Response to application from respondent Missouri, et al. — Joseph R. Biden, Jr., President of the United States, et al., Applicants v. Missouri, et al.
Supreme Court briefDec 30, 2021
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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
Attorney General of Missouri
DOUGLAS J. PETERSON
Attorney General of Nebraska
D. JOHN SAUER
Solicitor General
Counsel of Record
JAMES A. CAMPBELL
Solicitor General
JESUS A. OSETE
Deputy Attorney General
Maddie McMillian Green
Assistant Attorney General
Office of the Attorney General
2115 State Capitol
Lincoln, Nebraska 68509
Tel.: (402) 471-2682
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 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 regulate 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 historical 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 “necessary” measure to prevent the spread of COVID–19. Alabama Ass’n of Realtors 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 mandate would force millions of workers to choose between losing their jobs or complying with an unlawful federal mandate. But for the district court’s preliminary 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 logistical 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 Secretary 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 persuasive—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 mandating 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’ Appendix.
2 Press Briefing (July 23, 2021), The White House, https://bit.ly/3Dh3hl8.
3
the President called for several vaccine mandates, including the mandate challenged 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.37a109a. 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 Medicaid-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 provisions, 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
27, 2021), https://wapo.st/3zg8xoL.
variant,
4
Washington
Post
(Dec.
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 Rehabilitation Facilities (CORFs)).
The Secretary’s rule demands vaccines for practically every full-time employee, part-time worker, trainee, student, volunteer, and third-party contractor entering those facilities, including all staff “regardless of … patient contact,” App.52a, and third parties working on a “project” who “use shared facilities” 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 unexplained reason: because he believes that “vaccination is a more effective infection 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 “uncertainties … 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 balance 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 overbearing 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, particularly 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, dramatically reduce the surgeries it provides, and perhaps even shut down entirely. 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 Secretary 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 circumstances.” 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 Pension Tr. v. Chrysler LLC, 556 U.S. 960, 961 (2009) (per curiam). Additionally, “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
72% of unvaccinated workers vow to quit, CNN.COM (Oct. 28, 2021),
https://cnn.it/3G7JarE.
5
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 question 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 opinion 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 present, this Court would be unlikely to grant certiorari.
Alternatively, if this case raises issues of “exceptional national importance 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).
7
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 Congress 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 undoubtedly 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 nationwide 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 necessary 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 regulations 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’ “administration,” and “the further a regulation strays from truly facilitating the ‘administration’ of the Secretary’s duties, the less likely it is to fall within the statutory grant of authority.” Id. at 537–38.
11
The Secretary doesn’t dispute this textual analysis or even attempt to defend the vaccine mandate as “necessary” to Medicare’s and Medicaid’s “administration”; 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 statute even mentions “health and safety” (and the Secretary does not argue otherwise). 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 patients not having access to essential healthcare services. See, e.g., App.30a31a. 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 authorizing the mandate, he openly recognized that the mandate was unprecedented—never before had the agency mandated any vaccination. App.49a. Indeed, 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 requirements “do not ordinarily concern the national government”); Valdez v. Grisham, No. 21A253 (U.S. Dec. 21, 2021) (Gorsuch, J.) (denying stay of New Mexico’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 Residential 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 Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFsIID) 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 “requirements as the Secretary determines appropriate”).
13
for those facilities. Because CMS applied its mandate to those facilities anyway, 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 “hospital” and that term is defined, in a different statutory provision, as “an institution which … meets such other 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). 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 isolation, “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 therapeutic services for medical diagnosis, treatment, and care of injured,
disabled, or sick persons, or (B) rehabilitation services for the rehabilitation 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 psychologist 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 respect to any institution, insofar as such requirement relates to the
provision of twenty-four-hour nursing service rendered or supervised 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 discharge planning process that meets the requirements of subsection (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 meeting the standards established for such licensing;
(8) has in effect an overall plan and budget that meets the requirements of subsection (z); and
(9) meets such other 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).
