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1 RICHARD B. KATSKEE* JAMES R. WILLIAMS (SBN 271253) AMERICANS UNITED FOR SEPARATION GRETA S. HANSEN (SBN 251471) 2 OF CHURCH AND STATE LAURA S. TRICE (SBN 284837) 1310 L Street NW, Suite 200 MARY E. HANNA-WEIR (SBN 320011) 3 Washington, DC 20005 SUSAN P. GREENBERG (SBN 318055) Tel: (202) 466-3234; Fax: (202) 466-3234 H. LUKE EDWARDS (SBN 313756) 4 [email protected] OFFICE OF THE COUNTY COUNSEL, COUNTY OF SANTA CLARA 5 GENEVIEVE SCOTT* 70 West Hedding Street, East Wing, 9th Fl. CENTER FOR REPRODUCTIVE RIGHTS San José, CA 95110-1770 6 199 Water Street, 22nd Floor Tel: (408) 299-5900; Fax: (408) 292-7240 New York, NY 10038 [email protected] 7 Tel: (917) 637-3605; Fax: (917) 637-3666 [email protected] LEE H. RUBIN (SBN 141331) 8 MAYER BROWN LLP JAMIE A. GLIKSBERG* Two Palo Alto Square, Suite 300 LAMBDA LEGAL DEFENSE AND 9 EDUCATION FUND, INC. 3000 El Camino Real 105 West Adams, 26th Floor Palo Alto, CA 94306-2112 10 Chicago, IL 60603-6208 Tel: (650) 331-2000; Fax: (650) 331-2060 Tel: (312) 663-4413; Fax: (312) 663-4307 [email protected] 11 [email protected] Counsel for Plaintiffs County of Santa Clara et al. 12 UNITED STATES DISTRICT COURT 13 NORTHERN DISTRICT OF CALIFORNIA

14 COUNTY OF SANTA CLARA, TRUST Case No. 5:19-cv-2916 15 WOMEN SEATTLE, LOS ANGELES LGBT CENTER, WHITMAN-WALKER CLINIC, COMPLAINT FOR DECLARATORY 16 INC. d/b/a WHITMAN-WALKER HEALTH, AND INJUNCTIVE RELIEF BRADBURY-SULLIVAN LGBT 17 COMMUNITY CENTER, CENTER ON HALSTED, HARTFORD GYN CENTER, 18 MAZZONI CENTER, MEDICAL STUDENTS 19 FOR CHOICE, AGLP: THE ASSOCIATION OF LGBTQ+ PSYCHIATRISTS, AMERICAN 20 ASSOCIATION OF PHYSICIANS FOR HUMAN RIGHTS d/b/a GLMA: HEALTH 21 PROFESSIONALS ADVANCING LGBTQ EQUALITY, COLLEEN MCNICHOLAS, 22 ROBERT BOLAN, WARD CARPENTER, 23 SARAH HENN, and RANDY PUMPHREY, Plaintiffs, 24 vs. 25 U.S. DEPARTMENT OF HEALTH AND 26 HUMAN SERVICES and ALEX M. AZAR, II, in his official capacity as SECRETARY OF 27 HEALTH AND HUMAN SERVICES, 28 Defendants.

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1 INTRODUCTION 2 1. When people go to an emergency room, clinic, or public health program seeking 3 treatment for illness or injury, they expect and trust that they will receive care appropriate to meet 4 their health needs, without regard to their sex, gender identity, sexual orientation, disability status, 5 or religion, or the type of healthcare they seek. Healthcare providers have adopted nuanced policies 6 that respect healthcare workers’ religious and moral beliefs; protect patients’ access to information 7 and timely, high-quality care; and satisfy healthcare providers’ legal and professional duties of care 8 to all patients. 9 2. Now, however, the U.S. Department of Health and Human Services has issued a 10 new regulation (the “Denial-of-Care Rule”) that upsets this thoughtful approach. Although 11 purporting to implement long-standing healthcare statutes with specific provisions affording 12 protections for the religious or moral beliefs of certain individuals and entities (“religious 13 objections”), the Rule instead creates a wholly new regime that elevates religious objections over 14 all other interests and values. The Rule invites a much larger universe of healthcare workers to 15 decline to serve patients based on religious objections, defines with unprecedented breadth the types 16 of activities to which they may object, and fails to reconcile objections with the needs and rights of 17 patients—even though doing so is critical in any regulatory scheme administering these laws. And 18 the Rule does not include emergency exceptions. As a result, the Rule endangers patients’ health 19 in the name of advancing the religious beliefs of those who are entrusted with caring for them—a 20 result sharply at odds with the stated mission of the Department of Health and Human Services 21 (“HHS”), which is to “enhance and protect the health and well-being of all Americans” and to 22 “provid[e] for effective health and human services.” 23 3. The Rule applies to hospitals, medical schools, public- and community-health 24 programs, and state and local governments throughout the Nation that are recipients or 25 subrecipients of certain federal funds. These healthcare providers must comply with the Rule or 26 risk incurring draconian penalties, including the withdrawal or clawback of all federal funding. Yet 27 the Rule offers scant guidance on how healthcare providers might satisfy the Rule’s extreme 28 obligations while still reliably delivering patient care. And the Rule places vague and unworkable

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1 limits on the reasonable measures that are necessary to protect patients (and comply with the 2 applicable standards of care and medical ethics) when accommodating objections. By failing to 3 provide for emergency exceptions or to address an array of other issues about the Rule’s 4 requirements, the agency’s action leaves healthcare providers utterly in the dark about what they 5 may or may not do to protect patients consistent with the Rule. If they guess wrong, they could lose 6 federal funding, which would frustrate their ability to provide adequate care to their most needy 7 patients. 8 4. The Rule specifically invites refusals to provide care to women seeking reproductive 9 healthcare and transgender and gender-nonconforming patients seeking gender-affirming care, 10 adversely affecting the healthcare entities that provide reproductive healthcare services and that 11 serve the lesbian, gay, bisexual, and transgender (“LGBT”) community. The Rule stigmatizes and 12 shames these patients, depriving them of their constitutionally protected rights of access to 13 healthcare and their dignity and autonomy in seeking medically necessary healthcare central to their 14 self-determination. The Rule will delay and deny the provision of care and information to many 15 patients. It also will deter patients from disclosing their medical histories, gender identities, or 16 transgender status as they seek care; chill patients from expressing themselves in a manner 17 consistent with their gender identities; and render them less likely to seek healthcare services at all, 18 detrimentally affecting not only individual patients’ mental and physical health, but public health 19 generally. 20 5. In adopting the Rule, HHS acted arbitrarily and capriciously, in excess of its 21 statutory authority, and in conflict with other laws. Among other problems, HHS failed adequately 22 to consider significant factors, including the Rule’s lack of workability and its impact on patients, 23 despite numerous comments raising these concerns; it defined key statutory terms in a manner that 24 is contrary to the underlying statutes; and it ignored limitations contained in other federal laws on 25 HHS’s authority to limit patient access to information and care, including emergency care. 26 6. The Rule infringes the constitutional rights of patients by impermissibly advancing 27 the religious beliefs of individual employees over the constitutional rights of patients, including 28 patients’ rights to liberty and privacy guaranteed by the Fifth Amendment; their right to equal

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1 protection of the laws; and their rights to free speech and expression. The Rule also infringes the 2 constitutional rights of healthcare providers and their patients not to be compelled by the 3 government to live and act in accordance with religious beliefs to which they do not subscribe. 4 7. The Rule is ill-considered and dangerous, and it puts us all at risk. It should be 5 declared unlawful and enjoined. 6 JURISDICTION AND VENUE 7 8. This Court has jurisdiction under 28 U.S.C. § 1331, as this case arises under the 8 United States Constitution and the Administrative Procedure Act, 5 U.S.C. § 701 et seq., and 9 challenges final agency action for which there is no other adequate remedy, 5 U.S.C. § 704. 10 9. The Court has the authority to issue declaratory and injunctive relief under the 11 Declaratory Judgment Act, 28 U.S.C. § 2201 et seq., and the Administrative Procedure Act, 12 5 U.S.C. § 701 et seq. 13 10. Defendants are subject to suit in any federal jurisdiction in challenges to federal 14 regulations, and no real property is involved in this action. 42 U.S.C. §1391(e)(1). 15 11. Venue is proper in the Northern District of California under 28 U.S.C. § 1391(b) 16 and (e)(1) because at least one Plaintiff resides in this district and each defendant is an agency of 17 the United States or an officer of the United States sued in his or her official capacity. 18 12. The challenged Rule is final and subject to judicial review under 5 U.S.C. §§ 702, 19 704, and 706. 20 PARTIES 21 A. Plaintiffs 22 13. Plaintiffs include a governmental entity that owns healthcare facilities (the County 23 of Santa Clara); five private healthcare facilities that provide reproductive-health services and 24 healthcare services for LGBT individuals (Trust Women Seattle, the Los Angeles LGBT Center, 25 Whitman-Walker Clinic, Inc. d/b/a Whitman-Walker Health, Hartford Gyn Center, and Mazzoni 26 Center) (“private-healthcare-provider Plaintiffs”); four individual physicians and a licensed 27 counselor who work for these entities (“individual-provider Plaintiffs”); three national associations 28 of medical professionals (Medical Students for Choice, AGLP: Association of LGBTQ

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1 Psychiatrists, and American Association of Physicians for Human Rights d/b/a GLMA: Health 2 Professionals Advancing LGBTQ Equality) (“medical-association Plaintiffs”); and two 3 organizations that provide a wide range of services to the LGBT community (Bradbury-Sullivan 4 LGBT Community Center and Center on Halsted) (“LGBT-services Plaintiffs”). 5 14. The private-healthcare-provider and individual-provider Plaintiffs assert claims on 6 their own behalf and also on behalf of their patients and recipients of services, who face barriers to 7 asserting their own claims and protecting their own interests. The medical-association Plaintiffs 8 assert claims on behalf of themselves and their members. 9 15. Plaintiffs assert different but complementary interests, and share the common 10 objective of maintaining an effective, functioning healthcare system, one that protects patients’ 11 dignity and their rights of access to health services as well as the dignity of healthcare workers who 12 raise religious objections. Plaintiffs also support the objective of providing informed access to 13 comprehensive reproductive healthcare and gender-affirming and medically appropriate care to 14 transgender and gender-nonconforming patients without discrimination based on a patient’s sex, 15 gender identity, or transgender status and in accordance with medical and ethical standards of care. 16 16. Plaintiff County of Santa Clara is a charter county and political subdivision of the 17 State of California, located in the Northern District of California. It is home to almost two million 18 residents, is more populous than 14 States, and employs more than 20,000 people. 19 17. The County, as part of its governmental responsibilities, is tasked with providing 20 critical safety-net and public health services. These core County functions are undertaken by a 21 network of County departments and programs, including several County-owned and -operated 22 hospitals, public pharmacies, a public health department, an emergency-medical-services 23 department, a behavioral-health-services department, and a publicly run health-insurance plan. The 24 County of Santa Clara Health System is the only public safety-net healthcare provider in Santa 25 Clara County, and it is the second largest such provider in the State of California. 26 18. To operate this network, and because of the County’s focus on serving indigent and 27 vulnerable populations whose insurance is paid through federally funded Medicare or Medicaid, 28 the County is dependent on hundreds of millions of dollars of federal funding from HHS. The

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1 County also receives funding through a variety of other funding streams that pass through HHS, 2 including under the Public Health Services Act (“PHSA”). Because it receives this federal funding, 3 the County is subject to the Denial-of-Care Rule in its entirety. 4 19. At the center of the County’s health system are the County’s three hospitals. The 5 County owns and operates Santa Clara Valley Medical Center (“Valley Medical Center”), an acute- 6 care hospital with over 6,000 employees providing emergency medical services, primary care, 7 hospital care, and reproductive-health services. The mission of Valley Medical Center and its 8 satellite clinics is to provide high-quality, accessible, and compassionate care to all, regardless of 9 their socio-economic status or ability to pay. Last year, Valley Medical Center had an average daily 10 census of 363 patients and handled 3,087 births and 88,856 emergency department visits. 11 20. Valley Medical Center also operates a Gender Health Center that provides 12 (1) resources and psychological support for people of all ages, including children, teens, and young 13 adults, who seek to understand and explore their gender identity; (2) medical care, including 14 hormone treatments; and (3) primary care, including HIV and STI testing. Patient services at the 15 Gender Health Center include standard primary care and acute care, as well as specialized care for 16 the psychological and biological elements of gender transition. Valley Medical Center also operates 17 a family-planning clinic, which provides contraception and abortion services, and it operates a 18 dedicated clinic for LGBT patients. 19 21. In March 2019, the County purchased three additional major health facilities in 20 danger of closing—O’Connor Hospital, St. Louise Regional Hospital, and De Paul Health Center— 21 adding these critical local facilities to its safety net. O’Connor Hospital is the home of one of the 22 only family-medicine residency programs in the Bay Area. It provides emergency medical services, 23 urgent-care services, primary care, hospital care, and reproductive-health services. Last year, 24 O’Connor Hospital handled an estimated 51,948 emergency visits, 4,311 surgical cases, and 1,631 25 births. 26 22. St. Louise Regional Hospital, located in the City of Gilroy, operates the only acute- 27 care hospital in the southern part of Santa Clara County and specializes in maternal child-health 28 services, emergency services, women’s health, breast-cancer care, imaging, surgical procedures,

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1 and wound care. St. Louise Regional Hospital is the only hospital in reasonable proximity to many 2 County residents living in the vast rural areas to the north, east, and south of the City of Gilroy. 3 23. De Paul Health Center, located in the City of Morgan Hill, provides urgent-care 4 services and a breast cancer clinic, and is also one of the key healthcare clinics close to many of 5 the rural residents in the County. In 2018, De Paul Health Center provided care for approximately 6 8,858 patients. 7 24. The County also operates the local public health department, which is responsible 8 for providing immunizations; tracking disease outbreaks; offering long-term case management for 9 patients with conditions such as active tuberculosis; providing testing, prevention, and treatment 10 services for sexually transmitted diseases; operating a needle-exchange program; and planning for 11 health emergencies. The 15 cities within the County—including the City of San José, the nation’s 12 tenth largest city—lack their own public health departments and depend on the County to provide 13 all public health services. 14 25. To support its hospitals and public health department, the County operates numerous 15 pharmacies that supply essential medicines and treatments, including those used for contraceptive 16 care, abortions, hormone therapy as part of gender-transition-related care, sexually transmitted 17 infections, and HIV/AIDS. One County pharmacy provides free, donated medicine to individuals 18 who cannot afford the retail cost of needed medications. Another specializes in serving patients 19 with HIV/AIDS, patients with tuberculosis, patients from the Public Health Department’s STD 20 clinic, and patients being discharged from the County jail. Staff at these pharmacies supports 21 communicable-disease control by procuring, storing, maintaining, and distributing essential 22 medications and vaccines during outbreaks and by distributing state-funded influenza vaccines for 23 administration at no charge to low-income and elderly residents. 24 26. The County also operates the local emergency-medical-services system, overseeing 25 all 911 ambulance response countywide. The County is also the sole accreditor in the county for 26 emergency responders, such as ambulance workers and firefighters. 27 27. The Santa Clara County Behavioral Health Services Department serves County 28 residents in need of mental-health and substance-use-treatment services. It provides needed

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1 emergency and crisis care, short-term and long-term inpatient psychiatric care, outpatient mental- 2 health care, medication support, case-management services, and substance-abuse treatment. These 3 services are provided to many County residents from vulnerable populations, with a focus on 4 providing non-stigmatizing care to support those affected by mental illness and substance use. 5 28. The County also operates the only local publicly operated insurance plan, Valley 6 Health Plan. As a health-maintenance organization, Valley Health Plan offers various healthcare- 7 coverage plans that give enrolled members access to a range of medical services from physicians 8 and other healthcare providers within Valley Health Plan’s network. 9 29. Plaintiff Trust Women Seattle, located in Seattle, Washington, is a clinic that 10 provides full-spectrum reproductive-health services, including abortion and transgender-health 11 services. Its mission is to expand access to abortion, healthcare for LGBT people, and reproductive 12 healthcare in underserved communities throughout the United States. In serving this mission, Trust 13 Women strives to treat all patients with dignity and compassion. Trust Women Seattle is a 14 subrecipient of federal Medicaid funding through the State of Washington and therefore is subject 15 to the Denial-of-Care Rule. 16 30. Plaintiff Dr. Colleen McNicholas is the Medical Director for Trust Women, 17 overseeing medical practice at Trust Women’s Seattle, Oklahoma, and Kansas clinics. 18 Dr. McNicholas is involved in all aspects of medical decision-making with respect to abortion, 19 contraception, and transgender care offered at Trust Women Seattle. She provides full-spectrum 20 reproductive healthcare to her patients, including contraceptive care and abortion care into the 21 second trimester. In her hospital practice, Dr. McNicholas has developed a program to incorporate 22 gender-affirming gynecologic treatment for transgender children and adults. And she trains other 23 providers to provide abortion, contraception, and gender-affirming care. Dr. McNicholas is the 24 Director of the Ryan Residency Collaborative between Oklahoma University and Washington 25 University School of Medicine in St. Louis, Missouri, which offers formal training in abortion and 26 family planning to residents in obstetrics/gynecology; the Assistant Director of the Fellowship in 27 Family Planning at Washington University School of Medicine; and an Associate Professor at 28

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1 Washington University School of Medicine, in the Department of Obstetrics and Gynecology’s 2 Division of Family Planning. 3 31. Plaintiff Los Angeles LGBT Center is located in Los Angeles, California. Its 4 mission is to build a world in which LGBT people thrive as healthy, equal, and complete members 5 of society. The LA LGBT Center offers programs, services, and advocacy spanning four broad 6 categories: health, social services and housing, culture and education, and leadership and advocacy. 7 The LA LGBT Center has more than 650 employees and provides services for more LGBT people 8 than any other organization in the world, with about 500,000 patient visits per year. LA LGBT 9 Center receives funds under the PHSA. Approximately 80 percent of the LA LGBT Center’s 10 funding originates from the federal government, including, but not limited to, funding under the 11 Ryan White Comprehensive AIDS Resources Emergency Act of 1990, 42 U.S.C. § 300ff et seq. 12 (“Ryan White funding”); direct funding from the Centers for Disease Control and Prevention, 13 discounts under the 340B Drug Discount Program, grants under section 330 of the PHSA; grants 14 from HHS-HRSA-Bureau of Primary Health Care under which the LA LGBT Center is a Federally 15 Qualified Health Center; and Medicaid and Medicare reimbursements. The LA LGBT Center 16 therefore is subject to the Denial-of-Care Rule. 17 32. Plaintiff Dr. Robert Bolan is the Chief Medical Officer of the LA LGBT Center. 18 He oversees the delivery of healthcare for approximately 9,000 patients who come to the LA LGBT 19 Center and personally treats approximately 300 patients. Over 90% of these patients identify as 20 LGBT, many of them coming from different areas of California and other States to obtain services 21 in a safe and affirming environment. Dr. Bolan also oversees the LA LGBT Center’s Research 22 Department. Dr. Bolan and the providers he supervises treat patients who identify as transgender 23 and who require gender-affirming treatment, including medically necessary healthcare for gender 24 dysphoria. Many of Dr. Bolan’s patients and many of the patients of the providers he supervises at 25 the LA LGBT Center already have experienced traumatic and discriminatory denials of healthcare 26 based on their sexual orientation, gender identity, transgender status, or HIV status at the hands of 27 providers outside the LA LGBT Center, including by healthcare providers who have expressed 28

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1 religious or moral objections to treating them. Such experiences will increase as a result of the 2 Denial-of-Care Rule. 3 33. Plaintiff Dr. Ward Carpenter is the Co-Director of Health Services at the LA 4 LGBT Center. Dr. Carpenter is a nationally recognized expert in the field of transgender medicine. 5 In his role as Co-Director of Health Services, Dr. Carpenter oversees the healthcare of over 17,000 6 patients who come to the LA LGBT Center and personally treats 150 patients. All of Dr. 7 Carpenter’s patients identify within the LGBT community, and approximately 30% of them are 8 people living with HIV. These patients come from different areas of California and other States to 9 obtain services in a safe and affirming environment. Dr. Carpenter’s patient population is 10 disproportionately low-income and experiences high rates of chronic medical conditions, 11 homelessness, unstable housing, and extensive trauma history. In addition, many of Dr. Carpenter’s 12 patients, as well as those of the other medical providers he supervises at the Center, already have 13 experienced traumatic and discriminatory denials of healthcare based on their sexual orientation, 14 gender identity, transgender status, or HIV status at the hands of providers outside the LA LGBT 15 Center, including by healthcare providers who have expressed religious or moral objections to 16 treating them. Such experiences will increase as a result of the Denial-of-Care Rule. 17 34. Plaintiff Whitman-Walker Clinic, Inc. d/b/a Whitman-Walker Health, located 18 in Washington, D.C., provides a range of services, including medical and community healthcare, 19 transgender care and services, behavioral-health services, dental-health services, legal services, 20 insurance-navigation services, and youth and family support. It has particular expertise in LGBT 21 and HIV care. The mission of Whitman-Walker is to offer affirming community-based health and 22 wellness services to all with a special expertise in LGBT and HIV care. Whitman-Walker 23 empowers all persons to live healthy, love openly, and achieve equality and inclusion. In 2018, 24 Whitman-Walker provided health care services to more than 20,700 individuals. Whitman-Walker 25 receives various forms of federal funding from HHS and from institutions affiliated with or 26 themselves funded by HHS, including but not limited to funds under the PHSA, direct grants, Ryan 27 White funding, funds under the 340b drug subsidy program, research grants from the Centers for 28 Disease Control and Prevention and the National Institutes of Health, and Medicaid and Medicare

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1 reimbursements. For 2019, Whitman-Walker’s federally funded research contracts and grants total 2 more than $2 million. Whitman-Walker therefore is subject to the Denial-of-Care Rule. 3 35. Plaintiff Dr. Sarah Henn is the Chief Health Officer of Whitman-Walker. Dr. Henn 4 oversees all healthcare-related services at Whitman-Walker and maintains a panel of patients for 5 whom she provides direct care. Whitman-Walker’s patient population, including patients to whom 6 Dr. Henn provides direct care and whose care she oversees, includes many patients who have 7 experienced refusals of healthcare or who have been subjected to disapproval, disrespect, or 8 hostility from medical providers outside of Whitman-Walker because of their actual or perceived 9 sexual orientation, gender identity, or transgender status. Many of Dr. Henn’s patients and those 10 whose care she oversees are, therefore, apprehensive or fearful of encountering stigma and 11 discrimination in healthcare settings because of their past experiences. Such experiences will 12 increase as a result of the Denial-of-Care Rule. In addition to overseeing medical care of patients 13 and working with her own patients, Dr. Henn oversees Whitman-Walker’s Research Department, 14 and is personally involved in a number of clinical research projects, including as the Leader of 15 Whitman-Walker’s Clinical Research Site for the AIDS Clinical Trials Group funded by the 16 National Institutes of Health. 17 36. Plaintiff Dr. Randy Pumphrey is Senior Director of Behavioral Health at 18 Whitman-Walker. As Senior Director of Behavioral Health, Dr. Pumphrey oversees Whitman- 19 Walker’s portfolio of mental-health services and substance-use-disorder-treatment services and 20 maintains a panel of patients for whom he provides direct behavioral healthcare. In 2018, Whitman- 21 Walker provided mental-health or substance-use-disorder-treatment services to over 2,300 patients, 22 many of whom identify as LGBT or are living with HIV. Many, if not most, of the patients to whom 23 Dr. Pumphrey provides direct care and whose behavioral healthcare he oversees face considerable 24 stigma and discrimination as people living with HIV, as sexual or gender minorities, or as people 25 of color and have experienced difficulty finding therapists or other mental-health or substance-use- 26 disorder professionals who are understanding and welcoming of their sexual orientation, gender 27 identity, or transgender status. Such experiences of discrimination will increase as a result of the 28 Denial-of-Care Rule.

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1 37. Plaintiff Center on Halsted is a 501(c)(3) nonprofit organization based in Chicago 2 and incorporated in Illinois. Center on Halsted is a comprehensive community center dedicated to 3 securing the health and well-being of the LGBT people of the Chicago area. Center on Halsted 4 provides programs and services for the LGBT community, including HIV/HCV testing; behavioral 5 health services; case management, job development, social programming, meals, and housing for 6 seniors; housing, meals, counseling, and leadership for youth; and anti-violence services. Center 7 on Halsted also administers social programming for families and advises patrons on concerns 8 related to family planning. On average, more than 1400 community members visit Center on 9 Halsted each day. Center on Halsted receives various forms of pass-through federal funding from 10 HHS, including Ryan White funding and funding from the National Institutes of Health and the 11 Centers for Disease Control and Prevention. Center on Halsted also benefits from programs 12 governed by the Centers for Medicare through Medicare reimbursements. 13 38. Plaintiff Hartford Gyn Center, located in Hartford, Connecticut, is the only 14 independent, state-licensed family-planning clinic in Connecticut. Hartford Gyn Center provides 15 reproductive-health services, including contraception and abortion services through 21 weeks. 16 Hartford Gyn Center’s mission is to provide women with compassionate reproductive-health 17 services and abortion care, to respect the autonomy of each patient, to support and strengthen 18 reproductive rights, and to effect corresponding social change. Hartford Gyn Center sees patients 19 from all walks of life, including low-income patients who cannot easily access care elsewhere, if at 20 all. Hartford Gyn is one of the only facilities in the region that trains physicians in abortion care,

21 especially in the second trimester. The clinic also operates a medical-residency and training 22 program. Hartford Gyn Center is a subrecipient of federal Medicaid funding through the State of 23 Connecticut and therefore is subject to the Denial-of-Care Rule. 24 39. Plaintiff Bradbury-Sullivan LGBT Community Center is a 501(c)(3) nonprofit 25 organization based in Allentown, Pennsylvania, and incorporated in Pennsylvania. It is dedicated

26 to securing the health and well-being of LGBTQ people of the Greater Lehigh Valley. It provides 27 a variety of programs and services for the LGBTQ community, including HIV/STI testing, 28 healthcare-enrollment events, family-planning services, support groups, and a free legal clinic.

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1 Bradbury-Sullivan Center also provides referrals to LGBT-welcoming healthcare providers, 2 including providers engaged in family planning services. Patrons of Bradbury-Sullivan Center 3 often seek healthcare services from other healthcare organizations, including religiously affiliated 4 organizations. Bradbury-Sullivan Center works with patrons who have experienced discriminatory 5 treatment when seeking healthcare services from such organizations and it advocates on behalf of 6 those patrons by providing referrals to LGBT-welcoming agencies and providers, training agencies 7 to provide LGBT-welcoming services, and, when necessary, communicating with agencies to 8 inform them of their legal obligations to serve LGBT people. Bradbury-Sullivan Center also 9 conducts research documenting health disparities in the LGBT community and performs related 10 community-education efforts to improve public health within the LGBT community. Bradbury- 11 Sullivan Center receives pass-through funding from HHS through the Maternal and Child Health 12 Services Block Grant, and in the past also has received Ryan White funding. Bradbury-Sullivan 13 Center therefore is subject to the Denial-of-Care Rule. 14 40. Plaintiff Mazzoni Center, located in Philadelphia, Pennsylvania, is a multi-service, 15 community-based healthcare and social-service provider that primarily serves LGBTQ individuals 16 and individuals living with HIV. Its mission is to provide quality comprehensive health and 17 wellness services in an LGBTQ-focused environment, while preserving the dignity and improving 18 the quality of life of the individuals whom it serves. Mazzoni Center receives various forms of 19 federal funding, including Title X Family Planning, Centers for Disease Control, Department of 20 Justice, and Ryan White funding. Mazzoni Center therefore is subject to the Denial-of-Care Rule.

21 41. Plaintiff American Association Of Physicians For Human Rights d/b/a GLMA: 22 Health Professionals Advancing LGBT Equality (formerly known as the Gay & Lesbian 23 Medical Association) is a 501(c)(3) nonprofit membership organization based in Washington, D.C., 24 and incorporated in California. GLMA is a national organization committed to ensuring health 25 equity for lesbian, gay, bisexual, transgender, queer, and all sexual and gender minority individuals, 26 and equality for health professionals in such communities in their work and learning environments. 27 To achieve this mission, GLMA utilizes the scientific expertise of its diverse multidisciplinary 28 membership to inform and drive advocacy, education, and research. GLMA represents the interests

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1 of tens of thousands of LGBTQ health professionals and millions of LGBTQ patients and families 2 across the United States. GLMA’s membership includes approximately 1,000 member physicians, 3 nurses, advanced-practice nurses, physician assistants, researchers and academics, behavioral- 4 health specialists, health-profession students, and other health professionals throughout the country. 5 Their practices represent the major healthcare disciplines and a wide range of health specialties, 6 including internal medicine, family practice, psychiatry, pediatrics, obstetrics/gynecology, 7 emergency medicine, neurology, and infectious diseases. 8 42. Plaintiff Medical Students for Choice is a 501(c)(3) nonprofit organization based 9 in Philadelphia, Pennsylvania. MSFC provides training in the provision of abortion services to 10 medical students and residents throughout the country, works to destigmatize abortion provision, 11 and advocates for medical schools and residency programs to include abortion as part of the 12 reproductive-health-services curriculum. MSFC’s members include 163 chapters of medical 13 students and residents at medical schools in 45 States. MSFC has thousands of medical-student 14 members and thousands of alumni who are practicing physicians. 15 43. Medical students receive their clinical training disproportionally at academic 16 medical centers and teaching hospitals that receive significant federal funding. Likewise, residents 17 are almost entirely subsidized through federal funding from HHS, including through Medicare 18 grants. Residents receive salaries that are directly funded by Medicare, and hospitals bill Medicare 19 for services provided to patients by residents. MSFC guides student and resident members in how 20 to obtain abortion training and runs a reproductive-health externship program that places members 21 in abortion clinics for training. MSFC also runs its own educational programs, including a 22 competitive 400-student training institute taught by alumni. Because of resource constraints, the 23 institute is already limited to accepting fewer than half the students who apply for the program. 24 44. Many of MSFC’s members receive various forms of federal funding directly or 25 indirectly via federal programs. MSFC’s members are, thus, subject to the restrictions of the Denial- 26 of-Care Rule. Without federal funding, MSFC members may not have the resources to provide 27 proper treatment to their patients and have a reasonable fear that they could be sanctioned and lose 28 federal funding for providing and training others to provide abortion.

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1 45. Through its student and resident members across the country and its alumni who are 2 practicing physicians at hospitals and clinics, MSFC is aware that many hospitals, healthcare 3 facilities, and educational programs no longer provide abortion care or training. Because the 4 Denial-of-Care Rule creates strong incentives for even more healthcare institutions to cease 5 providing abortion training (including by putting at risk federal funding for those institutions that 6 provide such training), the Rule will further strain MSFC’s resources and threaten its mission of 7 ensuring that doctors receive training in abortions and abortion-related care. 8 46. Plaintiff AGLP: The Association of LGBTQ Psychiatrists is a 501(c)(3) nonprofit 9 organization based in Philadelphia, Pennsylvania. AGLP, the oldest association of LGBTQ+ 10 professionals in the country, is a national organization of psychiatrists that educates and advocates 11 on LGBTQ mental-health issues. AGLP represents the interests of 450 LGBTQ+ psychiatrists 12 throughout the country who are members of the Association, and works to influence policies 13 relevant to the LGBTQ+ community, as well as to support its members and advocate for its 14 members’ patients. AGLP also assists medical students and residents in their professional 15 development; encourages and facilitates the presentation of programs and publications relevant to 16 LGBTQ concerns at professional meetings; and serves as liaison with other minority and advocacy 17 groups within the psychiatric community. Many of AGLP’s members receive various forms of 18 federal funding directly or indirectly via federal programs. AGLP’s members therefore are subject 19 to the restrictions of the Denial-of-Care Rule. Without federal funding, AGLP members may not 20 have the resources to provide proper treatment to their patients or proceed with their medical- 21 research programs. AGLP’s members, therefore, have a reasonable fear that they could be 22 sanctioned and lose federal funding for the work that they do in enforcing nondiscrimination 23 policies and ensuring patient care in accordance with medical standards of care and ethical 24 requirements, which are vital to providing proper care to patients. 25 B. Defendants 26 47. Defendant HHS is a cabinet department of the federal government, headquartered 27 in the District of Columbia. It has responsibility for, among other things, enhancing and protecting 28 Americans’ health and well-being via the provision of health and human services.

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1 48. Defendant Alex M. Azar, II is the Secretary of HHS and is sued in his official 2 capacity. Secretary Azar is responsible for all aspects of the operation and management of HHS, 3 including the adoption, administration, and enforcement of the Denial-of-Care Rule. 4 STATEMENT OF FACTS 5 A. Statutory Background 6 49. A network of federal statutes mandates nondiscriminatory treatment of patients and 7 healthcare workers. Some statutes mandate that patients receive nondiscriminatory access to 8 healthcare, information about treatment options, and emergency services. Other statutes allow 9 individuals or entities to object to participating in certain medical procedures on religious or moral 10 grounds and prohibit discrimination against them. These statutes, together with the patients’ 11 constitutional rights and healthcare providers’ duties of care and ethical obligations, require 12 healthcare providers to accommodate religious objections in a manner that does not interfere with 13 the delivery of services or information to patients. 14 1. Laws Protecting Patients’ Access to Care and Information 15 50. Congress has repeatedly recognized the paramount importance of providing patients 16 with prompt and nondiscriminatory access to medical care and to information about all treatment 17 options. 18 51. For example, Section 1554 of the Patient Protection and Affordable Care Act (ACA) 19 provides that “[n]otwithstanding any other provision of this Act, the Secretary of Health and Human 20 Services shall not promulgate any regulation that—

21 (1) creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care; 22 (2) impedes timely access to healthcare services; 23 24 (3) interferes with communications regarding a full range of treatment options between the patient and the provider; 25 (4) restricts the ability of healthcare providers to provide full disclosure of all relevant 26 information to patients making healthcare decisions;

27 (5) violates the principles of informed consent and the ethical standards of healthcare professionals; or 28

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1 (6) limits the availability of healthcare treatment for the full duration of a patient’s medical needs.” 2 42 U.S.C. § 18114. 3 52. Section 1557 of the ACA, 42 U.S.C. § 18116, similarly protects against 4 discrimination in the provision of healthcare services. It provides: “[A]n individual shall not, on [a] 5 ground prohibited under title VI of the Civil Rights Act of 1964, title IX of the Education 6 Amendments of 1972, the Age Discrimination Act of 1975, or section 504 of the Rehabilitation 7 Act of 1973, be excluded from participation in, be denied the benefits of, or be subjected to 8 discrimination under, any health program or activity, any part of which is receiving Federal 9 financial assistance.” This provision therefore prohibits discrimination based on sex, including 10 discrimination based on a patient’s failure to conform to sex stereotypes, gender identity, or 11 transgender status, all of which are forms of sex discrimination. 12 53. The Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd(b)(1) 13 (“EMTALA”) governs when and how a patient must be examined and offered treatment (including 14 medically necessary abortion services) while in an unstable medical condition. It requires a hospital 15 that “determines that [an] individual has an emergency medical condition” to “provide either—(A) 16 within the staff and facilities available at the hospital, for such further medical examination and 17 such treatment as may be required to stabilize the medical condition, or (B) for transfer of the 18 individual to another medical facility . . . .” Id. 19 54. The ACA, which respects certain religious objections to healthcare procedures, 20 makes clear that nothing in it may “be construed to relieve any healthcare provider from providing 21 emergency services as required by State or Federal law,” including EMTALA. 42 U.S.C. 22 § 18023(d). 23 55. Title X of the Public Health Service Act, 42 U.S.C. §§ 300-300a-6, provides federal 24 funding for family-planning services. Congress requires Title X grantees to operate “voluntary 25 family planning projects which shall offer a broad range of acceptable and effective family planning 26 methods and services.” 42 U.S.C. § 300(a). Title X appropriations bills, e.g., 2019 Continuing 27 Appropriations Act, Pub. L. No. 115-245, Div. B., Tit. II, 132 Stat. 2981, 3070-71 (2018), require 28

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1 that “all pregnancy counseling shall be nondirective”; in other words, funded projects are to offer 2 pregnant women neutral, nonjudgmental information and counseling regarding their options, 3 including prenatal care and delivery; infant care, foster care, or adoption; and pregnancy 4 termination. 5 2. Laws Protecting Religious Objectors 6 56. Certain statutes applicable to recipients of federal funds allow individuals to opt out 7 of participating in certain medical procedures, training, or research based on their religious beliefs 8 or moral convictions, and prohibit discrimination against individuals or entities for asserting such 9 objections. These laws include, among others, the Weldon Amendment, e.g., Department of 10 Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and 11 Continuing Appropriations Act, 2019, Pub. L. 115-245, § 507(d)(2), 132 Stat. 2981, 3118 (2018); 12 the Coats-Snowe Amendment, 42 U.S.C. § 238n; and the Church Amendments, 42 U.S.C. § 300a- 13 7. 14 57. The Weldon Amendment is a rider that has been attached to the Labor, Health, and 15 Human Services, and Education, and Related Agencies Appropriations Act every year since 2004. 16 162 Cong. Rec. H4844, H4852 (July 13, 2016) (Rep. Weldon). It provides that none of the funds 17 appropriated under that Act “may be made available to a Federal agency or program, or to a State 18 or local government, if such agency, program, or government subjects any institutional or 19 individual healthcare entity to discrimination on the basis that the healthcare entity does not 20 provide, pay for, provide coverage of, or refer for abortions.” Pub. L. 115-245, § 507(d)(2), 132 21 Stat. 2981, 3118 (2018). 22 58. The Coats-Snowe Amendment prohibits abortion-related governmental 23 discrimination in the area of medical training. It provides that “[t]he federal government, and any 24 state or local government that receives Federal financial assistance,” may not discriminate against 25 a healthcare entity because “the entity refuses to undergo training in the performance of induced 26 abortions, to require or provide such training, to perform such abortions, or to provide referrals for 27 such training or such abortions,” 42 U.S.C. § 238n(a)(1); “refuses to make arrangements” for those 28

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1 activities, id. § 238n(a)(2); or attends or attended a program that does not perform abortions or 2 provide training in abortion care, id. § 238n(a)(3). 3 59. The Church Amendments, which were adopted in the 1970s, provide certain 4 protections for religious and moral objections arising in medical research and training. One 5 subsection provides that the receipt of certain federal funds by a healthcare provider does not 6 authorize “any court or any public official or other public authority” to require an individual to 7 perform or assist in the performance of an abortion or sterilization procedure, or to require an entity 8 to make its facilities or personnel available for those procedures. 42 U.S.C. § 300a-7(b). Another 9 subsection provides that an entity receiving federal funding for biomedical or behavioral research 10 may not discriminate against personnel on the basis that they refused on religious or moral grounds 11 to participate in a research or healthcare activity. 42 U.S.C. § 300a-7(c). A third subsection 12 provides that an entity receiving certain federal funds may not discriminate against a physician or 13 health care personnel in employment, promotion, termination, or the extension of staff or other 14 privileges because he performed or refused to perform or assist in the performance of an abortion 15 or sterilization procedure on the grounds that it would be contrary to his religious beliefs or moral 16 convictions. 42 U.S.C. § 300a-7(c)(1). A fourth subsection prohibits discrimination by certain 17 funding recipients against applicants for training or study based on their “reluctance, or willingness, 18 to counsel, suggest, recommend, assist, or in any way participate in abortions or sterilizations” 19 because of “the applicant’s religious beliefs or moral convictions.” 42 U.S.C. § 300a-7(e). 20 60. Subsection (d) of the Church Amendments provides that “[n]o individual shall be 21 required to perform or assist in the performance of any part of a health service program or research 22 activity funded in whole or in part under a program administered by the Secretary of Health and 23 Human Services if his performance or assistance in the performance of such part of such program 24 or activity would be contrary to his religious beliefs or moral convictions.” 42 U.S.C. § 300a-7(d). 25 61. The ACA prohibits discrimination by any recipient of federal funds against persons 26 or entities because of their refusal to cause or assist in suicide or euthanasia, 42 U.S.C. § 18113; 27 provides that the ACA does not require a health-insurance plan to provide coverage for abortions, 28 42 U.S.C. § 18023(b)(1)(A); prohibits any “qualified health plan offered through an [Insurance]

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1 Exchange” from “discriminat[ing] against any individual healthcare provider or facility because” 2 it does not “provide, pay for, provide coverage of, or refer for abortions,” 42 U.S.C. § 18023(b)(4); 3 and states that the ACA should not be construed to affect other federal laws regarding “conscience 4 protection” or willingness or refusal to provide abortions, 42 U.S.C. § 18023(c)(2)(A)(i)-(iii). 5 62. Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq., prohibits 6 discrimination against employees based on their religious beliefs and requires accommodation of 7 religious practices. Importantly, employers’ ability to ensure reliable care for their patients is 8 recognized as a “business necessity,” 42 U.S.C. § 2000e-2(k)(1)(A)(i), and religious 9 accommodation is required only if, and only to the extent that, it does not create “undue hardship,” 10 42 U.S.C. § 2000e( j). 11 3. The Implementation and Enforcement of Religious-Objection Laws 12 63. The religious-objection laws described above are self-executing and do not require 13 regulations to go into effect. Accordingly, healthcare providers covered by the laws, including both 14 the County and the private-healthcare-provider Plaintiffs, have adopted policies that accommodate 15 conscience interests without compromising patients’ access to care and information. 16 64. Nevertheless, HHS previously promulgated regulations purporting to clarify and 17 implement the religious-objection laws. On December 19, 2008, more than nine years before it 18 proposed the Denial-of-Care Rule, HHS promulgated a final rule that purported to implement the 19 Church Amendments, the Weldon Amendment, and the Coates-Snowe Amendment. See Ensuring 20 That Dep’t of Health & Human Services Funds Do Not Support Coercive or Discriminatory 21 Policies or Practices in Violation of Federal Law, 73 Fed. Reg. 78,072 (Dec. 19, 2008). On January 22 20, 2009, the final rule went into effect. 23 65. On March 10, 2009, HHS proposed to rescind the January 2009 rule in its entirety. 24 It noted that no statutory provision required promulgation of regulations and that commenters had 25 raised numerous questions and concerns about the regulations. See Rescission of the Regulation 26 Entitled “Ensuring That Dep’t of Health & Human Services Funds Do Not Support Coercive or 27 Discriminatory Policies or Practices in Violation of Federal Law”; Proposal, 74 Fed. Reg. 10,207 28 (Mar. 10, 2009).

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1 66. On February 23, 2011, HHS largely rescinded the regulations but retained 2 provisions delegating to HHS’s Office for Civil Rights (“OCR”) the authority to receive complaints 3 of violations of religious-objection laws. See Regulation for the Enforcement of Federal Health 4 Care Provider Conscience Protection Laws, 76 Fed. Reg. 9968 (Feb. 3, 2011). 5 67. The Rule challenged in this action is a centerpiece of the Trump Administration’s 6 concerted, aggressive effort to expand enforcement of religious-objection laws at the expense of 7 patients. On January 18, 2018, the Acting Secretary of HHS established a new Conscience and 8 Religious Freedom Division within OCR and delegated to this new Division the responsibility to 9 enforce religious-objection laws. OCR then increased the budget of the Conscience and Religious 10 Freedom division by $1.546 million. OCR also modified its mission statement to emphasize a 11 commitment to enforce “federal laws that guarantee the protection of conscience and free exercise 12 of religion and prohibit coercion and religious discrimination in HHS-conducted or funded 13 programs.” When it promulgated the final Denial-of-Care Rule, HHS emphasized OCR’s “singular 14 and critical responsibility . . . to vigorously enforce” federal conscience laws. See Protecting 15 Statutory Conscience Rights in Health Care, 84 Fed. Reg. 23,170, 23,178 (May 21, 2019) (to be 16 codified at 45 C.F.R. Pt. 88). 17 C. The Proposed Denial-of-Care Rule 18 68. On January 26, 2018, the Acting Secretary proposed the Denial-of-Care Rule. See 19 Protecting Statutory Conscience Rights in Health Care; Delegation of Authority, 83 Fed. Reg. 3880 20 (Jan. 28, 2018). The proposed Rule, like the final Rule, adopted an expansive construction of the 21 religious-objection laws; ignored healthcare providers’ obligations to ensure their patients’ 22 uninterrupted access to care and information and to advance the providers’ own missions as 23 healthcare institutions; imposed costly certification and recordkeeping requirements; would 24 undermine Plaintiffs’ ability to fulfill their missions; would require healthcare providers to rewrite 25 and re-conceptualize their existing religious-objection policies; and threatened draconian penalties 26 for violations without providing sufficient guidance on how to comply with the Rule. 27 69. During the 60-day notice-and-comment period, more than 72,000 comments were 28 filed by interested parties, including medical associations, medical providers, civil-rights

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1 organizations, states, and local governments. See 84 Fed. Reg. 23,170, 23,180 & n.41 (May 21, 2 2019). The comments explained that the proposed Rule’s expansive new right-of-refusal provisions 3 were unworkable; that the Rule would upset well-developed practices by healthcare providers and 4 medical schools that respect religious objections without compromising patient care; that it 5 conflicted with federal and state laws and medical ethics; that it would violate patients’ and 6 providers’ constitutionally protected rights; that it would severely threaten access to reproductive 7 healthcare and LGBT healthcare; and that it threatened to deprive the nation’s most vulnerable 8 citizens of healthcare by stripping States and hospitals of Medicare and Medicaid funds.1 9 70. Commenters identified the following problems, among others, with the proposed 10 Rule: 11 (a) The Rule would conflict with long-standing practices by healthcare 12 providers and medical schools that protect both the interests of healthcare workers and entities with 13 religious objections and the rights of the patients whom they serve. Indeed, commenters explained, 14 the Rule’s prohibitions are framed so broadly that they invite healthcare workers to deny 15 information and treatment to people without even alerting the medical facility or the patient that 16 they have done so, thereby preventing the facility or the patient from protecting the patient’s 17 interests.2 18 (b) Because the Rule would interfere with the effective management of religious 19 objections, it would increase barriers to care and deprive some patients of care altogether— 20 including in emergency situations. Commenters demonstrated that when healthcare providers give 21 22 23 1 Medicare is the federal insurance program principally for elderly and disabled individuals. 24 Medicaid provides health coverage to millions of Americans, including eligible low-income adults, children, pregnant women, elderly adults, and people with disabilities. Medicaid is administered by 25 the States, according to federal requirements, and is funded jointly by States and the federal government. 26 2 See, e.g., Comments of Lambda Legal HHS-OCR-2018-0002-72186; Comments of Office of the 27 County Counsel, County of Santa Clara HHS-OCR-2018-0002-54930; Comments of GLMA HHS- OCR-2018-0002-71703; Comments of National Family Planning & Reproductive Health 28 Association HHS-OCR-2018-0002-70260.

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1 religious concerns priority over patient well-being, patients are denied care and information about 2 treatment options.3 3 (c) The Rule would encourage discrimination by health professionals based on 4 sex, sexual orientation, gender identity, transgender status, and HIV status. 5 (d) Because it allows the imposition of catastrophic sanctions while failing to 6 articulate practicable methods of compliance, the Rule would cause many healthcare providers to 7 scale back their services drastically or close certain of their clinics completely, for fear of losing 8 hundreds of millions of dollars of funding for the rest of the medical services that they provide.4 9 (e) The Rule would impose significant administrative burdens on healthcare 10 providers, including burdens resulting from the rule’s recordkeeping and other compliance 11 requirements.5 12 (f) The Rule would prevent medical schools from adequately training doctors 13 to meet their professional obligations and would impair the ability to run teaching hospitals and 14 research facilities.6 15 71. The American Medical Association (AMA), among others, urged HHS to withdraw 16 the Denial-of-Care Rule.7 The AMA stated that the Rule would “undermine patients’ access to 17 medical care and information, impose barriers to physicians’ and health care institutions’ ability to 18 provide treatment, impede advances in biomedical research, and create confusion and uncertainty

19 3 See, e.g., Comments of Office of the County Counsel, County of Santa Clara HHS-OCR-2018- 20 0002-54930; Comments of Center for Reproductive Rights HHS-OCR-2018-0002-71830; Comments of Lambda Legal HHS-OCR-2018-0002-72186; Comments of Americans United for 21 Separation of Church and State HHS-OCR-2018-0002-71232; Comments of GLMA HHS-OCR- 2018-0002-71703. 22 4 Comments of National Family Planning & Reproductive Health Association HHS-OCR-2018- 23 0002-70260; Comments of Wisconsin Hospital Association, Inc. HHS-OCR-2018-0002-66144. 5 Comments of Wisconsin Hospital Association, Inc. HHS-OCR-2018-0002-66144. 24 6 Comments of Association of American Medical Colleges HHS-OCR-2018-0002-67592 (“AAMC 25 Comment”). 26 7 Comments American Medical Association HHS-OCR-2018-0002-70564, at 1. The AMA is the largest association of doctors and medical students in the United States. The AMA’s mission is “to 27 promote the art and science of medicine and the betterment of public health.” The AMA maintains the AMA Code of Medical Ethics, a guide to the ethical practice of medicine created by the AMA 28 in 1847.

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1 among physicians, other health care professionals, and health care institutions about their legal and 2 ethical obligations to treat patients.” Similarly, the Association of American Medical Colleges 3 warned that adoption of the Rule would “result in harm to patients, undermine standards of medical 4 professionalism, and raise serious concerns regarding individuals’ rights that are protected by other 5 federal and state laws.”8 6 D. The Final Denial-of-Care Rule 7 72. Despite the significant concerns raised during the comment period, HHS published 8 the final Rule in the Federal Register on May 21, 2019. See Protecting Statutory Conscience Rights 9 in Health Care, 84 Fed. Reg. 23,170 (May 21, 2019). It is attached as Exhibit 1 and incorporated 10 by reference. 11 73. In adopting the final Rule, HHS failed adequately to address many of the serious 12 issues raised by commenters, including the practical difficulties associated with the Rule, its 13 conflict with obligations relating to emergency care and informed consent, and its detrimental 14 effects on patients. HHS also lacked data to support its decisions and conclusions, refused without 15 justification to credit the data that commenters submitted to it, and failed to consider alternatives to 16 the Rule that would impose fewer costs and burdens on patients and providers. Furthermore, HHS 17 repeatedly declined to clarify key issues or to provide guidance to regulated entities necessary for 18 them to implement the Rule, stating instead that it would consider numerous questions on a case- 19 by-case basis. 20 74. For example, HHS acknowledged that it “received comments expressing concern 21 about the impact of the rule on access to care in rural communities, underprivileged communities, 22 or other communities that are primarily served by religious healthcare providers or facilities.” 84 23 Fed. Reg. at 23,180. The agency responded by stating that finalizing the rule is appropriate even if 24 the rule “impact[s] overall or individual access to a particular service,” such as abortion or treatment 25 8 AAMC Comment at 1. The AAMC is not-for-profit association of 151 accredited U.S. and 17 26 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and more than 80 academic societies. 27 The AAMC serves more than 173,000 full-time faculty members, 89,000 medical students, 129,000 resident physicians, and more than 60,000 graduate students and postdoctoral researchers in the 28 biomedical sciences.

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1 for gender dysphoria. Id. at 23,182. Although it acknowledged that it lacked data to support this 2 assumption, HHS asserted that the rule would be “reasonably likely to increase, not decrease, access 3 to care” in underserved communities by attracting providers who otherwise would not practice 4 medicine because of their religious objections. Id. at 23,180. In support, HHS cited a small, 5 outdated, and unreliable political poll, id. at 23,181, in which responders stated that they would not 6 practice medicine if doing so involved violation of their religious or moral convictions but said 7 nothing about where they would practice medicine. HHS cited no data showing that the Rule was 8 needed to keep providers from quitting or that it would attract any new providers to underserved 9 communities. HHS also failed to address how an increase in providers that refuse to provide care 10 would address the concern that patients will struggle to get the care that they need. Moreover, 11 HHS’s evaluation prefers certain types of care over others: The agency assumes that access to care 12 will increase, and cites this as a benefit of the Rule, but does not contradict comments asserting that 13 certain types of care, including reproductive healthcare and LGBT care, will be reduced, especially 14 in rural areas. 15 75. HHS rejected comments observing that the Rule conflicted with EMTALA. See 84 16 Fed. Reg. at 23,182-23,183. But it failed to address whether emergency exceptions are permissible, 17 and it cited cases where nurses with religious objections were required to assist patients in 18 emergencies as examples of discrimination that it was trying to remedy. Id. at 23,176. HHS also 19 stated that driving a patient to the hospital in an ambulance for an emergency procedure may qualify 20 as assisting in the performance of a procedure, id. at 23,188, without acknowledging that the 21 procedure (removal of an ectopic pregnancy) could be necessary to save the patient’s life. In so 22 doing, HHS failed to provide any clear rule for determining whether or when ambulance drivers 23 and paramedics might object under the Rule to caring for or transporting a patient, instead stating 24 that this determination depends on the facts and circumstances of each case. Id. HHS also failed to 25 acknowledge or address the risk to patients’ lives if paramedics or other individuals who provide 26 emergency care refuse to administer needed treatments or refuse to transport patients when no 27 alternate staff member is immediately available to perform the service. 28

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1 76. HHS acknowledged that the Rule has the potential to harm patients. See 84 Fed. 2 Reg. at 23,251 (“First, the patient’s health might be harmed if an alternative is not readily found, 3 depending on the condition. Second, there may be search costs for finding an alternative. Third, the 4 patient may experience distress associated with not receiving a procedure he or she seeks.”). Yet it 5 made no efforts to craft provisions that would reduce the risk of harm to patients. Instead, without 6 evidence, HHS downplayed the risks that patients would be harmed by assuming that various types 7 of objections would not be raised. See, e.g., id. at 23,188 (stating that HHS is unaware of any 8 medical professionals who would object to treating or transporting patients experiencing 9 complications after an abortion); id. at 23,244 (stating that HHS “is unaware of any religious or 10 ethical belief systems that prohibit treatment of a person on the basis of their HIV status”). It also 11 suggested, without citing statutory language, that the enactment of religious-objection laws justified 12 any harm to patients resulting from their enforcement. See, e.g., 84 Fed. Reg. at 23,251 (recognizing 13 that “some patients do experience emotional distress as a consequence of providers’ exercise of 14 religious beliefs or moral convictions” but stating that Congress “did not establish balancing tests 15 that weigh such emotional distress against the right to abide by one’s conscience”). 16 77. HHS asserted that any harm to patients was attributable not to the Denial-of-Care 17 Rule but to the religious-objection statutes themselves. For that reason, HHS deemed it unnecessary 18 to quantify the harm to patients. It concluded that “it is appropriate to finalize this rule . . . even 19 though the Department and commenters do not have data capable of quantifying all of its effects 20 on the availability of care.” 84 Fed. Reg. at 23,182. Again invoking purported congressional policy, 21 the agency deemed religious refusals “worth protecting even if they impact overall or individual 22 access to a particular service, such as abortion.” Id.; see id. at 23,251 (asserting that “objections 23 based on potential (often temporary) lack of access to particular procedures as a result of 24 enforcement of the law are really objections to policy decisions made by the people’s 25 representatives in Congress”). 26 1. The Rule’s Overly Broad and Distorted Definitions 27 78. Although HHS repeatedly attributes the Rule’s harmful consequences to the 28 underlying statutes, the Rule sharply departs from the will of Congress. The Rule contains

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1 numerous prohibitions, applicable to specified funding recipients, that purport to implement the 2 religious-objection laws. See 84 Fed. Reg. at 23,264, § 88.3. But the Rule defines or redefines key 3 statutory terms, expanding their reach far beyond their ordinary meaning and congressional intent. 4 See 84 Fed. Reg. at 23,263-23,264, § 88.2. 5 79. Through these overly broad definitions, the Rule will encourage individuals or 6 institutional healthcare providers, or even someone with only a tangential connection to a procedure 7 (such as a receptionist, lab technician, bookkeeper, janitor, or volunteer), to claim an absolute right 8 to refuse to provide or have any connection whatsoever to providing healthcare and information 9 based on a religious or moral objection—regardless of the impact on patients and on other 10 healthcare providers. The Rule also invites these individuals to refuse to provide a referral to 11 another provider or even general information about services to which the refuser objects, thereby 12 denying patients critical information about their treatment options. Taken together, these definitions 13 will embolden almost any person or entity whose work has even a vague tie to healthcare delivery 14 to decline to provide and even to block needed medical care, services, administrative support, 15 advice, and information. 16 80. The Rule redefines key terms with extraordinary and unwarranted breadth, 17 distorting the underlying statutes’ meaning. These terms are either undefined or more narrowly 18 defined in the underlying statues. When read together, the definitions of “assist in the performance,” 19 “refer,” “health care entity,” and “discriminate” greatly expand the Rule’s prohibitions beyond the 20 authority granted in any of the statutes. The Rule therefore interconnects various, separately enacted 21 provisions of the Coates, Weldon, and Church Amendments to create an unlawful regulation that 22 expands religious refusals to an unworkable, dangerous degree. For example, as discussed more 23 fully below, the definition of “assist in the performance” includes the term “refer,” which in turn is 24 defined with unprecedented breadth. 25 81. The Rule prohibits all federal funding recipients, including subrecipients, from 26 “requir[ing]” any “individual to perform or assist in the performance of any part of a health 27 service program or research activity . . . if the individual’s performance or assistance in the 28 performance of such part of such program or activity would be contrary to his religious beliefs or

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1 moral convictions.” 84 Fed. Reg. at 23,265, § 88.3(a)(2)(vi) (emphasis added). The Rule defines 2 the key terms with extraordinary and unwarranted breadth, thus distorting the underlying statutes’ 3 meaning. 4 82. First, the Rule defines “assist in the performance” extremely broadly to include 5 activities only tangentially related to any healthcare procedure. Only the Church Amendments refer 6 to “assist[ing] in the performance” of an activity, and nothing in that statutory scheme envisions 7 the broad definition in the Rule. 42 U.S.C. § 300a-7. Under the Rule, however, to “assist in the 8 performance” means to “take an action that has a specific, reasonable, and articulable connection 9 to furthering a procedure or a part of a health service program or research activity undertaken by 10 or with another person or entity,” including “counseling, referral, training, or otherwise making 11 arrangements for the procedure or a part of a health service program or research activity, depending 12 on whether aid is provided by such actions.” 84 Fed. Reg. at 23,263, § 88.2. 13 83. HHS rejected arguments that the definition was too broad, explaining instead that 14 the agency intends the Rule to be defined expansively. 84 Fed. Reg. at 23,186-23,187. The agency 15 likewise defended its inclusion of counseling and referral within the definition of “assist in the 16 performance,” asserting without authority that these are “common and well understood forms of 17 assistance that help people reach desired medical ends.” Id. at 23,188. But Congress made specific 18 references to “counsel[ing]” in one of the Church Amendments’ provisions, “training” in the Coats- 19 Snowe Amendment, and “refer for” in the Weldon Amendment. The separation of these terms in 20 the statutes is evidence of Congress’s intent to distinguish them. Yet the Rule includes each 21 category of actions, which themselves are defined with incredible breadth, within the definition of 22 “assist in the performance.” The inclusion of a panoply of additional activities within the definition 23 of “assist in the performance” is contrary to the statutes. 24 84. Second, the Rule defines “referral or refer”—terms that are part of the definition 25 of “assist in the performance”—with extreme breadth. Expanding those terms beyond any 26 commonsense understanding or traditional meaning in the medical context, the Rule defines them 27 to include the “provision of information in oral, written, or electronic form (including names, 28 addresses, phone numbers, email or web addresses, directions, instructions, descriptions, or other

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1 information resources), where the purpose or reasonably foreseeable outcome of provision of the 2 information is to assist a person in receiving funding or financing for, training in, obtaining, or 3 performing a particular health care service, program, activity, or procedure.” 84 Fed. Reg. at 4 23,264, § 88.2. This definition goes far afield from what is traditionally considered referral or 5 counseling, instead expanding it to invite an individual worker—one who may lack the medical 6 expertise or information about a patient’s medical history to understand the implications of this 7 decision—to refuse to notify either the patient or the worker’s employer of the decision to deny 8 information or care. When read in conjunction with the definition of “assist in the performance,” 9 this definition empowers an unprecedented universe of individuals to deny care and information 10 without providing these essential and ethically required notifications. The limited provisions of the 11 Rule that permit healthcare providers to require certain, limited advance notice of refusals, 12 discussed more fully below, are not sufficient to cure the unreasonable breadth and unworkability 13 of this definition. 14 85. By defining participation in a procedure as any activity with “a specific, reasonable, 15 and articulable connection” to a procedure; by explicitly including referrals, counseling, training. 16 and arrangements for a procedure; and by defining “referral” to include the provision of any 17 information that may foreseeably lead a person to obtain training, funding, or services, the Rule 18 vastly expands the class of people who will be empowered to assert objections and the activities 19 that may be the subject of objections. 20 86. The Rule defines “workforce” broadly to mean “employees, volunteers, trainees, 21 contractors, and other persons whose conduct, in the performance of work for an entity or health 22 care entity, is under the direct control of such entity or health care entity, whether or not they are 23 paid by the entity or health care entity, as well as health care providers holding privileges with the 24 entity or health care entity.” 84 Fed. Reg. at 23,264, § 88.3. The proposed Rule defined the word 25 “individual”—a word used in several of the Rule’s prohibitions—to include any member of an 26 entity’s workforce. 83 Fed. Reg. at 3924, § 88.2. That definition of “individual” was deleted from 27 the Rule, but the definition of “workforce” was retained. And the preamble’s discussion of that 28 decision makes clear that HHS’s Office for Civil Rights still asserts that it may interpret that term

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1 to include members of the “workforce” as defined in the Rule, stating that “sometimes [the term 2 individual] refers to members of the workforce of an entity or health care entity. . . .”). 84 Fed. Reg. 3 at 23,199. 4 87. The preamble to the Rule makes clear that these definitions allow objections to be 5 raised by a receptionist who schedules an appointment, a janitor who prepares an operating room, 6 an orderly who provides patients with assistance in the recovery room, or an ambulance driver who 7 transports a patient to the hospital. See 84 Fed. Reg. at 23,186-23,187. 8 88. Indeed, the Rule could be read to cover virtually any healthcare-related task, 9 including providing information about treatment options and coverage information to allow for 10 informed consent; providing, collecting, or filing forms related to patients’ health history, insurance 11 information, or informed consent; escorting patients to treatment areas; cleaning or restocking 12 treatment rooms, operating rooms, ambulances, or other facilities to allow for treatment of patients; 13 billing, collecting fees for, and administering insurance reimbursements for treatment; and even 14 minor administrative, clerical, or supporting tasks such as scheduling appointments. Invoking the 15 definitions of “assist in the performance” and “refer,” a worker could feel empowered to object to 16 providing even basic information to a patient—such as information about insurance coverage, the 17 phone number of a medical office, or directions to a bus stop—on the theory that the worker would 18 thereby be “assisting in the performance” of a procedure to which the worker has a moral objection. 19 89. These terms reach even further when read in conjunction with the Rule’s definition 20 of “discriminate.” As noted above, several statutes prohibit discrimination based on the assertion 21 of religious objections in specified circumstances. The Rule includes prohibitions employing 22 language from these statutes (e.g., 84 Fed. Reg. at 23,265, § 88.3(a)(2)(iv), citing 42 U.S.C. 300a- 23 7(c)(1)), but defines the word “discriminate” in an unreasonable and arbitrary manner, dramatically 24 expanding what the supposed authorizing statutes actually require or provide. That definition has 25 no basis in law and undermines policies designed to reconcile religious objections and the needs of 26 patients. 27 90. Under the Rule, “discriminate” means “(1) [t]o withhold, reduce, exclude from, 28 terminate, restrict, or make unavailable or deny any grant, contract, subcontract, cooperative

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1 agreement, loan, license, certification, accreditation, employment, title, or other similar instrument, 2 position, or status; (2) [t]o withhold, reduce, exclude from, terminate, restrict, or make unavailable 3 or deny any benefit or privilege or impose any penalty; or (3) [t]o utilize any criterion, method of 4 administration, or site selection, including the enactment, application, or enforcement of laws, 5 regulations, policies, or procedures directly or through contractual or other arrangements, that 6 subjects individuals or entities protected under this part to any adverse treatment with respect to 7 individuals, entities, or conduct protected under this part on grounds prohibited under an applicable 8 statute encompassed by this part.” 84 Fed. Reg. at 23,263, § 88.2. 9 91. This definition appears to classify as prohibited discrimination any action having 10 the slightest negative effect, even if there is a compelling reason for that action. Although Title VII 11 of the Civil Rights Act of 1964 provides that employers need not provide accommodations for an 12 employee’s religious beliefs when the accommodation would cause undue hardship to the 13 employer, the Rule incorporates no such consideration and does not recognize any exception for 14 business necessity or acknowledge that employers may have legitimate, nondiscriminatory reasons 15 for an allegedly adverse employment action. As a result, it appears that a healthcare entity could be 16 deemed to have engaged in unlawful discrimination when it takes measures that are reasonably 17 necessary to ensure patient care notwithstanding the religious views of individual workers—such 18 as taking religious objections into account when making scheduling decisions, enforcing policies 19 requiring advance notice of religious objections, requiring employees to tell someone when they 20 have refused to provide care to a patient, or considering whether a job candidate is willing to 21 perform the essential duties of the position or deliver healthcare services critical to the providers’ 22 mission when making hiring decisions. 23 92. HHS incorporated into the definition of “discrimination” exceptions that 24 purportedly allow certain methods, such as advance-notice requirements and use of alternate staff, 25 that providers use to reconcile objections with the needs of patients. But these provisions are 26 unreasonably narrow, vague, and unworkable. 27 93. First, the definition states that “an entity subject to any prohibition in this part shall 28 not be regarded as having engaged in discrimination against a protected entity where the entity

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1 offers and the protected entity [i.e., an employee or volunteer] voluntarily accepts an effective 2 accommodation for the exercise of such protected entity’s protected conduct, religious beliefs, or 3 moral convictions.” 84 Fed. Reg. at 23,263, § 88.2. The requirement that an accommodation be 4 “voluntarily accept[ed]” does not say what providers should do when an employee rejects an 5 offered accommodation and demands an accommodation that would put patients at risk or 6 otherwise compromise patient care. 7 94. The definition also states that “an entity subject to any prohibition in this part may 8 require a protected entity to inform it of objections to performing, referring for, participating in, or 9 assisting in the performance of specific procedures, programs, research, counseling, or treatments, 10 but only to the extent that there is a reasonable likelihood that the protected entity may be asked in 11 good faith to perform, refer for, participate in, or assist in the performance of, any act or conduct 12 just described. Such inquiry may only occur after the hiring of, contracting with, or awarding of a 13 grant or benefit to a protected entity, and once per calendar year thereafter, unless supported by a 14 persuasive justification.” 84 Fed. Reg. at 23,263, § 88.2. 15 95. This provision sharply constrains providers’ ability to require that workers provide 16 notice of their objections to procedures. Healthcare institutions may ask about “specific” 17 procedures, research, and treatment only; they may ask for advance notice of objections only if 18 there is “a reasonable likelihood” that the particular worker will be asked to participate in the 19 particular procedures; they may ask only after the worker is hired and then only once per year 20 thereafter. The Rule does not indicate how providers may handle unanticipated objections or 21 situations. Nor does it authorize providers to adopt policies requiring workers to alert them when 22 the workers decline to provide needed medical care or information to a patient, or (if the workers 23 have given such notice) when they decide to object to additional categories of patients or 24 procedures. And the Rule prohibits any questioning about religious objections before hiring, 25 notwithstanding the immense burden that would fall on a healthcare provider if it learned after 26 hiring a worker that the worker is unwilling to perform the critical and even primary aspects of the 27 job for which the worker was hired. 28

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1 96. Finally, the Rule limits the ability of healthcare providers to ensure that patients are 2 not denied care because of a religious objection. The Rule states that “[t]he taking of steps by an 3 entity subject to prohibitions in this part to use alternate staff or methods to provide or further any 4 objected‐to conduct . . . would not, by itself, constitute discrimination or a prohibited referral, if 5 such entity does not require any additional action by, or does not take any adverse action against, 6 the objecting protected entity (including individuals or health care entities), and if such methods do 7 not exclude protected entities from fields of practice on the basis of their protected objections. 8 Entities subject to prohibitions in this part may also inform the public of the availability of alternate 9 staff or methods to provide or further the objected‐to conduct, but such entity may not do so in a 10 manner that constitutes adverse or retaliatory action against an objecting entity.” 84 Fed. Reg. at 11 23,263, § 88.2. By appearing to foreclose requiring any “additional action” by objectors, the Rule 12 suggests that providers may not even require objectors to assist in transferring patients to alternative 13 providers or to tell patients that an alternative provider is available. Instead, the Rule envisions that 14 providers will post public notices to inform patients about the availability of alternatives. That will 15 create anxiety by alerting patients that some of a healthcare facility’s staff may refuse to treat them. 16 The patients may have no idea that they may need a treatment to which a healthcare worker might 17 object. This inappropriately shifts to patients the burden of anticipating possible objections by 18 employees and finding a way to ensure that they still can receive needed care and information. 19 97. The Rule also expansively redefines “health care entity”—a phrase that is used in 20 both the Coats-Snowe Amendment and the Weldon Amendment and is specifically defined in each. 21 The Rule’s new definition expands “health care entity” to include new entities not covered by either 22 statute. In so doing, the Rule goes far beyond those statutes’ scope. 23 98. Under the Coats-Snowe Amendment, “health care entity” “includes an individual 24 physician, a postgraduate physician training program, and a participant in a program of training in 25 the health professions.” 42 U.S.C. § 238n(c)(2). Under the Rule, “health care entity” for purposes 26 of the Coats-Snowe Amendment includes “an individual physician or other health care 27 professional, including a pharmacist; health care personnel; a participant in a program of training 28 in the health professions; an applicant for training or study in the health professions; a post‐graduate

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1 physician training program; a hospital; a medical laboratory; an entity engaging in biomedical or 2 behavioral research; a pharmacy; or any other health care provider or health care facility.” 84 Fed. 3 Reg. at 23,264, § 88.2. 4 99. Under the Weldon Amendment, “ ‘health care entity’ includes an individual 5 physician or other health care professional, a hospital, a provider-sponsored organization, a health 6 maintenance organization, a health insurance plan, or any other kind of health care facility, 7 organization, or plan.” E.g., Pub. L. 115-245, § 507(d)(2), 132 Stat. 2981, 3118 (2018). But in the 8 Rule, “health care entity” for purposes of the Weldon Amendment is defined to include “an 9 individual physician or other health care professional, including a pharmacist; health care 10 personnel; a participant in a program of training in the health professions; an applicant for training 11 or study in the health professions; a post‐graduate physician training program; a hospital; a medical 12 laboratory; an entity engaging in biomedical or behavioral research; a pharmacy; a provider‐ 13 sponsored organization; a health maintenance organization; a health insurance issuer; a health 14 insurance plan (including group or individual plans); a plan sponsor or third‐party administrator; 15 or any other kind of health care organization, facility, or plan.” 84 Fed. Reg. at 23,264, § 88.2. 16 100. Through these sweeping definitions, the Rule broadens the universe of potential 17 objectors to include individuals and entities not included in either of the statutory definitions of 18 “health care entity,” including applicants for training and study and pharmacists. And the Rule 19 expands the definition of “health care entity” for purposes of the Coats-Snowe Amendment to 20 include any healthcare professional, healthcare provider, or healthcare facility, notwithstanding that 21 such general terms do not appear in the statutory definition. 22 101. The Rule uses the term “sterilization” to describe medically necessary, gender- 23 affirming healthcare procedures sought by transgender patients. It does so to justify denials of care 24 to transgender and gender-nonconforming patients. But that understanding of the term sterilization 25 is inaccurate—it is contrary to current medical, traditional, and commonsense understandings of 26 the term. The Rule cites Minton v. Dignity Health, No. 17-558259 (Calif. Super. Ct. Apr. 19, 2017), 27 as justification for the Rule’s enactment. See 84 Fed. Reg. at 23,276, n.27. Minton concerned 28 whether a Catholic hospital was justified in blocking a surgeon’s performance of a hysterectomy

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1 on a transgender patient as part of the patient’s prescribed course of treatment for gender dysphoria 2 based on the hospital’s religious objection to “sterilization.” But equating treatment for gender 3 dysphoria with sterilization is medically inaccurate. Procedures undertaken for the purpose of 4 sterilization are distinct from medical procedures undertaken for other purposes that incidentally 5 affect reproductive function. The Rule also expressly and improperly declines to rule out whether 6 treatment for cancer, such as chemotherapy or surgical removal of testes or ovaries to treat 7 cancerous tumors, could constitute “sterilization” simply because such treatment also could affect 8 reproductive function. The Rule’s targeting of transgender patients by adopting a particular 9 religious definition of “sterilization” violates statutory nondiscrimination requirements and medical 10 and ethical standards of care, improperly endorses a particular religious belief, and threatens the 11 provision of medically necessary healthcare to transgender patients, thereby threatening public 12 health.

