Application - Scotus

Full text

                                  No. 21A240


In the Supreme Court of the United States
   J OSEPH R. B IDEN , J R ., P RESIDENT OF THE U NITED S TATES , ET AL .,
                                                Applicants,
                                       v.
                            STATE OF MISSOURI, ET AL.,
                                                  Respondents.


         On Application for Stay of the Injunction Issued by the
     United States District Court for the Eastern District of Missouri


             RESPONSE TO APPLICATION FOR A STAY


 ERIC S. SCHMITT                            DOUGLAS J. PETERSON
 Attorney General of Missouri               Attorney General of Nebraska
 D. JOHN SAUER                              JAMES A. CAMPBELL
 Solicitor General                          Solicitor General
  Counsel of Record
                                            Office of the Attorney General
 JESUS A. OSETE                             2115 State Capitol
 Deputy Attorney General                    Lincoln, Nebraska 68509
                                            Tel.: (402) 471-2682
 Maddie McMillian Green
 Assistant Attorney General
 Office of the Attorney General
 Supreme Court Building
 207 W. High St.
 P.O. Box 899
 Jefferson City, Missouri 65102
 Tel.: (573) 751-1800
 Fax: (573) 751-0774
 John.Sauer@ago.mo.gov
 Jesus.Osete@ago.mo.gov
                                            *Additional counsel listed
 Counsel for Respondents*
                                            on signature page
                                             TABLE OF CONTENTS

INTRODUCTION ................................................................................................................ 1
STATEMENT OF THE CASE ................................................................................................ 3
      I.     The Ongoing Healthcare Worker Crisis. ........................................................ 3
      II. The President’s Shifting Position on Vaccine Mandates. .............................. 3
      III. The CMS Vaccine Mandate. ............................................................................ 4
      IV. The Mandate’s Disastrous Consequences....................................................... 6
ARGUMENT ...................................................................................................................... 8
      I.     The Secretary Cannot Show a Reasonable Probability that Four
             Justices will Consider the Issues Sufficiently Meritorious to Grant
             Certiorari Now. ................................................................................................ 9
      II. The Secretary Cannot Show a Fair Prospect that Five Justices
          will Conclude that the District Court’s Decision is Erroneous on
          the Merits. ...................................................................................................... 10
             A. The mandate exceeds the Secretary’s statutory authority. .................. 10
             B. The mandate is arbitrary and capricious. ............................................. 24
             C. The mandate violates multiple procedural requirements. ................... 32
      III. The Remaining Factors Do Not Favor a Stay. ............................................. 34
CONCLUSION ................................................................................................................. 39




                                                               ii
                                            TABLE OF AUTHORITIES

Cases

Abbott v. Perez,
  138 S. Ct. 2305 (2018).............................................................................................. 35

Alabama Ass’n of Realtors v. HHS,
  141 S. Ct. 2485 (2021).................................................................. 1, 14, 16, 20, 22, 37

Am. Fed’n of Gov’t Emps. v. Block,
  655 F.2d 1153 (D.C. Cir. 1981) ................................................................................ 32

Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy,
  548 U.S. 291 (2006).................................................................................................. 24

AT&T Corp. v. Iowa Utilities Bd.,
  525 U.S. 366 (1999).................................................................................................. 16

Avon Nursing & Rehab. v. Becerra,
  995 F.3d 305 (2d Cir. 2021) ..................................................................................... 36

Azar v. Allina Health Servs,
  139 S. Ct. 1806 (2019)....................................................................................... 21, 22

Barr v. E. Bay Sanctuary Covenant,
  140 S. Ct. 3 (2019) ................................................................................................... 34

Bond v. United States,
  572 U.S. 844 (2014).................................................................................................. 20

BST Holdings, LLC v. OSHA,
  17 F.4th 6048 (5th Cir. 2021 ............................................................................. 34, 36

Conkright v. Frommert,
  556 U.S. 1401 (2009)........................................................................................ 8, 9, 10

Cooper v. Harris,
  137 S. Ct. 1455 (2017)................................................................................................ 8

Dem. Exec. Comm. v. Nat’l Repub. Sen. Comm.,
  950 F.3d 790 (11th Cir. 2020) ................................................................................... 9

Dep’t of Com. v. New York,
  139 S. Ct. 2551 (2019).............................................................................................. 27




                                                            iii
Dep’t of Homeland Sec. v. Regents of the Univ. of Cal.,
  140 S. Ct. 1891 (2020)...................................................................... 25, 28, 29, 30, 37

Dry Color Mfrs. Ass’n, Inc. v. Dep’t of Labor,
  486 F.2d 98 (3d Cir. 1973) ....................................................................................... 29

Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014),
   573 U.S. 302, 324 (2014) ..................................................................................... 1, 19

FCC v. Prometheus Radio Project,
  141 S. Ct. 1150 (2021).............................................................................................. 24

FDA v. Brown & Williamson Tobacco Corp.,
  529 U.S. 120 (2000)........................................................................................ 1, 10, 16

Florida v. HHS,
  19 F.4th 1271 (11th Cir. 2021) ................................................................ 9, 23, 31, 32

Free Enter. Fund v. Pub. Co. Acct. Oversight Bd.,
  537 F.3d 667 (D.C. Cir. 2008) .................................................................................... 1

Free Enter. Fund v. Pub. Co. Acct. Oversight Bd.,
  561 U.S. 477 (2010).............................................................................................. 1, 19

Graves v. Barnes,
  405 U.S. 1201 (1972).................................................................................................. 8

Gustafson v. Alloyd Co,
  513 U.S. 565 (1995)................................................................................................. 17

In re MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule:
   COVID-19 Vaccination & Testing,
   --- F.4th ----, 2021 WL 5914024 (6th Cir. Dec. 15, 2021) ................ 17, 18, 21, 32, 33

Ind. State Police Pension Tr. v. Chrysler LLC,
  556 U.S. 960 (2009)........................................................................................ 8, 34, 36

Jacobson v. Massachusetts,
   197 U.S. 18 (1905)....................................................................................... 13, 19, 21

King v. Burwell,
  576 U.S. 473 (2015)............................................................................................ 16, 21

Maryland v. King,
 567 U.S. 1301 (2012)................................................................................................ 35




                                                           iv
Massachusetts v. EPA,
 549 U.S. 497 (2007)...................................................................................... 34, 35, 36

Merck & Co. v. United States Dep’t of Health & Hum. Servs.,
 962 F.3d 531 (D.C. Cir. 2020) ............................................................................ 11, 12

Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
 463 U.S. 29 (1983).............................................................................................. 24, 29

Neal v. Clark,
  95 U.S. 704 (1877).................................................................................................... 16

NFIB v. Sebelius,
 567 U.S. 519 (2012)………………………………………………………………………..24

Nken v. Holder,
  556 U.S. 418 (2009)................................................................................................ 2, 3

Sabri v. United States,
  541 U.S. 600 (2004).................................................................................................. 23

Shalala v. Illinois Council on Long Term Care, Inc.,
  529 U.S. 1 (2000)...................................................................................................... 36

Solid Waste Agency of N. Cook Cnty. v. U.S. Army Corps of Eng’rs,
  531 U.S. 159 (2001)............................................................................................ 20, 21

Texas v. Becerra,
  --- F. Supp. 3d ----, 2021 WL 5964687 (N.D. Tex. Dec. 15, 2021) ........................... 19

Thorpe v. Hous. Auth. of City of Durham,
  393 U.S. 268 (1969).................................................................................................. 11

Thunder Basin Coal Co. v. Reich,
  510 U.S. 200 (1994).................................................................................................. 36

United States Telecom Ass’n v. FCC,
  855 F.3d 381 (D.C. Cir. 2017) .................................................................................. 21

United States v. Brewer,
  766 F.3d 884 (8th Cir. 2014) ................................................................................... 33

Valdez v. Grisham,
  No. 21A253 (U.S. Dec. 21, 2021)………………………………………………………...13

Whole Woman’s Health v. Jackson,
 142 S.Ct. 522 (2021)................................................................................................... 9

                                                             v
Williams v. Zbaraz,
  442 U.S. 1309 (1979)................................................................................................ 34

Statutes

5 U.S.C. § 553(b)-(c) ....................................................................................................... 4

42 U.S.C. 1395d(a)(1) ................................................................................................... 14

42 U.S.C. § 405(h) ........................................................................................................ 36

42 U.S.C. § 1395 ............................................................................................... 18, 19, 23

42 U.S.C. § 1395cc(h)(1)............................................................................................... 36

42 U.S.C. § 1395i-3(d)(1)-(2) ........................................................................................ 18

42 U.S.C. § 1395i-3(d)(3).............................................................................................. 18

42 U.S.C. § 1395i-3(d)(4)(B)......................................................................................... 17

42 U.S.C. § 1395ii ........................................................................................................ 36

