Petition for Writ of Certiorari — Little Sisters of the Poor Saints Peter and Paul Home, Petitioner v. Pennsylvania, et al.

Supreme Court briefOct 1, 2019

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APPENDIX A

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 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)

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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. Thomson

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

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

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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 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

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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

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

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Counsel for Amici Curiae American 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

Palo Alto, CA 94304

Counsel for Amicus Curiae Religious Sisters of

Mercy

Miles Coleman

Nelson Mullins Riley & Scarborough

104 South Main Street, Suite 900

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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

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

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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 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

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___________________________

OPINION OF THE COURT

___________________________

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.

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I

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[] 1and 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/womens-guidelines/index.html

(last visited May 8, 2019). This statutory and regula-

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.”

1

2 Congress expressly exempted two sets of actors from various

CA 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).

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tory 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 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

3 After a notice-and-comment rulemaking process, which includ-

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

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

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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 selfcertification 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 no

longer responsible for providing coverage for contraceptive care.

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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 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

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).

4

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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

7parties “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/aboutebsa/our-activities/resource-center/faqs/aca-part36.pdf. As a result, the Accommodation remained unchanged.

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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.

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 Sis-

5 These entities include the President, the Agencies and their

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

Government”).

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ters”) intervened.6 The District 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.

6 Little Sisters, a religious nonprofit operating a home in Pitts-

burgh, 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 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.”).

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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

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

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.

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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

barriers, women switched to the more effective and

expensive methods of contraception.10 Because the

8 Pennsylvania and New Jersey are referred to herein collective-

ly 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 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-of-pocket contraceptive

expenditures by 70%).

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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 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-x-familyplanning/about-title-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.

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

Medicaid.

11

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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.

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-andcomment requirement and this defect tainted the Final Rules. Id. at 813. Second, the Court held that the

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.

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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.

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,

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).

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“[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.

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) financiallyeligible women will turn to state-funded services for

22a

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 employersponsored 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.).

23a

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)).

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

24a

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

state-funded

programs.”15

App. 299;

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.

25a

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 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 de-

26a

termined [a] precise” woman who will seek such funding. Massachusetts, 549 U.S. at 523 n.21.16

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 in16 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-beflooded 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.

27a

creased 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’slicense 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

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.

28a

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.

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).

29a

2015) (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.

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-and-comment 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

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).

30a

rulemaking. 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.

§ 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 de-

31a

parting from the APA,” it does not authorize 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

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.

32a

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”), 683 F.2d 752, 764 (3d Cir. 1982) (alterations in original) (internal quotation marks and citation omitted). Thus, we construe the “good cause” ex-

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 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.

33a

ception to the notice-and-comment 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. Reynolds, 710 F.3d

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.

22

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 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

34a

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

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.

some continuing harm during the notice and comment

period antecedent to the promulgation of a rule.

710 F.3d at 512-13.

35a

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-and-comment 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, “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 post

promulgation 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.”).

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

36a

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 openmindedness 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

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.

37a

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

open-mindedness, 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-and-comment 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 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 posi-

38a

tion 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-inhand 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).

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, 42U.S.C. § 300gg-13(a)(4),

provides:

A group health plan and a health insurance issuer offering group or individual health insur-

39a

ance 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 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 guide25 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).

40a

lines 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

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 subsection’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

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 § 300gg-13(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

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.

41a

“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 those existing children’s preventive care guidelines. In § 300gg13(a)(4), Congress addressed the women’s preventive

care guidelines that were yet to be promulgated by

stating “as provided for in 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

42a

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. 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).

43a

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. § 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 ob27 No party argues that RFRA authorizes or requires the Moral

Exemption.

44a

ject 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

(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

28 Although we “defer to the reasonableness” of an objector’s re-

ligious 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.

45a

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 provides a means for an observer to adhere to religious precepts and simultaneously allows women to receive statutorily-mandated

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

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 RLUIPA law. Mack, 839 F.3d

at 304 n.103; see Holt v. Hobbs, 135 S. Ct. 853, 860 (2015).

46a

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

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

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 n.18. After Zubik,

we repeated that the Accommodation does “not impose a substantial burden.” Id.

47a

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 sincerelyheld 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 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

48a

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.

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,

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).

49a

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 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

50a

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 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

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.”).

51a

Cir. 2010) (same). Congress determined that rulevacatur 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 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 nonenjoined 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

52a

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 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

33 It is also likely that residents of the States will attend out-ofstate schools that invoke the Exemptions, and that such students will seek contraceptive services through programs 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 7980. 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 sur34

53a

V

For the foregoing reasons, we will affirm the District Court’s order granting the nationwide preliminary injunction.

rounding 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.

54a

APPENDIX B

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF

PENNSYLVANIA

COMMONWEALTH OF

PENNSYLVANIA AND

STATE OF NEW JERSEY,

Plaintiffs,

CIVIL ACTION

NO. 17-4540

v.

DONALD J. TRUMP, ALEX

M. AZAR II, UNITED

STATES DEPARTMENT OF

HEALTH AND HUMAN

SERVICES, STEVEN T.

MNUCHIN, UNITED

STATES DEPARTMENT OF

THE TREASURY, RENE

ALEXANDER ACOSTA,

THE UNITED STATES DEPARTMENT OF LABOR,

AND THE UNITED STATES

OF AMERICA,

Defendants,

LITTLE SISTERS OF THE

POOR SAINTS PETER AND

PAUL HOME,

Defendant-Intervenor.

ORDER

AND NOW, this 14th day of January, 2019, upon

consideration of the Plaintiffs’ Second Motion for a

Preliminary Injunction (ECF No. 90), Defendants’

55a

and Defendant-Intervenor’s Responses thereto (ECF

Nos. 107 & 108), the Plaintiffs’ Reply in Support

thereof (ECF No. 118), the Administrative Record

(ECF Nos. 23, 47 & 126), Briefs of the Amici Curiae

(ECF Nos. 110, 112, 113, 115, 117 & 127), and following a Hearing on Plaintiffs’ Motion on January 10,

2019, IT IS HEREBY ORDERED that the Motion is

GRANTED.

It is FURTHER ORDERED that Defendants

Alex M. Azar II, as Secretary of the United States

Department of Health and Human Service; the United States Department of Health and Human Services;

Steven T. Mnuchin, as Secretary of the United States

Department of Treasury; the United States Department of Treasury; Rene Alexander Acosta, as Secretary of the United States Department of Labor; and

the United States Department of Labor;1 and their

officers, agents, servants, employees, attorneys, designees, and subordinates, as well as any person acting in concert or participation with them, are hereby

ENJOINED from enforcing the following Final

Rules across the Nation, pending further order of this

Court:

1.

Religious Exemptions and Accommodations for Coverage of Certain Preventive

Services Under the Affordable Care Act,

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

1 In light of the constitutional concerns associated with enjoin-

ing the President of the United States for a claim under the

Administrative Procedure Act, this injunction does not apply to

the President. See Franklin v. Massachusetts, 505 U.S. 788, 801

(1992).

2.

56a

Moral Exemptions and Accommodations

for Coverage of Certain Preventive Services Under the Affordable Care Act, 83

Fed. Reg. 57,592 (Nov. 15, 2018).

The Court has considered the issue of security

pursuant to Rule 65(c) of the Federal Rules of Civil

Procedure and determines that Defendants will not

suffer any financial loss that warrants the need for

the Plaintiffs to post security.

BY THE COURT:

/s/Wendy Beetlestone, J.

WENDY BEETLESTONE, J.

57a

APPENDIX C

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT

OF PENNSYLVANIA

COMMONWEALTH OF

PENNSYLVANIA AND

STATE OF NEW JERSEY,

Plaintiffs,

v.

DONALD J. TRUMP, ALEX M.

AZAR II, UNITED STATES

DEPARTMENT OF HEALTH

AND HUMAN SERVICES,

STEVEN T. MNUCHIN,

UNITED STATES DEPARTMENT OF THE TREASURY,

RENE ALEXANDER ACOSTA,

THE UNITED STATES DEPARTMENT OF LABOR, AND

THE UNITED STATES OF

AMERICA,

Defendants,

LITTLE SISTERS OF THE

POOR SAINTS PETER AND

PAUL HOME,

Defendant-Intervenor.

CIVIL ACTION

NO. 17-4540

58a

OPINION

Table of Contents

I. Background .............................................................. 3

A. Contraceptive Mandate .................................... 3

B. Regulatory Action to Accommodate

Religious Objections ......................................... 4

C. Hobby Lobby & Wheaton College ..................... 6

D. Regulatory Response to Hobby

Lobby & Wheaton College ................................. 7

E. Zubik Remand & Impasse ................................ 8

F. 2017 IFRs & First Preliminary Injunction ...... 9

G. 2018 Final Rules & Second

Motion for Preliminary Injunction ................. 12

II. Analysis ................................................................. 13

A. Standing .......................................................... 13

1. Special Solicitude ........................................ 15

2. Article III Standing .................................... 18

B. Venue............................................................... 20

C. Preliminary Injunction ................................... 23

1. Legal Standard ........................................... 23

2. Likelihood of Success on the Merits ........... 24

a. APA Procedural Claim .......................... 24

i. Inadequate Response

to Comments .................................... 25

ii. IFRs Taint the Final Rules .............. 27

b. APA Substantive Claim ........................ 34

59a

i. The ACA ........................................... 35

ii. RFRA ................................................ 42

3. Irreparable Harm ....................................... 52

4. Balance of the Equities ............................... 55

5. Public Interest ............................................ 56

D. Remedy ............................................................ 57

Plaintiffs, the Commonwealth of Pennsylvania and

the State of New Jersey (collectively “the States”),

have sued the United States of America, President

Donald J. Trump, the United States Secretary of

Health and Human Services Alex M. Azar II, the

United States Secretary of the Treasury Steven T.

