Commonwealth of MA v. Dep't of Health & Human Servs. ( 2019 )


Menu:
  •           United States Court of Appeals
    For the First Circuit
    No. 18-1514
    COMMONWEALTH OF MASSACHUSETTS,
    Plaintiff, Appellant,
    v.
    UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES;
    ALEX MICHAEL AZAR II, in his official capacity as Secretary of
    Health and Human Services; UNITED STATES DEPARTMENT OF THE
    TREASURY; STEVEN T. MNUCHIN, in his official capacity as
    Secretary of the Treasury; UNITED STATES DEPARTMENT OF LABOR;
    R. ALEXANDER ACOSTA, in his official capacity as
    Secretary of Labor,
    Defendants, Appellees.
    APPEAL FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS
    [Hon. Nathaniel M. Gorton, U.S. District Judge]
    Before
    Torruella, Lynch, and Thompson,
    Circuit Judges.
    Julia E. Kobick, Assistant Attorney General, with whom Maura
    Healey, Attorney General of Massachusetts, Jon Burke, Assistant
    Attorney General, Jonathan B. Miller, Assistant Attorney General,
    and Elizabeth Carnes Flynn, Special Assistant Attorney General,
    were on brief, for appellant.
    Allan J. Arffa, Crystal Johnson, Elizabeth J. Grossman,
    Melina M. Meneguin Layerenza, and Paul, Weiss, Rifkind, Wharton &
    Garrison LLP on brief for amici curiae Planned Parenthood
    Federation of America, National Health Law Program, and National
    Family Planning and Reproductive Health Association.
    Michael J. Fischer, Chief Deputy Attorney General, Josh
    Shapiro, Attorney General Commonwealth of Pennsylvania, Jonathan
    Scott Goldman, Executive Deputy Attorney General, Aimee D.
    Thomson, Deputy Attorney General, Xavier Becerra, Attorney General
    of California, George Jepsen, Attorney General of Connecticut,
    Matthew P. Denn, Attorney General of Delaware, Karl A. Racine,
    Attorney General for the District of Columbia, Russell A. Suzuki,
    Attorney General of Hawai'i, Thomas J. Miller, Attorney General of
    Iowa, Janet T. Mills, Attorney General of Maine, Brian E. Frosh,
    Attorney General of Maryland, Lori Swanson, Attorney General of
    Minnesota, Barbara D. Underwood, Attorney General of New York,
    Joshua H. Stein, Attorney General of North Carolina, Ellen F.
    Rosenblum, Attorney General of Oregon, Peter F. Kilmartin,
    Attorney General of Rhode Island, Thomas J. Donovan, Jr., Attorney
    General of Vermont, Mark R. Herring, Attorney General of Virginia,
    and Robert W. Ferguson, Attorney General of Washington, on brief
    for amici curiae Pennsylvania, California, Connecticut, Delaware,
    District of Columbia, Hawai'i, Iowa, Maine, Maryland, Minnesota,
    New York, North Carolina, Oregon, Rhode Island, Vermont, Virginia,
    and Washington.
    Erin Bernstein, Supervising Deputy City Attorney, City of
    Oakland, Laura S. Trice, Lead Deputy County Counsel, Barbara J.
    Parker, City Attorney, Maria Bee, Attorney, Malia McPherson,
    Attorney, on brief for amici curiae the City of Oakland,
    California. Laura S. Trice, Lead Deputy County Counsel, County of
    Santa Clara, James R. Williams, County Counsel, Greta S. Hansen,
    Attorney, Adriana L. Benedict, Attorney, on brief for amici curiae
    the County of Santa Clara, California. Andre M. Davis, City
    Solicitor, City of Baltimore, Kimberly M. Foxx, State's Attorney
    for Cook County, Michael N. Feuer, City Attorney of the City of
    Los Angeles, Charles J. McKee, County Counsel, County of Monterey,
    William Litt, Deputy County Counsel, County of Monterey,
    Zachary W. Carter, Corporation Counsel, City of New York,
    Marcel S. Pratt, City Solicitor, City of Philadelphia Law
    Department, Dennis J. Herrera, City Attorney, City and County of
    San Francisco, Peter S. Holmes, Seattle City Attorney, Francis X.
    Wright, Jr., City Solicitor, City of Somerville, Michael Jenkins,
    City Attorney, City of West Hollywood, on brief for amici curiae
    13 Cities, Counties, and Local Agencies.
    Christopher Escobedo Hart, Emily J. Nash, and Foley Hoag LLP
    on brief for amicus curiae Public Health Scholars.
    Jamie A. Levitt, Rhiannon N. Batchelder, and Morrison &
    Foerster LLP on brief for amici curiae American Association of
    University Women, Service Employees International Union, and 12
    Additional Professional, Labor, and Student Associations.
    -2-
    Diana Kasdan, Center for Reproductive Rights, and Jon M.
    Greenbaum, Lawyers' Committee for Civil Rights Under Law, on brief
    for amici curiae Center for Reproductive Rights, Lawyers'
    Committee for Civil Rights Under Law, California Women's Law
    Center, GLBTQ Legal Advocates & Defenders, Lawyers' Committee for
    Civil Rights and Economic Justice, Legal Momentum, Legal Voice,
    Mississippi Justice Center for Justice, National Center for
    Lesbian Rights, Women's Law Project.
    Jessie J. Rossman, Matthew R. Segal, ACLU Foundation of
    Massachusetts, Inc., Brigitte Amiri, ACLU Foundation of New York,
    Kate R. Cook, and Sugarman Rogers, on brief for amici curiae
    American Civil Liberties Union, American Civil Liberties Union of
    Massachusetts, Anti-Defamation League, Leadership Conference on
    Civil and Human Rights, NARAL Pro-Choice Massachusetts, and
    National Urban League.
    M. Duncan Grant, Benjamin J. Eichel, and Pepper Hamilton LLP,
    on brief for amici curiae The Guttmacher Institute.
    Naomi D. Barrowclough, Jeffrey Blumenfeld, Lowenstein Sandler
    LLP, Fatima Goss Graves, Gretchen Borchelt, Sunu Chandy, Michelle
    Banker, National Women's Law Center, Sequoia Ayala, Jill
    Heaviside, Sisterlove, Inc., Jane Liu, National Asian Pacific
    American Women's Forum, on brief for amici curiae National Women's
    Law Center, National Latina Institute for Reproductive Health,
    Sisterlove, Inc., and National Asian Pacific Women's Forum.
    Bruce H. Schneider, Michele L. Pahmer, Gilana Keller, and
    Stroock & Stroock & Lavan LLP, on brief for amici curiae the Health
    Professional Organizations, American Nurses Association, American
    College of Obstetricians and Gynecologists, American Academy of
    Nursing, American Academy of Pediatrics, and Physicians for
    Reproductive Health.
    Ernest A. Young on brief for amicus curiae Professor Ernest A.
    Young.
    Karen Schoen, Attorney, Appellate Staff, Civil Division, U.S.
    Department of Justice, with whom Joseph H. Hunt, Assistant Attorney
    General, Andrew E. Lelling, United States Attorney, Hashim M.
    Mooppan, Deputy Assistant Attorney General, and Sharon Swingle,
    Attorney, Appellate Staff, were on brief, for appellees.
    May 2, 2019
    -3-
    TORRUELLA,   Circuit     Judge.1        The    Commonwealth     of
    Massachusetts brought suit on October 6, 2017, to enjoin the
    enforcement of two federal Interim Final Rules (together, the
    "IFRs") promulgated by the United States Departments of Health and
    Human   Services   ("HHS"),      Labor,   and      the     Treasury     (the
    "Departments"), which were to become effective that day.                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).