42 U.S.C. § 1395rr(b)(1)(A) .......................................................................................... 13

42 U.S.C. § 1395x(e)..................................................................................... 5, 14, 16, 22

42 U.S.C. § 1395x(iii)(3)(D)(i)(IV)................................................................................ 13

42 U.S.C. § 1395z ........................................................................................................... 4

42 U.S.C. § 1396d(d)(1) ................................................................................................ 13

42 U.S.C. § 1396d(h)(1)(B)(i) ................................................................................... 5, 13

42 U.S.C. §§ 1302(a)..................................................................................... 4, 10, 11, 12

42 U.S.C. § 1395hh(a)(1).............................................................................................. 11

Rules

Sup. Ct. R. 10……………………………………………………………………………………9

Fed. R. Civ. P. 52(a)(6) ................................................................................................... 8

Regulations

42 C.F.R. § 441.151 .................................................................................................. 5, 20


                                                              vi
42 C.F.R. § 482.42(a)...................................................................................................... 5

42 C.F.R. § 483.430 ...................................................................................................... 20

42 C.F.R. § 485.58 ................................................................................................ 5, 6, 20

42 C.F.R. § 485.904 ...................................................................................................... 20

42 C.F.R. § 486.525 ...................................................................................................... 20

42 C.F.R. § 491.8 .......................................................................................................... 20

Other Materials

17 Oxford English Dictionary (2d ed.1989)………………………………………………..16

Webster’s Third New International Dictionary (2002)…………………………………..16




                                                             vii
                              INTRODUCTION

    This Court “typically greet[s]” with skepticism an administrative agency’s

sudden discovery “in a long-extant statute” of “an unheralded power” to regu-

late matters of “vast ‘economic and political significance.’ ” Util. Air Regul.

Grp. v. EPA, 573 U.S. 302, 324 (2014) (quoting FDA v. Brown & Williamson

Tobacco Corp., 529 U.S. 120, 159–60 (2000)). That’s because the “lack of his-

torical precedent” is often “the most telling indication” that an agency lacked

the power to regulate. Free Enter. Fund v. Pub. Co. Acct. Oversight Bd., 561

U.S. 477, 505 (2010) (quoting Free Enter. Fund v. Pub. Co. Acct. Oversight Bd.,

537 F.3d 667, 699 (D.C. Cir. 2008) (Kavanaugh, J., dissenting)). Applying

these principles recently, the Court rejected the CDC’s “unprecedented” “claim

of expansive authority” to impose a nationwide eviction moratorium as a “nec-

essary” measure to prevent the spread of COVID–19. Alabama Ass’n of Real-

tors v. HHS, 141 S. Ct. 2485, 2487, 2489 (2021) (per curiam).

    The Court should do the same here. The Secretary of Health and Human

Services’ sweeping and unprecedented vaccine mandate for healthcare workers

threatens to create a crisis in healthcare facilities in rural America. The man-

date would force millions of workers to choose between losing their jobs or com-

plying with an unlawful federal mandate. But for the district court’s prelimi-

nary injunction, last year’s healthcare heroes would have become this year’s

unemployed. Preserving the status quo, as the district court did here, was
critical to avoid irreparable injury to the States and a catastrophe in rural

health care.

    The Secretary seeks an extraordinary stay to undo that necessary remedy

and immediately reimpose the mandate, creating confusion, causing a logisti-

cal nightmare, and unleashing the “prevalent, tangible, and irremediable”

harm that the injunction forestalls. App.34a. All this despite the district

court’s meticulous, 32-page opinion issued after full briefing, where the Secre-

tary was entitled to introduce whatever evidence he chose. The district court

carefully surveyed thirty declarations submitted by the States describing the

devastating impact the mandate will have on healthcare access in rural parts

of the States—reliance interests the Secretary simply failed to consider. The

court also reached sound legal conclusions showing the mandate exceeded the

Secretary’s statutory authority, bypassed notice-and-comment requirements,

and was arbitrary and capricious, in violation of the Administrative Procedure

Act (APA). The Court of Appeals found the district court’s opinion so persua-

sive—and the Government’s stay request so meritless—that it denied the same

relief requested here in a one-line order. App.1a; see also id. at 2a-4a (district

court denying stay pending appeal after finding four factors under Nken v.

Holder, 556 U.S. 418 (2009), did “not … weigh in favor” of one).

    At bottom, the lower courts got it right, and the Secretary is not entitled

to a stay of the preliminary injunction pending appeal. This Court should thus

deny his request for a stay here.




                                        2
                         STATEMENT OF THE CASE

    I.   The Ongoing Healthcare Worker Crisis.

    The Secretary admits that “currently there are endemic staff shortages for

almost all categories of employees at almost all kinds of health care providers

and supplier[s].” App.89a. One in five hospitals, he notes, “report that they

are currently experiencing a critical staffing shortage.” Id. at 41a. In addition,

“approximately 23 percent of LTC [long-term-care] facilities report[] a shortage

in nursing aides,” and “21 percent report[] a shortage of nurses.” Id.

    The States’ experience confirms this. App. 29a (citing declarations). The

situation is so dire that over the last few months, many of those States have

issued emergency orders aiming to alleviate the endemic staffing shortages.

ECF No. 9, at 3, 12 (discussing emergency measures in Missouri, Nebraska,

and Wyoming). 1

    II. The President’s Shifting Position on Vaccine Mandates.

    Initially, President Biden’s Administration correctly affirmed that man-

dating vaccines is “not the role of the federal government.” 2 Yet on September

9, 2021, amid flagging poll numbers, the Administration exhibited a dramatic

about-face. That day, the President announced a six-point plan on COVID-19,

and to further his first goal of “requir[ing] more Americans to be vaccinated,”




    1 Documents cited using “ECF No.” refer to district court filings not in the

Government’s Appendix. And “R.App.” refers to citations to Respondents’ Ap-
pendix.
    2 Press Briefing (July 23, 2021), The White House, https://bit.ly/3Dh3hl8.




                                        3
the President called for several vaccine mandates, including the mandate chal-

lenged here. 3 This week the President’s position shifted again; on a call with

state governors to discuss the COVID–19 pandemic (specifically the Omicron

variant), he stated that “there is no federal solution. This gets solved at the

state level.” 4

     III. The CMS Vaccine Mandate.

     Nearly two months after the President’s announcement, the Secretary

published the challenged vaccine mandate on November 5, 2021. App.37a-

109a. The Secretary recognizes that this mandate is unprecedented because

CMS had “not previously required any vaccinations.” Id. at 49a. Even so, he

did not comply with statutory obligations to provide notice and comment or to

consult with the States. See 5 U.S.C. § 553(b)-(c); 42 U.S.C. § 1395z.

     The mandate broadly commandeers 15 categories of Medicare- and Medi-

caid-certified providers and suppliers that are “diverse in nature,” App.84a,

ranging from LTC facilities serving elderly patients, to Psychiatric Residential

Treatment Facilities (PRTFs) for individuals under age 21, id. at 38a. The

Secretary invoked different statutory authority for his attempt to regulate each

of these facility types. Id. at 49a. In addition to two general rulemaking pro-

visions, see 42 U.S.C. §§ 1302(a) & 1395hh(a)(1), the Secretary cited statutes



     3 Joseph Biden, Remarks (Sept. 9, 2021), https://bit.ly/31jHiww.

     4 Dan Diamond et al., U.S. hospitals brace for continuing surge in covid

cases fueled by the omicron             variant,   Washington      Post   (Dec.
27, 2021), https://wapo.st/3zg8xoL.


                                       4
that mention regulatory “requirements” addressing “health and safety” for

some facilities, see, e.g., 42 U.S.C. § 1395x(e)(9) (hospitals); but many statutes

addressing other facilities do not reference “health” or “safety” at all, see, e.g.,

42 U.S.C. § 1396d(h)(1)(B)(i) (PRTFs). Likewise, while some of the regulations

amended by the rule already addressed “infection prevention and control,” 42

C.F.R. § 482.42(a) (hospitals), many of them did not, see, e.g., 42 C.F.R.

§ 441.151 (PRTFs); 42 C.F.R. § 485.58 (Comprehensive Outpatient Rehabilita-

tion Facilities (CORFs)).

    The Secretary’s rule demands vaccines for practically every full-time em-

ployee, part-time worker, trainee, student, volunteer, and third-party contrac-

tor entering those facilities, including all staff “regardless of … patient con-

tact,” App.52a, and third parties working on a “project” who “use shared facil-

ities” such as restrooms, id. at 53a. Given the scope of facilities and individuals

covered, the Secretary notes that “virtually all health care staff in the U.S.,”

id. at 55a—an estimate of 10.3 million individuals, id. at 85a—will fall under

the mandate.

