Commonwealth of Pennsylvania v. President United States , 930 F.3d 543 ( 2019 )


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  •                                          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)
    _____________
    ON APPEAL FROM THE UNITED STATES DISTRICT
    COURT FOR THE EASTERN DISTRICT OF
    PENNSYLVANIA
    (E.D. Pa. No. 2:17-cv-04540)
    District Judge: Hon. Wendy Beetlestone
    ______________
    Argued May 21, 2019
    ______________
    Before: McKEE, SHWARTZ, and FUENTES, Circuit
    Judges.
    (Filed July 12, 2019)
    Michael J. Fischer [ARGUED]
    Aimee D. Thompson
    Office of Attorney General of Pennsylvania
    1600 Arch Street, Suite 300
    Philadelphia, PA 19103
    Glenn J. Moramarco
    Office of Attorney General of New Jersey
    Department of Law & Public Safety, Division of Law
    2
    Richard J. Hughes Justice Complex
    25 Market Street, P.O. Box 112
    Trenton, NJ 08625
    Counsel for Appellees Commonwealth of
    Pennsylvania and State of New Jersey
    Lowell V. Sturgill, Jr.
    United States Department of Justice, Civil Division
    950 Pennsylvania Avenue, N.W., Room 7241
    Washington, DC 20530
    Hashim M. Moopan [ARGUED]
    United States Department of Justice
    Civil Division, Appellate Staff
    950 Pennsylvania Avenue, N.W.
    Washington, DC 20530
    Karen Schoen
    United States Department of Justice
    Civil Division, Appellate Section
    950 Pennsylvania Avenue, N.W. Room 7533
    Washington, DC 20530
    Counsel for Appellants President United
    States of America, Secretary United
    States Department of Health & Human
    Services, United States Department of
    Health & Human Services, United States
    Department of Treasury, Secretary
    United States Department of Treasury,
    United States Department of Labor,
    Secretary United States Department of
    3
    Labor, and United States of America
    Mark L. Rienzi [ARGUED]
    Lori H. Windham
    Becket Fund for Religious Liberty
    1200 New Hampshire Avenue, N.W., Suite 700
    Washington, DC 20036
    Nicholas M. Centrella
    Conrad O’Brien
    1500 Market Street
    West Tower, Suite 3900
    Philadelphia, PA 19102
    Counsel for Appellee-Intervenor Little
    Sisters of the Poor Saints Peter and Paul
    Home
    Jason R. LaFond
    Office of Attorney General of Texas
    209 West 14th Street, 7th Floor
    Austin, TX 78711
    Counsel for Amici Curiae in Support of
    Appellants States of Texas, Alabama,
    Arkansas, Georgia, Idaho, Louisiana,
    Missouri, Nebraska, Oklahoma, South
    Carolina, and West Virginia
    Elizabeth N. Dewar
    Office of Attorney General of Massachusetts
    20th Floor, One Ashburton Place
    McCormack Building
    4
    Boston, MA 02108
    Counsel for Amici Curiae States of
    Massachusetts, California, Colorado,
    Connecticut, Delaware, Hawaii, Illinois,
    Iowa, Maine, Maryland, Michigan,
    Minnesota, Nevada, New Mexico, New
    York, North Carolina, Oregon, Rhode
    Island, Vermont, Virginia, Washington
    and the District of Columbia
    Dariely Rodriguez
    Lawyers’ Committee for Civil Rights Under Law
    1500 K Street, N.W., Suite 900
    Washington, DC 20005
    Counsel for Amici Curiae Center for
    Reproductive Rights, Lawyers Committee
    for Civil Rights Under Law, California
    Womens Law Center, GLBTQ Legal
    Advocates and Defenders, LatinoJustice
    PRLDEF, Lawyers for Civil Rights,
    Legal Momentum, Legal Voice,
    Mississippi Center for Justice, National
    Center for Lesbian Rights, and Women’s
    Law Project
    Sara J. Rose
    American Civil Liberties Union
    313 Atwood Street
    Pittsburgh, PA 15213
    Counsel for Amici Curiae American
    5
    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
    6
    Palo Alto, CA 94304
    Counsel for Amicus Curiae Religious
    Sisters of Mercy
    Miles Coleman
    Nelson Mullins Riley & Scarborough
    104 South Main Street, Suite 900
    Greenville, SC 29601
    Counsel for Amici Curiae Ronald J.
    Colombo, Richard Epstein, Carl H.
    Esbeck, David F. Forte, Richard W.
    Garnett, Esq., Professor Robert P.
    George, Mary Ann Glendon, Michael P.
    Moreland, Stacy Scaldo, and Michael
    Uhlmann
    Bruce H. Schneider
    Stroock Stroock & Lavan
    180 Maiden Lane, 38th Floor
    New York, NY 10038
    Counsel for Amici Curiae American
    Nurses Association, American College of
    Obstetricians and Gynecologists,
    American Academy of Nursing,
    American Academy of Pediatrics, and
    Physicians for Reproductive Choice and
    Health
    Allan J. Arffa
    7
    Melina M. Meneguin-Layerenza
    Sierra Robart
    Paul Weiss Rifkind Wharton & Garrison
    1285 Avenue of the Americas
    New York, NY 10019
    Counsel for Amici Curiae Planned
    Parenthood Federation of America,
    National Health Law Program, and
    National Family Planning &
    Reproductive Health Association
    Priscilla J. Smith
    Yale Law School RRJP Clinic
    319 Sterling Place
    Brooklyn, NY 11328
    Counsel for Amicus Curiae Program for
    the Study of Reproductive Justice
    Leah Bruno
    Dentons US
    233 South Wacker Drive, Suite 5900
    Chicago, IL 60606
    Jeffrey S. Feldman
    The Feldman Firm
    600 West Germantown Pike, Suite 400
    Plymouth Meeting, PA 19462
    Counsel for Amici Curiae United States
    Women’s Chamber of Commerce and
    National Association for Female
    8
    Executives
    Joshua A. Matz
    Kaplan Hecker & Fink
    350 Fifth Avenue, Suite 7110
    New York, NY 10118
    Counsel for Amicus Curiae Church State
    Scholars
    Rhiannon N. Batchelder
    Jamie A. Levitt
    Morrison & Foerster
    250 West 55th Street
    New York, NY 10019
    Counsel for Amici Curiae American
    Association of University Women and
    Service Employees International Union
    Richard B. Katskee
    Americans United for Separation of Church & State
    1310 L Street, N.W., Suite 200
    Washington, DC 20005
    Counsel for Amicus Curiae Americans
    United for Separation of Church and
    State
    ______________________
    OPINION OF THE COURT
    ______________________
    9
    SHWARTZ, Circuit Judge.
    The Women’s Health Amendment to the Affordable
    Care Act (“ACA”) mandated that women’s health insurance
    include coverage for preventive health care. Through the
    Amendment, Congress directed the Health Resources and
    Services Administration (“HRSA”), a component of the
    Department of Health and Human Services (“HHS”), to issue
    guidelines setting forth the preventive health care services that
    women should be provided. Among the services HRSA
    identified was contraceptive care. Nowhere in the enabling
    statute did Congress grant the agency the authority to exempt
    entities from providing insurance coverage for such services
    nor did Congress allow federal agencies to issue regulations
    concerning this coverage without complying with the
    Administrative Procedure Act.
    Notwithstanding Congress’s directives, in 2017, HHS
    and the Departments of Labor and Treasury (collectively, “the
    Agencies”) promulgated regulations that expanded the entities
    that could invoke an exemption to the requirement that group
    health insurance plans cover contraceptive services as a form
    of women’s preventive health care. Because the state plaintiffs
    are likely to succeed in proving that the Agencies did not
    follow the APA and that the regulations are not authorized
    under the ACA or required by the Religious Freedom
    Restoration Act (“RFRA”), we will affirm the District Court’s
    order preliminarily enjoining the rules’ enforcement
    nationwide.
    I
    10
    A
    Enacted as a part of the ACA, Pub. L. No. 111-148, 124
    Stat. 119 (2010), the Women’s Health Amendment mandates
    that “[a] group health plan[ 1] and a health insurance issuer
    offering group or individual health insurance coverage shall, at
    a minimum provide coverage for and shall not impose any cost
    sharing requirements for . . . preventive care and screenings
    [for women] . . . as provided for in comprehensive guidelines
    supported by the [HRSA].” 2 42 U.S.C. § 300gg-13(a), (a)(4).
    HRSA commissioned an expert panel from the Institute of
    Medicine to recommend covered services. In 2011, HRSA
    adopted the Institute’s recommendations and issued guidelines
    defining preventive care to include all “Food and Drug
    Administration approved contraceptive methods, sterilization
    procedures, and patient education and counseling for all
    women with reproductive capacity,” “as prescribed” by a
    woman’s health care provider. HRSA, Women’s Preventive
    Services      Guidelines,       https://www.hrsa.gov/womens-
    guidelines/index.html (last visited May 8, 2019). This
    1
    Pursuant to 42 U.S.C. § 300bb-8(1), the term “group
    health plan” has the meaning set forth in 26 U.S.C.
    § 5000(b)(1), which defines a “group health plan” as “a plan
    (including a self-insured plan) of, or contributed to by, an
    employer . . . to provide health care (directly or otherwise) to
    the employees.”
    2
    Congress expressly exempted two sets of actors from
    various ACA requirements, including the Women’s Health
    Amendment: grandfathered health plans, 42 U.S.C. § 18011,
    and employers with fewer than 50 employees, 26 U.S.C.
    § 4980H(c)(2).
    11
    statutory and regulatory scheme was deemed the
    “Contraceptive Mandate.” Several regulations and litigation
    followed.
    1
    The same day that the Guidelines were issued, the
    Agencies promulgated an interim final rule (“IFR”), followed
    by a final rule in 2013, to exempt certain religious employers—
    namely, churches and similar entities—from the Contraceptive
    Mandate. Group Health Plans and Health Insurance Issuers
    Relating to Coverage of Preventive Services Under the Patient
    Protection Affordable Care Act, 77 Fed. Reg. 8,725 (Feb. 15,
    2012) (the “Church Exemption”); Group Health Plans and
    Health Insurance Issuers Relating to Coverage of Preventive
    Services Under the Patient Protection and Affordable Care Act,
    76 Fed. Reg. 46,621 (Aug. 3, 2011). 3 As the Agencies later
    3
    After a notice-and-comment rulemaking process,
    which included consideration of comments concerning
    whether coverage may conflict with the religious beliefs of
    some employers, Group Health Plans and Health Insurance
    Issuers Relating to Coverage of Preventive Services Under
    the Patient Protection and Affordable Care Act, 76 Fed. Reg.
    46,621, 46,623 (August 3, 2011), the Agencies defined
    “religious employer[s]” in the Church Exemption as entities
    “that [are] organized and operate[] as . . . nonprofit entit[ies]
    and [are] referred to” as such in the internal revenue code
    provision applying to “churches, their integrated auxiliaries,
    and conventions or associations of churches, as well as to the
    exclusively religious activities of any religious order,”
    Coverage of Certain Preventive Services Under the
    12
    explained, the “exemption for churches and houses of worship
    is consistent with their special status under longstanding
    tradition in our society and under federal law.” Coverage of
    Certain Preventive Services Under the Affordable Care Act, 80
    Fed. Reg. 41,318, 41,325 (July 14, 2015).
    The 2013 final rule also separately provided that a
    nonprofit religious employer who “(1) [o]pposes providing
    coverage for some or all of the contraceptive services required
    to be covered . . . on account of religious objections; (2) is
    organized and operates as a nonprofit entity; (3) holds itself out
    as a religious organization; and (4) self-certifies that it satisfies
    the first three criteria,” 78 Fed. Reg. at 39,874, is entitled to an
    accommodation to avoid “contracting, arranging, paying, or
    referring for contraceptive coverage,” 
    id. at 39,875.
    This
    accommodation process (the “Accommodation”) permits an
    employer to send a self-certification form to its insurance
    issuer, which then excludes contraceptive coverage, either in
    full or in part, from the group health plan and in turn
    “provide[s] payments for contraceptive services for plan
    participants and beneficiaries, separate from the group health
    plan, without the imposition of cost sharing, premium, fee, or
    other charge on plan participants or beneficiaries or on the
    eligible organization or its plan.” 
    Id. at 39,876.
    A third party
    administrator (“TPA”) may also be used as a claims or plan
    administrator “solely for the purpose of providing payments
    for contraceptive services for participants and beneficiaries in
    a self-insured plan of an eligible organization at no cost to plan
    participants or beneficiaries or to the eligible organization.” 
    Id. at 39,879.
    By invoking the Accommodation, the employer was
    Affordable Care Act, 78 Fed. Reg. 39,870, 39,871, 39,889
    (July 2, 2013); see 45 C.F.R. § 147.132.
    13
    no longer responsible for providing coverage for contraceptive
    care.
    2
    Various legal challenges followed. First, in Burwell v.
    Hobby Lobby Stores, Inc., 
    573 U.S. 682
    (2014), the Supreme
    Court held that the Accommodation must be extended to
    closely-held for-profit corporations with sincere religious
    objections to the provision of contraceptive coverage so that
    their religious beliefs were not substantially burdened under
    RFRA, 42 U.S.C. § 2000bb-1. 
    Id. at 724-26.
    The Court
    observed that use of the Accommodation process was a less
    restrictive means to ensure access to cost-free contraceptives.
    
