Court filing
Application for Stay of Injunction — Biden v. Missouri (CMS Vaccine Mandate) (U.S.)
Filed December 16, 2021 in Biden v. Missouri; one of 2 filings from this case.
Record facts
| Court | Supreme Court of the United States |
|---|---|
| Filed | 2021-12-16 |
Full text
________________________________________________________________
________________________________________________________________
No. 21A-_____
________________________________________________________________
________________________________________________________________
IN THE SUPREME COURT OF THE UNITED STATES
_______________
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
APPLICANTS
v.
STATE OF MISSOURI, ET AL.
_______________
APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED
STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF MISSOURI
PENDING APPEAL TO THE UNITED STATES COURT OF APPEALS FOR THE
EIGHTH CIRCUIT AND FURTHER PROCEEDINGS IN THIS COURT
_______________
ELIZABETH B. PRELOGAR
Solicitor General
Counsel of Record
Department of Justice
Washington, D.C. 20530-0001
SupremeCtBriefs@usdoj.gov
(202) 514-2217
(I)
PARTIES TO THE PROCEEDING
The applicants (defendants-appellants below) are Joseph R.
Biden, Jr., in his official capacity as President of the United
States; Xavier Becerra, in his official capacity as Secretary of
the United States Department of Health and Human Services; Chiquita
Brooks-LaSure, in her official capacity as Administrator for the
Centers for Medicare & Medicaid Services; Meena Seshamani, in her
official capacity as Deputy Administrator and Director of Center
for Medicare; Daniel Tsai, in his official capacity as Deputy
Administrator and Director of Center for Medicaid and CHIP
Services; the United States; the United States Department of Health
and Human Services; and the Centers for Medicare & Medicaid
Services.
The respondents (plaintiffs-appellees below) are the States
of Alaska, Arkansas, Kansas, Iowa, Missouri, Nebraska, New
Hampshire, North Dakota, South Dakota, and Wyoming.
IN THE SUPREME COURT OF THE UNITED STATES
_______________
No. 21A-_____
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
APPLICANTS
v.
STATE OF MISSOURI, ET AL.
_______________
APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED
STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF MISSOURI
PENDING APPEAL TO THE UNITED STATES COURT OF APPEALS FOR THE
EIGHTH CIRCUIT AND FURTHER PROCEEDINGS IN THIS COURT
_______________
Pursuant to this Court’s Rule 23 and the All Writs Act,
28 U.S.C. 1651, the Solicitor General, on behalf of applicants
President Joseph R. Biden, Jr., et al., respectfully applies for
a stay of the injunction issued by the United States District Court
for the Eastern District of Missouri, pending the consideration
and disposition of applicants’ appeal from that injunction to the
United States Court of Appeals for the Eighth Circuit and, if
necessary, pending the filing and disposition of a petition for a
writ of certiorari and any further proceedings in this Court.1
1
As
explained
further
below,
the
government
is
simultaneously filing an application for a stay of a similar
injunction entered by the U.S. District Court for the Western
District of Louisiana.
2
In response to an unprecedented pandemic that has killed
800,000 Americans, the Secretary of Health and Human Services
exercised his express statutory authority to protect the health
and safety of Medicare and Medicaid patients by requiring
healthcare facilities that choose to participate in those programs
to ensure that their staff are vaccinated (subject to medical and
religious exemptions). That requirement will save hundreds or
even thousands of lives each month, and the Eleventh Circuit has
held that it is a valid exercise of the Secretary’s authority.
Yet the requirement has been blocked in ten States by the district
court’s preliminary injunction in this case, which a divided panel
of the Eighth Circuit declined to stay in a one-sentence order.
This application seeks a stay of that injunction to allow the
Secretary’s urgently needed health and safety measure to take
effect before the winter spike in COVID-19 cases worsens further.
In establishing Medicare and Medicaid, Congress authorized
the Secretary to condition healthcare facilities’ participation in
those programs on compliance with, inter alia, “requirements
[that] the Secretary finds necessary in the interest of the health
and safety” of patients. 42 U.S.C. 1395x(e)(9) (hospitals). For
decades, the Secretary has exercised that authority to require
participating healthcare providers to establish active programs
for the “prevention” and “control” of “infectious diseases” within
their facilities. 42 C.F.R. 482.42 (hospitals).
3
In November 2021, the Secretary amended those regulations to
address the COVID-19 pandemic. 86 Fed. Reg. 61,555 (Nov. 5, 2021)
(App., infra, 37a-109a). At the time, the country was averaging
more than 70,000 new COVID-19 cases and more than 1000 COVID-19
deaths per day.2 In response to that ongoing public health
emergency, the Secretary required hospitals, nursing homes, and
other healthcare facilities that participate in Medicare and
Medicaid to ensure that their workers are vaccinated against COVID-
19, subject to medical and religious exemptions. The Secretary
explained that this vaccination condition was necessary to protect
Medicare and Medicaid patients -- who are particularly vulnerable
-- against infection with COVID-19 by staff members who could
safely and conscientiously obtain vaccination. Id. at 61,557-
61,569. And he stressed that adding the condition in light of the
start of the winter season was critical to preventing outbreaks of
the kind that had devastated Medicare- and Medicaid-participating
facilities earlier in the pandemic. Id. at 61,584.
Although vaccination requirements have broad support in the
healthcare industry, various States challenged the rule in federal
district court. The first district court to address the rule
denied a preliminary injunction, and the Eleventh Circuit then
issued a precedential decision denying an injunction pending
2
Unless otherwise noted, COVID-19 statistics in this
application are drawn from the tracker maintained by the Centers
for Disease Control and Prevention (CDC). See CDC, COVID Data
Tracker, https://go.usa.gov/xeFyx.
4
appeal. Florida v. Department of Health & Human Servs., No. 21-
14098, 2021 WL 5768796 (11th Cir. Dec. 6, 2021). The Eleventh
Circuit held that the rule falls squarely within the Secretary’s
“express statutory authority to require facilities voluntarily
participating in the Medicare or Medicaid programs to meet health
and safety standards to protect patients.” Id. at *11. The
Eleventh Circuit also concluded that “[i]mposing an injunction to
bar enforcement of the [requirement] would harm the public interest
in slowing the spread of COVID-19 and protecting the safety of
Medicare and Medicaid patients and staff.” Id. at *17.
In this case, in contrast, the district court preliminarily
enjoined enforcement of the rule in ten States, and a divided panel
of the Eighth Circuit denied the government’s motion for a stay
pending appeal. App., infra, 1a. And in a third case brought by
a different group of States, the Fifth Circuit narrowed a
preliminary injunction to apply only within the plaintiff States,
but otherwise denied a stay on the ground that the merits presented
a “close call” under circuit precedent. Order at 3, Louisiana v.
