On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States. As the country awaits final FDA approval for emergency use of other COVID-19 vaccines, employers are rapidly confronting the implications. For long-term care facilities in particular, availability of a COVID-19 vaccination raises urgent questions such as (1) can employers implement mandatory vaccination programs for their employees and (2) can health care facilities require mandatory vaccination for residents? 

Can Employers Implement Mandatory Vaccination Programs for Employees?

Generally, the answer is yes, but with caveats. Employers may impose mandatory vaccination programs for their employees so long as they consider religious accommodation requests under Title VII of the Civil Rights Act of 1964 (Title VII) and medical accommodation requests under the Americans with Disabilities Act (ADA). Employers also should be cognizant of any equivalent state or local anti-discrimination laws and requirements for religious and medical accommodations.¹

Comparisons can be drawn to mandatory flu vaccination programs long in place, particularly in the health care industry, and specifically allowed under guidance from the Equal Employment Opportunity Commission (EEOC). The EEOC has yet to issue similar guidance for a COVID-19 vaccination and thus it remains unclear how it will treat the vaccines once approved. Since the pandemic began, the EEOC has acknowledged that COVID-19 meets the ADA’s “direct threat standard,” which authorizes more control in the workplace than generally allowed, suggesting the EEOC may be amenable to mandatory vaccination programs. 

Employees wishing to obtain an exemption under a religious accommodation must establish that the vaccine would violate a sincerely held religious belief, practice or observance. Moral, ethical or personal objections are insufficient to obtain an accommodation. Similarly, employees seeking a medical accommodation must establish a qualifying disability under the ADA or state/local equivalent regulations that prevents them from taking the vaccine. If an exemption is requested under either ground, employers must engage in an interactive dialogue with the employee to determine whether a reasonable accommodation is feasible.²

Even if employees can establish qualifying religious or medical grounds for an exemption, employers can deny the request if it would pose an undue hardship or direct threat to the safety of the employee or the public. This is particularly relevant to the health care industry where employees are working in direct patient care. In light of the EEOC’s guidance acknowledging that COVID-19 meets the direct threat standard, it is possible health care facilities will have greater leeway in denying accommodation requests. 

To prepare, employers should consider whether a mandatory COVID-19 vaccination program is necessary and determine the scope of the program. Employers may consider confining the mandate to certain high-risk areas or departments, while allowing other departments to operate with alternative means of limiting the contagion, if possible. To the extent a mandatory program is implemented, employers should be prepared to receive, review and consider religious and medical accommodation requests. Employers may want to have a general “reasonable accommodation” policy in place, but must treat each request individually and engage in an interactive dialogue to ensure potential reasonable accommodations are explored, effective and feasible. Employers also should be sure to maintain as confidential all medical information and vaccination records collected from employees. 

As the COVID-19 vaccines are approved by the FDA, employers and health care providers should continue to monitor guidance and regulations relating to vaccinations in the workplace from the EEOC and other federal, state and local authorities. 

Can Long-Term Care (LTC) Facilities Require Mandatory Vaccinations of Their Residents?

Residents of LTC facilities have, as a general concept, autonomy over their own care and treatment. Whether via their personal decision or that of their legal representative, residents generally have the right to refuse care or treatment, with exceptions involving emergencies and safety. 

With the onset of COVID-19, the New York State Department of Health (DOH) has promulgated guidelines and regulations in an effort to protect the most vulnerable population, residents of LTC facilities. The DOH has issued mandates for visitation to facilities, health checks for personnel entering a facility, COVID-19 testing for all personnel and use of facemasks. If there are confirmed cases of COVID-19 in a facility, DOH mandates that residents remain in their rooms and that they must wear facemasks when direct care providers enter their rooms, unless such is not tolerable. 

Other than separating/isolating residents and requiring the use of facemasks, the DOH has not issued any health advisory or requirements/guidelines as to what can be mandated for LTC residents at this time. The questions of whether LTC facilities can require the administration of COVID-19 vaccine to residents and what recourse the facility has if a resident refuses have not yet been addressed by DOH, but will become an issue when the vaccines arrive. 

New York State is to receive 172,000 vaccine doses, with LTC residents and staff prioritized among the first to receive the vaccine. Facilities will be faced immediately with significant inquiries. 

