State of California v. Azar et al

Filing 1

COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF; ADMINISTRATIVE PROCEDURE ACT CASE; (NO PROCESS); against All Defendants ( Filing fee $ 400, receipt number 0971-13140312.). Filed by State of California. (Attachments: # 1 Civil Cover Sheet)(Rich, Anna) (Filed on 3/4/2019) Modified on 3/5/2019 (aaaS, COURT STAFF).

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1 2 3 4 5 6 7 8 9 XAVIER BECERRA Attorney General of California MICHAEL L. NEWMAN Senior Assistant Attorney General KATHLEEN BOERGERS Supervising Deputy Attorney General KARLI EISENBERG BRENDA AYON VERDUZCO ANNA RICH, SBN 230195 Deputy Attorneys General 455 Golden Gate Ave., Suite 11000 San Francisco, CA 94102 Telephone: (415) 510-3907 Fax: (415) 703-1699 E-mail: Anna.Rich@doj.ca.gov Attorneys for Plaintiff State of California, by and through Attorney General Xavier Becerra 10 IN THE UNITED STATES DISTRICT COURT 11 FOR THE NORTHERN DISTRICT OF CALIFORNIA 12 13 14 STATE OF CALIFORNIA, by and through ATTORNEY GENERAL XAVIER BECERRA, 15 16 17 18 19 20 21 v. Case No: COMPLAINT FOR Plaintiff, DECLARATORY AND INJUNCTIVE RELIEF ALEX AZAR, in his OFFICIAL CAPACITY as SECRETARY of the U.S. DEPARTMENT of HEALTH & HUMAN SERVICES; U.S. DEPARTMENT of HEALTH & HUMAN SERVICES, Defendants. 22 23 24 25 26 27 28 1 Administrative Procedure Act Case Date: Time: Dept: Judge: Trial Date: Action Filed: 1 2 INTRODUCTION 1. The State of California brings this action to challenge Defendants the U.S. 3 Department of Health and Human Services and its Secretary Alex Azar’s unlawful and unjustified 4 attempt to undermine Title X of the Public Health Service Act, our nation’s sole federally funded 5 program devoted to family planning. For decades, Title X has provided critical, evidence-based 6 healthcare services to women, men, and families in California, contributing to the State’s overall 7 health and well-being and furthering the State’s objectives of promoting public health and broad- 8 based access to contraceptive and other preventive care. Defendants’ new Rule, “Compliance 9 with Statutory Program Integrity Requirements” (hereinafter “the Rule”), imposes new, onerous 10 and unnecessary requirements for healthcare providers, including “gag” rules that prevent Title X 11 healthcare providers from giving comprehensive, accurate and nondirective healthcare 12 information to their female patients and mandating physical and financial separation between 13 family planning programs and facilities that provide either abortion services or referrals to such 14 services. The Rule undermines clinically established standards of care, interferes with the 15 patient-provider relationship, and contradicts a core purpose of the Title X program. This Rule 16 will deprive Californians of access to needed reproductive care and cause harm to public health in 17 California and the public fisc. 18 2. The U.S. Department of Health and Human Services (HHS) published its final 19 rule, HHS-OS-2018-0008, on March 4, 2019. See 84 Fed. Reg. 7714 (Mar. 4, 2019) (amending 20 42 C.F.R. Chapter I, Subchapter D, Part 59). The Rule purports to “ensure compliance with, and 21 enhance implementation of, the statutory requirement that none of the funds appropriated for Title 22 X may be used in programs where abortion is a method of family planning.” 84 Fed. Reg. at 23 7714. Yet nowhere in Defendants explanation of the Rule is there any evidence that current Title 24 X programs are, in fact, failing to implement federal law. Instead, the Rule itself deviates from 25 the Title X statute in ways that threaten to disrupt the financial and physical integrity of Title X 26 providers (including doctors, nurses, and clinics), disregarding well-established clinical 27 guidelines, and upending well-founded prior agency decisions. 28 2 1 3. California’s Title X provider network is the largest in the nation and plays a 2 central role in ensuring access to comprehensive family planning, education, and related 3 preventive health services to one million patients annually. The benefits of the existing Title X 4 program are many: helping women avoid an estimated 822,000 unplanned pregnancies in 2015 5 alone, which would have resulted in 387,000 unplanned births and 278,000 abortions; 6 substantially reducing teen unintended pregnancy rates; and reducing the transmission of sexually 7 transmitted diseases like gonorrhea and chlamydia. Only a determined intent to interfere with 8 women’s constitutionally protected rights to make their own choices about their reproductive 9 healthcare and futures can explain HHS’s decision to issue a Rule that will have such a 10 11 devastating effect on public health and the Title X network. 4. In a comment letter filed with HHS in opposition to the Rule on July 30, 2018, the 12 Attorneys General of California and thirteen other states urged HHS to withdraw the Rule on the 13 grounds that it harms state residents by interfering with the provider-patient relationship, 14 presenting women seeking or considering an abortion with illusory healthcare options, and 15 creating barriers for people seeking care, among many other negative impacts. The letter also 16 explained that the Rule, if finalized, would decrease access to care, with an especially negative 17 impact on low-income families, women (particularly women of color), and rural communities, as 18 well as harm public health and the public fisc. 19 5. Notwithstanding these and other comments from a host of affected state and local 20 governments, medical providers, public health officials, and patients, HHS failed to adequately 21 address these important concerns in the Rule. While paying lip-service to public comment, HHS 22 did not acknowledge or address the weight of mainstream medical providers’ views, such as the 23 American College of Obstetricians and Gynecologists’ comment opposing the Rule (which it 24 described as “prioritizing ideology over scientific evidence”), or public health experts’ evidence 25 showing that the Rule would have perverse consequences, including likely reducing access to 26 contraceptive care and increasing unintended pregnancies and abortions. 27 28 6. The Rule now places California and its Title X providers in an untenable situation. If existing healthcare providers are forced to decide whether to provide full and accurate 3 1 information to patients or forgo federal Title X funding, numerous providers will have no choice 2 but to sacrifice needed funds, to the detriment of the patients they serve. Many providers will be 3 forced to leave the program because its new strictures conflict with applicable California state 4 law. California stands to lose more than twenty million dollars annually. The funds of providers 5 that do remain in the program will be held hostage to requirements that are contrary to medically 6 approved, clinical standards of care. Moreover, the Rule establishes new eligibility requirements 7 for Title X providers that will lower overall standards for quality of care, allowing new, less 8 qualified providers to offer Title X services despite their failure to meet well-established clinical 9 standards, such as offering nondirective, nonjudgmental counseling for pregnant women about 10 their options, including complete and accurate referrals for patients who become pregnant and 11 wish to seek an abortion. 12 7. As a result, the availability and quality of family planning services in California 13 will be harmed. The low-income women, men, and teenagers who are the primary intended 14 beneficiaries of Title X will suffer. Reduced access to diagnostic and preventive healthcare 15 provided by the existing Title X network will ultimately weaken the public health of communities 16 in California and nationwide. 17 8. The Rule fits within the broader context of Defendants’ deliberate effort to limit 18 women’s access to the full range of reproductive healthcare, including abortion care, and interfere 19 with a woman’s constitutionally protected right to make her own reproductive choices. For 20 example, one of the current federal government’s first acts was to undo federal regulations 21 protecting Title X providers from state efforts to exclude them for reasons unrelated to their 22 ability to provide Title X services, efforts that HHS had previously found interfered with the 23 purpose of Title X. See Joint Res., Pub. L. No. 115-23, 131 Stat. 89 (2017) (providing for 24 congressional disapproval of HHS’s Title X requirements set forth in 81 Fed. Reg. 91852 (Dec. 25 19, 2016)). Defendants then unlawfully issued two interim final rules effective immediately, and 26 then issued final regulations, in an attempt to weaken the Affordable Care Act’s requirement of 27 28 4 1 cost-free contraceptive coverage.1 And the federal administration’s proposed fiscal year 2018 2 budget sought specifically to exclude Title X provider Planned Parenthood Federation of America 3 and its affiliates from Title X, Medicaid, and other federal programs. 4 9. In this latest extraordinary overreach, HHS has exceeded the scope of its statutory 5 authority and acted in a manner that is arbitrary, capricious, and not in accordance with law, in 6 violation of the Administrative Procedure Act (APA) and the U.S. Constitution. The Rule will 7 harm the State of California and its residents who depend upon Title X services. The Secretary 8 therefore should be preliminarily and permanently enjoined from enforcing the Rule. 9 10 JURISDICTION AND VENUE 10. The Court has jurisdiction pursuant to 28 U.S.C. § 1331 (action arising under the 11 laws of the United States), 28 U.S.C. § 1346 (United States as a defendant), and 5 U.S.C. §§ 701- 12 706 (Administrative Procedure Act). An actual controversy exists between the parties within the 13 meaning of 28 U.S.C. § 2201(a), and this Court may grant declaratory relief, injunctive relief, and 14 other relief pursuant to 28 U.S.C. §§ 2201-2202 and 5 U.S.C. §§ 705-706. 15 11. Defendants’ issuance of the Rule on March 4, 2019, constitutes a final agency 16 action and is therefore judicially reviewable within the meaning of the Administrative Procedure 17 Act. 5 U.S.C. §§ 704, 706. 18 12. Venue is proper in this Court pursuant to 28 U.S.C. § 1391(e) because this is a 19 judicial district in which the State of California resides and this action seeks relief against federal 20 agencies and officials acting in their official capacities. California, 911 F.3d at 568-69. 21 22 23 24 25 26 27 28 1 These interim final rules were the subject of preliminary injunctions entered by federal courts in California and Pennsylvania, and the final rules have been similarly enjoined. See State of California v. Health and Human Servs., 281 F. Supp.3d 806 (N.D. Cal. 2017), aff’d in part, vacated in part and remanded by California v. Azar, 911 F.3d 558 (9th Cir. 2018) (upholding preliminary injunction against interim final rules), State of California v. Health and Human Servs., 351 F. Supp.3d 1267 (N.D. Cal. 2019) (granting motion for preliminary injunction against final rules); Pennsylvania v. Trump, 281 F. Supp.3d 553 (E.D. Pa. 2017), appeal filed, 3rd Cir. Nos. 17-3752 (Dec. 21, 2017) and 18-1253 (Feb. 15, 2018) (interim final rules), 2019 WL 190324 (E.D. Pa. Jan. 14, 2019) (issuing nationwide injunction against final rules). 5 1 2 3 INTRADISTRICT ASSIGNMENT 13. Pursuant to Civil Local Rules 3-5(b) and 3-2(c), there is no basis for assignment of this action to any particular location or division of this Court. 4 5 PARTIES 14. Plaintiff the State of California, by and through Attorney General Xavier Becerra, 6 brings this action. The Attorney General is the chief law officer of the State and has the authority 7 to file civil actions in order to protect the health and welfare of Californians and advance the 8 State’s interest in protecting women’s access to critical healthcare services. Cal. Const., art. V, § 9 13; Cal. Bus. & Prof. Code § 321. This challenge is brought pursuant to the Attorney General’s 10 independent constitutional, statutory, and common law authority to represent the public interest. 11 15. Governor Gavin Newsom is the chief executive officer of the State. The Governor 12 is responsible for overseeing the operations of the State and ensuring that its laws are faithfully 13 executed. As the leader of the executive branch, the Governor is the chief of California’s 14 executive branch agencies, including those whose injuries are discussed in this Complaint. Cal. 15 Const., art. V, § 1. 