Becerra, No. 21-30734 (Dec. 15, 2021). The government is seeking
a stay of that injunction from this Court contemporaneously with
the filing of this application. See p. 1, n.1, supra.3
3
In a fourth challenge to the vaccination rule at issue
here, the Northern District of Texas last night issued a
preliminary injunction against application of the rule to Medicare
and Medicaid facilities within Texas. See D. Ct. Doc. 53, Texas
v. Becerra, No. 21-cv-229 (Dec. 15, 2021).
5
This Court should stay the injunctions pending appeal. As
the Eleventh Circuit recognized, the vaccine requirement falls
squarely within the plain text of the Secretary’s statutory
authority and complies with all procedural requirements. Indeed,
it is difficult to imagine a more paradigmatic health and safety
condition than a requirement that workers at hospitals, nursing
homes, and other medical facilities take the step that most
effectively prevents transmission of a deadly virus to vulnerable
patients. The conflicting positions of the courts of appeals make
it highly likely that this Court will grant review if the district
court’s injunction is affirmed. And the exceptionally urgent need
to reduce the risk of COVID-19 exposure for Medicare and Medicaid
patients given the anticipated winter surge in infections tips the
equities overwhelmingly in favor of a stay. Indeed, in the weeks
since the Secretary issued the requirement, new COVID-19 cases
have already increased by more than 60%, to nearly 120,000 per
day. And the highly transmissible Omicron variant, which emerged
after the issuance of the rule, threatens to drive up case rates
and risks to Medicare and Medicaid patients even higher.
STATEMENT
A.
Statutory and Regulatory Background
1.
Congress spends hundreds of billions of dollars each
year to pay for health care under the Medicare and Medicaid
programs. See Azar v. Allina Health Servs., 139 S. Ct. 1804, 1808
6
(2019). Medicare, which is funded entirely by the federal
government, covers individuals who are 65 or older or who have
specified disabilities. See ibid. Medicaid, which is funded by
the federal government and States, covers eligible low-income
individuals, including those who are elderly, pregnant, or
disabled. See Pharmaceutical Research & Mfrs. of Am. v. Walsh,
538 U.S. 644, 650-651 & n.5 (2003).
Medicare and Medicaid beneficiaries receive care at a variety
of medical facilities, including hospitals, skilled nursing
facilities (also known as nursing homes or long-term care
facilities), and hospices. To participate in the Medicare or
Medicaid program, each of those facilities must enter into a
provider agreement and meet specified conditions of participation.
E.g., 42 U.S.C. 1395cc, 1396a(a)(27).
Congress charged the Secretary with ensuring that facilities
participating in Medicare and Medicaid adequately protect the
health and safety of their patients. For example, the Medicare
statute authorizes payments for “hospital services,” 42 U.S.C.
1395d(a), and defines a “hospital” as an institution that meets
such “requirements as the Secretary finds necessary in the interest
of the health and safety of individuals who are furnished services
in the institution,” 42 U.S.C. 1395x(e)(9); see, e.g., 42 U.S.C.
1395i-3(d)(4)(B) (providing that a “skilled nursing facility must
meet” such “requirements relating to the health, safety, and well-
7
being of residents or relating to the physical facilities thereof
as the Secretary may find necessary”). The Medicaid statute also
imposes health and safety requirements, see, e.g., 42 U.S.C.
1396r(d)(4)(B), or incorporates by cross-reference analogous
Medicare standards for certain types of facilities, see, e.g., 42
U.S.C. 1396d(h) (psychiatric hospitals); 42 U.S.C. 1396d(l)(1)
(rural health clinics); 42 U.S.C. 1396d(o) (hospices).
The Secretary has exercised those authorities to promulgate
regulations establishing detailed conditions of participation in
Medicare and Medicaid. The regulations address, for example, the
qualifications of staff, the condition of the facilities, and other
requirements that the Secretary deems necessary to protect patient
health and safety. E.g., 42 C.F.R. Pt. 482 (conditions of
participation for hospitals). The regulations also “focus a great
deal on infection prevention and control standards, often
incorporating guidelines as recommended by CDC and other expert
groups.” 86 Fed. Reg. at 61,568. For example, the regulations
have long included a requirement that facilities maintain an
“infection prevention and control program designed to provide a
safe, sanitary, and comfortable environment and to help prevent
the development and transmission of communicable diseases and
infections.” 42 C.F.R. 483.80 (long-term care facilities); see,
e.g., 42 C.F.R. 482.42(a) (hospitals); 42 C.F.R. 416.51(b)
(ambulatory surgical centers).
8
2.
On September 9, 2021, President Biden announced that the
government would be undertaking “new steps to fight COVID-19,”
including a plan being developed by the Secretary to require
vaccinations for workers “who treat patients on Medicare and
Medicaid.” Remarks on the COVID-19 Response and National
Vaccination Efforts, Daily Comp. Pres. Docs., 2021 DCPD No. 00725,
at 1-2. On November 5, 2021, the Secretary issued an interim final
rule amending existing infection-control regulations and related
conditions of participation in Medicare and Medicaid to require
that participating facilities ensure that their covered staff are
vaccinated against COVID-19. 86 Fed. Reg. at 61,561; see id. at
61,616-61,627 (text of amendments). The rule requires facilities
to provide medical and religious exemptions. Id. at 61,572. It
also contains exceptions for staff who telework full-time and
others who perform infrequent, non-healthcare services. Id. at
61,571. Covered staff were originally required to receive the
first dose of a vaccine by December 6, 2021, or to request an
exemption by that date. Id. at 61,573. Non-exempt covered staff
were to be fully vaccinated by January 4, 2022. Ibid.
a.
The Secretary explained that he had determined that
“vaccination of staff is necessary for the health and safety of
individuals to whom care and services are furnished.” 86 Fed.
Reg. at 61,561. He observed that vaccination rates remain low in
many healthcare facilities. Id. at 61,559. For example, as of
9
mid-September 2021, COVID-19 vaccination rates for hospital staff
and long-term care facility staff averaged 64% and 67%,
respectively. Ibid.
The Secretary found that unvaccinated staff at healthcare
facilities pose a serious threat to the health and safety of
patients because the virus that causes COVID-19 is highly
transmissible and dangerous. 86 Fed. Reg. at 61,556-61,557. He
explained that, unless appropriate protections are implemented,
the virus can spread among healthcare workers and from workers to
patients. See id. at 61,557 & n.16. He further explained that
vaccination substantially diminishes the risk of such transmission
by preventing infection and, according to “[e]merging evidence,”
by lowering the risk of transmission even in the event of
“breakthrough infections.” Id. at 61,558. By contrast,
unvaccinated healthcare workers are at increased risk for
infection and therefore at increased risk of exposing their
patients and colleagues to the virus. See id. at 61,558 & nn.42-
43 (discussing studies linking unvaccinated staff to increased
risk of COVID-19 infection). And because eligibility for the
Medicare and Medicaid programs turns on factors such as advanced
age and disability, patients covered by those programs frequently
face a higher risk of developing severe disease and of experiencing
severe outcomes from COVID-19 if infected. Id. at 61,566, 61,609.