    The IFRs permitted employers with religious or moral
    objections to contraception to obtain exemptions from providing
    health insurance coverage to employees and their dependents for
    Food and Drug Administration ("FDA")-approved contraceptive care.
    Such coverage would otherwise be required by guidelines issued
    pursuant to a provision in the Affordable Care Act, subject to the
    limitations imposed by the Supreme Court in Burwell v. Hobby Lobby
    Stores, Inc., 
    573 U.S. 682
     (2014).
    These IFRs were superseded by final rules (the "Final
    Rules"), promulgated on November 15, 2018, with an effective date
    of January 14, 2019.   Religious Exemptions and Accommodations for
    1  I am particularly appreciative            of   my    panel   colleagues'
    contributions to this opinion.
    -4-
    Coverage of Certain Preventive Services Under the Affordable Care
    Act, 83 Fed. Reg. 57,536 (Nov. 15, 2018); Moral Exemptions and
    Accommodations for Coverage of Certain Preventive Services Under
    the Affordable Care Act, 83 Fed. Reg. 57,592 (Nov. 15, 2018).
    After both sides here moved for summary judgment, the
    district court determined that Massachusetts lacked standing to
    challenge the IFRs. Massachusetts v. U. S. Dep't of Health & Human
    Servs., 
    301 F. Supp. 3d 248
    , 266 (D. Mass. 2018).      And so, it did
    not reach the merits of the Commonwealth's challenges or its prayer
    for injunctive relief.   The Commonwealth appealed.2
    The issue on appeal is narrow: whether the Commonwealth
    has Article III standing to challenge the rules.    We hold that it
    does.   Specifically, we conclude that: (1) in agreement with the
    position of the United States, the Commonwealth's substantive
    challenges have not been mooted by the promulgation of the Final
    Rules, but the Commonwealth's procedural challenge to the IFRs has
    been mooted; and (2) the Commonwealth has established Article III
    standing to challenge the substance of the rules by demonstrating
    a sufficiently imminent fiscal injury under a traditional standing
    analysis (and so we do not reach the Commonwealth's alternative
    parens patriae standing argument).
    2  We appreciate the numerous amici who submitted briefs to this
    court.
    -5-
    I.
    A.   Factual Background
    1.      The Affordable      Care    Act   and   the   Contraceptive   Care
    Requirement
    The   Affordable    Care    Act    requires   employer-sponsored
    health plans to provide coverage for a range of preventive care
    and related medical services at no cost to the covered employee.
    See 42 U.S.C. § 300gg-13(a).3           A provision commonly known as the
    Women's Health Amendment requires coverage for, "with respect to
    women, such additional preventive care and screenings . . . as
    provided for in comprehensive guidelines supported by the Health
    Resources and Services Administration."4             Id. § 300gg-13(a)(4).
    While the Women's Health Amendment did not indicate the
    additional preventive care services that must be covered, it
    instructed    the    Health     Resources      and   Services   Administration
    ("HRSA"), part of HHS, to determine the specifics of such required
    3  Employers who provide health plans that existed before March
    23, 2010, and who have not made specified changes after that date
    to their health plans, are not subject to this requirement. 42
    U.S.C. §§ 18011(a), (e).
    4  The IFRs and the statutory provision at issue -- the Women's
    Health Amendment -- discuss only women.       The Commonwealth's
    complaint similarly focuses on women. The denial of coverage for
    contraceptive care and services may directly affect some
    transgender men and gender non-conforming people, as well as
    indirectly affect some men (for example, men who have dependents,
    whether children or partners, who rely on the man's employer-
    sponsored health insurance coverage for contraceptive care and
    services).
    -6-
    care and services. See 155 Cong. Rec. 511, 987 (daily ed. Nov. 30,
    2009) (Senate Amendment 2791).
    In August 2011, HRSA accepted the recommendations of the
    Institute of Medicine ("IOM") and issued guidelines requiring
    insurance coverage, at no cost to users, of all "Food and Drug
    Administration . . . approved contraceptive methods, sterilization
    procedures, and patient education and counseling for all women
    with   reproductive    capacity."        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)     (quoting   HRSA    Guidelines,
    http://www.hrsa.gov/womens-guidelines).              In its report, the IOM
    made   extensive    factual    findings      about   contraceptive   care   and
    public health outcomes.             See Institute of Medicine, Clinical
    Preventive Services for Women: Closing the Gaps (2011).                  Plans
    within the guidelines' ambit had to provide such contraceptive
    coverage for plan years starting on or after August 1, 2012.5               See
    77 Fed. Reg. at 8,725-26.
    2.    The Departments' Regulations and Related Litigation from
    2010 to 2016
    Concurrently, the Departments promulgated regulations,
    which became final in February 2012, that provided an exemption
    5 The Departments estimated in 2017 that about "46.6 million women
    aged 15 to 64 received the [contraceptive and related] coverage
    through employer sponsored private insurance plans," 82 Fed. Reg.
    -7-
    from     the    requirement     to    provide       contraceptive        coverage   to
    "churches,       their     integrated   auxiliaries,         and   conventions      or
    associations          of    churches"    with       religious       objections      to
    contraception.         76 Fed. Reg. at 46,623; see also 77 Fed. Reg. at
    8,725.
    Later regulations also created what the Departments
    termed an "accommodation" process.            Coverage of Certain Preventive
    Services Under the Affordable Care Act, 78 Fed. Reg. 39,870
    (July 2, 2013).            This process allowed nonprofit organizations,
    including colleges and universities, to submit a form to their
    health insurance issuers asserting their religious objections to
    contraception.         See id. at 39,874-77.          The insurance issuer was
    then required to remove contraceptive coverage from the objecting
    organization's         plan,   but   still    had    to   provide    contraceptive
    coverage to members of the plan (without directly involving the
    objecting organization) (the "Accommodation").                  Id. at 39,875-80.
    On June 30, 2014, the Supreme Court held in Hobby Lobby
    that   the      contraceptive     regulatory        requirement     as    applied   to
    closely        held    corporations     violated       the    Religious       Freedom
    Restoration Act ("RFRA"), 42 U.S.C. § 2000bb-1 et seq.                       573 U.S.
    at 47,821, and cited studies showing "that application of HRSA
    Guidelines had applied preventive services coverage to 55.6
    million women and had led to a 70 percent decrease in out-of-
    pocket expenses for contraceptive services among commercially
    insured women," id. at 47,805.
    -8-
    at 736.     That was because the regulations "clearly impose[d] a
    substantial burden" on closely held employers who had religious
    objections to contraception, and the regulations were not the least
    restrictive means of furthering a compelling government interest
    (assuming arguendo that one existed).            Id. at 726, 730-32.   The
    Supreme Court noted that the Accommodation already available to
    nonprofit     organizations   with    religious     objections   was   less
    restrictive    than   "requiring     employers    to   fund   contraceptive
    methods that violate their religious beliefs."           Id. at 730.
    After Hobby Lobby, the Departments issued a new rule in
    2015 which allowed "Closely Held for-Profit Entit[ies]" who had
    religious objections to providing contraceptive coverage to use
    the Accommodation process described above.             Coverage of Certain
    Preventive Services Under the Affordable Care Act, 80 Fed. Reg.
    41,318, 41,323 (July 14, 2015).
    Nevertheless,       numerous          religious       nonprofit
    organizations sued to obtain an exemption similar to that provided
    to churches rather than the more limited Accommodation process
    (which still allowed for contraceptive coverage for employees of
    the objecting organizations).        Nine circuits considered the issue
    from late 2014 to early 2016.              Eight circuits held that the
    Accommodation did not substantially burden religious exercise; one
    -9-
    held that it did.6   The Supreme Court granted certiorari in some
    of these cases (from the Third, Fifth, Tenth, and D.C. Circuits).
