. While health care employers should be able to establish that the screening questions are job-related and consistent with business necessity, employers should take into account the risks posed by eliciting this disability-related information from its employees. At a minimum, employers will want to ensure that any pre-screening information is not housed in an employee's personnel file, that this information is only shared with individuals who need this information to administer the vaccine, and that the information is treated as confidential medical information in accordance with the ADA.

Reasonable Accommodation Issues Under the ADA

With respect to mandating vaccines, the EEOC Guidance states that the ADA allows an employer to have a qualification standard that includes "a requirement that an individual shall not pose a direct threat to the health or safety of individuals in the workplace." However, if a safety-based qualification—such as a vaccination requirement—screens out or tends to screen out an individual with a disability, the employer must show that an unvaccinated employee would pose a direct threat due to a "significant risk of substantial harm to the health or safety of the individual or others that cannot be reduced by reasonable accommodation." (emphasis added)

The EEOC advised that employers should conduct an individualized assessment of four factors to determine whether a direct threat exists:

(1) the duration of the risk;

(2) the natured and severity of the potential harm;

(3) the likelihood that the potential harm will occur; and

(4) the imminence of the potential harm.

The EEOC further explained that a determination that an individual presents a direct threat would necessarily "include a determination that an unvaccinated individual will expose others to the virus at the worksite."

Even if such a determination is made, the employee cannot be excluded from the workplace or subject to any other action unless there is "no way" to provide a reasonable accommodation (absent undue hardship) that would eliminate or reduce the risk posed by the unvaccinated employee. Exclusion from the workplace is not the same as termination from employment, as employees may be entitled to telework or take leave provided by law or under the employer's policies.

In addition, employers must still engage in the interactive process regarding disability-related requests for accommodation. The EEOC stated that in determining whether there is undue hardship, the employer should consider the number of employees who have already been vaccinated in its workplace and the amount of contact the employee will have with others whose vaccination status is unknown. Employers may also consider CDC recommendations concerning what might be an effective accommodation and consider OSHA standards and guidance concerning particular job duties and workplaces. Such accommodations might include: allowing an employee to work remotely (where possible), requiring that the employee wear a mask or other personal protective equipment, receive periodic COVID-testing and socially distance where possible, or transferring the employee to a non-patient facing role.

Religious Accommodation Issues

Concerning religious objections, the EEOC opined that, once an employer is on notice that an employee's sincerely held religious belief, practice, or observance prevents the employee from receiving the vaccination, the employer must provide a reasonable accommodation unless it would pose an undue hardship under Title VII, which has been defined by courts as more than a de minimus  cost or burden on the employer. The EEOC reiterated its prior guidance that employers should normally assume that an employee's request for a religious accommodation is based on a sincerely held religious belief. However, if the employer has an objective basis for questioning the religious nature or sincerity of the belief, the employer can request documentation. At least one federal court has held that being an "anti-vaxxer" is not a religious belief. If there is no accommodation possible for an employee with a sincerely held religious objection to receiving the vaccine, the employer may exclude the employee from the workplace if it can establish undue hardship under Title VII standards.

Even though health care employers can mandate the vaccine, they should be prepared for an influx of requests from employees to be exempted from taking the vaccine. Employers will need to train managers and human resources personnel how to handle exemption requests and the types of accommodations that should be considered in responding to a request. Employers should also specify the types of information that managers and Human Resources personnel can request from employees (e.g., health care provider certification, certification from religious/spiritual leader) to support their exemption request. Each request should be individually assessed and employers should carefully document the request for an exemption, subsequent communication with the employee about the need for an accommodation, and the ultimate resolution. In order to minimize risks, it is important that employers set up a process that assists managers and Human Resources personnel to handle requests appropriately and consistently.

OSHA

Historically, OSHA has not mandated employee vaccinations, but has indicated that employers may do so. OSHA has not yet provided guidance regarding COVID-19 vaccines and the existing guidance does not paint a clear picture as to what position OSHA will take. In an interpretation letter dated November 9, 2009 concerning the H1N1 vaccine, OSHA stated that while health care employers may require employees to take vaccines, "an employee who refuses vaccination because of a reasonable belief that he or she has a medical condition that creates a real danger of serious illness or death (such as a serious reaction to the vaccine) may be protected under Section 11(c) of the Occupational Safety and Health Act (OSH Act) of 1970) pertaining to whistle blower rights." This position reinforces the need for a robust accommodation process to accompany any mandatory vaccine program.

There is some possibility that OSHA could require certain employers (like health care providers) to implement a mandatory vaccination program. Under the General Duty Clause of the OSH Act (Section 5(a)(1)), employers are required to "furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees." Although not anticipated, OSHA could take an aggressive position that health care employers who fail to implement a mandatory vaccination program are failing to provide a workplace that is "free from recognized hazards." The only similar regulation in effect is under the Blood-borne Pathogens Standard, which requires employers to make a Hepatitis B vaccine available to employees. To the extent that OSHA weighs in, it seems more likely that they would recommend employers institute programs that strongly encourage but do not require employees to get the COVID-19 vaccine.

The National Labor Relations Act

Both union and non-union health care employers should be mindful of Section 7 of the National Labor Relations Act, which protects employees' right to engage in protected concerted activity and makes it unlawful for an employer to interfere with or restrain employees in the exercise of this right. If employees join together to protest an employer's COVID-19 mandatory vaccine program (or lack of a program) and the employer takes adverse action against those employees as a result, it could lead to unfair labor practice charges being filed against the employer with the National Labor Relations Board. 