Mnuchin, and the United States Secretary of Labor

Rene Alexander Acosta in their official capacities, as

well as each of their agencies (collectively “Defendants”), seeking to enjoin enforcement of two Final

Rules that grant exemptions to the Affordable Care

Act’s requirement that health plans cover women’s

preventive services. The Final Rules “finalize” two Interim Final Rules, which Defendants issued in October

2017 and which this Court enjoined soon thereafter,

see Pennsylvania v. Trump, 281 F. Supp.3d 553, 585

(E.D. Pa. 2017). On November 15, 2018, while their

appeal of that preliminary injunction was pending,

Defendants promulgated the Final Rules currently before the Court. The States move to enjoin enforcement

of the Final Rules arguing that, like the IFRs before

them, the Final Rules violate a variety of constitutional and statutory provisions. For the reasons set

forth below, Plaintiffs’ Second Motion for a Preliminary Injunction shall be granted.

60a

I. Background 1

0F

Although the relevant factual and procedural history of this dispute has been laid out at length before,

see id. at 560-64, that background information is recounted here for the sake of clarity.

A. Contraceptive Mandate

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).

A provision of the ACA, the Women’s Health Amendment, mandated that insurance providers cover preventive health services and screenings for women

without cost-sharing responsibilities. Specifically, the

Women’s Health Amendment requires that “[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 . . . 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”] for purpose of this paragraph.”

42 U.S.C. § 300gg-13(a)(4). This requirement applies

to all health insurers offering individual or group insurance, as well as all group health plans, with an exception for certain “grandfathered” plans. 42 U.S.C.

§ 18011 (exempting “grandfathered” plans); see also

29 C.F.R. § 2590.715- 1251 (2010).

1 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.

61a

Rather than enumerate the preventive services to

be covered by the mandate, Congress delegated that

decision to HRSA, which is an agency of Defendant Department of Health and Human Services (“HHS”).

HRSA, in turn, commissioned the then-named Institute of Medicine (“the Institute”), to convene a panel of

experts to provide recommendations. 2 On July 19,

2011, the Institute issued its report, recommending

that the ACA cover “the full range of Food and Drug

Administration-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.” Institute of Medicine, Clinical Prevention Services for

Women: Closing the Gaps, at 109-10 (2011).

1F

On August 1, 2011, HRSA issued its preventive

care guidelines (“2011 Guidelines”), which adopted the

Institute’s recommendations. See HRSA, Women’s

Preventive Services

Guidelines,

available at

https://www.hrsa.gov/womens-guidelines/index.html. 3

The 2011 Guidelines hewed to the Institute’s report,

defining preventive care to include all FDA-approved

“contraceptive methods, sterilization procedures, and

patient education and counseling.” Id.

2F

2 The Institute, renamed the National Academy of Medicine in

2015, is an arm of the National 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).

3 The Guidelines were updated in 2016 but continue to define

“preventive services” to include contraceptive services and counseling. See Updating the HRSA-Supported Women’s Preventive

Services Guidelines, 81 Fed. Reg. 95,148, 95,149 (Dec. 27, 2016).

62a

Under the Women’s Health Amendment, “nongrandfathered group health plans and health insurance issuers are required to provide coverage consistent with the HRSA Guidelines, without cost sharing.” Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under

the Patient Protection and Affordable Care Act, 77 Fed.

Reg. 8,725, 8,725 (Feb. 15, 2012). Thus these interlocking statutory and regulatory requirements created the

so-called “Contraceptive Mandate.”

B. Regulatory Action to Accommodate

Religious Objections

At the same time, and based on “considerable feedback,” HHS, the Department of Labor, and the Department of the Treasury (collectively “the Agencies”)

found it was “appropriate that HRSA, in issuing [the

2011] Guidelines, take[] into account the effect on the

religious beliefs of certain religious employers if coverage of contraceptive services were required.” 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 (Aug. 3, 2011). The Agencies therefore provided

HRSA with “additional discretion to exempt certain

religious employers from the Guidelines where contraceptive services are concerned.” Id.

On August 1, 2011, the Agencies promulgated an

interim final rule exempting certain religious employers from providing contraceptive services. Id. Under

the exemption, a “religious employer” could be exempt

from the Contraceptive Mandate only if it: (1) had the

inculcation of religious values as its purpose; (2) primarily employed people who shared its religious ten-

63a

ets; (3) primarily served persons who shared its religious tenets; and (4) was a church, its integrated auxiliary, or a convention or association of a church exempt from taxation under the Internal Revenue Code.

Id. On February 15, 2012, after considering more than

200,000 responses to this interim final rule, the Agencies issued a final rule adopting the “religious employer” definition. 77 Fed. Reg. at 8,725.

On March 21, 2012, the Agencies issued a notice of

proposed rulemaking requesting comments on “alternative ways of providing contraceptive coverage without cost sharing in order to accommodate non-exempt,

non-profit religious organizations with religious objections to such coverage.” Certain Preventive Services

Under the Affordable Care Act, 77 Fed. Reg. 16,501,

16,503 (March 21, 2012). After receiving and considering over 400,000 comments, the Agencies issued their

final rule on July 2, 2013. Coverage of Certain Preventive Services Under the Affordable Care Act, 78 Fed.

Reg. 39,870, 39,871 (July 2, 2013). The final rule had

two noteworthy effects.

First, the rule “eliminate[ed] the first three prongs

and clarif[ied] the fourth prong of the definition” of “religious employer” adopted in 2012. Id. at 39,874. Under the new definition, an entity qualified as a “religious employer” so long as it “is organized and operates as a nonprofit entity and is referred to in section

6033(a)(3)(A)(i) or (iii)” of the Internal Revenue Code,

which applies to “churches, their integrated auxiliaries, and conventions or associations of churches, as

well as to the exclusively religious activities of any religious order.” Id.

Second, the rule established an accommodation for

“eligible organizations” with religious objections to

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providing contraceptive coverage. Id. The rule defined

an “eligible organization” as one that: “(1) [o]pposes

providing coverage for some or all of the contraceptive

services required to be covered . . . ; (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.” Id. An eligible organization was required to provide a copy of the self-certification to its insurance provider, which then would

provide contraceptive coverage to the organization’s

employees. Id. at 39,876. Thus an eligible organization

that self-certified as such was “not required to contract, arrange, pay, or refer for contraceptive coverage,” but its “plan participants and beneficiaries

[would] still benefit from separate payments for contraceptive services without cost sharing or other

charge,” consistent with the Contraceptive Mandate.

Id. at 39,874.

C. Hobby Lobby & Wheaton College

Meanwhile, a host of legal challenges to the Contraceptive Mandate progressed through the federal

courts, several of which eventually reached the Supreme Court.

On June 30, 2014, the Supreme Court issued its

opinion in Burwell v. Hobby Lobby Stores, Inc., 134 S.

Ct. 2751 (2014). There, three closely-held corporations

challenged the Contraceptive Mandate. Id. at 2765.

The Supreme Court held that the application of the

Contraceptive Mandate to the organizations violated

the Religious Freedom Restoration Act, 42 U.S.C.

§ 2000bb-1 (“RFRA”), because the Contraceptive Mandate imposed a substantial burden on the plaintiffs’

religious exercise and was not the “least restrictive

means” of guaranteeing cost-free access to certain

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methods of contraception. 134 S. Ct. at 2780-82. The

Supreme Court found the existence of the accommodation supported its conclusion that the Contraceptive

Mandate was not the “least restrictive means”: “HHS

itself has demonstrated that it has at its disposal an

approach that is less restrictive than requiring employers to fund contraceptive methods that violate

their religious beliefs HHS has already established

an accommodation for nonprofit organizations with religious objections.” Id. at 2782. Nevertheless, the Supreme Court refrained from deciding “whether an approach of this type”—meaning the accommodation—

“complies with RFRA for purposes of all religious

claims.” Id.

A few days later, the Supreme Court issued an order in a related case, Wheaton College v. Burwell, 134

S. Ct. 2806 (2014) (per curiam). There, Wheaton College, an organization eligible for the accommodation,

sought an injunction “on the theory that its filing of a

self-certification form [would] make it complicit in the

provision of contraceptives by triggering the obligation

for someone else to provide the services to which it objects.” Id. at 2808 (Sotomayor, J., dissenting). The Supreme Court granted the injunction, permitting

Wheaton College to “inform[] the Secretary of Health

and Human Services in writing that it has religious

objections to providing coverage for contraceptive services”—that is, the college did not have to “use the

[self-certification] form prescribed by the [g]overnment.” Id. at 2807 (per curiam). The Supreme Court

warned, however, that the “order should not be construed as an expression of the Court’s views on the

merits.” Id.