    In a per curiam opinion, it vacated and remanded, instructing that
    the parties "be afforded 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."   Zubik v. Burwell, 
    136 S. Ct. 1557
    , 1560
    (2016) (per curiam) (internal quotation marks omitted).
    After Zubik, the Departments sought comment in July 2016
    through a request for information, seeking alternative ways in
    which the contraceptive coverage mandate and employers' religious
    beliefs could coexist.     Coverage for Contraceptive Services, 81
    6  Specifically, the Second, Third, Fifth, Sixth, Seventh, Tenth,
    Eleventh, and D.C. Circuits held that the Accommodation did not
    substantially burden religious exercise. Eternal Word Television
    Network, Inc. v. Sec'y of U.S. Dep't of Health & Human Servs., 
    818 F.3d 1122
    , 1151 (11th Cir. 2016); Mich. Catholic Conf. & Catholic
    Family Servs. v. Burwell, 
    807 F.3d 738
    , 752 (6th Cir. 2015);
    Catholic Health Care Sys. v. Burwell, 
    796 F.3d 207
    , 226 (2d Cir.
    2015); Little Sisters of the Poor Home for the Aged, Denver, Colo.
    v. Burwell, 
    794 F.3d 1151
    , 1195 (10th Cir. 2015); E. Tex. Baptist
    Univ. v. Burwell, 
    793 F.3d 449
    , 463 (5th Cir. 2015); Univ. of Notre
    Dame v. Burwell, 
    786 F.3d 606
    , 619 (7th Cir. 2015); Geneva Coll.
    v. Sec'y U.S. Dep't of Health & Human Servs., 
    778 F.3d 422
    , 442
    (3d Cir. 2015); Priests for Life v. U.S. Dep't of Health & Human
    Servs., 
    772 F.3d 229
    , 252 (D.C. Cir. 2014). The Eighth Circuit
    held that the Accommodation process substantially burdened
    religion and faltered under strict scrutiny.      Sharpe Holdings,
    Inc. v. U.S. Dep't of Health & Human Servs., 
    801 F.3d 927
    , 945-46
    (8th Cir. 2015). All were vacated as a result of or in light of
    Zubik v. Burwell, 
    136 S. Ct. 1557
     (2016) (per curiam).
    -10-
    Fed.   Reg.    47,741,    47,741    (July    22,    2016).      The    Departments
    ultimately     stated     that,    though    they    received    54,000    public
    comments after this request, "includ[ing] [from] the plaintiffs in
    Zubik, . . . consumer advocacy groups, women's organizations [and]
    health insurance issuers," by September 20, 2016, "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."          United States Department of Labor, FAQs
    About Affordable Care Act Implementation Part 36, at 4 (Jan. 9,
    2017).
    3.     President's Executive Order and Interim Final Rules on
    Exemptions
    On May 4, 2017, the President issued an Executive Order
    "Promoting Free Speech and Religious Liberty."                  Exec. Order No.
    13,798, 82 Fed. Reg. 21,675 (May 4, 2017).               This Order directed
    the    Departments       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)."         Id.
    Several months later, the Departments issued two IFRs:
    a religious exemption IFR and a separate moral exemption IFR, both
    effective immediately on publication, on October 6, 2017.                  See 82
    Fed. Reg. at 47,792; 82 Fed. Reg. 47,838.                The IFRs included a
    -11-
    request for further comments before final rulemaking.                          82 Fed.
    Reg. at 47,792; 82 Fed. Reg. at 47,838.                The Departments did not
    go through the notice and comment process before issuing the IFRs,
    asserting first that these procedures did not apply, and second,
    that    if    the   Administrative       Procedure     Act   ("APA")      procedures
    applied, the "good cause" exception to notice and comment allowed
    for     the   Departments'      chosen     approach,     see   5    U.S.C.        § 553
    (b)(1)(B),(d); 82 Fed. Reg. at 47,813-15; 82 Fed. Reg. at 47,854-
    56.
    The   religious     exemption      IFR   expanded         the    previous
    exemption (which had covered only churches and related entities,
    see 76 Fed. Reg. at 46,623) to include nonprofit organizations,
    corporations,       institutions     of     higher     education,        and     health
    insurance      issuers   that     object   to    "establishing,         maintaining,
    providing,      offering,    or    arranging     (as    applicable)           coverage,
    payments, or a plan that provides coverage or payments for some or
    all contraceptive services, based on its sincerely held religious
    beliefs."      82 Fed. Reg. at 47,835.
    The moral exemption IFR created a similar exemption but
    based    on    "sincerely    held    moral      convictions"       as    opposed     to
    "sincerely held religious beliefs."               82 Fed. Reg. at 47,853-54.
    This second IFR did not define the term "moral conviction." Unlike
    the religious exemption, this exemption did not apply to publicly
    traded corporations; it did apply to privately held corporations.
    -12-
    See id. at 47,849-52.    Both IFRs allowed an objecting organization
    to use either the expanded exemptions (which would then leave their
    employees      and/or   students    without   direct   coverage   for
    contraceptive care and service), or the Accommodation (under which
    employees and/or students would continue to receive contraceptive
    care and services paid for and managed by the issuer, not by the
    employer or school).     See 82 Fed. Reg. at 47,812-13; 82 Fed. Reg.
    at 47,854.
    The Departments included a regulatory impact analysis in
    the IFRs (the "Regulatory Impact Analysis"), see 82 Fed. Reg. at
    47,815-28; 82 Fed. Reg. at 47,856-59, as required by law, see
    Regulatory Planning and Review, Executive Order 12,866, 58 Fed.
    Reg. 51,735 (Oct. 4, 1993).     In their Regulatory Impact Analysis,
    the Departments estimated that, nationwide, between about 31,700
    and 120,000 women would be affected by the expanded exemptions.
    See 82 Fed. Reg. at 47,821-23.7      In so doing, they accounted for
    various factors that could skew the estimates.     For example, they
    excluded publicly traded corporations from the estimates, as the
    Departments stated that "although publicly traded entities could
    make use of exempt status under these interim final rules, the
    7  The Commonwealth and several amici challenge these estimates as
    too low, arguing, for example, that they rely on data about women
    using a contraceptive method at a point-in-time rather than over
    time, and that the estimates do not adequately consider the impact
    of the untested moral exemption.
    -13-
    Departments do not expect that very many will do so."                   82 Fed.
    Reg. at 47,817.        This was based primarily on the fact that, at
    that point, "[n]o publicly traded for-profit entities ha[d] filed
    lawsuits challenging the Mandate."           Id.
    The Departments based their lower bound estimate of
    31,700    women    partially   on    the   number    of    employers   that   had
    previously challenged the contraceptive coverage requirement in
    litigation, and partially on an estimate of the number of employers
    using    the    Accommodation.       See   82   Fed.   Reg.    47815-21.       The
    Departments acknowledged that they had "not received complete data
    on the number of entities actually using the accommodation, because
    the accommodation does not require many accommodated entities to
    submit information to us."          Id. at 47,817.
