CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Workers

A link to the Omnibus Staff Vaccination Rule is here.

CMS’s Rule requires that all covered facilities develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. Unlike the emergency temporary standard that OSHA issued on November 4, the CMS Rule does not provide an “opt-out” provision that would allow employees to test weekly as an alternative to vaccination. The CMS Rule applies to all current staff and any new staff regardless of clinical responsibility or patient-facing roles. The Rule further states that it will preempt any state and local laws that ban or limit an employer from requiring vaccination. CMS indicates that the Rule takes priority over all other federal vaccination requirements. Below are some questions that the Rule addresses:

Is My Facility Subject to CMS’s Vaccination Rule?

• The Rule applies to all Medicare and Medicaid-certified facilities regulated under health and safety standards known as Conditions of Participation, Conditions of Coverage, or Requirements.
• The Rule applies to the following Medicare and Medicaid-certified provider and supplier types: 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 (PRTFs) Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities.

If My Facility Is Covered by the Rule, What Are My Obligations?

Covered facilities must develop and implement:

• A process ensuring that all covered staff have received, at least, 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 and a process for ensuring that all staff are fully vaccinated;
• A process for tracking and securely documenting COVID-19 employee vaccination status, including those who have received booster doses;
• A process for the facility to consider exemption requests based on applicable federal law (i.e., Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act (ADA)), including a process for tracking and securely documenting: (1) information provided by requesting staff and (2) all granted exemptions; and
• A contingency plan for staff who are not fully vaccinated from COVID-19.

Which Staff Members Are Subject to This Vaccination Rule​?

The following staff must be vaccinated:

• All eligible staff working at a covered facility, regardless of clinical responsibility or patient contact. That includes:
  • All current staff, as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients.
  • Facility employees, licensed practitioners, students, trainees, and volunteers.
  • And, individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements.

The following staff are exempt:

• Staff with recognized medical conditions for which vaccines are contraindicated and staff who object to vaccination based on sincerely held religious beliefs, observances, or practices.
• Staff who work 100% remotely and who have no direct contact with patients or other staff. This may include fully remote telehealth/telemedicine providers and payroll service providers.

There are rare situations where the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or the OSHA COVID-19 Healthcare Emergency Temporary Standard may also apply to staff who are not subject to the CMS Omnibus Staff Vaccination Rule. Facilities that operate multi-service operations should review these regulations and comply with requisite federal requirements as necessary.

When Does This Rule Take Effect?

• The Rule will take effect immediately upon its publication in the Federal Register, which occurred today, on November 5, 2021.
• Covered employees must have received, at a minimum, the first dose of a primary series (multi-dose vaccine) or a single dose COVID-19 vaccine by December 5, 2021 (30 days) after the regulation is published.
• Covered employees must have completed the primary vaccination series by January 4, 2022 (60 days) after the regulation is published.
• Under the Rule, completing primary vaccination series for COVID-19 means the administration of a single-dose vaccine (such as the Janssen (Johnson & Johnson) COVID-19 Vaccine), or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine). Additionally, under the Rule, staff who receive vaccines that the World Health Organization (WHO) has listed for emergency use, but that are not approved or authorized by the FDA or as a part of a clinical trial, are also considered to have completed the vaccination series in accordance with CDC guidelines.

How Does This Rule Interact With OSHA’s Health Care ETS?

• In June 2021, the Occupational Safety and Health Administration’ (OSHA) issued an emergency temporary standard (ETS) applicable to healthcare workers. Many employers that are Medicare and Medicaid-certified facilities are also subject to the ETS. The Healthcare ETS “encouraged” employees to become vaccinated and required that employers provide reasonable paid time off for employees to be vaccinated and recover from any associated side effects.
• CMS’s Rule now requires vaccination for covered staff. Otherwise, it does not disturb the Healthcare ETS’s employer obligation regarding paid time off. Furthermore, paid time off for employees to get vaccinated and recover from any associated side effects may be required by other applicable laws or collective bargaining agreements.

How Will This Rule Be Enforced?

• CMS will work with state survey agencies to conduct onsite compliance reviews. These agencies can conduct such reviews by assessing all facilities during standard recertification surveys or assessing vaccination status of staff on all complaint surveys.
• Facilities that violate the Rule face a number of penalties, depending on the facility’s classification. These penalties include:
  • For nursing homes, home health agencies, and hospices: civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program as a final measure.
  • For hospitals and certain other acute and continuing care providers: Termination from the Medicare and Medicaid program.

Takeaways

• Covered employers should immediately begin preparing a written vaccine policy that complies with the CMS’s Rule.
• They also should immediately develop procedures to handle medical and religious exemption requests.
• Additionally, covered employers that have implemented a mandatory vaccine policy should review and revise their policy as necessary to comply with CMS’s Rule.
• Covered employers should immediately begin to request and gather proof of vaccination from employees and receive and assess any employee exemption requests.