On November 4, 2021, the Centers for Medicare & Medicaid Services ("CMS") announced its interim final rule regarding vaccination requirements for eligible staff of certain health care providers. The rule, which becomes effective on November 5, 2021, is expected to apply to approximately 76,000 health care providers and cover over 17 million health care workers across the United States.

What Are the New Requirements?

The Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule ("IFC") contains three primary requirements for covered providers:

• A plan for fully vaccinating all eligible staff.
• A plan for providing exemptions and accommodations for those who are exempt from vaccinations.
• A plan for tracking and documenting staff vaccinations.

Who Is Covered by the Requirements?

The vaccination requirements apply to eligible staff of Medicare and Medicaid-certified health care providers and supplier types that are subject to CMS's health and safety regulations, which are commonly known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements of Participation. Covered providers include:

• Ambulatory Surgery Centers
• Clinics
• 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
• Long-Term Care Facilities
• Programs for All-Inclusive Care for the Elderly Organizations (PACE)
• Psychiatric Residential Treatment Facilities (PRTFs)
• Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
• Rural Health Clinics/Federally Qualified Health Centers
• Rehabilitation Agencies

Of note, the requirements do not apply to Assisted Living Facilities, Group Homes, Home and Community-based Services, or physician's offices. Additionally, Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers are excluded. Although excluded, certain providers working within covered facilities may be subject to the rule. These excluded providers could also be covered by OSHA's new rules applicable to employers with 100 or more employees.

Who Are Eligible Staff?

The vaccination requirements apply to staff members who provide any care, treatment, or other services for a covered provider or its patients. This includes individuals who provide care, treatment, or other services for the covered provider or its patients under contract or other similar arrangements. Examples of eligible staff include, but are not necessarily limited to:

• Employees
• Licensed practitioners
• Students
• Trainees
• Volunteers

While the vaccination requirements do not apply to full time teleworkers (i.e. those who provide services 100% remotely and have no contact whatsoever with patients and other staff members), the requirements do apply to staff who work offsite and have contact with patients or other staff, such as home health providers. Additionally, the requirements apply to physicians admitting or treating patients in-person within a covered provider. For example, a physician who enters a long-term care facility or hospital to treat patients would need to be vaccinated.

What Exactly Does the New Rule Require?

Plan for Vaccination

Covered providers must implement a plan for full vaccination of their eligible staff by December 5, 2021. Phase 1 requires that all eligible staff of covered providers have the first dose of a primary series or a single dose COVID-19 vaccine by December 5, 2021. Phase 2 requires that all eligible staff of covered providers complete the primary vaccination series by January 4, 2022. The completion of a primary vaccination series is defined as the administration of a single-dose vaccine (such as the 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). Although additional doses of the vaccine are currently recommended to some individuals, the IFC does not require that staff receive booster doses to be fully vaccinated.

Plan for Providing Exemptions and Accommodations

Because CMS has acknowledged that there may be limited circumstances when exemptions to the vaccination requirements are appropriate, covered providers must also implement a plan that establishes exceptions to the vaccine requirements. As a reasonable accommodation under the Americans with Disabilities Act (ADA), CMS requires covered providers to allow exemptions for eligible staff members who have medical conditions for which vaccines are contraindicated. Covered providers have the flexibility to establish their own processes that permit eligible staff to request medical exemptions. Any medical exemption must be signed and dated by a licensed practitioner. The documentation must also include information that specifies which of the authorized COVID-19 vaccines are clinically contraindicated and the recognized clinical reasons for the contraindications.

CMS also requires covered providers to allow exemptions for religious beliefs, observances, and practices, as part of the requirements of Title VII of the Civil Rights Act of 1964. Similar to medical exemptions, covered providers have the flexibility to establish their own processes that permit staff to request religious exemptions. Covered providers are encouraged to review the Equal Employment Opportunity Commission's Compliance Manual on Religious Discrimination when determining whether an individual's request for a religious exemption is valid.

Plan for Documentation

As part of the IFC, covered providers must also implement a plan for tracking and documenting staff vaccinations. The IFC does not, however, establish any new data reporting requirements. Hospitals and long-term care facilities are expected to continue complying with their current facility-specific data reporting requirements.

How Will CMS Enforce the IFC?

CMS has stated that it will work with State Survey Agencies to regularly review compliance with the IFC. State survey agencies will assess all covered providers for compliance with the requirements during standard recertification surveys and will also assess for compliance during complaint surveys.

How Does the IFC Interact with Other Rules?

On November 4, 2021, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) announced its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS), which applies to employers with 100 or more employees. To the extent that the IFC contradicts any other rule, covered providers should look to the IFC first. In other words, if a health care provider participates in and is certified under the Medicare and Medicaid programs and is regulated by Conditions of Participation, Conditions for Coverage, or Requirements for Participation, then the covered provider must abide by the requirements set forth in the CMS Omnibus Staff Vaccination Rule. Similarly, this rule pre-empts any state law to the contrary.

The IFC is open for comment until January 4, 2022. All stakeholders are encouraged to submit feedback.

For more information, please join our webinar on Tuesday, November 9th, from 1:00-2:00 CST. Our health care, labor and employment, and federal government contract attorneys will discuss this topic in more detail and will take questions from the participants. Register here.