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CMS Issues Interim Final Rule for Staff COVID-19 Vaccination

CMS issued the Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination, which is scheduled to be published in the Federal Register on Nov. 5, 2021.

Click here to see LAI's overview of the vaccine requirement.

Effective Date and Comment Period:

  • The rule is effective as of Friday, Nov. 5, 2021.  Staff at affected organizations must have their 1st vaccine dose or one-dose vaccine no later than Dec. 5, 2021 and their second dose of the series no later than Jan. 4, 2022. 
  • 60-day comment period closes Jan. 4, 2022.

Applicability:

  • Any provider that is certified under Medicare and Medicaid and are regulated under the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements of Participation (RoPs).
  • Provider types include 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 (PTRFs), Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care Facilities.

Who Is Covered under Staff:

  • Includes all staff, regardless of clinical responsibility or patient contact.
  • Includes employees, licensed practitioners, students, trainees, and volunteers.
  • Includes individuals who provide care, treatment, or other services for the provider and/or its patients under contract or other arrangements. 
  • Current staff as well as any new staff who provide any care, treatment or other services for the provider and/or its patients.
  • Includes any staff that perform services off-site (such as Home Health Agencies, Home Infusion Staff, anyone participating in off-site meetings, working in administrative offices, or other sites of care).
  • Based on the CMS webinar, CMS will interpret the term “staff” very broadly. The only excluded staff are those who provider services or work remotely 100% of the time and do not have any in-person contact with residents/patients or any other staff members that provide care to residents/patients.

This Interim Final Rule Does Not Apply to:

  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Organ Procurement Organizations (OPOs) (see note below)
  • Portable X-ray Suppliers. However, the FAQ document indicates that OPOs and Portable X-ray Suppliers are indirectly included in the vaccination requirements through their service arrangements with providers that are included in this rule.  A service arrangement is when these providers have a contract with other providers to furnish services, which would require individuals from these organizations to be vaccinated.
  • Providers that CMS does not have regulatory authority over, specifically listed are Assisted Living Facilities or Group Homes and physician’s offices because they are not subject to CMS health and safety regulations.
  • HCBS Community-Based Services because CMS’ health and safety regulations do not cover providers of HCBS services.
  • Schools that receive Medicaid funding, because CMS does not regulate schools.

What is Required?

  • Providers must establish a policy to fulfill the staff vaccination requirements over two phases.
    • Phase 1 – No later than December 5, 2021, the provider must have a process in place for vaccinating staff, and staff must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to providing any care, treatment, or other services for the provider and/or its patients.  
    • Phase 2 – No later than January 4, 2022, staff must complete the primary vaccination series.
    • Exemptions: Providers should establish a process for exemptions according to the exemptions permitted under the CMS rule and establish methods for assuring the safety of the residents/patients that are served from the unvaccinated staff with approved exemptions.
    • Tracking and Documenting: Providers must establish a process for tracking and documenting staff vaccinations and documentation of any exemptions. 

New Staff:

  • New staff must receive, at a minimum, the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services for the provider and/or its patients.

Exemptions:

  • CMS is allowing for exemptions for recognized medical conditions for which vaccines are contraindicated and for religious beliefs, observances or practices as outlined within the interim final rule.  Providers or suppliers should establish exceptions as a part of its policies and procedures and in alignment with Federal law.  CMS believes that exemptions could be appropriate in certain limited circumstances, but no exemption should be provided to any staff for whom is not legally required (under the ADA or Title VII of the Civil Rights Act of 1964), or who requests an exemption solely to evade vaccination.
  • The regulation allows for temporary delay of vaccination, for example, a recent COVID-19 diagnosis.
  • The regulation does not exempt staff members who previously had a COVID-19 infection because evidence suggests that vaccines offer better protection than natural immunity alone and that vaccines help prevent reinfections.

Religious Exemptions:

  • CMS encourages providers to review the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination for more information on religious exemptions.
  • Providers have flexibility to establish their own process that permits staff to request a religious exemption from the vaccine requirements.  CMS requires that providers ensure that requests for religious exemptions are documented and evaluated in accordance with applicable federal law as part of the policies and procedures.

Medical Exemptions:

  • Providers have flexibility to establish their own process that permit staff to request a medical exemption. 
  • Providers must ensure that medical exemptions are accompanied with documentation including:
    • Detail about which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member and the recognized clinical reasons for the contraindications;
    • A statement by the authenticating practitioner recommending that the staff member be exempted from the COVID-19 vaccination requirement
    • A signature and date by a licensed practitioner, who is not the individual requesting the exemptions and is acting within their respective scope of practice based on applicable state and local laws.   

Mitigation Measures for Unvaccinated Staff with Approved Exemptions:

  • The interim final rule requires providers develop a process for implementing additional precautions for any staff who are not vaccinated, to mitigate the transmission and spread of COVID-19. In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID-19 to an at-risk individual, in keeping their obligation to protect the health and safety of patients.
  • CMS expressed during the webinar this afternoon that additional measures may include source control, physical distancing, and enhanced testing.

Enforcement:

  • State Agencies will conduct on-site compliance reviews of these requirements in two ways:
    • Assess all providers for these requirements during the standard recertification survey.
    • Assess vaccination status of staff on all compliant surveys.
    • On-site surveyors will review:
      • The COVID-19 vaccination policies and procedures
      • The number of resident and staff cases of COVID-19 over the last 4 weeks
      • A list of all staff and their vaccination status.
      • Conduct interviews and observations to determine compliance of the provider or supplier with requirements. 
      •  Accreditation Organizations will be required to update their survey process to assess for compliance.