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D. Regulatory Response to Hobby Lobby &

Wheaton College

The Agencies responded to Hobby Lobby and

Wheaton College by issuing a notice of proposed rulemaking “amend[ing] the definition of an eligible organization [for purposes of the accommodation] to include a closely held for-profit entity that has a religious objection to providing coverage for some or all of

the contraceptive services otherwise required to be

covered.” Coverage of Certain Preventive Services Under the Affordable Care Act, 79 Fed. Reg. 51,118,

51,121 (Aug. 27, 2014). Furthermore, the Agencies issued an interim final rule, effective immediately, that

provided “an alternative process” for eligible organizations to self- certify “consistent with the Wheaton order.” Coverage of Certain Preventive Services Under

the Affordable Care Act, 79 Fed. Reg 51,092, 51,094-96

(Aug. 27, 2014). On July 14, 2015, the Agencies issued

a rule that finalized the extended accommodation and

alternative self- certification process. Coverage of Certain Preventive Services Under the Affordable Care

Act, 80 Fed. Reg. 41,318, 41,323-24 (July 14, 2015).

E. Zubik Remand & Impasse

On May 16, 2016, the Supreme Court issued its

third decision regarding the Contraceptive Mandate.

In Zubik v. Burwell, 136 S. Ct. 1557 (2016) (per curiam), several organizations eligible for the accommodation challenged the self-certification process on the

grounds that the requirement to submit a notice either

to their insurer or the federal government violated

RFRA. Id. at 1559. The Supreme Court declined to

reach the merits of the dispute, requesting instead

“supplemental briefing from the parties addressing

‘whether contraceptive coverage could be provided to

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petitioners’ employees, through petitioners’ insurance

companies, without any such notice from petitioners.’”

Id. at 1559-60. After the parties agreed that “such an

option [was] feasible,” the Supreme Court remanded

to afford them “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

and equal health coverage, including contraceptive

coverage.” Id. at 1560 (internal quotation marks omitted). Again, though, the Court “express[ed] no view on

the merits of the cases,” and refrained from “decid[ing]

whether petitioners’ religious exercise has been substantially burdened, whether the [g]overnment has a

compelling interest, or whether the current regulations are the least restrictive means of serving that interest.” Id.

Following the remand the Agencies reached an impasse. After reviewing over 50,000 comments submitted in response to a request for information, the Agencies concluded that there was “no feasible approach . .

. 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 (2016), available at https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf.

F. 2017 IFRs & First Preliminary

Injunction

On May 4, 2017, President Donald Trump issued

an Executive Order entitled “Promoting Free Speech

and Religious Liberty.” Exec. Order No. 13798, 82 Fed.

68a

Reg. 21,675 (May 4, 2017). The Order directed the

Agencies to “consider issuing amended regulations,

consistent with applicable law, to address consciencebased objections to the preventive-care mandate promulgated under [the Women’s Health Amendment].” Id.

at § 3.

On October 6, 2017, aiming to be “[c]onsistent with

the President’s Executive Order and the Government’s

desire to resolve the pending litigation and prevent future litigation from similar plaintiffs,” Religious Exemptions and Accommodations for Coverage of Certain

Preventive Services Under the Affordable Care Act, 82

Fed. Reg. 47,792, 47,799 (Oct. 13, 2017), the Agencies

issued two, new IFRs, referred to as the Religious Exemption IFR and the Moral Exemption IFR. See id. at

47,792 (“Religious Exemption IFR”); Moral Exemptions and Accommodations for Coverage of Certain

Preventive Services Under the Affordable Care Act, 82

Fed. Reg. 47,838, 47,838 (Oct. 13, 2017) (“Moral Exemption IFR”) (collectively, “the IFRs”).

The IFRs made several significant changes to the

prior exemption and accommodation framework. 4 For

one, the Moral Exemption IFR made the exemption

3F

4 The following is not an exhaustive list of the changes enacted

by the IFRs, and subsequently the Final Rules. For example, the

IFRs also changed the level at which exemptions are to be applied. So, whereas before the availability of an exemption was to

be “‘determined on an employer by employer basis,’” the IFRs

provide that an exemption “will be determined on a plan basis.”

82 Fed. Reg. at 47,810. The effect of this change, according to the

States, is that an employer may disregard the Contraceptive

Mandate by adopting a group health plan “established or maintained” by an objecting organization, id., even if the employer itself does not hold a sincere religious or moral objection to contraception.

69a

available to “additional entities”—including for-profit

entities that are not publicly traded—that object based

on “sincerely held moral convictions,” without any

need for the objection to be grounded in a religious objection to contraception. 82 Fed. Reg. at 47,862 (emphasis added). Second, the Religious Exemption IFR

significantly broadened the scope of the religious exemption to encompass any non-profit or for-profit entity, whether closely held or publicly traded. 82 Fed.

Reg. at 47,810. Third, the IFRs “likewise” expanded eligibility for the accommodation, allowing entities with

sincerely held religious or moral convictions to take

advantage of the accommodation process. 82 Fed. Reg.

at 47,813; 82 Fed. Reg. at 47,849. Fourth, the IFRs

made “the accommodation process optional for eligible

organizations,” such that entities taking advantage of

the accommodation would “not be required to comply

with a self-certification process.” 82 Fed. Reg at

47,808; 82 Fed. Reg. at 47,850. Finally, the IFRs eliminated the requirement to provide notice of an intent

to take advantage of the exemption or accommodation—entities that stop providing contraceptive care

“do not need to file notices or certifications of their exemption.” 82 Fed. Reg. at 47,808; 82 Fed. Reg. at

47,850. Thus the IFRs permit entities with religious

or moral objections to forgo providing contraceptive

coverage to employees without “fil[ing] notices or certifications of their exemption.” 82 Fed. Reg. at 47,838. 5

4F

5 The IFRs note that ERISA requires certain disclosures: “[u]nder

ERISA, the plan document provides what benefits are provided

to participants and beneficiaries under the plan and, therefore, if

an objecting employer would like to exclude all or a subset of contraceptive services, it must ensure that the exclusion is clear in

the plan document.” 82 Fed. Reg. at 47,838.

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The IFRs became effectively immediately. 82 Fed.

Reg. at 47,815; 82 Fed. Reg. at 47,855. Rather than

engage in advance notice-and-comment procedures,

the Agencies requested post-promulgation comments

be submitted by December 5, 2017, 60 days after the

IFRs went into effect. 82 Fed. Reg. at 47,792; 82 Fed.

Reg. at 47,838. The Commonwealth filed suit in the

interim seeking to enjoin enforcement of the IFRs, arguing: (1) they failed to comply with the notice-andcomment procedures required by the APA, 5 U.S.C.

§ 551, et seq.; (2) they are “arbitrary, capricious, an

abuse of discretion, or otherwise not in accordance

with law” in violation of the substantive provisions of

the APA, 5 U.S.C. § 706(2)(A); (3) they violate Title VII

of the Civil Rights Act, 42 U.S.C. § 2000e-2, et seq.;

(4) they violate the Equal Protection Guarantee of the

Fifth Amendment, U.S. Const. amend. V; and, (5) they

violate the Establishment Clause, U.S. Const. amend.

I. 6 This Court granted the preliminary injunction,

finding the Commonwealth was likely to succeed on its

claims that the IFRs violated both the procedural and

substantive strictures of the APA; it did not, however,

reach the merits of the other statutory or constitutional claims. See Pennsylvania, 281 F. Supp.3d at

585. 7

5F

6F

6 The State of New Jersey was not party to the original Com-

plaint, and thus, not a party to the first motion for a preliminary

injunction either.

7 Following this Court’s issuance of a preliminary injunction, sev-

eral other district courts issued decisions regarding the propriety

of the IFRs. See California v. Health & Human Servs., 281 F.

Supp.3d 806, 832 (N.D. Cal. 2017) (enjoining the IFRs for violating the procedural requirements of the APA only), aff’d in part,

vacated in part, remanded sub nom., California v. Azar, 911 F.3d

558, 566 (9th Cir. 2018) (upholding the lower court’s conclusion

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Defendants subsequently appealed the decision

and moved to stay proceedings while the appeal was

pending, which this Court granted. 8

7F

G. 2018 Final Rules & Second Motion for

Preliminary Injunction

On November 15, 2018, while their appeal of the

preliminary injunction was pending before the Third

Circuit, the Agencies promulgated two new rules that

“finalize[d]” the IFRs. Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 83 Fed. Reg.

57,536, 57,536 (Nov. 15, 2018) (“Final Religious Exemption”); Moral Exemptions and Accommodations for

Coverage of Certain Preventive Services Under the Affordable Care Act, 83 Fed. Reg. 57,592, 57,592 (Nov.

15, 2018) (“Final Moral Exemption”). “In response to

public comments,” the Agencies made “various

changes” to the Final Rules “to clarify the intended

scope of the language” in the IFRs. 83 Fed. Reg. at

57,537; 83 Fed. Reg. at 57,593. The changes, however,

were largely “non-substantial technical revisions.” 83

Fed. Reg. at 57,567. Defendants assert such changes

on the merits, but striking down the remedy as overbroad); Massachusetts v. Health & Human Servs., 301 F. Supp.3d 248, 266

(D. Mass. 2018) (finding State lacked standing to challenge the

IFRs), app. docketed, No. 18-1514 (1st Cir. June 6, 2018).

