PRECEDENTIAL

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

v.

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 

of Department of Health and Human Services, United States 

Department of Health and Human Services, Secretary United 
2

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)

_____________

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 

______________

Argued May 21, 2019

______________

Before: McKEE, SHWARTZ, and FUENTES, Circuit 

Judges.

(Filed July 12, 2019)

Michael J. Fischer [ARGUED]

Aimee D. Thompson

Office of Attorney General of Pennsylvania

1600 Arch Street, Suite 300

Philadelphia, PA 19103

Glenn J. Moramarco

Office of Attorney General of New Jersey

Department of Law & Public Safety, Division of Law
3

Richard J. Hughes Justice Complex

25 Market Street, P.O. Box 112

Trenton, NJ 08625

Counsel for Appellees Commonwealth of 

Pennsylvania and State of New Jersey

Lowell V. Sturgill, Jr.

United States Department of Justice, Civil Division

950 Pennsylvania Avenue, N.W., Room 7241

Washington, DC 20530

Hashim M. Moopan [ARGUED]

United States Department of Justice

Civil Division, Appellate Staff

950 Pennsylvania Avenue, N.W.

Washington, DC 20530

Karen Schoen

United States Department of Justice

Civil Division, Appellate Section

950 Pennsylvania Avenue, N.W. Room 7533

Washington, DC 20530

Counsel for Appellants President United 

States of America, Secretary United 

States Department of Health & Human 

Services, United States Department of 

Health & Human Services, United States 

Department of Treasury, Secretary 

United States Department of Treasury, 

United States Department of Labor, 

Secretary United States Department of 
4

Labor, and United States of America 

Mark L. Rienzi [ARGUED]

Lori H. Windham

Becket Fund for Religious Liberty

1200 New Hampshire Avenue, N.W., Suite 700

Washington, DC 20036

Nicholas M. Centrella

Conrad O’Brien

1500 Market Street

West Tower, Suite 3900

Philadelphia, PA 19102

Counsel for Appellee-Intervenor Little 

Sisters of the Poor Saints Peter and Paul 

Home

Jason R. LaFond

Office of Attorney General of Texas

209 West 14th Street, 7th Floor

Austin, TX 78711

Counsel for Amici Curiae in Support of 

Appellants States of Texas, Alabama, 

Arkansas, Georgia, Idaho, Louisiana, 

Missouri, Nebraska, Oklahoma, South

Carolina, and West Virginia

Elizabeth N. Dewar

Office of Attorney General of Massachusetts

20th Floor, One Ashburton Place 

McCormack Building
5

Boston, MA 02108

Counsel for Amici Curiae States of 

Massachusetts, California, Colorado, 

Connecticut, Delaware, Hawaii, Illinois, 

Iowa, Maine, Maryland, Michigan, 

Minnesota, Nevada, New Mexico, New 

York, North Carolina, Oregon, Rhode 

Island, Vermont, Virginia, Washington 

and the District of Columbia

Dariely Rodriguez

Lawyers’ Committee for Civil Rights Under Law

1500 K Street, N.W., Suite 900

Washington, DC 20005

Counsel for Amici Curiae Center for 

Reproductive Rights, Lawyers Committee 

for Civil Rights Under Law, California 

Womens Law Center, GLBTQ Legal 

Advocates and Defenders, LatinoJustice 

PRLDEF, Lawyers for Civil Rights, 

Legal Momentum, Legal Voice, 

Mississippi Center for Justice, National 

Center for Lesbian Rights, and Women’s 

Law Project 

Sara J. Rose

American Civil Liberties Union

313 Atwood Street

Pittsburgh, PA 15213

Counsel for Amici Curiae American 
6

Civil Liberties Union, Anti Defamation 

League, Leadership Conference on Civil 

and Human Rights, and National Urban 

League

Thomas W. Hazlett

Stephen J. Kastenberg

Ballard Spahr

1735 Market Street, 51st Floor

Philadelphia, PA 19103

Counsel for Amici Curiae Public Interest 

Law Center of Philadelphia, Washington 

Lawyers Committee for Civil Rights and 

Urban Affairs, Chicago Lawyers 

Committee for Civil Rights, Lawyers 

Committee for Civil Rights of the San 

Francisco Bay Area, and Public Counsel 

Jeffrey Blumenfeld

Lowenstein Sandler

2200 Pennsylvania Avenue, N.W., Suite 5

Washington, DC 20037

Counsel for Amici Curiae National 

Womens Law Center, National Latina 

Institute for Reproductive Health, 

Sisterlove Inc., and National Asian 

Pacific American Women Forum

Robert Dunn

Gibson Dunn & Crutcher

1881 Page Mill Road
7

Palo Alto, CA 94304

Counsel for Amicus Curiae Religious 

Sisters of Mercy

Miles Coleman

Nelson Mullins Riley & Scarborough

104 South Main Street, Suite 900

Greenville, SC 29601

Counsel for Amici Curiae Ronald J. 

