Since the onset of the Severe Acute Respiratory Syndrome Coronavirus 2 (“SARS-CoV-2”) pandemic in early 2020, the federal government has been working diligently through Operation Warp Speed to expedite vaccine development for the prevention of Coronavirus Disease 2019 (“COVID-19”). Given the possibility that one or more COVID-19 vaccines may become available before the new year, it is imperative that employers start considering the implications of this new vaccine, including whether to impose an employee vaccination mandate. Though at this stage, there are a myriad of unknowns, including, for example, restrictions or conditions that may be issued by the Food and Drug Administration (“FDA”), the Centers for Disease Control and Prevention (“CDC”) and/or state health departments, existing employment law schemes and COVID-19 regulations are instructional to begin developing a permissible and well-considered COVID-19 vaccine policy.
The Initial Question: Mandate or Offer?
Initially, the FDA may authorize the use of COVID-19 vaccines through an Emergency Use Authorization (“EUA”). As opposed to traditional FDA approval, which requires a more rigorous process of evaluation, an EUA for a COVID-19 vaccine would permit the use of a vaccine that may be effective for preventing COVID-19 and for which the known and potential benefits outweigh the known and potential risks, where there is no adequate, approved and available alternative. Due to a more limited supply of COVID-19 vaccines at the outset, the CDC has recommended that some groups, including health care workers and long-term care facility residents, receive priority status. Accordingly, health care providers must first be ready to navigate COVID-19 vaccine risks and issues as employers and further understand that these decisions will undoubtedly impact patient care operations, compliance with state and federal regulation of health care providers and public perception.
Recognizing the benefit of an EUA-permitted vaccine, some health care employers are prepared to approach the COVID-19 vaccine with the same policy and procedures used for mandating seasonal flu vaccines. Other health care employers are not comfortable with a mandate at this time, particularly given that the vaccine will not have received traditional FDA approval.
There are risks and benefits attendant to both approaches. Does an optional vaccine policy result in increased absences due to work-related illness, workers’ compensation claims and/or professional liability for hospital-acquired conditions that might have otherwise been avoidable? Does mandating the vaccine create new workers’ compensation risks and reasonable accommodation challenges? Because either approach could negatively impact staff relations and retention during a time in which retention is critical, the employer-employee relationship will be a crucial consideration for health care providers during the vaccine policy planning process. Similarly, planning efforts should anticipate questions and concerns from patients and the public such that employers may be well-advised to have media statements prepared to address their employee vaccination policy.
Existing Workplace Regulatory Frameworks
Anti-Discrimination Laws
Under existing federal laws, including Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act (“ADA”), employers may be permitted to mandate a vaccine as a condition of employment so long as the employer also considers reasonable accommodations for people with religious objections and disabilities, respectively. As per the usual exceptions, an employer is not required to provide a reasonable accommodation that creates an “undue hardship” within the meaning of each statutory scheme or when a reasonable accommodation is not available. Further, in the case of the ADA, a workplace vaccine policy that is either facially discriminatory or has a disparate impact on disabled individuals is permissible where it is necessary to prevent a “direct threat” to the health and safety of the employee or others and the threat cannot be moderated by a reasonable accommodation. Finally, states have their own anti-discrimination laws that may also contain provisions related to workplace vaccination policies that must be dually considered along with federal schemes. More detailed guidance on an employer’s rights and obligations regarding the provision of medical and religious accommodations in connection with mandatory vaccination programs is available here.
CDC, OSHA and Other Governmental Authorities Addressing Infection Control Practices
Under the Occupational Safety and Health Act of 1970 (“OSH Act”), employers are required to provide workers “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.” While this requirement does not itself impose a vaccination standard, in the context of employer policies for influenza vaccines, the OSH Administration (“OSHA”) has proffered that facilities providing health care services must perform a risk assessment of their workplace and that employees need to be properly informed of the benefits of vaccination. OSHA has been under tremendous pressure to respond more aggressively to complaints of unsafe workplace during the pandemic, and we expect that pressure to increase during a Biden administration.
That said, OSHA has its own accommodation-like requirement. The agency has indicated that employees refusing to take a vaccine due to a reasonable belief of a medical condition that creates a real danger of serious illness or death may be protected by whistleblower rights under the OSH Act. Accordingly, application of a consistent, legally compliant policy addressing medical certification for exemption will continue to be important for employers who choose to mandate vaccinations.
