Response to application from respondents Louisiana, 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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Nos. 21A240, 21A241

In the Supreme Court of the United States

XAVIER BECERRA, U.S. Department of Health and Human Services et al.,

Applicants,

STATES OF LOUISIANA, MONTANA, ARIZONA, ALABAMA, GEORGIA, IDAHO,

INDIANA, KENTUCKY, MISSISSIPPI, OHIO, OKLAHOMA, SOUTH CAROLINA, UTAH,

AND WEST VIRGINIA ET AL.,

Respondents.

RESPONSE TO APPLICATION FOR A STAY PENDING APPEAL

To the Honorable Samuel A. Alito, Associate Justice and Circuit

Justice for the Fifth Circuit

Jeff Landry

Louisiana Attorney

General

Elizabeth B. Murrill

Solicitor General

J. Scott St. John

Deputy Solicitor General

Morgan Brungard

Josiah Kollmeyer

Assistant Solicitors

General

LOUISIANA DEPARTMENT OF

JUSTICE

1885 N. Third Street

Baton Rouge, LA 70804

(225) 326-6766

Mark Brnovich

Arizona Attorney General

Joseph A. Kanefield

Chief Deputy & Chief of

Staff

Brunn (“Beau”) W. Roysden

III

Solicitor General

Drew C. Ensign

Deputy Solicitor General

Counsel of Record

Wilson C. Freeman

Senior Litigation Counsel

OFFICE OF THE ARIZONA

ATTORNEY GENERAL

2005 N. Central Ave.

Phoenix, AZ 85004

(602) 542-5025

Austin Knudsen

Montana Attorney

General

Kristin Hansen

Lieutenant General

David M.S. Dewhirst

Solicitor General

Kathleen L. Smithgall

Assistant Solicitor

General

MONTANA DEPARTMENT

OF JUSTICE

215 North Sanders Street

Helena, MT 59601

(406) 444-2026

Counsel for Respondent States

(additional counsel listed in signature block)

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ......................................................................................... iii

INTRODUCTION .......................................................................................................... 1

STATEMENT ................................................................................................................. 3

1. The Executive Branch’s Expanding Views of Executive Power. ...................... 3

2. The CMS Mandate. ............................................................................................ 5

3. CMS’s Statutory Authority. ............................................................................... 7

4. Harm to Healthcare Workers, Patients, and States. ....................................... 8

5. The Injunction Against the Mandate. ............................................................... 9

6. The Fifth Circuit’s Affirmance. ....................................................................... 11

7. Parallel Litigation. ........................................................................................... 11

8. The Applicants’ Emergency Stay Application. ............................................... 12

ARGUMENT ................................................................................................................ 13

Applicants Forfeited Challenges To The District Court’s Holdings

That The Mandate Independently Violates Three Specific Statutory

Mandates And Prohibitions. ............................................................................ 13

A. Section 1395 Prohibits The CMS Mandate Because It Seeks To

“Control … the Selection [Or] Tenure” Of Healthcare Workers. ............. 14

B. HHS Violated §1302(b) In Promulgating the CMS Mandate. ................. 16

C. HHS Violated §1395z’s Consultation Requirement By Not

Consulting With States Before Promulgating The Mandate................... 18

II. Applicants Are Unlikely To Prevail on the Merits of the Issues They

Properly Raise. ................................................................................................. 22

A. No Statute Authorizes the Mandate. ........................................................ 22

B. The Mandate Is Unconstitutional. ............................................................ 26

C. The Mandate Is Arbitrary and Capricious. .............................................. 28

D. HHS Violated the APA’s Notice-and-Comment Requirements

Without Good Cause. ................................................................................ 31

III. Applicants Seek Ultimate Relief Here But Cannot Establish Their

Entitlement to It. ............................................................................................. 35

IV. The Balance of Equities Disfavors a Stay. ...................................................... 37

V. Applicants Overstate the Certworthiness of Their Claims. ........................... 38

CONCLUSION............................................................................................................. 40

TABLE OF AUTHORITIES

Page(s)

CASES

Alabama Ass’n of Realtors v. HHS,

141 S. Ct. 2485 (2021) ....................................................................... 22, 23, 25, 26, 38

American Fed’n of Gov’t Emp. v. Block,

655 F.2d 1153 (D.C. Cir. 1981) ................................................................................. 34

Arbuckle Mountain Ranch of Tex., Inc. v. Chesapeake Energy Corp.,

810 F.3d 335 (5th Cir. 2016 ...................................................................................... 19

Ass’n of Cmty. Cancer Centers v. Azar,

509 F. Supp. 3d 482 (D. Md. 2020) ........................................................................... 32

Azar v. Allina Health Servs.,

139 S. Ct. 1804 (2019) ......................................................................................... 23, 34

Bloate v. United States,

559 U.S. 196 (2010) ................................................................................................... 21

Boos v. Barry,

485 U.S. 312 (1988) ................................................................................................... 28

Brown v. Gardner,

513 U.S. 115 (1994) ................................................................................................... 18

BST Holdings, L.L.C. v. OSHA,

2021 WL 5279381 (5th Cir. 2021) ............................................................................ 32

Carter v. Toyota Tsusho Am., Inc.,

529 Fed. Appx. 601 (6th Cir.2013) ........................................................................... 19

City of Emeryville v. Robinson,

621 F.3d 1251 (9th Cir. 2010) ................................................................................... 19

Cousins v. Wigoda,

409 U.S. 1201 (1972) ................................................................................................... 2

Danville Christian Acad., Inc. v. Beshear,

141 S. Ct. 527 (2020) ................................................................................................. 31

Demirayak v. City of New York,

746 F. App'x 49 (2d Cir. 2018) .................................................................................. 35

iii

Democratic Exec. Comm. v. Nat’l Repub. Sen. Comm.,

950 F.3d 790 (11th Cir. 2020) ................................................................................... 39

Dunn v. Retail Clerks Int’l Ass’n, AFL-CIO, Loc. 1529,

299 F.2d 873 (6th Cir. 1962) ..................................................................................... 35

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) ................................................................................................... 22

Florida v. Becerra,

2021 WL 2514138 (M.D. Fla. June 18, 2021) .......................................................... 32

Florida v. HHS,

19 F.4th 1271 (11th Cir. 2021) ................................................................................. 12

Florida v. HHS,

2021 WL 5768796 (11th Cir. 2021) .......................................................................... 32

Florida v. HHS,

No. 3:21-CV-2722, 2021 WL 5416122 (N.D. Fla. Nov. 20, 2021) ............................ 11

Gee v. Planned Parenthood of Gulf Coast, Inc.,

139 S. Ct. 408 (2019) ................................................................................................. 23

Good Samaritan Hosp. v. Shalala,

508 U.S. 402 (1993) ................................................................................................... 28

Gundy v. United States,

139 S. Ct. 2116 (2019) ............................................................................................... 27

Healthbridge Mgmt., LLC v. Nat’l Lab. Rels. Bd.,

672 F. App’x 1 (D.C. Cir. 2016)................................................................................. 19

Hollingsworth v. Perry,

558 U.S. 183 (2010) ................................................................................................... 13

In re MCP No. 165, Occupational Safety & Health Admin., Interim Final

Rule: COVID-19 Vaccination & Testing,

__ F.4th __, 2021 WL 5914024 (6th Cir. 2021) .......................................................... 3

John Wyeth & Bro. v. CIGNA Int’l Corp.,

119 F.3d 1070 (3d Cir. 1997) .................................................................................... 19

King v. Burwell,

576 U.S. 473 (2015) ............................................................................................. 22, 24

Mack Trucks, Inc. v. EPA,

682 F.3d 87 (D.C. Cir. 2012) ..................................................................................... 31

Missouri v. Biden,

No. 21-3725 (8th Cir. Dec. 13, 2021) ........................................................................ 12

N.Y. Progress & Prot. PAC v. Walsh,

733 F.3d 483 (2d Cir. 2013) ...................................................................................... 37

Nat’l Fed’n of Indep. Bus. v. Sebelius,

567 U.S. 519 (2012) ............................................................................................. 26, 27

National Ass’n of Mfrs. v. DOD,

138 S. Ct. 617 (2018) ................................................................................................. 16

National Socialist Party of Am. v. Vill. of Skokie,

434 U.S. 1327 (1977) ................................................................................................. 35

Nken v. Holder,

556 U.S. 418 (2009) ................................................................................................... 15

NRDC v. Abraham,

355 F.3d 179 (2d Cir. 2004) ...................................................................................... 33

NRDC v. NHTSA,

894 F.3d 95 (2d Cir. 2018) ........................................................................................ 33

Ohio Citizens for Responsible Energy, Inc. v. Nuclear Regul. Comm’n,

479 U.S. 1312 (1986) ..................................................................................... 14, 16, 31

Pennhurst State Sch. & Hosp. v. Halderman,

451 U.S. 1 (1981) ....................................................................................................... 27

Pennsylvania Med. Soc. v. Marconis,

942 F.2d 842 (3d Cir. 1991) ...................................................................................... 15

Regeneron Pharms., Inc. v. HHS,

510 F. Supp. 3d 29 (S.D.N.Y. 2020).......................................................................... 32

Republic of Argentina v. NML Cap., Ltd.,

573 U.S. 134 (2014) ................................................................................................... 15

Russello v. United States,

464 U.S. 16 (1983) ..................................................................................................... 18

See Missouri v. Biden,

No. 4:21-CV-01329, 2021 WL 5564501 (E.D. Mo. Nov. 29, 2021) ........................... 11

Solid Waste Agency of N. Cook Cty. v. U.S. Army Corps of Engineers,

531 U.S. 159 (2001) ....................................................................................... 22, 23, 24

Sorenson Commc’ns Inc. v. FCC,

755 F.3d 702 (D.C. Cir. 2014) ................................................................................... 31

South Bay United Pentecostal Church v. Newsom,

141 S. Ct. 716, 209 L. Ed. 2d 22 (2021) .................................................................... 24

Sprietsma v. Mercury Marine,

537 U.S. 51 (2002) ..................................................................................................... 17

