Pandemic Darlings The pandemic economy, in original documents
Home Court filings Scotus Application - Scotus

Court filing

Application - Scotus

Full text

                          No. 21A-_____
________________________________________________________________
________________________________________________________________


           IN THE SUPREME COURT OF THE UNITED STATES

                        _______________


 XAVIER BECERRA, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH
             AND HUMAN SERVICES, ET AL., APPLICANTS

                               v.

                   STATE OF LOUISIANA, ET AL.

                        _______________


 APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED
   STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA
  PENDING APPEAL TO THE UNITED STATES COURT OF APPEALS FOR THE
       FIFTH 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




________________________________________________________________
________________________________________________________________
                         PARTIES TO THE PROCEEDING

     The    applicants    (defendants-appellants     below)   are   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; 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 Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana,

Mississippi, Montana, Oklahoma, Ohio, South Carolina, Utah, and

West Virginia.




                                    (I)
             IN THE SUPREME COURT OF THE UNITED STATES

                          _______________


                           No. 21A-_____

  XAVIER BECERRA, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH
              AND HUMAN SERVICES, ET AL., APPLICANTS

                                v.

                    STATE OF LOUISIANA, ET AL.

                          _______________


  APPLICATION FOR A STAY OF THE INJUNCTION ISSUED BY THE UNITED
    STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA
   PENDING APPEAL TO THE UNITED STATES COURT OF APPEALS FOR THE
        FIFTH 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 the

Secretary of Health and Human Services (the Secretary), et al.,

respectfully applies for a stay of the injunction issued by the

United States District Court for the Western District of Louisiana,

pending the consideration and disposition of applicants’ appeal

from that injunction to the United States Court of Appeals for the

Fifth 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 Eastern
District of Missouri.
                                      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 14 States by the district

court’s preliminary injunction in this case, which the Fifth

Circuit declined to stay despite recognizing that a merits panel

could well “ultimately” uphold the rule because the case presents

“a close call.”     App., infra, 3a.      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
                                    3

for the “prevention” and “control” of “infectious diseases” within

their facilities.     42 C.F.R. 482.42 (hospitals).

     In November 2021, the Secretary amended those regulations to

address the COVID-19 pandemic.      86 Fed. Reg. 61,555 (Nov. 5, 2021)

(App., infra, 43a-115a).     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

     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

denied a preliminary injunction, and the Eleventh Circuit then

issued    a    precedential   decision   denying   an   injunction   pending

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.

     The next district court to rule -- the Eastern District of

Missouri -- enjoined application of the rule with respect to

Medicare and Medicaid facilities in the ten States that brought

that suit.       Missouri v. Biden, No. 21-cv-1329, 2021 WL 5564501

(Nov. 29, 2021).      A divided Eighth Circuit panel declined to grant

a stay pending appeal in a summary order.               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.

     The third district court to rule -- the Western District of

Louisiana, in this case brought by 14 States -- initially enjoined

application of the rule to Medicare and Medicaid facilities in the

40 States not covered by the Missouri injunction.             App., infra,
                                             5

9a-42a. 3    The Fifth Circuit narrowed the geographic scope of the

injunction to the 14 plaintiff States (respondents in this Court)

but otherwise declined to enter a stay pending appeal.                      Id. at 1a-

8a.   The panel considered the merits of the case “a close call,”

but   felt      itself    bound   by     a   circuit        precedent   enjoining    a

“meaningful[ly]          distinct[]”      workplace         COVID-19    safety     rule

promulgated by the Occupational Safety and Health Administration

(OSHA).     Id. at 3a (citing BST Holdings, LLC v. OSHA, 17 F.4th 604

(5th Cir. 2021)). 4

      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



      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).

      4   The Fifth Circuit’s decision in BTS Holdings temporarily
staying the OSHA rule was entered shortly before litigation over
the OSHA rule was transferred to the Sixth Circuit in accordance
with the multi-circuit lottery proceeding prescribed by 28 U.S.C.
2112. A motion to dissolve that stay, see 28 U.S.C. 2112(a)(4),
is fully briefed and awaiting a ruling.
                                     6

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.          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

(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).
                                        7

     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-

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).
                                             8

       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).