10
The Secretary also found that “[f]ear of exposure to and
infection with COVID-19 from unvaccinated health care staff can
lead patients to themselves forgo seeking medically necessary
care,” 86 Fed. Reg. at 61,558, which creates a further “risk[] to
patient health and safety,” ibid. The Secretary noted reports
that individuals are “refusing care from unvaccinated staff,”
which limits “the extent to which providers and suppliers can
effectively meet the health care needs of their patients and
residents.” Ibid. The Secretary also noted that absenteeism by
healthcare staff as a result of “COVID-19-related exposures or
illness” has created staffing shortages that have further
disrupted patient access to care. Id. at 61,559.
The Secretary emphasized that a vaccination requirement for
the facilities covered by the rule is consistent with the
recommendation of “more than 50 health care professional societies
and organizations,” including the American Medical Association and
the American Nurses Association (ANA), which had released a joint
statement supporting vaccination requirements for healthcare
workers. 86 Fed. Reg. at 61,565. Those various organizations
“represent[] millions of workers throughout the U.S. health care
industry,” including “doctors, nurses, pharmacists, physician
assistants, public health workers, and epidemiologists as well as
long term care, home care, and hospice workers.” Ibid. In the
joint statement, the organizations urged that “all health care and
11
long-term care employers require their workers to receive the
COVID-19 vaccine.” App., infra, 110a-113a (Joint Statement). The
organizations explained that this step fulfills “the ethical
commitment of all health care workers to put patients as well as
residents of long-term care facilities first and take all steps
necessary to ensure their health and well-being.” Ibid.
b.
Notwithstanding that broad support, the Secretary
acknowledged the risk that the rule could prompt some healthcare
workers to leave their jobs rather than be vaccinated. 86 Fed.
Reg. at 61,608. But he found that “many COVID-19 vaccination
mandates have already been successfully initiated in a variety of
health care settings,” and that those examples showed that “very
few workers quit their jobs rather than be vaccinated.” Id. at
61,569. The Secretary explained, for example, that after the
Houston Methodist Hospital system imposed a vaccine requirement,
99.5% of its staff received the vaccine. Ibid. Only 153 of its
26,000 workers resigned rather than receive the vaccine. See id.
at 61,569 n.155 (citing article with the relevant figures).
Similarly, a Detroit-based health system that imposed a vaccine
requirement reported that 98% of its 33,000 workers were fully or
partially vaccinated or in the process of obtaining a religious or
medical exemption when the requirement went into effect, with
exemptions comprising less than 1% of staff members. Id. at
61,569; see id. at 61,566, 61,569 (additional examples).
12
The Secretary also noted that any departures by staff to avoid
vaccination ought to be “offset by reductions in current staffing
disruptions caused by staff illness and quarantines once
vaccination is more widespread.” 86 Fed. Reg. at 61,608. And
although the net effect could not be predicted with certainty given
the “many variables and unknowns,” the Secretary judged that any
disruption from a vaccine requirement would likely be minor in
comparison to normal patterns of worker turnover. Ibid.
c.
The Secretary issued the rule as an interim final rule
with a comment period, finding “good cause” to make the rule
effective immediately, without prior notice and comment. 86 Fed.
Reg. at 61,586; see 5 U.S.C. 553(b)(B). In doing so, he determined
that “it would endanger the health and safety of patients, and be
contrary to the public interest,” to delay the vaccination
requirement. 86 Fed. Reg. at 61,586. The Secretary noted that
patients in facilities funded by the Medicare and Medicaid programs
are more likely than the general population to suffer severe
illness or death from COVID-19, id. at 61,609; that there had
already been more than half a million COVID-19 cases among
healthcare staff, id. at 61,585; that COVID-19 case rates among
staff have grown since the Delta variant’s emergence, ibid.; that
COVID-19 cases are expected to spike during the winter, id. at
61,584; and that this spike will coincide with flu season, raising
the additional danger of combined infections and increased
13
pressure on the healthcare system, ibid. The Secretary predicted
that the rule will save “several hundred * * * or perhaps several
thousand” lives every month. Id. at 61,612.
d.
After issuance of the rule, the Omicron variant emerged.
See
CDC,
Omicron
Variant:
What
You
Need
to
Know,
https://go.usa.gov/xeFhz. That variant, which “likely will spread
more easily than the original SARS-CoV-2 virus,” ibid., increases
the danger to Medicare and Medicaid patients and underscores the
urgent need for the rule.
B.
The Present Controversy
1.
On November 10, 2021, respondents -- a group of ten
States led by Missouri -- brought this action challenging the rule
in the Eastern District of Missouri. App., infra, 6a. On November
29, 2021, the district court preliminarily enjoined enforcement of
the rule within those States. Id. at 5a-36a. The court
principally reasoned that respondents are “likely to succeed in
their argument that Congress has not provided [the Centers for
Medicare & Medicaid Services (CMS)] the authority to enact the
regulation.” Id. at 7a. The court did not identify any basis in
the statutory language for that conclusion, and it relegated key
portions of the statutory text to a footnote. See id. at 8a n.5.
Instead, the court held that the Secretary could not adopt a
vaccination
requirement
without
“clear
authorization
from
Congress,” id. at 8a, which the court found to be lacking.
14
The district court also found that respondents were likely to
succeed on two other grounds. First, notwithstanding the
Secretary’s finding that the rule will save hundreds or thousands
of lives each month, the court held that the Secretary lacked good
cause to issue the rule without prior notice and comment. The
court faulted the Secretary for not acting sooner and declared
that “COVID no longer poses the dire emergency it once did.” App.,
infra, 15a; see id. at 14a-15a. Second, the court found that
respondents are likely to show that the rule is arbitrary and
capricious in several respects -- including because the Secretary
purportedly failed to give adequate consideration to the “reliance
interests” that would be unsettled if the rule caused staffing
shortages at healthcare facilities, id. at 24a-27a.
Finally, the district court determined that the remaining
factors supported a preliminary injunction. App., infra, 27a-35a.
In particular, the court reasoned that respondents would suffer
irreparable harm to their “sovereign interests” in enforcing state
laws “surrounding vaccination mandates,” id. at 28a; to their
“quasi-sovereign interests” in the health of their residents,
ibid., which the court viewed as threatened by the possibility of
staffing shortages, see id. at 29a-31a; and to their “proprietary
interests” in state-run facilities covered by the rule, id. at
32a. The court also reasoned that “the public would suffer little,
if any, harm from maintaining the ‘status quo’” during litigation,
15
observing that the pandemic “has continued for more than twenty
months.” Id. at 33a. The court later denied the government’s
motion for a stay pending appeal. Id. at 2a-4a.