    Id. at 730-31.
    Days later, in Wheaton College v. Burwell, 
    573 U.S. 958
    (2014), the Court concluded that Wheaton College,
    who also lodged a religious objection to providing insurance
    for services covered by the Contraceptive Mandate, did not
    have to use the Accommodation self-certification form, known
    as the ESBA Form 700, but could instead rely on its
    notification to HHS to satisfy the Accommodation’s
    prerequisites. 
    Id. at 959.
    To ensure compliance with these rulings, the Agencies
    promulgated another IFR and final rule. 4 Coverage of Certain
    Preventive Services Under the Affordable Care Act, 80 Fed.
    Reg. 41,318 (July 14, 2015). The rule “extend[ed] the
    [A]ccommodation to a for-profit entity that is not publicly
    4
    The final rule implementing Hobby Lobby was
    preceded by notice of proposed rulemaking. Coverage of
    Certain Preventive Services Under the Affordable Care Act,
    79 Fed. Reg. 51,118 (Aug. 27, 2014).
    14
    traded, is majority-owned by a relatively small number of
    individuals, and objects to providing contraceptive coverage
    based on its owners’ religious beliefs.” 
    Id. at 41,324.
    The rule
    also “allow[ed] eligible organizations to choose between using
    [the] ESBA Form 700 or the alternative process [of notifying
    HHS in writing of a religious objection to covering
    contraceptive services] consistent with the Wheaton interim
    order.” 
    Id. at 41,323.
    In Zubik v. Burwell, 
    136 S. Ct. 1557
    (2016) (per
    curiam), the Supreme Court addressed the petitioners’
    assertions that “submitting [the Accommodation] notice
    substantially burden[ed] the exercise of their religion, in
    violation of [RFRA].” 
    Id. at 1559.
    The Court did not reach the
    merits of this claim but rather remanded to afford the parties
    “an opportunity to arrive at an approach going forward that
    accommodates petitioners’ religious exercise while at the same
    time ensuring that women covered by petitioners’ health plans
    receive full . . . contraceptive coverage.” 
    Id. at 1560
    (internal
    quotation marks and citation omitted).
    In response to the Court’s direction in Zubik, the
    Agencies solicited comments regarding the current procedure
    and possible alternatives to the Accommodation. Coverage for
    Contraceptive Services, 81 Fed. Reg. 47,741 (July 22, 2016).
    The Agencies reviewed the comments and found that “no
    feasible approach has been identified at this time that would
    resolve the concerns of religious objectors while still ensuring
    that the affected women receive full and equal health coverage,
    including contraceptive coverage.” Dep’t of Labor, FAQs
    About Affordable Care Act Implementation Part 36, at 4 (Jan.
    9,                2017),              available                at
    https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-
    15
    activities/resource-center/faqs/aca-part-36.pdf. As a result, the
    Accommodation remained unchanged.
    3
    In May 2017, President Donald Trump issued an
    executive order directing the Agencies to “consider issuing
    amended regulations, consistent with applicable law, to
    address conscience-based objections to the preventive-care
    mandate promulgated under [42 U.S.C. § 300gg-13(a)(4)].”
    Exec. Order No. 13,798 § 3, 82 Fed. Reg. 21,675 (May 9,
    2017). In response, and without issuing a notice of proposed
    rulemaking or soliciting public comment, the Agencies issued
    two new IFRs: the Religious IFR and the Moral IFR. These
    IFRs expanded the existing exemption and Accommodation
    framework, made the Accommodation process voluntary, and
    offered similar protections to organizations with moral
    objections to contraceptives. See Religious Exemptions and
    Accommodations for Coverage of Certain Preventive Services
    Under the Affordable Care Act, 82 Fed. Reg. 47,792 (Oct. 13,
    2017); Moral Exemptions and Accommodations for Coverage
    of Certain Preventive Services Under the Affordable Care Act,
    82 Fed. Reg. 47,838 (Oct. 13, 2017). This litigation followed.
    16
    B
    1
    The Commonwealth of Pennsylvania filed suit against
    various governmental entities 5 and sought to enjoin the
    enforcement of the IFRs. Little Sisters of the Poor Saints Peter
    and Paul Home (“Little Sisters”) intervened. 6 The District
    5
    These entities include the President, the Agencies and
    their Secretaries, and the United States of America
    (collectively, “the Government”).
    6
    Little Sisters, a religious nonprofit operating a home
    in Pittsburgh, moved to intervene, the District Court denied
    its motion, and our Court reversed, concluding, at that time,
    intervention was appropriate because the litigation posed a
    threat to Little Sisters’ interest in an exemption, and that its
    interests are not adequately represented by the Government.
    See generally Pennsylvania v. President of the United States
    of Am., 
    888 F.3d 52
    (3d Cir. 2018). Since then, however, the
    United States District Court for the District of Colorado
    permanently enjoined enforcement of the Contraceptive
    Mandate for benefit plans in which Little Sisters participates.
    Pennsylvania v. Trump, 
    351 F. Supp. 3d 791
    , 829 n.27 (E.D.
    Pa. 2019) (“Defendant-Intervenor has secured a permanent
    injunction, preventing enforcement of the Contraceptive
    Mandate against it.”); Little Sisters of the Poor v. Azar, No.
    1:13-cv-02611, Dkt. No. 82 at 2-3 (D. Colo. May 29, 2018);
    Accordingly, Little Sisters is no longer aggrieved by the
    District Court’s ruling, its need for relief is moot, and thus
    they lack appellate standing. See Ass’n of Banks in Ins. v.
    Duryee, 
    270 F.3d 397
    , 403 (6th Cir. 2001) (“[T]he intervenor-
    defendants face the threat of economic injury should the Ohio
    17
    Court granted Pennsylvania’s request to preliminarily enjoin
    the IFRs. See generally Pennsylvania v. Trump, 
    281 F. Supp. 3d
    553 (E.D. Pa. 2017). The Court held that Pennsylvania was
    likely to succeed on its procedural and substantive challenges
    under the APA. 
    Id. at 576,
    581. The Government appealed,
    and the District Court granted a stay pending appeal.
    While the appeal of the order preliminarily enjoining
    the IFRs was pending, the Agencies promulgated two Final
    Rules, which are virtually identical to the Religious and Moral
    IFRs. See Religious Exemptions and Accommodations for
    Coverage of Certain Preventive Services Under the Affordable
    Care Act, 83 Fed. Reg. 57,536 (Nov. 15, 2018); 45 C.F.R.
    § 147.132 (“Religious Rule” or “Religious Exemption”);
    Moral Exemptions and Accommodations for Coverage of
    Certain Preventive Services Under the Affordable Care Act, 83
    Fed. Reg. 57,592 (Nov. 15, 2018); 45 C.F.R. § 147.133
    (“Moral Rule” or “Moral Exemption”) (collectively, “the
    Rules” or “the Exemptions”). Like the Religious IFR, the Final
    Rule creating the Religious Exemption expanded the
    categories of employers who are permitted to invoke the
    exemption from the Contraceptive Mandate to include all
    nonprofit, for-profit, and publicly-held companies. The
    Religious Exemption also made participation in the
    statutory provisions not be enforced. Such threatened injury is
    sufficient to confer appellate standing on the intervenor-
    defendants and allows them to challenge the merits of the
    district court’s decision.”); cf. In re Grand Jury, 
    111 F.3d 1066
    , 1071 (3d Cir. 1997) (“Since both intervenors remain
    aggrieved after the district court’s disposition, the
    constitutional requirements for standing to appeal as well as
    standing to sue are satisfied.”).
    18
    Accommodation process completely voluntarily, relieving
    employers from the need to “file notices or certifications of
    their exemption.” 7 83 Fed. Reg. at 57,558; see also 
    id. at 57,537,
    57,562. The Final Rule creating the Moral Exemption
    offered the same exemption and voluntary accommodation
    process to nonprofit organizations and non-publicly traded
    organizations “with sincerely held moral convictions opposed
    to coverage of some or all contraceptive or sterilization
    methods.” 
    Id. at 57,593.
    At Pennsylvania’s request, the District Court lifted the
    stay, and Pennsylvania filed an amended complaint, joined
    New Jersey as a plaintiff, 8 added challenges to the Final Rules
    and moved to enjoin them. 9
    7
    The Agencies assert that under ERISA, employees
    will at least receive notice that their plans no longer cover
    certain contraceptives because, “with respect to plans subject
    to ERISA, a plan document must include a comprehensive
    summary of the benefits covered by the plan,” which will
    “serve to help provide notice to participants and
    beneficiaries” of what services are covered. 83 Fed. Reg. at
    57,558. Even if this is true, this would apply only to certain
    employers.
    8
    Pennsylvania and New Jersey are referred to herein
    collectively as the “the States.”
    9
    The States’ amended complaint for declaratory and
    injunctive relief pleads five counts: (I) violation of Equal
    Protection of the laws under the Fifth Amendment;
    (II) violation of Title VII of the Civil Rights Act and the
    Pregnancy Discrimination Act; (III) violation of the
    procedural requirements of the APA; (IV) violation of the
    19
    2
    The District Court held hearings and received evidence
    regarding the Rules. Specifically, the States submitted
    evidence from health care professionals and state insurance
    regulators about the Rules’ impact. The evidence addressed
    the relationship between costs and contraceptive use and the
    impact the Rules would have on state-funded healthcare
    services.
    Cost is a significant barrier to contraceptive use and
    access. The most effective forms of contraceptives are the
    most expensive. After the ACA removed cost barriers, women
    switched to the more effective and expensive methods of
    contraception. 10 Because the Rules allow employers to opt out
    of providing coverage for contraceptive services, some women
    may no longer have insurance to help offset the cost for these
    and other contraceptives.
    Pennsylvania and New Jersey have state-funded
    programs that provide family planning and contraceptive
    services for eligible individuals. For example, Pennsylvania
    substantive requirements of the APA; and (V) violation of the
    Establishment Clause of the First Amendment.
    10
    Before the ACA, women spent between 30 and 40%
    of their total out-of-pocket health costs on contraceptives, and
    55% of women experienced a time where they could not
    afford contraceptives. Amicus Curiae Women’s Law Ctr. Br.
    at 15-17; 
    id. at 17
    (describing that the ACA dropped out-of-
    pocket contraceptive expenditures by 70%).
    20
    Medicaid and New Jersey’s FamilyCare 11 cover all health care
    for childless adults, pregnant women, and parents with
    incomes up to 138% and up to 215% of the federal poverty
    level, respectively. Pennsylvania’s Family Planning Services
    Program also covers all family planning-related services,
    including contraceptives, for individuals with incomes up to
    215% of the federal poverty level even if they have private
    insurance, and New Jersey’s Plan First program offers the
    same for individuals with incomes up to 205% of the federal
    poverty level.
    Women who lack contraceptive coverage and who meet
    certain income levels may also turn to Title X family planning
    clinics which “provide access to contraceptive services,
    supplies, and information to all who want and need them” with
    priority to low-income persons. Office of Population Affairs,
    Funding History, HHS, https://www.hhs.gov/opa/title-x-
    family-planning/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.
    The States expect that when women lose contraceptive
    insurance coverage from their employers, they will seek out
    these state-funded programs and services. The States further
    assert that women who do not seek or qualify for state-funded
    contraceptives may have unintended pregnancies. Public
    funds are used to cover the costs of many unintended
    11
    NJ FamilyCare is New Jersey’s state and federally-
    funded Medicaid.
    21
    pregnancies. 12 Accordingly, the States expect to spend more
    money due to the Rules.
    In addition to this evidence, the Agencies presented
    spread sheets that listed the organizations and companies that
    were previously involved in ACA Contraceptive Mandate
    litigation. The Agencies offered this evidence to demonstrate
    the likely universe of employers whom they contend may seek
    to invoke the Rules and opt out of covering contraceptive care.
    3
    The day the Final Rules were set to go into effect,
    January 14, 2019, the District Court issued a nationwide
    injunction enjoining their enforcement. Pennsylvania v.
    Trump, 
    351 F. Supp. 3d 791
    (E.D. Pa. 2019). The Court found
    that the States had standing to challenge the Final Rules and
    established a likelihood of success on the merits of their APA
    claims. First, the Court held that the States are likely to
    succeed on their procedural APA claims because the Agencies
    failed to comply with the notice-and-comment requirement and
    this defect tainted the Final Rules. 
    Id. at 813.
    Second, the
    Court held that the States were likely to succeed on their
    substantive APA challenges because neither the ACA nor
    RFRA authorized the Agencies to create exemptions.
    Specifically, the unambiguous language of the ACA’s
    Women’s Health Amendment only authorized the Agencies to
    decide what services would be covered, not who provides
    12
    Nationally, a publicly-funded birth in 2010 cost
    $12,770, and that year, New Jersey spent an estimated $186.1
    million on unintended pregnancies and Pennsylvania an
    estimated $248.2 million.
    22
    them, 
    id. at 821,
    and RFRA did not require or authorize such
    broad exemptions, particularly given RFRA’s remedial
    function that places the responsibility for adjudicating religious
    burdens on the courts, not the Agencies, 
    id. at 822-23.
    The
    Court concluded that the balance of equities and public interest
    favored an injunction, 
    id. at 829-30,
    and that a nationwide
    injunction was appropriate to ensure complete relief for the
    States, 
    id. at 834-35.
    The Government appeals.
    II 13
    We first address whether the States have standing. 14
    Article III limits the scope of federal judicial review to “cases”
    or “controversies.” U.S. Const. art. III § 2. A fundamental
    safeguard of this limitation is the doctrine of standing. Spokeo,
    Inc. v. Robins, 
    136 S. Ct. 1540
    , 1547 (2016). Put simply, only
    parties with standing “can invoke the jurisdiction of the federal
    courts.” Constitution Party of Pa. v. Aichele, 
    757 F.3d 347
    ,
    357 (3d Cir. 2014). To have standing to sue, “[t]he plaintiff
    must have (1) suffered an injury in fact, (2) that is fairly
    traceable to the challenged conduct of the defendant, and (3)
    that is likely to be redressed by a favorable judicial decision.”
    
