# Missouri, State of v. Biden

> District Court, E.D. Missouri · November 29, 2021

URL: https://www.frixlaw.com/law-library/cases/10236072

## Case

- **Court:** District Court, E.D. Missouri
- **Decided:** November 29, 2021
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10236072

## How later opinions describe it (automated extraction)

- noting agency “must not ignore evidence placed before it by interested parties”
- finding agency’s stated reason of “protecting the public safety” was insufficient to waive notice and comment requirement

## Opinion text

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

STATE OF MISSOURI, et al., )
)
Plaintiffs, )
)
vs. ) Case No. 4:21-cv-01329-MTS
)
JOSEPH R. BIDEN, JR., in his official capacity )
as the President of the United States of America, )
et al., )
)
Defendants. )

MEMORANDUM AND ORDER
I. INTRODUCTION
This case concerns the Centers for Medicare and Medicaid Services’ (“CMS”) federal
vaccine mandate on a wide range of healthcare facilities. On November 5, 2021, CMS issued an
Interim Final Rule with Comment Period (“IFC”) entitled “Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care Staff Vaccination” (the “mandate”), 86 Fed. Reg. 61,555 (Nov.
5, 2021), revising the “requirements that most Medicare- and Medicaid-certified providers and
suppliers must meet to participate in the Medicare and Medicaid programs.” 86 Fed. Reg. 61,555–
601. Specifically, the mandate requires nearly every employee, volunteer, and third-party
contractor working1 at fifteen2 categories of healthcare facilities to be vaccinated against SARS-

1 The mandate applies to a wide-range of people working at the facilities, including, employees, trainees, students,
volunteers, or contractors, who provide any care, treatment, or other services for the facility. 86 Fed. Reg. at 61,570
(emphasis added).

2 The CMS vaccine mandate covers fifteen categories of Medicare- and Medicaid-certified providers and suppliers:
(1) Ambulatory Surgical Centers (ASCs); (2) Hospices; (3) Psychiatric residential treatment facilities (PRTFs); (4)
Programs of All-Inclusive Care for the Elderly (PACE); (5) Hospitals (acute care hospitals, psychiatric hospitals, long
term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation
hospitals); (6) Long Term Care (LTC) Facilities, generally referred to as nursing homes; (7) Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICFs-IID); (8) Home Health Agencies (HHAs); (9)
Comprehensive Outpatient Rehabilitation Facilities (CORFs); (10) Critical Access Hospitals (CAHs); (11) Clinics,
CoV-2 (“COVID”) and to have received at least a first dose of the vaccine prior to December 6,
2021. See id. at 61,573. On November 10, 2021, Plaintiffs, the States of Missouri, Nebraska,
Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire
(collectively, “Plaintiffs”) filed a Complaint challenging the mandate. Doc. [1]. The Complaint
seeks preliminary and permanent injunctive and declaratory relief. On November 12, 2021,

Plaintiffs filed a motion for a preliminary injunction, Doc. [6], requesting that this Court issue a
preliminary injunction enjoining Defendants from imposing the mandate.
Having fully reviewed the administrative record and submitted material, the Court finds
that a preliminary injunction is warranted here.
II. DISCUSSION
A. The Court has jurisdiction.
Defendants argue that this Court “lacks jurisdiction” over Plaintiffs’ claims because
“Congress has withdrawn federal-question jurisdiction over claims like this one that arise under
the Medicare statute,” citing 42 U.S.C. § 405(h), as incorporated by 42 U.S.C. § 1395ii. Doc. [23]

at 15–19. The Court does not agree. As Defendants readily concede, “State governments” such
as the Plaintiff States are neither “institution[s]” nor “agenc[ies]” “dissatisfied” with the
Secretary’s determination regarding eligibility or receipt of benefits under 42 U.S.C.
§ 1395cc(h)(1) and, therefore, “the States3 themselves could not use that statute’s vehicle for
judicial review.” Id. at 19; see Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 16
(2000) (explaining that § 405(h) does not apply if application “would mean no review at all”). In

rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language
pathology services; (12) Community Mental Health Centers (CMHCs); (13) Home Infusion Therapy (HIT) suppliers;
(14) Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs); and (15) End-Stage Renal Disease
(ESRD) Facilities. 86 Fed. Reg. at 61,569–70.

3 The Plaintiff States bring their claims in a number of capacities: sovereign, quasi-sovereign/parens patriae, and
proprietary. See, e.g., Doc. [1] ¶¶ 5, 7, 9.
addition, Plaintiffs’ claims that arise under the Medicaid Act—as opposed to the Medicare Act—
are not subject to the § 405(h)’s jurisdictional bar. See Avon Nursing & Rehab. v. Becerra, 995
F.3d 305, 311 (2d Cir. 2021) (“Unlike the Medicare Act, the Medicaid Act does not incorporate
the Social Security Act’s claim-channeling and jurisdiction-stripping provisions, 42 U.S.C. §
405(g) and (h). Federal courts thus have jurisdiction over claims arising under the Medicaid Act

pursuant to 28 U.S.C. § 1331.”). Thus, all aspects of the mandate that purport to change a Medicaid
regulation are clearly not barred, even under Defendants’ arguments. Nonetheless, the Court finds
that it has jurisdiction over claims arising under both Medicare and Medicaid.
B. A preliminary injunction is warranted here.
Plaintiffs seek a preliminary injunction of the mandate’s enforcement pending a full
judicial review of the mandate’s legality. The Court addresses their request today. Whether a
court should issue a preliminary injunction involves consideration of (1) the threat of irreparable
harm to the movant; (2) the state of the balance between this harm and the injury that granting the
injunction will inflict on other parties litigant; (3) the probability that movant will succeed on the

merits; and (4) the public interest. Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109, 113 (8th
Cir. 1981). “While no single factor is determinative, the probability of success factor is the most
significant.” Home Instead, Inc. v. Florance, 721 F.3d 494, 497 (8th Cir. 2013) (internal
quotations and citations omitted).
Each of these factors favors a preliminary injunction here.
a. Plaintiffs demonstrate a likelihood of success on the merits.
i. Congress did not grant CMS authority to mandate the vaccine.

Plaintiffs are likely to succeed in their argument that Congress has not provided CMS the
authority to enact the regulation at issue here. “[A]n agency literally has no power to act, let alone
pre-empt4 the validly enacted legislation of a sovereign State, unless and until Congress confers
power upon it.” La. Pub. Serv. Comm’n v. FCC, 476 U.S. 355, 357 (1986). While the Court agrees
Congress has authorized the Secretary of Health and Human Services (the “Secretary”) general
authority to enact regulations for the “administration” of Medicare and Medicaid and the “health
and safety” of recipients, the nature and breadth of the CMS mandate requires clear authorization

from Congress—and Congressed has provided none.5 See Ala. Ass’n of Realtors v. Dep’t of Health
& Hum. Servs., 141 S. Ct. 2485, 2486 (2021) (“It would be one thing if Congress had specifically
authorized the action that the CDC has taken. But that has not happened.”). Courts have long
required Congress to speak clearly when providing agency authorization if it (1) intends for an
agency to exercise powers of vast economic and political significance; (2) if the authority would
significantly alter the balance between federal and state power; or (3) if an administrative
interpretation of a statute invokes the outer limits of Congress’ power. Any one of those
fundamental principles would require clear congressional authorization for this mandate, but here,
all three are present. Even in exigency, the Secretary cannot “bring about an enormous and

4 CMS intends for the mandate to preempt any arguably inconsistent state and local laws regarding vaccination. See,
e.g., 86 Fed. Reg. at 61,568 (“We intend . . . that this nationwide regulation preempts inconsistent State and local laws
applied to Medicare- and Medicaid-certified providers and suppliers.”).

