The Biden Administration, through the Centers for Medicare and Medicaid Services (“CMS”) and via Interim Final Rulemaking (“IFR”), has expanded vaccination requirements in many health care settings.

Effective November 5, 2021, CMS requires vaccination of all eligible staff for certain health care providers or suppliers that participate in or are regulated by the Medicare and Medicaid programs – a scope that likely encompasses over 17 million health care workers.  This mandate includes individuals who provide paid and unpaid services to covered providers and suppliers.  Per CMS, the staff vaccination requirement 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 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.

Significantly, as a federal regulation, this new rule pre-empts any state law that prohibits vaccine mandates.

The emergency IFR does not apply to certain healthcare settings such as physician offices and other small healthcare entities that are not regulated by CMS.  However, CMS notes that the IFR complements the OSHA ETS effective June 21, 2021, to ensure that staff are fully vaccinated from COVID-19 unless exempt.  CMS notes that providers and supplies may be covered by both the OSHA ETS and its IFR while others may not be.  

As a result of the new regulation, staff must now: (1) have received the first dose of a two-dose Covid-19 vaccine or a one-dose Covid-19 vaccine by December 5, 2021 and (2) have received all necessary shots to be fully vaccinated by January 4, 2022.  The regulation does not permit daily or weekly testing in lieu of vaccination. Additionally, there is no exemption for individuals who test positive for Covid-19 anti-bodies.

Notably, the regulation applies to all staff, regardless of whether an individual has patient contact or not.  It also applies to volunteers, students, and trainees.  It does, however, exempt individuals from the vaccination requirement if they work 100 percent remotely or have a recognized medical condition or religious reason for remaining unvaccinated.  

With only 1 month before the first deadline, affected providers/suppliers must act quickly.  Next steps for affected health care providers should include:

• Establishing and distributing written vaccination policies and procedures for staff.  

  • This policy, which the regulation requires, should outline the regulation’s vaccination requirements and deadlines and identify the permitted exemptions (for recognized medical conditions under the ADA; religious beliefs, observances or practices established under Title VII of the Civil Rights Act; and 100% remote working).

• Obtaining documentation that reflects each staff member’s Covid-19 vaccinations.  

  • Note that the IFR requires providers and suppliers to track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as receipt of monoclonal antibodies or convalescent plasma.  Vaccine exemption requests must also be documented. 

• Maintaining an updated list of all staff and their vaccination status.  This includes updating documentation when staff are on-boarded. 

• Developing a process by which staff can request a religious or medical exemption from the Covid-19 vaccination requirements.  

  • The requests should be documented and evaluated in accordance with applicable federal law.  Medical exemption requests should include a note from a licensed practitioner, signed and dated, specifying why a Covid-19 vaccine is clinically contraindicated for the staff member and recommending that the staff member be exempt from the facility’s vaccination requirement.  

• Creating (or affirming an existing) a process for implementing additional precautions for exempt staff who are not vaccinated in order to mitigate the transmission and spread of Covid-19.  

CMS will conduct surveys to enforce the regulation.  It has instructed state survey agencies to conduct onsite compliance reviews during the standard recertification surveys and during complaint surveys. Surveyors will be reviewing facilities’ Covid-19 vaccination policies and procedures and a list of all staff and their vaccination status.

Non-compliant providers will receive citations and face possible enforcement action, including civil monetary penalties (CMPs), denial of payment, and even termination from the Medicare and Medicaid program.  CMS has warned that facilities may receive “immediate jeopardy” citations if unvaccinated staff have close interaction with patients.

Providers and suppliers should assess whether this emergency IFR applies to them and whether any other Federal rules or regulations likewise apply.  

In accordance with the Administrative Procedures Act, providers and suppliers have 60 days (until January 4, 2022) to submit formal comments on this emergency rule.  Notably, because this IFR is an emergency regulation, it will go into effect immediately and before CMS is required to respond to any comments.  Providers and Suppliers can anticipate additional guidance through CMS’s responses through the formal comment and response process.