    Spokeo, 136 S. Ct. at 1547
    (citing Lujan v. Defenders of
    Wildlife, 
    504 U.S. 555
    , 560-61 (1992)). We will examine each
    element in turn.
    13
    The District Court had jurisdiction under 28 U.S.C.
    § 1331. We have jurisdiction under 28 U.S.C. § 1292(a)(1).
    14
    “We review the legal conclusions related to standing
    de novo, but review for clear error the factual elements
    underlying the District Court’s determination of standing.”
    Edmonson v. Lincoln Nat’l Life Ins. Co., 
    725 F.3d 406
    , 414
    (3d Cir. 2013) (internal quotation marks and citation omitted).
    23
    A
    To establish injury in fact, the alleged injury must be
    “concrete and particularized” and “actual or imminent, not
    conjectural or hypothetical.” 
    Id. at 1548
    (quoting 
    Lujan, 504 U.S. at 560
    ). An injury is concrete if it “actually exist[s]” and
    is not abstract. 
    Id. “For an
    injury to be particularized, it must
    affect the plaintiff in a personal and individualized way.” 
    Id. (internal quotation
    marks and citations omitted). Plaintiffs
    need not “demonstrate that it is literally certain that the harms
    they identify will come about.” Clapper v. Amnesty Int’l USA,
    