2.
The day after the district court issued its decision, on
November 30, 2021, the government filed an emergency motion in the
Eighth Circuit for a stay pending appeal. On December 13, a
divided panel denied the stay motion in a one-sentence order.
App., infra, 1a.
ARGUMENT
The government respectfully requests that this Court stay the
district court’s injunction pending appeal and, if necessary,
pending further proceedings in this Court. Under this Court’s
Rule 23 and the All Writs Act, 28 U.S.C. 1651, a single Justice or
the Court may stay a district court order pending appeal to a court
of appeals. In deciding whether to issue a stay, the Court
considers whether four Justices are likely to vote to grant
certiorari if the court of appeals ultimately rules against the
applicant; whether five Justices would then likely conclude that
the case was erroneously decided below; and whether, on balancing
the equities, the injury asserted by the applicant outweighs the
harm to the other parties or the public. See San Diegans for the
Mt. Soledad Nat’l War Mem’l v. Paulson, 548 U.S. 1301, 1302 (2006)
(Kennedy, J., in chambers). Here, all of those factors powerfully
support a stay.
16
I.
This Court Would Likely Grant Review If The Eighth Circuit
Affirmed The District Court’s Injunction
The district court’s injunction forbids the Secretary from
enforcing in ten States a rule that the Secretary found will help
to blunt the impact of ”the deadliest disease in American history”
and save “several hundred * * * or perhaps several thousand”
lives every month. 86 Fed. Reg. at 61,556, 61,612. Whether the
rule exceeds the Secretary’s statutory authority is an issue of
exceptional national importance that would warrant this Court’s
review if the Eighth Circuit allowed the injunction to stand. Sup.
Ct. R. 10(c).
The likelihood of certiorari is especially clear because the
district court’s order (as well as the unexplained conclusion of
the divided Eighth Circuit panel) contradicts a thorough published
decision by the Eleventh Circuit rejecting a parallel challenge to
the same rule. In that decision, the Eleventh Circuit specifically
rejected many of the arguments that the district court accepted
here, holding that “the Secretary was authorized to promulgate the
interim rule” under his “express statutory authority to require
facilities voluntarily participating in the Medicare or Medicaid
programs to meet health and safety standards to protect patients.”
Florida v. Department of Health & Human Servs., No. 21-14098, 2021
WL 5768796, at *11 (Dec. 6, 2021).4
4
Last night, Florida asked the en banc Eleventh Circuit
to grant an injunction pending appeal in its challenge to the rule.
That request is pending.
17
The Eleventh Circuit specifically rejected the argument that
the rule violates what respondents call the “major questions”
doctrine, which was a centerpiece of the district court’s reasoning
here. Florida, 2021 WL 5768796, at *12; see App, infra, 7a-11a.
The Eleventh Circuit explained that the rule does not bring about
any “enormous and transformative expansion” in federal regulatory
authority, ibid. (quoting Utility Air Regulatory Grp. v. EPA, 573
U.S. 302, 324 (2014)), because Medicare and Medicaid are federal
spending programs and the applicable statutes unambiguously give
the Secretary a “broad grant of authority” to “make regulations
for the ‘health and safety’ of Medicare and Medicaid recipients,”
ibid. The court found the rule to be a plainly permissible
exercise of that authority, explaining that “it is the very
opposite of efficient and effective administration for a facility
that is supposed to make people well to make them sick with COVID-
19.” Ibid.
Especially when combined with the importance of the rule, the
conflicting positions adopted by the federal courts of appeals
that have addressed the issue make it likely that this Court would
ultimately grant review if the Eighth Circuit affirmed. See, e.g.,
Department of Homeland Sec. v. New York, 140 S. Ct. 599 (2020)
(staying lower-court injunction pending appeal where courts of
appeals had adopted conflicting positions on a significant agency
rule); Wolf v. Cook County, 140 S. Ct. 681 (2020) (same).
18
II. The Government Is Likely To Succeed On The Merits
If the Eighth Circuit affirmed the district court’s
injunction and this Court granted review, this Court would likely
reverse. In holding that the Secretary lacked authority to issue
the rule, the district court did not conduct any meaningful
analysis of the relevant statutory text. Instead, it invoked an
expansive and unsound conception of what it called the “major
questions” doctrine that finds no support in this Court’s
precedents. The district court also erred in second-guessing the
Secretary’s expert judgments about the effectiveness and necessity
of a vaccination requirement to protect Medicare and Medicaid
patients. And this Court is unlikely to agree with the district
court’s apparent view that the COVID-19 pandemic no longer
represents a public-health emergency sufficient to invoke the
good-cause exception.
A.
The Rule Is Authorized By Statute
The vaccination requirement falls within the Secretary’s
“express statutory authority to require facilities voluntarily
participating in the Medicare or Medicaid programs to meet health
and safety standards to protect patients.” Florida, 2021 WL
5768796, at *11.
1.
Like any other question of statutory interpretation, an
analysis of an agency’s statutory authority “begins with the
statutory text” -- and, when the text is clear, it “ends there as
19
well.” National Ass’n of Mfrs. v. Department of Defense, 138 S.
Ct. 617, 631 (2018) (citation omitted); see, e.g., Little Sisters
of the Poor Saints Peter & Paul Home v. Pennsylvania, 140 S. Ct.
2367, 2380 (2020). Here, the Secretary’s authority to adopt the
rule flows directly from the unambiguous text of the statute.
Congress vested the Secretary with broad authority to make
“rules and regulations * * * as may be necessary to the efficient
administration of the functions with which he is charged under”
the Medicare and Medicaid programs. 42 U.S.C. 1302(a); see 42
U.S.C. 1395hh(a)(1). And Congress specifically charged the
Secretary with adopting requirements that he deems necessary to
ensure patient health and safety. For example, in authorizing
payments for “hospital services,” 42 U.S.C. 1395d(a)(1), the
Medicare statute defines a “hospital” as an institution that meets
such “requirements as the Secretary finds necessary in the interest
of the health and safety of individuals who are furnished services
in the institution,” 42 U.S.C. 1395x(e)(9). The statute similarly
provides that a “skilled nursing facility must meet * * *
requirements relating to the health, safety, and well-being of
residents * * * as the Secretary may find necessary.” 42 U.S.C.
1395i-3(d)(4)(B); see 42 U.S.C. 1395i-3(f)(1) (similar); see also
86 Fed. Reg. at 61,567 (listing statutory directions for each
category of facilities covered by the rule).
20
The rule at issue here fits squarely within the Secretary’s
statutory authority to create health-and-safety-related conditions
of participation. By “requiring healthcare workers to become
vaccinated against a transmissible and highly deadly disease,” the
Secretary “was imposing a ‘requirement’ that was ‘necessary in the
interest of the health and safety’ of the patients who obtained
services at federally funded Medicare and Medicaid facilities.”