13 2. The Rule’s Inadequate Explanation of Emergency Exceptions, Compliance Certification, and Notice Requirements 14

15 102. The Rule contains no exception for emergencies. In the Rule’s preamble, HHS 16 specifically contemplates that individuals will deny patients access to necessary care even in 17 emergency situations in which no alternative provider is available. Further, HHS cites cases 18 involving people being required to provide emergency care as evidence of the need for the Rule. 19 See, e.g., 84 Fed. Reg. at 23,176 (citing Cenzon-Decarlo v. Mount Sinai Hosp., No. 09 CV 20 3120(RJD), 2010 WL 169485, at *1 (E.D.N.Y. Jan. 15, 2010), aff ’d, 626 F.3d 695 (2d Cir. 2010) 21 (only on-call nurse did not want to provide emergency care for patient suffering from severe 22 preeclampsia)); id. at 23,176 n. 27 (citing Means v. U.S. Conference of Catholic Bishops, No. 1:15- 23 CV-353, 2015 WL 3970046 (W.D. Mich. 2015) (hospital turned away patient, refusing to complete 24 miscarriage following premature rupture of membranes, risking grave threats to patient’s health)). 25 HHS also cites as evidence of the need for the rule a medical-ethics opinion requiring emergency 26 care notwithstanding religious objections. See 83 Fed. Reg. at 3888 (citing, as evidence of the denial 27 of conscience rights in medicine, an American Congress of Obstetricians and Gynecologists ethics 28 opinion advising that providers have an obligation to provide emergency care in certain

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1 circumstances). These examples illustrate HHS’s intent to authorize the denial of care to patients 2 even in emergencies and in derogation of patients’ constitutionally protected rights. HHS’s only 3 response is that it will decide on a case-by-case basis how emergency needs and conscience 4 objections should be reconciled. 84 Fed. Reg. at 23,176. 5 103. The Rule requires funding recipients to certify their compliance with the Rule and 6 imposes recordkeeping requirements. 84 Fed. Reg. at 23,269-23,271, § 88.4-88.6. But the Rule 7 provides no practical guidance on compliance; it does not specify what form that the records should 8 take or how they should be maintained. 9 104. The Rule includes a notice requirement that will encourage individuals to 10 unilaterally refuse to provide care and information to patients. 84 Fed. Reg. at 23,270, § 88.5. The 11 notice purports to be “voluntary,” but the Rule pressures recipients to post certain recommended 12 text. The Rule states that OCR “will consider an entity’s voluntary posting of a notice of 13 nondiscrimination as non‐dispositive evidence of compliance” with the Rule, as long as “such 14 notices are provided according to the provisions of this section.” Id. The Department will take into 15 account where the notice is published—e.g., whether it is “[i]n a prominent and conspicuous 16 physical location” where it can be readily observed by the recipient’s workforce and the public; in 17 personnel manuals; and in employment applications. Id. § 88.5(b). The Rule recommends that the 18 notice read: “You may have the right under Federal law to decline to perform, assist in the 19 performance of, refer for, undergo, or pay for certain health care‐related treatments, research, or 20 services (such as abortion or assisted suicide, among others) that violate your conscience, religious 21 beliefs, or moral convictions.” 84 Fed. Reg. at 23,272, App. A to Pt. 88. This recommended notice 22 does not suggest that the objector must comply with advance-notice requirements, that the objector 23 must cooperate in handing off the patient to another workforce member, or that the objector must 24 assist in an emergency. The posting of a notice in the recommended form therefore would 25 undermine policies designed to reconcile religious objections with the needs of patient care. Yet 26 the Rule does not state what the consequences will be for failing to post a notice in this form. 27 28

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1 3. The Rule’s Vague and Coercive Enforcement Provisions 2 105. The Denial-of-Care Rule threatens entities that violate the Rule with punitive 3 sanctions, up to and including the total withdrawal and even clawback of Medicare and Medicaid 4 reimbursements and all other federal funds. See 84 Fed. Reg. at 23,180 (emphasizing that remedies 5 may include “termination of relevant funding, in whole or in part” and “funding claw backs to the 6 extent permitted by law”); 84 Fed. Reg. at 23,271, § 88.7(i) (remedies for noncompliance with the 7 Rule include withholding, denying, or terminating existing federal funding; denying or withholding 8 new federal funding; and suspending award activities). 9 106. These penalties could be applied for even a single violation by a covered entity or a 10 violation by a subrecipient or contractor. Direct recipients bear “primary responsibility to ensure 11 that” their subrecipients are “in compliance with Federal conscience and anti-discrimination laws 12 and this part, and shall take steps to eliminate any violations of the Federal conscience and anti- 13 discrimination laws and this part.” 84 Fed. Reg. at 23,270, § 88.6(a). The Rule makes clear that if 14 “a sub-recipient is found to have violated the Federal conscience and anti-discrimination laws, the 15 recipient from whom the sub-recipient received funds may be subject to the imposition of funding 16 restrictions or any appropriate remedies available under this part, depending on the facts and 17 circumstances.” Id. The preamble further states that the conduct of contractors is attributable to 18 States and local governments. 84 Fed. Reg. at 23,207 (“The conduct and activities of contractors 19 engaged by the Department, a Departmental program, or a State or local government is attributable 20 to such Department, program, or government for purposes of enforcement or liability under the 21 Weldon amendment.”). 22 107. Moreover, although the Rule asserts that matters will be resolved informally 23 “whenever possible,” it makes clear that loss of all funds can still be immediate: “Attempts to 24 resolve matters informally shall not preclude OCR from simultaneously pursuing any action 25 described in § 88.7.” 84 Fed. Reg. at 23,271-23,272, § 88.7(h)(2). 26 108. The preamble to the proposed Rule asserted that the Department may regulate an 27 unspecified “broader range of funds or broader categories of covered entities” for “noncompliant 28 entities.” 83 Fed. Reg. at 3898. In other words, HHS asserted the power to withhold not only federal

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1 funds that are used for programs in which violations are occurring, but also federal funds used for 2 programs unrelated to any alleged offense. And the Rule provides that OCR may temporarily 3 withhold “Federal financial assistance or other Federal funds, in whole or in part, pending 4 correction of the deficiency,” without limiting that authority to funds from HHS, a limitation that 5 is present in other provisions of the same section. 84 Fed. Reg. at 23,272, § 88.7(i)(3)(i). 6 109. These draconian enforcement mechanisms will have the effect of intimidating and 7 coercing healthcare providers—leading them to adopt overly limiting constructions of ambiguous 8 provisions or to stop providing certain services altogether. Likewise, direct recipients that face 9 liability for violations by subrecipients will have little option but to regulate aggressively or to pull 10 funding from subrecipients, particularly those that provide abortion, contraception, or LGBT 11 healthcare, as well as those that will not alter their nondiscrimination or emergency policies. 12 110. The Rule provides no mechanisms for notice, a hearing, or an appeal before HHS 13 terminates or withholds funds for asserted violations of the Rule. 14 111. The Rule provides no guidelines as to which enforcement mechanisms HHS will 15 use in particular circumstances, instead leaving it entirely to the discretion of enforcement officials. 16 As a result, HHS officials could employ the most draconian punishments for even the most trivial 17 technical violations, and the healthcare provider would have no outlined avenue for appeal. 18 112. Moreover, the Rule threatens recipients and subrecipients with onerous compliance 19 and investigation requirements that infringe on patient privacy. See 84 Fed. Reg. at 23,270, 20 § 88.6(c) (each recipient and subrecipient “shall cooperate with any compliance review, 21 investigation, interview, or other part of OCR’s enforcement process, which may include the 22 production of documents, participation in interviews, response to data requests, and making 23 available of premises for inspection where relevant”). Investigations are mandatory whenever there 24 is a violation or “threatened” or “potential” violation, which can be demonstrated through “any 25 information.” Id. at 23,271, § 88.7(d) (“OCR shall make a prompt investigation, whenever a 26 compliance review, report, complaint, or any other information found by OCR indicates a 27 threatened, potential, or actual failure to comply with Federal health care conscience and associated 28 anti-discrimination laws or this part.”).

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1 113. Each recipient or subrecipient is required to “permit access by OCR during normal 2 business hours to such of its books, records, accounts, and other sources of information, as well as 3 its facilities, as may be pertinent to ascertain compliance with this part.” The Rule expressly 4 overrides patients’ privacy rights, stating that “[a]sserted considerations of privacy or 5 confidentiality may not operate to bar OCR from evaluating or seeking to enforce compliance with 6 this part. Information of a confidential nature obtained in connection with compliance reviews, 7 investigations, or other enforcement activities shall not be disclosed except as required in formal 8 enforcement proceedings or as otherwise required by law.” 84 Fed. Reg. at 23,271, § 88.5(c). 9 114. Given the expansiveness and vagueness of the Rule, and the severity of its penalty 10 provisions, any individual or entity receiving federal funding—including direct recipients and 11 subrecipients, hospitals, independent providers, contractors, and affiliates—faces a substantial risk 12 of crippling sanctions. To avoid severe penalties, providers must either risk violating the laws (and 13 ethical and professional obligations) that require them to provide timely and adequate access to 14 information and care to patients, or cease offering services to which some employee or volunteer 15 might potentially object, including reproductive-health services, care for LGBT patients, and end- 16 of-life care. 17 115. The Rule thus creates especially strong disincentives for healthcare entities to 18 provide reproductive-health services and services to LGBT patients, for fear that their funding 19 (including their ability to obtain Medicare and Medicaid reimbursements) will be terminated and 20 their ability to provide medical care to underserved populations will be severely reduced or 21 curtailed. 22 116. The threat of punitive sanctions under the Rule also will deter healthcare facilities 23 from taking remedial action against discrimination by an employee against patients or other 24 employees, even when that discrimination is not tied to any religious belief. 25 E. The Rule’s Immediate and Irreparable Harms 26 1. Overview 27 117. The Denial-of-Care Rule will harm local governments, hospitals, small clinics, local 28 providers, community centers, healthcare and professional associations and their members, and

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1 their patients. These harms will occur nationwide. They will directly and irreparably injure 2 Plaintiffs, their members, their employees, and their patients. 3 118. The Rule privileges particular religious views over all other medical, legal, and 4 operational concerns, and it will force Plaintiff healthcare providers to rewrite their existing policies 5 to the extent that they are inconsistent with the Rule. Providers will have to choose between two 6 unacceptable courses of action: compromising their missions, operations, and medical ethics and 7 placing patients at risk by attempting to comply with the Rule, or jeopardizing the federal funding 8 supporting many of their most important functions and services. And even if providers attempt to 9 comply, the uncertainty created by the Rule will pose staffing, budgeting, and operational 10 dilemmas. The Rule fails to give providers necessary guidance on how the Rule will be applied. As 11 a result, it leaves providers unsure of what is required of them during emergencies, preventing them 12 from making critical judgments about the degree of redundant staffing and other measures that they 13 must implement to minimize the risk of harm to patients that may result from the Rule. The Rule 14 will further harm Plaintiffs’ operations by undermining patient trust, constraining already limited 15 resources, and flooding Plaintiffs’ facilities with patients denied care by other providers. 16 119. Patients will suffer the gravest harms. Some patients will be denied care (including 17 lifesaving care) or denied information needed for informed consent. Other patients will be exposed 18 to physical, mental, and dignitary harms, in violation of their constitutional rights. And many of the 19 most vulnerable patients will be afraid to give their providers information that is critical to 20 establishing the clinical relationship and guiding appropriate care—an unconstitutional chilling of 21 speech that harms patients and providers alike. If Plaintiffs are forced out of business or forced to 22 stop offering certain healthcare services, patients will be delayed in obtaining care and may be 23 entirely unable to obtain care. 24 120. The Rule threatens patients’ ability to obtain needed and even emergency care in 25 accordance with their medical needs, and in some instances their own religious and moral beliefs, 26 particularly with respect to contraception, abortion, end-of-life care, and gender-affirming 27 healthcare. It encourages and in some instances may require the imposition of the beliefs of a single 28 employee on healthcare institutions and patients, thereby overriding or preventing patients’ access

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1 to healthcare. It also invites discrimination on the basis of sex, gender identity, transgender status, 2 and disabilities such as addiction and positive HIV status. It deprives patients in need of 3 reproductive healthcare and transgender and gender-nonconforming patients of their right to equal 4 dignity and stigmatizes them as second-class citizens. And it impermissibly burdens and chills 5 constitutionally protected speech by threatening to penalize certain individuals based on their 6 gender identity, gender expression, or medical history. 7 121. The harms imposed on Plaintiffs, their members, and their patients reflect the harms 8 that will be imposed on all similarly situated providers across the country. The Rule will be 9 unworkable for any hospital or facility committed to providing objective, compassionate, and 10 responsible abortion, contraception, or transition-related healthcare, because most, if not all, 11 hospitals rely on HHS for a large percentage of their funding. Smaller medical providers may be 12 forced to close or sacrifice elements of the care that they provide, compromising their core missions. 13 And if Plaintiffs are either forced out of business or forced to stop offering certain healthcare 14 services, patients will likewise be delayed in accessing care and in some instances will be entirely 15 unable to access care. 16 122. Hospitals, clinics, community health centers, and other facilities that are unprepared 17 to risk the loss of federal funding may entirely forgo providing abortion, contraception, or LGBT 18 services (including referrals to such services). Indeed, the Rule will chill the provision of care in 19 any medical facility that is unwilling or unable to take on the risks imposed by the Rule. 20 123. At facilities that do continue to provide services to which some staff members may 21 object, the delivery of that care will suffer. Patients will be more likely to experience discriminatory 22 treatment or be denied care altogether because a member of the workforce disapproves of them or 23 the treatment they seek. 24 2. Harms to the County of Santa Clara 25 124. The County, through its departments and agencies, is committed to delivering high- 26 quality care, including to underserved and vulnerable populations, in settings that protect and 27 respect patients, their families, and providers alike. County departments already have in place 28 nondiscrimination and conscience-objection policies that respect and comply with existing legal

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1 requirements and medical ethics. If the Denial-of-Care Rule goes into effect, the County will 2 immediately need to rewrite and re-evaluate all of its conscience-objection polices, and it will need 3 to inquire as to the conscience objections of thousands of employees newly covered under the Rule. 4 125. For example, Valley Medical Center has a policy allowing its current and 5 prospective medical staff and employees to request in writing not to participate in certain patient 6 care that conflicts with staff members’ cultural values, ethics, or religious beliefs. Once an 7 exemption is requested, the appropriate manager or director determines whether the request can be 8 granted in light of staffing levels and other relevant circumstances. If the request is granted, the 9 staff member’s tasks, activities, and duties may be redistributed to ensure appropriate patient care. 10 The policy makes clear that requests for exemptions will not result in disciplinary or recriminatory 11 action. A manager or director may decline to accept an employee or medical-staff member for 12 permanent assignment, however, if the staff member has requested not to participate in an aspect 13 of care that is commonly performed in that assignment. The policy makes clear that patient care 14 must not be adversely affected by the granting of an exemption and that medical emergencies take 15 precedence over personal beliefs. 16 126. Valley Medical Center designed this policy to appropriately address the healthcare 17 needs of patients, including patients’ rights to be treated in a nondiscriminatory manner, and Valley 18 Medical Center’s need to plan in advance to ensure appropriate staffing, as well as to respect the 19 cultural values and ethical and religious beliefs of employees. Without prior notice and the ability 20 to plan assignments around conscience objections, the County would be unable to staff many of its 21 operations appropriately. Further, it is critical to patient care and to hospital functionality that 22 Valley Medical Center be able to rely on all medical staff to assist a patient in the event of an 23 emergency. 24 127. O’Connor and St. Louise Hospitals have similar policies regarding religious and 25 moral objections to providing certain patient care, with comparable requirements for advance notice 26 and attending to emergencies. In the near future, those facilities will transition to the Valley Medical 27 Center policy, as part of their ongoing integration into the County’s health system. 28

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1 128. The County is extremely concerned about the lack of an emergency exception on 2 the face of the Rule. An objector’s refusal to assist in patient care during an emergency could lead 3 to delays in care and worse medical outcomes, including fatalities. If it cannot rely on all staff to 4 provide care in an emergency, the County will have to consider whether backup or double staffing 5 is necessary to protect patient welfare. Moreover, the Rule’s lack of clarity about whether and when 6 an emergency exception exists creates unacceptable operational uncertainty, leaving the County in 7 the dark about what policies it would need to put in place around emergencies to be able to certify 8 compliance with the Rule. 9 129. Further, under a regime that permits only occasional inquiry into employees’ 10 objections and only voluntarily accepted accommodations, the County will be unable to ensure 11 proper patient care. For example, at some County-run pharmacies, there is only one pharmacist on 12 site at any given time. Patients will be prevented from obtaining their prescribed medications if a 13 pharmacist unilaterally decides not to provide certain types of medication, or not to serve certain 14 people, without first discussing the issue with a manager and agreeing to some accommodation. 15 130. The requirement that accommodation be “voluntarily accept[ed],” 84 Fed. Reg. at 16 23,263, § 88.2—meaning that staff must consent to any reassignment or shifting of hours made to 17 account for religious objections—will similarly pose staffing challenges for the County’s many 18 critical health-related programs. The County must ensure that there are sufficient non-objecting 19 staff members to cover each shift and ensure continuous patient care. If an employee’s religious 20 objection is incompatible with that person’s role, the person may need to be reassigned to another 21 role. And for some positions, no accommodation will be possible. For example, if a receptionist 22 objected to informing people that County hospitals provide contraceptive and abortion care and 23 also objected to connecting patients with someone who could discuss those options, there would be 24 no accommodation the County could offer that would avoid compromising access to care. 25 131. The Rule allows for an employer to ask for notice of an employee’s religious or 26 moral objections once a year. But it does not address what should happen if an employee develops 27 an objection after having already told the employer that he or she has no objections. The County 28 must be able to obtain or require notice of all religious or moral objections; otherwise, it could face

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1 a situation where a staff member unexpectedly objects to care, leading to staffing issues and lack 2 of continuous patient care. Under the Rule, the County could be wholly unaware that an objector 3 had ceased performing his or her assigned duties on the basis of a religious or moral objection, 4 which would gravely compromise patient care and the functioning of the County’s health systems. 5 The Rule’s failure to address these concrete logistical issues poses significant operational 6 challenges to the County and unacceptable health risks to patients. 7 132. The Rule will have grave effects on the County’s Gender Health Center. The 8 Clinic’s mission is to provide the care necessary for people of all ages to understand and explore 9 their gender identity. The Rule will imperil that mission because it will require the County to allow 10 employees who object on religious or moral grounds to the Clinic’s mission to work in that setting. 11 133. The Rule’s notice provision will adversely affect the County. The Rule’s model 12 notice tells employees that they “have the right to decline to participate in, refer for, undergo, or 13 pay for certain health care-related treatments, research, or services . . . which violate your 14 conscience, religious beliefs, or moral convictions under Federal law.” That might encourage or 15 suggest that it is permissible for employees to, for example, refuse to treat a transgender patient 16 who comes to the emergency room seeking care for a broken arm, based on the provider’s “moral 17 convictions,” even though refusal of service would violate federal nondiscrimination law and 18 EMTALA, 42 U.S.C. § 1395dd. And if the patient sees the notice, the patient would be discouraged 19 from communicating openly with the provider, for fear that services will be denied. Under the Rule, 20 the County must choose between displaying the model notice, or something like it, and risking loss 21 of federal funding for its decision not to display the model notice. 22 134. In the County’s view, complying with the Denial-of-Care Rule is operationally 23 unworkable, endangers patient health, and creates insurmountable staffing challenges. Further, the 24 Rule will require the County to risk malpractice actions or other suits by patients whose healthcare 25 was negatively affected by a County employee’s refusal to provide care. Were the County to fail to 26 provide care in an emergency situation because of an employee’s religious or moral objection, the 27 County might run afoul of state and federal laws requiring hospital emergency departments to 28 provide evaluation and emergency aid and requiring its Behavioral Health Services Department to

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1 provide timely access to an adequate network of mental-health care. See EMTALA, 42 U.S.C. 2 § 1395dd; Cal. Health & Safety Code §§ 1317-1317.10 (2008); 42 C.F.R. §§ 438.206-438.208. 3 135. The County faces withdrawal or even clawback of hundreds of millions of dollars 4 in federal funding annually if the Rule is enforced against it. 84 Fed. Reg. at 23,271, § 88.7(i). 5 Without federal funding, the County’s ability to provide a broad range of quality health services to 6 many thousands of patients—including to infants and children, those with chronic diseases, the 7 indigent, and the elderly—would be greatly diminished or potentially eliminated. These vulnerable 8 patients would face increased healthcare costs and would likely have little choice but to forgo care 9 or to seek it in already crowded emergency rooms of other hospitals. And those patients may face 10 additional barriers to treatment at those hospitals if those hospitals are covered by the Rule. 11 136. Because Valley Medical Center and other County healthcare facilities are safety-net 12 providers that primarily serve low-income individuals, vulnerable communities will be severely 13 harmed by a loss of federal funding. For example, the Public Health Department’s direct services 14 primarily benefit low-income persons, children, people of color, and people living with chronic 15 diseases such as HIV/AIDS. Because all 15 cities within the County are dependent on the County’s 16 public health department, many, if not most, of these individuals simply would not get the care and 17 resources that they need without federally funded services from the Public Health Department. 18 137. Further, the Rule creates untenable budgetary uncertainty for the County as a whole, 19 because the County is unsure what the Rule requires and whether the County is able to comply with 20 the Rule. This makes it infeasible for the County entirely to mitigate the risk that noncompliance 21 with the Rule could cause the County to lose more than a billion dollars in necessary federal 22 funding. 23 2. Harms to Private Healthcare Providers 24 138. Plaintiffs include clinics and healthcare providers that operate independently from 25 other healthcare systems, each with missions that include providing comprehensive and 26 compassionate care. For example, Trust Women Seattle’s mission is to treat patients with dignity, 27 empathy, and respect, to give them complete and accurate medical information and to empower 28 them to make decisions free from judgment or disruptions in their care. Likewise, the mission of

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1 the LA LGBT Center—the Nation’s largest provider of LGBT medical and mental-health 2 services—is to provide a safe and affirming environment for LGBT people seeking healthcare 3 services. To fulfill that mission, the LA LGBT Center must be able to treat its patients with dignity, 4 empathy, and respect; to give them complete and accurate medical information; and to empower 5 them to make decisions free from judgment or disruptions in their care. At Hartford Gyn, clinic 6 procedures and practices are designed to ensure that patients receive the highest quality, 7 nonjudgmental care. Hartford Gyn and Trust Women have taken a public stance defending 8 reproductive rights. Abortion clinics and their patients are routinely targeted and harassed, 9 including by protestors outside clinics and by groups and individuals who pose grave security 10 threats to physicians, staff, and volunteers. Hartford Gyn and Trust Women have been targeted by 11 the anti-choice movement for harassment and threatened violence, and they are symbols of the 12 determined provision of constitutionally protected care. Ensuring the safety of everyone in the 13 clinic, including patients, is of paramount concern for both providers. 14 139. Whitman-Walker, Bradbury-Sullivan Center, Center on Halsted, and the Mazzoni 15 Center also are mission-driven healthcare providers and entities. 16 140. In the reproductive-healthcare and LGBT-healthcare settings, the Rule invites 17 individuals to deny patients care and information, which will threaten both the health of patients 18 and the sustainability of the providers’ operations. The Rule will frustrate these mission-driven 19 providers’ ability to hire personnel who will work to support their missions. By expanding the 20 definition of what it means to “assist in the performance” of a procedure to include people not 21 directly engaged in providing care, and by inviting religious or moral objections without notice to 22 patients or providers, the Rule threatens grave harms to the healthcare-provider Plaintiffs’ 23 operations, provision of care to their patients, their core missions, and their reputations. 24 141. The Plaintiff healthcare providers seek to empower patients to make their own 25 decisions. But the Rule’s broad definitions invite an employee to substitute his or her own opinion 26 about a patient’s care for sound medical judgment and the patient’s consent. As with Santa Clara, 27 these providers could face situations in which a staff member unexpectedly objects to care, leading 28 to staffing issues and inadequate responses in an emergency. Even worse, Plaintiffs could be wholly

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1 unaware that an objector has ceased performing his or her assigned duties on the basis of a religious 2 or moral objection, or has turned a patient away altogether, which would gravely compromise 3 patient care and Plaintiffs’ missions. The Rule’s failure to address these concrete logistical issues 4 poses unacceptable operational challenges and health risks to patients. 5 142. Small providers face a significant concern that staff members who assert 6 unanticipated objections will be able to unilaterally veto key aspects of patient care. This concern 7 affects even clinics devoted to providing reproductive or LGBT care. For example, someone willing 8 to process billing for pregnancy services may have objections to contraception or abortion, or 9 someone comfortable with scheduling an appointment for gay patients may have objections to 10 transgender patients. Because the Rule is designed to protect objectors from any consequences, 11 providers may be forced to reorganize their staffing structures, consume precious resources with 12 unnecessary workarounds, duplicate staffing in cost-prohibitive ways, unfairly burden 13 nonobjecting employees, reduce services, and even close programs in an attempt to reduce the risk 14 that a single employee will deny care or information to a patient. 15 143. Trust Women Seattle, for example, is a small business. It cross-trains clinical and 16 some nonclinical staff to serve multiple roles, many of which touch on providing information about 17 or scheduling, or directly providing abortion, contraception, or transgender healthcare. Likewise, 18 Hartford Gyn must operate efficiently because of its already limited income. In order to do so, all 19 staff must perform functions that touch on providing abortion and contraception. No alternative 20 human-resources structure could sustain the clinic. 21 144. At Trust Women Seattle, some employees monitor the provision of abortion care 22 and contraceptive care at the clinic. Others perform medication management, sanitize instruments, 23 and clean operating rooms and laboratories that may be used for general gynecological exams one 24 day and the provision of contraception or hormone therapy the next. Under the Rule, these sanitary 25 and custodial activities could fall within the definition of “assist in the performance,” though they 26 do not involve the direct provision of care. 27 145. Further, Trust Women has an emergency policy requiring all office personnel to be 28 familiar with the facilities’ agreements to transfer patients to other facilities in the case of an

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1 emergency. This policy requires that any staff member assist in an emergency transfer, even if only 2 by calling ahead to the hospital. Hartford Gyn likewise has emergency practices requiring all staff 3 to be willing to help in an emergency. Trust Women also has a “no turn-away” policy for patients 4 and a nondiscrimination policy. To the extent that the Rule would prevent Trust Women and 5 Hartford Gyn from continuing to enforce these policies, it would be unworkable. To the extent that 6 they would be prevented from requiring that front-facing employees like receptionists (who do not 7 assist in procedures according to Trust Women’s current understanding) are compassionate and 8 supportive of the independent decision-making of patients, it would both undermine Trust 9 Women’s business and inhibit its patients’ access to healthcare. 10 146. The Rule will strain already limited resources. Because patients will fear refusal of 11 care at traditional healthcare facilities, providers such as the LA LGBT Center and Whitman- 12 Walker that specialize in reproductive and LGBT healthcare likely will see an increase in demand 13 resulting from patients’ hope that those clinics, which are designed to meet their specific needs, 14 will remain safe spaces. The same is true for plaintiffs who provide abortion and contraception 15 care. Such an increase will strain the limited resources of these providers. At the same time, the 16 providers will need to invest resources in educating the community about the Rule and in battling 17 the erosion of community members’ confidence in the healthcare system that will result from the 18 Rule’s application. These consequences will increase the LA LGBT Center’s and Whitman- 19 Walker’s operating costs and will take a toll on the health and well-being of the LGBT community. 20 147. In anticipation of the release of the Rule, Center on Halsted’s staff already has been 21 forced to devote resources to addressing the Rule. It has conducted additional “Know Your Rights” 22 programming regarding discrimination against LGBT people; sent and prepared staff to attend 23 meetings and events with other LGBT stakeholders in the city; and held internal training for staff 24 to manage the added strains on the mental health of Center on Halsted’s patients. This diversion 25 and additional expenditure of resources frustrates Center on Halsted’s efforts to counsel those 26 whom it serves and to advocate for them to receive necessary healthcare services from outside 27 organizations. 28

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1 148. As a result of the Rule, Bradbury-Sullivan Center will be required to redirect its staff 2 and resources from providing its own services to assisting patrons in determining who among the 3 healthcare providers in the region will serve LGBT patients in a nondiscriminatory manner. Indeed, 4 Bradbury-Sullivan Center already has had to divert staff and resources from other program 5 activities to advocacy, policy analysis, and development of additional resources to address the ill 6 effects of the Rule. 7 149. Loss of funding threatens dire results for these Plaintiffs. For example, Trust Women 8 Seattle and Hartford Gyn are dependent on Medicaid funding to continue providing the full range 9 of services they offer patients and keep their doors open. 10 3. Harms to Patients 11 150. If implemented, the Rule will harm Plaintiffs’ patients. The Rule attacks access to 12 reproductive and LGBT healthcare at hospitals, clinics, and other facilities throughout the country 13 and invites an unprecedented number of individuals to delay or deny care to patients, directly 14 affecting the patients’ access to healthcare. As detailed in the comments to the proposed Rule, 15 discrimination against these patients already is widespread and well-known, as are the harms that 16 result from delayed and denied care. 17 a. Harms to patients generally 18 151. Healthcare refusals often result in significant costs for and harms to patients. Under 19 the Rule, an individual employee, because of that employee’s morally or religiously motivated 20 refusal to provide care, may force a patient to choose between forgoing care or taking on the burden 21 of locating and traveling to a willing provider. When patients are turned away from a doctor’s office 22 or a hospital without a referral or even basic information about their condition or treatment options, 23 they must find willing providers to provide the healthcare that they need. They incur additional 24 expenditures of time and money researching and trying other providers, including additional time 25 off work for new appointments. In areas with a limited number of affordable healthcare providers, 26 patients may need to travel long distances to find care, requiring additional travel expenses, 27 sometimes including overnight stays and childcare. The harms from the additional time and expense 28

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1 fall most heavily on low-income individuals and those without the job flexibility to take paid sick 2 time. Some patients will lack the resources to continue to pursue the treatment they need. 3 152. Patients seeking treatment from healthcare entities of last resort, such as the County 4 and other Plaintiffs, may be entirely denied the care that they seek and desperately need. 5 153. The Rule may result in denials of time-sensitive or emergency care, putting patients’ 6 health and even their very lives at substantial risk. 7 154. Because the Rule does not always require objecting providers to alert either their 8 employers or the patients about religious or moral objections (and permits healthcare employers to 9 require such notice only in limited circumstances), the Rule may mean not only that some patients 10 will be denied necessary care, but also that those patients will not know that they are being denied 11 that care on the basis of an employee’s religious objection. That will be true even if the patient 12 chooses to go to a particular healthcare facility because the facility normally provides that care. 13 Either way, the patient is harmed. If patients know that they are being denied care because of who 14 they are or what services they seek, that is a stigmatizing and potentially traumatizing experience. 15 If patients do not know that they are being denied the care that they seek, they will not know to 16 seek it elsewhere and their healthcare needs will remain unmet. 17 b. Special burdens on reproductive rights 18 155. The Rule threatens to impede or eliminate access to abortion and contraception. 19 156. Patients who are denied contraception are less able to safeguard their own health 20 and welfare. 21 157. The ability to prevent or space pregnancy, facilitated by easy and affordable access 22 to contraception, has significant health benefits. 23 158. Abortion is a fundamental part of healthcare. It is a common medical procedure: one 24 in three women in the United States has undergone an abortion and an estimated one in four women 25 will need an abortion in the future. And it is extremely safe: it is 14 times safer than childbirth and 26 even safer than a shot of penicillin. But abortion care already is a marginalized healthcare service, 27 often provided at clinics that operate independently from other healthcare systems. Because of 28 increasing regulation and targeting of abortion clinics and their staff for violence and harassment,

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1 there is a national shortage of abortion providers in the United States, and their numbers are 2 shrinking. As a result, a woman who is denied abortion care at a healthcare facility may find it 3 difficult to find an available provider in a reasonable timeframe. Eighty-nine percent of counties in 4 the United States do not have a single abortion clinic, and some counties that have a clinic provide 5 abortion services only on certain days. Several States have only one clinic that provides abortion 6 care anywhere within the State. 7 159. Reproductive choice is a reality for patients only when there are enough family 8 planning providers available to meet patients’ needs and those providers are available in an 9 equitable distribution. Currently, the supply of those providers is not meeting the needs of U.S. 10 patients, in large part because facilities providing abortion are increasingly concentrated in cities, 11 and very few primary-care providers are skilled in family-planning services. 12 160. Four of the ten largest healthcare systems in the United States by hospital count are 13 now religiously sponsored, often because of hospital consolidations between Catholic or other 14 religious healthcare systems and secular institutions. As a result of hospital mergers and other 15 factors, significant parts of the Southern and Midwestern United States have deserts of abortion 16 training and care. 17 161. Hospitals across the United States are large businesses that demand significant 18 administrative resources. Many hospitals already decline to provide contraception and abortion 19 because of the effort required to accommodate refusals and the additional expense that they entail. 20 If the Rule goes into effect, the United States will see an even more dramatic reduction in the 21 number of large medical education institutions that provide abortions and teach students and 22 residents about it. Access to these services in the United States already is very limited, and the Rule 23 will immeasurably exacerbate the problem. 24 162. Because of the shortage of providers, patients already must travel long distances 25 (and incur the associated costs) to obtain abortion care. In addition, in some areas the shortage of 26 providers results in significantly increased wait times or leads to some patients’ being turned away 27 altogether. 28

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1 163. Delays in obtaining an abortion compound the logistical and financial burdens that 2 patients face and substantially increase the health risks to patients. On average, patients must wait 3 at least a week between initially attempting to make an appointment and receiving an abortion. 4 Delays also increase the cost of an abortion, because abortions during the second trimester are 5 substantially more expensive than during the first trimester: The median price of a surgical abortion 6 at ten weeks is $508; the cost at 20 weeks rises to $1,195. Other costs also increase with delays. 7 For example, one recent study found that Utah’s mandatory waiting period caused 47 percent of 8 women having an abortion to miss an extra day of work. More than 60 percent of the women in the 9 study were negatively affected in other ways, including having to pay increased transportation 10 costs, lost wages, or having to disclose the abortion to someone whom they otherwise would not 11 have told. Delays in obtaining an abortion also mean that patients obtain that care in later stages of 12 pregnancy. Although abortion is a safe procedure, risks increase with later gestational ages. Patients 13 approaching legal limits in their State for obtaining a medical abortion may be forced to seek care 14 in another State. Because the Rule will create incentives for more healthcare providers to stop 15 offering abortion services, it will increase delays and add to the costs of obtaining an abortion. 16 164. The Rule also further stigmatizes abortion and contraception. Stigma has 17 tremendous impact on patients, fostering fear and psychological stress. When patients perceive the 18 community’s disapproval of their choice, they feel the need to maintain secrecy around their 19 decisions and will be deterred from seeking care out of fear of judgment and discrimination. 20 165. Patients seeking treatment from healthcare entities of last resort, such as the County 21 and other Plaintiffs, may be entirely denied the care that they seek and desperately need, even in 22 emergency situations. This will put patients’ health and even their lives at substantial risk. If 23 patients are denied care entirely, they will encounter a whole host of additional harms. Denying 24 someone an abortion and forcing them to carry to term increases the risk of serious health harms, 25 including eclampsia and death. In addition, denying someone an abortion may lead to increased 26 risk of life-threatening bleeding, cardiovascular complications, diabetes associated with pregnancy, 27 as well as all other risks of pregnancy. A pregnant person is 14 times more likely to die from giving 28 birth than from having an abortion.

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1 166. Whether because patients encounter an objector, providers are forced to close their 2 doors, or patients are deterred from seeking care because of stigma and fear of discrimination, 3 individuals seeking abortion and contraception will be either delayed or totally denied such care 4 because of the Rule. 5 167. Objections to other types of procedures will also increase healthcare costs. For 6 example, a patient who has a cesarean section and wants to have a postpartum tubal ligation 7 immediately following delivery might be denied that option by an employee of a healthcare facility 8 who objects to the latter procedure—even though having the procedure at that time is medically 9 recommended, presents fewer risks to the patient, and is more cost-effective than delaying the 10 procedure. If the patient cannot have that procedure immediately following delivery, the patient 11 must first recover from the cesarean surgery and then schedule the tubal ligation at least six weeks 12 later, when the patient is busy caring for a newborn; the patient will be required to go to another 13 doctor and possibly a different hospital; will have to arrange for the transfer of medical records; 14 and will incur duplicative costs and duplicative risks, pain, and recovery time for the second round 15 of anesthesia and invasive surgery. 16 c. Special burdens on LGBT patients 17 168. The Rule imposes particular burdens on transgender and gender-nonconforming 18 people as well. Transgender people are defined as transgender because their gender identity does 19 not align with the sex that they were assigned at birth. Gender identity refers to an individual’s 20 sense of being a particular gender, and constitutes an essential element of human identity. Everyone 21 possesses a gender identity, which is innate, has biological underpinnings, and is fixed at an early 22 age. An individual’s sex is generally assigned at birth solely on the basis of visual observation of 23 external genitalia. Other sex-related characteristics such as chromosomes, hormone levels, internal 24 reproductive organs, secondary sex characteristics, and gender identity typically are not assessed 25 or considered during the assignment of sex at birth. Most people have a gender identity that matches 26 their sex assigned at birth and other sexual characteristics. 27 169. Where an individual’s gender identity does not match that individual’s sex assigned 28 at birth, gender identity is the critical determinant of sex. External genitalia are but one of several

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1 sex-related characteristics and are not always indicative of a person’s sex. A scientific consensus 2 recognizes that attempts to change an individual’s gender to bring it into alignment with the sex 3 assigned at birth are ineffective and harmful. 4 170. The dissonance between individuals’ gender identity and the sex that they were 5 assigned at birth can be associated with clinically significant distress, which is known as gender 6 dysphoria. Gender dysphoria is a medical condition recognized in the American Psychiatric 7 Association’s Diagnostic and Statistical Manual of Mental Disorders and by leading medical and 8 mental-health professional groups, including the AMA and the American Psychological 9 Association (APA). 10 171. Gender dysphoria can be treated in accordance with internationally recognized 11 Standards of Care formulated by the World Professional Association for Transgender Health and 12 recognized as authoritative by national medical and behavioral health organizations such as the 13 AMA and APA. 14 172. The ability to live in a manner consistent with one’s gender identity is critical to a 15 person’s health and well-being and is a key aspect in the treatment of gender dysphoria. The process 16 by which transgender people come to live in a manner consistent with their gender identity, rather 17 than the sex they were assigned at birth, is known as transition. The steps that each transgender 18 person takes to transition are not identical, but usually include social, legal, and medical transition. 19 Medical transition includes treatments that bring transgender people’s bodies into alignment with 20 their gender identity, such as hormone-replacement therapy or surgical care such as hysterectomy 21 or orchiectomy. Whether any particular treatment is medically necessary or even appropriate 22 depends on the medical needs of the individual. 23 173. All Plaintiffs, regardless of whether they provide particular transition-related 24 treatments and services, are committed to providing inclusive and individually tailored gender- 25 affirming care and services that respect each patient’s gender identity and status without 26 discrimination, in accordance with medical and ethical standards of care. 27 174. LGBT individuals, and especially transgender and gender-nonconforming people, 28 already face particularly acute barriers to care and health disparities that will be compounded by

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1 the Rule. A majority of LGBT patients fear going to a healthcare provider because of past 2 experiences of anti-LGBT bias in a healthcare setting. Many LGBT patients report negative 3 experiences, including hostility, discrimination, and denials of care, when they disclose to 4 healthcare providers their sexual orientation, history of sexual conduct, gender identity, transgender 5 status, or history of gender-affirming medical treatment, and related medical histories. 6 175. For example, multiple LGBT patients at Whitman-Walker have previously been 7 refused medical care, including routine care unrelated to gender dysphoria, by providers outside of 8 Whitman-Walker simply because they are transgender or gay. In one instance, a radiological 9 technician refused to perform an ultrasound for testicular cancer on a transgender patient. In 10 another, a healthcare worker at a dialysis clinic confronted a Whitman-Walker patient with end- 11 stage renal disease and objected to being involved in the patient’s care because of hostility to his 12 sexual orientation. In another, after a Whitman-Walker patient—a transgender teenager—was 13 hospitalized in a local hospital following a suicide attempt, the staff would only address or refer to 14 the young person with pronouns inconsistent with their gender identity, exacerbating the teenager’s 15 acutely fragile state of mind. Local hospitals and surgeons have refused to perform transition- 16 related surgeries on Whitman-Walker transgender patients, even when they routinely perform the 17 very same procedures on non-transgender patients, including in situations when the patient’s 18 insurance would have covered the procedure or when the patient was able to pay for the procedure. 19 Many local primary-care physicians unaffiliated with Whitman-Walker have refused to prescribe 20 hormone therapy for transgender patients. And multiple Whitman-Walker patients have been 21 denied prescriptions by pharmacists. Behavioral-health providers at Whitman-Walker report that 22 the vast majority of transgender patients—as many as four out of five—report instances of 23 mistreatment or discrimination by healthcare providers, hospitals, clinics, doctors’ offices, or other 24 facilities outside of Whitman-Walker. 25 176. Patients of the LA LGBT Center report similar experiences of discrimination by 26 other providers. One transgender patient, who developed profuse bleeding after surgery, was denied 27 treatment at an emergency room and arrived at the LA LGBT Center in distress three days later, 28 having lost a significant amount of blood. Another patient required extensive surgery to repair

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1 damage caused by a prior silicone breast-augmentation procedure. But she was turned down by an 2 academic plastic-surgery center in Los Angeles because her surgeon there said that her health 3 problems were caused by her own poor decision-making and she therefore would not be considered 4 for treatment. By the time she was able to identify a surgeon who was willing to treat her, with the 5 assistance of a physician at the LA LGBT Center, years had passed and her condition had become 6 life-threatening. For patients at the LA LGBT Center, the ability to receive gender-affirming 7 medical care can mean the difference between life and death. 8 177. In many geographic regions, a majority of LGBT people lack a provider whom they 9 consider to be their personal doctor. As a result, when they seek healthcare services, they are likely 10 to encounter a healthcare provider with whom they do not have a relationship. This makes them 11 especially vulnerable to discriminatory treatment from providers who are not LGBT-affirming. For 12 some medical specialties, there are only a handful of healthcare providers in the region who have 13 the expertise necessary to treat a patient for a particular condition, so a denial of care from even 14 one provider could make it practically impossible for an LGBT patient to receive any care at all. 15 178. In a recent study, nearly one in five LGBT people, including 31 percent of 16 transgender people, said that if they were turned away from a hospital, it would be very difficult or 17 impossible to get the healthcare that they need elsewhere. The rate was substantially higher for 18 LGBT people living in non-metropolitan areas, with 41 percent reporting that it would be very 19 difficult or impossible to find an alternative provider. Even when they are able to get access to care, 20 many individuals report that healthcare professionals have used harsh language toward them, 21 refused to touch them, used excessive precaution, or blamed the individuals for their health status. 22 179. Consequently, LGBT patients are disproportionately likely to delay preventative 23 screenings and necessary medical treatment and therefore to end up with more acute health 24 problems and outcomes. Research has identified pervasive health disparities for LGBT people with 25 respect to cancer, HIV, obesity, mental health, tobacco use, and more. In other words, LGBT 26 people, who are disproportionately likely to need a wide range of routine medical care, already 27 have reason to fear, and often do fear, negative consequences of “coming out” to healthcare 28

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1 providers about their sexual orientation, history of sexual conduct, gender identity, transgender 2 status, history of gender-affirming medical treatment, and related medical histories. 3 180. The Rule encourages these patients to remain closeted to the extent possible when 4 seeking medical care. But remaining closeted to a health care provider may result in significant 5 adverse health consequences. For instance, a patient who conceals or fails to disclose a same-sex 6 sexual history may not be screened for HIV or other relevant infections or cancers, or may not be 7 prescribed preventative medications such as Pre-Exposure Prophylaxis or PrEP, which is extremely 8 effective at preventing HIV transmission. Patients who fail fully to disclose their gender identity 9 and sex assigned at birth may not undergo medically indicated tests or screenings (such as tests for 10 cervical or breast cancer for some transgender men, or testicular or prostate cancer for some 11 transgender women). The barriers to care are particularly high for transgender individuals. Nearly 12 one-quarter of transgender individuals report delaying or avoiding medical care when sick or 13 injured, at least partially because of fear of discrimination by and disrespect from healthcare 14 providers. 15 181. In the past, OCR has investigated numerous complaints from transgender patients 16 about being denied certain health services, ranging from routine to life-saving care, because of the 17 patients’ gender identities. The Rule will make it more likely that these patients will be denied care 18 or will avoid seeking care altogether. 19 d. Harms to vulnerable populations 20 182. The effects of refusals will fall particularly heavily on rural patients in need of 21 reproductive healthcare. These patients are four times more likely than urban dwellers to reside in 22 medically underserved communities. Reproductive-health services are especially difficult for rural 23 patients to obtain because obstetric and gynecologic services and other medical specialties are not 24 common in rural settings. Further, for healthcare providers such as the County of Santa Clara that 25 operate clinics and hospitals in rural communities, experience has shown that reproductive health 26 care and gender-affirming health care are frequently in demand, contrary to the Department’s 27 assertion that patients in rural communities may be more likely to share providers’ religious 28 objections and therefore are not likely to seek such care. See 84 Fed. Reg. 23,181. The inappropriate

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1 expansion of refusals under the Denial-of-Care Rule will undoubtedly exacerbate the harms to these 2 individuals. 3 183. Patients and recipients of non-medical services coming to Trust Women Seattle, 4 Hartford GYN Center, Whitman-Walker, the LA LGBT Center, Bradbury-Sullivan Center, Center 5 on Halsted, and the Mazzoni Center have been disrespected and demeaned by other healthcare 6 providers for their reproductive and LGBT healthcare decisions and will have no other options if 7 they cannot obtain care from these providers. These Plaintiffs serve communities with already 8 limited options for healthcare services. 9 184. For example, in the region where Bradbury-Sullivan Center is located, there often 10 is only one or very few healthcare providers who have the specialty necessary to treat an LGBT 11 patient for a specific service, so a denial of care from that provider could make it practically 12 impossible for a patient to receive any care at all. And some of the region’s healthcare providers 13 are religiously affiliated organizations that could claim religious objections to providing care to 14 LGBT people, exempting them under the Rule from adhering to existing nondiscrimination laws 15 and standards. 16 185. The Rule will chill the expressive rights of Plaintiffs’ patients by causing them to 17 hide their identities and same-sex relationships when seeking healthcare services from other 18 organizations with religious objections to serving LGBT people. 19 186. Further, the additional demand for services and advocacy caused by discrimination 20 resulting from the Rule will drain the resources of these Plaintiffs. 21 4. Harms to Medical-Association Plaintiffs 22 a. AGLP 23 187. The Denial-of-Care Rule will harm AGLP, its members, and the patients whom they 24 treat because the Rule threatens AGLP’s federal funding. AGLP’s members depend on that funding 25 to provide vital services and to conduct critical medical research. In addition, the Rule will frustrate 26 AGLP’s mission of achieving and enforcing safe workspaces for LGBT psychiatrists and 27 nondiscriminatory healthcare services for AGLP members’ patients. The Rule also will frustrate 28 AGLP’s mission of advocating for nondiscriminatory standards of care for patients, culturally

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1 competent standards of care for treatment of LGBTQ patients, and nondiscriminatory work 2 environments for members that protect against discrimination on the basis of sexual orientation and 3 gender identity. 4 188. The Rule invites additional burdens, harassment, and even discriminatory treatment 5 of AGLP members in the workplace by fellow employees who will claim that that the Rule gives 6 them a right to accommodations for discriminatory behavior. AGLP members and their LGBTQ 7 patients are stigmatized and demeaned by the message communicated by the Rule—that their 8 government privileges beliefs that disparage transgender people and their medical needs, and 9 invites denials of care at the cost of the dignity and physical and mental health of patients based 10 solely on transgender status. 11 b. MSFC 12 189. The Rule will also cause severe harms to MSFC and its members. 13 190. First, medical students receive their clinical training disproportionally at academic 14 medical centers and teaching hospitals that receive significant federal funding. Likewise, residents 15 depend on federal funding for their continuing medical education. If HHS determines that the 16 institutions at which these individuals work are violating the Rule, their funding to continue 17 working at that institution may be reduced or eliminated. Those institutions also may stop providing 18 certain services or training in order to avoid risk of catastrophic sanctions under the Rule. 19 191. Second, MSFC is committed to creating the next generation of abortion providers. 20 There is already a shortage in training opportunities. For example, members of MSFC have reported 21 instances in which facilities across the nation have ceased providing these services based on the 22 religious or moral objection of select staff or funders or because of the stigma and controversy 23 surrounding these services. Even in progressive States, religious refusals by hospital leadership 24 have already pushed abortion training out of certain facilities. Further, mergers of secular teaching 25 hospitals with religiously affiliated facilities have reduced the number of facilities that provide 26 abortion training, and clinic closures across the country further threaten access to training and 27 services. 28

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1 192. The Rule is so broad as to be unworkable for some hospitals and other facilities 2 providing abortion and contraception, creating incentives for institutions to stop providing and 3 training for abortion services. As a consequence, MSFC members will be able to acquire training 4 at a shrinking number of facilities. As training programs grow more limited, fewer new physicians 5 will be able to achieve competency in family planning sufficient to join existing practices or clinics 6 right out of medical school or residency. The result will be a shrinking pool of providers that will 7 be unable to replenish itself through normal training programs, significantly longer wait times even 8 for patients who are able to travel and can afford to obtain care from trained providers, and 9 decreased access to care for patients around the country. 10 c. GLMA 11 193. If not enjoined, the Denial-of-Care Rule will harm both GLMA members and the 12 LGBT patients whose interests GLMA represents. The Rule creates a safe haven for discrimination 13 and prevents GLMA from achieving its goals with professional accreditation bodies by preventing 14 such bodies from holding healthcare providers accountable for discrimination against LGBT people 15 and denial of care whenever the discriminatory conduct is ostensibly grounded in religious beliefs. 16 194. GLMA collaborates with professional accreditation bodies, such as The Joint 17 Commission, on the development, implementation, and enforcement of sexual-orientation and 18 gender-identity nondiscrimination policies as well as cultural-competency standards of care for 19 treatment of LGBT patients. GLMA has worked with The Joint Commission, and continues to work 20 with similar professional bodies and health-professional associations, on standards, guidelines, and 21 policies that address LGBT health and protect individual patient health and public health in general. 22 195. In order for a healthcare organization to participate in and receive federal payment 23 from Medicare or Medicaid programs, the organization must meet certain requirements, including 24 a certification of compliance with health and safety requirements. That certification is achieved 25 based on a survey conducted either by a state agency on behalf of the federal government, or by a 26 federally recognized national accrediting organization. Accreditation surveys include requirements 27 that healthcare organizations not discriminate on the basis of sex, sexual orientation, or gender 28 identity in providing services or in employment. A healthcare organization that discriminates in

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1 those ways or that otherwise deviates from medical, professional, and ethical standards of care can 2 lose its accreditation. 3 196. As explained above, all of the leading health-professional associations, including 4 the AMA, have adopted policies stating that healthcare providers should not discriminate in 5 providing care for patients and clients because of sexual orientation or gender identity. 6 197. The Rule presents a direct conflict with nondiscrimination standards adopted by the 7 Joint Commission and all the major health-professional associations, which have recognized the 8 need to ensure that LGBT patients are treated with respect and without bias or discrimination in 9 hospitals, clinics, and other healthcare settings. 10 198. The Rule would prevent state agencies and other recipients of federal funds from 11 recognizing, to the extent allowed by law, the loss of accreditation of a healthcare organization 12 because of specified anti-LGBT beliefs and denials of care. The Rule therefore will frustrate 13 GLMA’s mission of achieving and enforcing accreditation standards relating to nondiscrimination 14 on the basis of sexual orientation and gender identity and cultural competency standards of care for 15 treatment of LGBT patients. 16 199. Some members of GLMA are employed by religiously affiliated healthcare 17 organizations (such as hospitals, hospices, or ambulatory-care centers) that receive federal funding. 18 These healthcare providers treat LGBT patients. Members of GLMA employed by religiously 19 affiliated providers will experience additional burdens for adhering to their medical and ethical 20 obligations to treat all patients in a nondiscriminatory manner, including providing all medically 21 necessary care that is in the patient’s best interests. 22 200. The Rule invites harassment and discriminatory treatment of GLMA members in 23 the workforce by fellow employees who will claim that the Rule gives them a right to 24 accommodation for discriminatory behavior. GLMA members and their LGBT patients are 25 stigmatized and demeaned by the Rule’s message that their government privileges beliefs that result 26 in the disapproval and disparagement of LGBT people in the healthcare context. 27 201. As an organization of health professionals who often serve and care for patients 28 from the LGBT community, GLMA knows that discrimination against LGBT individuals in

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1 healthcare access and coverage remains a pervasive problem and that too often this discrimination 2 is based on religious objections. GLMA members have reported numerous instances of 3 discrimination in care based on religious grounds. Since HHS issued the proposed Rule, GLMA 4 members shared with GLMA many ways that religious objections have been used to the detriment 5 of the healthcare of LGBT patients. 6 CAUSES OF ACTION

7 FIRST COUNT Administrative Procedure Act, 5 U.S.C. § 706(2)(A) 8 Arbitrary And Capricious 9 202. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 10 203. Defendants are subject to the Administrative Procedure Act (APA), 5 U.S.C. § 551 11 et seq. See 5 U.S.C. § 703. 12 204. The Denial-of-Care Rule violates the APA, 5 U.S.C. § 706(2)(A), because it is 13 arbitrary, capricious, an abuse of discretion, and not in accordance with law, in that HHS failed 14 adequately to consider important aspects of the issue, including harm to patients, costs to healthcare 15 facilities, impracticability of the Rule for the efficient administration of healthcare facilities and 16 programs and for delivery of health services, and possible alternatives to the Rule. 17 205. Commenters showed that the Denial-of-Care Rule will cause substantial harms to 18 patients. The Rule nonetheless fails adequately to quantify and inappropriately disregards these 19 costs and harms, particularly in its cost-benefit analysis. HHS also has ignored that the Rule is 20 unnecessary and that current law provides sufficient protection for religious objectors while also 21 considering patients’ rights to care and information. Notwithstanding the concerns raised by 22 commenters that the Rule would harm patients, HHS omitted from the Rule any provisions to lessen 23 the Rule’s adverse effects on the delivery of healthcare and on patients’ health and well-being, 24 instead opting to expand objection rights without regard to the practical effects of the rule on the 25 healthcare system. Further, by failing to address the many issues arising from its requirements, or 26 stating that they will be resolved on a case-by-case basis, the Rule leaves employers in the dark 27 about what they may or may not do without running afoul of the Rule’s prohibitions. 28

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1 206. In addition, HHS adopted an unprecedented, confusing, and unreasonable definition 2 of what it means to “discriminate” against an individual or entity based on a religious or moral 3 objection. HHS’s definition would consider virtually any action to manage objections to be 4 “discriminatory” unless the action falls within narrowly drawn and unworkable exceptions. These 5 provisions contain no undue-hardship exception or legitimate-nondiscriminatory-reason defense, 6 and they unreasonably limit the measures providers can take to accommodate religious and moral 7 objections without compromising patient care. 8 207. Although Commenters detailed the substantial and potentially unmanageable costs 9 of compliance with the Rule and other administrative burdens on healthcare facilities and providers 10 that the Rule would impose, the Rule fails to take account of these costs and burdens. 11 208. In adopting the final Rule, HHS failed to consider pertinent data and failed to 12 articulate a reasoned or legally sufficient basis for the Rule. 13 209. In adopting the Rule, HHS failed to consider alternative ways of achieving the 14 objectives of the underlying statutes. 15 210. Additionally, HHS failed to respond adequately to significant comments critical of 16 the proposed Rule that were submitted during the notice-and-comment period.

17 SECOND COUNT Administrative Procedure Act, 5 U.S.C. § 706(2)(C) 18 Exceeds Statutory Authority 19 211. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 20 212. The Denial-of-Care Rule violates the APA, 5 U.S.C. § 706(2)(C), because it is 21 greatly in excess of statutory jurisdiction, authority, or limitation. 22 213. When read together, HHS’s definitions of critical statutory terms—including “assist 23 in the performance,” “referral or refer,” “health care entity,” and “discrimination”—are inconsistent 24 with the statutory provisions that HHS purports to be construing, as well as the plain, accepted 25 meanings of those terms. As a result, HHS’s construction of the statutory provisions that it purports 26 to be implementing is inconsistent with the plain scope and meaning of those provisions, rendering 27 the Rule in excess of statutory jurisdiction and authority. 28

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1 THIRD COUNT Administrative Procedure Act, 5 U.S.C. § 706(2)(A) 2 Not in Accordance with Other Federal Laws 3 214. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 4 215. The Denial-of-Care Rule violates the APA, 5 U.S.C. § 706(2), because it is 5 arbitrary, capricious, an abuse of discretion, and not in accordance with law in that it conflicts with 6 numerous federal laws. These laws include: 7 (a) 42 U.S.C. § 18114 (because the Rule will impede individuals’ timely access 8 to medical care and information about treatment options); 9 (b) EMTALA, 42 U.S.C. § 1395dd(b)(1) and its implementing regulations 10 (because the Rule will provide blanket license to emergency-room personnel to decline to provide 11 or assist in the provision of emergency services, to decline to facilitate patients’ transfer to other 12 facilities, or to decline to make referrals); 13 (c) ACA, 42 U.S.C. § 18023(d) (because the Rule contravenes the ACA’s 14 prohibition against construing right-of-conscience exemptions to relieve any healthcare provider of 15 the legal obligation to provide emergency services as required by State or Federal law, including 16 the EMTALA); 17 (d) ACA, 42 U.S.C. § 18116 (because the Rule contravenes the statutory 18 provisions stating that “[a]n individual shall not, on [a] ground prohibited under title VI of the Civil 19 Rights Act of 1964, title IX of the Education Amendments of 1972, the Age Discrimination Act of 20 1975, or section 504 of the Rehabilitation Act of 1973, be excluded from participation in, be denied 21 the benefits of, or be subjected to discrimination under, any health program or activity, any part of 22 which is receiving Federal financial assistance”); 23 (e) Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq. (because 24 in creating such expansive religious-accommodation requirements and inviting employees to veto 25 the types of accommodations that may be offered, the Rule may require employing healthcare 26 entities to take actions that are contrary to the rights of other employees to be free from the forms 27 of discrimination prohibited by Title VII); and 28

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1 (f) Title X of the Public Health Service Act, 42 U.S.C. §§ 300-300a-6 (because 2 the Rule contravenes Congress’ requirement that Title X grantees operate “voluntary family 3 planning projects which shall offer a broad range of acceptable and effective family planning 4 methods and services,” 42 U.S.C. § 300(a), and because Title X appropriations bills, e.g., 2019 5 Continuing Appropriations Act, Pub. L. No. 115-245, Div. B., Tit. II, 132 Stat. 2981, 3070-71 6 (2018), require that “all pregnancy counseling shall be nondirective,” meaning that funded projects 7 are to offer pregnant women neutral, non-judgmental information and counseling regarding their 8 options, including “prenatal care and delivery; infant care, foster care, or adoption; and pregnancy 9 termination”).