5 The Court notes that Congress has provided the Secretary of Health and Human Services (the “Secretary”) authority
to enact regulations “necessary to the efficient administration” of the Social Security Act and regulations “necessary
to carry out the administration of” of Medicare. 42 U.S.C. §§ 1302(a), 1395hh(a)(1). Among the regulations the
Secretary may promulgate under its power of “administration” is the setting of things like “standards,” “criteria,” or
“requirements” for specific facilities. See, e.g., Id. at § 1396d(h)(1)(B)(i) (governing Psychiatric Residential
Treatment Facilities (“PRTFs”) and mentioning “standards as may be prescribed in regulations by the Secretary”); Id.
at § 1395i–4(e) (governing Critical Access Hospitals (“CAHs”) and mentioning “criteria as the Secretary may
require”); Id. at § 1395rr(b)(1)(A) (governing End-Stage Renal Disease (“ESRD”) facilities and mentioning
“requirements as the Secretary shall by regulation prescribe”). For some facilities, Congress has authorized the
Secretary to set rules or conditions necessary to, or that will ensure, the “health and safety” of recipients of services.
See, e.g., Id. at § 1395i–3(d)(4)(B) (addressing LTC facilities and mentioning “requirements relating to the health,
safety, and well-being of residents . . . as the Secretary may find necessary”); Id. at § 1395x(e)(9) (addressing hospitals
and mentioning “requirements as the Secretary finds necessary in the interest of the health and safety of individuals
who are furnished services”). However, the Court need not decide whether those regulations are properly interpreted
by CMS to confer it authority to issue the vaccine mandate that it has. Instead, and irrespective of that determination,
the Court’s inquiry focuses on whether Congress specifically authorized such action, for reasons discussed above.
transformative expansion in [his] regulatory authority without clear congressional authorization.”
See Util. Air Reg. Grp. v. EPA, 573 U.S. 302, 324 (2014).
1. Given the vast economic and political significance of this
vaccine mandate, only a clear authorization from Congress
would empower CMS to act.

First, Congress must “speak clearly when authorizing an agency to exercise powers of ‘vast
economic and political significance.’” Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (quoting Util. Air
Reg., 573 U.S. at 324). The mandate’s economic cost is overwhelming. CMS estimates that
compliance with the Mandate—just in the first year—is around 1.38 billion dollars. 86 Fed. Reg.
at 61,613. Those costs, though, do not take into account the economic significance this mandate
has from the effects on facilities closing or limiting services and a significant exodus of employees
that choose not to receive a vaccination.6 Likewise, the political significance of a mandatory
coronavirus vaccine is hard to understate, especially when forced by the heavy hand of the federal
government. Indeed, it would be difficult to identify many other issues that currently have more
political significance at this time. Had Congress wished to assign this question fraught with deep
economic and political significance to CMS, “it surely would have done so expressly.” See King
v. Burwell, 576 U.S. 473, 486 (2015). “It is especially unlikely that Congress would have delegated
this decision to [CMS], which has no expertise in crafting” vaccine mandates. Id.
2. Because this mandate significantly alters the balance
between federal and state power, only a clear authorization
from Congress would empower CMS.

Second, Congress must use “exceedingly clear language if it wishes to significantly alter
the balance between federal and state power.” Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (quoting

6 Medicare and Medicaid programs “touch[] the lives of nearly all Americans” and are two of the “largest federal
program[s]” in the country. Azar v. Allina Health Servs., 139 S. Ct. 1804, 1808 (2019). Even “minor changes” to the
way those programs are administered “can impact millions of people and billions of dollars in ways that are not always
easy for regulators to anticipate.” Id. at 1816.
United States Forest Service v. Cowpasture River Preservation Assn., 140 S. Ct. 1837, 1850
(2020)); see also United States v. Bass, 404 U.S. 336, 349 (1971). The regulation at issue alters
that balance because it requires vaccination, which CMS has never attempted to do, for millions
of individuals who would otherwise be outside the reach of the federal government. This concern
is “heightened” since CMS’s “administrative interpretation alters the federal-state framework by

permitting federal encroachment upon a traditional state power.” Solid Waste Agency of N. Cook
Cty. v. U.S. Army Corps of Engineers, 531 U.S. 159, 173 (2001). It has long been the states’ power
to legislate health—including vaccination. Gibbons v. Ogden, 22 U.S. 1, 203 (1824) (noting
“health laws of every description” belong to the states); BST Holdings, L.L.C. v. Occupational
Safety & Health Admin., 17 F.4th 604, ---, 2021 WL 5279381, at *7 (5th Cir. 2021) (citing Zucht
v. King, 260 U.S. 174, 176 (1922) (noting that precedent had long “settled that it is within the
police power of a state to provide for compulsory vaccination”)). Sometimes “the most telling
indication of [a] severe constitutional problem . . . is the lack of historical precedent” for an
agency’s action. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 549 (2012). With such a

history of exclusive state power, the Court is far from certain that Congress intended the Center
for Medicare and Medicaid Services to require mandatory vaccinations for millions of Americans.
See Bond v. United States, 572 U.S. 844, 858 (2014) (noting “it is incumbent upon the federal
courts to be certain of Congress’ intent before finding that federal law overrides the usual
constitutional balance of federal and state powers” (internal quotations omitted)).
Truly, the impact of this mandate reaches far beyond COVID.7 CMS seeks to overtake an
area of traditional state authority by imposing an unprecedented demand to federally dictate the

7 Of course, this situation is novel and messy in that COVID has created a “unique pandemic scenario,” 86 Fed. Reg.
at 61,568, but equally problematic is that it remains unclear that COVID-19—however tragic and devastating the
pandemic has been—poses the kind of grave danger that justifies the federal government trampling on sovereign state
private medical decisions of millions of Americans. Such action challenges traditional notions of
federalism, as discussed above. “The independent power of the States [] serves as a check on the
power of the Federal Government: by denying any one government complete jurisdiction over all
the concerns of public life, federalism protects the liberty of the individual from arbitrary power.”
NFIB, 567 U.S. at 536 (quoting Bond v. United States, 564 U.S. 211, 222 (2011)). This is

especially true, since “a healthy balance of power between the States and the Federal Government
will reduce the risk of tyranny and abuse from either front.” Gregory v. Ashcroft, 501 U.S. 452,
458 (1991).
3. In the absence of a clear indication that Congress intended
for CMS to invoke such significant authority, the Court
will not infer congressional intent.

Third, “[w]here an administrative interpretation of a statute invokes the outer limits of
Congress’ power,” Congress must provide “a clear indication that [it] intended that result.” Solid
Waste, 531 U.S. at 172. This “requirement” stems from the “prudential desire not to needlessly
reach constitutional issues.”8 Id. And this requirement is “heightened” here since CMS’s claim
“alters the federal-state framework by permitting federal encroachment upon a traditional state
power.” Id. Whether Congress itself could impose the vaccination requirement is a tough
question, cf. BST Holdings, 17 F.4th at ---, 2021 WL 5279381, at *7 (Duncan, J., concurring), one
that CMS would force to its crisis. But even if Congress has the power to mandate the vaccine

rights. Regardless, disrupting this balance of power must have been expressly authorized by Congress, and as
discussed, Congress has not.

8 A court—especially a district court—should be reluctant to opine on an unsettled constitutional issue when the court
can resolve a case on an alternative ground. See Xiong v. Lynch, 836 F.3d 948, 950 (8th Cir. 2016) (quoting Lyng v.
Nw. Indian Cemetery Protective Ass’n, 485 U.S. 439, 445, 108 (1988)) (“A fundamental and longstanding principle
of judicial restraint requires that courts avoid reaching constitutional questions in advance of the necessity of deciding
them.”). And, at the very least, the Court should “pause to consider the implications of the [State’s] arguments” when
confronted with such new conceptions of federal power. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 550
(2012) (quoting Lopez,115 S. Ct. at 1624).
and the authority to delegate such a mandate to CMS—topics on which the Court does not opine
today—the lack of congressional intent for this monumental policy decision speaks volumes.
In conclusion, even if Congress’s statutory language was susceptible to CMS’s exceedingly
broad reading—which it is most likely not—Congress did not clearly authorize CMS to enact the
this politically and economically vast, federalism-altering, and boundary-pushing mandate, which

Supreme Court precedent requires.
ii. CMS improperly bypassed notice and comment requirements.

Even if CMS has the authority to implement the vaccine mandate—which the Court finds
is unlikely, as discussed above—the mandate is likely an unlawful promulgation of regulations.
Both the Administrative Procedure Act (“APA”) and the Social Security Act ordinarily require
notice and a comment period before a rule like this one takes effect.9 5 U.S.C. § 553; 42 U.S.C.
§ 1395hh(b)(1). Failure to allow notice and comment, where required, is grounds for invalidating
the rule. Iowa League of Cities v. EPA, 711 F.3d 844, 876 (8th Cir. 2013) (vacating a rule based
on an administrative agency’s failure to abide by the APA’s notice and comment procedure). The
notice and comment requirements do not apply if “good cause” establishes that they “are
impracticable, unnecessary, or contrary to the public interest” under the circumstances. 5 U.S.C.
§ 553(b)(B). The exception is read narrowly and only used in “rare” circumstances. Nw. Airlines,
Inc. v. Goldschmidt, 645 F.2d 1309, 1321 (8th Cir. 1981) (noting that the good cause exception
should be “narrowly construed and only reluctantly countenanced”); Nat. Res. Def. Council, Inc.
v. EPA, 683 F.2d 752, 764 (3d Cir. 1982) (noting “circumstances justifying reliance on [the good
cause] exception are indeed rare and will be accepted only after the court has examined closely
proffered rationales justifying the elimination of public procedures” (internal quotations omitted)).

