Petition for Writ of Certiorari — Donald J. Trump, President of the United States, et al., Petitioners v. Pennsylvania, et al.

Supreme Court briefOct 3, 2019

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No.

In the Supreme Court of the United States

DONALD J. TRUMP, PRESIDENT OF THE UNITED STATES,

ET AL., PETITIONERS

COMMONWEALTH OF PENNSYLVANIA, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

NOEL J. FRANCISCO

Solicitor General

Counsel of Record

JOSEPH H. HUNT

Assistant Attorney General

JEFFREY B. WALL

Deputy Solicitor General

HASHIM M. MOOPPAN

Deputy Assistant Attorney

General

JONATHAN C. BOND

Assistant to the Solicitor

General

SHARON SWINGLE

LOWELL V. STURGILL JR.

KAREN SCHOEN

Attorneys

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

QUESTIONS PRESENTED

The Patient Protection and Affordable Care Act

(ACA), 42 U.S.C. 18001 et seq., requires many group

health plans and health-insurance issuers that offer group

or individual health coverage to provide coverage for preventive services, including women’s preventive care, without cost-sharing. See 42 U.S.C. 300gg-13(a). Guidelines

and regulations implementing that requirement promulgated in 2011 by the Departments of Health and Human

Services, Labor, and the Treasury mandated that such

entities cover contraceptives approved by the Food and

Drug Administration. The mandate exempted churches,

and subsequent rulemaking established an accommodation for certain other entities with religious objections to

providing contraceptive coverage. In October 2017, the

agencies promulgated interim final rules expanding the

exemption to a broad range of entities with sincere religious or moral objections to providing contraceptive coverage. In November 2018, after considering comments

solicited on the interim rules, the agencies promulgated

final rules expanding the exemption. The questions presented are as follows:

1. Whether the agencies had statutory authority

under the ACA and the Religious Freedom Restoration

Act of 1993, 42 U.S.C. 2000bb et seq., to expand the conscience exemption to the contraceptive-coverage mandate.

2. Whether the agencies’ decision to forgo notice and

opportunity for public comment before issuing the interim

final rules rendered the final rules—which were issued

after notice and comment—invalid under the Administrative Procedure Act, 5 U.S.C. 551 et seq., 701 et seq.

3. Whether the court of appeals erred in affirming a

nationwide preliminary injunction barring implementation of the final rules.

(I)

PARTIES TO THE PROCEEDING

Petitioners are the President of the United States of

America; the Secretary of Health and Human Services;

the U.S. Department of Health and Human Services;

the Secretary of the Treasury; the U.S. Department of

the Treasury; the Secretary of Labor; and the U.S.

Department of Labor.

Respondents are the Commonwealth of Pennsylvania; the State of New Jersey; and the Little Sisters of

the Poor Saints Peter and Paul Home.

RELATED PROCEEDINGS

United States District Court (E.D. Pa.):

Commonwealth of Pennsylvania v. Donald J.

Trump, No. 17-4540 (Jan. 14, 2019)

United States Court of Appeals (3d Cir.):

Commonwealth of Pennsylvania v. President,

United States of Am., No. 17-3679 (Apr. 24, 2018)

(reversing denial of motion to intervene)

Commonwealth of Pennsylvania v. President,

United States of Am., Nos. 17-3752, 18-1253,

19-1129, and 19-1189 (July 12, 2019) (affirming

preliminary injunction)

Supreme Court of the United States:

Little Sisters of the Poor Saints Peter & Paul

Home v. Commonwealth of Pennsylvania,

No. 19-431 (filed Oct. 1, 2019) (pending petition

for writ of certiorari to review Third Circuit’s

judgment in Nos. 17-3752, 18-1253, 19-1129, and

19-1189)

(II)

TABLE OF CONTENTS

Page

Opinions below .............................................................................. 1

Jurisdiction .................................................................................... 1

Statutory and regulatory provisions involved ........................... 2

Statement ...................................................................................... 2

Reasons for granting the petition ............................................. 14

I. The court of appeals’ holding that the final

rules are likely unlawful is incorrect and

warrants this Court’s review ..................................... 16

A. The agencies had statutory authority to

adopt the expanded exemptions ............................ 16

1. The ACA authorized the expanded

exemptions......................................................... 16

2. RFRA authorized and, for certain

employers, required the expanded

religious exemption .......................................... 20

3. The court of appeals’ holding that

the exemptions are likely statutorily

unauthorized warrants review ........................ 26

B. The final rules do not violate the APA .................. 27

1. The final rules, adopted after notice

and comment, comply with the APA

regardless of whether the interim rules

were procedurally defective ............................ 28

2. The court of appeals’ holding that

the final rules are likely procedurally

invalid warrants review .................................... 30

II. The court of appeals’ holding affirming a

nationwide injunction is incorrect and

warrants this Court’s review ................................ 32

Conclusion ................................................................................... 35

Appendix A — Court of appeals opinion (July 12, 2019) ...... 1a

Appendix B — District court opinion (Dec. 15, 2017) ......... 47a

Appendix C — District court order (Dec. 15, 2017) .......... 101a

(III)

Table of Contents—Continued:

Page

Appendix D — District court opinion (Jan. 14, 2019) ....... 104a

Appendix E — District court order (Jan. 14, 2019) .......... 185a

Appendix F — Statutory and regulatory provisions ........ 188a

TABLE OF AUTHORITIES

Cases:

Advocate Health Care Network v. Stapleton,

137 S. Ct. 1652 (2017) ........................................................... 4

Advocates for Highway & Auto Safety v. Federal

Highway Admin., 28 F.3d 1288 (D.C. Cir. 1994) ............ 30

Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682 (2014).....................................5, 6, 20, 21, 25, 26

California v. Azar, 911 F.3d 558 (9th Cir. 2018),

cert. denied, 139 S. Ct. 2716 (2019) ............................. 34, 35

Corporation of the Presiding Bishop of the Church

of Jesus Christ of Latter-Day Saints v. Amos,

483 U.S. 327 (1987).............................................................. 26

Federal Express Corp. v. Mineta,

373 F.3d 112 (D.C. Cir. 2004) ............................................. 31

Gill v. Whitford, 138 S. Ct. 1916 (2018) ............................... 32

Grupo Mexicano de Desarrollo, S.A. v. Alliance

Bond Fund, Inc., 527 U.S. 308 (1999) ............................... 32

Levesque v. Block, 723 F.2d 175 (1st Cir. 1983) .................. 30

Lewis v. Casey, 518 U.S. 343 (1996) ..................................... 32

Long Island Care at Home, Ltd. v. Coke,

551 U.S. 158 (2007).............................................................. 29

Madsen v. Women’s Health Ctr., Inc.,

512 U.S. 753 (1994).............................................................. 32

Nazareth Hosp. v. Secretary, HHS,

747 F.3d 172 (3d Cir. 2014) ................................................ 30

Priests for Life v. HHS, 808 F.3d 1 (D.C. Cir. 2015) ... 24, 25

Ricci v. DeStefano, 557 U.S. 557 (2009) .............................. 22

Cases—Continued:

Page

Russello v. United States, 464 U.S. 16 (1983) ..................... 18

Sharpe Holdings, Inc. v. HHS,

801 F.3d 927 (8th Cir. 2015),

vacated and remanded sub nom.

HHS v. CNS Int’l Ministries,

136 S. Ct. 2006 (2016) ................................................... 24, 25

Summers v. Earth Island Inst., 555 U.S. 488 (2009) ......... 32

Thomas v. Review Bd. of the Ind. Emp’t Sec. Div.,

450 U.S. 707 (1981).............................................................. 25

Town of Chester v. Laroe Estates, Inc.,

137 S. Ct. 1645 (2017) ......................................................... 32

Trump v. Hawaii, 138 S. Ct. 2392 (2018) ............................ 33

United States v. Mendoza, 464 U.S. 154 (1984).................. 33

Walz v. Tax Comm’n, 397 U.S. 664 (1970) .......................... 22

Zubik v. Burwell, 136 S. Ct. 444 (2015) ................................. 6

Zubik v. Burwell, 136 S. Ct. 1557 (2016) ......................... 7, 14

Constitution, statutes, and regulations:

U.S. Const.:

Art. III .................................................................. 15, 32, 33

Amend. I (Free Exercise Clause) .................................. 19

Administrative Procedure Act, 5 U.S.C. 551 et seq.,

701 et seq. ............................................................................... 8

5 U.S.C. 553 ...................................................................... 29

5 U.S.C. 553(b) ..............................................8, 13, 28, 188a

5 U.S.C. 553(b)(B) ........................................8, 13, 28, 188a

5 U.S.C. 553(c) ..............................................8, 13, 28, 188a

5 U.S.C. 559 ...................................................................... 28

5 U.S.C. 706(2)(A) .............................................................. 9

Civil Rights Act of 1964, 42 U.S.C. 2000e et seq. ................ 22

Tit. VII.............................................................................. 22

Statutes and regulations—Continued:

Page

Employee Retirement Income Security Act of

1974, Pub. L. No. 93-406, 88 Stat. 829

(29 U.S.C. 1001 et seq.) ......................................................... 2

29 U.S.C. 1002(33)(C)(i) .................................................... 4

29 U.S.C. 1003(b)(2) .......................................................... 4

29 U.S.C. 1185d.................................................................. 2

29 U.S.C. 1191c .............................................2, 8, 13, 17, 28

Internal Revenue Code (26 U.S.C.):

26 U.S.C. 4980H(c)(2) (2012 & Supp. V 2017)................. 5

26 U.S.C. 9815(a)(1) ........................................................... 2

26 U.S.C. 9833 ...............................................2, 8, 13, 17, 28

Patient Protection and Affordable Care Act,

42 U.S.C. 18001 et seq. .......................................................... 2

42 U.S.C. 18011 .................................................................. 5

Public Health Service Act, 42 U.S.C. 201 et seq. .................. 2

42 U.S.C. 300gg-13(a).............................2, 12, 16, 19, 189a

42 U.S.C. 300gg-13(a)(1) ..............................2, 16, 19, 189a

42 U.S.C. 300gg-13(a)(1)-(3) ................................. 18, 189a

42 U.S.C. 300gg-13(a)(2) ......................................... 2, 189a

42 U.S.C. 300gg-13(a)(3) ............................................. 3, 19

42 U.S.C. 300gg-13(a)(4) ............ 3, 10, 16, 17, 18, 19, 190a

42 U.S.C. 300gg-92 .......................................2, 8, 13, 17, 28

Religious Freedom Restoration Act of 1993,

42 U.S.C. 2000bb et seq. ....................................................... 5

42 U.S.C. 2000bb-1(b) ..................................... 20, 23, 191a

45 C.F.R. (2018):

Section 147.131(a) (2016) ...................................... 20, 191a

Section 147.131-147.133 .......................................... 8, 192a

Section 147.132(a) .................................................. 10, 199a

Section 147.132(b) .................................................. 10, 201a

VII

Regulations—Continued:

Page

Section 147.133(a) .................................................. 10, 205a

Section 147.133(b) .................................................. 10, 206a

Miscellaneous:

Administrative Conference of the U.S.,

Recommendation 95-4, Procedures for

Noncontroversial and Expedited Rulemaking,

60 Fed. Reg. 43,108 (Aug. 18, 1995) .................................. 31

Samuel L. Bray, Multiple Chancellors: Reforming

the National Injunction,

131 Harv. L. Rev. 417 (2017) ............................................. 33

47 Fed. Reg. 38,409 (Aug. 31, 1982) ....................................... 3

76 Fed. Reg. 46,621 (Aug. 3, 2011) ................................... 3, 17

77 Fed. Reg. 8725 (Feb. 15, 2012) .......................................... 3

78 Fed. Reg. 8456 (Feb. 6, 2013) ............................................ 3

78 Fed. Reg. 39,870 (July 2, 2013).......................................... 4

79 Fed. Reg. 51,092 (Aug. 27, 2014) ....................................... 5

80 Fed. Reg. 41,318 (July 14, 2015) ........................................ 6

81 Fed. Reg. 47,741 (July 22, 2016) ........................................ 7

82 Fed. Reg. 47,792 (Oct. 13, 2017) .................5, 6, 7, 8, 24, 28

82 Fed. Reg. 47,838 (Oct. 13, 2017) ........................................ 8

83 Fed. Reg. 57,536 (Nov. 15, 2018) ............................ passim

83 Fed. Reg. 57,592 (Nov. 15, 2018) ............................... 10, 30

U.S. GAO, GAO-13-21, Federal Rulemaking:

Agencies Could Take Additional Steps to Respond

to Public Comments (2012) ................................................ 31

In the Supreme Court of the United States

No.

DONALD J. TRUMP, PRESIDENT OF THE UNITED STATES,

ET AL., PETITIONERS

COMMONWEALTH OF PENNSYLVANIA, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

The Solicitor General, on behalf of President Donald

J. Trump, et al., respectfully petitions for a writ of certiorari to review the judgment of the United States

Court of Appeals for the Third Circuit in this case.

OPINIONS BELOW

The amended opinion of the court of appeals (App.,

infra, 1a-46a) is reported at 930 F.3d 543. The opinion

of the district court granting a preliminary injunction

(App., infra, 104a-184a) is reported at 351 F. Supp. 3d

791. An earlier opinion of the district court granting

a preliminary injunction (App., infra, 47a-100a) is

reported at 281 F. Supp. 3d 553.

JURISDICTION

The judgment of the court of appeals was entered on

July 12, 2019. The jurisdiction of this court is invoked

under 28 U.S.C. 1254(1).

(1)

STATUTORY AND REGULATORY

PROVISIONS INVOLVED

Pertinent statutory and regulatory provisions are

reproduced in the appendix to this petition. App., infra,

188a-210a.

STATEMENT

1. a. The preventive-services provision of the Patient

Protection and Affordable Care Act (ACA or Act),

42 U.S.C. 18001 et seq., requires many group health

plans and health-insurance issuers that offer group or

individual health coverage to provide coverage for certain preventive services without “any cost sharing

requirements.” 42 U.S.C. 300gg-13(a). The preventiveservices provision is part of the Public Health Service

Act, 42 U.S.C. 201 et seq., and it is also incorporated into

the Employee Retirement Income Security Act of 1974

(ERISA), Pub. L. No. 93-406, 88 Stat. 829 (29 U.S.C. 1001

et seq.), see 29 U.S.C. 1185d, and the Internal Revenue

Code, see 26 U.S.C. 9815(a)(1). The Departments of

Health and Human Services (HHS), Labor, and the

Treasury, respectively, enforce and have authority to

promulgate regulations implementing the relevant portions of those statutes. E.g., 42 U.S.C. 300gg-92; 29 U.S.C.

1191c; 26 U.S.C. 9833.

The ACA’s preventive-services provision requires

covered plans to provide coverage for “evidence-based

items or services” that are recommended by the United

States Preventive Services Task Force, an independent

panel of experts, 42 U.S.C. 300gg-13(a)(1); immunizations recommended by an advisory committee of the

Centers for Disease Control and Prevention (CDC),

42 U.S.C. 300gg-13(a)(2); and, “with respect to infants,

children, and adolescents, evidence-informed preventive

care and screenings provided for” in already-existing

“comprehensive guidelines supported by the” Health

Resources and Services Administration (HRSA), a component of HHS. 42 U.S.C. 300gg-13(a)(3); see 47 Fed.

Reg. 38,409 (Aug. 31, 1982). In addition, as relevant here,

Section 300gg-13(a)(4) requires covered plans to provide,

“with respect to women, such additional preventive care

and screenings not described in paragraph (1) as provided for in comprehensive guidelines supported by

[HRSA] for purposes of this paragraph.” 42 U.S.C.

300gg-13(a)(4).

b. In August 2011, HRSA issued guidelines that

adopted the recommendation of the Institute of Medicine to require coverage for women of (among other

things) all contraceptive methods approved by the Food

and Drug Administration (FDA). See 77 Fed. Reg.

8725, 8725 (Feb. 15, 2012). Coverage for such contraceptive methods was required for plan years beginning

on or after August 1, 2012. See 76 Fed. Reg. 46,621,

46,623 (Aug. 3, 2011). At the same time, the agencies that

administer the ACA—HHS, the Department of Labor,

and the Department of the Treasury—invoked their

authority under 42 U.S.C. 300gg-13(a)(4) to promulgate

interim final rules authorizing HRSA to exempt

churches and their integrated auxiliaries from the

contraceptive-coverage mandate. See 76 Fed. Reg. at

46,623. Those interim rules were finalized in February

2012. 77 Fed. Reg. at 8725.

Various religious groups urged the agencies to

expand the church exemption to cover all organizations

that had religious or moral objections to providing contraceptive coverage. See 78 Fed. Reg. 8456, 8459-8460

(Feb. 6, 2013). Instead, in a subsequent rulemaking, the

agencies made available what they termed an “accommodation,” which was limited to religious not-for-profit

organizations that had religious objections to providing

contraceptive coverage. See 78 Fed. Reg. 39,870,

39,874-39,882 (July 2, 2013). The accommodation

allowed a group health plan established or maintained

by an eligible objecting employer to opt out of any

requirement that the plan “contract, arrange, pay, or

refer for contraceptive coverage” by notifying its

insurer—or, in the case of self-insured plans, the plan’s

third-party administrator—of its objection. Id. at

39,874. The insurer or administrator would then be

required to provide or arrange contraceptive coverage

for plan participants. See id. at 39,875-39,880.

For certain self-insured plans, however, coverage by

the plan’s third-party administrator under the accommodation was effectively voluntary. The authority to

enforce a third-party administrator’s obligation to provide separate contraceptive coverage derives solely from

ERISA. But ERISA does not apply to so-called “church

plan[s],” 29 U.S.C. 1003(b)(2), which it defines to

“include[ ] a plan maintained by an organization” that has

as its “principal purpose or function” the “administration

or funding of a plan or program for the provision of

retirement benefits or welfare benefits, or both, for the

employees of a church or a convention or association of

churches” and that “is controlled by or associated with a

church or a convention or association of churches.”