Florida, 2021 WL 5768796, at *12 (quoting 42 U.S.C. 1395x(e)(9))
(brackets omitted).
That straightforward reading of the statutory text accords
with both science and common sense. Requiring healthcare workers
at facilities participating in Medicare and Medicaid to be
vaccinated protects the health and safety of patients at those
facilities by reducing their risk of contracting the virus that
causes COVID-19. As the Secretary explained, a recent study of
heath care workers found that “full vaccination with COVID–19
vaccines was 80 percent effective in preventing * * * infection
among frontline workers.” 86 Fed. Reg. at 61,558. On top of that,
“[e]merging evidence also suggests that vaccinated people who
become infected with the * * * Delta variant have potential to
be less infectious than infected unvaccinated people.” Ibid.
Together, “[f]ewer infected staff and lower transmissibility
equates to fewer opportunities for transmission to patients.”
Ibid. Lowering such risks is particularly urgent for patients
21
covered
by
Medicare
and
Medicaid
because
they
are
disproportionately vulnerable to death or severe illness from
COVID-19 -- as the devastating outbreaks at nursing homes have
repeatedly demonstrated. See id. at 61,566, 61,568.
Reducing the risk that such patients will be infected by
healthcare workers with COVID-19 also addresses a separate but
significant health and safety problem: “[f]ear of exposure to and
infection with COVID–19 from unvaccinated health care staff can
lead patients to themselves forgo seeking medically necessary
care.” 86 Fed. Reg. at 61,558. At the most basic level, the
purpose of the Medicare and Medicaid programs is to ensure that
beneficiaries can access health care. Removing an obstacle to
that access by assuring beneficiaries that a trip to the hospital
or other participating facility will not entail exposure to
unvaccinated staff directly advances that objective. See ibid.
The COVID-19 vaccination condition also fits with the history
of the statute and the agency’s practice. Congress directed the
Secretary to create “health and safety” conditions on providers’
participation in Medicare and Medicaid, 42 U.S.C. 1395x(e)(9),
precisely “because it would be inappropriate and unnecessary to
include in the legislation all the precautions against fire
hazards, contagion, etc., which should be required of institutions
to make them safe,” H. R. Rep. No. 213, 89th Cong., 1st Sess. 25-
26 (1965) (House Report) (emphasis added). As noted above, those
22
conditions have long included a requirement that facilities
maintain “active * * * programs for” the “prevention” and
“control” of “infectious diseases.” 42 C.F.R. 482.42; see pp. 5-
6, supra. The vaccine condition at issue here gives specific
content to that requirement in the particular context of the COVID-
19 pandemic. And although CMS had not itself directly required
vaccination in the past, healthcare workers and Medicare and
Medicaid facilities have long been subject to “employer or State
* * * vaccination requirements,” including for “influenza, and
hepatitis B virus.” 86 Fed. Reg. at 61,567; see id. at 61,568
(noting that many healthcare workers were also subject to childhood
school vaccination requirements).
Indeed, “vaccination requirements, like other public-health
measures, have been common in this nation.” Klaassen v. Trustees
of Ind. Univ., 7 F.4th 592, 593 (7th Cir. 2021) (Easterbrook, J.)
(holding that a state university vaccination requirement was among
the “normal and proper” conditions of enrollment), application for
stay denied, No. 21A15 (Aug. 12, 2021). This Court upheld the
constitutional validity of such requirements and traced their
historical roots more than a century ago. See Jacobson v.
Massachusetts, 197 U.S. 11, 25-35 (1905) (identifying vaccine
requirements in the United States and other Western countries in
the early 1800s). Consistent with that history, at least a dozen
States have already established requirements for healthcare
23
workers to be vaccinated against COVID-19. See KFF, State COVID-
19
Data
and
Policy
Actions
(Dec.
14,
2021),
https://www.kff.org/report-section/state-covid-19-data-and-
policy-actions-policy-actions/.
Courts have uniformly recognized that those requirements
further “the State’s interest in maintaining * * * safety within
healthcare facilities.” We The Patriots USA, Inc. v. Hochul, 17
F.4th 266, 295-296 (2d Cir. 2021) (per curiam) (upholding New York
requirement in light of, inter alia, the devastating experience of
“New York City nursing homes” during the pandemic), application
for stay denied, No. 21A125 (Dec. 13, 2021); see Does 1-6 v. Mills,
16 F.4th 20, 27 (1st Cir. 2021) (upholding Maine requirement
because, inter alia, “health care facilities are uniquely
susceptible to outbreaks of infectious diseases like COVID-19”),
application for stay denied, No. 21A90 (Oct. 29, 2021). And
because the rule at issue here provides for religious exemptions,
it does not raise the sort of free-exercise questions presented by
some of those state requirements. 86 Fed. Reg. at 61,569; cf.
Does 1-3 v. Mills, 142 S. Ct. 17, 19 (2021) (Gorsuch, J.,
dissenting from denial of application for injunctive relief).
The vaccination requirement thus falls squarely within the
Secretary’s statutory authority to set conditions on participation
in Medicare and Medicaid to ensure the health and safety of
patients. As the Eleventh Circuit summarized, “required
24
vaccination is a common-sense measure designed to prevent
healthcare workers, whose job it is to improve patients’ health,
from making them sicker.” Florida, 2021 WL 5768796, at *12.
Indeed, it would be striking and anomalous if the Secretary’s broad
authority to adopt conditions protecting patient health and safety
did not include a traditional, common, and highly effective
mechanism like a vaccine requirement.
2.
Respondents
do
not
seriously
dispute
that
the
vaccination condition falls within the plain terms of CMS’s
statutory authority. But they nevertheless assert, and the
district court held, that the condition is impermissible based on
various extratextual arguments. App., infra, 7a-12a. That
analysis is seriously flawed.
a. The district court principally reasoned that Congress
must “speak clearly when authorizing an agency to exercise powers
of ‘vast economic and political significance.’” App., infra, 9a
(quoting Alabama Ass’n of Realtors v. Department of Health & Human
Servs., 141 S. Ct. 2485, 2489 (2021) (per curiam)). As explained
above, however, Congress did speak clearly by authorizing the
Secretary to impose, inter alia, “requirements as the Secretary
finds necessary in the interest of the health and safety of
individuals
who
are
furnished
services”
by
facilities
participating in Medicare and Medicaid. 42 U.S.C. 1395x(e)(9)
(hospitals). “Congress could have limited [the Secretary’s]
25
discretion in any number of ways, but it chose not to do so.”
Little Sisters of the Poor, 140 S. Ct. at 2380. And courts may
not “impos[e] limits on an agency’s discretion that are not
supported by the text.” Id. at 2381.