16 16. The State of California has an interest in ensuring that healthcare is both available 17 and accessible, including women’s reproductive care. Healthcare is an important function within 18 the police powers of the States. California relies on Defendants’ compliance with the 19 requirements of the APA in order to meaningfully participate in an impartial and public decision- 20 making process and to implement federal programs, including Title X, according to reasonable 21 rules that are consistent with federal law. 22 17. Implementation of Defendants’ illegal Rule will cause immediate and irreparable 23 injuries to California’s sovereign, quasi-sovereign, and proprietary interests. The Rule will have 24 an adverse impact on public health in California by curtailing residents’ access to quality 25 reproductive healthcare, interfering with doctor-patient relationships, and destabilizing existing 26 Title X provider networks. The Rule will increase unwanted pregnancies, resulting in new 27 burdens and costs for California women, the state’s Medicaid program, and public health 28 6 1 generally. California’s state agencies will be impacted by this rule as they seek to implement 2 California laws relating to nondiscrimination and access to state family planning programs. 3 18. Defendant Alex Azar is Secretary of HHS and is sued in his official capacity. 4 Secretary Azar is responsible for implementing and fulfilling HHS’s duties under the Constitution 5 and the APA. 6 19. Defendant HHS is an agency of the United States government and bears 7 responsibility, in whole or in part, for the acts complained of in this Complaint. The Office of the 8 Assistant Secretary for Health is an entity within the HHS. BACKGROUND 9 10 11 I. TITLE X AND RELATED FEDERAL REGULATIONS AND LAWS 20. In July 1969, President Richard Nixon wrote in a message to Congress that “no 12 American woman should be denied access to family planning assistance because of her economic 13 condition. I believe, therefore, that we should establish as a national goal the provision of 14 adequate family planning services within the next five years to all those who want them but 15 cannot afford them.” 16 21. Congress responded in 1970 by enacting Title X of the Public Health Services Act 17 (PHSA), 42 U.S.C. §§ 300-300a-6 (the Act), a bipartisan effort to provide federal funding for 18 family planning services. The Act authorizes the Secretary to “make grants to and enter into 19 contracts with public or nonprofit private entities to assist in the establishment and operation of 20 volunteer family planning projects which shall offer a broad range of acceptable and effective 21 family planning methods and services (including natural family planning methods, infertility 22 services, and services for adolescents).” 42 U.S.C. § 300(a). In addition to establishing the 23 federal Office of Population Affairs (OPA), the division of HHS that administers Title X, 24 Congress’ stated intentions included: 25 26 27 28 (l) to assist in making comprehensive voluntary family planning services readily available to all persons desiring services; (2) to coordinate domestic population and family planning research with the present and future needs of family planning programs; (3) to improve administrative and operational supervision of domestic family planning services and of population research programs related to such services; 7 1 2 3 4 5 6 7 (4) to enable public and nonprofit private entities to plan and develop comprehensive programs of family planning services; (5) to develop and make readily available information (including educational materials) on family planning and population growth to all persons desiring such information; (6) to evaluate and improve the effectiveness of family planning service programs and of population research; [and] (7) to assist in providing trained manpower needed to effectively carry out programs of population research and family planning services[.] Pub. L. No. 91-572 § 2, 84 Stat. 1504 (1970). 22. Almost fifty years after its original passage, Title X is a public health triumph, 8 having helped create a strong network of providers committed to supporting the delivery of 9 quality preventive health services, including reproductive care. Nationally, more than four 10 million Americans rely on affordable family planning services that are funded by Title X; 11 including more than one million patients in California alone. 12 23. According to OPA, Title X is the only federal program dedicated solely to 13 supporting the delivery of family planning and related preventive health care. It is designed to 14 provide contraceptive supplies and information to all who want and need them, with priority 15 given to persons from low-income families. In addition to offering a broad range of effective and 16 acceptable contraceptive methods on a voluntary and confidential basis, Title X-funded service 17 sites provide contraceptive education and counseling; breast and cervical cancer screening; 18 sexually transmitted disease (STD) and human immunodeficiency virus (HIV) testing, referral, 19 and prevention education; and pregnancy diagnosis and counseling. 20 24. Title X gives the Secretary authority to promulgate grant making regulations, 42 21 U.S.C. § 300a-4(a), and the Secretary first issued detailed regulations governing grant-making 22 when the Title X program began in 1971. See 36 Fed. Reg. 18467 (Sept. 15, 1971) (setting forth 23 initial evaluation criteria). 24 25. The Title X statute lists four factors that the Secretary “shall take into account” in 25 making grant awards: “the number of patients to be served, the extent to which family planning 26 services are needed locally, the relative need of the applicant, and its capacity to make rapid and 27 effective use of such assistance.” 42 U.S.C. § 300(b). 28 8 1 26. Eligible projects must be “voluntary family planning projects consisting of the 2 educational, comprehensive medical, and social services necessary to aid individuals to determine 3 freely the number and spacing of their children.” 36 Fed. Reg. at 18,466; 42 C.F.R. § 59.1. Prior 4 to the Rule, each project had to “provide a broad range of acceptable and effective medically 5 approved family planning methods (including natural family planning methods) and services 6 (including infertility services and services for adolescents).” 42 C.F.R. § 59.5 (Mar. 1, 2019). 7 27. Former federal regulations required that Title X family planning grantees must 8 “[o]ffer pregnant women the opportunity to be provided with information and counseling 9 regarding . . . [p]regnancy termination.” Id. at § 59.5(a)(5)(i) (Mar. 1, 2019). If a pregnant 10 woman requests such information, the Title X grantee was required to “provide neutral, factual 11 information and nondirective counseling.” Id. at § 59.5(a)(5)(ii). 12 28. Section 1008 of the PHSA prohibits Title X funds from being “used in programs 13 where abortion is a method of family planning.” 42 U.S.C. § 300a-6. As the Supreme Court has 14 recognized, however, Title X “expressly distinguishes between a Title X grantee and a Title X 15 project.” Rust v. Sullivan, 500 U.S. 173, 196 (1991) (emphasis in the original). While upholding 16 a prior attempt at a Title X gag rule, the Court explained that the “Title X grantee can continue to 17 perform abortions, provide abortion-related services […] it simply is required to conduct those 18 activities through programs that are separate and independent from the project that receives Title 19 X funds.” Id. (citing 42 C.F.R. § 59.9 (1989)). 20 29. Despite the Supreme Court’s decision in Rust, the 1988 gag rule was short-lived. 21 The 1988 regulations were never fully implemented, and in 1993 HHS completely rescinded 22 them, concluding that they “inappropriately restrict[ed] grantees.” 58 Fed. Reg. 7462, 7462 (Feb. 23 5, 1993). 24 30. The Court in Rust had found itself “unable to say that the Secretary’s construction 25 [in the 1988 regulations] of the prohibition in § 1008 to require a ban on counseling, referral, and 26 advocacy within the Title X project is impermissible.” 500 U.S. at 184. Starting in 1996, 27 however, Congress clarified the law by routinely requiring as part of Title X appropriations that 28 “all pregnancy counseling shall be nondirective.” See, e.g., Continuing Appropriations Act, 2019, 9 1 P.L. 115-245, Div. B, Title II, §§ 207 and 208 (2018); Consolidated Appropriations Act, 2018, 2 P.L. 115-141, Div. H, Title II, 132 Stat. 348, 716-17 (2018); Consolidated Appropriations Act, 3 2017, P.L. 115-31, Div. H, Title II, 131 Stat. 521 (2017). 4 31. According to HHS regulations issued in 2000, Title X grantees’ abortion activities 5 must be “separate and distinct” from their Title X project activities. HHS, OPA, “Provision of 6 Abortion-Related Services in Family Planning Services Projects,” 65 Fed. Reg. 41282 (July 3, 7 2000). These well-established rules permit shared facilities that host Title X programs and 8 provide for abortion care “so long as it is possible to distinguish between the Title X supported 9 activities and non-Title X abortion-related activities.” Id. Common waiting rooms, common 10 staff, and maintenance of a single filing system are all permissible as long as costs are properly 11 pro-rated or allocated between Title X projects and other programs. 12 32. OPA provides strict oversight of projects that receive Title X grants to ensure that 13 federal funds are used appropriately and that funds are not used for any ineligible activities, such 14 as abortion services. Existing safeguards to maintain this separation include: (1) careful review of 15 grant applications to ensure that the applicant understands and has the capacity to comply with all 16 requirements; (2) independent financial audits to examine whether there is a system to account for 17 program-funded activities and non-allowable program activities; (3) yearly comprehensive 18 reviews of the grantees’ financial status and budget report; and (4) periodic and comprehensive 19 program reviews and site visits by OPA regional offices. 20 33. The basic primary and preventive health care services funded by Title X programs 21 include well-woman exams, lifesaving cervical and breast cancer screenings, birth control, 22 contraception education, and testing and treatment for sexually transmitted infections (STIs), 23 including HIV. 24 34. Title X-funded programs are specifically focused on pre-pregnancy care. Patients 25 receive preventive healthcare such as preventive screenings, tests, and counseling related to 26 family planning. When a woman becomes pregnant, under the previous program rules, all Title X 27 providers referred all pregnant patients to high-quality, non-Title X programs to handle their 28 pregnancy-related needs, including both prenatal care and abortion-related services. 10 1 35. Prior to the issuance of the new Rule, OPA had routinely set forth specific clinical 2 standards for Title X programs, requiring grantees to adhere to the federal Quality Family 3 Planning Guidelines issued by the Centers for Disease Control and Prevention (CDC) which set 4 forth broadly accepted, evidence-based standards for high-quality clinical practice regarding the 5 provision of family planning services.2 See “Providing Quality Family Planning Services” 6 (hereinafter Quality Family Planning Guidelines), 63:4 Morbidity and Mortality Weekly Report 7 (Apr. 25, 2014). These guidelines are nationally recognized protocols developed in collaboration 8 with professional medical associations like the American College of Obstetricians and 9 Gynecologists (ACOG). The federal OPA required these standards for Title X care by 10 incorporating the Quality Family Planning Guidelines into its program guidance for Title X 11 services projects, “Program Requirements for Title X Funded Family Planning Projects” 12 (“Program Requirements”), also published in April 2014. 13 36. According to these guidelines, quality family planning services take a “client- 14 centered approach” in which “the client’s primary purpose for visiting the service site must be 15 respected.” 16 37. The Quality Family Planning Guidelines explain that pregnancy testing and 17 counseling services are a “core” part of “family planning services, in accordance with 18 recommendations of major professional medical organizations.” To that end, after administration 19 of a pregnancy test, providers are instructed that the “test results should be presented to the client, 20 followed by a discussion of options and appropriate referrals.” (Emphasis added.) The Quality 21 Family Planning Guidelines further recommend that “[r]eferral to appropriate providers of 22 follow-up care should be made at the request of the client, as needed,” and “[e]very effort should 23 be made to expedite and follow through on all referrals.” 24 25 38. According to the Quality Family Planning Guidelines, when giving referrals, family planning providers should “provide a resource listing or directory of providers to help the 26 27 28 2 HHS continues to refer Title X providers to the Quality Family Planning Guidelines. See HHS Office of Population Affairs, https://www.hhs.gov/opa/guidelines/clinical-guidelines/qualityfamily-planning/index.html (last visited March 3, 2019). 