    To calculate an "upper bound" of 120,000 women likely to
    lose contraceptive coverage because of the IFRs, the Departments
    started    from     the   number     of    women    that    used   FDA-approved
    contraceptives but were employed by entities that did not cover
    such care before the Affordable Care Act was enacted, relying on
    a survey from the Kaiser Family Foundation.                Id. at 47,822.     This
    estimate did not consider employees of the "31 percent of survey
    respondents that did not know about contraceptive coverage."                  Id.
    at n.88.       After reducing the extrapolated numbers to account for
    already exempt church plans and the assumption that publicly-
    traded employers would not make use of the expanded exceptions,
    -14-
    the Departments reached an amount of 362,100 women.                        From there,
    the Departments calculated their final "upper bound" estimate of
    120,000 women based on the view that a "reasonable estimate is
    that no more than approximately one third of the persons covered
    by relevant entities . . . would likely be subject to potential
    transfer impacts."         Id. at 47,823.            The Departments based this
    "one   third"      estimate    on    several      factors,    including      employers
    potentially objecting to only certain contraceptive methods and a
    "prominent poll" purporting to "show[] that 89 percent of Americans
    say they believe in God, while 11 percent say they do not or are
    agnostic."      Id.
    The      Departments     then       estimated    an    "average    annual
    expenditure on contraceptive products and services of $584 per
    user," so a "transfer effect[]" attributable to the IFRs of between
    about $18.5 and $63.8 million annually nationwide.                    Id. at 47,823-
    24.    In a footnote, the Departments also noted the "noteworthy
    potential    impact[]"        of    "increased      expenditures      on    pregnancy-
    related medical services," but did not provide a numerical estimate
    of such expenditures (or of how many women might face unintended
    pregnancies due to the IFRs).              Id. at 47,828 n.113.
    In their Regulatory Impact Report, the Departments also
    included    spreadsheets         listing     either    litigating      employers    or
    employers currently using the Accommodation that the Departments
    flagged     could       switch      to     the     expanded        exemption.    Three
    -15-
    Massachusetts employers were listed.
    4.     Relevant Commonwealth Laws and Public Health Structure
    The Commonwealth legislature has enacted two laws that
    are relevant to this case and factor into the Commonwealth's claims
    of injury.      In 2002, the legislature passed "An Act Providing
    Equitable Coverage of Services Under Health Plans," see 2002 Mass.
    Acts ch. 49, §§ 1-4, which required employer-sponsored health
    plans to cover contraceptive care and services at the same level
    that the plans covered other outpatient care and services, see
    Mass. Gen. Laws ch. 175, § 47W; id. Mass. Gen. Laws ch. 176A, § 8W;
    id. Mass. Gen. Laws ch. 176B, § 4W; id. Mass Gen. Laws ch. 176G,
    § 4O. Under this Act, people using contraceptive care and services
    pursuant to insurance plans could be required to pay cost-sharing
    fees such as deductibles and copays for the care and services.
    Moreover, in November 2017, the Commonwealth legislature passed
    "An Act Relative to Advancing Contraceptive Coverage and Economic
    Security in Our State" (the "ACCESS Act"), which barred employer-
    sponsored    health   plans   from   collecting    cost-sharing    fees    for
    contraceptive    care   and   services.     2017    Mass.   Acts   ch.    120,
    § 4(e)(1).    The ACCESS Act did not provide any moral exemption for
    employers, but did provide an exemption for churches and "qualified
    church-controlled organization[s]."         Id. § 3.
    Importantly, Massachusetts healthcare laws -- including
    the ACCESS Act and the earlier Equitable Coverage law -- do not
    -16-
    apply to self-insured plans, because such plans come under the
    Employee Retirement Income Security Act of 1974 ("ERISA") (which
    preempts state regulation).      29 U.S.C. §§ 1144(a) & (b)(2)(A).        A
    study submitted by the Commonwealth shows that, as of March 2017,
    fifty-six    percent   of   Commonwealth   residents    who   have   private
    commercial health insurance had such insurance from ERISA plans.
    Center for Health Information and Analysis, Enrollment Trends:
    August 2017 Edition, Ctr. For Health Info. And Analysis 3 (2017).
    Thus, to the extent the ACCESS Act and the Equitable Coverage law
    mitigate any injury done by the IFRs, that mitigation does not
    apply to fifty-six percent of the Commonwealth's residents who
    have private ERISA-covered insurance.
    The Commonwealth also provides health services to about
    two million Commonwealth residents through its Medicaid program,
    the MassHealth Program.       Massachusetts, 301 F. Supp. 3d at 255-
    56. This program provides access to contraceptives. See 130 Mass.
    Code   Regs.   450.105   ("The   following   services   are   covered   for
    MassHealth Standard members . . . [:] family planning services.").
    MassHealth also serves as a "secondary payer" for about 150,000
    residents.     This means that qualifying residents with employer-
    sponsored plans who lose contraceptive coverage would then be
    covered by MassHealth, and the Commonwealth would owe ten percent
    of the cost of contraceptive coverage paid by MassHealth (and so
    ten percent of the cost for loss of coverage occasioned by the
    -17-
    IFRs).     See 42 U.S.C. § 1396b(a)(5); Robert Seifert & Stephanie
    Anthony, The Basics of MassHealth, Mass. Medicaid Policy Inst. 3
    (Feb. 2011).
    In addition to the MassHealth program, the Sexual and
    Reproductive     Health     Program     ("SRHP")     of    the     Commonwealth's
    Department of Public Health reimburses groups and clinics that are
    providing contraceptive care and services in the Commonwealth.
    Services    funded    by   the   SRHP    are     available    to   Massachusetts
    residents that either (1) do not have insurance and make less than
    300% of the poverty level; (2) need confidential care; or (3) make
    less than 300% of the poverty level and have insurance that does
    not cover all contraception methods and services.                  See 101 Mass.
    Code Regs. 312.00.     The Commonwealth provides about three-quarters
    of SRHP's total funding.         Massachusetts, 301 F. Supp. 3d at 256.
    B.      Procedural History of This Litigation
    The Commonwealth filed suit to enjoin the IFRs in October
    2017.    The Commonwealth included, with its amended complaint filed
    in November 2017, various declarations from medical professionals,
    state    officials,   the    CEO   of    a     partially   Commonwealth-funded
    nonprofit organization specializing in "sexual and reproductive
    health," and an investigator, all in support of its assertion that
    the Commonwealth would be harmed by the IFRs.                These declarations
    are discussed further below where relevant.
    -18-
    Both sides moved for summary judgment. In its memorandum
    in opposition to defendants' cross-motion to dismiss or for summary
    judgment, the Commonwealth asserted standing based on a procedural
    injury, financial harm, and harm to the Commonwealth's quasi-
    sovereign     interests.       The       Departments     asserted   that     the
    Commonwealth's      projections    of    injury   were   too   speculative   to
    support standing.
    This case is in an unusual posture for the following
    reasons.     When filed, it was brought as a pre-enforcement suit.
    Before the district court ruled on the cross motions for summary
    judgment,     two    federal      district      courts    issued    nationwide
    injunctions blocking the IFRs, after finding that the plaintiff
    states had standing.       See California v. Health & Human Servs.
    ("California I"), 
    281 F. Supp. 3d 806
    , 832 (N.D. Cal. 2017);
    Pennsylvania v. Trump ("Pennsylvania I"), 
    281 F. Supp. 3d 553
    , 585
    (E.D. Pa. 2017).       The former injunction, out of California, was
    modified to include only the plaintiff states.             See California v.
    Azar ("California II"), 
    911 F.3d 558
    , 585 (9th Cir. 2018).                   The
    IFRs were only effective in the Commonwealth, then, for about two
    months.     There is no suggestion in the record that, during those
    two   months,   it   was   possible      to    measure   any   injury   to   the
    Commonwealth's interests, much less to measure projected future
    injury from this period.          Indeed, under the religious exemption
    IFR, "[i]f contraceptive coverage is currently being offered by an
    -19-
    issuer or third party administrator through the accommodation
    process, the revocation will be effective on the first day of the
    first plan year that begins on or after 30 days after the date of
    the revocation," or alternatively sixty days after notice is
    provided.    82 Fed. Reg. at 47,831.           The moral exemption IFR does
    not have a similar rule, likely because no Accommodation process
    existed for organizations with moral objections to contraception
    prior to this IFR.
