Long-term care facilities have been the epicenter of COVID-19 infections and deaths. According to the Centers for Disease Control and Prevention (“CDC”), nursing homes and other long-term care populations are at a high risk of being affected by COVID-19 due to their congregate nature and high risk population. The CDC reports that as of December 20, 2020, there were 471,953 nationwide cases of COVID-19 cases among long-term care residents, which resulted in 92,373 deaths from COVID-19. The total confirmed COVID-19 cases for long-term care facility employees during the same period of time was 402,956 nationwide, which resulted in 1,268 deaths from COVID-19. Hopefully, with the development and distribution of COVID-19 vaccines, there will be a significant decline in cases and deaths from COVID-19 in long-term care facilities.  
 
On December 11, 2020, the U.S. Food and Drug Administration (“FDA”) approved a COVID-19 vaccine for emergency use, thereby permitting the nationwide distribution of the Pfizer vaccine. On December 18, 2020, the FDA issued an emergency use authorization for the nationwide distribution of the Moderna COVID-19 vaccine. The availability of the COVID-19 vaccines brings hope that the worst is behind us, but it also raises many new challenges for operators of long-term care facilities. With the vaccines now being distributed and with state phased distribution plans placing long-term care facility employees and residents at the head of the line to receive a vaccine, important questions arise regarding long-term care facilities' duty to inoculate staff and residents, and whether that duty extends to requiring that their facilities' staff and residents take the vaccines. This article address to what extent long-term care facilities can require their employees and residents to take a COVID-19 vaccine, and the liability associated with both mandating and not mandating that they take a COVID-19 vaccine.  
 
Long-Term Care Facilities Can Require that Their Employees Receive the COVID-19 Vaccine, with Exceptions
 
Long-term care facilities can require facility employees to receive the COVID-19 vaccine as a condition of employment. However, the rule is not absolute, and there are important exceptions that managers of long-term care facilities must understand. On December 16, 2020, the U.S. Equal Employment Opportunity Commission (“EEOC”) issued guidance regarding whether employers can require mandatory COVID-19 vaccines. The guidance states that employers may require employees to get the COVID-19 vaccine, subject to exceptions. These exceptions include physical disability, pursuant to the Americans with Disabilities Act ("ADA"), and sincere religious objections, pursuant to Title VII of the Civil Rights Act of 1964.
 
The EEOC provided guidance on how employers should respond to an employee's objection to receiving COVID-19 vaccine due to a physical disability. The ADA bars employers from requiring medical examinations that seek information regarding an employee’s physical or mental conditions. However, an employee's vaccination status is not included in this prohibition. If an employee indicates that he or she cannot get the vaccine due to a disability, employers should conduct an assessment on whether the employee poses a direct threat to the health and safety of other facility employees and/or residents. The guidance put forth by the EEOC states that “[a] conclusion that there is a direct threat would include a determination that an unvaccinated individual will expose others to the virus at the worksite.” An employee is entitled to reasonable accommodations unless there is no way to provide a reasonable accommodation absent undue hardship. Reasonable accommodations in a long-term care facility setting may include the mandatory use of masks, or transferring an employee into a different position that does not allow for interaction with residents. If the employer cannot reduce the threat, it can prevent the employee from physically entering the workplace, but that does not mean that the employer can automatically terminate the employee.
 
Title VII of the Civil Rights Act of 1964 prohibits employers from discriminating against employees based on religion. Pursuant to Title VII, once an employer gets notice that an employee’s sincerely held religious belief, practice, or observance prevents him from getting the vaccine, the employer must provide a reasonable accommodation unless it would pose an undue hardship. An example of a reasonable accommodation is requiring the employee with the sincerely held religious belief to wear a mask. However, what constitutes a reasonable accommodation may be different for employees who have patient contact versus those who do not. Thus, employers should consider reasonable accommodations on a case-by-case basis. Title VII religious accommodation causes “undue hardship” whenever the accommodation results in “more than a de minimis cost” to the employer. Undue hardship includes a case-by-case assessment by the employer including “assessment of the public risk posed at a particular time, the availability of effective alternative means of infection control, and potentially the number of employees who actually request accommodation.” Therefore, not all accommodations are equal, and if the accommodation places an undue hardship upon the employer, the employer is not required to make that accommodation.
 
