On May 21, 2021, a new CMS Interim Final Rule went into effect that imposes COVID-19 vaccination requirements on Long-Term and Intermediate Care Facilities (LTCFs and ICFs-IID). This Client Advisory will address these new requirements and will highlight topics CMS is seeking comment on to bolster this rule and future, similar rulemaking efforts. For purposes of this Client Advisory the term “residents” will be used to collectively refer to “residents of LTCFs” and “clients of ICFs-IID” and the term “representatives” will be used to collectively refer to “resident representatives”, “parents”, and “legal guardians” unless otherwise noted.
Final Rule Provisions for LTCFs and ICFs-IID
The final rule requires LTCFs and ICFs-IID to develop and implement policies that ensure they offer residents and staff COVID-19 vaccines when supplies are available. For purposes of this rule, “staff” is defined as individuals who work in the facility at least once a week and includes those who may be away from the facility due to illness, disability, or leave but will be expected to return to work at the facility. This provision permits, but does not require, facilities to offer the COVID-19 vaccine directly. However, if a resident or staff member has already received, or has a known medical contraindication to, the vaccine, the LTCF does not need to offer vaccination to that individual. To see if a resident or staff person has a medical contraindication to the vaccine, the facility should refer to CDC’s “Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States” (the interim final rule explicitly states that this is a provided reference, not a regulatory requirement). If a resident or representative refuses the vaccine, or if the resident receives the vaccine elsewhere or otherwise, that should be documented in the resident’s medical record.
LTCFs and ICFs-IID must educate all residents, representatives, and staff on the COVID-19 vaccine, including benefits, risks, and potential side effects. LTCFs should educate staff on the importance of vaccination for residents, staff personal health, and the health of the general community. In addition to covering the same topics with residents and representatives, residents and representatives should be informed that they can currently receive the vaccine without any copay or out of pocket expense. During this education, the resident or representative must be afforded the opportunity for follow-up questions and the education must be provided to them in a manner they can reasonably understand. The resident or representative must consent to the vaccine so if a resident or representative declines the vaccine the facility should speak to the resident or representative about why the vaccine is being declined and tailor any educational messages to address their identified concerns.
If the facility administers any COVID-19 vaccines, they must be administered in a safe and sanitary manner that complies with applicable Infection Control standards and vaccine provider agreements. All individuals about to receive the vaccine should be screened for suspected or confirmed cases of COVID-19, previous allergic reactions, and current administration of therapeutic treatments and services to ensure they are appropriate candidates for vaccination. In such cases, guidelines from the CDC, FDA, vaccine manufacturers, or other experts should be followed. LTCFs should document all vaccinations within 24 hours of administration.
LTCFs must continue to report to NHSN weekly the COVID-19 vaccination status and related data elements of all residents and staff. This data will be cumulative so that the vaccination of every facility will be known on a weekly basis. LTCFs must also report administration of COVID-19 therapeutics in the same manner. While LTCFs do not maintain medical records of staff, LTCFs should document staff vaccinations in a manner that allows the facility to report immunization in accordance with this rule. At this time, such reporting is not being mandated for ICFs-IID but they are encouraged to voluntarily report these data when able to do so.
Requests for Comment
While the provisions of this interim final rule only apply to LTCFs and ICFs-IID, CMS is seeking public comment on the feasibility of imposing similar vaccination policies on other Medicare/Medicaid participating shared residences and congregate living facilities such as psychiatric residential treatment facilities, psychiatric hospitals, forensic hospitals, adult foster care homes, group homes, assisted living facilities, supervised apartments, and inpatient hospice facilities. Additionally, CMS is seeking comment on the following specific questions:
CMS intends these new requirements for LTCFs and ICFs-IID to facilitate an expedited return to normal routines and operations within these facilities. Skepticism of the vaccine remains one of society’s current largest barriers to putting this pandemic behind us and returning to a “new normal.” CMS hopes that these new requirements will help overcome this hurdle.
Should you or your facility have any questions about the provisions of this rule or would like assistance in submitting a comment, please contact Peter Mellette, Harrison Gibbs, or Elizabeth Dahl Coleman at Mellette PC.
This client advisory is for general educational purposes and does not cover every provision of the Interim Final Rule. It is not intended to provide legal advice specific to any situation you may have. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.