29 U.S.C. 1002(33)(C)(i); see Advocate Health Care Network v. Stapleton, 137 S. Ct. 1652, 1656 (2017). Thus, in

addition to exempting churches and their integrated

auxiliaries from the contraceptive-coverage mandate,

the agencies in effect also exempted self-insured plans

for church-affiliated not-for-profit organizations—such

as hospitals and universities—because the agencies

could not require the third-party administrators of

those plans to provide or arrange for contraceptive coverage, nor impose fines or penalties for failing to do so.

See 79 Fed. Reg. 51,092, 51,095 n.8 (Aug. 27, 2014).

The ACA itself also exempted certain other employers from the contraceptive-coverage mandate. The Act

exempts from many of its requirements, including the

preventive-services requirement, so-called grandfathered

health plans—generally, those plans that have not made

certain specified changes since the Act’s enactment.

See 42 U.S.C. 18011. Grandfathered plans cover tens

of millions of people. See 82 Fed. Reg. 47,792, 47,794

& n.5 (Oct. 13, 2017). Employers with fewer than

50 employees also are not subject to the tax imposed

on employers that fail to offer health coverage, see

26 U.S.C. 4980H(c)(2) (2012 & Supp. V 2017), although

small employers that do provide non-grandfathered

coverage must comply with the preventive-services

requirement.

2. a. Many employers objected to the contraceptivecoverage mandate on religious grounds and filed suits

challenging it. Those challenging the mandate principally contended that it violated the Religious Freedom

Restoration Act of 1993 (RFRA), 42 U.S.C. 2000bb

et seq. See 82 Fed. Reg. at 47,796-47,797. A circuit conflict developed, and this Court granted certiorari to

resolve it in Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682 (2014).

Hobby Lobby held that RFRA prohibited applying

the mandate to closely held for-profit corporations with

religious objections to providing contraceptive coverage. See 573 U.S. at 705-736. The Court determined

that the mandate “impose[d] a substantial burden on

the exercise of religion” for such employers. Id. at 726;

see id. at 719-726. The Court further concluded that,

even assuming a compelling governmental interest in

“guaranteeing cost-free access to the four challenged

contraceptive methods,” applying the mandate was not

the least restrictive means of furthering that interest

and therefore was prohibited by RFRA. Id. at 728; see

id. at 726-732. The Court observed that the agencies

had already established an accommodation available to

not-for-profit employers and that, at a minimum, this

less restrictive alternative could be extended to closely

held for-profit corporations that have religious objections to the mandate but not to the accommodation. See

id. at 730-731. The Court “d[id] not decide * * *

whether an approach of this type complies with RFRA

for purposes of all religious claims.” Id. at 731 (emphasis added).

b. Following Hobby Lobby, the agencies promulgated rules that extended the accommodation to closely

held for-profit entities that have religious objections to

providing contraceptive coverage. 80 Fed. Reg. 41,318,

41,323-42,328 (July 14, 2015); see 82 Fed. Reg. at

47,797-47,798. Numerous entities, however, continued

to challenge the mandate even with the extended accommodation. Such entities principally asserted that the

accommodation made them complicit in providing coverage for contraceptives “because it utilized the plans the

[entities] themselves sponsored to provide services to

which they objected on religious grounds.” 82 Fed. Reg.

at 47,798. Another circuit split developed, and this Court

granted certiorari in several of the cases, which it consolidated. Ibid.; see, e.g., Zubik v. Burwell, 136 S. Ct. 444

(2015).

After briefing and argument in Zubik and the consolidated cases, the Court vacated all of the judgments

and remanded the cases to the respective courts of appeals without resolving the underlying merits. Zubik v.

Burwell, 136 S. Ct. 1557 (2016) (per curiam). The Court

“d[id] not decide whether [the plaintiffs’] religious

exercise ha[d] been substantially burdened, whether

the Government ha[d] a compelling interest, or whether

the current regulations [we]re the least restrictive

means of serving that interest.” Id. at 1560. Instead,

the Court directed that, on remand, the parties be given

an opportunity to resolve the dispute. See ibid. In the

meantime, the Court precluded the government from

“impos[ing] taxes or penalties on [the plaintiffs] for failure to provide” the notice required under the accommodation. Id. at 1561.

c. In response to this Court’s decision in Zubik, the

agencies sought public comment on whether further

modifications to the accommodation could resolve the

religious objections asserted by various organizations

while providing a mechanism for contraceptive coverage

for their employees. See 81 Fed. Reg. 47,741 (July 22,

2016). The agencies received over 54,000 comments but

could not identify a way to amend the accommodation

that would both satisfy objecting organizations and

ensure that women covered by those organizations’ plans

receive seamless contraceptive coverage. 82 Fed. Reg.

at 47,798-47,799, 47,814.

As a result, as of January 2017, the pending litigation

concerning the mandate and extended accommodation—

consisting of more than three dozen cases, brought by

more than 100 separate plaintiffs—remained unresolved. In addition, some nonreligious organizations

with moral objections to providing contraceptive cover-

age had filed suits challenging the mandate. That litigation also led to conflicting decisions by the courts.

See 82 Fed. Reg. 47,838, 47,843 (Oct. 13, 2017).

3. a. In an effort “to resolve the pending litigation

and prevent future litigation,” the agencies subsequently “reexamine[d]” the contraceptive-coverage

mandate’s “exemption and accommodation scheme.”

82 Fed. Reg. at 47,799. In October 2017, the agencies

jointly issued two interim final rules that expanded the

exemption to a broad range of entities that have either

sincere religious objections or sincere moral objections

to providing contraceptive coverage, while continuing to

offer the existing accommodation as an optional alternative. See id. at 47,792 (religious exemption); id. at

47,838 (moral exemption); 45 C.F.R. 147.131-147.133.

The agencies explained that their statutory authority to issue “interim final rules,” 26 U.S.C. 9833;

29 U.S.C. 1191c; 42 U.S.C. 300gg-92, permitted the

issuance of immediately effective interim rules without

the prior notice and opportunity for public comment

that is ordinarily required by the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., 701 et seq.; see

5 U.S.C. 553(b) and (c); 82 Fed. Reg. at 47,813-47,815,

47,854-47,856. The agencies additionally concluded that

the “good cause” exception to the APA’s notice-andcomment requirement, 5 U.S.C. 553(b)(B), permitted

them to issue interim rules without notice and comment

in order to protect religious liberty and end the litigation that had beset the prior rules. 82 Fed. Reg. at

47,813-47,815, 47,854-47,856. The agencies did, however, solicit public comments for 60 days following

promulgation of the interim rules in anticipation of final

rulemaking. See id. at 47,792, 47,838.

Pennsylvania brought this suit challenging the

interim rules, alleging (as relevant here) that the rules

(1) failed to comply with the APA’s notice-and-comment

requirements; and (2) were arbitrary and capricious,

an abuse of discretion, or otherwise contrary to law,

5 U.S.C. 706(2)(A), because they violated the ACA

and were not justified by RFRA. C.A. App. 193-196.

Pennsylvania sought a preliminary injunction barring

enforcement of the interim rules, which the district court

granted. App., infra, 47a-103a. The court rejected the

government’s objection to Pennsylvania’s standing; held

that the agencies lacked statutory authority or good cause

to issue the rules without notice and comment; and further

held that neither the ACA nor RFRA authorized the

expanded exemption from the contraceptive-coverage

mandate. See id. at 66a-91a.

The government appealed the preliminary injunction. The Little Sisters of the Poor Saints Peter and

Paul Home (Little Sisters), which intervened in the district court to defend the interim rules, also appealed,

and the appeals were consolidated. 17-3752 C.A. Order

1-2 (June 20, 2018); see 888 F.3d 52, 57-62 (3d Cir. 2018)

(reversing denial of Little Sisters’ motion to intervene).

b. In November 2018, while the government’s appeal

of the preliminary injunction against implementation of

the interim rules was pending, and after considering the

public comments received on the interim rules, the

agencies promulgated final rules that superseded the

interim rules. See 83 Fed. Reg. 57,536 (Nov. 15, 2018)

(religious exemption); 83 Fed. Reg. 57,592 (Nov. 15,

2018) (moral exemption).

i. Like the interim rules, the final rules expanded

the existing religious exemption to cover nongovern-

mental plan sponsors and institutions of higher education that arrange student health plans, to the extent

that those entities have sincere religious objections to

providing contraceptive coverage. See 83 Fed. Reg. at

57,558-57,565, 57,590 (45 C.F.R. 147.132(a)). The agencies also finalized an exemption for entities (except for

publicly traded companies) that have sincere moral

objections to such coverage. See id. at 57,614-57,621,

57,630-57,631 (45 C.F.R. 147.133(a)). Both rules retained

the accommodation as a voluntary option. See, e.g., id.

at 57,537-57,538. And both rules finalized an individual

exemption that allowed—but did not require—willing

employers and insurers to offer plans that omit contraceptive coverage to individuals who have religious or

moral objections to such coverage. See id. at 57,590,

57,631 (45 C.F.R. 147.132(b), 147.133(b)).

The agencies concluded that Congress had granted

HRSA discretion to determine the content and scope

of any preventive-services guidelines adopted under

42 U.S.C. 300gg-13(a)(4). 83 Fed. Reg. at 57,540-57,542.

The agencies observed that, “[s]ince the[ir] first rulemaking on this subject in 2011,” they “ha[d] consistently

interpreted the broad discretion granted to HRSA in

section [300gg-13(a)(4)] as including the power to reconcile the ACA’s preventive-services requirement with

sincerely held views of conscience on the sensitive subject of contraceptive coverage—namely, by exempting

churches and their integrated auxiliaries from the contraceptive [m]andate.” Id. at 57,541. The agencies concluded that, “[b]ecause of the importance of the religious liberty values being accommodated” and “the limited impact of these rules,” the expanded exemptions

“are good policy.” Id. at 57,552. The agencies also took

into account “Congress’s long history of providing

exemptions for moral convictions, especially in certain

health care contexts,” id. at 57,598, state “conscience

protections,” id. at 57,601, and “the litigation surrounding the [m]andate,” id. at 57,602.

The agencies additionally determined that the religious exemption was independently authorized by

RFRA. See 83 Fed. Reg. at 57,544-57,548. They concluded that, “even if RFRA does not compel” the religious exemption, “an expanded exemption rather than

the existing accommodation is the most appropriate

administrative response to the substantial burden identified by the Supreme Court in Hobby Lobby.” Id. at

57,544-57,545. They further concluded that RFRA in

fact required the exemption. See id. at 57,546-57,548.

ii. Following the issuance of the two final rules, New

Jersey joined Pennsylvania’s suit. The two States filed

an amended complaint challenging the final rules,

and they sought a preliminary injunction against their

implementation. App., infra, 11a. The district court

granted a nationwide preliminary injunction barring

the implementation of both rules. Id. at 104a-187a.

The district court again held that the plaintiff States

have standing. App., infra, 120a-128a. On the merits, it

concluded that the final rules were procedurally invalid

under the APA. Id. at 133a-145a. The court determined

that, although the agencies had likely complied with the

APA’s notice-and-comment requirements with respect

to the final rules themselves, the States were likely to

succeed on their claim that the final rules were “fatally

tainted” by the interim rules, which the court had previously determined were likely adopted in violation of

the APA. Id. at 144a. The court further held that the

final rules, like the interim rules, are unlawful because

neither the ACA nor RFRA authorizes the expanded

exemption. See id. at 146a-168a.

Finding that the equities warranted a preliminary

injunction, see App., infra, 168a-173a, the district court

enjoined the agencies from “enforcing” the final rules

“across the Nation,” id. at 185a-186a. The court reasoned that an injunction limited to the plaintiff States

would not fully redress their alleged injuries because

such an injunction would not reach residents of those

States who work for out-of-state employers or students

covered under the insurance plans of parents who live

out of state. See id. at 174a-184a. 1

4. The government appealed, and its appeal was consolidated with the pending appeal concerning the

interim rules. See 17-3752 C.A. Order 2 (Jan. 9, 2019).

The court of appeals affirmed. App., infra, 1a-46a. 2

The court of appeals held that the plaintiff States have

standing to challenge the final rules. App., infra, 14a-22a.

On the merits, the court held that the States were likely

to prevail on their claim that the agencies lacked statutory

authority to promulgate the final rules. See id. at 32a-36a.

The court concluded that Section 300gg-13(a) does

not confer authority to establish any exemptions to the

contraceptive-coverage mandate. See ibid. The court

rejected the government’s contention that, if the ACA did

not authorize the final rules’ religious and moral exemptions, then it also did not authorize the earlier exemption

for churches. Id. at 33a n.26.

The district court correctly declined to impose injunctive relief

against the President. App., infra, 186a n.1.

Little Sisters also appealed, but the court of appeals concluded

that it lacked appellate standing because of an injunction issued in

another case applicable to plans in which it participates. App., infra,

9a n.6.

The court of appeals also held that RFRA did not

authorize the religious exemption. App., infra, 36a-42a.

The court concluded that the existing accommodation

satisfies RFRA, so RFRA did not require the agencies

to provide the religious exemption. See ibid. The court

did not address the agencies’ additional argument that,

even if RFRA does not require the religious exemption,

RFRA at a minimum permits the agencies to adopt that

exemption as a means of eliminating the substantial burden on religion imposed by the mandate. Cf. Gov’t C.A.

Br. 49-53.

The court of appeals additionally held that the States

were likely to succeed in showing that the final rules

were procedurally invalid under the APA. App., infra,

23a-32a. The court concluded that the agencies had

improperly promulgated the interim rules without first

providing the public notice and opportunity for comment

required by 5 U.S.C. 553(b) and (c). App., infra, 23a-28a.

The court rejected the government’s contentions that the

agencies were authorized to adopt interim rules without

notice and comment based on other statutory provisions,

see id. at 23a-25a (discussing 26 U.S.C. 9833, 29 U.S.C.

1191c, and 42 U.S.C. 300gg-92), or the APA’s own “good

cause” exception, 5 U.S.C. 553(b)(B), see App., infra,

26a-28a.

The court of appeals likewise rejected the government’s contention that the final rules, adopted after

notice and comment, were valid irrespective of any putative procedural defect in the interim rules. See App., infra, 29a-32a. It determined that “deficits in the promulgation of the [interim rules] compromised the procedural

integrity of the Final Rules.” Id. at 31a-32a. The court

concluded that “[t]he notice and comment exercise surrounding the Final Rules d[id] not reflect any real open-

mindedness toward the position set forth in the [interim

rules],” citing the similarity between the interim and final

rules.

The court of appeals concluded that the balance of

equities supported a preliminary injunction. See App.,

infra, 42a-43a. The court determined that the plaintiff

States will suffer irreparable harm if the final rules are

implemented, and the exemptions are not necessary to

protect any legally cognizable interest. See ibid. The

court also upheld the injunction’s “nationwide” scope.

Id. at 43a; see id. at 43a-46a. It stated that “[a]n injunction geographically limited to the [plaintiff] States alone

will not protect them from financial harm, as some share

of their residents” are covered by plans of out-of-state

employers and may lose coverage and turn to statefunded services if their plans invoke the exemption. Id.

at 44a.

REASONS FOR GRANTING THE PETITION

In Zubik v. Burwell, 136 S. Ct. 1557 (2016) (per

curiam), and the consolidated cases, this Court granted

certiorari to address whether the contraceptive-coverage

mandate violated RFRA notwithstanding the accommodation that federal agencies had adopted for entities

that objected to the mandate. But the Court ultimately

did not answer that question, and instead remanded

each case to allow the agencies and other parties to

explore potential modifications to the accommodation

that might resolve the parties’ disagreements. See id.

at 1560-1561. The agencies, however, were unable to

find a way to modify the accommodation that adequately addressed the concerns of all sides.

Seeking to resolve the continuing uncertainty and

litigation, the agencies subsequently promulgated, after

soliciting public comment, the final rules at issue here,

which leave the mandate in place but exempt those with

sincere religious or moral objections to providing contraceptive coverage. That effort to resolve the controversy through rulemaking was thwarted by the decision

below, in which the court of appeals held that the final

rules are likely unlawful and upheld a nationwide

injunction against their implementation. Litigation

over the final rules is also ongoing elsewhere. This

Court’s review is once again warranted to bring clarity

and closure that neither lower courts nor now the agencies can provide.

Indeed, the need for this Court’s intervention is even

more acute than in Zubik because the court of appeals’

decision erroneously restricts the agencies’ ability to

redress religious burdens caused by the mandate. The

court’s conclusion that the ACA itself confers no authority on the agencies to recognize conscience exceptions

imperils not only the exemptions in these rules, but the

longstanding exemption for churches and (in practical

effect) self-insured church plans. The court’s unexplained holding that the agencies cannot go beyond

measures the court determined are compelled by

RFRA—in redressing a substantial burden on religion

identified by this Court—is also incorrect, and it threatens to impair agencies’ ability to address religious

objections in other contexts.

The court of appeals’ alternative holding—that the

final rules were tainted by putative procedural defects

it found in the interim rules—is contrary to law and

logic, creates a circuit conflict, and casts doubt over

many other rulemakings. And the court’s affirmance of

a nationwide injunction to redress the asserted injuries

to two States contravenes bedrock principles of Article

III and equity and sweeps far beyond what is necessary

and appropriate to redress any harm to them. The

result the court of appeals reached—effectively nullifying regulations jointly promulgated by three federal

agencies to bring years of litigation to a close—and the

multiple errors in its reasoning amply warrant this

Court’s review. The petition should be granted.