       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
                                        9

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

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
                                          10

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.

      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
                                          11

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

long-term care employers require their workers to receive the

COVID-19 vaccine.”         App., infra, 116a-119a (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
                                         12

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).

      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.
                                            13

      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

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
                                  14

the danger to Medicare and Medicaid patients and underscores the

urgent need for the rule.

     B.     The Present Controversy

     1.     On November 15, 2021, respondents -- a group of 14 States

led by Louisiana -- brought this action in the Western District of

Louisiana.     D. Ct. Doc. 1.   On November 30, 2021, the district

court preliminarily enjoined enforcement of the rule “nationwide,”

except in ten States already covered by the Missouri injunction.

App., infra, 42a; see id. at 9a-42a; p. 4, supra.      The court found

that respondents are likely to succeed in arguing that that the

Secretary “do[es] not have the authority to implement the [Centers

for Medicare & Medicaid Services (CMS)] Mandate.”        App., infra,

9a-10a.     The court acknowledged that the Secretary has express

statutory authority to adopt rules “‘necessary to the efficient

administration’” of the Medicare and Medicaid programs, and that

the Secretary also invoked separate “statutory authority for each

specific category” of facility.        Id. at 27a (citation omitted).

But the court reasoned that, under what it called the “major

questions doctrine,” the government may not rely on such “general

authority statutes to mandate COVID-19 vaccines,” given what the

court viewed as the “vast economic and political significance” of

doing so.    Id. at 28a.

     The district court also found that respondents were likely to

succeed   on   additional   grounds.     First,   notwithstanding   the
                                     15

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 “[e]vidently[] the situation was not so urgent.” App., infra,

26a.    Second, the court found that respondents are likely to show

that the rule is “contrary to law,” based on a perceived conflict

with three provisions in Title 42.           Id. at 30a.     Third, the court

found   that    respondents   are   likely    to   show   that   the    rule    is

arbitrary      and   capricious,    including      because    the      Secretary

purportedly failed to give adequate consideration to the risk that

the rule will cause “staff shortages.”             Id. at 32a.      Fourth, the

court indicated that respondents are likely to succeed in showing

that, if the statutory scheme is construed to authorize the rule,

then the statutory scheme itself is unconstitutional under the

Tenth Amendment and the non-delegation doctrine.             Id. at 37a-38a.

       Finally, the district court determined that the remaining

factors supported a preliminary injunction.           App., infra, 39a-41a.

With respect to the balance of equities, the court relied on what

it regarded as the public interest in “maintaining the liberty of

individuals who do not want to take the COVID-19 vaccine,” id. at

40a, without addressing any interest in preventing unvaccinated

healthcare staff from spreading COVID-19 within facilities that
                                      16

participate in Medicare and Medicaid.          The court later denied the

government’s motion for a stay pending appeal.           Id. at 7a-8a.

       2.   The day after the district court issued its decision, on

December 1, 2021, the government filed an emergency motion in the

Fifth Circuit for a stay pending appeal.           On December 15, 2021,

the court of appeals granted in part and denied in part the

government’s motion, maintaining the injunction but narrowing its

scope to the 14 plaintiff States.          App., infra, 1a-6a.    The court

focused exclusively on the “major questions doctrine” and did not

address or endorse any of the other grounds on which the district

court had found a likelihood of success.         Id. at 2a.     In the court

of appeals’ view, its prior decision in a challenge to OSHA’s

separate and “meaningful[ly] distinct[]” workplace COVID-19 safety

rule   (a   case   in   which   the   Sixth   Circuit    now   properly   has

jurisdiction) rendered the merits of this case a “close call.”

Id. at 3a; see BST Holdings, LLC v. OSHA, 17 F.4th 604, 617 (5th

Cir. 2021).     Thus, the court found that the government had not

made a “strong showing of likely success” before a merits panel

bound by that prior decision.         App., infra, 3a.

                                  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
                                   17

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.

