After a year that has required long term care facilities to manage various, often competing, considerations while making a series of difficult decisions, they now are grappling with the question of whether they can require employees to get vaccinated.
Understandably, in the wake of the pandemic’s devastating effects on both residents and staff, LTC facilities are eager to achieve 100% vaccination rates among their employees and mitigate any further risk. From a legal perspective, however, employer-mandated vaccinations remain untenable for the time being.
The EEOC set the stage
Equal Employment Opportunity Commission guidance from December 16, 2020, indicates that neither requiring an employee to be vaccinated nor asking whether an employee has been vaccinated constitutes a “medical examination” under the Americans with Disabilities Act, indicating that a facility could legally require its employees to be vaccinated, subject to certain restrictions discussed further below. However, other federal authorities strongly suggest that implementing such a requirement should be delayed until a vaccine receives full licensure by the Food and Drug Administration.
FDA requirements prevent employer-mandated vaccinations of non-licensed vaccines
COVID-19 vaccines currently are subject to an FDA Emergency Use Authorization. While the vaccines remain subject to an EUA, certain FDA guidance and statutory obstacles appear to prevent LTC facilities from requiring their employees to be vaccinated. For instance, the Food, Drug, and Cosmetics Act mandates that the U.S. Secretary of Health and Human Services establish appropriate conditions to ensure that every individual, prior to receiving a vaccine under an EUA, is “informed . . . of the option to accept or refuse administration” of the vaccine. This statutory requirement is explicitly reflected in the FDA explanation of EUAs, further underscoring the incompatibility of EUAs with employer-mandated vaccinations.
These obstacles to vaccination requirements will persist as long as the vaccines are subject to EUAs. Once they are fully licensed by the FDA, which most sources project could happen in the spring or summer of 2021, the vaccines will not be subject to the EUA statutes and FDA guidance.
Once vaccination mandates are permitted, approach with caution
The EEOC guidance provides several significant restrictions on any vaccination requirement. First, if the vaccine is administered by an employer or a third party contracted by the employer, the CDC-recommended pre-screening inquiries (e.g., asking whether vaccine recipients have a history of allergic reactions to any medications, other vaccinations, etc.) are likely disability-related inquiries under the ADA. Further, asking an employee why they did not obtain a vaccine is likely a disability-related inquiry. The EEOC also reminds employers that, under the ADA, any such inquiries must be job-related and consistent with business necessity.
LTC facilities could avoid this risk if employees are vaccinated by a third party who is not under contract with the LTC facility (e.g., a local pharmacy chain) because the medical pre-screening inquiries are not attributed to the employer under this scenario. The LTC facility could then require proof that the individual received a vaccination without triggering the ADA because inquiry into an employee’s vaccination status is not, on its own, a medical examination or inquiry under the ADA.
Be prepared to make exceptions
Under the ADA, if an employer implements a vaccination requirement then wants to exclude an unvaccinated employee from the workplace, the employer must show that the 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 eliminated or reduced by reasonable accommodation. Similarly, if an employee has a sincerely held religious belief that prevents the employee from receiving the vaccination, under Title VII of the Civil Rights Act of 1964, the employer must provide a reasonable accommodation unless it would pose an undue hardship.
In either situation, an unvaccinated employee could argue that reasonable accommodation would eliminate or reduce the risk of harm and would not impose an undue hardship on the facility. For instance, an unvaccinated employee could be required to continue wearing a mask, socially distance, and undergo daily COVID-19 testing and symptom screening. These analyses are done on a case-by-case basis and will likely depend on the frequency and proximity of a particular employee’s contact with LTC facility residents.
While the updated EEOC guidance allows for mandatory employee vaccinations once a vaccine has received full FDA licensure, LTC facilities should familiarize themselves with these restrictions and be prepared to deal with employee requests for exceptions to the policy under the ADA and Title VII.
Incentives are ill-advised
Offering employees incentives to get the COVID-19 vaccine also presents potential legal issues. Any type of incentives provided to employees to encourage getting vaccinated could violate both the ADA and the Health Insurance Portability and Accountability Act nondiscrimination rules for wellness plans under the Employee Retirement Income Security Act of 1974, as amended.
The ADA permits employers to make medical examinations or inquiries in connection with a wellness program, but only if such a program is “voluntary,” which, according to the EEOC, requires that, among other things, the program offers a reasonable accommodation to persons for whom it is medically inadvisable to participate and that incentives are “limited.” Again, an employee with a medical condition may have a strong argument that the LTC facility can provide a reasonable accommodation. Moreover, what constitutes a “limited” incentive is in flux.
Additionally, when a facility provides or pays for employees’ medical care, including a vaccination, the facility has likely created a group health plan under ERISA. Certain programs that incentivize employees to get vaccinated could create an ERISA compliance obligation. Wrapping the vaccine incentive program into an existing medical plan for ERISA compliance purposes may be considered. However, if any incentive or stipend is extended to employees not enrolled in the health plan, then the facility may need to amend its health plan to provide special coverage for all employees, whether enrolled or not.
Finally, HIPAA nondiscrimination rules require that, for any wellness program that is part of or supplements a group health plan under ERISA, an employer must provide a reasonable alternative for employees with medical conditions preventing participation to otherwise qualify for the incentive. Thus, as with reasonable accommodations under the ADA, there is no guarantee that an incentive-based program will be successful, and there are still attendant legal risks.
Where there’s a will, there’s a way
The optimal approach is for LTC employees to get vaccinated voluntarily. The Centers for Disease Control and Prevention’s Essential Workers COVID-19 Vaccine Toolkit may help LTC facilities educate their employees on the importance and benefits of vaccination against COVID-19. If your facility is considering implementing any policy that will require or incentivize employees to get a COVID-19 vaccine, we recommend consulting with legal counsel to draft the policy and any necessary forms.
Andrew Roach is an associate in Baker Donelson’s Memphis office and a member of the Advocacy Department. He concentrates his practice in litigation with a focus on healthcare and employment law.