I. THE COURT OF APPEALS’ HOLDING THAT THE FINAL

RULES ARE LIKELY UNLAWFUL IS INCORRECT AND

WARRANTS THIS COURT’S REVIEW

A. The Agencies Had Statutory Authority To Adopt The

Expanded Exemptions

The court of appeals erred in concluding that the

religious and moral exemptions likely exceeded the

agencies’ statutory authority. Both exemptions are

authorized by the ACA itself, which empowers HRSA to

determine which preventive services for women plans

must cover. 42 U.S.C. 300gg-13(a)(4). The religious

exemption is also independently authorized—indeed,

required—by RFRA. The court of appeals’ contrary

holdings lack merit and warrant this Court’s review.

1. The ACA authorized the expanded exemptions

a. The ACA’s preventive-services provision states

that certain health plans “shall * * * provide coverage,”

without cost-sharing, for certain preventive services.

42 U.S.C. 300gg-13(a). For example, for all individuals,

such plans must cover preventive services recommended

by the Preventive Services Task Force. 42 U.S.C.

300gg(a)(1). In addition, “with respect to women,” the

provision requires plans to cover “such additional preventive care * * * as provided for in comprehensive

guidelines supported by [HRSA] for purposes of this

paragraph.” 42 U.S.C. 300gg-13(a)(4).

The statute does not specify any particular types of

“additional preventive care” for women that such guidelines must include. Instead, Congress reserved the

scope, substance, and enforcement of those guidelines

to HRSA—and in turn its parent, HHS. Congress has

also authorized HHS and the Departments of Labor and

the Treasury to adopt rules implementing (inter alia)

the preventive-services provision. 42 U.S.C. 300gg-92;

29 U.S.C. 1191c; 26 U.S.C. 9833.

Together, Section 300gg-13(a)(4) and those grants of

rulemaking authority empower the agencies to exempt

particular entities from providing services that HRSA’s

guidelines would otherwise require. Indeed, since August

2011—when HRSA first issued its guidelines generally

requiring coverage for FDA-approved contraceptives,

see p. 3, supra—the agencies have exercised their statutory authority under Section 300gg-13(a)(4) by exempting churches and their integrated auxiliaries from the

contraceptive-coverage mandate. See 76 Fed. Reg. at

46,623. The plaintiff States have never disputed the

agencies’ authority to create that exemption. The agencies properly invoked that same authority in adopting

the expanded religious and moral exemptions at issue

here.

b. The court of appeals erred in concluding that Section 300gg-13(a)(4) does not authorize the agencies to

exempt particular entities from the requirement to cover

particular preventive services for women. App., infra,

32a-35a. The court concluded that Section 300gg-13(a)(4)

“concerns the type of services that are to be provided and

does not provide authority to undermine Congress’s

directive concerning who must provide coverage for

these services.” Id. at 33a. That is incorrect.

Nothing in Section 300gg-13(a)(4)’s text compels

HRSA to require that every service enumerated in its

guidelines be covered on an all-or-nothing basis by all

plans, or precludes the agency from specifying conditions under which a plan need not cover particular services. On the contrary, the provision’s language requiring that services be covered “as provided for in comprehensive guidelines supported by [HRSA],” 42 U.S.C.

300gg-13(a)(4) (emphases added), indicates that the

agency may determine the manner and circumstances

in which services are covered. Moreover, Congress’s

use of the phrase “comprehensive guidelines supported

by [HRSA] for purposes of this paragraph,” ibid.

(emphasis added), suggests that the agency can and

should consider the context and purpose of the statutory mandate in shaping its guidelines.

Context reinforces the natural reading of the text.

Paragraph (a)(4) of Section 300gg-13 contrasts with the

preceding three paragraphs, which require covered

plans to cover “evidence-based items or services that

have in effect” a particular rating “in the current recommendations of ” the Preventive Services Task Force;

“immunizations that have in effect a recommendation

from the [CDC’s] Advisory Committee”; and, “with

respect to infants, children, and adolescents, evidenceinformed preventive care and screenings provided for in

the comprehensive guidelines supported by [HRSA].”

42 U.S.C. 300gg-13(a)(1)-(3). None of those paragraphs

employs the “as provided for” or “for purposes of this

paragraph” language that appears in paragraph (a)(4),

an omission that courts should presume is purposeful,

see Russello v. United States, 464 U.S. 16, 23 (1983).

In addition, each of those earlier paragraphs refers

to recommendations or guidelines that were already in

existence when the ACA was enacted. In contrast, the

“comprehensive guidelines” for women’s preventive

services mentioned in paragraph (a)(4) did not yet exist.

42 U.S.C. 300gg-13(a)(4). Congress thus necessarily

vested HRSA with discretion to determine the content

of those guidelines going forward. Moreover, two of the

preceding paragraphs describe the services addressed

in those already-existing recommendations or guidelines as “evidence-based” or “evidence-informed.”

42 U.S.C. 300gg-13(a)(1) and (3). Paragraph (a)(4) lacks

similar language, which suggests that Congress contemplated that HRSA could and would consider factors

beyond scientific evidence of a service’s medical risks

and benefits in deciding whether to support a coverage

mandate for that particular service.

The court of appeals emphasized that Section

300gg-13(a) uses the word “ ‘shall,’ ” which “denotes a

requirement.” App., infra, 33a (citation omitted). That

is true but beside the point. The word “shall” imposes a

mandatory obligation on covered plans to cover without

cost-sharing the services that Congress in paragraph

(a)(4) authorized HRSA to specify. But it does not speak

to HRSA’s authority to determine whether to support

coverage of a service by a particular plan or insurer in

the first place. The fact that a covered plan “shall * * *

provide coverage” for services that HRSA’s guidelines

direct the plan to provide, 42 U.S.C. 300gg-13(a), has no

bearing on whether HRSA may conclude that, for

example, churches need not cover particular methods of

contraceptives to which they object—as the agencies

have done since HRSA first adopted its guidelines in

2011.

As the court of appeals acknowledged, its reading of

Section 300gg-13(a)’s text is “facially at odds” with the

original church exemption itself. App., infra, 33a n.26.

The court suggested that the church exemption might

be required by the First Amendment’s Free Exercise

Clause, and it pointed to this Court’s precedents affirming “ministerial exception[s]” to other statutes. Ibid.

But the church exemption applies to all churches regardless of whether they have a religious objection to

providing contraceptive coverage, see 45 C.F.R.

147.131(a) (2016), and thus is not tailored to any cognizable free-exercise concern. If the agencies nevertheless had authority to adopt that exemption in its full

scope—which neither the court of appeals nor the

States have disputed—then they likewise had authority

to adopt the final rules’ exemptions for other, nonchurch entities that have religious or moral objections

to the mandate.

2. RFRA authorized and, for certain employers, required

the expanded religious exemption

a. The religious exemption is independently authorized by RFRA, which prohibits the government from

“substantially burden[ing] a person’s exercise of religion” unless the application of the burden to that person

is “the least restrictive means” of furthering a “compelling governmental interest.” 42 U.S.C. 2000bb-1(b). In

Burwell v. Hobby Lobby Stores, Inc., 573 U.S. 682

(2014), this Court held that the contraceptive-coverage

mandate “imposes a substantial burden” on objecting

employers. Id. at 726. The Court further held that

applying the mandate to objecting employers was not

the least restrictive means of furthering any compelling

governmental interest. See id. at 728-732.

In light of Hobby Lobby, RFRA requires the government to eliminate the substantial burden that the

contraceptive-coverage mandate imposes on religion.

But the Court in Hobby Lobby did not determine how

the government may or must eliminate that burden.

Although the Court pointed to the existence of the

accommodation as one less-restrictive means of furthering any compelling governmental interest with respect

to the employers in that case, the Court had no occasion,

and expressly declined, to “decide * * * whether an

approach of th[at] type complies with RFRA for purposes of all religious claims.” 573 U.S. at 731 (emphasis

added). Nor did the Court suggest that, if the accommodation complied with RFRA in all cases, it would

then be the only permissible way for the government to

eliminate the burden on religion caused by the mandate.

The agencies reasonably determined that “the most

appropriate administrative response to the substantial

burden identified by [this Court] in Hobby Lobby” was

to adopt the expanded religious exemption rather than

merely retain the existing accommodation. 83 Fed.

Reg. at 57,545. As the agencies explained, “[a]lthough

RFRA prohibits the government from substantially

burdening a person’s religious exercise where doing so

is not the least restrictive means of furthering a compelling interest,” RFRA does not “prescribe[ ] the remedy by which the government must eliminate that burden.” Ibid. (emphasis omitted). “The prior administration chose” to attempt to comply with RFRA “through

the complex accommodation,” but RFRA did not “compel[ ] that novel choice or prohibit[ ] the current administration from employing the more straightforward

choice of an exemption—much like the existing and

unchallenged exemption for churches.” Ibid. After all,

had the agencies adopted the religious exemption from

the outset, “no one could reasonably have argued that

doing so was improper because they should have

invented the accommodation instead,” and nothing in

RFRA “compels a different result now based merely on

path dependence.” Ibid. The agencies thus correctly

concluded that, regardless of whether RFRA requires

the expanded religious exemption (or would be satisfied

by the accommodation), RFRA at least permits them to

adopt the exemption to satisfy their duty to eliminate

the substantial burden on religion caused by the mandate. Id. at 57,544-57,545.

The agencies’ decision to adopt the religious exemption in their discretion—even if it was not required by

RFRA—was especially reasonable in light of the “continued litigation” and “legal uncertainty” over whether

the existing accommodation violates RFRA. 83 Fed.

Reg. at 57,545; see Ricci v. DeStefano, 557 U.S. 557, 585

(2009). In Ricci, this Court recognized that an entity

faced with potentially conflicting statutory obligations

should be afforded some leeway in resolving that conflict. Ibid. “[T]o resolve any conflict between the

disparate-treatment and disparate-impact provisions

of ” Title VII of the Civil Rights Act of 1964, 42 U.S.C.

2000e et seq., the Court held that an employer need only

have a strong basis to believe that an employment practice violates the disparate-impact ban in order to take

certain types of remedial action that would otherwise

violate its disparate-treatment ban. 557 U.S. at 584; see

id. at 583-585. Here, likewise, the agencies reasonably

responded to the considerable doubt about the accommodation’s legality by adopting the religious exemption.

Cf. Walz v. Tax Comm’n, 397 U.S. 664, 669 (1970) (recognizing “room for play in the joints” when accommodating exercise of religion).

To be sure, RFRA would not prohibit applying the

contraceptive mandate to a particular employer if the

agencies carried their burden of “demonstrat[ing] that

application of the” mandate to that employer both “is in

furtherance of a compelling governmental interest” and

“is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. 2000bb-1(b).

But, as the agencies found, application of the mandate

to objecting entities neither serves a compelling governmental interest nor is narrowly tailored to any such

interest. See 83 Fed. Reg. at 57,546-57,548. As they

explained, Congress itself did not mandate coverage of

contraceptives, and the mandate is already inapplicable to

various plans, including church and other plans that have

always been actually or effectively exempt and “grandfathered plans” (which are exempt from the preventiveservices mandate altogether). Id. at 57,546-57,547.

Moreover, some entities that object to providing coverage for certain methods of contraception may not object

to others, and various federal, state, and local programs

provide free or subsidized contraceptives to low-income

women. Id. at 57,548.

b. The court of appeals held that RFRA does not

authorize the religious exemption, reasoning that the

existing accommodation satisfies RFRA and therefore

“RFRA does not require” the agencies to go further by

adopting the religious exemption. App., infra, 39a

(emphasis added); see id. at 36a-41a. But the court never

confronted the agencies’ determination in the final rule

that, “even if RFRA does not compel” the exemption,

RFRA at least permits them to adopt it. 83 Fed. Reg. at

57,544. The court erred by focusing exclusively on

whether the accommodation itself imposes a substantial

burden on religion that must be remedied under RFRA.

See App., infra, 38a-41a. The court never explained why

the agencies lack discretion to eliminate the underlying

substantial burden on religion caused by the contraceptive mandate, which this Court recognized in Hobby

Lobby, by adopting the exemption.

In any event, the court of appeals’ conclusion that the

accommodation complies with RFRA in all cases is incorrect. As the agencies explained, the accommodation does

violate RFRA with respect to at least some employers.

See 83 Fed. Reg. at 57,545-57,548. Specifically, an

employer that objects on religious grounds to providing

coverage for certain contraceptives may sincerely

believe that using the plan sponsored by that employer

to provide such coverage makes the employer complicit

in providing contraceptive coverage. See id. at 57,546.

In light of that sincere religious belief, requiring the

employer “to choose between the Mandate, the accommodation, or incurring penalties for noncompliance

imposes a substantial burden on religious exercise under

RFRA.” Ibid.; see 82 Fed. Reg. at 47,798, 47,800; accord

Sharpe Holdings, Inc. v. HHS, 801 F.3d 927, 939-943

(8th Cir. 2015), vacated and remanded sub nom. HHS v.

CNS Int’l Ministries, 136 S. Ct. 2006 (2016); Priests for

Life v. HHS, 808 F.3d 1, 16-21 (D.C. Cir. 2015) (Kavanaugh, J., dissenting from the denial of rehearing en

banc). Indeed, after extensive study, the agencies were

unable to identify any means short of an exemption that

would resolve all religious objections. And after further

examination, the agencies found in the final rule that

denying an exemption would not be narrowly tailored to

achieving any compelling interest. See pp. 7-8, supra.

The court of appeals concluded that the accommodation does not impose a substantial burden on religion,

reasoning that an employer’s “submission of the selfcertification form” to its insurer to invoke the accommodation “does not make the employer[ ] ‘complicit’ in the

provision of contraceptive coverage.” App., infra, 39a

(brackets and citation omitted). But this Court made

clear in Hobby Lobby that a court may not reject a RFRA

claim on the ground that “the connection between what

the objecting parties must do” and “the end that they

find to be morally wrong” is “too attenuated.” 573 U.S.

at 723. As long as a claimant’s asserted belief “reflects

‘an honest conviction,’ ” “it is not for [courts] to say” that

those “religious beliefs are mistaken.” Id. at 725 (citations omitted); see Sharpe, 801 F.3d at 941 (“As Hobby

Lobby instructs, * * * we must accept [plaintiffs’]

assertion that self-certification under the accommodation process * * * would violate their sincerely held

religious beliefs.”); Priests for Life, 808 F.3d at 17

(Kavanaugh, J., dissenting from the denial of rehearing

en banc) (Hobby Lobby “emphasized that judges in

RFRA cases may question only the sincerity of a plaintiff ’s religious belief, not the correctness or reasonableness of that religious belief.”); cf. Thomas v. Review Bd.

of the Ind. Emp’t Sec. Div., 450 U.S. 707, 714 (1981).

The court of appeals thus had no warrant under

RFRA to reject as incorrect a religious objector’s sincere belief that invoking the accommodation would

make it complicit in providing contraceptive coverage.

The court instead should have credited such sincere

beliefs and focused on the amount of pressure the government places on such employers’ religious exercise.

Hobby Lobby answers that question as well. The Court

had “little trouble” concluding that the significant financial penalties imposed on employers that did not comply

with the mandate imposed a substantial burden.

573 U.S. at 719. Employers that do not comply with the

mandate or accommodation face the same penalties.

The court of appeals also stated that the religious

exemption would “impose an undue burden on

nonbeneficiaries—the female employees who will lose

coverage for contraceptive care.” App., infra, 41a. But

that likewise does not justify rejecting the religious

exemption: a RFRA remedy is not invalid merely

because it allows a religious objector to withhold a benefit

from third parties. See Hobby Lobby, 573 U.S. at 729

n.37 (“[I]t could not reasonably be maintained that any

burden on religious exercise * * * is permissible under

RFRA so long as the relevant legal obligation requires

the religious adherent to confer a benefit on third parties”). And any loss of contraceptive coverage to women

whose private employers invoke the religious exemption would result from decisions of those employers, not

the government. The ACA does not confer any right to

contraceptive coverage from a private employer. The

obligation to provide such coverage was imposed by the

agencies, and the agencies did not burden women

merely by declining to require every private employer

to provide contraceptive coverage, as they had already

done in the exemption for churches and the accommodation’s effective exemption for self-insured church plans.

See 83 Fed. Reg. at 57,549; cf. Corporation of the Presiding Bishop of the Church of Jesus Christ of Latter-Day

Saints v. Amos, 483 U.S. 327, 337 n.15 (1987).

3. The court of appeals’ holding that the exemptions are

likely statutorily unauthorized warrants review

The question whether the agencies acted within their

statutory authority in adopting the exemptions warrants this Court’s review. The Court granted certiorari

in Zubik and the consolidated cases to address challenges to the existing accommodation. Plenary review

is even more appropriate now. Zubik left unresolved

the disputes over the legality of the accommodation,

remanding for the agencies and challengers to try to

resolve their remaining differences. After soliciting

public input and concluding that no measure short of an

exemption would resolve all objections, the agencies

adopted the final rules seeking to end the long-running

uncertainty and litigation by establishing the religious

and moral exemptions.

The court of appeals’ decision thwarts those efforts

and appears to leave the agencies no viable path forward. Under Hobby Lobby, the accommodation marks

the floor: whether or not RFRA requires more, a question the Court expressly reserved, the agencies cannot

afford religious objectors any less protection than the

accommodation offers. But by concluding that the ACA

does not authorize any exemptions from the mandate

and that RFRA does not authorize going beyond the

existing accommodation, the decision below sets the

accommodation as the ceiling. It thereby freezes in

place a measure that the agencies had already concluded would not resolve all objections. The decision

below thus requires the agencies to maintain rules that

they have concluded, and some courts have held, substantially burden sincere religious beliefs—and that do

not address moral objections at all. That ruling implicates a compelling governmental interest in safeguarding rights of conscience. And the decision’s reasoning

casts doubt on the church exemption that has coexisted

with the contraceptive-coverage mandate from the

beginning and the accommodation’s effective exemption

for self-insured church plans.

