Federal COVID-19 Vaccination Mandates and Related Litigation: An Overview

Federal COVID-19 Vaccination Mandates and Related Litigation: An Overview

Legal Sidebari

Federal COVID-19 Vaccination Mandates and
Related Litigation: An Overview
Updated December 1, 2021
During 2021, various federal, state, and private entities instituted Coronavirus Disease 2019 (COVID-19)
vaccination requirements to address the pandemic, particularly as the Delta variant—a highly contagious
strain of SARS-CoV-2 (the virus that causes COVID-19)—spreads in the United States. The federal
COVID-19 vaccination requirements issued to date by the President or executive agencies include those
directed at (1) federal executive agency civilian employees; (2) federal contractors for executive
departments, agencies, and offices; (3) most Medicare- and Medicaid-certified providers and suppliers;
and (4) employers with 100 or more employees. These employment- or workforce-based mandates—
subject to accommodations required by federal law—either directly require certain employees to receive
COVID-19 vaccinations or direct certain employers to impose a vaccination or vaccination-and-testing
requirement on their employees or staff. (In addition to these mandates, the Secretary of Defense has
mandated COVID-19 vaccination for servicemembers. For more information about the military’s
COVID-19 vaccination mandate, see this CRS Insight.)
The federal vaccination mandates, like those imposed by states and state entities like public universities,
have generated numerous legal challenges. While both federal and state vaccination requirements are
subject to constitutional provisions that protect individual rights, federal requirements imposed by the
executive branch are also subject to statutory constraints. Specifically, such requirements generally must
stem from the federal government’s existing statutory authority and may be subject to additional context-
specific statutory limits. Thus, each federal mandate raises unique legal issues specific to the particular
statutory framework, in addition to legal issues raised by governmental vaccination requirements
generally.
This Sidebar provides an overview of each set of federal COVID-19 vaccination requirements and the
statutory authorities cited for their basis. It then highlights some of the key legal issues raised by the
pending legal challenges against each mandate, and provides some potential considerations for Congress
based on a preliminary order issued by the U.S. Court of Appeals for the Fifth Circuit in the early stages
of one of the pending proceedings.
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Table 1. Summary of Federal Non-Military COVID-19 Vaccination Mandates
As of December 1, 2021
Federal
Statutory
Covered
Vaccination
Compliance
Mandate
Authority
Individuals/Entities
Requirement
Deadline(s)
Status
Executive Order
5 U.S.C.
Federal executive
Employees must be ful y
Receive a one-dose
In effect
14,043 (Federal
§§ 3301,
branch employees
vaccinated unless
vaccine or two-dose
Employee)
3302, 7301
granted a legally
vaccine series by
required exception
November 8, 2021.
based on a disability/
Be ful y vaccinated by
medical condition or a
November 22, 2021.
sincerely held religious
belief.
Remote-working
employees are subject to
requirement.
Executive Order
40 U.S.C.
Federal contractors
Covered contractors
As of January 18, 2022,
Enjoined in
14,042 (Federal
§ 101 et
and subcontractors
must ensure covered
covered contractor-
three states
Contractor)
seq.; 3
that have a covered
contractor-employees
employees must be ful y
(Kentucky,
U.S.C. § 301
contract with
are ful y vaccinated,
vaccinated on the first
Ohio,
executive
except in circumstances
day of performance on a
Tennessee).
departments and
where an employee is
new contract or the

agencies
legally entitled to an
renewal, extension, or
exemption based on a
exercised option of an
In effect in
disability/medical
existing contract.
other
condition or a sincerely
jurisdictions.
held religious belief.
Remote-working
covered contractor-
employees are subject to
requirement.
Centers for
42 U.S.C.
Specified provider
Covered providers and
By December 6, 2021,
Enjoined by
Medicare &
§§ 1302,
and supplier types
suppliers must ensure
(1) covered providers
courts
Medicaid Services
1395hh, and
that participate in
covered staff who
and suppliers must
(CMS) Interim
other
Medicare and
directly provide care or
establish and begin to
Final Rule (IFR)
provider- or
Medicaid
other services for their
implement the
supplier-
facilities and/or patients
vaccination policies and
specific
are ful y vaccinated,
(2) covered staff must
provisions
except in circumstances
receive first dose of a
where a staff member is
two-dose vaccine or a
legally entitled to an
one-dose vaccine.
exemption based on a
Covered staff must
disability/medical
complete two-dose
condition or a sincerely
vaccine series by January
held religious belief.
4, 2022
Staff who work 100%
remotely from sites of
patient care or away
from onsite staff are not
subject to the
requirement.