    The Secretary rejected the option of allowing workers to undergo “daily or

weekly [COVID-19] testing” instead of mandatory vaccination for only one un-

explained reason: because he believes that “vaccination is a more effective in-

fection control measure” than testing. Id. at 96a. The Secretary also rejected

the alternative of affording different options to healthcare workers who have




                                         5
developed infection-induced (or natural) immunity because of perceived “un-

certainties … as to the strength and length of [natural] immunity.” Id.

    The Secretary was “aware of concerns about health care workers choosing

to leave their jobs rather than be vaccinated” and knew that “there might be a

certain number of health care workers who choose to do so.” Id. at 51a. But

without seeking public comment or consulting with States, he dismissed these

concerns because “there is insufficient evidence to quantify” that risk and bal-

ance it against others. Id.

    The Secretary intends for the mandate to “preempt[] inconsistent State

and local laws.” Id. at 50a. He also demands that “State-run facilities that

receive Medicare and Medicaid funding” administer the vaccine mandate by

“imposing [it] on their employees,” id. at 95a, and by complying with overbear-

ing record-keeping obligations (including tracking booster vaccination status

even though the mandate does not (yet) require boosters), id. at 53a. And the

Secretary forces “State surveyors … to assess compliance with” the mandate.

Id. at 56a.

    IV. The Mandate’s Disastrous Consequences.

    The mandate will have disastrous consequences on healthcare, particu-

larly in rural communities. The States submitted thirty declarations detailing

the coming catastrophe, and the district court carefully reviewed them.

App.28a-32a (summarizing those declarations). These declarations, many of

which indicate how many healthcare workers are likely to “leave employment”




                                       6
under the mandate, explain that the workforce reduction “will decrease the

quality of care provided at facilities, compromise the safety of patients, and

place even more stress on the remaining staff.” Id. at 29a. In addition, the

loss of staffing “will diminish entire areas of care” within certain facilities and

“in many instances will result in no care at all, as some facilities will be forced

to close altogether.” Id. at 30a-31a. These threats face both private healthcare

facilities and state-run institutions. E.g., R.App.39a-40a.

    Cherry County Hospital in rural Valentine, Nebraska projects that the

mandate will force 50 of its 159 employees to leave their positions, which will

require the hospital to close its dialysis and chemotherapy departments, dra-

matically reduce the surgeries it provides, and perhaps even shut down en-

tirely. R.App.87a-90a. Likewise, 20 of 65 employees at Scotland County Care

Center—a nursing home in rural Memphis, Missouri—have indicated that “if

the mandate is imposed, … they will quit,” which will cause the facility to

“ ‘close its doors’ and displace residents.” App.31a (quoting R.App.63a-64a).

Similar examples abound throughout the States’ declarations.

    None of this should have been a surprise to the Secretary. He admits that

vaccination rates “are disproportionately low among nurses and health care

aides” in rural locations, App.48a, and that “rural hospitals are having greater

problems with employee vaccination … than urban hospitals,” id. at 95a. A

recent survey predating the mandate also shows that a substantial portion of

“unvaccinated workers”—a whopping 72%—“say they will quit” rather than




                                        7
submit to a vaccine mandate. 5 Here, the district court found—and the Secre-

tary did not dispute—that some workers have already followed through and

resigned. App.29a. 6

                                   ARGUMENT

    “Stays pending appeal to this Court are granted only in extraordinary cir-

cumstances.” Graves v. Barnes, 405 U.S. 1201, 1203 (1972) (Powell, J., in

chambers). “A lower court judgment, entered by a tribunal that was closer to

the facts ... is entitled to a presumption of validity.” Id. This Court will grant

a stay pending appeal only where the applicant demonstrates (1) “a reasonable

probability that four Justices will consider the issue sufficiently meritorious to

grant certiorari”; (2) “a fair prospect that a majority of the Court will conclude

that the decision below was erroneous”; and (3) “a likelihood that irreparable

harm will result from the denial of a stay.” Conkright v. Frommert, 556 U.S.

1401, 1402 (2009) (Ginsburg, J., in chambers). Yet “[a] stay is not a matter of

right, even if irreparable injury might otherwise result.” Ind. State Police Pen-

sion Tr. v. Chrysler LLC, 556 U.S. 960, 961 (2009) (per curiam). Addition-

ally, “in a close case it may be appropriate to balance the equities, to assess the

relative harms to the parties, as well as the interests of the public at



    5 72% of unvaccinated workers vow to quit, CNN.COM (Oct. 28, 2021),
https://cnn.it/3G7JarE.
    6 The Secretary simply refuses to engage with—much less refute—the dis-

trict court’s extensive factual findings, which “are subject to review only for
clear error.” Cooper v. Harris, 137 S. Ct. 1455, 1465 (2017) (citing Fed. R. Civ.
P. 52(a)(6)).


                                        8
large.” Id. at 960 (quotation marks omitted). The Secretary fails to meet this

daunting standard at every turn.

I.   The Secretary Cannot Show a Reasonable Probability that Four
     Justices will Consider the Issues Sufficiently Meritorious to Grant
     Certiorari Now.

     The Secretary has not shown “a reasonable probability that four Justices

will consider the issue[s here] sufficiently meritorious to grant certiorari” now.

Conkright, 556 U.S. at 1402. Because the Eighth Circuit’s denial of a stay is

not a determination on the merits, it has not yet “decided an important ques-

tion of federal law that has not been, but should be, settled by this Court[.]”

Sup. Ct. R. 10(c). Thus, certiorari is not warranted at this time. 7

     The Secretary relies heavily on the Eleventh Circuit motions panel’s opin-

ion in Florida v. HHS, 19 F.4th 1271 (11th Cir. 2021), to argue (at 3 and 16)

that a split in “precedential decision[s]” justifies certiorari. But that 2-to-1

denial of the State of Florida’s stay application is not precedential, see Dem.

Exec. Comm. v. Nat’l Repub. Sen. Comm., 950 F.3d 790, 795 (11th Cir. 2020)

(“a stay-panel opinion” does not have “effect outside” a particular case), and as

shown below, the majority’s analysis is thoroughly unpersuasive. Thus, at pre-

sent, this Court would be unlikely to grant certiorari.




     7Alternatively, if this case raises issues of “exceptional national im-
portance that would warrant this Court’s review”—as the Solicitor General
states (at 16)—then Respondents have no objection to the Court treating the
Secretary’s Application as requesting certiorari before judgment. Cf. Whole
Woman’s Health v. Jackson, 142 S.Ct. 522, 531–32 (2021).


                                        9
II. The Secretary Cannot Show a Fair Prospect that Five Justices will
    Conclude that the District Court’s Decision is Erroneous on the
    Merits.

    The Secretary has also failed to show that there is “a fair prospect that a

majority of the Court will conclude that the decision below was erroneous,”

Conkright, 556 U.S. at 1402, for a simple reason: he is wrong on the merits.

    A. The mandate exceeds the Secretary’s statutory authority.

    The Secretary offers several arguments why the Court should issue a stay,

each of which has been soundly rejected by both the district court and the Court

of Appeals. These twice-rejected arguments are no more meritorious for their

repetition.

    1.   The text, structure, and context of the statutes the Secretary invokes

here do not support his interpretation that he had authority to promulgate the

vaccine mandate. See FDA, 529 U.S. at 132–33 (in analyzing “whether Con-

gress has directly spoken to the precise question at issue,” the Court “should

not confine itself to examining a particular statutory provision in isolation”

because “the meaning—or ambiguity—of certain words or phrases may only

become evident when placed in context” and “with a view to their place in the

overall statutory scheme”) (cleaned up).

    a.   Start with the text of the statutes the Secretary invokes. First, the

Secretary argues (at 19) that he is vested with “broad authority” under

42 U.S.C. §§ 1302(a) & 1395hh(a)(1) and such authority allowed him to impose

the challenged nationwide vaccine mandate.




                                      10
    Not so. To be sure, the Secretary’s “administrative authority is undoubt-

edly broad.” Merck & Co. v. United States Dep’t of Health & Hum. Servs., 962

F.3d 531, 537 (D.C. Cir. 2020) (citing Thorpe v. Hous. Auth. of City of Durham,

393 U.S. 268, 277 n.28 (1969)). “But it is not boundless.” Id. And here neither

§ 1302(a) nor § 1395hh(a)(1) gives the Secretary the power to impose a nation-

wide vaccine mandate.

    Section 1302(a) directs the Secretary to “make and publish such rules and

regulations, not inconsistent with [the Social Security Act], as may be neces-

sary to the efficient administration of the functions with which [the Secretary]

is charged under” the Medicare and Medicaid programs. (Emphasis added).

Similarly, Section 1395hh(a)(1) directs the Secretary to “prescribe such regu-

lations as may be necessary to carry out the administration of the insurance

programs under” the Medicare Act. (Emphasis added).