Sugar Cane Growers Co-op. of Fla. v. Veneman,

289 F.3d 89 (D.C. Cir. 2002) ..................................................................................... 35

Tanner Motor Livery, Ltd. v. Avis, Inc.,

316 F.2d 804 (9th Cir. 1963) ..................................................................................... 35

Texas v. Becerra,

No. 2:21-CV-229, 2021 WL 5964687 (N.D. Tex. Dec. 15, 2021) .............................. 11

Texas v. Biden,

10 F.4th 538 (5th Cir. 2021) ..................................................................................... 30

Touby v. United States,

500 U.S. 160 (1991) ................................................................................................... 27

U.S. Forest Serv. v. Cowpasture River Pres. Ass’n,

140 S. Ct. 1837 (2020) ......................................................................................... 22, 24

U.S. Steel Corp. v. EPA,

595 F.2d 207 (5th Cir. 1979) ..................................................................................... 34

United States Steel Corp. v. EPA,

595 F.2d 207 (5th Cir.1979) ...................................................................................... 33

United States v. Hardman,

297 F.3d 1116 (10th Cir. 2002) ................................................................................. 19

United States v. Johnson,

632 F.3d 912 (5th Cir. 2011) ..................................................................................... 31

United States v. Shabani,

513 U.S. 10 (1994) ..................................................................................................... 18

United States v. Sineneng-Smith,

140 S. Ct. 1575 (2020) ............................................................................................... 15

University of Texas v. Camenisch,

451 U.S. 390 (1981) ................................................................................................... 36

Unspam Techs., Inc. v. Chernuk,

716 F.3d 322 (4th Cir. 2013) ..................................................................................... 19

Utility Air Regulatory Group v. EPA,

573 U.S. 302 (2014) ................................................................................................... 22

WarnerVision Ent. Inc. v. Empire of Carolina, Inc.,

101 F.3d 259 (2d Cir. 1996) ...................................................................................... 35

Wayman v. Southard,

23 U.S. 1 (1825) ......................................................................................................... 27

Whole Woman’s Health v. Jackson,

141 S. Ct. 2494 (2021) ............................................................................................... 39

Zucht v. King,

260 U.S. 174 (1922) ................................................................................................... 23

STATUTES

42 U.S.C. § 1302(a) ........................................................................................................ 8

42 U.S.C. § 1302(b) ...................................................................................................... 17

42 U.S.C. § 1302(b)(1) .................................................................................................. 18

42 U.S.C. § 1302(b)(2) .................................................................................................. 18

42 U.S.C. § 1395 ..................................................................................................... 15, 16

42 U.S.C. § 1395i-3 ........................................................................................................ 4

42 U.S.C. § 1396r ........................................................................................................... 4

42 U.S.C. §1302(b) ....................................................................................................... 29

Pub. L. No. 117-2, Title IX, § 9402 (Mar. 11, 2021), 135 Stat. 127 .............................. 4

REGULATIONS

42 C.F.R. § 51a.5 .......................................................................................................... 25

42 C.F.R. §416.51(c) ....................................................................................................... 5

42 C.F.R. §416.51(c)(1)................................................................................................... 5

vii

42 C.F.R. §416.51(c)(2)(i) ............................................................................................... 5

42 C.F.R. §416.51(c)(3)................................................................................................... 6

42 C.F.R. §416.51(c)(3)(i) ............................................................................................... 5

42 C.F.R. §416.51(c)(3)(ii) .............................................................................................. 6

42 C.F.R. §416.51(c)(3)(iv)-(v) ........................................................................................ 7

42 C.F.R. §416.51(c)(3)(vi)-(vii) ..................................................................................... 6

42 C.F.R. §416.51(c)(3)(viii) ........................................................................................... 6

86 Fed. Reg. 61555 (Nov. 5, 2021) ..................5, 6, 7, 8, 9, 17, 19, 20, 23, 24, 27, 34, 38

OTHER AUTHORITIES

AARP Nursing Home COVID-19 Dashboard, AARP Public Policy Institute

(Dec. 16, 2021), bit.ly/30lrvgs ..................................................................................... 9

AARP, AARP Nursing Home COVID-19 Dashboard (updated Dec. 16, 2021),

https://bit.ly/3HhAWyy ............................................................................................. 28

Administration, Black’s Law Dictionary (10th ed. 2014) ........................................... 25

Chris Isidore & Virginia Langmaid, 72% of unvaccinated workers vow to quit

if ordered to get vaccinated, CNN.com (Oct. 28, 2021),

https://cnn.it/3HdgDlw ............................................................................................. 28

Cong. Research Serv., Mandatory Vaccinations: Precedent and Current Laws

9 (RS21414; May 21, 2014), https://bit.ly/3sEnEaf ................................................... 3

Guidance for the Interim Final Rule—Medicare and Medicaid Programs;

Omnibus COVID-19 Health Care Staff Vaccination;

https://go.cms.gov/3pxIOoE ........................................................................................ 6

Lauran Neergaard & Mike Stobbe, CDC Recommends Pfizer, Moderna

COVID-19 shots over J&J’s, Assoc. Press (Dec. 16, 2021),

https://bit.ly/32GzLIN ............................................................................................... 36

Liz Hamel, et al., KFF COVID-19 Vaccine Monitor: Oct, 2021, Kaiser Family

Foundation (Oct. 28, 2021), https://bit.ly/3wEiJWN ............................................... 28

Necessary, Black’s Law Dictionary (10th ed. 2014) .................................................... 25

viii

OIRA, EO 12866 Meetings Search Results, available at

https://bit.ly/3FJBwUo ............................................................................................. 20

Press Briefing by Press Secretary Jen Psaki, April 6, 2021,

https://bit.ly/3rBJVoL ................................................................................................. 3

Press Briefing by Press Secretary Jen Psaki, July 23, 2021,

https://bit.ly/3pWnJVr ................................................................................................ 3

Remarks by President Biden at COVID-19 Response Team’s Regular Call

With the National Governors Association (Dec. 27, 2021);

https://bit.ly/34c27M9 ................................................................................................. 5

Rural COVID patients in ICUs at higher risk of dying than urban

counterparts, according to WVU researcher, WVU Today (Nov. 11, 2021),

https://bit.ly/3HnFB1Q ............................................................................................. 17

The White House, Remarks by President Biden on Fighting the COVID-19

Pandemic (Sept. 9, 2021), https://bit.ly/3oI0pKr ....................................................... 4

INTRODUCTION

The Federal Government seeks a stay to permanently change the status quo,

not to preserve it. If the Court grants this relief, millions of healthcare providers and

workers will immediately fall into noncompliance with the new CMS Vaccine

Mandate and be subject to termination. Across the country, healthcare workers are

already far too scarce. This new Mandate worsens the problem, sidelining providers,

professionals, and support staff who have led the fight against COVID-19. And, as is

often the case, rural communities—already straining from threadbare resources—

will bear the brunt of these consequences. Virtually every equitable consideration

counsels against staying the injunctions entered below.

So do the merits. The Mandate is plainly unlawful. Most fundamentally, it

exceeds CMS’s statutory authority, which does not encompass such a sweeping

mandate—especially in light of multiple clear-statement doctrines that apply here.

CMS moreover eschewed notice and comment without good cause, even though it had

sufficient time to take comments in the nearly two months from announcing the

Mandate to promulgating it. And the Mandate is arbitrary and capricious for several

reasons. Constitutionally, the Mandate also likely violates the Tenth Amendment

and the Non-Delegation Doctrine. And it violates at least three statutory provisions

within the Social Security Act, as the district court properly held. But the Applicants

failed to address two of those grounds in their stay application, and addressed the

third only in a footnote—omissions that shut down their likelihood of obtaining both

a grant of certiorari (because their questions presented aren’t dispositive) and a

reversal from this Court (because they do not answer all holdings supporting the

injunction).

In sum, CMS, through the Vaccine Mandate, assumes sweeping new federal

power over individuals even though Congress has never claimed such expansive

authority for itself and even though the Executive Branch expressly disclaimed it

only five months ago. To get there, the agency ignored and undermined the Social

Security Act’s driving purpose, repeatedly violated the APA, and rearranged the

Constitution’s structures of federalism and separation of powers.

HHS’s application should also be denied because it effectively seeks ultimate

relief, without either acknowledging that fact or attempting to satisfy the

heightened—indeed extraordinary—burden that applies. See, e.g., Cousins v. Wigoda,

409 U.S. 1201, 1206 (1972) (Rehnquist, J., in chambers). If the injunctions are lifted,

healthcare workers are put to the choice immediately, with little or no time to comply

before losing their jobs. And States, who were not consulted, face immediate

destabilization of their Medicaid provider bases and must assume the task of

enforcing the very Mandate that causes this disastrous result.

Lifting the injunctions puts patients across the country at risk of losing access

to the healthcare they need now. Denying the stay merely prevents those harms from

materializing at the cost of the President’s vaccination agenda—an agenda

formalized in ex post facto agency pronouncements the lower courts have already

signaled are illegal.

The Court should deny the application for a stay.

STATEMENT

1. The Executive Branch’s Expanding Views of Executive Power.

Just months ago, the Biden Administration disclaimed any legal authority over

vaccine mandates, calling them “not the role of the federal government”—let alone of

the Executive Branch acting alone. Press Briefing by Press Secretary Jen Psaki, July

23, 2021, https://bit.ly/3pWnJVr. Instead, the Administration thought it should

ensure that “Americans’ privacy and rights [were] protected” and that the vaccine

rollout was “not used against people unfairly.” See Press Briefing by Press Secretary

Jen Psaki, April 6, 2021, https://bit.ly/3rBJVoL.

That position accords with the longstanding view that federal law does not

authorize mandatory vaccination programs among the general population. See, e.g.,

Cong. Research Serv., Mandatory Vaccinations: Precedent and Current Laws 9

(RS21414; May 21, 2014), https://bit.ly/3sEnEaf (“No mandatory vaccination

programs are specifically authorized, nor do there appear to be any regulations

regarding the implementation of a mandatory vaccination program at the federal

level during a public health emergency.”); cf. In re MCP No. 165, Occupational Safety

& Health Admin., Interim Final Rule: COVID-19 Vaccination & Testing, __ F.4th __,

2021 WL 5914024, at *18-20 (6th Cir. 2021) (Bush, J., dissenting) (“For while

Congress has long sought to facilitate safe and effective vaccines, it has never invoked

the commerce power to mandate their administration upon the public at large.”)