8 Following the Commonwealth’s initial motion for a preliminary

injunction, Defendant-Intervenor Little Sisters filed a motion to

intervene. The Court denied that motion. See Pennsylvania v.

Trump, 2017 WL 6206133, at *1 (E.D.Pa. Dec. 8, 2017). On appeal, however, the Third Circuit reversed, remanding the case to

permit intervention. See Pennsylvania v. President United States

of Am., 888 F.3d 52, 62 (3d Cir. 2018). The Court duly vacated its

prior ruling and granted Defendant-Intervenor Little Sisters’ motion.

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“do not alter the fundamental substance of the exemptions set forth in the IFRs.” The Final Rules were

scheduled to take effect on January 14, 2019. 83 Fed.

Reg. at 57,567; 83 Fed. Reg. at 57,592.

The Commonwealth then sought to lift the stay to

challenge the Final Rules. The Court granted the motion, 9 and Pennsylvania—now joined by New Jersey—

filed an Amended Complaint and a Second Motion for

a Preliminary Injunction, seeking to enjoin enforcement of the Final Rules. 10 The States argue the Final

Rules: (1) failed to comply with the notice-and- comment procedures required by the APA; (2) are “arbitrary, capricious, an abuse of discretion, or otherwise

not in accordance with law” in violation of the substantive provisions of the APA; (3) violate Title VII of the

Civil Rights Act; (4) violate the Equal Protection Guarantee of the Fifth Amendment; and, (5) violate the Establishment Clause. It is to the merits of these contentions that the Court now turns.

8F

9F

9 While the filing of a notice of appeal is generally “an event of

jurisdictional significance—it confers jurisdiction on the court of

appeals and divests the district court of its control over those aspects of the case involved in the appeal,” Griggs v. Provident Consumer Disc. Co., 459 U.S. 56, 58 (1982),—“[a]n appeal from the

grant or denial of a preliminary injunction does not divest the

trial court of jurisdiction or prevent it from taking other steps in

the litigation while the appeal is pending,” 11A Wright & Miller,

Fed. Prac. & Pro. § 2962 (3d ed.); see also In re Merck & Co., Inc.

Sec. Litig., 432 F.3d 261, 268 (3d Cir. 2005) (observing that the

district court retains the power to “modify or grant injunctions”

following an appeal).

10 The Third Circuit stayed Defendants’ appeal pending the resolution of the Second Motion for a Preliminary Injunction. Pennsylvania v. President United States of Am., No. 17-3752 (3d Cir.

Jan. 9, 2019).

73a

II. Analysis 11

10F

A. Standing

A threshold question is whether the States have

standing. Standing is a litigant’s ticket to federal

court—a constitutional requirement that “limits the

category of litigants empowered to maintain a lawsuit

in federal court to seek redress for a legal wrong.”

Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).

The States contend that they are properly before the

Court because the Final Rules will imminently cause

direct harm to their sovereign, quasi-sovereign and

proprietary interests. Additionally, they assert that

they have parens patriae standing to protect the

health, safety and well-being of their residents in ensuring that they enjoy access to healthcare services.

Defendants, on the other hand, contend that the

States have not suffered any legal wrong that would

allow them to get through the turnstile into federal

court.

“No principle is more fundamental to the judiciary’s proper role in our system of government than the

constitutional limitation of federal-court jurisdiction

to actual cases or controversies.” Simon v. E. Kentucky

Welfare Rights Org., 426 U.S. 26, 37 (1976). The doctrine of standing “is part of this limitation.” Id.; see

also Finkleman v. Nat’l Football League, 810 F.3d 187,

203 (3d Cir. 2016). “[T]he irreducible constitutional

minimum of standing contains three elements.” Lujan

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

First, a plaintiff must have suffered an “injury in fact,”

11 This section and all others afterwards includes the Court’s legal

conclusions as required under Rule 52(a) of the Federal Rules of

Civil Procedure.

74a

which is “an invasion of a legally protected interest

which is (a) concrete and particularized and (b) actual

or imminent, not conjectural or hypothetical.” Id. (internal quotation marks and citations omitted). Second,

a plaintiff must show that there is a “causal connection

between the injury and the conduct complained of”—

that is, the injury must be “fairly traceable” to the

“challenged action of the defendant.” Id. (internal quotation marks omitted). Third, a plaintiff must show

that it is “likely, as opposed to merely speculative, that

the injury will be redressed by a favorable decision.”

Id. at 561 (internal quotation marks omitted).

As “[t]he party invoking federal jurisdiction,” the

States “bear[] the burden of establishing these elements.” Id. And, “[s]ince they are not mere pleading

requirements but rather an indispensable part of the

plaintiff’s case, each element must be supported in the

same way as any other matter on which the plaintiff

bears the burden of proof, i.e., with the manner and

degree of evidence required at the successive stages of

the litigation.” Id. “[A]t the preliminary injunction

stage, allegations are”—without more—“not enough to

support standing;” rather, the States must “adduce[]

evidence demonstrating more than a mere possibility”

that the elements of standing are met. Doe v. Nat’l Bd.

of Med. Exam’rs, 199 F.3d 146, 152-53 (3d Cir. 1999).

1. Special Solicitude

This standing inquiry must be made with recognition that States, like Pennsylvania and New Jersey

here, “are not normal litigants for the purposes of invoking federal jurisdiction.” Massachusetts v. EPA,

549 U.S. 497, 518 (2007). They are “entitled to special

solicitude in [the] standing analysis” if they have: (1)

a procedural right that authorizes them to challenge

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the conduct at issue; and, (2) a “stake in protecting

[their] quasi-sovereign interests.” Id. at 520; see also

Texas v. United States, 809 F.3d 134, 151 (5th Cir.

2015), aff’d by an equally divided Court, 136 S. Ct.

2271 (2016) (per curiam).

In determining whether the States have met these

conditions, both Massachusetts v. EPA and Texas v.

United States are instructive. In Massachusetts v.

EPA, Massachusetts sued the Environmental Protection Agency (“EPA”), alleging that the EPA had “abdicated its responsibility under the Clean Air Act” when

it failed to issue regulations regarding the emission of

certain greenhouse gases. 549 U.S. at 505. The EPA

challenged Massachusetts’ standing to bring the suit,

arguing greenhouse gas emissions are a widespread

and generalized harm not unique to any specific plaintiff. Id. at 517. The Supreme Court nonetheless held

that Massachusetts had special solicitude in the

standing inquiry to challenge the EPA’s inaction:

First, Massachusetts had a procedural right under the

relevant statute, the Clean Air Act, which allowed it

to “challenge agency action unlawfully withheld.” Id.

(citing 42 U.S.C. § 7607(b)(1)). Second, Massachusetts

had a quasi-sovereign interest—a “well-founded desire

to preserve its sovereign territory” from the effects of

global warming because Massachusetts “own[ed] a

great deal of the territory alleged to be affected.” Id. at

519 (internal quotation marks omitted); see also id. at

522 (noting affidavits asserting that “rising seas have

already begun to swallow Massachusetts’ coastal

land.”). After concluding that Massachusetts was entitled to special solicitude in the standing analysis, the

Supreme Court ultimately held that it had Article III

standing to sue the EPA based on the injury to its territory stemming from global warming. Id. at 526.

76a

In Texas v. United States, the Fifth Circuit, relying

on Massachusetts v. EPA, similarly concluded that

Texas and a multitude of other States were entitled to

special solicitude in seeking to enjoin implementation

of the Deferred Action for Parents of Americans and

Lawful Permanent Residents program (“DAPA”). 809

F.3d at 154-55. There, non-citizens in Texas could apply for a driver’s license if they presented “documentation issued by the appropriate United States agency

that authorizes the applicant to be in the United

States.” Id. at 155 (internal quotation marks omitted).

DAPA would have permitted at least 500,000 non-citizens to qualify for these driver’s licenses. Id. Because

Texas subsidized its licenses, it would have lost money

for each license issued to a DAPA beneficiary. Id.

Texas therefore sought injunctive relief to prevent

DAPA’s implementation. See id. at 149.

The Fifth Circuit applied the Massachusetts v. EPA

framework and concluded that Texas was entitled to

special solicitude. First, the Fifth Circuit considered

whether the States’ challenge was similar in kind to

the challenge brought by Massachusetts, and concluded that it was. Both suits turned on the construction of a federal statute that specifically provided for a

procedural right to judicial review, and Texas’ use of

the APA to challenge an “affirmative decision” made

by a federal agency was comparable to Massachusetts’

use of the judicial review provision in the Clean Air Act

to challenge the EPA’s inaction. Id. at 152. Second, as

to the quasi-sovereign interest, the Fifth Circuit held

that DAPA imposed “substantial pressure” on Texas to

change its laws to avoid bearing further costs from

subsidizing additional driver’s licenses. Id. at 153. The

Fifth Circuit thus concluded that Texas, and its fellow

plaintiff States, warranted special solicitude in their

77a

suit against the federal government under the APA.