    On   March    12,   2018,    the   district    court   granted   the
    Departments' motion for summary judgment.            Massachusetts, 301 F.
    Supp. 3d at 266.         The district court held that the Commonwealth
    failed to establish standing because the Commonwealth had not "set
    forth specific facts establishing that it will likely suffer future
    injury from the defendants' conduct."             Id. at 250.      It rejected
    the   Commonwealth's        proportional       argument,     based    on     the
    Departments' own estimates of women affected, as too "tenuous,"
    id. at 259, and faulted the Commonwealth for failing to "identify
    any particular woman who is likely to lose contraceptive coverage
    because of the IFRs" or "any Massachusetts employer that is likely
    to avail itself of the expanded exemptions," id. at 265.                     The
    district court similarly rejected the Commonwealth's alternative
    procedural injury and quasi-sovereign harm theories.               Id. at 265-
    66.
    -20-
    The Commonwealth appealed.            After the Commonwealth filed
    its opening brief, the Departments issued Final Rules superseding
    the IFRs in November 2018, effective in January 2019.                          83 Fed.
    Reg. at 57,536; 83 Fed. Reg. at 57,592.                  In December 2018, this
    court directed the parties to address, in the remaining briefing,
    whether the appeal was moot. Order, Commonwealth of Mass. v. Dep't
    of Health & Human Servs., et al. (18-1514) (Dec. 21, 2018), ECF
    No. 117.     The parties did so in their response brief and reply
    brief,     respectively,         and     agreed     that      the        Commonwealth's
    substantive arguments as to the IFRs also apply to the Final Rules
    and so that aspect of the case is not moot and should proceed.
    During the briefing of this case, California and another
    group of states, which did not include the Commonwealth, obtained
    an injunction against the Final Rules for the plaintiff states in
    January 2019, see California v. Health & Human Servs. ("California
    III, 
    351 F. Supp. 3d 1267
    , 1301 (N.D. Cal. 2019); this decision
    has been appealed.           Pennsylvania and New Jersey, together as
    plaintiffs,      obtained    a   nationwide       injunction        in    January   2019
    against the Final Rules, see Pennsylvania v. Trump ("Pennsylvania
    II"), 
    351 F. Supp. 3d 791
    , 835 (E.D. Pa 2019); this decision has
    also been appealed. In both district court cases, the courts found
    Article III standing for the plaintiff states.                  The net effect of
    these    cases   is   that   the       Final    Rules   are   currently       enjoined
    nationwide.
    -21-
    II.
    A.    Mootness
    We first consider whether the Commonwealth's challenges
    to the rules are moot because the Departments have promulgated
    superseding Final Rules.         A case is moot where it is "impossible
    for   a    court   to   grant   any   effectual   relief   whatever   to   the
    prevailing party."        Chafin v. Chafin, 
    568 U.S. 165
    , 172 (2013)
    (quoting Knox v. Serv. Employees Int'l Union, Local 1000, 
    567 U.S. 298
    , 307 (2012)).       The mootness review is grounded in "[t]he case
    or controversy requirement [and] ensures that courts do not render
    advisory opinions."         Overseas Military Sales Corp. v. Giralt-
    Armada, 
    503 F.3d 12
    , 16–17 (1st Cir. 2007).            "But as long as the
    parties have a concrete interest, however small, in the outcome of
    the litigation, the case is not moot."              Ellis v. Bhd. of Ry.,
    Airline & S.S. Clerks, Freight Handlers, Express & Station Emps.,
    
    466 U.S. 435
    , 442 (1984).
    1.     Mootness of the Substantive Challenges
    Both parties agree that the Commonwealth's substantive
    challenges to the rules have not been mooted by the promulgation
    of the Final Rules.       We still must independently review the issue.
    The parties' view accords with our view, based on Supreme Court
    -22-
    and First Circuit caselaw, that this aspect of the case is not
    moot.
    The   challenged   portions   of    the   Final     Rules   are
    sufficiently similar to the IFRs that the case is not moot as to
    the Commonwealth's substantive challenges.          See Ne. Fla. Chapter
    of the Associated Gen. Contractors of Am. v. City of Jacksonville,
    
    508 U.S. 656
    , 662 & n.3 (1993) (holding that the case was not moot
    where the statute challenged had been replaced by a different but
    sufficiently similar statute that "disadvantage[d] [plaintiffs] in
    the same fundamental way"); Conservation Law Found. v. Evans, 
    360 F.3d 21
    , 25-30 (1st Cir. 2004) (holding that the case was not moot
    where the framework then in place was "largely an extension" of
    the originally challenged framework).           The Final Rules have not
    excised the features of the IFRs that Massachusetts challenges;
    instead, if they were to harm Massachusetts, they would do so in
    the "same fundamental way" as the IFRs.         City of Jacksonville, 508
    U.S. at 662.       And the Final Rules are not based on "entirely new
    analysis."    Gulf of Me. Fishermen's All. v. Daley, 
    292 F.3d 84
    , 90
    (1st Cir. 2002).       Here, the "challenged regulation[s]" are "only
    superficially altered by [the] subsequent regulation[s]."            Evans,
    360 F.3d at 26.        The Departments correctly recognize that the
    "changes are immaterial to the scope of the challenge." Therefore,
    the     Commonwealth's    substantive    challenges    to      the   federal
    regulations are not moot.
    -23-
    2.   Mootness of the Procedural Challenge to the IFRs
    Nevertheless,   we   find    that   the   Commonwealth's   APA
    procedural challenge to the IFRs is moot.       Although the IFRs did
    not go through notice and comment rulemaking, the Final Rules
    superseded the IFRs.   83 Fed. Reg. 57592 (Nov. 2018).
    The Final Rules would have become effective as planned
    on January 14, 2019, if not enjoined before that date.       Past that
    date, it would be "impossible for a court to grant any effectual
    relief whatever to the prevailing party" as to the IFRs.       Chafin,
    568 U.S. at 172 (quoting Knox, 567 U.S. at 307).          As the Ninth
    Circuit has stated, there is "no justiciable controversy regarding
    the procedural defects of IFRs that no longer exist."       California
    II, 911 F.3d at 569; see Daley, 292 F.3d at 88 ("[P]romulgation of
    new regulations and amendment of old regulations are among such
    intervening events as can moot a challenge to the regulation in
    its original form."); Nat. Res. Def. Council v. U.S. Nuclear
    Regulatory Comm'n, 
    680 F.2d 810
    , 814-15 (D.C. Cir. 1982) (holding
    that a procedural challenge to a regulation promulgated in alleged
    violation of notice and comment requirements became moot due to
    re-promulgation of the rule with notice and comment).
    Levesque, which the Commonwealth relies upon to argue
    that its procedural challenge to the IFRs has not been mooted, is
    distinguishable.   Levesque v. Block, 
    723 F.2d 175
     (1st Cir. 1983).
    In that case, the district court had found the interim rule to be
    -24-
    void for "procedural omissions" while it was still in effect.                   Id.
    at 177.      Here, any determination by us as to the validity of the
    IFRs would be made for the first time after they have ceased to
    exist.    We see no point in that.          Moreover, in Levesque, the court
    also considered whether the existing final rule was valid, which
    is not the issue here.          Id. at 187.