(setting forth history of federal vaccination programs). And when Congress recently

amended various CMS statutes in response to the COVID-19 pandemic, none of its

amendments authorized mandating vaccines. See, e.g., Pub. L. No. 117-2, Title IX,

§9402 (Mar. 11, 2021), 135 Stat. 127; 42 U.S.C. §§1395i-3, 1396r.

In early September, however, the Administration suddenly changed its

collective mind after the President announced his plan to “use my power as President”

to mandate vaccinations on “100 million Americans.” The White House, Remarks by

President

Biden

Fighting

the

COVID-19

Pandemic

(Sept.

2021),

https://bit.ly/3oI0pKr. He announced a series of federal vaccine mandates designed to

compel most of the adult population of the United States to get a COVID-19 vaccine.

Id. The Administration changed course not because Congress had authorized it to—

in fact, Congress has done nothing to support vaccine mandates in the past year—

but because the President’s “patience” was “wearing thin” with those “who haven’t

gotten vaccinated.” Id.

This case concerns the part of the President’s mandatory vaccination agenda

that targets healthcare workers and suppliers. In his early September remarks, the

President announced that one of his vaccine mandates would apply to “a total of 17

million healthcare workers.” Sept. 9, 2021 Remarks, supra. Specifically, his Executive

Branch would “be requiring vaccinations” on all “those who work in hospitals, home

healthcare facilities, or other medical facilities.” Id. Notwithstanding his past

remarks, he then declared, “I have that federal authority.” Id.

Yet remarkably, on December 27 the President declared that “there is no

federal solution. This gets solved at a state level.”1

See Remarks by President Biden at COVID-19 Response Team’s Regular Call With

2. The CMS Mandate.

More than eight weeks after the President’s September 9 remarks, the Centers

for Medicare & Medicaid Services (CMS) published an interim final rule mandating

vaccinations for healthcare workers. Medicare and Medicaid Programs; Omnibus

COVID-19 Heath Care Staff Vaccination, 86 Fed. Reg. 61555 (Nov. 5, 2021). The

Mandate governs 21 categories of Medicare or Medicaid providers and suppliers. See

id. at 61556. It applies the same substantive standards to each. See id. at 61570,

61616-61627. As CMS explained, “we are issuing a common set of provisions for each

applicable provider and supplier.” Id. at 61570.

The Mandate requires that every covered entity “develop and implement

policies and procedures to ensure that all staff are fully vaccinated for COVID–19.”

See, e.g., 42 C.F.R. §416.51(c). The vaccination requirement applies to anyone “who

provides any care, treatment, or other services for the [entity] and/or its patients”—

including employees, contractors, trainees, students, and volunteers—even if they

have no contact with patients. Id. §416.51(c)(1). To be exempt, a healthcare worker

has to “exclusively provide” telehealth or support services “outside of the [entity’s]

setting” in permanent isolation. Id. §416.51(c)(2)(i).

The Mandate also originally required each covered entity to ensure that, by

December 6, 2021, all healthcare workers submit to at least one vaccine dose. Any

worker who did not submit cannot provide “any care, treatment, or other services for

the [entity] and/or its patients.” Id. §416.51(c)(3)(i); 86 Fed. Reg. at 61555. By January

the National Governors Association (Dec. 27, 2021); https://bit.ly/34c27M9.

4, 2022, all such healthcare workers would have to be “fully vaccinated.” 42 C.F.R.

§416.51(c)(3)(ii); 86 Fed. Reg. at 61555. A covered entity is allowed to provide an

exemption for those granted temporary delays when mandated by federal law or

counseled to do so by the CDC’s own guidance. 42 C.F.R. §416.51(c)(3).

But on December 28, 2021, CMS announced delayed enforcement of the

Mandate in states in which it is not currently enjoined. See Guidance for the Interim

Final Rule—Medicare and Medicaid Programs; Omnibus COVID-19 Health Care

Staff Vaccination; https://go.cms.gov/3pxIOoE. For those 25 states, CMS establishes

“enforcement action thresholds” of 80%, 90%, and 100% compliance after 30, 60, and

90 days, respectively. See id. (https://go.cms.gov/3eBm7K0). It then provides that

after “90 days … following issuance of this memorandum [March 28, 2022], facilities

failing to maintain compliance with the 100% standard may be subject to enforcement

action.” Id. Potential penalties include “civil monetary penalties, denial of payment,

[and] termination.” Id.

The Mandate also imposes heavy-handed surveillance obligations. It requires

covered entities to “track[] and securely document[] information provided by those

staff who have requested, and for whom the [entity] has granted, an exemption” or

delay. 42 C.F.R. §416.51(c)(3)(vi)-(vii). It requires them to ensure that all

documentation “support[ing] staff requests for medical exemptions from vaccination,

has been signed and dated by a licensed practitioner.” Id. §416.51(c)(3)(viii). And it

requires that the covered entities implement a “process for tracking and securely

documenting the COVID–19 vaccination status of all staff,” including booster-shot

status. Id. §416.51(c)(3)(iv)-(v). And finally, because States implement Medicaid

programs, the burden of surveying and terminating non-compliant providers falls

upon the States. See D. Ct. Docs. 2-3, 2-14.

According to CMS, the Mandate captures 10.4 million healthcare workers—2.4

million of whom CMS contends are unvaccinated—and CMS anticipates the Mandate

would apply to another 2.66 million new hires annually. 86 Fed. Reg. at 61608. The

Mandate, by CMS’s own calculation, would impose over $1 billion in compliance costs.

Id. at 61609. Any entity that fails to fire its non-compliant workers faces penalties up

to and including “termination of the Medicare/Medicaid provider agreement.” 86 Fed.

Reg. at 61574.

The Mandate provides no exception or alternative for healthcare workers with

natural immunity. It likewise provides no exception or alternative for those who

submit to routine testing. And though CMS issued the Mandate eight weeks after it

was announced, and over six months after vaccines became widely available, it

promulgated the Mandate without notice or comment.

CMS acknowledges that its Mandate is unprecedented. See 86 Fed. Reg. at

61567 (“We have not previously required any vaccinations.”) (emphasis added); id. at

61568 (“We acknowledge that we have not previously imposed such requirements.”).

3. CMS’s Statutory Authority.

According to Applicants, the Executive Branch’s newly discovered “authority

to adopt the [Mandate] flows directly from the unambiguous text of the statute.” Stay

App. 20. The “statute” that Applicants refer to is presumably 42 U.S.C. §1302(a)

because, while CMS invoked a hodgepodge of authorities in issuing the Mandate, the

only statute that it claimed could support the Mandate’s application in full was

§1302(a). See 86 Fed. Reg. at 61567; see also Stay App. 20.

Section 1302(a) delegates to the Secretary of Health and Human Services mere

administrative responsibility in maintaining Medicare and Medicaid:

The … Secretary of Health and Human Services … shall make

and publish such rules and regulations, not inconsistent with this

chapter, as may be necessary to the efficient administration of the

functions with which [he] is charged under this chapter.

42 U.S.C. §1302(a).

Beyond §1302(a), CMS had originally listed other statutory provisions as

authority for some aspects of the Mandate’s application. For example, CMS applied

the Mandate to “Ambulatory Surgery Centers,” in part based on 42 U.S.C.

§1395k(a)(2)(F)(i). See 86 Fed. Reg. at 61567. In their stay application before this

Court, however, Applicants no longer mention many of those other statutory

provisions.

4. Harm to Healthcare Workers, Patients, and States.

If the Mandate goes into effect, it will—and has already begun to—disrupt the

lives and livelihoods of millions of Americans. CMS estimates it will force 2.4 million

currently unvaccinated healthcare workers to either forfeit informed consent and

bodily autonomy or their jobs. See 86 Fed. Reg. at 61607. It unabashedly admits that

the Mandate is designed to exploit people’s “fear of job loss” to coerce them into

compliance. Id.

But many American healthcare workers will give up their jobs rather than

violate their consciences or submit to a medical procedure they deem potentially

harmful or unnecessary. CMS gives only a cursory nod to this reality: “there may be

disruptions in cases where substantial numbers of health care staff refuse vaccination

and are not granted exemptions and are terminated,” which would lead to

“consequences for employers, employees, and patients.” 86 Fed. Reg. at 61608.

Those consequences will be more than painful—especially for the Americans

that Medicare and Medicaid are designed to serve. All parties agree that currently

“endemic staff shortages for all categories of employees at almost all kinds of health

care providers and suppliers” exist. Id. at 61607. Indeed, in many of Plaintiff States,

over 40% of nursing homes already faces staffing shortages. See AARP Nursing Home

COVID-19 Dashboard, AARP Public Policy Institute (Dec. 16, 2021), bit.ly/30lrvgs.

At the same time, in most Plaintiff States, over 30% of healthcare workers remain

unvaccinated. Id. The Mandate is therefore likely to exacerbate these pre-existing

labor shortages in the healthcare industry, which CMS does not dispute will cause

sick and dying Americans to lose access to medical care.

5. The Injunction Against the Mandate.

Plaintiff States sued to enjoin the Mandate and have it vacated and declared

unlawful before it could wreak its devastating toll. See D. Ct. Doc. 1. They administer

Medicaid programs—Medicaid provider agreements are contracts with the States—

and they operate regulated entities themselves. They will incur both enforcement and

compliance costs. Additionally, they enforce laws that are purportedly preempted by

the Mandate. And they stand for their citizens who will lose access to or control over

their medical care, or their jobs, as a result of the Mandate. To avoid those harms,

Plaintiff States sought—and the district court granted—a preliminary injunction

against the Mandate. See App.7a-8a.

The district court held that the Plaintiffs were likely to succeed on the merits

of their claims on eight independent grounds and were not likely to succeed on the

merits on two grounds due to a lack of evidence submitted with the preliminaryinjunction motion. In particular, the district court held that Applicants:



Exceeded their statutory authority in enacting the Mandate. App.27a-30a.



