On November 16, 2021, 12 additional states filed a complaint in the US District Court for the Western District of Louisiana requesting that the Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered health care facilities and staff (the CMS Mandate) be set aside as an “unlawful agency action under the Administrative Procedure Act” (APA), 5 U.S.C. §§ 701–706. This challenge follows similar actions by 10 attorneys general against the CMS Mandate on November 10, 2021, in the US District Court for the Eastern District of Missouri and against the Occupational Safety and Health Administration’s (OSHA) Emergency Temporary Standard (OSHA ETS), which mandates vaccination or testing for employees of companies with 100+ employees. The OSHA ETS was stayed by the US Court of Appeals for the Fifth Circuit on November 12, 2021, and has been consolidated with other challenges before the US Court of Appeals for the Sixth Circuit for reconsideration. Both the IFR and the OSHA ETS were released on November 5, 2021, as part of the Biden administration’s multi-prong “whole of government” approach to combatting the COVID-19 pandemic. Given the short time until the December 6, 2021, first compliance deadline for the IFR and ETS, employers affected by these rules should continue to prepare for implementation while watching for any actions in relation to this suit that may result in a delay of the anticipated compliance timeline.
On November 10, 2021, 10 states filed a complaint in the US District Court for the Eastern District of Missouri requesting that the Centers for Medicare and Medicaid Services (CMS) Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered healthcare facilities and staff (the CMS Mandate) be set aside as an “unlawful agency action under the Administrative Procedure Act” (APA), 5 U.S.C. §§ 701–706. The plaintiff states seek to have the CMS Mandate set aside, via preliminary and permanent injunction, and to further preliminarily and permanently enjoin CMS from issuing a similar mandate without complying with notice and comment procedures under the APA and Social Security Act.
On November 10, 2021, the Safer Federal Workforce Task Force updated its guidance for federal contractors to move the December 8, 2021, deadline to January 18, 2022. This means that covered contractor employees must receive their final vaccination shot by January 4, 2022, in order to be fully vaccinated by the January 18 deadline.
On November 6, 2021, the US Court of Appeals for the Fifth Circuit in Louisiana temporarily blocked the Emergency Temporary Standard (ETS) issued on November 4, 2021, by the Occupational Safety and Health Administration (OSHA) requiring employers with 100 or more employees to implement COVID-19 vaccination policies. The Fifth Circuit wrote that the pending lawsuit raised “cause to believe that there are grave statutory and constitutional issues” surrounding the ETS. The ETS is stayed until further notice, halting its implementation temporarily. The Court ordered the parties to submit further briefing on the validity of the ETS by November 8 and 9. While the future of the ETS remains uncertain, planning for employers to comply with the current ETS deadlines will take additional time, and employers may want to continue preparing for the ETS as if it is going to take effect while litigation continues.
On November 4, 2021, the US Occupational Safety and Health Administration (OSHA) unveiled its Emergency Temporary Standard (ETS) to protect employees of large employers in all industries from COVID-19. The Centers for Medicare and Medicaid Services (CMS) simultaneously released its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule, applicable to most Medicare- and Medicaid-certified providers and suppliers, which must be met to continue participation in Medicare and Medicaid programs. Finally, the White House announced that its previously published federal contractor vaccination mandate would be updated to move the compliance deadline from December 8, 2021, to January 4, 2022.
Key highlights of OSHA’s ETS include the following:
Vax-or-Test: By January 4, 2022, all employees of large employers (i.e., those with at least 100 employees) must be fully vaccinated or show a weekly negative COVID-19 test.
Paid Time Off: Beginning December 5, 2021, large employers must provide paid time off for employees to receive the vaccine and recover from any side effects caused by the vaccine. Specifically, the ETS requires all covered employers to support vaccination by providing employees with “reasonable” time—including up to four hours of paid time—to receive each primary vaccination dose, and “reasonable” time and paid sick leave to recover from primary vaccination dose side effects.
Paying for Tests: Generally speaking, OSHA’s position is that large employers are not required to provide, or pay for, COVID-19 tests if their employees choose not to be vaccinated; however, employers will still need to pay for the tests if employees are unable to be vaccinated due to legally protected reasons (i.e., disability or sincerely held religious belief). (Note that other federal and state laws may still require certain reimbursements or compensation for time beyond what the OSHA ETS provides.)
Masks for Unvaccinated Employees: If an employee is not vaccinated, the employer must ensure the employee wears a face mask while in the workplace.
Exempted Employees: Employees who work completely remotely or who work only outdoors are included for purposes of the 100-employee count, but they are exempt from the “vax-or-test” requirements. That said, employees who work primarily remotely but who do some work where other people are present (e.g., an office) are covered and must be vaccinated or test; however, the frequency of testing in that situation would depend on how often they perform work where others are present.
The OSHA regulation is also clear about how it interacts with other standards already in place:
Interaction with Stricter Employer Policies: Employers may impose stricter vaccine mandates that do not include a testing option, subject to legally protected reasons for remaining unvaccinated.
Interaction with State OSHA Plans: In the 22 states that maintain their own state OSHA (e.g., Cal/OSHA), the state OSHA will be responsible for either adopting the federal OSHA ETS as written or modifying it to impose stricter requirements. Likewise, this ETS does not replace existing state or local vaccination requirements, such as requirements that all indoor dining patrons be fully vaccinated.
Interaction with the CMS Rule (described below): The OSHA rule will not apply to workplaces that receive Medicare or Medicaid funds, as these workplaces are covered by the CMS rule described in further detail below.
CMS INTERIM FINAL RULE
The CMS interim final rule (IFR) applies to certain facilities that receive payment under Medicare and/or Medicaid.
Deadline for Compliance: The IFR provides that covered facilities must ensure that all eligible staff have received 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 byDecember 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated—either two doses of Pfizer or Moderna or one dose of Johnson & Johnson—by January 4, 2022.
Eligible staff includes: facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. In addition, contractors and others with direct or indirect patient contact—including administrative staff, facility leadership, volunteer or other fiduciary board members and environmental services staff—are covered by the rule. Very limited exceptions apply.
Facilities covered by the regulation include:
Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly (PACE), Hospitals (all types), Long Term Care Facilities (including SNFs), Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, Clinics, Community Mental Health Centers, Home Infusion Therapy Suppliers, Rural Health Clinics/Federally Qualified Health Centers and End-Stage Renal Disease Facilities
Note: The CMS rule does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS; however, other components of the IFR (and/or other federal mandates, such as the OSHA ETS and federal contractor rules) may apply to these entities.
Exemptions to vaccination requirement: The rule provides for exemptions based on recognized medical conditions or religious beliefs, observances or practices. Facilities must develop a similar process or policy for permitting exemptions that aligns with federal law.
No Testing Option: The IFR does not include testing as an alternative to vaccination (i.e., “Vax or Test” is not permitted, unlike the OSHA ETS).
Enforcement: CMS will ensure compliance through established survey and enforcement processes. If a provider or supplier does not meet the requirements, it will first be cited as being noncompliant and will have an opportunity to comply before CMS takes additional action, which could include termination of the facility’s Medicare/Medicaid provider agreement.
The rule will be implemented in two phases:
In Phase 1 (within 30 days after rule publication), eligible staff must have received their first dose or a documented exemption.
In Phase 2, (within 60 days of rule publication), eligible employees must have received their second dose.
FEDERAL CONTRACTOR VACCINATION MANDATE
The White House announced that its previously published federal contractor vaccination mandate would be updated to move the initial vaccination compliance deadline from December 8, 2021, to January 4, 2022. Further details of the federal contractor mandate are available in McDermott’s previously published alert, available here.