9 The parties do not dispute that the notice and comment requirements applied to the mandate. 86 Fed. Reg. at 61,583.
CMS concedes it did not follow these requirements but attempts to justify its omission
under the “good cause” exception. 86 Fed. Reg. at 61,583. Here, Plaintiffs are likely to succeed
in their argument that CMS unlawfully bypassed the APA’s notice and comment requirements.
1. CMS’s own delay undermines its “emergency”
justification for bypassing notice and comment
requirements.

Use of the “good cause” exception is “limited to emergency situations” and is “necessarily
fact-or context-dependent.” Thrift Depositors of Am., Inc. v. Off. of Thrift Supervision, 862 F.
Supp. 586, 591 (D.D.C. 1994). Here, CMS’s delay in requiring mandatory vaccination undermines
its contention that COVID is an emergency such that it has the “good cause” necessary to dispense
with notice and comment requirements. In justifying the good cause exception, CMS stated that
“[t]he data showing the vital importance of vaccination” indicates that it “cannot delay taking this
action” to protect peoples’ health and safety. 86 Fed. Reg. at 61,583. Yet, CMS’s good cause
claim is undermined by its own delay in promulgating the mandate. See United States v. Brewer,
766 F.3d 884, 890 (8th Cir. 2014) (“[C]oncern for public safety further is undermined by [the
Attorney General’s] own seven-month delay in promulgating the Interim Rule.”); Chamber of
Com. v. United States Dep’t of Homeland Sec., 504 F. Supp. 3d 1077, 1089 (N.D. Cal. 2020)
(finding an agency’s six-month delay in promulgating rules relating to COVID precluded
presumption of urgency); Nat. Res. Def. Council v. Nat’l Highway Traffic Safety Admin., 894 F.3d
95, 115 (2nd Cir. 2018) (“Good cause cannot arise as a result of the agency’s own delay, because
otherwise, an agency unwilling to provide notice or an opportunity to comment could simply wait
until the eve of a statutory, judicial, or administrative deadline, then raise up the ‘good cause’
banner and promulgate rules without following APA procedures.” (internal quotations and
alterations omitted)). The CMS mandate was announced nearly two months10 before the agency
released it, and the mandate itself prominently features yet another one-month delay. Moreover,
two vaccines were authorized under Emergency Use Authorization (“EUA”)11 more than ten
months before the CMS mandate took effect, and one vaccine was fully licensed by the FDA well
over two months before.12 It is also worth mentioning that since the onset of COVID, CMS has

issued five IFC mandates, such as the one here; the most recent on May 13, 2021. 86 Fed. Reg. at
61,561. One could query how an “emergency” could prompt such a slow response; such delay
hardly suggests a situation so dire that CMS may dispense with notice and comment requirements13
and the important purposes they serve.
The COVID pandemic is an event beyond CMS’s control, yet it was completely within its
control to act earlier than it did. See 86 Fed. Reg. at 61,583 (“CMS initially chose, among other
actions, to encourage rather than mandate vaccination[.]”); see id. (explaining CMS had authority
to impose vaccination requirements even when the only vaccines available were those authorized
under EUAs in December 2020). The mere desire or need to have the mandate does not suffice

for good cause. Nat’l Ass’n of Farmworkers Orgs. v. Marshall, 628 F.2d 604, 621 (D.C. Cir. 1980)
(“[G]ood cause to suspend notice and comment must be supported by more than the bare need to
have regulations.”); United States v. Cain, 583 F.3d 408, 421 (6th Cir. 2009) (“A desire to provide

10 On September 9, 2021, the President announced his intention to promulgate federal vaccinate mandates, including
the CMS vaccine mandate challenged here.

11 The FDA issued vaccines under Emergency Use Authorization (“EUA”) for two COVID vaccines on December
11, 2020 and December 18, 2020. According to CMS, the agency could have imposed a vaccine requirement, even
when the only vaccines available are those authorized under EUAs. See 86 Fed. Reg. at 61,583.

12 On August 23, 2021, the FDA licensed the first COVID vaccine.

13 The Court also takes note that CMS reviewed several communications from stakeholders in favor of the mandate.
Thus, CMS apparently found it quite possible to consult with the interested parties it selected. See, e.g., 86 Fed. Reg.
at 61,565.
immediate guidance, without more, does not suffice for good cause.”). And good cause is not
automatically created based on an agency’s conclusion that bypassing the notice and comment
requirements is necessary to protect public safety.14 See Brewer, 766 F.3d at 889 (finding agency’s
stated reason of “protecting the public safety” was insufficient to waive notice and comment
requirement); Sorenson Commc’ns Inc. v. FCC, 755 F.3d 702, 706 (D.C. Cir. 2014) (“To accord

deference to an agency’s invocation of good cause would be to run afoul of congressional intent.”).
COVID cannot be a compelling justification forever, Does 1-3 v. Mills, --- S. Ct. ---, 2021 WL
5027177, at *3 (U.S. Oct. 29, 2021) (Gorsuch, J., dissenting), and CMS’s evidence shows COVID
no longer poses the dire emergency it once did. See, e.g., 86 Fed. Reg. at 61,583 (noting “newly
reported COVID-19 cases, hospitalizations, and deaths have begun to trend downward at a national
level”). Notably, today, there are three widely distributed vaccines. Additionally, there are several
therapeutics and treatments, and as CMS states, more are on the horizon. See, e.g., id. at 61,609.
Thus, CMS’s purported “emergency”15—one that the entire globe has now endured for nearly two
years, and to which CMS itself demonstrated ease in responding to—is unavailing. United States

v. Reynolds, 710 F.3d 498, 512–13 (3rd Cir. 2013) (“Most, if not all, laws passed . . . are designed
to eliminate some real or perceived harm. If the mere assertion that such harm will continue while

14 Other circuits, like the Eighth, have held that protecting the public, without more, is insufficient to waive procedural
requirements. United States v. Reynolds, 710 F.3d 498, 509 (3rd Cir. 2013); United States v. Johnson, 632 F.3d 912,
928 (5th Cir. 2011); United States v. Valverde, 628 F.3d 1159, 1168 (9th Cir. 2010); United States v. Cain, 583 F.3d
408, 421–24 (6th Cir. 2009).

15 CMS also asserted that there is an “emergency” now (such that CMS must immediately implement the mandate)
because “the 2021–2022 influenza season” will soon begin. 86 Fed. Reg. at 61,584. CMS offered this justification
while simultaneously admitting that “the intensity of the upcoming 2021-2022 influenza season cannot be predicted”
and that “influenza activity during the 2020-2021 season was low throughout the U.S.” Id. For a “risk of future harm”
to “justify a finding of good cause,” the “risk must be more substantial than a mere possibility.” Brewer, 766 F.3d at
890. Thus, CMS did not find a concrete “threat” to remedy but rather speculated as to a mere possibility of harm, and
there is a “difference between addressing present legal uncertainty and addressing the possibility of future legal
uncertainty.” Id. Notably, CMS did not mandate flu vaccines, despite mentioning that the flu has been daunting the
healthcare system, that recent studies show approximately half of healthcare workers refuse the flu vaccine, id. at
61,568, and that CMS has evidence that influenza vaccination of health care staff is directly associated with declines
in nosocomial influenza in hospitalized patients and nursing home residents. Id. at 61,557.
an agency gives notice and receives comments were enough to establish good cause, then notice
and comment would always have to give way.”).
2. CMS failed to meet its “good cause” burden, especially in
light of the unprecedented, controversial, and health-
related nature of the mandate.