    B.     Article III Standing for Substantive Challenges
    We turn to whether the Commonwealth has established
    Article III standing for its substantive challenges to the federal
    regulations.       "[N]o        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."          DaimlerChrysler Corp. v. Cuno, 
    547 U.S. 332
    ,   341    (2006).      As    one   aspect     of   the    case-or-controversy
    requirement, plaintiffs must "establish that they have standing to
    sue." Raines v. Byrd, 
    521 U.S. 811
    , 818 (1997); see also Arizonans
    for Official English v. Arizona, 
    520 U.S. 43
    , 64 (1997).                    "[T]he
    standing     inquiry    [is]    focused     on    whether    the   party   invoking
    jurisdiction had the requisite stake in the outcome when the suit
    was filed."      Davis v. Fed. Election Comm'n, 
    554 U.S. 724
    , 734
    (2008).
    "The existence of standing is a legal question, which we
    review de novo."        Kerin v. Titeflex Corp., 
    770 F.3d 978
    , 981 (1st
    Cir. 2014).      "The party invoking federal jurisdiction bears the
    -25-
    burden of establishing" that it has standing.          Lujan v. Defs. of
    Wildlife, 
    504 U.S. 555
    , 560 (1992).        There are three requirements
    for Article III standing.       A plaintiff must demonstrate (1) an
    injury in fact which is "concrete and particularized" and "actual
    or imminent, not conjectural or hypothetical," (2) that the injury
    is "fairly traceable to the challenged action," and (3) that it is
    "likely . . . that the injury will be redressed by a favorable
    decision."    Id. at 560 (internal quotation marks and alterations
    omitted).     "In   response   to   a   summary   judgment   motion,"   the
    "specific facts" set forth by a plaintiff "will be taken as true."
    Id. at 561.
    The Commonwealth's primary argument for standing is
    based on a fiscal injury to itself.        In this circuit, "[i]t is a
    bedrock proposition that 'a relatively small economic loss -- even
    an identifiable trifle -- is enough to confer standing.'"         Katz v.
    Pershing, LLC, 
    672 F.3d 64
    , 76 (1st Cir. 2012) (quoting Adams v.
    Watson, 
    10 F.3d 915
    , 924 (1st Cir. 1993)); see also United States
    v. Students Challenging Regulatory Agency Procedures (SCRAP), 
    412 U.S. 669
    , 690 n.14 (1973) ("We have allowed important interests to
    be vindicated by plaintiffs with no more at stake in the outcome
    of an action than a fraction of a vote[,] a $5 fine and costs[,]
    and a $1.50 poll tax." (internal citations omitted)).
    We hold that the Commonwealth has demonstrated Article
    III standing for its substantive claim based on an imminent fiscal
    -26-
    injury that is fairly traceable to the federal regulations and
    redressable   by    a   favorable   decision.    We    do   not   afford    the
    Commonwealth "special solicitude in [the] standing analysis,"
    Massachusetts v. EPA, 
    549 U.S. 497
    , 520 (2007), in light of its
    demonstration      of   fiscal   injury.    As   the    Commonwealth        has
    established standing under a traditional Article III analysis, we
    need not consider the Commonwealth's self-described "alternative
    basis" of parens patriae standing based on an alleged "injury to
    the Commonwealth's legally protected quasi-sovereign interests."
    See, e.g., Alfred L. Snapp & Son, Inc. v. Puerto Rico, ex rel.,
    Barez, 
    458 U.S. 592
    , 600-02, 607 (1982).
    1.   Imminent Fiscal Injury to the Commonwealth
    The heart of the Departments' standing challenge is that
    the Commonwealth has not demonstrated an imminent injury.                  That
    requires us to decide whether the Commonwealth has adequately
    demonstrated that a fiscal injury is imminent due to the challenged
    federal regulations.       Of course, the Commonwealth need not wait
    for an actual injury to occur before filing suit.             See Adams, 10
    F.3d at 921 ("[I]t could hardly be thought that administrative
    action likely to cause harm cannot be challenged until it is too
    late." (quoting Rental Hous. Ass'n of Greater Lynn v. Hills, 
    548 F.2d 388
    , 389 (1st Cir. 1977))).
    The imminence requirement is met "if the threatened
    injury is 'certainly impending' or there is a 'substantial risk'
    -27-
    that the harm will occur."    Susan B. Anthony List v. Driehaus, 
    573 U.S. 149
    , 158 (2014) (quoting Clapper v. Amnesty Int'l, USA, 
    568 U.S. 398
    , 409, 414 n.5 (2013)).     Either a certainly impending harm
    or substantial risk of harm suffices.         See Reddy v. Foster, 
    845 F.3d 493
    , 500 (1st Cir. 2017).          We have considered risk of harm
    for Article III standing in a range of cases asserting different
    forms of injury, from allegations of future environmental harm,
    see Me. People's Alliance v. Mallinckrodt, Inc., 
    471 F.3d 277
    , 283
    (1st Cir. 2006), to future harm stemming from a store's policy of
    a "refusal to sell alcoholic beverages to a disabled person whose
    symptoms mimic the traits of intoxication," Dudley v. Hannaford
    Bros. Co., 
    333 F.3d 299
    , 301 (1st Cir. 2003).                 The "imminence
    concept, while . . . far reaching, is bounded by its Article III
    purpose:   'to    ensure   that   the    alleged     injury    is    not     too
    speculative.'"     Berner v. Delahanty, 
    129 F.3d 20
    , 24 (1st Cir.
    1997) (quoting Lujan, 504 U.S. at 564 n.2).
    The Commonwealth's argument that it faces an imminent
    fiscal   injury   proceeds   in   steps:    First,   it   argues      that   it
    established a substantial risk that the rules will cause women in
    the Commonwealth to lose their contraceptive coverage.              Second, it
    argues that it established a substantial likelihood that some of
    these women will then obtain state-funded contraceptive services
    or prenatal and postnatal care for unintended pregnancies, and
    thus that the Commonwealth will incur costs as a result.               As for
    -28-
    those women who go forward with pregnancies because of the loss of
    contraceptive      services     or     the     loss   of   the     most   effective
    contraceptive devices, the Commonwealth states it "will incur
    costs providing pre- and post-natal care to some of the women who
    lose    contraceptive       coverage     and     consequently      experience       an
    unintended pregnancy."
    The Departments counter that the Commonwealth (1) has
    failed to show that employers therein "will use the expanded
    exemption under the challenged rules to deprive employees of
    contraceptive      coverage     they     previously        had";    (2)     has    not
    identified any particular women who would be affected by employers'
    use    of   the   exemptions;   and,     (3)     "[e]ven    assuming      that    some
    Massachusetts       women     will     lose     coverage     of     their     chosen
    contraceptive       method,"    the      Commonwealth       has     "fail[ed]       to
    demonstrate economic injury as a result."
    In our view, the Commonwealth has demonstrated that
    there is a substantial risk of fiscal injury to itself.                       It has
    made "rational economic assumptions," Adams, 10 F.3d at 923, and
    presented "concrete evidence." Clapper, 568 U.S. at 420.8                           We
    explain.
    8  Unlike in Clapper, the issue here is not whether a plaintiff
    would ever be subject to the challenged government policy (there,
    surveillance under the Foreign Intelligence Surveillance Act).
    See 568 U.S. at 411-14. No one disputes that, barring injunctions,
    employers in the Commonwealth would have been subject to the IFRs.