11 1 client identify options for [pregnancy] care.” This instruction is not limited to only those women 2 who choose to continue with their pregnancy. Rather, the CDC instruction broadly instructs that 3 providers give referrals, “at the request of the client,” including for termination of pregnancy. 4 39. When referring pregnant clients, Title X-funded programs act in accordance with 5 evidence-based clinical standards for nondirective counseling. These standards have been 6 developed in order to provide quality family planning services in a safe, effective, and client- 7 centered manner. The American College of Obstetricians and Gynecologists, the American 8 College of Physicians, and the American Academy of Family Physicians all endorse nondirective 9 options counseling, including referral to appropriate providers, as the most clinically appropriate 10 role for providers caring for a patient who is facing an unexpected pregnancy. 11 40. These standards allow patients to trust their Title X providers and ensure the 12 delivery of unbiased information regarding their reproductive and sexual health. This high 13 standard of care helps patients make the best decisions for themselves and their loved ones when 14 facing an unintended pregnancy, or needing to make other time-sensitive decisions about their 15 reproductive health. 16 II. 17 CALIFORNIA LAWS, REGULATIONS, AND PROGRAMS 41. California state laws and policies recognize the importance of protecting a 18 woman’s right to reproductive healthcare, and specifically a women’s right to abortion. In 1972, 19 California voters amended the state Constitution to include a right of privacy among the 20 inalienable rights protected by article I, section 1. Chico Feminist Women’s Health Cent. v. Butte 21 Glen Med. Soc’y, 557 F. Supp. 1190, 1201-1202 (E.D. Cal. 1983) (citing White v. Davis, 13 Cal. 22 3d 757, 774 (1975)). Under article I, section 1, “all women in this state - rich and poor - alike 23 possess a fundamental constitutional right to choose whether or not to bear a child.” Comm. to 24 Defend Reprod. Rights v. Myers, 29 Cal. 3d 252, 262 (1981). Private parties cannot interfere with 25 the Constitutional right to procreative choice. Chico, 557 F. Supp. at 1202-03; Hill v. Nat’l 26 Collegiate Athletic Ass’n, 7 Cal. 4th 1, 20 (1994). In addition, the Constitutional right of a 27 woman to decide whether to bear a child or terminate a pregnancy is protected from State 28 interference. Chico, 557 F. Supp. at 1202; Myers, 29 Cal. 3d at 284. 12 1 42. Echoing these constitutional protections, the state Reproductive Privacy Act of 2 2002 (RPA) declared as state law that “[e]very woman has the fundamental right to choose to 3 bear a child or to choose and to obtain an abortion[.]” Cal. Health & Saf. Code § 123462(b). The 4 RPA expressly provides that: “The state may not deny or interfere with a woman’s right to choose 5 or obtain an abortion [. . .] .” Id. § 123466. This requirement applies to all Medi-Cal managed 6 care health plans, as state contractors. Cal. Dept. of Health Care Servs., All Plan Letter 15-020 7 (Sept. 30, 2015). 8 43. 9 California law also requires that a female survivor of sexual assault shall be provided with “the option of postcoital contraception by a physician or other health care 10 provider” and that “[p]ostcoital contraception . . . be dispensed by a physician or other health care 11 provider upon the request of the victim at no cost to the victim.” Cal. Penal Code § 12 13823.11(e)(1), (e)(2), (g)(4)(A), (g)(4)(B). 13 44. California’s recent Contraceptive Coverage Equity Act further protects women’s 14 access to contraceptive care by requiring certain private health plans and policies as well as Medi- 15 Cal managed care health plans to provide coverage for all prescribed, FDA-approved 16 contraceptives with no cost-sharing. Cal. Health & Saf. Code § 1367.25; Cal. Ins. Code § 17 10123.196; Cal. Welf. & Inst. Code § 14132. 18 45. California’s longstanding Unruh Civil Rights Act since 1959 provides that all 19 persons “are entitled to the full and equal accommodations, advantages, facilities, privileges, or 20 services in all business establishments of every kind whatsoever.” Cal. Civ. Code § 51(b). 21 Characteristics protected under the Unruh Civil Rights Act are sex, race, color, religion, ancestry, 22 national origin, disability, medical condition, genetic information, marital status, sexual 23 orientation, citizenship, primary language, and immigration status. Id. “Sex” is defined to 24 include, but not be limited to, gender, gender identity, gender expression, pregnancy, childbirth, 25 and medical conditions related to pregnancy or childbirth. Cal. Civ. Code § 51(e)(5). 26 46. California regulates its registered physicians, licensed midwives, registered nurses, 27 nurse-midwives, and licensed vocational nurses. Cal. Bus. & Prof. Code §§ 101, 125.6; Cal. 28 Penal Code § 13823.11(e) and (g)(4); Cal. Health & Saf. Code §§ 10123.196, 1367.25, 13 1 123420(d). State boards establish minimum qualifications and levels of competency in order to 2 “protect the people of California” and in order “to provide safe and effective services to the 3 public.” Cal. Bus. & Prof. Code § 101.6. Failure to meet these minimum qualifications exposes a 4 regulated professional to disciplinary action for unprofessional conduct, including incompetence 5 or gross negligence. See, e.g., id. § 2761; see also Cal. Bus. & Prof. Code § 733 (a California 6 licensee “shall not obstruct a patient in obtaining a prescription drug or device that has been 7 legally prescribed or ordered for that patient”). 8 9 47. California has sovereign authority and quasi-sovereign interests in regulating healthcare, criminal acts, and California-licensed entities and professionals. See New York v. 10 United States, 505 U.S. 144, 155-56 (1992); Cal. Bus. & Prof. Code §§ 101, 101.6, 125.6; 733 (a 11 California licensee “shall not obstruct a patient in obtaining a prescription drug or device that has 12 been legally prescribed or ordered for that patient”); 2761; Cal. Penal Code § 13823.11(e) and 13 (g)(4); Cal. Health & Saf. Code §§ 10123.196, 1367.25, 123420(d); Cal. Civ. Code § 51; N. 14 Coast Women’s Care Med. Group, Inc. v. San Diego County Superior Court, 44 Cal.4th 1145, 15 1158 (2008). “[T]he structure and limitations of federalism . . . allow the States great latitude 16 under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and 17 quiet of all persons.” Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (internal quotation marks 18 and citation omitted). 19 48. States have a sovereign interest in the creation and enforcement of a legal code. 20 Pursuant to that interest, California has an interest in challenging HHS’s acts that undermine 21 California’s authority to regulate matters that California controls and frustrate enforcement of 22 state law where California statutes provide for the administration and regulation of state-licensed 23 healthcare professionals and businesses. 24 III. SCOPE AND IMPACT OF CURRENT TITLE X PROGRAM 25 26 A. 49. Scope of California’s Title X Program and Related State Programs California is home to the nation’s largest Title X program, which collectively 27 serves more than one million patients annually—over 25% of all Title X patients nationwide. 28 Essential Access Health is California’s sole Title X grantee. This non-profit organization 14 1 administers sub-grants to a diverse array of qualified family planning and related preventive 2 health service providers through 70 different healthcare organizations, operating 356 clinic sites 3 in 38 of California’s 58 counties. In 2017, OPA awarded Essential Access Health $20.5 million 4 dollars to support access to high-quality family planning and sexual healthcare across the state. 5 50. Essential Access Health’s sub-grantees include: federally qualified health centers 6 (FQHCs), community-based health care providers that provide primary care to underserved and 7 uninsured individuals regardless of their ability to pay (59% of all California Title X providers); 8 family planning and women’s health centers, such as Planned Parenthood affiliates (11%); faith 9 and community-based education and outreach organizations (13%); city and county health 10 departments (10%); community action partnerships and economic opportunity commissions (3%); 11 Native American health centers and outreach organizations (3%) and hospitals (1%). 12 51. In addition to California’s extensive federally funded Title X program, state 13 residents have access to family planning services through California’s state-funded Family 14 Planning, Access, Care, and Treatment (Family PACT) program. Family PACT is administered 15 by the state Office of Family Planning (OFP), an entity within the California Department of 16 Health Care Services (DHCS). 17 52. Family PACT is California’s innovative approach to provide comprehensive 18 family planning services. The goal of Family PACT is to promote optimal reproductive health 19 and to reduce unintended pregnancies by lowering the barriers that many women with unmet 20 needs face in obtaining family planning services. All current Title X-funded providers screen 21 clients for eligibility for Family PACT. 22 53. Family PACT is available to eligible low-income (under 200% of federal poverty 23 level) men and women who are residents of California, who do not have access to family 24 planning coverage (or they meet the criteria specified for eligibility) and have a medical necessity 25 for family planning services. As of Fiscal Year 2015-2016, the program serves 1.15 million 26 eligible men and women of childbearing age through a network of 2,500 public and private 27 clinicians. Services include comprehensive education, assistance, and services related to family 28 planning. 15 1 54. Essential Access Health requires that all of its Title X subgrantees also be Family 2 PACT providers. This requirement ensures that California’s Title X providers adhere to the same 3 minimum clinical standards as other California Medicaid providers. The Family PACT provider 4 agreement incorporates all applicable federal and state laws, such as the Reproductive Privacy 5 Act. 6 55. California state standards require that providers electing to participate in Family 7 PACT must provide the full scope of family planning, education, counseling, and medical 8 services specified by Family PACT, either directly or by referral, consistent with standards of 9 care issued by DHCS. Cal. Welf. & Inst. Code § 24005(c). These standards include that Long 10 Acting Reversible Contraception (LARC), e.g., intrauterine devices (IUDs) and contraceptive 11 implants, must be offered onsite or by prescription. Only licensed personnel with family planning 12 skills, knowledge and competency may provide the family planning medical services covered by 13 Family PACT. Cal. Welf. & Inst. Code § 24005(b). 14 56. Title X is available to pay for services for women who are ineligible for Family 15 PACT. Individuals with incomes between 200 and 250% of the federal poverty level (between 16 $24,280 and $30,350 for individuals in 2018) who need reproductive healthcare services are 17 eligible for services through Title X, but not Family PACT. 18 57. Family PACT and Title X patients who become pregnant are generally eligible for 19 services under California’s Medicaid program, known as Medi-Cal. Most pregnancy-related 20 services are paid for with a combination of state and federal funds. California pays for abortion 21 services for all Medi-Cal enrollees, using state funds only. Medi-Cal enrollees are not charged 22 co-insurance or co-payments, nor do they need to pay out-of-pocket costs for abortion services. 23 58. Despite these safety net healthcare programs, there is still unmet need in California 24 for family planning services. In 2014, 2.6 million California women were still in need of publicly 25 funded family planning based on income, age and health status, and the State’s family planning 26 network was only able to meet 50% of this need. 27 28 16 1 2 B. 59. Benefits of California’s Existing Title X Network The services provided by California’s existing network of qualified Title X 3 providers have a significant, positive impact on family health and well-being, and by extension 4 the state’s overall public health generally. In recent decades, a substantial body of scientific 5 evidence has developed to show that Title X programs operating according to long-standing rules 6 currently in effect are clinically effective and succeed in helping individuals and families achieve 7 their desired number and spacing of children. 