With COVID-19 cases significantly rising across the country, access to and the distribution of a COVID-19 vaccine will be imperative to ensuring the health and safety of long term care residents and health care personnel who provide care to such residents. On December 11, 2020, the Food and Drug Administration issued an Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine, which consists of 2 doses administered 3 weeks apart. Approval of other manufacturers’ vaccines are imminent, and the vaccines are beginning to be distributed. The Centers for Disease Control and Prevention (“CDC”), with input from the Advisory Committee on Immunization Practices (“ACIP”), has recommended that long term care facility residents and health care personnel be the first to receive a COVID-19 vaccine. The Pennsylvania Department of Health (“DOH”) has indicated that it plans to make the vaccine available to Pennsylvanians in three phases following the CDC guidance, with Phase 1A including healthcare personnel and long term care facility residents.
At the present time, nursing home residents and personal care residents are not required to get a COVID-19 vaccine under federal or state law. Rather, residents have the right to refuse vaccinations. For example, the federal Requirements of Participation for Long Term Care Facilities in the Medicaid and Medicare programs provides that the resident or the resident’s representative has the opportunity to refuse influenza and pneumococcal vaccinations. In the absence of future guidance from the Centers for Medicare and Medicaid Services (“CMS”), DOH and/or the Pennsylvania Department of Human Services (“DHS”), residents arguably may also refuse a COVID-19 vaccine as well. Long term care providers will need to be prepared to address situations where a resident refuses the COVID-19 vaccine, absent a change in position under federal and/or state law. One option a provider may want to consider from a risk management standpoint is the development of an acknowledgement of risk and informed consent document related to a resident’s refusal of the COVID-19 vaccine that can be included in the resident’s clinical record. Residents should be educated regarding the benefits and potential side effects of a COVID-19 vaccine as well as the risks and adverse consequences of refusing such a vaccine. Whether a provider can cohort residents who refuse the vaccine will depend upon further guidance to be issued by DOH, CMS, DHS and/or the CDC.
Senior housing providers also will need to consider the implications of the COVID-19 vaccine as it relates to their independent living (“IL”) residents. The elderly housing component of a continuing care retirement community (“CCRC”) is not regulated or governed under the protocols applicable to the nursing and personal care components. Nevertheless, CCRCs have a duty to exercise reasonable care to protect the health, safety and welfare of their residents under Pennsylvania Insurance Department rules. Like nursing home residents and personal care residents, IL residents also have the right to refuse a COVID-19 vaccine. From a risk management perspective, there are a number of issues that CCRCs should take into consideration when determining the appropriate standard of reasonable care to apply to their housing component given the elderly population and the potential consequences of IL residents refusing to get vaccinated against COVID-19. Such considerations include the potential execution of informed consent agreements, and other operational policy considerations designed to protect the community from the spread of infection.
We will continue to monitor all state and/or federal guidance to be issued regarding the COVID-19 vaccine, as well as, any related liability implications, which impact on long term care and senior housing operations, and are prepared to discuss these issues further in order to help our clients determine the best course of action.
From an employment perspective, employers will want to know whether they can mandate the COVID-19 vaccine for staff. The simple answer is, “Yes.” However, there are several caveats to such a mandate that must be considered. In analyzing the patchwork of applicable laws, rules, regulations and caselaw, there is not yet a specific authority that directly addresses the COVID-19 vaccine. However, as with current flu vaccine policies, any COVID-19 vaccine policy should carve out exceptions under Title VII and the ADA. Under Title VII, if an employer receives notice from an employee that his/her sincerely held religious belief, practice or observance would prevent him/her from receiving the vaccine, the employer must provide a reasonable accommodation absent undue hardship to the employer. Under the ADA, an employer must provide a reasonable accommodation (unless it causes an undue hardship) if an ADA-covered disability (such as an existing health condition) would prevent an employee from receiving the COVID-19 vaccine. We would expect these exceptions to be the minimum. Additionally, DOH, CMS, EEOC, CDC, OSHA or others could implement orders or regulations to address employee COVID-19 vaccines.
In deciding whether to make a COVID-19 vaccine policy mandatory or optional, employers should consider a variety of factors, including whether it historically mandates other vaccines, its ability to provide vaccines on campus, whether the vaccine is provided at low or no cost, employee-relations issues that may be associated with a mandate, and the opportunity to build a positive employee experience through COVID-19 vaccine education, employee buy-in, and potential incentives.
Regardless of whether an employer makes the COVID-19 vaccine policy mandatory or optional, employers should ensure that the vaccine policy is written. At a minimum, the policy should clearly spell out the employer’s expectations, should notify employees of exceptions and/or exemptions, and should notify employees of any consequence of non-compliance with the policy. The policy should be communicated throughout the organization in the same manner that employment policies would normally be communicated.
If you have any questions regarding these important COVID-19 vaccine issues and your organization’s plans, please do not hesitate to contact us. Thank you, and stay well.