Improperly bypassed notice and comment. App.22a-27a.



Violated 42 U.S.C. §1395, which forbids Applicants from exercising

“supervision or control over” the “selection, tenure, or compensation of any

officer or employee of” healthcare providers. App.30a-31a.



Did not comply with 42 U.S.C. §§1395z or 1302(b), which impose statutory

procedural requirements that the Applicants flatly ignored. App.30a-31a.



Violated the APA, as the Mandate was arbitrary and capricious for many

reasons. App.31a-36a.



Violated the Constitution by intruding into an area of traditional State police

power and, if authorized by statute, exercising unconstitutionally delegated

federal legislative power. App. 36a-39a.

The district court found that Plaintiff States would suffer at least four

independent irreparable injuries if the Mandate went into effect. Specifically,

Plaintiff States’ laws would be preempted, they would incur the increased cost of

enforcing and complying with the Mandate, their procedural rights to their concrete

interests would be denied, and their citizens’ interests would be burdened. App.39a40a. Carefully balancing those interests and the federal government’s, it then held

that the threatened harm outweighed any harm to the Applicants and that the

injunction would advance the public interest. App.40a-41a.

6. The Fifth Circuit’s Affirmance.

A Fifth Circuit panel of Judges Costa, Graves, and Southwick unanimously

refused to stay the district court’s preliminary injunction in all respects other than

its geographic scope. App.6a. The panel held that the Applicants had not

demonstrated a strong showing of likely success on the merits in defending the

Mandate because it implicates a major question of the sort that would require clear

congressional authorization. App.2a-3a. Echoing the district court’s conclusion, the

panel also held that because “the Secretary’s vaccine rule has not gone into effect,” it

would not stay the injunction because “preserving the status quo ‘is an important’

equitable consideration in a stay decision.” App.4a. It then narrowed the injunction’s

scope to the fourteen Plaintiff States. App.6a.

7. Parallel Litigation.

Meanwhile, two other district courts enjoined the Mandate—on similar

bases—and one declined.2 An Eighth Circuit panel upheld one of those injunctions,

See Missouri v. Biden, No. 4:21-CV-01329, 2021 WL 5564501 (E.D. Mo. Nov. 29,

2021); Texas v. Becerra, No. 2:21-CV-229, 2021 WL 5964687 (N.D. Tex. Dec. 15, 2021);

Florida v. HHS, No. 3:21-CV-2722, 2021 WL 5416122 (N.D. Fla. Nov. 20, 2021).

the other remains unappealed, and a split Eleventh Circuit panel upheld the denial

of a preliminary injunction over Judge Lagoa’s dissent.3

8. The Applicants’ Emergency Stay Application.

After the Fifth Circuit denied a stay, Applicants filed this application for an

emergency stay of the district court’s injunction so that they could enforce the

Mandate immediately. They contend that this Court would likely reverse the district

court on the merits because the “unambiguous text of the statute” authorizes the

Mandate as “necessary to the efficient administration” of the Secretary of Health and

Human Service’s operation of Medicaid and Medicare. App. 20. In support of their

reading, Applicants invoke legislative history. Id. at 23. They reason that the Fifth

Circuit “invoked an expansive and unsound conception of what [it] called the ‘major

questions’ doctrine that finds no support in this Court’s precedents.” Id. at 19. And,

remarkably, they claim they are not regulating “a significant portion of the American

economy.” Id. at 29.

Applicants

also

contend

that

the Mandate

not

exercise

unconstitutionally delegated federal legislative power or an intrusion into the States’

traditional police power because healthcare employees “choose to work” at entities

that accept Medicaid or Medicare funding. Id. at 31. They also claim that there is “no

merit” to the district court’s holding that the Mandate was arbitrary and capricious,

id. at 32, and contend that they could bypass notice and comment (contrary to

See Missouri v. Biden, No. 21-3725 (8th Cir. Dec. 13, 2021); Florida v. HHS, 19

F.4th 1271 (11th Cir. 2021).

Congress’s express command) because they “acted in response to the rapidly evolving

conditions of the pandemic,” id. at 36-37. Finally, they reason that the public interest

favors allowing them to enforce the Mandate immediately because of “the real-world

impact” of enforcing it. Id. at 39. They do not, however, address the district court’s

independent holdings that the Mandate illegally violated 42 U.S.C. §§1395 and

1302(b), and they relegate to a footnote any discussion of its holding that the Mandate

violated 42 U.S.C. §1395z.

ARGUMENT

The Court will stay a district court’s order still pending before a court of

appeals only in the rare circumstance when (1) four Justices are likely to vote to grant

certiorari, (2) a majority of the Court is likely to reverse the district court’s judgment,

and (3) equitable factors—irreparable harm from granting or denying the stay, and

(in close cases) the balance of harms to the applicant and respondent—favor granting

a stay. Hollingsworth v. Perry, 558 U.S. 183, 190 (2010). Whatever might be said

about the certworthiness of some issues here, see infra §V, Applicants fail to carry

their burden of showing error in the district court’s judgment and that the balance of

equities favors a stay. The Court should deny the application.

Applicants Forfeited Challenges To The District Court’s Holdings

That The Mandate Independently Violates Three Specific Statutory

Mandates And Prohibitions.

The Mandate is unlawful not just because HHS lacks general authority to

promulgate it, see §II infra, but also because it violates three specific statutory

requirements or prohibitions in 42 U.S.C. §§1395, 1302(b), and 1395z. The district

court held that HHS “did not comply with any of the[se] provisions, [and thus] the

Plaintiff States are likely to succeed on the merits.” App.30a-31a.

When Applicants sought a stay from the Fifth Circuit, they challenged only

two of those holdings (ignoring §1302(b)). And in this Court, they challenge only one,

§1395z—and then only in a footnote (at 37 n.6). Applicants’ failure to address those

district court holdings in any meaningful way effectively eliminates their chances of

obtaining a grant of certiorari because the Court’s decision on the few issues

presented will not be dispositive. It also precludes their chances of securing a majority

vote to reverse; they give no basis for this Court to conclude that every district court

holding supporting the injunction is wrong.

Even setting aside those failures, their arguments would fail on the merits,

making Applicants doubly unlikely to obtain a reversal of the injunction.

Section 1395 Prohibits The CMS Mandate Because It Seeks To

“Control … the Selection [Or] Tenure” Of Healthcare Workers.

The district court held that Plaintiff States were likely to succeed in

showing that the Mandate violates 42 U.S.C. §1395, which prohibits the federal

government from exercising “any supervision or control” over the “selection, tenure,

or compensation” of any person providing health services or the “administration or

operation” of any health care institution. App.30a-31a. By failing to challenge this

holding in its application, Applicants concede it for present purposes. See Ohio

Citizens for Responsible Energy, Inc. v. Nuclear Regul. Comm’n, 479 U.S. 1312, 1312

(1986) (Scalia, J., in chambers) (“I will not consider counsel to have asked for such

extraordinary relief where, as here, he has neither specifically requested it nor

addressed the peculiar requirements for its issuance.”).

More generally, this Court “follow[s] the principle of party presentation.”

United States v. Sineneng-Smith, 140 S. Ct. 1575, 1579 (2020). The Court “rel[ies] on

the parties to frame the issues for decision[.]’” Id. (citation omitted). Federal courts

“‘do not, or should not, sally forth each day looking for wrongs to right. They wait for

cases to come to them, and when cases arise, courts normally decide only questions

presented by the parties.’” Id. (cleaned up) (citation omitted). That’s true in every

case, but especially so when seeking a stay. For the party seeking that equitable relief

“bears the burden of showing that the circumstances justify an exercise of that

discretion.” Nken v. Holder, 556 U.S. 418, 433–34 (2009). By failing to address the

district court’s holding on §1395, Applicants necessarily have failed to carry their

burden. Id. Nor would belated presentation in their reply brief suffice. See, e.g.,

Republic of Argentina v. NML Cap., Ltd., 573 U.S. 134, 140 n.2 (2014).

Section 1395 plays a critical role in preserving the federal-state balance.

This provision reflects the longstanding recognition that “the practice of medicine is,

in general, a subject of state regulation.” Pennsylvania Med. Soc. v. Marconis, 942

F.2d 842, 846 n.4 (3d Cir. 1991). Titled “Prohibition against any federal interference,”

§1395 provides, in broad language, that “[n]othing in this subchapter shall be

construed to authorize any Federal officer or employee to exercise any supervision or

control” over numerous matters, including the “selection, tenure, or compensation” of

health care employees. 42 U.S.C. §1395 (emphasis added).

By (1) mandating that millions of health care employees either undergo

vaccination or face termination, and (2) precluding the future hiring of unvaccinated

healthcare workers—with an estimated 2.66 million hires each year—the Mandate

plainly constitutes attempted “supervision or control” over “selection [and] tenure” of

health care employees. In fact, that appears to be the Mandate’s entire point.

Though Applicants ignore this issue in this Court, they attempted a cursory

defense in the Fifth Circuit, arguing that the Mandate is nothing more than a

“condition on federal funding for health care facilities.” But that argument neither

cited nor grappled with Congress’s specific limitation on federal power over “selection

[or] tenure” of employees. Id. No matter; Applicants’ argument would render §1395

superfluous. Medicare is a spending program. Nearly everything that HHS can do

under the subchapter could be characterized as a mere “condition on federal

funding”—yet Congress nonetheless deemed it important to expressly limit federal

authority in §1395. “As this Court has noted time and time again, the Court is obliged

to give effect, if possible, to every word Congress used.” See National Ass’n of Mfrs. v.

DOD, 138 S. Ct. 617, 632 (2018) (cleaned up). But under HHS’s interpretation, §1395

does nothing beyond occupy space in the U.S. Code.

HHS Violated §1302(b) In Promulgating the CMS Mandate.