B. The Final Rules Do Not Violate The APA

The court of appeals also erred in concluding that the

States are likely to succeed on their claim that the final

rules are procedurally invalid. App., infra, 23a-32a. Far

from counseling against review, that alternative ground

increases the need for this Court’s intervention.

1. The final rules, adopted after notice and comment,

comply with the APA regardless of whether the

interim rules were procedurally defective

The APA ordinarily requires agencies to publish a

“notice of proposed rule making” and to “give interested persons an opportunity to participate” before

promulgating regulations. 5 U.S.C. 553(b) and (c). An

agency may forgo those steps, however, if Congress has

expressly authorized it to do so, 5 U.S.C. 559, or if the

agency has “good cause,” 5 U.S.C. 553(b)(B). The agencies properly invoked both grounds for issuing the

interim rules in 2017 without notice and comment. Congress has authorized each agency to issue “any interim

final rules as the Secretary determines are appropriate

to carry out [specified provisions].” 42 U.S.C. 300gg-92;

see 26 U.S.C. 9833; 29 U.S.C. 1191c. And the agencies

reasonably determined that the uncertainty created by

conflicting lower-court decisions and ongoing litigation,

as well as the need to protect objecting employers from

potentially devastating penalties, made delaying the

interim rules’ effective dates pending notice and comment “impracticable” and “contrary to the public interest.” 82 Fed. Reg. at 47,813; see Gov’t C.A. Br. 65-75.

The court of appeals disagreed, concluding that neither exception to the notice-and-comment requirement

applies to the interim rules. App., infra, 23a-28a. But

whether the agencies validly issued the interim rules

without notice and comment is irrelevant here because

the agencies issued the final rules—which superseded

the interim rules—only after soliciting and considering

public comments. See 83 Fed. Reg. at 57,552. The

validity of the interim rules might matter at most with

respect to the period before the final rules’ effective

date (January 14, 2019). Id. at 57,536. But in this suit

seeking prospective relief, any putative deficiency in

the process of adopting the interim rules is now academic.

The court of appeals nevertheless concluded that the

final rules likely are procedurally invalid as well

because they too closely track the interim rules. App.,

infra, 29a-32a. That conclusion is untenable. Even

assuming arguendo that the interim rules were procedurally improper, nothing in the APA suggests that a

regulation issued after notice and comment is invalid

merely because it was preceded by a procedurally deficient interim rule.

Nor does the fact that the final rules’ “substance” and

“reason[ing]” resemble that of the interim rules, App.,

infra, 30a, in which the agencies solicited comment, render the final rules suspect. On the contrary, the APA

requires a proposed rule to provide “fair notice” of the

final rule’s content, and a final rule that departs too far

from the proposal may violate 5 U.S.C. 553. Long Island

Care at Home, Ltd. v. Coke, 551 U.S. 158, 174 (2007)

(noting that lower courts require final rule to be “a ‘logical outgrowth’ of the rule proposed” (citation omitted)).

On the court of appeals’ view, it is unclear whether, when,

or how an agency whose interim rule is declared procedurally invalid could ever cure the defect through further

rulemaking.

The court of appeals faulted the final rules for “not

reflect[ing] any real open-mindedness toward the position set forth in the [interim rules].” App., infra, 30a.

But as the court of appeals itself has previously recognized, “all that the [APA] requires” is that “the agency

considered” comments, Nazareth Hosp. v. Secretary,

HHS, 747 F.3d 172, 185 (3d Cir. 2014) (brackets and

citation omitted)—not that it adopted a particular proportion of them. “While changes and revision are indicative

of an open mind, an agency’s failure to make any does

not mean its mind is closed.” Advocates for Highway &

Auto Safety v. Federal Highway Admin., 28 F.3d 1288,

1292 (D.C. Cir. 1994) (citation omitted). The agencies

did consider various changes to the interim rules raised

by public comments, adopting some proposals and

rejecting others. See, e.g., 83 Fed. Reg. at 57,557-57,558,

57,568-57,571, 57,616-57,619, 57,622-57,623. The court

did not identify any comment or relevant factor the

agencies failed to consider; it “express[ed] no opinion on

whether the Agencies appropriately responded to comments collected.” App., infra, 30a. And the district

court found that, “[f ]or each example” the States cited of

comments the agencies purportedly failed to address,

the agencies in fact “acknowledged the comments and

provided an explanation as to why the Agencies did (or

did not)” adopt commenters’ views. Id. at 136a.

2. The court of appeals’ holding that the final rules are

likely procedurally invalid warrants review

The court of appeals’ decision is in significant tension

with the decisions of other courts of appeals, which have

upheld final rules in similar circumstances regardless of

the procedural validity of a preceding interim rule. See

Levesque v. Block, 723 F.2d 175, 185, 188-189 (1st Cir.

1983) (voiding interim rule but concluding that final rule

satisfied notice-and-comment requirements, where

agency “present[ed] evidence of a level of public participation and a degree of agency receptivity that demonstrate that a real ‘public reconsideration of the issued

rule’ has taken place”); Federal Express Corp. v.

Mineta, 373 F.3d 112, 120 (D.C. Cir. 2004) (holding that

final rule satisfied notice-and-comment requirements

where agency provided “a meaningful opportunity to

comment,” without addressing whether agency had

good cause to issue interim final rule (citations omitted)); cf. Administrative Conference of the U.S., Recommendation 95-4, Procedures for Noncontroversial and

Expedited Rulemaking, 60 Fed. Reg. 43,108, 43,110,

43,113 (Aug. 18, 1995) (“Where an agency has used postpromulgation comment procedures * * * courts are

encouraged not to set aside such ratified or modified

rule solely on the basis that inadequate good cause

existed originally to dispense with prepromulgation

notice and comment procedures.”).

Whether and in what circumstances a procedural

defect in an interim rule invalidates an ensuing final rule

is also important. A study by the Government Accountability Office (GAO) found that, between 2003 and 2010,

federal agencies issued dozens of “major” interim rules,

which were frequently followed by finalized rules. U.S.

GAO, GAO-13-21, Federal Rulemaking: Agencies Could

Take Additional Steps to Respond to Public Comments

24-26, 41-44 (2012). Moreover, the procedural validity of

an interim rule may not be definitively resolved in litigation for months or years, as this case illustrates—

potentially long after a final rule would be promulgated

in the ordinary course. The court of appeals’ position

would put agencies to a choice between deferring issuance of final rules—leaving allegedly defective interim

rules in place—or risking a future judicial decision finding the interim rules invalid and the final rules tainted.

II. THE COURT OF APPEALS’ HOLDING AFFIRMING A

NATIONWIDE INJUNCTION IS INCORRECT AND

WARRANTS THIS COURT’S REVIEW

A. This Court’s review is independently warranted

because the “nationwide” injunction the court of

appeals affirmed, App., infra, 44a, transgresses fundamental Article III and equitable principles. Article III

requires a “plaintiff ’s remedy [to] be ‘limited to the inadequacy that produced his injury in fact.’ ” Gill v. Whitford, 138 S. Ct. 1916, 1930 (2018) (quoting Lewis v. Casey,

518 U.S. 343, 357 (1996)) (brackets omitted). A plaintiff

must “demonstrate standing * * * for each form of

relief that is sought.” Town of Chester v. Laroe Estates,

Inc., 137 S. Ct. 1645, 1650 (2017) (citation omitted). And

just as a plaintiff cannot pursue relief to benefit others

if his own injury has already been redressed, see Summers v. Earth Island Inst., 555 U.S. 488, 494-497 (2009),

a plaintiff cannot seek relief in the first instance beyond

what is necessary to redress his own injury, see Whitford, 138 S. Ct. at 1929-1931 (plaintiffs challenging

legislative-districting plan could not seek statewide

relief because injury was district-specific).

Longstanding principles of equity likewise require

that injunctive relief “be no more burdensome to the

defendant than necessary to provide complete relief to

the plaintiff [ ].” Madsen v. Women’s Health Ctr., Inc.,

512 U.S. 753, 765 (1994) (citation omitted); see Lewis,

518 U.S. at 359-360. Moreover, federal courts’ equitable

authority is generally confined to relief “traditionally

accorded by courts of equity” in 1789. Grupo Mexicano

de Desarrollo, S.A. v. Alliance Bond Fund, Inc.,

527 U.S. 308, 318 (1999). Absent-party injunctions generally, and so-called nationwide injunctions in particular, are a modern creation that did not exist at equity.

Samuel L. Bray, Multiple Chancellors: Reforming the

National Injunction, 131 Harv. L. Rev. 417, 424-445

(2017). Such orders also “take a toll on the federal court

system—preventing legal questions from percolating

through the federal courts, encouraging forum shopping, and making every case a national emergency for

the courts and for the Executive Branch.” Trump v.

Hawaii, 138 S. Ct. 2392, 2425 (2018) (Thomas, J., concurring). In addition, nationwide injunctions create an

inequitable one-way ratchet: any prevailing plaintiff

can obtain relief on behalf of all others, but a ruling for

the government does not preclude other plaintiffs from

seeking relief. Cf. United States v. Mendoza, 464 U.S.

154, 158-162 (1984).

B. The injunction the court of appeals affirmed cannot be reconciled with those principles. This suit was

brought by two States, Pennsylvania and New Jersey.

As the government explained below, the States have not

demonstrated any cognizable injury-in-fact that is actual or imminent and fairly traceable to the final rules.

Gov’t C.A. Br. 22-39. Their suit should be dismissed,

and their request for a preliminary injunction denied,

on that basis alone. But even if the States had demonstrated some Article III injury, enjoining the final rules

throughout the country is not necessary or appropriate

to redress it.

The court of appeals stated that “a nationwide

injunction is necessary to provide the States complete

relief ” principally because some of their residents work

out of state; if those residents’ employers are exempt, it

reasoned, those residents will turn to state-funded services. App., infra, 44a-45a. But many New Jersey residents who work out of state do so in Pennsylvania, and

vice versa. Gov’t C.A. Br. 82. And although some of

those States’ residents may work in other adjoining

States—New York, Delaware, Maryland, Ohio, and West

Virginia—all but one of those States (Ohio) requires

health-insurance plans (aside from self-insured plans) to

provide contraceptive coverage. Id. at 82-83. Those who

work in other States may also be unaffected because

their out-of-state employer is ineligible for the exemption or legally or effectively exempt from the mandate

for other reasons. Id. at 83-84. The court’s conjecture

about out-of-state employment (or study) does not

establish that nationwide relief is necessary to redress

any cognizable, irreparable injury to the plaintiff

States.

At a minimum, nationwide relief is not appropriate

because the balance of equities tips decisively in the

government’s favor. Weighed against the government’s

interest in implementation of its rules and in safeguarding religious liberty and moral conscience, the States’

speculative injuries predicated on residents who might

be covered by out-of-state plans and who might resort

to state-funded assistance if their plans invoke the

exemptions cannot equitably justify enjoining the

exemptions everywhere.

C. This Court’s review of the court of appeals’ decision affirming nationwide relief is warranted because

that decision extends a concerning trend among lower

courts of issuing categorical, absent-party injunctions

that bar any enforcement of federal laws or policies

against any person. The decision below is also in tension with the Ninth Circuit’s holding that a different

district court abused its discretion by imposing nationwide injunctive relief against the interim rules in a parallel suit by other States. See California v. Azar,

911 F.3d 558, 582-584 (2018), cert. denied, 139 S. Ct.

2716 (2019). After cataloguing the “detrimental consequences” of nationwide injunctions, the Ninth Circuit

concluded that relief limited to the plaintiff States there

“would provide complete relief to them,” including the

“economic harm” those States asserted. Id. at 583-584.

The district court here expressly rejected “the Ninth

Circuit’s approach.” App., infra, 180a. In affirming that

decision, the court of appeals sought to distinguish this

case on the ground that “the record” here was more

extensive. Id. at 44a n.32. But the scope of the record in

this case is irrelevant because the court of appeals cited

nothing in that record that justifies categorical relief.

CONCLUSION

The petition for a writ of certiorari should be granted.

Respectfully submitted.

NOEL J. FRANCISCO

Solicitor General

JOSEPH H. HUNT

Assistant Attorney General

JEFFREY B. WALL

Deputy Solicitor General

HASHIM M. MOOPPAN

Deputy Assistant Attorney

General

JONATHAN C. BOND

Assistant to the Solicitor

General

SHARON SWINGLE

LOWELL V. STURGILL JR.

KAREN SCHOEN

Attorneys

OCTOBER 2019

APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

Nos. 17-3752, 18-1253, 19-1129, 19-1189

COMMONWEALTH OF PENNSYLVANIA;

STATE OF NEW JERSEY

PRESIDENT UNITED STATES OF AMERICA;

SECRETARY UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES; UNITED STATES

DEPARTMENT OF HEALTH AND HUMAN SERVICES;

SECRETARY UNITED STATES DEPARTMENT OF

TREASURY; UNITED STATES DEPARTMENT OF

TREASURY; SECRETARY UNITED STATES

DEPARTMENT OF LABOR; UNITED STATES

DEPARTMENT OF LABOR; UNITED STATES OF AMERICA

LITTLE SISTERS OF THE POOR

SAINTS PETER AND PAUL HOME

(INTERVENOR IN D.C.), APPELLANT IN 17-3752, 19-1129

PRESIDENT UNITED STATES OF AMERICA;

SECRETARY UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES; UNITED STATES

DEPARTMENT OF HEALTH AND HUMAN SERVICES;

SECRETARY UNITED STATES DEPARTMENT OF

TREASURY; UNITED STATES DEPARTMENT OF

TREASURY; SECRETARY UNITED STATES

DEPARTMENT OF LABOR; UNITED STATES

DEPARTMENT OF LABOR, APPELLANTS IN 18-1253,

19-1189 (EXCEPT PRESIDENT UNITED STATES OF

AMERICA)

(1a)

Argued: May 21, 2019

Filed: July 12, 2019*

On Appeal from the United States District Court

for the Eastern District of Pennsylvania

(E.D. Pa. No. 2:17-cv-04540)

District Judge: Hon. Wendy Beetlestone

OPINION OF THE COURT

Before:

Judges.

MCKEE, SHWARTZ, and FUENTES, Circuit

SHWARTZ, Circuit Judge.

The Women’s Health Amendment to the Affordable

Care Act (“ACA”) mandated that women’s health insurance include coverage for preventive health care.

Through the Amendment, Congress directed the Health

Resources and Services Administration (“HRSA”), a

component of the Department of Health and Human Services (“HHS”), to issue guidelines setting forth the preventive health care services that women should be provided. Among the services HRSA identified was contraceptive care. Nowhere in the enabling statute did

Congress grant the agency the authority to exempt entities from providing insurance coverage for such services nor did Congress allow federal agencies to issue

regulations concerning this coverage without complying

with the Administrative Procedure Act.

As amended by order of July 18, 2019.

Notwithstanding Congress’s directives, in 2017, HHS

and the Departments of Labor and Treasury (collectively, “the Agencies”) promulgated regulations that expanded the entities that could invoke an exemption to

the requirement that group health insurance plans cover

contraceptive services as a form of women’s preventive

health care. Because the state plaintiffs are likely to

succeed in proving that the Agencies did not follow the

APA and that the regulations are not authorized under

the ACA or required by the Religious Freedom Restoration Act (“RFRA”), we will affirm the District Court’s

order preliminarily enjoining the rules’ enforcement nationwide.

Enacted as a part of the ACA, Pub. L. No. 111-148,

124 Stat. 119 (2010), the Women’s Health Amendment

mandates that “[a] group health plan[ 1] and a health insurance issuer offering group or individual health insurance coverage shall, at a minimum provide coverage for

and shall not impose any cost sharing requirements for

. . .

preventive care and screenings [for women]

. . . as provided for in comprehensive guidelines supported by the [HRSA].” 2 42 U.S.C. § 300gg-13(a),

Pursuant to 42 U.S.C. § 300bb-8(1), the term “group health plan”

has the meaning set forth in 26 U.S.C. § 5000(b)(1), which defines a

“group health plan” as “a plan (including a self-insured plan) of, or

contributed to by, an employer . . . to provide health care (directly or otherwise) to the employees.”

Congress expressly exempted two sets of actors from various

ACA requirements, including the Women’s Health Amendment:

grandfathered health plans, 42 U.S.C. § 18011, and employers with

fewer than 50 employees, 26 U.S.C. § 4980H(c)(2).

(a)(4). HRSA commissioned an expert panel from the

Institute of Medicine to recommend covered services.

In 2011, HRSA adopted the Institute’s recommendations and issued guidelines defining preventive care to

include all “Food and Drug Administration approved

contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity,” “as prescribed” by a woman’s health

care provider. HRSA, Women’s Preventive Services

Guidelines, https://www.hrsa.gov/womens-guidelines/

index.html (last visited May 8, 2019). This statutory

and regulatory scheme was deemed the “Contraceptive

Mandate.” Several regulations and litigation followed.

The same day that the Guidelines were issued, the

Agencies promulgated an interim final rule (“IFR”), followed by a final rule in 2013, to exempt certain religious

employers—namely, churches and similar entities—

from the Contraceptive Mandate. Group Health Plans

and Health Insurance Issuers Relating to Coverage of

Preventive Services Under the Patient Protection Affordable Care Act, 77 Fed. Reg. 8,725 (Feb. 15, 2012)

(the “Church Exemption”); Group Health Plans and

Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act, 76 Fed. Reg. 46,621 (Aug. 3, 2011). 3

After a notice-and-comment rulemaking process, which included

consideration of comments concerning whether coverage may conflict with the religious beliefs of some employers, Group Health

Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care

Act, 76 Fed. Reg. 46,621, 46,623 (August 3, 2011), the Agencies defined “religious employer[s]” in the Church Exemption as entities

As the Agencies later explained, the “exemption for

churches and houses of worship is consistent with their

special status under longstanding tradition in our society and under federal law.” Coverage of Certain Preventive Services Under the Affordable Care Act, 80 Fed.