    The word “administration” is the “central focus” of these statutes, and its

original meaning in 1935 was “the practical management and direction of its

various programs (including eventually Medicare and Medicaid), as well as

their management and conduct.” Merck, 962 F.3d at 537 (quotations omitted).

In other words, a regulation must be “necessary” to the programs’ “administra-

tion,” and “the further a regulation strays from truly facilitating the ‘admin-

istration’ of the Secretary’s duties, the less likely it is to fall within the statu-

tory grant of authority.” Id. at 537–38.




                                         11
    The Secretary doesn’t dispute this textual analysis or even attempt to de-

fend the vaccine mandate as “necessary” to Medicare’s and Medicaid’s “admin-

istration”; instead, he claims (at 24) that “it would be striking and anomalous

if [his] broad authority to adopt conditions protecting patient health and safety

did not include a … mechanism like a vaccine requirement.”

    But the Secretary’s invocation of results-oriented purposivism—i.e., the

Secretary has always had regulatory authority to promote the health and

safety of Medicare and Medicaid recipients—is a poor substitute for any text in

§§ 1302(a) and 1395hh(a)(1) that supports his authority. Indeed, neither stat-

ute even mentions “health and safety” (and the Secretary does not argue oth-

erwise). The cruel irony here—one the district court found based on facts that

the Secretary does not dispute—is that the mandate will actually result in pa-

tients not having access to essential healthcare services. See, e.g., App.30a-

31a. That’s quite the opposite of promoting patients’ “health and safety.”

    Further supporting the States’ interpretation of §§ 1302(a) and

1395hh(a)(1) is that even though the Secretary invoked these statutes as au-

thorizing the mandate, he openly recognized that the mandate was unprece-

dented—never before had the agency mandated any vaccination. App.49a. In-

deed, the Secretary recognized that vaccination requirements on healthcare

workers in Medicare- and Medicaid-certified facilities had traditionally been

left to the States and private employers—not the federal government. See




                                       12
id.; accord Jacobson v. Massachusetts, 197 U.S. 11, 38 (1905) (vaccine require-

ments “do not ordinarily concern the national government”); Valdez v. Gri-

sham, No. 21A253 (U.S. Dec. 21, 2021) (Gorsuch, J.) (denying stay of New Mex-

ico’s healthcare worker vaccine mandate); App’l, at 23 (collecting stay denials

of Maine’s and New York’s healthcare worker vaccine mandates).

    Thus, the Secretary’s characterization of this sweeping mandate as a mere

routine exercise of his broad regulatory authority is simply wrong.

    b.   The Secretary next argues (at 19) that Congress vested him with spe-

cific statutory authority to adopt “requirements that he deems necessary to

ensure patient health and safety.” Again, this argument is meritless.

    For starters, many of the statutes the Secretary invokes do reference

“health and safety” requirements, but only for some covered facilities, such as

hospitals. The Secretary ignores that the statutes mentioning “standards,”

“criteria,” or “requirements” for many other facilities—such as Psychiatric Res-

idential Treatment Facilities (PRTFs) for individuals under age 21 and Home

Infusion Therapy (HIT) suppliers—do not reference “health and safety” at all. 8

Such nondescript statutes do not come close to authorizing a vaccine mandate




    8 See, e.g., 42 U.S.C. § 1396d(h)(1)(B)(i) (governing PRTFs and mentioning

“standards as may be prescribed”); 42 U.S.C. § 1396d(d)(1) (governing Inter-
mediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-
IID) and mentioning “standards as may be prescribed”); 42 U.S.C.
§ 1395rr(b)(1)(A) (governing End-Stage Renal Disease (ESRD) facilities and
mentioning “requirements as the Secretary shall by regulation prescribe”); 42
U.S.C. § 1395x(iii)(3)(D)(i)(IV) (governing HIT suppliers and mentioning “re-
quirements as the Secretary determines appropriate”).


                                      13
for those facilities. Because CMS applied its mandate to those facilities any-

way, the agency vastly exceeded its statutory authority.

    Moreover, the specific statutes that the Secretary cites in his brief (at 19)

fail to clearly authorize this mandate. The Secretary points to 42 U.S.C.

1395d(a)(1), which authorizes payments for “hospital services.” But nothing in

the text of this provision even mentions “health” or “safety” or vaccinations

and, when read in context—not in isolation—the primary audience is Medicare

beneficiaries, not Medicare-certified providers.

    The Secretary argues, however, that this provision uses the term “hospi-

tal” and that term is defined, in a different statutory provision, as “an institu-

tion which … meets such other requirements as the Secretary finds necessary

in the interest of the health and safety of individuals who are furnished ser-

vices in the institution.” 42 U.S.C. § 1395x(e)(9). Thus, the Secretary contends

that, through the vaccine mandate, he was merely imposing a “requirement[]”

that was “necessary in the interest of the health and safety” of patients.

    Reading the entirety of § 1395x(e)(1)-(9), rather than § 1395x(e)(9) in iso-

lation, “it is a stretch to maintain that” this statute gives the Secretary the

authority to impose this vaccine mandate. Alabama Ass’n of Realtors, 141 S.

Ct. at 2488. Under § 1395x(e), a “hospital” is defined as an institution that:

      (1) is primarily engaged in providing, by or under the supervision
      of physicians, to inpatients (A) diagnostic services and therapeu-
      tic services for medical diagnosis, treatment, and care of injured,
      disabled, or sick persons, or (B) rehabilitation services for the re-
      habilitation of injured, disabled, or sick persons;




                                       14
(2) maintains clinical records on all patients;

(3) has bylaws in effect with respect to its staff of physicians;

(4) has a requirement that every patient with respect to whom
payment may be made under this subchapter must be under the
care of a physician, except that a patient receiving qualified psy-
chologist services (as defined in subsection (ii)) may be under the
care of a clinical psychologist with respect to such services to the
extent permitted under State law;

(5) provides 24-hour nursing service rendered or supervised by a
registered professional nurse, and has a licensed practical nurse
or registered professional nurse on duty at all times; except that
until January 1, 1979, the Secretary is authorized to waive the
requirement of this paragraph for any one-year period with re-
spect to any institution, insofar as such requirement relates to the
provision of twenty-four-hour nursing service rendered or super-
vised by a registered professional nurse (except that in any event
a registered professional nurse must be present on the premises
to render or supervise the nursing service provided, during at
least the regular daytime shift), where immediately preceding
such one-year period he finds that—

     (A) such institution is located in a rural area and the supply
of hospital services in such area is not sufficient to meet the needs
of individuals residing therein,

    (B) the failure of such institution to qualify as a hospital
would seriously reduce the availability of such services to such
individuals, and

     (C) such institution has made and continues to make a good
faith effort to comply with this paragraph, but such compliance is
impeded by the lack of qualified nursing personnel in such area;

(6)(A) has in effect a hospital utilization review plan which meets
the requirements of subsection (k) and (B) has in place a dis-
charge planning process that meets the requirements of subsec-
tion (ee);

(7) in the case of an institution in any State in which State or
applicable local law provides for the licensing of hospitals, (A) is
licensed pursuant to such law or (B) is approved, by the agency of


                                 15
      such State or locality responsible for licensing hospitals, as meet-
      ing the standards established for such licensing;

      (8) has in effect an overall plan and budget that meets the require-
      ments of subsection (z); and

      (9) meets such other requirements as the Secretary finds neces-
      sary in the interest of the health and safety of individuals who are
      furnished services in the institution.

42 U.S.C. § 1395x(e).

    While the Secretary contends that the last provision in § 1395x(e) gives

him authority to establish requirements he deems necessary to health and

safety—including issuing the vaccine mandate—the phrase “such other re-

quirements” informs the agency’s “grant of authority,” Alabama Ass’n of Real-

tors, 141 S. Ct. at 2488, because it ties the provision back to the kinds of re-

quirements listed in § 1395x(e)(1)-(8). Accord FDA, 529 U.S. at 132–33; AT&T

Corp. v. Iowa Utilities Bd., 525 U.S. 366, 408 (1999) (Thomas, J., concurring in

part & dissenting in part) (statutory provision “best interpreted by reference

to that which precedes and follows it”) (quoting Neal v. Clark, 95 U.S. 704, 708

(1877) (Harlan, J.)); see also King v. Burwell, 576 U.S. 473, 487 (2015) (defining

“such” as “that or those; having just been mentioned”) (cleaned up); 17 Oxford

English Dictionary 101 (2d ed.1989) (defining “such” as “of the character, de-

gree, or extent described ... in what has been said”) (cleaned up); Webster’s

Third New International Dictionary 2283 (2002) (defining “such” as something

“previously characterized or specified”). Indeed, phrases must be construed by




                                       16
the surrounding text to avoid ascribing a meaning so broad that it gives “unin-

tended breadth to the Acts of Congress.” Gustafson v. Alloyd Co., 513 U.S. 561,

575 (1995).