10 FOURTH COUNT U.S. Constitution, First Amendment; Administrative Procedure Act, 11 5 U.S.C. § 706(2)(B) 12 Establishment Clause 216. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 13 217. The Denial-of-Care Rule is contrary to constitutional rights, powers, privileges, or 14 immunities and therefore must be set aside under 5 U.S.C. § 706(2)(B). 15 218. The Establishment Clause of the First Amendment prohibits the government from 16 favoring one religion over another or favoring religion over nonreligion. 17 219. The Establishment Clause permits government to afford religious accommodations 18 or exemptions from generally applicable laws only if, among other requirements, the 19 accommodation (1) lifts a substantial, government-imposed burden on the exercise of religion and 20 (2) does not impose on innocent third parties the costs or burdens of accommodating another’s 21 religious exercise. 22 220. The Rule fails both of these requirements and therefore violates the Establishment 23 Clause. 24 221. The Rule violates the Establishment Clause because it creates expansive religious 25 exemptions for healthcare employees at the expense of third parties, namely, Plaintiffs, other 26 providers, and, crucially, patients. 27 28

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1 222. HHS’s asserted statutory authority for the Rule cannot be read to authorize the Rule, 2 because if so read, those statutes would exceed Congress’s legislative authority and constitute 3 unconstitutional religious preferences, both by granting religious exemptions for purported burdens 4 on religious exercise that are not of the federal government’s own making, and by imposing costs 5 and burdens on third parties to accommodate the religious beliefs or exercise of objecting 6 employees.9 7 223. The effect of the Rule will be that patients who seek care at odds with the religious 8 beliefs of a provider’s employee—or whose very identity is at odds with that employee’s religious 9 beliefs—may be delayed in receiving care (including emergency care) or denied care altogether. 10 Patients will suffer the stigma of government-sanctioned discrimination. The Rule also will burden 11 Plaintiffs and other providers because by leaving them unable to treat patients in accord with their 12 own ethical and legal obligations and precluding them from carrying out their organizational 13 missions, based solely on the religious views of a single employee. 14 224. The Rule impermissibly advances religious beliefs in violation of the Establishment 15 Clause because it imposes on Plaintiffs an unqualified obligation to give preferential protection to 16 religious objections of their employees, regardless of the costs and harms to Plaintiffs, their 17 patients, and the greater public health. 18 225. The Denial-of-Care Rule further violates the Establishment Clause of the First 19 Amendment because, among other reasons, it: 20 (a) has the primary purpose of favoring, preferring, and endorsing certain 21 religious beliefs and certain religious denominations over others and over nonreligion; 22 (b) has the primary effect of favoring, preferring, and endorsing certain religious 23 beliefs and certain religious denominations over others and over nonreligion; 24

25 9 Attempts by HHS to mandate federal exemptions from burdens on religious exercise imposed by 26 state or local governments are permissible, only if (among other requirements) there is a clear 27 constitutional commitment of congressional power and express legislative authorization for the federal action. Otherwise, HHS impermissibly intrudes on the States’ traditional prerogatives and 28 general authority to regulate for the health and welfare of their citizens, exceeding the federal government’s statutory authority in violation of the APA. See Second Count, supra.

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1 (c) has the primary purpose and primary effect of preferring the religious beliefs 2 of some people and institutions over the lives, health, and other rights and interests of third parties; 3 (d) impermissibly entangles government with religion; 4 (e) makes Plaintiffs, their patients, and other third parties bear the costs and 5 harms of objecting employees’ religious beliefs or religious exercise; and 6 (f) imposes on Plaintiffs a requirement to accommodate employees’ religious 7 objections without taking constitutionally required account of the actual burdens (if any) on the 8 objectors or the effects on or harms to Plaintiffs, their patients, or the greater public health.

9 FIFTH COUNT (Brought by Plaintiffs other than County of Santa Clara) 10 U.S. Constitution, Fifth Amendment; Administrative Procedure Act, 11 5 U.S.C. § 706(2)(B) Substantive Due Process/Right To Privacy And Personal Autonomy 12 226. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 13 227. The Denial-of-Care Rule is contrary to constitutional rights, powers, privileges, or 14 immunities and therefore must be set aside under 5 U.S.C. § 706(2)(B). 15 228. The Fifth Amendment’s Due Process Clause protects individuals’ substantive rights 16 to be free to make certain decisions central to privacy, bodily autonomy, integrity, self-definition, 17 intimacy, and personhood without unjustified governmental intrusion. Those decisions include the 18 right to abortion and other reproductive decision-making, as well as the right to live openly and 19 express oneself consistent with one’s gender identity. 20 229. By imposing conditions on funding that require healthcare providers to interfere 21 with and unduly burden patients’ access to medically necessary health care, including reproductive 22 healthcare and healthcare necessary to preserve health or life, the Rule violates the rights of 23 Plaintiffs’ patients to privacy, liberty, dignity and autonomy guaranteed by the Fifth Amendment. 24 230. In particular, a person’s gender identity and ability to live and express oneself 25 consistent with one’s gender identity without unwarranted governmental interference constitutes a 26 core aspect of each person’s autonomy, dignity, self-definition and personhood. By imposing 27 conditions on funding that interfere with patients’ access to gender-affirming medical care, 28 including surgical procedures, hormone therapy, and other medically necessary care, and by

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1 interfering with the ability of transgender and gender-nonconforming patients to live and express 2 themselves in accordance with their gender identities, the Rule infringes on patients’ interests in 3 privacy, liberty, dignity, and autonomy protected by the Fifth Amendment. 4 231. There is no legitimate interest supporting the Rule’s infringement on patients’ 5 fundamental rights, let alone an interest that can survive the elevated scrutiny required to justify 6 infringement of these fundamental rights.

7 SIXTH COUNT (Brought by Plaintiffs Other Than County of Santa Clara) 8 U.S. Constitution, First Amendment; Administrative Procedure Act, 9 5 U.S.C. § 706(2)(B) Free Speech 10 232. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 11 233. The Denial-of-Care Rule is contrary to constitutional rights, powers, privileges, or 12 immunities and therefore must be set aside under 5 U.S.C. § 706(2)(B). 13 234. A person’s disclosure of transgender or gender-nonconforming status, speech, or 14 expression that discloses gender identity, and the person’s gendered speech and expressive conduct, 15 all receive constitutional protection under the First Amendment. 16 235. The Rule has the purpose and effect of chilling constitutionally protected First 17 Amendment activity. As a result of the Rule, an increased number of LGBT people will remain 18 closeted in healthcare settings and to doctors, nurses, and other healthcare providers, and will 19 decline to disclose their sexual orientation, transgender or gender-nonconforming status, or gender 20 identities. Further, an increased number of LGBT people will decline to engage in gendered speech 21 and expression, including by declining to disclose related medical histories—even when that self- 22 censorship impedes the ability of their healthcare providers to provide appropriate treatment and 23 results in negative health consequences to the patients and to public health. 24 236. The Rule imposes conditions on funding that invite denials of care to Plaintiffs’ 25 patients based on religious or moral objections to these patients’ identity or past or present 26 healthcare decisions and needs. 27 237. The Rule impermissibly chills patients who are seeking medical care from being 28 open about their reproductive-health histories and needs, including abortion and contraception.

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1 238. The Rule will chill a patient of ordinary firmness from making such disclosures. 2 239. The Rule violates the Free Speech Clause of the First Amendment because it 3 impermissibly burdens the exercise of patients’ constitutionally protected speech, expression and 4 expressive conduct based on the content and viewpoint of patients’ speech. 5 240. Additionally, the Rule is overbroad because it will chill protected First Amendment 6 activity.

7 SEVENTH COUNT (Brought by Plaintiffs Other Than County of Santa Clara) 8 U.S.. Constitution, Fifth Amendment; Administrative Procedure Act, 9 5 U.S.C. § 706(2)(B) Equal Protection 10 241. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 11 242. The Denial-of-Care Rule is contrary to constitutional rights, powers, privileges, or 12 immunities and therefore must be set aside under 5 U.S.C. § 706(2)(B). 13 243. The Fifth Amendment’s Due Process Clause provides that no person shall be 14 deprived of life, liberty, or property without due process of law. 15 244. That Clause includes within it a prohibition against the denial of equal protection of 16 the laws by the federal government, its agencies, or its officials or employees. 17 245. The purpose and effect of the Rule are to discriminate against Plaintiffs’ patients 18 based on their sex, gender identity, transgender status, gender nonconformity, and exercise of 19 fundamental rights, including the rights to bodily integrity and autonomous medical decision- 20 making, the rights of access to abortion and contraceptives, and the rights to live and express oneself 21 consistent with one’s gender identity. 22 246. Additionally, the purpose of the Rule is to facilitate, authorize, and encourage 23 private discrimination against Plaintiffs’ patients on the basis of sex, gender identity, transgender 24 status, gender nonconformity, and exercise of fundamental rights, including the rights to abortion 25 and contraceptives and to live and express oneself consistent with one’s gender identity. 26 247. Further, the Rule is intended to have, and will have, a disproportionate impact on 27 women and transgender people, people who exercise their rights to abortion and contraception, and 28

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1 people who wish to live and express themselves consistent with their gender identity. The Rule 2 places an impermissible special burden on these individuals. 3 248. Discrimination based on sex is presumptively unconstitutional and subject to 4 heightened scrutiny. 5 249. Discrimination based on gender identity or transgender status also is presumptively 6 unconstitutional and subject to heightened scrutiny. Transgender people have suffered a long 7 history of discrimination and continue to suffer that discrimination; they are a discrete and insular 8 group and lack the power to protect their rights through the political process; a person’s gender 9 identity or transgender status bears no relation to that person’s ability to contribute to society; 10 gender identity is a core, defining trait that is so fundamental to a person’s sense of self and 11 personhood that a person cannot be required to abandon it as a condition of equal treatment; and 12 efforts to change a person’s gender identity through intervention have been widely condemned. 13 250. Discrimination based on the exercise of a fundamental right is presumptively 14 unconstitutional and is subject to strict scrutiny. 15 251. The Denial-of-Care Rule lacks even a rational or legitimate justification, let alone 16 the important or compelling one that is constitutionally required. The Rule also lacks adequate 17 tailoring under any standard of review. 18 252. Defendants’ requirement of disparate treatment of patients and encouragement of 19 private discrimination deprives patients of their right to equal dignity and stigmatizes them as 20 second-class citizens in violation of equal protection.

21 EIGHTH COUNT (Brought only by County of Santa Clara) 22 Spending Clause 23 253. Plaintiffs incorporate the preceding paragraphs as if fully set forth here. 24 254. The Denial-of-Care Rule violates the Spending Clause for at least four reasons. 25 (a) First, the Denial-of-Care Rule is vague and ambiguous, and it fails to provide 26 adequate notice of what conduct by a recipient would result in HSS withholding federal funds. 27 (b) Second, the Rule attaches new, after-the-fact conditions to Santa Clara’s 28 receipt of federal funds, in violation of the Spending Clause.

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1 (c) Third, the Rule is not rationally related to the federal interest in the particular 2 programs that receive federal funds. See South Dakota v. Dole, 483 U.S. 203 (1987); Massachusetts 3 v. United States, 435 U.S. 444, 461 (1978) (plurality op.) (conditioning federal grants illegitimate 4 if conditions are unrelated “to the federal interest in particular national projects or programs”). The 5 Rule places various federal grants at risk, but there is no rational relationship between the federal 6 religious-objection laws that Defendants seek to enforce and the federal interest in those programs. 7 (d) Fourth, the Rule unconstitutionally attempts to coerce state and local 8 government recipients, such as the County of Santa Clara, to adopt the federal government’s policy 9 by threatening to withhold, terminate, and claw back unprecedented levels of federal funding, 10 whether or not those funds are related to the provision of health care or to the specific violation 11 alleged. Such conditions on federal funding go beyond “relatively mild encouragement” to put a 12 “gun to the head” of public entities, coercing them to adopt federal policy in contravention of the 13 Spending Clause. See National Federation of Independent Business v. Sebelius, 567 U.S. 519, 581 14 (2012).

15 NINTH COUNT (Brought only by County of Santa Clara) 16 Separation of Powers 17 255. The Constitution vests the Spending Power in Congress, not in the Executive 18 Branch. U.S. Const. art. I, § 8, cl. 1. 19 256. Congress may delegate some discretion to the Executive Branch to decide how to 20 spend appropriated funds, but that discretion is cabined by the scope of the delegation. City of 21 Arlington, Texas v. FCC, 569 U.S. 290, 297 (2013). 22 257. The Executive Branch cannot amend or cancel appropriations that Congress has 23 duly enacted. Clinton v. City of New York, 524 U.S. 417, 439 (1998); Train v. City of New York, 24 420 U.S. 35, 38, 44 (1975). 25 258. The Rule imposes requirements not authorized by the underlying federal statutes 26 and would allow defendants to withhold, deny, suspend, or terminate federal financial assistance 27 for noncompliance with those requirements. 28

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1 259. The Rule’s conditions improperly usurp Congress’s spending power and amount to 2 an unconstitutional refusal to spend money appropriated by Congress, in violation of constitutional 3 separation-of-powers principles. 4 260. Defendants’ violation causes ongoing harm to the County of Santa Clara and its

5 residents.

6 TENTH COUNT Equitable Relief To Preserve Remedy 7

8 261. Plaintiffs incorporate by reference the foregoing paragraphs as if fully set forth. 9 262. The Denial-of-Care Rule will become effective on July 22, 2019, unless it is 10 enjoined. Plaintiffs are entitled to a full, fair, and meaningful process to adjudicate the lawfulness 11 of the Rule before being required to implement its far-reaching and harmful requirements. 12 263. Plaintiffs will suffer irreparable injury by implementation of the Rule, which would 13 erode hard-won trust between vulnerable populations and their healthcare providers, stigmatize and 14 traumatize patients, interfere with core governmental and medical operations, and result in delays 15 and denials of care leading to physical harm and even death. Preliminary and permanent injunctive 16 relief is therefore needed to ensure that Plaintiffs’ injuries are fully remedied. 17 264. Injunctive relief is also needed to prevent the immediate harm resulting from the 18 uncertainty created by the Rule about the policies and procedures guiding critical medical 19 operations and the conditions being placed on huge swaths of federal funding. On the first day that 20 this Rule takes effect, Plaintiff providers must know how to handle medical emergencies as they 21 happen; they cannot wait to see how HHS chooses to interpret concededly confusing provisions in 22 after-the-fact enforcement actions. The hospitals and clinics that Plaintiffs operate need to know 23 how to staff their facilities, how staff must handle objections when they arise, and whether the 24 providers can rely on continued receipt of federal funding that supports life-saving services. 25 Patients need assurance that they will receive complete, accurate information and timely and 26 responsive medical care in an environment that protects their constitutional rights and does not 27 expose them to stigma and harm. This Court should step in to protect Plaintiffs’ institutions, their 28

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1 patients, and the foremost principle guiding medical providers in responding to those in need of 2 assistance and care—first, do no harm. 3 265. Accordingly, to ensure that Plaintiffs receive meaningful relief should they prevail 4 in this action, the Court should preliminarily and permanently enjoin Defendants from 5 implementing the Denial-of-Care Rule. 6 REQUEST FOR RELIEF 7 Plaintiffs request that the Court grant the following relief: 8 (a) A declaratory judgment under 28 U.S.C. § 2201(a) and 5 U.S.C. § 706(a) 9 that the Denial-of-Care Rule is unlawful and unconstitutional; 10 (b) Preliminary and permanent injunctions enjoining Defendants from 11 implementing and enforcing the Denial-of-Care Rule; 12 (c) Attorneys’ fees, costs, and expenses and other disbursements for this action; 13 and 14 (d) Any further and additional relief that this Court deems just and proper. 15 Dated: May 28, 2019 Respectfully submitted, 16 By: /s/ Richard B. Katskee By: /s/ Mary E. Hanna-Weir RICHARD B. KATSKEE* JAMES R. WILLIAMS (SBN 271253) 17 [email protected] GRETA S. HANSEN (SBN 251471) KENNETH D. UPTON, JR.** LAURA S. TRICE (SBN 284837) 18 [email protected] MARY E. HANNA-WEIR (SBN 320011) AMERICANS UNITED FOR SEPARATION SUSAN P. GREENBERG (SBN 318055) 19 OF CHURCH AND STATE H. LUKE EDWARDS (SBN 313756) 1310 L Street NW, Suite 200 [email protected] 20 Washington, DC 20005 OFFICE OF THE COUNTY COUNSEL, Tel: (202) 466-3234; Fax: (202) 466-3234 COUNTY OF SANTA CLARA 21 70 West Hedding Street, East Wing, 9th Floor Counsel for Plaintiffs Other Than County of San José, CA 95110-1770 22 Santa Clara Tel: (408) 299-5900; Fax: (408) 292-7270

23 Counsel for Plaintiff County of Santa Clara

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1 By: /s/ Genevieve Scott By: /s/ Lee H. Rubin 2 GENEVIEVE SCOTT* LEE H. RUBIN (SBN 141331) [email protected] [email protected] 3 RABIA MUQADDAM* MAYER BROWN LLP [email protected] Two Palo Alto Square, Suite 300 4 CHRISTINE PARKER* 3000 El Camino Real [email protected] Palo Alto, CA 94306-2112 5 CENTER FOR REPRODUCTIVE RIGHTS Tel: (650) 331-2000; Fax: (650) 331-2060 199 Water Street, 22nd Floor 6 New York, NY 10038 MIRIAM R. NEMETZ* Tel: (917) 637-3605 Fax: (917) 637-3666 [email protected] 7 NICOLE A. SAHARSKY* Counsel for Plaintiffs Other Than County of [email protected] 8 Santa Clara MAYER BROWN LLP 1999 K Street, Northwest 9 Washington, DC 20006-1101 Tel: (202) 263-3000; Fax: (202) 263-3300 10 By: /s/ Jamie A. Gliksberg JAMIE A. GLIKSBERG* Counsel for Plaintiffs County of Santa Clara, 11 [email protected] Trust Women Seattle, LA LGBT Center, CAMILLA B. TAYLOR* Whitman-Walker, Bradbury-Sullivan Center, 12 [email protected] Center on Halsted, Hartford Gyn Center, Mazzoni Center, Medical Students for LAMBDA LEGAL DEFENSE AND 13 EDUCATION FUND, INC. Choice, AGLP, GLMA, Ward Carpenter, 105 West Adams, 26th Floor Sarah Henn, and Randy Pumphrey 14 Chicago, IL 60603-6208 Tel: (312) 663-4413; Fax: (312) 663-4307 15 * To be admitted pro hac vice OMAR GONZALEZ-PAGAN* ** Licensed in Oklahoma and Texas only. 16 [email protected] Supervised by Richard B. Katskee, a member of LAMBDA LEGAL DEFENSE AND the D.C. Bar. To be admitted pro hac vice 17 EDUCATION FUND, INC. 120 Wall Street, 19th Floor 18 New York, NY 10005-3919 Tel: (212) 809-8585 19 Counsel for Plaintiffs Other Than County of 20 Santa Clara

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EXHIBIT 1 Case 5:19-cv-02916 Document 1-1 Filed 05/28/19 Page 2 of 104 23170 Federal Register / Vol. 84, No. 98 / Tuesday, May 21, 2018 / Rules and Regulations

DEPARTMENT OF HEALTH AND online database through http:// and conscience protections for HUMAN SERVICES www.govinfo.gov, a service of the U.S. providers, organizations, or their Government Publishing Office. employees regarding counseling Office of the Secretary regarding the same (42 U.S.C. 14406(1)); I. Background • Conscience protections regarding 45 CFR Part 88 This document adopts as final, with exemptions applicable to the ACA’s changes in response to public RIN 0945–AA10 individual mandate (26 U.S.C. 5000A; comments, a revised part 88, Protecting 42 U.S.C. 18081); Protecting Statutory Conscience Statutory Conscience Rights in Health • Conscience protections under the Rights in Health Care; Delegations of Care; Delegations of Authority. This ACA for qualified health plans related Authority preamble to the final rule provides a to coverage of abortion, and for brief background of the rule, individual health care providers and AGENCY: Office for Civil Rights (OCR), summarizes the final rule provisions, health care facilities that do not provide, Office of the Secretary, HHS. and discusses in detail the comments pay for, provide coverage of, or refer for ACTION: Final rule. received on the proposed rule. abortions (42 U.S.C. 18023(b)(1)(A) and A. Statutory History (b)(4)); SUMMARY: The United States has a long • Conscience protections for history of providing protections in The freedoms of conscience and of Medicare Advantage organizations and health care for individuals and entities religious exercise are foundational Medicaid managed care organizations on the basis of religious beliefs or moral rights protected by the Constitution and with moral or religious objections to convictions. Congress has passed many numerous Federal statutes. Congress has counseling or referral for certain such laws applicable to the Department acted to protect these freedoms with services (42 U.S.C. 1395w–22(j)(3)(B) of Health and Human Services (‘‘HHS’’ particular force in the health care and 1396u–2(b)(3)(B)); or the ‘‘Department’’) and the programs context, and it is these laws that are the • Conscience protections related to or activities it funds or administers, subject of this final rule. Specifically, the performance of advanced directives some of which are the subject of existing this final rule concerns Federal laws (42 U.S.C. 1395cc(f), 1396a(w)(3), and HHS regulations. This final rule revises that provide: 14406(2)); existing regulations to ensure vigorous • Conscience protections related to • Conscience and nondiscrimination enforcement of Federal conscience and abortion, sterilization, and certain other protections for organizations related to anti-discrimination laws applicable to health services applicable to the Global Health Programs, to the extent the Department, its programs, and Department of Health and Human such funds are administered by the recipients of HHS funds, and to delegate Services and recipients of certain Secretary of HHS (the ‘‘Secretary’’) (22 overall enforcement and compliance Federal funds encompassed by 42 U.S.C. 7631(d)); responsibility to the Department’s Office U.S.C. 300a–7 (the ‘‘Church • Conscience protections attached to for Civil Rights (‘‘OCR’’). In addition, Amendments’’); Federal funding, to the extent such this final rule clarifies OCR’s authority • Conscience protections for health funding is administered by the to initiate compliance reviews, conduct care entities related to abortion Secretary, regarding abortion and investigations, supervise and coordinate provision or training, referral for such involuntarily sterilization (22 U.S.C. compliance by the Department and its abortion or training, or accreditation 2151b(f), see, e.g., the Consolidated components, and use enforcement tools standards related to abortion (the Appropriations Act, 2019, Pub. L. 116– otherwise available in existing ‘‘Coats-Snowe Amendment,’’ 42 U.S.C. 6, Div. F, sec. 7018 (the ‘‘Helms, Biden, regulations to address violations and 238n); 1978, and 1985 Amendments’’)); resolve complaints. In order to ensure • Protections from discrimination for • Conscience protections from that recipients of Federal financial health care entities that do not provide, compulsory health care or services assistance and other Department funds pay for, provide coverage of, or refer for generally (42 U.S.C. 1396f and 5106i(a)), comply with their legal obligations, this abortions under programs funded by the and under specific programs for hearing final rule requires certain recipients to Department’s appropriations acts (e.g., screening (42 U.S.C. 280g–1(d)), maintain records; cooperate with OCR’s Departments of Labor, Health and occupational illness testing (29 U.S.C. investigations, reviews, or other Human Services, and Education, and 669(a)(5)); vaccination (42 U.S.C. proceedings; and submit written Related Agencies Appropriations Act, 1396s(c)(2)(B)(ii)), and mental health assurances and certifications of 2019, Div. B., sec. 507(d), Public Law treatment (42 U.S.C. 290bb–36(f)); and compliance to the Department. The final 115–245, 132 Stat. 2981 (Sept. 28, 2018) • Protections for religious rule also encourages the recipients of (the ‘‘Weldon Amendment’’); id., sec. nonmedical health care providers and HHS funds to provide notice to 209); their patients from certain requirements individuals and entities about their right • Protections from discrimination under Medicare and Medicaid that may to be free from coercion or under the Patient Protection and burden their exercise of their religious discrimination on account of religious Affordable Care Act (‘‘ACA’’) for health beliefs regarding medical treatment (e.g., beliefs or moral convictions. care entities that do not provide any 42 U.S.C. 1320a–1(h), 1320c–11, 1395i– health care item or service furnished for 5, 1395x(e), 1395x(y)(1), 1396a(a), and DATES: This rule is effective July 22, the purpose of causing, or for the 2019. 1397j–1(b)). purpose of assisting in causing, the For purposes of this final rule, these FOR FURTHER INFORMATION CONTACT: death of any individual, such as by laws will be collectively referred to as Sarah Bayko Albrecht at (800) 368–1019 assisted suicide, euthanasia, or mercy ‘‘Federal conscience and anti- 2 S

E or (800) 537–7697 (TDD).

L killing, applicable to the Federal discrimination laws.’’ U R SUPPLEMENTARY INFORMATION: Government and any State or local Congress has recognized that modern h t i w

government that receives Federal health care practices may give rise to D Electronic Access O conflicts with the religious beliefs and

R financial assistance (42 U.S.C. 18113); P 2

8 This Federal Register document is moral convictions of payers, providers, 0 Q

L also available from the Federal Register 83 FR 3880 (Jan. 26, 2018). and patients alike. The existence of G 3 K S D n o l l e

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moral and ethical objections on the part funds under certain HHS programs, (1) services or activities more generally. 42 of health care clinicians about to permit sterilizations or abortions in U.S.C. 300a–7(c)(2). participating in, assisting with, referring the entity’s facilities if the performance Fourth, paragraph (d) of the Church for, or otherwise being complicit in of such procedures there violates the Amendments applies to any part of a certain procedures is well documented entity’s religious beliefs or moral health service program or research by ethicists. Religious institutions and convictions, or (2) to make its personnel activity funded in whole or in part entities, too, have expressed objections available for such procedures if contrary under a program administered by the to the provision of or participation in to the personnel’s religious beliefs or Secretary. For these health service insurance coverage for certain moral convictions. 42 U.S.C. 300a– programs or research activities, no procedures or services, such as abortion, 7(b)(2). The individuals and entities individual shall be required to perform sterilization, and assisted suicide. To protected by this provision are or assist in the performance of any part address these problems, Congress has recipients of grants, contracts, loans, or of the program or research activity if repeatedly legislated conscience loan guarantees under the Public Health doing so would be contrary to his or her protections for individuals and Service Act (42 U.S.C. 201 et seq.), and religious beliefs or moral convictions. institutions providing health care to the those entities’ personnel. 42 U.S.C. 300a–7(d). Fifth, paragraph (e) of the Church American public, as outlined below. Second, paragraph (c)(1) of the The Church Amendments. The Amendments applies to health care Church Amendments applies to training or study programs, including Church Amendments were enacted at decisions on employment, promotion, various times during the 1970s in internships and residencies. Paragraph or termination of employment, as well (e) prohibits any entity receiving certain response to debates over whether as extension of staff or other privileges judicially recognized rights to abortions, funds from denying admission to, or with respect to physicians and other otherwise discriminating against, sterilizations, or related practices might health care personnel. 42 U.S.C. 300a– lead to the requirement that individuals applicants for training or study based on 7(c)(1). This paragraph prohibits certain the applicant’s reluctance or willingness or entities participate in activities to entities from discriminating in these which they have religious or moral to counsel, suggest, recommend, assist, decisions based on an individual or in any way participate in the objections. The Church Amendments declining to perform or assist in an consist of five provisions, codified at 42 performance of abortions or abortion or sterilization because of that sterilizations contrary to, or consistent U.S.C. 300a–7, that protect those who individual’s religious beliefs or moral hold religious beliefs or moral with, the applicant’s religious beliefs or convictions. 42 U.S.C. 300a–7(c)(1). It moral convictions. 42 U.S.C. 300a–7(e). convictions regarding certain health also prohibits those entities from care procedures from discrimination by Any recipient of a grant, contract, loan, discriminating in such decisions based loan guarantee, or interest subsidy entities that receive certain Federal on an individual’s performance of a funds, and in health service programs under the Public Health Service Act or lawful abortion or sterilization the Developmental Disabilities and research activities funded by HHS. procedure, or on an individual’s Notably, the Church Amendments Assistance and Bill of Rights Act of religious beliefs or moral convictions 2000 (42 U.S.C. 15001 et seq.) must contain provisions explicitly protecting about such procedures more generally. the rights of both individuals and comply with paragraph (e). Id. Like paragraph (b), any recipients of The Coats-Snowe Amendment. entities. a grant, contract, loan, or loan guarantee First, paragraph (b) of the Church Enacted in 1996, section 245 of the under the Public Health Service Act Public Health Service Act (also known Amendments provides, with regard to must comply with paragraph (c)(1). as the ‘‘Coats-Snowe Amendment’’ or individuals, that no court, public ‘‘Coats-Snowe’’) applies official, or other public authority can Third, paragraph (c)(2) of the Church nondiscrimination requirements to the use an individual’s receipt of certain Amendments applies to the recipients of Federal government, and to State or Federal funding as grounds to require the Department’s grants or contracts for local governments receiving Federal the individual to perform, or assist in, biomedical or behavioral research under financial assistance. 42 U.S.C. 238n. sterilization procedures or abortions, if any program administered by the Such governments may not discriminate doing so would be contrary to his or her Secretary. 42 U.S.C. 300a–7(c)(2). This against any health care entity that religious beliefs or moral convictions. paragraph prohibits discrimination by refuses to undergo training in, require or 42 U.S.C. 300a–7(b)(1). Paragraph (b) such entity against physicians or other provide training in, or perform further prohibits those public health care personnel in employment, promotion, or termination of abortions; refer for abortions or abortion authorities from requiring an entity, training; or make arrangements for any based on the entity’s receipt of Federal employment, as well as discrimination in the extension of staff or other of those activities. 42 U.S.C. 238n(a)(1)– (2). Furthermore, those governments See, e.g., Farr A. Curlin M.D., et al., Religion, privileges, because of an individual’s Conscience, and Controversial Clinical Practices, performance or assistance in any lawful may not discriminate against a health New Eng. J. Med. 593–600 (2007); Stephen J. Genuis health service or research activity, care entity because the entity attends or & Chris Lipp, Ethical Diversity and the Role of declining to perform or assist in any attended a health care training program 2013 Int’l. J. Conscience in Clinical Medicine, such service or activity based on that does not (or did not) perform Family Med. 1, 9 (2013); Harris, et al., Obstetrician– abortions; require, provide, or refer for Gynecologists’ Objections to and Willingness to religious beliefs or moral convictions, or Help Patients Obtain an Abortion 118 Obstet. & the individual’s religious beliefs or training in the performance of abortions; Gyn. 905 (2011); Armand H. Matheny Antommaria, moral convictions respecting such or make arrangements for any such Adjudicating Rights or Analyzing Interests: training. 42 U.S.C. 238n(a)(3). The law Ethicists’ Role in the Debate Over Conscience in defines the term ‘‘health care entity’’ as 2 Clinical Practice, 29 Theor. Med. Bioeth. 201, 206 The Church Amendments also reference the S

E including (and, therefore, not limited to) L (2008); William W. Bassett, Private Religious Community Mental Health Centers Act, Public Law U R

Hospitals: Limitations Upon Autonomous Moral 88–164, 77 Stat. 282 (1963), and the Developmental an individual physician, a postgraduate h t i Choices in Reproductive Medicine, 17 J. Contemp. Disabilities Services and Facilities Construction w

physician training program, and a

D Health L. & Pol’y 455, 529 (2001); Peter A. Clark, Amendments of 1970, Public Law 91–517, 84 Stat. O participant in a program of training in R Medical Ethics at Guantanamo Bay and Abu 1316 (1970). However, those statutes were repealed P 2

8 Ghraib: The Problem of Dual Loyalty, 34 J.L. Med. by subsequent statute and, accordingly, are not the health professions. 42 U.S.C. 0 Q

L & Ethics 570 (2006). referenced here. 238n(c)(2). G 3 K S D n o l l e

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In addition, Coats-Snowe applies to Weldon, current appropriations acts applies the plain text of section 1303 of accreditation of postgraduate physician include other health care conscience the ACA. 42 U.S.C. 18023. training programs. Therefore, the protections. For example, one provision, Finally, under section 1411 of the Federal government, and State or local using language similar to the Weldon ACA, 42 U.S.C. 18081, HHS is governments receiving Federal financial Amendment, prohibits the Department responsible for issuing certifications to assistance, may not deny a legal status from denying participation in Medicare individuals who are entitled to an (including a license or certificate) or Advantage to an otherwise eligible exemption from the individual financial assistance, services, or other entity, such as a provider-sponsored responsibility requirement imposed benefits to a health care entity based on organization, because the entity informs under Internal Revenue Code sec. an applicable physician training the Secretary it will not provide, pay 5000A, including when such program’s lack of accreditation due to for, provide coverage of, or provide individuals are exempt based on a the accrediting agency’s requirements referrals for abortions. Department of hardship (such as the inability to secure that a health care entity perform Defense and Labor, Health and Human affordable coverage without abortion), induced abortions; require, provide, or Services, and Education Appropriations are members of an exempt religious refer for training in the performance of Act, 2019 and Continuing organization or division, or participate induced abortions; or make Appropriations Act, 2019, Public Law in a ‘‘health care sharing ministry.’’ See arrangements for such training, 115–245, Div. B, sec. 209, 132 Stat. also 26 U.S.C. 5000A(d)(2). Under regardless of whether such standard 2981. section 1311(d)(4)(H) of the ACA, 42 provides exceptions or exemptions. 42 The Patient Protection and Affordable U.S.C. 18031(d)(4)(H), health benefit U.S.C. 238n(b)(1). Additionally, the Care Act’s Conscience and Associated exchanges are responsible for issuing statute requires the government Anti-Discrimination Protections. Passed certificates of exemption consistent with involved to formulate regulations or in 2010, the Patient Protection and the Secretary’s determinations under other mechanisms, or enter into Affordable Care Act (ACA) also includes section 1411 of the ACA. agreements with accrediting agencies, as several conscience and associated anti- Other Protections Related to the are necessary to comply with this discrimination protections. Performance of Advance Directives or accreditation provision of Coats-Snowe. Section 1553 of the ACA prohibits the Assisted Suicide. Before passage of Id. Federal government, and any State or section 1553 of the ACA, Congress had The Weldon Amendment. The local government or health care passed other conscience protections Weldon Amendment (or ‘‘Weldon’’) was provider that receives Federal financial related to assisted suicide. Section 7 of originally adopted in 2004 and has been assistance under the ACA, or any ACA the Assisted Suicide Funding readopted (or incorporated by reference) health plans, from discriminating Restriction Act of 1997 (Pub. L. 105–12, in each subsequent appropriations act against an individual or institutional 111 Stat. 23) clarified that the Patient for the Departments of Labor, Health health care entity because of the Self-Determination Act’s provisions and Human Services, and Education. individual or entity’s objection to stating that Medicare and Medicaid See, e.g., Department of Defense and providing any health care items or beneficiaries have certain self- Labor, Health and Human Services, and service for the purpose of causing or determination rights do not (1) require Education Appropriations Act, 2019, assisting in causing death, such as by any provider, organization, or any and Continuing Appropriations Act, assisted suicide, euthanasia, or mercy employee of such provider or 2019, Public Law 115–245, Div. B., sec. killing. 42 U.S.C. 18113. Section 1553 organization participating in the 507(d). Weldon provides that none of designates OCR to receive complaints of Medicare or Medicaid program to the funds made available in the discrimination on that basis. Id. inform or counsel any individual about applicable Labor, HHS, and Education Section 1303 declares that the ACA a right to any item or service furnished appropriations act be made available to does not require health plans to provide for the purpose of causing or assisting a Federal agency or program, or to a coverage of abortion services as part of in causing the death of such individual, State or local government, if such ‘‘essential health benefits for any plan such as assisted suicide, euthanasia, or agency, program, or government year.’’ 42 U.S.C. 18023(b)(1)(A). mercy killing; or (2) apply to or affect subjects any institutional or individual Furthermore, no qualified health plan health care entity to discrimination on offered through an ACA exchange may See Guidance on Hardship Exemptions from the the basis that the health care entity does discriminate against any individual Individual Shared Responsibility Provision for health care provider or health care Persons Experiencing Limited Issuer Options or not provide, pay for, provide coverage Other Circumstances, Center for Consumer of, or refer for abortions. E.g., facility because of the facility or Information and Insurance Oversight, Centers for Department of Defense and Labor, provider’s unwillingness to provide, pay Medicare & Medicaid Services (CMS), April 9, 2018. Health and Human Services, and for, provide coverage of, or refer for https://www.cms.gov/CCIIO/Resources/Regulations- abortions. 42 U.S.C. 18023(b)(4). And and-Guidance/Downloads/2018-Hardship- Education Appropriations Act, 2019, Exemption-Guidance.pdf. As discussed in the and Continuing Appropriations Act, section 1303 of the ACA makes clear description of § 88.3(g) below, Congress reduced the 2019, Public Law 115–245, Div. B., sec. that nothing in that Act should be penalty in 26 U.S.C. 5000A for a lack of minimum 507(d). Weldon states that the term construed to undermine Federal laws essential coverage to $0. SUPPORT for Patients and regarding—(i) conscience protection; (ii) Communities Act, Public Law 115–271, section ‘‘health care entity’’ includes an 4003, 26 U.S.C. 5000A(d)(2) (2018). individual physician or other health willingness or refusal to provide Organizations that are religiously exempt care professional, a hospital, a provider- abortion; and (iii) discrimination on the include those with established tenets or teachings sponsored organization, a health basis of the willingness or refusal to in opposition to acceptance of the benefits of any maintenance organization, a health provide, pay for, cover, or refer for private or public insurance. 26 U.S.C. 1402(g)(1). abortion or to provide or participate in A ‘‘health care sharing ministry’’ is an 2 insurance plan, or any other kind of organization, described in section 501(c)(3) and S

E training to provide abortion. 42 U.S.C. L health care facility, organization, or taxed under section 501(a) of the Internal Revenue U R plan. Id. 18023(c)(2)(A)(i)–(iii). Qualified health Code, comprising members who share a common h t i set of ethical or religious beliefs and who share w

Conditions on Federally Appropriated plans, as defined under 42 U.S.C. 18021, D medical expenses among members in accordance O Funds Requiring Compliance with offered on any Exchange created under R with those beliefs without regard to the State in P 2

8 Federal Conscience and Anti- the ACA, are required to comply with which a member resides or is employed. 26 U.S.C. 0 Q

L Discrimination Laws. In addition to § 88.3(f)(2)(i) and (ii), which faithfully 5000A(d)(2)(B). G 3 K S D n o l l e

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any requirement with respect to a or under any amendment made by the Medicaid for persons and institutions portion of an advance directive that Tom Lantos and Henry J. Hyde United objecting to the acceptance or provision directs the purposeful causing of, or States Global Leadership Against HIV/ of medical care or services based on a assistance in causing, the death of an AIDS, Tuberculosis, and Malaria belief in a religious method of healing individual, such as by assisted suicide, Reauthorization Act of 2008 (Pub. L. through approval of religious euthanasia, or mercy killing. 42 U.S.C. 110–293), cannot be required, as a nonmedical health care institutions 14406 (by cross-reference to 42 U.S.C. condition of receiving such funds, (1) to (RNHCIs). RNHCIs do not provide 1395cc(f) (Medicare) and 1396a(w) ‘‘endorse or utilize a multisectoral or standard medical screenings, (Medicaid)); see also 42 U.S.C. comprehensive approach to combating examination, diagnosis, prognosis, 1395cc(f)(4) (by cross-reference to 42 HIV/ AIDS,’’ or (2) to ‘‘endorse, utilize, treatment, or the administration of U.S.C. 14406); 1396a(w)(3), make a referral to, become integrated medications. 42 U.S.C. 1395x(ss)(1). 1396a(a)(57); 1396b(m)(1)(A); and with, or otherwise participate in any Instead, RNHCIs furnish nonmedical 1396r(c)(2)(E). Those protections program or activity to which the items and services such as room and extend to Medicaid and Medicare organization has a religious or moral board, unmedicated wound dressings, providers, such as hospitals, skilled objection.’’ 22 U.S.C. 7631(d)(1)(B). The and walkers, and they provide care nursing facilities, home health or government also cannot discriminate exclusively through nonmedical nursing personal care service providers, hospice against such recipients in the personnel assisting with nutrition, programs, Medicaid managed care solicitation or issuance of grants, comfort, support, moving, positioning, organizations, health maintenance contracts, or cooperative agreements for ambulation, and other activities of daily organizations, Medicare+Choice (now the recipients’ refusal to do any such living. Medicare Advantage) organizations, and actions. 22 U.S.C. 7631(d)(2). Congress has acknowledged RNHCIs prepaid organizations. Exemptions from Compulsory Medical through several statutes. For example, Protections Related to Counseling and Screening, Examination, Diagnosis, or although such institutions would not Referrals Under Medicare Advantage Treatment. This rule incorporates four otherwise meet the medical criteria for Plans, Medicaid Plans, and Managed statutory provisions that protect parents Medicare providers, see 42 U.S.C. Care Organizations. Certain Federal who, on the basis of conscience, object 1395x(e) (definition of ‘‘hospital’’), protections prohibit organizations to their children being forced to receive 1395x(y)(1) (definition of ‘‘skilled offering Medicare+Choice (now certain treatments or health nursing facility’’), 1395x(k), and 1320c– Medicare Advantage) plans and interventions. First, under the Public 11 (exemptions from other medical Medicaid managed care organizations Health Service Act, certain suicide criteria and standards), Congress from being compelled under certain prevention programs are not to be expressly included them within the circumstances to provide, reimburse for, construed to require ‘‘suicide definition of designated Medicare or cover, any counseling or referral assessment, early intervention, or providers. Congress prohibited States service in plans over an objection on treatment services for youth’’ if their from excluding RNHCIs from licensure moral or religious grounds. 42 U.S.C. parents or legal guardians have religious through implementation of State 1395w–22(j)(3)(B) (Medicare+Choice); or moral objections to such services. 42 definitions of ‘‘nursing home’’ and 42 U.S.C. 1396u–2(b)(3)(B) (Medicaid U.S.C. 290bb–36(f); section 3(c) of the ‘‘nursing home administrator,’’ 42 managed care organization). Department Garrett Lee Smith Memorial Act (Pub. L. U.S.C. 1396g(e), and Congress exempted regulations provide that this conscience 108–355, 118 Stat. 1404, reauthorized RNHCIs from certain Medicaid provision for managed care by Pub. L. 114–255 at sec. 9008). requirements for medical criteria and organizations also applies to prepaid Second, authority to issue certain grants standards. 42 U.S.C. 1396a(a) inpatient health plans and prepaid through the Health Resources and (exempting RNHCIs from 42 U.S.C. ambulatory health plans under the Services Administration (HRSA), 1396a(a)(9)(A), 1396a(a)(31), Medicaid program. 42 CFR Centers for Disease Control and 1396a(a)(33), and 1396b(i)(4)). Finally, 438.102(a)(2). Prevention (CDC), and the National Congress permitted patients at RNHCIs Federal Conscience and Anti- Institutes of Health (NIH) may not be to file an election with HHS stating that Discrimination Protections Applying to construed to preempt or prohibit State they are ‘‘conscientiously opposed to Global Health Programs. The laws which do not require hearing loss acceptance of’’ medical treatment, that Department administers certain screening for newborn, infants or young programs under the President’s children whose parents object to such is neither received involuntarily nor Emergency Plan for AIDS Relief screening based on religious beliefs. 42 required under Federal or State law or (PEPFAR), to which additional U.S.C. 280g–1(d). Third, certain State the law of a political subdivision of a conscience protections apply. and local child abuse prevention and State, on the basis of ‘‘sincere religious Specifically, recipients of foreign treatment programs funded by HHS are beliefs,’’ yet remain eligible for the assistance funds for HIV/ AIDS not to be construed as creating a Federal nonmedical care and services ordinarily prevention, treatment, or care requirement that a parent or legal covered under Medicare, Medicaid, and authorized by section 104A of the guardian provide a child any medical CHIP. See, e.g., 42 U.S.C. 1395x(e), Foreign Assistance Act of 1961 (22 service or treatment against the religious 1395x(y), and 1395i–5 (Medicare U.S.C. 2151b–2), 22 U.S.C. 7601–7682, beliefs of that parent or legal guardian. provisions). Federal courts have upheld 42 U.S.C. 5106i(a). Fourth, in providing the constitutionality of such religious Similar protections exist under the Department’s pediatric vaccines funded by Federal accommodations. See, e.g., Kong v. regulations applicable to hospitals, nursing medical assistance programs, providers Scully, 341 F.3d 1132 (9th Cir. 2003); facilities, and other medical facilities, See, e.g., 42 Children’s Healthcare v. Min De Parle,

2 CFR 489.102(c)(2); Medicare Advantage, 42 CFR must comply with any State laws S

E 212 F.3d 1084 (8th Cir. 2000).

L 422.128(b)(2)(ii); and Medicare Health Maintenance relating to any religious or other U R Organizations and Comprehensive Medical Plans, exemptions. 42 U.S.C. 1396s(c)(2)(B)(ii). h t i 42 CFR 417.436 (such organizations, plans, and https://www.medicare.gov/coverage/rnhci- w

Conscience Clauses Related to D their agents are not required to implement advance items-and-services.html. O Religious Nonmedical Health Care. R directives if the provider cannot do so ‘‘as a matter https://www.cms.gov/Medicare/Provider- P 2

8 of conscience’’ and State law allows such Since 1965, Congress has provided Enrollment-and-Certification/Certificationand 0 Q

L conscientious objection). accommodations in Medicare and Complianc/RNHCIs.html. G 3 K S D n o l l e

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Congress has also provided particular variety of individuals and organizations, to coordinate handling those complaints accommodations for persons and including private citizens, individual with the Departmental components from institutions that object to medical and institutional health care providers, which the covered entity receives services and items. Section 6703(a) of religious organizations, patient funding. the Elder Justice Act of 2009 (Pub. L. advocacy groups, professional Proposed Changes in 2009 Resulting 111–148, 124 Stat. 119) provides that organizations, universities and research in New Final Rule in 2011. On March Elder Justice and Social Services Block institutions, consumer organizations, 10, 2009, with the advent of a new Grant programs may not interfere with and State and Federal agencies and Administration, the Department or abridge an elder person’s ‘‘right to representatives. Comments dealt with a proposed to rescind, in its entirety, the practice his or her religion through range of issues surrounding the 2008 Rule. 74 FR 10207 (Mar. 10, 2009) reliance on prayer alone for healing,’’ proposed rule, including whether the (2009 Proposed Rule). The Department when the preference for such reliance is rule was needed, what individuals declared that certain comments on the contemporaneously expressed, would be protected by the proposed August 2008 Proposed Rule raised a previously set forth in a living will or rule, what services would be covered by number of questions warranting further similar document, or unambiguously the proposed rule, whether health care review of the 2008 Rule to ensure its deduced from such person’s life history. workers would use the regulation to consistency with that Administration’s 42 U.S.C. 1397j–1(b). Additionally, the discriminate against patients, what policy. The Department invited further Child Abuse Prevention and Treatment significant implementation issues could comments to reevaluate the necessity for Act (CAPTA) specifies that it does not be associated with the rule, what legal regulations implementing the Federal require (though it also does not prevent) arguments could be made for and conscience and anti-discrimination a State finding of child abuse or neglect against the rule, and what cost impacts laws. In response to the proposal to in cases in which a parent or legal of the proposed rule could be rescind the 2008 Rule, for which the guardian relies solely or partially upon anticipated. Many comments confirmed Department received supporting spiritual means rather than medical the need to promulgate a regulation to comments, the Department also received treatment, in accordance with religious raise awareness of Federal conscience comments stating that health care beliefs. 42 U.S.C. 5106i(a)(2). and anti-discrimination protections and workers should not be required to provide for their enforcement. violate their religious beliefs or moral B. Regulatory History The Department responded to those convictions; expressing concern that The Department engaged in substantive comments and issued a final health care providers would be coerced rulemaking to enforce some of these rule on December 19, 2008, codifying into violating their consciences; and Federal conscience and anti- the rule at 45 CFR part 88 (‘‘2008 identifying the 2008 Rule as protecting discrimination laws on previous Rule’’), which consisted of six sections: First Amendment religious freedom occasions: In the 2008 final rule at 45 Section 88.1 stated that the purpose of rights, the capacity to uphold the tenets CFR part 88 (the ‘‘2008 Rule,’’ 73 FR the 2008 Rule was ‘‘to provide for the of the Hippocratic Oath, and the ethical 78072, 78074 (Dec. 19, 2008)), in the implementation and enforcement’’ of integrity of the medical profession. revocation and replacement of that Rule the Church, Coats-Snowe, and Weldon Numerous commenters identified in 2011 (the ‘‘2011 Rule’’), and in Amendments. It specified that those concerns that there would be no existing CMS regulations at 42 CFR Amendments and the implementing regulatory scheme to protect the legal parts 422 and 438, which implement regulations ‘‘[we]re to be interpreted rights afforded to health care providers, 1395w–22(j)(3)(b) and 1396u–2(b)(3)(B), and implemented broadly to effectuate including medical students. 76 FR 9968, respectively. This section of the their protective purposes.’’ 9971 (Feb. 23, 2011) (2011 Rule). On February 23, 2011, the Department preamble briefly summarizes the first Section 88.2 of the 2008 Rule defined rescinded most of the 2008 Rule and two actions. several terms used in part 88 and finalized a new rule. 76 FR 9968. The 2008 Rule. The Department issued a applicable to various provider 2011 Rule left in place section ‘‘88.1 notice of proposed rulemaking in 2008 nondiscrimination protections, namely, Purpose,’’ but removed the word to enforce, and clarify the applicability the terms ‘‘Assist in the Performance,’’ ‘‘implementation,’’ describing the 2011 of, the Church, Coats-Snowe, and ‘‘Entity,’’ ‘‘Health Care Entity,’’ ‘‘Health Rule’s purpose as ‘‘provid[ing] for the Weldon Amendments. 73 FR 50274 Service Program,’’ ‘‘Individual,’’ enforcement’’ of the Church, Coats- (Aug. 26, 2008) (August 2008 Proposed ‘‘Instrument,’’ ‘‘Recipient,’’ ‘‘Sub- Snowe, and Weldon Amendments. It Rule). That proposed rule recognized (1) recipient,’’ and ‘‘Workforce.’’ Section 88.3 of the 2008 Rule set forth then removed the 2008 Rule’s sections inconsistent awareness of Federal the scope of applicability of the sections 88.2 through 88.5, redesignated the 2008 conscience and anti-discrimination and paragraphs of part 88 as they related Rule’s § 88.6 as § 88.2, and modified protections among federally funded to each conscience law implemented in that section to consist of two sentences, recipients and protected persons and the 2008 Rule. stating that OCR is designated to receive entities; and (2) the need for greater Section 88.4 of the 2008 Rule set forth complaints based on the Federal health enforcement mechanisms to ensure that the substantive requirements and care provider conscience protection Department funds do not support applications of the Church, Coats- statutes, and will coordinate the morally coercive or discriminatory Snowe, and the Weldon Amendments. handling of complaints with the policies or practices in violation of Section 88.5 of the 2008 Rule required Departmental funding component(s) Federal law. covered federally funded entities to from which the entity with respect to The Department received a ‘‘large provide written certification of which a complaint has been filed, volume’’ of comments on the August compliance with the laws encompassed receives funding. 2

S 2008 Proposed Rule. See 73 FR at E The preamble to the 2011 Rule stated, L by the 2008 Rule. U 78074. Comments came from a wide R

Section 88.6 of the 2008 Rule ‘‘The Department supports clear and h t i w

designated HHS OCR to receive strong conscience protections for health

D For instance, the prohibition against coercion O complaints based on the three specified care providers who are opposed to R in 42 U.S.C. 1395w–22(j)(3) (section 1852 of the P 2

8 Social Security Act) is regulated within the Federal conscience and anti- performing abortions.’’ 76 FR at 9969. 0 Q

L Medicare Program at 42 CFR 422.206(b), (d). discrimination laws, and directed OCR The Department recognized, ‘‘The G 3 K S D n o l l e

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comments received suggested that there Allegations and Evidence of Multiple commenters reported that is a need to increase outreach efforts to Discrimination and Coercion Have some hospitals had forced health care make sure providers and grantees are Existed Since the 2008 Rule and providers to sign affidavits agreeing to aware of these statutory protections. It is Increased Over Time. The 2008 Rule participate in abortions if asked. One also clear that the Department needs to sought to address an environment of obstetrician/ gynecologist commented have a defined process for health care discrimination toward, and attempted that he had been pressured to providers to seek enforcement of these coercion of, those who object to certain participate in abortions and abortion protections.’’ 76 FR at 9969. health care procedures based on counseling during his entire time in Accordingly, the summary of the 2011 religious beliefs or moral convictions. health care—from medical school, Rule stated that ‘‘enforcement of the Yet in February 2009, the Department through his residency, and during Federal statutory health care provider announced its intent to rescind the 2008 private practice. Medical and nursing conscience protections will be handled Rule just one month after its effective students, in twenty-five comments, by the Department’s Office for Civil date. It completed that rescission in expressed their reluctance to enter the Rights, in conjunction with the 2011, despite significant evidence of an health care field as a whole, and Department’s funding components.’’ 76 environment of discrimination and particularly specialties such as FR at 9968. The Department announced coercion, including thousands of public obstetrics, family medicine, and elder that OCR was beginning to lead ‘‘an comments during the rulemakings that care, where their objections to abortion initiative designed to increase the led to the 2008 and 2011 Rules or euthanasia might not be respected. awareness of health care providers describing that environment. For At least ninety commenters said that, if about the protections provided by the example, a 2009 article in the New forced to choose between their careers health care provider conscience statutes, England Journal of Medicine argued, or violating their conscience, they and the resources available to providers ‘‘Qualms about abortion, sterilization, would quit their jobs. Tens of who believe their rights have been and birth control? Do not practice violated.’’ 76 FR at 9969. The 2011 Rule women’s health.’’ In a 2009 survey of Comment Nos. HHS–OPHS–2009–0001–0739, provided that OCR would ‘‘collaborate 2,865 members of faith-based medical –52648, –52677. with the funding components of the associations, 39% reported having faced Comment No. HHS–OPHS–2009–0001–0868. Department to determine how best to pressure or discrimination from Comment Nos. HHS–OPHS–2009–0001–0026, –1035, –10522, –12117, –14427, –34439, –11404 inform health care providers and administrators or faculty based on their (‘‘future physician’’ concerned about shortages), grantees about health care conscience moral, ethical, or religious beliefs. –35236 (granddaughter entering the medical protections, and the new process for Additionally, 32% of the survey profession will change career path), –11579 (son enforcing those protections.’’ Id. respondents reported having been entering the medical profession), –14435 pressured to refer a patient for a (concerned mother of medical student), –18783 II. Overview of the Final Rule (spoke to student who is distraught and may leave), procedure to which they had moral, –5571, –41431 (sister is a medical student), –5638, A. Overview of Reasons for the Final ethical, or religious objections. Some –0068, –1791 (student would quit job), –2750 Rule 20% of medical students in that poll (exacerbates healthcare issues), –5255 (opposed and said that they would not pursue a career has used exemption), –7058, –7276, –7671, –5270 After reviewing the previous (has already seen others leave the profession over rulemakings, comments from the public, in obstetrics or gynecology because of pressure for their beliefs), –5638, –5566 (nurse who and OCR’s enforcement activities, the perceived discrimination and coercion chose not to specialize in obstetrics and gynecology Department has concluded that there is in that specialty against their beliefs. In for fear of pressure), –5566 (nurse who chose not total, 91% of respondents reported that to enter obstetrics and gynecology because of a significant need to amend the 2011 pressure to perform abortions). Rule to ensure knowledge of, they ‘‘would rather stop practicing Almost 90 comments are cited here, but this is compliance with, and enforcement of, medicine altogether than be forced to merely a sample of the total. See Comment Nos. Federal conscience and anti- violate [their] conscience.’’ HHS–OPHS–2009–0001–0540, –0017, –0264, discrimination laws. The 2011 Rule Comments received during the –0350, –0356, –0485, –0540, –0880, –0881, –0902, rulemaking that led to the 2011 Rule –0917, –0932, –10154, –15148, –20381 (woman in created confusion over what is and is California whose daughter is a nurse), –23290 not required under Federal conscience were consistent with this survey. (already left the profession), –32951, –9188, –47007 and anti-discrimination laws and (patient’s doctor said he would retire), –14287, post notices to which they objected. See Nat’l Inst. –19128, –9873, –29603 (physician stating many will narrowed OCR’s enforcement processes. of Family and Life Advocates v. Becerra, 138 S. Ct. retire), –50498 (patient’s doctor said he would Since November 2016, there has been a 2361 (Jun. 26, 2018). retire), –27384, –44458, –18837, –14216, –18015, significant increase in complaints filed 73 FR at 78073. –18015, –34140 (already retired but would have with OCR alleging violations of the laws Rob Stein, ‘‘Obama Plans to Roll Back retired earlier), –32593, –15341, –14837, –8582, that were the subject of the 2011 Rule, ‘Conscience’ Rule Protecting Health Care Of –16541, –11579 (patient’s doctor said he would Workers Who Object to Some Types of Care,’’ The retire), –0229, –51896 (children would be forced to compared to the time period between Washington Post (Feb. 28, 2009) http:// leave), –32009 (other physicians will be driven out), the 2009 proposal to repeal the 2008 www.washingtonpost.com/wp-dyn/content/article/ –10280 (physician with objections), –19029, Rule and November 2016. The increase 2009/02/27/AR2009022701104.html (writing that –33116, –50663, –3675, –24456, –11327, –19221, underscores the need for the ‘‘The administration’s plans, revealed quietly with –34888 (nurse saying others will leave), –14535 a terse posting on a Federal website, unleashed a (daughter will leave the profession), –21679 (four Department to have the proper flood of heated reaction’’). members in the family who may leave), –0283, enforcement tools available to Julie D. Cantor, M.D., J.D., ‘‘Conscientious –0340, –0905, –9272, –0055 (will give up serving appropriately enforce all Federal Objection Gone Awry—Restoring Selfless underserved population), –10862 (two sisters who conscience and anti-discrimination Professionalism in Medicine,’’ 360 New England J. are nurses will leave, hospital shut down), –17401, Med. 1484–85 (April 9, 2009). –29674 (son who is a physician will be forced out), laws. The Polling Company, Inc./ WomanTrend, –26795 (physician who says doctors will be forced Highlights of The Polling Company, Inc. Phone out), –25742, –49731, –15087, –13138, –17563,

2 –0006 (refuse to accept violation of beliefs in

S Since 2011, conscience and coercion in health Survey of the American Public, fielded March 31, E

L care have been the subjects of significant litigation 2009 through April 3, 2009), https://www.cmda.org/ practice), –0815, –7665, –8091, –2598 (private U R

at the State and local level. Recently, the Supreme library/doclib/pollingsummaryhandout.pdf (last family physician who intentionally avoided h t i obstetrics because it was made clear that ‘‘pro-life w Court held that the State of California likely visited Jan. 18, 2018); see also Public Comment

D violated the Free Speech rights of prolife pregnancy from Jonathan Imbody, Christian Medical candidates need not apply’’; also cites strong O

R pressure in universities and organizations in favor

P resource centers that do not provide information Association, (‘‘CMA Comment’’), available at 2

8 about where to obtain abortions by adopting a https://www.regulations.gov/document?D=HHS- of abortion provision, and is concerned physicians 0 Q

L statute that required them, among other things, to OCR-2018-0002-64461. Continued G 3 K S D n o l l e

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thousands of comments to the 2009 exemptions in the future. Hundreds of other providers if they do not feel that proposed rule expressed concern that, commenters expressed concern over the they can in conscience provide the without robust enforcement of Federal exclusion and marginalization of health standard reproductive services that their conscience and anti-discrimination care entities and employees holding patients request,’’ and ‘‘In resource-poor laws, individuals with conscientious religious beliefs or moral convictions, areas . . . [p]roviders with moral or objections simply would not enter the and fears that the moral agency of the religious objections should either health care field, or would leave the medical profession was eroding. practice in proximity to individuals profession, and hospitals would shut According to news reports, in 2010, who do not share their views or ensure down, contributing to the shortage of Nassau University Medical Center that referral processes are in place so health care providers or affecting the disciplined eight nurses when they that patients have access to the service quality of care provided. Thousands raised objections to assisting in the that the physician does not wish to also feared personnel with objections performance of abortions. Nurses in provide.’’ would be terminated or otherwise Illinois and New York filed lawsuits Public comments received on the unable to find employment, training, or against private hospitals alleging they proposed rule published in January opportunities to advance in their had been coerced to participate in 2018 shared additional anecdotes of fields. abortions. Mendoza v. Martell, No. coercion, discriminatory conduct, or Commenters also identified a culture 2016–6–160 (Ill. 17th Jud. Cir. June 8, other actions potentially in violation of of hostility to conscience concerns in 2016); Cenzon-DeCarlo v. Mount Sinai Federal conscience and anti- health care. Some expressed concern Hosp., 626 F.3d 695 (2d Cir. 2010). A discrimination laws. Commenters also that the rescission of the 2008 Rule nurse-midwife in Florida alleged she shared their assessments of the would contribute to these problems by had been denied the ability to apply for knowledge, or lack thereof, among the inappropriately politicizing, and a position at a federally qualified health general public, health care field, health interfering in, the practice of medicine center due to her objections to care insurance industry, and and individual providers’ judgment. prescribing hormonal contraceptives. employment law field of the rights and Thousands of comments from medical Hellwege v. Tampa Family Health Ctrs., obligations that this rule implements personnel stated their disagreement 103 F. Supp. 3d 1303 (M.D. Fla. 2015). and enforces. Examples are detailed in with the rescission, often stating that Twelve nurses in New Jersey sued a the Regulatory Impact Analysis as part they had requested exemptions in the public hospital over a policy allegedly of the Department’s analysis under past and were concerned rescission requiring them to assist in abortions and Executive Orders 12,866 and 13,563 would make it harder to request for disciplining one nurse who raised a regarding the need for this rule. conscientious objection to the same. Recently Enacted State and Local will leave the practice more), –3564, –0199, –5230 Complaint, Danquah v. University of Government Health Care Laws and (discrimination already present), –6603, –1397 Medicine and Dentistry of New Jersey, Policies Have Resulted in Numerous (nurse who has been forced to do things against her conscience in the past before the 2008 Rule came No. 2:11–cv–6377 (D.N.J. Oct. 31, 2011). Lawsuits by Conscientious Objectors. into effect, and who will quit if put in that scenario Many religious health care personnel The Department has also witnessed an again), –1100 (nurse who says others will leave the and faith-based medical entities have increase in lawsuits against State and practice), –6669, –0272, –0925, –0125, –4668, further alleged that health care local laws that plaintiffs allege violate –6709, –7900, –2544, –3535, –1852, –7684, –1381. Comment Nos. HHS–OPHS–2009–0001–20613, personnel are being targeted for their conscience or unlawfully discriminate. –43039, –27699, –42804, –6001, –10850, –27147, religious beliefs. For example, many State and local –50621, –52878, –19586, –40775, –4824, 27384, In 2016, the American Congress of governments have enacted legislation –11138, –52997, –53001, –4460, –12878, –12575, Obstetricians and Gynecologists (ACOG) requiring health care providers offering –43364, –27262, –42942, –26426, –38158, –43672, –52381, –32173, –16541, –19751, –2697, –52935, reaffirmed a prior ethics opinion that pregnancy resources as an alternative to –6369, –44571, –53022, –48387, –21990, –50837, recommended, ‘‘Physicians and other abortion to post notices related to –42069, –14662, –51974, –45449, –17364, –5370, health care professionals have the duty abortion, to which plaintiffs objected on –2922, –15005, –18783, –23376, –50685, –17401, to refer patients in a timely manner to –52946, –11206, –33828, –38997, –3925, –21036, First Amendment and analogous –50894, –27155, –10529, –47113, –7266, –22291, grounds. The Supreme Court held that –4016, –0204, –8788, –25608, –52932, –39199, Comment Nos. HHS–OPHS–2009–0001–3107, California’s version of such a law likely –12340, –52950 (form letter with 1,916 copies), –15617, –19496, –27506, –9586, –35721, –49748, violated the First Amendment free –31897, –52984 (form letter with 62 copies), –53081 –1650, –19965, –18365, –23095, –6332, –3405, (form letter with 22 copies), –52968 (form letter –1762, –4395, –4569, –6890, –0729, –0943, –1490, speech rights of centers that object to with 9,532 copies), –52961 (patients concerned –2994, –3248, –3419, –5341, –6479, –7079, –4525, abortion in National Institute of Family about access to pro-life doctors: Form letter with –7093, –2486, –2039, –7750, –6270, –1903, –3293, and Life Advocates v. Becerra, No. 16– –3405, –1127, –5505, –1823, –4939, –5881, –4529, 3,272 copies), –53098 (patients concerned effort to 1140, 585 U.S. , 138 S. Ct. 2361 push people out: Form letter with 976 copies), –5829, –1773, –2220, –2345, –3089, –7163, –7471, 77 –52977 (form letter with 3,516 copies), –53021 –3840, –0389, –1933, –3493, –3088, –5088, –5702. (Jun. 26, 2018) (‘‘NIFLA’’). (form letter with 4,842 copies), –52949 (form letter Comment Nos. HHS–OPHS–2009–0001–52974 with 688 copies), –53039 (form letter with 742 (form letter with 428 copies). https://www.acog.org/Clinical-Guidance-and- copies), –0476. LI Hospital issues abortion apology to nurses, Publications/Committee-Opinions/Committee-on- Comment Nos. HHS–OPHS–2009–0001–0558, N.Y. Post (Apr. 28, 2010), http://nypost.com/2010/ Ethics/The-Limits-of-Conscientious-Refusal-in- –10144, –53026 (claims documentation of 04/28/li-hospital-issues-abortion-apology-to-nurses. Reproductive-Medicine (reaffirming ACOG, ‘‘The unaddressed discrimination), –52985 (claims See, e.g., Roman Catholic Diocese of Albany v. Limits of Conscientious Refusal in Medicine,’’ documentation of unaddressed discrimination), Vullo, No. 02070–16 (N.Y. Albany County S. Ct. Committee Opinion No. 385, 110 Obstet Gyn. 1479 –52960 (claims documentation of unaddressed May 4, 2016); Means v. U.S. Conference of Catholic (2007)) The 2007 ACOG opinion had, at least in discrimination), –52735 (lack of knowledge about Bishops, No. 1:15–CV–353, 2015 WL 3970046 (W.D. part, prompted the 2008 Rule. Then-HHS Secretary rights), –53048 (evidence of discrimination), –53047 Mich. 2015); ACLU v. Trinity Health Corporation, Leavitt wrote to ACOG and the American Board of (evidence of discrimination: Form letter with 3,196 178 F. Supp. 3d 614 (E.D. Mich. 2016); Minton v. Obstetrics and Gynecology (ABOG) and noted that