There is precedent we can look to for guidance on answering the question of whether a facility can require its employees to get a specific vaccination; the flu vaccine. The flu is a serious health threat for people older than age 65. “People older than age 65 are at the highest risk for hospitalization and complications from influenza and account for the majority of influenza hospitalization and complications from influenza and account for the majority of influenza hospitalizations and deaths in the United States each year.” For years, healthcare workers have been required to receive a flu vaccine as a condition of their continued employment. The EEOC and Occupational Safety and Health Administration (“OSHA”) have addressed the issue of mandatory flu vaccination policies. In most cases, employers can require employees to get a flu vaccine with exceptions for physical disability and sincere religious belief. Eighteen states have flu vaccine requirements for all healthcare workers in long-term care facilities. For example, Kentucky law states that “[e]very long-term care facility shall require each employee to be immunized against . . . influenza virus.” However, even when healthcare employees are required to receive the flu vaccine, an employer is still required to make reasonable accommodations in light of an employee’s disability or religious beliefs. Based on the precedent established by administration of the flu vaccine, long-term care facilities can mandate that their staff receive the COVID-19 vaccine as a condition of employment, but management must make reasonable accommodations for employees with physical disabilities or sincerely held religious beliefs that prevent them from getting the vaccine.   
 
Due to the various factors, there is trepidation among long-term care facility staff members about getting a COVID-19 vaccine. In North Carolina, this anxiety about the COVID-19 vaccines has resulted in most nursing home workers refusing to voluntarily take a COVID-19 vaccine. In response to citizens' fear of being required to take a COVID-19 vaccine by their employers, some states are introducing legislation to prevent mandatory vaccinations. On December 16, 2020, lawmakers in South Carolina pre-filed House Bill 3511. The bill has subsequently been referred to committee. South Carolina House Bill 3511 seeks to change state law and states that vaccines “may be provided only to those individuals who agree to vaccinations.” The bill would block employers from requiring employees to be vaccinated. If passed, legislation like South Carolina House Bill 3511 will prohibit mandatory vaccinations as a condition of employment. Spilman will monitor this legislation, and other similar legislation in other states, and provide updates when additional information becomes available.

In conclusion, long-term care facilities in all states can currently require that their employees receive a COVID-19 vaccine as a condition of employment, with exceptions. In the future, mandatory vaccination programs may be prohibited depending in which state the facility is located. If an employee requests an exemption pursuant to the ADA or the Civil Rights Act, employers should engage in a discussion with the employee to determine whether there is a reasonable accommodation that will enable the employees to perform their job while maintaining the safety of the residents and other employees. 
 
Long-Term Care Facilities Can Require Residents to Take the COVID-19 Vaccine as a Condition of Admission, with Exceptions
 
Just as with their employees, long-term care facilities can currently require residents to receive the COVID-19 vaccine as a condition of admission, with certain exceptions. Currently, there is limited guidance related to mandatory COVID-19 vaccines for long-term care residents. The CDC has produced “Frequently Asked Questions about COVID-19 Vaccination in Long-Term Care Facilities” in an attempt to answer such questions. In response to the question of whether residents can be required to receive the COVID-19 vaccine, the CDC stated that “[t]he federal government does not mandate vaccination for individuals. However whether a state, local government, or employer, for example may require or mandate individuals to be vaccinated is a matter of state or other applicable law.” However, if bills like South Carolina House Bill 3511, discussed above, are passed into law, then long-term care facilities will not be permitted to require that their residents receive a COVID-19 vaccine. In the absence of express guidance from the CDC or local and state governments, we need to look again at other vaccine protocols for guidance.
 