Colombo, Richard Epstein, Carl H. 

Esbeck, David F. Forte, Richard W. 

Garnett, Esq., Professor Robert P.

George, Mary Ann Glendon, Michael P. 

Moreland, Stacy Scaldo, and Michael 

Uhlmann

Bruce H. Schneider

Stroock Stroock & Lavan

180 Maiden Lane, 38th Floor

New York, NY 10038

Counsel for Amici Curiae American 

Nurses Association, American College of 

Obstetricians and Gynecologists, 

American Academy of Nursing,

American Academy of Pediatrics, and 

Physicians for Reproductive Choice and 

Health

Allan J. Arffa
8

Melina M. Meneguin-Layerenza

Sierra Robart

Paul Weiss Rifkind Wharton & Garrison

1285 Avenue of the Americas

New York, NY 10019

Counsel for Amici Curiae Planned 

Parenthood Federation of America, 

National Health Law Program, and 

National Family Planning & 

Reproductive Health Association

Priscilla J. Smith

Yale Law School RRJP Clinic

319 Sterling Place

Brooklyn, NY 11328

Counsel for Amicus Curiae Program for 

the Study of Reproductive Justice 

Leah Bruno

Dentons US

233 South Wacker Drive, Suite 5900

Chicago, IL 60606

Jeffrey S. Feldman

The Feldman Firm

600 West Germantown Pike, Suite 400

Plymouth Meeting, PA 19462

Counsel for Amici Curiae United States 

Women’s Chamber of Commerce and 

National Association for Female 
9

Executives 

Joshua A. Matz

Kaplan Hecker & Fink

350 Fifth Avenue, Suite 7110

New York, NY 10118

Counsel for Amicus Curiae Church State 

Scholars

Rhiannon N. Batchelder

Jamie A. Levitt

Morrison & Foerster

250 West 55th Street

New York, NY 10019

Counsel for Amici Curiae American 

Association of University Women and 

Service Employees International Union

Richard B. Katskee

Americans United for Separation of Church & State

1310 L Street, N.W., Suite 200

Washington, DC 20005

Counsel for Amicus Curiae Americans 

United for Separation of Church and 

State

______________________

OPINION OF THE COURT

______________________
10

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. 

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.

I
11

A

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

 1 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.” 

2 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). 
12

statutory and regulatory scheme was deemed the 

“Contraceptive Mandate.” Several regulations and litigation 

followed. 

1

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 As the Agencies later 

 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 

“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
13

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 

administrator (“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 

 

Affordable Care Act, 78 Fed. Reg. 39,870, 39,871, 39,889 

(July 2, 2013); see 45 C.F.R. § 147.132.
14

no longer responsible for providing coverage for contraceptive 

care.

2

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 self-certification 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

 Coverage 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 

 4 The final rule implementing Hobby Lobby was 

preceded by notice of proposed rulemaking. Coverage of 

Certain Preventive Services Under the Affordable Care Act,

79 Fed. Reg. 51,118 (Aug. 27, 2014). 
15

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 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-
16

activities/resource-center/faqs/aca-part-36.pdf. As a result, the 

Accommodation remained unchanged. 

3

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 preventive-care 

mandate promulgated under [42 U.S.C. § 300gg-13(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. 
17

B

1

The Commonwealth of Pennsylvania filed suit against 

various governmental entities5 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 

 5 These entities include the President, the Agencies and 

their Secretaries, and the United States of America 

(collectively, “the Government”). 

6 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 
18

Court granted Pennsylvania’s 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 

 

statutory provisions not be enforced. Such threatened injury is 

sufficient to confer appellate standing on the intervenordefendants 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.”).
19

Accommodation process completely voluntarily, relieving 

employers from the need to “file notices or certifications of 

their exemption.”7

 83 Fed. Reg. at 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

 7 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 

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

57,558. Even if this is true, this would apply only to certain 

employers.

8 Pennsylvania and New Jersey are referred to herein 

collectively as the “the States.”

9 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 
20

2

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 barriers, 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 

 

substantive requirements of the APA; and (V) violation of the 

Establishment Clause of the First Amendment. 

