Legal Alert: CMS Omnibus COVID-19 Healthcare Staff Vaccination Interim Final Rule

The Centers for Medicare and Medicaid Services (CMS) released an interim final rule regarding mandatory vaccinations of healthcare staff to protect against COVID-19. The interim final rule is effective as of November 5, 2021. CMS found good cause to take immediate action without comment period expiration before the effective date, although stakeholders have 60 days to submit formal comments on the emergency regulation. The comment period officially closes on January 4, 2022; over 588 comments have been received from the public, healthcare providers, doctors, lawyers and healthcare workers. You can view the interim final rule and comments here. You can view the CMS FAQ release here. Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose vaccine Pfizer or Moderna or a one-dose vaccine, Johnson & Johnson before providing any care treatment or other services by December 6, 2021, and be fully vaccinated no later than January 4, 2022. Currently, a booster is not a requirement for fully vaccinated status. The rule does not permit weekly (or more regular) testing in lieu of vaccines.

What facilities are covered under this regulation?

•  Ambulatory Surgical Centers, Hospices Programs of All-Inclusive Care for the Elderly Hospitals



• Home Infusion Therapy suppliers



• Long-term care facilities



• Home Health Agencies



• Community Mental Health Centers



• Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services)



• Rural Health Clinics/Federally Qualified Health Centers



• Intermediate Care Facilities for Individuals with Intellectual Disabilities



• Comprehensive Outpatient Rehabilitation Facilities



• End-Stage Renal Disease Facilities



• Psychiatric Residential Treatment Facilities



• Critical Access Hospitals

The staff vaccination requirements apply to Medicare and Medicaid certified provider and supplier types that are regulated under the Medicare health and safety standards known as CoPs (conditions of participation) CfCs (conditions for coverage). These are health and safety standards established by CMS to protect individuals receiving healthcare services from Medicare and Medicaid-certified facilities.

What provider and supplier types does this apply under CoPs and CfCs?

• 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



• 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



• Long-term Care Facilities

Vaccine Exemptions

The regulation provides for exemptions based on recognized medical conditions or religious beliefs, observances or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.

• It is important to note that this regulation requires staff vaccination only, there is no weekly covid-19 testing option as there is under the OSHA regulations.



• These rules apply to staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. This includes facility employees, licensed practitioners, students, trainees, volunteers and those who provide care treatment or other services for the facility and/or its patients under contract or other arrangements.



• Staff who work offsite are not exempt- the rules apply to all staff who interact with other staff, patients, residents, clients, or PACE program participants anywhere beyond a formal clinic setting such as homes, clinics, administrative offices, off-site meetings, etc. For example, a payroll person who meets with front-line employees would need to be vaccinated.



• The rule does not apply to full-time teleworkers, if they are providing services 100% remotely with no direct contact- they are not subject to the vaccine requirement.



• The requirements apply to Indian Health Services facilities



• Religious Nonmedical Healthcare Institutions (RNHCI’s), Organ Procurement Organizations (OPOs) and Portable X-Ray Suppliers are not subject to the vaccine requirement.



• The regulation only applies to Medicare and Medicaid-certified facilities. CMS does not have authority of care settings such as assisted living facilities, group homes, physicians’ offices, schools or provides of home and community-based services.



• Under the Supremacy Clause of the U.S. Constitution, the CMS regulation preempts any state law to the contrary.

Compliance and Enforcement

Compliance with the interim final rule requirements is through established survey and enforcement processes. If a provider or supplier does not meet the requirements, it will be cited by the surveyor as being non-compliant but will be given an opportunity to return to compliance before additional actions occur. CMS works directly with the State Survey Agencies to regularly review compliance with Medicare and Medicaid regulations. CMS expects state survey agencies to conduct an onsite compliance review of the requirements in two ways:

• State survey agencies would assess all facilities for these requirements during the standard recertification survey.



• State survey agencies would assess the vaccination status of staff on all compliant surveys.

While onsite, surveyors will review the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last four weeks and a list of all staff and their vaccination status. This information in addition to interviews and observations will determine compliance with the requirements.

Penalties

CMS has a variety of established enforcement remedies however the goal is making corrections to come into compliance.

• For nursing homes, home health agencies and hospices (beginning in 2022).



• Includes civil and monetary penalties.



• Denial of payments.



• Termination from the Medicare and Medicaid Program, as a final measure.

Opportunities to come into compliance for hospitals and other acute and continuing care providers

CMS surveyors cite hospitals and other facilities based on the severity of the deficiency, classified among three levels, from most to least severe: “Immediate Jeopardy”, “Condition” and “Standard.” In all cases, healthcare facilities have an opportunity to return to compliance before termination.

• “Immediate Jeopardy” citations indicate a serious scope of non-compliance, failure of the provider 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” level citations indicate substantial non-compliance that needs to be addressed to avoid termination.



• “Standard” level citations indicate minor non-compliance where (with respect to this rule) 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 facility’s agreement to a CMS-approved plan of correction.

Which rule is a given healthcare facility expected to follow: the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard or the upcoming (or new) OSHA Emergency Temporary Standard?

If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.

If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation (CoPs), Conditions for Coverage (CfCs) and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.

This rule takes priority above other federal vaccination requirements. CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.

There are rare situations where the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or the OSHA COVID-19 Healthcare Emergency Temporary Standard (ETS) may also apply to staff who are not subject to the vaccination requirements outlined in the CMS Omnibus Staff Vaccination Rule. Facilities should review these regulations and comply with any other federal requirements as necessary.

If facilities are not certified under the Medicare and Medicaid programs and therefore not regulated by the CoPs, then the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or OSHA COVID-19 Healthcare Emergency Temporary Standard apply. The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations. Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements. In closing, the FAQs for CMS Health Care Staff Interim Final Rule, the agency made a point of clarity that all federal entities, including CMS, OSHA and others, worked closely together to ensure that all requirements were complementary, ensure maximum coverage of staff across settings and were not overly duplicative.

The information contained herein should be understood to be general insurance brokerage information only and does not constitute advice for any particular situation or fact pattern and cannot be relied upon as such. Statements concerning financial, regulatory or legal matters are based on general observations as an insurance broker and may not be relied upon as financial, regulatory or legal advice. This document is owned by Alera Group, Inc., and its contents may not be reproduced, in whole or in part, without the written permission of Alera Group, Inc. Updated as of 11/19/2021.