Reg. 41,318, 41,325 (July 14, 2015).

The 2013 final rule also separately provided that a

nonprofit religious employer who “(1) [o]pposes providing coverage for some or all of the contraceptive services

required to be covered . . . on account of religious

objections; (2) is organized and operates as a nonprofit

entity; (3) holds itself out as a religious organization; and

(4) self-certifies that it satisfies the first three criteria,”

78 Fed. Reg. at 39,874, is entitled to an accommodation

to avoid “contracting, arranging, paying, or referring

for contraceptive coverage,” id. at 39,875. This accommodation process (the “Accommodation”) permits an

employer to send a self-certification form to its insurance issuer, which then excludes contraceptive coverage, either in full or in part, from the group health plan

and in turn “provide[s] payments for contraceptive services for plan participants and beneficiaries, separate

from the group health plan, without the imposition of

cost sharing, premium, fee, or other charge on plan participants or beneficiaries or on the eligible organization

or its plan.” Id. at 39,876. A third party administra-

“that [are] organized and operate[] as . . . nonprofit entit[ies]

and [are] referred to” as such in the internal revenue code provision applying to “churches, their integrated auxiliaries, and conventions or associations of churches, as well as to the exclusively

religious activities of any religious order,” Coverage of Certain

Preventive Services Under the Affordable Care Act, 78 Fed. Reg.

39,870, 39,871, 39,889 (July 2, 2013); see 45 C.F.R. § 147.132.

tor (“TPA”) may also be used as a claims or plan administrator “solely for the purpose of providing payments

for contraceptive services for participants and beneficiaries in a self-insured plan of an eligible organization

at no cost to plan participants or beneficiaries or to the

eligible organization.” Id. at 39,879. By invoking the

Accommodation, the employer was no longer responsible for providing coverage for contraceptive care.

Various legal challenges followed. First, in Burwell

v. Hobby Lobby Stores, Inc., 573 U.S. 682 (2014), the

Supreme Court held that the Accommodation must be

extended to closely-held for-profit corporations with

sincere religious objections to the provision of contraceptive coverage so that their religious beliefs were

not substantially burdened under RFRA, 42 U.S.C.

§ 2000bb-1. Id. at 724-26. The Court observed that

use of the Accommodation process was a less restrictive

means to ensure access to cost-free contraceptives. Id.

at 730-31. Days later, in Wheaton College v. Burwell,

573 U.S. 958 (2014), the Court concluded that Wheaton

College, who also lodged a religious objection to providing insurance for services covered by the Contraceptive

Mandate, did not have to use the Accommodation selfcertification form, known as the ESBA Form 700, but

could instead rely on its notification to HHS to satisfy

the Accommodation’s prerequisites. Id. at 959.

To ensure compliance with these rulings, the Agencies promulgated another IFR and final rule. 4 Cover-

The final rule implementing Hobby Lobby was preceded by

notice of proposed rulemaking. Coverage of Certain Preventive

age of Certain Preventive Services Under the Affordable Care Act, 80 Fed. Reg. 41,318 (July 14, 2015). The

rule “extend[ed] the [A]ccommodation to a for-profit entity that is not publicly traded, is majority-owned by a

relatively small number of individuals, and objects to

providing contraceptive coverage based on its owners’

religious beliefs.” Id. at 41,324. The rule also “allow[ed] eligible organizations to choose between using

[the] ESBA Form 700 or the alternative process [of notifying HHS in writing of a religious objection to covering contraceptive services] consistent with the Wheaton

interim order.” Id. at 41,323.

In Zubik v. Burwell, 136 S. Ct. 1557 (2016) (per curiam), the Supreme Court addressed the petitioners’ assertions that “submitting [the Accommodation] notice

substantially burden[ed] the exercise of their religion, in

violation of [RFRA].” Id. at 1559. The Court did not

reach the merits of this claim but rather remanded to

afford the parties “an opportunity to arrive at an approach going forward that accommodates petitioners’

religious exercise while at the same time ensuring that

women covered by petitioners’ health plans receive full

. . . contraceptive coverage.” Id. at 1560 (internal

quotation marks and citation omitted).

In response to the Court’s direction in Zubik, the

Agencies solicited comments regarding the current procedure and possible alternatives to the Accommodation.

Coverage for Contraceptive Services, 81 Fed. Reg.

47,741 (July 22, 2016). The Agencies reviewed the comments and found that “no feasible approach has been

identified at this time that would resolve the concerns of

Services Under the Affordable Care Act, 79 Fed. Reg. 51,118 (Aug.

27, 2014).

religious objectors while still ensuring that the affected

women receive full and equal health coverage, including

contraceptive coverage.” Dep’t of Labor, FAQs About

Affordable Care Act Implementation Part 36, at 4 (Jan.

9, 2017), available at https://www.dol.gov/sites/default/

files/ebsa/about-ebsa/our-activities/resource-center/faqs/

aca-part-36.pdf. As a result, the Accommodation remained unchanged.

In May 2017, President Donald Trump issued an executive order directing the Agencies to “consider issuing

amended regulations, consistent with applicable law, to

address conscience-based objections to the preventivecare mandate promulgated under [42 U.S.C. § 300gg13(a)(4)].” Exec. Order No. 13,798 § 3, 82 Fed. Reg.

21,675 (May 9, 2017). In response, and without issuing

a notice of proposed rulemaking or soliciting public comment, the Agencies issued two new IFRs: the Religious IFR and the Moral IFR. These IFRs expanded

the existing exemption and Accommodation framework,

made the Accommodation process voluntary, and offered similar protections to organizations with moral objections to contraceptives. See Religious Exemptions

and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 82 Fed.

Reg. 47,792 (Oct. 13, 2017); Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 82 Fed. Reg.

47,838 (Oct. 13, 2017). This litigation followed.

The Commonwealth of Pennsylvania filed suit

against various governmental entities 5 and sought to enjoin the enforcement of the IFRs. Little Sisters of the

Poor Saints Peter and Paul Home (“Little Sisters”) intervened. 6 The District Court granted Pennsylvania’s

These entities include the President, the Agencies and their

Secretaries, and the United States of America (collectively, “the

Government”).

Little Sisters, a religious nonprofit operating a home in Pittsburgh, moved to intervene, the District Court denied its motion, and

our Court reversed, concluding, at that time, intervention was appropriate because the litigation posed a threat to Little Sisters’ interest in an exemption, and that its interests are not adequately represented by the Government. See generally Pennsylvania v. President of the United States of Am., 888 F.3d 52 (3d Cir. 2018). Since

then, however, the United States District Court for the District of

Colorado permanently enjoined enforcement of the Contraceptive

Mandate for benefit plans in which Little Sisters participates.

Pennsylvania v. Trump, 351 F. Supp. 3d 791, 829 n.27 (E.D. Pa. 2019)

(“Defendant-Intervenor has secured a permanent injunction, preventing enforcement of the Contraceptive Mandate against it.”); Little Sisters of the Poor v. Azar, No. 1:13-cv-02611, Dkt. No. 82 at 2-3

(D. Colo. May 29, 2018); Accordingly, Little Sisters is no longer aggrieved by the District Court’s ruling, its need for relief is moot, and

thus they lack appellate standing. See Ass’n of Banks in Ins.

v. Duryee, 270 F.3d 397, 403 (6th Cir. 2001) (“[T]he intervenordefendants face the threat of economic injury should the Ohio statutory provisions not be enforced. Such threatened injury is sufficient to confer appellate standing on the intervenor-defendants and

allows them to challenge the merits of the district court’s decision.”);

cf. In re Grand Jury, 111 F.3d 1066, 1071 (3d Cir. 1997) (“Since both

intervenors remain aggrieved after the district court’s disposition,

the constitutional requirements for standing to appeal as well as

standing to sue are satisfied.”).

10a

request to preliminarily enjoin the IFRs. See generally Pennsylvania v. Trump, 281 F. Supp. 3d 553 (E.D.

Pa. 2017). The Court held that Pennsylvania was likely

to succeed on its procedural and substantive challenges

under the APA. Id. at 576, 581. The Government appealed, and the District Court granted a stay pending

appeal.

While the appeal of the order preliminarily enjoining

the IFRs was pending, the Agencies promulgated two

Final Rules, which are virtually identical to the Religious and Moral IFRs. See Religious Exemptions and

Accommodations for Coverage of Certain Preventive

Services Under the Affordable Care Act, 83 Fed. Reg.

57,536 (Nov. 15, 2018); 45 C.F.R. § 147.132 (“Religious

Rule” or “Religious Exemption”); Moral Exemptions

and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 83 Fed.

Reg. 57,592 (Nov. 15, 2018); 45 C.F.R. § 147.133 (“Moral

Rule” or “Moral Exemption”) (collectively, “the Rules”

or “the Exemptions”). Like the Religious IFR, the Final Rule creating the Religious Exemption expanded

the categories of employers who are permitted to invoke

the exemption from the Contraceptive Mandate to include all nonprofit, for-profit, and publicly-held companies. The Religious Exemption also made participation in the Accommodation process completely voluntarily, relieving employers from the need to “file notices or

certifications of their exemption.” 7 83 Fed. Reg. at

The Agencies assert that under ERISA, employees will at least

receive notice that their plans no longer cover certain contraceptives

because, “with respect to plans subject to ERISA, a plan document

must include a comprehensive summary of the benefits covered by

the plan,” which will “serve to help provide notice to participants and

11a

57,558; see also id. at 57,537, 57,562. The Final Rule

creating the Moral Exemption offered the same exemption and voluntary accommodation process to nonprofit

organizations and non-publicly traded organizations

“with sincerely held moral convictions opposed to coverage of some or all contraceptive or sterilization methods.” Id. at 57,593.

At Pennsylvania’s request, the District Court lifted

the stay, and Pennsylvania filed an amended complaint,

joined New Jersey as a plaintiff, 8 added challenges to

the Final Rules and moved to enjoin them. 9

The District Court held hearings and received evidence regarding the Rules. Specifically, the States

submitted evidence from health care professionals and

state insurance regulators about the Rules’ impact.

The evidence addressed the relationship between costs

and contraceptive use and the impact the Rules would

have on state-funded healthcare services.

Cost is a significant barrier to contraceptive use and

access. The most effective forms of contraceptives are

the most expensive. After the ACA removed cost bar-

beneficiaries” of what services are covered. 83 Fed. Reg. at 57,558.

Even if this is true, this would apply only to certain employers.

Pennsylvania and New Jersey are referred to herein collectively

as the “the States.”

The States’ amended complaint for declaratory and injunctive relief pleads five counts: (I) violation of Equal Protection of the laws

under the Fifth Amendment; (II) violation of Title VII of the Civil

Rights Act and the Pregnancy Discrimination Act; (III) violation of

the procedural requirements of the APA; (IV) violation of the substantive requirements of the APA; and (V) violation of the Establishment Clause of the First Amendment.

12a

riers, women switched to the more effective and expensive methods of contraception. 10 Because the Rules allow employers to opt out of providing coverage for contraceptive services, some women may no longer have insurance to help offset the cost for these and other contraceptives.

Pennsylvania and New Jersey have state-funded programs that provide family planning and contraceptive

services for eligible individuals. For example, Pennsylvania Medicaid and New Jersey’s FamilyCare 11 cover

all health care for childless adults, pregnant women,

and parents with incomes up to 138% and up to 215% of

the federal poverty level, respectively. Pennsylvania’s

Family Planning Services Program also covers all family planning-related services, including contraceptives,

for individuals with incomes up to 215% of the federal

poverty level even if they have private insurance, and

New Jersey’s Plan First program offers the same for individuals with incomes up to 205% of the federal poverty

level.

Women who lack contraceptive coverage and who

meet certain income levels may also turn to Title X family planning clinics which “provide access to contraceptive services, supplies, and information to all who want

and need them” with priority to low-income persons.

Before the ACA, women spent between 30 and 40% of their total out-of-pocket health costs on contraceptives, and 55% of women

experienced a time where they could not afford contraceptives.

Amicus Curiae Women’s Law Ctr. Br. at 15-17; id. at 17 (describing

that the ACA dropped out-of-pocket contraceptive expenditures by

70%).

NJ FamilyCare is New Jersey’s state and federally-funded

Medicaid.

13a

Office of Population Affairs, Funding History, HHS,

https://www.hhs.gov/opa/title-x-family-planning/abouttitle-x-grants/funding-history/index.html (last visited

May 12, 2019). State and federal governments fund Title X clinics, but recently, federal funding has decreased.

The States expect that when women lose contraceptive insurance coverage from their employers, they will

seek out these state-funded programs and services.

The States further assert that women who do not seek

or qualify for state-funded contraceptives may have unintended pregnancies. Public funds are used to cover

the costs of many unintended pregnancies. 12 Accordingly, the States expect to spend more money due to the

Rules.

In addition to this evidence, the Agencies presented

spread sheets that listed the organizations and companies that were previously involved in ACA Contraceptive Mandate litigation. The Agencies offered this evidence to demonstrate the likely universe of employers

whom they contend may seek to invoke the Rules and

opt out of covering contraceptive care.

The day the Final Rules were set to go into effect,

January 14, 2019, the District Court issued a nationwide

injunction enjoining their enforcement. Pennsylvania

v. Trump, 351 F. Supp. 3d 791 (E.D. Pa. 2019). The

Court found that the States had standing to challenge

the Final Rules and established a likelihood of success

on the merits of their APA claims. First, the Court

Nationally, a publicly-funded birth in 2010 cost $12,770, and

that year, New Jersey spent an estimated $186.1 million on unintended pregnancies and Pennsylvania an estimated $248.2 million.

14a

held that the States are likely to succeed on their procedural APA claims because the Agencies failed to comply

with the notice-and-comment requirement and this defect tainted the Final Rules. Id. at 813. Second, the

Court held that the States were likely to succeed on

their substantive APA challenges because neither the

ACA nor RFRA authorized the Agencies to create exemptions. Specifically, the unambiguous language of

the ACA’s Women’s Health Amendment only authorized

the Agencies to decide what services would be covered,

not who provides them, id. at 821, and RFRA did not require or authorize such broad exemptions, particularly

given RFRA’s remedial function that places the responsibility for adjudicating religious burdens on the courts,

not the Agencies, id. at 822-23. The Court concluded

that the balance of equities and public interest favored

an injunction, id. at 829-30, and that a nationwide injunction was appropriate to ensure complete relief for the

States, id. at 834-35. The Government appeals.

II 13

We first address whether the States have standing. 14

Article III limits the scope of federal judicial review to

“cases” or “controversies.” U.S. Const. art. III § 2. A

fundamental safeguard of this limitation is the doctrine

of standing. Spokeo, Inc. v. Robins, 136 S. Ct. 1540,

1547 (2016). Put simply, only parties with standing

The District Court had jurisdiction under 28 U.S.C. § 1331.

We have jurisdiction under 28 U.S.C. § 1292(a)(1).

“We review the legal conclusions related to standing de novo, but

review for clear error the factual elements underlying the District

Court’s determination of standing.” Edmonson v. Lincoln Nat’l

Life Ins. Co., 725 F.3d 406, 414 (3d Cir. 2013) (internal quotation

marks and citation omitted).

15a

“can invoke the jurisdiction of the federal courts.”

Constitution Party of Pa. v. Aichele, 757 F.3d 347, 357

(3d Cir. 2014). To have standing to sue, “[t]he plaintiff

must have (1) suffered an injury in fact, (2) that is fairly

traceable to the challenged conduct of the defendant,

and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, 136 S. Ct. at 1547 (citing Lujan

v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992)).

We will examine each element in turn.

To establish injury in fact, the alleged injury must be

“concrete and particularized” and “actual or imminent,

not conjectural or hypothetical.” Id. at 1548 (quoting

Lujan, 504 U.S. at 560). An injury is concrete if it “actually exist[s]” and is not abstract. Id. “For an injury

to be particularized, it must affect the plaintiff in a personal and individualized way.” Id. (internal quotation

marks and citations omitted).

Plaintiffs need not

“demonstrate that it is literally certain that the harms

they identify will come about.” Clapper v. Amnesty

Int’l USA, 568 U.S. 398, 414 n.5 (2013). Instead, “[a]n

allegation of future injury may suffice if . . . there is

a substantial risk that the harm will occur.” Susan B.

Anthony List v. Driehaus, 573 U.S. 149, 158 (2014) (internal quotation marks and citation omitted); see also

Clapper, 568 U.S. at 410 (rejecting lower court’s use of

an “objectively reasonable likelihood” standard to assess injury).

The States have established that they will suffer a

concrete and particularized injury. The States de-

16a

scribe that (1) employers will take advantage of the exemptions and women covered by their plans will lose

contraceptive coverage; and (2) financially-eligible

women will turn to state-funded services for their contraceptive needs and for the unintended pregnancies

that may result from the loss of coverage. As a result,

the States will suffer a concrete financial injury from the

increased use of state-funded services. See Cottrell v.

Alcon Labs., 874 F.3d 154, 163 (3d Cir. 2017) (“Typically,

a plaintiff’s allegations of financial harm will easily satisfy each of these components, as financial harm is a

classic and paradigmatic form[ ] of injury in fact.” (alteration in original) (internal quotation marks and citations omitted)). The States will suffer this injury in a

particularized manner, as each State’s coffers will be depleted by the expenditure of funds to meet the increased

demand for state services. Having concluded that the

States have identified a concrete and particular injury,

we next examine whether the injury at issue is not conjectural and is actual or imminent.