2 copies), –52960 (evidence of discrimination: Form Dignity Health, No. 17–558259 (Calif. Super. Ct. the interaction between the ACOG opinion and S

E letter with 1,685 copies), –53028 (evidence of L Apr. 19, 2017); Chamorro v. Dignity Health, No. 15– ABOG certification requirements could constitute a U

R discrimination: Form letter with 2,002 copies). violation of Federal conscience and anti- 549626 (Calif. Super. Ct. Dec. 28, 2015). See also h t i Comment Nos. HHS–OPHS–2009–0001–0739, U.S. Conference of Catholic Bishops, Ethical and discrimination laws. w

D –52677, –26812, –53013 (form letter with 8,472 Religious Directives for Catholic Health Services On January 18, 2019, OCR issued a Notice of O

R copies). (Nov. 17, 2009) (identifying Catholic objections to Violation to the State of California for OCR P 2

8 Comment No. HHS–OPHS–2009–0001–10280, performing abortions, tubal ligations, and Complaint Nos. 16–224756 and 18–292848, finding 0 Q

L –2486, –46903, –19125, –36940, –12020, –41551. hysterectomies). that California’s version of such a law violated the G 3 K S D n o l l e

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Courts have also enjoined similar violated Federal conscience and anti- for example, sent a letter to seven ordinances in New York City; Austin, discrimination laws, were recently insurance companies seeking to enforce Texas; Montgomery County, Maryland; resolved with a finding by OCR that the a California legal requirement that the Baltimore, Maryland; Illinois; and State of California violated the Weldon insurers include abortion coverage in Hawaii. Greater Baltimore Center for and Coats-Snowe Amendments. OCR plans used by persons who objected to Pregnancy Concerns, Inc. v. Mayor and determined that ‘‘California’s enactment such coverage. See Letter from City Council of Baltimore, 879 F.3d 101, of the FACT Act violate[d] the Weldon California Department of Managed 105 (4th Cir. 2018), cert. denied, 138 S. and Coats-Snowe Amendments by Health Care, Re: Limitations or Ct. 2710, (2018) (holding that Baltimore discriminating against health care Exclusions of Abortion Services (Aug. ordinance requiring pregnancy resource entities that object to referring for, or 22, 2014) (interpreting State statutes, center to State abortion services are not making arrangements for, abortion.’’ regulations, and court decisions). The available in their facilities violated the Complaints filed with OCR against the State of California estimates that at least Free Speech Clause); Evergreen Ass’n, State of Hawaii, alleging Hawaii Revised 28,000 individuals subsequently lost Inc. v. City of New York, 740 F.3d 233 Statute section 321–561(b)–(c) violated their abortion-free health plans, and (2d Cir. 2014) (affirming an injunction, Federal conscience and anti- houses of worship have challenged based on the First Amendment, of discrimination laws, were recently California’s policy in court. See Foothill ordinance provisions requiring satisfactorily resolved when Hawaii Church v. Rouillard, 2:15–cv–02165– disclosures about whether pregnancy Attorney General Clare E. Connors KJM–EFB, 2016 WL 3688422 (E.D. Cal. resource centers refer for abortion and issued a Memorandum to the July 11, 2016); Skyline Wesleyan Church conveying city health department’s Department of the Attorney General for v. California Department of Managed recommendation to consult a licensed the State of Hawaii stating, ‘‘the Health Care, No. 3:16–cv–00501–H– medical provider); Austin LifeCare v. Department will not enforce section DHB (S.D. Cal. 2016). The New York City of Austin, No. 1:11–cv–00875–LY 321–561(b)–(c), HRS, against any State Department of Financial Services (W.D. Tex. Jun. 23, 2014) (permanently limited service pregnancy centers, as has similarly sought to require enjoining enforcement of ordinance as defined in section 321–561(a), HRS;’’ individual and small group employers, void for vagueness); Centro Tepeyac v. the memorandum also stated that it regardless of the number of employees Montgomery County, 5 F. Supp. 3d 745 ‘‘shall remain in effect indefinitely or or any religious affiliation, to provide (D. Md. Mar. 7, 2014) (applying strict until such time as there is a change in insurance coverage for abortions, scrutiny in finding that ordinance the laws discussed above warranting prompting additional lawsuits. See, e.g., violated pregnancy resource center’s reconsideration.’’ In her letter to OCR Roman Catholic Diocese of Albany v. First Amendment rights); Pregnancy regarding the Memorandum, Attorney Vullo, No. 02070–16 (N.Y. Albany Care Center of Rockford v. Rauner, No. General Connors also said that ‘‘the County Sup. Ct. May 4, 2016). 2016–MR–741 (Ill. 17th Jud. Cir. Dec. Department will advise the Hawai’i Over the past several years, an 20, 2016) (preliminary injunction Legislature of its decision not to enforce increasing number of jurisdictions in entered on free speech grounds); Prelim. section 321–561(b)–(c), HRS, against the United States have legalized assisted Inj., Nat’l Instit. of Family and Life any limited service pregnancy suicide. See District of Columbia B21– Advocates v. Rauner, No. 3:16–cv– center.’’ Attorney General Connors 0038 (Feb. 18, 2017), Colorado Prop. 106 50310 (N.D. Ill. Sept. 29, 2016) took appropriate corrective action in (Dec. 16, 2016); California ABX2–15 (preliminary injunction entered on free Hawaii to assure current and future (June 9, 2016); 18 Vermont Act 39 (May speech grounds); Calvary Chapel Pearl compliance with the Weldon and Coats- 20, 2013) (‘‘Act 39’’). In Vermont, for Harbor v. Chin, No. 1:17–cv–00326– Snowe Amendments, as they apply to example, Act 39 states that health care DKW–KSC (D. Haw. Sept. 20, 2018) Hawaii Revised Statute section 321– professionals must inform patients ‘‘of (permanent injunction and final 561(b)–(c), and the complaints regarding all available options related to terminal judgment). this provision were resolved without care.’’ 18 Vt. Stat. Ann. section 5282. Before NIFLA, several courts had having to find Hawaii in violation of When the Vermont Department of rejected challenges to California’s law. Federal conscience and anti- Health construed Act 39 to require all See, e.g., Mountain Right to Life v. discrimination laws. health care professionals to counsel for Harris, No. 5:16–cv–00119 (C.D. Cal. Some States have also sought to assisted suicide, individual health care July 8, 2016) (denying preliminary require health insurance plans to cover professionals and associations of injunction); A Woman’s Friend abortions, triggering additional religious health care providers sued Pregnancy Resource Clinic v. Harris, conscience-related lawsuits. California, Vermont, alleging a violation of their 153 F. Supp. 3d 1168 (E.D. Cal. Dec. 21, conscience rights. Compl., Vermont 2015); Livingwell Medical Clinic v. Letter from Roger T. Severino, Dir., Dep’t of Alliance for Ethical Health Care, Inc. v. Harris, No. 3:15–cv–04939, 2015 WL Health & Human Serv’s. Office for Civil Rights, to Hoser, No. 5:16–cv–205 (D. Vt. Apr. 5, 13187682 (N.D. Cal. Dec. 18, 2015). Xavier Becerra, Att’y. Gen., State of Cal. (Jan. 18, 2019), available at https://www.hhs.gov/sites/ 2017) (dismissed by consent agreement). Some of the plaintiffs in these default/files/california-notice-of-violation.pdf. More recently still, the family of a lawsuits also filed complaints with OCR Id. at 9. alleging that the State laws violate the California cancer patient sued UCSF Memorandum from Haw. Att’y. Gen. Clare E. Medical Center for alleged elder abuse Weldon, Coats-Snowe, and/ or Church Connors to the Dep’t. of the Att’y. Gen., State of because the cancer patient died after the Amendments. Complaints filed with Haw. 2 (Mar. 15, 2019) (on file with HHS OCR). OCR against the State of California, Letter from Haw. Att’y. Gen. Clare E. Connors, oncologists on staff declined to to Luis E. Perez, Deputy Dir. of the Conscience & participate in assisted suicide, but alleging California’s Reproductive Religious Freedom Div., Office for Civil Rights, U.S. before she could obtain a new

2 Freedom, Accountability, Dep’t of Health & Human Servs. (Mar. 15, 2019) (on S

E physician. L Comprehensive Care, and Transparency file with HHS OCR). U R

Letter from Roger T. Severino, Dir., Dep’t of h Act (FACT Act) (Cal. Health & Safety t i Health & Human Serv’s. Office for Civil Rights, to https://www.dmhc.ca.gov/Portals/0/ w Code Ann. sections 123470, et seq.) D Clare E. Connors, Att’y. Gen., State of Haw. (Mar. 082214letters/abc082214.pdf. O

R 21, 2019), available at https://www.hhs.gov/sites/ Bob Egelko, California’s assisted-dying P 2

8 Weldon and Coats-Snowe Amendments, as default/files/hawaii-ocr-notice-of-resolution- loophole: Some doctors won’t help patients die, San 0 Q

L discussed infra. final.pdf. Continued G 3 K S D n o l l e

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Finally, some States have passed laws For instance, some advocacy court in 2009, but her case was appearing to require health care organizations have filed lawsuits dismissed on the ground that she did professionals to provide referrals for claiming that Federal or State laws not have a private right to file a civil implementation of advance directives require private religious entities to action against such a hospital under the without accommodation for religious perform abortions and sterilizations Church Amendments. Cenzon-DeCarlo belief or moral conviction. See Iowa despite the existence of longstanding v. Mount Sinai Hospital, 626 F.3d 695 Code Ann. section 144D.3(5) (2012) conscience and anti-discrimination (2d Cir. 2010). The Second Circuit (requiring that providers take ‘‘all protections on this topic. See Means v. affirmed the dismissal, holding that the reasonable steps to transfer the patient U.S. Conference of Catholic Bishops, Church Amendments ‘‘may be a statute to another health care provider, No. 1:15–CV–353, 2015 WL 3970046 in which Congress conferred an hospital, or health care facility’’ even (W.D. Mich. 2015) (abortion); ACLU v. individual right,’’ but that Congress had when there is an objection based on Trinity Health Corp., 178 F.Supp.3d 614 not implied a remedy to file suit against ‘‘religious beliefs, or moral (E.D. Mich. 2016) (abortion); Minton v. private entities in Federal court. Id. at convictions’’); Idaho Code Ann. 39– Dignity Health, No. 17–558259 (Cal. 698–99. After the dismissal of the 4513(2) (2012) (requiring that a provider Super. Ct. Apr. 19, 2017) Federal lawsuit, the nurse then filed a ‘‘make[ ] a good faith effort to assist the (hysterectomy); Chamorro v. Dignity case in State court, but that case too was person in obtaining the services of Health, No. 15–549626 (Cal. Super. Ct. dismissed for lack of a private right of another physician or other health care Dec. 28, 2015) (tubal ligation). A patient action. Cenzon-DeCarlo v. Mount Sinai provider who is willing to provide care also sued a secular public hospital for Hosp., 962 N.Y.S.2d 845 (Sup. Ct. Kings for the person in accordance with the accommodating doctors’ and nurses’ County 2010), aff’d by 957 N.Y.S.2d 256 person’s expressed or documented religious objections to abortion in (App. Div. 2012). The nurse then filed wishes’’). alleged violation of a State law, a complaint with OCR on January 1, Since the Department issued the Washington’s Reproductive Privacy Act. 2011, and OCR resolved the complaint proposed Conscience Rule in 2018, OCR Coffey v. Pub. Hosp. Dist. No. 1, 20–15– after the hospital changed its written issued a Notice of Violation to the State 2–00217–4 (Wash. 2015). policy for health care professionals. of California for OCR Complaint Nos. Congress has exercised the broad 16–224756 and 18–292848, finding that authority afforded to it under the Similar results occurred in a Federal California’s FACT Act violated the Spending Clause to attach conditions on lawsuit brought by a nurse in 2014, Weldon and Coats-Snowe Amendments, Federal funds to protect conscience alleging that a health center had as discussed supra. Beyond this finding, rights. Such conditions override violated the Church Amendments when in this final rule, the Department does conflicting provisions of State law for it denied her the ability to apply for a not opine on or judge the legal merits States that accept the conditioned funds position as a nurse because she objected or sufficiency of any of the above-cited according to the terms of the statutes to prescribing abortifacients. Hellwege v. lawsuits or challenged laws. They are applicable to such funding streams. Tampa Family Health Centers, 103 F. discussed here to illustrate a notable States have long been able to harmonize Supp. 3d 1303 (M.D. Fla. 2015). Like the number of disputes about alleged and comply with other ‘‘cross-cutting’’ court in New York, the court held that violations of health care conscience, anti-discrimination laws imposed the Church Amendments ‘‘recognize broadly understood, by State and local through such conditions on Federal important individual rights’’ but do not governments. They also illustrate the financial assistance. See, e.g., Title VI of confer a remedy to bring suit against a need for greater clarity concerning the the Civil Rights Act of 1964, 42 U.S.C. private entity in Federal court. Id. at scope and operation of the Federal 2000d et seq., and Title IX of the 1310. More recently, a Federal district conscience and anti-discrimination laws Education Amendments of 1972, 20 court in Illinois held that there is no that are the subject of this final rule. The U.S.C. 1681 et seq. The Department private right of action for a doctor who Department anticipates that this final seeks to clarify the scope and alleges that the State required her to rule will result in greater public application of Federal conscience and refer for abortions in violation of the familiarity with Federal conscience and anti-discrimination laws in this final Coats-Snowe Amendment. Order at 4, anti-discrimination laws, and may rule as it has with other anti- Nat’l Instit. of Family and Life inform both State and local governments discrimination laws. See 45 CFR part 80 Advocates, v. Rauner, No. 3:16–cv– and health care institutions of their (Title VI) and part 86 (Title IX). 50310 (N.D. Ill. July 19, 2017), ECF No. obligations, and individual and Courts Have Found No Alternative 65. institutional health care entities of their Private Right of Action to Remedy In light of these decisions and the rights, under those laws. Violations. The government, rather than increase in conscience-based challenges Confusion Exists About the Scope and private parties, has the central role in to State and local laws in the health care Applicability of Federal Conscience and enforcement of Federal conscience and context, OCR has a singular and critical Anti-Discrimination Laws. Even though anti-discrimination laws. In lawsuits responsibility to provide clear and Federal conscience and anti- filed by health care providers for alleged appropriate interpretation of Federal discrimination laws are currently in violations of certain of these laws, conscience and anti-discrimination effect, the public has sometimes been courts have generally held that such laws, to engage in outreach to protected confused about their applicability in laws do not contain, or imply, a private parties and covered entities, to conduct relation to other Federal, State, or local right of action to seek relief from such compliance reviews, to investigate laws. One of the purposes of the 2008 violations by non-governmental covered alleged violations, and to vigorously Rule was to address confusion about the entities. Thus, adequate governmental enforce those laws. enforcement mechanisms are critical to 2

S interaction between Federal conscience

E Addressing Confusion Caused by OCR

L the enforcement of these laws.

U and anti-discrimination laws and other

R Sub-Regulatory Guidance. This final The case of a New York nurse who h t i Federal statutes.

w rule also resolves confusion caused by

alleged that a private hospital forced her D

O to assist in an abortion over her sub-regulatory guidance issued through R Francisco Chronicle (Aug. 12, 2017), http:// P

2 OCR’s high-profile closure of three 8 www.sfchronicle.com/news/article/California-s- religious objections illustrates the point. 0

Q Weldon Amendment complaints against L assisted-dying-loophole-Some-11761312.php. The nurse filed a lawsuit in Federal G 3 K S D n o l l e

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the State of California filed in 2014. guidance issued by OCR with respect to from coercion and discrimination On June 21, 2016, OCR declared it interpretation of the Weldon including that stemming from moral found no violation stemming from Amendment no longer reflects the convictions or religious beliefs. California’s policy requiring that health Department’s position on, and B. Structure of the Final Rule insurance plans include coverage for interpretation of, the Weldon abortion based on the facts alleged in Amendment. The Department continues This final rule generally reinstates the the three complaints it had received. to hold the views it expressed on that structure of the 2008 Rule, includes OCR’s closure letter concluded that the issue in the preamble to the proposed further definitions of terms, and Weldon Amendment’s protection of rule, see 83 FR at 3890–91, and has provides robust certification and health insurance plans included issuers reflected those views in its analysis enforcement provisions comparable to of health insurance plans but not contained in the Notice of Violation to provisions found in OCR’s other civil institutions or individuals who the State of California for OCR rights regulations.This final rule also purchase or are insured by those plans. Complaint Nos. 16–224756 and 18– encourages certain recipients of Federal Even though California’s policy resulted 292848, discussed supra, in which OCR financial assistance from the in complainants losing abortion-free discussed the rationale behind its Department or of Federal funds from the insurance that was consistent with their determination that ‘‘California’s Department to notify individuals and beliefs and that insurers were willing to enactment of the FACT Act violate[d] entities protected under Federal provide, the letter concluded that none the Weldon . . . Amendment[ ] by conscience and anti-discrimination laws qualified as an entity or person discriminating against health care (such as employees, applicants, or protected under the Weldon entities that object to referring for, or students) of their Federal conscience Amendment because none was an making arrangements for, abortion.’’ rights. In addition, this final rule insurance issuer. Relying on an The Department is concerned that requires certain such entities to assure interpretation of legislative history, segments of the public have been and certify to the Department their instead of the Weldon Amendment’s dissuaded from complaining about compliance with the requirements of text, OCR also declared that health care religious discrimination in the health these laws. It also sets forth in more entities are not protected under Weldon care setting to OCR as the result, at least detail the investigative and enforcement unless they possess a ‘‘religious or in part, of these unduly narrow responsibility of OCR, along with the moral objection to abortion,’’ and interpretations of the Weldon tools at OCR’s disposal for carrying out concluded that the insurance issuers at Amendment. For example, Foothill its responsibility with respect to these issue did not merit protection because Church, located in Glen Morrow, laws. they had not raised any religious or California, expressed concern that filing Congress has imposed obligations on moral objections. Finally, OCR called a complaint with OCR about California’s the Department and funding recipients into question its ability to enforce the abortion-coverage requirement was through these statutes, and the Weldon Amendment against a State at pointless because the Department had Department is, therefore, required to all because, according to the letter, to do already closed three similar complaints, ensure its own compliance and the so could ‘‘potentially’’ require the finding no violation of Federal compliance of its funding recipients. In revocation of Federal funds to California conscience and anti-discrimination 2008 and 2011, the Secretary delegated in such a magnitude as to violate State laws. See Foothill Church v. Rouillard, to OCR the authority to receive sovereignty and constitute a violation of No. 2:15–cv–02165–KJM–EFB, 2016 WL complaints of discrimination under the the Constitution. 3688422 (E.D. Cal. July 11, 2016). Church, Coats-Snowe, and Weldon The Department does not opine upon, With this final rule, the Department Amendments, in coordination with and has not yet made a judgment on, the seeks to educate protected entities and Department components that provide compatibility of California’s policy with covered entities as to their legal rights Federal financial assistance. Congress the Weldon Amendment. But and obligations; to encourage later designated OCR as responsible for clarification is in order with respect to individuals and organizations with receiving complaints under section 1553 the general interpretations of the religious beliefs or moral convictions to of the ACA. Many of the remaining Weldon Amendment offered in OCR’s enter, or remain in, the health care statutes that are the subject of the closure of complaints against industry; and to prevent others from proposed rule do not have any California’s abortion coverage being dissuaded from filing complaints implementing regulations. To the extent requirement. The Department has due to prior OCR complaint resolutions not already delegated to OCR, the engaged in further consideration of this or sub-regulatory guidance that no Secretary is, therefore, delegating to general matter and has also further longer reflect the views of the OCR enforcement authority—that is, the reviewed Federal conscience and anti- Department. authority to receive complaints, and, in discrimination laws, their legislative Additional Federal Conscience and consultation and coordination with the history, and the record of rulemaking Anti-Discrimination Laws. Finally, in funding components of the Department, and public comments. Based on this addition to all of the concerns discussed investigate alleged violations and take review, the Department indicated, in the above, the Department is using this appropriate enforcement action—over preamble to the proposed rule, that the rulemaking to address various other those additional Federal statutes as well above-mentioned sub-regulatory conscience protection and anti- as the statutes covered by the 2008 and discrimination laws not discussed in the 2011 Rules. OCR Complaint Nos. 14–193604, 15–193782, 2008 and 2011 Rules. Some of these The compliance and enforcement and 15–195665. provisions were enacted after 2008. All sections specify in much greater detail Letter from OCR Director to Complainants (June provide additional protections, such as than either the 2008 Rule or 2011 Rule 2 21, 2016) available at http://www.adfmedia.org/ S

E for health care providers and patients, how OCR will, in consultation and L files/CDMHCInvestigationClosureLetter.pdf. U R In reaching this conclusion, the letter cited coordination with HHS funding h t i

w advice from ‘‘HHS’ Office of General Counsel, after Letter from Roger T. Severino, Dir., Dep’t of

components, enforce the Federal D consulting with the Department of Justice,’’ but Health & Human Serv’s. Office for Civil Rights, to O conscience and anti-discrimination R

P HHS has not located any written legal analysis from Xavier Becerra, Att’y. Gen., State of Cal., at 9 (Jan. 2

8 either the HHS Office of the General Counsel or the 18, 2019), available at https://www.hhs.gov/sites/ laws. Implementation of the 0 Q

L Department of Justice despite a diligent search. default/files/california-notice-of-violation.pdf. requirements set forth in this final rule G 3 K S D n o l l e

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will be conducted in the same way that III. Analysis and Response to Public fully exercising their consciences as OCR implements other civil rights Comments on the Proposed Rule protected by law. requirements (such as the prohibition of The Department agrees with its HHS received over 242,000 comments discrimination on the basis of race, previous response. The Federal in response to the notice of proposed color, or national origin), which conscience and anti-discrimination laws rulemaking (NPRM). HHS considered includes outreach, investigation, pre-exist these regulations. They all comments filed in accordance with provide rights and protections to health compliance, technical assistance, and the Administrative Procedure Act and enforcement practices. Enforcement will care providers, including in rural the instructions provided in the NPRM communities, underprivileged be based on complaints, referrals, and published in the Federal Register on communities, or other communities that other information OCR may receive January 26, 2018. are primarily served by religious about potential violations, such as news The Department’s evaluation of the healthcare providers or facilities reports and OCR-initiated compliance comments led to a number of changes (together, ‘‘underserved communities’’). reviews and communications activities between the NPRM and this final rule. There appears to be no empirical data, if facts suffice to support an The public comments and the changes however, on how previous legislative or investigation. If OCR becomes aware of made in issuing this final rule are regulatory actions to protect conscience a potential violation of Federal discussed below. rights have affected access to care or conscience and anti-discrimination health outcomes. Studies have laws, OCR will investigate, in A. General Comments specifically found that there is coordination with the Department The Department received many insufficient evidence to conclude that component providing Federal financial comments on the proposed rule that conscience protections have negative assistance or Federal funds to the expressed general support or opposition effects on access to care. The investigated entity. If OCR concludes an and did not include substantive or Department is not aware of data in its entity is not in compliance, OCR, in technical commentary upon the rule. possession, in the public comments, or in the public domain that provides a consultation and coordination with the Comment: The Department received Department funding component(s), will way to estimate how many health care comments expressing concern about the providers either in general or in assist covered entities with corrective impact of the rule on access to care in action or compliance, or require underserved communities are—and are rural communities, underprivileged not—exercising their conscience rights violators to come into compliance. If, communities, or other communities that and protections, even though they are despite the Department’s assistance, are primarily served by religious encompassed by Federal conscience and corrective action is not satisfactory or healthcare providers or facilities. anti-discrimination laws, nor is the compliance is not achieved, OCR, in Response: Access to care is a critical Department aware of data to determine coordination with the funding concern of the Department. The how many providers, among those, component, may consider all legal Department does not believe this rule would exercise their conscience rights options available to the Department, to will harm access to care. When the and protections once this rule is overcome the effects of such Department promulgated the 2008 Rule finalized, and because it is finalized. discrimination or violations. protecting conscience rights in health Because enforcement of the rule will Enforcement mechanisms where care, it addressed comments about the remove barriers to entry into the health voluntary resolution cannot be reached rule’s impact on access to care. In that care professions, it is reasonable to include termination of relevant funding, response, the Department stated that the assume that the rule may, in fact, induce either in whole or in part, funding claw regulation did not expand the scope of more people and entities to enter or backs to the extent permitted by law, existing Federal conscience and anti- remain in the health care field. On a voluntary resolution agreements, discrimination laws, and noted that broad level, this effect is reasonably referral to the Department of Justice (in implementation and enforcement of likely to increase, not decrease, access consultation and coordination with the such laws would help alleviate the to care, including—and perhaps Department’s Office of the General country’s shortage of health care especially—in underserved Counsel), or other measures, as set forth providers. The Department also communities. The Department is not in applicable regulations, procedures, observed that it was contradictory to aware of data, including from public and funding instruments. This final rule argue, as many commenters did, both commenters, that would provide a clarifies that recipients are responsible that the rule would decrease access to useful basis for a quantitative estimate care and that the then-current for their own compliance with Federal of how many more providers would conscience protections for providers enter the health care field, or serve conscience and anti-discrimination laws were sufficient: If the Department’s new and implementing regulations, as well rule would decrease access to care Id. as for ensuring their sub-recipients because of an increase in providers’ See Chavkin et al., ‘‘Conscientious objection comply with these laws. This final rule exercise of conscientious objections, it and refusal to provide reproductive healthcare: A also clarifies that parties subject to OCR White Paper examining prevalence, health would seem that the statutory consequences, and policy responses,’’ 123 Int’l J. investigation have a duty to cooperate protections that existed before the Gynecol. & Obstet. 3 (2013), S41–S56 (‘‘[I]t is and preserve documents and to report to regulation did not result in providers difficult to disentangle the impact of conscientious their Department funding component(s) objection when it is one of many barriers to if they are subject to a determination by reproductive healthcare. . . . [C]onscientious The comments are available at https:// objection to reproductive health care has yet to be

2 OCR of noncompliance. Finally, this www.regulations.gov/docket?D=HHS-OCR-2018- rigorously studied.’’); K. Morrell & W. Chavkin, S

E 0002. While Regulations.gov shows 72,417 public L final rule specifies that OCR may ‘‘Conscientious objection to abortion and U

R submissions were received, many comment

reproductive healthcare: A review of recent h remedy claims of intimidation and t i submissions attached hundreds or thousands of literature and implications for adolescents,’’ 27 w

D retaliation against those who file a individual comments, resulting in over 242,000 Curr. Opin. Obstet. Gynecol. 5 (2015), 333–38 O

R complaint or assist in an OCR actual comments. (‘‘[T]he degree to which conscientious objection has P 2

8 73 FR at 78080–81 (Dec. 19, 2008). compromised sexual and reproductive healthcare 0 investigation. Q

L 73 FR at 78081. for adolescents is unknown.’’). G 3 K S D n o l l e

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underserved communities, as a result of because they anticipated they would be institutions as well, not just individuals. this rule, nor what the corresponding pressured to violate their consciences. Religious hospitals or clinics, for increase of access to care might be. In some cases, that decision may be the example, if they are assured greater However, no public commenter result of discrimination occurring enforcement of their rights to practice provided any data that undermines the during medical training, such as medicine consistent with their religious reasoning that leads the Department to medical students’ experiences of beliefs, may find it worthwhile to believe that the rule will have such an discrimination on the basis of their expand to serve more people, including effect. And several factors support the religious beliefs or moral convictions, in underserved communities. Some Department’s position. or by pressures faced by institutions commenters contend this could lead First, predictions that the rule will because of their religious identity or religious hospitals to move into reduce services in underserved moral convictions. Reducing that underserved communities and crowd communities may be based on incorrect discrimination and pressure may lead to out other providers who might not have assumptions. As the Department has more individual and institutional health objections to certain services. The made clear, the rule does not expand the care providers overall, which could help Department is not, however, aware of substantive protections of Federal increase, rather than decrease, services data demonstrating that the expansion conscience and anti-discrimination for underserved communities. Another of health care services by religious laws. Thus, to the extent commenters way this effect may manifest itself is if providers, particularly in underserved believe the rule would reduce services the average facility has access to more communities, would crowd out other in underserved communities, that highly qualified candidates because providers who perform services that would seem to be based on an there is a larger pool of medical they do not, and market forces assumption that there are health care professionals from which to choose. ordinarily would not dictate that result. providers in underserved communities Having more providers overall, so that Again, the Department is not aware of who are protected by these laws but are the field as a whole provides a wide and data demonstrating the dire results offering services to which they object diverse range of services, is preferable to predicted by some commenters. anyway (for example, abortions or having fewer providers, particularly In addition, the relationship between abortion referrals) because the laws are with respect to underserved areas. religious or other conscientiously inadequately enforced. That is not Third, the rule may prevent some objecting providers and underserved necessarily a correct assumption. Such health care providers from leaving the communities may be far more complex health care providers might be field. A certain proportion of decisions than assumed by the prediction that this responding to a threat to their by currently practicing health providers rule will decrease services. There are conscientious practice, not by offering to leave the profession may be reasons to believe that many persons the services despite their objections, but motivated by such pressure. With the who might make use of protections by leaving the health care field or a rule’s added emphasis on enforcing under Federal conscience and anti- particular practice area involving that protections for rights of conscience, discrimination laws are already more service. One poll suggests that over 80% fewer individuals may leave the likely to be located in certain of religious health care providers in profession, and in turn they may help underserved areas, and that their underserved communities would likely meet unmet needs for care. In addition, patients are similarly likely to share limit their scope of practice if they were in some instances where a provider their views on issues such as abortion. required to participate in practices and objects, based on conscience, to According to the Pew Research Center, procedures to which they have moral, providing a service, there may be some for example, ‘‘urban dwellers are far ethical, or religious objections, rather underserved communities where other more likely than their rural counterparts than provide the services. If that is providers who have no such objections to say abortion should be legal in all or correct, improving enforcement of are available to provide the service. By most cases.’’ This suggests that the Federal conscience and anti- contrast, without enforcement of enforcement of Federal conscience and discrimination laws might reduce Federal conscience and anti- anti-discrimination laws is not likely to infringement of conscience protections, discrimination laws, some providers be the cause of religious and other not by reducing the availability of with religious beliefs or moral objecting providers being located in services such as abortion, but by convictions could close their doors rural communities, but that such increasing the availability of other (rather than violate their consciences), providers are already in those services by encouraging providers not to leaving a community even more communities, and Congress passed self-limit their practices in underserved underserved than if the provider were in these laws to protect them, among other communities. practice. individuals and entities, from being Second, and relatedly, the rule might The rule might allow an increase in driven out of practice, which could result in an increase in the number of the provision of health care by religious exacerbate the lack of access to health providers overall, or in certain care overall in those communities. specialties within the health care field. The CMA comment cited a poll finding that There is also reason to believe that Individuals and entities may have twenty percent of responding faith-based medical religious institutions and individuals students chose not to pursue a career in obstetrics/ are disposed to serve in underserved chosen not to enter the health care field gynecology because of perceived coercion and discrimination in that field. communities because of elements of The CMA comment cited poll data from 2009 The Christian Medical Association and their religious mission besides and 2011, which found that 82% of medical Freedom2Care poll of May 3, 2011, found that 82% objections protected by Federal professionals ‘‘said it was either ‘very’ or of medical professionals ‘‘said it was either ‘very’ conscience and anti-discrimination ‘somewhat’ likely that they personally would limit or ‘somewhat’ likely that they personally would laws. For example, various commenters 2 the scope of their practice of medicine if conscience limit the scope of their practice of medicine if S E

L rules were not in place. This was true of 81% of conscience rules were not in place. This was true U R

medical professionals who practice in rural areas of 81% of medical professionals who practice in Pew Research Center, ‘‘What Unites and h t i and 86% who work full-time serving poor and rural areas and 86% who work full-time serving Divides Urban, Suburban, and Ruran Communities’’ w

D medically-underserved populations . . . 91% poor and medically-underserved populations . . . (May 22, 2018), available at https:// O

R agreed, ‘I would rather stop practicing medicine 91% agreed, ‘I would rather stop practicing www.pewsocialtrends.org/2018/05/22/what-unites- P 2

8 altogether than be forced to violate my medicine altogether than be forced to violate my and-divides-urban-suburban-and-rural- 0 Q

L conscience.’ ’’ conscience.’ ’’ communities/. G 3 K S D n o l l e

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contend the reason why Catholic enhance, not impede, access to care in patient relationship is best served by hospitals are overrepresented in serving areas with fewer providers, such as rural open communication of conscience certain underserved populations is communities. The Department is not issues surrounding the provision of because the hospitals are motivated by aware of data establishing the views of health care services, including any their Catholic beliefs to serve unserved, commenters who say the rule will conscientious objections providers or underserved, underprivileged, or reduce services in underserved patients may have to providing, minority communities, and these communities, or of data establishing assisting, participating in, or receiving commenters argue that Catholic quantitatively how much the rule will certain services or procedures. By hospitals (and, by extension, other increase and enhance access to health protecting a diversity of beliefs among religious providers) provide an overall care services in underserved health care providers, these protections benefit to underserved communities. communities. The Department ensure that options are available to This overall benefit is consistent with concludes, instead, that it is reasonable patients who desire, and would feel Congress’s apparent intent, in the to agree with commenters who believe most comfortable with, a provider Federal conscience and anti- the rule will not decrease access to care, whose religious beliefs or moral discrimination laws, to ensure that the and may increase it. convictions match their own. Even health care system remains open to the The Department finds that finalizing where a patient and provider do not vibrant participation of religious and the rule is appropriate without regard to share the same religious beliefs or moral other providers, without barriers that whether data exists on the competing convictions, it is not necessarily the can be created by discrimination against contentions about its effect on access to case that patients would want providers them, or infringements of their services. Most significantly, finalizing to be forced to violate their religious conscientious beliefs. Any loss of such the rule is appropriate because it beliefs or moral convictions. providers because of the lack of enforces Federal conscience and anti- Comment: The Department received enforcement of Federal conscience and discrimination laws, which represent comments expressing concern that the anti-discrimination laws could decrease Congress’s considered judgment that proposed rule would expand Federal access to care for underserved these rights are worth protecting even if conscience and anti-discrimination communities. Therefore, when other they impact overall or individual access statutes to cover areas beyond the scope commenters contend that women of to a particular service, such as abortion. of the statutes. Several commenters color would be disproportionately But finalizing the rule is also raised concerns about expanding harmed by this rule due to the appropriate because the Department’s protection to HIV treatment, pre- significant services provided by belief that the rule will enhance access exposure prophylaxis, and infertility Catholic hospitals, they do not seem to to care is based on reasonable, informed treatment. account for the fact that, without those assumptions unrebutted by public Response: The Department drafted the hospitals’ overall ability to exercise comments submitted in opposition to proposed rule to track the scope of each their religious mission, they would not the rule. Ultimately, the Department statute’s covered activities as Congress be providing health care services to believes that this rule will result in drafted them, without being unduly those communities in the first place. more health care provider options and, broad or unduly narrow. For example, The Department also disagrees with thus, better health care for all where the scope of laws that are the the assumption that the rule’s Americans. The Department thus subject of this regulation is limited to enforcement of Federal conscience and believes that it is appropriate to finalize certain enumerated procedures, the final anti-discrimination laws will result in this rule to enforce Federal conscience rule makes clear that OCR will only harm, or in more harm than the benefits and anti-discrimination laws, even pursue enforcement under those laws that derive from implementing Federal though the Department and commenters with respect to those enumerated laws. As explained in the Regulatory do not have data capable of quantifying procedures. Impact Analysis, infra at part IV.C.3.vii, all of its effects on the availability of The Department is unaware of any the Department expects the rule to care. cases claiming denial of service Comment: The Department received regarding these procedures brought Ascension, REF: Docket HHS–OCR–2018–0002, comments stating that protecting health under any of the statutes implemented Protecting Statutory Conscience Rights in Health care professionals’ moral and religious by this rule. Public comments received Care; Delegations of Authority (Mar. 27, 2018) (‘‘As convictions places health care providers by the Department did not cite such the largest non-profit health system in the U.S. and above patients. cases. In the event that the Department the world’s largest Catholic health system, Ascension is committed to delivering Response: The Department disagrees. receives a complaint with respect to HIV compassionate, personalized care to all, with First, this final rule provides for the treatment, pre-exposure prophylaxis, or special attention to persons living in poverty and enforcement of protections established infertility treatment, the Department those most vulnerable. In FY2017, Ascension by the people’s representatives in would examine the facts and provided more than $1.8 billion in care of persons living in poverty and other community benefit Congress; the Department has no circumstances of the complaint to programs.’’); Catholic Health Association, REF: RIN authority to override Congress’s determine whether it falls within the 0945–ZA 03 Protecting Statutory Conscience Rights balancing of the protections. Second, scope of the statute in question and in Health Care; Delegations of Authority: Proposed protecting health care providers’ rights these regulations. Rule, 83 FR 3880, January 26, 2018 (Mar. 27, 2018) (‘‘As a Catholic health ministry, our mission and of conscience ensures that health care Discussion of this rule’s potential our ethical standards in health care are rooted in providers with deeply held religious application with regard to gender and inseparable from the Catholic Church’s beliefs or moral convictions are not dysphoria is located in the section-by- teachings about the dignity of each and every driven out of the health care industry— section analysis regarding comments on human person, created in the image of God. Access and, therefore, made unavailable to the Church Amendments, at part 2 to health care is essential to promote and protect infra S

E serve any patients and provide any L the inherent and inalienable worth and dignity of III.B. U R

every individual. These values form the basis for health care services—because of their Comment: The Department received h t i our steadfast commitment to the compelling moral w

refusal to participate in certain objected- many comments expressing confusion

D implications of our heath care ministry and have O to activities, such as abortion, or concern as to how the proposed rule R driven CHA’s long history of insisting on and P 2

8 working for the right of everyone to affordable, sterilization, or assisted suicide. Third, would interact with or be in conflict 0 Q

L accessible health care.’’). the Department believes the provider- with other Federal laws, such as the G 3 K S D n o l l e

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Emergency Medical Treatment and compliance, as compared to the status identify and respect a diversity of views, Active Labor Act (EMTALA) and quo. This rule provides appropriate further the provision of health care, and Federal anti-discrimination statutes enforcement mechanisms in response to comply with the law. The final rule’s (such as section 1557 of the ACA). a significant increase in complaints modifications to the definition of Response: This final rule provides the alleging violations of Federal conscience ‘‘discrimination’’ permit employers of Department with the means to enforce and anti-discrimination laws. Each law such personnel to accommodate the Federal conscience and anti- that is the subject of this rule professionals’ religious or moral discrimination laws in accordance with meaningfully differs from the next. objections, without interfering in the their terms and to the extent permitted Moreover, the Department believes employer’s delivery of health services. under the laws of the United States and some laws have never been enforced, Comment: The Department received the Constitution. This final rule, like the not necessarily because of widespread comments questioning whether the 2008 Rule and the 2011 Rule, does not compliance with other overlapping Department has authority to issue go into detail as to how its provisions laws, but because the Department has regulations implementing some or all of may or may not interact with other devoted no meaningful attention to the Federal conscience and anti- statutes or in all scenarios, but OCR those laws, has not conducted outreach discrimination laws encompassed by intends to read every law passed by to the public on them, and has not this rule. Congress in harmony to the fullest adopted regulations with enforcement Response: The Federal conscience extent possible so that there is procedures for them. and anti-discrimination laws maximum compliance with the terms of Comment: The Department received a encompassed by this part, including the each law. With respect to EMTALA, the comment requesting that the Church Amendments, section 245 of the Department generally agrees with its Department clarify that health care Public Health Service Act, and the explanation in the preamble to the 2008 providers may establish systems to help Weldon Amendment, require, among Rule that the requirement under meet patients’ health care needs when a other things, that the Department and EMTALA that certain hospitals treat and provider holds a religious belief or recipients of Department funds refrain stabilize patients who present in an moral conviction that may affect the from discriminating against institutional emergency does not conflict with service or procedure that a patient is and individual health care entities that Federal conscience and anti- seeking. do not participate in certain medical discrimination laws. The Department Response: Nothing in the rule procedures or services, including intends to give all laws their fullest prohibits an entity from providing a certain health services or research possible effect. lawful service it wants to provide, even activities funded in whole or in part by Comment: The Department received as it respects the rights of personnel the Federal government. comments stating that the Department who may be protected by Federal laws Compliance by the Department. should withhold Federal financial from being required to provide, or assist Inherent in Congress’s adoption of the assistance from any State that does not in, the service. As discussed later in this statutes that require compliance by the provide for religious exemptions to preamble, the rule provides incentives Department, by departmental programs, vaccination. for (but does not mandate) notices that and by recipients of Federal funds from Response: This rule is only intended parallel notice provisions under other the Department is the authority of the to provide enforcement mechanisms for anti-discrimination regulations. The Department to take measures to ensure the Federal conscience and anti- Department believes that the provider- its own compliance. As explained more discrimination laws that Congress has patient relationship is best served by fully below, compliance reviews, enacted. The creation of a new open communication of conscience complaint investigation, and record- substantive conscience protection is issues surrounding the provision of keeping are standard measures for outside of the scope of this rulemaking. health care services, so that the ensuring compliance with conditions With respect to vaccination in consciences of patients, providers, and Congress has imposed upon the particular, this rule provides for employees are respected whenever Department and on recipients of Federal enforcement of 42 U.S.C. possible or required. Nothing in the rule funds, including statutory 1396s(c)(2)(B)(ii), which requires precludes such communication or nondiscrimination requirements. providers of pediatric vaccines funded systems that encourage such Moreover, 5 U.S.C. 301 empowers the by Federal medical assistance programs communication. For example, providers head of an Executive department to to comply with any State laws relating may include notices in patient intake prescribe regulations ‘‘for the to any religious or other exemptions. materials notifying patients that a government of his department, the Under the statute’s plain text, this provider’s service provision is governed conduct of his employees, the protection applies only to the extent a by certain ethical or religious principles. distribution and performance of its State already provides (or, in the future, Providers may also encourage business, and the custody, use, and chooses to provide) such an communication of moral or religious preservation of its records, papers, and accommodation, and does not require a views by patients with respect to property.’’ State to adopt such an accommodation. treatment in order to respect patients’ Compliance through funding Comment: The Department received wishes to the extent it is mutually instruments and agreements. In large comments stating that the proposed acceptable or required. The Department part, the rule’s enforcement mechanisms rule’s enforcement mechanisms will not declines to mandate any particular concerning entities that receive funds meaningfully further conscience timeline or form in which a provider or from the Department involve placing protection because existing laws patient must raise these sensitive issues. terms and conditions that implement The Department encourages providers, Federal law in contracts, grants, and

2 protecting religious beliefs or moral S

E other Federal funding instruments and L convictions are sufficient. if they are working with, or employing, U R Response: The Department disagrees, health care professionals who may have agreements. HHS has the authority to h t i w

and believes that the rule would make religious or moral objections, especially impose terms and conditions in its D

O with regard to certain procedures or grants, contracts, and other funding R a meaningful difference in terms of P 2

8 treatments, to openly discuss these instruments, to ensure recipients 0 Q

L 73 FR at 78087–88. issues and have processes in place to comply with applicable law, including G 3 K S D n o l l e

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the aforementioned Federal conscience grants or other funding instruments, administrative impact on contractors or and anti-discrimination laws. The with OCR coordinating its investigation offerors. See 48 CFR 301.101(b); see also Department, furthermore, will enforce and compliance activities with the 48 CFR 301.103(b) (‘‘The Assistant such terms and conditions requiring funding component. If the Department Secretary for Financial Resources compliance with such conscience and becomes aware that a State or local (ASFR) prescribes the HHSAR under the anti-discrimination law in accordance government or a health care entity may authority of 5 U.S.C. 301 and section with existing statutes, regulations and have undertaken activities that may 205(c) of the Federal Property and policies that govern such instruments, violate any statutory conscience Administrative Services Act of 1949, as such as the Federal Acquisition protection, the Department will work to amended (40 U.S.C. 121(c)(2)), as Regulation; the Uniform Administrative assist such government or entity to delegated by the Secretary[ ].’’). As a Requirements, Cost Principles, and comply with, or come into compliance result, the Department has ample Audit Requirements for HHS Awards with, such requirements or prohibitions. authority to include terms and (HHS UAR), 45 CFR part 75; regulations If, despite the Department’s assistance, conditions in its contracts consistent applicable to CMS programs; the compliance is not achieved, the with the Federal conscience and anti- associated regulations relating to Department will consider all legal discrimination laws. Furthermore, the suspension and debarment; as well as options as may be provided under 45 Federal Acquisition Regulation provides any other regulations or procedures that CFR parts 75 (HHS UAR) and 96 a variety of mechanisms that may be govern the Department’s ability to (regulations addressing HHS block grant used to enforce such contract provisions impose and enforce terms and programs), as applicable. (e.g., 48 CFR part 49 ‘‘Termination of conditions on funding recipients to Contracts. With respect to Federal Contracts’’). Thus, the Department comply with Federal requirements. contracts and contractors, the Federal intends to implement and enforce Grants and cooperative agreements. Property and Administrative Services contract terms on the Federal With respect to grants and cooperative Act of 1949 (‘‘FPASA’’) authorizes the conscience and anti-discrimination laws agreements, the HHS UAR, 45 CFR part promulgation of the Federal Acquisition through the FAR and HHSAR and other 75, requires adherence by award Regulation (‘‘FAR’’). 40 U.S.C. 121(c). Federal laws and regulations that govern recipients to all applicable Federal the administration and performance of The FAR, in turn, authorizes agency statutes and regulations. For example, Federal contracts. heads to ‘‘issue or authorize the section 75.300(a) requires that the Other rulemaking authorities. Under Department administer Federal awards issuance of agency acquisition the ACA section 1321(a), 42 U.S.C. to ensure that Federal funding and regulations that implement or 18041, the Department has the authority associated programs ‘‘are implemented supplement the FAR and incorporate, to promulgate regulations implementing in full accordance with U.S. statutory together with the FAR, agency policies, the ACA conscience provisions. Section and public policy requirements: procedures, contract clauses, 1321(a) provides authority to the Including, but not limited to, those solicitation provisions, and forms that Secretary to issue regulations setting protecting public welfare, the govern the contracting process or standards for meeting the requirements environment, and prohibiting otherwise control the relationship under Title I of the ACA, and the discrimination.’’ The regulation also between the agency, including any of its amendments made by Title I, with requires the Department to suborganizations, and contractors or respect to the establishment and communicate to non-Federal entities all prospective contractors.’’ 48 CFR 1.301– operation of Exchanges (including policy requirements and include them (a)(1). In addition, Federal agencies are SHOP Exchanges), the offering of in the conditions of the award. 45 CFR required to prepare their solicitations qualified health plans through such 75.300(a). and resulting contracts utilizing a Exchanges, the establishment of the Furthermore, section 75.371 sets forth uniform contract format, which permits reinsurance and risk adjustment remedies for non-compliance where the agencies to include a clear statement of programs under part V, and such other award recipient ‘‘fails to comply with any ‘‘special contract requirements’’ that requirements as the Secretary Federal statutes, regulations, or the are not included in its standard determines appropriate. This provision terms and conditions of the Federal government contract clauses or in other authorizes the Secretary to promulgate award.’’ These remedies include sections of the uniform contract format. regulations setting standards for disallowance, withholding, suspension, 48 CFR 15.204–2–(h). Finally, pursuant regulated entities to meet the conscience and termination of funding. 45 CFR to the FAR and other legal authorities, protection requirements in ACA 75.371. The HHS UAR also contains the Department has established the sections 1303(b)(1)(A) & (b)(4), 1411, provisions relating to recordkeeping (45 Department of Health and Human and 1553, 42 U.S.C. 18023(b)(1)(A) & CFR 75.503) and program specific audits Services Acquisition Regulation (b)(4), 18081, 18113, all of which are (45 CFR 75.507), which the Department (‘‘HHSAR’’) [48 CFR parts 300 through located in Title I of the ACA. may invoke when enforcing grant terms 370], which establishes uniform With respect to the Medicare, and conditions that operate to departmental acquisition policies and Medicaid, and Children’s Health implement the Federal conscience and procedures that implement and Insurance Program (CHIP), section 1102 anti-discrimination laws. In addition, supplement the FAR. The HHSAR of the Social Security Act, 42 U.S.C. Federal grant recipients must also sign contains departmental policies that 1302, authorizes the Secretary to ‘‘make OMB-approved assurances which certify govern the acquisition process or and publish such rules and regulations, compliance with all Federal statutes otherwise control acquisition not inconsistent with this Act, as may relating to non-discrimination and all relationships between the Department’s be necessary to the efficient applicable requirements of all other contracting activities and contractors. administration of the functions with 2 S

E The HHSAR contains (1) requirements which [he] is charged under this Act.’’ L Federal laws governing the program. U R

In sum, the Department’s enforcement of law; (2) HHS-wide policies; (3) This provides the Secretary with h t i w

of the Federal conscience and anti- deviations from FAR requirements; and authority to promulgate regulations that D

O discrimination laws for grantees will be (4) policies that have a significant effect provide for compliance by participants R P 2

8 conducted through the normal grant beyond the internal procedures of the in the Medicare, Medicaid, and CHIP 0 Q

L compliance mechanisms applicable to Department or a significant cost or programs, including Medicare G 3 K S D n o l l e

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providers, State Medicaid and CHIP Qualified Health Plans offering rulemaking would be enforced through programs, etc., with applicable Federal individual market coverage on State a compliance action under section conscience and anti-discrimination exchanges. 1902(a)(4) of the Social Security Act. laws. To the extent that terms and For Medicare Advantage or Part C Furthermore, with respect to funding conditions relating to Federal contracts, there are intermediate instruments administered by the Centers conscience and anti-discrimination laws sanctions, civil money penalties, and for Medicare & Medicaid Services are incorporated into CMS’s instruments potential contract termination for (CMS), including instruments or or agreements, CMS would have the violations of contract requirements. In authority to enforce such terms agreements authorized by the Social the case of Medicare providers and pursuant to the relevant enforcement Security Act and ACA, the Secretary has suppliers, enforcement could involve mechanism for each instrument or the authority under section 1115(a)(2) of loss of a provider agreement or agreement. For example, with respect to the Social Security Act to authorize certification. a special term and condition under a Federal matching funds in expenditures Debarment and suspension. Finally, section 1115 demonstration, the by State Medicaid agencies that would the Department notes that it has the demonstration could be terminated for a not otherwise be eligible for Federal authority, where appropriate, to initiate failure to comply with a term and matching in order to carry out a debarment or suspension proceedings condition. With respect to section demonstration project that promotes the against entities that are otherwise 1115A, it would depend on the legal eligible to receive Federal funding objectives of the Medicaid or CHIP instrument used. For cooperative programs. Under section 1115A of the pursuant to grants and cooperative agreements, the enforcement agreements, contracts and other funding Social Security Act, Federal funds are mechanism would be Federal grants available to test innovative payment and instruments. See, e.g., 48 CFR part 9.4; law. For addenda to existing contracts, 2 CFR part 376. Entities that are service delivery models expected to the enforcement mechanism would be reduce costs to Medicare, Medicaid, or debarred, suspended, or proposed for Federal procurement law. For debarment are also excluded from CHIP, while preserving or enhancing the participation agreements and quality of care furnished to the conducting business with the regulations—through which CMMI Government and, thus, are generally not beneficiaries of these programs. The operates most of its section 1115A Secretary has the authority to include eligible to receive Federal funds during models—CMS could enforce these the duration of the suspension or terms and conditions addressing Federal requirements under the terms of the debarment. The Department notes that, conscience and anti-discrimination laws agreement or regulation itself (which under the FAR, an entity may be in certain funding instruments or allow CMS to take certain corrective debarred for the ‘‘[c]ommission of any agreements under these authorities. The actions, up to and including termination other offense indicating a lack of Secretary also has the authority to of a non-compliant participant from the business integrity or business honesty impose terms and conditions in certain model) and, under certain that seriously and directly affects the grant instruments under some of its circumstances, under general CMS present responsibility of a Government grant authorities, such as the grants regulations (e.g., regarding contractor or subcontractor.’’ 48 CFR available to States for ACA recoupments). In the case of a CMS 9.406–2(a)(5). In addition, a contractor implementation under section grant program, it would depend on the 2794(c)(2)(B) of the Public Health terms included in the grant award, but may be debarred for a ‘‘[w]illful failure Service Act. In addition, the Secretary grant funds could be subject to forfeiture to perform in accordance with the terms has the authority to include such in some instances. Medicaid of one or more contracts.’’ 48 CFR requirements, through rulemaking, with requirements imposed through 9.406–2(b). Thus, the Department will respect to State Medicaid programs consider whether suspension or generally, Medicaid managed care 7. Rehabilitation agencies and Clinics as debarment may be appropriate when organizations (section 1902(a)(4) of the providers of physical, occupational therapy and enforcing terms and conditions Social Security Act), Medicare speech language pathology services—section implementing the Federal conscience 1861(p)(4)(A)(v) of the Act and 1861(p)(4) flush and anti-discrimination laws. Advantage organizations (section language [42 U.S.C. 1395x(p)(4)]. 1856(b)(1) of the Social Security Act) 8. Comprehensive outpatient rehabilitation Receipt and processing of complaints. and Medicare Part D sponsors (section facilities (CORFs)—section 1861(cc)(2)(J) of the Act With regard to the receipt and 1857(e)(1) of the Social Security Act), [42 U.S.C. 1395x(cc)(2)(J)]. processing of complaints of violations of other types of Medicare providers and 9. Hospice—section 1861(dd)(2)(G) of the Act [42 the Federal conscience and anti- U.S.C. 1395x(dd)(2)(G)]. discrimination laws, it is well settled in suppliers of items and services, and 10. Community mental health centers (CMHCs)— section 1861(ff)(3)(B)(iv) of the Act [42 U.S.C. case law that every agency has the Through delegation from the Secretary, CMS 1395x(ff)(3)(B)(iv)]. inherent authority to issue interpretive has statutory authority to place conditions on 11. Religious nonmedical health care institution rules and rules of agency practice and participation in its programs under the following (RNHCIs)—section 1861(ss)(1)(J) of the Act [42 authorities: procedure. 1 Richard J. Pierce, Jr., U.S.C. 1395x(ss)(1)(J)]. Administrative Law Treatise § 6.4 (4th 1. Skilled nursing facilities (SNFs)—section 12. Portable x-ray suppliers—1861(s)(3) of the Act 1819(d)(4)(B) of the Act [42 U.S.C. 1395i– [42 U.S.C. 1395x(s)(3)] ed. 2002). This rule does not 3(d)(4)(B)]. 13. Independent clinical laboratories—section substantively alter or amend the 2. Medicaid nursing facilities (NFs)—section 353(f)(1)(E) of the Public Health Act [42 U.S.C. obligations of the respective statutes, 1919(d)(4)(B) of the Act [42 U.S.C. 1396r(d)(4)(B)]. 263a(f)(1)(E)] (authorizing the Secretary to make JEM Broad. v. FCC, 22 F.3d 320 (D.C. 3. Hospitals—section 1861(e)(9) of the Act [42 additional regulations ‘‘necessary to assure Cir. 1994), and the definitions offered in U.S.C. 1395x(e)(9)]. consistent performance by such laboratories of this rule are reasonably drawn from the

2 4. Psychiatric hospitals—section 1861(f)(2) of the accurate and reliable laboratory examinations and S

E Act [42 U.S.C. 1395x(f)(2)], cross referencing procedures’’). existing statutes. Hoctor v. Dept. of L U

R 1861(e)(9). 14. Rural health clinics (RHCs)—section Agriculture, 82 F.3d 165 (7th Cir. 1996). h t i 5. Long term care hospitals—section 1861(ccc)(3) 1861(aa)(2)(K) of the Act [42 U.S.C. w

As a result, the Department and OCR

D of the Act [42 U.S.C. 1395x(ccc)(3)], cross 1395x(aa)(2)(K)]. O have authority to issue interpretations R referencing section 1861(e). 15. Intermediate care facilities for individuals P 2

8 6. Home health agencies (HHAs)—section with intellectual disabilities (ICF/ IIDs)—section regarding the Federal conscience and 0 Q

L 1861(o)(6) of the Act [42 U.S.C. 1395x(o)(6)]. 1861(e)(9) of the Act [42 U.S.C. 1395x(e)(9)]. anti-discrimination laws, many of G 3 K S D n o l l e

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which have been placed in the ‘‘certain’’ in regard to health care arrangements for the procedure, health Department’s program statutes. services, remove the term ‘‘for example’’ service, health program, or research Comment: The Department received a and ‘‘comprehensively’’ in relation to activity.’’ The Department received comment requesting that long-term care the degree of the protections, for clarity, comments on this definition, including and post-acute providers be exempted and to refer to the statutes part 88 comments generally supportive of the from the rule because such entities are addresses as ‘‘Federal conscience and proposed definition and generally already heavily regulated. anti-discrimination laws, which are opposed to it. Because comments Response: The Department declines to listed in § 88.3 of this part.’’ evidenced significant confusion over the provide this exemption. The rule Definitions (§ 88.2) proposed definition, the Department provides for appropriate enforcement of amends the definition, as described statutes protecting foundational civil In the NPRM, the Department further below. rights, and Congress did not exempt proposed definitions of various terms. Comment: The Department received long-term care or post-acute providers The comments and the responses comments suggesting that the definition from these civil rights laws. applicable to each definition are set of ‘‘assist in the performance’’ is forth below. B. Section-by-Section Analysis unnecessary because employees Administered by the Secretary. The maintain the option to seek employment Purpose (§ 88.1) Department proposed that a federally elsewhere. funded program or activity is In the NPRM, the Department’s Response: The Department disagrees. ‘‘administered by the Secretary’’ when it ‘‘Purpose’’ section set forth the objective Congress established requirements, is ‘‘subject to the responsibility of the that the proposed regulation would, including the protections interpreted by Secretary of the U.S. Department of when finalized, provide for the this final rule, for recipients of certain implementation and enforcement of Health and Human Services, as established via statute or regulation.’’ Federal financial assistance or Federal conscience and anti- participants in certain Federal discrimination laws. It also stated that The Department did not receive comments specifically on this programs. Those obligations are not the statutory provisions and regulations obviated merely because an employee contained in this part are to be definition. In proposing the definition for who desires to make use of the interpreted and implemented broadly to ‘‘administered by the Secretary,’’ the protections that Congress provided effectuate their protective purposes. The Department noted that the 2008 Rule could, instead, find employment Department did not receive comments had not defined the phrase, and that the elsewhere. Indeed, forcing a person to on this section beyond the general proposed definition was intended to find employment elsewhere (which comments addressed above. Section add clarity. Upon further review and in includes as a result of being fired), 88.1 of the final rule reflects technical consideration of general comments because they make certain protected edits to replace the word ‘‘persons’’ received concerning whether the objections to procedures, or because of with ‘‘individuals,’’ for clarity, and to proposed rules are sufficiently clear, the their religious beliefs or moral refer to the set of statutes encompassed Department has concluded that the convictions, is a quintessential example by this rule collectively as the ‘‘Federal proposed definition does not add of the discrimination and coercion that conscience and anti-discrimination substantial clarity to the plain meaning these laws prohibit. The existence of laws, which are listed in § 88.3 of this of the phrase ‘‘administered by the numerous comments employing this part.’’ Throughout the final rule, the line of reasoning provides additional Department has made changes to refer to Secretary.’’ No commenters submitted comments on this question, which evidence of the need for this final rule, those statutes as ‘‘Federal conscience so that the Department may better and anti-discrimination laws,’’ rather suggests that there is no confusion about the meaning of this phrase. The educate both recipients and the public than ‘‘Federal conscience protection and on the law, and may ensure vigorous associated anti-discrimination laws.’’ Department is finalizing this rule without adopting the proposed enforcement where education proves Summary of Regulatory Changes: The insufficient to achieve compliance. Department believes, as discussed definition, or any definition, of Comment: The Department received above, that there are various reasons ‘‘administered by the Secretary.’’ In the comments stating that the proposed why this rule is needed and appropriate event that the Department is asked to ‘‘articulable connection’’ standard is too to provide for the implementation and consider the meaning of this phrase in broad and would permit objections by enforcement of Federal conscience and its application of the rule, the persons whom certain commenters anti-discrimination laws. In addition, Department will apply the standard contend have only a tangential the Department believes it is canons of statutory construction. appropriate to interpret the rules Summary of Regulatory Changes: For connection to the objected-to procedure broadly, within the scope of the text set the reasons described above, the or health service program or research forth in each statute, to effectuate their Department finalizes the rule without a activity. Some commenters included protective purposes. Generally, it is definition of the phrase ‘‘administered examples such as a person preparing a appropriate to broadly interpret laws by the Secretary.’’ room for an abortion or scheduling an enacted to protect civil rights and Assist in the Performance. The abortion. prevent discrimination. For the reasons Department proposed that ‘‘assist in the Response: The Department believes described in the proposed rule and performance’’ means ‘‘to participate in that the proffered examples are properly above, and considering the comments any program or activity with an considered as within the scope of the received, the Department finalizes this articulable connection to a procedure, protections enacted by Congress for health service, health program, or those who choose to assist and those 2 section as proposed, but with technical S

E research activity, so long as the who choose not to assist in the L edits to replace the word ‘‘persons’’ U R

individual involved is a part of the performance of an abortion. Scheduling h

t with ‘‘individuals,’’ add the term i w

workforce of a Department-funded an abortion or preparing a room and the D

O entity.’’ The definition specified that instruments for an abortion are R Unless indicated otherwise, the Department P 2

8 adopts the regulation text as proposed. ‘‘[t]his includes but is not limited to necessary parts of the process of 0 Q

L 83 FR 3880, 3892. counseling, referral, training, and other providing an abortion, and it is G 3 K S D n o l l e