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Federal
Statutory
Covered
Vaccination
Compliance
Mandate
Authority
Individuals/Entities
Requirement
Deadline(s)
Status
Occupational
29 U.S.C.
In all jurisdictions,
A covered employer
Covered employers
Stayed by
Safety and Health
§ 655(c)
private employers
must establish and
must establish and begin
court
Administration’s
with 100 or more
enforce a policy that
to implement the
(OSHA’s)
employees.
either (1) ensures
vaccination policies by
Emergency
In 26 states, Puerto
employees are ful y
December 6, 2021.
Temporary
Rico, and the U.S.
vaccinated, except in
Covered employees
Standard (ETS)
Virgin Islands with
circumstances where an
must receive either a
OSHA-approved
employee is legally
one-dose vaccine or a
state plans, state and
entitled to an exemption
two-dose vaccine series,
local government
based on a
or begin regular testing
employers with 100
disability/medical
by January 4, 2022.
or more employees.
condition or sincerely
held religious belief; or

(2) requires employees
to be ful y vaccinated or
provide proof of regular
COVID-19 testing and
wear a face covering
when indoors.
Employees who work
remotely, at a site where
other people are not
present, or exclusively
outside are not subject
to the requirements.
Source: CRS analysis of the relevant Executive Orders, CMS IFR, and OSHA ETS.
Executive Agency Employee Mandate
Executive Order 14,043 (Federal Employee EO), issued on September 9, 2021, instructs each executive
agency to implement a program to require COVID-19 vaccination for all of its federal employees, subject
to exceptions required by law, including those based on a disability or medical condition or a sincerely
held religious belief. The Federal Employee EO directs the Safer Federal Workforce Task Force (Task
Force) to issue guidance on this requirement’s implementation. The Federal Employee EO is based on the
President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and 7301. These provisions grant the
President general authority to prescribe rules and/or regulations for executive branch employees.
Under the Task Force’s guidance, federal employees must be fully vaccinated or obtain an exception by
November 22, 2021. Because employees will be considered fully vaccinated two weeks after they
complete the requisite number of COVID-19 vaccine doses, federal employees must have received either
a one-dose vaccine or a two-dose vaccine series by no later than November 8, 2021. The vaccination
requirements apply to employees who are under maximum telework or remote-work arrangements.
Employees who refuse to be vaccinated or provide proof of vaccination, and have neither an exception
nor an exception request under consideration, are subject to disciplinary measures, up to and including
removal or termination. Under the guidance, however, the removal or termination would be preceded by a
brief period of education and counseling and a suspension period up to 14 days.
Several federal employees and at least one employee union have sued to challenge the federal employee
mandate. These suits raise a variety of claims, including some claims that are common to challenges to
state vaccination requirements. For example, one common claim is based on an alleged violation of the
plaintiffs’ substantive due process rights to bodily integrity or a right to refuse unwanted medical
treatment. In the context of COVID-19 vaccination mandate litigation to date, courts have generally