    568 U.S. 398
    , 414 n.5 (2013). Instead, “[a]n allegation of
    future injury may suffice if . . . there is a substantial risk that
    the harm will occur.” Susan B. Anthony List v. Driehaus, 
    573 U.S. 149
    , 158 (2014) (internal quotation marks and citation
    omitted); see also 
    Clapper, 568 U.S. at 410
    (rejecting lower
    court’s use of an “objectively reasonable likelihood” standard
    to assess injury).
    1
    The States have established that they will suffer a
    concrete and particularized injury. The States describe that
    (1) employers will take advantage of the exemptions and
    women covered by their plans will lose contraceptive
    coverage; and (2) financially- eligible women will turn to state-
    funded services for their contraceptive needs and for the
    unintended pregnancies that may result from the loss of
    coverage. As a result, the States will suffer a concrete financial
    injury from the increased use of state-funded services. See
    Cottrell v. Alcon Labs., 
    874 F.3d 154
    , 163 (3d Cir. 2017)
    (“Typically, a plaintiff’s allegations of financial harm will
    easily satisfy each of these components, as financial harm is a
    24
    classic and paradigmatic form[ ] of injury in fact.” (alteration
    in original) (internal quotation marks and citations omitted)).
    The States will suffer this injury in a particularized manner, as
    each State’s coffers will be depleted by the expenditure of
    funds to meet the increased demand for state services. Having
    concluded that the States have identified a concrete and
    particular injury, we next examine whether the injury at issue
    is not conjectural and is actual or imminent.
    The record shows that the injury the States expect to
    sustain is not conjectural. First, the Agencies’ regulatory
    impact analysis acknowledges that between 70,500 and
    126,400 women nationwide will lose contraceptive coverage
    as a result of their employers’ invocation of the Religious
    Exemption, 83 Fed. Reg. at 57,578, 57,581, and fifteen women
    will lose coverage as a result of their employers’ use of the
    Moral Exemption, 83 Fed. Reg. at 57,627. See California v.
    Azar (“California II”), 
    911 F.3d 558
    , 572 (9th Cir. 2018)
    (noting that the Agencies’ own regulatory impact analysis
    estimates loss of coverage, and therefore “it is reasonably
    probable that women in the plaintiff states will lose some or all
    employer-sponsored contraceptive coverage due to the IFRs”),
    cert. denied Little Sisters of the Poor v. California, No. 18-
    1192, -- S. Ct. --, 
    2019 WL 1207008
    (June 17, 2019) (Mem.).
    Second, based on the Agencies’ list of entities who challenged
    the Contraceptive Mandate, eight employers, not including
    Little Sisters, between New Jersey and Pennsylvania would
    likely take advantage of the Exemptions. Massachusetts v.
    U.S. Dep’t of Health & Human Servs., 
    923 F.3d 209
    , 224 (1st
    Cir. 2019) (relying on spreadsheet of litigating entities to find
    “it is highly likely that at least three employers in the
    Commonwealth with self-insured health plans . . . will use the
    expanded exemptions”). Accordingly, it is not conjecture to
    25
    conclude that employers in Pennsylvania and New Jersey will
    take advantage of the Exemptions and, as a result, women will
    lose coverage. 
    Id. at 224
    n.12 (stating that “it is improbable
    based on the evidence that no women in the [States] would lose
    contraceptive coverage” (emphasis omitted)).
    2
    The record also supports the District Court’s conclusion
    that the injury is imminent. The States have provided evidence
    showing that the Exemption will result in the expenditure of
    state funds because some women who lose coverage will
    inevitably seek out state-sponsored programs providing
    contraceptive services; and some women will forego
    contraceptive use, causing the States to shoulder the costs of
    unintended pregnancies.
    With the ACA, many patients “switch[ed] from a
    cheaper, less effective [contraceptive] method to a more
    effective, expensive method that was better for their medical
    health and personal needs.” App. 272. Contraceptives are not
    only used for pregnancy prevention. They are the “standard
    first-line of care for a number of hormonal, and other,
    disorders, including poly-cystic ovarian syndrome, primary
    ovarian insufficiency/premature ovarian failure, amenorrhea,
    dysmenorrhea/chronic pelvic pain, and abnormal uterine
    bleeding.” App. 292. A “vast majority” of women use 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.
    26
    “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 Ohio App. 299
    ; App. 317.
    Thus, the State-funded programs will be tapped to provide
    coverage for financially eligible women whose employers
    invoke the Exemptions.
    Furthermore, some women who lose contraceptive
    coverage may either fail to qualify for state services or elect to
    forego the use of contraceptives altogether. “Women who stop
    using contraception are more likely to have unplanned
    pregnancies and to require additional medical attention.” App.
    312. The costs of such unintended pregnancies are often
    15
    The Agencies “theorize” that some women may be
    able to pay out of pocket or obtain coverage through a spouse
    or family member’s plan. 
    Massachusetts, 923 F.3d at 227
    .
    While “[s]uch a hypothetical woman may exist, . . . the
    number of women with incomes that make them eligible for
    state-assisted contraceptive coverage but who still fit in that
    category would, logically, be very small.” 
    Id. 27 shouldered
    by states, costing hundreds of millions of dollars.
    Therefore, the evidence supports the conclusion that the loss of
    contraceptive coverage may also result in unintended
    pregnancies for which the States will bear associated health
    care costs.
    For these reasons, “[t]he expanded exemptions are
    expected to result in greater financial expenditures” by the
    States on contraceptive services. App. 318. This anticipated
    substantial impact on state finances presents an imminent
    injury. Thus, the District Court properly found that the States
    showed an imminent injury in fact.
    The Government faults the States for failing to identify
    a specific woman who will be affected by the Final Rules, but
    the States need not define injury with such a demanding level
    of particularity to establish standing. Massachusetts v. EPA,
    
    549 U.S. 497
    , 523 n.21 (2007); see 
    Massachusetts, 923 F.3d at 225
    ; California 
    II, 911 F.3d at 572
    . The likelihood that
    employers will invoke the Exemptions and leave women
    without contraceptive coverage, and that women will turn to
    the States for coverage, is sufficient to demonstrate imminent
    injury. This likelihood “has nothing to do with whether
    petitioners have determined [a] precise” woman who will seek
    such funding. 
    Massachusetts, 549 U.S. at 523
    n.21. 16
    16
    In the context of an environmental case and a claim
    that the plaintiff-state Massachusetts lacked standing because
    it failed to identify land that would be impacted by federal
    regulators’ inaction, the Supreme Court observed that
    the likelihood that Massachusetts’ coastline will
    recede has nothing to do with whether petitioners
    28
    B
    The States’ imminent injury is causally connected and
    fairly traceable to the Exemptions. The States will suffer
    financial injury when employers in Pennsylvania and New
    Jersey take advantage of the Exemptions, leaving female
    employees without contraceptive coverage and prompting
    financially eligible women to turn to state-funded services.
    See Texas v. United States, 
    809 F.3d 134
    , 159 (5th Cir. 2015)
    (“For Texas to incur injury, DAPA beneficiaries would have to
    apply for driver’s licenses as a consequence of DHS’s action,
    and it is apparent that many would do so.”), aff’d by an equally
    divided court, United States v. Texas, 
    136 S. Ct. 2271
    (2016)
    (Mem.) (per curiam). In other words, the States will not
    experience an increased demand for services and the resulting
    financial burden unless the new Exemptions, which create a
    void in contraceptive coverage, go into effect. See 
    id. at 160
    (“Far from playing an insignificant role, DAPA would be the
    have determined the precise metes and bounds of
    their soon-to-be-flooded land.           Petitioners
    maintain that the seas are rising and will continue
    to rise, and have alleged that such a rise will lead
    to the loss of Massachusetts’ sovereign
    territory. . . . Our cases require nothing more.
    