CMS also failed to meet its burden based on the unprecedented, controversial, and health-
related nature of the mandate. Alcaraz v. Block, 746 F.2d 593, 612 (9th Cir. 1984) (holding that
the inquiry into an agency invoking “good cause proceeds case-by-case, sensitive to the totality of
the factors at play”). CMS had the burden “to establish that notice and comment need not be
provided.” Nat. Res. Def. Council, 894 F.3d at 113–14. In a situation like here, where there is
significant and known opposition to the mandate, “good cause” is even more important than usual.
See, e.g., Asbestos Information Ass’n of N. Am. v. Occupational Safety & Health Admin., 727 F.2d
415, 426 (5th Cir. 1984) (explaining that rules “may be more uncritically accepted after public
scrutiny, through notice-and-comment rulemaking, especially when the conclusions it suggests are
controversial”). The fact that this mandate effects issues relating to health16 increases the
importance even further. See Nat’l Ass’n of Farmworkers, 628 F.2d at 621 (“Especially in the
context of health risks, notice and comment procedures assure the dialogue necessary to the
creation of reasonable rules.”); Cmty. Nutrition Inst. v. Butz, 420 F. Supp. 751, 754 (D.D.C. 1976)
(noting that “when a health-related standard such as this is involved, the good cause exemption
may not be used to circumvent the legal requirements designed to protect the public”).
Accordingly, CMS’s argument that undertaking normal notice and comment requirements would
be “contrary to the public interest” based on delaying the mandate, id. at 61,586, is unavailing in
light of the circumstances. Alcaraz, 746 F.2d at 612. Rather, these requirements “serve the public

16 CMS acknowledges that “[s]erious adverse reactions [] have been reported following COVID-19 vaccines.” 86
Fed. Reg. at 61,565.
interest by providing a forum for the robust debate of competing and frequently complicated policy
considerations having far-reaching implications and, in so doing, foster reasoned decision
making.” Id. They are far from “mere formalities.” Id.
Moreover, the failure to take and respond to comments feeds into the very vaccine
hesitancy CMS acknowledges is so daunting. 86 Fed. Reg. at 61,559, 61,568. Besides fostering

reasoned decision making, notice and comment “provide a ‘surrogate political process’ that takes
some of the sting out of the inherently undemocratic and unaccountable rulemaking process.”
Dep’t of Homeland Sec. v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1929 n.13 (Thomas, J.,
dissenting). Requiring already hesitant individuals to get the vaccine—without giving them an
opportunity to be heard—undermines the democratic process that the APA’s procedural safeguards
are intended to protect and exacerbates the underlying hesitancy problem. Batterton v.
Marshall, 648 F.2d 694, 703 (D.C. Cir. 1980) (according notice and comment great importance
because it “reintroduce[s] public participation and fairness to affected parties after governmental
authority has been delegated to unrepresentative agencies”). Far from being “good cause” for

circumventing the normal rulemaking requirements, the unprecedented and controversial mandate
affecting personal health constitutes a compelling reason to utilize those procedures, and CMS
failed to provide the good cause necessary to overcome these factors.
In conclusion, because CMS’s “emergency” does not justify use of the “good cause”
exception, see Thrift, 862 F. Supp. at 591, and the unprecedented, controversial, and health-related
mandate requires more good cause than CMS provided, Alcaraz, 746 F.2d at 612, Plaintiffs are
likely to succeed in establishing that CMS improperly invoked the 5 U.S.C. § 553(b)(B) “good
cause” exception.
iii. The mandate is arbitrary and capricious.
Finally, Plaintiffs are likely to succeed in establishing that the CMS vaccine mandate is
arbitrary or capricious. Under the APA, a court must “hold unlawful and set aside agency action”
that is “arbitrary” or “capricious.” 5 U.S.C. § 706(2)(A). The APA’s arbitrary-and-capricious
standard requires that agency action be reasonable and reasonably explained. Fed. Commc’ns

Comm’n v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021) (“A court simply ensures that
the agency has acted within a zone of reasonableness and, in particular, has reasonably considered
the relevant issues and reasonably explained the decision.”). Under this “narrow” and deferential
standard of review, a court may not substitute its own policy judgment for that of the agency. Id.
Rather, the court must ensure there is a “rational connection between the facts found and the choice
made.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43
(1983).
1. The mandate is arbitrary and capricious because the
record is devoid of evidence regarding the covered
healthcare facilities.

CMS lacks evidence showing that vaccination status has a direct impact on spreading
COVID in the mandate’s covered healthcare facilities. CMS acknowledges its lack of
“comprehensive data” on this matter but attempts to “extrapolate” the abundant data that it does
have on Long Term Care Facilities (“LTCs”), generally referred to as nursing homes, to the other
dozen-plus Medicare and Medicaid facilities covered by the mandate. 86 Fed. Reg. at 61,585.
However, CMS’s path of analysis appears misguided and the inferences it produced are
questionable. State Farm, 463 U.S. at 43 (finding that in an arbitrary and capricious challenge,
the court will “uphold a decision of less than ideal clarity if the agency’s path may reasonably be
discerned”). As CMS’s own record shows, COVID disproportionally devastates LTC facilities.
Residents of LTC facilities—who make up less than 1-percent of the U.S. population—accounted
for more than 35-percent of all COVID deaths during the first twelve months of the pandemic. 86
Fed. Reg. at 61,566. Equally staggering is that “[o]f the approximately 656,000 Americans
estimated to have died from COVID through September 10, 2021, 30-percent are estimated to have
died during or after an LTC facility stay.” Id. at 61,601. Thus, CMS’s decision to extrapolate

LTC data to justify its lack of data regarding the other fourteen facilities covered is likely not
reasonable. Michigan v. EPA, 576 U.S. 743, 750 (2015) (requiring agencies to engage in “reasoned
decision making”); Encino Motorcars, LLC v. Navarro, 579 U.S. 211, 220 (2016) (“[A]n agency
must give adequate reasons for its decisions.”). While a wide-sweeping mandate might make sense
in the context of LTCs, based on CMS’s evidence, CMS presents no similar evidence for imposing
a broad-sweeping mandate on the other fourteen covered facilities. Camp v. Pitts, 411 U.S. 138,
143 (1973) (“If [a] finding is not sustainable on the administrative record made, then the [agency’s]
decision must be vacated[.]”). Although the Court appreciates its deferential review, the Court’s
duty is not to “rubber-stamp” administrative decisions devoid of reasonableness. Alaska Oil and

Gas Ass’n v. Jewell, 815 F.3d 544 (9th Cir. 2016) (“A court must not substitute its judgment for
that of the agency, but also must not “rubber-stamp” administrative decisions.”).
In general, the overwhelming lack of evidence likely shows CMS had insufficient evidence
to mandate vaccination on the wide range of facilities that it did. Looking even beyond the
evidence deficiencies relating to the specific facilities covered, the lack of data regarding
vaccination status and transmissibility—in general—is concerning. Indeed, CMS states that “the
effectiveness of the vaccine[s] to prevent disease transmission by those vaccinated [is] not
currently known.”17 86 Fed. Reg. at 61,615.18 CMS also admits that the continued efficacy of the
vaccine is uncertain. See, e.g., id. at 61,612 (“[M]ajor uncertainties remain as to the future course
of the pandemic, including but not limited to vaccine effectiveness in preventing ‘breakthrough’
disease transmission from those vaccinated, [and] the long-term effectiveness of vaccination[.]”).
No one questions that protecting patients and healthcare workers from contracting COVID is a

laudable objective. But the Court cannot, in good faith, allow CMS to enact an unprecedented
mandate that lacks a “rational connection between the facts found and the choice made.” State
Farm, 463 U.S. at 43; see also Sierra Club v. Mainella, 459 F. Supp. 2d 76, 90 (D.D.C. 2006)
(“Under the APA . . . the function of the district court is to determine whether or not as a matter
of law the evidence in the administrative record permitted the agency to make the decision it did.”).
The reasoned explanation and evidentiary requirement “of administrative law, after all, is meant
to ensure that agencies offer genuine justifications for important decisions, reasons that can be
scrutinized by courts and the interested public.” Dep’t of Com. v. New York, 139 S. Ct. 2551, 2575
(2019). If judicial review is to be more than an “empty ritual,” the Court here must demand

something more than the explanation offered for the action taken by CMS here. Id.
2. The mandate is arbitrary and capricious because CMS
improperly rejected alternatives to the mandate.

CMS failed to consider or rejected obvious alternatives to a vaccine mandate without
evidence. For example, CMS rejected daily or weekly testing—an option that even OSHA
approved in its ETS—without citing any evidence for such a conclusion. 86 Fed. Reg. at 61,614.