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rejected those claims, concluding that a fundamental right is not implicated by the vaccination mandate,
which reasonably furthers a legitimate government interest.
Another common claim is based on the emergency use authorization (EUA) provision of the Federal
Food, Drug & Cosmetic Act. Plaintiffs asserting this claim generally allege that a vaccination mandate
violates the informed consent requirement of the EUA provision, which directs the Secretary of the
Department of Health and Services (HHS), when issuing an EUA for a medical product, to impose
conditions necessary to protect the public health, including appropriate conditions designed to inform
individuals “of the option to accept or refuse administration of the product.” Courts to date have also
generally rejected this claim, holding that the EUA’s informed consent provision only requires medical
providers administering the vaccines to inform would-be recipients of the vaccines’ risks and their right to
refuse it. As a result, courts generally have concluded that the provision does not prohibit entities from
requiring individuals, duly informed by their medical providers, to be vaccinated. In addition, courts have
emphasized that at least one COVID-19 vaccine has received full FDA approval, and is therefore no
longer being distributed under an EUA.
Plaintiffs have also asserted several claims more specific to the federal employee mandate. One set of
claims, for instance, challenged the agencies’ alleged denial of religious exemption requests as violating
the Religious Freedom Restoration Act and the First Amendment’s Free Exercise Clause. In a November
2021 decision, however, the district court considering these claims rejected them as unripe—or too
early—for review, given that each plaintiff has a pending request for exemption and has not suffered any
adverse employment consequence. Another claim challenges the manner by which the mandate was
implemented. According to the plaintiffs, the vaccination requirement was implemented without
undergoing the notice-and-comment rulemaking procedures required by the Administrative Procedure Act
(APA). This claim is currently subject to a pending motion for preliminary injunction by the plaintiffs, but
the district court is likely to consider whether the mandate falls under an exception from APA rulemaking
requirements as “a matter relating to agency management or personnel.”
Federal Contractor Mandate
Executive Order 14,042 (Federal Contractor EO), also issued on September 9, 2021, directs federal
executive departments and agencies to include in certain contracts a clause requiring compliance with the
Task Force’s workplace safety guidance. The Task Force guidance, issued on September 24, 2021,
requires federal contractors and subcontractors with a covered contract to conform to several workplace
safety protocols, including COVID-19 vaccination of covered contractor-employees, subject to exceptions
required by law. Covered contractor-employees include those working on or in connection with a covered
contract or working at a covered contractor workplace. Covered contractor-employees working remotely
are subject to the vaccination requirements.
Consistent with the Federal Contractor EO, the guidance sets forth a phase-in period for the new clause to
be added to federal contracts. Generally, new contracts awarded on or after November 14, 2021 must
include the new clause, while contracts awarded prior to October 15, 2021 would incorporate the new
clause only at the point at which the government renews the contract or exercises an option. As of January
18, 2022, covered contractors must ensure that their covered employees are fully vaccinated by the first
day of performance of a new contract or when there is a renewal, extension, or exercised option on an
existing contract. The Task Force guidance instructs that “significant actions, such as termination of the
contract,” should be taken if a contractor does not take steps to comply with the requirements. For more
information about Federal Contractor EO’s requirements, see this CRS Insight.
The Federal Contractor EO is based on the President’s authorities under 3 U.S.C. § 301 and the Federal
Property and Administrative Services Act (Procurement Act), including 40 U.S.C. § 121. The
Procurement Act empowers the President to “prescribe policies and directives that the President considers