The record shows that the injury the States expect to

sustain is not conjectural. First, the Agencies’ regulatory impact analysis acknowledges that between 70,500

and 126,400 women nationwide will lose contraceptive

coverage as a result of their employers’ invocation of the

Religious Exemption, 83 Fed. Reg. at 57,578, 57,581, and

fifteen women will lose coverage as a result of their employers’ use of the Moral Exemption, 83 Fed. Reg.

at 57,627. See California v. Azar (“California II”),

911 F.3d 558, 572 (9th Cir. 2018) (noting that the Agencies’ own regulatory impact analysis estimates loss

of coverage, and therefore “it is reasonably probable

that women in the plaintiff states will lose some or all

employer-sponsored contraceptive coverage due to the

17a

IFRs”), cert. denied Little Sisters of the Poor v. California, No. 18-1192, — S. Ct. —, 2019 WL 1207008 (June

17, 2019) (Mem.). Second, based on the Agencies’ list

of entities who challenged the Contraceptive Mandate,

eight employers, not including Little Sisters, between

New Jersey and Pennsylvania would likely take advantage of the Exemptions. Massachusetts v. U.S.

Dep’t of Health & Human Servs., 923 F.3d 209, 224 (1st

Cir. 2019) (relying on spreadsheet of litigating entities

to find “it is highly likely that at least three employers

in the Commonwealth with self-insured health plans

. . . will use the expanded exemptions”). Accordingly, it is not conjecture to conclude that employers in

Pennsylvania and New Jersey will take advantage of the

Exemptions and, as a result, women will lose coverage.

Id. at 224 n.12 (stating that “it is improbable based on

the evidence that no women in the [States] would lose

contraceptive coverage” (emphasis omitted)).

The record also supports the District Court’s conclusion that the injury is imminent. The States have provided evidence showing that the Exemption will result

in the expenditure of state funds because some women

who lose coverage will inevitably seek out state-sponsored

programs providing contraceptive services; and some

women will forego contraceptive use, causing the States

to shoulder the costs of unintended pregnancies.

With the ACA, many patients “switch[ed] from a

cheaper, less effective [contraceptive] method to a more

effective, expensive method that was better for their

medical health and personal needs.” App. 272. Contraceptives are not only used for pregnancy prevention.

They are the “standard first-line of care for a number of

18a

hormonal, and other, disorders, including poly-cystic ovarian syndrome, primary ovarian insufficiency/premature

ovarian failure, amenorrhea, dysmenorrhea/chronic pelvic

pain, and abnormal uterine bleeding.” App. 292. A

“vast majority” of women use inter-uterine devices

(“IUDs”)—a treatment religious objectors are particularly focused on, App. 350-83—“for purposes other than

birth control.” App. 293 (describing 90-95% of patients

using IUDs for non-birth control purposes). Contraceptive use “carries long-term health benefits for

women[,]” including reducing the risk of ovarian and

uterine cancer. App. 294. “Contraception also helps

protect the health of those women for whom pregnancy

can be hazardous, or even life-threatening.” Amici Curiae Health Prof ’l Orgs. Br. at 16. Thus, removing cost

free contraceptive coverage can have ramifications on

women’s health beyond birth control and unplanned

pregnancies.

Without insurance to defray or eliminate the cost for

the more-effective contraceptive methods, women will

use “less expensive and less effective methods,” App.

245, and both Pennsylvania and New Jersey “anticipate[] that women who lose contraceptive coverage

through employer plans—whether the plan of their own

employer or that of another family member—may seek

contraception from other sources, including statefunded programs.” 15 App. 299; App. 317. Thus, the

The Agencies “theorize” that some women may be able to pay

out of pocket or obtain coverage through a spouse or family member’s plan. Massachusetts, 923 F.3d at 227. While “[s]uch a hypothetical woman may exist, . . . the number of women with incomes that make them eligible for state-assisted contraceptive coverage but who still fit in that category would, logically, be very

small.” Id.

19a

State-funded programs will be tapped to provide coverage for financially eligible women whose employers invoke the Exemptions.

Furthermore, some women who lose contraceptive

coverage may either fail to qualify for state services or

elect to forego the use of contraceptives altogether.

“Women who stop using contraception are more likely

to have unplanned pregnancies and to require additional

medical attention.” App. 312. The costs of such unintended pregnancies are often shouldered by states, costing hundreds of millions of dollars. Therefore, the evidence supports the conclusion that the loss of contraceptive coverage may also result in unintended pregnancies

for which the States will bear associated health care

costs.

For these reasons, “[t]he expanded exemptions are

expected to result in greater financial expenditures” by

the States on contraceptive services. App. 318. This

anticipated substantial impact on state finances presents an imminent injury. Thus, the District Court

properly found that the States showed an imminent injury in fact.

The Government faults the States for failing to identify a specific woman who will be affected by the Final

Rules, but the States need not define injury with such a

demanding level of particularity to establish standing.

Massachusetts v. EPA, 549 U.S. 497, 523 n.21 (2007); see

Massachusetts, 923 F.3d at 225; California II, 911 F.3d

at 572. The likelihood that employers will invoke the

Exemptions and leave women without contraceptive

coverage, and that women will turn to the States for coverage, is sufficient to demonstrate imminent injury.

20a

This likelihood “has nothing to do with whether petitioners have determined [a] precise” woman who will seek

such funding. Massachusetts, 549 U.S. at 523 n.21. 16

The States’ imminent injury is causally connected

and fairly traceable to the Exemptions. The States will

suffer financial injury when employers in Pennsylvania

and New Jersey take advantage of the Exemptions,

leaving female employees without contraceptive coverage and prompting financially eligible women to turn to

state-funded services. See Texas v. United States,

809 F.3d 134, 159 (5th Cir. 2015) (“For Texas to incur

injury, DAPA beneficiaries would have to apply for

driver’s licenses as a consequence of DHS’s action, and

it is apparent that many would do so.”), aff ’d by an

equally divided court, United States v. Texas, 136 S. Ct.

2271 (2016) (Mem.) (per curiam). In other words, the

In the context of an environmental case and a claim that the

plaintiff-state Massachusetts lacked standing because it failed to

identify land that would be impacted by federal regulators’ inaction,

the Supreme Court observed that

the likelihood that Massachusetts’ coastline will recede has

nothing to do with whether petitioners have determined the

precise metes and bounds of their soon-to-be-flooded land.

Petitioners maintain that the seas are rising and will continue

to rise, and have alleged that such a rise will lead to the loss of

Massachusetts’ sovereign territory. . . . Our cases require

nothing more.

Massachusetts, 549 U.S. at 523 n.21. Just as it was unnecessary for

Massachusetts to identify specific coastline that would be flooded by

the agencies’ inaction, it is unnecessary for the States to identify a

specific woman who would be impacted by the Government’s action

where in both instances, the record provided a basis to infer specific

imminent injury.

21a

States will not experience an increased demand for services and the resulting financial burden unless the new

Exemptions, which create a void in contraceptive coverage, go into effect. See id. at 160 (“Far from playing an

insignificant role, DAPA would be the primary cause

and likely the only one. Without the program, there

would be little risk of a dramatic increase in the costs of

the driver’s-license program.”). Thus, there is a link

between the Exemptions and the impact on the States’

fiscs.

The District Court also correctly concluded that an

injunction would redress the financial injury the States

face from the Rules. Enjoining the Final Rules until

their legality is adjudicated on the merits will avoid the

imminent financial burden the States face if they are not

enjoined. Massachusetts, 923 F.3d at 228 (“[A]n injunction preventing the application of these exemptions

would stop the alleged fiscal injury from occurring, making it not only ‘likely,’ Spokeo, 136 S. Ct. at 1547, but

certain that this injury would not occur for as long as the

exemptions are enjoined.”); see Massachusetts, 549 U.S.

at 526 (“The risk of catastrophic harm, though remote,

is nevertheless real. That risk would be reduced to

some extent if petitioners received the relief they

seek.”).

For these reasons, the States have standing to bring

this suit. 17

Based upon of the foregoing discussion, we need not decide

whether the States also have standing under the special solicitude

or parens patriae doctrines.

22a

III

Having determined that the States have standing, we

now address whether they are entitled to a preliminary

injunction. The decision to grant or deny a preliminary

injunction is within the sound discretion of the district

court. 18 Winter v. Nat. Res. Def. Council, Inc., 555 U.S.

7, 24, 33 (2008). To obtain a preliminary injunction, the

movants must:

demonstrate (1) that they are reasonably likely to

prevail eventually in the litigation and (2) that they

are likely to suffer irreparable injury without relief.

If these two threshold showings are made the District Court then considers, to the extent relevant, (3)

whether an injunction would harm the [defendants]

more than denying relief would harm the plaintiffs

and (4) whether granting relief would serve the public interest.

K.A. ex rel. Ayers v. Pocono Mountain Sch. Dist.,

710 F.3d 99, 105 (3d Cir. 2013) (alteration in original)

(quoting Tenafly Eruv Ass’n v. Borough of Tenafly,

309 F.3d 144, 157 (3d Cir. 2002)); accord Fed. R. Civ. P.

65. To establish a likelihood of success, “a sufficient

degree of success for a strong showing exists if there

is ‘a reasonable chance, or probability, of winning.’ ”

In re Revel AC, Inc., 802 F.3d 558, 568 (3d Cir. 2015)

“We employ a tripartite standard of review for . . . preliminary injunctions. We review the District Court’s findings of fact

for clear error. Legal conclusions are assessed de novo. The ultimate decision to grant or deny the injunction is reviewed for abuse

of discretion.” K.A. ex rel. Ayers v. Pocono Mountain Sch. Dist.,

710 F.3d 99, 105 (3d Cir. 2013) (omission in original) (internal quotation marks and citations omitted).

23a

(quoting Singer Mgmt. Consultants, Inc. v. Milgram,

650 F.3d 223, 229 (3d Cir. 2011) (en banc)).

Here, we must decide whether the District Court correctly concluded that the States have a reasonable probability of showing that the Final Rules violate the APA,

and if so, whether the equitable factors warrant a nationwide injunction.

A 19

To promulgate binding regulations, agencies engage

in what is known as notice-and-comment rulemaking.

5 U.S.C. § 553. This requires an agency to publish notice of the proposed rule in the Federal Register, collect

and consider public comments, and issue a concise statement of purpose upon finalizing the new rule. Id.

§ 553(b)-(c). Deviation from these procedures is only

permitted where expressly authorized by statute, id.

§ 559, or when the agency has “good cause” to dispense

with them, id. § 553(b)(3)(B). The Agencies assert that

both grounds justify their decision to forego notice-andcomment procedures here. They are mistaken.

The Government first argues that provisions within

the Health Insurance Portability and Accountability Act

of 1996 (“HIPAA”) grant the Agencies discretion to proceed by IFR in lieu of notice-and-comment rulemaking.

Quite appropriately, the Agencies do not challenge the States’

statutory standing to sue under the APA. 5 U.S.C. § 702; Massachusetts, 549 U.S. at 520 (recognizing states’ “procedural right to

challenge the rejection of its rulemaking petition as arbitrary and

capricious” under the EPA).

24a

The provisions upon which the Government relies provide:

The Secretary, consistent with section 104 of

[HIPAA], may promulgate such regulations as may

be necessary or appropriate to carry out the provisions of this [subchapter]. The Secretary may promulgate any interim final rules as the Secretary determines are appropriate to carry out this [subchapter].

26 U.S.C. § 9833; 29 U.S.C. § 1191c; 42 U.S.C. § 300gg92 [hereinafter “Regulation Provision”]. This language

does not eliminate the need for notice and comment.

First, the APA only allows a subsequent statute to

modify or supersede its procedural requirements “to the

extent [the statute] does so expressly.” 5 U.S.C. § 559.

The Regulation Provision contains no express language

supplanting APA procedures, and the sole reference to

“interim final rules” does not confer a license to ignore

APA requirements. Indeed, in contrast to statutory

authorizations to forego APA procedures, the Regulation Provision is “permissive (‘The Secretary may promulgate any interim final rules as the Secretary determines are appropriate . . . ’), wide-ranging (applying to any regulatory proceeding relating to group

health insurance plans), and do[es] not contain any specific deadlines for agency action.” Coal. for Parity,

Inc. v. Sebelius, 709 F. Supp. 2d 10, 18-19 (D.D.C. 2010)

(omissions in original and emphasis omitted); see also

California II, 911 F.3d at 578-80. In short, because the

Regulation Provision “neither contain[s] express language exempting agencies from the APA nor provide[s]

alternative procedures that could reasonably be understood as departing from the APA,” it does not authorize

25a

the Agencies to disregard the notice-and-comment requirements. California II, 911 F.3d at 579.

Second, the statutory reference within the Regulation Provision sheds light on the scope and purpose of

its IFR sentence. As the Court of Appeals for the

Ninth Circuit points out, § 104 of HIPAA aims to assure

regulatory coordination between the Agencies’ Secretaries for matters over which they share responsibility.

See California II, 911 F.3d at 579-80 (citing Pub. L. No.

104-191, 110 Stat. 1936 (1996) (codified at 42 U.S.C.

§ 300gg-92)). The first sentence of the Regulation Provision authorizes each Secretary to promulgate regulations “consistent with” the HIPAA section on coordination. The second sentence is identical but for two differences: it discusses IFRs instead of final regulations, and it omits any mention of HIPAA’s coordination

section. Read in light of the first sentence, the second

ensures that each Agency can proceed by IFR where a

Secretary “need[s] to regulate within his or her own domain temporarily while sorting out . . . inter-agency

conflict.” Id. at 579. Thus, “we need not give the second sentence the [A]gencies’ expansive interpretation in

order for the second sentence to retain independent effect.” Id. at 579-80. In sum, the Regulation Provision

does not expressly excuse the Agencies from complying

with APA procedures and therefore does not provide a

basis for issuing the IFRs without notice and comment. 20

Congress knows how to excuse an agency from complying with

the APA. For example, one HIPAA provision expressly permits

the Agencies to promulgate a rule prior to notice and comment.

42 U.S.C. § 1320a-7b note. That provision requires the Secretary

of Health and Human Services to publish a rule prescribing penalties for kickbacks by January 1, 1997, then less than four months

26a

The Agencies also lacked good cause for dispensing

with notice of and comment to the IFRs. An agency has

“good cause” to forego APA procedures where following

them would be “impracticable, unnecessary, or contrary

to the public interest.” 21 5 U.S.C. § 553(b)(3)(B). “[C]ircumstances justifying reliance on [the good cause] exception are indeed rare and will be accepted only after

the court has examine[d] closely proffered rationales

justifying the elimination of public procedures.” Nat.

Res. Def. Council, Inc. v. EPA (“NRDC”), 683 F.2d 752,

764 (3d Cir. 1982) (alterations in original) (internal quotation marks and citation omitted). Thus, we construe

the “good cause” exception to the notice-and-comment

requirement narrowly. 22 Id.

away. It provides that “[s]uch rule shall be effective and final immediately on an interim basis, but is subject to change and revision

after public notice and opportunity for . . . public comment.”

Unlike the Regulation Provision, § 1320a-7b expressly provides for

notice and comment after the promulgation of an IFR. Congress’s

omission of that procedure from the Regulation Provision demonstrates that it did not provide the Agencies authority to promulgate

IFRs without notice and comment.

5 U.S.C. § 553(b)(3) provides

[e]xcept when notice or hearing is required by statute, this

subsection does not apply—

...

(B) when the agency for good cause finds (and incorporates

the finding and a brief statement of reasons therefor in the

rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.

Though the review standard for agency assertions of good cause

remains an open question in our circuit, see United States v. Reynolds, 710 F.3d 498, 509 (3d Cir. 2013), we need not answer that question here. Even applying the most deferential of the potential

27a

When they issued the IFRs, the Agencies claimed

good cause to waive notice and comment based on (1) the

urgent need to alleviate harm to those with religious objections to the current regulations; (2) the need to address “continued uncertainty, inconsistency, and cost”

arising from “litigation challenging the previous rules”;

and (3) the fact that the Agencies had already collected

comments on prior Mandate-related regulations. 82 Fed.

Reg. at 47,813-15; see also 82 Fed. Reg. at 47,855-59.

None of these assertions meet the standard for good

cause.

First, the Agencies’ desire to address the purported

harm to religious objections does not ameliorate the

need to follow appropriate procedures. All regulations

are directed toward reducing harm in some manner. 23

See United States v. Reynolds, 710 F.3d 498, 512-13

(3d Cir. 2013). Thus, “[a] need to regulate affected parties does not create the urgency necessary to establish

good cause.” Id. at 511. “As with any other administrative agency conclusion, we require some statement of

facts or circumstances that justifies the existence of

standards—reviewing the agency’s good cause determination to see

if it is arbitrary and capricious—the IFRs cannot stand.

As we observed in Reynolds,

[m]ost, if not all, laws passed by Congress requiring agencies

to promulgate new rules are designed to eliminate some real

or perceived harm. If the mere assertion that such harm will

continue while an agency gives notice and receives comments

were enough to establish good cause, then notice and comment

would always have to give way. An agency will invariably be

able to point to some continuing harm during the notice and

comment period antecedent to the promulgation of a rule.

710 F.3d at 512-13.

28a

good cause (e.g., an imminent, externally imposed deadline or the existence of an emergency).” Id. at 512.

The Agencies fail to cite any facts or impending deadlines sufficient to raise “good cause” here.

Second, the need to address uncertainty is likewise

insufficient to establish good cause. Uncertainty precedes every regulation, and to allow uncertainty to excuse compliance with notice-and-comment procedures

“would have the effect of writing [those] requirements

out of the statute.” Id. at 510. Furthermore, our

precedent forecloses the acceptance of uncertainty as a

basis for good cause. Id. (“An agency’s intention to

provide clarity, without more, cannot amount to good

cause.”).