Id. at 154-55. 12

1F

The Fifth Circuit’s reasoning in Texas v. United

States is persuasive here. Here as there, the States

bring suit under the APA to challenge an affirmative

action by the federal government. See Texas, 809 F.3d

at 152. And, the Final Rules—like DAPA—“affect[] the

[S]tates’ ‘quasi-sovereign’ interest by imposing substantial pressure on them to change their laws.” Id.

Specifically, they put pressure on provisions of the

States’ laws that provide state- funded contraceptive

care to low-income citizens. As the States show, the

Final Rules permit more employers to exempt themselves from the Contraceptive Mandate, which would

result in more of the States’ women seeking state12 Defendants here question the binding effect of Texas v. United

States beyond the facts of that case, given that the Supreme Court

summarily affirmed the Fifth Circuit’s decision “by an equally divided Court.” United States v. Texas, 136 S. Ct. 2271 (2016) (per

curiam). While an affirmance by an equally divided Supreme

Court typically does not constitute binding precedent, see Eaton

v. Price, 364 U.S. 263, 264 (1960), where the Supreme Court is

equally divided on an issue of subject matter jurisdiction, it has

determined that the proper course is to remand the issue of jurisdiction to a lower court. See Silliman v. Hudson River Bridge Co.,

66 U.S. 582, 584-85 (1861). In other words, if the Supreme Court

were equally divided on whether Texas had standing to challenge

DAPA, it would have remanded that issue to the Fifth Circuit.

The Supreme Court did not, and instead affirmed the Fifth Circuit, indicating that a majority of the Supreme Court decided that

Texas had standing to pursue its APA claim. Certainly, if the Supreme Court had determined that Texas did not have standing,

it would not have had jurisdiction to hear the case. Even if the

affirmance by an equally divided Supreme Court as it relates to

subject matter jurisdiction were not binding, the Court is persuaded by the reasoning of the Fifth Circuit in Texas v. United

States as it pertains to State standing.

78a

funded sources of contraceptive care. The harm to the

States’ fiscs are “intrusions . . . analogous to pressure

to change the law,” id., implicating the States’ quasisovereign interests. See also Alfred L. Snapp & Son,

Inc. v. Puerto Rico, 458 U.S. 592, 607 (1982) (holding

that a State has a “quasi-sovereign interest in the

health and wellbeing—both physical and economic—

of its residents in general.”). The States, then, meet

the two conditions outlined in Massachusetts v. EPA

and shall be accorded special solicitude in the standing

analysis.

2. Article III Standing

While the States are entitled to special solicitude

in the standing analysis, they must nevertheless meet

the “irreducible constitutional minimum of standing”—namely, injury in fact, causation, and redressability. Lujan, 504 U.S. at 560. In its initial challenge

to the IFRs, the Commonwealth satisfied this burden,

see Pennsylvania, 281 F. Supp.3d at 569, and the same

is true of the States’ challenge to the Final Rules. See

also California, 911 F.3d at 571 (finding another group

of States had standing to challenge the IFRs).

First, the Final Rules inflict a direct injury upon

the States by imposing substantial financial burdens

on their coffers. An agency rule that has “a major effect

on the states’ fiscs” is sufficient to find injury in fact.

Texas, 809 F.3d at 152; id. at 155 (“[Texas] satisfied

the first standing requirement by demonstrating that

it would incur significant costs in issuing driver’s licenses to DAPA beneficiaries.”); see also Wyoming v.

Oklahoma, 502 U.S. 437, 448 (1992) (holding that Wyoming had Article III standing because it undisputedly

suffered a “direct injury in the form of a loss of specific

tax revenues”); Danvers Motor Co., Inc. v. Ford Motor

79a

Co., 432 F.3d 286, 291 (3d Cir. 2005) (“While it is difficult to reduce injury-in-fact to a simple formula, economic injury is one of its paradigmatic forms.”). If the

Final Rules go into effect, the States will have to increase their expenditures for State funded programs

that provide contraceptive services. This is not a speculative harm. As Defendants themselves noted in issuing the IFRs, “there are multiple Federal, State, and

local programs that provide free or subsidized contraceptives for low-income women.” 82 Fed. Reg. at

47,803. As more of the States’ women residents are deprived of contraceptive services through their insurance plans and turn to these State funded programs,

the States will be pressed to make greater expenditures to ensure adequate contraceptive care. See Mendelsohn Decl. ¶ 15; Steinberg Decl. ¶¶ 24-25. And although Defendants point out that the States have not

yet identified a woman resident who has lost contraceptive coverage due to the Final Rules, the States

need not sit idly by and wait for fiscal harm to befall

them. See McNair v. Synapse Group Inc., 672 F.3d

213, 223 (3d Cir. 2012) (“When, as in this case, prospective relief is sought, the plaintiff must show that

he is ‘likely to suffer future injury’ from the defendant’s conduct.”) (quoting City of Los Angeles v. Lyons,

461 U.S. 95, 105 (1983) (emphasis added)). At bottom,

just as Texas’ estimated loss due to DAPA supported a

finding that Texas suffered an injury in fact, so too

does the States’ estimated loss due to the Final Rules

support a finding that the States have suffered an injury in fact. See Texas, 809 F.3d at 155.

Second, the States’ financial injury is “fairly traceable” to the issuance of the Final Rules. By their

terms, the Final Rules expand the scope of the existing

80a

religious exemption rule and allow entities a new rationale for refusing to provide employees with contraceptive coverage if the refusal is “based on sincerely

held moral convictions,” 83 Fed. Reg. at 57,593. Thus,

the Final Rules allow more entities to stop providing

contraceptive coverage, which will result in more

women residents seeking contraceptive care through

State-funded programs. See Mendelsohn Decl. ¶ 15;

Steinberg Decl. ¶¶ 24-25. The States have thus shown

a causal connection between the Final Rules and their

financial injury.

As the Court previously explained, Pennsylvania v.

New Jersey, 426 U.S. 660 (1976), is not to the contrary.

See also California, 911 F.3d at 574 (finding Pennsylvania did not bar States’ challenge to the IFRs on a

similar theory of standing). In that case, Pennsylvania

voluntarily gave tax credits to Pennsylvania residents

who paid taxes in New Jersey, and then proceeded to

sue New Jersey, contending that the New Jersey tax

injured Pennsylvania’s fiscs and was constitutionally

impermissible. Pennsylvania, 426 U.S. at 662-63. The

Supreme Court found that Pennsylvania lacked standing because the injuries to its fiscs were “self-inflicted,” resulting, as they did, from a decision of its

state legislature to enact a law that incorporated the

legislative choices of New Jersey. Id. at 664. Here, by

contrast, the States’ laws funding contraceptive care

do not “directly and explicitly” tie the States’ finances

to another sovereign’s law. California, 911 F.3d at 574.

Rather, the States’ described injuries flow from the

unilateral decision by the Agencies to issue the Final

Rules. See id. (finding Pennsylvania did control in an

analogous challenge); cf. Texas, 809 F.3d at 158 (“The

fact that Texas sued in response to a significant

change in the [federal government’s] policies shows

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that its injury is not self- inflicted.”). The States have

therefore met the traceability requirement.

Finally, the States have satisfied the redressability

requirement. As to the States’ procedural claims, enjoining the Final Rules could prompt the Agencies “to

reconsider the program, which is all a plaintiff must

show when asserting a procedural right.” Texas, 809

F.3d at 161; see also Massachusetts, 549 U.S. at 518

(noting that where, as here, a litigant is “vested with

a procedural right, that litigant has standing if there

is some possibility that the requested relief will

prompt the injury-causing party to reconsider the decision that allegedly harmed the litigant”). And, as for

the States’ substantive claims, enjoining the Final

Rules “would prevent [the States’] injury altogether.”

Texas, 809 F.3d at 161.

In sum, the States have established the irreducible

constitutional minimum of standing to challenges the

Final Rules in federal court. 13

12F

B. Venue

The next question to address is whether the States’

choice of venue—the Eastern District of Pennsylvania—is proper. Notwithstanding Defendants’ argument to the contrary, it is.

Defendants’ argument is grounded in the structure

of the venue statute, Section 1391(e)(1) of which provides that in a civil action against an officer of the

United States, venue lies “in any judicial district in

which . . . the plaintiff resides if no real property is

13 Because the States have identified an imminent, direct injury

to its state coffers that would result from the Final Rules, there

is no need to address whether they have parens patriae standing.

82a

involved in the action.” 28 U.S.C. § 1391(e)(1). Section

1391(c) defines a party’s residence “[f]or all venue purposes,” and distinguishes between three, and only

three, categories of litigants: “a natural person,” “an

entity with the capacity to sue and be sued in its common name under applicable law, whether or not incorporated,” and “a defendant not resident in the United

States.” Id. at § 1391(c). Because Pennsylvania is neither a natural person nor a non-resident, Defendants

argue it must be treated as an entity for purposes of

determining residency. Section 1391(c)(2) provides

that “if a plaintiff,” an entity “shall be deemed to reside . . . only in the judicial district in which it maintains its principal place of business.” Id. Thus, according to Defendants, Pennsylvania resides only in the

Middle District—the district that encompasses Harrisburg, the state capital—because that is where

Pennsylvania maintains its principal place of business.