    -29-
    a.     The Commonwealth Has Shown There Are Employers
    Likely to Use the Exemptions
    First, the Commonwealth established that there is a
    substantial     risk    that   some   women    in   Massachusetts   will    lose
    coverage due to the regulations.             It pointed to the Departments'
    Regulatory Impact Analysis, which estimated that between 31,715
    and 120,000 women would lose coverage.              From there, Massachusetts
    set forth that based on its 2.1 percent of the national population
    "and [a]djusting these figures to exclude women in fully-insured
    plans   covered    by    Massachusetts'       contraceptive   coverage     laws,
    between 373 and 1,414 Massachusetts women in self-insured plans
    will lose coverage because of the IFRs."                  The district court
    rejected what it deemed Massachusetts' "proportional theory,"
    relying in part on Summers v. Earth Island Inst., 
    555 U.S. 488
    (2009).    Massachusetts, 301 F. Supp. 3d at 259.                   Yet unlike
    Summers, this is not a case resting on unsupported "statistical
    probability" for organizational standing.              See Summers, 555 U.S.
    at 497-98.      Summers rejected as insufficient "self-descriptions"
    the plaintiff organization's assertions, as the Supreme Court
    characterized them, that "some (unidentified) members have planned
    to visit some (unidentified) small parcels affected by the Forest
    Service's procedures and will suffer (unidentified) concrete harm
    as a result."     Id.
    -30-
    Moreover, the Commonwealth has demonstrated that it is
    highly likely that at least three employers in the Commonwealth
    with   self-insured   health    plans       (that    is,    exempt    from   state
    regulation due to ERISA) will use the expanded exemptions, based
    in part on their past litigating positions or their past objections
    to providing contraceptive coverage. The three are Autocam Medical
    Devices,   LLC   ("Autocam"),       Hobby    Lobby       Stores,   Inc.   ("Hobby
    Lobby"), and Cummins-Allison Corporation ("Cummins-Allison"), all
    identified in the Departments' administrative record.9                        In a
    spreadsheet listing litigating entities likely to use the expanded
    exemptions, the Departments included both Autocam and Hobby Lobby,
    both employers in Massachusetts.            Additionally, the Departments
    included   Cummins-Allison     in    a   list       of    employers   using    the
    Accommodation that had notified the Departments of their religious
    9  Before the district court, the Commonwealth also listed Little
    Sisters of the Poor as a litigating entity operating in the
    Commonwealth. Massachusetts, 301 F. Supp. 3d at 261. Though this
    is technically correct, the Little Sisters of the Poor likely
    denied contraceptive coverage even before the IFRs.       As the
    Departments correctly point out, the Little Sisters of the Poor
    provided healthcare coverage through a self-insured church plan,
    which allowed them to effectively avoid the obligation to provide
    contraceptive care prior to the implementation of the IFRs. See
    Little Sisters of the Poor Home for the Aged, 794 F.3d at 1166-
    67.
    -31-
    objections to providing contraceptive coverage.10    See 82 Fed. Reg.
    47,817-18.
    The Commonwealth refers to data, which the Departments
    do not contest, stating that as of September 2018, Autocam employed
    over one hundred people in the Commonwealth, and Hobby Lobby
    operated four stores with employees in the Commonwealth.11       See
    Brief for Nat'l Women's Law Ctr. et al., as Amici Curiae in Support
    of Plaintiff-Appellant and in Favor of Reversal, at 7 nn.14, 15
    (2019).
    The Departments' record further supports standing in two
    respects.    First, the Departments acknowledge that for purposes of
    the Regulatory Impact Analysis, they assumed that the litigating
    entities, excluding previously exempt ones, would use the expanded
    exemption under the interim rules.         82 Fed. Reg. 47,817-18.
    Moreover, the Departments estimated that "just over half of the
    [estimated 209 previously accommodated entities] will use the
    expanded exemption."12      82 Fed. Reg. at 47,818.       Hence, the
    10  Cummins Allison had used the Accommodation process under the
    prior rules, but had not litigated against the Accommodation
    process.
    11 In Column H of the spreadsheets of "litigating entities" used
    for the Departments' Regulatory Impact Analysis, the Departments
    list the "number of [employees] counted towards final total." Both
    Autocam and Hobby Lobby have a positive number listed in Column H
    -- 183 for Autocam, 13,250 for Hobby Lobby -- and both have
    employees in the Commonwealth.
    12 The estimate of 209 employers using the accommodation process
    was made by HHS in 2014.   See 82 Fed. Reg. at 47,817-18.    The
    -32-
    Departments have done much of the legwork in establishing that
    there is a substantial risk (as opposed to a certainty) that at
    least Hobby Lobby, Autocam, and Cummins-Allison would choose to
    use the expanded exemptions.       See Davis, 554 U.S. at 735 (finding
    standing based on third party's likely behavior, and crediting
    evidence    in   the   record   that   "most   candidates   who   had   the
    opportunity to receive expanded contributions had done so").
    We turn to the argument that because the Commonwealth
    "cannot point to a single woman who will lose coverage she would
    otherwise   want,"     the   Commonwealth   lacks   standing.     First,   a
    plaintiff need not "demonstrate that it is literally certain that
    the harms they identify will come about."           Clapper, 568 U.S. at
    414 n.5.    The Departments' brief fails to cite the "substantial
    risk" standard drawn from Clapper and Susan B. Anthony List.            Its
    effort to recast the imminence requirement as one of near certainty
    does not comport with the law. Moreover, plaintiffs need not point
    to a specific person who will be harmed in order to establish
    Departments acknowledge a paucity of data concerning how many
    employers used the accommodation process, since employers were not
    required to inform the Departments that they were using that
    process.   Id. at 47,817.    A reasonable inference would be that
    more employers would have used the Accommodation process over time.
    Even if women employed by organizations who would use the exemption
    are not scattered proportionally by state, it is improbable based
    on the evidence that no women in the Commonwealth would lose
    contraceptive coverage.     See California II, 911 F.3d at 572
    ("Evidence supports that, with reasonable probability, some women
    residing in the plaintiff states will lose coverage due to the
    IFRs." (emphasis added)).
    -33-
    standing in situations like this.13   See Monsanto Co. v. Geertson
    Seed Farms, 
    561 U.S. 139
    , 153-55 (2015) (holding that plaintiffs,
    alfalfa farmers, had standing based on a causal chain, though
    plaintiffs did not identify particular alfalfa plants that had
    been, or would necessarily be, pollinated by bees who carried the
    genetically engineered gene at issue).   Hence, we agree with the
    statement of the Ninth Circuit that, though "[a]ppellants fault
    the [plaintiff] states for failing to identify a specific woman
    likely to lose coverage," "[s]uch identification is not necessary
    to establish standing."   California II, 911 F.3d at 572.14
    13  In Massachusetts v. EPA, the Commonwealth's declarations did
    not identify particular coastal land that had been lost or would
    necessarily be lost based on rising sea levels, but the Supreme
    Court found standing, stating that "the likelihood that
    Massachusetts' coastline will recede has nothing to do with whether
    [Massachusetts] ha[s] determined the precise metes and bounds of
    [its] soon-to-be-flooded land." 549 U.S. at 523 n.21. Similarly,
    the likelihood of a fiscal injury to the Commonwealth does not
    turn on the identification of specific women, and such
    identification is not required for standing here.
    14 Here, as the Commonwealth discusses in its reply brief, it is
    not clear how it could reasonably be expected to point to
    particular women affected by the IFRs, even if the IFRs or Final
    Rules were in effect and employers in the Commonwealth had used
    the exemptions.   Like the IFRs, the Final Rules do not require
    employers to notify the Commonwealth that they are using the
    exemptions, see 83 Fed. Reg. at 57,558; 83 Fed. Reg. at 57,614,
    nor do women have to tell the Commonwealth when they are seeking
    contraceptive care and services from a state-funded program.
    Indeed, medical privacy concerns cut against any such formal
    notification by women to the Commonwealth.