    Massachusetts, 549 U.S. at 523
    n.21. Just as it was
    unnecessary for Massachusetts to identify specific coastline
    that would be flooded by the agencies’ inaction, it is
    unnecessary for the States to identify a specific woman who
    would be impacted by the Government’s action where in both
    instances, the record provided a basis to infer specific
    imminent injury.
    29
    primary cause and likely the only one. Without the program,
    there would be little risk of a dramatic increase in the costs of
    the driver’s-license program.”). Thus, there is a link between
    the Exemptions and the impact on the States’ fiscs.
    C
    The District Court also correctly concluded that an
    injunction would redress the financial injury the States face
    from the Rules. Enjoining the Final Rules until their legality
    is adjudicated on the merits will avoid the imminent financial
    burden the States face if they are not enjoined. 
    Massachusetts, 923 F.3d at 228
    (“[A]n injunction preventing the application of
    these exemptions would stop the alleged fiscal injury from
    occurring, making it not only ‘likely,’ 
    Spokeo, 136 S. Ct. at 1547
    , but certain that this injury would not occur for as long as
    the exemptions are enjoined.”); see 
    Massachusetts, 549 U.S. at 526
    (“The risk of catastrophic harm, though remote, is
    nevertheless real. That risk would be reduced to some extent
    if petitioners received the relief they seek.”).
    For these reasons, the States have standing to bring this
    17
    suit.
    III
    Having determined that the States have standing, we
    now address whether they are entitled to a preliminary
    injunction. The decision to grant or deny a preliminary
    17
    Based upon of the foregoing discussion, we need not
    decide whether the States also have standing under the special
    solicitude or parens patriae doctrines.
    30
    injunction is within the sound discretion of the district court.18
    Winter v. Nat. Res. Def. Council, Inc., 
    555 U.S. 7
    , 24, 33
    (2008). To obtain a preliminary injunction, the movants must:
    demonstrate (1) that they are reasonably likely to
    prevail eventually in the litigation and (2) that
    they are likely to suffer irreparable injury
    without relief. If these two threshold showings
    are made the District Court then considers, to the
    extent relevant, (3) whether an injunction would
    harm the [defendants] more than denying relief
    would harm the plaintiffs and (4) whether
    granting relief would serve the public interest.
    K.A. ex rel. Ayers v. Pocono Mountain Sch. Dist., 
    710 F.3d 99
    ,
    105 (3d Cir. 2013) (alteration in original) (quoting Tenafly
    Eruv Ass’n v. Borough of Tenafly, 
    309 F.3d 144
    , 157 (3d Cir.
    2002)); accord Fed. R. Civ. P. 65. To establish a likelihood of
    success, “a sufficient degree of success for a strong showing
    exists if there is ‘a reasonable chance, or probability, of
    winning.’” In re Revel AC, Inc., 
    802 F.3d 558
    , 568 (3d Cir.
    2015) (quoting Singer Mgmt. Consultants, Inc. v. Milgram,
    
    650 F.3d 223
    , 229 (3d Cir. 2011) (en banc)).
    18
    “We employ a tripartite standard of review
    for . . . preliminary injunctions. We review the District
    Court’s findings of fact for clear error. Legal conclusions are
    assessed de novo. The ultimate decision to grant or deny the
    injunction is reviewed for abuse of discretion.” K.A. ex rel.
    Ayers v. Pocono Mountain Sch. Dist., 
    710 F.3d 99
    , 105 (3d
    Cir. 2013) (omission in original) (internal quotation marks
    and citations omitted).
    31
    Here, we must decide whether the District Court
    correctly concluded that the States have a reasonable
    probability of showing that the Final Rules violate the APA,
    and if so, whether the equitable factors warrant a nationwide
    injunction.
    A 19
    To promulgate binding regulations, agencies engage in
    what is known as notice-and-comment rulemaking. 5 U.S.C.
    § 553. This requires an agency to publish notice of the
    proposed rule in the Federal Register, collect and consider
    public comments, and issue a concise statement of purpose
    upon finalizing the new rule. 
    Id. § 553(b)-(c).
    Deviation from
    these procedures is only permitted where expressly authorized
    by statute, 
    id. § 559,
    or when the agency has “good cause” to
    dispense with them, 
    id. § 553(b)(3)(B).
    The Agencies assert
    that both grounds justify their decision to forego notice-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 rulemaking. The provisions upon
    which the Government relies provide:
    19
    Quite appropriately, the Agencies do not challenge
    the States’ statutory standing to sue under the APA. 5 U.S.C.
    § 702; 
    Massachusetts, 549 U.S. at 520
    (recognizing states’
    “procedural right to challenge the rejection of its rulemaking
    petition as arbitrary and capricious” under the EPA).
    32
    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 . . .’), wide-
    ranging (applying to any regulatory proceeding relating to
    group health insurance plans), and do[es] not contain any
    specific deadlines for agency action.” Coal. for Parity, Inc. v.
    Sebelius, 
    709 F. Supp. 2d 10
    , 18-19 (D.D.C. 2010) (omissions
    in original and emphasis omitted); see also California 
    II, 911 F.3d at 578-80
    . In short, because the Regulation Provision
    “neither contain[s] express language exempting agencies from
    the APA nor provide[s] alternative procedures that could
    reasonably be understood as departing from the APA,” it does
    33
    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. 42 U.S.C. § 1320a-7b
    note. That provision requires the Secretary of Health and
    Human Services to publish a rule prescribing penalties for
    34
    2
    The Agencies also lacked good cause for dispensing
    with notice of and comment to the IFRs. An agency has “good
    cause” to forego APA procedures where following them would
    be “impracticable, unnecessary, or contrary to the public
    interest.” 21 5 U.S.C. § 553(b)(3)(B). “[C]ircumstances
    justifying reliance on [the good cause] exception are indeed
    rare and will be accepted only after the court has examine[d]
    closely proffered rationales justifying the elimination of public
    procedures.” Nat. Res. Def. Council, Inc. v. EPA (“NRDC”),
    kickbacks by January 1, 1997, then less than four months
    away. It provides that “[s]uch rule shall be effective and final
    immediately on an interim basis, but is subject to change and
    revision after public notice and opportunity for . . . public
    comment.” Unlike the Regulation Provision, § 1320a-7b
    expressly provides for notice and comment after the
    promulgation of an IFR. Congress’s omission of that
    procedure from the Regulation Provision demonstrates that it
    did not provide the Agencies authority to promulgate IFRs
    without notice and comment.
    21
    5 U.S.C. § 553(b)(3) provides
    [e]xcept when notice or hearing is required by
    statute, this subsection does not apply—
    ...
    (B) when the agency for good cause finds (and
    incorporates the finding and a brief statement of
    reasons therefor in the rules issued) that notice
    and public procedure thereon are impracticable,
    unnecessary, or contrary to the public interest.
    35
    
    683 F.2d 752
    , 764 (3d Cir. 1982) (alterations in original)
    (internal quotation marks and citation omitted). Thus, we
    construe the “good cause” exception to the notice-and-
    comment requirement narrowly. 22 
    Id. When they
    issued the IFRs, the Agencies claimed good
    cause to waive notice and comment based on (1) the urgent
    need to alleviate harm to those with religious objections to the
    current regulations; (2) the need to address “continued
    uncertainty, inconsistency, and cost” arising from “litigation
    challenging the previous rules”; and (3) the fact that the
    Agencies had already collected comments on prior Mandate-
    related regulations. 82 Fed. Reg. at 47,813-15; see also 82 Fed.
    Reg. at 47,855-59. None of these assertions meet the standard
    for good cause.
    First, the Agencies’ desire to address the purported
    harm to religious objections does not ameliorate the need to
    follow appropriate procedures. All regulations are directed
    toward reducing harm in some manner. 23 See United States v.
    22
    Though the review standard for agency assertions of
    good cause remains an open question in our circuit, see
    United States v. Reynolds, 
    710 F.3d 498
    , 509 (3d Cir. 2013),
    we need not answer that question here. Even applying the
    most deferential of the potential standards—reviewing the
    agency’s good cause determination to see if it is arbitrary and
    capricious—the IFRs cannot stand.
    23
    As we observed in Reynolds,
    [m]ost, if not all, laws passed by Congress
    requiring agencies to promulgate new rules are
    designed to eliminate some real or perceived
    36
    Reynolds, 
    710 F.3d 498
    , 512-13 (3d Cir. 2013). Thus, “[a]
    need to regulate affected parties does not create the urgency
    necessary to establish good cause.” 
    Id. at 511.
    “As with any
    other administrative agency conclusion, we require some
    statement of facts or circumstances that justifies the existence
    of good cause (e.g., an imminent, externally imposed deadline
    or the existence of an emergency).” 
    Id. at 512.
    The Agencies
    fail to cite any facts or impending deadlines sufficient to raise
    “good cause” here.
    Second, the need to address uncertainty is likewise
    insufficient to establish good cause. Uncertainty precedes
    every regulation, and to allow uncertainty to excuse
    compliance with notice-and-comment procedures “would have
    the effect of writing [those] requirements out of the statute.”
    