    The vaccine mandate is not authorized under this statute because the

mandate is materially unlike the requirements listed in the preceding eight

provisions. For starters, the prior provisions impose structural requirements

on hospitals themselves: medical services rendered, administration, manage-

ment, recordkeeping, licensing, and location. They do not authorize require-

ments on hospital staff—much less immunization requirements.

    In addition, compulsory COVID–19 vaccines require staff to submit to a

permanent medical procedure that, according to CMS, entails some risk of

“[s]erious adverse reactions” even though “they are rare.” App.47a; cf. In re

MCP No. 165, Occupational Safety & Health Admin., Interim Final Rule:

COVID-19 Vaccination & Testing, --- F.4th ----, 2021 WL 5914024, at *12 (6th

Cir. Dec. 15, 2021) (en banc) (Sutton, C.J., dissenting from the denial of initial

hearing en banc) (contrasting wearing a mask during work with undergoing a

vaccination “medical procedure that cannot be removed at the end of the shift”).

None of the explicit statutory conditions remotely implies the authority to force

healthcare workers to submit to a permanent medical procedure.

    The same analysis applies to the Secretary’s cited statute governing long-

term-care (LTC) facilities. See 42 U.S.C. § 1395i-3(d)(4)(B). That statute con-

tains the same “such other requirements” language. Id. While the explicit




                                       17
conditions in that statute include the generic mandate for each facility to have

“an infection control program” on the premises, 42 U.S.C. § 1395i-3(d)(3), in

addition to administrative and licensing requirements, 42 U.S.C. § 1395i-

3(d)(1)-(2), none of those requirements is akin to forcing staff to undergo a med-

ical procedure that lasts long after work hours end.

    Moreover, the breadth of authority that the Secretary claims counsels

against his reading of these statutes. The mandate operates indirectly in its

attempt to protect patients: it aims to keep workers from getting sick, which,

in turn, may prevent transmission to patients. But holding that the Secretary

may require healthcare workers to take steps to bolster their own health in

hopes of indirectly protecting patients “would facilitate a breathtaking expan-

sion of the [Secretary’s] power.” MCP No. 165, 2021 WL 5914024, at *7 (Sut-

ton, C.J., dissenting). It would allow CMS to regulate countless off-duty details

of healthcare workers’ lives, including the places they go, the people they visit,

the supplements they ingest, and the foods they eat.

    42 U.S.C. § 1395 confirms the States’ reasonable reading of the Secretary’s

authority. That statute forbids CMS from “exercise[ing] any supervision or

control … over the selection [or] tenure … of any officer or employee of any

institution, agency, or person providing health services.” 42 U.S.C. § 1395. Yet

the Secretary understands his power to afford precisely that authority—by per-

mitting him, through the mandate, to tell covered facilities that they cannot




                                       18
hire or retain unvaccinated workers. It is unreasonable to construe the Secre-

tary’s power to allow what 42 U.S.C. § 1395 forbids. Texas v. Becerra, --- F.

Supp. 3d ----, 2021 WL 5964687, at *5 (N.D. Tex. Dec. 15, 2021).

    Without clear support in the statutory text, the Secretary argues (at 21)

that “the agency’s practice” illustrates its power to issue this vaccine mandate.

In fact, the opposite is true. As CMS admits, this mandate is unprecedented:

the agency has “not previously required any vaccinations.” App.49a. A “lack

of historical” precedent is often “the most telling indication” that an agency

lacks the power to promulgate a regulation. Free Enter. Fund, 561 U.S. at

505 (cleaned up); see also Util. Air Regul. Grp., 573 U.S. at 324.

    The Secretary nevertheless argues (at 22) that the mandate fits squarely

within CMS’s past practices because healthcare facilities “have long been sub-

ject to ‘employer or State … vaccination requirements.’ ” This does not help

the Secretary. That the States or employers might have the power to mandate

vaccines does nothing to prove that a federal agency has that authority. See

Jacobson, 197 U.S. at 38 (noting that vaccine requirements “do not ordinarily

concern the national government”).

    The Secretary also mentions (at 22) that some of the covered facilities have

already been subject to regulations addressing the “ ‘prevention’ and ‘control’

of ‘infection diseases.’ ” This, too, is unavailing. While some of the covered




                                       19
facilities have been subject to such regulations, many have not. 9 This confirms

that CMS never thought it had the power to impose infection-control measures

on those facilities. And even for the facilities previously subject to infection-

control regulations, that CMS never mandated vaccines through those regula-

tions shows that it has not considered its authority to reach that far.

    2.   “Even if the text were ambiguous, the sheer scope” of the Secretary’s

“claimed authority” under the foregoing statutes “would counsel against the

Government’s interpretation.” Alabama Ass’n of Realtors, 141 S. Ct. at 2489.

    This Court “expect[s] Congress to speak clearly” in at least three situations

relevant here: (1) “when authorizing an agency to exercise powers of vast eco-

nomic and political significance,” id.; (2) when “federal law overrides the usual

constitutional balance of federal and state powers,” Bond v. United States, 572

U.S. 844, 858 (2014) (cleaned up); and (3) when “an administrative interpreta-

tion of a statute invokes the outer limits of Congress’ power,” Solid Waste

Agency of N. Cook Cnty. v. U.S. Army Corps of Eng’rs, 531 U.S. 159, 172 (2001).

    These are often referred to as clear-statement rules.          They “elimi-

nate any power-enhancing uncertainty in the meaning of the statute.”       In re

MCP No. 165, 2021 WL 5914024, at *12 (Sutton, C.J., dissenting). And where,




    9 See, e.g., 42 C.F.R. § 441.151 (PRTFs); 42 C.F.R. § 483.430 (ICFs-IID); 42

C.F.R. § 485.58 (CORFs); 42 C.F.R. § 485.904 (Community Mental Health Cen-
ters (CMHCs)); 42 C.F.R. § 486.525 (HIT suppliers); 42 C.F.R. § 491.8 (Rural
Health Clinics).


                                       20
as here, there are “ ‘significant … federalism questions raised’ ” and a “feder-

alism-protecting interpretation of the statute [is] not clearly ruled out,” courts

“must accept that interpretation[.]” Id. (quoting Solid Waste Agency, 531 U.S.

at 174). At bottom, agencies seeking to take major regulatory action must do

so with clear authorization from Congress; “an ambiguous grant of statutory

authority is not enough.” United States Telecom Ass’n v. FCC, 855 F.3d 381,

421 (D.C. Cir. 2017) (en banc) (Kavanaugh, J., dissenting from the denial of

rehearing en banc).

    All three of these rules apply here. First, this first-of-its-kind national

vaccine mandate covers “virtually all health care staff in the U.S.,” App.55a—

an estimate of 10.3 million individuals, id. at 85a—alters massive government

programs involving “billions of dollars,” Azar v. Allina Health Servs., 139 S. Ct.

1804, 1816 (2019), and threatens economic ruin and patient harm throughout

the healthcare industry. Such a sweeping mandate affecting “billions of dol-

lars” and “millions of people” requires a clear statement of congressional au-

thorization. King, 576 U.S. at 485–86. Attempting to cobble together congres-

sional intent through vague sections scattered throughout the Social Security

Act does not provide the clear authorization needed. Second, the mandate

seeks to usurp the States’ traditional police power to “protect the public health”

by addressing mandatory vaccination—a topic that “do[es] not ordinarily con-

cern the national government.” Jacobson, 197 U.S. at 24–25, 38. Third, in

attempting to mandate vaccines without clear congressional notice to the




                                       21
States, the mandate reaches beyond the outer limits of Congress’s power. The

district court correctly found that all these “fundamental principles” apply and

that “clear congressional authorization” is needed. App.8a.

    The Secretary disputes (at 24-31) that any of the clear-statement rules ap-

plies here. He is wrong.

    Starting with the major-questions doctrine, the Secretary’s efforts to dis-

tinguish Alabama Association of Realtors (at 25) fail. Here, as explained above,

the explicit conditions in the statutes that CMS cites, much like the specific

statutory examples in Alabama Association of Realtors, do in fact cabin CMS’s

authority to create “such other requirements” addressing health and safety. 42

U.S.C. § 1395x(e)(9) (hospitals).

    Moreover, Alabama Association of Realtors applied the major-questions

doctrine because the eviction moratorium covered “[a]t least 80% of the coun-

try, including between 6 and 17 million tenants at risk of eviction,” and im-

pacted billions of dollars. 141 S. Ct. at 2489. Similarly, here, the CMS man-

date applies throughout the entire country, covers “virtually all health care

staff,” App.55a—about 10.3 million workers, id. at 85a—and modifies large

government programs in which even “minor changes” affect “billions of dol-

lars.” Azar, 139 S. Ct. at 1816; see also App.95a (estimating that compliance

for only the first year will cost $1.38 billion). The major-questions doctrine

thus applies here, just as it did in Alabama Association of Realtors.