Can a facility require the administration of the vaccine to residents? The Centers for Medicare & Medicaid Services (CMS), as a condition of participation in Medicare and Medicaid, requires that LTC facilities ensure residents are offered and receive influenza vaccines. Residents, or their representatives, can refuse. Facilities are required to then educate the resident and/or representative about the advantages and disadvantages of receiving the vaccine, and document this discussion. Similarly, LTC facilities may be required to offer and encourage receipt of the COVID-19 vaccine, and document any refusals after thorough discussions. However, because of the high risk of transmission, along with the severe morbidity and mortality associated with COVID-19, more directed guidance is needed from CMS, the Centers for Disease Control and Prevention (CDC), and state health departments. 

What if a resident, or representative on behalf of a resident, of a LTC facility refuses to be vaccinated for COVID-19? Facilities can look for guidance in addressing similar medical issues such as flu, MRSA and C. diff, which are easily transmitted from person to person. Infectious disease management principles should apply. Residents who refuse the vaccine may be deemed as suspected positive for COVID-19 and placed in isolation with a facemask as tolerated, with dedicated staff assigned. This may be challenging for both the resident and the facility. Isolating a resident can affect their quality of life and well-being. Also, a facility may not have the quantity of staff needed to allocate to isolated residents. 

Lastly, can a LTC facility be held liable by a resident if the resident is cared for by an employee who is not vaccinated, and the resident then tests positive? Is there a viable cause of action by the resident for negligence, negligent supervision or intentional/negligent infliction of emotional distress? These are novel issues that facilities may face in the months to come. 

As to whether facilities can be held liable for claims related to the administration of the vaccine, there is protection under the Public Readiness and Emergency Preparedness (PREP) Act, which provides immunity from suit and liability under state and federal law with respect to all claims for loss caused by, arising from, relating to or resulting from the administration to or use by a covered entity or individual who is a “covered person” as defined by the Act. The availability of this broad immunity should be part of every analysis applied to potential and actual suits brought involving COVID-19. 

LTC facilities are on the front line of the COVID-19 pandemic with more than one million residents living in such facilities. The information regarding the distribution of COVID-19 vaccines to LTC facilities is coming in day-to-day and subject to change. Federal and state health agencies will need to provide guidance just as quickly on these specific issues, which will impact who will receive the COVID-19 vaccine in the coming weeks.     

¹ Many jurisdictions have their own laws governing workplace accommodations, which impose different and generally more stringent requirements from federal law. The California equivalent is the Fair Employment and Housing Act, the New York State equivalent is the New York State Human Rights Law and the New York City equivalent is the New York City Human Rights Law. In New York and California, the definition of what constitutes a disability is broader than under federal law and the process for addressing the need for an accommodation also is different. In this regard, the ADA defines “disability" as a physical or mental impairment that substantially limits one or more major life activities. However, under California law disability is defined as an impairment that makes performance of a major life activity difficult, and in New York it is “a physical, mental or medical impairment resulting from anatomical, physiological, genetic or neurological conditions that prevents the exercise of a normal bodily function or is demonstrable by medically accepted clinical or laboratory diagnostic techniques” or a record of same. The New York City law requires that employers engage in a “cooperative dialogue” and the person seeking the accommodation does not have to state that they have a disability or use the phrase “reasonable accommodation.” 

² The laws governing vaccinations and accommodations in the employer/employee context, and specifically as they relate to health care workers, should not be confused with the laws requiring the vaccination of school children. Laws requiring childhood vaccination do not apply in the employer/employee context. For example, in New York, the requirement that school children be vaccinated is found in the Public Health Law and it applies only to students attending schools, i.e., public, private or parochial; child care centers, day nursery, day care agency, nursery school; and kindergarten, elementary, intermediate or secondary schools. Moreover, as of 2019, New York’s school vaccination law does not include a religious exemption, unlike the statutes governing the employer/employee relationship. New York is one of a handful of states that have done away with the religious exemption for its school children’s vaccination requirements. The others are California, Maine, Mississippi and West Virginia. Fifteen states allow philosophical/personal belief exemptions to their school children’s vaccination requirements, including Oregon, Idaho, Arizona, Utah, Colorado, Oklahoma, Texas, Arkansas, Louisiana, North Dakota, Wisconsin, Minnesota, Michigan, Ohio and Pennsylvania.