UPDATED | CMS Issues Vax Mandate for Health Care Employers

UPDATE ON CMS MANDATE: On December 15th, the Court of Appeal for the Fifth Circuit upheld the preliminary injunction issued by the Western District of Louisiana, but only in the states that were part of the initial lawsuit, which include Indiana, Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio. The injunction is no longer nationwide.  Also on December 15, 2021, a federal court in Texas issued a preliminary injunction prohibiting CMS from implementing or enforcing the vaccine mandate in Texas. The preliminary injunction issued by the Eastern District of Missouri is still in place and covers Alaska, Arkansas, Iowa, Kansas, Missouri, New Hampshire, Nebraska, Wyoming, North Dakota, South Dakota. CMS has appealed the preliminary injunctions to the United States Supreme Court. We are awaiting further legal developments on this issue and will provide further information as it becomes available.
 

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On November 4, 2021, the Centers for Medicare & Medicaid Services (“CMS”) published its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“IFR”) applicable to health care employers. The IFR is effective upon publication, and must be in compliance with most obligations within 30 days, with final compliance within 60 days. In addition to issuing the IFR, CMS also issued a list of FAQs for health care employers to assist with compliance obligations.

In general terms, the IFR requires health care entities develop and implement policies and procedures to ensure that all staff are fully vaccinated against COVID-19 within 60 days, or by January 4, 2022. The IFR also requires that health care employers have processes in place to identify staff member vaccination status, to determine the appropriateness of exemptions due to medical or religious reasons under federal law, to implement clinical precautions for those who are not fully vaccinated (including those who are granted exemptions), and to document all policies, procedures and processes. The IFR also requires that health care organizations have contingency plans for circumstances that may arise when there are insufficient fully vaccinated staff members.

A few of the most pertinent, and immediate, questions are covered below.
 

Who is covered?

All new and current staff (including physicians with admitting privileges at a hospital) working for Medicare- and Medicaid-certified providers, such as Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal Disease Facilities, Home Health Agencies, Home Infusion Therapy Suppliers, Hospices, Hospitals, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities Programs for All-Inclusive Care for the Elderly Organizations, Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities.
 

Who is not covered?  

Health care entities that are not covered by CMS health and safety regulations, such a physician offices, schools, assisted living facilities, or group homes are not covered by the IFR. Also, Religious Nonmedical Health Care Institutions, Organ Procurement Organizations, and Portable X-ray Suppliers are not covered. 

Some staff may also be exempted from the vaccine mandate if they exclusively provide telehealth or telemedicine services outside of the health care facility and do not ever have any direct contact with patients or other staff.

Note that there may be health care entities not covered by the IFR that may still be covered by the recently issued OSHA Emergency Temporary Standard or federal contractor requirements.
 

How long do we have to comply with the vaccine mandate?

The IFR requires health care providers to establish policies, procedures, and processes to meet vaccination requirements in two phases: Phase 1) within 30 days (or December 5, 2021), all covered staff must have already received at least the first dose of a COVID-19 vaccine; and Phase 2) within 60 days (or January 4, 2022), all covered staff must have completed the vaccination series. 

For purposes of this IFR, “fully vaccinated,” will mean it has been a minimum of two weeks since the vaccination series has been completed. However, all staff members who have completed the full vaccine regimen by January 4, 2022, will be considered to have met the definition of “fully vaccinated” even if they have not yet completed the fourteen-day waiting period. They may still be required to comply with additional safeguards during the fourteen day waiting period, but the health care entity will still be considered to be in compliance with the IFR.
 

What vaccines will “count” for this mandate?

All vaccines approved by the Food and Drug Administration (“FDA”), which currently includes the Pfizer-BioNTech COVID19 Vaccine (also licensed as Comirnaty vaccine), Moderna COVID-19 Vaccine, and the Janssen (Johnson & Johnson) COVID-19 Vaccine. Also acceptable are vaccines listed by the World Health Organization (“WHO”) for emergency use, even if they are not authorized by the FDA. Staff are also included within the definition of “fully vaccinated” if they participated in a clinical trial for a COVID 19 vaccine. “Boosters” are not required in order to be considered in compliance with the vaccine mandate.
 

Is testing allowed as an alternative to mandating vaccination?

No. Although health care organizations may voluntarily implement testing procedures and other infection prevention and control measures, such measures will not be a substitute for vaccination.
 

Are any exemptions allowed?

In order to maintain compliance with other federal laws, health care employers must put in place policies and processes to allow for exemptions from the vaccine mandate if staff members have recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act (ADA)) or if they have sincerely held religious beliefs that would preclude vaccination. All such requests and determinations must be fully documented. 

The IFR also requires health care employers to implement policies and procedures for additional precautions to be taken for anyone who is granted an exemption or is not fully vaccinated to minimize the risk of transmission of COVID19.

We are in the process of reviewing the requirements of the ETS and will be providing additional information on specific issues and topics.

If you have questions about the ETS, please contact Paul Sinclair or any member of Ice Miller’s Labor, Employment and Immigration Practice Group.

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.