Vaccine Law Client Act : November 2021 # 4

Shook, Hardy & Bacon L.L.P.

Additional Lawsuits Filed Challenging OSHA’s ETS

On November 10, labor unions filed lawsuits in the Second, Fourth and Ninth Circuits challenging OSHA’s Emergency Temporary Standard for Private Employers. This means there are lawsuits challenging the ETS pending before almost every federal Circuit. Next week, it is expected that the cases will be consolidated in multidistrict litigation (MDL) via a random lottery and reassigned to one Circuit to decide them. Some commentators suggest that the labor unions filed in the Second, Fourth and Ninth Circuits in order to increase odds that one of these Circuits gets the consolidated cases—and/or to decrease the odds that the cases are consolidated before the Fifth Circuit, which temporarily enjoined enforcement of the ETS and is considering expedited briefing on the petitioners’ request for a permanent injunction.

CMS Health Care Staff Vaccination – What You Should Know

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule requiring most Medicare and Medicaid providers and suppliers to develop and implement policies and procedures requiring that all staff be fully vaccinated against COVID-19 within 60 days.

On November 10, a coalition of ten states—Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming—filed suit challenging the mandate. This case is discussed in greater depth below, but as of the date of this Client Alert, no ruling has yet issued with respect to this mandate.

Covered Entities

  • Applies to Medicare and Medicaid-certified provider and supplier types (referred to as “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions of Coverage (CfCs) or Requirements. These facilities are required to have a process or policy in place to ensure that all staff are vaccinated against COVID-19. This includes:
    • 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;
    • Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services;
    • Psychiatric Residential Treatment Facilities;
    • Programs for All-Inclusive Care of the Elderly Organizations (PACE);
    • Rural Health Clinics/Federally Qualified Health Centers; and
    • Long Term Care Facilities.
  • Applies to staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. This includes all current staff as well as new staff who provide any care, treatment or other services for the facility or its patients. This also encompasses facility employees, licensed practitioners, students, trainees and volunteers. Additionally, it includes individuals who provide care, treatment or other services for the facility and/or its patients under contract or other arrangements.
  • Applies to all staff who interact with other staff, patients, residents, clients or PACE program participants in any location beyond the formal clinic setting (e.g., homes, clinics, other sites of care, administrative offices, off-site meetings, etc.).


  • Individuals who provide services 100% remotely and who do not have any direct contact with patients and other staff are not subject to CMS’s vaccination requirements.
  • Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs) and Portable X-Ray Suppliers are not included in CMS’s vaccination requirements. However, OPO staff members that provide organ transplantation services directly to hospitals and transplant center patients and families must meet the CMC’s vaccination requirements.
  • This CMS regulation does not apply to Assisted Living Facilities, Group Homes, providers of Home and Community-Based Services, nor physicians’ offices because they are not subject to CMS health and safety regulations.


  • Covered health care providers must establish a process or policy to fulfill staff vaccination requirements over two phases:
    • Phase 1 – within 30 days after the regulation is published (December 5, 2021), staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose of the COVID-19 vaccine prior to staff providing any care, treatment or other services for the facility and/or its patients.
    • Phase 2 – within 60 days after the regulation is published (January 4, 2022), staff at all health care provider and supplier types included in the regulation must complete the primary vaccination series (except those who have been granted an exemption from the COVID-19 vaccine or those for whom the COVID-19 vaccination must be temporarily delayed, per the CDC’s recommendations).
  • Staff are considered “fully vaccinated” if it has been two weeks or more since they completed a primary vaccination series for COVID-19. Staff who have completed the primary series for the vaccine received by the Phase 2 implementation date are considered to have satisfied these requirements, even if they have not completed the 14-day waiting period required for full vaccination.
  • Facilities must track and document the vaccination status of each staff member and facilities must develop a process for implementing additional precautions for any staff who are not vaccinated in order to mitigate the transmission and spread of COVID-19.
  • The regulation does not impose testing requirements for unvaccinated staff.

Overlap with Other Mandates

  • If a Medicare or Medicaid-certified provider falls under the requirements of CMS’s Staff Vaccination Rule, it should look to the CMS requirements first, as CMS’s Final Rule takes priority above other federal vaccination requirements.
  • There are rare situations where the Executive Order for Federal Contractors or the OSHA Healthcare ETS may also apply to staff who are not subject to CMS’s Final Rule.
  • If a facility is not certified under the Medicare and Medicaid programs and, therefore, is not regulated by the CoPs, then the Executive Order regarding Federal Contractors or the OSHA ETS applies.
  • OSHA’s ETS (for facilities with greater than 100 employees) applies to employers not subject to the Executive Order for Federal Contractors and not subject to CMS’s Final Rule.

CMS’s Final Rule went into effect on November 5, 2021. Stakeholders have until January 4, 2022, to submit formal comments on the emergency regulation, but the regulation’s requirements will go into effect immediately, before CMS provides any response to the comments.

Any Legal Challenges?

Unsurprisingly, yes. The first state-based legal challenge is Missouri v. Biden, No. 4:21-cv-01329 (E.D. Mo.), filed on November 10.

The Backdrop: The Plaintiff States focused on the “national healthcare worker crisis” and shortages of available healthcare workers as the backdrop for arguing against imposition of the vaccine mandate.

The Arguments: The States argued that CMS’s Interim Final Rule violated the Administrative Procedures Act (APA) because it was (1) an arbitrary and capricious action not in accordance with law; (2) exceeded CMS’s authority and was not in accordance with law; and (3) failed to provide notice and comment (under both the APA and the Social Security Act). In addition, the States alleged that CMS violated federal statutes by failing to consult with appropriate state agencies prior to issuance of the Interim Final Rule and by failing to prepare a regulatory impact analysis. Finally, the States asserted CMS’s action was unconstitutional, as it was an improper exercise of the spending power, a violation of the anti-commandeering doctrine, and a violation of the Tenth Amendment.

The Relief Sought: The States are asking the Court to:

  • Issue a declaratory judgment that the CMS Interim Final Rule violates one or more federal statutes and is unconstitutional;
  • Set aside the vaccine mandate;
  • Preliminarily and permanently enjoin imposition of the CMS vaccine mandate; and/or
  • Preliminarily and permanently enjoin imposition of the CMS vaccine mandate without first following the required notice and comment procedures of the APA and Social Security Act.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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