    -34-
    b.    The Commonwealth Has Shown Its Costs Will Most
    Likely Rise with Increased Numbers of Women Using
    State-Funded Contraceptive Care
    The   Commonwealth's   evidence      has    also    established   a
    substantial risk that a portion of the women who would lose
    contraceptive    coverage   would       then         obtain    state-funded
    contraceptive care or state-funded prenatal care for unintended
    pregnancies, and thus cause the Commonwealth to incur costs.            The
    evidence establishes the following: (1) the Commonwealth provides
    at least partially state-funded contraceptive services through
    MassHealth, which has about two million enrolled members, through
    the Massachusetts Department of Public Health, and through the
    University of Massachusetts Boston; (2) women with incomes up to
    300 percent of the federal poverty line usually can receive
    contraceptive care through programs funded by the Commonwealth's
    Department of Public Health; and (3) on average, about twenty-five
    percent of women in the Commonwealth who currently have employer-
    sponsored coverage could qualify for these state-funded programs
    because they (a) have "employer or union provided health insurance
    and . . . [b] have household insurance unit income[s] less than or
    equal to 300% of the [Federal Poverty Level]," adding up to 365,762
    between the ages of 15 and 45 who have employer or union provided
    -35-
    health insurance and are in household insurance units with income
    less than or equal to 300% of the federal poverty level.
    Applying    the    state's        calculation      that     at   least
    twenty-five percent of women who currently have employer-sponsored
    coverage will be eligible for state-funded care, and adjusting the
    upper and lower bound estimates of the Departments' Regulatory
    Impact Analysis to the Commonwealth's percentage of the national
    population, the Commonwealth set forth that 99 to 354 women that
    will likely lose coverage as a result of the regulations will
    qualify for state funded programs.            Considering that, based on the
    Departments'      Regulatory   Impact     Analysis,      the   annual    cost    of
    contraceptive coverage averages around $584 a year per woman, 82
    Fed. Reg. 47,821, the state estimated it will likely be liable for
    about $54,312 to $206,736 a year for contraceptive care.
    None of these statements have been seriously contested
    by the Departments (and besides, at the summary judgment stage,
    the "specific facts" "'set forth' [by a plaintiff] by affidavit or
    other evidence . . . will be taken as true," Lujan, 504 U.S. at
    561).    The   Commonwealth      has     indeed    produced     specific     facts
    regarding   the    imminent    injury,    and     they   go    well   beyond    the
    proportional theory on which the district court focused on.                     The
    Departments' attack on the accuracy of the numbers provided by the
    Commonwealth misses the point: the Commonwealth need not be exactly
    correct in its numerical estimates in order to demonstrate an
    -36-
    imminent fiscal harm.        Indeed, the Departments have assumed in
    their   own    regulatory    impact   analysis    that    "state   and    local
    governments will bear additional economic costs," California II,
    911 F.3d at 572, and the Commonwealth's evidence fleshes this out.
    The Departments' own estimate is based on average costs
    across the nation rather than what might be higher costs in the
    Commonwealth.     Even so, the average cost to the Commonwealth of a
    single woman relying fully on state-funded contraceptive care for
    one year would be $584 (if no portion was covered by other
    sources), based on the national estimate.             82 Fed. Reg. at 47,823.
    Whether costs to the Commonwealth are above or below this average,
    they are not zero.          The declaration submitted by the General
    Counsel of the Massachusetts Department of Public Health states
    that, based on the General Counsel's personal knowledge and review
    of relevant information, "[a]n increase in the prevalence of
    employer-sponsored insurance that does not provide coverage for
    comprehensive family planning services would likely result in an
    increase in the number of Massachusetts residents eligible for and
    receiving services funded" by the Commonwealth.
    And a birth resulting from the denial of contraceptive
    access will likely have significant costs to the Commonwealth as
    well.    A     2010   analysis   found   that   the    average   cost    to   the
    Commonwealth of an unplanned birth was $15,109 in maternity care
    and other healthcare in the first year of the child's life alone.
    -37-
    See Adam Sonfield & Kathryn Kost, Public Costs from Unintended
    Pregnancies and the Role of Public Insurance Programs in Paying
    for Pregnancy-Related Care: National and State Estimates for 2010,
    Guttmacher Inst., p.8 (Feb. 2015), https://www.guttmacher.org/
    sites/default/files/report_pdf/public-costs-of-up-2010.pdf.
    The Departments theorize about a hypothetical woman who
    loses coverage but is "able to pay out of pocket for contraceptive
    services" or "ha[s] access to such coverage through a spouse's (or
    parent's) plan."        Such a hypothetical woman may exist, but 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.     The    argument    is   largely
    irrelevant to the Commonwealth's claims of injury.
    c.     The Commonwealth Has Shown a Likely Chain of Events
    for Standing
    The     Commonwealth's     "cause   and     effect     [chain    is]
    predicated on . . . probable market behavior."           Adams, 10 F.3d at
    923.     That    the   asserted   imminent   fiscal   injury     relies    on   a
    prospective chain of events does not defeat standing.             Indeed, the
    Supreme Court has found standing in cases involving causal chains
    more attenuated than this one.         In Monsanto, standing was found
    where the claim of injury was based on a causal chain of at least
    four steps: (1) "genetically engineered alfalfa seed fields [we]re
    . . . being planted in all the major alfalfa seed production
    -38-
    areas"; (2) "bees that pollinate alfalfa have a range of at least
    two to ten miles"; (3) the alfalfa seed farms at issue were in an
    area within the bees' range, due to the "compact geographic area
    of the prime alfalfa seed producing areas"; all of which, taken
    together, meant that (4) growers would incur injury by taking, for
    example, "certain measures to minimize the likelihood of potential
    contamination and to ensure an adequate supply of non-genetically-
    engineered alfalfa."           561 U.S. at 153 n.4 & 154-55 (internal
    quotation marks omitted); accord Clapper, 568 U.S. at 420.                    The
    Commonwealth has set forth predictions of injury, supported by
    evidence, that are even more likely than those in Monsanto, and
    thus    they       are   not   merely   a   "highly   attenuated      chain   of
    possibilities."          Clapper, 568 U.S. at 410.
    2.   The Alleged Injury is Concrete and Particularized
    The next question is whether the imminent injury alleged
    is concrete and particularized.             See Spokeo, Inc. v. Robins, 
    136 S. Ct. 1540
    , 1548 (2016).          The Departments do not claim that the
    Commonwealth's alleged fiscal injury would not be both concrete
    and particularized.
    Concreteness        requires       something    "real,     and    not
    abstract."         Id. (internal quotation marks omitted).           An imminent
    fiscal injury, supported by evidence, as here, is a concrete
    injury.        A   sufficiently   particularized      injury   "affect[s]     the
    plaintiff in a personal and individual way."               Id. (quoting Lujan,
    -39-
    504 U.S. at 560 n.1).      The imminent financial harm alleged would
    impact     the   Commonwealth   in   an     "individual"   way.     So,     the
    Commonwealth's asserted imminent financial injury is concrete and
    particularized.
    3.     The Commonwealth Has Shown Causation and Redressability
    Causation   and    redressability      are    the    final     two
    requirements for Article III standing.            Lujan, 504 U.S. at 561-
    62.   The Departments do not contest that the alleged injury would
    be caused by the federal regulations and would be redressable by
    an injunction.       As to causation, the asserted imminent fiscal
    injury is clearly "fairly traceable to the challenged action,"
    Monsanto, 561 U.S. at 149, as we have described earlier.                  As to
    redressability, an 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.
    III.
    In sum, the Commonwealth's substantive challenges to the
    Departments' federal regulations are not moot.              Its procedural
    challenge to the IFRs, however, has been mooted by the promulgation
    of the Final Rules, but this does not preclude the Commonwealth
    from asserting any procedural challenges to the Final Rules.
    Finally, the Commonwealth has Article III standing to challenge
    -40-
    the Departments' actions.   We vacate and remand for proceedings
    consistent with this opinion.
    VACATED AND REMANDED.
    -41-