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reasonable to consider performing these The Department believes these rule describes ‘‘to take an action that has actions as constituting ‘‘assistance.’’ changes adequately respond to a specific, reasonable, and articulable The definition will ensure a sufficient commenters who contend the proposed connection to furthering a procedure or connection between the conduct for definition of ‘‘assist in the performance’’ health service program or research which (or from which) the is insufficiently clear, without activity undertaken by or with another conscientious objector is seeking relief narrowing the definition to exclude person or entity.’’ This standard would and the protections Congress actions that do constitute assistance in preclude irrational assertions that an established in law. This approach the performance. The Department action constitutes assisting in the would ensure that health care workers believes the definition in the final rule, performance of a procedure, because it are not driven from the health care while still requiring OCR to weigh the requires the action to have a specific, industry because of conflicts with their facts and circumstances of each case, reasonable, and articulable connection religious beliefs or moral convictions in provides additional clarity. Congress to furthering the procedure. If the connection with practices as set forth by did not define ‘‘assist in the connection between an action and a Congress, such as abortion. It would performance.’’ The Department procedure is irrational, there is no also dissuade employers from considered not finalizing a definition of actual connection by which the action attempting to skirt protections through ‘‘assist in the performance,’’ but without specifically furthers the procedure. The improperly narrow interpretations of the any definition, there may be confusion Department does not interpret the term. about what the term includes, with language to permit irrational Nevertheless, in response to concerns different employers interpreting it more applications. about the potential overbreadth and broadly or more narrowly. For example, Comment: The Department received a need for increased clarity of the in the Danquah lawsuit, where nurses comment suggesting that the definition, the Department finalizes the contended they were required to assist ‘‘articulable connection’’ standard be definition with a change to the first abortion cases in violation of the Church replaced with a standard that connects sentence, so that it reads: To assist in Amendments, a public hospital that assistance to the clinical setting and the performance means ‘‘to take an receiving Public Health Service Act includes a complete, not illustrative, list action that has a specific, reasonable, funds filed a brief in Federal court of activities subject to the protections. and articulable connection to furthering stating that ‘‘to administer routine pre Response: The Department believes a procedure or a part of a health service and post-operative care’’ to abortion this concern is adequately addressed by program or research activity undertaken patients does not constitute assisting in the changes described above to clarify by or with another person or entity.’’ the performance of an abortion under the definition of ‘‘assist in the The Department believes that replacing the Church Amendments. Without performance.’’ The Department the phrase ‘‘to participate in any taking a position on the facts of that disagrees with the recommended activity’’ with the phrase ‘‘to take an case, the Department disagrees with a approach because the statutory action’’ more clearly and precisely narrow interpretation of assisting in the protections for objecting to assisting in explains the conduct covered by ‘‘assist performance that excludes pre- and the performance of procedures in the performance.’’ The phrase post-operative support to a scheduled encompasses situations beyond the ‘‘undertaken by or with another person abortion procedure. The Department narrow scope proposed by the or entity’’ distinguishes ‘‘assisting’’ from believes that the confusion among commenter. For example, an unlawfully ‘‘performing,’’ as assisting implies covered entities and members of the coerced assistance in an abortion is no working with another. This change public about what constitutes assistance less unlawful if the coercion takes place would also ensure that any articulable in the performance of a health service outside a particular clinical setting, as connection must also be ‘‘reasonable’’ makes it appropriate for the Department opposed to within such clinical setting. and ‘‘specific.’’ It would, therefore, to define ‘‘assist in the performance’’ Furthermore, creating an exhaustive list preclude vague or attenuated allegations with the changes as set forth in this final of potentially protected conduct does that do not support a claim of assisting rule. not allow for variations from State to in a procedure or health service program Comment: The Department received a State, or even clinic to clinic, in how or research activity. For example, a comment requesting that ‘‘articulable procedures are handled. Such an health care worker who objects to being connection’’ be replaced with approach also does not consider the scheduled to conduct physicals on some ‘‘reasonable connection’’ because diverse ways in which protected moral patients, when abortions are scheduled ‘‘articulable connection’’ may be abused or religious objections may manifest, on the same day for unrelated patients by persons articulating connections that and would not account for changes in elsewhere in the building, would not are irrational. practices over time. have a claim of being coerced into Response: The Department agrees in Comment: The Department received ‘‘assisting’’ with an abortion, barring part, to the extent that the comments stating that the scope of additional facts. Conversely, where a reasonableness standard should be persons protected by the definition of provider requires the designation and included in the definition. As stated ‘‘assist in the performance’’ is too broad availability of a backup doctor above, in response to similar concerns because it extends beyond health care whenever an abortion is to be about potential overbreadth, the professionals and includes other performed, that designation may Department has modified the sentence members of the workforce. The Department constitute assistance in the performance containing the phrase, ‘‘to participate in Response: acknowledges that inclusion of a of an abortion even if no complications any program or activity with an arise requiring the backup doctor to articulable connection to a procedure,’’ reference to workforce members in the intervene during or after an abortion in definition of ‘‘assist in the performance’’ 2

S to add the word ‘‘reasonable,’’ and other

E has caused confusion among

L a particular instance. In addition, the

U language to limit its scope and add R

Department clarifies that the activities commenters. The Department has h t i greater specificity. Specifically, the final w

need only to regard ‘‘part of a health concluded this reference is not D

O service program or research activity,’’ in necessary because the scope of persons R Defs.’ Brief in Opp. To Pls.’ App. For Prelim. P 2

8 contrast to, for example, furthering the Inj. at 26, Danquah, No. 2:11–cv–06377–JLL–MAH, and entities protected from being forced 0 Q

L health service program as a whole. doc. # 26 (D.N.J. filed Nov. 22, 2011). to ‘‘assist in the performance’’ of an G 3 K S D n o l l e

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objected to procedure is already byproduct of a completed procedure. ‘‘referral’’ in Weldon or Coats-Snowe; or governed by provisions in the relevant Further, the Department is not aware of ‘‘make arrangements for’’ in Coats- law and this rule. Accordingly, the any entities or medical professionals Snowe. Some commenters contend that Department is finalizing the definition that would object to treating someone, the meaning of these terms are of ‘‘assist in the performance’’ to delete or transporting someone to treatment, completely distinct and should never be the reference to workforce members. under these circumstances. interpreted as overlapping. The Similarly, the Department is removing To the extent commenters are Department disagrees. When Congress the reference to ‘‘any program or referring to emergency transportation of enacted paragraphs (b) and (c)(1) of the activity’’ as part of the definition of persons with conditions such as an Church Amendments in 1973, and ‘‘assist in the performance’’ because the ectopic pregnancy, where the potential paragraphs (c)(2) and (d) in 1974, it used new language in the definition—‘‘to take procedures performed at the hospital the phrase ‘‘assist in the performance’’ an action that has a specific articulable may include abortion, the question of regarding certain medical procedures. connection’’—makes the reference to whether such transportation falls under Congress then enacted paragraph (e) in ‘‘any program or activity’’ unnecessary. the definition of ‘‘assist in the 1979 to protect applicants for medical The Department is also removing the performance’’ would depend on the training or study from discrimination reference to ‘‘health program or facts and circumstances. However, as a based on their reluctance or willingness activity’’ because that term is no longer general matter, the Department does not ‘‘to counsel, suggest, recommend, assist, defined in the final rule, as discussed believe that mere speculation that an or in any way participate in the further below. objected-to service or procedure may performance of abortions or Comment: The Department received occur suffices to establish a specific and sterilizations.’’ comments expressing concern that the reasonable connection between the Counseling and referral are common definition of ‘‘assist in the performance’’ objected-to service or procedure and the and well understood forms of assistance would cover ambulance drivers. act of transporting the patient. that materially help people reach Response: EMTs and paramedics are The Department’s existing regulation desired medical ends. Indeed, because treated like other health care implementing EMTALA at 42 CFR referrals are so tightly bound to the professionals under this definition. 489.24 defines EMTALA’s statutory ultimate performance of medical Federal conscience and anti- language ‘‘comes to the emergency procedures, Congress banned many discrimination laws would apply to department’’ to include an individual forms of referral fees or ‘‘kickbacks’’ them, or not, based on whether the who is en route to a hospital in an among providers receiving Medicare elements of the law (and this final rule) ambulance owned and operated by the and Medicaid reimbursements. See the are satisfied in a particular hospital, with limited exceptions, as Medicare and Medicaid Patient circumstance. To the extent the well as, in certain circumstances, an Protection Act of 1987, as amended, 42 commenters contend that the kinds of individual who is en route to a hospital U.S.C. 1320a–7b (the ‘‘Anti-Kickback actions that ambulance crews perform in an ambulance that is not owned and Statute’’) and the Ethics in Patient never count as assisting in the operated by the hospital. Federal Referrals Act of 1989, as amended, 42 performance of a procedure Appeals Courts in the Ninth and First U.S.C. 1395nn (the ‘‘Stark Law’’). encompassed by a Federal conscience or Circuits have examined the Similarly, counseling of some form anti-discrimination law, the Department Department’s regulatory definition of regarding abortion is often required declines to take such a categorical ‘‘comes to the emergency department,’’ before the procedure can be performed, approach. As discussed earlier, where and have upheld the Department’s as is the case in 33 States, and many EMTALA might apply in a particular regulatory definition for EMTALA as hospitals and health care facilities likely case, the Department would apply both reasonable, and have distinguished require some kind of counseling as a EMTALA and the relevant law under other Federal Circuits’ cases interpreting prerequisite to abortion of their own this rule harmoniously to the extent EMTALA by differentiating the cases by accord. possible. EMTs and paramedics are their facts or by the nature of the courts’ Based on the text, structure, and trained medical professionals, not mere analyses. purpose of the statutes at issue, the ‘‘drivers.’’ If commenters contend that Comment: The Department received Department interprets ‘‘assist in the driving a patient to a procedure should comments stating that the inclusion of performance’’ broadly and does not never be construed to be assisting in the counseling and referral in the definition believe the presence of more specific performance of a procedure, the of ‘‘assist in the performance’’ was not terms of assistance elsewhere in the Department disagrees and believes it the intent of Congress in enacting the would depend on the facts and Church Amendments, or in other laws Church Amendments. Some that are the subject of this rule, narrows circumstances of each case. For commenters pointed to differing example, the Department believes the meaning of the phrase. It would be language in the Church, Weldon, and contrary to the structure and history of driving a person to a hospital or clinic Coats-Snowe Amendments to support for a scheduled abortion could the Church Amendments to interpret this assertion. provisions protecting conscience in the constitute ‘‘assisting in the performance Response: Congress did not define the of’’ an abortion, as would physically study of abortion procedures phrases ‘‘assist in the performance,’’ significantly more broadly than delivering drugs for inducing abortion. ‘‘counsel,’’ or ‘‘recommend’’ in the To the extent commenters are provisions protecting conscience in the Church Amendments; ‘‘refer’’ or referring to emergency transportation of actual performance of an abortion procedure. persons experiencing unforeseen 42 U.S.C. 1395dd(a). complications after, for example, an The Department, however, does not 2 42 CFR 489.24(b)(3) and (4). S believe that every form of counseling, E abortion procedure, the Department L Morales v. Sociedad Espanola de Auxilio U training, or referral (as defined under R

does not believe such a scenario would Mutuo y Beneficencia, 524 F.3d 54, 60–61 (1st Cir. h t i 2008) (holding that the HHS regulatory definition w

implicate the definition of ‘‘assist in the

D comports with EMTALA’s purpose and remedial Counseling and Waiting Periods for Abortion, O performance of’’ an abortion, because R framework and distinguishing cases from the Fifth Guttmacher Institute (Oct. 1, 2018), https:// P 2

8 the complications in need of treatment and Seventh Circuits); Arrington v. Wong, 237 F.3d www.guttmacher.org/state-policy/explore/ 0 Q

L would be an unforeseen and unintended 1066, 1073–74 (9th Cir. 2001) (same). counseling-and-waiting-periods-abortion. G 3 K S D n o l l e

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this rule) necessarily constitutes patients about objected-to treatment applicable statute, as those actions assistance in the performance of a options, potentially in violation of relate to any grant, contract, procedure under this rule. The principles of informed consent. subcontract, cooperative agreement, Department, therefore, finalizes the Response: The Department disagrees loan, license, certification, definition of ‘‘assist in the performance’’ that the rule would violate principles of accreditation, employment, title, or by changing the second sentence to read informed consent. Medical ethics have other similar instrument, position, or ‘‘This may include counseling, referral, long protected rights of conscience status. Paragraph (2) addressed training, or otherwise making alongside the principles of informed prohibited adverse actions or treatment, arrangements for the procedure or consent. The Department does not as permitted by the applicable statute, health service program or research believe that enforcement of conscience as those actions relate to any benefit or activity, depending on whether aid is protections, many of which have been privilege. For both paragraphs, provided by such actions.’’ in place for nearly fifty years, violates or prohibited adverse actions or treatment Comment: The Department received undermines the principles of informed included those to withhold, reduce, comments expressing concern that the consent. This rule will not change the exclude, terminate, restrict, or otherwise definition of ‘‘assist in the performance’’ obligation that, absent exigent make unavailable or deny the categories combined with the language of 42 circumstances, doctors secure informed listed in paragraphs (1) and (2). U.S.C. 300a–7(d) could impact consent from patients before engaging in Paragraph (3) addressed the use of any counseling or referrals for LGBT a medical procedure. criterion, method of administration, or persons. Summary of Regulatory Changes: For site selection, including the enactment, Response: Several provisions of the reasons described in the proposed application, or enforcement of laws, statutes that are the subject of this rule rule and above, and considering the regulations, policies, or procedures are specific to abortion, sterilization, comments received, the Department directly or through contractual or other assisted suicide, or other procedures, adopts the definition of ‘‘assist in the arrangements, that tends to subject and provide specific protections. In 42 performance’’ with changes to read that individuals or entities protected under U.S.C. 300a–7(d) (and 300a–7(c)(2)), it means ‘‘to take an action that has a the rule to any adverse effect described Congress directed the protection of specific, reasonable, and articulable in this definition, or has the effect of conscientious objections in contexts not connection to furthering a procedure or defeating or substantially impairing tied to specific treatments. When the health service program or research accomplishment of a health program or previous administration finalized 45 activity undertaken by or with another activity with respect to individuals, CFR part 88 in 2011, it affirmed its person or entity.’’ The definition entities, or conduct protected under the commitment to enforce Federal specifies that ‘‘[t]his may include rule. Finally, paragraph (4) of the conscience and anti-discrimination counseling, referral, training, or definition set forth a catch-all for which laws, including 42 U.S.C. 300a–7(d). (76 otherwise making arrangements for the discriminate or discrimination means to FR at 9972). The Department continues procedure or health service program or otherwise engage in any activity and expands on that commitment in this research activity, depending on whether reasonably regarded as discrimination, rule. The Department does not pre-judge aid is provided by such actions.’’ This including intimidation or retaliatory matters without the benefit of specific new definition removes ‘‘so long as the action. facts and circumstances, and particular individual involved is a part of the The Department received comments claims under 42 U.S.C. 300a–7(d) will workforce of a Department-funded on this definition, including comments be evaluated on a case-by-case basis. entity’’ for accuracy and clarity and generally supporting or opposing the Nevertheless, the Department believes makes other minor language changes, proposed definition. that some commenters may for example, changing ‘‘includes but is Comment: The Department received misunderstand the scope of paragraph comments stating that the definition of not limited to’’ to ‘‘may include.’’ (d). Generally, the protections of Department. The Department ‘‘discriminate or discrimination’’ would paragraph (d) follow the funds provided proposed that ‘‘Department means the encompass situations in which States by any program administered by the Department of Health and Human apply neutral laws of general Secretary. But paragraph (d) does not Services and any component thereof.’’ applicability that require the encompass every medical treatment or performance of abortion, and such The Department did not receive service performed by any entity commenters disagreed that a neutral law receiving Federal funds from HHS for comments on this definition. Summary of Regulatory Changes: For of general applicability can be deemed whatever purpose. Instead, Congress the reasons described in the proposed an act of discrimination. narrowly focused paragraph (d) to Response: The term ‘‘neutral law of rule and above, the Department prohibit the coercion of persons ‘‘in general applicability’’ is a legal term of adopts the definition of ‘‘Department’’ performance of’’ health service art that derives from case law as proposed. programs funded under a program interpreting the Free Exercise Clause of Discriminate or Discrimination. The administered by the Secretary. As the First Amendment. What renders a Department proposed ‘‘discriminate or explained more fully in response to law ‘‘neutral’’ in the Free Exercise discrimination,’’ to mean one of four other comments below with respect to context is that the law is not by its text, categories of adverse actions or paragraph (d), many medical treatments history, motive, or operation targeted at treatment, for which each paragraph or and services performed by health care the protected activity of religious type of action within each paragraph providers are not ‘‘part of’’ a health exercise. If commenters are contending would apply as permitted by the service program receiving funding from that States that might otherwise be applicable statute. Paragraph (1) of the HHS. In such circumstances, paragraph prohibited by a Federal conscience or 2

S definition addressed prohibited adverse E anti-discrimination law from L (d) would not apply.

U actions or treatment, as permitted by the R

Comment: The Department received discriminating against doctors who h t i w

comments expressing concern that the refuse to perform abortions may

D 83 FR 3880, 3892 (stating the reasons for the O definition of ‘‘assist in the performance’’ nonetheless do so pursuant to a neutral R proposed definition of ‘‘assist in the performance,’’ P 2

8 will result in conscientious objectors except for the modifications adopted herein). State law of general applicability, the 0 Q

L refusing to provide information to 83 FR 3880, 3892. Department disagrees. States that accept G 3 K S D n o l l e

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applicable Federal funds and thereby entity’s discrimination is accompanied anti-discrimination law to which this subject themselves to Federal by anti-religious animus, or whether the part applies. conscience and anti-discrimination laws entity would also penalize doctors who Any allegation of discrimination cannot evade the requirements of those refuse to perform abortions for non- under the laws to which this part laws through neutral laws of general protected reasons. Nothing in the applies will be considered in light of a applicability. For example, the Weldon legislative history of the Church reasonable interpretation of applicable Amendment flatly prevents State laws Amendments suggests that Congress law and an application of that law to the from discriminating against doctors intended to permit entities receiving facts. By making the definition because they do not perform abortions applicable funds to coerce religiously or inclusive, instead of exclusive, by use of against their will regardless of whether morally motivated doctors to perform the word ‘‘includes,’’ the definition will the law is ‘‘neutrally’’ worded or abortions, so long as those entities also not exclude the types of actions that applied. Subjecting persons to penalties require doctors who do not have qualms constitute discrimination but might not or adverse treatment because they about abortions to perform them. fall squarely into one of the descriptions decline to perform abortions is a form of Consequently, the Department set forth in paragraphs (1) to (3) of the discrimination encompassed by the concludes that the concept of definition. Additionally, in light of the Weldon Amendment. Even if a State law discrimination, as used in Federal language added to address concerns were to impose penalties on OB/ GYNs conscience and anti-discrimination with respect to how this definition because they decline to perform any laws, can encompass a situation where interacts with reasonable lawful procedure they are competent to a State takes adverse action against a accommodations, the Department perform (the Department is not aware of doctor because of the doctor’s refusal to believes that making the definition such a law), and that law were used to perform an abortion, even under a inclusive, while eliminating proposed impose penalties on OB/ GYNs because general or ‘‘neutral’’ law mandating the paragraph (4), ensures that the they do not perform abortions, that performance of abortions. definition is not overly broad. would also constitute discrimination Comment: The Department received Comment: The Department received encompassed by the Weldon comments stating that the phrase ‘‘any comments stating that the proposed Amendment. The Coats-Snowe activity reasonably regarded as definition of ‘‘discriminate or Amendment similarly prohibits discrimination’’ is overbroad or discrimination’’ conflicts with or is discrimination against a health care impermissibly vague. inconsistent with other Federal laws Response: Discrimination standards entity, such as an individual physician, such as Title VII of the Civil Rights Act usually do not limit themselves to an who (among other things) declines to and Title X of the Public Health Service exclusive list of discriminatory actions, perform abortions. Additionally, under Act. because adverse action based on both the Coats-Snowe and Weldon Response: The Department disagrees prohibited grounds can take various Amendments, protected entities and that these regulations conflict with forms depending on the facts and statutes applicable to the Title X family individuals need not specify a motive, circumstances of the case. This rule or provide a justification, for declining. planning program under the Public encompasses several statutes barring Health Service Act. The Department Paragraph (c)(1) of the Church discrimination. As such, the Department agrees that regulations finalized in 2000 Amendments provides that a covered believes it is appropriate for this governing the Title X program, which in entity cannot discriminate against any definition to encompass an array of some cases required referrals, physician or other health care personnel actions that might be taken against a information, and counseling about (1) because he or she performed or person on the basis of such person’s abortion, conflicted with certain Federal assisted in the performance of a exercise of the rights protected by conscience and anti-discrimination laws sterilization or abortion procedure, (2) Federal conscience and anti- and, consequently, with this rule. The because he or she refused to so perform discrimination laws. On the other hand, Department acknowledged this conflict or assist ‘‘on the grounds that’’ doing so the Department agrees in part with in the preamble to the 2008 Rule (73 FR ‘‘would be contrary to his [or her] commenters that the language ‘‘any at 78087), in the preamble to the notice religious beliefs or moral convictions,’’ activity reasonably regarded as of proposed rulemaking for the Title X or (3) ‘‘because of his religious beliefs or discrimination’’ does not provide regulations in 2018 (83 FR 25502, 25506 moral convictions respecting precise guidance on the scope of the (June 1, 2018)), and in the preamble to sterilization procedures or abortions.’’ definition. Therefore the Department the Title X final rule published in 2019 The last provision covers circumstances will finalize the definition of (84 FR 7714, 7716 (March 4, 2019)). In where a covered entity’s motive is ‘‘discriminate or discrimination’’ by all three instances the Department arguably driven by anti-religious deleting proposed paragraph (4). The stated it would operate the Title X animus. But the second prohibition of Department will also change the word program in compliance with Federal discrimination does not rely on animus ‘‘means’’ to ‘‘includes’’ in the opening conscience and anti-discrimination on the part of the entity committing the phrase of the discrimination definition, laws, notwithstanding the language of discrimination; it rests solely on and change the phrase ‘‘as permitted by the 2000 Title X regulations. The whether the person refused to perform the applicable statute’’ to ‘‘to the extent or assisted in the performance of a permitted by the applicable statute.’’ In addition, in the preamble to the 2000 Title sterilization or abortion procedure on This will maintain the definition’s X regulations, the Department acknowledged the the grounds of the person’s religious description of types of discrimination, implications of the Church Amendment when it beliefs or moral convictions with and ensure that the definition only addressed a comment that the requirement to respect to such procedures. Therefore, applies to the extent it is authorized by provide options counseling ‘‘should not apply to 2 employees of a grantee who object to providing S

E under paragraph (c)(1), a covered entity the applicable statute, while also L such counseling on moral or religious grounds,’’ U R

cannot discriminate against a doctor, for rendering the descriptions in the and rejected it, contending that it is not necessary h t i because, under the Church Amendments, ‘‘grantees w

example, because of his or her refusal to definition non-exclusive, so OCR can

D may not require individual employees who have O perform abortions on the grounds of consider other actions that might R such objections to provide such counseling,’’ but P 2

8 religious beliefs or moral convictions constitute discrimination in violation of ‘‘in such cases the grantees must make other 0 Q

L regardless of whether the covered an applicable Federal conscience and arrangements to ensure that the service is available G 3 K S D n o l l e

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recently published Title X final rule reasonable accommodation of religion discrimination’’ would prohibit revised the 2000 Title X regulations to standard set forth under Title VII. The employers from accommodating eliminate that conflict and achieve Department believes components of that religious objections by placing the consistency with Federal conscience approach are appropriate in this context conscientious objector in a different statutes. Nothing in the Title X statute and is therefore adding a new paragraph position, potentially requiring the itself or in appropriations restrictions (4) to the definition of ‘‘discriminate or double-staffing of certain positions. applicable to Title X funding requires discrimination’’ to properly recognize Response: The Department agrees abortion referrals, counseling, or that the voluntary acceptance of an with this concern in part. As discussed information. This includes Congress’s effective accommodation of protected above, the Department is adding directive that, in Title X programs, ‘‘all conduct, religious beliefs, or moral language in response to public pregnancy counseling shall be convictions, will not, by itself, comments to acknowledge the nondirective.’’ That provision does constitute discrimination. Further, the reasonable accommodations that entities not address referrals or information, Department will take into account an make for persons protected by Federal only counseling, and does not require entity’s adoption and implementation of conscience and anti-discrimination pregnancy counseling, but merely policies to accommodate objecting laws. In this way, the Department specifies that, if pregnancy counseling persons in making determinations of recognizes that staffing arrangements occurs, it shall be nondirective—and discrimination. The Department finds can be acceptable accommodations in now the regulation permits, but does not this approach appropriate because it is certain circumstances. The Department require abortion counseling and generally consistent with the text and has addressed this through the addition information (and bars abortion intent of Federal conscience and anti- of a new paragraph (4) in the definition referrals). Accordingly, this rule is discrimination laws to respect of ‘‘discriminate or discrimination’’ that consistent with both Title X and the objections based on religious beliefs by recognizes the effective and timely Federal conscience and anti- accommodating them. The Department’s accommodation of an employee (which discrimination laws. approach will differ from Title VII, may include non-retaliatory staff With respect to Title VII, the however, by not incorporating the rotations) as not constituting Department agrees with some additional concept of an ‘‘undue discrimination. Additionally, to address commenters that the definition of hardship’’ exception for reasonable concerns raised by these commenters, ‘‘discriminate or discrimination’’ as accommodations under Title VII. the Department is adding new proposed does not function in the same Despite having previously enacted Title paragraphs (5) and (6) to clarify that, way as the approach set forth in Title VII, Congress did not adopt an undue within limits, employers may require a VII, specifically regarding parts of the hardship exception for the protections protected employee to inform them of found in Federal conscience and anti- objections to referring for, participating, to Title X clients who desire it.’’ 65 FR 41270, discrimination laws that are the subject or assisting in the performance of 41274 (July 3, 2000). At the time, the Department of this rule. The Department believes specific procedures, programs, research, apparently did not consider the implications of the counseling, or treatments to the extent Coats-Snowe Amendment, adopted in 1996, with Congress’s decision to take a different respect to Title X grantees and applicants; the approach in Title VII as compared to there is a reasonable likelihood that Weldon Amendment was adopted subsequently. Federal conscience and anti- the protected entity or invidivdual may See Department of Defense and Labor, Health discrimination laws is consistent with be asked in good faith to refer for, and Human Services, and Education participate in, or assist in the Appropriations Act, 2019 and Continuing the fact that Title VII’s comprehensive Appropriations Act, 2019, Public Law 115–245, regulation of American employers performance of such conduct, and that Div. B, 132 Stat. 2981, 3070–71. applies in far more contexts, and is the employer may use alternate staff or The Department acknowledges that, as of the more vast, variable, and potentially methods to provide or further any date of publication of this final rule, several district burdensome (and, therefore, warranting objected-to conduct, subject to certain courts have issued preliminary injunctions, on a limitations designed to protect the nationwide basis, against the enforcement or of greater exceptions) than the more implementation of the 2019 Title X final rule, and targeted conscience statutes that are the objecting person. requiring the Title X program to maintain the status subject of this rule, which are health On the other hand, as a general quo under the 2000 Title X regulations. Those care specific, and often procedure matter, it is not an acceptable practice injunctions do not purport to otherwise enjoin the under Federal conscience and anti- Department’s enforcement of the Federal specific, and which are specific to the conscience and anti-discrimination laws. Since at exercise of Congress’s Spending Clause discrimination laws for covered entities least 2008, under the 2000 Title X regulations, the authority. Therefore, the Department to deem persons with religious or moral Department has recognized that it cannot, by deems it appropriate to recognize that, objections to covered practices, such as regulation, require abortion counseling or referral abortion, to be disqualified for certain by a Title X applicant, grantee, project, clinic, or when appropriate accommodations are provider where such requirement would constitute made for objections protected by job positions on that basis. For example, a violation of one or more of the Federal conscience Federal conscience and anti- a hospital receiving Public Health and anti-discrimination laws, and the Department discrimination laws, those Service Act funds could not deem a has stated that it operates the Title X program doctor or a nurse with a religious accordingly. The 2019 Title X final rule accommodations do not themselves memorialized HHS’s longstanding recognition that constitute discrimination. The objection to performing abortions to be Federal conscience and anti-discrimination laws Department also finds it appropriate not ineligible to practice obstetrics and bar enforcement of certain requirements of the 2000 to adopt the undue hardship exception gynecology on that basis. An important Title X regulations, but the 2019 Title X final rule purpose of laws such as the Church did not alter HHS’s preexisting policy dating back for enforcing Federal conscience and at least to 2008 of not enforcing requirements of the anti-discrimination laws because Amendments is to prevent fields such as 2000 regulations where they may conflict with the Congress chose not to place that

2 Federal conscience statutes as explained in this For example, nurses assigned exclusively to S

E limitation on the protections set forth in

L rule. This rule, similarly, does not alter that status nursing homes for elderly patients would not be U

R the Federal conscience and anti-

quo, but sets forth general processes for expected to refer or assist in the performance of any h t i enforcement of the Federal conscience and anti- sterilization procedures or abortions, and, thus, it w discrimination laws.

D discrimination laws. The Department will would be inappropriate for an entity subject to the O Comment: The Department received R implement all of its programs consistent with the prohibitions in this rule to require such nurses to P 2

8 Federal conscience and anti-discrimination laws comments expressing concern that the disclose whether or not they have any objections to 0 Q

L and with any applicable court orders. proposed definition of ‘‘discriminate or referring or assisting in such procedures. G 3 K S D n o l l e

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obstetrics and gynecology from being passed by Congress that are the subject ‘‘discrimination’’ as adopted in this purged of pro-life personnel just of this rule. final rule is non-exclusive, as discussed because abortion is legal and some Comment: The Department received above, OCR is not prejudging any health care entities perform them. In comments stating that the proposed complaints of violations of part 88 that this sense, the Department disagrees definition of ‘‘discriminate or are based on a claim of disparate with commenters who essentially discrimination’’ would turn any adverse impact, and will consider the contend that pro-life medical personnel action taken against a protected party circumstances of each complaint and can be placed outside of women’s health for any reason into per se unlawful apply each statute according to its text positions for that reason. The discrimination. and any applicable court precedents. Department need not address in this Response: The Department disagrees. Comment: The Department received rule whether a covered entity could The definition of ‘‘discriminate or comments stating that the proposed disqualify a person with religious or discrimination’’ does not trigger definition of ‘‘discriminate or moral objections to covered practices if violations based on any adverse action discrimination’’ is either such covered practices made up the whatsoever, but must be read in the unconstitutional or violates precedential primary or substantial majority of the context of each underlying statute at definitions of what constitutes duties of the position, as the Department issue, any other related provisions of the discrimination. is not aware of any instances in which rule, and the facts and circumstances. In Response: The Department disagrees individuals with religious or moral this rule, the prohibition on that the definition of ‘‘discriminate or objections to such practices have sought discrimination is always conditioned discrimination’’ finalized in this rule out such jobs. on, and applied in the context of, generally violates legal standards, Overall, under new paragraph (6) of violating a specific right or protection, constitutional or otherwise, as to what the definition, taking steps to use and each protected right is typically constitutes discrimination. There is no alternate staff or methods to provide for associated with a particular Federal universal definition of discrimination or further the objected-to conduct would funding stream or streams. For example, that governs all Federal statutes. in § 88.3(c)(2), ‘‘discrimination’’ is not run afoul of the definition of Discrimination can take different forms unlawful when done ‘‘ discrimination, or constitute a on the basis that depending on the particular context and the health care entity’’—the protected prohibited referral, if the employer or language of each statute prohibiting it. entity in the provision—‘‘does not program does not require any additional The Department nevertheless has drawn provide, pay for, provide coverage of, or action by the objecting individual or substantially from definitions and refer for, abortion.’’ Thus, an adverse health care entity and if such methods interpretations of ‘‘discrimination’’ action taken for reasons wholly do not exclude individuals from areas or found in other anti-discrimination unrelated to abortion or the health care fields of practice on the basis of their statutes and case law, and has made entity’s actions or beliefs objecting to protected objections. The employer may various changes in response to public abortion would not constitute a comments. The Department believes also inform the public of the availability violation under this provision. In of alternate staff or methods to provide that the definition finalized here addition, as noted above, whether an reasonably describes forms and methods or further the objected-to conduct, if action is regarded as adverse is subject doing so does not constitute retaliation of discrimination that are likely to be to a standard of reasonableness. encountered in the context of the or other adverse action against the Comment: The Department received Federal conscience and anti- objecting individual or health care comments suggesting that the definition discrimination laws at issue in this rule, entity. For example, an employer may of ‘‘discriminate or discrimination’’ and that are encompassed by the post such a notice and a phone number should not include elements of protections set forth in those statutes in a reception area or at a point of sale, disparate impact. Because circuit courts and this rule. but may not list staff with conscientious of appeals handle disparate impact Summary of Regulatory Changes: For objections by name if such singling out analysis differently, its inclusion here the reasons described in the proposed constitutes retaliation. will lead to confusion and differing rule and above, and considering the The definition also clarifies that outcomes depending on the circuit in comments received, the Department employers cannot use information which the conduct occurred, and finalizes the definition of ‘‘discriminate gained from this process to discriminate including elements of disparate impact against any protected entity or would create incentives to manipulate or discrimination’’ (with additional employee, and any attempts to, for data in order to bring illegitimate minor changes for accuracy and clarity); example, ask questions of prospective complaints. changing ‘‘means’’ to ‘‘includes;’’ employees or grant applicants Response: The Department agrees in limiting the definition ‘‘to the extent’’ concerning potential objections before part and disagrees in part. Because there permitted by the statute; changing hiring or a grant award will require a is uncertainty about which laws, or ‘‘exclude’’ to ‘‘exclude from;’’ deleting persuasive justification because of the parts of laws, implemented by this rule ‘‘otherwise’’ from paragraphs (1) and (2); risk of unlawful but difficult-to-detect may or may not support a disparate adding ‘‘or impose any penalty’’ to the ‘‘screening’’ of applicants. impact claim, the Department is end of paragraph (2); in paragraph (3), The Department believes these choosing to finalize the rule without deleting ‘‘defeating or substantially modifications to the scope of prohibited explicitly including terms traditionally impairing accomplishment of a health discrimination under this final rule associated with disparate impact program or activity,’’ changing ‘‘tends to strike the right balance by respecting the theories. It is specifically replacing the subject’’ to ‘‘subjects,’’ and adding ‘‘on interests of employers and entities that phrase ‘‘adverse effects’’ with ‘‘adverse grounds prohibited under an applicable 2

S statute encompassed by this part;’’ E wish to provide services allowed by treatment’’ and is deleting ‘‘otherwise,’’ L

U deleting the proposed paragraph (4) and R

their consciences; respecting the ‘‘tends to,’’ and ‘‘defeats or substantially h t i w

interests, privacy, and conscience of impairs accomplishment of a health

D 83 FR 3880, 3892–93 (stating the reasons for the O patients and customers; and respecting program or activity’’ as elements of the R proposed definition of ‘‘discriminate or P 2

8 the conscience of employees and health definition of ‘‘discrimination.’’ discrimination,’’ except for the modifications 0 Q

L care entities protected by the laws However, because the definition of adopted herein). G 3 K S D n o l l e

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adding new paragraph (4) as described Federal statutes at issue apply their As described further below, to ensure above regarding entities that ‘‘shall not protections to the funds at issue, uniformity, the Department also be regarded as having engaged in regardless of whether those funds are modifies the definitions of ‘‘recipient’’ discrimination;’’ adding paragraph (5) as awarded to domestic or foreign entities. and ‘‘sub-recipient’’ to include, as described above allowing an entity If foreign entities wish not to be bound applicable, a foreign government, subject to any prohibition in this part to by these conscience protections, they foreign nongovernmental organization, ‘‘require a protected entity to inform may choose not to accept the relevant or intergovernmental organization (such them of objections;’’ and adding funds. as the United Nations or its affiliated paragraph (6) as described above Comment: The Department received a agencies). addressing what actions by the entity comment stating that the definition of Federal financial assistance. The subject to this part ‘‘would not, by itself, ‘‘entity’’ would permit any employer to Department proposed that Federal constitute discrimination.’’ deny its employees coverage for Entity. The Department proposed that financial assistance align with the abortion or other objected-to services, definition of this term in the ‘‘Entity means a ‘person’ as defined in even if otherwise required by law. Other 1 U.S.C. 1; or a State, political Department’s regulations implementing comments expressed concern that Title VI of the Civil Rights Act of 1964 subdivision of any State, defining ‘‘entity’’ to include State or instrumentality of any State or political at 45 CFR 80.13, which includes the local governments expands covered provision of assistance of Federal funds subdivision thereof, or any public entities beyond the health care industry. agency, public institution, public and non-cash assistance, such as the Response: The Department disagrees. detail of Federal personnel. The organization, or other public entity in The definition section must be read in any State or political subdivision of any Department received comments on this conjunction with other sections of the term. State.’’ The Department received rule when determining whether any comments on this definition. particular entity must comply with any Comment: The Department received a Comment: The Department received particular provision of the rule. For comment stating that the uses of the comments requesting that the definition example, the fact that private employers word ‘‘arrangement’’ and the ‘‘provision of ‘‘entity’’ include non-profit religious are a type of organization that falls of assistance’’ were difficult to interpret, corporations as well. under the definition of ‘‘entity’’ does not and that the definition of ‘‘Federal Response: Non-profit religious make every private employer in financial assistance’’ should clarify corporations are already encompassed whether it ‘‘includes any claim for by the definition of ‘‘person’’ in 1 U.S.C. America automatically subject to the Federal protection statutes for which payment, payments in exchange for 1. See Burwell v. Hobby Lobby Stores, this rule provides enforcement health care services, or applications to Inc., 134 S. Ct. 2751, 2768 (2014). mechanisms. Similarly, the fact that participate in a Federal program through Comment: The Department received a which payment would be made.’’ comment noting that the definition of natural persons fall under the definition ‘‘entity’’ does not mention foreign of entity does not mean that every Response: The Department disagrees. governments, the United Nations, and person in America is automatically The proposed definition of ‘‘Federal related bodies. The comment proposed granted protection under the rule. financial assistance’’ mirrors the explicitly excluding foreign Rather, obligations and protections definition used in the Department’s governments and the United Nations apply only to those entities that are regulations implementing Title VI and is from the definition of ‘‘entity’’ because subject to a relevant provision of a intended to carry the same meaning as of sovereignty concerns. statute under the rule. Each provision in it has traditionally been understood to Response: The Department agrees that this final rule that addresses a Federal carry in the application of those the term ‘‘entity’’ should address foreign conscience statute has a paragraph titled regulations. See 45 CFR 80.13(f). The governments, foreign nongovernmental ‘‘Applicability’’ (see § 88.3), which Department believes that entities subject organizations, intergovernmental specifies whether an entity is subject to to this regulation will be sufficiently organizations (such as the United any given provision of a Federal statute familiar with that meaning to Nations), and related bodies, but the at issue. For some statutes or some understand its application in this final Department disagrees that they should portions of statutes, the Applicability rule. Further, numerous Federal courts be explicitly excluded. Some of the paragraph by its own terms may only have recognized that Federal financial Federal conscience statutes to be implicate certain types of entities or assistance encompasses subsidies, but enforced by the Department may only entities receiving certain types of not fair market value compensation paid implicate foreign entities, but funding. in return for services. See, e.g., Jarno v. Congress did not exempt certain kinds Summary of Regulatory Changes: For Lewis, 256 F. Supp. 2d 499, 504 (E.D. of foreign entities that would otherwise the reasons described in the proposed Va. 2003); DeVargas v. Mason & Hanger- be covered. Accordingly, the definition rule and above, and considering the Silas Mason Co., 911 F.2d 1377, 1382 of ‘‘entity’’ is modified to clarify that comments received, the Department (10th Cir. 1990); Cook v. Budget Rent-a- ‘‘entity’’ may include a foreign finalizes the definition of ‘‘entity’’ by Car, 502 F. Supp. 494 (S.D.N.Y. 1980); government, foreign nongovernmental including ‘‘or, as applicable, a foreign Shotz v. American Airlines, 420 F.3d organization, or intergovernmental government, foreign nongovernmental 1332 (11th Cir. 2005); Venkatraman v. organization (including the United organization, or intergovernmental REI Systems, 417 F.3d 418 (4th Cir. Nations and its affiliated agencies). The organization (such as the United 2005). In light of the comments, the Nations or its affiliated agencies).’’ The Department finalizes this definition

2 Such as funds administered by the Secretary of Department also adds the term ‘‘the

S with a minor clarifying change to avoid E L Health and Human Services under section 104A of Department’’ to the definition of

U a circular definition, by replacing R

the Foreign Assistance Act of 1961 (22 U.S.C. h ‘‘entity,’’ for clarity. t i 2151b–2); under Chapter 83 of Title 22 of the U.S. ‘‘funds, support, or aid’’ with ‘‘subsidy’’ w

D Code; or under the Tom Lantos and Henry J. Hyde in paragraph (5) of the definition. O

R United States Global Leadership Against HIV/ AIDS, 83 FR 3880, 3893 (stating the reasons for the P

2 Summary of Regulatory Changes: For 8 Tuberculosis, and Malaria Reauthorization Act of proposed definition of ‘‘entity,’’ except for the 0

Q the reasons described in the proposed L 2008. modifications adopted herein). G 3 K S D n o l l e

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rule and above, and considering the are not natural persons can hold moral forcefully and effectively in the public comments received, the Department or religious beliefs. realm. As the Supreme Court has finalizes the definition of ‘‘Federal Response: Federal law routinely recognized, there is nothing about financial assistance’’ as proposed, with recognizes corporations, organizations, organizing in a group that diminishes a modification in paragraph (5) to or other non-natural persons as holders the rights they would enjoy as remove references to a ‘‘Federal’’ of legal rights and subject to legal individuals. Therefore, the agreement and ‘‘arrangement’’ so that obligations. The Federal Government Department considers it appropriate to the text now refers to ‘‘any agreement or has long recognized the Free Speech finalize the definition of health care other contract between the Federal and Free Exercise rights of non-profit entities to include non-natural persons. government and a recipient,’’ and to organizations with charitable missions Comment: The Department received clarify the terminology by referring to related to the religious beliefs or moral comments stating that the proposed ‘‘provision of a subsidy to the recipient’’ convictions of its members, and has definition of ‘‘health care entity’’ to avoid a circular definition related to recognized the Free Speech rights of exceeds the Department’s statutory the provision of ‘‘assistance.’’ public corporations. Citizens United v. authority under the Weldon Health care entity. The Department FEC, 558 U.S. 310, 365 (2010). The Amendment and the Coats-Snowe proposed that ‘‘health care entity’’ definition of ‘‘person’’ that is protected Amendment. includes an individual physician or under the Religious Freedom Response: The Weldon and Coats- other health care professional; health Restoration Act includes both natural Snowe Amendments and ACA section care personnel; a participant in a and non-natural persons (corporations, 1553 each provide a definition of program of training in the health partnerships, etc.). In Hobby Lobby, ‘‘health care entity’’ that contains a non- professions; an applicant for training or having found that the text of the exhaustive list of entities that are study in the health professions; a post- Religious Freedom Restoration Act, 42 ‘‘health care entities.’’ The Coats-Snowe graduate physician training program; a U.S.C. 2000bb–2000bb–4 (‘‘RFRA’’), Amendment says that ‘‘health care hospital; a laboratory; an entity engaging does not preclude its application to entity’’ ‘‘includes an individual in biomedical or behavioral research; a corporations, the Supreme Court held physician, a postgraduate physician provider-sponsored organization; a that a closely held for-profit corporation training program, and a participant in a health maintenance organization; a can assert the religious beliefs of its program of training in the health health insurance plan (including group owners. More specifically, from the professions.’’ The Weldon Amendment or individual plans); a plan sponsor, enactment of the first paragraph of the and ACA section 1553 state that the issuer, or third-party administrator; or Church Amendments in 1973, Federal term ‘‘includes an individual physician any other kind of health care conscience and anti-discrimination laws or other health care professional, a organization, facility, or plan. The have recognized that entities such as hospital, a provider-sponsored Department also proposed that the term hospitals can possess ‘‘religious beliefs organization, a health maintenance may also include components of State or or moral convictions’’ when prohibiting organization, a health insurance plan, or local governments. The Department their facilities from being used for any other kind of health care facility, proposed a single definition of the term abortions or sterilizations. In addition, organization, or plan.’’ All three laws use the word ‘‘includes,’’ which means ’’health care entity,’’ a term used in the the Coats-Snowe and Weldon the lists of such entities in the Weldon Amendment, the Coats-Snowe Amendments, and ACA section 1553, definitions are non-exhaustive, and Amendment, and ACA section 1553. protect organizations or institutions as other entities could also be ‘‘health care The Department received comments on ‘‘health care entities’’ when they object entities’’ under the plain meaning of the this definition. to certain activities concerning abortion term as used in those statutes. The Comment: The Department received a or assisted suicide without regard to the Coats-Snowe Amendment also uses a comment stating that ‘‘health care motivation for the objection. Both the catch-all phrase for entities in ‘‘any entity’’ should include social workers Coats-Snowe and Weldon Amendments other program of training in the health and schools of social work. contain definitions of ‘‘health care professions.’’ The Weldon Amendment Response: The Department declines to entity’’ that include, as examples, both and ACA section 1553 likewise include make an explicit inclusion of social natural persons and corporate persons. catch-all provisions such as ‘‘other workers and schools of social work to The same is true of the definition of health care professional’’ and ‘‘any other the definition of health care entity. It is ‘‘health care entity’’ in ACA section kind of health care facility, organization, unclear in many circumstances that 1553. such entities deliver health care. The Finally, religious faith and moral or plan.’’ Thus, in defining the term for Department’s intention in this definition convictions are often the organizing purposes of this rule, it is consistent is to provide a non-exclusive list of principle for entities covered in this with the statutory text to list certain entities Congress has intended to rule, and natural persons form these entities that are not explicitly include as a health care entity. Because organizations for the purpose of See, e.g., Hobby Lobby, 134 S. Ct. at 2768 the list is non-exclusive, there may be asserting their faith or convictions more (‘‘When rights, whether constitutional or statutory, circumstances where a social worker is are extended to corporations, the purpose is to considered a health care entity under a See, e.g., 42 U.S.C. 2000bb–1 (‘‘Government protect the rights of these people [who constitute Federal conscience or anti- shall not substantially burden a person’s exercise of the corporation] . . . And protecting the free- religion even if the burden results from a rule of exercise rights of corporations like Hobby Lobby discrimination law, but that will depend general applicability, except as provided in . . . protects the religious liberty of the humans on the facts and the circumstances in subsection (b).’’); 1 U.S.C. 1 (‘‘In determining the who own and control those companies.’’); Citizens each case as they arise. meaning of any Act of Congress, unless the context United, 558 U.S. at 391–93 (Roberts, C.J.,

2 indicates otherwise . . . the words ‘‘person’’ and concurring) (‘‘[T]he individual person’s right to S Comment: The Department received E

L ‘‘whoever’’ include corporations, companies, speak includes the right to speak in association with U comments questioning how entities that R

associations, firms, partnerships, societies, and joint other individual persons . . . [The First h t i stock companies, as well as individuals.’’); Burwell Amendment’s] text offers no foothold for excluding w

D 83 FR 3880, 3893 (stating the reasons for the v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2768 any category of speaker, from single individuals to O

R proposed definition of ‘‘Federal financial (2014) (‘‘We see nothing in RFRA that suggests a partnerships of individuals, to unincorporated P 2

8 assistance,’’ except for the modifications adopted congressional intent to depart from the Dictionary associations of individuals, to incorporated 0 Q

L herein). Act definition . . . .’’). associations of individuals.’’). G 3 K S D n o l l e

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mentioned in the statutes, because the uses the same definition of ‘‘health care not just providing and referring for, but statutory lists are non-exhaustive; entity’’ as the Weldon Amendment, in also providing coverage of, and payment including those entities is consistent specifying that health care entities for, abortions. Similar to the Weldon with the plain meaning of the terms set cannot be subject to discrimination for Amendment, and unlike the Coats- forth in those statutes. As explained in choosing not to provide certain items or Snowe Amendment, ACA section 1553 the following discussion, however, the services related to assisted suicide. focuses on the context of health plans Department is finalizing the definition Because the focus of both laws includes and coverage in addition to the of health care entity to better conform protection of health plans, it is provision of items and services. the definition to the varying texts of the consistent with their language and Consequently, the Department specific Federal conscience and anti- scope to include ‘‘a plan sponsor’’ as a concludes that it is appropriate to discrimination laws that use the term. protected ‘‘heath care entity.’’ In the finalize a definition of health care entity Comment: The Department received action of sponsoring a health plan or for the Coats-Snowe Amendment that is comments stating that the inclusion of health coverage, the plan sponsor somewhat different from the definition ‘‘a plan sponsor’’ in the definition of engages in an important function with applicable to the Weldon Amendment ‘‘health care entity’’ would subject all respect to health care. Although the and ACA section 1553, and to not employers who sponsor group health sponsor, the plan, and the issuer are all include in the definition for purposes of plans to the conscience statutes using distinct entities, sponsoring a plan and the Coats-Snowe Amendment entities that term. Other commenters contended paying for coverage (by an issuer, in the pertaining specifically to the health the laws using those terms did not case of a fully insured plan) or for insurance and coverage context, namely, intend to protect plan sponsors that are health care services (in the case of a self- a provider-sponsored organization, a not otherwise health care entities. Other insured plan) are part and parcel of the health maintenance organization, a commenters suggest that the term provision of health coverage under a health insurance plan (including group ‘‘health care entity’’ should not be the group health plan. The Weldon or individual plans), a plan sponsor, an same for the Coats-Snowe Amendment, Amendment is written to prohibit issuer, or a third-party administrator. the Weldon Amendment, and ACA discrimination against, among others, Likewise, the Department deems it section 1553. entities that do not provide abortion in appropriate not to list in the definition The Department received other health coverage; ACA section 1553 is applicable to the Coats-Snowe comments supporting the inclusion of similarly written to protect entities from Amendment the catch-all phrase that is ‘‘plan sponsor’’ and ‘‘third party being required to provide certain health in the statutory text of the Weldon administrator’’ in the definition of care items or services in connection Amendment and ACA section 1553: ‘‘or ‘‘health care entity.’’ One comment with health plans and the ACA. Both third-party administrator; or any other expressed that faith-based organizations laws define health care entity to include kind of health care organization, facility, that fund health plans should not be the catch-all phrase ‘‘any other kind of or plan.’’ required to fund services or procedures health care facility, organization, or Otherwise, the Department deems it that violate their religious beliefs. plan,’’ in order to protect a broad range appropriate to include in both Response: Commenters contending of entities that might be engaged in definitions of health care entity the that including particular types of proposed rule’s non-exhaustive entities in the definition of ‘‘health care providing coverage or services and subject to discrimination for not enumeration of various individual and entity’’ would require such entities to organizational entities that engage in comply with the Coats-Snowe providing or covering abortion or assisted suicide, respectively. Therefore, health care practices or services: ‘‘an Amendment, the Weldon Amendment, individual physician or other health or ACA section 1553 are incorrect. The treating a plan sponsor as a protected health care entity is consistent with the care professional; health care personnel; term ‘‘health care entity’’ is used in a participant in a program of training in those statutes—and in this final rule— text of the Weldon Amendment and ACA section 1553. the health professions; an applicant for to specify not which entity must comply training or study in the health In further consideration of public with the statute, but which kinds of professions; a post-graduate physician comments, however, the Department entities are protected from training program; a hospital; a medical has concluded that the definition of discrimination. Thus, including an laboratory; [or] an entity engaging in ‘‘health care entity’’ should be different entity in the term ‘‘health care entity’’ biomedical or behavioral research.’’ for the Coats-Snowe Amendment than under those statutes does not expand or Because the Department intended these for the Weldon Amendment and ACA affect which governmental or non- entities to be health care entities, and governmental fund recipients must section 1553, including with respect to the term ‘‘laboratory’’ could be whether to include a plan sponsor. The comply with those statutes. interpreted to include laboratories that The Department concludes it is Coats-Snowe Amendment, while are not related to health care, the appropriate to include ‘‘a plan sponsor’’ providing a non-exclusive list of entities Department finalizes the term in the definition ‘‘health care entity’’ for and individuals included in the term ‘‘laboratory’’ in these definitions to add purposes of the Weldon Amendment ‘‘health care entity,’’ contains a different the word ‘‘medical’’ to clarify its health and ACA section 1553. The Weldon list of entities and individuals than that care scope. set forth in the Weldon Amendment and Amendment explicitly protects entities These entities are health care entities that do not pay for or provide coverage ACA section 1553. Moreover, the nature under the ordinary meaning of that term and scope of protections set forth in the of abortions, and includes ‘‘health because they are engaged in health care Coats-Snowe Amendment—which can insurance plans, or any other kind of practices, training, or research. They are health care facility, organization, or assist in understanding the intended 2

S also similar to the types of individuals

E plan’’ within its own illustrative list of range of protected health care entities— L

U and entities listed in the non-exclusive R

protected health care entities. ACA also differ. The Coats-Snowe h t i lists of health care entities in the Coats- w

section 1553 applies to government Amendment focuses generally on the D

O entities receiving Federal financial performance of, training for, and referral R That is not to say that certain types of health P 2

8 assistance under the ACA, and any for abortions, whereas the Weldon plans could not also be health care providers, e.g., 0 Q

L health plan created under the ACA. It Amendment focuses more broadly on staff model health maintanence organizations. G 3 K S D n o l l e

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Snowe Amendment, the Weldon and entities set forth in these or ‘‘health care professional’’ in the Amendment, and ACA section 1553. All definitions. definition of ‘‘health care entity’’ is, three statutes list individuals and Comment: The Department received therefore, consistent with Congress’s personnel in the health professions, not comments suggesting that ‘‘health care explicit inclusion of individual persons just corporate entities. This entity’’ should include public school in the health care field. Doing so demonstrates that Congress explicitly districts that provide on-campus effectuates the remedial purposes of the intended the term health care entity in medical care or manage vaccination Coats-Snowe Amendment, the Weldon all three to protect individuals, not just records. Amendment, and ACA section 1553, organizational entities. All three Response: The definition specifies and is consistent with their texts. definitions also list organizational that ‘‘health care entity’’ also includes Comment: The Department received entities, and of course they all contain components of State or local comments requesting that ‘‘health care the basic term ‘‘health care entity,’’ governments. The Department does not professional’’ and ‘‘health care which must be interpreted to encompass believe the definitions need to specify personnel’’ be defined terms. further that public school districts terms included in its ordinary meaning. Response: The Department declines to Finally, the proposed definition of providing on-campus medical care are included. The Department will evaluate define these terms. The Department ‘‘health care entity’’ concludes by believes it is appropriate to determine specifying that it ‘‘may also include the applicability of the rule to public school entities with health care remaining potential questions about the components of State or local scope and application of the term governments.’’ To clarify the meaning of functions according to the facts and circumstances of each case as they arise ‘‘health care entity’’ based on an this sentence, the Department finalizes analysis of facts and circumstances it with a change in each definition of and the applicable laws. Comment: The Department received a presented in each case as they arise. ‘‘health care entity,’’ to read: ‘‘As comment proposing that ‘‘health care Regarding health care professionals, applicable, components of State or local entity’’ exclude occupational therapists. State and local law might also be governments may be health care entities Response: To the extent that relevant concerning which persons are under’’ the Coats-Snowe Amendment, occupational therapists are health care considered health care professionals. the Weldon Amendment, and ACA personnel qualifying as ‘‘other health Because those laws differ, the section 1553. care professionals,’’ the Department Department considers it appropriate not Comment: The Department received a disagrees that they would be necessarily to specify a single definition of health comment stating that pharmacies and excluded from protection. While some care professional or health care pharmacists are sometimes not questions concerning who qualifies for personnel in this rule. Parts of the understood to be health care providers protection in a particular circumstance Church Amendments use the terms and asking that pharmacists and are relatively straightforward, such as ‘‘personnel’’ and ‘‘health care pharmacies be included in the physicians under certain conscience personnel,’’ but do not define those provisions of this rule. protection laws, some questions are terms. Although this rule also does not Response: The Department accepts closer and depend on the facts and the define those terms, the Department this recommendation and is including applicable law. The Department, believes this rule provides some pharmacies and pharmacists in the therefore, declines to make explicit additional clarity to the application of definitions of ‘‘health care entity.’’ A exclusions, such as for occupational Federal conscience and anti- pharmacy is a health care entity, therapists, to the definitions of health discrimination laws. considering the ordinary meaning of care professionals, and will instead Summary of Regulatory Changes: For that term, because it provides consider individual cases based on the the reasons described in the proposed pharmaceuticals and information, facts and circumstances presented in rule and above, and considering the which are health care items and each case as they arise and the comments received, the Department services. Regarding pharmacists, applicable law. finalizes the definition of ‘‘health care because Congress specified that the term Comment: The Department received entity’’ with changes to bifurcate the ‘‘health care entity’’ in the Coats-Snowe comments stating that the inclusion of definition into two: One applicable for Amendment, the Weldon Amendment, ‘‘health care personnel’’ exceeds the purposes of the Coats-Snowe and ACA section 1553, includes certain definition of ‘‘health care entity’’ under Amendment, and the other applicable individuals in the health professions, the Weldon Amendment or other laws for purposes of the Weldon Amendment and does not provide an exclusive using that term. and ACA section 1553. Both definitions definition, the Department deems it Response: The Department disagrees. add pharmacies and pharmacists. Both appropriate to include pharmacists, who The list of individuals, persons and add the word ‘‘medical’’ before the term are also health care professionals. entities included as a ‘‘health care ‘‘laboratory’’ to more clearly describe its Whether a particular protection in those entity’’ in the Weldon Amendment and health care scope, and both note that ‘‘as three laws applies to a pharmacist or ACA section 1553 includes ‘‘an applicable, components of State or local pharmacy in a particular case, or individual physician,’’ and also the governments may be health care whether it applies to any of the catch-all phrases ‘‘or other health care entities.’’ The definition applicable to examples in these definitions, is a professional.’’ The Coats-Snowe the Coats-Snowe Amendment omits the separate question that will be Amendment says the term includes terms ‘‘a provider-sponsored determined in the context of the factual ‘‘individual physician’’ and ‘‘a organization; a health maintenance and legal issues applicable to the participant in a program of training in organization; a health insurance plan situation. For the purpose of specifying the health professions.’’ Because the 2 (including group or individual plans); a S

E whether a pharmacist or pharmacy term ‘‘health care entity’’ includes L plan sponsor, issuer, or third-party U R

could possibly be covered by the term individuals, and the definitions are non- h administrator; or any other kind of t i w

health care entity in these three laws, exclusive, the Department deems it D

O depending on the circumstances, the appropriate to include other individuals R 83 FR 3880, 3893 (stating the reasons for the P 2

8 Department deems it appropriate to who are health care personnel. proposed definition of ‘‘health care entity,’’ except 0 Q

L include them in the list of individuals Including ‘‘health care personnel’’ and/ for the modifications adopted herein). G 3 K S D n o l l e

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health care organization, facility, or Department believes vaccination Department adopts the definition of plan.’’ programs would reasonably be ‘‘health program or activity’’ as Health program or activity. The considered a health program or activity proposed as the definition of ‘‘health Department proposed that ‘‘Health (or a health service program) and notes service program,’’ except makes a program or activity’’ includes the that one of the statutes that is the technical edit for clarity by replacing provision or administration of any subject of this rule concerns vaccination commas with semicolons after health-related services, health service explicitly (42 U.S.C. 1396s(c)(2)(B)(ii)). ‘‘directly,’’ the phrase ‘‘through programs and research activities, health- Comment: The Department received payments, grants, contracts, or other related insurance coverage, health comments stating that the definition of instruments,’’ and after ‘‘through studies, or any other service related to ‘‘health program or activity’’ (now insurance.’’ Additionally, it deletes the health or wellness, whether directly ‘‘health service program’’), when reference to ‘‘health service program’’ through payments, grants, contracts, or combined with the definition of ‘‘assist from the proposed definition as circular. other instruments, through insurance, or in the performance’’ and ‘‘refer,’’ could Health service program. The otherwise. result in disparate impact against Department proposed that ‘‘Health Under the proposed rule the terms women, LGBT persons, and religious service program includes any plan or ‘‘health program or activity’’ and minorities. program that provides health benefits, ‘‘health service program’’ differed Response: The Department disagrees. whether directly, through insurance, or mainly in that the former included ‘‘the This rule implements underlying otherwise, and is funded, in whole or provision or administration of any statutory requirements and prohibitions part, by the Department. It may also health-related services,’’ while the latter set forth by Congress. The terms defined include components of State or local included any ‘‘plan or program that in this rule do not apply to women, programs.’’ The Department received provides health benefits.’’ Because LGBT persons, or religious minorities in comments on this definition. ‘‘health service program’’ could be seen any way that differs from how Congress Comment: The Department received as narrower, the phrase health program applied the terms in the statutes it comments stating that the definition of or activity incorporated ‘‘health service adopted. To the extent commenters ‘‘health service program’’ expands the program’’ explicitly as part of its contend that some Federal conscience scope of the Federal conscience and definition. The Department asked for and anti-discrimination laws themselves anti-discrimination laws ‘‘to include comment ‘‘on whether the terms mean adversely impact women because they virtually any medical treatment or the same thing and should or could be concern abortion, the Department defined interchangeably for purposes of service, biomedical and behavioral disagrees, but is in any event required research, and health insurance.’’ this regulation.’’ to implement and enforce Federal The Department did not receive Response: The Department disagrees. conscience and anti-discrimination laws Among the statutes that are the subject specific comments on this question, but as Congress wrote them. the comments received regarding the of this rule, the phrase ‘‘health service Comment: The Department received program’’ appears only once, in two definitions generally treated the two comments stating that the definition of phrases as identical. Upon further paragraph (d) of the Church the term ‘‘health program or activity’’ Amendments. That paragraph addresses consideration the Department has (now ‘‘health service program’’), is concluded that there are insufficient the right of persons to decline to overly broad; and, when combined with ‘‘perform or assist in the performance’’ grounds for defining such similar terms section 104A of the Foreign Assistance differently under the rule. of ‘‘any part’’ of a health service Act of 1961, could result in otherwise program or research activity funded in The Department is finalizing the rule unauthorized discrimination against without defining ‘‘health program or whole or in part under a program minority groups or persons in sex administered by the Secretary of HHS if activity’’ because other revisions have trafficking in programs funded under eliminated the use of the phrase in the such performance or assistance would section 104A. be contrary to the person’s religious regulation text as finalized. However, Response: The Department disagrees. beliefs or moral convictions. Many for reasons explained below, the The relevant language of section 104A, commenters’ objections to this Department adopts (with minor edits) ‘‘any program or activity’’ (22 U.S.C. definition are fundamentally objections the definition proposed for ‘‘health 7631(d)(1)(B)), is broader than, and to the text of paragraph (d) of the program or activity’’ as the definition for clearly includes, any ‘‘health service Church Amendments as passed by ‘‘health service program.’’ All questions program.’’ As the Department only Congress. The Department believes that and responses to comments concerning administers section 104A funds (as other commenters may misunderstand ‘‘health program or activity’’ apply fully relevant to this rule) with respect to the scope of paragraph (d). Generally, and ‘‘transfer’’ to ‘‘health service health, the definition of ‘‘health the protections of paragraph (d) follow program.’’ program or activity’’ is not intended to the funds provided by any program Comment: The Department received limit, and in no way limits, any administered by the Secretary. But comments stating that the definition of protection from discrimination provided paragraph (d) does not encompass every ‘‘health program or activity’’ should in section 104A of the Foreign medical treatment or service performed explicitly include vaccination programs Assistance Act of 1961. Additionally, by any entity receiving Federal funds or the processing of vaccination records. nothing in 22 U.S.C. 7631(d)(1)(B) Response: Because of the broad scope from HHS for whatever purpose. exempts certain programs or activities of what could constitute a ‘‘health Instead, Congress narrowly focused from its conscience protections. paragraph (d) to prohibit the coercion of program or activity’’ (now ‘‘health Summary of Regulatory Changes: For service program’’), the Department persons ‘‘in performance of’’ health 2

S the reasons described in the proposed

E service programs funded under a L declines to attempt a comprehensive

U rule, above and below, and R listing of examples of such programs or program administered by the Secretary. h t i considering the comments received, the w

activities and instead relies on the Many medical treatments and services D

O performed by health care providers are R general standard proposed. The 83 FR 3880, 3893–94 (stating the reasons for the P 2

8 proposed definition of ‘‘health program or activity,’’ not ‘‘part of’’ a health service program 0 Q

L 83 FR 3880, 3894. except for the modifications adopted herein). receiving funding from HHS. In such G 3 K S D n o l l e