By failing to challenge in their application the district court’s holding

that they violated 42 U.S.C. §1302(b)’s regulatory-impact-statement requirement,

Applicants also waived this issue. See Ohio Citizens, 479 U.S. at 1312 (Scalia, J., in

chambers). Applicants likewise did not raise this issue in their Fifth Circuit stay

briefs, which fail even to cite §1302(b). See, e.g., Sprietsma v. Mercury Marine, 537

U.S. 51, 56 n.4 (2002) (failure to raise argument below waives it).

Had Applicants preserved a challenge to the district court’s §1302(b)

holding, their argument would again fail on the merits. Section 1302(b) requires the

Secretary to prepare a regulatory impact analysis when publishing a rule that “may

have a significant impact on the operations of a substantial number of small rural

hospitals[.]” The Mandate itself identifies significant impacts on rural hospitals,

stating that “early indications are that rural hospitals are having greater problems

with employee vaccination refusals than urban hospitals, and [HHS] welcome[s]

comments on ways to ameliorate this problem.” 86 Fed. Reg. at 61613 (emphasis

added). Plaintiff States submitted substantial uncontroverted evidence showing the

Mandate “may have a significant impact on the operations of a substantial number

of small rural hospitals.” §1302(b)(1). See D. Ct. Docs. 2-2, 2-7, 2-12; see also Rural

COVID patients in ICUs at higher risk of dying than urban counterparts, according

to WVU researcher, WVU Today (Nov. 11, 2021), https://bit.ly/3HnFB1Q.

Applicants addressed this issue only in the district court. There, they

did not dispute that §1302(b)’s “significant impact” threshold was met. D. Ct. Doc. 21

at 24. Instead, they made a novel statutory argument: that §1302(b) did not apply

because “[t]he Secretary did not publish a notice of proposed rulemaking, and this is

not the final version of a rule with respect to which an initial regulatory impact

analysis was required.” Id.

That argument fails because §1302(b)(1) requires a final regulatory impact

statement whenever “an initial regulatory impact analysis is required by paragraph

(1),” §1302(b)(2)—that is, for any rule “that may have a significant impact on the

operations of a substantial number of small rural hospitals,” §1302(b)(1). Subsection

(b)(2)’s requirement is thus triggered by what a rule does, not how it is promulgated.

In essence, HHS’s arguments attempt to engraft the APA’s “good cause”

exception onto §1302(b). But Congress included no such exception in §1302(b), and

that omission is presumptively intentional. See United States v. Shabani, 513 U.S.

10, 14 (1994) (“When a statutory term is absent in one statute, but is explicit in

analogous statutes, Congress’ silence speaks volumes.” (cleaned up)); cf. Brown v.

Gardner, 513 U.S. 115, 118 (1994) (“‘[W]here Congress includes particular language

in one section of a statute but omits it in another section of the same Act, it is

generally presumed that Congress acts intentionally and purposely in the disparate

inclusion or exclusion.’” (quoting Russello v. United States, 464 U.S. 16, 23 (1983)).

Nor do Applicants’ novel district court arguments comport with Congress’s

statutory design. Nothing in §1302(b) suggests that Congress would be less concerned

about impacts to rural hospitals when those hospitals had been denied the

opportunity to comment on a proposed rule. If anything, the need for a regulatory

impact statement is heightened by lack of opportunity to comment.

HHS Violated §1395z’s Consultation Requirement By Not

Consulting With States Before Promulgating The Mandate.

The only specific statutory requirement Applicants address in this Court

is §1395z’s requirement of consulting with States—and even then only in passing by

footnote (at 37 n.6). The courts of appeals generally agree that raising an argument

only in a footnote constitutes a waiver.4 That rationale would support a holding by

this Court that Applicants waived any challenge to the district court’s conclusion that

HHS “did not comply with” §1395z. App.31a.

Even if not waived, Applicants’ footnote-only argument fails on the

merits. For rules like the CMS Mandate, §1395z requires “the Secretary” to “consult

with appropriate State agencies and recognized national listing or accrediting

bodies,” and permits him to “consult with appropriate local agencies.” Applicants do

not deny that HHS refused to engage in such consultation before promulgating the

Mandate, and they identify no evidence that it has attempted to do so since then.

Applicants’ only argument—yet another novel statutory claim—is that HHS’s

complete failure to consult with the States to date is lawful because §1395z “does not

require that consultation occur in advance of a rulemaking.” Stay App. 37 n.6 (citing

86 Fed. Reg. at 61567). Notwithstanding a clear statutory command to consult States,

HHS posits that “[g]iven the urgent need to issue this rule, however, we do not believe

that there exists an entity with which it would be appropriate to engage in these

See, e.g., Healthbridge Mgmt., LLC v. Nat’l Lab. Rels. Bd., 672 F. App’x 1 (D.C. Cir.

2016) (“Petitioners’ arguments … are forfeited because they were only briefly

mentioned in a footnote.”); Carter v. Toyota Tsusho Am., Inc., 529 Fed. Appx. 601, 612

n.2 (6th Cir.2013) (“Generally, an argument raised in a footnote without further

development is deemed waived.”); Arbuckle Mountain Ranch of Tex., Inc. v.

Chesapeake Energy Corp., 810 F.3d 335, 339 n.4 (5th Cir. 2016) (same); Unspam

Techs., Inc. v. Chernuk, 716 F.3d 322, 330 n* (4th Cir. 2013) (same); John Wyeth &

Bro. v. CIGNA Int’l Corp., 119 F.3d 1070, 1076 n.6 (3d Cir. 1997) (same);City of

Emeryville v. Robinson, 621 F.3d 1251, 1262 n.10 (9th Cir. 2010) (same); United

States v. Hardman, 297 F.3d 1116, 1131 (10th Cir. 2002) (same).

consultations in advance of issuing this IFC,” and that it did not “understand the

statute to impose a temporal requirement to do so in advance of the issuance of this

rule.” 86 Fed. Reg. at 61567. That argument fails for at least four reasons.

First, HHS’s reasoning seemingly attempts (again) to graft a non-existent

good-cause exception into §1395z’s consultation requirement by claiming an “urgent

need to issue this rule.” Id. In other words, HHS attempts to rewrite the statute

according to its own vision rather than what Congress enacted. But unlike the APA,

§1395z contains no good-cause exception. And because CMS rules are generally

subject to the APA, and because 42 U.S.C. §1302(a) provides general rulemaking

authority under the APA’s auspices, this omission is presumptively intentional. See

supra at 18. HHS’s attempt to invoke a good-cause exception that does not exist

through rewriting statutes is not likely to succeed on appeal.

Second, even if an atextual good-cause exception could be read into §1302(b),

Applicants could not satisfy it here. HHS had ample time between the September 9

announcement and the November 5 promulgation to engage in consultation. Indeed,

OSHA managed to hold some 140 meetings during the same time window.5

Applicants never actually argue that those eight full weeks were insufficient

time to consult with the States if HHS were so inclined. To the contrary, it appears

HHS arbitrarily decided States weren’t worthy of consulting. See 86 Fed. Reg. at

61567 (“[W]e do not believe that there exists an entity with which it would be

See OIRA, EO 12866 Meetings Search Results, available at https://bit.ly/3FJBwUo.

appropriate to engage in these consultations in advance of issuing this IFC.”).

Congress mandated otherwise.

Third, Applicants’ contention (at 37 n.6) that §1395z “does not require that

consultation occur in advance of a rulemaking” is unavailing. By mandating

consultation with the States, the statute requires a meaningful consultation rather

than an ex-post rubber stamp. The suggestion that a post-promulgation consultation

with States can satisfy that requirement is at best an empty formalism. Instead, the

statute requires consultation with States before rules issue—just as the APA

generally requires that notice and opportunity to comment before final rules issue.

HHS’s suggestion that it can simply relegate consultation to a perfunctory

afterthought—a process occurring after federal regulators have picked, publicly

committed to, and started enforcing a particular course—improperly renders the

consultation requirement meaningless. See, e.g., Bloate v. United States, 559 U.S.

196, 209 (2010) (“A statute ought, upon the whole, to be so construed that, if it can be

prevented, no clause, sentence, or word shall be superfluous, void, or insignificant.”)

(cleaned up). In any event, HHS’s reliance on multiple novel revisions of the law are

more reasons the injunction is appropriate now while it continues to litigate those

claims below.

Fourth, even if HHS were correct that the consultation could occur after the

IFR issues, HHS has not submitted any evidence that it has attempted to engage in

such consultation with the States in the eight weeks since the CMS Mandate issued

on November 5. That omission is particularly meaningful here as HHS has the

burden of proof in seeking a stay, and its failure to provide any supporting evidence

undermines its claim that its putative post hoc efforts will be sufficient.

II.

Applicants Are Unlikely To Prevail on the Merits of the Issues They

Properly Raise.

No Statute Authorizes the Mandate.

Under this Court’s precedent, agencies must show clear statements of

congressional authority before enacting regulations with particularly important or

sensitive implications. After all, “Congress does not casually authorize” major

regulations. Solid Waste Agency of N. Cook Cty. v. U.S. Army Corps of Engineers, 531

U.S. 159, 172 (2001). So, for instance, an agency may not address issues of “deep

economic and political significance” without showing that Congress has “expressly”

given it the power to do so. King v. Burwell, 576 U.S. 473, 486 (2015).6 Nor may an

agency “significantly alter the balance between federal and state power” without

showing that Congress has given it the power to do so through “exceedingly clear

language.” U.S. Forest Serv. v. Cowpasture River Pres. Ass’n, 140 S. Ct. 1837, 184950 (2020). And an agency may not “invoke[] the outer limits of Congress’ power”

without showing a “clear indication that Congress intended that result.” Solid Waste,

Applicants’ contention (at 19) that the States’ arguments based on this principle

“find[] no support in this Court’s precedents” is puzzling. See, e.g., Utility Air

Regulatory Group v. EPA, 573 U.S. 302, 324 (2014) (“We expect Congress to speak

clearly if it wishes to assign to an agency decisions of vast ‘economic and political

significance.’”); FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 160 (2000)

(“Congress could not have intended to delegate a decision of such economic and

political significance to an agency in so cryptic a fashion.”); Alabama Realtors, 141 S.

Ct. at 2489 (“We expect Congress to speak clearly when authorizing an agency to

exercise powers of vast economic and political significance.”) (quotation marks

omitted).