The district court erred in suggesting that this Court’s
decision in Alabama Association of Realtors held otherwise. There,
the Court held that an eviction moratorium imposed by the CDC
exceeded the agency’s authority to “prevent the [interstate]
introduction, transmission, or spread of communicable diseases.”
42 U.S.C. 264(a). Reading that language in context, the Court
held that its scope was informed by the next sentence “illustrating
the kinds of measures that could be necessary,” such as
“fumigation” or “pest extermination.” 141 S. Ct. at 2488. Those
measures “directly relate to preventing the interstate spread of
disease,” whereas the eviction moratorium “relate[d] to interstate
infection” only “indirectly,” through the “downstream connection
between eviction” and possible spread of COVID-19 by evicted
individuals who move “from one State to another.” Ibid.
Here, in contrast, there is no analogous language cabining
the Secretary’s broad authority. And even more to the point, the
connection between the vaccine requirement and patient health and
safety is clear and direct: By requiring healthcare workers to
take the measure that most effectively reduces the risk that they
contract and spread the virus that causes COVID-19, the Secretary
26
reduced the risk that vulnerable patients would contract the virus
from those workers. See Florida, 2021 WL 5768796, at *12.
Respondents and the district court do not appear to dispute
that the Secretary generally has authority to adopt measures
preventing the spread of infectious diseases in Medicare- and
Medicaid-funded facilities. Instead, the district court suggested
that Congress had to expressly single out vaccination (or, even
more specifically,
COVID-19
vaccination)
to
authorize the
condition at issue here. App., infra, 9a. That reasoning reflects
a serious misreading of this Court’s precedents.
The district court relied upon what it labeled the “political
significance of a mandatory coronavirus vaccine,” asserting that
“it would be difficult to identify many other issues that currently
have more political significance.” App., infra, 9a. But this
Court has never suggested that the emergence of political
controversy about a particular agency action triggers a clear-
statement requirement. See, e.g., Little Sisters, 140 S. Ct. at
2380 (analyzing whether HHS’s contraceptive-mandate rule -- which
generated considerable political controversy -- complied with the
statutory text without any heightened-clarity requirement). The
meaning of a statute does not change with the shifting winds of
politics or public opinion, and opponents of an agency’s policy
cannot succeed in limiting the agency’s authority merely by vocally
opposing it.
27
Instead, the decisions on which the district court purported
to rely have considered the enacting Congress’s perspective,
declining to interpret ambiguous statutes to grant agencies
sweeping powers on the theory that Congress should “speak clearly
if it wishes to assign to an agency decisions of vast ‘economic
and political significance.’” Utility Air, 573 U.S. at 324
(quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
160 (2000)). This case is entirely different for two reasons.
First, this Court’s decisions in Utility Air, Brown &
Williamson, and Alabama Association of Realtors all began with the
statutory text and made clear that considerations of “‘economic
and political significance’” are relevant only “if the text [is]
ambiguous.” Alabama Ass’n, 141 S. Ct. at 2489. In both Utility
Air and Brown & Williamson, for example, this Court reasoned that
adopting the agency’s position would have conflicted with other
provisions of the very statute that the agency was interpreting.
See, e.g., Utility Air, 573 U.S. at 321 (explaining that the
agency’s position was “inconsistent with -- in fact, would
overthrow -- the Act's structure and design”); Brown & Williamson,
529 U.S. at 141, 156 (explaining that the agency’s interpretation
would be “incompatible” with other aspects of the statute). Here,
no such ambiguity or incompatibility exists, and the district court
did not even purport to conduct a traditional textual and
structural analysis.
28
Second, and in any event, the Secretary does not claim any
“unheralded power to regulate ‘a significant portion of the
American economy.’” Utility Air, 573 U.S. at 324 (quoting Brown
& Williamson, 529 U.S. at 159). Instead, he is simply exercising
long-recognized and common-sense power to adopt health and safety
conditions for medical providers in federal spending programs that
are already subject to extensive conditions of participation. And
there is no reason to think that Congress -- which granted the
Secretary broad authority to protect Medicare and Medicaid
recipients precisely because it could not foresee all future
threats to patient health and safety, see House Report 25-26 --
would have regarded a vaccine requirement as a matter requiring
specific authorization. To the contrary, vaccine requirements
have existed for centuries as a commonplace feature of American
life. See, e.g., Klaassen, 7 F.4th at 593. Thus, “when it comes
to vaccination mandates, there was no reason for Congress to be
more specific than authorizing the Secretary to make regulations
for the ‘health and safety’ of Medicare and Medicaid recipients.”
Florida, 2021 WL 5768796, at *12.
b.
The district court also reasoned that “Congress must use
‘exceedingly clear language if it wishes to significantly alter
the balance between federal and state power.’” App., infra, 9a
(quoting Alabama Ass’n, 141 S. Ct. at 2489). But that rationale
ignores the nature of the requirement at issue: CMS’s vaccine
29
requirement is a funding condition of facilities’ participation in
the federal Medicare and Medicaid programs. See 86 Fed. Reg. at
61,556. The requirement is not a “federal encroachment upon a
traditional state power,” App., infra, 10a (citation omitted),
because States have traditionally not had any power to set
conditions on the expenditure of federal funds.
To the contrary, this Court has long acknowledged -- and the
Constitution expressly provides -- that “Congress has authority
under the Spending Clause to appropriate federal moneys to promote
the general welfare” and “to see to it that taxpayer dollars
appropriated under that power are in fact spent for the general
welfare.” Sabri v. United States, 541 U.S. 600, 605 (2004).
Congress’s power to impose conditions on the acceptance of federal
funds, moreover, applies regardless of whether Congress legislates
“in an area historically of state concern.” Id. at 608 n.*.
Indeed, that principle holds even when (unlike here) States are
the sole recipients of the federal funds. See, e.g., South Dakota
v. Dole, 483 U.S. 203, 205–206 (1987). Because CMS’s vaccine
condition involves only “regulating a federal program,” Florida,
2021 WL 5768796, at *12 (citation omitted), the district court’s
federalism concerns are misplaced.
c.
Finally, the district court was similarly mistaken in
reasoning that the vaccination requirement “invokes the outer
limits of Congress’ power.” App., infra, 11a (citation omitted).
30
Contrary to the court’s apparent understanding, the vaccination
condition does not “dictate the private medical decisions of
millions of Americans.” Id. at 10a-11a. It instead imposes a
health and safety requirement regarding vaccination of employees
who choose to work at a facility that accepts federal funding
through Medicare and Medicaid. Cf. We The Patriots, 17 F.4th at
293-294 (“Although individuals who object to receiving the
vaccines * * * have a hard choice to make, they do have a choice.