Penalties:

  • For nursing homes, home health agencies and hospice (beginning in 2022) enforcement penalties will include CMPs, Denial of Payment, Termination from Medicare and Medicaid program as a final measure. 
  • For hospitals and certain other acute and continuing care providers will result in termination from the Medicare and Medicaid program. 
    • Will be cited based on the scope and severity of the deficiency classified among three levels from most to least severe. In all cases, providers will have the opportunity to return to compliance before termination. 
    • Immediate Jeopardy – serious scope of non-compliance, failure to address deficiencies, and close interaction with patients of unvaccinated staff.  Termination of the provider type will occur within 23-days following the citation if not immediately addressed.
    • Condition – substantial non-compliance that needs to be addressed to avoid termination.
    • Standard – minor non-compliance where almost all staff are vaccinated, the provider has a reasonable policy in place to educate staff on the vaccinations, and the provider has procedures for tracking and monitoring vaccination rates.  CMS generally allows for continued operation subject to the agreement of a CMS-approved plan of correction.
    • CMS’ goal is to bring health care providers into compliance and termination would generally occur only after providing a provider the opportunity to make corrections to come into compliance.

Hierarchy of Federal Laws:

  1. CMS Vaccine Requirement:  If a provider is certified under the Medicare and Medicaid program and are regulated by the CoPs or CfCs, and RoPs, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule. The CMS rule takes priority above other federal vaccination requirements.
  2. If a provider is not covered by the CMS Rule, they should review whether the COVID Safety Protocols for Federal Contractors applies requiring mandatory vaccination and other safety protocols.  Note that participation as a health care provider in the Medicaid or VA TRICARE program does not rise to the level of becoming a federal contractor.  The Office of Federal Contract Compliance Programs has an FAQ page addressing jurisdiction and other things for federal contractor requirements which may be useful in determining applicability.  Providers may have contract and contract-like instruments with the federal government that categorize them as a federal contractor.  (See definitions on page 3 of the Guidance for more information on “contracts and contract-like instruments)          
  3. Any employer that provides health care services or health care support services must comply with the OSHA COVID-19 Healthcare ETS.  This flow chart helps determine whether the OSHA COVID-19 Healthcare ETS applies. Since the OSHA COVID-19 Healthcare ETS does not have a vaccine requirement, health care providers who do not fall into the vaccine requirements by CMS or as a federal contractor does not have a federal vaccine requirement.  This would generally be state-only regulated health care entities who do not part of an organization that also provides CMS regulated services (example:  stand-alone Assisted Living Provider or adult day program).
  4. If an employer does not fall into one of the federal requirements above and has 100 or more employees, they shall follow the OSHA COVID-19 Vaccine and Testing ETS.  Note that the OSHA COVID-19 Vaccine and Testing ETS requirement may apply to employers following the OSHA COVID-19 Healthcare ETS if the large employer determined that some employees/areas did not fall under the Healthcare ETS.

Impact of Iowa’s State Law on CMS Vaccine Requirement:

  • CMS Vaccine Requirement:  The CMS requirement supersedes all state laws.  Providers subject to the CMS vaccine requirement should exclusively follow the CMS requirement related to exemptions. 

Fully Vaccinated:

  • Two weeks or more following the completion of a primary vaccination series for COVID-19.
  • Staff who have completed the primary series by the Phase 2 implementation date are considered as having met the requirements, even if they’ve not completed the 14-day waiting period required for full vaccination.
  • Staff who receive vaccines listed by the World Health Organization (WHO) for emergency use that are not approved or authorized by the FDA or as part of a clinical trial are also considered to have completed the vaccination series in accordance with CDC guidelines.
  • CMS expects that staff will utilize vaccines that are currently authorized or approved by the FDA, however, providers will be in compliance if staff received a vaccine listed by the WHO that is not approved or authorized by the FDA, or are in a clinical trial. 
  • Staff that have been vaccinated outside of the United States will be in compliance, as long as they received a vaccine that is by the WHO for emergency use.
  • Follow guidance under CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for details regarding additional doses or boosters.  At this time, additional doses or booster doses are not included in the definition of fully vaccinated.
  • If a staff member received a vaccine that was not authorized or approved by the FDA or on the WHO list of acceptable vaccines, the staff member should wait at least 28 days following the last dose to begin a new series.  Staff should consult with their doctor or other health care provider if they have questions about their vaccination. 
  • If a staff member participated in a clinical trial in the U.S. and received a full series of an “active” vaccine (not placebo) and vaccine efficacy has been independently reviewed and confirmed (by a data and safety monitoring board), they are considered in compliance with regulations. 
  • If a staff member received a primary series of vaccines that was interchanged, they may be considered compliant with the requirements if they have received any combination of two doses of a vaccine licensed or authorized by the FDA or listed on the WHO emergency use list as part of a two-dose series.  The second dose of the vaccine must have been received no earlier than 28 days after the first dose.

Testing:

  • CMS recognizes that vaccination is more effective as an infection control measure than daily or weekly testing of unvaccinated individuals.  CMS will review the evidence and stakeholder feedback on this issue.
  • Providers may voluntarily institute testing alongside other infection prevention measures such as physical distancing and source control. 
  • CMS expects continued compliance with regulations that were established related to testing under F886 (QSO-20-38-NH-Revised)

Additional Reporting Requirements?

  • No, CMS has not established any new data reporting requirements.  However, hospitals and LTC providers are expected to continue complying with NHSN reporting under F884.

CMS has also released an FAQ document to provide additional insight on the Interim Final Rule.