531 U.S. at 172. This Court recently reiterated these clear-statement requirements

in emphatic terms. See Alabama Ass’n of Realtors v. HHS, 141 S. Ct. 2485, 2489

(2021).

The Mandate triggers all three clear-statement requirements. First, if the

Mandate is not an issue of “deep economic and political significance,” nothing is. The

Mandate is controversial, heavy-handed, and unprecedented. 86 Fed. Reg. at 61567.

It forces 2.4 million Americans to either submit to injections against their wills or

lose their livelihoods. Id. at 61607. It commands States to enforce its terms upon

threat of losing billions in Medicaid funding or valued and irreplaceable providers in

an already-stressed employment market. 86 Fed. Reg. at 61574. It imposes over $1

billion in compliance costs. Id. at 61609.7 And it will cause lost or reduced access to

healthcare for the tens of millions of Americans who depend on Medicaid or

Medicare—programs that “touch[] the lives of nearly all Americans.” Azar v. Allina

Health Servs., 139 S. Ct. 1804, 1808 (2019). Second, the Mandate “significantly

alter[s] the balance between federal and state power.” Vaccine-mandate policy falls

within the “police power of a state.” Zucht v. King, 260 U.S. 174, 176 (1922). More

broadly, the “Constitution principally entrusts the safety and the health of the people

The estimated compliance costs do not appear to take into account State

enforcement costs and exposure to litigation for terminations. States, who administer

the Medicaid program, are required by federal law to provide an administrative and

judicial process for challenging terminations and deficiency reports. States have been

sued over such terminations by providers and beneficiaries under the “free choice of

provider” statute. See, e.g., Gee v. Planned Parenthood of Gulf Coast, Inc., 139 S. Ct.

408 (2019) (Thomas, J., dissenting from denial of certiorari) (recognizing that

Medicaid patients in some circuits can sue states under §1983 over termination of a

provider based on some circuits’ interpretation of 42 U.S.C. §1396(a)(23)).

to the politically accountable officials of the States.” South Bay United Pentecostal

Church v. Newsom, 141 S. Ct. 716, 717, 209 L. Ed. 2d 22 (2021) (Roberts, C.J.,

concurring). And third, the Mandate raises close constitutional questions and tests

the “outer limits of Congress’ power”—power that Congress, itself, has never

acknowledged. Supra at 3-4.

Because the Mandate triggers those three rules, Applicants may not impose it

unless Congress authorized them to do so “expressly,” in “exceedingly clear

language,” and with the “clear indication that Congress intended that result.”

Burwell, 576 U.S. at 486; Cowpasture River, 140 S. Ct. at 1849-50, Solid Waste, 531

U.S. at 172. But Congress did not authorize them to impose the Mandate at all, let

alone in express and clear terms.

Applicants rely upon only 42 U.S.C. §1302(a) to support the Mandate in full.

But that housekeeping statute cannot bear the Mandate’s freight.

To be sure, Applicants’ initial publication listed other statutory provisions as

authorizing some aspects of the Mandate. See 86 Fed. Reg. at 61567. Yet in their stay

application before this Court, Applicants no longer mention many of those other

statutes. Should Applicants try to reinvoke them, not one addresses—let alone

authorizes—mandating employee vaccinations. See D. Ct. Doc. 1 at 11-17.

Applicants are left, then, with §1302(a), which merely delegates to the

Secretary of HHS administrative responsibility for maintaining Medicare and

Medicaid:

The … Secretary of Health and Human Services … shall make

and publish such rules and regulations, not inconsistent with this

chapter, as may be necessary to the efficient administration of the

functions with which [he] is charged under this chapter.

§1302(a). This authorization to make rules “necessary” to the “efficient

administration” of his functions related to Medicaid and Medicare does not fairly

suggest the sort of sweeping power that the Applicants assert here. Indeed, it is not

even health-specific. Rather, the Act’s structure demonstrates that §1302(a) confers

the authority to make practical rules that help keep Medicaid and Medicare operating

smoothly and economically, such as rules that update billing procedures or clarify

discretionary grant-allocation criteria. See, e.g., 42 C.F.R. §51a.5. Reading these

grants of practical administrative authorities together with §1302(a) confirms that

the terms “necessary” and “administration” do not grant the sweeping powers

Applicants claim. See Alabama Realtors, 141 S. Ct. at 2488.

The plain meaning of the terms “administration” and “necessary” also preclude

Applicants’ expansive interpretation. The word “administration” refers to “the

practical management and direction of the executive department and its agencies.”

Administration, Black’s Law Dictionary (10th ed. 2014). The word “necessary” refers

to that which “is needed for some purpose or reason” or which “must exist or happen

and cannot be avoided.” Necessary, Black’s Law Dictionary (10th ed. 2014). And this

Court has just recently rejected a federal assertion that the term “necessary” confers

limitless power. Alabama Realtors, 141 S. Ct. at 2489 (“[T]he Government has

identified no limit in [the statute] beyond the requirement that the [agency] deem a

measure ‘necessary’”). If Congress had wanted to authorize the Secretary to forcibly

vaccinate or fire millions of healthcare workers, it would have needed to replace this

confining and mundane language with a precise and resounding grant of authority.

It did not.

On Applicants’ reading of §1302(a), there are no meaningful limits to the

Secretary’s power. Applicants contend that the Mandate is necessary because it

“protects” and “ensure[s]” the “health and safety of patients.” Stay App. 21, 25. But if

that reading sufficed, the Secretary could also mandate—to take just one example—

that all healthcare workers track and report their sleep schedules to their employers

to ensure that they are alert enough to provide safe and competent care, with covered

entities then firing those workers who rely on coffee to make up for late nights or

early mornings. HHS could similarly require healthcare workers to satisfy maximum

BMI or minimum exercise requirements, or mandate consumption of healthy foods

like broccoli in the name of ensuring that can provide maximally effective and

efficient care. Cf. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 557-58 (2012).

Hypothetical directives that control health care workers’ lives are endless but

would all fall within the Secretary’s view of his authority. Section 1302(a), however,

“is a wafer-thin reed on which to rest such sweeping power.” Alabama Realtors, 141

S. Ct. at 2489.

The Mandate Is Unconstitutional.

If Congress authorized the Mandate, it is unconstitutional under both the

Spending Clause and the Non-Delegation Doctrine. Under the Spending Clause,

Congress’s power to legislate “rests on whether the State voluntarily and knowingly

accepts the terms of the ‘contract,’” which means that the federal government may

not “impose a condition on the grant of federal money” unless it “do[es] so

unambiguously.” Pennhurst State Sch. & Hosp. v. Halderman, 451 U.S. 1, 17 (1981).

Even if the federal government imposes a condition unambiguously, it may not use

its power under the Spending Clause to “indirectly coerce[] a State” to adopt its policy.

Sebelius, 567 U.S. at 577-78. Whether a condition on funding is impermissibly

coercive turns on the consequences of opting out. Id. at 580-81. Here, when Plaintiff

States accepted Medicaid funding, they had no notice of the Mandate. Quite the

opposite: such matters have long been quintessential police powers reserved to

States. And even if they had notice, the condition was impermissibly coercive because

the consequence of opting out would be the loss of all Medicare and Medicaid funds.

See 86 Fed. Reg. at 61574.

And under the Non-Delegation Doctrine, Congress may not delegate the

federal legislative power to the Executive Branch. Touby v. United States, 500 U.S.

160, 165 (1991). While “power [may be] given to those who are to act under such

general provisions to fill up the details” concerning certain legislation, “important

subjects … must be entirely regulated by the legislature itself.” Wayman v. Southard,

23 U.S. 1, 43 (1825); see also Gundy v. United States, 139 S. Ct. 2116, 2136 (2019)

(Gorsuch, J., dissenting). Here, if §1302(a) or any other provision authorizes the

Secretary to legislate the vaccination schedules of 10.4 million healthcare workers, it

is an unconstitutional delegation of legislative authority.

At a minimum, those constitutional concerns warrant construing §1302(a) to

avoid them. “[I]t is well established that statutes should be construed to avoid

constitutional questions if such a construction is fairly possible.” Boos v. Barry, 485

U.S. 312, 333 (1988). Here, it is not only “possible,” but natural, to read §1302(a) as

authorizing practical rules that help keep Medicaid and Medicare operating smoothly

and economically, not sweeping and constitutionally questionable employee

vaccination mandates.

Thus, the Secretary’s arguments fail to meet the threshold requirement of

showing a majority of this Court likely will vote to reverse.

The Mandate Is Arbitrary and Capricious.

The Mandate is arbitrary and capricious for several independently sufficient

reasons. Most notably, as the district court found, the Mandate is at war with the

central objective of the Social Security Act—patient wellbeing and access to care. See

Good Samaritan Hosp. v. Shalala, 508 U.S. 402, 404 (1993). There is no dispute that

the Mandate will adversely affect the healthcare labor market. The most Applicants

can say (at 33) is that this impact will be “relatively small” and only “partially offset

by countervailing effects.” But their failure to consult with States renders this flawed

assumption nothing more than self-serving. And in any event, overwhelming

evidence shows that the Mandate will exacerbate already critical staff shortages.8

Applicants’ admission that the Mandate will adversely affect patient wellbeing—even

There is already a critical shortage of healthcare workers. Montana, for example,

already has a 39% nurse and aide shortage in nursing homes. AARP, AARP Nursing

Home COVID-19 Dashboard (updated Dec. 16, 2021), https://bit.ly/3HhAWyy.

Studies show that vaccine mandates will exacerbate those shortages. See Liz Hamel,

et al., KFF COVID-19 Vaccine Monitor: Oct, 2021, Kaiser Family Foundation (Oct.

28, 2021), https://bit.ly/3wEiJWN; Chris Isidore & Virginia Langmaid, 72% of

unvaccinated workers vow to quit if ordered to get vaccinated, CNN.com (Oct. 28,

2021), https://cnn.it/3HdgDlw.

a little bit—is dispositive. The Social Security Act’s goal of patient wellbeing and

access to care must trump the Biden Administration’s non-statutory vaccination

goals. Applicants admit that the Mandate will reduce the number of healthcare

workers and cannot dispute that fewer healthcare workers means greater harm to

patients.