                                      22
    The Secretary then (at 27) dismisses Utility Air Regulatory Group and

Brown & Williamson Tobacco because the Court in those cases “reasoned that

adopting the agency’s position would have conflicted with other provisions.”

Yet the same is true here, as the prior discussion of 42 U.S.C. § 1395 shows.

    The Secretary also argues (at 27) that the major-questions doctrine does

not apply because the statutes at issue are not “ambiguous.” But the prior

analysis demonstrates that the statutes CMS cites, see App.49a—many of

which do not even reference “health” or “safety”—fail to unambiguously au-

thorize this sweeping mandate. The Secretary thus cannot avoid the major-

questions doctrine on this basis.

    The Eleventh Circuit motions panel’s rejection of the major-questions doc-

trine is unconvincing. While conceding that this vaccine mandate is “an is-

sue of economic and political significance,” the panel said that “a broad grant

of authority” to an agency “does not require an indication that specific activities

are permitted.” Florida, 19 F.4th at 1288. But this flawed logic essentially

rejects the premise of the major-questions doctrine, which by its nature cabins

seemingly broad grants of regulatory authority.

    The Secretary next discards (at 28-29) the federalism clear-statement rule

because this mandate is an exercise of Spending Clause power. But this

Court—including in the Secretary’s only cited case, Sabri v. United States, 541

U.S. 600 (2004)—has not dismissed this clear-statement rule in the Spending

Clause context. Sabri decided a constitutional challenge to a federal criminal




                                        23
statute, and the Court neither construed a statute nor mentioned this clear-

statement rule. That opinion is thus irrelevant to the issues raised here.

    In any event, it would be improper to assess the “Spending Clause power”

“without concern for the federal balance” because that would allow the federal

government “to set policy in the most sensitive areas of traditional state con-

cern.” NFIB v. Sebelius, 567 U.S. 519, 675–76 (2012) (plurality op.) (noting

that an unchecked spending power “would present a grave threat to the system

of federalism created by our Constitution”). And because Spending Clause

statutes must give “clear notice” to “recipients of federal funds” of “federally

imposed conditions,” Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy, 548

U.S. 291, 296 (2006), the federalism clear-statement rule is fully consistent

with Spending Clause analysis, which likewise requires the statute to provide

“clear notice” to the States. No such clear statement is provided here.

    B. The mandate is arbitrary and capricious.

    “The APA’s arbitrary-and-capricious standard requires” the agency to

“reasonably consider[] the relevant issues and reasonably explain[] the deci-

sion.” FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021). “[T]he

agency must examine the relevant data and articulate a satisfactory explana-

tion for its action including a ‘rational connection between the facts found and

the choice made.’ ” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.

Auto. Ins. Co., 463 U.S. 29, 43 (1983) (citation omitted). It must also “assess




                                      24
whether there were reliance interests, determine whether they were signifi-

cant, and weigh any such interests against competing policy concerns.” Dep’t

of Homeland Sec. v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1915 (2020).

    The district court identified five reasons why the mandate is arbitrary and

capricious: (1) CMS’s lack of evidence regarding most of the covered healthcare

facilities; (2) CMS’s improper rejection of alternatives; (3) the mandate’s irra-

tionally broad scope; (4) CMS’s pretextual change in course; and (5) CMS’s fail-

ure to consider or properly weigh reliance interests and the risk that this fail-

ure will impose devastating consequences on healthcare services. App.18a-

27a. To prevail on appeal, the Secretary must refute all five reasons. But he

cannot rebut even one.

    1.   Lack of Evidence on Most Facilities. The district court held that it is

unreasonable for CMS to “extrapolate” its data on long-term-care (LTC) facili-

ties that house the elderly “to justify” applying its mandate to the 14 other

diverse types of covered facilities, which include places like Psychiatric Resi-

dential Treatment Facilities (PRTFs) for individuals under age 21. App.18a-

20a. Illustrating the irrationality of this explanation is CMS’s recognition that

the “risk of death from infection from an unvaccinated 75- to 84-year-old person

is 320 times more likely than the risk for an 18- to 29-years old person.”

App.92a.

    The Secretary defends his heavy reliance on LTC facility data (at 34-35)

because that data “was just one piece of the ample evidence.” But the Secretary




                                       25
does not cite anything indicating what “ample evidence” he is referencing and

does not highlight evidence derived from other covered facilities.

    2.   Improperly Rejected Alternatives. The district court identified two al-

ternatives that CMS improperly rejected: “daily or weekly testing” for all work-

ers; and different treatment for workers with “natural immunity.” App.20a-

21a. The Secretary argues (at 34) that the district court “substitute[d] its views

on epidemiology” for CMS’s judgment. But the court did no such thing. Rather,

it pointed out CMS’s own inconsistencies on these issues.

    Concerning the testing option, the district court noted that CMS an-

nounced an unexplained one-sentence conclusion, cited no evidence, and con-

tradicted itself through “its admission that it lacks solid evidence regarding

transmissibility of COVID by the vaccinated.” App.20a-21a (footnote omitted).

And regarding natural immunity, the court observed that CMS “contradict[ed]

itself regarding the value of natural immunity” when it acknowledged that in-

dividuals who “have recovered from infection … are no longer sources of future

infections.” App.21a (quoting App.86a). Furthermore, while CMS questioned

the supposed “uncertainties” about “the strength and length” of natural im-

munity “compared to people who are vaccinated,” App.96a, it simultaneously

conceded that “the duration of vaccine effectiveness” is “not currently known,”

id. at 97a. “Such contradictions,” the district court aptly observed, “are tell-

tale signs of unlawful agency actions.” App.21a.




                                       26
    3.   The Mandate’s Irrationally Broad Scope and CMS’s Pretextual

Change. The Secretary seeks to excuse the mandate’s irrational scope and the

agency’s pretextual change in position (at 35) by arguing that this is a “unique

pandemic.” But pretext, regardless of whether it arises in unique circum-

stances, necessarily renders agency action arbitrary and capricious. Dep’t of

Com. v. New York, 139 S. Ct. 2551, 2575–76 (2019). Here, the mandate is pre-

textual because the Administration originally (and correctly) declared that vac-

cine mandates are “not the role of the federal government,” supra, at n.2; the

President then announced that the goal of this and other mandates is to in-

crease societal vaccination rates, supra, at n.3; and CMS now justifies this

mandate as necessary to protect patient health. Because “the evidence tells a

story that does not match the explanation [CMS] gave,” this mandate cannot

stand. Dep’t of Com., 139 S. Ct. at 2575.

    4.   Reliance Interests and Devastating Consequences on Healthcare. The

district court also held that “CMS did not properly consider all necessary reli-

ance interests of facilities, healthcare workers, and patients” in “concluding

that the mandate’s benefits outweigh the risks to the healthcare industry.”

App.25a. “CMS looked only at evidence from interested parties in favor of the

mandate,” and by dispensing with procedural rulemaking requirements, the

agency “ignored evidence showing that the mandate threatens devastating

consequences” by exacerbating already severe workforce shortages in

healthcare. Id. at 25a-26a.




                                      27
    Despite CMS’s recognition that “compliance with [the mandate] may cre-

ate some short-term disruption of current staffing levels for some providers or

suppliers in some places,” App.91a, if “[e]ven a small fraction” of unvaccinated

healthcare workers leave their jobs, id. at 94a, the agency dismissed those con-

cerns because it thought “there is insufficient evidence to quantify” and bal-

ance those against other risks. Id. at 51a. But this Court requires the agency

to “assess … reliance interests … and weigh [them] against competing policy

concerns.” Regents, 140 S. Ct. at 1915. And as the district court held, it was

irrational to foreclose interested “parties’ ability to provide information regard-

ing the mandate’s effects on the healthcare industry, while simultaneously dis-

missing those concerns based on ‘insufficient evidence.’ ” App.25a.

    Trying to justify himself, the Secretary places great weight (at 33) on a

joint statement of professional associations supporting vaccine mandates for

healthcare workers. But this simply proves the district court’s point that CMS

acted arbitrarily in “look[ing] only at evidence from interested parties in favor

of the mandate, while completely ignoring evidence from interested parties in

opposition.” App.25a. The thirty declarations filed in this case show that there

is a different perspective widely held in the healthcare industry that CMS un-

reasonably ignored. See R.App.35a-139a.

    The Secretary also cites (at 32) experiences of a few private healthcare

systems that implemented vaccine mandates in mostly urban areas to justify




                                        28
CMS’s dismissal of workforce concerns. But those cherry-picked examples can-

not bear the weight CMS puts on them. Privately imposed mandates are poor

proxies for a nationwide government-imposed mandate. And the experiences

of healthcare providers in mainly urban areas, which have larger labor pools

and higher community vaccination rates than rural areas, are not representa-

tive of the impact on rural providers. As the district court found, “whatever

might make sense in Chicago, St. Louis, or New York City, could be actually

counterproductive and harmful in rural communities like Memphis (MO) or

McCook (NE).” App.34a.