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circumstances, paragraph (d) would not Comment: The Department received a ‘‘health service program.’’ The apply. comment stating that the definition of Department believes that it is also This distinction can be illustrated by ‘‘health service program’’ should only appropriate to consider the Public considering the parallel term used in apply in the context of biomedical Health Service Act (PHSA) as a source paragraph (d), ‘‘research activity.’’ For research. for defining the term ‘‘health service example, if an entity receives a grant Response: The Department disagrees. program’’ because, (1) the Church from a program administered by HHS to Congress used the disjunctive phrase Amendments themselves cite the PHSA conduct research on a new cancer ‘‘health service program or research to help establish what programs are treatment, paragraph (d) of the Church activity’’ in paragraph (d) of the Church covered and (2) the PHSA uses the Amendments would protect individuals Amendments. Nothing in the phrase or phrase ‘‘health service program’’ and involved in the performance of any part its context (the surrounding text) ‘‘health services’’ numerous times. For of that research activity. But if the entity indicates that the protection provided example, the PHSA provides grant engages in other research activities that by Congress is limited only to authority to assist States and other are not funded by HHS (i.e., not related biomedical research. If ‘‘health service public entities ‘‘in meeting the costs of to the cancer treatment for which the program’’ meant only research activities, establishing and maintaining preventive research grant was issued in this then Congress’s addition of ‘‘or research health service programs’’ (42 U.S.C. example), paragraph (d) would not activity’’ would be superfluous. Further, 247b), and grants the Secretary apply to those other activities. This in a separate provision of the Church permission to enter into contracts to would hold true even if other statutory Amendments enacted at the same time ‘‘furnish health services to eligible provisions that are the subject of this as paragraph (d), paragraph (c)(2), Indians’’ (42 U.S.C. 238m). rule would apply to those other research Congress provided specific prohibitions The terms ‘‘health services’’ and activities. for entities that receive grants or ‘‘health service program,’’ as used by the Similarly, Medicaid is funded in contracts ‘‘for biomedical or behavioral PHSA, clearly include the provision of whole or in part under a program research’’ alone, without including health care or health benefits, but they health service programs. This administered by the Department. also include health-related services. For demonstrates that Congress’s inclusion Nevertheless, if a health care provider example, the PHSA uses the phrase or omission of ‘‘health service program’’ receives Medicaid reimbursements for ‘‘environmental health services’’ to was a considered decision intended to some medical treatments, but is describe programs that deal with the have substantive effect. detection and alleviation of providing other medical treatments that Summary of Regulatory Changes: The ‘‘unhealthful conditions’’ associated are not being reimbursed by Medicaid or Department asked for comment on with water supply, chemical and otherwise funded by the Department, whether ‘‘health program or activity’’ the provider—with respect to the non- and ‘‘health service program’’ should or pesticide exposures, air quality or Medicaid treatment—is not performing could be defined interchangeably for exposure to lead. 42 U.S.C. ‘‘part of a health service program’’ purposes of this regulation but 254b(b)(2)(C). These are health-related funded by a program administered by received no specific comments on the programs. Moreover, the PHSA uses the HHS. Because Medicaid generally question. Upon further consideration phrase ‘‘health service programs’’ provides reimbursements for particular the Department has concluded that explicitly and includes ‘‘preventive’’ treatments, not for a medical practice there are insufficient grounds for programs within its ambit including— overall, providing a treatment not defining such similar terms differently for example, programs for ‘‘the control reimbursed by Medicaid would under the rule. of rodents’’ and ‘‘for community and generally not be ‘‘part of a health service The Department’s definition for school-based fluoridation programs.’’ 42 program . . . funded in whole or in part ‘‘health service program’’ in the U.S.C. 300w–3(a)(1)(B). These are under’’ Medicaid for the purposes of proposed rule mirrored the definition of health-related programs. paragraph (d) of the Church the term in the 2008 Rule. The 2008 In light of the above, and for the sake Amendments, even if the overall Rule, in turn, incorporated the phrase of consistency and to avoid confusion, medical practice also receives Medicaid ‘‘health benefits’’ into the definition of the Department finalizes the term reimbursements for other treatments. ‘‘health service program’’ by borrowing ‘‘health service program’’ as equivalent The Department intends to enforce from Section 1128B(f)(1) of the Social to ‘‘health program or activity’’ (with paragraph (d) of the Church Security Act’s (42 U.S.C. 1320a–7b(f)(1)) minor changes). The Department is no Amendments consistent with the text of definition of ‘‘Federal health care longer including a definition of ‘‘health the statute. It would be inappropriate for program’’—the rationale being that program or activity’’ but in light of the Department to define ‘‘health service ‘‘Federal health care program’’ was public comments, is finalizing a program’’ to exclude programs that similar enough to ‘‘health service definition of ‘‘health service program’’ involve health services and that are program,’’ to warrant the borrowing. with changes that incorporate some of funded (in whole or in part) under a With respect to the inclusion of ‘‘health the elements of both terms, based on program administered by HHS, when benefits,’’ in the definition of ‘‘health concerns raised about both definitions Congress specified that paragraph (d) of service program,’’ this was appropriate in the public comments. The finalized the Church Amendments covers such because the Federal health service definition states that ‘‘health service programs. The Department believes that programs implemented under the Social program includes the provision or the specific limitations in paragraph (d) Security Act are programs administered administration of any health or health- concerning the circumstances in which by the Secretary—and, thus, consistent related services or research activities, it applies has already (under the statute) health benefits, health or health-related

2 with the language of the Church S

E prevented the realization of many insurance coverage, health studies, or L Amendment. However, the Social U R overbreadth concerns raised by Security Act is not (and was not) the any other service related to health or h t i w commenters, and will continue to do so exclusive basis for defining the scope of wellness, whether directly; through D

O under this rule, notwithstanding the payments, grants, contracts, or other R P 2

8 plainly broad meaning of the term 83 FR 3880, 3894. instruments; through insurance; or 0 Q

L ‘‘health service program’’ itself. Id. otherwise.’’ G 3 K S D n o l l e

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Individual. The Department proposed adopts the definition of ‘‘instrument’’ as clarify that they all may encompass ‘‘a that ‘‘Individual means a member of the proposed. foreign government, foreign workforce of an entity or health care OCR. The Department proposed that nongovernmental organization, or entity.’’ The Department received OCR means the Office for Civil Rights of intergovernmental organization (such as comments on this definition. the Department of Health and Human the United Nations or its affiliated Comment: The Department received a Services. The Department did not agencies).’’ comment stating that the definition of receive comments on this definition. Summary of Regulatory Changes: For ‘‘individual’’ should include ‘‘persons Summary of Regulatory Changes: For the reasons described in the proposed exercising their right of informed the reasons described in the proposed rule and above, and considering the consent to decline a healthcare service rule and above, the Department comments received, the Department on the basis of religion or conscience.’’ adopts the definition of ‘‘OCR’’ as finalizes the definition of ‘‘recipient’’ Response: Upon considering this proposed. with a change to the last sentence, so comment and reviewing the use of the Recipient. The Department proposed that rather than referring only to word ‘‘individual’’ throughout the that ‘‘Recipient means any State, ‘‘foreign or international organizations,’’ proposed rule, the Department agrees political subdivision of any State, it reads ‘‘The term may include a foreign instrumentality of any State or political that the term has multiple meanings government, foreign nongovernmental subdivision thereof, and any person or depending on the context of its use in organization, or intergovernmental any public or private agency, the rule and in applicable statutes. organization (such as the United institution, organization, or other entity Sometimes it refers to members of the Nations or its affiliated agencies).’’ workforce of an entity or health care in any State including any successor, Referral or refer for. The Department entity, and other times it refers to assign, or transferee thereof, to whom persons who are not health care Federal financial assistance is extended proposed that ‘‘Referral or refer for’’ be providers and yet are protected by the directly from the Department or a defined as including the provision of Federal conscience and anti- component of the Department, or who any information (including but not discrimination laws at issue in this rule, otherwise receives Federal funds limited to name, address, phone such as an individual who makes use of directly from the Department or a number, email, website, instructions, or a religious nonmedical health care component of the Department, but such description) by any method (including institution or an individual who ‘‘is term does not include any ultimate but not limited to notices, books, conscientiously opposed to acceptance beneficiary. The term may include disclaimers or pamphlets online or in of the benefits of any private or public foreign or international organizations print), pertaining to a health care insurance.’’ Because ‘‘individual’’ has (such as agencies of the United service, activity, or procedure, including multiple meanings throughout the rule, Nations).’’ The Department received related to availability, location, training, and the meaning of ‘‘individual’’ is clear comments on this definition. information resources, private or public in each instance from its context, the Comment: The Department received a funding or financing, or directions that inclusion of a definition for comment stating that while the could provide any assistance in a person ‘‘individual’’ introduces unnecessary proposed definition of ‘‘recipient’’ obtaining, assisting, training in, funding, confusion. Consequently, the recognizes that an individual or financing, or performing a particular Department is deciding not to finalize organization must comply with the health care service, activity, or the proposed definition, or any provider conscience regulations if the procedure, when the entity or health definition, of the word ‘‘individual’’ in individual or organization receives care entity making the referral sincerely the final rule. As ‘‘individual’’ is no funds ‘‘directly from the Department or understands that particular health care longer a defined term, additional component of the Department’ to carry service, activity, or procedure to be a comments on the definition of the word out a project or program,’’ the proposed purpose or possible outcome of the ‘‘individual’’ are either addressed by rule does not explain how ‘‘compliance referral. The Department received that change, or not necessary to address with the regulations would not be comments on this definition, including further. required for products or services offered general comments in support of and Summary of Regulatory Changes: For by the individual or organization that opposition to the proposed definition. the reasons described above, and are unrelated to the Federal funding.’’ Comment: The Department received considering the comments received, the Response: Fitting within the comments stating that the proposed Department does not finalize the definition of a ‘‘recipient’’ alone does definition of ‘‘referral or refer for’’ proposed definition of ‘‘individual’’ and not necessarily subject an entity to all of should be maintained as it appropriately removes the word ‘‘individual’’ and its the requirements of the statutes allows healthcare professionals to abide definition from the list of defined terms. implemented through this rule. In each by their own professional and ethical Instrument. The Department proposed paragraph of § 88.3 of this rule, there is judgments. that ‘‘Instrument is the means by which an ‘‘Applicability’’ paragraph and a Response: The Department agrees that Federal funds are conveyed to a ‘‘Requirements and prohibitions’’ the definition of ‘‘referral or refer for’’ is recipient, and includes grants, paragraph that describe, in more appropriate, except for the addition of cooperative agreements, contracts, particularity for each Federal relatively minor narrowing and grants under a contract, memoranda of conscience and anti-discrimination law clarifying changes as discussed below. understanding, loans, loan guarantees, being implemented by the paragraph, Comment: The Department received stipends, and any other funding or the scope of the statute and, thus, this comments stating that the proposed employment instrument or contract.’’ regulation. definition of ‘‘referral or refer for’’ As discussed concerning the 2 The Department did not receive exceeds the scope of the Weldon S E

L comments on this definition. definition of the term ‘‘entity,’’ the Amendment or the Coats-Snowe U R Summary of Regulatory Changes: For Department is finalizing the terms h Amendment. t i w

the reasons described in the proposed ‘‘entity,’’ ‘‘recipient,’’ and ‘‘sub- D O

R rule and above, the Department recipient’’ with parallel language to 83 FR 3880, 3894 (stating the reasons for the P 2

8 proposed definition of ‘‘recipient,’’ except for the 0 Q

L 83 FR 3880, 3894. 83 FR 3880, 3894. modifications adopted herein). G 3 K S D n o l l e

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Response: The Department disagrees. address the concerns raised by religious convictions. To the extent a Neither the Weldon nor Coats-Snowe commenters concerning the definition State subject to this rule (under, for Amendment defines ‘‘referral’’ or ‘‘refer of referral. Specifically, the Department example, the Coats-Snowe Amendment for.’’ The definition is a reasonable recognizes greater latitude for or the Weldon Amendment) legally interpretation of these terms and accommodation procedures by mandates that protected individuals and faithfully effectuates the text and employers and entities and has added entities refer for abortion, Congress has structure of Congress’s protection of additional exclusions and exemptions indicated such mandates are health care professionals and entities under the rule. In doing so, the rule inconsistent with Federal law. from being coerced or compelled to narrows the scope of possible bases of Comment: The Department received facilitate conduct (with respect to a violation under the rule. comments stating that the proposed Weldon and Coats-Snowe, concerning For example, the rule allows an definition of ‘‘referral or refer for’’ abortion) that may violate their legally employer, when there is a reasonable would violate the requirement that protected rights through the forced likelihood it may ask its employees in patients receive informed consent before provision of referrals. For example, in good faith to refer for, participate in, or performing treatments. the Weldon Amendment and section assist in the performance of potentially Response: A similar objection is 1303 of the ACA, Congress did not objected to conduct, to require its discussed above concerning the merely protect the action of declining to employee to inform it of any objections. definition of ‘‘assist in the performance’’ refer to an abortion provider, but of Thus, a hospital that regularly performs and its inclusion of referrals. The declining to refer ‘‘for’’ abortions elective abortions may ask a nurse hired Department disagrees with the generally. This more broadly protects a to work in the OB/ GYN department if he objection. Federal conscience and anti- decision not to provide contact or she anticipates having any objections discrimination laws specifically shield information or guidance likely to assist to assisting in the performance of certain persons and entities from being a patient in obtaining an abortion elective abortions to allow the hospital required to provide referrals for elsewhere. to make appropriate, non-discriminatory abortion. Indeed, medical ethics have The rule’s definition of ‘‘referral’’ or staffing arrangements. Barring other long protected rights of conscience ‘‘refer for’’ also comports with facts, if the nurse refuses to answer, the alongside the principles of informed dictionary definitions of the word Department would not treat any consent. The Department does not ‘‘refer,’’ such as the Merriam-Webster’s resultant adverse action by the employer believe that enforcement of conscience definition of ‘‘to send or direct for against the nurse as ‘‘discrimination’’ protections, many of which date to the treatment, aid, information, or under the rule. era of Roe v. Wade and Doe v. Bolton, decision.’’ Refer, Merriam-Webster.com, These significant changes to the rule’s violates or undermines the principles of available at https://www.merriam- definition of discrimination respect the informed consent. This final rule will webster.com/dictionary/refer (last laws provided by Congress and the not change existing laws requiring accessed April 9, 2019) (emphasis interests of all parties—employers, doctors to secure informed consent from added); see also Refer, Dictionary.com, health care entities, and individual patients before performing medical available at https:// physicians—who wish to provide procedures. www.dictionary.com/browse/refer (last services allowed by law according to Comment: The Department received accessed April 9, 2019) (defining refer their consciences. comments stating that the proposed as ‘‘to direct for information or anything Additionally, the Department agrees definition of ‘‘referral or refer for’’ required’’ and ‘‘to hand over or submit that some proposed terms in the conflicts with Title X of the Public for information, consideration, decision, definition of refer or referral were Health Service Act. etc.’’). unnecessarily broad, and therefore the Response: As discussed above, the This interpretation properly serves Department finalizes the definition with Department concluded in 2008 and the remedial purposes of these narrowing edits as set forth in response again in the preamble to the proposed protections. Recent attempts at coerced to comments regarding specific phrases rule in this rulemaking that the 2000 referrals for abortion, such as discussed below. Regulations governing the Title X California’s Reproductive FACT Act, Comment: The Department received program, which required Title X have taken the form of compelled comments stating that the proposed projects and providers to provide display of information discussing the definition of ‘‘referral or refer for’’ abortion counseling, information and availability of State-subsidized would interfere with legal and ethical referrals in certain circumstances, abortions. The purpose, design, and duties of doctors to provide information conflict with certain Federal conscience effect of such displays of information is to their patients. and anti-discrimination laws. Notably, precisely to assist patients in obtaining Response: The Department disagrees. that requirement was imposed by the abortions if they so choose. As The rules do not prohibit any doctor or Department, not by Congress in Title X discussed elsewhere in this rule, OCR health care entity from providing itself, which has long prohibited the use found that the FACT Act’s compelled information to their patients—or of Title X funds ‘‘in programs where display of such information to members referring for a medical service or abortion is a method of family of the public is a type of referring or treatment—if they feel they have a planning.’’ 42 U.S.C. 300a–6. The referral ‘‘for’’ abortion that Congress medical, legal, ethical, or other duty to Department has amended the Title X prohibited in the Weldon and Coats- do so. The rules simply enforce existing regulations to remove the requirements Snowe Amendments. laws that prevent doctors or other for abortion counseling, information, Nevertheless, the Department has protected entities from being forced to and referrals, while permitting the made significant modifications to the refer for abortions against their will or provision of nondirective counseling on, 2 S

E definition of ‘‘discrimination’’ that judgment. The rule’s definition of and information about, abortion. Under L U R

‘‘referral or refer for’’ ensures that the 2019 final rule governing the Title h t i

w Letter from Roger T. Severino, Dir., Dep’t of

doctors can use their own professional, X program, the Title X regulations no D Health & Human Serv’s. Office for Civil Rights, to O medical, and ethical judgment without longer conflict with Federal conscience R

P Xavier Becerra, Att’y. Gen., State of Cal. (Jan. 18, 2

8 2019), available at https://www.hhs.gov/sites/ being coerced by entities receiving and anti-discrimination laws or this 0 Q

L default/files/california-notice-of-violation.pdf. Federal funds to violate their moral or final rule. Regardless, as the Department G 3 K S D n o l l e

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recognized in the 2008 Rule, a Federal refusing to refer a woman for treatment rather than including the plans’ regulatory requirement that a Title X of ovarian cancer because sterilization employees, exempting administrative applicant, grantee, program, or clinic— would be a ‘‘possible outcome of the tasks performed by a health plan’s a recipient of Federal funds in carrying referral.’’ employees, or limiting the definition of out a HHS program—provide abortion Response: The Department agrees that ‘‘referral or refer for’’ to not include counseling, information, and referrals ‘‘possible outcome of the referral’’ is health plans or their employees. cannot be enforced against such entities unnecessarily broad. The Department is Response: The Department replaced whose refusal to do so is protected by therefore changing the word ‘‘possible’’ paragraph (4) to the definition of applicable Federal conscience and to ‘‘reasonably foreseeable,’’ which still ‘‘discriminate or discrimination’’ to related nondiscrimination statutes. recognizes robust protection to make clear that employers can use, and Comment: The Department received conscientious objectors as provided by are encouraged to pursue, comments stating that including ‘‘the Congress, but requires a stronger accommodation procedures with provision of any information . . . by connection between the referral and the protected employees. Additionally, the any method’’ in the definition ‘‘referral’’ objected-to activity or result. The Department added paragraphs (5) and or ‘‘refer for’’ goes beyond the meaning Department also finalizes the definition (6) to the definition of discrimination to of those words in the statutes. with a change to eliminate subjective clarify that, within limits, employers Response: The definition’s breadth language concerning what an entity may require protected employees to reflects the fact that conscientious ‘‘sincerely understands’’ out of similar inform them of objections to referring objections to, or the nonperformance of, concerns about overbreadth. for, participating in, or assisting in the acts that facilitate the conduct of a third Comment: The Department received a performance of specific procedures, party may take many forms and occur in comment suggesting that ‘‘referral or programs, research, counseling, or many contexts. Nevertheless, the refer for’’ should be defined as ‘‘active treatments to the extent there is a Department agrees that the phrases ‘‘any facilitation of access.’’ reasonable likelihood that the information’’ and ‘‘any method’’ as well Response: The Department disagrees protected entity or member may be and believes such a definition would as ‘‘any assistance’’ are unnecessarily asked in good faith to refer for, risk improperly narrowing the broad, and therefore deletes the three participate in, or assist in the protections provided by Congress. For appearances of the word ‘‘any’’ from the performance of such conduct. example, California’s Reproductive definition. The rule instead relies on the Consistent with the terms of FACT Act (which the Supreme Court non-exhaustive list of illustrations to paragraphs (5) and (6) of the definition ruled in NIFLA likely violates the guide the scope of the definition. of discrimination regarding advance Constitution, 138 S. Ct. at 2371–76), Additionally, the rule permits the notice by an employee of the potential description of specific methods of involved a requirement that health care for a conscientious objection, an transmitting information, namely, ‘‘any facilities opposed to abortion tell employer may similarly require an method (including but not limited to women that the State may provide free employee to notify them in a timely notices, books, disclaimers or or low cost abortion, and provide the manner of an actual conscientious pamphlets, online or in print),’’ and women a phone number for further objection that the employee has to a replaces the list with the clearer and information on how to access those specific act, in the day-to-day course of more concise statement of ‘‘in oral, abortions. After investigating work, that the employee would written, or electronic form.’’ complaints related to the FACT Act, the Comment: The Department received Department found that mandating the otherwise be expected to perform. comments stating that the proposed communication of such information to For example, nurses assigned exclusively to definition of ‘‘referral or refer for’’ could members of the public is a type of nursing homes for elderly patients would not be permit a provider to turn away a patient referring or referral ‘‘for’’ abortion that expected to refer or assist in the performance of any experiencing complications from an Congress prohibited in conscience sterilization procedures or abortions, and thus, it objected-to medical drug, device, or protection statutes. Narrowing the would be inappropriate for an entity subject to the prohibitions in this rule to require such nurses to service without providing any definition to the ‘‘active facilitation of disclose whether or not they have any objections to information. access’’ may subject many health care referring or assisting in such procedures. Response: To the extent the comments providers to coercive requirements that The Department notes material legal and concern providers that decline to the Department has already found factual distinctions between, on the one hand, an volunteer certain information or make violate the law. The definition finalized employer requiring an employee to notify it of a conscientious objection covered by this rule and, on referrals to other providers, the here better includes the full range of the other, the accommodation process for religious applicability of the rule would turn on referral activities protected by Congress. employers in the Department’s previous regulations the individual facts and circumstances Comment: The Department received mandating employer coverage of contraception and of each case. In making a determination, comments stating that the definition of sterilization. 80 FR 41318 (July 14, 2015). ‘‘referral or refer for,’’ when applied to Numerous religious organizations brought the Department will consider the challenges under RFRA concerning the relationship between the treatment employees of health plans, could hinder ‘‘accommodation’’ process promulgated under those subject to a referral request and the people who are attempting to determine rules. RFRA prevents the Federal Government from underlying service or procedure giving what services are covered by their substantially burdening a person’s religious insurance plans and what doctors are in exercise unless in furtherance of a compelling rise to the request. The Department, governmental interest and in the manner least however, is not aware of any providers their plans or could be used to not restrictive of that exercise. Under the that would refuse to treat or refer a process claims for objected-to services accommodation, objecting religious organizations person with unforeseen and unintended under a health plan. The comments that self-insured would have been required to notify complications arising from, for example, suggested limiting conscience either the third-party administrator of their health 2 plan, via a certain prescribed form, or HHS, via a S

E protections to health plans themselves

L an abortion procedure that the provider letter containing certain prescribed information, of U R would not perform. their objection to including contraception and h t i sterilization in their health plans. Plaintiffs in those

w Letter from Roger T. Severino, Dir., Dep’t of

Comment: The Department received D Health & Human Serv’s. Office for Civil Rights, to cases argued that providing such notice would itself O comments stating that the proposed R have violated their religious beliefs. But a crucial

P Xavier Becerra, Att’y. Gen., State of Cal. (Jan. 18, 2

8 definition of ‘‘referral or refer for’’ could 2019), available at https://www.hhs.gov/sites/ element of the plaintiffs’ argument in the context 0 Q

L result in a health care professional default/files/california-notice-of-violation.pdf. Continued G 3 K S D n o l l e

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Employers and programs that Comment: The Department received have implemented policies to prohibit subsequently take steps to use alternate comments stating that the proposed foreign assistance for family planning to staff or methods to provide for or further definition of ‘‘referral or refer for,’’ go to entities that perform or actively the objected-to conduct would not be because it applies to public notices, promote abortion as a method of family considered to engage in would prohibit California’s planning, and Congress has been aware discrimination—nor would the Reproductive FACT Act, ‘‘which of those policies. Furthermore, the requirement for the objecting entity to requires facilities specializing in DeConcini Amendment’s discussion of a provide notice to the employer or pregnancy-related care to disseminate broad range of family planning methods program be considered a referral—if the notices to all clients about the and services is nearly identical to the employer or program does not take any availability of public programs that scope of the Title X statute, 42 U.S.C. adverse action against the objecting provide free or subsidized family 300. In that context, Congress made person or entity, if such methods do not planning services, including prenatal clear that it does not consider abortion exclude persons from fields of practice care and abortion.’’ to be a method of family planning and, on the basis of their protected Response: As discussed above, the in fact, prohibits the use of Federal objections, and if the employer or Department has already found that the funds in programs where abortion is a program does not require any additional FACT Act violated the Weldon and method of family planning. See 42 action by the objecting person or entity Coats-Snowe Amendments, and the U.S.C. 300–6. beyond the provision of notice Supreme Court, in NIFLA, 138 S. Ct. at Comment: The Department received discussed above. The employer may 2371–76, ruled that it likely violates the comments stating that the definition of also inform the public of the availability First Amendment’s free speech ‘‘referral or refer for’’ could permit a of alternate staff or methods to provide protections for targeting pro-life health health care provider to refuse to ever or further the objected-to conduct if it care entities and compelling them to refer a patient to an OB/ GYN for any does not constitute taking any adverse provide information about how to reason because a future possible action against the objecting person or obtain abortions. outcome of such a referral could be that entity. Comment: The Department received the patient seeks an abortion or The Department believes that comments stating that the proposed sterilization from the OB/ GYN, even incorporating these significant definition of ‘‘referral or refer for’’ though the direct referral is not for such limitations to the scope of conflicts with the DeConcini service. discrimination and, thus, addressing Amendment, which states, ‘‘[I]n order to Response: The commenters’ concerns issues that may arise for an employer reduce reliance on abortion in seem far-fetched, but are, nevertheless, when a health care entity objects to developing nations, funds [to carry out addressed by the change from the word making a referral, solves concerns such the provisions of chapters 1 and 10 of ‘‘possible outcome’’ to ‘‘reasonably as those raised by this comment. part I of the Foreign Assistance Act of foreseeable outcome,’’ which requires a 1961] shall be available only to stronger connection between the referral of self-insured plans was that the notice, via either voluntary family planning projects and the objected-to conduct. The method, was a prerequisite without which the which offer, either directly or through Department does not find there to be plan’s third-party administrator would lack legal referral to, or information about access authority to deliver the objected-to coverage. ‘‘If a reason to foresee that objectors would self-insured religious organization uses Form 700, to, a broad range of family planning use the Weldon or Coats-Snowe the form becomes ‘an instrument under which the methods and services’’ (Consolidated Amendments or these rules to refuse to plan is operated [and is] treated as a designation of Appropriations Act, 2019, Public Law refer women to every OB/ GYN. the [third-party administrator] as the plan 116–6, Div. F, sec. 7018). administrator under section 3(16) of ERISA[, 29 Summary of Regulatory Changes: For U.S.C. 1002(33),] for any contraceptive services Response: The Department disagrees. the reasons described in the proposed required to be covered. 29 CFR 2510.3–16(b). Form The DeConcini Amendment’s reference rule and above, and considering the 700 authorizes the [third-party administrator] to to ‘‘a broad range of family planning ‘provide or arrange payments for contraceptive comments received, the Department methods and services’’ does not include finalizes the definition of ‘‘referral or services . . . 29 CFR 2590.715–2713A(b)(2) . . . If abortion. Rather, the amendment itself the self-insured religious organization instead self- refer for’’ with changes as described certifies by HHS Notice, DOL’s ensuing notification contrasts abortion with that broad range above. The comments lead the to the [third-party administrator] also operates to of family planning methods and services ‘designate’ the [third-party administrator] ‘as plan Department to believe the text as and excludes abortion as a method of originally proposed was unduly long, administrator’ under ERISA for contraceptive family planning. Another proviso bars benefits. 79 FR at 51095; see also 29 CFR 2510.3– confusing, and repetitive and therefore the use of ‘‘funds made available under 16(b).’’ Sharpe Holdings v. U.S. Dept. of Health & finalizes the definition with numerous Human Services, 801 F.3d 927, 935 (8th Cir. 2015). this Act . . . to pay for the performance stylistic changes and deletions and The provision of notice triggered coverage of the of abortion as a method of family nonsubstantive reordering of text to objected-to contraceptives by the religious planning or to motivate or coerce any employer’s third party administrator, thus—in the substantially improve readability. The person to practice abortions’’ and ‘‘[t]hat eyes of the objecting religious employers—making Department also finalizes the rule to nothing in this paragraph shall be them complicit in a grave wrong. clarify that assistance related to a The provision of notice by an employee to her construed to alter any existing statutory ‘‘program’’ is also encompassed by the employer differs from the accommodation’s notice prohibitions against abortion under requirement in key respects. First, absent unusual definition in order to track the use of circumstances, burdens placed by a private section 104 of the Foreign Assistance Act of 1961.’’ The Department believes that phrase in statutes, including the employer on an employee’s religious exercise Weldon and Coats-Snowe Amendments, would not be subject to the stringent demands of the best reading of that amendment is RFRA. Second, under the accommodation, the that the broad range of family planning U.S. Policy Statement for the International third-party administrator of an objecting employer’s methods and services is viewed as an 2 self-insured plan would have had no legal Conference on Population, 10 Population & Dev. S

E alternative to abortion, not that the L obligation to provide the objected-to coverage Rev. 574, 578 (1984) (reproducing the Policy U

R Statement of the United States of America at the absent the employer’s provision of notice, but if amendment mandates referrals for h t i under this rule an objecting employee refuses to United Nations International Conference on w

abortion as if they are part of family

D provide her employer with notice of her objection, Population, also known as the Mexico City Policy). O planning. In the context of foreign R her employer would nevertheless retain its 83 FR 3880, 3894–95 (stating the reasons for the P 2

8 authority and ability to provide the objected-to assistance, since the 1980s, four proposed definition of ‘‘referral or refer for,’’ except 0 Q

L service without the employee’s involvement. different presidential administrations for the modifications adopted herein). G 3 K S D n o l l e

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that protect against forced referrals in of Federal financial assistance. The Workforce. The Department proposed certain programs. The revised definition commenter proposes that ‘‘sub- that workforce means employees, includes the provision of information in recipient’’ should be limited ‘‘to those volunteers, trainees, contractors, and oral, written, or electronic form for whom there is a direct pass-through other persons whose conduct, in the (including names, addresses, phone of Federal financial assistance and who performance of work for an entity or numbers, email or web addresses, are identified as sub-recipients of such health care entity, is under the direct directions, instructions, descriptions, or dollars in contracts with the direct control of such entity or health care other information resources), where the recipient.’’ entity, whether or not they are paid by purpose or reasonably foreseeable Response: The Department agrees that the entity or health care entity, as well outcome of provision of the information the definition should be clarified so that as health care providers holding is to assist a person in receiving funding it does not include every entity that privileges with the entity or health care or financing for, training in, obtaining, contracts with a recipient of Federal entity. The Department received or performing a particular health care financial assistance. The Department, comments on this definition. service, program, activity, or procedure. therefore, finalizes this definition with a Comment: The Department received State. The Department proposed that change to the definition of ‘‘sub- comments stating that the inclusion of ‘‘State includes, in addition to the recipient’’ replacing the phrase ‘‘to volunteers, trainees, and contractors several States, the District of Columbia. whom Federal financial assistance is within the definition of ‘‘workforce’’ is For those provisions related to or extended through a recipient or another too broad. relying upon the Public Health Service sub-recipient,’’ with ‘‘to whom there is Response: The Department does not Act, the term ‘State’ includes the several a pass-through of Federal financial agree. Under the revised rule text States, the District of Columbia, the assistance through a recipient or another adopted in this final rule, the defined Commonwealth of Puerto Rico, Guam, sub-recipient.’’ The Department term ‘‘workforce’’ is used in a limited the Northern Mariana Islands, the U.S. disagrees, however, that a sub-recipient number of places and for limited Virgin Islands, American Samoa, and must be explicitly declared as a sub- purposes related to voluntary notice the Trust Territory of the Pacific Islands. recipient in a contract (or a grant). provisions in this rule. Limiting For those provisions related to or Requiring explicit designation as a sub- ‘‘workforce’’ to employees fails to relying upon the Social Security Act, recipient could permit sub-recipients in acknowledge the complexity of the such as Medicaid or the Children’s fact to avoid such designation by health care system. The Department Health Insurance Program, the term contracting around such designation. adapted the proposed definition from ‘State’ follows the definition of, State, As discussed concerning the term the definition of ‘‘workforce’’ in the found at 42 U.S.C. 1301.’’ The regulations implementing the HIPAA Department did not receive comments ‘‘entity,’’ the Department is finalizing the terms ‘‘entity,’’ ‘‘recipient,’’ and administrative simplification on this definition. provisions, including the HIPAA Summary of Regulatory Changes: For ‘‘sub-recipient’’ with parallel language Privacy Rule. See 45 CFR 160.103 the reasons described in the proposed to clarify that they all may encompass (definition of ‘‘workforce’’). That rule and above, the Department ‘‘a foreign government, foreign definition has worked well to ensure, adopts the definition of ‘‘State’’ with nongovernmental organization, or among other things, the protection of one change, omitting ‘‘follows’’ and intergovernmental organization (such as the privacy and security of protected replacing it with ‘‘shall be defined in the United Nations or its affiliated accordance with.’’ agencies).’’ health information. Just as is the case with the HIPAA Rules, compliance with Sub-recipient. The Department Summary of Regulatory Changes: For Federal conscience and anti- proposed that sub-recipient means any the reasons described in the proposed discrimination laws would not be State, political subdivision of any State, rule and above, and considering the appropriately comprehensive if only the instrumentality of any State or political comments received, the Department employees of covered entities were subdivision thereof, and any person or finalizes the definition of ‘‘sub- protected, or if institutional entities any public or private agency, recipient’’ changing ‘‘and’’ to ‘‘or,’’ chose to avoid providing notice to institution, organization, or other entity replacing the phrase ‘‘to whom Federal contractors, volunteers, and trainees. in any State including any successor, financial assistance is extended through The Department received a assign, or transferee thereof, to whom a recipient or another sub-recipient, or Comment: Federal financial assistance is extended who otherwise receives Federal funds comment suggesting that volunteers and through a recipient or another sub- from the Department or a component of contractors be included in the definition of ‘‘workforce’’ only if they are recipient, or who otherwise receives the Department indirectly through a Federal funds from the Department or a recipient or another sub-recipient’’ with performing or assisting in the component of the Department indirectly ‘‘to whom there is a pass-through of performance of health care activities. through a recipient or another sub- Federal financial assistance or Federal Response: The Department disagrees. recipient, but such term does not funds from the Department through a As stated above, the defined term include any ultimate beneficiary. The recipient or another sub-recipient,’’ and ‘‘workforce’’ is used in only a limited term may include foreign or to change the last sentence previously number of places and for limited international organizations (such as referring to ‘‘foreign or international purposes under the rule. Generally, the agencies of the United Nations). The organizations’’ to read, ‘‘The term may statutes enforced under these rules Department received comments on this include a foreign government, foreign apply to health care activities and definition. nongovernmental organization, or entities, but where they do not, the Comment: The Department received a terms of the statute govern. 2 intergovernmental organization (such as S

E Summary of Regulatory Changes: For L comment stating that the proposed the United Nations or its affiliated U R definition of ‘‘sub-recipient’’ is overly the reasons described in the proposed h agencies).’’ t i w rule and above, and considering the broad and could be read to include D

O comments received, the Department R every contracting party with a recipient 83 FR 3880, 3895 (stating the reasons for the P 2

8 proposed definition of ‘‘sub-recipient,’’ except for 0 Q

L 83 FR 3880, 3895. the modifications adopted herein). 83 FR 3880, 3895. G 3 K S D n o l l e

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adopts the definition of ‘‘workforce’’ as or to the Department’s enforcement of Regarding the breadth and accuracy of proposed. them. § 88.3 overall, however, the Department Comment: The Department received finalizes the paragraph with changes to Applicable Requirements and comments stating that the proposed rule more accurately reflect the statutory Prohibitions (§ 88.3) only protects health care providers who text. With respect to § 88.3(a)(2)(v), The Department proposed a statute- hold moral or religious convictions however, the Department agrees that the by-statute recapitulation of the against the provision of abortion or proposed rule was imprecise in omitting substantive provisions of each statute sterilization, but provides no protection one limiting phrase that Congress had that is the subject of this rule, and of the for health care providers whose moral or included in paragraph (c)(2) of the applicability and scope of requirements religious convictions motivate them to Church Amendments. The proposed and prohibitions of each such statute. provide abortions or sterilizations. rule ended § 88.3(a)(2)(v) with, ‘‘because The proposed ‘‘Applicability’’ Response: To the extent the of his or her religious beliefs or moral provisions outlined the specific commenters’ concerns reflect an convictions,’’ while the statute reads, requirements of the Federal conscience accurate reading of the Church ‘‘because of his religious beliefs or and anti-discrimination laws that apply Amendments, these concerns raised by moral convictions respecting any such to various persons and entities. These the commenters are a result of choices service or activity.’’ The Department provisions were taken from the relevant Congress itself made. This final rule finalizes this paragraph to add the statutory language and would direct reasonably interprets the protections phrase ‘‘respecting any such service or covered entities to the appropriate that Congress established, but it can activity’’ that Congress included in this sections that contain the relevant neither eliminate nor transform the part of the statute. requirements that form the basis of this policy judgments embedded in the text Comment: The Department received a regulation. of the Church Amendments or of any comment stating that the rule should The ‘‘Requirements and Prohibitions’’ other applicable law. To the extent the clarify that the protections provided by provisions explained the obligations Church Amendments apply because Congress under 42 U.S.C. 300a–7(b) and that the Federal conscience and anti- someone performed or assisted in the (c) apply only to abortions and discrimination laws impose on the performance of a lawful sterilization sterilizations in the circumstances Department and on entities that receive procedure or abortion, this rule would provided for in the statute. applicable Federal financial assistance enforce those provisions to the extent Response: Paragraphs (b) and (c)(1) of and other Federal funding from the consistent with other statutory and the Church Amendments specify that Department. These provisions were constitutional requirements. See, e.g., they apply in the context of abortion taken from the relevant statutory § 88.3(a)(2)(iv), (v), and (vii). and sterilization procedures language. The Department received Comment: The Department received specifically. Paragraph (c)(2) has a comments on this section. The comments stating that proposed responses to comments are provided broader reach, encompassing ‘‘any § 88.3(a)(2)(v) and (vi), which apply 42 lawful health service or research below following the proposed U.S.C. 300a–7(c)(2) and (d), are too applicability and requirements and activity.’’ As discussed in response to broad, and that 42 U.S.C. 300a–7(d) the similar comment asking that (c)(2) prohibitions provisions for each Federal should be or has been interpreted to conscience and anti-discrimination law. and (d) be interpreted to encompass provide protections only for only abortion and sterilizations, One conforming revision to the participation in abortion or sterilization proposed rule that the Department has Congress limited paragraphs (b), (c)(1), procedures. and (e) to abortions and sterilizations, made throughout the ‘‘Requirements Response: The Department disagrees and Prohibitions’’ provisions is to but used different language in that these paragraphs should be limited paragraphs (c)(2) and (d). The rule remove § 88.5 of 45 CFR part 88 to situations involving abortion and (provision of notice) from the list of tracks the text of paragraphs (b) and sterilization. Paragraphs (b), (c)(1), and (c)(1) accordingly, as established by sections with which applicable persons (e) of the Church Amendments clearly and entities must comply. As described Congress. Paragraphs (a)(2)(i) through specify they apply concerning abortions (iv) and (vii) in § 88.3 of the rule in the section-by-section analysis for or sterilizations. But paragraphs (c)(2) § 88.5 of this rule, the provision of a explicitly relate to abortions or and (d) do not use that language; sterilizations, while § 88.3(a)(2)(v) notice of rights of Federal conscience instead, as Congress specified, they and anti-discrimination laws is no through (vi) relate to any lawful health encompass ‘‘any lawful health service or service or research activity. longer a requirement for the Department research activity’’ or ‘‘any part of a and recipients. health service program or research Another conforming revision to the Church Amendments. It excuses individuals activity,’’ respectively. The Department engaged in health care or research from any proposed rule that the Department has is required to implement the statutes as obligation to perform abortions or other procedures made throughout the ‘‘Requirements written by Congress. Reading which may violate religious beliefs or moral convictions.’’ (emphasis added)); and Prohibitions’’ provisions is to paragraphs (c)(2) and (d) to address only Franciscan modify the phrase ‘‘entities to whom’’ Alliance, Inc. v. Burwell, 227 F. Supp. 3d 660, 683 abortion and sterilization procedures (Dec. 31, 2016) (‘‘The Church Amendment forbids various paragraphs apply ’’ to ‘‘entities would narrow the scope of those requiring any individual ‘to perform or assist in the to which.’’ The Department believes the statutory provisions in contravention of performance of any part of a health service program word ‘‘which’’ avoids confusion the clear text of the statute. . . . if his performance or assistance in the regarding the nature and scope of performance of such part of such program . . . Furthermore, court opinions would be contrary to his religious beliefs or moral entities to whom the rule applies. interpreting 42 U.S.C. 300a–7(d) have convictions.’ ’’ (alterations)). 88.3(a). The Church Amendments. 2 Paragraph 88.3(a)(2)(i) implements

S varied in their interpretations, but

E The Department received comments

L subparagraph (b)(1) of the Church Amendments;

U recognize that it applies to more than

R paragraphs 88.3(a)(2)(ii) and (iii) implement generally supportive of the Church h t i abortion or sterilization procedures. paragraph (b)(2) of the Church Amendments; and w

Amendments and supportive of the

D paragraph 88.3(a)(2)(iv) implements paragraph O inclusion of the Church Amendments in R See, e.g., Vt. Alliance for Ethical Healthcare, (c)(1) of the Church Amendments. P 2

8 the rule, as well as comments opposed Inc. v. Hoser, 274 F. Supp. 3d 227, 232 (D. Vt. 2017) Paragraph 88.3(a)(2)(v) implements 0 Q

L to the Church Amendments themselves (‘‘Section 300a–7(d) is one of several so-called subparagraph (c)(2) of the Church Amendment. G 3 K S D n o l l e

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Comment: The Department received Church Amendments were too broad or Secretary of Health and Human comments asking for clarification did not faithfully apply the statutory Services.’’ The Department finalizes whether the provisions in § 88.3(a) that text. § 88.3(a)(2)(ii) and (iii) by changing the relate to sterilization include only Response: The Department intended word ‘‘entity’’ to ‘‘recipient’’ where intentional sterilizations, or whether § 88.3 to faithfully apply the text of applicable, in order to avoid confusion they also include procedures or services applicable statutes, including the potentially created by the use of the that have sterilization as a side effect, Church Amendments. As a result of word ‘‘entity’’ to refer both to protected such as hysterectomies performed for comments, the Department became entities and entities obligated to comply reasons other than sterilization, or aware of instances in which the with 88.3(a). Additionally, in chemotherapy. proposed rule text did not accurately § 88.3(a)(2)(i) through (vii), concerning Response: Congress did not provide a reflect the content of the statute. paragraphs and paragraphs of the definition of sterilization in the Church Accordingly, the Department finalizes Church Amendments, the Department Amendments, or further specify the the rule with changes to more accurately finalizes paragraphs (a)(2)(i) through scope of objections under those statutes, reflect the statute. Specifically, in (vii) by changing the language of each but provided broad protections for § 88.3(a)(2)(ii) and (iii), concerning paragraph to adopt the statutory text as religious and moral objections to paragraphs (b)(2)(A) and (B) of the closely as possible in relevant part, sterilization procedures. Generally Church Amendments, the Department including by adding the words speaking, the Department understands finalizes the rule by changing the phrase ‘‘respecting any such service or activity’’ the term ‘‘sterilization’’ as used in the ‘‘entities to whom this paragraph . . . to the end of § 88.3(a)(2)(v); amending Church Amendments to encompass the applies shall not require any entity § 88.3(a)(2)(i) to clarify that the statute ordinary meaning of that term, and does funded under the Public Health Service enforces a rule of construction regarding not understand the term to include Act’’ to ‘‘the receipt of a grant, contract, the receipt of certain Federal financial treatment of a physical disease where loan, or loan guarantee under the Public assistance; by rephrasing the sterilization is an unintended side effect Health Service Act by any entity does requirements to state that the receipt of of the treatment, such as chemotherapy not authorize entities to which this relevant funds ‘‘does not authorize to treat uterine cancer or testicular paragraph . . . applies to require such entities to which this paragraph [ ] cancer. To the extent that a Church entity to . . . .’’ applies to require’’ practices specified Amendment complaint with respect to The Department also finalizes by 42 U.S.C. 300a–7(b); adding in the sterilization is filed, the Department § 88.3(a)(1)(vi) by changing ‘‘Any entity parenthetical from the statute, would examine the facts and that carries out’’ to ‘‘Any entity that ‘‘(including applicants for internships circumstances of each such claim to receives funds for any health service and residencies)’’, to § 88.3(a)(2)(vii); determine whether an act falls within program or research activity under any and replacing short form descriptions of the scope of the statute and these program administered by the Secretary the statutory text with the full statutory regulations. of Health and Human Services.’’ The text, such as by changing the words Comment: The Department received Department makes this change to ‘‘doing so’’ in § 88.3(a)(2)(v) to ‘‘his comments asking for clarification about provide clarity regarding which entities performance or assistance in the whether provisions in § 88.3(a) apply to are required to comply with paragraph performance of such service or activity.’’ sterilizations performed in the context (d) of the Church Amendments. The Department also eliminates some of gender dysphoria. Comment: The Department received a articles and terms, like ‘‘the’’ and ‘‘or Response: The Department is aware of comment stating that the rule should her,’’ and replaces the term ‘‘whom’’ three cases brought at least in part under clarify that the protections provided by with the term ‘‘which’’ for readability the Church Amendments, in which the Congress under 42 U.S.C. 300a–7(d) and accuracy. claimants argued that the Church apply only to individuals. 88.3(b). Coats-Snowe Amendment. Amendments’ sterilization provisions Response: The rule tracks the The Department received comments protect the claimants’ conscientious statutory language. Namely, generally supportive of the Coats-Snowe objections to performing gender § 88.3(a)(2)(vi) states that covered Amendment and supportive of the dysphoria related surgery. In one case, entities ‘‘shall not require any inclusion of the Coats-Snowe Franciscan Alliance, Inc. v. Burwell, 227 individual . . . ’’ (emphasis added) to Amendment in the rule, as well as F. Supp. 3d 660 (Dec. 31, 2016), act contrary to their religious beliefs or comments opposed to the Coats-Snowe enforcement of the challenged moral convictions in the performance of Amendment or the rule’s regulation, which plaintiffs contended certain health service programs or implementation of that statute. would have required the performance of research activities. The Department Comment: The Department received procedures such as hysterectomies to maintains such language in this final comments on the definition of terms treat gender dysphoria, was rule. used by the Coats-Snowe Amendment, preliminarily enjoined on other Summary of Regulatory Changes: For such as what constitutes a ‘‘health care grounds. In the other two, consolidated the reasons described in the proposed entity.’’ All such comments are as Religious Sisters of Mercy, et al., v. rule and above, and considering the addressed in the responses to comments Burwell, No. 3:16–cv–386 (D.N.D. 2017), comments received, the Department on definitions under § 88.2. which challenged the same regulation, makes certain changes in this paragraph Comment: The Department received a comment stating that the Coats-Snowe the court issued an order staying in this final rule. The Department enforcement of the regulation in light of finalizes § 88.3(a)(1)(vi) by changing Amendment was only a ‘‘narrow the nationwide preliminary injunction ‘‘Any entity that carries out’’ to ‘‘Any response to a specific problem’’— issued in In the correcting a loophole that could have 2 Franciscan Alliance.

S entity that receives funds for any health

E conditioned Federal financial assistance L event the Department receives any such

U service program or research activity R complaints, the Department will on the provision of abortions indirectly h t i under any program administered by the w consider them on a case-by-case basis. through the Accrediting Council on D

O Comment: The Department received Graduate Medical Education’s R 83 FR 3880, 3895 (stating the reasons for the P 2

8 comments contending that the proposed § 88.3(a), except for the modifications accreditation standards for obstetrics 0 Q

L paragraphs of the rule concerning the adopted herein). and gynecology graduate programs—not G 3 K S D n o l l e

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a pronouncement of new national policy the protected party acts or refuses to act response to comments, the Department and ‘‘cannot justify the rulemaking on the basis of religious beliefs or moral has included language at the end of authority the Department claims in the convictions specifically (as distinct from § 88.3(b)(2)(ii) reflecting this relevant NPRM.’’ other reasons), it explicitly includes statutory text. Response: The Department disagrees. such a limitation. The text of the Coats- Summary of Regulatory Changes: For While the Coats-Snowe Amendment Snowe Amendment, unlike the text of the reasons described in the proposed may have been motivated by the the Church Amendments, does not rule and above, and considering the situation involving the Accrediting include any such limitation. It comments received, the Department Council on Graduate Medical encompasses objections concerning finalizes § 88.3(b) with the following Education’s accreditation standards for such activities as training, performing, changes. obstetrics and gynecology graduate providing referrals for, or making Further consideration led the medical education programs and arrangements for referrals for abortions Department to determine that the standards for the receipt of Federal or abortion training, without specifying proposed text of § 88.3(b)(1)(i) presented financial assistance based on that the objections are only protected if concerns regarding the scope of entities accreditation, the plain language of the they are based on religious beliefs or to which the proposed § 88.3(b) would text of the Coats-Snowe Amendment is moral convictions. Limiting the apply. Accordingly, the Department is broader than that situation. While application of the Coats-Snowe finalizing § 88.3(b)(1)(i) to read ‘‘The paragraph (b) of the Coats-Snowe Amendment to only situations in which Department is required to comply with’’ Amendment addresses the accreditation the protected entity is acting on the in lieu of the proposed rule’s statement and treatment of postgraduate physician basis of religious beliefs or moral that ‘‘The Federal government, training programs (and physicians convictions would be to add narrowing including the Department, is required to trained in such programs) that are or are language to the Coats-Snowe comply with.’’ not accredited by accrediting agencies Amendment that Congress did not that require the performance and include. The Department removes references to training in the performance of induced Comment: The Department received a ‘‘individual or institutional’’ in abortions, paragraph (a) of the Coats- comment stating that parts of proposed § 88.3(b)(2)(i), in order to avoid Snowe Amendment establishes far § 88.3 could affect the ability of confusion regarding the definition of the broader protections for health care independent institutions to set term ‘‘health care entity.’’ While the entities that refuse, among other things, standards for accreditation or licensure. Department makes this change, it is not to provide or undergo training in the Response: The Department agrees in intended to change the scope of performance of induced abortions, to part. As other commenters have noted, protection provided by the Coats-Snowe perform such abortions, or to provide one purpose leading to enactment of the Amendment (and this final rule)— referrals for such training or such Coats-Snowe Amendment was to namely, both individuals and abortions. The Amendment was, thus, prevent States from basing their organizations (or institutions) that drafted with separate language to accreditation or licensure decisions on constitute health care entities. The provide both general protections, grounds that eliminate medical schools Department also removes a reference to relating to the training, performance of, or their graduates from the medical ‘‘require attendees to’’ in (b)(2)(i)(C) in and referral for abortions, and specific profession on the basis that they refuse order to more accurately track the protections, relating to governmental to be involved in abortion. The Coats- language of the statute. The Department treatment of physicians and physician Snowe Amendment prevents States that finalizes § 88.3(b)(2)(ii) by changing ‘‘an training programs where the receive Federal financial assistance from accreditation standard or standards’’ to accreditation agency had accreditation engaging in discrimination that would, ‘‘accreditation standards’’ and changing standards that requires performance or for example, refuse accreditation to ‘‘such standard provides’’ to ‘‘such training in the performance of induced medical schools, or licensure to standards provide;’’ and adding ‘‘that abortion. physicians or nurses, because they did require an entity to’’ in order to more This rule must be governed by the text not provide training for, train on, or clearly articulate the requirements of the of the law, not legislative intent or perform, abortions. The Amendment statute. Finally, in order to fully legislative history that may or may not does not directly regulate any non- incorporate the text of the Coats-Snowe have been reflected in the text passed by governmental entity. The amendment, Amendment, the Department also adds Congress and signed by the President. however, would preclude a State from the sentence ‘‘Entities to which this The Department finds it appropriate for relying on a private entity’s refusal to paragraph (b)(2)(ii) applies and which this rule to follow the text of the Coats- accredit on the bases just described in are involved in such matters shall Snowe Amendment, and not to narrow order to, among other things, deny formulate such regulations or other its scope based on what may have been recognition to the medical school as a mechanisms, or enter into such the impetus for the introduction, medical school, or to deny recognition agreements with accrediting agencies, as passage or enactment of the statute. The of the medical degree of a graduate of are necessary to comply with this Department intends to provide that school. paragraph.’’ enforcement mechanisms for the The Department finalizes § 88.3 with Additionally, the Department removes protections that Congress actually other changes from the proposed rule to the Federal government from the enacted. include language from the statute as applicability section in § 88.3(b)(1)(i) Comment: The Department received follows. Specifically, the proposed rule but leaves ‘‘the Department.’’ Although comments stating that the Coats-Snowe did not reflect, as set forth in paragraph the relevant statutory provision applies Amendment only provides protections (b)(1) of the statute, that ‘‘the 2 to the Federal government, this rule S

E government involved,’’ meaning L for entities that object to abortions for concerns the activities and programs U R religious or moral reasons. Federal, State, or local, ‘‘shall formulate h funded or administered by the t i w

Response: The Department disagrees. such regulations or other mechanisms, D

O As the text of the Church Amendments or enter into such agreements with R 83 FR 3880, 3895 (stating the reasons for the P 2

8 makes clear, when Congress wants to accrediting agencies, as are necessary to proposed § 88.3(b), except for the modifications 0 Q

L limit a protection to situations in which comply with this subsection.’’ In adopted herein). G 3 K S D n o l l e

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Department rather than the entire Amendment as written. This was due to ‘‘Nothing in this Act shall be construed Federal Government. the inclusion of paragraph (c)(1)(iii) in to preempt or otherwise have any effect 88.3(c). Weldon Amendment. The that section, which required compliance on State laws regarding the prohibition Department received comments on this with the Weldon Amendment by ‘‘any of (or requirement of) coverage, funding, paragraph, including comments entity’’ that receives funds to which the or procedural requirements on generally supportive of the Weldon Weldon Amendment applies. This abortions.’’ Amendment and supportive of the paragraph would render superfluous Response: The Weldon Amendment is inclusion of the Weldon Amendment in paragraphs (c)(1)(i) and (ii), which not part of the Affordable Care Act. the proposed rule, as well as comments require compliance with the Weldon Therefore, 42 U.S.C. 18023(c)(1), which opposed to the Weldon Amendment Amendment by the Department and its states, ‘‘[n]othing in this Act’’ shall be itself or the proposed rule’s programs and by any State or local construed to have an effect on State implementation of the Amendment. government that receives funds to laws requiring abortion coverage, does Comment: The Department received which the Weldon Amendment applies. not apply to the Weldon Amendment. comments on the definition of terms The Department is therefore finalizing More importantly, ACA section 1303 used by the Weldon Amendment, such § 88.3(c)(1) by removing paragraph also provides that ‘‘[n]othing in this Act as what constitutes a ‘‘health care (c)(1)(iii). shall be construed to have any effect on entity.’’ All such comments are The Department notes, however, that Federal laws regarding—(i) conscience addressed above in the responses to the conduct and activities of contractors protection; (ii) willingness or refusal to comments on definitions under § 88.2. engaged by the Department, a provide abortion; and (iii) Comment: The Department received Departmental program, or a State or discrimination on the basis of the comments stating that the Weldon local government is attributable to such willingness or refusal to provide, pay Amendment does not provide authority Department, program, or government for for, cover, or refer for abortion or to for the Department to impose any purposes of enforcement or liability provide or participate in training to burdens or obligations on health care under the Weldon amendment. provide abortion.’’ 42 U.S.C. entities, such as the requirement of an Comment: The Department received 18023(c)(2). In addition, the Weldon assurance of compliance and the notice comments stating that the Department Amendment has been renewed more requirement. cannot engage in permanent rulemaking recently than Congress enacted the Response: Assurance requirements to based on an annual appropriations Affordable Care Act, and therefore is remedy past discrimination or prevent amendment that may or may not be generally owed deference if the two future discrimination are common reenacted with each appropriations act. laws did conflict, which they do not. regulatory features of anti- Response: The Department disagrees. Comment: The Department received discrimination laws like those that are The Department has outlined, above, the comments stating that the Weldon the subject of this rule and such authority that it relies upon to Amendment, as evidenced by its authority has been affirmed by the promulgate regulations containing the legislative history, does not apply to Supreme Court. See Grove City College substantive requirements established in refusals unrelated to conscience-based v. Bell, 465 U.S. 555 (1984) (affirming the Weldon Amendment. The (that is, religious or moral) objections, partial termination of institution’s Department further notes that it has such as purely financial or operational Federal funds for refusing to sign a Title promulgated rules based on the Weldon motives. IX assurance of compliance form). In Amendment in 2008 and 2011 and has Response: The Department disagrees, response to comments, the Department operated under such rules based in part for similar reasons described above in has revised the proposed notice on the annual appropriations response to comments arguing for a provisions from being a requirement to amendment cited. The Department has narrow interpretation of the Coats- being one factor that OCR considers in similarly issued regulations to Snowe Amendment. As the text of the its determinations as to whether a implement annual appropriations Church Amendments makes clear, when covered entity is in violation of this amendments, such as the Hyde Congress wants to limit a protection to part. Comments concerning assurance Amendment. Paragraphs (c)(1)(i) and situations in which the protected party and notice provisions are discussed in (ii) in § 88.3 of this rule specify that acts or refuses to act on the basis of more detail below in §§ 88.4 and 88.5, compliance is only effective ‘‘under an religious beliefs or moral convictions, it proposing to impose those provisions. appropriations act . . . that contains the explicitly includes such limitation in Comment: The Department received Weldon Amendment.’’ Therefore, the the text of the statute. The text of the comments stating that the proposed rule provisions of this rule enforcing the Weldon Amendment, unlike the text of impermissibly extends the Weldon Weldon Amendment will only be the Church Amendments, does not Amendment to apply to non- applicable to a State or local include any such limitation. On its face, governmental entities, and that the government that receives funds subject the Weldon Amendment encompasses a proposed rule disagrees with the to such appropriation. If Congress were decision by a health care entity not to position taken by the government in to substantially change or not renew the provide, pay for, provide coverage of, or National Family Planning and Weldon Amendment, the final rule refer for abortions, without specifying Reproductive Health Association v. would not apply to that extent. that such decisions must be based on Gonzales, 391 F. Supp. 2d 200 (D.D.C. Comment: The Department received religious, moral, conscientious, or any 2005), regarding whether the Weldon comments stating that the Weldon other particular motive. Limiting the Amendment extends to non- Amendment cannot be interpreted to application of the Weldon Amendment governmental entities through those prevent States from requiring abortion only to situations in which the health entities’ receipt of Federal financial coverage, because the Affordable Care care entity is acting on the basis of 2 S

E Act, at 42 U.S.C. 18023(c)(1), states,

L assistance. conscientious, moral or religious U R Response: The Department agrees convictions would be to refuse to apply h t i

w See, e.g., 42 CFR 441.202, 441.203, 441.206 that, as proposed, § 88.3 was worded to the Weldon Amendment according to D (prohibiting the use of Federal funds under O extend the Weldon Amendment to non- R the text enacted by Congress.