While inventive, Defendants’ interpretation of Section 1391(c) is ultimately unpersuasive. See California, 911 F.3d at 570 (rejecting the argument); Alabama v. U.S. Army Corps of Eng’rs, 382 F. Supp.2d

1301, 1328 (N.D. Ala. 2005) (rejecting a similar argument for an earlier version of the venue statute). Defendants’ argument hinges on the assumption that, because Section 1391(c) refers to only three categories of

litigants and because a state is neither a natural person nor a non-resident, a state must necessarily be “an

entity” for purposes of the venue statute. There are,

however, several issues with that assumption.

First, the statute explicitly refers to an entity’s incorporation status, indicating “that the term [entity]

refers to some organization, not a state.” California,

83a

911 F.3d at 570. The legislative history confirms that

Congress was contemplating “unincorporated associations, such as partnerships and labor unions, and

other entities with capacity to sue in their common

name,” when it defined the residency of unincorporated entities in Section 1391(c). H.R. Rep. No. 11210, at 21 (2011). There is no indication, however, that

Congress intended for that provision to dictate the residency of sovereign States by equating a State with an

“unincorporated association[]” like a labor union.

Second, Congress explicitly distinguishes between

States and entities within Section 1391. Compare 28

U.S.C. § 1391(c) (defining the residency of an “entity”),

with id. at § 1391(d) (“Residency of corporations in

States with multiple districts”). “Where Congress includes particular language in one section of a statute

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

generally presumed that Congress acts intentionally

and purposely in the disparate inclusion or exclusion.”

Russello v. United States, 464 U.S. 16, 23 (1983) (internal quotation marks and citations omitted). Thus,

courts typically “refrain from concluding . . . that the

differing language in [] two subsections [of a statute]

has the same meaning in each.” Id. Here, Congress’s

differentiation between “an entity” and “States”

within Section 1391 indicates that Congress did not

intend to include the latter within the definition of the

former.

Finally, reading Section 1391 as Defendants suggest would yield an absurd result. As several courts

have observed, an interpretation that “limit[s] residency to a single district in the state would defy common sense,” because “[a] state is ubiquitous throughout its sovereign borders.” California, 911 F.3d at 570;

84a

Alabama, 382 F. Supp.2d at 1329 (“[C]ommon sense

dictates that a state resides throughout its sovereign

borders”). 14

13F

Thus, the Court will follow the lead of the Ninth

Circuit in concluding that “the statute . . . dictates that

a state with multiple judicial districts ‘resides’ in every

district within its borders.” California, 911 F.3d at

570. Venue is therefore proper in the Eastern District

of Pennsylvania. 15

14F

C. Preliminary Injunction

Because the States have established standing to

bring their claims into federal court and that this is a

proper venue to hear those claims, the Court now

14 The unreported district court cases that Defendants rely upon

are not to the contrary. See Gaskin v. Pennsylvania, 1995 WL

154801, at *1 (E.D. Pa. Mar. 30, 1995); Bentley v. Ellam, 1990 WL

63734, at *1 (E.D. Pa. May 8, 1990). Both Gaskin and Bentley

discuss the residency of state agencies or officials, which is different in kind from the residency of a sovereign State itself.

15 Section 1391(e) also provides that venue is proper in a civil ac-

tion against an officer of the United States, where “a substantial

part of the events or omissions giving rise to the claim occurred.”

28 U.S.C. § 1391(e). Because the Court finds Pennsylvania resides throughout the State, it need not address the States’ alternative argument that venue is proper because “a substantial part

of the events” giving rise to their claim occurred here.

Relatedly, New Jersey’s residency does not bear on the question of because “in an action against the federal government or

an agent thereof [t]here is no requirement that all plaintiffs reside in the forum district.” Exxon Corp. v. FTC, 588 F.2d 895, 89990 (3d Cir. 1978); Superior Oil Co. v. Andrus, 656 F.2d 33, 37 n.7

(3d Cir. 1981) (“[O]nly one plaintiff need satisfy the residency requirement of [Section 1391(e)].”).

85a

turns to the merits of the preliminary injunction motion.

1. Legal Standard

A preliminary injunction is an extraordinary remedy; it “should be granted only in limited circumstances.” American Tel. & Tel. Co. v. Winback & Conserve Program, Inc., 42 F.3d 1421, 1426-27 (3d Cir.

1994). “A plaintiff seeking a preliminary injunction

must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the

absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the

public interest.” Winter v. NRDC, 555 U.S. 7, 20

(2008). The first two are the “most critical factors: [a

movant] must demonstrate that it can win on the merits (which requires a showing significantly better than

negligible but not necessarily more likely than not)

and that it is more likely than not to suffer irreparable

harm in the absence of preliminary relief.” Reilly v.

City of Harrisburg, 858 F.3d 173, 179 (3d Cir. 2017),

as amended (June 26, 2017) (internal quotation marks

omitted). “If these gateway factors are met, a court

then considers the remaining two factors and determines in its sound discretion if all four factors, taken

together, balance in favor of granting the requested

preliminary relief.” Id.

2. Likelihood of Success on the Merits

In demonstrating the likelihood of success on the

merits, a plaintiff need not show that it is more likely

than not that it will succeed. Singer Mgmt. Consultants, Inc. v. Milgram, 650 F.3d 223, 229 (3d Cir. 2011)

(en banc). Instead, all a plaintiff must show is “a likelihood of success on the merits (that is, a reasonable

86a

chance, or probability, of winning) to be granted relief.” Id. (emphasis in original).

a. APA Procedural Claim

The States argue that the Final Rules should be enjoined because Defendants failed to comply with the

procedural requirements of the APA.

The APA generally requires that, when promulgating regulations, administrative agencies meet a set of

procedural requirements, called notice-and-comment

rulemaking. See 5 U.S.C. § 553. Agencies must: issue

a general notice of proposed rulemaking, see id. at

§ 553(b); “give interested persons an opportunity to

participate in the rule making through submission of

written data, views or arguments . . .” id. at § 553(c);

and, “[a]fter consideration of the relevant matter presented, . . . incorporate in the rules adopted a concise

general statement of their basis and purpose,” id.

Notice-and-comment rulemaking serves two distinct purposes—it both “give[s] the public an opportunity to participate in the rule-making process,” and

“enables the agency promulgating the rule to educate

itself before establishing rules and procedures which

have a substantial impact on those regulated.” Texaco,

Inc. v. Fed. Power Comm’n, 412 F.2d 740, 744 (3d Cir.

1969). Nevertheless, there are limited exceptions to

the requirement that all rules be issued pursuant to

notice-and-comment rulemaking, such as when an

agency has “good cause” to forgo the strictures of notice-and-comment rulemaking, 5 U.S.C. § 553(b), or

when a subsequent act of Congress abrogates the

APA’s procedural requirements, id. at § 559.

87a

In issuing the IFRs, the Agencies failed to meet the

various requirements of notice-and- comment rulemaking. See Pennsylvania, 281 F. Supp.3d at 570. Defendants argued, however, that the IFRs were not procedurally invalid because they fell under one (or more)

of the limited exceptions to notice-and-comment rulemaking. Id. at 571. The Court found otherwise and enjoined the IFRs for violating the procedural strictures

of Section 553. Id. at 576; see also California, 281 F.

Supp.3d at 829 (enjoining the IFRs for violating the

procedural requirements of the APA), aff’d in part, vacated in part, California, 911 F.3d at 575 (upholding

the conclusion that the IFRs violated the APA).

While Defendants continue to maintain that the

IFRs were procedurally valid, 16 they now argue that,

even assuming the IFRs were procedurally improper,

the subsequent action taken by the Agencies in promulgating the Final Rules satisfied notice-and-comment

requirements, and thus the Final Rules comply with

the APA. The States’ response is two-fold. First, they

argue that the Agencies notice-and-comment procedures fell short of the APA’s requirements because the

Agencies did not adequately respond to significant

comments in their statement of the basis and purpose

of the Final Rules. Second, the States contend that, no

matter the Agencies’ subsequent actions, the procedural defects that characterized the issuance of the

15F

16 The Court, for the reasons stated in its prior opinion, again

finds the Agencies’ position unpersuasive, see Pennsylvania, 281

F. Supp.3d at 570, and therefore declines Defendants’ invitation

to revisit its prior holding. See Hayman Cash Register Co. v. Sarokin, 669 F.2d 162, 165 (3d Cir. 1982) (“Under the law of the case

doctrine, once an issue is decided, it will not be relitigated in the

same case, except in unusual circumstances.”).

88a

IFRs fatally taint the Final Rules. These arguments

are considered seriatim.

i. Inadequate Response to

Comments

The States argue that the Agencies’ issuance of the

Final Rules failed to meet the requirements of noticeand-comment rulemaking by not responding to all “vital questions[] raised by comments which are of cogent

materiality.” United States v. Nova Scotia Food Prod.

Corp., 568 F.2d 240, 252 (2d Cir. 1977). The APA requires federal agencies to “consider and respond to significant comments received during the period for public comment.” Perez v. Mortg. Bankers Ass’n, 135 S. Ct.