    Id. at 510.
    Furthermore, our precedent forecloses the
    acceptance of uncertainty as a basis for good cause. 
    Id. (“An agency’s
    intention to provide clarity, without more, cannot
    amount to good cause.”).
    Third, the Agencies’ previous solicitation and collection
    of   comments regarding other rules concerning the
    harm. If the mere assertion that such harm will
    continue while an agency gives notice and
    receives comments were enough to establish
    good cause, then notice and comment would
    always have to give way. An agency will
    invariably be able to point to some continuing
    harm during the notice and comment period
    antecedent to the promulgation of a 
    rule. 710 F.3d at 512-13
    .
    37
    Contraceptive Mandate cannot substitute for notice and
    comment here. If the APA permitted agencies to forego notice-
    and-comment concerning a proposed regulation simply
    because they already regulated similar matters, then the good
    cause exception could largely obviate the notice-and-comment
    requirement. Furthermore, the IFRs did not make a minor
    change. The IFRs create exemptions from the Contraceptive
    Mandate with unprecedented scope and make the
    Accommodation wholly voluntary. Such a dramatic overhaul
    of the Contraceptive Mandate regulations required 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 postpromulgation
    comments to the Interim Rule can satisfy [the purposes of
    notice-and-comment rulemaking] misses the point.” (internal
    citation omitted)); Sharon Steel Corp. v. EPA, 
    597 F.2d 377
    ,
    381 (3d Cir. 1979) (“We hold that the period for comments
    after promulgation cannot substitute for the prior notice and
    comment required by the APA.”).
    38
    APA notice-and-comment procedures serve several
    goals, including “(1) to ensure that agency regulations are
    tested via exposure to diverse public comment, (2) to ensure
    fairness to affected parties, and (3) to give affected parties an
    opportunity to develop evidence in the record to support their
    objections to the rule and thereby enhance the quality of
    judicial review.” Prometheus Radio Project v. FCC, 
    652 F.3d 431
    , 449 (3d Cir. 2011) (quoting Int’l Union, United Mine
    Workers of Am. v. Mine Safety & Health Admin., 
    407 F.3d 1250
    , 1259 (D.C. Cir. 2005)). The comment process also
    allows each agency to “maintain[] a flexible and open-minded
    attitude towards its own rules,” 
    Reynolds, 710 F.3d at 511
    (alteration in original and citation omitted) (quoting
    Prometheus 
    Radio, 652 F.3d at 449
    ); see also Azar v. Allina
    Health Servs., 
    139 S. Ct. 1804
    , 1816 (2019) (“Notice and
    comment . . .affords the agency a chance to avoid errors and
    make a more informed decision.” (internal citation omitted)).
    To preserve the integrity of this process, “[t]he opportunity for
    comment must be a meaningful opportunity,” Prometheus
    
    Radio, 652 F.3d at 450
    (alteration in original), to have
    interested parties share their views, and to have the agency
    consider them with an “open mind,” 
    Reynolds, 710 F.3d at 517-19
    .
    The notice and comment exercise surrounding the Final
    Rules does not reflect any real open-mindedness toward the
    position set forth in the IFRs. 24 First, as the Government
    admits, the minor changes to the Final Rules do not “alter the
    24
    We express no opinion on whether the Agencies
    appropriately responded to comments collected during this
    process, see 
    Trump, 351 F. Supp. 3d at 811-12
    , as this issue is
    not before us.
    39
    fundamental substance of the exemptions set forth in the
    IFRs.” Dkt. 107-1 at 8. Second, the reasons the Agencies
    supplied for promulgating the Final Rules simply echoed those
    provided for issuing the IFRs. See 83 Fed. Reg. at 57,552,
    57,609. These rationales do not show the “flexible and open-
    minded attitude” the notice-and-comment process requires.
    
    Reynolds, 710 F.3d at 511
    .            Together, the Agencies’
    justifications for avoiding notice and comment to the IFRs, and
    the fact that the IFRs and the Final Rules are virtually identical,
    suggest that the opportunity for comment was not a
    “meaningful” one in the way the APA requires. Prometheus
    
    Radio, 652 F.3d at 450
    .
    Lastly, even setting aside the Agencies’ lack of 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 should be continued. This would
    40
    allow agencies to circumvent [our case law] and
    the APA. We cannot countenance such a 
    result. 683 F.2d at 768
    (citation omitted). This reasoning applies with
    equal force here. By first promulgating the IFRs that granted
    the expanded exemptions without notice and comment, the
    Agencies changed the question presented concerning the Final
    Rules from whether they should create the exemptions to
    whether they should depart from them. This starting position
    is impermissible under the APA. Id.; see also Sharon 
    Steel, 597 F.2d at 381
    (“Provision of prior notice and comment
    allows effective participation in the rulemaking process while
    the decisionmaker is still receptive to information and
    argument. After the final rule is issued, the petitioner must
    come hat-in-hand and run the risk that the decisionmaker is
    likely to resist change.” (citation omitted)).
    In sum, because deficits in the promulgation of the IFRs
    compromised the procedural integrity of the Final Rules, the
    States have demonstrated a likelihood of success in showing
    that the Final Rules are procedurally defective, and in turn,
    violate the APA.
    C
    There are also serious substantive problems with the
    Final Rules. More specifically, neither of the statutes upon
    which the Agencies rely, the ACA and RFRA, authorize or
    require the Final Rules. Thus, they were enacted “in excess of
    statutory jurisdiction, authority, or limitations, or short of
    statutory right,” making them “arbitrary, capricious, an abuse
    of discretion, or otherwise not in accordance with law.” 5
    U.S.C. § 706(2)(A), (C).
    41
    1
    The Agencies argue that their authority under the ACA
    to issue preventive care guidelines includes the power to
    promulgate the Exemptions. This assertion is without textual
    support. The Women’s Health Amendment to the ACA, 42
    U.S.C. § 300gg-13(a)(4), provides:
    A group health plan and a health insurance issuer
    offering group or individual health insurance
    coverage shall, at a minimum provide coverage
    for and shall not impose any cost sharing
    requirements for— . . .
    (3) with respect to infants, children,          and
    adolescents, evidence-informed preventive      care
    and screenings provided for in                   the
    comprehensive guidelines supported by           the
    [HRSA].
    (4) with respect to women, such additional
    preventive care and screenings not described in
    paragraph (1)[25] as provided for in
    comprehensive guidelines supported by the
    [HRSA] for purposes of this paragraph.
    42 U.S.C. § 300gg-13(a).            The authority to issue
    “comprehensive guidelines” concerns the type of services that
    are to be provided and does not provide authority to undermine
    25
    Paragraph (1) refers to “evidence-based items or
    services that have in effect a rating of ‘A’ or ‘B’ in the current
    recommendations of the United States Preventive Services
    Task Force.” 42 U.S.C. § 300gg-13(a)(1).
    42
    Congress’s directive concerning who must provide coverage
    for these services. Section 300gg-13(a) unambiguously
    dictates that group health plans and health insurance issuers
    “shall provide” the preventive care services set forth in the
    HRSA-supported comprehensive guidelines, and “shall” not
    impose cost sharing. The term “shall” denotes a requirement,
    Prometheus Radio Proj. v. FCC, 
    824 F.3d 33
    , 50 (3d Cir. 2016)
    (“Th[e] repeated use of ‘shall’ creates ‘an obligation
    impervious to . . . discretion.’” (omission in original) (quoting
    Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 
    523 U.S. 26
    , 35 (1998)), and HRSA’s authority to issue the
    guidelines does not empower it to ignore that requirement.
    Nothing from § 300gg-13(a) gives HRSA the discretion to
    wholly exempt actors of its choosing from providing the
    guidelines services. On the contrary, the mandate articulated
    in § 300gg-13(a) forecloses such exemptions. 26
    26
    The Government argues that if the ACA does not
    grant the authority to issue the Exemptions, then HRSA was
    equally without authority to issue the Church Exemption and
    the Accommodation. This argument fails. Though the
    Church Exemption may seem facially at odds with § 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
    43
    The Agencies’ reliance on the language that directed
    HRSA to create the guidelines concerning women’s preventive
    health care and the use of the phrase “as provided for in” such
    guidelines does not advance their position. The Agencies
    contrast § 300gg-13(a)(4)’s use of the phrase “as provided for
    in” comprehensive guidelines with a neighboring sub-section’s
    provision addressing preventive care for infants, children, and
    adolescents, which is “provided for in the” comprehensive
    guidelines for those services. Compare 42 U.S.C. § 300gg-
    13(a)(3) (describing “preventive care and screenings provided
    for in the comprehensive guidelines”), with 
    id. § 300gg-
    13(a)(4) (describing “preventive care and screenings as
    provided for in comprehensive guidelines”). They assert that
    the use of the word “as” in § 300gg-13(a)(4) gives HRSA
    authority to dictate the preventive services to be provided and
    who must provide them. This argument overlooks the clear
    explanation for the different language. When the ACA was
    passed, the comprehensive guidelines for children’s preventive
    care already existed, but guidelines for women’s preventive
    care were not yet written. Congress used the definite article
    “the” in § 300gg-13(a)(3) to refer to those existing children’s
    preventive care guidelines. In § 300gg-13(a)(4), Congress
    addressed the women’s preventive care guidelines that were
    yet to be promulgated by stating “as provided for in the
    comprehensive guidelines.”
    The Agencies’ interpretation of “comprehensive” as
    authorizing them to issue guidelines that exempt entities from
    through which a statutorily identified actor “shall provide”
    the mandated coverage. In any event, the Agencies’ authority
    to issue the Church Exemption and Accommodation is not
    before us.
    44
    complying with the Mandate likewise fails. Put simply, the
    discretion the statute grants HRSA to issue comprehensive
    guidelines concerning services to be provided does not include
    the power to exempt actors from the statute itself. This is borne
    out by the fact that the word “comprehensive” is also used to
    describe the children’s preventive care guidelines, and those
    guidelines do not exempt any statutorily required party from
    providing services. See HHS, Preventive Care Benefits for
    Children,          https://www.healthcare.gov/preventive-care-
    children (last visited May 8, 2019). Congress was obviously
    aware of the existing children’s guidelines when it drafted the
    Women’s Health Amendment, and Congress’s use of
    “comprehensive” to describe both sets of guidelines conveys
    that it intended them to cover the same type of subject matter,
    namely health care services for the identified groups. See
    F.A.A. v. Cooper, 
    566 U.S. 284
    , 292 (2012) (“[W]hen
    Congress employs a term of art, it presumably knows and
    adopts the cluster of ideas that were attached to each borrowed
    word in the body of learning from which it was taken.”
    (internal quotation marks and citation omitted)).
    Other portions of the ACA also show that Congress
    retained the authority to exempt certain employers from
    providing contraceptive coverage. In passing the ACA,
    Congress explicitly exempted grandfathered 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.
    45
    See United States v. Johnson, 
    529 U.S. 53
    , 58 (2000) (“When
    Congress provides exceptions in a statute,” we may infer “that
    Congress considered the issue of exceptions and, in the end,
    limited the statute to the ones set forth.”). Relatedly, by
    promulgating the Moral Exemption, which sought to do what
    Congress refused to do with the conscience amendment, the
    Agencies contravened Congress’s intent. See Food & Drug
    Admin. v. Brown & Williamson Tobacco Corp., 
    529 U.S. 120
    ,
    147 (2000) (considering Congress’s prior refusal to pass laws
    as material to whether an agency’s interpretation of its statute
    is entitled to deference).
    Because § 300gg-13(a) does not authorize the Agencies
    to exempt plans from providing the required coverage, the
    Agencies’ authority under the ACA to enact the Final Rules is
    without merit.
    2 27
    The Agencies’ effort to cast RFRA as requiring the
    Religious Exemption is also incorrect. Even assuming that
    RFRA provides statutory authority for the Agencies to issue
    regulations to address religious burdens the Contraceptive
    Mandate may impose on certain individuals, RFRA does not
    require the enactment of the Religious Exemption to address
    this burden.
    RFRA provides that the federal government “[s]hall not
    substantially burden a person’s exercise of religion even if the
    burden results from a rule of general applicability,” 42 U.S.C.
    27
    No party argues that RFRA authorizes or requires
    the Moral Exemption.
    46
    § 2000bb-1(a), unless “that application of the burden to the
    person—(1) is in furtherance of a compelling governmental
    interest; and (2) is the least restrictive means of furthering that
    compelling governmental interest,” 
    id. § 2000bb-1(b).
    “[A]
    person whose religious exercise has been burdened in violation
    of this section” may seek relief in a judicial proceeding. 
    Id. § 2000bb-1(c).
    Thus, RFRA authorizes a cause of action for
    government actions that impose a substantial burden on a
    person’s sincerely-held religious beliefs, and provides a
    judicial remedy via individualized adjudication. See 42 U.S.C.
    § 2000bb-3(a); City of Boerne v. Flores, 
    521 U.S. 507
    , 529
    (1997) (“[RFRA] prevents and remedies laws which are
    enacted with the unconstitutional object of targeting religious
    beliefs and practices.”). Because Congress has deemed the
    courts the adjudicator of private rights of actions under RFRA,
    Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal,
    