P Medicaid to pay for abortions except when 2

8 governmental entities in ways not continuation of the pregnancy would endanger the Comment: The Department received 0 Q

L encompassed by the text of the mother’s life). comments asking for clarification that G 3 K S D n o l l e

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the Weldon Amendment only applies 209. The Department did not receive any act violative of personally-held with respect to abortions. comments on this paragraph. The moral principles.’’ Similarly, in Doe Response: The Department agrees Department has updated the title of this the Court spoke favorably about with the commenter. The text of the paragraph for the most recent Georgia’s statutory language giving a proposed rule already makes clear that, appropriations rider for the current hospital the freedom not to admit a as stated in the text of the Weldon fiscal year. For clarity and accuracy, in patient for an abortion, and protecting a Amendment and as described in this paragraph (d)(1), the Department physician or other hospital employee rule, the Weldon Amendment only changed ‘‘under the Medicare ‘‘for moral or religious reasons’’ from protects against discrimination on the Advantage program’’ to read ‘‘with participating in an abortion basis that a health care entity does not respect to the Medicare Advantage procedure. The Department interprets provide, pay for, provide coverage of, or program,’’ and updated the citation section 1553 as specifically refer for abortions. therein. encompassing the decision by a health Comment: The Department received a Summary of Regulatory Changes: For care entity not to provide information comment stating that the proposed rule the reasons described in the proposed about, or referrals for, assisted would impermissibly extend the rule and above, the Department suicide. Weldon Amendment’s protection finalizes § 88.3(d) primarily as Comment: The Department received a beyond the abortion context to protect proposed, but updates the header and comment stating that, while Congress refusals to provide, pay for, provide citations in paragraph (d)(1) to reflect explicitly granted the Department the coverage of, or refer for ‘‘any lawful the citation for this appropriations ride authority to promulgate regulations to health service.’’ for FY 2019, and replaced ‘‘under,’’ and implement section 1557 of the ACA, Response: The Department disagrees. adds ‘‘informs the Secretary that it’’ for Congress did not provide such a grant Nothing in the proposed rule or in this clarity in paragraph (d)(2). for section 1553, but only gave the final rule extends protections under the 88.3(e). Section 1553 of the Affordable Department the authority to ‘‘receive Weldon Amendment outside of the Care Act, 42 U.S.C. 18113. The complaints of discrimination’’ under abortion context. As § 88.3(c)(2) states, Department received comments on this section 1553. ‘‘The entities to whom this paragraph paragraph, including comments Response: As discussed supra at part (c)(2) applies shall not subject any generally supportive of section 1553 of III.A, multiple statutes and regulations institutional or individual health care the Affordable Care Act and supportive authorize the Department to issue these entity to discrimination on the basis that of the inclusion of section 1553 in the rules—including with respect to ACA the health care entity does not provide, rule, as well as comments opposing that section 1553—to ensure that the pay for, provide coverage of, or refer for, section and the Department’s Department and covered entities comply abortion’’ (emphasis added). The enforcement of it. with Federal conscience and anti- regulatory provision in the proposed Comment: The Department received discrimination laws that apply to rule and in this final rule that makes comments stating that section 1553 certain Federal funding. With respect to reference to ‘‘any lawful health service’’ cannot allow a health care professional section 1553 specifically, that section addresses and would implement to omit information about ‘‘all choices’’ imposes specific provisions, including paragraph (c)(2) of the Church available at end-of-life because a patient construction provisions, and mandates Amendments, which prohibits certain has a right to be informed. that the Department’s Office for Civil discrimination against a physician or Response: The Department disagrees Rights implement section 1553 by other health care personnel because, with this comment. Congress specified receiving complaints. This rule follows among other things, ‘‘he performed or in section 1553 that a health care entity that language and provides assisted in the performance of any is protected in its decision not to Departmental mechanisms for acting lawful health service or research provide ‘‘any health care item or service upon complaints under section 1553. activity.’’ furnished for the purposes of causing, or Such authority is implicit in the Summary of Regulatory Changes: For for the purpose of assisting in causing’’ authority to receive complaints set forth the reasons described in the proposed assisted suicide, euthanasia, or mercy in 1553. If that were not the case, OCR rule and above, and considering the killing. The Department is unaware of would not be able to comply with comments received, the Department any Federal requirement that an Congress’s direction under section 1553 finalizes § 88.3(c) as proposed, except individual or health care entity provide to handle and respond to complaints it for changes to the citation to the most information about a service that it does receives, making the authority current Public Law where the Weldon not provide. Medical ethics have long designated to OCR in section 1553 mere Amendment may be found, and the protected rights of conscience alongside surplusage, hollow, or inoperative. removal of proposed paragraph the principles of informed consent. The The fact that section 1557 of the (c)(1)(iii). Additionally, the Department Department does not believe that Affordable Care Act specifically is adding the phrase ‘‘and its programs’’ enforcement of conscience protections, authorized, but did not require, the after ‘‘the Department’’ to track the many of which date to the era of Roe v. Department to issue regulations to statutory language more closely. Wade and Doe v. Bolton, violates or 88.3(d). Medicare Advantage, undermines the principles of informed 410 U.S. at 143–44. Department of Defense and Labor, consent. In fact, in Roe the Supreme 410 U.S. at 197–98. Health and Human Services, and Court favorably cited an American A referral is a health care service, and the Education Appropriations Act, 2019 Medical Association resolution on phrase ‘‘assisting in causing’’ is reasonably and Continuing Appropriations Act, abortion affirming ‘‘[t]hat no physician interpreted to carry the same meaning as ‘‘assisting in performing,’’ which the Department interprets to 2019, Public Law 115–245, Div. B, sec. or other professional personnel shall be 2 include the act of referring. S E

L compelled to perform any act which See Hibbs v. Winn, 542 U.S. 88, 101 (2004) U

R See 42 U.S.C. 300a–7(c)(2); compare 45 CFR violates his good medical judgment. (statutes should be construed so as to avoid h t i 88.3(a)(2)(v) (implementing Church (c)(2) with 45 rendering superfluous any statutory language; w

Neither physician, hospital, nor hospital D CFR 88.3(c) (implementing Weldon Amendment). ‘‘statute should be construed so that effect is given O

R 83 FR 3880, 3895 (stating the reasons for the personnel shall be required to perform to all its provisions, so that no part will be P 2

8 proposed § 88.3(c), except for the modifications inoperative or superfluous, void or insignificant. 0 Q

L adopted herein). 83 FR 3880, 3895. . . .’’). G 3 K S D n o l l e

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implement that section, does not negate section 1303(b)(1) and (b)(4) provide to coordinate with State Health Benefit the authority Congress provided the standalone conscience protections that Exchanges (State Exchanges) in the Secretary under 5 U.S.C. 301 and the are independent of other Federal implementing of the certification other statutory and regulatory conscience protection provisions. While requirements of 42 U.S.C. authorities cited supra at part III.A to the language used in section 1303(b)(1) 18031(d)(4)(H)(ii) where applicable. The carry out the duties Congress designated and (b)(4) is similar to other conscience Department works closely with State to OCR under section 1553 of the ACA. protection statutes, these provisions Exchanges to implement the Affordable In particular, as discussed above, provide independent conscience Care Act, and for clarity, the final rule section 1321(a) of the ACA authorizes protections both with respect to reflects that coordination. For similar the Department to ‘‘issue regulations governmental requirements of qualified reasons, the Department modified setting standards for meeting the health plans, and with respect to § 88.3(g)(2)(i) to reflect changes requirements under [title I of the ACA] qualified health plans’ discrimination Congress made to 26 U.S.C. 5000A with respect to . . . the offering of against individual health care providers through section 4003 of the SUPPORT qualified health plans through such and health care facilities. Additionally, for Patients and Communities Act, Exchanges . . . and . . . such other were other Federal conscience and anti- which became law October 24, 2018. requirements as the Secretary discrimination laws to be revoked, the Those changes retained a reference in 26 determines appropriate.’’ Section conscience protections in section U.S.C. 5000A to 26 U.S.C. 1402(g)(1), 1321(a), thus, provides the Department 1303(b)(1) and (b)(4) of the ACA could which sets out various conditions for with the authority to issue regulations remain in effect. The Department does eligibility for the conscience exemption setting setting standard for meeting the not presume that separate Federal from the individual responsibility requirements established in section conscience and anti-discrimination laws requirement. Among those conditions is 1553, which is part of title 1 of the ACA. enacted by Congress are redundant. It is a requirement that the religious sect or Summary of Regulatory Changes: For a principle of statutory construction that division thereof to which the applicant the reasons described in the proposed effect should be given to overlapping for the exemption belongs must have rule and above, and considering the statutes as long as there is no ‘‘positive been in existence at all times since comments received, the Department repugnance’’ between them. See, e.g., December 31, 1950. The Department has finalizes § 88.3(e) as proposed with Connecticut Nat’l Bank v. Germain, 503 omitted this particular requirement from minor technical changes for clarity and U.S. 249, 253 (1992). And there is no § 88.3(g)(2)(i) out of concern that it may adherence to the text of section 1553 of such positive repugnance here. conflict with the Establishment Clause. the ACA, for example changing ‘‘any Summary of Regulatory Changes: For The Department understands that amendment’’ to ‘‘an amendment’’ and the reasons described in the proposed Public Law 115–97 (December 22, 2017) clarifying that ‘‘the Act’’ refers to the rule and above, and considering the reduced the penalty in 26 U.S.C. 5000A ‘‘Patient Protection and Affordable Care comments received, the Department for a lack of minimum essential Act.’’ Paragraph (e)(1)(iv) clarifies that finalizes § 88.3(f) as proposed, with a coverage to zero dollars, and that the the amendment would have been ‘‘made technical correction to reflect that 42 implications of this law is the subject of by the Patient Protection and Affordable U.S.C. 18023(b)(1)(A) is a rule of substantial litigation. The Department, Care Act,’’ and paragraph (e)(2) deletes construction regarding Title I of the nevertheless, believes it is prudent to ‘‘provided, that.’’ Patient Protection and Affordable Care implement the certification requirements as proposed because we 88.3(f). Section 1303 of the Affordable Act, rather than a substantive understand the law still requires Care Act, 42 U.S.C. 18023. The prohibition. In paragraph (f)(2)(i), the individuals to submit proof of essential Department received comments on this Department clarifies that the entities coverage or be certified as exempt paragraph, including comments shall not ‘‘construe anything in Title I despite the penalty being zeroed out. generally supportive of section 1303 of of the Patient Protection and Affordable Summary of Regulatory Changes: For the Affordable Care Act and supportive Care Act (or any amendment made by the reasons described in the proposed of the inclusion of section 1303 in the Title I of the Patient Protection and rule and above, the Department rule, as well as comments critical of this Affordable Care Act) to.’’ finalizes § 88.3(g) as proposed, with proposed paragraph. 88.3(g). Section 1411 of the Affordable technical corrections to reflect that the Comment: The Department received a Care Act, 42 U.S.C. 18081. The individuals to whom the Department comment stating that the inclusion of Department did not receive comments grants certifications under 42 U.S.C. section 1303 of the ACA in this rule is on this paragraph. 18081 are individuals who have applied redundant, as the conscience The Department intended § 88.3 to for such certifications and to ensure the protections provided for in section 1303 faithfully apply the text of applicable language follows that of the statute, a are also provided by other conscience statutes, including section 1411 of the typographical correction to change the protection statutes, and by the Religious Affordable Care Act, while at the same reference to ‘‘5000A(2)(B)(ii)’’ to Freedom Restoration Act, 42 U.S.C. time, providing clarity to regulated ‘‘5000A(d)(2)(B)(i),’’ modifications to 2000bb et seq. persons and entities. To this end, the comport with Congress’s revisions to 42 Response: The Department disagrees. final rule clarifies in § 88.3(g)(2) that the U.S.C. 5000A(d) through the October 24, Section 1303 contains several distinct Department is required not only to 2018, enactment of the SUPPORT for provisions relating to conscience and provide a certification documenting a Patients and Communities Act, which conscience protections, in section 1303. religious exemption from the individual broadens the application of the While section 1303(c)(2) references and responsibility requirement and penalty exemption and discusses exclusions preserves the applicability of Federal under the Affordable Care Act, which regarding what constitutes medical 2 S

E laws regarding conscience protection, appeared in the proposed rule, but also L U

R SUPPORT for Patients and Communities Act, h t i 83 FR 3880, 3895. discrimination on the basis of the willingness or Public Law 115–271, sec. 4003, 26 U.S.C. w

D 42 U.S.C. 18023(c)(2) (‘‘[n]othing in this Act refusal to provide, pay for, cover, or refer for 5000A(d)(2) (2018). O

R shall be construed to have any effect on Federal abortion or to provide or participate in training to Budget Fiscal Year, 2018, Public Law 115–97, P 2

8 laws regarding—(i) conscience protection; (ii) provide abortion’’). Part VIII, sec. 11081, 131 Stat. 2092 (Dec. 22, 2017). 0 Q

L willingness or refusal to provide abortion; and (iii) 83 FR 3880, 3895. 83 FR 3880, 3895. G 3 K S D n o l l e

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health services, and the Department procedures to inform patients of their rule and above, and considering the adds clarification for the Department to ‘‘individual rights under State law to comments received, the Department comply with the applicable prohibitions make decisions concerning such finalizes § 88.3(i) with a change to in coordination with State Exchanges. medical care, including the right to correct a typographical error in 88.3(h). Counseling and referral accept or refuse medical or surgical § 88.3(i)(2)(i), where ‘‘1395a(w)’’ should provisions of 42 U.S.C. 1395w– treatment and the right to formulate instead read ‘‘1396a(w)(3).’’ 22(j)(3)(B) and 1396u–2(b)(3)(B). The advanced directives,’’ but the proposed 88.3(j). Global Health Programs, 22 Department received comments on this rule ‘‘attempt[s] to rewrite this provision U.S.C. 7631(d). The Department paragraph. by prohibiting this statute from being received comments on this paragraph. Comment: The Department received a construed to require covered entities to Comment: The Department received comment stating that, while the provide full information to patients comments in opposition to the statutory text of 42 U.S.C. 1395w– about services to which they may Department’s enforcement of Federal 22(j)(3)(B) and 1396u–2(b)(3)(B) object.’’ conscience and anti-discrimination laws outside of the United States, because established rules of construction, the Response: The Department disagrees. populations served by U.S. foreign aid proposed rule converted these statutes This final rule provides for the often have less financial resources and into freestanding exemptions. enforcement of 42 U.S.C. 14406, which access to fewer medical providers than Response: The Department agrees that states, ‘‘. . . section 1395cc(f) . . . shall the proposed rule is worded imprecisely persons in the United States. not be construed (1) to require any Response: The Department disagrees to treat 42 U.S.C. 1395w–22(j)(3)(B) and provider or organization, or any 1396u–2(b)(3)(B) as freestanding with the underlying premise of this employee of such a provider or comment. As described above, the exemptions, rather than as rules of organization, to inform or counsel any construction as set forth in the statutory Department believes that enforcing individual regarding any right to obtain statutory conscience rights will text. The Department, therefore, an item or service furnished for the modifies the final rule accordingly to increase, not decrease, the availability of purpose of causing, or the purpose of quality medical care because it will conform to the statutory text. assisting in causing, the death of the Summary of Regulatory Changes: For prevent the exclusion of health care individual, such as by assisted suicide, the reasons described in the proposed professionals motivated by deep euthanasia, or mercy killing. . . .’’ This rule and above, and considering the religious beliefs or moral convictions to statutory language is adopted almost comments received, the Department serve others, often the most verbatim into § 88.3(i)(2)(i). Far from finalizes § 88.3(h)(2)(i) by referring to underprivileged. Moreover, this rule ‘‘attempt[ing] to rewrite this provision,’’ regulations that also implement the merely provides for the enforcement of this rule merely adopts Congress’s rule statutes containing the requirements laws enacted by Congress that, by their of construction provision as Congress and prohibitions, for example by adding own terms, may apply abroad. enacted it. ‘‘construe 42 U.S.C. 1395w–22(j)(3)(A) Comment: The Department received a or 42 CFR 422.206(a) to,’’; by deleting Comment: The Department received comment stating that the provisions ‘‘offer a plan that provides, reimburses comments stating that advance with respect to foreign policy may lead for, or provides’’ and replace it with directives should be followed regardless to confusion as to which laws properly ‘‘provide, reimburse for, or provide,’’; of a physician’s personal objections. govern foreign aid. Response: Upon reviewing the text of inserting ‘‘offering the plan’’ to the end Response: Paragraph (i) in § 88.3 this paragraph, the Department has of paragraph (h)(2)(i); and adding provides for the implementation and revised the language to make it clearer paragraph (h)(2)(i)(B) regarding making enforcement of provisions at 42 U.S.C. to which entities the requirements information available to prospective 1395cc(f), 1396a(w)(3), and 14406, apply, and the circumstances in which enrollees and enrollees. The Department which assure that applicable Federal they apply, and to more closely track also made changes to paragraph laws (relating to Medicare and the language enacted by Congress. The (h)(2)(ii) by changing the phrase ‘‘shall Medicaid) are not used contrary to proposed rule would have applied the not require a Medicaid managed care statute to prohibit health care providers requirements of this paragraph to the organization to provide’’ to ‘‘shall not from exercising their rights of Department and recipients of relevant construe 42 U.S.C. 1396u–2(b)(3)(A) or conscience with respect to advance Federal financial assistance. However, 42 CFR 438.102(a)(1) to require,’’; directives, including with respect to 22 U.S.C. 7631(d) does not impose deleting ‘‘objects to the provision of assisted suicide. This provision does not requirements on what recipients of such service on moral or religious affect State laws governing the assistance can and cannot do; rather, it grounds,’’; and adding paragraphs enforceability of advance directives. imposes requirements on the conditions (h)(2)(ii)(A) and (B), (A) stating the But, in general, the Department believes that may be placed on receipt of organization objects on moral or that protecting health care providers’ assistance. The statute does not provide religious grounds and (B) regarding the rights of conscience with respect to a description of the entities that the policies to prospective enrollees and advance directives ensures that doctors, statute governs—i.e., entities that are in enrollees. nurses, and other persons in the health a position to place conditions on the 88.3(i). Advance Directives, 42 U.S.C. care industry are not forced to choose receipt of assistance of assistance. The 1395cc(f), 1396a(w)(3), and 14406. The between continuing to serve as health Department believes that class of Department received comments on this care providers and remaining faithful to entities is best described as those that paragraph. their deepest convictions. Such are authorized to obligate the assistance. Comment: The Department received a conscience protection ensures diversity Accordingly, the Department is 2

S comment stating that 42 U.S.C. in the health care industry and E

L modifying § 88.3(j)(1) to apply to the

U 1395cc(f) requires that certain entities maximizes the number of health care R Department and entities that are h t i maintain written policies and professionals in the United States, w

authorized by statute, regulation, or D which helps all patients. O

R 83 FR 3880, 3895 (stating the reasons for the agreement to obligate Federal financial P

2 Summary of Regulatory Changes: For 8 proposed § 88.3(h), except for the modifications 0

Q the reasons described in the proposed L adopted herein). 83 FR 3880, 3895. G 3 K S D n o l l e

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assistance under section 104A of the than only to the Helms Amendment. For enacted by Congress, and adding clarity Foreign Assistance Act of 1961 (22 consistency with the statute, the through citations to paragraphs within U.S.C. 2151b–2), under Chapter 83 of paragraph includes a new paragraph in this part. Title 22 of the U.S. Code or under the the ‘‘Applicability’’ paragraph 88.3(l). Newborn and Infant Hearing Tom Lantos and Henry J. Hyde United identifying as a distinct class of covered Loss Screening, 42 U.S.C. 280g–1(d). States Global Leadership Against HIV/ entities those entities that are The Department received comments on AIDS, Tuberculosis, and Malaria authorized to obligate or expend the this paragraph. Reauthorization Act of 2008, to the Federal financial assistance in question, Comment: The Department received a extent such Federal financial assistance separate from entities that merely comment asking that the rule interpret is administered by the Secretary, and is receive such Federal financial 42 U.S.C. 280g–1(d) to provide an deleting the reference regarding the assistance. The paragraph also now affirmative conscience exemption for Federal financial assistance being ‘‘for specifies that the Federal financial parents who do not want their children HIV/ AIDS prevention, treatment, or care assistance in question for this paragraph to receive a hearing loss screening. to the extent administered by the is that which is appropriated for the Response: 42 U.S.C. 280g–1(d) is a Secretary.’’ purposes of carrying out part I of the rule of construction that the Department Summary of Regulatory Changes: For Foreign Assistance Act of 1961. is unable to convert into an affirmative the reasons described in the proposed The proposed rule would have exemption. The Department can, rule and above, and considering the applied the requirements of this however, enforce such rules to assure comments received, the Department paragraph to the Department and that entities administering the statute do finalizes § 88.3(j) with technical changes recipients of relevant Federal financial not misapply the statute to the clarifying the language regarding to assistance. However, 22 U.S.C. 2151b(f) detriment of the conscience rights of which entities the requirements apply, and section 7018 of the Consolidated parents and their children. and the circumstances in which they Appropriations Act of 2019 impose both Comment: The Department received apply, to more closely follow the requirements on what recipients of comments stating that the proposed rule language of such statutes and assistance can and cannot do and also would endanger public health by amendments as enacted by Congress, requirements on the entities providing providing conscience protections for eliminating in paragraph (j)(2)(i) ‘‘To the that assistance to recipients. The statute parents to object to compulsory medical extent administered by the Secretary’’ does not provide a description of the procedures such as hearing loss and inserting ‘‘Require an organization, entities that provide assistance to screenings. including a faith-based organization, recipients. The Department believes that Response: The Department disagrees. that is otherwise eligible to receive class of entities is best described as 42 U.S.C. 280g–1(d) is a rule of assistance,’’ deleting ‘‘require applicants those that are authorized to obligate the construction, and this final rule does for’’ and replacing it with ‘‘to the extent assistance. Accordingly, the Department not convert it into an affirmative Federal such assistance is administered by the is modifying § 88.3(k)(1) to apply to the exemption. This rule’s enforcement Secretary, . . . as a condition of such Department, to recipients of relevant provisions do not create a right for assistance.’’ The Department also assistance, and to entities that are parents to object to a hearing loss changed ‘‘applicant’’ to ‘‘organization’’ authorized by statute, regulation, or screening for their children generally or and removed ‘‘as a condition of agreement to obligate the relevant as against other State or Federal laws. assistance’’ in (j)(2)(i)(B), and made assistance. Additionally, considering Rather, they only prevent interpreting significant edits to paragraph (j)(2)(ii) that the 1985 Amendment has been this Federal law to override State laws for accuracy regarding the statutory text included in annual appropriations acts that already provide a religious and references to other paragraphs of rather than codified as a statute, the exemption regarding the screening at this part. Department is modifying the description issue. Summary of Regulatory Changes: For 88.3(k). The Helms, Biden, 1978, and of covered entities’ obligations under the reasons described in the proposed 1985 Amendments, 22 U.S.C. 2151b(f); § 88.3(k)(2) to clarify that the rule’s rule and above, and considering the e.g., Consolidated Appropriations Act, provisions regarding the 1985 comments received, the Department 2019, Public Law 116–6, Div. F, sec. Amendment apply only to funds under finalizes § 88.3(l) with minor changes to 7018. The Department received an appropriations act containing the ensure clarity and consistency with the comments on this paragraph. 1985 Amendment. statute, for example by deleting Comment: The Department received a Summary of Regulatory Changes: For ‘‘newborn infants or young,’’ changing comment stating that the provisions the reasons described in the proposed articles, and making other minor with respect to foreign policy may lead rule and above, and considering the changes. to confusion as to which laws properly comments received, the Department govern foreign aid. 88.3(m). Medical Screening, finalizes § 88.3(k) with technical Examination, Diagnosis, Treatment, or Response: Upon reviewing the text of changes clarifying the citations and this paragraph, the Department has Other Health Care or Services, 42 U.S.C. language as to which statutes and 1396f. The Department received revised the language to make it clearer amendments are referenced, and to as to which laws and amendments are comments on this paragraph. more closely follow the language of Comment: The Department received implicated by this paragraph, and to such statutes and amendments as more closely track the statutory numerous comments supporting the rule’s provision of enforcement language enacted by Congress. For See, e.g., the Consolidated Appropriations Act, clarity, the heading of the paragraph has 2019, Public Law 116–6, Div. F, sec. 7018 (‘‘None mechanisms for 42 U.S.C. 1396f. Other commenters opposed the 2 of the funds made available to carry out part I of

S been revised to refer to each of the four E

L the Foreign Assistance Act of 1961, as amended, enforcement mechanisms, alleging they

U separate statutory provisions

R may be obligated or expended for any country or create an affirmative mandate that a h t i implemented by the paragraph, rather organization if the President certifies that the use w

State agency that administers a State

D of these funds by any such country or organization O

R 83 FR 3880, 3895 (stating the reasons for the would violate any of the above provisions related Medicaid Plan may not compel any P 2

8 proposed § 88.3(j), except for the modifications to abortions or involuntary sterilizations.’’) 0 Q

L adopted herein). 83 FR 3880, 3895. 83 FR 3880, 3895. G 3 K S D n o l l e

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person to undergo any medical 88.3(o). Vaccination, 42 U.S.C. rule and above, and considering the screening, examination, diagnosis, or 1396s(c)(2)(B)(ii). The Department comments received, the Department treatment if such person objects on received comments on this paragraph. finalizes § 88.3(o) with changes to religious grounds. Comment: The Department received ensure it follows the language of 42 Response: The Department disagrees comments suggesting that the scope of U.S.C. 1396s(c)(2)(B)(ii), which applies with commenters opposing the this paragraph be expanded beyond to program-registered providers of paragraph. 42 U.S.C. 1396f is a rule of pediatric vaccines to encompass all pediatric vaccines, not to States construction, and this rule does not vaccines, or that it should be expanded generally, and to specify that applicable convert it into an affirmative Federal to create a personal right to decline State law may include State statutory, exemption. This rule’s enforcement vaccinations based on moral or religious regulatory, or constitutional protections provisions do not create a freestanding objections. for conscience and religious freedom, right for persons or their families to be Response: The Department is aware of where applicable. free to decline certain medical complaints asserting religious or moral 88.3(p). Specific Assessment, screenings or treatments. Rather, they objections to administering or receiving Prevention and Treatment Services, 42 only prevent an interpretation of 42 vaccines, including, for example, U.S.C. 290bb–36(f), 5106i(a). Comment: The Department received U.S.C. 1396f as requiring States to objections to administering or receiving comments on this paragraph expressing compel the acceptance of such vaccines derived from aborted fetal concern that the provision of conscience screening or treatment when the tissue. Because § 88.3(o) of the rule protections for parents who object to Medicaid statute has no such provides enforcement mechanisms for youth suicide assessments for their requirement. 42 U.S.C. 1396s, it is therefore limited to the scope of 42 U.S.C. 1396s. As 42 children should be balanced with the Summary of Regulatory Changes: For risk to the child’s life. the reasons described in the proposed U.S.C. 1396s applies only to the pediatric vaccine program under Response: Paragraph (p) in § 88.3 is a rule and above, and considering the rule of construction that prevents comments received, the Department Medicaid (the Vaccines for Children Program), the Department is unable to persons or entities administering finalizes § 88.3(m) as proposed. programs under 42 U.S.C. 290bb–36 or expand the scope of this paragraph 42 U.S.C. 5106i(a) from relying on the 88.3(n). Occupational Illness beyond such programs. Likewise, as 42 particular statutes at issue to require Examinations and Tests, 29 U.S.C. U.S.C. 1396s requires compliance with assessments or treatments that conflict 669(a)(5). religious or other exemptions under with religious belief. The provisions in Comment: The Department received State law with respect to pediatric this rule related to these statutes do not, comments generally supporting the vaccines, the Department is unable to however, prevent or interfere with any concept of conscience protections for expand this rule provision to preempt other State or Federal law that reaches occupational medical examinations, State laws that do not provide such a different (or the same) conclusion on immunizations, and treatments, and conscience protections. these questions. other comments generally opposing that Comment: The Department received concept. The Department did not In reviewing this paragraph in light of comments asking for clarification as to the comments received on it, however, receive specific comments on § 88.3(n) how the proposed § 88.3(o) interacts or its implementation of the rule of the Department has determined that with State laws such as school paragraph (p)(2)(iii) needs to be construction described in 29 U.S.C. immunization requirements. 669(a)(5). modified to more closely track the Response: Upon reviewing the statutory language, in order to ensure it Response: Although Congress granted proposed § 88.3(o), the Department operates as a rule of construction HHS authority to conduct research, agrees that the language can be clarified consistent with 42 U.S.C. 290bb–36(f). experiments, and demonstrations regarding how the paragraph might Summary of Regulatory Changes: For related to occupational illnesses in the interact with State law. The Department the reasons described in the proposed Occupational Safety and Health Act of therefore finalizes § 88.3(o) to more rule and above, and considering the 1970, such authority did not include the accurately reflect the text of 42 U.S.C. comments received, the Department power to require ‘‘medical examination, 1396s(c)(2)(B)(ii) by changing the finalizes § 88.3(p) with changes to immunization, or treatment for those applicability of the requirement of paragraph (p)(2)(iii) to more closely who object thereto on religious grounds, § 88.3(o)(2) to reflect the statute’s track the language of 42 U.S.C. 290bb– except where such is necessary for the requirement that, under any State- 36(f), which establishes it as a rule of protection of the health or safety of administered pediatric vaccine construction. others.’’ 29 U.S.C. 669(a)(5). The distribution program, the provider 88.3(q). Religious nonmedical health Department is required to abide by this agreement executed by any provider care, 42 U.S.C. 1320a–1, 1320c–11, limitation, and considers it appropriate registered to participate in the program 1395i–5, 1395x(e), 1395x(y)(1), 1396a(a), to issue a final rule ensuring includes the requirement that the and 1397j–1(b). The Department compliance. program-registered provider comply received comments on this paragraph. Summary of Regulatory Changes: For with applicable State law, including any Comment: The Department received the reasons described in the proposed such law relating to any religious or comments opposed to the provision of rule and above, and considering the other exemption. In order to further Federal funds to religious nonmedical comments received, the Department clarify the scope of § 88.3(o), the health care facilities because such finalizes § 88.3(n) with minor changes, Department finalizes this paragraph to funding could be interpreted as for example, deleting ‘‘With respect to specify that applicable State ‘‘law’’ may legitimating such facilities, resulting in 2 S

E occupational illness examinations and include State statutory, regulatory, or L U

R constitutional protections for 83 FR 3880, 3895 (stating the reasons for the tests, the entities’’ and replacing it with h t i proposed § 88.3(o), except for the modifications

w conscience and religious freedom,

‘‘Entities.’’

D adopted herein).

O where applicable. R 83 FR 3880, 3895 (stating the reasons for the P

2 Summary of Regulatory Changes: For 8 83 FR 3880, 3895. proposed § 88.3(p), except for the modifications 0

Q the reasons described in the proposed L 83 FR 3880, 3895. adopted herein). G 3 K S D n o l l e

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patients of such facilities not seeking provided for in 42 U.S.C. 1396a(a) and and (iv).’’ The Department added ‘‘(h)’’ other treatment options. as upheld in Children’s Healthcare Is a to the reference to 42 U.S.C. 1320a–1 to Response: Whether to permit Federal Legal Duty, Inc. v. Min De Parle, 212 clarify the particular paragraph funds to be used to pay religious F.3d 1084 (8th Cir. 2000) (‘‘[S]tate plans containing relevant information. The nonmedical health care facilities for may not establish State agency oversight Department clarified in paragraph particular services provided to Medicare of the quality of care provided in (q)(1)(ii) that some State agencies are or Medicaid beneficiaries has been RNCHIs [sic].’’). The Department, required to comply, in paragraph determined by Congress through 42 therefore, rejects this proposal. (q)(1)(iii) that entities receiving Federal U.S.C. 1320a–1, 1320c–11, 1395i–5, Nonetheless, the Department financial assistance from Medicare have 1395x(e), 1395x(y)(1), 1396a(a), and recognizes that the structure and compliance obligations, and in 1397j–1(b), and the Department is description of the relevant exemptions paragraph (q)(1)(iv) that entities unable to alter that decision. The in § 88.3(q) was unclear in many including States that receive Federal purpose of including these provisions in respects, and so the Department makes financial assistance from Medicaid have the proposed rule and this final rule is substantial changes to the compliance obligations, and in only to provide enforcement ‘‘Requirements and prohibitions’’ to paragraph (q)(1)(v) clarified the mechanisms for the determination of correct and clarify § 88.3(q) to more authority related to an elder’s right to Congress with respect to funding of accurately describe the activities from practice his or her religion through religious nonmedical health care which the applicable covered entities reliance on prayer alone is subtitle B of facilities. Nevertheless, the Department are required to exempt religious Title XX of the Social Security Act (42 believes that most if not all persons who nonmedical health care institutions, U.S.C. 1397j–1397m–5) and eliminated make use of religious nonmedical health including a change to more fully what was the last paragraph regarding care facilities do so because they hold incorporate the exemption established the Elder Justice Block Grants. The religious objections to the receipt of in 42 U.S.C. 1396(a)(31). paragraph incorporates multiple medical care and would be unwilling to Comment: The Department received a references to 42 U.S.C. 1395x(ss)(1), seek other treatment options regardless comment requesting that the which defines a religious nonmedical of the religious nonmedical health care exemptions for religious nonmedical health care institution, to add clarity to facilities’ funding status. health care facilities concerning the regulation. The paragraph clarifies Comment: The Department received Medicare Part A funding be explicitly the application of various provisions to comments expressing concern that applied to Medicare Advantage as well entities that make an agreement with the providing conscience protections for because, while Medicare Advantage is Secretary of the Department pursuant to attendees of religious nonmedical health required to provide coverage for all 42 U.S.C. 1320a–1(b), or receive Federal care facilities could prevent people, services that are covered by Medicare financial assistance from Medicare, particularly children, from accessing Part A and Part B, many Medicare Medicaid, or Subtitle B of Title XX of necessary medical health care. Advantage organizations do not the Social Security Act (42 U.S.C. Response: This rule only provides for recognize religious nonmedical health 1397j–397m–5). Last, the Department enforcement mechanisms for conscience care. removed the references requiring protection statutes that Congress has Response: As noted by the compliance with § 88.5, as compliance enacted, and determinations of policy commenter, because Medicare with that section is now voluntary. matters raised by these comments are Advantage organizations are required to outside the scope of this rulemaking to Assurance and Certification of cover services covered by Medicare Compliance Requirements (§ 88.4) the extent they conflict with decisions Parts A and B pursuant to 42 U.S.C. made by Congress. That said, this 1395w–22(a)(1)(A), the exemptions for In the ‘‘Assurance and Certification of provision regarding religious religious nonmedical health care Compliance’’ section of the proposed nonmedical health care does not facilities related to Medicare Part A rule, the Department proposed to prevent people from accessing care, but funding apply to Medicare Advantage as require certain recipients of Federal rather, has a role in enabling people to well. Because the applicability financial assistance or other Federal access care that does not violate their paragraphs of § 88.3(q) follow the funds from the Department or that the religious beliefs, which will benefit all statutory language concerning religious Department administers to submit patient populations, including children. nonmedical health care exemptions, the written assurances and certifications of Comment: The Department received a Department declines to adopt the compliance with the Federal conscience comment stating that exempting commenter’s suggested modification. and anti-discrimination laws, as religious nonmedical health care Summary of Regulatory Changes: For applicable, as part of the terms and facilities from State standards for the reasons described in the proposed conditions of acceptance of Federal cleanliness and quality of care rule and above, and considering the financial assistance or other Federal potentially threatens the quality of care comments received, the Department funding from the Department. The that attendees of such facilities receive. made significant changes to the Department stated its belief that both an The commenter proposed striking these structure of § 88.3(q) to clarify assurance and a certification provide provisions from the rule and ensuring applicable statutes and paragraphs, important protections to persons and that religious nonmedical health care correct typographical errors, and more entities under these laws and would be facilities adhere to the same standards closely track the statutory language. The consistent with requirements under as other skilled nursing facilities and Department more clearly articulates other civil rights laws. The Department providers. which paragraphs are applicable to noted its concern that there is a lack of Response: Requiring religious knowledge on the part of States, local 2

S different entities by, for example,

E nonmedical health care facilities to governments, the health care industry, L

U changing ‘‘(q)(2)(i) through (iii)’’ so that R

adhere to the same standards as other and the public of the rights of protected h t i it now clearly states ‘‘(q)(2)(i), (ii), (iii), w

skilled nursing facilities and providers persons and entities, and the D

O would contradict Congress’s corresponding obligations on covered R 83 FR 3880, 3895 (stating the reasons for the P 2

8 determination to exempt religious proposed § 88.3(q), except for the modifications entities provided by Federal conscience 0 Q

L nonmedical health care facilities, as adopted herein). and anti-discrimination laws. G 3 K S D n o l l e

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Section 88.4 proposed to require intent to work with recipients of Federal Comment: The Department received certain applicants for Federal financial financial assistance or other Federal comments requesting that exemptions assistance or other Federal funds from funds from the Department to ensure for religious beliefs or moral the Department to which this part compliance with the requirements or convictions, such as for vaccinations, be applies to submit assurances and prohibitions promulgated in this included in form HHS–690. certifications of compliance with regulation. If the applicant or recipient Response: The Department’s Federal conscience and anti- would fail or refuse to furnish a implementation of the assurance and discrimination laws and this part. The required assurance or certification, the certification of compliance will address Department proposed that covered Department proposed that OCR, in the Federal conscience and anti- applicants operationalize the assurance coordination with the relevant discrimination laws implicated by this and certification requirement by filing Department component, would be rule. Because none of the statutes that revised versions of applicable civil authorized to effect compliance by any this rule implements create across-the- rights forms, such as the HHS–690 of the remedies provided in § 88.7. See board exemptions on the basis of Assurance of Compliance Form once per Grove City College, 465 U.S. 555 religious beliefs or moral convictions to year and incorporate such filing by (affirming partial termination of vaccination requirements, the assurance reference in all other applications institution’s Federal funds for refusing and certification of compliance submitted that year, rather than for to sign a Title IX assurance of requirement does not either. every application that year. To this end, compliance form). Comment: The Department received and as consistent with other civil rights The Department also proposed that, comments requesting that any assurance regulations requiring assurances or while both recipients and sub- of compliance be acquired through form certifications, the Department proposed recipients, as defined herein, must HHS–690 to avoid the increased in § 88.4(b)(6) to permit an applicant to comply with the substantive administrative burden of adding new incorporate the assurance by reference requirements of Federal conscience and forms or procedures. in subsequent applications to the anti-discrimination laws, as applicable, Response: The Department agrees Department. The proposed rule sub-recipients would not be subject to with this proposal and is working to explained that both the assurance and the requirements of § 88.4 regarding obtain Paperwork Reduction Act certification would constitute a assurance and certifications of clearance for updates to the HHS–690 condition of continued receipt of compliance. The Department invited form entitled Assurance of Compliance, Federal financial assistance or other comment on whether this approach which previously had OMB PRA Federal funds from the Department. strikes the appropriate balance between clearance as OMB No. 0945–0006. (The With respect to the certification achievement of this rulemaking’s policy Department’s operationalization of the required in proposed § 88.4(a)(2), objectives and avoidance of undue certification of compliance required in proposed § 88.4(b)(7) clarified that, as burden on the health care industry. § 88.4(a)(1) is described in the RIA and with other anti-discrimination laws, a Proposed § 88.4(c) also contained PRA portions of this rule.) violation of the requirements of the several important exceptions from the The HHS–690 form enables an certification may result in enforcement proposed requirements for written applicant to provide an assurance that it by the Department, as provided in § 88.7 assurance and certification of will comply with certain Federal civil of this part. compliance, including (1) physicians, rights laws and regulations ‘‘in Noting the need to increase public physician offices, and other health care consideration of and for the purpose of awareness of Federal conscience and practitioners participating only in Part B obtaining Federal grants, loans, anti-discrimination laws, the of the Medicare program; (2) recipients contracts, property, discounts, or other Department solicited public comment of Federal financial assistance or other Federal financial assistance’’ from the on the various options available for Federal funds from the Department Department. By signing the assurance public education and outreach. awarded under certain grant programs of compliance, the applicant ‘‘agrees Proposed paragraph (b) identified currently administered by the that compliance with this assurance specific requirements for the proposed Administration for Children and constitutes a condition of continued assurance and compliance Families, whose purpose is unrelated to receipt of Federal financial assistance, requirements: (b)(1) Addressed the health care provision as specified; (3) and that it is binding upon the timing to submit the assurance for recipients of Federal financial assistance Applicant, its successors, transferees current applicants or recipients as of the or other Federal funds from the and assignees for the period during effective date of this part; (b)(2) Department awarded under certain grant which such assistance is provided.’’ addressed the form and manner of such programs currently administered by the As finalized, § 88.4(b)(1) requires submittals; and (b)(3) addressed the Administration on Community Living, entities that are already recipients as of duration of obligations for both the whose purpose is unrelated to health the effective date of the rule and assurance and certification. care provision as specified; and (4) applicants to submit the assurance and Proposed § 88.4(b)(2) explained that Indian Tribes and Tribal Organizations the certification as a condition of any applicants would submit assurance and when contracting with the Indian application or reapplication for funds to certification forms in an efficient Health Service under the Indian Self- which the rule applies. Pursuant to the manner specified by OCR, in Determination and Education finalized § 88.4(b)(6), it would be coordination with the relevant Assistance Act. The Department sought permissible to incorporate assurances Department component, or alternatively public comment on whether further and certifications by reference in in a separate writing. exceptions should be made to the subsequent applications, which is The Department proposed that its requirements of § 88.4 in contexts where 2

S consistent with the Department’s Grants E components be given discretion to

L the requirements would be unduly

U Policy Statement, which states that R

phase in the written assurance and burdensome or in contexts unrelated to h t i w

certification requirement by no later health care or medical research. The

D U.S. Dep’t of Health & Human Servs., O than the beginning of the next fiscal Department received comments on this R Assurance of Compliance, HHS 690, https:// P 2

8 year following the effective date of the section, including general comments in www.hhs.gov/sites/default/files/hhs-690.pdf. 0 Q

L regulation. The Department stated its support of this section. Id. G 3 K S D n o l l e

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because recipients file an assurance of American public for protecting the that covered entities provide assurances compliance form ‘‘for the organization integrity of Federal financial assistance and certifications of compliance could and . . . not . . . for each application,’’ and other Federal funds that the lead to third-party qui tam lawsuits a recipient with a signed assurance on Department awards. The Department’s parallel to the Department’s file assures through its signature on the administration of a requirement for a enforcement actions. award application that it has a signed person or entity at the time of Response: Whether a third-party may Form 690 on file. application or reapplication to assure bring or prevail in a qui tam lawsuit The Department proposed to add a and certify compliance with Federal with respect to an assurance or provision to § 88.4(b)(1) that would conscience and anti-discrimination laws certification required by this rule is a require submission of the assurance and the final rule demonstrates that the legal question dependent on statutes more frequently than at the time of person or entity was aware of its and precedent governing qui tam application if the applicant or recipient obligations under those laws and the lawsuits and is beyond the scope of this fails to meet a requirement of the rule, rule. rulemaking. The Department does not or if OCR or the relevant Department In addition, this collection of consider the possibility that such laws component has reason to suspect or assurances and certifications would may apply as a sufficient reason not to cause to investigate the possibility of operationalize the obligations of persons require assurance or certification of such failure. For instance, OCR may and entities to comply with applicable compliance with Federal conscience have reason to suspect through its Federal conscience and anti- and anti-discrimination laws in order to investigations or the number of discrimination laws. As discussed achieve the goals described in this Final complaints received that a particular above, the Department has the authority Rule for requiring such assurance or recipient is not complying with the to place terms and conditions with certification. Federal conscience and anti- respect to the Federal conscience and Comment: The Department received a discrimination laws or the rule and anti-discrimination laws in any comment stating that the proposed rule consequently asks the recipient to sign instrument HHS issues or to which it is is unclear as to whether a person that an assurance of compliance form a party (e.g., grants, contracts, or other falls within one of the exempt categories offcycle from the normal grants process. HHS agreements). A Department described in § 88.4(c)(1) and (2) remains To forgo as-needed assurances outside component extending an award must exempt if such person receives Federal of the application process jeopardizes communicate and incorporate statutory funds under a separate agency or OCR’s and the Department’s flexibility and public policy requirements and program. obligate the recipient to comply with to ensure that the Federal financial Response: The Department does not Federal statues and ‘‘public policy assistance or other Federal funds that agree that the proposed rule is unclear requirements, including . . . those . . . the Department awards are used in a as to whether such a person would prohibiting discrimination.’’ More manner compliant with Federal remain exempt. Proposed § 88.4(c) states specifically, the Department component conscience and anti-discrimination laws that certain persons or entities shall not ‘‘must communicate . . . all relevant and this rule. be required to comply with paragraphs public policy requirements, including Comment: The Department received a (a)(1) and (2) of § 88.4 ‘‘provided that those in general appropriations comment requesting that the such persons or entities are not provisions, and incorporate them either certification of compliance contain recipients of Federal financial assistance directly or by reference in the terms and additional language, such as explicit or other Federal funds from the conditions of the Federal award.’’ To protections for LGBT patients. Department through another instrument, execute this obligation, the Response: The scope of this rule and program, or mechanism, other than Departmental component may require a the certifications of compliance sought those set forth in paragraphs (c)(1) recipient ‘‘to submit certifications and herein are limited to the Federal through (4) of this paragraph.’’ representations required by Federal conscience and anti-discrimination Therefore, a person who would be laws. Certifications with respect to other statutes, or regulations . . . .’’ Furthermore, the proposed exempt under one of these provisions, topics or laws not the subject of this rule but receives Federal financial assistance are outside the scope of this rulemaking. requirements of § 88.4 are consistent with the requirements of other Federal or other Federal funds from a non- Comment: The Department received a exempt HHS program, is no longer comment stating that conditioning civil rights laws and would bring Federal conscience and anti- exempt. receipt of Federal financial assistance or ‘‘Federal financial assistance’’ as used Federal funds on receipt of an assurance discrimination laws into parity with those other civil rights laws. Although in the phrase ‘‘Federal financial and certification is unnecessary in light assistance or other Federal funds from of the proposed enforcement instituting an enforcement action against an entity is effective in ensuring the Department’’ should be read to mean mechanisms provided by § 88.7. such assistance from the Department. Response: The Department does not that the enforced-against entity is aware of its requirements under the statutes Therefore, a person that falls within one agree. This collection of assurances and of the exempt categories described in certifications would facilitate the implemented through this rule, the requirement of an assurance and § 88.4(c)(1) and (2) remains exempt if Department’s obligation to ensure that such person receives Federal financial the Federal financial assistance or other certification of compliance would ensure that such awareness is shared by assistance from an agency or department Federal funds that the Department other than HHS. awards are used in a manner that entities subject to proposed § 88.4 before violations occur and may help prevent Comment: The Department received a complies with Federal conscience and comment stating that the proposed rule 2 them. S anti-discrimination laws and this rule. E is unclear because, while the rule states L Comment: The Department received a U The Department is accountable to the R

that it is appropriate to exempt h comment stating that the requirement t i w

clinicians who are part of State

D U.S. Dep’t of Health & Human Serv., HHS O Medicaid programs, such clinicians are R Grants Policy Statement, I–31 (Jan. 2007), https:// 45 CFR 75.300(a). P 2

8 www.hhs.gov/sites/default/files/grants/grants/ Id. not included in the exemptions of 0 Q

L policies-regulations/hhsgps107.pdf. Id. sec. 75.208. § 88.4(c). G 3 K S D n o l l e

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Response: The exclusion in § 88.4(c) instead are sub-recipients. Under the change to paragraph (b)(1) to insert ‘‘or does not need to explicitly exempt State Medicare Part C program, HHS makes any applicants’’ and to insert Medicaid program clinicians because payments to the private plan, which is ‘‘application or’’ to clarify that new such participants are already excluded the recipient for the purpose of applicants are included; a change to from § 88.4’s application by virtue of Medicare Part C, and the plan pays the paragraph (b)(1), regarding timing, to being sub-recipients of the Department, provider, which under this rule would clarify that submission of assurance and not recipients. States are the direct be considered a sub-recipient. certifications may be required on a more recipients of Medicaid funding from the Therefore, § 88.4(c) does not need to frequent basis if ‘‘OCR or the relevant Department, and States may offer exempt Medicare Part C providers Department component has reason to Medicaid benefits on a fee-for-service because, as a threshold manner, the suspect or cause to investigate the (FFS) basis, through managed care assurances and certifications possibility of [a] failure’’ to meet a plans, or both. Regardless of the model requirement of § 88.4 do not apply to requirement of this part; changes to that the States use, clinicians are sub- providers participating in Medicare Part paragraph (b)(6) to clarify that both prior recipients as this term is used in this C. The same is true of participants in assurances and certifications may be rule. Under the fee-for-service model, Medicare Part D. incorporated by reference; a change to the State pays the clinicians directly Comment: The Department received a the end of paragraph (b)(7) by adding and under the managed care model, a comment asking that the assurance and the phrase ‘‘including by referral to the State pays a fee to a managed care plan, certification of compliance provisions Department of Justice, in coordination which in turn pays the clinician for the become effective one year after the final with the Department’s Office of General services a beneficiary may require that rule is published or provide a one-year Counsel, where appropriate’’ as are within the managed care plan’s safe harbor to entities that make a good discussed above; a change to paragraph contract with the State to serve faith effort to inform their employees (b)(8) to replace ‘‘remedies’’ with Medicaid beneficiaries. The 2008 about the Federal conscience and anti- ‘‘mechanisms’’ for accuracy; and a Rule expressly exempted State Medicaid discrimination laws and come into change to paragraph (c)(1) to include program clinicians because the compliance. pharmacies and pharmacists in the list certification requirement applied to Response: Although ultimate of Medicare Part B exclusions. recipients and sub-recipients; in responsibility for compliance resides Notice of Rights Under Federal contrast, the certification requirement in with covered entities, OCR plans to do Conscience and Anti-Discrimination this rule applies to recipients only. significant outreach and public Laws (§ 88.5) Comment: The Department received a education to inform covered entities of comment stating that, while some their obligations and timelines. The NPRM proposed requiring the pharmacies and pharmacists participate Recipients are also free to inform their Department and recipients to notify the in Medicare Part B, the exemption for employees about Federal conscience public, patients, and workforce, which health care practitioners in § 88.4(c) and anti-discrimination laws through may include students or applicants for does not explicitly include pharmacists policies and procedures or internal employment or training, of their and pharmacies, and ‘‘health care communications efforts, such as by protections under the Federal practitioners’’ may not be understood to posting notices of rights under Federal conscience and anti-discrimination laws include pharmacists or pharmacies. conscience and anti-discrimination and this rule. Response: The Department agrees laws, using the model in appendix A to For consistency with other notice with the commenter’s observation and, 45 CFR part 88. Section 88.5 of this rule requirements in civil rights regulations, accordingly, will finalize § 88.4(c)(1) to no longer requires recipients to post paragraph (a) of § 88.5 proposed to explicitly include pharmacists and notices, but OCR will consider the require the Department and recipients to pharmacies within the exemption if posting of notices as non-dispositive post the notice provided in Appendix A they participate in Medicare Part B and evidence of compliance if OCR were to of the proposed rule within 90 days of are not otherwise subject to this part. investigate the recipients’ compliance the effective date of this part. This Comment: The Department received a with Federal conscience and anti- proposed notice would advise persons comment asking that the exemption in discrimination laws. Because the notice and entities about their rights and the § 88.4(c) be expanded to include provision is being finalized as a Department’s and/ or recipients’ participants in Medicare Part C as well voluntary best practice that serves as obligations under Federal conscience as Part B. non-dispositive evidence of compliance, and anti-discrimination laws. The Response: In contrast to doctors and there is no deadline for posting of notice would provide information about other health care practitioners who notices. how to file a complaint with OCR. The participate in Medicare Part B and are Summary of Regulatory Changes: For Department sought comment on considered recipients under this rule the reasons described in the proposed whether there are categories of because these providers receive direct rule and above, and considering the recipients that should be exempted from payments from the Centers for Medicare comments received, the Department this requirement to post such notices. & Medicaid Services, Medicare Part C finalizes § 88.4 with the following The proposed rule did not propose to (Medicare Advantage) providers are not changes: A change to paragraph (b)(1), require sub-recipients to post the notice. recipients, as defined by this rule, but deleting ‘‘applicants or recipients’’ and The proposed rule would require all replacing with ‘‘entities’’ for accuracy; a Department components and recipients See, e.g., Provider Payment and Delivery to use the notice text in appendix A of Systems, MACPAC, https://www.macpac.gov/ medicaid-101/provider-payment-and-delivery- See Medicare Advantage Program Payment the proposed rule. The Department invited comment on whether the 2 systems/ (last visited Jan. 29, 2019). System, MEDPAC 1 (Oct. 2016), http:// S

E www.medpac.gov/docs/default-source/payment- L 73 FR at 78101. proposed rule should permit recipients U

R basics/medpac_payment_basics_16_ma_final.pdf Compare 2008 Rule, 73 FR at 78098 (requiring to draft their own notices for which the h t i sub-recipients to provide the Certification of (describing the payment system). w content meets certain criteria and does D Compliance set out in the rule as part of the sub- See id. O

R recipient’s original agreement with the recipient) 83 FR 3880, 3896–3897 (stating the reasons for not compromise the intent of § 88.5. P 2

8 with § 88.4(a)(1)–(2) infra (requiring an applicant or the proposed § 88.4, except for the modifications Proposed paragraph (b) set forth two 0 Q

L recipient to submit an assurance and certification). adopted herein). categories of locations where the notice G 3 K S D n o l l e

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would be required to appear: On the compliance with other Federal civil and accept self-drafted notices to Department’s and recipient’s website(s), rights protections. provide greater flexibility. and in a physical location of each At the same time, the Department Comment: The Department received a Department and recipient establishment appreciates the potential burden of such comment stating that recipients should where notices to the public and notices notices and the fact that they are not not be permitted to deviate from the text to their workforce are customarily explicitly required by statute. In of the proposed notice in Appendix A, posted. With regard to the physical response to comments concerning because deviations from the text of posting, paragraph (b)(2) would impose notice requirements, the Department is appendix A could describe Federal readability requirements without finalizing § 88.5 to change the notice conscience and anti-discrimination laws identifying prescriptive font-size or provision from a requirement to a in subtly incorrect manners and the other display requirements. voluntary action and to accept self- Department would be forced to expend Proposed paragraph (c) would drafting of notices to provide greater additional resources to determine incentivize recipients to display the tailoring to individual circumstances. whether myriad notices are accurate. notice in locations other than their In investigating complaints and Response: While the Department websites and physical establishments. initiating compliance reviews, OCR will agrees that a fixed notice avoids the The Department explained that, in the consider the extent to which entities concern that a recipient-drafted notice event that the OCR Director, pursuant to post notices, as well as the inclusion of will subtly misstate the protections the enforcement authority proposed in such notices in the type of documents provided by the rule and mitigates the § 88.7, investigates or initiates a identified in the proposed rule at time and expense of ensuring that self- compliance review of a recipient, the § 88.5(c), according to the rule’s notice drafted notices are accurate, the OCR Director would consider, as one of provisions as non-dispositive evidence Department is convinced by other many factors with respect to of compliance with the substantive commenters that permitting recipients compliance, whether the recipient provisions of this rule applicable to to draft their own notices is preferable, posted the notice in the documents such entities. The existence or not of so as to provide greater flexibility and avoid statements that might be false or described in paragraphs (c)(1) through posted or published notices may also be misleading in the context of, and (3), as applicable. Because this part considered in the determination of considering the status of, a particular regulates a diverse range of recipients, potential corrective action in cases of recipient. To the extent that covered the Department identified three violation. categories of documents most common entities misstate statutory protections in The Department believes that the across all recipients for proposed listing the drafting of their own notices, they change of the notice provisions of this in paragraph (c). The Department sought risk such misstatement being considered rule from a requirement to a voluntary comment on the proposed approach of by the Department negatively during action to be considered in complaint paragraph (c) and on the categories of complaint investigation or compliance investigations addresses any concerns documents identified in paragraphs reviews. about the Department’s authority to (c)(1) through (3). Comment: The Department received a Finally, paragraph (d) of § 88.5 implement mandatory notice comment stating that recipients should proposed to permit recipients to provisions. Providing guidance on be permitted to combine this notice combine the text of the notice required notices and considering notices with with other notices. in paragraph (a) with other notices respect to enforcement, including Response: Under the proposed under the condition that the recipients corrective action, are matters concerning § 88.5(d), an entity would be permitted retain all of the language provided in the government of the Department and to combine this notice with other Appendix A of the proposed rule in an the performance of Department business notices ‘‘if it retains all of the language unaltered state. The Department as authorized by the authorities provided in appendix A of this part in requested comment on whether the discussed supra at part III.A. an unaltered state.’’ Because the proposed paragraph (d) struck the best Comment: The Department received a Department has made the notice balance based on recipients’ comment stating that, although the provision voluntary and permits experiences. The Department received commenter approves of the notice recipients to draft their own notices, the comments on this section, including proposed in Appendix A of the NPRM, requirement that such combination comments that were general expressions the commenter believes that recipients maintain the language of appendix A of support or opposition to proposed should be free to draft their own notice ‘‘in an unaltered state’’ is removed. § 88.5. if they desire, so long as they clearly Comment: The Department received Comment: The Department received state what protections are available comments stating that requiring that the comments objecting to the burdens of under the law. The commenter proposes notices be posted by April 26, 2018, is required notices, and stating that none that permitting recipients to draft their unreasonable. The Department also of the Federal conscience and anti- own notice will permit them to tailor received comments asking that § 88.5 discrimination laws give the the notice to their unique settings and not be required until one year after the Department authority to issue the notice avoid possible unintentional final rule is published. requirements of § 88.5. misrepresentations that may arise based Response: Because the notice Response: The Department has on their status. The commenter provision is being finalized as a considered these and other comments proposes that any such recipient-drafted voluntary practice that serves as non- objecting to the notice requirements of notice could be required to state where dispositive evidence of compliance in the proposed rule. Each Federal the text of Appendix A may be found or investigations and compliance reviews, conscience and anti-discrimination law to provide such text upon request. the notice provision no longer has a 2 S

E requires the Department and covered Response: The Department agrees that L timeframe in which such notices must U R entities to comply with its substantive recipients should be permitted to draft be posted. h t i w

provisions. Notice of rights under those their own notices so as to avoid Comment: The Department received D

O provisions is an important means of misrepresentations and to tailor their comments stating that the broad, general R P 2

8 ensuring proper compliance. Notices are notice to their particular circumstances language proposed in appendix A could 0 Q

L also commonly used in ensuring and is modifying § 88.5 to acknowledge lead a health care provider to believe G 3 K S D n o l l e

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that they may violate Federal non- conscience and anti-discrimination health insurance issuers, the discrimination laws or the Emergency laws. Department disagrees with such Medical Treatment and Active Labor Comment: The Department received a assumption. The notice provision is Act. comment stating that if a patient sees being finalized not as a requirement, but Response: The Department disagrees. the proposed notice, such patient may as guidance on best practices that the The broad nature of the proposed be less likely to engage in open Department will consider in complaint language in appendix A specifically conversation with the patient’s health investigation and compliance reviews. avoids implying that providers have a care provider for fear that services will Certain Federal conscience and anti- categorical, unconditional right under be denied. discrimination laws clearly implicate Federal law to exercise conscientious Response: The Department disagrees health insurance issuers; accordingly, in objections. The notice text is clear that that a statement of the requirements of investigation of complaints or only ‘‘certain health-care related certain Federal civil rights laws will compliance reviews involving health treatments, research, or services’’ are discourage patients from engaging in insurance issuers, the Department may covered by the Federal conscience and open conversation with their health care consider whether the issuer has posted anti-discrimination laws, and only providers. First, the overwhelming such a notice as non-dispositive states that providers ‘‘may,’’ in a given number of patient-physician evidence of compliance with the rule. If circumstance, be protected by the rule. interactions do not involve issues that a health insurance issuer is subject to Nothing in the language of the proposed are likely to raise religious or moral provisions of the rule, as at least some notice states that other Federal laws are considerations. Second, knowing that will be, notice provided by an insurer to waived. The appendix continues to health care providers are free to work both its employees and the public are serve as a valid model notice. according to their own consciences appropriate factors to consider as Comment: The Department received could encourage patients to engage in evidence of compliance with this rule. comments stating that the proposed open conversation, either by raising the Comment: The Department received a notice should require mention of an subject where it might not have comment stating that requiring the exemption for vaccinations. otherwise been discussed, or because a proposed notice to be displayed in Response: As stated above, the patient may prefer a health care emergency rooms may violate the Department has changed its approach to provider with values consistent with Emergency Medical Treatment and the notice provisions, and they are now their own. Third, as discussed Active Labor Act because patients who voluntary and flexible. In addition, with previously, compliance with the Federal see the notice may leave before they are respect to vaccination, this rule conscience and anti-discrimination laws treated. provides for enforcement of 42 U.S.C. and this implementing rule would likely Response: The Department disagrees. 1396s(c)(2)(B)(ii), which requires increase the diversity of providers and The regulations enacted under the providers of pediatric vaccines funded health care professionals, thus Emergency Medical Treatment and by Federal medical assistance programs providing patients more tailored options Active Labor Act at 42 CFR 489.20(q)(1) to comply with any State laws relating and higher quality service on average. require that public notices be posted in to any religious or other exemptions, but Finally, the Department does not believe emergency rooms to inform patients of this rule does not create a new that, when members of the public are the requirements of EMTALA. substantive conscience protection simply informed about Federal laws, Furthermore, while the Department concerning vaccination, nor does it they are thereby dissuaded from disagrees that a notice of Federal require a State to adopt such an engaging in conversation with their conscience and anti-discrimination laws accommodation. In investigating a health care providers. would in any way discourage a patient complaint or conducting a compliance Comment: The Department received seeking emergency treatment, a patient’s review, OCR will consider an entity’s comments stating that the proposed rule voluntary refusal to seek treatment voluntary posting of a notice of was unclear as to who is responsible for would not be a violation of EMTALA. nondiscrimination as non-dispositive posting the notice required by § 88.5. Comment: The Department received a evidence of compliance with the Response: Paragraph (a) in § 88.5 comment proposing that, instead of applicable substantive provisions of this states that ‘‘the Department and each specifying particular locations for the part, to the extent such notices are recipient’’ should post the notice text. notice to be placed, the rule instead provided according to the provisions of Because the notice provisions in the require covered entities to provide the this section and are relevant to the rule will now be voluntary, this notice using the same means that such particular investigation or compliance provision is deleted from § 88.5(a) as entities regularly use to provide review. finalized. Nevertheless, because the important notices. Comment: The Department received a voluntary posting of notices may be Response: The Department believes comment stating that the statutes considered by the Department in its that the proposed rule’s specificity with referenced by the proposed notice in handling of complaints and compliance respect to how to place the notice appendix A do not apply to health plan reviews, entities specifically subject to provides appropriate guidance on how employees and, thus, the proposed this rule (such as certain recipients of to effectively communicate its content notice is overly broad. Federal funds) would be the appropriate to the intended audiences. Because the Response: While the Department parties for ensuring that such notices are notice provisions are now voluntary, but disagrees that the statutes referenced by posted if they chose to post them. the posting of such notices would be the proposed notice cannot apply to Comment: The Department received considered as positive evidence of health plan employees, the Department comments stating that health insurance compliance, covered entities will have agrees that the proposed appendix A issuers should not be required to flexibility regarding whether, how, and 2 S

E could be misleading for a particular where they post notices. At the same L provide the notice to the public. U R

entity, and has modified both § 88.5 to Response: To the extent the time, if entities post notices only in h t i w

provide greater flexibility as to content commenters took this position because contexts or ways where persons to D

O and appendix A to provide a more they did not believe that the protections whom the notices are directed are not R P 2

8 accurate model notice as to the of the Federal conscience and anti- likely to receive the benefit of the 0 Q

L protections provided by the Federal discirmination laws would apply to notices, the Department will take that G 3 K S D n o l l e

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into consideration in investigations and paragraph (b)(2) in the proposed rule to determination of violation is made. The compliance reviews. The notice paragraph (b)(6) in the final rule. Department disagrees that such records provisions under this final rule provide of violations are unnecessary as to Compliance Requirements (§ 88.6) appropriate suggestions for effective future awards of Federal financial placement while still acknowledging This section of the proposed rule assistance or Departmental funding, that not all circumstances are identical. identified specific requirements for because the Department does not Comment: The Department received compliance with the Federal conscience maintain records of all such findings in comments stating that there should be and anti-discrimination laws. The a manner that is generally accessible to no exceptions to the notice requirement Department proposed to subject funding components across the in § 88.5. recipients to the imposition of funding Department. Response: The Department restrictions and other appropriate Therefore, the Department is revising appreciates the comments, but has remedies if they or a sub-recipient is the reporting requirements under § 88.6 decided not to finalize the notice found to have violated a Federal to reduce the burden on covered entities provision as a requirement. The notice conscience and anti-discrimination law. and to eliminate the reporting provision is being finalized as a The Department proposed to require requirements in situations in which voluntary best practice that the recipients, sub-recipients, and agency such reports are unnecessary or Department will consider in complaint components to maintain records redundant with actions that will be investigation and compliance reviews. evidencing compliance with these laws taken by the Department. The final rule Summary of Regulatory Changes: For and the proposed rule and to require retains the requirement that recipients the reasons described in the proposed such entities to cooperate with any OCR or sub-recipients subject to a rule and above, and considering the compliance review or investigation determination by OCR of comments received, the Department (including by producing documents or noncompliance with this part must, in finalizes § 88.5 with changes so that participating in interviews). The any application for new or renewed notices are not required, but will be a proposed rule further would require Federal financial assistance or voluntary best practice that may recipients and sub-recipients to inform Departmental funding following such demonstrate compliance in any OCR any Departmental funding component, determination, disclose the investigation. The rule specifies that and to disclose, on applications for determination of noncompliance. The OCR may, in investigating complaints Departmental funding, the existence of rule also clarifies that applicants must and conducting compliance reviews, any OCR compliance review, also disclose OCR determinations made consider the extent to which covered investigation, or complaint under the against their sub-recipients under entities post notices according to the rule. This section also addressed claims previous or existing contracts, grants, or rule’s notice provisions as non- in the event a covered entity intimidates other instruments providing Federal dispositive evidence of compliance with or retaliates against those who complain financial assistance. Sub-recipients substantive provisions of the rule to OCR or participate in or assist in an would only have to disclose findings applicable to covered entities. The OCR enforcement action. The made against them if they are seeking section also now permits recipients to Department received comments new or renewed funding as recipients of draft their own version of the notice, or suggesting improvements to this section, HHS funds or Federal financial to combine the notice with other non- as well as comments generally assistance. The final rule shortens the discrimination notices, to allow greater supporting proposed § 88.6. period for reporting from five years to accuracy, flexibility, and tailoring to Comment: The Department received three years. their particular circumstances. The comments stating that it is unduly Comment: The Department received Department also changes the section to burdensome and unnecessary to require comments stating that none of the reflect that, while guidance regarding recipients to report to the Department Federal conscience and anti- particular placement of notices remains funding component all compliance discrimination laws authorize the a factor for compliance consideration reviews, investigations, and complaints Department to require record-keeping, purposes, all notice placement when they occur and to disclose any conduct compliance reviews, or provisions may not be applicable or compliance review, investigation, or investigate complaints. appropriate to all covered entities. The complaint for five years prior in any Response: As discussed supra at part Department also changes the section to application for new or renewed Federal III.A, various statutes and regulations remove the requirement that the notice financial assistance or Departmental authorize the Department to issue these be posted within 90 days of the funding. Commenters noted that such regulations. The Department, and publishing of the rule, or, with respect requirements are burdensome on the entities to which this rule applies, are to new recipients, within 90 days of covered entities, are unnecessary if an required by statute to comply with becoming a recipient, to reflect that investigation found no violation, and various Federal conscience and anti- posting of the notice is voluntary and require the covered entity to provide the discrimination laws. Inherent in that there is no mandated time frame Department with information that the Congress’s adoption of the statutes that within which a notice must be posted. Department should already have. require the recipients of Federal funds The Department agrees that The Department also changes the Response: from the Department to comply with section to include, in paragraphs (b)(3) such reporting requirements are certain Federal health conscience and (4), ‘‘the Department’’ in addition to unnecessary in situations in which an statutes is the authority of the investigation has found no violation. Department to take measures to ensure recipients, for additional clarity. The Department also agrees that the compliance. Further, complaint Finally, the Department makes a provision of such reports to funding investigation, compliance reviews, and 2

S technical change to relocate the

E components of the Department for record-keeping are standard measures L

U proposed rule’s provision regarding the R

already awarded Federal financial that the Department employs with h t i readability of the notice text from w

assistance or Departmental funding is respect to the grants and contracts that D

O unnecessary because the Office for Civil it issues—to ensure compliance with R 83 FR 3880, 3897–98 (stating the reasons for P 2

8 the proposed § 88.5, except for the modifications Rights can notify such funding requirements imposed by Congress with 0 Q

L adopted herein). components at the time such a respect to particular programs and on G 3 K S D n o l l e

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recipients of Federal funds, including regulations implementing section 504 of Summary of Regulatory Changes: For statutory non-discrimination the Rehabilitation Act, and the the reasons described in the proposed requirements. Below, the Department Department or the Department of Justice rule and above, and considering the discusses in more detail objections to imposed similar requirements in comments received, the Department the Department’s authority to conduct regulations under Title II of the finalizes § 88.6 with substantial changes compliance reviews. Americans with Disabilities Act, the as described above, by making a Issuing this rule as finalized provides Age Discrimination Act of 1975, and technical correction to provide OCR for the application and imposition of Title IX of the Education Amendments with greater enforcement discretion standard Departmental terms, of 1972. And HHS regulations under concerning the responsibility of conditions, and procedures to ensure Title VI, Age Discrimination Act of recipients for violations of the rule by compliance by recipients with statutory 1975, and Titles VI and XVI of the sub-recipients, by changing ‘‘shall’’ to non-discrimination requirements, Public Health Service Act generally ‘‘may’’ in paragraph (a); by providing pursuant to the Department’s authorities require that a recipient maintain records greater specificity as to the records discussed supra at part III.A. Those necessary to determine whether the covered entities are required to maintain authorities allow, among other things, recipient has complied with the law. and for how long in paragraphs (b)(1) the imposition of terms and conditions Comment: The Department received a through (3); by making a technical on grant awards, contracts, and other comment requesting that the correction to provide greater clarity on funding instruments, and authorize the requirements of § 88.6 not go into effect how a covered entity’s failure to Department to require certain until at least one year after the cooperate may result in an OCR referral information from entities applying for publication of the final rule. to the Department of Justice by inserting such funds. Response: The Department believes ‘‘in coordination with the Department’s Comment: The Department received that covered entities will have sufficient Office of General Counsel’’ in paragraph comments requesting more specificity as time to begin abiding by the (c); by making a technical correction, in to how long records should be requirements of § 88.6 60 days after the keeping with the Department’s intent for maintained, in what form or manner publication of this final rule. To the § 88.6 to mirror Title VI enforcement they should be maintained, and what extent that entities have specific reasons regulations where applicable, to add a content such records should include. why they cannot comply within that provision regarding the time and Response: The Department agrees that timeframe, the Department will consider manner of OCR’s access to records, and greater specificity as to the records that exercising enforcement discretion and the applicability of confidentiality and should be maintained, how long such take those reasons into consideration privacy concerns to OCR’s access in records should be maintained, and in during any investigation of complaints paragraph (c); by shortening from five what format such records should be that may arise. years to three years in paragraph (d) the kept is appropriate. Therefore the Comment: The Department received period for disclosing in any application Department will finalize the rule with comments requesting that the for new or renewed Federal financial modifications specifying that records (1) imposition of funding restrictions or assistance or Departmental funding any shall be maintained for a period of three other remedies on recipients based on determination by OCR of years from the date the record was their sub-recipients’ violations of noncompliance to reduce the burden on created, was last in force, or was Federal conscience and anti- covered entities; by revising reporting obtained, by the recipient or sub- discrimination laws be made requirements in paragraph (d) to reduce recipient; (2) shall contain any discretionary instead of mandatory the burden on covered entities by information maintained by the recipient because some recipients may have eliminating reporting requirements in or sub-recipient that pertains to limited control over their sub-recipients. situations in which such reports are discrimination on the basis of religious Response: As with other anti- unnecessary or redundant with actions belief or moral conviction, including discrimination regulations OCR taken by the Department, such as any complaints; statements, policies, or enforces, such as the Age disclosing the existence of complaints, notices concerning discrimination on Discrimination Act (45 CFR 90), Title IX compliance reviews, or investigations in the basis of religious belief or moral (45 CFR 86), and Title VI (45 CFR 80), any application for new or renewed conviction; procedures for this rule assures that Federal funds Federal financial assistance or accommodating employees’ or other channeled from recipients to sub- Departmental funding; and by making a protected individuals’ religious beliefs recipients do not become immune to the technical correction at the end of or moral convictions; and records of protections provided by conscience and paragraph (d) to clarify that recipients requests for such religious or moral associated anti-discrimination laws. The disclose any OCR determinations made accommodation and the recipient or Department, however, agrees that the against their sub-recipients. rule should reflect greater enforcement sub-recipient’s response to such Enforcement Authority (§ 88.7) requests; and (3) may be maintained in discretion, and will finalize § 88.6(a) by any form and manner that affords OCR changing ‘‘shall’’ with respect to the This section of the proposed rule with reasonable access to them in a imposition of funding restrictions ‘‘and’’ reaffirmed the delegation to OCR of the timely manner. These modifications are other remedies to read ‘‘may’’ and ‘‘or,’’ Department’s authority to enforce the consistent with recordkeeping respectively. Federal conscience and anti- requirements employed in other civil discrimination laws, in collaboration rights regulations. For example, the requirements of this part and, to the extent with the relevant Department Department of Justice imposed three- modification of any such services, policies, and components. The Department also noted