1199, 1203 (2015). The requirement, however, is not

“particularly demanding.” Nazareth Hosp. v. Sec’y

U.S. Dep’t of Health & Human Servs., 747 F.3d 172,

185 (3d Cir. 2014) (quoting Pub. Citizen, Inc. v. FAA,

988 F.2d 186, 197 (D.C. Cir. 1993)). All that is required

is a response that “‘demonstrates that the [agency]

considered and rejected’ the arguments.” Id. (quoting

Covad Commc’ns Co. v. FCC, 450 F.3d 528, 550 (D.C.

Cir. 2006)).

The States contend that the Agencies failed to clear

this relatively low bar, pointing to several examples of

comments that purportedly received an inadequate response: comments that discuss the scientific evidence

of the harm to the health and economic security of

women that would result from the Final Rules, 83 Fed.

Reg. at 57,555-56; comments that assert the broad religious and moral exemptions will cause women to lose

contraceptive coverage, id. at 57,548- 49; comments

that argue the exemptions violate the ACA prohibition

on regulations that create barriers to medical care, id.

at 57,551-52; and, specifically, a comment submitted

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by various States—including Pennsylvania and New

Jersey—regarding the medical risks associated with

pregnancy, id. at 57,555.

For each example, however, a review of the Final

Rules demonstrates that the Agencies acknowledged

the comments and provided an explanation as to why

the Agencies did (or did not) amend the Final Rules

based on the comment. See 83 Fed. Reg. at 57,548,

57,551, 57,555. While the Agencies’ explanations are

not always the picture of clarity, they meet the not

“particularly demanding” requirement, Nazareth

Hosp., 747 F.3d at 185, that the Agencies “consider

and respond to significant comments received during

the period for public comment,” Perez, 135 S. Ct. at

1203. Put differently, the Final Rules “demonstrate [to

a commenter] that the [the Agencies] considered and

rejected, the arguments” put forth by a commenter,

which is “all that the [APA] requires.” Nazareth Hosp.,

747 F.3d at 185 (internal quotation marks omitted).

Thus, the States are unlikely to succeed on the

merits of their argument that, in promulgating the Final Rules, the Agencies’ actions failed to meet the requirements of notice- and-comment rulemaking. 17

16F

ii. IFRs Taint the Final Rules

The States maintain that, even if the Agencies complied with the requirements of notice- and-comment

rulemaking in promulgating the Final Rules, the failure to do so in promulgating the IFRs fatally infected

17 The States’ argument is limited to the claim that the Agencies

failed to adequately respond to significant comments. The States

do not argue, for example, that the notice provided was inadequate. See 5 U.S.C. § 552(b).

90a

the process such that the Final Rules should also be

held invalid.

Generally, “the period for comments after promulgation cannot substitute for the prior notice and comment required by the APA.” Sharon Steel. Corp. v.

EPA, 597 F.2d 377, 381 (3d Cir. 1979). The Circuit

courts however, diverge on the procedural validity of a

final rule that follows an IFR promulgated in a procedurally flawed manner—that is, the question of

whether a “procedural defect that taints the original,

interim-final rule carr[ies] over to the succeeding final

rule.” Kristin E. Hickman & Mark Thomson, Open

Minds and Harmless Errors: Judicial Review of Postpromulgation Notice and Comment, 101 Cornell L.

Rev. 261, 267 (2016) (discussing various approaches

taken by the Circuit courts); compare Salman Ranch,

Ltd. v. Comm’r, 647 F.3d 929, 940 (10th Cir. 2011)

(“While the . . . temporary regulations were issued

without notice and comment, now that the regulations

have issued in final form [after notice and comment],

these arguments are moot . . .”) (internal quotation

marks omitted), rev’d on other grounds, Salman

Ranch, Ltd. v. Comm’r, 566 U.S. 971 (2012), with Air

Transp. Ass’n of Am. v. Dep’t of Transp., 900 F.2d 369,

379 (D.C. Cir. 1990) (“Although we have suggested

that there might be circumstances in which ‘defects in

an original notice [could] be cured by an adequate later

notice’ and opportunity to comment, we have emphasized that we could reach such a conclusion only upon

a compelling showing that ‘the agency’s mind remain[ed] open enough at the later stage.’ The FAA has

not come close to overcoming the presumption of

closed-mindedness in this case.”) (quoting McLouth

Steel Prods. Corp. v. Thomas, 838 F.2d 1317, 1323

(D.C. Cir. 1988)), vacated on other grounds, 498 U.S.

91a

1077 (1991). For its part, the Third Circuit has evidenced a deep skepticism towards the curative powers

of post-promulgation notice-and-comment procedures,

see NRDC v. EPA, 683 F.2d 752, 767-68 (3d Cir. 1982);

United States v. Reynolds, 710 F.3d 498, 519 (3d Cir.

2013); accord Sharon Steel. Corp., 597 F.2d at 381,

which warrants a conclusion that the States are likely

to succeed on the claim that the procedural faults that

characterized the issuance of the IFRs fatally tainted

the Final Rules such that the issuance of the Final

Rules violated the APA.

The Third Circuits’ decision most directly on point

is NRDC v. EPA. There, the NRDC challenged EPA

action that indefinitely postponed the effective date of

certain Clean Water Act amendments. NRDC, 683

F.2d at 757. The EPA did not engage in notice-andcomment procedures before acting to postpone the implementation of the amendments. 18 Id. at 756. After

NRDC initiated litigation challenging the agency’s action, the EPA issued a notice of proposed rulemaking,

seeking comments on whether the agency should issue

a rule further postponing the effective date. Id. at 757.

After going through notice-and-comment procedures,

the EPA then issued a final rule implementing some

of the amendments, while further postponing the most

controversial bits. Id. Nevertheless, NRDC maintained its challenge to the EPA’s initial action to postpone the effective date. The Third Circuit rejected the

17F

18 The EPA argued that the initial action to postpone was not a

“rule” under the APA, and thus did not require notice-and-comment procedures. NRDC, 683 F.2d at 761. The Third Circuit rejected that argument, holding the EPA’s action postponing the

effective date qualified as a rule, requiring notice-and-comment

procedures. Id.

92a

EPA’s argument that its notice- and-comment procedures after the initial action to postpone “cured” any

failure to engage in such procedures before the initial

action, and held the initial action postponing the effective date was procedurally invalid. Id. at 767.

Critical to this dispute, however, the Third Circuit

further held that, even though the NRDC did not challenge the final rule—that is, the rule promulgated following notice-and- comment procedures—the final

rule “was likewise invalid.” Id. at 768. The court of appeals explained that the appropriate remedy for the

EPA’s failure to engage in notice-and-comment rulemaking before taking its initial action required holding both the initial action and the subsequent, final

rule “ineffective.” Id. at 767. EPA’s notice-and-comment procedures “could not serve as the procedural

mechanism” for the final rule because “that rulemaking [could not] replace one on the question of whether

the amendments should be postponed in the first

place.” Id. That is, if the EPA had engaged in noticeand-comment procedures before initially acting to

postpone the effective date, then “the question to be

decided in the [subsequent] rulemaking”—the rulemaking that complied with notice-and-comment procedures—“would have been whether the amendments . . . should be suspended, and not whether they

should be further postponed.” Id. The Third Circuit

warned that:

To allow the APA procedures in connection with

the further postponement to substitute for APA

procedures in connection with an initial postponement would allow EPA to substitute post-promulgation notice and comment procedures for prepromulgation notice and comment procedures at

93a

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 We cannot countenance such a result.

Id.

That reasoning applies with equal force here. The

Agencies issued the IFRs without engaging in noticeand-comment rulemaking. As in NRDC, the issuance

of the procedurally defective IFRs fundamentally

changed the “question to be decided in the [subsequent] rulemaking”—instead of asking whether substantial expansions to the exemption and accommodation should be made at all, the Agencies solicited comments on whether those changes should be finalized.

Thus, the subsequent “rulemaking on [finalizing the

IFRs] could not serve as the procedural mechanism,”

for the Final Rules because “that rulemaking [could

not] replace one on the question of whether” the Agencies should broaden the existing exemption and accommodation “in the first place.” Id. The Agencies are, in

essence, engaging in precisely the behavior that the

Third Circuit warned against in NRDC: “substitute[ing] post-promulgation notice and comment procedures for pre-promulgation notice and comment procedures . . . 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.” Id. The Court, like the Third Circuit, “cannot countenance such a result.” Id.

Defendants and Defendant-Intervenor advance

several arguments to the contrary, none of which are

ultimately persuasive. For one, Defendants argue that

94a

NRDC is not on all fours with this case and so “provides no support for the Plaintiffs’ procedural challenge.” Defendants are correct that NRDC differs factually from the case at hand: there the NRDC challenged only the initial action, here the States challenged both the IFRs and the Final Rules. But, even

though the plaintiff did not challenge the final rule in

NRDC, the Third Circuit held both the initial action to

postpone and the subsequent rule procedurally invalid. In reaching that determination, the Third Circuit

rejected the notion—advanced by the Agencies here—

that subsequent notice-and- comment rulemaking procedures “cured” the failure to engage in such procedures “in the first place.” Id. at 767-78. Both the holding and the reasoning given for that holding are binding on this Court. See Tate v. Showboat Marina Casino

P’ship, 431 F.3d 580, 582 (7th Cir. 2005) (Posner, J.)