    546 U.S. 418
    , 434 (2006) (holding RFRA “plainly
    contemplates that courts would . . . consider whether
    exceptions are required under the test set forth by Congress”
    (emphasis omitted)), we owe the Agencies no deference when
    reviewing determinations based upon RFRA, see Adams Fruit
    Co., Inc. v. Barrett, 
    494 U.S. 638
    , 649 (1990) (declining to
    defer to an agency’s statutory interpretation where Congress
    “expressly established the Judiciary and not the [agency] as the
    adjudicator of private rights of action arising under the
    statute”).
    A prima facie RFRA case requires a plaintiff to prove
    that the government imposed a substantial burden on religious
    exercise. Mack v. Warden Loretto FCI, 
    839 F.3d 286
    , 304 (3d
    Cir. 2016). A substantial burden exists if
    47
    (1) a follower is forced to choose between
    following the precepts of his religion and
    forfeiting benefits otherwise generally available
    to other [persons] versus abandoning one of the
    precepts of his religion in order to receive a
    benefit; or (2) the government puts substantial
    pressure on an adherent to substantially modify
    his behavior and to violate his beliefs.[28]
    Real Alternatives, Inc. v. Sec’y Dep’t of Health & Human
    Servs., 
    867 F.3d 338
    , 371 (3d Cir. 2017) (alteration in original)
    (internal quotation marks and citation omitted). The Supreme
    Court has directed that, when considering a requested
    accommodation to address the burden, “courts must take
    adequate account of the burdens a requested accommodation
    may impose on nonbeneficiaries.” Cutter v. Wilkinson, 
    544 U.S. 709
    , 720 (2005) (referring to third parties who may face
    collateral consequences from accommodating an observer’s
    burden). 29 The Accommodation fulfills this directive as it
    28
    Although we “defer to the reasonableness” of an
    objector’s religious beliefs, “this does not bar our objective
    evaluation of the nature of the claimed burden and the
    substantiality of that burden on [the objector’s] religious
    exercise.” Real Alternatives, Inc. v. Sec’y Dep’t of Health &
    Human Servs., 
    867 F.3d 338
    , 356 (3d Cir. 2017) (emphasis
    omitted) (citation omitted).
    29
    Although Cutter v. Wilkinson, 
    544 U.S. 709
    (2005),
    dealt with an application of the Religious Land Use and
    Institutionalized Persons Act (“RLUIPA”), we have said that
    RLUIPA and RFRA “are analogous for the purpose of the
    substantial burden test,” and we may therefore may apply
    48
    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 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
    RLUIPA law. 
    Mack, 839 F.3d at 304
    n.103; see Holt v.
    Hobbs, 
    135 S. Ct. 853
    , 860 (2015).
    30
    While Zubik vacated our opinion in Geneva College,
    it did not reach the merits of the Accommodation nor did it
    “attack our reasoning.” Real 
    Alternatives, 867 F.3d at 356
    49
    The    religious      objectors    who     oppose     the
    Accommodation mechanism disapprove of “what follows
    from” filing the self-certification form, but under Free Exercise
    jurisprudence, we examine the conduct of the objector, not
    third parties.      
    Id. at 439-40.
         Here, through the
    Accommodation process, “the actual provision of
    contraceptive coverage is by a third party,” so any possible
    burden from the notification procedure is not substantial. 
    Id. at 442.
    For these reasons, RFRA does not require that the
    Agencies permit religious objectors to decline to provide
    contraceptive coverage without notifying their insurance
    issuer, TPA, HHS, or the employees.
    Contrary to the Agencies’ assertions in the Rule, the
    Supreme Court has not held that the Accommodation imposes
    substantial burdens on religious rights. Hobby Lobby ruled
    that closely-held corporations are entitled to take advantage of
    the Accommodation process rather than facing fines for non-
    compliance with the contraceptive mandate, observing that the
    Accommodation was a less restrictive alternative to forcing
    objectors to choose between adhering to the mandate or
    violating their sincerely-held 
    beliefs. 573 U.S. at 730-31
    .
    While the Court “did not decide” whether the Accommodation
    “complies with RFRA,” it found that “[a]t a minimum . . . it
    does not impinge on that plaintiffs’ religious belief that
    providing insurance coverage for [certain contraceptives]
    violates their religion, and it serves HHS’s stated interests
    equally well.” 
    Id. at 731;
    see also 
    Zubik, 136 S. Ct. at 1561
    (Sotomayor, J., concurring) (“The opinion does
    n.18. After Zubik, we repeated that the Accommodation does
    “not impose a substantial burden.” 
    Id. 50 not
    . . . endorse the petitioners’ position that the existing
    regulations substantially burden their religious exercise or that
    contraceptive coverage must be provided through a separate
    policy, with a separate enrollment process.” (internal quotation
    marks and citations omitted)); 
    Wheaton, 573 U.S. at 960
    (noting that Hobby Lobby “expressly rel[ied] on the
    availability of the religious-nonprofit accommodation” to
    reach its holding).
    Furthermore, the Religious Exemption and the new
    optional Accommodation would impose an undue burden on
    nonbeneficiaries—the female employees who will lose
    coverage for contraceptive care. The Agencies downplayed
    this burden on women, contradicting Congress’s mandate that
    women be provided contraceptive coverage. “No tradition,
    and no prior decision under RFRA, allows a religion-based
    exemption when the [A]ccommodation would be harmful to
    others—here, the very persons the contraceptive coverage
    requirement was designed to protect.” Hobby 
    Lobby, 573 U.S. at 764
    (Ginsburg, J., concurring). As the Agencies recognize,
    the record shows that thousands of women may lose
    contraceptive coverage if the Rule is enforced and frustrate
    their right to obtain contraceptives. 
    Id. at 727
    (citation
    omitted); 42 U.S.C. § 300gg-13(a)(4) (directing the enactment
    of the Women’s Preventive Services Guidelines, which include
    contraceptives).
    In short, the status quo prior to the new Rule, with the
    Accommodation, did not infringe on the religious exercise of
    covered employers, nor is there a basis to conclude the
    Accommodation process infringes on the religious exercise of
    any employer. For these reasons, RFRA does not demand the
    Religious Exemption.
    51
    D
    Because the States demonstrated a likelihood of success
    on the merits as to their APA claim, we next turn to the
    remaining equitable factors.        To obtain a preliminary
    injunction, a plaintiff must “demonstrate that irreparable injury
    is likely in the absence of an injunction.” 
    Winter, 555 U.S. at 22
    (emphasis omitted). Because the States cannot collect
    money damages under the APA, 31 5 U.S.C. § 702 (enabling
    claimants to obtain “relief other than money damages”); see
    also California 
    II, 911 F.3d at 581
    , the States will suffer
    irreparable harm if the Rules are enforced. The States will face
    unredressable financial consequences from subsidizing
    contraceptive services, providing funds for medical care
    associated with unintended pregnancies, and absorbing
    medical expenses that arise from decreased use of
    contraceptive medications for other health conditions.
    Therefore, the District Court did not abuse its discretion in
    holding that the States demonstrated a likelihood of irreparable
    harm.
    Furthermore, because the current Accommodation does
    not substantially burden employers’ religious exercise and the
    Exemption is not necessary to protect a legally-cognizable
    interest, the States’ financial injury outweighs any purported
    injury to religious exercise. Moreover, the public interest
    favors minimizing harm to third-parties by ensuring that
    women who may lose ACA guaranteed contraceptive coverage
    31