Again, just as we did with long-term care facility employees, we can look at how the flu vaccine has been handled in relation to residents entering and living in long-term care facilities in order to extrapolate whether a facility can mandate that residents receive the a COVID-19 vaccine. Thirty-two states have flu vaccine statutes/regulations that expressly reference long-term care facilities. The laws “establish requirements based on the long-term care facility and patient category and the type of vaccination requirement.” Some states require facilities to offer the vaccine to residents and document the status of each resident, while other states require facilities to ensure residents receive the flu vaccine. For example, in New Jersey, long-term care facilities must “document evidence of annual vaccination against influenza for each resident.” In South Carolina, long-term care facilities must ensure that “residents . . . have an annual influenza vaccination.” Of course, that would change if South Carolina House Bill 3511 is passed. 
 
Similar to requirements for employees, many states have exemptions for residents of long-term care facilities from receiving mandatory vaccines. These exceptions are for physical disability and sincerely held religious beliefs. There are 29 states that explicitly allow long-term care facility residents to be exempt from flu vaccine requirements for medical reasons. For example, in Texas, long-term care facilities must “offer influenza vaccinations to residents . . . unless the vaccination is medically contraindicated.” However, even if a state does not explicitly exempt individuals for medical reasons, it is likely that individuals with medical reasons are not required to receive the flu vaccine. Thirteen states explicitly permit religious exemptions to flu vaccines for residents of long-term care facilities. For example, in North Carolina, long-term care facility residents are required to receive the flu vaccine, but the law states that “[n]o individual shall be required to receive vaccine under this section if . . . the vaccine is against the individual’s religious beliefs.” In Pennsylvania, a resident of a long-term care facility is not required to receive the flu vaccine if “it is against his religious beliefs.” Therefore, a long-term care facility resident cannot be required to get a COVID-19 vaccination if he or she has a physical disability or sincere religious belief that prohibits them from getting a vaccine.
 
Furthermore, long-term care facilities that accept Medicare and Medicaid beneficiaries are required by the Centers for Medicare & Medicaid Services ("CMS") to provide immunizations against flu and pneumococcal disease to all residents. The regulation requires that each resident of a long-term care facility receive the flu vaccine unless there is a medical reason or the resident/resident’s legal representative refuses after being told about the benefits/potential side effects of the vaccine. The regulation does not require employees of long-term care facilities to receive the vaccine, but CMS encourages long-term care facilities to provide the flu vaccine to their employees. 
 
Regardless of the status of governmental mandates, the facility must obtain informed consent from the resident, or the resident’s legal representative before administering the vaccine. While there is no federal requirement for informed consent relating to immunization, there may be state and local regulations. For example, the North Carolina Department of Health and Human Services issued guidance that written consent is not required to get a COVID-19 vaccine and verbal consent can be provided; however, providers may require written consent. For future residents of long-term care facilities, facilities can make it a contractual requirement to receive the COVID-19 vaccine, absent an exception. In conclusion, if long-term care facilities decide to implement mandatory vaccination for residents, the facilities should do so carefully in order to avoid violating residents' rights. 
 
Failing to Require Employees and Residents of Long-Term Care Facilities May Constitute Gross Negligence
 
In response to a wave of COVID-19 related lawsuits, some states have enacted laws or issued executive orders that grant long-term care facilities immunity against COVID-19 related claims. For example, the governor of Connecticut issued an executive order providing liability protections for certain healthcare providers, including hospitals and long-term care facilities. The executive order states that long-term care facilities are “immune from suit for civil liability for any injury or death alleged to have been sustained because of the individual’s or health care facility’s acts or omissions undertaken in good faith while providing while providing health care services in support of the State’s COVID-19 response, including but not limited to acts or omissions undertaken because of a lack of resources.” The executive order states, as do most COVID-19 shield laws, that immunity under the order does not extend to acts or omission that constitute gross negligence. Gross negligence is generally defined as behavior that goes beyond carelessness to include reckless, unreasonable, or willful misconduct by a person.
 