Vaccination is a condition of employment in the healthcare field;
the State is not forcibly vaccinating healthcare workers.”);
Klaassen, 7 F.4th at 593 (“People who do not want to be vaccinated
may go [to college] elsewhere.”). Thus, whatever constitutional
questions might arise about the contours of direct federal or state
vaccination mandates, see App., infra, 11a, they are not presented
by the funding condition here. Just as healthcare personnel who
might prefer to operate on patients without surgical gloves or
forgo vaccination “against * * * other infectious diseases,” 86
Fed. Reg. at 61,569, must decide whether to subordinate those
personal preferences to their work at particular medical
facilities imposing those requirements, so too employees who
prefer not to get the COVID-19 vaccine for reasons other than
medical need or religious objection must decide whether to follow
that preference or instead to receive a vaccine to work at
31
facilities that are funded by federal taxpayers through the
Medicare and Medicaid programs.
B.
The Rule Is Not Arbitrary And Capricious
There is no merit to the district court’s view that the rule
is arbitrary and capricious. The Secretary “examined ‘the relevant
data’ and articulated ‘a satisfactory explanation’ for his
decision, ‘including a rational connection between the facts found
and the choice made.’” Department of Commerce v. New York, 139 S.
Ct. 2551, 2569 (2019) (quoting Motor Vehicle Mfrs. Ass’n of the
U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43
(1983)). The arbitrary-and-capricious standard does not require
more. Nor does it license a court to “substitute its judgment for
that of the agency.” State Farm, 463 U.S. at 43. The Eleventh
Circuit thus correctly rejected many of the same arguments,
explaining
that
“ample
evidence”
supports
the
Secretary’s
determination that staff vaccination at facilities participating
in Medicare and Medicaid “will provide important protections for
patients.” Florida, 2021 WL 5768796, at *15; see id. at *2-*3.
1.
The district court identified several purported problems
with the Secretary’s reasoning, but respondents and the court
focused on one in particular: that the Secretary failed to
adequately consider the “reliance interests” that the rule would
allegedly upset by causing staffing shortages, particularly in
rural areas. App., infra, 25a; see id. at 25a-31a. But the
32
Secretary carefully considered “concerns about health care workers
choosing to leave their jobs rather than be vaccinated” and how
that dynamic might affect the availability of health care, and the
Secretary determined that those concerns did not outweigh the need
for a nationwide rule. 86 Fed. Reg. at 61,569; see id. at 61,608-
61,609. The Secretary found that any adverse impact on the labor
market is likely to be relatively small; at least partially offset
by countervailing effects, such as reduced absenteeism due to
COVID-19; and dwarfed by the regular staff turnover in the
healthcare workforce, in which about 25% of the 10.4 million person
workforce is newly hired in a typical year. See ibid.
For example, after the Houston Methodist Hospital system
imposed a COVID-19 vaccine mandate, only 153 of its more than
26,000 workers -- that is, only 0.6% -- resigned rather than
receive the vaccine. See p. 11, supra. Widespread compliance
with vaccine mandates likewise occurred at a Detroit-based health
system with more than 33,000 employees, a Delaware-based health
system with more than 14,000 employees, and a long-term care
corporation with more than 250 facilities. 86 Fed. Reg. at 61,566,
61,569. And at the North Carolina-based Novant Health system,
only 375 of 35,000 employees across 15 hospitals, 800 clinics, and
hundreds of outpatient facilities -- that is, only 1% of the
workforce -- failed to comply. See id. at 61,566 n.132 (link to
Novant press release containing those figures). In sum, the
33
Secretary found that “workers across the economy are responding to
mandates by getting vaccinated,” even if they previously expressed
hesitation. Id. at 61,569.
The Secretary’s decision to adopt the rule is also supported
by a joint statement by more than 50 leading healthcare
associations urging that “all health care and long-term care
employers require their workers to receive the COVID-19 vaccine.”
Joint Statement. The signatories represent millions of workers
throughout the Nation’s healthcare industry. 86 Fed. Reg. at
61,565 & n.122. For example, the ANA -- which signed the joint
statement and “represent[s] the interests of the nation’s 4.2
million registered nurses” -- “supports health care employers
mandating nurses and all health care personnel to get vaccinated
against
COVID-19.”
ANA,
ANA
Supports
Mandated
COVID-19
Vaccinations for Nurses and All Health Care Professionals (July
26, 2021), https://perma.cc/MS5A-4WTU.
The district court nevertheless dismissed that significant
evidence and faulted the Secretary for purportedly not considering
“all necessary reliance interests,” including among workers who
would resist a vaccine condition. App., infra, 25a. But the
Secretary did consider this precise concern -- and reasonably
concluded that the benefits of the rule outweighed this risk. Any
suggestion that the Secretary “‘entirely fail[ed] to consider’”
34
this “important aspect of the problem” is thus unfounded. App.,
infra, 26a (quoting State Farm, 463 U.S. at 43).
2.
The other purported defects identified by the district
court also cannot support the injunction. The court was wrong to
suggest (App., infra, 20a-21a) that the Secretary failed to
consider alternatives to vaccination, such as requiring testing of
unvaccinated individuals or limiting the requirement to healthcare
workers not previously infected with the virus that causes COVID-
19. The Secretary specifically considered “daily or weekly testing
of unvaccinated individuals,” “[e]xempting previously infected
individuals,” and other alternatives, but concluded that those
measures would not adequately protect patients. 86 Fed. Reg. at
61,614; see Florida, 2021 WL 5768796, at *3. Ultimately, the
Secretary determined that the vaccination requirement was “the
minimum regulatory action necessary” to protect the health and
safety of Medicare and Medicaid patients in participating
facilities. 86 Fed. Reg. at 61,613. Substantial evidence
supported that determination, and the district court should not
have “substitute[d] its views on epidemiology” for the Secretary’s
judgment. Florida, 2021 WL 5768796, at *15.
Nor was it arbitrary for the Secretary to “extrapolate” from
data on the effects of COVID-19 in long-term care facilities when
assessing the need for a vaccination requirement at other
facilities. App., infra, 18a (citation omitted). The district
35
court found reliance on that data arbitrary because COVID-19
“disproportionally devastates [long-term care] facilities.” Ibid.
But the data from long-term care facilities was just one piece of
the ample evidence supporting the Secretary’s judgments about the
risks of COVID-19 transmission and the benefits to patient safety
of a vaccine condition.
Finally, neither the “broad scope” of the facilities covered
by the rule (App., infra, 22a) nor the lack of prior vaccination
requirements
in
the
Secretary’s
condition-of-participation
regulations (id. at 23a) provides any sound basis to enjoin the
rule. The Medicare and Medicaid programs are themselves broad,
and the conditions of participation that Congress expressly
authorized the Secretary to adopt therefore may have comparable
scope. The Secretary was not required to proceed in piecemeal
fashion in adopting a measure he deemed urgently necessary to
protect the lives and safety of patients in the many different
types of facilities funded by Medicare and Medicaid. And as the
Secretary explained, the vaccine requirement is a response to a
“unique pandemic” in which Americans now have “unique access to
effective vaccines.” 86 Fed. Reg. at 61,568; see ibid. (explaining
that it has not been necessary to require vaccination for other
diseases “because other entities, including employers, states, and
licensing organizations, already impose” such requirements).