8 9 60. California’s current network of Title X-funded clinics provides a broad range of family planning services, and serves as an access point for more than one million Californians 10 annually to receive quality sexual and reproductive healthcare. These patients were 88% female 11 and 12% male; 66% were under the age of thirty; and 73% had family incomes below the federal 12 poverty line ($12,140 for an individual in 2018). 13 61. California’s current network of Title X-funded clinics also provides preventive 14 care services, such as screening for breast and cervical cancer, as well as education regarding 15 prevention of sexually transmitted diseases and HIV. In 2017, California recipients of Title X 16 funds provided more than 1.6 million family planning visits, including more than 148,000 pap 17 tests, more than 118,000 clinical breast exams, more than 642,000 chlamydia screenings, more 18 than 700,000 gonorrhea screenings, and more than 341,000 HIV tests. 19 62. Title X-funded family planning providers have been shown to improve access to 20 high quality family planning services, including contraceptives, and related preventive health 21 services. 22 23 24 63. Title X clinics tend to be strategically located in areas where the number of women in need of publicly funded family planning services is high. 64. California’s Title X providers deliver a higher quality of services compared to 25 other publicly funded family planning providers. The current network of Title X clinics is more 26 likely than other publicly funded family planning providers to provide patients with on-site, 27 specialized services that have a higher up-front cost, but are more effective and cost-efficient in 28 the long run, such as vasectomies or LARCs. And Title X providers have greater adherence than 17 1 other publicly funded family planning providers to chlamydia screening guidelines that require 2 different levels of screening for different age groups. 3 65. California’s Title X providers are more likely than other publicly funded family 4 planning providers to participate in clinical training opportunities. These training opportunities 5 help Title X clinicians offer higher quality, evidence-based services. Title X-funded web-based 6 training opportunities play a particularly valuable role in rural and/or small clinics. 7 8 9 66. California’s Title X providers are more likely than other publicly funded family planning providers to use advanced technologies in their clinics. 67. California’s Title X providers are more likely than other publicly funded family 10 planning providers to provide outreach services. In fiscal year 2017, Title X funding in California 11 supported outreach that connected more than 500,000 individuals with information about family 12 planning services, including where and how to access these services in their communities. 13 68. California’s Title X providers are more likely than other publicly funded family 14 planning providers to provide outreach services to patients who may otherwise have difficulty 15 connecting with healthcare services. These Title X-funded clinics have greater proportions of 16 bilingual staff, and are more likely to provide outreach to vulnerable or hard-to-reach populations, 17 such as adolescents; males; lesbian, gay and transgender individuals; persons experiencing 18 homelessness, those with limited English proficiency; migrant workers; individuals coping with 19 alcohol and substance abuse; refugees and immigrants; and persons with disabilities. 20 69. California’s Title X funds help providers offer extended clinic hours, compared to 21 other providers that receive public funds. California’s Title X providers are also more likely than 22 other publicly funded family planning providers to provide sexual and reproductive health 23 education to their communities. Health education helps connect individuals to needed healthcare 24 and information needed to support their reproductive health goals. 25 70. Use of contraceptive services has resulted in lower unintended pregnancy and 26 abortion rates in the United States, including California. By allowing women to avoid unintended 27 pregnancies and to time and space wanted pregnancies, contraception helps avoid pregnancies 28 18 1 that occur too early in a woman’s life or that are spaced too closely. In doing so, contraception 2 improves health outcomes. 3 71. In 2010, an estimated 45% of unintended pregnancies in California ended in 4 abortion. The risk of unintended pregnancy is greatest for women who are young, women of 5 color, those who have low incomes, live in rural communities, or those who have limited 6 education. 7 72. Unintended pregnancies are associated with risks to maternal health and adverse 8 birth outcomes, including preterm birth, low birth weight, still birth; and negative psychological 9 outcomes for both mothers and children. 10 73. Contraceptive use also benefits women’s health overall. Contraceptive use can 11 prevent preexisting health conditions from worsening and new health problems from occurring, 12 because pregnancy can exacerbate existing health conditions such as diabetes, hypertension and 13 heart disease. Contraception is regularly used to treat menstrual disorders and pelvic pain. Long- 14 term use of oral contraceptives has been shown to reduce women’s risk of endometrial cancer, 15 pelvic inflammatory disease, and some breast diseases. 16 74. The benefits of Title X extend to society at large. Access to contraceptive services 17 benefits women in particular, helping narrow the gender wage gap. Access to contraception helps 18 women choose to delay childbearing and pursue additional education, spend additional time in 19 their careers, and have increased earning power over the long-term. An estimated one-third of the 20 wage gains women have made since the 1960s are the result of access to oral contraceptives. 21 75. Contraceptive use achieves significant cost savings as well. In 2002, the direct 22 medical cost of unintended pregnancy in the United States was nearly $5 billion, with the cost 23 savings due to contraceptive use estimated to be $19.3 billion. 24 76. The State of California directly benefits from these cost savings. The potential 25 gross public savings from preventing unintended pregnancies in California alone would have 26 been an estimated $1.3 billion in 2010 alone. 27 28 77. More broadly, for every dollar invested in publicly funded family planning programs, federal and state governments saved an estimated $7.09 in 2010 in Medicaid-related 19 1 costs that would otherwise have been associated with unintended pregnancies as well higher rates 2 of adverse birth effects, sexually transmitted diseases, and cervical cancer. 3 IV. HHS’S FLAWED AND UNLAWFUL NEW RULE 4 5 6 78. The Rule was originally proposed in a Notice of Proposed Rulemaking (NPRM) on June 1, 2018. 83 Fed. Reg. 25502, RIN 0937-ZA00. 79. Prior to promulgating the Rule, Defendants failed to meet or convene publicly with 7 leading healthcare experts such as the American Academy of Pediatrics, the American 8 Association of Family Physicians, the American College of Physicians, or the National 9 Association of Nurse Practitioners in Women’s Health. Yet Defendants engaged in numerous 10 meetings with proponents of the Rule who are not experts in the provision of women’s 11 reproductive healthcare. 12 80. Anticipating the NPRM, California wrote to Defendants on May 24, 2018 13 requesting a meeting with HHS to discuss the Rule and its effects. On July 18, 2018, California 14 along with Massachusetts, New Jersey, Oregon, Vermont, and Washington wrote to Defendants 15 requesting an extension of the comment period. Defendants submitted these letters as 16 “comments” into the Federal Register, but effectively denied the requests. 17 81. In response to the NPRM, HHS received more than 500,000 comments, many 18 describing a number of grave concerns about the regulation and its impact. California, along with 19 Delaware, Hawai’i, Illinois, Iowa, Maine, Maryland, Minnesota, New Jersey, New Mexico, North 20 Carolina, and the District of Columbia filed a multistate comment letter explaining that the Rule, 21 if implemented, would create barriers to women’s healthcare, including abortion. Major medical 22 health services provider organizations and experts in reproductive health filed comments similarly 23 opposing the Rule as medically misguided and/or contrary to law. 24 25 26 27 82. On March 4, 2019, HHS took final agency action when it caused the Rule to be published as a final rule in the Federal Register. 83. In promulgating the Rule, HHS stated its intent to revise existing regulations in order “to ensure compliance with, and enhance the implementation of” the provision of the Public 28 20 1 Health Services Act which prohibits use of Title X funds from being used in “programs where 2 abortion is a method of family planning.” 84 Fed. Reg. at 7714. 3 84. In doing so, however, HHS failed to identify any evidence showing that funds 4 appropriated for Title X were, in fact, being illegally used by recipients of those funds, or any 5 other evidence warranting such a drastic change in regulation. In the preamble to the final Rule, 6 HHS acknowledged that the examples it had cited relating to improper use of funds involved 7 Medicaid, not Title X grant funds. 84 Fed. Reg. at 7725. 8 9 10 11 85. To the contrary, substantial evidence shows that Title X grantees and subgrantees consistently keep clear and proper separation between their Title X projects and other programs that grantees may operate. 86. In addition to failing to identify any substantial evidentiary basis supporting the 12 Rule, HHS essentially ignored commenters’ serious and substantial concerns about the regulation. 13 Key problematic features of the new Rule are described below. 14 Separation Requirement 15 87. The Rule mandates a new “physical and financial separation” between a Title X 16 program and a facility that engages in “abortion activities.” Factors relevant to the determination 17 of whether the Title X program is physically and financially separate include the existence of 18 separate waiting, consultation, examination, and treatment rooms, office entrances and exits, 19 phone numbers, email addresses, educational services, websites, personnel, electronic or paper- 20 based healthcare records, and workstations. 42 C.F.R. § 59.15. 21 88. These separation requirements apply not only to the minority of Title X providers 22 that actually offer abortion services. They also apply to (a) all Title X-funded projects that give 23 “referrals” to patients who wish to choose an abortion, and (b) any and all Title X projects, like 24 Essential Access Health, that engage in separately funded advocacy or public education activities 25 that Defendants may determine “promote” abortion. See 42 C.F.R. § 59.15 (requiring physical 26 and financial separation from all “activities which are prohibited under […] §§ 59.13, 59.14, and 27 59.16 of these regulations”). 28 21 1 89. To obtain Title X funding, providers will effectively have to open a second clinic 2 to continue to provide even a referral to patients who wish to choose an abortion—an option that 3 is entirely impracticable. 4 90. In promulgating the new physical separation mandate, HHS ignored— or worse, 5 relied on— substantial evidence that this provision would cause well-qualified providers to leave 6 the Title X program and that this loss would impede women’s access to reproductive health 7 services. 8 9 91. For example, the American Public Health Association explained in its July 30, 2018 comments on the proposed Rule that in states that have already eliminated Planned 10 Parenthood from their family planning programs, the “public health results have been disastrous,” 11 leaving many people without access to care. 12 Gag Rule on Healthcare Information 13 92. 14 15 The Rule does not allow providers to “promote, refer for, or support abortion as a method of family planning.” 42 C.F.R. §§ 59.5(a)(5), 59.14(a). 93. Even when a woman wishes to exercise her lawful choice to access an abortion, 16 the provider is prohibited from providing her with a specific list of healthcare entities that 17 perform abortions, arranging her appointment, or assisting with needed transportation. 42 C.F.R. 18 § 59.14(a) (prohibiting Title X programs from taking “any other affirmative action to assist a 19 patient to secure such an abortion”). At most, the healthcare provider may provide a list of 20 “comprehensive health services providers (including providers of prenatal care).” 42 C.F.R. § 21 59.14(b)(ii). A Title X provider may also choose to exclude providers that perform abortion 22 entirely from the list. 42 C.F.R. § 59.14(b)(2). 