         In its stay application, the Government replicates the Secretary’s er-

ror by repeatedly citing vaccine mandates in Detroit and Houston to justify

imposing a mandate in rural Missouri, Nebraska, Alaska, and similar areas.

Thus, the Government studiously overlooks “obvious distinctions” between the

problems and challenges facing rural healthcare providers in tiny communi-

ties, as opposed to those in major urban centers. Dry Color Mfrs. Ass’n, Inc. v.

Dep’t of Labor, 486 F.2d 98, 105 (3d Cir. 1973). The mandate is quintessen-

tially arbitrary and capricious because the Secretary “ ‘failed to consider ... im-

portant aspect[s] of the problem’ before [him].” Regents, 140 S. Ct. at 1910

(quoting State Farm, 463 U.S. at 43). In its rule, CMS also relied on New York’s

experience imposing a statewide vaccine mandate on healthcare workers.

App.51a. But the New York Times article that CMS cited raises cause for se-




                                        29
rious concern. Id. (citing Thousands of N.Y. Health Care Workers Get Vac-

cinated Ahead of Deadline, N.Y. Times (Sept. 28, 2021)). It reported that when

the mandate took effect, only 92% of “the state’s more than 650,000 hospital

and nursing home workers had received at least one vaccine dose.” That means

8% of those healthcare workers—a total of 52,000 people—had not even begun

the vaccination process. This directly undercuts CMS’s assertion, which im-

mediately followed its Times citation, that the mandate “will result in nearly

all health care workers being vaccinated.” Id. (emphasis added). 10

    Beyond this, the Times article noted that New York “hospitals and nursing

homes continue[d] to brace for potential staffing shortages,” and that “even

minor staff losses … could put some patients at risk.” The article also observed

that the “governor declared a state of emergency” just days before the man-

date’s deadline “allow[ing] her to use the National Guard to fill staffing short-

ages.” And it reported that a hospital-affiliated nursing home in Buffalo placed

20% of its staff “on unpaid leave … for refusing to get vaccinated,” causing the

facility to “transfer[] staff in from other facilities, reduc[e] beds at the nursing

home[,] and suspend[] some elective surgeries at the hospital.” Facing these




    10 Recent media coverage has reported that since New York’s mandate on

healthcare workers took effect, “31,858 health care workers at nursing homes,
hospitals and other health providers have been terminated, furloughed or
forced to resign because they would not comply with the mandate.” Termina-
tion of unvaccinated health care workers backfires, Fox News (Dec. 28, 2021),
https://fxn.ws/3qxu5cz.


                                        30
disturbing facts, it was unreasonable for CMS to fail to mention them, let alone

to rely on this article to dismiss the workforce shortage concerns. 11

    The Secretary additionally speculates (at 32) that the mandate’s “adverse

impact on the labor market” will be offset by “reduced absenteeism due to

COVID-19.” But this conjecture unreasonably ignores that maintaining a

larger pool of employees, even if some might have a bout with COVID–19, is

better than excluding an entire group of current workers.

    The Secretary lastly insists (at 32) that any workforce losses will be

“dwarfed by the regular staff turnover in the healthcare workforce.” Not so.

CMS admits that the mandate covers “virtually all health care staff” and that

it disqualifies all unvaccinated workers from those positions. App.55a. Ex-

cluding an entire category of workers from most healthcare jobs is not the or-

dinary “turnover” of the labor market. The notion that “business as usual”

measures can counteract the impending doom is unreasonable. And the exten-

sive credible evidence from the States’ thirty declarants belies CMS’s rose-

tinted views on this point.




      11 Later developments continue to demonstrate the fallout from New

York’s mandate. See Long Island hospital temporarily closing ER, ABC 7 New
York (Nov. 22, 2021), https://bit.ly/3G6rzA2 (“The emergency department at a
Nassau County hospital has temporarily closed due to nursing staff shortages
as a result of New York’s vaccine mandate.”).


                                       31
    The Eleventh Circuit motions panel’s decision does not refute these points.

Florida, 19 F.4th at 1290–91. The panel addressed only two of the five arbi-

trary-and-capricious arguments that the district court accepted here. Even for

those two arguments (CMS’s improper rejection of alternatives and the risk of

exacerbating workforce shortages), the panel’s perfunctory discussion is unper-

suasive because, among other things, it ignores the many CMS contradictions

discussed above.

    C. The Mandate Violates Multiple Procedural Requirements.

    The district court determined that CMS did not establish good cause to

excuse compliance with notice-and-comment procedural requirements.

App.12a-17a. The good-cause standard is particularly stringent here, the court

concluded, given “the unprecedented, controversial, and health-related nature

of the mandate,” and “CMS’s own delay” in implementing its mandate. Id. 12

Also, “[t]he ‘more expansive’ a rule’s reach, ‘the greater the necessity for public

comment.’ ” MCP No. 165, 2021 WL 5914024, at *10 (Sutton, C.J., dissenting)

(quoting Am. Fed’n of Gov’t Emps. v. Block, 655 F.2d 1153, 1156 (D.C. Cir.

1981)).




    12 The district court found that the “mandate was announced nearly two

months before” its official release. App.14a. The Secretary could have received
comments within that sixty-day period just as he is receiving comments during
the current sixty-day comment period. See id. at 37a (rule published November
5, 2021, with comments due January 4, 2022).


                                        32
    In arguing that the district court erred, the Secretary raises (at 36) five

justifications for skipping notice and comment: (1) some patients’ vulnerability

to COVID-19; (2) the number of total COVID-19 cases among healthcare work-

ers; (3) the Delta variant’s emergence in June; (4) an anticipated winter spike

in cases; and (5) the coming flu season.

    The first two reasons are generalized to healthcare during the pandemic;

they do not address why undertaking notice and comment now will cause

harm, and they do not explain why the Secretary could not have accepted com-

ments in the two months between the President’s announcement and the man-

date’s promulgation. If these excuses suffice, that will effectively “sideline the

notice-and-comment process” for the remainder of the pandemic. MCP No.

165, 2021 WL 5914024, at *11 (Sutton, C.J., dissenting). Reliance on Delta is

also unavailing because, as CMS recognizes, Delta’s June uptick had “begun to

trend downward” when the mandate issued. App.65a. Finally, speculation

about a coming winter “spike” and the “flu season” fails because CMS admits

that flu season’s “intensity” “cannot be predicted.” App.15a (quoting App.66a).

This “mere possibility” of “future harm” cannot establish good cause. United

States v. Brewer, 766 F.3d 884, 890 (8th Cir. 2014).

    The Secretary then claims (at 37) that the States “have not identified any

prejudice arising out of the lack of a prior comment period.” But all the infor-

mation in the hundreds of pages of declarations filed below could have been




                                       33
communicated to CMS during the comment period, thus showing the impend-

ing healthcare disaster. Cutting off that information shaded the rulemaking

process and prejudiced everyone opposing the mandate. In any event, to assert

this procedural claim, the States need only show “some possibility” that their

comments might have persuaded or affected the agency’s decision—a very low

bar. Massachusetts v. EPA, 549 U.S. 497, 518 (2007).

III. The Remaining Factors Do Not Favor a Stay.

    For the reasons stated above, this is not “a close case,” Ind. State Police,

556 U.S. at 960, so the Court need not reach the balancing of equities, the rel-

ative harms, and the public interest. But if it does, these additional factors

weigh overwhelmingly against granting a stay.

    A. Balancing Irreparable Harm. Where, as here, “the lower court has

already performed th[e] task” of determining the parties’ respective harms “in

ruling on a stay application, its decision is entitled to weight and should not

lightly be disturbed.” Williams v. Zbaraz, 442 U.S. 1309, 1312 (1979) (Stevens,

J., in chambers). Before the district court, it was the States—not the Secre-

tary—that demonstrated irreparable harm. Thus, this part of the district

court’s “thorough analysis” “warrant[s] respect.” Barr v. E. Bay Sanctuary

Covenant, 140 S. Ct. 3, 5 (2019) (Sotomayor, J., dissenting from grant of stay).

    Preventing the Secretary from enforcing his unlawful mandate will inflict

no cognizable injury—let alone irreparable harm—on him because “[a]ny in-

terest [he] may claim in enforcing an unlawful … [regulation] is illegitimate.”

BST Holdings, LLC v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021). On the flip

                                      34
side, granting the stay would irreparably harm the States in several ways.

App.27a-32a.