17 “As explained in various places within this RIA and the preamble as a whole, there are major uncertainties as to the
effects of current variants of SARS-CoV-2 on future infection rates, medical costs, and prevention of major illness or
mortality. For example, the duration of vaccine effectiveness in preventing COVID-19, reducing disease severity,
reducing the risk of death, and the effectiveness of the vaccine to prevent disease transmission by those vaccinated are
not currently known.” 86 Fed. Reg. at 61,615.

18 Also, CMS has no data showing forced vaccinations in the healthcare industry has stopped the spread of COVID in
hospitals.
Rather, it assured that it “reviewed scientific evidence on testing” but “found that vaccination is a
more effective infection control measure.” Id. at 61,614. As discussed elsewhere, this conclusion
comes despite its admission that it lacks solid evidence19 regarding transmissibility of COVID by
the vaccinated. Id. at 61,615, 61,612. Although it is not the Courts duty to ask whether CMS’s
decision was “the best one possible” or even whether there were “better [] alternatives,” Federal

Energy Regulatory Commission v. Electric Power Supply Ass’n, 136 S. Ct. 760, 782 (2016), the
Court must ensure there exists a “rational connection between the facts found and the choice
made.” State Farm, 463 U.S. at 43.
As another example, CMS rejected20 mandate alternatives in those with natural immunity
by a previous coronavirus infection. 86 Fed. Reg. at 61,614 (noting “many uncertainties” about
the immunity in those previously infected “compared to people who are vaccinated”). But,
elsewhere, it plainly contradicts itself regarding the value of natural immunity. Id. at 61,604
(“[A]bout 100,000 a day have recovered from infection . . . . These changes reduce the risk to both
health care staff and patients substantially, likely by about 20 million persons a month who are no

longer sources of future infections.”) (emphasis added). Such contradictions are tell-tale signs of
unlawful agency actions. See State Farm, 463 U.S. at 43 (finding agency action arbitrary and
capricious if the agency explained its decision in a way that “runs counter to the evidence before
the agency”); see also Bethesda Health, Inc. v. Azar, 389 F. Supp. 3d 32, 41 (D.D.C. 2019) (setting
aside as arbitrary and capricious agency action that contradicts its own regulations).

19 Far from being reasonable to prohibit alternatives to vaccination, this constitutes a compelling reason to utilize,
rather than reject, other alternatives before subjecting the public to a never-before CMS vaccine mandate.

20 CMS also rejected natural immunity, despite an intense public debate and a trove of scientific data on the strength
and durability of natural immunity from COVID-19—alone and compared to vaccine-induced immunity. State Farm,
463 U.S. at 43 (noting “the agency must examine the relevant data”).
3. The mandate is arbitrary and capricious because of its
broad scope.

The broad scope of healthcare facilities covered by the mandate renders it arbitrary. The
mandate applies equally to the varying healthcare facility types it covers, such as Psychiatric
Residential Treatment Facilities (“PRTFs”) for individuals under age twenty-one, see 86 Fed. Reg.
at 61,576, and LTCs, see id. at 61,575. But, at the same time, CMS acknowledges that the risk of
COVID to those in the former age group is markedly smaller. See, e.g., id. at 61,610 n.247
(recognizing that “risk of death from infection from an unvaccinated 75-to 84-year-old person is
320 times more likely than the risk for an 18- to 29-years old person”); id. at 61,601 (“Among
those infected, the death rate for older adults age 65 or higher was hundreds of time higher than
for those in their 20s during 2020.”); id. at 61,566 (noting those aged 65 years and older account
for more than 80-percent of U.S. COVID-19 related deaths). What is more, besides applying to
all facilities equally, the mandate applies to all facilities’ staff equally, “regardless of . . . patient
contact.” Id. at 61,570 (emphasis added). The mandate goes so far as to cover a third-party
vendor’s “crew working on a construction project” whose members use the same bathrooms
“during their breaks.” Id. at 61,571. CMS provides no reasoned21 explanation for this overbroad
approach, and it further belies its asserted interest in protecting patients from COVID.22 Cty. of
Los Angeles v. Shalala, 192 F.3d 1005, 1021 (D.C. Cir. 1999) (“Where the agency has failed to
provide a reasoned explanation, or where the record belies the agency’s conclusion, [the court]
must undo its action.”).

21 As explained in infra note 24, upping vaccination nation-wide is not a “reasonable” reason for CMS to enact its
mandate because the agency’s powers are limited to Medicare and Medicare—not federalizing healthcare and reaching
the general public. Rather, the overbroad approach indicates the pretextual nature of this mandate.

22 The Court also notes that recently, on November 12, 2021, CMS itself revised its pandemic guidance for nursing
home visitation, specifically opening facility visitation “for all residents at all times” by family and friends who are
not required to be vaccinated. This also belies CMS’s asserted interest in protecting patients from COVID, and
instead, shows that the mandate’s overbreadth is to increase the national vaccination rate by any means necessary.
4. The mandate is arbitrary and capricious due to CMS’s
sudden change in course.

CMS failed to adequately explain its contradiction to its long-standing practice of
encouraging rather than forcing—by governmental mandate—vaccination. For years, CMS has
promulgated regulations setting the conditions for Medicare and Medicaid participation; never has
it required any vaccine for covered facilities’ employees—despite concerns over other illnesses
and their corresponding low vaccination rates.23 As recent as this May, CMS adopted an IFC
requiring education on COVID vaccines but again decided against forced vaccination.
It is generally “arbitrary or capricious” to depart from a prior policy sub silentio; when
agencies contradict a prior policy, they must show “good reasons for the new policy.” FCC v. Fox
Television Stations, Inc., 556 U.S. 502, 515 (2009); accord EPA v. EME Homer City Generation,
L.P., 572 U.S. 489, 510 (2014) (holding that agency “retained discretion to alter its course [under
a regulation] provided it gave a reasonable explanation for doing so”). Here, CMS’s purported
reason for changing its policy is to force those unwilling or hesitant to receive the vaccine into
receiving it, all under the guise of protecting recipients of Medicare and Medicaid. See 86 Fed.
Reg. at 61,583 (noting “CMS initially chose . . . to encourage rather than mandate vaccination”
but “vaccine uptake among health care staff [was not] as robust as hoped for”); id. at 61,569 (noting

that despite healthcare worker hesitation about the vaccine, “mandates have already been
successfully initiated in a variety of health care settings, systems, and states”); id. at 61,560 (noting
it was “compelled to require staff vaccinations for COVID-19” given its “responsibility to protect
the health and safety of individuals . . . receiving care and services from for Medicare- and

23 In the Mandate, CMS discusses how influenza is a major problem plaguing the healthcare industry. Nonetheless,
CMS states that half of healthcare workers resist the seasonal influenza vaccine nationwide, 86 Fed. Reg. at 61,568,
but that it continues to “recommend” influenza vaccination rather than mandate it. Id. Even though CMS has evidence
that influenza vaccination of health care staff is associated with declines in nosocomial influenza in hospitalized
patients and nursing home residents. Id. at 61,557.
Medicaid-certified providers and suppliers”). But even if forcing the administration of a specific
vaccine, into the otherwise unwilling, in an effort to protect the recipients of these programs could
be a reasonable explanation to justify the extraordinary action—action that long has been the
province of the states, see Zucht, 260 U.S. at 176 (noting that precedent had long “settled that it is
within the police power of a state to provide for compulsory vaccination”); Jacobson v.

Massachusetts, 197 U.S. 11, 25–26 (1905) (similar)—CMS has not shown that it is reasonable in
this instance.24 Rather, it specifically notes that the vaccines’ effectiveness to prevent disease
transmission by those vaccinated is not currently known. 86 Fed. Reg. at 61,615 (noting “the
duration of vaccine effectiveness in preventing COVID-19, reducing disease severity, reducing the
risk of death, and the effectiveness of the vaccine to prevent disease transmission by those
vaccinated are not currently known”).
5. The mandate is arbitrary and capricious because CMS
failed to consider or properly weigh necessary reliance
interests.

