To assist health care providers that will soon be required to enforce a COVID-19 vaccine mandate, the Centers for Medicare & Medicaid Services issued guidance on December 28, 2021 regarding updated timelines for compliance and available enforcement remedies.

As noted in our December 16, 2021 alert, the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule or “CMS Vaccine Mandate,” was permitted to move forward in states that were not covered by a court-ordered stay.

The CMS Vaccine Mandate requires:

  • vaccination of all employees of health care providers that participate in the Medicare and Medicaid programs, regardless of responsibility or patient contact
  • development of policies and procedures related to the same

While employees may submit requests for medical or religious exemptions from the vaccination, they cannot choose to be tested rather than vaccinated.

The new guidance is directed to health care providers and surveyors and focuses on how to proceed in Washington, DC and the 25 states that are currently subject to the CMS Vaccine Mandate.

The 25 states are: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin.

Compliance Deadlines

By January 27, 2022, covered health care providers must demonstrate the following to be deemed in compliance with the CMS Vaccine Mandate:

  • policies and procedures for ensuring all facility staff are vaccinated or received an exemption have been implemented, and
  • 100% of staff have received at least one does of the COVID-19 vaccine, or have a pending request for, or have been granted, an exemption, or have been identified as needing a temporary delay in receipt of vaccine. (A delay may be necessary if a staff member has recently had COVID-19 or for other medical reasons.)

If a provider does not meet the above criteria but can show that 80% of its staff are vaccinated or received an acceptable exemption/delay and the provider has a plan in place to achieve a 100% vaccination rate by March 28, 2022, then the provider will not be subject to additional enforcement actions at this time.

By February 28, 2022, covered health care providers must demonstrate:

  • policies and procedures for ensuring all facility staff are vaccinated or received an exemption have been implemented, and
  • 100% of staff have received the necessary doses to complete the vaccine series (one dose of a single dose vaccine, all doses of multiple dose vaccine) or have been granted an exemption or identified as needing a temporary delay prior to receipt of the vaccine.

If a provider does not meet the above criteria but can show that more than 90% of its staff are vaccinated or received an exemption or notice of delay and there is a plan to achieve a 100% vaccination rate by March 28, 2022, then the provider will not be subject to additional enforcement actions at this time.

At this time CMS is not considering a booster shot to be necessary to have completed the vaccine series. However, CMS is asking providers to implement a process by which staff obtain recommended booster doses and track and document the receipt of booster doses.

By March 28, 2022, providers must be maintaining 100% compliance with the vaccination standard to be deemed in compliance with the CMS Vaccine Mandate.

Possible Enforcement Mechanisms

CMS has noted that it has a variety of enforcement mechanisms available from issuance of civil monetary penalties and denial of payments for new admissions to termination of participation from the Medicare and Medicaid programs. CMS has stated that its goal is for all Medicare and Medicaid health care facilities to be in compliance with the CMS Vaccine Mandate, and termination would only be implemented as a last resort after giving the provider the opportunity to make corrections and come into compliance.

Provider Specific Guidance

In additional to the general guidance, CMS has published additional provider specific guidance for the following providers:

(a) Long-Term Care Providers, (b) Ambulatory Surgery Centers, (c) Hospices, (d) Hospitals, (e) Psychiatric Residential Treatment Facilities, (f) Intermediate Care Facilities for Individuals with Intellectual Disabilities; (g) Home Health Agencies, (h) Comprehensive Outpatient Rehabilitation Facilities, (i) Critical Access Hospitals, (j) Outpatient Physical Therapy Providers, (k) Community Mental Health Centers, (l) Home Infusion Therapy Providers, (m) Rural Health Clinics/Federally Qualified Health Clinics, and (n) End-Stage Renal Disease Facilities.

The provider specific guidance can be accessed here.

What’s Next?

The U.S. Supreme Court is set to hear oral arguments regarding the CMS vaccine mandate on January 7, 2022. A decision by the U.S. Supreme Court should provide clarity regarding whether the CMS Vaccine Mandate is enforceable against covered health care providers. However, this decision may not be issued prior to January 27, 2002.

It is advisable for providers in Washington DC and states currently subject to the CMS vaccine mandate to move forward with implementing the requirements of the mandate to avoid enforcement actions in the coming months.  All providers are also cautioned that there could be existing state or local laws containing additional vaccination requirements that may be applicable whether a not a provider is governed by the CMS vaccine mandate.