The question that arises for long-term care facilities in states that have COVID-19 shield laws is whether failing to require that employees and residents of long-term care facilities receive a COVID-19 vaccine constitutes gross negligence, thereby exposing long-term care facilities to civil liability for COVID-19 related injuries moving forward. It is anticipated that regardless of the facts of the case that plaintiffs will plead gross negligence in an attempt circumvent COVID-19 shield laws and avoid the early dismissal of their cases. Whether the court grants a motion to dismiss is dependent on whether the long-term care facility can show that the facts as pled by the plaintiff do not rise to the level of gross negligence. As discussed above, many states and CMS require that at least residents of long-term care facilities receive the flu vaccine, a virus that has a much lower mortality rate than COVID-19. With the availability of COVID-19 vaccines, it is now arguably unreasonable for a long-term care facility to not require staff and residents to be vaccinated against a virus the facility knows is more deadly than the flu and has a statistically larger impact on the resident population. Therefore, if a plaintiff can plead facts that show that the plaintiff suffered a COVID-19 related injury due to the fact that the long-term care facility acted recklessly by not requiring its staff and residents to get a COVID-19 vaccine, then that is likely sufficient for the plaintiff to survive a motion to dismiss plaintiff's gross negligence claim. Whether a plaintiff's gross negligence claim due to the lack of a mandatory COVID-19 vaccination program at a long-term care facility will survive summary judgment or prevail at trial is yet to be seen.  Not until we have rulings from the trial and appellate courts regarding what constitutes gross negligence pursuant to these shield laws will we be able to definitively answer to this question. While we wait for the courts to provide us with a definitive answer, it is our recommendation that long-term care facilities implement a mandatory COVID-19 vaccination policy as the best defense against future COVID-19 claims.      
 
Long-Term Care Facilities Cannot be Held Liable If an Employee or Resident is Injured as a Result of Being Required to Receive a COVID-19 Vaccine
 
There are concerns that a facility will be held liable for injuries caused by the vaccine if the facility requires its staff and residents to receive the COVID-19 vaccine. These concerns are without any basis. There are two federal agencies that handle vaccine injury claims—the Vaccine Injury Compensation Program and the Counter Measures Injury Compensation Program (“CICP”). The CICP, a program run by the HHS, is the program authorized to handle injury claims arising from the COVID-19 vaccine. The Secretary of HHS invoked the Public Readiness and Emergency Preparedness Act (the “PREP Act”) and declared COVID-19 to be a public health emergency warranting liability protection for covered countermeasures. The Secretary of HHS stated that the PREP Act precludes liability claims (1) alleging “negligence by a health care provider in prescribing the wrong dose, absent willful misconduct” and (2) “relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure . . .”  In guidance provided by HHS, it states that private sector employers that establish requirements or provide guidance may be afforded immunity from liability under the PREP Act.
 
While there has not been an extensive analysis of the PREP Act in the courts, current case law indicates that a claim against a facility related to a vaccine injury will be precluded. In Parker v. St. Lawrence County Public Health Department, parents sued a school district in state court in relation to the administration of the H1N1 flu vaccine to their child without permission. The sole issue presented on appeal was whether the PREP Act preempted plaintiff's state law claims for negligence and battery. The court answered that question in the affirmative. Because the COVID-19 vaccine will constitute a covered countermeasure under the PREP Act, the PREP Act will control and provide immunity from vaccine related claims so long as the employer “acts in accordance with applicable directions, guidelines, or recommendations issued by the HHS regarding administration and use of a countermeasure.” Furthermore, most state’s workers’ compensation laws would preempt claims against employers for injuries allegedly caused by a vaccine administered as the result of a mandatory vaccine program instituted by the facility. Even if vaccine injuries are not covered under workers’ compensation laws, an employee would have to show that the vaccine was negligently administered by the employer, which is difficult to plead because the vaccine, while required by the employer, will be administered by a third-party medical provider. Therefore, pursuant to the PREP Act and state workers' compensation programs, long-term care facilities will not be liable for injuries employees or residents may suffer as a result of being required to take a COVID-19 vaccine.                                                                                
 
Conclusion

There is a lot of uncertainty that surrounds the legal implications associated with COVID-19. However, it is clear that long-term care facilities can implement mandatory vaccine programs for their employees and residents, albeit subject to limited exceptions. Spilman Thomas & Battle is happy to help navigate any questions you have regarding the COVID-19 vaccines and drafting policies for implementing a mandatory COVID-19 vaccination program.