Health care employers with a unionized workforce should examine their collective bargaining agreements to determine the extent of their duty to bargain with the union over vaccine programs. Employers may need to consider whether their management rights clauses should be renegotiated with this in mind. But, even if a collective bargaining agreement gives the employer the right to unilaterally institute such programs, employers may want to consider at least consulting with the union when developing such programs in order to foster goodwill with the union and to increase employee buy-in.

Non-union employers should also consider how instituting a COVID-19 vaccine program might affect their union avoidance strategy. When employees feel as though their employer is not listening to their concerns or adequately communicating with them, they are more likely to turn to labor unions for help. Employers should consider:

  • Could the position that the employer takes regarding a COVID vaccine program change employees' views on the potential benefits of bringing in a union and/or give union organizers more leverage in their efforts to organize employees?
  • To what extent is the employer going to consider employee concerns about efficacy, side effects, and/or general fears about or aversions to vaccines, and how is the employer going to communicate with employees about those concerns?
  • How is the employer going to balance the concerns of employees who resist the vaccine against employees who want all employees in the organization to get vaccinated?
  • Should the employer consider alternatives for employees who are reluctant to get the COVID-19 vaccine, such as transfers to a non-patient facing position, the option to wear a face covering, or work from home?

Workers Compensation

Another issue for health care employers to consider is whether a mandatory COVID-19 vaccination program could lead to an increase in workers' compensation claims. Although the question of whether workers' compensation laws apply to harm and side effects allegedly caused by COVID-19 vaccinations will vary case-by-case and state-by-state, it is possible that state systems could cover injuries suffered as a result of employees' reactions to a COVID-19 vaccination, particularly if an employer mandated that its employees receive the vaccinations. Factors that generally favor a finding that workers' compensation applies include whether an employer encouraged the vaccination, whether the vaccination occurred at work or was paid for by the employer, and whether the vaccination served a business purpose.

State Laws

Without a specific mandate from the federal government, it is likely that states will take differing approaches with respect to vaccine programs. Some states may mandate that certain groups of health care workers be vaccinated while other states will likely make any vaccine program voluntary. States may be more likely to mandate vaccines now that the EEOC has taken the position that such mandatory programs are permissible, particularly if other federal regulatory agencies (e.g., CDC, OSHA) follow suit. Regardless, employers will need to stay up to date on applicable state and local requirements regarding vaccine requirements.

Other Considerations

Aside from these legal considerations, there are a number of other issues that health care employers may want to consider in the design and implementation of any COVID-19 vaccine program.

  • Leading from the top - Unlike annual flu vaccine programs, employees may be skeptical (for various reasons) of any COVID-19 vaccine offered by an employer. Business leaders should consider demonstrations of personal commitment to any mandatory or voluntary vaccine program, as a way to build employee trust and compliance. Participation by well-respected members of the medical community may put employees at ease, increase voluntary compliance, and reduce objections and disputes.
  • Political atmosphere - Given the current politicization of topics related to COVID-19, employees may react negatively to a program that mandates vaccines or take issue with other employees who are reluctant to get the vaccine. Employers will want to focus on the facts related to the efficacy and safety of the vaccine being offered as well as the safety of patients, customers, and coworkers—avoiding political talking points and justifications. In a unionized environment, employers may be able to partner with the union to align on messages of safety and other shared areas of concern.
  • Staffing shortages - In developing a vaccine program, organizations will also want to consider the effect that a mandatory vaccine program may have on its staffing. As a result of the pandemic, many health care organizations are already facing staff shortages caused by the increase in patients as well as the loss of employees who have contracted COVID-19 and are unable to work. A mandatory vaccine program may further diminish an organization's staffing resources if a sizeable portion of the employee population opts to leave their job rather than get the vaccine. In the Spring of 2020, traveling clinicians were able to relieve some staffing challenges, but those options are less available this Fall and Winter because of the widespread nature of the pandemic. While the steps outlined above may assist in reducing opposition to the vaccine, employers who institute a mandatory vaccine program will need to consider the consequences such a program may have on its staffing.

While COVID-19 vaccines present an array of legal and morale issues for employers, they also promise hope of reducing the spread of COVID-19 and easing the current burden on health care organizations.

Footnotes

1. Health care personnel (HCP) refers to all paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP may include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the health care facility, and persons (e.g., clerical, dietary, environmental services, laundry, security, maintenance, engineering and facilities management, administrative, billing, and volunteer personnel) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted among from HCP and patients.

2. Specifically, the Fact Sheet states: "It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care." This statement appears to be addressed to the patients of the health care provider who is administering the vaccine. It is unclear how this statement would affect an employer mandated COVID-19 vaccine program, if at all.

3See,  https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html.

4Seehttps://www.cdc.gov/phlp/docs/menu-shfluvacclaws.pdf.

5. As noted in the Guidance, the CDC recommends that health care personnel who administer vaccines should always screen patients for contraindications and precautions before a vaccine is administered. Accordingly, health care employers should assume any pre-screening questionnaire may elicit information about a disability.

Originally published by theAmerican Health Law Association on the 21st of December, 2020

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.