Because CMS changed course, it was required to “be cognizant that longstanding policies
may have ‘engendered serious reliance interests that must be taken into account.’” Fox Television,

24 The inadequacy of the explanation for the reversal is especially true since Plaintiffs will likely succeed in
demonstrating it is a pretextual rationale. See Dep’t of Com. v. New York, 139 S. Ct. 2551, 2575–76 (2019); id. at
2583 (Thomas, J., concurring in part and dissenting in part) (noting Court “opened a Pandora’s box of pretext-based
challenges in administrative law”); id. at 2597 (Alito, J., concurring in part and dissenting in part). While a court may
not set aside an agency’s policymaking decision “solely because it might have been influenced by political
considerations or prompted by an Administration’s priorities,” Department of Commerce, 139 S. Ct. at 2573, an
agency’s change in course “cannot be solely a matter of political winds and currents.” North Carolina Growers’
Association, Inc. v. United Farm Workers, 702 F.3d 755, 772 (4th Cir. 2012) (Wilkinson, J., concurring). Plaintiffs
have demonstrated that they could likely show pretext. See, e.g., Doc. [9] at 4 (citing Joseph Biden, Remarks at the
White House (Sept. 9, 2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/ (decrying “nearly 80 million Americans who have failed to get
the shot” while announcing “a new plan to require more Americans to be vaccinated” and explaining that “[i]f you’re
seeking care at a health facility, you should be able to know that the people treating you are vaccinated. Simple.
Straightforward. Period.”); see also 86 Fed. Reg. at 61,601 (“the protective scope of this rule is far broader than the
health care staff that it directly affects”); see also id. at 61,612 (“Staff vaccination will also provide significant
community benefits when staff are not at work.”). The Court “cannot ignore the disconnect between the decision
made and the explanation given.” Dep’t of Com., 139 S. Ct. at 2575.
556 U.S. at 515. Ignoring reliance interests is necessarily arbitrary and capricious. Id. Yet, it
appears this is what CMS did. An agency is required to assess whether there were reliance
interests, determine whether they were significant, and weigh any such interests against competing
policy concerns. Regents, 140 S. Ct. at 1915.
In concluding that the mandate’s benefits outweigh the risks to the healthcare industry,

CMS did not properly consider all necessary reliance interests of facilities, healthcare workers,
and patients. 86 Fed. Reg. at 61,607–10. CMS looked only at evidence from interested parties in
favor of the mandate, while completely ignoring evidence from interested parties in opposition.
Consumers Union of U. S., Inc. v. Consumer Prod. Safety Comm’n, 491 F.2d 810, 812 (2d Cir.
1974) (noting agency “must not ignore evidence placed before it by interested parties”). In fact,
CMS foreclosed these parties’ ability to provide information regarding the mandate’s effects on
the healthcare industry, while simultaneously dismissing those concerns based on “insufficient
evidence.” 86 Fed. Reg. at 61,569. But facts do not cease to exist simply because they are ignored,
and “[s]tating that a factor was considered25 is not a substitute for considering it.” Texas v. Biden,

10 F.4th 538, 556 (5th Cir. 2021) (internal quotations and alterations omitted); Sierra Club, 459
F. Supp. 2d at 100 (“Merely describing an impact and stating a conclusion of non-impairment is
insufficient[.]”); Gresham v. Azar, 363 F. Supp. 3d 165, 177 (D.D.C. 2019) (“The bottom line: the
Secretary did no more than acknowledge—in a conclusory manner, no less—that commenters
forecast a loss in Medicaid coverage.”). Had CMS followed the proper procedural requirements,

25 Several times throughout the mandate, CMS acknowledges the countervailing effect it will have on the healthcare
industry. See, e.g., 86 Fed. Reg. at 61,607 (“currently there are endemic staff shortages for almost all categories of
employees at almost all kinds of health care providers and supplier and these may be made worse if any substantial
number of unvaccinated employees leave health care employment altogether”); id. at 61,567 (“and the urgent need to
address COVID-related staffing shortages that are disrupting patient access to care, provides strong justification as to
the need to issue this IFC requiring staff vaccination for most provider and supplier types over which we have
authority.”). Yet, despite these acknowledged concerns about intensifying an already-existing healthcare crisis, CMS
decided to move forward anyway, without properly considering the totality of interests affected by the mandate, such
as rural hospitals.
States, healthcare providers, and healthcare workers would have submitted critical information to
CMS—instead of to the Courts26—showing that the mandate portends a disaster for the healthcare
industry, particularly in rural communities. Azar v. Allina Health Servs., 139 S. Ct. 1804, 1816,
(2019) (requiring HHS to undertake notice-and-comment rulemaking, in part, because it
“neglected to acknowledge the potential countervailing benefits”); Time Warner Cable Inc. v.

FCC, 729 F.3d 137, 168 (2nd Cir. 2013) (explaining APA policies are “to ensure the agency has
all pertinent information before it when making a decision”). By dispensing with those
requirements, CMS ignored evidence showing that the mandate threatens devastating
consequences to healthcare providers, staff, and patients throughout the nation.
Even if CMS did properly consider these reliance issues—which this Court finds it most
likely did not—the scant evidence of record shows CMS was unable to adequately balance these
reliance interests because it placed a rock on one side of the scale and a feather on the other.
Regents, 140 S. Ct. at 1914 (failing to weigh reliance interests against competing policy concerns
is arbitrary and capricious). And as already explained, these evidence deficiencies are solely a

product of its own doing. So, either CMS entirely failed to consider an important aspect of the
problem or failed to weigh the interests properly; regardless, either way the pendulum swings,
CMS’s actions, or rather, inaction, violates basic tenants of administrative law. Id.; State Farm,
463 U.S. at 43 (noting that “entirely fail[ing] to consider an important aspect of the problem” is

26 It is not the job of this Court to collect evidence and opposition from affected parties; rather, this is the role, actually
a duty, of CMS when promulgating a rule. See District of Colombia v. United States Dep’t of Agriculture, 496 F.
Supp. 3d 213, 228 (D.D.C. 2020) (emphasizing that one purpose of notice and comment rulemaking is to “give affected
parties an opportunity to develop evidence in the record to support their objections to the rule and thereby enhance the
quality of judicial review”); Hoctor v. U.S. Dept. of Agriculture, 82 F.3d 165, 167 (7th Cir. 1996) (“Notice and
comment rulemaking . . . facilitates the marshaling of opposition to a proposed rule, and may result in the creation of
a very long record that may in turn provide a basis for a judicial challenge to the rule if the agency decides to
promulgate it.”).
arbitrary and capricious); Michigan, 576 U.S. at 750–52 (noting “agency action is lawful only if it
rests on a consideration of the relevant factors” and “important aspects of the problem”).
In conclusion, Plaintiffs likely can show the CMS mandate is arbitrary and capricious
because the evidence does not show a rational connection to support implementing the vaccine
mandate, the mandate’s broad scope, the unreasonable rejection of alternatives to vaccination,

CMS’s inadequate explanation for its change in course, and its failure to consider or properly
weigh reliance interests.
Accordingly, Plaintiffs’ challenges to the mandate show a great likelihood of success on
the merits, and this fact weighs critically in favor of a preliminary injunction. Home Instead, 721
F.3d at 497 (“While no single factor is determinative, the probability of success factor is the most
significant.” (internal quotations and citations omitted)).
b. Plaintiffs demonstrate irreparable harm.
The Court must next determine whether Plaintiffs have shown that they are “likely to suffer
irreparable harm in the absence of preliminary relief.” Benisek v. Lamone, 138 S. Ct. 1942, 1944

(2018) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)). Plaintiffs must
show more than a mere “possibility,” but they need not show a certainty; rather, they need to
demonstrate “irreparable injury is likely in the absence of an injunction.” Winter, 555 U.S. at 22.
Plaintiffs have done so here.
The Plaintiff States bring their claims in a number of capacities: sovereign, quasi-
sovereign/parens patriae, and proprietary. See, e.g., Doc. [1] ¶¶ 5, 7, 9. Through their various
interests, they have shown irreparable injury is more than likely in the absence of an injunction.
First, Plaintiffs sovereign interests27 are likely to suffer irreparable harm without a
preliminary injunction because they will be unable to enforce their duly enacted laws surrounding
vaccination mandates and providing proof of vaccination. See, e.g., Mo. Rev. Stat § 67.265; 2021
Alaska Sess. Laws ch. 2, § 17; Ark. Code § 20-7-143; see also, e.g., Ark. Code § 11-5-118. The
mandate notes that it “preempts inconsistent State and local laws as applied to Medicare- and

Medicaid-certified providers and suppliers.” 86 Fed. Reg. at 61,568. Generally, this preemption
would be unremarkable. See U.S. Const. art. VI, § 2. But, as here, where CMS likely did not
lawfully enact its mandate, Plaintiffs are harmed because they cannot enforce their duly enacted
laws and no lawfully enacted regulation preempts them. The injury that results when a state cannot
enforce “statutes enacted by representatives of its people” is irreparable. Maryland v. King, 567
U.S. 1301, 1303 (2012) (Roberts, C.J., in chambers) (quoting New Motor Vehicle Bd. of Cal. v.
Orrin W. Fox Co., 434 U.S. 1345, 1351 (1977) (Rehnquist, J., in chambers)); accord Org. for
Black Struggle v. Ashcroft, 978 F.3d 603, 609 (8th Cir. 2020) (“Prohibiting the State from
enforcing a statute properly passed . . . would irreparably harm the State.”).