Third, the Agencies’ previous solicitation and collection of comments regarding other rules concerning the

Contraceptive Mandate cannot substitute for notice and

comment here. If the APA permitted agencies to forego notice-and-comment concerning a proposed regulation simply because they already regulated similar matters, then the good cause exception could largely obviate

the notice-and-comment requirement. Furthermore,

the IFRs did not make a minor change. The IFRs create exemptions from the Contraceptive Mandate with

unprecedented scope and make the Accommodation

wholly voluntary. Such a dramatic overhaul of the

Contraceptive Mandate regulations required noticeand-comment under the APA.

For these reasons, the Agencies did not have good

cause to ignore the APA’s notice and comment requirement.

29a

The Government also contends that, even if the IFRs

were procedurally deficient, the Agencies’ subsequent

use of notice-and-comment rulemaking to finalize the

Rules cured any procedural defects. Under our precedent, however, “post-promulgation notice and comment

procedures cannot cure the failure to provide such procedures prior to the promulgation of the rule at issue.”

NRDC, 683 F.2d at 768; see Reynolds, 710 F.3d at 519

(“Any suggestion that the postpromulgation comments

to the Interim Rule can satisfy [the purposes of noticeand-comment rulemaking] misses the point.” (internal

citation omitted)); Sharon Steel Corp. v. EPA, 597 F.2d

377, 381 (3d Cir. 1979) (“We hold that the period for comments after promulgation cannot substitute for the prior

notice and comment required by the APA.”).

APA notice-and-comment procedures serve several

goals, including “(1) to ensure that agency regulations

are tested via exposure to diverse public comment, (2) to

ensure fairness to affected parties, and (3) to give affected parties an opportunity to develop evidence in the

record to support their objections to the rule and

thereby enhance the quality of judicial review.” Prometheus Radio Project v. FCC, 652 F.3d 431, 449

(3d Cir. 2011) (quoting Int’l Union, United Mine Workers of Am. v. Mine Safety & Health Admin., 407 F.3d

1250, 1259 (D.C. Cir. 2005)). The comment process also

allows each agency to “maintain[] a flexible and openminded attitude towards its own rules,” Reynolds,

710 F.3d at 511 (alteration in original and citation omitted) (quoting Prometheus Radio, 652 F.3d at 449); see

also Azar v. Allina Health Servs., 139 S. Ct. 1804, 1816

(2019) (“Notice and comment

. . .

affords the

30a

agency a chance to avoid errors and make a more informed decision.” (internal citation omitted)). To preserve the integrity of this process, “[t]he opportunity for

comment must be a meaningful opportunity,” Prometheus Radio, 652 F.3d at 450 (alteration in original), to

have interested parties share their views, and to have

the agency consider them with an “open mind,” Reynolds, 710 F.3d at 517-19.

The notice and comment exercise surrounding the Final Rules does not reflect any real open-mindedness toward the position set forth in the IFRs. 24 First, as the

Government admits, the minor changes to the Final

Rules do not “alter the fundamental substance of the exemptions set forth in the IFRs.” Dkt. 107-1 at 8. Second, the reasons the Agencies supplied for promulgating

the Final Rules simply echoed those provided for issuing

the IFRs. See 83 Fed. Reg. at 57,552, 57,609. These

rationales do not show the “flexible and open-minded attitude” the notice-and-comment process requires.

Reynolds, 710 F.3d at 511. Together, the Agencies’

justifications for avoiding notice and comment to the

IFRs, and the fact that the IFRs and the Final Rules

are virtually identical, suggest that the opportunity for

comment was not a “meaningful” one in the way the APA

requires. Prometheus Radio, 652 F.3d at 450.

Lastly, even setting aside the Agencies’ lack of openmindedness, the IFRs also impaired the rulemaking

process by altering the Agencies’ starting point in considering the Final Rules. In NRDC, our Court rejected the EPA’s argument that the opportunity for

We express no opinion on whether the Agencies appropriately

responded to comments collected during this process, see Trump,

351 F. Supp. 3d at 811-12, as this issue is not before us.

31a

post-promulgation comment remedied the EPA’s initial

failure to promulgate a rule through notice-andcomment rulemaking:

[t]o allow the APA procedures in connection with

the [new rule] to substitute for APA procedures in

connection with [the initial, procedurally defective

rule] would allow [the] EPA to substitute postpromulgation notice and comment procedures for

pre-promulgation notice and comment procedures at

any time by taking an action without complying with

the APA, and then establishing a notice and comment

procedure on the question of whether that action

should be continued. This would allow agencies to

circumvent [our case law] and the APA. We cannot

countenance such a result.

683 F.2d at 768 (citation omitted). This reasoning applies with equal force here. By first promulgating the

IFRs that granted the expanded exemptions without notice and comment, the Agencies changed the question

presented concerning the Final Rules from whether

they should create the exemptions to whether they

should depart from them. This starting position is impermissible under the APA. Id.; see also Sharon Steel,

597 F.2d at 381 (“Provision of prior notice and comment

allows effective participation in the rulemaking process

while the decisionmaker is still receptive to information

and argument. After the final rule is issued, the petitioner must come hat-in-hand and run the risk that the

decisionmaker is likely to resist change.” (citation omitted)).

In sum, because deficits in the promulgation of the

IFRs compromised the procedural integrity of the Final

32a

Rules, the States have demonstrated a likelihood of success in showing that the Final Rules are procedurally

defective, and in turn, violate the APA.

There are also serious substantive problems with the

Final Rules. More specifically, neither of the statutes

upon which the Agencies rely, the ACA and RFRA, authorize or require the Final Rules. Thus, they were enacted “in excess of statutory jurisdiction, authority, or

limitations, or short of statutory right,” making them

“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A),

(C).

The Agencies argue that their authority under the

ACA to issue preventive care guidelines includes the

power to promulgate the Exemptions. This assertion

is without textual support.

The Women’s Health

Amendment to the ACA, 42 U.S.C. § 300gg-13(a)(4), provides:

A group health plan and a health insurance issuer

offering group or individual health insurance coverage shall, at a minimum provide coverage for

and shall not impose any cost sharing requirements

for— . . .

(3) with respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines

supported by the [HRSA].

(4) with respect to women, such additional preventive care and screenings not described in paragraph

33a

(1)[ 25 ] as provided for in comprehensive guidelines

supported by the [HRSA] for purposes of this paragraph.

42 U.S.C. § 300gg-13(a). The authority to issue “comprehensive guidelines” concerns the type of services

that are to be provided and does not provide authority

to undermine Congress’s directive concerning who must

provide coverage for these services. Section 300gg13(a) unambiguously dictates that group health plans

and health insurance issuers “shall provide” the preventive care services set forth in the HRSA-supported comprehensive guidelines, and “shall” not impose cost sharing. The term “shall” denotes a requirement, Prometheus Radio Proj. v. FCC, 824 F.3d 33,50 (3d Cir. 2016)

(“Th[e] repeated use of ‘shall’ creates ‘an obligation impervious to . . . discretion.’ ” (omission in original)

(quoting Lexecon Inc. v. Milberg Weiss Bershad Hynes

& Lerach, 523 U.S. 26, 35 (1998)), and HRSA’s authority

to issue the guidelines does not empower it to ignore

that requirement. Nothing from § 300gg-13(a) gives

HRSA the discretion to wholly exempt actors of its

choosing from providing the guidelines services. On

the contrary, the mandate articulated in § 300gg-13(a)

forecloses such exemptions. 26

Paragraph (1) refers to “evidence-based items or services that

have in effect a rating of ‘A’ or ‘B’ in the current recommendations

of the United States Preventive Services Task Force.” 42 U.S.C.

§ 300gg-13(a)(1).

The Government argues that if the ACA does not grant the authority to issue the Exemptions, then HRSA was equally without authority to issue the Church Exemption and the Accommodation.

This argument fails. Though the Church Exemption may seem facially at odds with § 300gg-13(a), Supreme Court precedent dictates

34a

The Agencies’ reliance on the language that directed

HRSA to create the guidelines concerning women’s preventive health care and the use of the phrase “as provided for in” such guidelines does not advance their position. The Agencies contrast § 300gg-13(a)(4)’s use of

the phrase “as provided for in” comprehensive guidelines with a neighboring sub-section’s provision addressing preventive care for infants, children, and adolescents, which is “provided for in the” comprehensive

guidelines for those services.

Compare 42 U.S.C.

§ 300gg-13(a)(3) (describing “preventive care and

screenings provided for in the comprehensive guidelines”), with id. § 300gg-13(a)(4) (describing “preventive

care and screenings as provided for in comprehensive

guidelines”). They assert that the use of the word “as”

in § 300gg-13(a)(4) gives HRSA authority to dictate the

preventive services to be provided and who must provide them. This argument overlooks the clear explanation for the different language. When the ACA was

passed, the comprehensive guidelines for children’s preventive care already existed, but guidelines for women’s

preventive care were not yet written. Congress used

the definite article “the” in § 300gg-13(a)(3) to refer to

a narrow form of exemption for houses of worship. See 80 Fed.

Reg. at 41,325 (describing the exemption for churches and houses of

worship as “consistent with their special status under longstanding

tradition in our society and under federal law”); see, e.g., HosannaTabor Evangelical Lutheran Church & Sch. v. EEOC, 565 U.S. 171

(2012) (discussing the existence of a ministerial exception precluding

application of employment legislation to a religious institution to respect churches’ internal autonomy). The Accommodation likewise

does not plainly run afoul of the ACA. Instead, it provides a process through which a statutorily identified actor “shall provide” the

mandated coverage. In any event, the Agencies’ authority to issue

the Church Exemption and Accommodation is not before us.

35a

those existing children’s preventive care guidelines.

In § 300gg-13(a)(4), Congress addressed the women’s

preventive care guidelines that were yet to be promulgated by stating “as provided for in the comprehensive

guidelines.”

The Agencies’ interpretation of “comprehensive” as

authorizing them to issue guidelines that exempt entities from complying with the Mandate likewise fails.

Put simply, the discretion the statute grants HRSA to

issue comprehensive guidelines concerning services to

be provided does not include the power to exempt actors

from the statute itself. This is borne out by the fact

that the word “comprehensive” is also used to describe

the children’s preventive care guidelines, and those

guidelines do not exempt any statutorily required party

from providing services. See HHS, Preventive Care

Benefits for Children, https://www.healthcare.gov/

preventive-care-children (last visited May 8, 2019).

Congress was obviously aware of the existing children’s

guidelines when it drafted the Women’s Health Amendment, and Congress’s use of “comprehensive” to describe both sets of guidelines conveys that it intended

them to cover the same type of subject matter, namely

health care services for the identified groups. See

F.A.A. v. Cooper, 566 U.S. 284, 292 (2012) (“[W]hen Congress employs a term of art, it presumably knows and

adopts the cluster of ideas that were attached to each

borrowed word in the body of learning from which it was

taken.” (internal quotation marks and citation omitted)).

Other portions of the ACA also show that Congress

retained the authority to exempt certain employers

from providing contraceptive coverage. In passing the

ACA, Congress explicitly exempted grandfathered

36a

plans from the Contraceptive Mandate and other ACA

requirements. 42 U.S.C. § 18011(a), (e). Congress

also considered and rejected a statutory conscience

amendment that would have operated similarly to the

challenged Exemptions. 158 Cong. Rec. S1162, 117374 (2012). Between the substantially analogous exemption Congress rejected, and the one it decided to

keep, Congress demonstrated that exempting specific

actors from the ACA’s mandatory requirements is its

job, not the Agencies. See United States v. Johnson,

529 U.S. 53, 58 (2000) (“When Congress provides exceptions in a statute,” we may infer “that Congress considered the issue of exceptions and, in the end, limited the

statute to the ones set forth.”). Relatedly, by promulgating the Moral Exemption, which sought to do what

Congress refused to do with the conscience amendment,

the Agencies contravened Congress’s intent. See Food

& Drug Admin. v. Brown & Williamson Tobacco Corp.,

529 U.S. 120, 147 (2000) (considering Congress’s prior

refusal to pass laws as material to whether an agency’s

interpretation of its statute is entitled to deference).

Because § 300gg-13(a) does not authorize the Agencies to exempt plans from providing the required coverage, the Agencies’ authority under the ACA to enact the

Final Rules is without merit.

2 27

The Agencies’ effort to cast RFRA as requiring the

Religious Exemption is also incorrect. Even assuming

that RFRA provides statutory authority for the Agencies to issue regulations to address religious burdens the

No party argues that RFRA authorizes or requires the Moral

Exemption.

37a

Contraceptive Mandate may impose on certain individuals, RFRA does not require the enactment of the Religious Exemption to address this burden.

RFRA provides that the federal government “[s]hall

not substantially burden a person’s exercise of religion

even if the burden results from a rule of general applicability,” 42 U.S.C. § 2000bb-1(a), unless “that application

of the burden to the person—(1) is in furtherance of a

compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest,” id. § 2000bb-1(b). “[A] person whose

religious exercise has been burdened in violation of this

section” may seek relief in a judicial proceeding. Id.

§ 2000bb-1(c). Thus, RFRA authorizes a cause of action for government actions that impose a substantial

burden on a person’s sincerely-held religious beliefs,

and provides a judicial remedy via individualized adjudication. See 42 U.S.C. § 2000bb-3(a); City of Boerne

v. Flores, 521 U.S. 507, 529 (1997) (“[RFRA] prevents

and remedies laws which are enacted with the unconstitutional object of targeting religious beliefs and practices.”). Because Congress has deemed the courts the

adjudicator of private rights of actions under RFRA,

Gonzales v. O Centro Espirita Beneficente Uniao do

Vegetal, 546 U.S. 418, 434 (2006) (holding RFRA “plainly

contemplates that courts would . . . consider whether

exceptions are required under the test set forth by Congress” (emphasis omitted)), we owe the Agencies no deference when reviewing determinations based upon

RFRA, see Adams Fruit Co., Inc. v. Barrett, 494 U.S.

638, 649 (1990) (declining to defer to an agency’s statutory interpretation where Congress “expressly estab-

38a

lished the Judiciary and not the [agency] as the adjudicator of private rights of action arising under the statute”).

A prima facie RFRA case requires a plaintiff to prove

that the government imposed a substantial burden on

religious exercise.

Mack v. Warden Loretto FCI,

839 F.3d 286, 304 (3d Cir. 2016). A substantial burden

exists if

(1) a follower is forced to choose between following

the precepts of his religion and forfeiting benefits

otherwise generally available to other [persons] versus abandoning one of the precepts of his religion in

order to receive a benefit; or (2) the government puts

substantial pressure on an adherent to substantially

modify his behavior and to violate his beliefs.[ 28]

Real Alternatives, Inc. v. Sec’y Dep’t of Health & Human Servs., 867 F.3d 338, 371 (3d Cir. 2017) (alteration

in original) (internal quotation marks and citation omitted). The Supreme Court has directed that, when considering a requested accommodation to address the burden, “courts must take adequate account of the burdens

a requested accommodation may impose on nonbeneficiaries.” Cutter v. Wilkinson, 544 U.S. 709, 720 (2005)

(referring to third parties who may face collateral consequences from accommodating an observer’s burden). 29

Although we “defer to the reasonableness” of an objector’s religious beliefs, “this does not bar our objective evaluation of the

nature of the claimed burden and the substantiality of that burden

on [the objector’s] religious exercise.” Real Alternatives, Inc. v.

Sec’y Dep’t of Health & Human Servs., 867 F.3d 338, 356 (3d Cir.

2017) (emphasis omitted) (citation omitted).

Although Cutter v. Wilkinson, 544 U.S. 709 (2005), dealt with an

application of the Religious Land Use and Institutionalized Persons

39a

The Accommodation fulfills this directive as it provides

a means for an observer to adhere to religious precepts

and simultaneously allows women to receive statutorilymandated health care coverage.

RFRA does not require the broad exemption embodied in the Final Rule nor to make voluntary a notice of

the employer’s decision not to provide such coverage to

avoid burdening those beliefs. As our Court has explained,

the self-certification form does not trigger or facilitate the provision of contraceptive coverage because

coverage is mandated to be otherwise provided by

federal law. Federal law, rather than any involvement by the [employers] in filling out or submitting

the self-certification form, creates the obligation of

the insurance issuers and third-party administrators

to provide coverage for contraceptive services. . . .

[And] the submission of the self-certification form

does not make the [employers] “complicit” in the provision of contraceptive coverage.

Geneva Coll. v. Sec’y of U.S. Dep’t of Health & Human

Servs., 778 F.3d 422, 437-38 (3d Cir. 2015) (emphasis omitted), vacated and remanded sub nom. Zubik, 136 S. Ct.

1557. 30

Act (“RLUIPA”), we have said that RLUIPA and RFRA “are analogous for the purpose of the substantial burden test,” and we may

therefore may apply RLUIPA law. Mack, 839 F.3d at 304 n.103;

see Holt v. Hobbs, 135 S. Ct. 853, 860 (2015).

While Zubik vacated our opinion in Geneva College, it did not

reach the merits of the Accommodation nor did it “attack our reasoning.” Real Alternatives, 867 F.3d at 356 n.18. After Zubik,

40a

The religious objectors who oppose the Accommodation mechanism disapprove of “what follows from” filing

the self-certification form, but under Free Exercise jurisprudence, we examine the conduct of the objector, not

third parties. Id. at 439-40. Here, through the Accommodation process, “the actual provision of contraceptive coverage is by a third party,” so any possible

burden from the notification procedure is not substantial. Id. at 442. For these reasons, RFRA does not

require that the Agencies permit religious objectors to

decline to provide contraceptive coverage without notifying their insurance issuer, TPA, HHS, or the employees.

Contrary to the Agencies’ assertions in the Rule, the

Supreme Court has not held that the Accommodation

imposes substantial burdens on religious rights.

Hobby Lobby ruled that closely-held corporations are

entitled to take advantage of the Accommodation process rather than facing fines for non-compliance with the

contraceptive mandate, observing that the Accommodation was a less restrictive alternative to forcing objectors to choose between adhering to the mandate or violating their sincerely-held beliefs. 573 U.S. at 730-31.