    Monetary injuries ordinarily do not constitute
    irreparable harm because they are compensable. See Instant
    Air Freight Co. v. C.F. Air Freight, Inc., 
    882 F.2d 797
    , 801
    (3d Cir. 1989).
    52
    are able to maintain access to the preventive care to which they
    are entitled under the ACA and HRSA’s comprehensive
    guidelines while final adjudication of the Rules is pending.
    Therefore, the District Court did not abuse its discretion in
    concluding that the balance of the equities and the public
    interest both favor issuing an injunction.
    E
    Having determined that a preliminary injunction is
    warranted, the final question we address is whether the District
    Court abused its discretion by enjoining the Final Rules
    nationwide. “Crafting a preliminary injunction is an exercise
    of discretion and judgment, often dependent as much on the
    equities of a given case as the substance of the legal issues it
    presents.” Trump v. Int’l Refugee Assistance Project, 137 S.
    Ct. 2080, 2087 (2017) (per curiam). While courts are vested
    with the power to issue equitable relief with a nationwide
    reach, see 
    Texas, 809 F.3d at 188
    (quoting U.S. Const. art. III,
    § 1), they must ensure that “injunctive relief [is] no more
    burdensome to the defendant than necessary to provide
    complete relief to plaintiffs,” Novartis Consumer Health, Inc.
    v. Johnson & Johnson-Merck Consumer Pharm. Co., 
    290 F.3d 578
    , 598 (3d Cir. 2002) (internal quotation marks and citation
    omitted). We must also bear in mind that the purpose of
    injunctions is “not to conclusively determine the rights of the
    parties, but to balance the equities as the litigation moves
    forward.” 
    Trump, 137 S. Ct. at 2087
    (internal citation
    omitted).
    Mindful of these considerations, the District Court did
    not abuse its discretion in concluding that a nationwide
    injunction is necessary to afford complete relief to the States
    53
    and that it is not “more burdensome to the defendant than
    necessary” to provide such relief. 32 Groupe SEB USA, Inc. v.
    Euro-Pro Operating LLC, 
    774 F.3d 192
    , 206 (3d Cir. 2014)
    (internal quotation marks and citations omitted). First, our
    APA case law suggests that, at the merits stage, courts
    invalidate—without qualification—unlawful administrative
    rules as a matter of course, leaving their predecessors in place
    until the agencies can take further action. See, e.g.,
    Prometheus 
    Radio, 652 F.3d at 453-54
    & n.25 (vacating
    procedurally defective rule and leaving the prior rule in effect);
    Council Tree Commc’ns, Inc. v. FCC, 
    619 F.3d 235
    , 258 (3d
    Cir. 2010) (same). Congress determined that rule-vacatur was
    not unnecessarily burdensome on agencies when it provided
    vacatur as a standard remedy for APA violations. See 5 U.S.C.
    § 706(2) (“The reviewing court shall . . . hold unlawful and set
    aside agency action” that is outside an agency’s authority, or
    “without observance of procedure required by law,” among
    other things). While vacatur is the ultimate remedy the States
    seek, and that is not the relief being granted here, by enjoining
    enforcement of the Rules we provide a basis to ensure that a
    regulation that the States have shown likely to be proven to be
    unlawful is not effective until its validity is finally adjudicated.
    Second, a nationwide injunction is necessary to provide
    the States complete relief. Many individuals work in a state
    that is different from the one in which they reside. See Amici
    32
    Our sister circuit declined to uphold a nationwide
    injunction concerning the IFRs, but the record before us is
    substantially more developed than the record before that
    court. California 
    II, 911 F.3d at 584
    (“On the present record,
    an injunction that applies only to the plaintiff states would
    provide complete relief to them.”).
    54
    Curiae Massachusetts, et al., Br. at 24 (“Mass. Amici Br.”)
    (stating that 14% of the workforce in New Jersey and 5.4% in
    Pennsylvania work out of state, comprising more than 800,000
    workers in total). An injunction geographically limited to the
    States alone will not protect them from financial harm, as some
    share of their residents who work out-of-state will lose
    contraceptive coverage originally provided through employers
    in non-enjoined states who will exempt themselves. Women
    covered by these plans who live in the States will seek state-
    funded services, and a state specific injunction will not be
    sufficient to prevent the resulting financial harm.
    Out-of-state college attendance further exacerbates the
    States’ injury. As the Moral Exemption points out, “[o]nly a
    minority of students in higher education receive health
    insurance coverage from plans arranged by their colleges or
    universities.” 83 Fed. Reg. at 57,564; 83 Fed. Reg. at 57,619.
    Instead, most of these students remain on their parents’
    employer-based plans. Mass. Amici Br. at 26. The States host
    many such students at their colleges. “Each year, for example,
    Pennsylvania takes in more than 32,000 first-time out-of-state
    students alone—the second most of any state in the country.”
    Mass. Amici Br. at 25 (citing Nat’l Ctr. For Educ. Statistics,
    Residence and Migration of All First-Time Degree/Certificate-
    Seeking Undergraduates, Digest of Education Statistics
    (2017)). In the absence of a nationwide injunction, students
    attending school in the States may lose contraceptive coverage
    from their parents’ out-of-state plans, again leaving programs
    within the States to pick up the bill. 33 In light of the impact of
    33
    It is also likely that residents of the States will attend
    out-of-state schools that invoke the Exemptions, and that such
    students will seek contraceptive services through programs in
    55
    these interstate activities, the District Court did not abuse its
    discretion in concluding that a nationwide injunction was
    necessary to afford the States complete relief. 34
    V
    For the foregoing reasons, we will affirm the District
    Court’s order granting the nationwide preliminary injunction.
    their home states, also giving rise to fiscal injuries to the
    States that only a nationwide injunction can remedy.
    34
    The Government also argues that a nationwide
    injunction takes a toll on the court system, foreclosing
    “adjudication by a number of different courts and judges,”
    Califano v. Yamasaki, 
    442 U.S. 682
    , 702 (1979), thereby
    preventing legal questions from “percolating” throughout the
    court system, Gov’t Br. at 79-80. The argument has little
    force in this case. First, other federal courts have examined
    substantially the same legal issues as we confront here. See
    generally Massachusetts, 
    923 F.3d 209
    ; California II, 
    911 F.3d 558
    . Second, the extensive litigation surrounding the
    Exemption and Accommodation have allowed for an airing of
    the legal issues. See Petition for Writ of Certiorari at 27, The
    Little Sisters of the Poor Jeanne Jugan Residence v.
    California (No. 18-1192) (“Further percolation is
    unnecessary. . . . [T]his issue was adjudicated by ten courts of
    appeals and dozens of district courts. . . . The arguments have
    all been aired.”). Thus, there is no “percolation” problem
    here.
    56
    

Document Info

Docket Number: 17-3752

Citation Numbers: 930 F.3d 543

Filed Date: 7/12/2019

Precedential Status: Precedential

Modified Date: 1/12/2023

Authorities (27)

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association-of-banks-in-insurance-inc-american-bankers-association , 270 F.3d 397 ( 2001 )

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Council Tree Communications, Inc. v. Federal Communications ... , 619 F.3d 235 ( 2010 )

Califano v. Yamasaki , 99 S. Ct. 2545 ( 1979 )

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Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach , 118 S. Ct. 956 ( 1998 )

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