Second, Plaintiffs quasi-sovereign interests are likely to suffer irreparable harm without a
preliminary injunction. Unlike the harm Plaintiffs likely would face to their sovereign interests—
which though significant, is more abstract—the harm Plaintiffs likely would face to their quasi-
sovereign interests would be observable and appreciable. Indeed, the likely harm would be harm
in the colloquial sense—pain, suffering, distress. Plaintiffs have a quasi-sovereign interest “in the
health and well-being—both physical and economic—of [their] residents, Alfred L. Snapp & Son,
Inc. v. Puerto Rico, 458 U.S. 592, 607 (1982), and Plaintiffs have put forth evidence that this
mandate would have a detrimental effect on the health and well-bring of their citizens.

27 The States also have an interest in seeing their constitutionally reserved police power over public health policy
defended from federal overreach, as discussed in depth in section II.B.a.i.2.
Review of the affidavits filed in support of Plaintiffs’ motion for preliminary injunction
shows the harm to the physical health and well-being of their states’ citizens if the mandate is not
enjoined. The Plaintiffs’ affidavits came from varying healthcare entities and associations in their
states impacted by the mandate. The affiants describe existing and significant staffing shortages
as well as open and unfilled positions for an extended period of time, some for more than a year.

See, e.g., Doc. [9-7] at 3; Doc. [9-11] at 3; Doc. [9-25] at 3; Doc. [9-3] at 4. The affidavits also
demonstrate that the mandate will more than likely exacerbate the already-existing staffing
problem. Many of the affidavits generally describe the number of individuals employed by the
entity and the number or percentage of employees either known or reasonably known to have not
been vaccinated.28 See, e.g., Doc. [9-4] at 3, 4; Doc. [9-3] at 4. Through talks, surveys, and direct
conversations with staff, the affiants know the individuals that will leave employment if CMS goes
ahead with its mandate. See, e.g., Doc. [9-4] at 3; Doc. [9-5] at 3; Doc. [9-13] at 4; Doc. [9-19] at
3; Doc. [9-20] at 3. Already, in some cases, the mere announcement of CMS’s mandate has
compelled some to resign. See, e.g., Doc. [9-26] at 2.

Staff reductions due to implementing the mandate, especially in light of the already
understaffed healthcare facilities, will cause a cascade of consequences. See, e.g., Doc. [9-16] at
3–6. The mandate’s effect of reducing staff will decrease the quality of care provided at facilities,
compromise the safety of patients, and place even more stress on the remaining staff. See, e.g.,
Doc. [9-11] at 4. The mandate “creates a risk in patient safety” and will create “ongoing ripple
effects on . . . patients, remaining employees and [the] community for some time in the future.”
Doc. [9-18] at 5. An affiant noted that “even if we can technically staff services with extra shift
and call, we are already doing that, have been doing that for more than a year, and our vaccinated

28 CMS itself notes that rural hospitals are less vaccinated than urban. 86 Fed. Reg. at 61,613 (recognizing that “rural
hospitals are having greater problems with employee vaccination . . . than urban hospitals”).
staff will not be capable of doing it for much longer. At this point, considering it is nearly
impossible to recruit clinical staff today, more will resign due to the stress and burnout that will
inevitably exist.” Doc. [9-23] at 5.
The loss of certain staffing categories will diminish entire areas of care within a facility
that inevitably implicate others. See, e.g., Doc. [9-19] at 3 (warning of the loss of the only

remaining anesthesiologist); Doc. [9-21] at 3 (warning of the loss of 80% of imaging department);
Doc. [9-14] at 3; Doc. [9-18] at 4; Doc. [9-25] at 4. Facilities in rural locations, already hard-
pressed to find qualified applicants regardless of vaccination status, will have to evaluate what
healthcare services they could still safely provide, if any at all, in the region they serve. See, e.g.,
Doc. [9-4] at 4; Doc. [9-7] at 3–4; Doc. [9-9] at 2–5; Doc. [9-12] at 4; Doc. [9-13] at 4; Doc. [9-
19] at 3; Doc. [9-23] at 4. As an example, for a general hospital located in North Platte, Nebraska,
implementation of the mandate would result in the loss of the only remaining anesthesiologist.
Doc. [9-19] at 3. Understandably, without an anesthesiologist, there could be no surgeries—at all.
Thus, such a loss irreparably causes a cascading effect on the entire facility and a wide-range of

patients. Other examples show the mandate’s far-reaching implications not just on the
administration of healthcare itself, but the functioning of the facilities in general. For example,
the building manager of a nursing home in Memphis, Missouri states he will leave if the choice is
between his job or the vaccine. Doc. [9-9] at 3–4. If the mandate takes effect, then, the nursing
home would have “no one competent enough to run [the] building and [perform] all the
complicated systems and required inspections.” Id. Also, this type of position is not the kind that
can be filled “quickly, especially with today’s workforce and being in a rural setting.” Id. Other
affidavits also detail an especially hard impact to emergency services in rural areas. See, e.g., Doc.
[9-21] at 2–3 (“If we lose our imaging department we will have to divert many of our emergency
patients to other facilities; the closest one is 45 miles away.”); Doc. [9-11] at 4 (explaining that in
the event this hospital closes, the nearest one would be thirty miles away); Doc. [9-12] at 2–3
(similar); Doc. [9-16] at 6 (similar).
Further, the loss of staffing in many instances will result in no care at all, as some facilities
will be forced to close altogether. For example, the Administrator of the Scotland County Care

Center (SCCC), a nursing home located in Memphis, Missouri, notes that out of about sixty-five
employees, twenty have indicated that they are opposed to taking the vaccine, and if the mandate
is imposed, that they will quit.29 Doc. [9-9] at 2. A loss of twenty staff members will cause SCCC
to “close its doors” and displace residents that have lived in that community their entire lives. Id.
at 5; see also Doc. [9-26] at 4. Thus, if the mandate goes into effect, it will irreparably harm
patients30 by impeding access to care for the elderly and for persons who cannot afford it—directly
contrary to Medicare and Medicaid’s core objective of providing proper care. In sum, Plaintiffs’
evidence shows that facilities—rural facilities in particular—likely would face crisis standards of
care or will have no choice but to close to new patients or close altogether, both of which would

cause significant, and irreparable, harm to Plaintiffs’ citizens. Kai v. Ross, 336 F.3d 650, 656 (8th
Cir. 2003) (finding “danger to plaintiffs’ health, and perhaps even their lives, gives them a strong
argument of irreparable injury”).31

29 This includes SCCC’s billing and accounting staff members, which would create a “substantial disruption” in
SCCC’s business functions, as well as their building plant manager, “that would leave me with no one competent
enough to run my building and all the complicated systems and required inspections.” Id. at 4.

30 Medicare and Medicaid programs “touch[] the lives of nearly all Americans” and are two of the “largest federal
program[s]” in the country. See Allina Health Servs., 139 S. Ct. at 1808.