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necessary to carry out” the Act if they are consistent with the Act, the purpose of which is to provide “an
economical and efficient system” for, among other objectives, federal procurement. The Federal
Contractor EO states that it was issued to promote this purpose “by ensuring that the parties that contract
with the Federal Government provide adequate COVID-19 safeguards to their workers” performing on or
in connection with a covered contract. The President determined that the safeguards would “decrease
worker absence, reduce labor costs, and improve the efficiency of contractors and subcontractors at sites
where they are performing work for the Federal Government.”
The Federal Contractor EO, pursuant to 3 U.S.C. § 301, tasked the Director of the Office of Management
and Budget (OMB) with determining whether the Task Force’s guidance “will promote economy and
efficiency in Federal contracting.” In accordance with this delegation, the OMB Director made an
affirmative determination in a Federal Register notice published on the same date of the Task Force
guidance’s release. The Federal Contractor EO also directs the Federal Acquisition Regulatory Council to
make corresponding amendments to the Federal Acquisition Regulation, and to issue guidance to federal
agencies on how to comply with the federal contractor mandate in the interim. The Council issued the
guidance on September 30, 2021.
More than twenty states, on behalf of their state agencies and political subdivisions that may have a
covered contract subject to the Federal Contractor EO, have filed at least four separate suits in different
district courts to challenge the federal contractor mandate. Plaintiffs in each case filed a motion for
preliminary injunction seeking to enjoin—or suspend—the mandate while the litigation is pending. In
November 2021, one district court—in the challenge filed by Kentucky, Ohio, and Tennessee—granted
the plaintiffs-states’ motion and enjoined the mandate while the litigation is pending. Among other
determinations, the court concluded that the President likely exceeded his statutory authority under the
Procurement Act in imposing the vaccination requirement because the requirement, as a public health
measure, does not “ha[ve] a close enough nexus to economy and efficiency in federal procurement.” The
motions for preliminary injunctions remain pending in the other cases.
Vaccination Requirement for Most Medicare- and Medicaid-Certified Providers and
Suppliers
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final
Rule (IFR), effective November 5, 2021, that requires specified Medicare- and Medicaid-certified
providers and suppliers to establish and enforce a policy that requires, subject to legally required
exceptions, all eligible staff to receive the first dose of a two-dose COVID-19 vaccine or a one-dose
COVID-19 vaccine by December 6, 2021, and to complete their vaccination series by January 4, 2022.
This requirement applies to 15 provider and supplier types that participate in Medicare and Medicaid,
including hospitals, long-term-care facilities, and rural health clinics. The requirement does not apply to
other health care entities such as physician offices, organ procurement organizations, and portable X-Ray
suppliers.
For providers and suppliers subject to the IFR, their vaccination policy must apply to all staff who directly
provide any care, treatment, or other services for the facility and/or its patients, including (1) employees
(including administrative staff as well as facility leadership); (2) licensed practitioners; (3) students,
trainees, and volunteers; and (4) individuals who provide care, treatment, or other services for the facility
and/or its patients under contract or other arrangements (including housekeeping and food services).
Individuals who provide services 100% remotely from sites of patient care and away from staff who work
at sites of care—such as fully remote telehealth or payroll services—are not subject to the vaccination
requirements. CMS states that noncompliant providers and suppliers will be subject to enforcement
remedies based on the level of noncompliance and available remedies, which may include civil monetary
penalties, denial of payment for new admissions, and termination of the Medicare/Medicaid provider
agreement.

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According to CMS, the IFR is based on its determination that COVID-19 vaccination “is central to any
multi-pronged approach for reducing health system burden, safeguarding health care workers and the
people they serve, and ending the COVID-19 pandemic.” The agency found “good cause” to waive the
notice-and-comment rulemaking procedures under the APA and Section 1871(b) of the Social Security
Act (SSA). In particular, the agency based this determination on several considerations, including (1) that
outbreaks associated with the Delta variant have shown that current levels of COVID-19 vaccination
coverage have been inadequate to protect health care consumers and staff; (2) the pandemic’s strain on
the health care system; (3) that respiratory infections typically circulate more frequently during the winter
months; and (4) the onset of the 2021–2022 influenza season.
CMS relies on several layers of statutory authorities in issuing the IFR. Across all providers and suppliers,
CMS invokes SSA Section 1102, a provision that grants the HHS Secretary with general authority to issue
rules “as may be necessary to the efficient administration of the functions” with which the Secretary is
charged under the SSA. For Medicare providers and suppliers, CMS additionally relies on SSA Section
1871, which authorizes the Secretary to prescribe regulations “as may be necessary to carry out the
administration” of the Medicare programs. Finally, for each provider and supplier, CMS also relies on
certain provider- and supplier-specific provisions, many of which, for instance, authorize the Secretary to
impose requirements he “finds necessary in the interest of the health and safety of individuals” who
receive service from the relevant entities.
At least 24 states, on behalf of certain state-run health care facilities that may be subject to the vaccination
requirements, filed four separate suits to challenge the IFR shortly after its issuance. Plaintiffs in each
case filed a motion for preliminary injunction seeking to enjoin the IFR while the litigation is pending. In
November 2021, one district court, in the challenge filed by the state of Florida, declined to enjoin the
IFR, concluding the state had not shown “irreparable harm” to justify an injunction. In the court’s view,
the state had not provided sufficient factual evidence to demonstrate that the vaccination requirements’
alleged likely adverse impact, such as potential staffing shortages, would result if the requirements were
not halted.
Later in the same month, however, two district courts granted the plaintiffs-states’ motions in each
respective case. Together, these orders enjoined the IFR nationwide during the pendency of the litigation.
Among other determinations, both courts generally concluded that CMS likely exceeded its statutory
authority in issuing the IFR because the applicable provisions do not specifically authorize the agency to
mandate vaccination; the agency likely lacked “good cause” to waive the notice-and-comment rulemaking
procedures; and the plaintiffs-states sufficiently demonstrated they would suffer irreparable harm—
including in the form of significant staffing shortages—if the IFR was not enjoined.
Vaccination and Testing Emergency Temporary Standard (ETS) for Employers with
100 or More Employees
On the same day that CMS released its IFR, the Occupational Safety and Health Administration (OSHA)
released an ETS that generally requires private employers with 100 employees or more to establish and
enforce a policy that either (1) requires all employees to receive COVID-19 vaccination, subject to legally
required exceptions; or (2) requires employees to receive COVID-19 vaccination or provide proof of
regular COVID-19 testing and wear a face covering when indoors or occupying a vehicle with another
person. For the 26 states, Puerto Rico, and the U.S. Virgin Islands that have opted to adopt their own
OSHA-approved state plans, as discussed in more detail in this CRS report, the ETS also applies to state
agency and local government employers. To the extent a workplace is subject to both the ETS and one of
the preceding mandates, the more specific mandate generally applies. For those workplaces, OSHA
specifically states either that the ETS does not apply (in the case of federal contractors or health care
providers and suppliers) or that compliance with the other mandate is deemed sufficient to meet the
employers’ obligations under the ETS (in the case of executive agencies).