Many states also have safe workplace statutes or may be issuing guidance in light of COVID-19. The CDC has and will likely continue to issue various guidance recommendations throughout the SARS-CoV-2 pandemic, as may CMS, The Joint Commission and other accreditation bodies. In crafting a COVID-19 vaccine policy, employers should continue to consider federal and state law, rules and guidance concerning workplace infection control practices.
Unionized Employment
As collective bargaining agreements (“CBAs”) between employers and unions may contain provisions that limit employers’ ability to impose a COVID-19 vaccine requirement, CBAs should be reviewed and considered in the vaccine policy planning process. The imposition of a vaccine requirement is a mandatory subject of bargaining that would require notice to the union and an opportunity to bargain. In the absence of language conferring to management the right to impose a vaccination requirement without bargaining, employers would be limited in their ability to unilaterally impose a COVID-19 vaccine requirement.
Injury Compensation & Employer Immunity
Workers’ Compensation
The terms of the applicable state workers’ compensation program determine whether coverage is available for an injury or illness occurring after the administration of an employer-mandated, FDA-authorized COVID-19 vaccine. However, it is likely that such injuries or illnesses would be compensable in the same manner that other workplace injuries and illnesses are compensable, regardless of whether the COVID-19 vaccine was EUA-permitted or received traditional FDA-approval. Further, coverage may also be available where the employer merely encouraged vaccination, particularly where the vaccine served a business purpose or benefited the employer. However, whether workers’ compensation would be an injured worker’s exclusive remedy is subject to the relevant state statutory schemes and common law, including, in some states, consideration of an employer’s negligent or reckless conduct. Accordingly, consideration of the state’s current position on exclusive remedy may be important in an employer’s vaccination policy development.
PREP Act Liability Protection
The Public Readiness and Emergency Preparedness (“PREP”) Act provides immunity from liability to certain individuals and entities, including manufacturers, distributors, program planners and those who prescribe, administer and dispense medical countermeasures that constitute a qualified pandemic or epidemic product during a Public Health Emergency (“Covered Countermeasures”), including FDA-authorized vaccines. This immunity is granted against all claims for any type of loss, including death, physical or mental injury, fear of injury, and property damage, excluding claims involving “willful misconduct.” As such, PREP Act immunity may afford employers another layer of protection where the employer administers a COVID-19 vaccine on its premises in accordance with its instructions (irrespective of whether the vaccine was EUA-permitted or FDA-approved). The Countermeasures Injury Compensation Program (“CICP”) was established to fund covered injuries due to the administration of Covered Countermeasures, including drugs and biologics that are authorized for emergency use, under investigational use in accordance with FDA regulations, or otherwise authorized for marketing by FDA. Such drugs and biologics include antivirals, neutralizing monoclonal antibodies and the COVID-19 vaccine. As the CICP is the payor of last resort, health insurance and workers’ compensation payments would be used to offset injury costs.
Practical Takeaways
With an FDA-authorized COVID-19 vaccine looming around the corner, employers must begin developing a plan for the workplace. Since current employment regulatory frameworks and COVID-19 regulation can provide an initial planning template, existing resources and tools previously used to develop other workplace vaccine and infection control policies can be leveraged to meet new challenges in the COVID-19 context. Accordingly, employers should start adapting current vaccine-related practices and policies to fashion an effective and well-considered plan for the COVID-19 vaccine, including:
- Establishment of a Planning Committee for determination of vaccination as mandated or optional
- If mandated, determine if mandated for all or certain job classes/facilities; in what order of priority
- If mandated, identify reasonable accommodation alternatives for those who are exempted
- Develop vaccine exemption request forms
- Develop vaccine exemption policy and procedure
- Establish multi-disciplinary review committee for exemption requests
- Determine whether informed consent for the vaccine will be required under applicable state or federal guidance
- Develop a tracking system and reporting process for vaccinations provided in compliance with vaccine requirements
- Evaluate the need to modify existing policy
- Train managers and supervisors on any new or modified policy
- Ensure that someone is designated as the spokesperson for questions on vaccinations from employees, the community and the media.
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Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