31 “No right is held more sacred, or is more carefully guarded . . . than the right of every individual to the possession
and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable
authority of law.” Union Pacific R. Co. v. Botsford, 141 U.S. 250, 251 (1891). As already explained, CMS most
likely does not have the authority to promulgate the mandate, and clear congressional authorization is also lacking.
“Irreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully
compensated through an award of damages.’” Rogers Group, Inc. v. City of Fayetteville, Ark., 629 F.3d 784, 789 (8th
Cir. 2010) (quoting Gen. Motors Corp. v. Harry Brown’s, L.L.C., 563 F.3d 312, 319 (8th Cir. 2009)). It follows then,
Besides the harm to physical health that Plaintiffs have shown will likely occur absent a
preliminary injunction, the mandate also would have a negative effect on the economies in Plaintiff
states, especially, once again, in rural areas.32 While economic injuries normally would be
reparable at law, “federal agencies generally enjoy sovereign immunity for any monetary
damages.” Wages & White Lion Invs., L.L.C. v. United States Food & Drug Admin., 16 F.4th

1130, 1142 (5th Cir. 2021); see also 5 U.S.C. § 702 (providing for an action seeking relief “other
than money damages”). Therefore, the economic loses in Plaintiff states would be unrecoverable
and thus irreparable. Iowa Utls. Bd. v. FCC, 109 F.3d 418, 426 (8th Cir. 1996) (“The threat of
unrecoverable economic loss, however, does qualify as irreparable harm.”); DISH Network Serv.
L.L.C. v. Laducer, 725 F.3d 877, 882 (8th Cir. 2013).
Fourth, and finally, Plaintiffs would likely face irreparable harm to their proprietary
interests absent a preliminary injunction. Plaintiffs themselves operate healthcare facilities that
CMS’s mandate reaches. They therefore would face the same harms any private owner of a facility
faces, like the “business and financial effects of a lost or suspended employee, compliance and

monitoring costs associated with the Mandate, [or] the diversion of resources necessitated by the
Mandate.” BST Holdings, 17 F.4th at ---. As just noted, since these costs could not be recovered
from the federal government, they are irreparable. Iowa Utls. Bd., 109 F.3d at 426.
For all these reasons, the Court finds that Plaintiffs are likely to suffer significant
irreparable harm absent a preliminary injunction.

that forcing individuals to choose “between their job(s) and their jab(s),” BST Holdings, 17 F.4th at ---, substantially
burdens the liberty interests of individuals, which cannot be fully compensated through an award of damages.

32 For example, Callaway District Hospital and Medical Clinics is the largest employer in Callaway, Nebraska and is
a “significant driver of the local business and agriculture economy.” Doc. [9-12] at 4. The expected loss of staff
would “almost certainly” lead to closure of the facility. Id. “Cherry County Hospital is a leader of employment” for
its county. Doc. [9-16] at 6. “Kimball County Manor and Assisted Living employs 55 full time staff and as such is
one of the largest employers in Kimball County, a rural county located in Nebraska’s western panhandle.” Doc. [9-
22] at 3.
c. The balance of equities tip in favor of Plaintiffs, and the public has an
interest in an injunction.

Finally, the Court must determine whether Plaintiffs have shown that the “balance of
equities tips in [their] favor” and that “an injunction is in the public interest.” Winter, 555 U.S. at
20. Courts “must balance the competing claims of injury and must consider the effect on each
party of the granting or withholding of the requested relief.” Id. at 24. When the party opposing
the injunction is the federal government, the balance-of-harms factor “merge[s]” with the public-
interest factor. Nken v. Holder, 556 U.S. 418, 436 (2009).
The public has an interest in stopping the spread of COVID. No one disputes that. But the
Court concludes that the public would suffer little, if any, harm from maintaining the “status quo”
through the litigation of this case. Defendants argue that “enjoining the rule would harm the public
interest by further exposing Medicare and Medicaid patients and staff—and the Medicare and
Medicaid programs—to unvaccinated health care workers.” Doc. [23] at 48. But CMS’s own
conclusions undercut this argument. See id. at 61,615 (“[T]he effectiveness of the vaccine to
prevent disease transmission by those vaccinated [is] not currently known.”); id. at 61,612.
Regardless, the pandemic has continued more than twenty months now. Vaccine rates rise every
day, and more therapeutics and treatments for the virus are available than ever before. The status
quo today, without the CMS mandate, is still far better than the public faced even just a few months
ago.
And while, according to CMS, the effectiveness of the vaccine to prevent disease

transmission by those vaccinated is not currently known, what is known based on the evidence
before the Court is that the mandate will have a crippling effect on a significant number of
healthcare facilities in Plaintiffs’ states, especially in rural areas,33 create a critical shortage of
services (resulting in no medical care at all in some instances), and jeopardize the lives of
numerous vulnerable citizens. The prevalent, tangible, and irremediable impact of the mandate
tips the balance of equities in favor of a preliminary injunction.
To be sure, the Court looks at the principles underlying preliminary injunctions.

Dataphase, 640 F.2d at 113 n.5 (quoting Love v. Atchison, T. & S. F. Ry. Co., 185 F. 321, 331 (8th
Cir. 1911) (“The controlling reason for the existence of the judicial power to issue a [preliminary]
injunction is that the court may thereby prevent such a change in the relations and conditions of
persons and property as may result in irremediable injury to some of the parties before their claims
can be investigated and adjudicated.”). Although the parties disagree on the magnitude of the
mandate’s disruption to the healthcare industry, both agree a disruption is certain and imminent.
Thus, the importance of enjoining the mandate, and thus preserving the “status quo,” is imperative.
Dataphase, 640 F.2d at 113 (8th Cir. 1981) (“[T]he question is whether the balance of equities so
favors the movant that justice requires the court to intervene to preserve the status quo until the

merits are determined.”). And “[t]here is clearly a robust public interest in safeguarding prompt
access to health care.” Whitman-Walker Clinic, Inc. v. DHS, 485 F. Supp. 3d 1, 61 (D.D.C. 2020).
The Court finds that in balancing the equities, the scale falls clearly in favor of healthcare
facilities operating with some unvaccinated employees, staff, trainees, students, volunteers, and

33 The disproportionate impact the mandate will have on rural communities is why CMA’s “one-size-fits-all
sledgehammer” approach does not work and in fact, undermines CMA’s focus on providing proper care. See BST
Holdings, 17 F.4th at ---. This is why healthcare matters are typically left to the States, because these policy decisions
are matters dependent on local factors and conditions, and Federalism allows States to tailor such matters in the best
interests of their communities. The Court agrees with Plaintiffs point that whatever might make sense in Chicago, St.
Louis, or New York City, could be actually counterproductive and harmful in rural communities like Memphis (MO)
or McCook (NE). Doc. [1] at 1–2.
contractors, rather than the swift, irremediable impact of requiring healthcare facilities to choose
between two undesirable choices—providing substandard care or providing no healthcare at all.34
It is true that the Agency would face irreparable harm if it is unable to enforce a properly
authorized and enacted regulation. But, as discussed above, the Court has concluded CMS likely
did not enact the mandate at issue lawfully. Thus, any interest CMS may have in enforcing an

unlawful rule is likely illegitimate. See BST Holdings, 17 F.4th at ---. By this same conclusion,
the public would benefit from the preliminary injunction because it would ensure that federal
agencies do not extend their power beyond the express delegation from Congress, as already
discussed. And while “it is indisputable that the public has a strong interest in combating the
spread of COVID-19,” “our system does not permit agencies to act unlawfully even in pursuit of
desirable ends.” Ala. Ass’n of Realtors, 141 S. Ct. at 2490.
In conclusion, CMS mandate raises substantial questions of law and fact that must be
determined, as discussed throughout this opinion. Because it is evident CMS significantly
understates the burden that its mandate would impose on the ability of healthcare facilities to

provide proper care, and thus, save lives, the public has an interest in maintaining the “status quo”
while the merits of the case are determined. Dataphase, 640 F.2d at 113; Love, 185 F. at 331.
III. CONCLUSION
For the foregoing reasons, Plaintiffs’ Motion for Preliminary Injunction, Doc. [6], is
GRANTED.
Accordingly,

34 CMS also discusses that the upcoming influenza season will further exacerbate the strain on the healthcare system.
However, one would assume that the onset of flu season coupled with COVID would be a reason to avoid critical
staffing shortages at healthcare facilities—not to exacerbate them.
IT IS HEREBY ORDERED that Defendants are preliminarily enjoined from the
implementation and enforcement of 86 Fed. Reg. 61,555 (Nov. 5, 2021), the Interim Final Rule
with Comment Period entitled “Medicare and Medicaid Programs; Omnibus COVID-19 Health
Care Staff Vaccination,” against any and all Medicare- and Medicaid-certified providers and
suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New
Hampshire, North Dakota, South Dakota, and Wyoming pending a trial on the merits of this action
or until further order of this Court. Defendants shall immediately cease all implementation or
enforcement of the Interim Final Rule with Comment Period as to any Medicare- and Medicaid-
certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri,
Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.
IT IS FURTHER ORDERED that no security bond shall be required under Federal Rule
of Civil Procedure 65(c).
Dated this 29th day of November, 2021. }
ah
JUN
MATTHEW T. SCHELP
UNITED STATES DISTRICT JUDGE

32

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10236072. Public record. Not legal advice.