23 94. The Rule’s mandate that the provider lists given to women seeking an abortion 24 contain only providers that also provide “comprehensive primary care” seems to mean that a 25 specialty clinic or individual provider who provides abortions and other healthcare services, but 26 not “comprehensive primary care,” would be ineligible to be placed on a list, even if they were 27 the most convenient and/or most highly qualified provider offering the abortion care services that 28 the Title X patient seeks. 22 1 95. The Rule not only authorizes Title X doctors and nurses to give a misleading 2 provider list, but it also prohibits those clinicians from informing their patient—who has 3 requested a referral for an abortion (a time sensitive medical procedure)—that the list includes 4 healthcare facilities that do not provide abortions. “Neither the list nor project staff may identify 5 which providers on the list perform abortion.” 42 C.F.R. § 59.14(c)(2). As the American College 6 of Obstetricians and Gynecologists (ACOG) explained in its July 31, 2018, comment to HHS, 7 such a regulation “restricts the ability of physicians to provide clear, direct information to 8 patients, and it even goes so far as to actively require physicians to withhold full and accurate 9 information and provide referrals to providers that do not offer the service requested by the 10 11 12 13 patient.” 96. Nothing in the Rule requires that Title X providers notify women of this drastic change in referral practices. 97. The Rule steers all pregnant women toward prenatal care and social services, 14 regardless of whether the patient’s choice is to obtain information regarding pregnancy 15 termination only. 16 98. The Rule applies exclusively to women’s reproductive health care, by placing an 17 artificial and unnecessary limit on what information a provider can share with his or her female 18 patients in making referrals. No limits are placed on referrals for any family planning services 19 needed by men. 20 99. As the administrative record showed, the Rule runs counter to accepted principles 21 of medical ethics and to accepted standards for clinical practice in the area of family planning and 22 reproductive healthcare. 23 100. Defendants ignore the CDC’s Quality Family Planning standards for high quality, 24 evidence-based clinical practice regarding the provision of family planning services, among other 25 sources of mainstream guidance. Title X providers who abide by the Rule would be in violation 26 of these guidelines. 27 101. 28 In promulgating the Rule, HHS ignored the concerns of the medical community that the Rule would interfere with the relationships between health providers and their patients, 23 1 and impede women’s access to reproductive health services. The major national professional 2 bodies who commented on the rule, including the American Medical Association, the American 3 College of Nurse-Midwives, ACOG, the American Public Health Association, the National 4 Family Planning & Reproductive Health Association, universally concur: the Rule contravenes 5 medical ethics, which require doctors and other health professionals to put patients’ needs first, 6 and undermines doctors and other health professionals’ abilities to provide high quality, evidence- 7 based medical care. 8 9 10 Removing Requirements for Nondirective, Medically Approved Family Planning Healthcare 102. The Rule removes the requirements that Title X providers offer a “broad range of 11 medically approved family planning methods,” eliminating the words “medically approved.” 42 12 C.F.R. § 59.5(a)(1). 13 103. A facility that may be eligible under this criterion, such as a so-called crisis 14 pregnancy center, may have no licensed medical providers, and is now potentially eligible for the 15 Title X program despite offering women patients only abstinence or natural family planning as 16 methods of family planning. 17 104. The Rule removes the requirement that Title X providers offer nondirective 18 pregnancy options counseling that includes information about prenatal care and delivery, 19 adoption, and pregnancy termination, if requested. 84 Fed. Reg. at 7716. 20 21 22 105. The Rule also allows use of Title X funds toward entities that promote only abstinence, or only adoption, as methods of family planning. 106. Moreover, the Rule effectively prohibits nondirective counseling by prohibiting 23 referrals for abortion, by issuing a vague prohibition on providers who “encourage” or “support” 24 abortion (inhibiting providers’ ability to provide respectful, client-centered counseling), by 25 banning referrals for abortion, but not other post-conception care, and by requiring that pregnant 26 patients be referred to a health care provider for “medically necessary prenatal health care.” 42 27 C.F.R. § 59.14(b). None of these limitations can be squared with an evidence-based 28 24 1 understanding of nondirective options counseling. They leave providers with unclear guidance, 2 potentially causing providers to forgo discussions altogether for fear of violating the Rule. 3 107. At numerous points, Defendants misleadingly imply that there are no standard or 4 widely accepted norms within the medical community about what constitutes “medically 5 approved,” by stating, for example, “different medical doctors and professional organization may 6 differ on which methods of health care they approve, including different methods of family 7 planning.” 84 Fed. Reg. at 7741. 8 9 10 11 12 108. These changes usurp Congressional authority by removing the statutory mandate that Title X provide comprehensive, evidence-based reproductive healthcare. 109. The removal and weakening of requirements for comprehensive, evidence-based reproductive healthcare apply exclusively to care provided to women. 110. The administrative record shows that the aspects of the Rule that remove or 13 weaken requirements regarding comprehensive, evidence-based reproductive care run counter to 14 accepted principles of medical ethics and to accepted standards for clinical practice in the area of 15 reproductive healthcare. 16 111. Removal or weakening of Title X requirements regarding comprehensive, 17 evidence-based reproductive care also run counter to the Quality Family Planning guidelines and 18 the weight of the administrative record. 19 112. HHS ignored evidence that nondirective care is considered high quality care. 20 113. HHS ignored evidence that 65% of all U.S. women are currently using 21 contraception; that nearly all women use contraception during their lifetime; and that the most 22 popular methods of family planning are also those that are most effective. 23 114. HHS ignored evidence that family planning providers who adhere to the long- 24 standing Title X-requirements to provide nondirective care and offer a broad range of effective 25 family planning methods offer higher quality care. 26 27 115. HHS selectively relied upon statements such as that of the ACOG supporting inclusion of natural family planning as a method of contraception in order to misleadingly suggest 28 25 1 that those organizations view natural family planning as equally effective compared to other 2 FDA-approved contraceptive methods. 3 4 116. HHS ignored evidence that lower-quality family planning providers with a mission to prevent abortion who refuse to offer nondirective care have deceived and harmed women. 5 117. In removing requirements for comprehensive, evidence-based reproductive 6 healthcare, HHS ignored substantial evidence that these provisions would merely encourage the 7 entry of lower-quality providers into the Title X program and impede women’s access to quality 8 reproductive health services. 9 Barriers to Care for Adolescents 10 11 118. The Rule imposes numerous additional requirements that will affect minors seeking contraceptive services and the healthcare providers that provide them care. 12 119. First, the Rule requires that a minor may be found to be financially eligible for 13 subsidized Title X services only after documentation of “specific actions taken to encourage the 14 minor to involve her/his family (including her/his parents or guardian) in her/his decision to seek 15 family planning services.”3 42 C.F.R. § 59.2. 16 120. Even for minors who manage to pay for Title X services out-of-pocket, the Rule 17 requires that providers document in the medical record the specific actions taken to encourage 18 family participation or any specific reason why family participation was not encouraged. Id. 19 20 121. The administrative record shows that family participation is often not practicable for adolescents, for reasons other than abuse or incest. 21 122. The record shows that providers who specialize in the treatment of adolescents 22 overwhelmingly believe that the new requirements will create barriers to access to care for 23 adolescents in need of reproductive health services. 24 25 123. For example, according to the American Academy of Pediatrics and Society for Adolescent Health and Medicine’s July 31, 2018 comment on the Rule, requiring clinicians to 26 27 28 3 The only exception to this family involvement requirement is when the provider suspects child abuse or incest, has reported the situation to State or local authorities, and has documented that reporting in the record. 26 1 take “specific actions” to encourage family participation, even after they have learned that this 2 involvement is not practicable, “is not only contrary to medical ethics, but it also undermines the 3 relationship between the minor and the health care professional and is likely to drive some minors 4 away from returning for critical health care services, including contraception and testing and 5 treatment for sexually transmitted infections.” 6 Limitation on Providers Who May Offer Pregnancy Options Counseling 7 124. In addition to severely limiting the circumstances in which Title X providers may 8 refer patients to abortion providers, the Rule provides that only doctors and nurses with advanced 9 degrees may provide options counseling to pregnant women. 10 125. Doctors and advance practice nurses with graduate degrees are often not the 11 reproductive healthcare providers actually discussing options with the patient. Nurses and health 12 educators, among others, often provide such care, within their scope of practice and training. 13 126. Counseling regarding medical options can be, and is, safely and effectively 14 provided by clinicians with a variety of credentials, subject to appropriate training and 15 supervision. 16 127. In promulgating the new requirement that only doctors and nurses with graduate 17 degrees may provide patients with options counseling or refer them to primary care services, HHS 18 ignored evidence that such a provision would impede women’s access to reproductive health 19 services. As the CEO of the Northeast Valley Health Corporation, an FQHC serving the San 20 Fernando and Santa Clarita Valleys, explained in her July 30, 2018 comment, “health care 21 professionals at Title X-funded health centers must be able to continue to work to the ceiling of 22 their scope and training,” otherwise the Rule will “interfere with the progress made in California 23 and other states across the country to address workforce shortages.” 24 128. Furthermore, HHS’s decision to allow doctors and nurses with graduate degrees, 25 but not other well-trained professionals, to provide counseling for pregnant patients is not a 26 logical outgrowth of the original proposal. 27 28 27 1 Limitation on So-Called “Infrastructure” Building 2 129. The Rule also includes an unnecessary and arbitrary ban on use of Title X funds to 3 “build infrastructure for purposes prohibited with these funds, such as support of the abortion 4 business of a Title X grantee or subrecipient.” 42 C.F.R. § 59.18(a). 5 130. Defendants’ evidence that Title X funds are being used to “build infrastructure” 6 shows that those activities are consistent with the purposes of the Title X statute. The single, 7 anecdotal example from 2007 cited by Defendants of so-called infrastructure building—the Los 8 Angeles, California-based Venice Family Clinic’s use of health educators wearing backpacks 9 with condoms and educational materials to go out into the community, and to visit homeless 10 shelters—shows that these funds are being used for purposes that are entirely consistent with the 11 purposes of Title X. 12 131. Far from supporting an “abortion business,” 42 C.F.R. § 59.18(a), these so-called 13 infrastructure building activities directly increase access to contraceptives, and decrease the need 14 for abortion. 