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Under the ETS, employees who are not fully vaccinated—including those who have been granted
exceptions—generally must be tested at least once every seven days if they report at least once every
seven days to a work site where others are present. Employees who do not report to such a workplace
during a period of seven or more days must be tested within seven days prior to returning to the
workplace. Employees exempt from the ETS’s requirements include (1) employees who work remotely or
at a site where other people are not present; and (2) employees who work exclusively outside. Covered
employers can, but are not required to, pay for any costs associated with testing, and they must provide
employees with paid leave to receive and recover from the vaccination. Covered employers must establish
and begin to implement the relevant vaccination policy by December 6, 2021, and ensure their employees
have received a one-dose vaccine or a two-dose vaccine series by January 4, 2022. After that, all covered
employers must ensure that employees who are not fully vaccinated are subject to regular COVID-19
testing. Noncompliant covered employers could face OSHA citations and civil monetary penalties. (For
more information about the ETS’s requirements, see this CRS Report and Sidebar.)
The vaccination and testing ETS is based on OSHA’s authority under Section 6(c) of the Occupational
Safety and Health Act of 1970. The provision authorizes the agency to issue an ETS that takes effect
immediately upon publication in the Federal Register, without undergoing the APA’s rulemaking
proceedings, if it determines “(A) that employees are exposed to grave danger from exposure to
substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such
emergency standard is necessary to protect employees from such danger.” OSHA issued the ETS upon its
determination that unvaccinated workers face a grave danger from exposure to SARS-CoV-2 in the
workplace, given that COVID-19 has killed more than 725,000 people in the United States in fewer than
two years; that unvaccinated individuals remain at much higher risk of severe health outcomes; and that
evidence demonstrates the virus’s transmissibility in the workplace and the prevalence of infections in
employee populations. OSHA further determined that the ETS is necessary to protect unvaccinated
workers from the risk of contracting COVID-19 given the potential severe health consequences from
occupational exposure to COVID-19 and the fact that vaccination provides the most effective and
efficient control available, with the use of other mitigation measures further protecting workers who
remain unvaccinated.
On the same day the ETS was issued, numerous petitioners—including covered employers, states, and
religious groups—moved to stay and permanently enjoin the mandate in several federal courts of appeals.
In response to a petition and motion to stay filed by several covered employers and four states, the Fifth
Circuit stayed the enforcement of the ETS the day after it was issued. On November 12, 2021, the court
affirmed the stay, largely based on its conclusion that the ETS “grossly exceeds OSHA’s statutory
authority.”
In the court’s view, an airborne virus like SARS-CoV-2 likely falls outside the scope of a “new hazard”
within the meaning of Section 6(c) under a canon of statutory construction known as noscitur a sociis,
which counsels that the more precise meaning of a word should be determined by the neighboring words
with which it is associated. Because “new hazard” is neighbored by “substances or agents” and “toxic or
physically harmful”—phrases that, in the court’s view, connote toxicity and poisonousness—the term
likely does not encompass an airborne virus that is both widely present in society and “non-life-
threatening to a vast majority of employees.” Moreover, the court concluded that COVID-19 does not
pose the required “grave danger” for purposes of Section 6(c), given that the agency cannot demonstrate
that all covered workplaces are in fact exposed to COVID-19, the effects of COVID-19 could be mild,
and the status of the virus’s spread has changed over time. The ETS, in the court’s view, was also not
“necessary” to protect unvaccinated workers given its “staggering[] overb[readth],” such that it was both
overinclusive—applying to employers and employees in virtually all industries and workplaces in
America without an attempt to account for differences in COVID-19 exposure—and underinclusive—
disregarding workplaces with 99 or fewer employees.