I.   This Court Would Likely Grant Review If The Fifth Circuit
     Affirmed The District Court’s Injunction

     The district court’s injunction forbids the Secretary from

enforcing in 14 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 Fifth Circuit allowed the injunction to stand.

Indeed, the Fifth Circuit itself recognized that this case presents

“a close call” on “an issue of great significance currently being

litigated throughout the country.”       App., infra, 3a, 5a.
                                        18

       The likelihood of certiorari is especially clear because the

Fifth Circuit’s truncated analysis (as well as the unexplained

conclusion of the divided Eighth Circuit panel in the Missouri

litigation)     contradicts      a   thorough   published    decision    by   the

Eleventh Circuit rejecting a parallel challenge to the same rule.

In that decision, the Eleventh Circuit squarely rejected the

argument that was the centerpiece of the Fifth Circuit’s reasoning

here -- that the rule is impermissible under what the States in

both cases have termed the “major questions” doctrine.                Florida v.

Department of Health & Human Servs., No. 21-14098, 2021 WL 5768796,

at *12 (Dec. 6, 2021); see App., infra, 2a-3a.                   The Eleventh

Circuit explained that the rule does not bring about any “enormous

and transformative expansion” in federal regulatory authority,

2021 WL 5768796, at *12 (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 Eleventh Circuit found the rule

to be a plainly permissible exercise of that authority, explaining

that    “it    is   the   very   opposite     of    efficient   and   effective
                                  19

administration for a facility that is supposed to make people well

to make them sick with COVID-19.”      Ibid. 5

      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 Fifth 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).

II.   The Government Is Likely To Succeed On The Merits

      If the Fifth Circuit affirmed the district court’s injunction

and this Court granted review, the Court would likely reverse.           In

concluding that the Secretary likely lacked authority to issue the

rule, neither the Fifth Circuit nor the district court conducted

any meaningful analysis of the relevant statutory text.           Instead,

those courts invoked an expansive and unsound conception of what

they 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


      5   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.
                                       20

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

well.”     National Ass’n of Mfrs. v. Department of Def., 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
                                      21

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 (analogous statutes for other facilities

covered by the rule).

      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
                                     22

facilities by reducing their risk of contracting the virus that

causes COVID-19.     As the Secretary explained, a recent study of

healthcare 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 Medicare and

Medicaid patients 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
                                         23

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

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. 7-

8, 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).
                                           24

     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

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
                                             25

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

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 courts

below held, that the government failed to make “a strong showing

of likely success on the merits” based on the court’s application
                                       26

of the “‘major questions doctrine.’”             App., infra, 2a-3a; see id.

at 28a-30a.      That analysis is seriously flawed.

     a.    In    discussing    the    Secretary’s     authority,    the   Fifth

Circuit noted this Court’s statement that Congress must “speak

clearly when authorizing an agency to exercise powers of ‘vast

economic and political significance.’”             App., infra, 3a (quoting

Alabama Ass’n of Realtors v. Department of Health & Human Servs.,

141 S. Ct. 2485, 2489 (2021) (per curiam)); see id. at 28a (similar

discussion by the district court).           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] 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   courts    below    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
                                       27

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

reduced the risk that vulnerable patients would contract the virus

from those workers.     See Florida, 2021 WL 5768796, at *12.

      Respondents and the courts below do not appear to dispute

that the Secretary generally has authority to adopt measures

preventing    the   spread     of   infectious     diseases   in    facilities

participating in Medicare and Medicaid.               Instead, the courts

suggested that Congress had to expressly single out vaccination

(or, even more specifically, COVID-19 vaccination) to authorize

the condition at issue here.           That reasoning reflects a serious

misreading of this Court’s precedents.
                                          28

       The Fifth Circuit and the district court both emphasized what

they    labeled     the   “political      significance”      of    the    vaccination

condition.      App., infra, 3a (citation omitted); see id. at 29a.

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.

       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
                                         29

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.