15 132. Indeed, the Rule’s ban on so-called “infrastructure building” and the new 16 requirement that a majority of funds “provide direct services to clients” would severely limit the 17 funding of the following: a wide variety of activities that make family planning services more 18 readily available to persons desiring those services; improving the administration and operational 19 supervision of those services; enabling public and nonprofit entities to plan and develop 20 comprehensive programs of family planning services; developing educational materials and other 21 information about family planning; evaluating and improving the effectiveness of family planning 22 services programs; or assisting in providing training needed to carry out family planning 23 programs. Yet each one of these activities fall within Congress’ express purpose in enacting Title 24 X. See ¶ 21, supra. 25 State and Local Costs and Impacts 26 133. Furthermore, in issuing the Rule, HHS failed to fulfill its responsibilities for 27 analysis and consultation under Executive Order 13132, which establishes requirements that an 28 agency must meet when it promulgates a rule that imposes substantial direct requirement costs on 28 1 state and local governments or has federalism implications, and Executive Order 12372, which 2 requires intergovernmental review for certain programs and activities. See 64 Fed. Reg. 43255 3 (Aug. 10, 1999) (policies that have federalism implications) and 47 Fed. Reg. 30959 (July 14, 4 1982) (requiring intergovernmental review for certain programs). 5 134. HHS determined that the Rule did “not contain policies that have substantial direct 6 effects on the States, on the relationship between the National Government and the States, or on 7 the distribution of power and responsibilities among the various levels of government,” and 8 concluded that the Rule instead merely represented “the Federal Government regulating its own 9 program.” 84 Fed. Reg. at 7776. 10 135. HHS’s determination ignores substantial evidence of impacts on state and local 11 governments, and a disruption of the allocation of power and responsibilities among the various 12 levels of government. 13 136. As California explained in its comments, the Rule will substantially interfere with 14 the State’s policy-making discretion in the area of healthcare and will impose substantial costs on 15 state and local governments. 16 137. In California, several local entities are Title X sub-recipients and will be subject to 17 the Rule. For example, the San Francisco Department of Public Health (SFDPH), an agency of 18 the City and County of San Francisco, is one of Essential Access Health’s subgrantees. It has 19 used Title X funds to develop training programs that greatly improve the quality and effectiveness 20 of care offered at SFDPH family planning clinic sites across the county, as well as for ongoing 21 public education on topics relating to family planning and reproductive health, such as its recent 22 “Go Folic” project to increase awareness of the importance of folic acid supplementation in the 23 prevention of birth defects. If the Rule is implemented, however, SFDPH will forego Title X 24 funds entirely, because of the restrictions on referrals for patients who choose to obtain an 25 abortion and because the costs of compliance with the new physical and financial separation 26 requirements are too high. SFDPH explained in its July 31, 2018 comment letter that the Rule 27 would undermine access to critical preventive health services for some of San Francisco’s most 28 vulnerable residents. 29 1 138. HHS recognized these federalism implications in prior rulemaking on Title X, 2 which included a federalism impact statement and invited States to consult with the federal 3 agency in promulgating the final rule. 81 Fed. Reg. 61646 (Sept. 7, 2016). Defendants offered 4 no such opportunity for consultation prior to promulgating the current Rule. 4 5 139. The Rule demonstrates a clear intent to undermine the laws and policy choices 6 made by California and similarly situated states that are consistent with Title X and the United 7 States Constitution. 8 140. 9 Specifically, the Rule frustrates California law and policy choices that guarantee women’s ability to choose abortion. In doing so, it prevents California from protecting the health 10 and safety of its residents, and induces Title X grant recipients to violate state consumer 11 protection laws. 12 141. Because California law prohibits licensed healthcare providers from discriminating 13 or refusing service on the basis of a patient’s pregnancy, California Civil Code section 51(e)(5), 14 the Rule frustrates state licensing agencies’ responsibilities (described in paragraph 46 above) to 15 uphold and enforce California law. 16 142. Finally, Title X grant recipients that act in accordance with the Rule’s 17 unreasonable, non-client-centered limitations on counseling and referrals—such as by providing 18 misleading provider lists to women seeking to obtain abortion services—may violate California 19 law and terms and conditions for Medi-Cal provider participation. 20 Improper Assessment of Costs of Rule 21 143. More broadly, Defendants failed to assess the costs of the Rule. Among 22 Defendants’ many unfounded assumptions are that the quality of Title X providers will improve 23 as entities that cannot abide by the financial and physical separation requirements are excluded; 24 that the Rule will cause more clients to be served, and reduce gaps in service; and that the Rule 25 will not lead to an increase in unintended pregnancies. 84 Fed. Reg. at 7718, 7723, and 7741. 26 27 28 4 California and other state Attorneys General did meet with the Office of Management and Budget on February 15, 2019, just prior to the release of the Rule. HHS staff did not attend this meeting. 30 1 144. In fact, none of these assumptions are reasonable in light of the evidence before 2 the administration. Quality and access to Title X-funded services will be reduced, and the 3 number of Title X clients served will declined. Unintended pregnancies will rise. The costs and 4 consequences will be serious, and are nowhere captured in Defendants’ analysis. 5 6 Intent to Deprive Women of Access to High Quality Healthcare Services 145. Overall, Defendants’ rationale for the Rule is so implausible and disconnected 7 from the weight of the evidence in the administrative record that there can be no other 8 explanation for it apart from an intent to deprive women of a full range of high quality, needed 9 reproductive healthcare services. 10 146. For example, Defendants assert that HHS “does not agree that the final rule will 11 negatively impact access to family planning,” speculating (without any citation to evidence) that 12 “more patients could have access to services” as a result of the Rule. 84 Fed. Reg. at 7785. In 13 California alone, however, dozens of clinics, medical providers, and statewide or regional 14 professional organizations submitted comments speaking directly to this point.5 Their consensus: 15 the Rule will reduce access to family planning services for the one million Title X patients who 16 live in California. 17 147. The Rule’s many unsupported revisions effectively rewrite the Title X statute, 18 operating well beyond the agency’s regulatory authority, to effectuate a policy principle that 19 relegates women’s healthcare to second class status. 20 148. Reorienting the Title X program toward lower-quality, less comprehensive and 21 non-medically approved care is contrary to the ACA, recent appropriations bills, and the very 22 purpose of Title X. 23 149. Statements by President Trump support the conclusion that Defendants’ stated 24 rationale for the Rule change is pretextual. In remarks at the Susan B. Anthony List’s “Annual 25 Campaign for Life Gala” on May 22, 2018, the President explained that the Title X rules 26 27 28 5 These comments include, for example, those of the California Medical Association, the California Primary Care Association, ACOG District IX, the California Academy of Family Physicians, the California Association of Nurse Practitioners, Community Health Councils, County Health Executives Association of California, the California Association of Public Hospitals and Health Systems, the Community Clinic Association of Los Angeles County. 31 1 represented a fulfillment of campaign promises and then claimed, without further evidence or 2 explanation, that “American taxpayers” have been “forced to subsidize the abortion industry 3 through Title X federal funding.” 4 V. 5 HHS’S RULE WILL HARM CALIFORNIA AND ITS RESIDENTS 150. The Rule, if finalized, will force Title X funds recipients into an untenable position 6 of deciding whether to accept program funds with mandates that restrict access to care and force a 7 gag on clinicians, or to forfeit Title X funding altogether, leaving gaps in access to family 8 planning care that the Title X program was first established to fill. The former scenario will 9 result in the invasion of the physician-patient relationship; the transmission of incomplete, 10 misleading, and medically dangerous information to women; and the frustration of the right to 11 make an informed, independent decision as to whether to terminate a pregnancy. The latter 12 scenario will reduce funding available to crucial family planning providers, thereby reducing 13 critical healthcare services available to women and vulnerable populations. 14 151. Implementation of the Rule will cause harm to women, men, including adolescents 15 who currently benefit from Title X services. These irreparable harms have been abundantly 16 demonstrated throughout the administrative record. Ultimately, the State will bear the cost of 17 many of these serious harms. 18 19 20 21 A. 152. Rule Harms the Patient-Provider Relationship The Rule will undermine confidence and trust needed for an effective provider- patient relationship among family planning providers who continue to accept Title X funding. 153. According to the American Medical Association, truthful and open communication 22 between physician and patient is essential for trust in the relationship and for respect for 23 autonomy; withholding information without the patient’s knowledge or consent is contrary to 24 medical ethics. Yet the Rule requires physicians to disregard their Code of Medical Ethics and to 25 tailor their speech when providing a patient with requested medical information, including but not 26 limited to referrals for time-sensitive healthcare. 27 28 32 1 154. In addition, the Rule invites intrusive federal scrutiny into the subjective 2 motivations of Title X providers by prohibiting any conversations between doctors or nurses and 3 their patients that Defendants deem to be “promoting” or “supporting” access to abortion. 4 155. These same concerns extend to registered nurses, physician assistants, and licensed 5 vocational nurses. The patient-provider relationship remains the foundational responsibility of 6 healthcare providers. For instance, the American Nurses Association Code of Ethics states that, 7 “[t]he nurse’s primary commitment is to the patient, whether an individual, family, group, 8 community, or population.”6 The Rule undermines that responsibility by inhibiting all healthcare 9 providers from providing comprehensive medical information to patients seeking referrals. 10 156. The Rule’s prohibition on abortion referrals will shame and stigmatize patients 11 who express a desire for abortion, making those patients less willing to return to that provider for 12 later contraceptives and other health care needs, or causing patients to doubt whether or not 13 abortion is a lawful service available to them at all. 14 157. Limiting permission to provide options counseling only to doctors and nurses with 15 graduate degrees will further impact provider-patient relationships. Counseling regarding 16 medical options is safely and effectively provided by professionals with a variety of credentials; 17 Defendants cite no evidence to the contrary. If a well-qualified and trained registered nurse with 18 a baccalaureate degree, but no master’s degree, is present in a family planning clinic, a patient in 19 need would be turned away without receiving any nondirective pregnancy options counseling at 20 all. 21 22 158. Furthermore, the requirement that lists of local providers contain only providers that also offer “comprehensive primary care” will exclude many qualified abortion providers, 23 24 25 26 27 28 6 American Nurses Association, Code of Ethics for Nurses (2015); id. (“[t]he nurse practices with compassion and respect for the inherent dignity, worth, and unique attributes of every person.”); see also, e.g., Cal. Code Regs. tit. 16, § 1443.5 (outlining the standards of competent performance for nurses as including “[a]ct[ing] as the client’s advocate . . . by giving the client the opportunity to make informed decisions about healthcare before it is provided” and “[f]ormulat[ing] a care plan, in collaboration with the client”). 