    First, a stay would inflict sovereign harm by overriding the States’ “duly

enacted laws surrounding vaccination mandates.” Id. at 28a (citing preempted

state laws). This Court has repeatedly affirmed that this kind of injury is ir-

reparable. See, e.g., Abbott v. Perez, 138 S. Ct. 2305, 2324 n.17 (2018) (“[T]he

inability to enforce its duly enacted plan clearly inflicts irreparable harm on

the State.”); Maryland v. King, 567 U.S. 1301, 1303 (2012) (Roberts, C.J., in

chambers) (“Any time” a State is blocked “from effectuating statutes enacted

by representatives of its people, it suffers a form of irreparable injury”).

    Second, a stay would harm the States’ quasi-sovereign interest in the

health and wellbeing of their citizens because the loss of healthcare staff, re-

duction of services, and closure of facilities caused by the mandate will

“imped[e] access to care for the elderly and for persons who cannot afford it.”

App.28a-31a. The Secretary says (at 39) that the States lack standing to raise

this interest, but that is not true. Though a State may not file suit solely “to

protect her citizens from the operation of federal statutes,” it may “assert its

rights under federal law,” including procedural administrative rights like

those at issue here, and when doing so, the State may “litigate as parens pa-

triae to protect quasi-sovereign interests—i.e., public … interests that concern




                                        35
the state as a whole.” Massachusetts, 549 U.S. at 520 n.17 (cleaned up). Be-

cause the States are raising their own rights here, they also have standing to

assert quasi-sovereign interests in the health and wellbeing of their citizens.

    Third, the States, as operators of state-run healthcare facilities, will also

experience irreparable proprietary harms. App.32a. 13 These include the “bus-

iness and financial effects of a lost or suspended employee, compliance and

monitoring costs associated with the Mandate, [and] the diversion of resources

necessitated by the Mandate.” Id. (quoting BST Holdings, 17 F.4th at 618);

see also Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 220–21 (1994) (Scalia,

J., concurring) (“[A] regulation later held invalid almost always produces the

irreparable harm of nonrecoverable compliance costs.”).

    B. Public Interest. Finally, even if this were a “close case,” the Court

should consider “the interests of the public at large.” Ind. State Police, 556 U.S.




    13 The Secretary argues (at 39) that state-run facilities sanctioned for fail-

ing to comply with conditions of participation may seek judicial review under
42 U.S.C. § 1395cc(h)(1). But the Secretary has already conceded that States
cannot use § 1395cc(h)(1)’s procedural mechanism because they are plainly
neither “institution[s]” nor “agenc[ies]” “dissatisfied” with the Secretary’s de-
termination regarding eligibility or receipt of benefits under that statute.
App.6a-7a; see also Massachusetts, 549 U.S. at 518 (States are “not normal lit-
igants for the purposes of invoking federal jurisdiction”). Thus, consistent
with Shalala v. Illinois Council on Long Term Care, Inc., 529 U.S. 1, 16 (2000),
the district court correctly concluded that 42 U.S.C. § 405(h), as incorporated
by 42 U.S.C. § 1395ii, has no application here. App.6a-7a. And the States’
claims that arise under the Medicaid Act—as opposed to the Medicare Act—
“are not subject to the § 405(h)’s jurisdictional bar”—a conclusion the Secretary
doesn’t challenge here. Id. (citing Avon Nursing & Rehab. v. Becerra, 995 F.3d
305, 311 (2d Cir. 2021)).

                                        36
at 960. The public interest favors continuing to “enjoin[] the mandate[] and

thus preserving the ‘status quo.’ ” App.34a. If the mandate were to take effect,

it “will have a crippling effect on a significant number of healthcare facilities

in Plaintiffs’ states, especially in rural areas, create a critical shortage of ser-

vices (resulting in no medical care at all in some instances), and jeopardize the

lives of numerous vulnerable citizens.” Id. at 33a-34a.

    The Secretary argues (at 38) that the public interest nonetheless favors a

stay because “patients may die” from “COVID-19 infections transmitted to

them by staff.”    Despite the public’s interest in preventing the spread of

COVID-19, agencies cannot act unlawfully—even in the pursuit of desirable

ends. Ala. Ass’n of Realtors, 141 S. Ct. at 2490. And according to CMS, “the

effectiveness of the vaccine to prevent disease transmission by those vac-

cinated [is] not currently known.” App.97a (emphasis added); see also id. at

33a. The Secretary’s public-interest argument—and the principal justification

for the mandate itself—is thus admittedly speculative. In contrast, the States’

undisputed evidence concretely shows that the mandate will drive out

healthcare workers, reduce services, and close facilities—all of which will harm

people seeking healthcare. The harm this poses to the public is even more

pressing now, as evidenced by the President’s announcement earlier this week




                                        37
that existing staff shortages are so great he is mobilizing “1,000 military doc-

tors and nurses and medics to help staff hospitals.” Supra, at n.10. Given this,

the public interest weighs decidedly against the Secretary. 14

    The Court should also reject the Secretary’s last-ditch plea (at 40) to limit

the injunction “to facilities operated by the … States.” As discussed above, the

States have a cognizable quasi-sovereign interest in the health and wellbeing

of their citizens, and thus the injunction must reach private facilities within

their States. In addition, the State’s irreparable sovereign injuries, which in-

clude the preemption of their laws, are alone sufficient to justify applying the

injunction throughout their borders.




    14 The Secretary (at 5 and 13) repeatedly references the Omicron variant

to bolster the purported need for the mandate, but this is purely “impermissi-
ble post hoc rationalization[]” and thus is “not properly before” the Court. Re-
gents, 140 S. Ct. at 1909.


                                       38
                                 C O N C L U SI O N

   The Court should deny the motion for a stay pending appeal.


Respectfully submitted,

ERIC S. SCHMITT                              DOUGLAS J. PETERSON
Attorney General of Missouri                 Attorney General of Nebraska
D. JOHN SAUER                                JAMES A. CAMPBELL
Solicitor General                            Solicitor General
 Counsel of Record                           Office of the Attorney General
JESUS A. OSETE                               2115 State Capitol
Deputy Attorney General                      Lincoln, Nebraska 68509
                                             Tel.: (402) 471-2682
Maddie McMillian Green
Assistant Attorney General
Office of the Attorney General
Supreme Court Building
207 W. High St.
P.O. Box 899
Jefferson City, Missouri 65102
Tel.: (573) 751-1800
Fax: (573) 751-0774
John.Sauer@ago.mo.gov
Jesus.Osete@ago.mo.gov

Counsel for Respondents*                     *Additional counsel listed
                                             on the next page




                                        39
Additional counsel:

LESLIE RUTLEDGE
Attorney General of Arkansas
Dylan L. Jacobs
Assistant Solicitor General
Dylan.Jacobs@arkansasag.gov
Office of the Attorney General
323 Center St., Suite 200
Little Rock, Arkansas 72201
Tel.: (501) 682-2007

DEREK SCHMIDT
Attorney General of Kansas
Kurtis Wiard
Assistant Solicitor General
Kurtis.Wiard@ag.ks.gov
Office of the Attorney General
120 SW 10th Avenue, 2nd Floor
Topeka, Kansas 66612
Tel.: (785) 296-2215
Fax: (785) 296-6296

JEFFREY S. THOMPSON
Solicitor General of Iowa
Samuel P. Langholz
Assistant Solicitor General
Sam.Langholz@ag.iowa.gov
Office of the Attorney General
1305 E. Walnut Street
Des Moines, Iowa 50319
Tel.: (515) 281-5164




                                 40
BRIDGET HILL
Attorney General of Wyoming
Ryan Schelhaas
Chief Deputy Attorney General
Ryan.Schelhaas@wyo.gov
Office of the Attorney General
109 State Capitol
Cheyenne, Wyoming 82002
Tel.: (307) 777-5786
TREG R. TAYLOR
Attorney General of Alaska
Cori M. Mills
Deputy Attorney General
Cori.Mills@alaska.gov
Alaska Department of Law
1031 W. 4th Avenue, Suite 200
Anchorage, Alaska 99502
Tel.: (907) 269-5100

JASON R. RAVNSBORG
South Dakota Attorney General
David M. McVey
Assistant Attorney General
David.McVey@state.sd.us
Office of the Attorney General
1302 E. Highway 14, Suite 1
Pierre, South Dakota 57501-8501
Tel.: (605) 773-3215

WAYNE STENEHJEM
North Dakota Attorney General
Matthew A. Sagsveen
Solicitor General
Masagsve@nd.gov
Office of Attorney General
500 North 9th Street
Bismarck, ND 58501-4509
Tel.: (701) 328-3640
Fax: (701) 328-4300




                                  41
JOHN M. FORMELLA
New Hampshire Attorney General
Anthony J. Galdieri
Solicitor General
Anthony.J.Galdieri@doj.nh.gov
New Hampshire Department of Justice
33 Capitol Street
Concord, NH 03301
Tel.: (603) 271-3658




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