While the Court “did not decide” whether the Accommodation “complies with RFRA,” it found that “[a]t a minimum . . . it does not impinge on that plaintiffs’ religious belief that providing insurance coverage for [certain contraceptives] violates their religion, and it serves

HHS’s stated interests equally well.” Id. at 731; see

also Zubik, 136 S. Ct. at 1561 (Sotomayor, J., concur-

we repeated that the Accommodation does “not impose a substantial burden.” Id.

41a

ring) (“The opinion does not . . . endorse the petitioners’ position that the existing regulations substantially burden their religious exercise or that contraceptive coverage must be provided through a separate policy, with a separate enrollment process.” (internal

quotation marks and citations omitted)); Wheaton,

573 U.S. at 960 (noting that Hobby Lobby “expressly

rel[ied] on the availability of the religious-nonprofit accommodation” to reach its holding).

Furthermore, the Religious Exemption and the new

optional Accommodation would impose an undue burden

on nonbeneficiaries—the female employees who will

lose coverage for contraceptive care. The Agencies

downplayed this burden on women, contradicting Congress’s mandate that women be provided contraceptive

coverage. “No tradition, and no prior decision under

RFRA, allows a religion-based exemption when the

[A]ccommodation would be harmful to others—here, the

very persons the contraceptive coverage requirement

was designed to protect.” Hobby Lobby, 573 U.S. at

764 (Ginsburg, J., dissenting). As the Agencies recognize, the record shows that thousands of women may

lose contraceptive coverage if the Rule is enforced and

frustrate their right to obtain contraceptives. Id. at

727 (citation omitted); 42 U.S.C. § 300gg-13(a)(4) (directing the enactment of the Women’s Preventive Services Guidelines, which include contraceptives).

In short, the status quo prior to the new Rule, with

the Accommodation, did not infringe on the religious exercise of covered employers, nor is there a basis to conclude the Accommodation process infringes on the religious exercise of any employer. For these reasons,

RFRA does not demand the Religious Exemption.

42a

Because the States demonstrated a likelihood of success on the merits as to their APA claim, we next turn

to the remaining equitable factors. To obtain a preliminary injunction, a plaintiff must “demonstrate that irreparable injury is likely in the absence of an injunction.” Winter, 555 U.S. at 22 (emphasis omitted). Because the States cannot collect money damages under

the APA, 31 5 U.S.C. § 702 (enabling claimants to obtain

“relief other than money damages”); see also California

II, 911 F.3d at 581, the States will suffer irreparable

harm if the Rules are enforced. The States will face

unredressable financial consequences from subsidizing

contraceptive services, providing funds for medical care

associated with unintended pregnancies, and absorbing

medical expenses that arise from decreased use of contraceptive medications for other health conditions.

Therefore, the District Court did not abuse its discretion in holding that the States demonstrated a likelihood

of irreparable harm.

Furthermore, because the current Accommodation

does not substantially burden employers’ religious exercise and the Exemption is not necessary to protect a

legally-cognizable interest, the States’ financial injury

outweighs any purported injury to religious exercise.

Moreover, the public interest favors minimizing harm to

third-parties by ensuring that women who may lose

ACA guaranteed contraceptive coverage are able to

maintain access to the preventive care to which they are

entitled under the ACA and HRSA’s comprehensive

Monetary injuries ordinarily do not constitute irreparable

harm because they are compensable. See Instant Air Freight Co.

v. C.F. Air Freight, Inc., 882 F.2d 797, 801 (3d Cir. 1989).

43a

guidelines while final adjudication of the Rules is pending. Therefore, the District Court did not abuse its discretion in concluding that the balance of the equities and

the public interest both favor issuing an injunction.

Having determined that a preliminary injunction is

warranted, the final question we address is whether the

District Court abused its discretion by enjoining the Final Rules nationwide. “Crafting a preliminary injunction is an exercise of discretion and judgment, often dependent as much on the equities of a given case as the

substance of the legal issues it presents.” Trump v.

Int’l Refugee Assistance Project, 137 S. Ct. 2080, 2087

(2017) (per curiam). While courts are vested with the

power to issue equitable relief with a nationwide reach,

see Texas, 809 F.3d at 188 (quoting U.S. Const. art. III,

§ 1), they must ensure that “injunctive relief [is] no more

burdensome to the defendant than necessary to provide

complete relief to plaintiffs,” Novartis Consumer

Health, Inc. v. Johnson & Johnson-Merck Consumer

Pharm. Co., 290 F.3d 578, 598 (3d Cir. 2002) (internal

quotation marks and citation omitted). We must also

bear in mind that the purpose of injunctions is “not to

conclusively determine the rights of the parties, but to

balance the equities as the litigation moves forward.”

Trump, 137 S. Ct. at 2087 (internal citation omitted).

Mindful of these considerations, the District Court

did not abuse its discretion in concluding that a nationwide injunction is necessary to afford complete relief to

the States and that it is not “more burdensome to the

44a

defendant that necessary” to provide such relief. 32

Groupe SEB USA, Inc. v. Euro-Pro Operating LLC,

774 F.3d 192, 206 (3d Cir. 2014) (internal quotation

marks and citations omitted). First, our APA case law

suggests that, at the merits stage, courts invalidate—

without qualification—unlawful administrative rules as

a matter of course, leaving their predecessors in place

until the agencies can take further action. See, e.g.,

Prometheus Radio, 652 F.3d at 453-54 & n.25 (vacating

procedurally defective rule and leaving the prior rule in

effect); Council Tree Commc’ns, Inc. v. FCC, 619 F.3d

235, 258 (3d Cir. 2010) (same). Congress determined

that rule-vacatur was not unnecessarily burdensome on

agencies when it provided vacatur as a standard remedy

for APA violations. See 5 U.S.C. § 706(2) (“The reviewing court shall . . . hold unlawful and set aside

agency action” that is outside an agency’s authority, or

“without observance of procedure required by law,”

among other things). While vacatur is the ultimate

remedy the States seek, and that is not the relief being

granted here, by enjoining enforcement of the Rules we

provide a basis to ensure that a regulation that the

States have shown likely to be proven to be unlawful is

not effective until its validity is finally adjudicated.

Second, a nationwide injunction is necessary to provide the States complete relief. Many individuals work

in a state that is different from the one in which they

reside. See Amici Curiae Massachusetts, et al., Br. at

Our sister circuit declined to uphold a nationwide injunction concerning the IFRs, but the record before us is substantially more developed than the record before that court. California II, 911 F.3d

at 584 (“On the present record, an injunction that applies only to the

plaintiff states would provide complete relief to them.”).

45a

24 (“Mass. Amici Br.”) (stating that 14% of the workforce in New Jersey and 5.4% in Pennsylvania work out

of state, comprising more than 800,000 workers in total).

An injunction geographically limited to the States alone

will not protect them from financial harm, as some share

of their residents who work out-of-state will lose contraceptive coverage originally provided through employers

in non-enjoined states who will exempt themselves.

Women covered by these plans who live in the States will

seek state-funded services, and a state specific injunction will not be sufficient to prevent the resulting financial harm.

Out-of-state college attendance further exacerbates

the States’ injury. As the Moral Exemption points out,

“[o]nly a minority of students in higher education receive health insurance coverage from plans arranged by

their colleges or universities.” 83 Fed. Reg. at 57,564;

83 Fed. Reg. at 57,619. Instead, most of these students

remain on their parents’ employer-based plans. Mass.

Amici Br. at 26. The States host many such students

at their colleges. “Each year, for example, Pennsylvania takes in more than 32,000 first-time out-of-state students alone—the second most of any state in the country.” Mass. Amici Br. at 25 (citing Nat’l Ctr. For Educ.

Statistics, Residence and Migration of All First-Time

Degree/Certificate-Seeking Undergraduates, Digest of

Education Statistics (2017)). In the absence of a nationwide injunction, students attending school in the

States may lose contraceptive coverage from their parents’ out-of-state plans, again leaving programs within

the States to pick up the bill. 33 In light of the impact of

It is also likely that residents of the States will attend out-ofstate schools that invoke the Exemptions, and that such students will

46a

these interstate activities, the District Court did not

abuse its discretion in concluding that a nationwide injunction was necessary to afford the States complete relief. 34

For the foregoing reasons, we will affirm the District

Court’s order granting the nationwide preliminary injunction.

seek contraceptive services through programs in their home states,

also giving rise to fiscal injuries to the States that only a nationwide

injunction can remedy.

The Government also argues that a nationwide injunction takes

a toll on the court system, foreclosing “adjudication by a number of

different courts and judges,” Califano v. Yamasaki, 442 U.S. 682, 702

(1979), thereby preventing legal questions from “percolating”

throughout the court system, Gov’t Br. at 79-80. The argument has

little force in this case. First, other federal courts have examined

substantially the same legal issues as we confront here. See generally Massachusetts, 923 F.3d 209; California II, 911 F.3d 558. Second, the extensive litigation surrounding the Exemption and Accommodation have allowed for an airing of the legal issues. See Petition for Writ of Certiorari at 27, The Little Sisters of the Poor

Jeanne Jugan Residence v. California (No. 18-1192) (“Further percolation is unnecessary. . . . [T]his issue was adjudicated by ten

courts of appeals and dozens of district courts. . . . The arguments have all been aired.”). Thus, there is no “percolation” problem here.

47a

APPENDIX B

UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

No. 17-4540

COMMONWEALTH OF PENNSYLVANIA, PLAINTIFF

DONALD J. TRUMP, DONALD J. WRIGHT,

UNITED STATES DEPARTMENT OF HEALTH AND

HUMAN SERVICES, STEVEN T. MNUCHIN,

UNITED STATES DEPARTMENT OF THE TREASURY,

RENE ALEXANDER ACOSTA AND THE UNITED STATES

DEPARTMENT OF LABOR, DEFENDANTS

Filed: Dec. 15, 2017

OPINION

The interests at stake in this litigation are great, but

the issues that must be decided here on Plaintiff ’s Motion for a Preliminary Injunction are narrow. This

case implicates access to healthcare, religious freedom,

women’s rights, and executive power. However, the

Court currently addresses only two precise questions:

Did the Defendants here follow the proper procedure in

issuing new rules that greatly expand exemptions to the

law requiring health plans to cover women’s preventive

services at no cost, and do the new rules contradict the

text of the statute that they are meant to interpret?

48a

Plaintiff, the Commonwealth of Pennsylvania (“Commonwealth”), seeks to enjoin enforcement of two Interim Final Rules (“New IFRs”), referred to as the

Moral Exemption Rule and the Religious Exemption

Rule, modifying the Affordable Care Act. The New

IFRs were issued by the Departments of Health and

Human Services, the Department of Treasury, and the

Department of Labor on October 6, 2017. They permit

employers to opt out of providing no-cost contraceptive

coverage on the basis of sincerely held religious beliefs

or sincerely held moral convictions. The parties here

have vastly different perspectives on the import of the

New IFRs. The Defendants assert that they are meant

to permit a small number of religious objectors to opt

out of covering contraceptive services in their employersponsored health plans because the requirement to provide contraceptive coverage imposes a substantial burden on their exercise of religion. Quite to the contrary,

the Commonwealth argues that the Rules allow almost

any employer to withhold insurance coverage for contraceptive services from their female employees, thus impacting millions of women—all in contravention of the

Affordable Care Act and the United States Constitution.

The Commonwealth has sued President Donald J.

Trump, United States Secretary of Health and Human

Services Donald J. Wright, 1 United States Secretary

of the Treasury Steven T. Mnuchin, and United States

Secretary of Labor Rene Alexander Acosta in their official capacities, as well as each of their agencies (collectively, “Defendants”). It now seeks to enjoin the Defendants from enforcing the New IFRs for a variety of

Eric D. Hargan substitutes Donald J. Wright pursuant to Rule

25(d) of the Federal Rules of Civil Procedure.

49a

constitutional and statutory violations. For the reasons explained below, the Motion for a Preliminary Injunction shall be granted.

Background 2

In March 2010, Congress enacted the Affordable

Care Act. See Patient Protection and Affordable Care

Act (ACA), Pub. L. No. 111-148, 124 Stat. 119 (2010). The

ACA included a provision called the Women’s Health

Amendment, which mandated that group health plans

and health insurance issuers offering group or individual health insurance provide coverage for preventive

health services and screenings for women without costsharing responsibilities. The preventive services that

must be covered include, “with respect to women, such

additional preventive care and screenings . . . as

provided for in comprehensive guidelines supported by

the Health Resources and Services Administration

(HRSA).” See 42 U.S.C. § 300gg-13(a)(4). Thus, Congress left the decision about which preventive care and

screenings should be covered by the ACA up to the

HRSA, which is an agency of the Department of Health

and Human Services (HHS).

The HRSA commissioned the Institute of Medicine

(“the Institute”) to issue recommendations identifying

what specific preventive women’s health services should

be covered under the ACA’s mandate. See 77 Fed.

Reg. 8725-26. The Institute is an arm of the National

The factual statements found here and elsewhere in the opinion constitute this Court’s findings of fact, as required under Rule 52(a) of the

Federal Rules of Civil Procedure, regardless of any heading or lack

thereof.

50a

Academy of Sciences, an organization that Congress established for the explicit purpose of furnishing advice to

the federal government. See Pub. Citizen v. Dep’t of

Justice, 491 U.S. 440, 460 n.11 (1989). The Institute, in

turn, convened a committee of sixteen members (the

“Committee”), including specialists in disease prevention, women’s health issues, adolescent health issues,

and evidence-based guidelines, to formulate specific recommendations.

The Committee defined preventive

health services to include measures “shown to improve

well-being and/or decrease the likelihood or delay the

onset of a targeted disease or condition.” Institute,

Clinical Prevention Services for Women: Closing the

Gaps 23 (2011) (“Institute Report”).

On July 19, 2011, the Institute, through the Committee, issued a comprehensive report that identified health

services that should be covered under the Women’s

Health Amendment. Id. at 8-12. It recommended

that the ACA cover “the full range of [FDA]-approved

contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.” Id. at 109-10. The Committee considered: (1) the prevalence of unintended pregnancy in

the United States; (2) potential health risks of pregnancy; (3) that decreased intervals between pregnancies

lead to an “increased risk of adverse pregnancy outcomes”; (4) the effectiveness of contraceptives in preventing unintended pregnancy; (5) the health benefits of

contraceptives for other diseases and conditions; and

(6) the barrier to contraceptive access presented by its

cost. See id. at 104-10.

51a

Original Religious Exemption

On August 1, 2011, HRSA adopted the Institute’s recommendations in guidelines, which required, among

other things, that plans must cover all FDA-approved

contraceptive methods (“Contraceptive Mandate”).

45 C.F.R. § 147.130(a)(1)(iv); 29 C.F.R. § 2590.7152713(a)(1)(iv); 26 C.F.R. § 54.9815-2713(a)(1)(iv). This

requirement applied to all health insurers offering individual or group insurance, as well as all group health

plans, with the exception of certain “grandfathered”

plans. See 29 C.F.R. § 2590.715-1251. Simultaneously,

the Departments of HHS, Labor, and the Treasury (“the

Agencies” or “Defendant Agencies”) also promulgated

an Interim Final Rule (“IFR”) exempting certain religious employers from providing contraceptive services

(“Original Religious Exemption”). See 76 Fed. Reg.

46621. To take advantage of that exemption, an employer must: (1) have the inculcation of religious values

as its purpose; (2) primarily employ people who share its

religious tenets; (3) primarily provide services to persons who share its religious tenets; and, (4) be a church,

its integrated auxiliary, or a convention or association

of a church, all of which are exempt from taxation under

26 U.S.C. § 501(a). See id. at 46623.

Second Religious Exemption and Accommodation Process

Following several legal challenges to the Contraceptive Mandate, the Agencies began to consider changes

to the religious exemptions. In March 2012, they issued an Advanced Notice of Proposed Rulemaking concerning a potential accommodation process for religious

objectors to the Contraceptive Mandate. 77 Fed. Reg.

52a

16501. After a comment period, they then issued a Notice of Proposed Rulemaking proposing changes to the

definition of religious organizations in the exemption

and creating an accommodation process for religious objectors to the Contraceptive Mandate. 78 Fed. Reg.

8456. The Agencies published final regulations on July

2, 2013 (“Second Religious Exemption”). See 78 Fed.

Reg. 39870. These regulations redefined a religious

employer to only refer to churches, their integrated auxiliaries, and conventions or associations of churches,

eliminating the need to fulfill the first three requirements of the prior regulations of the exemption. Upon

a covered entity claiming the exemption, the provider or

administrator would then have to provide the legally required contraceptive services directly to women covered

under the employer’s plan (“Accommodation Process”).

Third Religious Exemption and Accommodation Process

Following enactment of the ACA and the Second Religious Exemption, the Supreme Court granted certiorari to decide whether the Contraceptive Mandate violated the Religious Freedom Restoration Act, 42 U.S.C.

§ 2000bb-1 (RFRA). In Burwell v. Hobby Lobby Stores,

Inc., 134 S. Ct. 2751 (2014), the Supreme Court concluded that applying the Contraceptive Mandate to

closely held corporations violated RFRA. In Wheaton

Coll. v. Burwell, 134 S. Ct. 2806 (2014), the Court identified an alternative process by which Wheaton College

could comply with the Contraceptive Mandate without

informing its health insurer or third-party administrator: The Court permitted Wheaton College to “inform[] the Secretary of Health and Human Service in

writing that it

. . .

has religious objections to

53a

providing coverage for contraceptive services. Id. at

2807. In response to Hobby Lobby and Wheaton College, the Agencies issued a third set of IFRs to augment

the Accommodation Process to comply with the Supreme Court’s orders. See 79 Fed. Reg. 51092, 51118

(expanding th

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