33 1 including for example many Planned Parenthood clinics, leaving women with even less 2 information and fewer choices. 3 159. In some areas, the only qualified abortion provider is a specialized facility that 4 does not provide prenatal care or primary care services. Omitting these providers from reference 5 lists will leave Title X patients who wish to terminate their pregnancy unable to obtain any local 6 referral. 7 160. The Rule’s negative impact on provider-patient relationships will have other 8 serious consequences. Some women will lack the necessary information and support to effectuate 9 their decisions about their reproductive healthcare condition and options. Defendants’ blithe 10 assertion that counseling and referrals about abortion services are not needed for women’s health 11 because information is “widely available and easily accessible, including on the internet” belies 12 the importance of these services to women’s health and healthcare. 84 Fed. Reg. at 7746. 13 Indeed, counseling and referrals about abortion help women to take control of their most 14 “intimate and personal choices . . . central to personal dignity and autonomy.” Planned 15 Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 851 (1992) (plurality op.). 16 161. Lack of reliable information from trusted providers will delay access to abortion 17 for some women, causing further harms. Reductions in trust within the provider-patient 18 relationship will also reduce some patients’ willingness to access services in the first place, or to 19 return for additional contraceptive care later on. 20 162. The Rule will cause particular harm to relationships between Title X providers and 21 adolescent patients in need of family planning services. New requirements that necessitate 22 intrusive questioning and unnecessary documentation will prevent Title X providers from offering 23 the highest quality medical care to these patients, and reduce their willingness to access needed 24 sexual education and contraceptive services in the first place. 25 26 B. 163. Loss of Title X Funding Will Reduce Access to Family Planning Services If implemented, the Rule will dramatically reduce the number of providers 27 participating in California’s Title X program, impeding access to care for and disproportionately 28 harming individuals with limited incomes. 34 1 164. Providers who choose not to accept the Rule’s mandates to compromise their high 2 clinical standards of care will face reductions in needed funding due to the loss of Title X grants. 3 Loss of Title X grants will render former Title X providers unable to provide the same reach and 4 quality of services to low-income and under-served populations 5 165. While California’s Family PACT program can cover fee-for-service contraceptive 6 care for a majority of California’s Title X patients, it does not cover all such patients (for 7 example, non-state residents or those with incomes between 200 and 250% of the federal poverty 8 level), nor does it pay for a number of crucial budget categories, such as outreach. 9 166. Loss of Title X funding will have a disproportionate impact on the most vulnerable 10 patients by reducing the funds available for services that connect hard-to-reach patients with 11 healthcare. For example, in 2017 Title X paid for outreach that connected 65,000 homeless 12 women statewide to a broad range of contraceptive methods, STD screening and prevention, and 13 other Title X-covered services. Without Title X funds, women experiencing homelessness in 14 California will be less able to access family planning. 15 167. A number of clinics will respond to loss of Title X funding by reducing clinic 16 hours, or by eliminating off-site or remote locations that currently provide services at times and 17 places that are convenient to certain patients. Title X programs serve primarily low-income 18 individuals who have no easy alternative sources of care. 19 168. Loss of Title X funds will undermine the long-term financial viability of some 20 family planning clinics, especially in rural or under-served areas. This poses a particular risk to 21 low-income rural residents, such as those in the seven rural California counties in which a Title 22 X-funded clinic is currently the only publicly funded clinic offering a full range of contraceptive 23 methods. 24 169. Because the Rule will cause the exit from the Title X program of many facilities 25 that specialize in reproductive health, such as Planned Parenthood, the remaining clinics, which 26 are already stretched thin, will be forced to serve even more Title X patients, increasing wait 27 times and reducing accessibility of family planning services. 28 35 1 170. Title X sites exist in just over 2,000 counties nationwide. In approximately one 2 third of those counties, there is no FQHC site providing contraceptive services, leaving women in 3 those counties with no option for Title-X supported services. In almost half of those counties, the 4 FQHC, if they remained in the Title X program, would have to double their contraceptive client 5 caseloads in order to serve all of those currently served by other Title X sites. 6 171. In California’s less populous regions, the Rule will create “contraceptive deserts” 7 where women in need of Title X-funded contraceptive services will be unable to find a well- 8 qualified provider within their county. If all qualified family planning providers that also provide 9 abortion services in California were to exit the Title X program, then eighteen counties would be 10 11 left without any Title X-funded health center. 172. In many U.S. states, women already must travel long distances in order to receive 12 reproductive healthcare services. Traveling to a reproductive health clinic requires taking days 13 off work, incurring lost income, transportation and/or lodging costs. The Rule will exacerbate 14 those burdens. 15 173. Where clinics continue to accept Title X funds, the Rule will create additional new 16 barriers to patients seeking appropriate reproductive healthcare. The Rule’s new ban on referrals 17 for abortions, in combination with the weakening of requirements to offer a wide-range of 18 medically approved contraceptive methods, will result in Title X patients having to visit a greater 19 number of providers in order to find and obtain the family planning methods that are appropriate 20 for them. 21 174. Some areas in California lack comprehensive primary health service providers that 22 provide abortions. For women in these areas, even if they clearly state to their Title X provider 23 that they have decided to have an abortion, their doctor will not be able to include reasonably 24 accessible abortion providers in the list of providers, creating further barriers for the patient. 25 Californian women in rural parts of Northern California will have to travel more than five hours 26 in order to visit a provider that qualifies for the list and offers abortion services. Women in the 27 Central Valley, central coast, and southeastern regions of California will have to drive 2-4 hours 28 in order to visit a provider that qualifies for the list and offers abortion services. 36 1 175. All of these reductions in accessibility will cause patients to reduce utilization of 2 family planning services and to reduce utilization of contraceptive methods that are the best 3 personal or medical choice. Patients’ choice of a method of contraceptive is influenced by the 4 accessibility of the medical provider, as well as their preferred method’s onsite availability and 5 cost. If access to the full range of contraceptive methods become less available or convenient, 6 then patients will make do with less effective contraceptive methods, or go without. 7 8 9 C. 176. Delayed Access to Contraception and Abortion Harms Women As women resort to less effective contraceptive methods, or go without contraceptives altogether, the result of the Rule will be an increase in unintended pregnancies. 10 Some pregnant women who receive incomplete or misleading referral information will experience 11 delays in accessing desired abortion services, or will be prevented altogether from accessing these 12 services even if medically necessary for the women’s health. 13 177. More than half of all unintended pregnancies end in miscarriage or abortion. 14 178. For pregnancies carried to term, intervals between pregnancies of less than 18 15 16 months are associated with poor obstetric outcomes and maternal health problems. 179. In the context of women’s health decisions, and in particular with respect to a 17 woman’s decision about whether to carry to full term or terminate a pregnancy, obtaining 18 complete and honest health care information and access to a full range of services is important 19 and urgent. Terminating a pregnancy is a time-sensitive medical decision. Any delay in 20 obtaining information or obtaining the necessary medical services is harmful to the patient and 21 results in increased potential for complications. Delays in accessing proper care can push women 22 into later, more complex procedures with increased chance of complications and poor health 23 outcomes. 24 180. The consequences of the Rule will be particularly severe in circumstances where 25 an abortion may not qualify as an “emergency service” under the Rule’s narrow definition, but 26 nevertheless implicate a woman’s health. Pregnancy may exacerbate existing medical conditions, 27 such as diabetes, sickle cell anemia, cancer, and AIDS. 28 37 1 181. An increase in unwanted pregnancy will harm women’s lives more broadly, 2 because “[t]he ability of women to participate equally in the economic and social life of the 3 Nation has been facilitated by their ability to control their reproductive lives.” Casey, 505 U.S. at 4 856 (plurality op.). 5 6 D. 182. The Rule Will Encourage and Support Poorer Quality Title X Service The Rule will make the family planning services provided by Title X programs 7 less effective, because they will permit and, in some respects, mandate the provision of services 8 that do not meet accepted clinical standards. 9 183. Just as the Rule will cause the flight of high quality family planning providers 10 from the Title X program, it will encourage new, lower-quality Title X providers to apply for and 11 obtain funding. 12 184. A number of clinics that do not adhere to the Quality Family Planning Guidelines 13 have expressed interest in obtaining Title X funds, if the Rule takes effect. So-called “crisis 14 pregnancy centers” have unsuccessfully sought access to California Title X funding in the past, 15 and are now more likely to qualify for Title X funding under the new Rule. 16 185. The principal aim of these types of family planning service providers is not to 17 provide high quality family planning services, but to discourage or prevent women from seeking 18 abortions. 19 186. Many lower-quality providers do not offer comprehensive contraception services. 20 Staff at some lower-quality providers have been trained not to answer phone inquiries such as, 21 “do you provide abortions?,” or “can I get the birth control pill at your center?” During 22 appointments, staff at these lower-quality providers strongly encourage pregnant women to 23 continue their pregnancies, and attempt to delay women’s decisions so that abortion becomes a 24 less safe and accessible alternative. 25 26 187. These lower-quality providers will undermine patient trust generally, place unnecessary barriers to women’s access to reproductive healthcare services, including abortion. 27 28 38 1 188. Lower-quality providers will also be less likely to provide other important health 2 services currently offered by all of California’s Title X providers, such as STD screening and 3 preventive services. 4 E. 189. 5 6 The Rule threatens California’s concrete and proprietary interest in ensuring access to healthcare and maintaining a stable network of healthcare providers. 190. 7 8 Damage to California’s Well-Established Title X Network Over the years, Essential Access Health has made substantial investments in training and supporting the existing Title X provider network. 191. 9 In fiscal year 2017 alone, Essential Access provided 1,011 hours of technical 10 assistance to Title X clinics. From 2015 to 2018, more than 7,500 staff members of Title X 11 facilities in California attended Essential Access’ trainings regarding high quality provision of 12 family planning and STD prevention services, covering subjects as diverse as prevention of 13 human trafficking and responding to the Zika outbreak. 192. 14 15 The Rule will undermine years of investments that have raised the overall level of clinical practice for California’s Title X providers as a group. 193. 