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 requirements” informs the agency’s “grant of authority,” Alabama Ass’n of Realtors, 141 S. Ct. at 2488, because it ties the provision back to the kinds of requirements 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, degree, 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 “unintended 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, management, recordkeeping, licensing, and location. They do not authorize requirements 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 longterm-care (LTC) facilities. See 42 U.S.C. § 1395i-3(d)(4)(B). That statute contains 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. § 1395i3(d)(1)-(2), none of those requirements is akin to forcing staff to undergo a medical 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 expansion of the [Secretary’s] power.” MCP No. 165, 2021 WL 5914024, at *7 (Sutton, 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 permitting him, through the mandate, to tell covered facilities that they cannot
18
hire or retain unvaccinated workers. It is unreasonable to construe the Secretary’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 subject 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 infectioncontrol regulations, that CMS never mandated vaccines through those regulations 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 economic 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 interpretation 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 Centers (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 “federalism-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 dollars” and “millions of people” requires a clear statement of congressional authorization. King, 576 U.S. at 485–86. Attempting to cobble together congressional 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 concern 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 applies here. He is wrong.
Starting with the major-questions doctrine, the Secretary’s efforts to distinguish 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 country, including between 6 and 17 million tenants at risk of eviction,” and impacted billions of dollars. 141 S. Ct. at 2489. Similarly, here, the CMS mandate 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 dollars.” 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 authorize this sweeping mandate. The Secretary thus cannot avoid the majorquestions doctrine on this basis.
The Eleventh Circuit motions panel’s rejection of the major-questions doctrine is unconvincing. While conceding that this vaccine mandate is “an issue 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 clearstatement 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 concern.” 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 decision.” FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021). “[T]he
agency must examine the relevant data and articulate a satisfactory explanation 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 significant, 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 irrationally broad scope; (4) CMS’s pretextual change in course; and (5) CMS’s failure to consider or properly weigh reliance interests and the risk that this failure will impose devastating consequences on healthcare services. App.18a27a. 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) facilities that house the elderly “to justify” applying its mandate to the 14 other
diverse types of covered facilities, which include places like Psychiatric Residential Treatment Facilities (PRTFs) for individuals under age 21. App.18a20a. 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 workers; and different treatment for workers with “natural immunity.” App.20a21a. 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 announced an unexplained one-sentence conclusion, cited no evidence, and contradicted 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 individuals 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 immunity “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 telltale 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 circumstances, 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 pretextual because the Administration originally (and correctly) declared that vaccine 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 increase 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 reliance 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 create 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 concerns because it thought “there is insufficient evidence to quantify” and balance 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 regarding the mandate’s effects on the healthcare industry, while simultaneously dismissing 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 unreasonably 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 cannot 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 representative 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 error 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 communities, 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 quintessentially arbitrary and capricious because the Secretary “ ‘failed to consider ... important 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 Vaccinated 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 immediately 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 mandate’s deadline “allow[ing] her to use the National Guard to fill staffing shortages.” 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.” Termination 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. Excluding an entire category of workers from most healthcare jobs is not the ordinary “turnover” of the labor market. The notion that “business as usual”
measures can counteract the impending doom is unreasonable. And the extensive credible evidence from the States’ thirty declarants belies CMS’s rosetinted 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 arbitrary-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 unpersuasive 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 workers; (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 comments in the two months between the President’s announcement and the mandate’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 information in the hundreds of pages of declarations filed below could have been
33
communicated to CMS during the comment period, thus showing the impending 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 relative 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 Secretary—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 interest [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 irreparable. 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, reduction 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 patriae 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). Because 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 “business 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 determination regarding eligibility or receipt of benefits under that statute.
App.6a-7a; see also Massachusetts, 549 U.S. at 518 (States are “not normal litigants 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 services (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 vaccinated [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 doctors 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 include 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 “impermissible post hoc rationalization[]” and thus is “not properly before” the Court. Regents, 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
Attorney General of Missouri
DOUGLAS J. PETERSON
Attorney General of Nebraska
D. JOHN SAUER
Solicitor General
Counsel of Record
JAMES A. CAMPBELL
Solicitor General
Office of the Attorney General
2115 State Capitol
Lincoln, Nebraska 68509
Tel.: (402) 471-2682
JESUS A. OSETE
Deputy Attorney General
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
on the next page
Counsel for Respondents*
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
42
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.