      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

patients precisely because it could not foresee all future threats

to patient health and safety, see House Report 25-26 -- would have
                                       30

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 lower courts’ analysis further ignored the nature of

the requirement at issue.         CMS’s vaccine 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 an assertion of police power to regulate in the manner of

a   State.     Cf.   App.,   infra,    28a-29a,   36a-37a   (district   court

discussing the rule as a direct regulation and concluding that it

intrudes on the power of States). 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
                                    31

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.   The district court was similarly mistaken in reasoning

that the vaccination requirement may be unconstitutional.              App.,

infra, 36a-37a.      Contrary to the court’s apparent understanding,

the    vaccination    condition   does    not   dictate   private     medical

decisions.    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
                                       32

“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 receive a vaccine to work at 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 -- which the

Fifth Circuit did not embrace -- that the rule is arbitrary,

capricious, or otherwise contrary to law.             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
                                       33

protection for patients.”          Florida, 2021 WL 5768796, at *15; see

id. at *2-*3.

       The district court identified several purported problems with

the Secretary’s reasoning, but respondents focused on one in

particular:       that the Secretary failed to adequately consider the

potential for the rule to cause “staff shortages” that would in

turn “have the effect of harming patient well-being.” App., infra,

32a. But the 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.       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. 11-12, 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
                                         34

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

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 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 also erred in finding (App., infra, 33a)

that the Secretary failed to consider alternatives to vaccination,
                                         35

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.        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 judgment of

the Secretary.        Florida, 2021 WL 5768796, at *15; cf. App., infra,

34a (district court’s query asking “[i]f boosters are needed six

months after being ‘fully vaccinated,’ then how good are the COVID-

19 vaccines, and why is it necessary to mandate them?”).

      C.      The Secretary Had Good Cause To Issue The Rule Without
              Advance Notice And Comment

      The district court further erred by concluding, in a holding

that the Fifth Circuit did not endorse, that the Secretary lacked

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
                                36

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 danger of

combined infections and added pressure on the 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.”).

     The district court observed that the Secretary issued the

rule two months after the President announced that CMS was working

on it, but that sequence of events hardly shows that “the situation

was not so urgent” as to justify invoking the good-cause exception.

App., infra, 26a.   Any suggestion that the Secretary should have

acted sooner 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
                                    37

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 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.”).

Indeed, they have not identified any significant issue that the

Secretary failed to address.      Respondents have thus 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”). 6

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 --

interests that “merge” here.       Nken v. Holder, 556 U.S. 418, 435

(2009).   Indeed, delaying the rule would cause serious, tangible


     6    The Secretary also was not required to consult with state
agencies before issuing the rule.      The district court read 42
U.S.C. 1395z to impose such a requirement, App., infra, 30a-31a,
but that provision does not require that consultation occur in
advance of a rulemaking, see 86 Fed. Reg. at 61,567.
                                        38

harm to public health.         If the rule remains enjoined 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.

     The district court entirely failed to take account of that

concrete threat to human life and health in balancing the equities.

App.,    infra,    40a-41a    (stating       that   the   public      interest   in

“maintaining      the   constitutional       structure    and   maintaining      the

liberty of individuals who do not want to take the COVID-19 vaccine

* * *    outweighs [applicants’] interests”).             No sound basis exists

to reject the consensus of leading healthcare organizations and

the judgment of the Secretary that the benefits of the vaccination

requirement 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 14 respondent States.                  They do
                                      39

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

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).

       The balance of equities and public interest are unaltered by

state laws purporting to restrict vaccine mandates.           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.
                                    40

      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).

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

Fifth 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 2021


File and source

File
21A241_002_Dec_16_2021_Main_Document_20211216173745233_Becerra_v._Louisiana_-_CMS_Vaccine_Mandate_Stay_Application.pd.pdf
Size
196,705 bytes
SHA-256
18d9f739eaeabd694ce4b4a67ffad7d974a784b9d14b463e2ba5a21450563aca
Our copy
21A241_002_Dec_16_2021_Main_Document_20211216173745233_Becerra_v._Louisiana_-_CMS_Vaccine_Mandate_Stay_Application.pd.pdf
Original
www.supremecourt.gov
Back to top