(“[T]he holding of a case includes, besides the fact and

the outcome, the reasoning essential to that outcome.”); see also IFC Interconsult, AG v. Safeguard

Int’l Partners, LLC, 438 F.3d 298, 311 (3d Cir. 2006)

(quoting Judge Posner’s definition approvingly). Because the Third Circuit’s reasoning invalidating the

subsequent rule was essential to the holding, and because that reasoning applies with equal force to the

promulgation of the Final Rules, that reasoning controls here.

Next, Defendants argue that the States suffered no

procedural injury because they had an opportunity to

submit a comment in response to the IFRs, an opportunity that the States “admit” to taking advantage of.

The problem for Defendants is that the EPA made the

exact argument to the Third Circuit in NRDC, which

the court of appeals flatly rejected. NRDC, 683 F.2d at

768. As the Third Circuit explained, it did not matter

95a

that “notice and comment were provided in connection

with the proposal that the amendments be further

postponed, and NRDC was able to make all of the arguments in connection with the further postponement

that NRDC would have made in connection with the

initial postponement.” Id. The problem was that the

initial, procedurally defective action fundamentally

changed the question to be presented in the subsequent rulemaking, prejudicing NRDC, which “‘must

come hat-in-hand and run the risk that the decisionmaker is likely to resist change.’” Id. at 768 (quoting Sharon Steel, 597 F.2d at 381). Here, the procedurally invalid IFRs similarly changed the question to be

presented in the subsequent rulemaking, prejudicing

the States’ ability to have their comments heard by an

impartial decisionmaker. Cf. Wagner Elec. Corp. v.

Volpe, 466 F.2d 1013, 1020 (3d Cir. 1972) (“Section

[553(b)] of the [APA] requires notice before rulemaking, not after. The right of interested persons to petition for the issuance, amendment or repeal of a rule,

granted in [5 U.S.C. § 553(e)], is neither a substitute

for nor an alternative to compliance with the mandatory notice requirements of [5 U.S.C. § 553(b)].”) (emphasis in original).

Defendant-Intervenor’s attempt to distinguish

away the reasoning of NRDC fares no better. It argues

the court of appeals’ reasoning does not control because, while “unique circumstances” existed in NRDC

“to establish prejudice,” no such circumstances are

present here. Specifically, Defendant-Intervenor argues that the Third Circuit invalidated the final rule

in NRDC because of the “asymmetry between using an

interim rule to repeal a rule promulgated with prior

notice and comment,” whereas, here, the Final Rules

are not “an abrupt change in federal policy” because

96a

the Final Rules do not rescind the Contraceptive Mandate. According to Defendant-Intervenor, that makes

this case “readily distinguishable from NRDC.”

The argument is premised on a misreading of

NRDC. The Third Circuit did not invalidate the EPA

action because of the degree of change affected by the

procedurally invalid action. Rather, it held that the

subsequent notice-and-comment rulemaking “[could

not] replace [a rulemaking] on the question of whether

the amendments should be postponed in the first

place.” NRDC, 683 F.2d at 768. More fundamentally,

the court of appeals did not rest its decision on the existence of any “unique circumstances,” as DefendantIntervenor suggests. Instead, the Third Circuit voiced

a general admonition against the practice of using

post- promulgation procedures to cure pre-promulgation procedural flaws. Id. As discussed, the reasoning

underpinning that warning informs the result here.

Defendant-Intervenor also advances an altogether

different argument. It points out that the Agencies

“created the [Contraceptive] Mandate via a series of

IFRs without notice and comment,” suggesting that

the Final Rules are procedurally valid because the

Agencies followed similar procedures in the past. The

Court rejected a version of this argument last go

around. See Pennsylvania, 281 F. Supp.3d at 573 n.8.

Whether a party could have brought a successful challenge to the procedures followed in the past is not before the Court—what is at issue here is whether the

procedures the Agencies followed in issuing the Final

Rules violated the APA. Id. (explaining that the IFRs

were “not identical to prior regulations” because “they

make significant changes in the law, and the Supreme

Court did not require immediate action”). The same

97a

flawed reasoning characterizes Defendant-Intervenor’s related argument that invalidating the Final

Rules would “cast a pall on thousands of regulations,”

because, according to the Government Accountability

Office, 35% of all major rules were finalized with postIFR notice-and-comment procedures. Obviously, those

regulations are not currently before this Court, and,

accordingly, the Court is not asked—and thus, cannot

decide—whether the specific procedures employed in

promulgating those regulations were defective.

The States are likely to prevail on their claim that

the issuance of the Final Rules violated the procedural

requirements of the APA in that the procedural defect

that characterized the IFRs fatally tainted the issuance of the Final Rules. That is so, regardless of

whether the procedure followed by the Agencies in the

Final Rules may otherwise meet the requirements of

notice-and- comment rulemaking. 19

18F

19 As noted, other courts of appeals employ other approaches

when evaluating whether a procedural defect in an interim-rule

fatally infects a final rule issued after notice-and-comment procedures are followed—one example being the “open mind” approach. See, e.g., Air Transp. Ass’n of Am., 900 F.2d at 379 (employing the “open mind standard”). While it has never adopted

this approach, the Third Circuit in Reynolds indicated that

whether a promulgating agency “maintained a flexible and openminded attitude towards” an interim rule is a relevant consideration in determining whether an APA violation occurred generally. 710 F.3d at 519.

Even under the more flexible “open mind standard,” however,

the States would likely succeed on the merits of their procedural

claim. As the D.C. Circuit has explained, while “defects in an original notice could be cured by an adequate later notice and opportunity to comment,” the remedial measures cure the earlier

lapses only if the promulgating agency makes “a compelling

showing that the agency’s mind remained open enough at the

98a

b. APA Substantive Claim

The States also contend that the Final Rules violate the substantive requirements of the APA. As the

Court has previously noted, the breadth of the exemptions set out in the IFRs, and now the Final Rules, is

remarkable. The Final Religious Exemption allows all

non-profit and for-profit entities, whether closely held

or publicly traded, to deny contraceptive coverage

based on sincerely held religious beliefs. The Final

Moral Exemption allows any non-profit or for- profit

later stage.” Air Transp. Ass’n of Am., 900 F.2d at 379 (internal

quotation marks omitted). That is, “it is the agency’s burden to

persuade the court that it has accorded the comments a full and

fair hearing.” Advocates for Highway & Auto Safety v. Fed. Highway Admin., 28 F.3d 1288, 1292 (D.C. Cir. 1994). Courts that use

this approach have established that an agency can demonstrate

open-mindedness by making changes to a final rule in response

to public comments, or giving careful consideration to comments

submitted in response to a proposed rule. Air Transp. Ass’n of

Am., 900 F.2d at 380; see also Advocates for Highway & Auto

Safety, 28 F.3d at 1292.

Here, the Agencies have not made a “compelling showing”

that they kept an open mind at the later stages of the rulemaking

process. Most notably, while the Agencies made some changes to

the Final Rules based on public comments, those rules were

largely “non-substantial technical revisions,” 83 Fed. Reg. at

57,567, that Defendants concede “do not alter the fundamental

substance of the exemptions set forth in the IFRs.” Indeed, the

Final Rules and the preambles that accompany them “demonstrate[] a single-minded commitment to the substantive result

reached,” Reynolds, 710 F.3d at 519—to wit, expanding the exemption and accommodation. Because the Agencies’ actions indicate closed-mindedness on “the very subject matter about which

[they] w[ere] to keep an ‘open mind,’” id., the States would likely

prevail on their procedural claim even under the more lenient

open mind standard.

99a

organization that is not publicly traded to deny contraceptive coverage for its employees for any sincerely

held moral conviction.

The APA’s substantive requirements command

that an administrative rule must be set aside if it is

“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” or “in excess of statutory jurisdiction, authority, or limitations, or short of

statutory right.” 5 U.S.C. § 706(2)(A), (C). “It is well

settled that an agency may only act within the authority granted to it by statute.” NRDC v. Nat’l Highway

Traffic Safety Admin., 894 F.3d 95, 108 (2d Cir. 2018).

Because “administrative agencies may act only pursuant to authority delegated to them by Congress,” an

agency must “point to something” in a statute that

“gives it the authority” to take the specific action at

issue. Clean Air Council v. Pruitt, 862 F.3d 1, 9 (D.C.

Cir. 2017) (internal quotation marks omitted).

Defendants cite two potential fonts of statutory authority to issue the Final Rules. First, they assert that

the ACA includes a broad delegation of authority to

the Agencies, permitting them to issue the Final

Rules. Second, with specific regard to the Religious Exemption, Defendants assert that RFRA not only authorizes the Agencies to create a religious exemption

to the Contraceptive Mandate, but in fact requires that

the Agencies issue the broad exemption contained

within the Final Religious Exemption.

As explained below, both arguments fail. The Final

Rules—just as the IFRs before them—exceed the scope

100a

of the Agencies’ authority under the ACA, and, further, cannot be justified under RFRA. As a result, the

Final Rules must be set aside. 20

19F

i. The ACA

To reiterate for purposes of clarity, the ACA requires that group health plans and insurance issuers

“shall, at a minimum provide coverage for and shall

not impose any cost sharing requirements for— . . .

with respect to women, such additional preventive

care and screenings . . . as provided for in comprehensive guideline

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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