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In addition to its statutory analysis, the court commented that the ETS likely exceeds the federal
government’s authority under the Constitution’s Commerce Clause. Characterizing the relevant regulated
activity as compulsory vaccination, the Fifth Circuit expressed the view that the ETS impermissibly
“regulates noneconomic inactivity that falls squarely within the States’ police power.”
Pursuant to 28 U.S.C. § 2112, which specifies the procedures for review when an agency order is
challenged in more than one federal appellate court, the Judicial Panel on Multistate Litigation, on
November 16, 2021, randomly selected the U.S. Court of Appeals for the Sixth Circuit (Sixth Circuit) as
the court in which all of the pending petitions will be consolidated for review. The Sixth Circuit may
modify, revoke, or extend the Fifth Circuit’s stay while adjudicating the merits of the petitions.
Considerations for Congress
The federal vaccination requirements imposed by the executive branch to date are based on the
President’s or the relevant executive agencies’ existing statutory authorities. Thus, Congress—subject to
constitutional limits—can generally clarify the scope or parameter of such authorities as they apply to
vaccination requirements. The Fifth Circuit’s statement that the ETS likely exceeds the federal
government’s authority under the Commerce Clause, however, may have broader implications. Under the
Fifth Circuit rationale, Congress could lack authority under the Commerce Clause to require private
employers to institute a vaccination policy for their employees.
It is unclear whether other courts would agree with the Fifth Circuit on this issue. In considering a
Commerce Clause challenge to a provision of the Affordable Care Act (ACA) that requires employers to
offer a minimum level of health insurance coverage to their employees and dependents, for instance, the
Fourth Circuit rejected the argument that the employer mandate at issue there impermissibly compels
employers to engage in unwanted economic activity. All employers, the Fourth Circuit observed, “by their
very nature” are already “engaged in economic activity” and “in the market for labor.” Thus, the Fourth
Circuit held that the ACA’s employer mandate does not compel employers “to become active in
commerce,” but rather “merely ‘regulate[s] existing commercial activity.” Under this reasoning, a
requirement on employers to institute a vaccination policy for its employees could be considered another
regulation of existing commercial activity, not unlike other federal workplace or employment regulations.
While the Supreme Court has long recognized the states’ central role in regulating public health, the Court
has also recognized, for equally as long albeit in dicta, Congress’s power over infectious disease control
under its Commerce Clause authority. Commenting on quarantine laws used to prevent the introduction or
spread of disease, for example, the Supreme Court wrote in Minnesota Rate Cases, 230 U.S. 352, 406
(1913), that “[s]uch laws undoubtedly operate upon interstate and foreign commerce” and “could not be
effective otherwise.” The significant impact of the COVID-19 pandemic on the national economy,
discussed in detail in other CRS products, may give weight to the Court’s observation from more than a
century ago.

Author Information

Wen W. Shen

Legislative Attorney

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