Federal COVID-19 Vaccine Mandates
January 13, 2022 U.S. Supreme Court decisions:
Historically, vaccines have been relied upon as the most effective strategy to prevent disease transmission. Although the COVID-19 vaccine is widely available to healthcare workers, surveys reveal significant levels of vaccine hesitancy in this population. Top concerns include vaccine development occurring too quickly; not receiving enough information about safety, side effects, and administration; and skepticism regarding the clinical trial process.  With hundreds of millions of vaccine doses now administered in the US, safety and efficacy of the available vaccines is better understood.
Mandatory Vaccination Considerations and Guidance
Prior to COVID-19 vaccine availability, the best and only method to prevent the spread of SARS-CoV-2 relied on the implementation of pandemic infection prevention and control measures per CDC guidance. Now that the available vaccines demonstrate effectiveness in preventing COVID-19 infection and in preventing hospitalizations and deaths, this is an added measure that can be taken to ensure the safety of both patients and healthcare workers.  In fact, after review of vaccine efficacy in clinical trials, real-world effectiveness studies, and post-authorization safety monitoring a findings, a multispecialty consensus statement released in July 2021 recommends COVID-19 vaccination should be a condition of employment for healthcare workers.
Notably, the consensus statement acknowledges exemptions to mandatory vaccination for healthcare workers with medical contraindications to all of the available vaccines and other exemptions that are specified by state or federal law.  Examples of federal law exceptions include religious accommodations under Title VII of the Civil Rights Act of 1964 and medical accommodations under the Americans with Disabilities Act (ADA). The Equal Employment Opportunity Commission (EEOC) addresses the question regarding how employers should respond to employees who indicate they are unable to receive a required COVID-19 vaccination due to disability or religious beliefs. The EEOC explains that EEO laws do not prevent employers from mandating vaccination, but that Title VII and the ADA require reasonable accommodations be provided to employees who opt not to get the vaccine due to religion or disability, unless the accommodation would create an undue hardship for the employer. [2,3] Additionally, the EEOC allows employers to inquire about employee vaccination status including proof of vaccination without violating federal laws as long as this information is stored confidentially. [2,3]
Federal Agency Regulation Related to Vaccines
OSHA determined that SARS-CoV-2 exposure is a hazard to healthcare workers. To protect healthcare workers, OSHA adopted the COVID-19 Healthcare Emergency Temporary Standard (ETS) on June 21, 2021. OSHA announced on December 27, 2021 that a final rule cannot be completed in the timeframe contemplated under the OSHA Act and withdrew the non-recordkeeping portions of this ETS.  However, OSHA anticipates finalizing this rule at a later date and will continue to enforce the general duty clause and existing standards to protect healthcare employees from COVID-19.  Accordingly, OSHA noted that it strongly encourages healthcare employers to implement the ETS's requirements and believes the terms of the Healthcare ETS remain relevant in general duty cases.  The 28 states with OSHA-approved State Plans may have varying requirements, but these must be at least as effective as federal OSHA in protecting workers. If you practice in one of these states, be sure you are familiar with the details of your State Plan.
In light of the U.S. Supreme Court decision, OSHA released a statement on the status of the COVID-19 Vaccination and Testing ETS on January 25, 2022. This statement explains that while this has been withdrawn as an enforceable standard, it has not been withdrawn as a proposed rule and strongly encourages workers be vaccinated. 
CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule
Summary: The Interim Final Rule establishes a condition of participation that requires COVID-19 vaccination for workers in settings regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements. 
Application: The staff vaccination requirements apply to Medicare and Medicaid-certified provider and supplier types (collectively, “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal 2 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 (PRTFs) Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities. 
Timing: The emergency regulation is effective as of November 5, 2021. CMS has since modified the phased compliance dates, which vary by state. Per CMS, the phased requirements are as follows: 
- Phase 1 Requirements:
- Facilities must have all policies and procedures in place for ensuring staff are fully vaccinated, providing exemptions, and tracking staff vaccinations.
- Staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients.
- Phase 2 Requirements:
- Staff must be fully vaccinated (with the exemption of those who have been granted exemptions from the COVID-19 vaccine or for those staff for whom the COVID-19 vaccination must be temporarily delayed, as recommended by CDC).
Even if exempt from applicable federal mandates, you may consider mandatory vaccination of healthcare workers as an added infection control strategy to protect them and other employees, as well as patients. Additionally, a fully vaccinated workforce can improve infection control in the entire community by breaking the chain of transmission in and out of the healthcare setting. Consult with a health law and employment law attorney prior to finalizing any mandatory vaccination plan to ensure your compliance with all applicable federal and state laws.
- CMS. CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule - Frequently Asked Questions
CMS Health Care Staff Vaccination FAQs
- CMS. Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination
Summary of CMS regulation mandating vaccination of eligible health care facility staff and implementation guidance
- OSHA. COVID-19 Healthcare ETS Landing Page
Updated details regarding the Standard, implementation, and enforcement
- OSHA. Summary: COVID-19 Healthcare ETS
Summary of Healthcare ETS
- OSHA. COVID-19 Vaccination and Testing ETS Landing Page
Statement on the status of the OSHA COVID-19 Vaccination and Testing ETS
- EEOC: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws
FAQs regarding mandatory vaccinations and related ADA and Title VII issues (see, Section K. Vaccinations)
- NORCAL Group: COVID-19 Information, Resources & Tools
Compilation of healthcare operations resources including healthcare workforce infection control resources
 Biswas N, Mustapha T, Khubchandani J, et al. The Nature and Extent of COVID-19 Vaccination Hesitancy in Healthcare Workers. 2021. J Community Health. https://link.springer.com/article/10.1007/s10900-021-00984-3. Published April 20, 2021. Accessed February 1, 2022.
 Weber D, Al-Tawfiq J, Babcock H, Bryant K, Drees M, et al. Multisociety Statement on COVID-19 Vaccination as a Condition of Employment for Healthcare Personnel. Infection Control & Hospital Epidemiology DOI: 10.1017/ice.2021.322. https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/multisociety-statement-on-covid19-vaccination-as-a-condition-of-employment-for-healthcare-personnel/690D1804B72FFF89C5FC0AED0043AD62 Published July 13, 2021. Accessed February 1, 2022.
 EEOC. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws (Section K). Updated October 25, 2021. Accessed February 1, 2022.
 OSHA. Emergency Temporary Standard Summary: COVID-19 Healthcare ETS. Statement on the Status of the OSHA COVID-19 Healthcare ETS. https://www.osha.gov/coronavirus/ets Updated December 27, 2021. Accessed February 1, 2022.
 OSHA. Emergency Temporary Standard: COVID-19 Vaccination and Testing ETS. Statement on the Status of the OSHA COVID-19 Vaccination and Testing ETS. https://www.osha.gov/coronavirus/ets2?mkt_tok=MTQ0LUFNSi02MzkAAAGAijxe73s6X3PcpbugGmniKi4xEIzXe0kk4GyTlBtMQ4oJXFBkyFOLsIrGgcs58AEYPfdDNz8IEe8-GnNkB9V4aUPO1SECLDPd8Cj_LbZ_. Updated January 25, 2022. Accessed February 1, 2022.
 CMS. CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule - Frequently Asked Questions. https://www.cms.gov/files/document/cms-omnibus-covid-19-health-care-staff-vaccination-requirements-2021.pdf. Updated February 3, 2022. Accessed February 25, 2022.
 CMS. CMS Omnibus COVID-19 Health Care Staff Vaccination Rule- Implementation Timeline. https://www.cms.gov/files/document/health-care-staff-vaccination-rule-implementation-timeline.pdf. Published January 19, 2021. Accessed February 1, 2022.