On Friday December 11, 2020, the FDA granted Emergency Use Authorization (“EUA”) of the Pfizer-BioNtech COVID-19 vaccine. Approval of the Moderna vaccine is expected soon. Approval of the vaccines has raised a myriad of issues for long-term care providers, including whether providers can require residents and employees to receive the vaccine. This alert specifically addresses the availability of the vaccine for residents of long-term care facilities and the potential difficulties associated with vaccination as a means to prevent COVID-19.
Under the EUA, all recipients and care givers are required to receive a copy of the Fact Sheet published by the FDA. One of the main questions raised by facilities is whether they can mandate vaccination for current and potential residents. This is a difficult issue and one that we expect HHS, CMS, and state regulators to issue more guidance on. However, the Fact Sheet specifically provides that it is the individual’s “choice to receive” the vaccine. This statement appears several times in the Fact Sheet, suggesting that residents have the right to choose whether to become vaccinated.
Although vaccination would seem to provide an effective means to prevent COVID-19 among this vulnerable population and reduce the risks of the virus that have plagued residents of long-term care facilities since the onset of the pandemic, facilities need to be prepared to manage situations where some residents decide not to receive the vaccine.
Several key considerations for facilities as the vaccine becomes available include:
- Whether a resident’s decision not to receive the vaccine places other residents at risk and how to mitigate risk;
- Whether the facility can make accommodations for residents who refuse vaccination;
- How to balance residents’ rights with potential efforts to mitigate potential risk to other residents;
- Whether facilities may develop policies concerning vaccination that are different for current versus potential residents;
- How to address vaccination and decision-making in residents who lack the capacity to make health care decisions;
- Whether facilities will face fair housing issues if some residents refuse vaccination and whether facilities will impede equal access and enjoyment of the facility for all residents;
- Whether to institute risk management agreements for assisted living and independent living residents associated with residents’ decision not to receive the vaccination;
- How to manage informed consent if the vaccine is administered by the facility;
- Whether to cohort residents according to those that have received the vaccine and those that have not; and
- How to address vaccination with regard to visitors, private duty care givers, and third party providers entering the facility.
To protect themselves and in anticipation of surveyors’ questions, facilities need to develop specific Covid-19 policies to address the above issues, particularly as they relate to managing and mitigating risk. Additionally, it may be helpful for facilities to consider risk management agreements for residents who refuse vaccination as such agreements may provide a means for reducing any potential liability associated with Covid-19. Further, facilities may want to consider identifying the reasons why residents may be inclined to forego vaccination and help staff become prepared to have informed discussions with residents and their families about those issues and the risks of not becoming vaccinated.
*We recognize that there are unique factors related to vaccination policies for employees, particularly in the long-term care space. That is a subject for a separate alert. Should you have specific questions related to those issues, please consult legal counsel.