On November 5, 2021, the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule become effective. In essence, the rule imposes a mandatory COVID-19 vaccination requirement applicable to all health care providers and suppliers that receive reimbursement under the Medicare and Medicaid programs and are regulated under CMS health and safety regulations. If CMS does not have regulatory authority over a facility, e.g., assisted living facilities or group homes, the Regulation does not apply.
The Regulation applies to eligible staff of the covered health care providers and suppliers, which includes current and new staff who provide care, treatment or any other services for the facility and/or its patients. This includes facility employees, licensed practitioners, students, trainees, and volunteers, as well as individuals who provide care, treatment and/or other services for the facility or its patients under contracts or other arrangements. It does not apply to individuals who provide 100% of their services remotely.
The Regulation provides for two phases and the covered entities must establish a process or policy to fulfill the vaccination requirements during the two phases. Within 30 days following the Regulation’s effective date, Phase 1 must be completed. During Phase 1, all covered individuals must have received, at a minimum, the first dose of a primary series or a single dose (for example, Johnson & Johnson) prior to being eligible to provide care, treatment or any other services. For Phase 2, the series must be completed, for example, the second Pfizer or Modern dose must have been received. CMS does not require 14 days from the last dose to meet the Phase 2 requirement, only that the dose be administered.
The vaccines that count toward the requirement are those that have been licensed or authorized for emergency use by the FDA. Additionally, vaccine’s identified by WHO (World Health Organization) and not yet approved for use by the FDA, emergency or otherwise, are also acceptable. Currently the vaccines licensed or approved for emergency use by the FDA for include Pfizer, Moderna and Johnson & Johnson. At this time, CMS has indicated it does not require a booster shot to be deemed fully vaccinated, but does suggest that if the booster becomes required as part of a series, as opposed to recommended, the requirement would change under the current form of the Regulation. Since the booster is delayed by 6 months, it is expected that further guidance would be provided in conjunction with making the booster a requirement.
There are exemptions that must be made available for staff with recognized medical conditions for which vaccines are contraindicated, or religious beliefs. These exemptions should be contained within the policies and procedures and should be aligned with and administered in accordance with federal law. Any individual seeking an exemption should consult with the provider or supplier for whom the individual works or provides services. The Regulation does not mandate testing of those with an exemption, but instead anticipates that the provider/supplier determine under federal law what requirements/accommodations should be contained within its policy.
Non-compliance will be enforced against the provider or supplier. Healthcare providers are also instructed by the CMS that this regulation has primary application over other potentially applicable regulations. This means that all applicable regulations apply, however, if there is a conflict, then the conflicting provision of this regulation will apply to healthcare providers and suppliers as opposed to conflicting provisions of other regulations.
Please note that this post is only a brief summary of the CMS Regulation and does not constitute legal advice nor does it establish an attorney/client relationship. Should you have specific questions regarding the above, please contact Bonnie C. Coleman at Hodges and Davis, P.C.
Hodges & Davis-November 2021