16 Likewise, California has invested a great deal of time and resources into a “no 17 wrong door” approach to reproductive healthcare; the goal is that women experience a seamless 18 system that connects them with needed healthcare regardless of their particular eligibility 19 category or where or how they first seek healthcare. The expectation that any Title X providers 20 will provide high quality, comprehensive referrals to all needed reproductive healthcare is an 21 integral part of that “no-wrong-door” approach. The Rule and the resulting exit of many of 22 California’s well-established providers from Title X will undermine the effectiveness of this 23 policy. 24 194. This rule takes particular aim at one valuable safety-net health provider, Planned 25 Parenthood. Planned Parenthood affiliates provide healthcare to women including nondirective 26 counseling on all pregnancy options, including termination of pregnancy. As a result of this rule, 27 Planned Parenthood affiliates will likely refuse to participate in the Title X program. 28 39 1 195. In California, however, the types of Title X providers who are likely to exit the 2 program as a result of the Rule are diverse and varied, and include many of comprehensive 3 primary healthcare providers, whom Defendants claim will increase participation in Title X as a 4 result of the Rule. 5 6 F. 196. Harm to State Health and Well-Being As described in paragraphs 61-64 above, California’s existing Title X providers 7 play an essential and important role in providing a number of other vital health services for low- 8 income residents. They provide screenings and treatment or referrals for infectious disease, and 9 act as a trusted entry point for medical care generally. 10 11 12 197. Reduced funding for outreach and reduced accessibility of services will have direct and indirect adverse effects on the health and well-being of Californians generally. 198. Unintended pregnancies have a serious, negative public health impact on the State. 13 They are associated with increases in maternal and child morbidity, including increased odds of 14 preterm birth term, low birth weight, and the potentially life-long negative health outcomes of 15 premature birth. 16 199. Specifically, an increase in unintended pregnancies will result in more incidents of 17 intervals between pregnancies of less than 18 months. Shortened pregnancy intervals carry 18 consequences for children, as they are associated with higher rates of premature birth, birth 19 defects, low birth weight, and low mental and physical functioning in early childhood. 20 200. For some patients, reduced access to Title X services will mean delays in the 21 diagnosis and treatment of serious infectious diseases. Delays in the diagnosis and treatment of 22 infectious disease, in turn, cause negative consequences for California’s entire population. When 23 communicable diseases spread, the effects are felt broadly, especially among individuals with 24 compromised immune systems, such as newborns and persons with chronic illnesses. 25 201. For example, syphilis is a highly preventable disease that infects infants born to 26 mothers with untreated or insufficiently treated syphilis. Congenital syphilis can cause 27 miscarriages, prematurity, and low birth weights. Infants born with syphilis are at high risk for 28 serious complications, including blindness, deafness, severe anemia, deformed bones, brain and 40 1 nerve problems, meningitis, and death. If fewer women are able to access Title X services, which 2 include screening and prevention of sexually transmitted diseases like syphilis, then more 3 children will experience these serious consequences. 4 5 G. 202. Financial Harm to the State Finally, if women experience delays in access to contraception and abortion, and 6 all the harms concomitant to delays, the State of California will absorb much of the financial and 7 administrative burden that results in both the short and long term. 8 9 203. California funds a significant portion of the costs of medical procedures associated with unintended pregnancies and their aftermath. According to the Guttmacher Institute, 64.3% 10 of unplanned births in California were publicly funded, primarily by Medi-Cal. In 2010, 11 California spent $1.8 billion on unintended pregnancies, of which $689.3 million was paid for 12 from state coffers. 13 204. Furthermore, California and other states will bear the primary responsibility for the 14 increased costs of treating health conditions, ranging from cervical cancer to sexually transmitted 15 diseases, due to delays in diagnosis and treatment. Additional costs for uninsured patients will be 16 borne by hospitals that are required to provide uncompensated care for emergency services. 17 205. In addition, California will have to bear increased costs due to the Rule’s 18 expansion of the definition of “low-income” to include women who have trouble affording 19 contraception because their employer refuses to abide by the Affordable Care Act’s mandate for 20 contraceptive coverage. This change to Title X eligibility criteria appears to be Defendants’ 21 attempt to compensate for their decision to weaken the Affordable Care Act’s requirement that 22 employers provide women with no-cost contraceptive coverage. This new regulation is currently 23 subject to an injunction. See n.1, supra. These additional expenses are created by Defendants’ 24 illegal rule change. 25 206. 26 27 28 The State of California and its residents will therefore suffer irreparable injury if the Rule is not enjoined and declared unlawful. FIRST CAUSE OF ACTION (Violation of APA; 5 U.S.C. § 706—Contrary to Law) 41 1 207. Paragraphs 1 through 206 are realleged and incorporated herein by reference. 2 208. The APA requires courts to “hold unlawful and set aside” agency action that is 3 4 5 6 7 8 9 10 “not in accordance with law.” 5 U.S.C. § 706(2)(A). 209. The Rule conflicts with Section 1554 of the Affordable Care Act, which forbids the HHS Secretary from promulgating “any regulation” that: creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care; (2) impedes timely access to health care services; (3) interferes with communications regarding a full range of treatment options between the patient and provider; (4) restricts the ability of health care providers to provide full disclosure of all relevant information to patients making health care decisions; [or] (5) violates the principles of informed consent and the ethical standards of health care professionals. 11 42 U.S.C. § 18114. 12 210. The Rule conflicts with the nondirective mandate in the Consolidated 13 Appropriations Act of 2018, P.L. 115-41, div. H, tit. II, 132 Stat. 716 (2018), which provides that 14 “all pregnancy counseling” in Title X family planning projects “shall be nondirective.” For 15 example, the Rule that Title X projects may provide inaccurate or misleading referral lists for 16 patients seeking abortions (but no other postconception services) and requiring that all pregnant 17 women be referred for prenatal services (even if they have expressed a choice to seek an abortion) 18 are inconsistent with the nondirective mandate. 19 211. By promulgating this new Rule, Defendants have acted contrary to the Affordable 20 Care Act and the 2018 Appropriations Act. In doing so, Defendants have taken action in 21 violation of the APA. The Rule is therefore invalid. 22 SECOND CAUSE OF ACTION 23 (Violation of APA; 5 U.S.C. § 706—Exceeded Statutory Authority) 24 212. Paragraphs 1 through 212 are realleged and incorporated herein by reference. 25 213. The APA requires courts to “hold unlawful and set aside” agency action that is “in 26 excess of statutory jurisdiction, authority, or limitations, or short of statutory right.” 5 U.S.C. § 27 706(2)(C). 28 42 1 214. The Rule exceeds Defendants’ authority under the Title X statute, which requires 2 that grants for Title X programs “shall offer a broad range of acceptable and effective family 3 planning methods and services” and a “comprehensive program of family planning services.” 42 4 U.S.C. §§ 300(a), 300a(a). The Rule directs that fund recipients may not offer a comprehensive 5 program of family planning services, directly contrary to law, and will result in Title X programs 6 that offer a narrower range of effective methods and services. 7 215. By promulgating this new Rule, Defendants have acted in excess of their statutory 8 authority under Title X. In doing so, Defendants have taken action in violation of the APA. The 9 Rule is therefore invalid. THIRD CAUSE OF ACTION 10 (Violation of APA; 5 U.S.C. § 706—Arbitrary and Capricious) 11 12 217. Paragraphs 1 through 215 are realleged and incorporated herein by reference. 13 218. The APA requires courts to “hold unlawful and set aside” agency action that is 14 “arbitrary” or “capricious.” 5 U.S.C. § 706(2)(A). 15 219. In issuing the Rule, Defendants ignored impacts of the Rule as a whole that were 16 raised by California and others in public comments. Defendants have offered an explanation for 17 their decision that “runs counter to the evidence before the agency”; it is “so implausible that it 18 could not be ascribed to a difference of view or the product of agency expertise.” Motor Veh. 19 Mfrs. Ass’n v. State Farm Ins., 463 U.S. 29, 43 (1983). Indeed, Defendants ignored evidence that 20 the impact of the Rule to undermine the very purpose of the Title X statute. 21 220. By promulgating this new Rule, Defendants have acted arbitrarily and capriciously 22 and have abused their discretion. In doing so, Defendants have taken action in violation of the 23 APA. The Rule is therefore invalid. 24 FOURTH CAUSE OF ACTION 25 (Violation of the Fifth Amendment of the U.S. Constitution) 26 221. Paragraphs 1 through 220 are realleged and incorporated herein by reference. 27 222. The Due Process Clause of the Fifth Amendment prohibits the federal 28 43 1 government from denying equal protection of the laws. Bolling v. Sharpe, 347 U.S. 497, 499 2 (1954). 3 223. The Rule specifically targets and harms women. In particular, the Rule and the 4 weakening of requirements for comprehensive, evidence-based reproductive healthcare adversely 5 targets and invidiously discriminates against women. 6 224. The Rule targets individuals for discriminatory treatment based on pregnancy. 7 Pregnant individuals will not enjoy the same comprehensive, evidence-based healthcare 8 information as other individuals who are not pregnant. Specifically, the Rule targets individuals 9 seeking abortion care, and denies them access to accurate and complete referral information. 10 11 12 225. The Rule targets individuals for discriminatory treatment based on a gender classification, and thereby discriminates based on sex. 226. The Rule is not substantially related to an important government interest, let alone 13 rationally related to a legitimate government interest. The reasons offered by Defendants in the 14 preamble of the Rule are unfounded and pretextual. 15 16 17 18 19 20 21 22 227. Even if Defendants have an interest, the Rule is not tailored to achieve that interest. The Rule will impermissibly impose burdens on women. 228. By promulgating the Rule, Defendants have violated the equal protection guarantee of the Fifth Amendment of the U.S. Constitution. 229. Defendants’ violation causes ongoing harm to the States and their residents. PRAYER FOR RELIEF WHEREFORE, the State of California, by and through Attorney General Xavier Becerra, respectfully requests that this Court: 23 1. Issue a declaratory judgment that the Rule is contrary to the law; 24 2. Issue a declaratory judgment that the Rule exceeds Defendants’ statutory authority; 25 3. Issue a declaratory judgment that the Rule is arbitrary, capricious, and an abuse of 26 27 discretion, in violation of the Administrative Procedures Act; 4. Issue a declaratory judgment that the Rule violates the Equal Protection Clause; 28 44 1 2 5. Postpone the effective date of the Rule, pending judicial review, pursuant to 5 U.S.C. § 705; 3 6. Hold unlawful and set aside the Rule, pursuant to 5 U.S.C. § 706(2); 4 7. Issue a preliminary injunction prohibiting implementation of the Rule; 5 8. Issue a permanent injunction prohibiting implementation of the Rule; 6 9. Award California costs, expenses, and reasonable attorneys’ fees; 7 10. Award such other relief as the Court deems just and proper. 8 Dated: March 4, 2019 9 10 11 12 /s/ Anna Rich ANNA RICH BRENDA AYON VERDUZCO KARLI EISENBERG Deputy Attorneys General Attorneys for Plaintiff State of California, by and through Attorney General Xavier Becerra 13 14 15 16 Respectfully Submitted, XAVIER BECERRA Attorney General of California MICHAEL L. NEWMAN Senior Assistant Attorney General KATHLEEN BOERGERS Supervising Deputy Attorney General SA2018101519/71770475.docx 17 18 19 20 21 22 23 24 25 26 27 28 45

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