The isolated examples HHS pulls out of context do not rebut the overwhelming

evidence that the Mandate will result in staff shortages and facility closures. HHS,

which did not bother to take comments, see infra, ignored the Mandate’s disparate

impact on rural hospitals—a particularly egregious omission given the Act’s special

protections for rural healthcare populations. 42 U.S.C. §1302(b). Applicants’ focus on

large, primarily urban, hospital systems ignores a vital and statutorily-mandated

aspect of the problem. Worse yet, Applicants try to elude the district court’s factual

findings demonstrating the Mandate’s devastating impact on rural facilities and

systems by simply ignoring them.9 App.32a. But the APA denies Applicants the right

Had HHS taken comments, Respondents would have presented the evidence about

rural facilities that HHS failed to consider—and upon which the district court found

(at App.32a) that patient wellbeing at rural facilities will be devastated:

This is backed up by a number of declarations of various individuals that

verify healthcare worker shortages, a significant number of healthcare

workers that remain unvaccinated, and the harm that will be caused to

these facilities in the event that even a few of the unvaccinated

healthcare workers quit or are fired as a result of the CMS Mandate.

Some of the declarations also verify the huge percentage of money paid

to these facilities through the Medicare and Medicaid Programs,

showing these facilities would have to shut down or severely cut back on

healthcare services if funding is cut off by the Government Defendants

to these facilities. The Plaintiff States also provided a declaration which

shows increased enforcement costs that would result if required to

survey and enforce the CMS Mandate.

to be willfully blind to reality. Simply put, patient wellbeing is disserved by

preventing the hiring and retention of qualified healthcare workers—a fact CMS

would have known had it consulted the States and taken comments.

The district court also correctly concluded that HHS failed to consider

alternatives to a mandate. Applicants contend (at 35) that “substantial evidence

supported” the Secretary’s determination that testing and natural immunity were

not viable alternatives, but they fail to identify such evidence. That is because it does

not exist. HHS both failed to identify its own evidence and contradicted evidence from

the States demonstrating that testing requirements prevent employee reductions and

preserve patient wellbeing. See App.33a (“The Declaration of Tracy Gruber declares

that since July 2021, employees at the Utah State Hospital and Utah State

Development Center have been required to be vaccinated or take a weekly COVID19 test. That alternative has caused no apparent harm to patients or staff.”). HHS’s

conclusory dismissal of obvious alternatives was not supported by any evidence

whatsoever. Cf. Texas v. Biden, 10 F.4th 538, 556 (5th Cir. 2021) (“‘Stating that a

factor was considered ... is not a substitute for considering it.’”).

Applicants also fail to address several other independent bases supporting the

district court’s judgment. The court held that “CMS failed to adequately explain its

departure from its prior position of not requiring mandatory vaccines,” App. 34a-35a;

that the agency’s rationale was likely pretextual, id. at 35a; that the agency ignored

the States’ reliance interests, id. at 35a-36a; and that the Mandate’s scope is

arbitrary, id. at 36a. Applicants fail to address any of those independently sufficient

reasons why the Mandate is arbitrary and capricious. Particularly given the burden

they bear in this emergency posture, that failure is dispositive. Cf. Danville Christian

Acad., Inc. v. Beshear, 141 S. Ct. 527, 528 (2020); Ohio Citizens for Responsible

Energy, 479 U.S. at 1312 (Scalia, J., in chambers).

HHS Violated the APA’s Notice-and-Comment Requirements

Without Good Cause.

Applicants do not dispute that HHS failed to employ notice-and-comment

procedures. Instead, they invoke the APA’s “good cause” exception to notice and

comment to excuse that failure. This Court owes HHS’s good-cause determination no

deference because “[t]o accord deference to an agency’s invocation of good cause would

be to run afoul of congressional intent.” Sorenson Commc’ns Inc. v. FCC, 755 F.3d

702, 706 (D.C. Cir. 2014). The good cause exception to notice-and-comment should be

read narrowly so that agencies do not get “an ‘escape clause’ from the requirements

Congress prescribed” in the APA. United States v. Johnson, 632 F.3d 912, 928 (5th

Cir. 2011); see also Mack Trucks, Inc. v. EPA, 682 F.3d 87, 93 (D.C. Cir. 2012) (goodcause exception is not an “escape clause[]” to be “arbitrarily utilized at the agency’s

whim”). And “the good cause exception should not be used to circumvent the notice

and comment requirements whenever an agency finds it inconvenient to follow them.”

Johnson, 632 F.3d at 929 (quotation marks omitted).

The district court faithfully applied those principles, yet Applicants dispute (at

36) the district court’s conclusion that HHS’s delay in issuing the Mandate

undermines HHS’s reliance on the exception. But delay usually precludes a goodcause finding not only because it undermines the agency’s conclusion that the rule is

needed immediately, but also because an agency cannot avoid notice and comment

through a crisis of its own creation. Applicants ignore this critical second rationale.

Applicants’ good-cause arguments focus (at 35-36) on the health risks from

COVID-19. But after almost two years, COVID-19 is a persistent feature of life and

cannot itself constitute good cause; similarly, COVID-19 vaccinations have been

approved under emergency authorizations for nearly a year. See, e.g., Florida v. HHS,

19 F.4th at 1306 (Lagoa, J., dissenting) (“To allow COVID-19 to constitute good cause

now would be to effectively repeal notice and comment requirements for the duration

of the pandemic.”). That is why courts have consistently rejected agency attempts to

rely on COVID-19 to ignore notice and comment. See Florida v. Becerra, 2021 WL

2514138, at *45 (M.D. Fla. June 18, 2021); Regeneron Pharms., Inc. v. HHS, 510 F.

Supp. 3d 29, 48 (S.D.N.Y. 2020); Ass’n of Cmty. Cancer Centers v. Azar, 509 F. Supp.

3d 482, 496 (D. Md. 2020). After so much time has passed, to deem the desire for

universal vaccination against COVID-19 “good cause” for ignoring notice-andcomment requirements would effectively repeal those requirements indefinitely. See

also BST Holdings, L.L.C. v. OSHA, 2021 WL 5279381, at *3 & n.10 (5th Cir. 2021)

(OSHA vaccine mandate’s “stated impetus—a purported ‘emergency’ that the entire

globe has now endured for nearly two years … is unavailing[.]” (cleaned up)). That is

particularly true here, where eight weeks passed between the September 9

announcement and the November 5 promulgation.

Applicants downplay the legal implication of their own delay by invoking (at

36) flu season. But this concern about winter and flu season—an annual and thus

eminently foreseeable occurrence—is a crisis of the agency’s own making, which is

not sufficient to establish good cause. See, e.g., United States Steel Corp. v. EPA, 595

F.2d 207, 213-14 & n.15 (5th Cir.1979); see also NRDC v. Abraham, 355 F.3d 179, 205

(2d Cir. 2004) (“We cannot agree ... that an emergency of [an agency’s] own making

can constitute good cause.”). HHS waited months to issue this supposedly emergency

measure. But even if “flu season” might normally constitute good cause, it cannot

here; “‘[o]therwise, an agency unwilling to provide notice or an opportunity to

comment could simply wait until the eve of a statutory, judicial, or administrative

deadline, then raise up the ‘good cause’ banner and promulgate rules without

following APA procedures.’” NRDC v. NHTSA, 894 F.3d 95, 114-15 (2d Cir. 2018)

(collecting cases); see also App. 26a (“It took CMS longer to prepare the interim final

rule without notice than it would have taken to comply with the notice and comment

requirement.”). In any event, if flu season is such a concern, it raises the question

why CMS has never, even now, mandated the flu vaccine for health care workers and

suppliers as a condition of participation in Medicare and Medicaid.

Delay aside, HHS failed to substantively establish good cause to forgo notice

and comment. Applicants contend (at 22-24) that good cause excuses notice-andcomment requirements because a delay would harm the health and safety of patients.

But CMS’s good-cause analysis did not even consider how the Mandate will harm

patients by exacerbating healthcare workforce shortages and, as explained, CMS

elsewhere unreasonably dismissed that concern. And beyond that, the “more

expansive the regulatory reach of” a rule, “the greater the necessity for public

comment” to allow those affected to be heard. American Fed’n of Gov’t Emp. v. Block,

655 F.2d 1153, 1156 (D.C. Cir. 1981). There is no overlooking the Mandate’s

magnitude—never before has CMS conditioned participation in Medicare and

Medicaid upon mandatory vaccination of the healthcare industry. 86 Fed. Reg. at

61,567. And the notice-and-comment process is even more vital in the Medicare and

Medicaid context because those programs “touch[] the lives of nearly all Americans”

and are two of the country’s “largest federal program[s].” Azar, 139 S. Ct. at 1808.

Even “minor changes” to the way those programs function “can impact millions of

people and billions of dollars in ways that are not always easy for regulators to

anticipate.” Id. at 1816. The Mandate’s importance only further confirms the need for

notice and comment.

Applicants’ attempt (at 37) to establish harmless error—an almost

unattainable standard in the notice-and-comment context—easily fails. The

harmless-error doctrine is to be used only “when a mistake of the administrative body

is one that clearly had no bearing on the procedure used or the substance of decision

reached.” U.S. Steel Corp. v. EPA, 595 F.2d 207, 215 (5th Cir. 1979) (citation omitted).

Here, however, HHS’s error altered its procedure for promulgating the Mandate,

precluding a finding of harmless error. See id. What’s more, in a comment period the

States would have raised the issues described above for the agency’s consideration.

The States’ inability to submit comments on the Mandate—which directly regulates

them and their citizens and threatens billions of dollars in health care funding upon

which States rely to provide services to the poor, elderly, disabled, and children—is

thus prejudicial. Sugar Cane Growers Co-op. of Fla. v. Veneman, 289 F.3d 89, 96-97

(D.C. Cir. 2002) (“Here the government would have us virtually repeal section 553’s

requirements: if the government could skip those procedures, engage in informal

consultation, and then be protected from judicial review unless a petitioner could

show a new argument—not presented informally—section 553 obviously would be

eviscerated.”).