10 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-ofpocket contraceptive expenditures by 70%). 
21

Medicaid and New Jersey’s FamilyCare11 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. Office of Population Affairs, 

Funding History, HHS, https://www.hhs.gov/opa/title-xfamily-planning/about-title-x-grants/fundinghistory/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 

 11 NJ FamilyCare is New Jersey’s state and federallyfunded Medicaid. 
22

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.

3

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 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 

 12 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. 
23

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.

II13

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 “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. 

 13 The District Court had jurisdiction under 28 U.S.C. 

§ 1331. We have jurisdiction under 28 U.S.C. § 1292(a)(1). 

14 “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). 
24

A

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). 

1

The States have established that they will suffer a 

concrete and particularized injury. The States describe 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 statefunded 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 
25

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 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 
26

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)).

2

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 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 interuterine 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. 
27

“Contraception also helps protect the health of those women 

for whom pregnancy can be hazardous, or even lifethreatening.” 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 state-funded programs.”15 App. 299; App. 317. 

Thus, the 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 

 15 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.
28

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. 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

 16 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 
29

B

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 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 

 

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.
30

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. 

C

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

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 

 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. 
31

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) (quoting Singer Mgmt. Consultants, Inc. v. Milgram, 

650 F.3d 223, 229 (3d Cir. 2011) (en banc)). 

 18 “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).
32

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. 

A19

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.

1

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. The provisions upon 

which the Government relies provide:

 19 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). 
33

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. § 300gg-92 

[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 . . .’), wideranging (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 
34

not authorize the Agencies to disregard the notice-andcomment 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 . . . interagency 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

 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 
35

2

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”), 

 

kickbacks by January 1, 1997, then less than four months 

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.

21 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. 
36

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-andcomment requirement narrowly.22 Id.

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 Mandaterelated 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. 

 22 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 standards—reviewing the 

agency’s good cause determination to see if it is arbitrary and 

capricious—the IFRs cannot stand.

23 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 
37

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 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 

 

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.
38

Contraceptive Mandate cannot substitute for notice and

comment here. If the APA permitted agencies to forego noticeand-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 notice-andcomment under the APA. 

For these reasons, the Agencies did not have good cause 

to ignore the APA’s notice and comment requirement.

B

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, “postpromulgation 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 

notice-and-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.”).
39

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 open-minded 

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 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

 24 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.
40

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 openminded 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 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 post-promulgation 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 
41

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 Rules, the 

States have demonstrated a likelihood of success in showing 

that the Final Rules are procedurally defective, and in turn, 

violate the APA. 

C

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). 
42

1

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 (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 

 25 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). 
43

Congress’s directive concerning who must provide coverage 

for these services. Section 300gg-13(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 

 26 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 § 300gg13(a), Supreme Court precedent dictates 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., 

Hosanna-Tabor 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 
44

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. § 300gg13(a)(3) (describing “preventive care and screenings provided 

for in the comprehensive guidelines”), with id. § 300gg13(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 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 

 

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. 
45

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-carechildren (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 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, 1173-74 (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. 
46

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. 

227

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 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. 

 27 No party argues that RFRA authorizes or requires 

the Moral Exemption. 
47

§ 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 established 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
48

(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 The Accommodation fulfills this directive as it 

 28 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). 

29 Although Cutter v. Wilkinson, 544 U.S. 709 (2005), 

dealt with an application of the Religious Land Use and 

Institutionalized Persons 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 
49

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 thirdparty 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 

 

RLUIPA law. Mack, 839 F.3d at 304 n.103; see Holt v. 

Hobbs, 135 S. Ct. 853, 860 (2015).

30 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 
50

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 noncompliance 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., concurring) (“The opinion does 

 

n.18. After Zubik, we repeated that the Accommodation does 

“not impose a substantial burden.” Id.
51

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., concurring). 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.
52

D

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 

 31 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). 
53

are able to maintain access to the preventive care to which they 

are entitled under the ACA and HRSA’s comprehensive 

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. 

E

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
54

and that it is not “more burdensome to the defendant than 

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 

 32 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.”). 
55

Curiae Massachusetts, et al., Br. at 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 statefunded 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/CertificateSeeking 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 

 33 It is also likely that residents of the States will attend 

out-of-state schools that invoke the Exemptions, and that such 

students will seek contraceptive services through programs in 
56

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 

V

For the foregoing reasons, we will affirm the District 

Court’s order granting the nationwide preliminary injunction.

 

their home states, also giving rise to fiscal injuries to the 

States that only a nationwide injunction can remedy.

34 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.