On November 4, the Centers for Medicare & Medicaid Services (CMS) released CMS-3415-IFC mandating COVID-19 vaccination for all staff in CMS-certified settings. The requirement applies to a number of LeadingAge providers including hospice, home health, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), nursing homes, and programs of all-inclusive care for the elderly (PACE). Requirements will be phased in over a period of 30 days and 60 days and include medical and religious exemptions.

Phase 1 Compliance – December 5, 2021

By December 5, 2021, providers must meet requirements for phase 1 of compliance. These requirements include:

• All staff must have received at least one dose of COVID-19 vaccination, or
• Have requested an exemption from COVID-19 vaccination based on a medical contraindication to COVID-19 vaccination or a sincerely held religious belief, practice, or observance.
• Providers must have all required policies and processes in place.

For the purposes of this rule, “staff” includes employees, licensed practitioners, students, trainees, volunteers, contracted staff, and any individual providing care, treatment, or services under contract or other arrangement.

Policies and procedures must include, at a minimum, processes addressing the following:

• Ensuring that all staff have at least one dose of COVID-19 vaccine prior to providing any care, treatment, or services.
• Ensuring that all staff are fully vaccinated against COVID-19.
• Requesting exemption from COVID-19 vaccination based on a medical contraindication or sincerely held religious belief.
• Tracking and securely documenting exemption requests and outcomes.
• Ensuring exemption requests due to medical contraindication meet documentation requirements outlined in the rule.
• Additional precautions to be taken by those who are not fully vaccinated including but not limited to testing, physical distancing, and source control.
• Tracking and securely documenting the vaccination status of all staff, including those who are exempt from vaccination.
• Tracking and securely documenting the status of those who are temporarily delayed from becoming fully vaccinated based on recommendations from the Centers for Disease Control & Prevention (CDC).
• Contingency plans for unvaccinated staff.

The rule notes that a provider’s emergency plan should also be updated to reflect contingency plans for unvaccinated staff. Examples include the use of fully vaccinated agency staff during staffing shortages or the temporary use of unvaccinated staff and volunteers to assist with emergency evacuation during emergencies.

Phase 2 Compliance – January 4, 2022

By January 4, 2022, providers must meet requirements for phase 2 of compliance. This means that all staff who have not been granted an exemption must be fully vaccinated. Fully vaccinated means that the individual has completed a primary vaccination series – both doses of a 2-dose vaccine series such as the Pfizer or Moderna vaccines or a single dose of a 1-dose vaccine series such as the Johnson & Johnson vaccine. At this time, individuals are not required to receive a booster dose of COVID-19 vaccine to be considered fully vaccinated.

Additionally, for the purposes of phase 2 compliance only, an individual is considered to have met requirements if they have completed an initial vaccine series, even if they have not completed the 2-week wait period following the final dose in a vaccine series that is typically required to be considered fully vaccinated. This means that an individual who receives the single dose of the Johnson & Johnson vaccine or the second dose of either the Pfizer or Moderna vaccines on January 1, 2022 is considered compliant with phase 2 requirements even though 2 weeks have not elapsed since the final dose of the primary vaccine series.

If an individual is delayed in receiving vaccination due to unforeseen circumstances that comply with CDC recommendations, such as receiving monoclonal antibody treatment for COVID-19 infection, the provider must ensure additional precautions are taken and that the status of this individual is tracked and securely documented.

Exemptions

As noted above, the rule allows exemptions based on medical contraindications or a sincerely held religious belief, practice, or observance. Individuals requesting an exemption must do so prior to the phase 1 compliance date December 5, 2021.

Providers must determine their own processes for granting exemptions. CMS offers resources for determining exemptions including this CDC resource for medical contraindications and this document from the Equal Employment Opportunity Commission (EEOC). Additionally, the Safer Federal Workforce task force provides templates for requesting medical exemptions and religious exemptions.

Documentation confirming medical contraindications and supporting request for a medical exemption must:

• Be signed and dated by a licensed practitioner who is not the individual requesting the exemption and who is acting within the respective scope of practice.
• Contain all information specifying which of the vaccines are contraindicated for the individual and the recognized clinical reasons for contraindication.
• Contain a statement from the practitioner recommending that the individual be exempt from vaccination.

Other individuals who may be exempt from vaccination requirements include those who perform 100% remote work or telework and who have absolutely no contact with patients/residents/participants or other staff. Employees and individuals who have any contact with other staff must be vaccinated, regardless of whether they have contact with patients/residents/participants. An exception to this would be individuals who infrequently enter the building to perform services in which they have no interaction with residents/patients/participants and limited interaction with staff. Examples include elevator inspectors or individuals performing a one-time repair on structures or machinery. These individuals would be required to adhere to additional precautions as outlined in the provider’s policies.

Survey and Enforcement

CMS will work with state survey agencies to evaluate compliance with these requirements on-site during standard recertifications and complaint surveys. Surveyors will review the following:

• COVID-19 vaccination policies and procedures
• Number of resident and staff COVID-19 cases over the last 4 weeks
• A list of all staff and vaccination status

In addition to reviewing this documentation, surveyors will conduct interviews and observations. Accrediting organizations will also be required to update survey processes to assess for compliance. Citations and enforcement remedies will be determined based on scope and severity of noncompliance.

What This Means for Providers

If a provider is CMS-certified, the CMS rule takes all precedence. This means that the CMS rule supersedes the OSHA Emergency Temporary Standard and, due to the Supremacy Clause of the US Constitution, the CMS rule supersedes any state or local laws. A CMS-certified provider must comply with the CMS rule even if the state or jurisdiction in which the provider operates has a law that prohibits employers from mandating COVID-19 vaccination.

Providers should review all available resources including the interim final rule, the accompanying Frequently Asked Questions document released by CMS, and relevant guidance from CDC and EEOC, then immediately begin identifying staff vaccination status.

Provide education and vaccination opportunities for those who are not currently vaccinated and ensure staff understand the requirements of this rule, including the fact that these requirements supersede state or local law for all CMS-certified settings.

Develop or review the required policies to ensure all processes are covered as required by this rule, including the process for requesting exemptions. Review the emergency plan to ensure contingency plans include staff vaccination considerations per this rule. Communicate requirements, processes, and timelines with all staff including those providing services under contract or arrangement.

Remember that new hires are also subject to these provisions. Newly hired staff must receive at least one dose of vaccine prior to providing care, treatment, or services and must be fully vaccinated ahead of the phase 2 compliance deadline. LeadingAge is seeking clarification about new hires after the phase 2 compliance deadline. CMS states that timing flexibility applies only to initial implementation of this rule and has no bearing on ongoing compliance.

LeadingAge will continue to review these provisions and provide additional information as available. CMS hosted a national stakeholders’ call on this rule on November 4 and a recording of this call will be available on the CMS Current Emergencies page. Interpretive guidance on this rule is also expected imminently from CMS.

In addition to the interim final rule released by CMS, OSHA has released an emergency temporary standard on vaccines and testing. Read a review of this rule here. Read here to find out how the CMS rule and OSHA emergency temporary standard apply to assisted living, adult day, and other home and community-based services providers.