III.

Applicants Seek Ultimate Relief Here But Cannot Establish Their

Entitlement to It.

The stay application elides an extraordinary aspect of Applicants’ request:

granting the requested stay is tantamount to awarding ultimate relief. “[T]he fact

that the entry of the stay would be tantamount to a decision on the merits in favor of

the applicants” militates against granting it. National Socialist Party of Am. v. Vill.

of Skokie, 434 U.S. 1327, 1328 (1977) (Stevens, J., in chambers); accord Cousins, 409

U.S. at 1206 (Rehnquist, J., in chambers). Similarly, the courts of appeals recognize

that a “heightened standard applies” for requests for preliminary injunctions that

“would provide the ultimate relief sought in the underlying action.”10 This Court has

Demirayak v. City of New York, 746 F. App'x 49, 51 (2d Cir. 2018) (“A heightened

standard applies when a movant seeks a preliminary injunction that either alters the

status quo or would provide the ultimate relief sought in the underlying action.”);

accord WarnerVision Ent. Inc. v. Empire of Carolina, Inc., 101 F.3d 259, 262 (2d Cir.

1996) (“As a general rule, therefore, a temporary injunction ‘ought not to be used to

give final relief before trial.’” (citation omitted)); Tanner Motor Livery, Ltd. v. Avis,

Inc., 316 F.2d 804, 808–09 (9th Cir. 1963) (“[I]t is not usually proper to grant the

moving party the full relief to which he might be entitled if successful at the

conclusion of a trial.”); Dunn v. Retail Clerks Int’l Ass’n, AFL-CIO, Loc. 1529, 299 F.2d

873, 874 (6th Cir. 1962) (“We ought not to grant temporary relief which would finally

dispose of the case on its merits.”).

likewise cautioned that “it is generally inappropriate for a federal court at the

preliminary-injunction stage to give a final judgment on the merits.” University of

Texas v. Camenisch, 451 U.S. 390, 395 (1981).

Those equitable considerations strongly militate against granting a stay here

because the stay’s effect would be tantamount to awarding ultimate victory to HHS.

CMS’s most recent guidance makes clear that it expects rapid progress within 30 days

(up to at least 80% compliance) and 100% compliance with 90 days. Supra at 6-7.

Because there is no masking alternative to vaccination, if the Court were to

stay the injunctions after the January 7, 2022 oral argument, virtually all healthcare

workers subject to the CMS Mandate would have little (or negative) time to become

fully vaccinated or be fired from their jobs. With the CDC now recommending twoshot Pfizer or Moderna vaccines over the one-shot Johnson & Johnson regimen, see

Lauran Neergaard & Mike Stobbe, CDC Recommends Pfizer, Moderna COVID-19

shots over J&J’s, Assoc. Press (Dec. 16, 2021), https://bit.ly/32GzLIN, healthcare

workers suddenly subject to the Mandate must get two shots in a truncated time—

long before the Fifth Circuit could resolve Applicants’ appeal from the injunction.

Or, worse yet, healthcare workers suddenly facing a past-due deadline to be

fully vaccinated may rush to take the single-shot Johnson & Johnson vaccine—which

the CDC affirmatively recommends they not take. Id. The Court should not deploy its

equitable powers to coerce healthcare workers into accepting risks that the Executive

Branch elsewhere recognizes are material, unwarranted, and affirmatively advisedagainst. And vaccination, of course, is irreversible—once individuals accede to HHS’s

unlawful mandate, they will incur the resulting permanent infringement upon their

liberties and whatever side effects are in store for them—and cannot be remedied by

money damages (which are unavailable from HHS anyway).11

In short, the difference between Applicants winning a stay now and a merits

judgment later is thus de mininis. Though Applicants’ requested stay would not

formally moot this case, the Mandate would become an irreversible fait accompli for

nearly all healthcare workers. Applicants are not seeking a stay pending appeal so

much as this Court’s blessing in perpetuity.

IV.

The Balance of Equities Disfavors a Stay.

Preventing Applicants from enforcing the unlawful Mandate pending appeal

of the injunction will result in no cognizable injury—let alone irreparable harm—on

them. Government officials simply “do[] not have an interest in the enforcement of”

an unlawful statute or regulation. N.Y. Progress & Prot. PAC v. Walsh, 733 F.3d 483,

488 (2d Cir. 2013). In contrast, the district court held that Plaintiff States had shown

a likelihood of “irreparable injury” in their sovereign, quasi-sovereign, and

proprietary capacities without an injunction. App.39a-40a. Applicants do not

meaningfully challenge those findings.

Instead, Applicants urge principally that “delaying the rule would cause

serious, tangible harm to public health,” Stay App. 37-38, contending that “hundreds

and potentially thousands of patients may die at hospitals, nursing homes, and other

The CDC’s changing guidance about which vaccines to receive has a material

impact on immunization and consent, decisions already being made under duress.

facilities participating in Medicare and Medicaid as the result of COVID-19 infections

transmitted to them by staff,” id. at 38. But in the Mandate itself, CMS acknowledged

that “the effectiveness of the vaccine to prevent disease transmission by those

vaccinated [is] not currently known.” 86 Fed. Reg. at 61615; see also id. at 61612

(“[P]redicting the full range of benefits … is all but impossible”). Applicants’ publicinterest argument is thus admittedly speculative. Moreover, “our system does not

permit agencies to act unlawfully even in pursuit of desirable ends,” thus precluding

Applicants’ reliance on the public interest. Alabama Realtors, 141 S. Ct. at 2490.

Plaintiff States’ evidence further shows that the Mandate will drive out

healthcare workers, reduce services, and close facilities—particularly in rural

areas—thereby harming the very Medicare and Medicaid beneficiaries Applicants

purport to serve. See D. Ct. Docs. 2-2 at 3 (“[O]ur rural nursing facility will soon face

closing the doors permanently[.]”); 2-7 at 4 (“We are facing losing 67% of our radiology

staff, 25% of surgical staff, 81% of nursing staff, and 50% of physical therapy staff.”);

2-8 at 3-4 (“[T]he number of vacant staff positions has roughly doubled from

September 2020 to September 2021,” from 124 to 250.); 2-12 at 3 (“[L]osing even 10

or 20 employees, which is a likely outcome of the mandate, may have devastating

results to our ability to provide the level of care we have provided in the past.”).

The public interest thus weighs decidedly against Applicants’ requested stay.

Applicants Overstate the Certworthiness of Their Claims.

Finally, Applicants overstate the certworthiness of the questions they

presently advance. As an initial matter, Applicants have ignored case-dispositive

grounds on which the challenged injunctions rest, thus rendering the questions they

do present unworthy of this Court’s review. Supra §I. This Court does not typically

grant review where the incomplete set of questions presented cannot alter the

outcome below.

Moreover, Applicants mischaracterize the split by contenting (at 3-4) that it

rests on a “precedential decision denying an injunction pending appeal.” Eleventh

Circuit stay decisions, however, are nonprecedential. See, e.g., Democratic Exec.

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

“the necessarily tentative and preliminary nature of a stay-panel opinion precludes

the opinion from having an effect outside that case”). What’s more, because Florida

has sought initial en banc review of its Florida v. HHS appeal, the “conflicting

positions adopted by the federal courts of appeals” upon which Applicants rely (at 19)

could easily disappear before the dispute ever reaches this Court on the merits.

Applicants raise complex and novel antecedent procedural questions about the

Secretary’s authority to impose sweeping new changes and conditions for

participation in the Medicaid and Medicare programs on States, providers, and

employees without notice and comment or consultation. Cf. Whole Woman’s Health v.

Jackson, 141 S. Ct. 2494, 2495 (2021). No doubt this dispute is important and may

easily warrant this Court’s review—after the courts of appeals have passed on the

merits of the underlying appeals. But Applicants’ claim of a split based on nonprecedential panel stay decisions badly misstates Applicants’ principal current

certworthiness argument.

CONCLUSION

For these reasons, the Court should deny the application for a stay pending

appeal.

December 30, 2021

Jeff Landry

Louisiana Attorney

General

Elizabeth B. Murrill

Solicitor General

J. Scott St. John

Deputy Solicitor General

Morgan Brungard

Josiah Kollmeyer

Assistant Solicitors

General

LOUISIANA DEPARTMENT

OF JUSTICE

1885 N. Third Street

Baton Rouge, LA 70804

(225) 326-6766

Jimmy R. Faircloth, Jr.

Mary Katherine Price

FAIRCLOTH MELTON SOBEL

& BASH, LLC

105 Yorktown Drive

Alexandria, LA 71303

(318) 619-7755

Respectfully submitted,

Mark Brnovich

Arizona Attorney

General

Joseph A. Kanefield

Chief Deputy & Chief of

Staff

Brunn (“Beau”) W.

Roysden III

Solicitor General

Drew C. Ensign

Deputy Solicitor

General

Counsel of Record

Wilson C. Freeman

Senior Litigation

Counsel

OFFICE OF THE ARIZONA

ATTORNEY GENERAL

2005 N. Central Ave.

Phoenix, AZ 85004

(602) 542-3333

Austin Knudsen

Montana Attorney

General

Kristin Hansen

Lieutenant General

David M.S. Dewhirst

Solicitor General

Kathleen L. Smithgall

Assistant Solicitor

General

MONTANA DEPARTMENT

OF JUSTICE

215 North Sanders

Street

Helena, MT 59601

(406) 444-2026

STEVE MARSHALL

Alabama Attorney General

DAVE YOST

Ohio Attorney General

CHRISTOPHER M. CARR

Georgia Attorney General

JOHN M. O’CONNOR

Oklahoma Attorney General

LAWRENCE G. WASDEN

Idaho Attorney General

ALAN WILSON

South Carolina Attorney General

THEODORE E. ROKITA

Indiana Attorney General

SEAN D. REYES

Utah Attorney General

DANIEL CAMERON

Kentucky Attorney General

PATRICK MORRISEY

West Virginia Attorney General

LYNN FITCH

Mississippi Attorney General

Counsel for Respondent States

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.