36
C.
The Secretary Had Good Cause To Issue The Rule Without
Advance Notice And Comment
The district court further erred in rejecting the Secretary’s
determination that there was good cause to make the rule effective
immediately. See 86 Fed. Reg. at 61,583-61,585. The Secretary
determined that patients in facilities funded by the Medicare and
Medicaid programs are more likely than the general population to
suffer severe illness or death from COVID-19, id. at 61,609; that
there have already been more than half a million COVID-19 cases
among healthcare staff, id. at 61,585; that rates among staff have
grown since the Delta variant’s emergence, ibid.; that COVID-19
cases are expected to spike during the coming winter months, id.
at 61,584, and that this spike will coincide with flu season,
raising the additional danger of combined infections and added
pressure on the healthcare system, ibid.
The Secretary determined that “a further delay in imposing a
vaccine mandate would endanger the health and safety of additional
patients and be contrary to the public interest.” 86 Fed. Reg. at
61,584. And he predicted that the rule will save hundreds and
potentially thousands of lives every month, id. at 61,612, which
manifestly constitutes good cause to proceed immediately. See
Sorenson Commc’ns Inc. v. FCC, 755 F.3d 702, 706 (D.C. Cir. 2014)
(“[W]e have approved an agency’s decision to bypass notice and
comment where delay would imminently threaten life.”).
37
The district court’s suggestion that the Secretary should
have acted “earlier,” App., infra, 14a, would not, even if true,
be reason to block a rule that will prevent many patient deaths in
the coming weeks and months. And in any event, the Secretary acted
in response to the rapidly evolving conditions of the pandemic,
including low vaccination rates among healthcare workers, 86 Fed.
Reg. at 61,559-61,560, and “the emergence and spread of the highly
transmissible Delta variant,” id. at 61,559; see also Florida,
2021 WL 5768796 at *14 n.2 (noting that the Secretary acted within
a few months after the first vaccine received “final approval”
from the Food and Drug Administration).
In addition, respondents have not identified any prejudice
arising out of the lack of a prior comment period. 5 U.S.C. 706
(“[D]ue account shall be taken of the rule of prejudicial error.”).
They did not identify any significant issue that the Secretary
failed to address, instead relying heavily on the staff-departure
risk that the Secretary thoroughly addressed. Thus, respondents
have failed to show any harm from the alleged procedural error.
See Shinseki v. Sanders, 556 U.S. 396, 409–411 (2009) (explaining
that the “burden of showing that an error is harmful normally falls
upon the party attacking the agency’s determination”).
III. The Balance Of Equities Overwhelmingly Favors A Stay
The district court’s injunction causes direct, irreparable
injury to the interests of the United States and the public --
38
interests that “merge” here. Nken v. Holder, 556 U.S. 418, 435
(2009). Indeed, delaying the rule would cause serious, tangible
harm to public health. If the rule remains stayed during this
winter’s anticipated COVID-19 surge, hundreds and potentially
thousands of patients may die at hospitals, nursing homes, and
other facilities participating in Medicare and Medicaid as the
result of COVID-19 infections transmitted to them by staff. The
Secretary reasonably determined that this direct threat to human
life and health greatly outweighs the potential indirect effects
if some workers quit rather than receive the vaccine. See App.,
infra, 28a-31a. There is no sound reason to reject the consensus
of leading healthcare organizations and the judgment of the
Secretary that the benefits of requiring healthcare workers to be
vaccinated far outweigh any countervailing concerns.
Nor have respondents identified any other irreparable harm
that could justify the broad preliminary injunction entered by the
district court. As this Court has emphasized, the “role of courts”
is limited to providing “relief to claimants, in individual or
class actions, who have suffered, or will imminently suffer, actual
harm.” Lewis v. Casey, 518 U.S. 343, 349 (1996). The only
claimants before the Court are the ten respondent States. They do
not speak for healthcare workers, whose representatives strongly
support COVID-19 vaccination requirements. See Joint Statement.
Nor can the States bring suit on behalf of private providers or
39
other private parties, because “[a] State does not have standing
as parens patriae to bring an action against the Federal
Government.” Alfred L. Snapp & Son, Inc. v. Puerto Rico, 458 U.S.
592, 610 n.16 (1982). And even with respect to their own state-
run facilities, respondents cannot demonstrate irreparable harm,
because any sanctions that might be imposed against such facilities
for failing to comply with conditions of Medicare- or Medicaid-
participation would be subject to judicial review. See Shalala v.
Illinois Council on Long Term Care, Inc., 529 U.S. 1, 8-9 (2000)
(describing the Medicare statute’s special review system).
The balance of equities and public interest are unaltered by
state laws purporting to restrict vaccine mandates. Cf. App.,
infra, 28a. Even assuming that a State’s abstract interest in
enforcing its law is a cognizable Article III interest, the federal
government has a compelling interest in enforcing the vaccination
condition in facilities it pays to care for Medicare and Medicaid
patients. Thus, the balance of equities and public interest do
not depend on abstract notions of sovereignty, but on the real-
world impact of the vaccination rule. And as already explained,
the protections that the rule provides for the health and safety
of patients substantially outweigh any countervailing concerns.
At a minimum, a partial stay should be granted because the
injunction is overbroad. See, e.g., Trump v. International Refugee
Assistance Project, 137 S. Ct. 2080, 2088 (2017) (per curiam).
40
Article III demands that the remedy sought “be limited to the
inadequacy that produced the injury in fact that the plaintiff has
established.” Gill v. Whitford, 138 S. Ct. 1916, 1931 (2018)
(citation omitted). Bedrock principles of equity support the same
requirement that injunctions be no broader than “necessary to
provide complete relief to the plaintiff[].” Madsen v. Women’s
Health Ctr., Inc., 512 U.S. 753, 765 (1994) (citation omitted).
Here, as already explained, respondents do not represent privately
run facilities or their workers, whose leading professional
associations strongly support vaccination requirements for staff.
Thus, the Court should at a minimum stay the preliminary injunction
except as to facilities operated by the respondent States.
CONCLUSION
The injunction should be stayed pending appeal and, if the
Eighth Circuit affirms the injunction, pending the filing and
disposition of a petition for a writ of certiorari and any further
proceedings in this Court. At a minimum, it should be stayed as
to all facilities other than those operated by respondents.
Respectfully submitted.
ELIZABETH B. PRELOGAR
Solicitor General
DECEMBER 2021File and source
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