2 practices is required, the public entity shall proceed S year record maintenance for self- that OCR has been expressly delegated E to make the necessary modifications.’’ 28 CFR L

U evaluations required under the authority to enforce the Church,

R 35.105(a). h t i See 45 CFR 84.6(c) and 85.11(c), 28 CFR Coats-Snowe, and Weldon Amendments w

D See, e.g., ‘‘A public entity shall, within one 35.105(c), 45 CFR 90.43(b), and 45 CFR 86.3(d), O

R year of the effective date of this part, evaluate its respectively. 83 FR 3880, 3898 (stating the reasons for the P 2

8 current services, policies, and practices, and the See 45 CFR 80.6(b), 45 CFR 90.42(a) and 91.31, proposed § 88.6, except for the modifications 0 Q

L effects thereof, that do not or may not meet the and 42 CFR 124.605(b), respectively. adopted herein). G 3 K S D n o l l e

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since the 2008 Rule, which was rule should establish notice, hearing, nondiscrimination statutes, such as reaffirmed in the 2011 Rule. and appeal procedures similar to those Title VI of the Civil Rights Act of 1964, Enforcement of section 1553 is also established in the Department’s do not explicitly mention them. expressly delegated to OCR in the ACA. regulations implementing Title VI of the Executive Order 12250 directed the The NPRM provided notice that the Civil Rights Act of 1964, at 45 CFR Attorney General to implement Secretary delegated to OCR the 80.8–80.10. The Department also regulations that addressed authority to enforce all Federal requested comment on whether and in investigations and compliance reviews conscience and anti-discrimination laws what circumstances it would be for the Federal nondiscrimination that were the subject of the proposed appropriate to require remedies against statutes. The order also directed rule. a recipient for the violations of a sub- agencies administering Federal This section also proposed to specify recipient, or against entities’ nondiscrimination statutes to that OCR’s enforcement authority would subsidiaries that are found to be in implement directives, via either policy include the authority to handle violation of any Federal conscience and guidance or regulations, consistent with complaints, perform compliance anti-discrimination law or the proposed the Attorney General’s regulations. reviews, investigate, and seek regulation. Regulations subsequently promulgated appropriate action (in coordination with The Department received comments by the Department of Justice regarding the leadership of any relevant HHS on this section, including those coordination of Title VI compliance, component) that the Director deems generally supporting the proposed pursuant to Executive Order 12250, necessary to remedy the violation of § 88.7. interpret Title VI as authorizing Federal Federal conscience and anti- Comment: The Department received agencies to conduct compliance reviews discrimination laws and the proposed comments stating that the Federal for Title VI enforcement. See, e.g., 28 regulation, as allowed by law. The conscience and anti-discrimination laws CFR 42.407(c)(1) (‘‘Federal agencies proposed text of § 88.7 of this part do not provide the Department with the shall establish and maintain an effective would provide OCR discretion in authority to conduct compliance program of post-approval compliance choosing the means of enforcement, reviews under these statutes or to reviews regarding approved new from informal resolution to more engage in the investigatory actions applications (see 28 CFR 50.3(c) II A), rigorous enforcement leading to, for provided for in § 88.7. The Department applications for continuation or renewal example, funding termination, as also received a comment stating that of assistance (28 CFR 50.3(c) II B) and appropriate to the particular facts, law, conducting a compliance review all other federally assisted programs.’’). and availability of resources. without having received a complaint is Nevertheless, in order to address The Department also proposed to unreasonable. these concerns, the Department is explicitly establish its authority to Response: Inherent in Congress’s finalizing § 88.7(c) with certain changes investigate and handle (a) alleged adoption of the statutes that require the to clarify that OCR may conduct violations and conduct compliance recipients of Federal funds from the compliance reviews based on reviews whether or not a formal Department to comply with certain information from a complaint or other complaint has been filed, and (b) Federal health conscience statutes is the source that causes OCR to suspect non- ‘‘whistleblower’’ complaints, or authority of the Department to take compliance by an entity subject to the complaints made on behalf of others, measures to ensure compliance. This is rule. whether or not the particular especially true in light of the fact that Comment: The Department received complainant is a person or entity courts have refused to recognize private comments stating that, to provide clarity protected by Federal conscience and rights of action under certain statutes for covered entities and to ensure anti-discrimination laws. that are the subject of this rule, thus fairness of enforcement, potential In this section of the proposed rule, leaving victims of unlawful penalties set forth in the rule should be the Department proposed to adopt the discrimination with no possible remedy clear and uniform. enforcement procedures for other civil without the Department’s intervention. Response: The Department agrees rights laws, such as Title VI and section Further, under the various statutes and with this comment in part. Potential 504 of the Rehabilitation Act, for the regulations governing HHS grants, penalties vary among the Federal Federal conscience and anti- contracts and other programs discussed conscience and anti-discrimination laws discrimination laws. The Department in part III.A above concerning the as set by Congress. In addition, to the solicited comments on what authority to issue this rule, the extent penalties may be imposed administrative procedures or Department has authority to ensure that involuntarily, regulations such as those opportunities for due process the both it, and covered entities, are that apply to HHS grants, contracts, and Department should, as a matter of spending Federal funds and operating CMS programs discussed above provide policy, or must, as a matter of law, programs consistent with Federal laws a well-established process for enforcing provide (1) with respect to the remedial applicable to those funds and programs. compliance with the terms and and enforcement measures that the The Secretary similarly has authority conditions of grants and contracts and Department may consider imposing or under 5 U.S.C. 301 to prescribe programmatic regulations that require utilizing in response to a failure or regulations for the government of the compliance with certain non- threatened failure to comply with Department and the distribution and discrimination provisions. Federal conscience and anti- performance of its business. Providing Consequently, in order to increase the discrimination laws or this part, (2) for Departmental procedures to ensure clarity and uniformity of involuntary before the Department may terminate compliance, including to undertake remedial processes applied through this Federal financial assistance or other compliance reviews, falls under such rule, the Department has concluded that 2 S

E Federal funds from the Department, or penalties imposed involuntarily under L authorities. U R

(3) before the Department may As for their reasonableness, this rule will be imposed through those h t i w

implement any or all of the remedial compliance reviews are a standard tool applicable regulations, such as 45 CFR D

O measures identified in § 88.7(i)(3) of the for ensuring compliance with Federal part 75, or the FAR and HHSAR. This R P 2

8 proposed rule. For example, comment nondiscrimination statutes, despite the is preferable both to an independent 0 Q

L was requested on whether the proposed fact that most Federal framework mirroring those of Title VI G 3 K S D n o l l e

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and section 504 of the Rehabilitation penalties violate the Spending Clause of Justice. Additionally, the Department of Act, as the Department had proposed, the Constitution because, for Congress Justice would be the appropriate party and to a new set of uniform penalties as to place a condition on receipt of to receive referrals of potential the commenter may have been Federal funds by a State, the condition violations of 42 U.S.C. 300a–8 which proposing. Under this rule, in the event placed on the State must be imposes criminal penalties on any the Department deems that involuntary unambiguous, and the amount in officer or employee of the United States, remedies may be appropriate, OCR will question cannot be so great that it can or of any entity that administers coordinate with the relevant funding be considered coercive to the State’s federally funded programs (including component(s) of HHS in pursuing such acceptance of the condition. States), and on any person receiving remedies. Response: The Department disagrees. Federal financial assistance, who Comment: The Department received a The substantive requirements of laws coerces or endeavors to coerce any comment stating that conducting a enforced by this rule were set forth by person to undergo an abortion or compliance review without having Congress, and the Department is not sterilization procedure by threatening received a complaint is unreasonable. aware of any successful Spending such person with the loss of, or Response: The Department disagrees. Clause challenge to such laws, even disqualification for the receipt of, any The Department’s Office for Civil Rights though some of those laws have existed benefit or service under a program routinely conducts compliance reviews for decades. The Department believes receiving Federal financial assistance. to ensure covered entities follow the the conditions and requirements As a result, the Department finalizes the requirements of other Federal civil imposed on the States by the Federal rule by amending § 88.7(i) (renumbered rights laws, as well as the Health conscience and anti-discrimination laws as § 88.7(h)) to clarify that possible Insurance Portability and are unambiguous, and that these rules, appropriate referrals to the Department Accountability Act of 1996 and its in mirroring those requirements, are of Justice include potential violations of associated regulations. Providing for similarly clear. The Department has 42 U.S.C. 300a–8 and 18 U.S.C. 1001. compliance reviews to ensure that provided a clear description of entities Comment: The Department received Federal conscience and anti- to which each such statute applies, and comments stating that health care discrimination laws are not violated of what is required of each entity in entities should not be subject to the brings the Department’s ability to § 88.3 of this rule and elsewhere. Only mechanisms in § 88.7 unless a enforce such laws into parity with other after a violation has been found should discriminated-against employee had civil rights laws that the Department the question of the appropriate remedy provided prior notice to the entity of the enforces. available under the law be answered. employee’s religious beliefs or moral Comment: The Department received It is the consistent policy of the convictions. comments stating that proposed § 88.7 Federal government to presume that Response: While the Department does not provide for adequate due statutes passed by Congress and signed encourages employers and employees to process. by the President are constitutional. openly discuss religious and moral Response: The Department agrees in Funding remedies in cases of violations convictions that may impact which part, and is finalizing the rule to make under this rule will be applied services or tasks the employer may ask use of remedial processes under other consistently with the Constitution and of employees, where Federal conscience existing HHS regulations. As clarified relevant case law. The Department’s and anti-discrimination laws do not herein, where OCR is not able to reach decision to finalize this section to make require prior notice of religious beliefs a voluntary resolution of a complaint use of existing remedial mechanisms or moral convictions, neither does this with a covered entity, involuntary under longstanding HHS regulations rule. In other situations involving enforcement will occur by the applicable to certain funding religious accommodations, the Supreme mechanisms established in the instruments, with OCR coordinating Court has held that notice is not Department’s existing regulations, such with HHS funding components, will required. Nevertheless, during as those that apply to grants, contracts, also ensure that remedies imposed will complaint investigations and or CMS programs, with OCR be consistent with any constitutional compliance reviews, the Department coordinating with the relevant funding concerns. takes into consideration facts such as component(s) of HHS. In those Comment: The Department received a whether the covered entity knew or instances, the due process available comment stating that referral to the should have known about the objection. under the applicable regulations will be Department of Justice for additional Comment: The Department received a available to covered entities. For enforcement is not provided for in any comment stating that imposing the example, 45 CFR 75.374 provides for of the Federal conscience and anti- penalties described in § 88.7(j)(3) opportunities for grantees to object, discrimination laws. (renumbered as § 88.7(i)(3)) on the basis obtain hearings, and seek appeals when Response: The Department of Justice of a ‘‘threatened failure’’ to comport the Department or a component take a acts as the Department’s representative with the Federal conscience and anti- remedy for grantee non-compliance. in court, and the Department routinely discrimination laws is excessive. Consistent with this approach, the refers matters that require litigation on Response: The Department agrees and language of § 88.7(a) is finalized with its behalf, or on behalf of the United is removing the phrase ‘‘threatened changes to clarify that the Director of States, to the Department of Justice failure’’ from § 88.7(j)(3) (renumbered as OCR is authorized to pursue voluntary including laws enforced by OCR. § 88.7(i)(3)). resolutions of complaints, and that Furthermore, entities that make Comment: The Department received a remedial action beyond that will occur assurances or certifications of comment stating that § 88.7 threatens all compliance under § 88.4, or that make

2 through coordination of OCR with S

E other statements or productions to the L funding components, consistent with See, e.g., EEOC v. Abercrombie & Fitch Stores, U R applicable laws and regulations. Department under this part, do so under Inc., 135 S. Ct. 2028, 2033 (2015) (stating that h t i importation of a notice requirement would ‘‘add w Comment: The Department received a penalty of 18 U.S.C. 1001 (prohibiting D words to the law’’ and that a prior request for O materially false statements regarding an R comment stating that the proposed accommodation ‘‘may make it easier to infer P 2

8 agency matter), violations of which may motive, but is not a necessary condition of 0 Q

L 45 CFR 160.308. warrant referral to the Department of liability.’’). G 3 K S D n o l l e

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funding streams for any violation of the components when remedial actions are who have objections to abortion, fertility Federal conscience and anti- pursued, and such remedies will be treatments, sterilization, assisted discrimination laws. pursued under regulations applicable to suicide, and euthanasia, among others. Response: The Department disagrees. relevant funding instruments, rather The Department proposed to uphold the The only funding streams threatened by than under an independent enforcement maximum protection for the rights of a violation of the Federal conscience framework set forth in this rule as had conscience and the broadest prohibition and anti-discrimination laws are the been proposed. Consistent with changes on discrimination provided by Federal, funding streams that such statutes made to the definition of State, or local law, as consistent with directly implicate. The Department ‘‘discrimination’’ regarding the the Constitution. Where a State or local cannot terminate funding for violation applicability of disparate impact law provides as much or greater of a Federal conscience or anti- analysis, the Department deletes the protection than Federal law for religious discrimination law unless Congress has phrase ‘‘to overcome the effects of freedom and moral convictions, the applied that law to that funding. Section violations of Federal conscience and Department proposed not to construe 88.7 is intended to provide a general anti-discrimination laws and this part’’ Federal law to preempt or impair the description of the range of possible from § 88.7(a)(8). The Department application of that law, unless expressly enforcement mechanisms available to deletes the phrase ‘‘from time to time’’ provided. the Department, not an exhaustive list of from § 88.7(c) and, in place of the The Department noted that the actions to be taken for each violation or sentence ‘‘OCR may conduct these proposed rule would not relieve OCR of prescribed amounts. Termination of reviews in the absence of a complaint,’’ its obligation to enforce other civil funding as a possible remedy is a adds the sentence ‘‘OCR may initiate a rights authorities, such as Title VI of the necessary corollary of Congressional compliance review of an entity subject Civil Rights Act of 1964, Title IX of the requirements that certain funding not be to this part based on information from Education Amendments of 1972, the provided to entities that engage in a complaint or other source that causes Age Discrimination Act of 1975, section impermissible discrimination. OCR to suspect non-compliance by such 504 of the Rehabilitation Act of 1973, Nevertheless, OCR commonly entity with this part or the laws and the Americans with Disabilities Act investigates complaints under civil implemented by this part.’’ The of 1990. The Department affirmed that rights laws that permit termination of Department also adds certain criminal OCR would enforce all civil rights laws funding on a finding of a violation, and statutes as possible bases of referrals to consistent with the Constitution and the yet OCR only rarely imposes the Department of Justice under statutory language. The Department termination of funding as a penalty for § 88.7(h); and removes the phrase received comments on this section. such violations. For example, under ‘‘threatened failure’’ from § 88.7(j)(3) of Comment: The Department received HIPAA, civil monetary penalties are not the proposed rule (renumbered as comments stating that the proposed rule uncommon, although they still § 88.7(i)(3) in this final rule). The conflicted with other Federal laws, such represent the minority of resolutions to Department also makes a technical as Title X of the Public Health Service cases where a violation was found to the correction, in order to maintain Act, that were raised in comments satisfaction of the Department. In civil consistency of terminology, to replace related to other provisions of the rights cases, complaint investigations in the phrase ‘‘cash payments’’ with proposed rule. which OCR finds a violation are usually ‘‘Federal financial assistance’’ in Response: Issues of potential statutory resolved by corrective action. What § 88.7(j)(3)(i) of the proposed rule conflict have already been raised by specific remedy is appropriate in the (renumbered § 88.7(i)(3)(i) in this final other comments and answered in case of a particular violation depends on rule); makes technical changes to responses set forth above, so they are the facts and circumstances, and OCR § 88.7(a); adds reference to coordination not repeated here. does not prejudge those facts in this rule with the Department’s Office of General Comment: The Department received to suggest termination of funding will be Counsel to § 88.7(a)(6) and (h); makes a comments stating that the proposed rule either a common or an uncommon stylistic change to § 88.7(d), including violates 42 U.S.C. 18114, a section of the ACA that states that, notwithstanding outcome. The Department simply the deletion of ‘‘health care,’’ any other provision of ACA, the observes that, just because the rule ‘‘associated,’’ ‘‘the,’’ and ‘‘but not Secretary shall not promulgate any provides for termination of funding as a limited to;’’ removes proposed § 88.7(e), regulation that creates any unreasonable possible corrective action, does not which discussed destruction of barriers to the ability of individuals to mean that funding, either in whole or in evidence; makes an edit for clarity and obtain appropriate medical care, part, will be terminated in all or even readability to relocate the phrase ‘‘in impedes timely access to health care most cases. It would be premature and whole or in part’’ within paragraph services, interferes with contrary to the history of OCR (i)(3)(v); for greater accuracy replaces communications regarding a full range enforcement to deem this rule as a ‘‘created by Federal law’’ with ‘‘under of treatment options between the patient requirement that OCR terminate all, or Federal law or this part’’ in paragraph and the provider, restricts the ability of even some, funding of all entities found (i)(3)(vi); and inserts a new § 88.7(j) to health care providers to provide full to have committed a violation. specifically address handling of disclosure of all relevant information to Summary of Regulatory Changes: For noncompliance with assurances and the reasons described in the proposed certifications, as discussed above. patients making health care decisions, violates the principles of informed rule and above, and considering the Relationship to Other Laws § 88.8 consent and the ethical standards of comments received, the Department finalizes § 88.7 by making the changes This section would clarify the health care professionals, or limits the relationship between this part and other availability of health care treatment for 2

S discussed above, which include

E Federal, State, and local laws that the full duration of a patient’s medical L

U clarifying that OCR will serve a R

protect religious freedom and moral needs. Such comments argued that the h t i coordinating role with other Department w

convictions. In the proposed rule, the proposed rule would violate this section D

O preamble for this section acknowledged by permitting providers to observe their R 83 FR 3880, 3898–3899 (stating the reasons for P 2

8 the proposed § 88.7, except for the modifications that many State laws provide additional consciences when responding to a 0 Q

L adopted herein). conscience protections for providers patient’s request for a particular medical G 3 K S D n o l l e

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service or treatment, or when section 1554, 42 U.S.C. 18114, Congress or interferes with doctor-patient determining whether or not to refer for intended to prohibit the enforcement of communications. The underlying a particular medical service or ACA sections 1303(b)(1)(A) and (b)(4) statutes enforced by this rule apply, or treatment, instead of requiring providers and 1553 as written. Generally, one part do not apply, to communications to comply with such requests by of a statute should not be interpreted to between a patient and provider of their patients. negate many other parts of the same own force, and this final rule does not Response: The Department disagrees. statute, because that would render those ‘‘interfere’’ in those communications ACA section 1554, 42 U.S.C. 18114, in parts of the statute meaningless. merely by protecting conscience rights no way negates the Federal conscience Fourth, even assuming that section established by Congress. and anti-discrimination laws enforced 1554 applies, it must be construed in by this rule. First, section 1554 is harmony with the ACA conscience Comment: The Department received limited to regulations promulgated provisions, as well as the other Federal comments alleging that the proposed under the ACA. Only a minority of the conscience protections, especially in rule conflicts with the Americans with laws implemented by this rule are set light of section 1303(c)(2) that nothing Disabilities Act, 42 U.S.C. 12101 et seq., forth in the ACA—most, including for in the ACA shall be construed to have or the Rehabilitation Act, 29 U.S.C. 701 example the Church Amendments, the any effect on Federal laws regarding et seq., because health care providers Coats-Snowe Amendments, and the conscience protection: There is a may exercise their religious beliefs or Weldon Amendment, are not part of the presumption that Congress does not moral convictions to refuse to treat ACA, and therefore regulations silently repeal its own statutes, but it patients with HIV, or may decline to implementing those statutes are not intends multiple statutes to be read provide an abortion to a woman with a affected by section 1554. without conflict. And this is the manner life-threatening condition. Second, it is a basic principle that in which the Department interprets Response: The Department is unaware Congress ‘‘does not alter the section 1554. fundamental details of a regulatory Fifth, again, even assuming that of any religious or ethical belief systems scheme in vague terms or ancillary section 1554 applies, this Final Rule that prohibit treatment of persons on the provisions—it does not, one might say, does not ‘‘create[ ] any unreasonable basis of their HIV status. Additionally, hide elephants in mouseholes.’’ barriers to the ability of individuals to the Department disagrees that there is a Whitman v. Am. Trucking Ass’ns, 531 obtain appropriate medical care.’’ The conflict between the requirements of U.S. 457, 468 (2001). It is implausible protections enforced by this rule are this rule and the Americans with that Congress intended section 1554 to duly enacted laws, passed by Congress Disabilities Act or the Rehabilitation Act impliedly repeal Federal conscience and signed by the President. Such under the hypotheticals presented. No protections when section 1554 contains protections are, by definition, regulation can, of its own force, no reference to conscience whatsoever— reasonable under 42 U.S.C. 18114. supersede statutes enacted by Congress and when, at the same time and in the Further, by removing or reducing unless such statute is superseded or same legislation, Congress added several barriers that discourage health care limited by another act of Congress. This new conscience provisions (e.g., ACA providers from remaining in the health rule merely provides the Department sections 1303(b)(1)(A) and (b)(4), 1553), care industry, this rule promotes with the means to adequately enforce as well as a provision that nothing in diversity and full participation of the Federal conscience and anti- the ACA shall be construed to have any providers in health care generally and in discrimination laws to the extent effect on Federal laws regarding HHS-funded programs in particular, and permissible under the laws of the conscience protection; willingness or enhances the ability of individuals to United States and the Constitution. See refusal to provide abortion; and obtain appropriate medical care. As for Maher v. Roe, 432 U.S. 464 (1977) discrimination on the basis of the the compliance with 42 U.S.C. 18114’s (holding that government may favor willingness or refusal to provide, pay provisions concerning timely access to childbirth over abortion through public for, cover, or refer for abortion or to health care services or for full duration funding); Harris v. McRae, 448 U.S. 917 provide or participate in training to of a period of medical need, this rule (1980) (upholding laws limiting Federal provide abortion (e.g., ACA section does not limit a health care provider’s funding of abortions). 1303(c)(2)). ability to provide timely care and Third, ‘‘it is a commonplace of appropriate care, and for the reasons Comment: The Department received a statutory construction that the specific just discussed, should result in a greater comment alleging that the proposed rule governs the general,’’ Morales v. Trans number of providers and thus more conflicts with international treaties, World Airlines, Inc., 504 U.S. 374, 384 timely and complete care overall. such as the International Covenant on (1992). Each Federal conscience and Additionally, as discussed in response Civil and Political Rights (‘‘ICCPR’’), anti-discrimination law enforced by this to a previous comment above, the which includes a ‘‘right to health,’’ and rule is more specific to each set of Emergency Medical Treatment and the International Covenant on circumstances than is section 1554, so Labor Act (EMTALA) would not be Economic, Social and Cultural Rights that, to the extent there could be a displaced by the rule, and requires (‘‘ICESCR’’), which describes four potential conflict between the statutes, provision of treatment in certain components of the right to health as the more specific Federal conscience emergency situations and facilities. As availability, accessibility, acceptability and anti-discrimination laws require for 42 U.S.C. 18114’s provisions and quality. that section 1554 not be interpreted to concerning informed consent and supersede them. For example, to the interference with communications and Response: The Department disagrees extent this rule enforces specific the ability for doctors and patients to that the proposed rule conflicts with the 2

S ICCPR. The ICCPR does not include a E provisions of the ACA, such as ACA

L communicate freely, the Department

U ‘‘right to health’’ as described by the R

sections 1303(b)(1)(A) and (b)(4) and addressed similar concerns in response h t i commenter. Instead, the ICCPR includes w

1553, the rule enforces those laws to several comments above and D

O according to their own text. The incorporates such responses here by ‘‘public safety, order, health, or morals’’ R P

2 as a permitted limitation on certain

8 Department disagrees with the reference. Moreover, nothing in this rule 0

Q fundamental rights, such as free speech L commenter’s implication that, in ACA restricts the doctor-patient relationship G 3 K S D n o l l e

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and religious liberty. When the accommodate an objector without protections, and, therefore, the scope Senate ratified the ICCPR, however, it violating this rule. of rights defined by either case cannot did so subject to a declaration ‘‘[t]hat it Comment: The Department received be read to conflict with conscience is the view of the United States that comments stating that the proposed rule protections relating to abortion. This States Party to the Covenant should could harm efforts to assist persons with rule, additionally, furthers the wherever possible refrain from imposing substance use disorder because a health legitimate governmental interest in any restrictions or limitations on the care provider may hold a religious or ensuring a large and diverse pool of exercise of the rights recognized and moral conviction that drug use should health care providers by removing protected by the Covenant, even when be treated as a moral or criminal matter obstacles to persons who are interested such restrictions and limitations are instead of a medical matter. in serving as health care providers but permissible under the terms of the might be unwilling to do so for fear of Response: This rule does not conflict Covenant.’’ Additionally, the Senate being coerced to violate their religious with any Federal statutes that would ratified the ICCPR with the beliefs or moral convictions. require the treatment of persons understanding that the ICCPR is not Comment: The Department received suffering from substance use disorder, self-executing. comments stating the proposed rule because no regulation can, of its own The Department also disagrees that would violate the Establishment Clause force, supersede statutes enacted by the proposed rule conflicts with the by providing for an affirmative Congress. This rule merely provides the ICESCR. First, the description of the accommodation for religious beliefs that Department with the means to ICESCR provided by the commenter is burden a third party. adequately enforce the Federal incorrect. The ICESCR simply requires Response: The Department disagrees conscience and anti-discrimination laws that ‘‘States Parties to the present that religious accommodations such as to the extent permissible under the laws Covenant recognize the right of those provided by Congress and of the United States and the everyone to the enjoyment of the highest enforced by this rule violate the Constitution. The Department is attainable standard of physical and Establishment Clause. Congress began unaware of any faith community that mental health.’’ Additionally, the enacting laws such as the Church holds the views identified by the United States has not ratified the Amendments in 1973, and none of them commenter. To the contrary, the ICESCR; thus, it is not binding. have been invalidated under the Department’s experience reveals that Nevertheless, because the Department Establishment Clause. As the Supreme many members of the faith community believes, as described elsewhere in this Court recognized in Corporation of are actively involved and voluntarily preamble, that this rule will increase Presiding Bishop of the Church of Jesus play an important role in efforts to help access to and quality of health care in Christ of Latter-day Saints v. Amos, ‘‘the address the opioid crisis and other government may (and sometimes must) America, this rule furthers the goals of substance use disorders. accommodate religious practices and the ICESCR. . . . it may do so without violating the Comment: The Department received a Comment: The Department received Establishment Clause.’’ 483 U.S. 327, comment stating that the proposed rule comments stating that the proposed rule 334 (1987) (quoting Hobbie v. violated the Eighth Amendment to the would violate the Equal Protection Unemployment Appeals Comm’n of U.S. Constitution because the proposed Clause of the Constitution by permitting Fla., 480 U.S. 136, 144–45 (1987)). As rule would reduce access to care in discrimination against women seeking one commenter noted, in Burwell v. prisons. abortion. Hobby Lobby Stores, Inc., 134 S. Ct. Response: The Department disagrees. Response: The Department disagrees. 2751, 2781 (2014), the Supreme Court Nothing in this rule permits the Federal First, as noted above, the Department held that the Department’s regulation believes that this rule will result in government to discriminate against a mandating group health plans to cover greater access to health care or greater person on the basis of such person’s contraceptives violated the Religious options from a wider and more diverse membership in a suspect class. Neither Freedom Restoration Act by failing to pool of medical professionals. the equal protection doctrine nor any provide an exemption for Hobby Lobby Additionally, the finalized definition of other constitutional doctrine negates to exercise its sincerely held religious ‘‘discriminate or discrimination’’ any of the Federal conscience and anti- beliefs. The Supreme Court also ensures that a facility that must respect discrimination laws pertaining to observed that any burden on third conscience can use alternative staff to abortion that this rule enforces. On the parties could be addressed in other contrary, the Supreme Court has upheld ways, including through the See, e.g., International Covenant on Civil and laws limiting Federal funding of establishment of a new governmental Political Rights arts. 18–19, adopted Dec. 19, 1966, abortions, even of those deemed to be 999 U.N.T.S. 171. program if necessary. The Court held medically necessary, against equal that Hobby Lobby itself did not have to Senate Comm. on Foreign Relations, Report on protection challenges. v. the International Covenant on Civil and Political See Harris bear a religious burden merely because Rights, S. Exec. Rep. No. 23, 23 (102d Sess. 1992) McRae, 448 U.S. 917 (1980) (upholding its religious accommodation may Id. the Hyde Amendment against a burden a third party. International Covenant on Economic, Cultural challenge under the Equal Protection Furthermore, this rule merely and Social Rights art. 12, adopted Dec. 16, 1966, Clause because the Hyde Amendment is 993 U.N.T.S. 3. (The ICECSR states that the ‘‘steps provides for the enforcement of the to be taken by the States Parties to the present rationally related to the legitimate Federal conscience and anti- Covenant to achieve the full realization of this right governmental interest in preserving the discrimination laws as Congress enacted shall include those necessary for: (a) The provision life of the unborn); Maher v. Roe, 432 them. These protections are limited to for the reduction of the stillbirth-rate and of infant U.S. 464 (1977) (holding that particular programs, particular 2 mortality and for the healthy development of the S

E government may legitimately favor

L child; (b) The improvement of all aspects of governmental involvement, and U

R childbirth over abortion through public environmental and industrial hygiene; (c) The particular funding streams, as Congress h t i prevention, treatment and control of epidemic, w funding); Rust v. Sullivan, 500 U.S. 173 determined necessary to ensure that D endemic, occupational and other diseases; (d) The O (1991) (same). Roe v. Wade and Doe v. R creation of conditions which would assure to all conscience rights are respected and that P

2 Bolton both explicitly affirmed the 8 medical service and medical attention in the event 0

Q appropriateness of conscience L of sickness.’’ Id.) 410 U.S. at 143–44; 410 U.S. at 197–98. G 3 K S D n o l l e

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health care entities with moral or comments received, the Department invalidate parts of the rule that remain religious objections to certain medical finalizes § 88.9 by rephrasing it to add statutorily supported. services or certain aspects of health clarity so that it now says, ‘‘This part Summary of Regulatory Changes: For service programs or research activities shall be construed in favor of a broad the reasons described in the proposed are not driven from the health care protection of the free exercise of rule and above, and considering the industry. religious beliefs and of moral comments received, the Department Comment: The Department received convictions, to the maximum extent finalizes § 88.10 without change. comments stating that the proposed rule permitted by the Constitution and the Appendix A to Part 88—Notice of Rights will conflict with various State laws and terms of the Federal conscience Under Federal Conscience and Anti- medical standards. protection and associated anti- Discrimination Laws Response: This rule does not establish discrimination statutes.’’ new Federal law, but provides for the The Department received comments enforcement of laws enacted by Severability § 88.10 on appendix A to part 88, which were Congress. To the extent State or local In § 88.10, the Department proposed a responded to above, with the comments laws or standards conflict with the severability provision that would govern to § 88.5. Federal laws that are the subject of this the Department’s interpretation and Summary of Regulatory Changes: For rule, the Federal conscience and implementation of 45 CFR part 88 if any the reasons described above, and antidiscrimination laws preempt such section of part 88 should be held invalid considering the comments received, the laws and standards with respect to or unenforceable, either facially or as Department finalizes appendix A to part funded entities and activities, in applied. In the event this occurs, the 88 to provide a more accurate notice as accordance with the terms of such Department proposed that the provision to the protections provided by the Federal laws. With respect to States, in question be construed in a manner Federal conscience and anti- States can decline to accept Federal that gives maximum extent to the force discrimination laws. For instance, the funds that are conditioned on respecting of the provision as permitted by law. Department replaces proposed text Federal conscience rights and For instance, a provision held to be stating that the entity ‘‘does not’’ engage protections. unenforceable as applied to a particular in certain acts with language stating that Summary of Regulatory Changes: For circumstance should be construed so as entity ‘‘complies with’’ laws prohibiting the reasons described in the proposed to continue the application of the certain acts. The Department also rule and above, and considering the provision to dissimilar circumstances. modifies the notice text to say that ‘‘You comments received, the Department Proposed § 88.10 would provide that if may have the right’’ instead of ‘‘You finalizes § 88.8 without change, beyond the provision is held to be utterly have the right,’’ and replaces global edits to the rule as a whole. invalid or unenforceable, the provision ‘‘participate in’’ with ‘‘perform, assist in the performance of.’’ The Department Rule of Construction § 88.9 in question shall be severable from part 88, and the remainder of part 88 should also makes stylistic changes to the This section proposed that the remain in full force and effect to the heading and certain portions of the body protections for religious freedom and maximum extent permitted by law. The text of the model notice in appendix A. moral conviction for which enforcement Department received a comment on this IV. Regulatory Impact Analysis mechanisms are provided by this part section. would be construed broadly and to the Comment: The Department received a A. Introduction and Summary maximum extent permitted by law and comment stating that a severability The Department has examined the the Constitution. The Department clause is unnecessary because, impacts of this final rule as required received comments on this section, following consideration of public under Executive Order 12866 on including comments in general support comments to the proposed rule, the Regulatory Planning and Review of the proposed section. Department should be aware of any (September 30, 1993), Executive Order Comment: The Department received a portions of the rule that are invalid or 13563 on Improving Regulation and comment stating that § 88.9 could be unenforceable. Regulatory Review (January 18, 2011), more clearly stated as follows: ‘‘This Response: The Department does not Executive Order 13771 on Reducing part shall be construed in favor of a agree that the severability clause is Regulation and Controlling Regulatory broad protection of free exercise of inappropriate. The Department Costs (January 30, 2017), the Regulatory religious beliefs and moral convictions, considers all the provisions of this final Flexibility Act (September 19, 1980, to the maximum extent permitted by the rule as being legally supported, has fully Pub. L. 96–354, 5 U.S.C. 601–612), Constitution and the terms of the considered all comments received, and section 202 of the Unfunded Mandates Federal conscience protection and has made appropriate modifications, Reform Act of 1995 (March 22, 1995, associated anti-discrimination statutes.’’ additions, and deletions. Nevertheless, Pub. L. 104–04), Executive Order 13132 Response: The Department agrees that as a general matter, severability on Federalism (August 4, 1999), the this proposed language is clearer and is represents the Department’s intention Congressional Review Act (5 U.S.C. modifying § 88.9 to so read, with some regarding whether the rule should go 804(2)), the Assessment of Federal stylistic changes to the proposed text, into effect if parts of it are held invalid Regulation and Policies on Families characterizing the Federal laws in or enjoined by a court. The Department (Pub. L. 105–277, sec. 654, 5 U.S.C. 601 question as ‘‘Federal conscience and deems it appropriate to maintain the (note)), and the Paperwork Reduction anti-discrimination laws.’’ severability clause as proposed, so that Act of 1995 (44 U.S.C. 3501–3520). Summary of Regulatory Changes: For this rule will remain in place to the

2 This rule revises the regulation that

S the reasons described in the proposed E maximum extent allowable in the event L allows OCR to accept and coordinate the

U rule and above, and considering the R of adverse court action. In addition, handling of complaints alleging h t i w future additions to statutes enforced by violations of the Weldon, Coats-Snowe

D 83 FR 3880, 3899. O this rule could render parts of the rule R 83 FR 3880, 3899 (stating the reasons for the and Church Amendments, three Federal P 2

8 proposed § 88.9, except for the modifications inapplicable, and it is the Department’s 0 Q

L adopted herein). intention that such changes will not 83 FR 3880, 3899. G 3 K S D n o l l e

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laws that collectively protect and associated anti-discrimination laws (3) Requires certain persons and conscience, prohibit coercion, and that exist across the Department and entities covered by this rule to adhere to require nondiscrimination in certain that the Secretary has delegated to OCR procedural and administrative programs and activities operated by to handle, requirements that aim to improve recipients or sub-recipients or that are (2) Articulates the scope of compliance with Federal conscience administered by the Secretary. and anti-discrimination laws and to enforcement mechanisms available to Specifically, this rule: achieve parity with procedural and HHS to address noncompliance with (1) Expands the regulation’s scope to administrative requirements of other encompass the full panoply of Federal Federal conscience and anti- Federal civil rights authorities enforced health-related conscience protection discrimination laws, and by OCR.

TABLE 1—ACCOUNTING TABLE OF BENEFITS AND COSTS OF ALL CHANGES

Present value over 5 years Annualized value over 5 years by discount rate by discount rate (millions of 2016 dollars) (millions of 2016 dollars)

3 Percent 7 Percent 3 Percent 7 Percent

Benefits: Quantified Benefits ......

Non-quantified Benefits: Compliance with the law; protection of conscience rights, the free exercise of religion and moral convictions; more di- verse and inclusive providers and health care professionals; improved provider-patient relationships that facilitate improved quality of care; equity, fairness, nondiscrimination; increased access to care.

Costs: Quantified Costs ...... 900.7 731.5 214.9 218.5

Non-quantified Costs: Compliance procedures (recordkeeping and compliance reporting) and seeking of alternative providers of certain objected- to medical services or procedures.

Analysis of Economic Impacts: legal or policy issues arising out of legal behavior or manner of compliance that Executive Orders 12866 and 13563 mandates, the President’s priorities, or regulated entities must adopt,’’ and the principles set forth in Executive HHS has examined the economic • ‘‘identify and assess available Order 12866. A rule is likely to be implications of this final rule as alternatives to direct regulation, economically significant where the required by Executive Orders 12866 and including providing economic agency estimates that it will (a) have an 13563. Executive Orders 12866 and incentives to encourage the desired annual effect on the economy of $100 13563 direct agencies to assess all costs behavior . . . or providing information million or more in any one year, or (b) and benefits of available regulatory upon which the public can make adversely and materially affect the alternatives and, when regulation is choices.’’ economy, a sector of the economy, necessary, to select regulatory Executive Order 13563 encourages productivity, competition, jobs, the approaches that maximize net benefits agencies to promote innovation; avoid environment, public health or safety, or (including potential economic, creating redundant, inconsistent, or State, local, or tribal governments or environmental, public health and safety overlapping requirements applicable to communities. The Department has effects; distributive impacts; and already highly regulated industries and determined that this rule will have an equity). The Department estimates that sectors; and consider approaches that annual effect on the economy of $100 the benefits of this rule, although not maintain flexibility and freedom of million or more in one year and, thus, always quantifiable or monetized, choice for the public. Finally, Executive is economically significant. The rule justify the burdens of the regulatory Order 13563 requires that agencies use also furthers a presidential priority of action. the best reasonably obtainable scientific, protecting conscience and religious technical, and economic information B. Executive Order 12866 freedom. Executive Order 13798, 82 FR available in evaluating the burdens and 21675 (May 4, 2017). Section 6(3)(C) of Executive Order benefits of a regulatory action. 12866 requires agencies to prepare a C. Executive Order 13563 The Department considered these regulatory impact analysis (RIA) for Executive Order 13563 supplements objectives and used the best reasonably major rules that are significant. Section and reaffirms the principles of obtainable technical and economic 3(f) of Executive Order 12866 defines a Executive Order 12866. Section 1(b) of information to determine that this final regulatory action as significant if it is Executive Order 13563 requires agencies rule creates net benefits, is tailored to likely to result in a rule that meets one to: impose the least burden on society, of four conditions: (1) Is economically • ‘‘propose or adopt a regulation only incentivizes the desired behavior, and significant, (2) creates a serious upon a reasoned determination that its maximizes flexibility. This impact inconsistency or otherwise interferes analysis also strives to promote 2 benefits justify its costs,’’ S

E with an action taken or planned by transparency in how the Department L • ‘‘tailor its regulations to impose the U R another agency, (3) materially alters the least burden on society,’’ derived the estimates. To this end, this h t i w budgetary impacts of entitlement grants, • ‘‘select . . . regulatory approaches RIA notes the extent to which key D

O user fees, or loan programs or the rights uncertainties in the data and R that maximize net benefits,’’ P 2

8 and obligations of the recipients of these • ‘‘[as] feasible, specify performance assumptions affect the Department’s 0 Q

L grants and programs, or (4) raises novel objectives, rather than specifying the analytic conclusions. G 3 K S D n o l l e

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1. Need for the Rule connection with the 2011 Rule that persons who are unlawfully coerced to (i) Problems That This Rule Seeks To limited the scope of prohibited violate their consciences, or otherwise Address discrimination, contrary to the language discriminated against because they have that Congress passed, see supra at part acted in accord with their moral In developing regulatory actions, I.B (addressing confusion caused by convictions or religious beliefs, may ‘‘[e]ach agency shall identify the OCR sub-regulatory guidance); and experience real harms that are problem that it intends to address • A lack of strategic coordination significant and sometimes devastating (including . . . the failures of private across the Department to promote psychologically, emotionally, and/ or markets or public institutions . . .) as awareness of Federal protections for financially. This can include loss of well as assess the significance of the conscience and religious freedom in jobs, loss of promotion possibilities, problem.’’ E.O. 12866, sec. 1(b)(1). In health care, and to address the ‘‘blackballing’’ in the medical identifying the problem warranting enforcement of Federal conscience and community, denial of acceptance into or agency regulatory action, ‘‘[e]ach agency anti-discrimination laws set forth in graduation from a medical school, shall examine whether existing authorizing statutes of programs denial of board certification, regulations (or other law) have created, conducted or administered by stigmatization, shunning by peers, and or contributed to, the problem . . . .’’ Departmental components. See supra at trauma and stress from forced violations E.O. 12866, sec. 1(b)(2). part I.A (identifying additional Federal of the Hippocratic Oath. Commenters This rule seeks to address two conscience and anti-discrimination shared anecdotes of the occurrence and categories of problems: (1) Inadequate laws). nature of coercion, discriminatory enforcement tools to address unlawful The second category of problems— conduct, or other actions potentially in discrimination and coercion faced by lack of awareness and, where there is violation of Federal conscience and protected persons, entities, or health awareness, confusion concerning anti-discrimination laws. Commenters care entities, and (2) lack of awareness, Federal conscience protection also shared their assessment of the and, to the extent there is awareness, obligations and associated anti- knowledge, or lack thereof, among the confusion, concerning Federal discrimination rights, of covered entities general public, health care field, health conscience protection obligations and and individuals and entities, care insurance industry, and associated anti-discrimination rights, of respectively—stems from inadequate employment law field of the rights and covered entities and individuals and information and understanding about obligations that this rule implements organizations, respectively, leading to such Federal law, leading to possible and enforces. Examples follow. possible violations of law. The array of violations of law. Relevant situations • Numerous commenters shared issues described in supra at part I.B where persons, entities, and health care anecdotes of bias and animus in the (describing the final rule’s regulatory entities with religious beliefs or moral health care sector against individuals history) fall into one or both of these convictions may be coerced or suffer with religious beliefs or moral categories. discrimination include: convictions with respect to abortion. The first category—inadequate • Being required to perform, • Employees shared that they enforcement tools to address unlawful participate in, pay for, provide coverage experienced discrimination based on discrimination and coercion—stems for, counsel or refer for abortion, their objections to prescribing from inadequate to non-existent sterilization, euthanasia, or other health abortifacients or participating in regulatory frameworks to enforce services; abortion or assisted suicide. existing Federal conscience and anti- • participating in health professional • Commenters stated that many discrimination laws. The absence of training that pressures students, health care professionals’ careers are adequate Federal governing frameworks residents, fellows, etc., to perform, assist jeopardized because entities are to remedy discrimination may have in the performance of, refer for, or completely unaware or willfully undermined incentives for covered counsel for, abortion or sterilization; dismissive of applicable Federal law persons and entities to institute • being steered away from a career in that protects conscience, prohibits proactive measures to protect obstetrics, family medicine, or geriatric coercion, or requires nondiscrimination. conscience, prohibit coercion, and medicine, when one has a religious or • Students, fellows, and residents promote nondiscrimination. Although moral objection, as applicable, to shared being forced out of residency some public comments argued that abortion, sterilization, physician- programs or fields of medicine because existing law is sufficient to protect assisted suicide or euthanasia; of their beliefs about abortion or conscience and religious freedom, the • being asked to perform or assist in contraception. Department disagrees, given the certain services within the scope of • Commenters shared that they mutually reinforcing deficiencies at the one’s employment but contrary to one’s considered avoiding obstetrics and Federal level, which include: religious beliefs or moral convictions. gynecology programs for fear of • An inadequate, minimalistic Comments received in support of the discrimination and shared polling data, regulatory scheme set forth in the proposed rule demonstrated that which the RIA’s benefits section Department’s 2011 Rule that rescinded describes infra at part IV.C.4, the comprehensive 2008 Rule, which California, for example, sent a letter to seven documenting discrimination insurance companies requiring insurers to include addressed three of the 25 statutory abortion coverage in plans used by persons who experienced by medical students on the provisions that are the subject of this objected to such coverage. See Letter from basis of their religious beliefs or moral rule. See supra at part I (describing California Department of Managed Health Care, Re: convictions. existing and prior versions of the rule Limitations or Exclusions of Abortion Services • Commenters expressed concern that and identifying confusion about the (Aug. 22, 2014). The State of California estimates States are coercing persons and entities 2 that at least 28,000 individuals subsequently lost S E

L scope and applicability of Federal their abortion-free health plans, and multiple U R conscience and anti-discrimination churches have challenged California’s policy in See. e.g., Compl. Cenzon-DeCarlo v. Mount h t i court. See Foothill Church v. Rouillard, 2:15–cv– Sinai Hosp., No: 09–3120 (E.D.N.Y. Jul. 21, 2009) w laws); D 02165–KJM–EFB, 2016 WL 3688422 (E.D. Calif. July at 15 (‘‘Being forced to assist in this abortion has O An unduly narrow Departmental R • 11, 2016); Skyline Wesleyan Church v. California caused Mrs. DeCarlo extreme emotional, P 2

8 interpretation of the Weldon Department of Managed Health Care, No. 3:16–cv– psychological, and spiritual suffering.’’) (dismissed 0 Q

L Amendment adopted by OCR in 00501–H–DHB (S.D. Calif. 2016). on other grounds). G 3 K S D n o l l e

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to violate their religious beliefs or moral obligations of the laws and often set Coats-Snowe and Church Amendments, convictions through laws mandating forth procedural requirements (e.g., and have concluded that persons must health coverage for abortion. assurances of compliance, rely on OCR’s administrative complaint • One commenter noted that recordkeeping of compliance, etc.) to process to secure relief. Some academic medical institutions are not advance compliance with substantive commenters also viewed litigation as self-policing compliance with, or rights and obligations. In addition, the unviable given the high economic costs educating students on, applicable regulatory schemes outline the of litigation, which may be against well- Federal conscience and anti- enforcement procedures to provide funded States or medical providers. discrimination laws. regulated entities notice of the Second, this rule promotes voluntary • Commenters shared barriers to enforcement tools available to HHS and compliance with laws governing the obtaining coverage by Medicare the type of remedies HHS may seek. Part ability of health care entities to act in Advantage plans for care provided by 88 in effect as a result of the 2011 Rule, accord with their legally protected RNHCIs. Commenters shared that by contrast, was only three sentences religious beliefs or moral convictions by plans justified the denials of coverage long and provided considerably less ensuring that health care entities are and preauthorization requests because notice and clarity about the conduct aware of, and understand, Federal medical professionals did not provide prohibited under Federal law and the conscience and anti-discrimination the care (even though by definition, an enforcement mechanisms available to laws. The rule incentivizes entities to RNHCI provides nonmedical care). HHS. provide notice of rights and obligations Some commenters have suggested that This rule confirms HHS will have the under the rule by identifying the the thirty-four complaints that OCR authority to initiate compliance reviews provision of notice as non-dispositive received between November 2016 and where it believes compliance issues evidence of compliance that OCR will January 2018 that allege coercion, have arisen, conduct investigations, consider if an entity is subject to an violation of conscience, or resolve complaints, and supervise and OCR investigation or compliance discrimination do not necessitate this coordinate appropriate action(s) with review. Entities will be more likely to final rule. These commenters the relevant Department component(s) accommodate conscience and associated misconstrue the reasons for this rule; to assure compliance. Under this rule, anti-discrimination rights if entities the increase in complaints received by certain persons and entities must understand that they are legally OCR is one of the many metrics used to maintain records regarding compliance obligated to do so. Entities will also be demonstrate the importance of this rule. with part 88; cooperate with OCR in a better position to accommodate During FY 2018, the most recently investigations, compliance reviews, these rights if they understand these completed fiscal year for which data are interviews, or other parts of OCR’s rights are akin to other civil rights available, OCR received 343 complaints investigative process; and submit protecting people from discrimination alleging conscience violations. Some written assurances and certifications of on the basis of race, national origin, complaints raise issues that affect more compliance to the Department. These disability, etc.—rights for which entities than one aggrieved person, entity or procedural and administrative already provide notice and are familiar health care entity; therefore, although requirements are similar to those in with respecting. one person may have filed the other civil rights regulations that In addition, as described infra at part complaint, the complaint may represent promote compliance with, and IV.C.3.i, the Department anticipates that the concerns and objections of all nurses enforcement of, the Federal civil rights a subset of recipients that assure and at a hospital, multiple pregnancy care laws that the regulations implement. certify compliance in accordance with facilities or providers in a State, or Finally, by expanding the scope of part § 88.4 will take organization-wide entire populations (or subpopulations) 88 to cover the 25 statutory conscience action, such as to update policies and of States or communities. and anti-discrimination laws applicable procedures, implement staffing or to HHS that are the subject of this rule, scheduling practices that respect the (ii) How the Rule Seeks To Address the the rule supports the Department’s exercise of conscience rights under Problems strategic coordination with respect to Federal law, or take steps to disseminate This rule corrects those problems. compliance with, and enforcement of, the recipient’s policies and procedures First, the Department revises 45 CFR these laws across the Department, as concerning these laws. Greater part 88 from a minimal regulatory well as providing one location that transparency of practices through open scheme to one comparable to the identifies all of the health care related communication of recipient and sub- regulatory schemes implementing other conscience protections and associated recipient policies ‘‘should strengthen civil rights laws. Such schemes anti-discrimination laws enforced by the relationships between . . . entities and typically include a dozen provisions, Department so that regulated entities their . . . [workforce members].’’ addressing a range of conduct. These have clear knowledge of the applicable Protection of religious beliefs and provisions typically restate the conscience requirements. moral convictions serves not only substantive requirements and The investigative and enforcement individual rights, but also society as a processes set forth by the rule are vital whole. Protections for conscience help because other avenues of relief are RNHCIs can participate in Medicare and ensure a society free from inadequate or unavailable. The Medicaid as long as they meet the requisite discrimination and more respectful of conditions of coverage and participation. See supra Department solicited comment on personal freedom and fundamental at part I.A (summarizing the history of statutory whether alternate remedies, such as provisions regarding RNHCIs, among other pursuing litigation, have been sufficient provisions, which this rule implements and See, e.g., Vermont All. for Ethical Healthcare, to address discrimination, coercion, or 2 enforces). See also https://www.cms.gov/Medicare/ Inc. v. Hoser, 274 F. Supp. 3d 227, 240 (D. Vt. S

E Provider-Enrollment-and-Certification/

L other treatment that the laws that are the 2017); Hellwege v. Tampa Family Health Centers, U

R CertificationandComplianc/RNHCIs.html. 103 F. Supp. 3d 1303, 1311–12 (M.D. Fla. 2015); subject of this rule prohibit. Many h t i See 83 FR 3880, 3886 (proposed Jan. 26, 2018) Order at 4, National Institute of Family and Life w

commenters stated that litigation was an

D (to be codified at 45 CFR pt. 88) (summarizing the Advocates, et al. v. Rauner, No. 3:16–cv–50310 (N. O inadequate option because several R history of OCR enforcement of conscience laws). D. Ill. July 19, 2017), ECF No. 65. See also supra P 2

8 Complaint data based on OCR’s system of courts have declined to recognize a at part II.A (describing the lack of private remedies). 0 Q

L records as of December 20, 2018. private right of action, such as under the 73 FR 78074, 78074 (2008 Rule). G 3 K S D n o l l e

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rights enshrined in the First (A) The Department available in the annual Labor, Health Amendment and Federal law. The As a result of the 2011 Rule, 45 CFR and Human Services, and Education Department shares the anticipation of part 88 applied, and still applies, to the Appropriations Act. Second, the many commenters who reasoned that Department because the Weldon and Coats-Snowe Amendment applies to the rule will promote a culture of Coats-Snowe Amendments, as well as State and local governments that receive respect for rights of conscience and specific parts of the Church Federal financial assistance, including religious freedom in health care that is Amendments, apply to the Department. Federal financial assistance from the currently lacking. The boundaries of The Weldon Amendment states that Department (without restriction to any protection for conscience may be tested ‘‘[n]one of the funds made available in particular funding stream), ‘‘includ[ing] when protections for religious beliefs [the Departments of Labor, Health and governmental payments provided as and moral convictions appear to impose Human Services, and Education, and reimbursement for carrying out health- a cost or compete with other public Related Agencies Appropriations Act, related activities.’’ Third, several purposes. However, as with other 2019] may be made available to a paragraphs of the Church Amendments civil rights laws, it is in those cases Federal agency or program . . . if such apply to State and local governments. where fidelity to the law becomes of agency [or] program . . . subjects any Paragraph (b) of the Church paramount importance. institutional or individual health care Amendments prohibits coercion by a entity to discrimination . . . .’’ The ‘‘public authority,’’ and thereby 2. Affected Persons and Entities Department is a Federal agency that includes States and local governments. receives substantial funds made The final rule affects (1) persons and Paragraphs (c) and (e) of the Church available in the Department of Defense entities already obligated to comply Amendments apply to State and local and Labor, Health and Human Services, governments to the extent that such with the Weldon Amendment, Coats- and Education Appropriations Act, 2019 governments receive funds to Snowe Amendment, or Church and Continuing Appropriations Act, implement programs authorized in the Amendments (or a combination thereof) 2019, which are the funds addressed in public laws cited in such paragraphs. under the 2008 and 2011 Rules; and (2) Weldon. The Department must Finally, paragraph (d) of the Church persons and entities obligated to comply comply with the Weldon Amendment. Amendments applies to a State or local with at least one of the other Federal The Coats-Snowe Amendment states government (or a component thereof) to statutory provisions that this rule that ‘‘[t]he Federal Government . . . the extent that such State or local implements. may not subject any health care entity government receives funding under any to discrimination on the [bases]’’ listed (i) Scope of Persons and Entities program administered by the in paragraphs (a)(1)–(3) of 42 U.S.C. Covered by 45 CFR Part 88 in 2011 Rule Secretary. 238n. The Department, as part of the Federal Government, must comply with State and local governments (such as Depending on the operation and counties or cities) and instrumentalities applicability of the underlying statutes, the Coats-Snowe Amendment in its operations. of governments (such as State health the 2011 Rule, i.e., 45 CFR part 88 as and human services agencies) receive currently in effect, extended, and Paragraphs (d) and (c)(2) of the Church Amendments apply to certain Federal financial assistance or Federal continues to extend, broadly. As funds from the Department from a explained below, the diversity of programs administered by the Secretary. Paragraph (d) applies to all health variety of financing streams as entities estimated as covered is due to service programs or research activities recipients or sub-recipients. Examples the applicability of the Church funded in whole or part under programs of programs and activities for which Amendments, which applies to non- administered by the Secretary, State and local governments (in some governmental (as well as governmental) regardless of the source of funding. cases, not exclusively) receive Federal entities that operate ‘‘any part of a Paragraph (c)(2) applies to entities that financial assistance or Federal funds health service program or research receive grants or contracts ‘‘for from the Department may include activity funded in whole or in part biomedical or behavioral research under Medicaid and the Children’s Health under a program administered by the any program administered by the Insurance Program; Title X programs, Secretary’’; or receive a grant, Secretary.’’ The requirements would, public health and prevention programs, contract, loan, or loan guarantee under thus, apply to such programs or research HIV/ AIDS and STD prevention and the Public Health Service (PHS) Act, activities conducted by, or funded by or education, and substance abuse which contains thirty titles and through, the Department. screening; biomedical and behavioral authorizes dozens of programs, or under research at State institutions of higher the Developmental Disabilities (B) State and Local Governments education; services for older Americans; Assistance and Bill of Rights Act of As a result of the 2008 and 2011 medical assistance to refugees; and 2000 (DD Act), or receive an interest Rules, 45 CFR part 88 applied, and will adult protection services to combat subsidy under the DD Act. continue to apply, to all State and local elder abuse. governments that receive HHS Federal See Kevin Theriot & Ken Connelly, Free to Do financial assistance by virtue of several See, e.g., Public Law 115–245, Div. B, section No Harm: Conscience Protections for Healthcare statutory provisions. First, the Weldon 507(d), 132 Stat. 2981, 3118 (‘‘None of the funds Professionals, 49 Ariz. St. L.J. 549, 550–51 (2017) Amendment applies to State and local made available in [the Departments of Labor, Health (‘‘[T]he growing acceptance of this ‘public utility’ and Human Services, and Education, and Related model of medicine means in practice that extant governments that receive funds made Agencies Appropriations Act, 2019] may be made Federal and State laws protecting conscience—most available to a . . . State or local government[ ] if of which cover only a limited range of procedures 2 E.g., Department of Defense and Labor, Health such . . . government . . . .’’). S

E and medical practitioners, lack meaningful and Human Services, and Education

L 42 U.S.C. 238n(a), (c)(1).

U enforcement mechanisms, and . . . are inadequate

R Appropriations Act, 2019 and Continuing

Id. section 300a–7(d) (‘‘No individual shall be h t i to the task of protecting the right to conscience[] Appropriations Act, 2019, Public Law 115–245, required to perform or assist in the performance of w . . .’’ (citations omitted)). D Div. B, sec. 507(d), 132 Stat. 2981, 3118 (September any part of a health service program or research O

R 42 U.S.C. 300a–7(d). 28, 2018). activity funded in whole or in part under a program P 2

8 42 U.S.C. 300a–7(c). Id. administered by the Secretary of Health and Human 0 Q

L 42 U.S.C. 300a–7(e). 42 U.S.C. 300a–7(c)(2) and (d). Services . . . .’’). G 3 K S D n o l l e

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(C) Persons and Entities paragraph (d) of the Church 115–245, Div. B, Tit. II, sec. 209, 132 As a result of the 2008 and 2011 Amendments applies to ‘‘any part of a Stat. 2981, 3090 (2018); Provisions of the Affordable Care Rules, 45 CFR part 88 applied, and still health service program or research • Act related to assisted suicide (42 U.S.C. applies, to recipients and sub-recipients activity funded in whole or in part 18113), the ACA individual mandate (26 that operate ‘‘any part of a health service under a program administered by the U.S.C. 5000A(d)(2)), and other matters program or research activity funded in Secretary of Health and Human of conscience (42 U.S.C. whole or in part under a program Services.’’ Paragraph (d) of the Church Amendment does not tie the 18023(c)(2)(A)(i)–(iii), (b)(1)(A) & (b)(4)); administered by the Secretary’’ ; or • Provisions regarding conscience receive a grant, contract, loan, or loan funding source to a particular appropriation, instrument, or protections for objections to counseling guarantee under the Public Health and referral for certain services in Service (PHS) Act or the authorizing statute, nor does the receipt of funds under Church (d) automatically Medicaid or Medicare Advantage (42 Developmental Disabilities Assistance U.S.C. 1395w–22(j)(3)(B) and 1396u– and Bill of Rights Act of 2000 (DD Act), trigger coverage of all of an entity’s operations. 2(b)(3)(B)); or receive an interest subsidy under the • Provisions regarding conscience DD Act. (ii) Persons and Entities Obligated To protections related to the performance Examples of recipients and sub- Comply With Additional Federal Laws of advanced directives (42 U.S.C. recipients may include: That This Rule Implements and 1395cc(f), 1396a(w)(3), and 14406); • Health facilities, including Enforces • Provisions exempting individuals hospitals, federally qualified health This rule only affects persons and from compulsory health care or services centers, community health centers, and generally (42 U.S.C. 1396f & 5106i(a)(1)) mental health clinics; entities obligated to comply with at least one of the Federal statutory provisions and under specific programs for hearing • Health-related schools and other screening (42 U.S.C. 280g–1(d)), education entities that provide health that this rule implements and enforces. There is substantial overlap between occupational illness testing (29 U.S.C. professions training for medicine, oral 669(a)(5)), vaccination (42 U.S.C. health, behavioral health, geriatric care, persons and entities currenty obligated to comply with 45 CFR part 88, as based 1396s(c)(2)(B)(ii)), and mental health nursing, etc.; treatment (42 U.S.C. 290bb–36(f)); and • Community-based organizations on the 2011 Rule and persons and entities subject to at least one of the • Protections for religious that provide substance abuse screening, nonmedical health care relating to HIV/ AIDS prevention and treatment, additional Federal laws that this final rule enforces. This overlap occurs health facility review (42 U.S.C. 1320a– and domestic violence screening; 1), peer review (42 U.S.C. 1320c–11), • Title X-funded family planning because such persons and entities largely were, and continue to be, subject certain health standards (42 U.S.C. clinics; 1396a(a)(9)(A)), medical evaluation (42 • Private non-profit and for-profit to 45 CFR part 88 by virtue of the Church Amendments, but also the U.S.C. 1396a(a)(31)), medical licensing agencies that provide medical care to review (42 U.S.C. 1396a(a)(33)), and unaccompanied minors; Weldon Amendment and the Coats- Snowe Amendment, as explained above. utilization review plan requirements (42 • Interdisciplinary university centers U.S.C. 1396b(i)(4)), and by protecting or public or nonprofit entities associated Because of this substantial overlap, the Department estimated in the proposed the exercise of religious nonmedical with universities that receive financial health care in the Elder Justice Block assistance to implement the DD Act ; rule that OCR’s authority to enforce the following statutory provisions would Grant Program (42 U.S.C. 1397j–1(b)) and and in the Child Abuse Prevention and • State Councils on Developmental not add any new persons and entities to the coverage of this rule: Treatment Act (42 U.S.C. 5106i(a)(2)). Disabilities and States’ Protection In the proposed rule, the Department • Provisions protecting health care and Advocacy Systems that receive estimated that the OCR enforcement of entities and individuals from funds to implement the DD Act. the following Federal statutory discrimination who object to furthering Several statutory provisions support provisions could add new persons and or participating in abortion under this application. First, paragraphs (c)(1) entities to the coverage of 45 CFR part Medicare Advantage, e.g. Public Law and (2) of the Church Amendments 88: apply to entities that receive a ‘‘grant, • Global Health Programs for HIV/ contract, loan, or loan guarantee under [or] loan guarantee . . . under the Public Health Service Act . . . or the Developmental Disabilities AIDS Prevention, Treatment, or Care (22 the [PHS Act],’’ or a ‘‘grant or contract Assistance and Bill of Rights Act of 2000 may U.S.C. 7631(d)), and for biomedical or behavioral research.’’ . . . .’’). In addition to the PHS Act, paragraphs • The Helms, Biden, 1978, and 1985 Second, paragraph (e) of the Church (c)(1) and (e) of the Church Amendments apply to Amendments, 22 U.S.C. 2151b(f), e.g., Amendments applies to entities that entities that receive funding under the Community Consolidated Appropriations Act, 2019, Mental Health Centers Act, 42 U.S.C. 2689 et seq. receive a ‘‘grant, contract, loan, or loan Paragraph (c)(1) of the Church Amendments Public Law 116–6, Div. F, sec. 7018. guarantee, or interest subsidy’’ under additionally applies to entities that receive funding However, the proposed rule explained the PHS Act or the DD Act. Third, under the Developmental Disabilities Services and that because paragraph (d) of the Church Facilities Construction Act, 42 U.S.C. 6000 et seq. Amendments does not require that the Congress repealed both of these laws. See Omnibus 42 U.S.C. 300a–7(d). Reconciliation Act of 1981, Public Law 97–35, Title funding for the health service program The PHS Act contains thirty titles and IX, sec. 902(e)(2)(B), 95 Stat. 560 (1981); or research activity be appropriated to authorizes dozens of programs. Developmental Disabilities Assistance and Bill of HHS, but only that it be ‘‘funded in E.g., https://www.acl.gov/node/466. Rights Act of 2000, Public Law 106–402, Title IV, whole or part under a program E.g., https://www.acl.gov/node/110.https:// sec. 401(a), 114 Stat. 1737 (2000). Thus, there are administered by the [HHS] Secretary,’’ 2 www.acl.gov/sites/default/files/about-acl/2017-12/ no entities receiving funds under programs S

E DDC-2017.pdf. funding appropriated to other Federal

L authorized by these statutes to consider in this RIA. U

R E.g., https://www.acl.gov/sites/default/files/ Id. section 300a–7(d) (‘‘No individual shall be Departments, but awarded by HHS in its h t i about-acl/2017-06/PADD-2017.pdf. required to perform or assist in the performance of w

administration of certain global health

D Id. 300a–7(c)(1)(B) (‘‘No entity which receives any part of a health service program or research O programs would be covered by R a grant, contract, loan, or loan guarantee under the activity funded in whole or in part under a program P 2

8 Public Health Service Act . . . .’’); 300a–7(e) (‘‘No administered by the Secretary of Health and Human paragraph (d) of the Church 0 Q

L entity which receives . . . any grant, contract, loan, Services . . . .’’). Amendments. Consequently, HHS’s G 3 K S D n o l l e

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implementation of 22 U.S.C. 2151b(f) industry (called an ‘‘establishment’’), health and patient care, the Department and 7631(d) may not expand the scope how many of those establishments are adopted ranges more appropriate for of persons and entities covered by this under common ownership or control of those industries. For the social services part. a business organization or entity (called industries, the Department adopted a a ‘‘firm’’), and the number of people range with 25 percent as the lower- (iii) Methodology who work in a particular business or bound and 100 percent as the upper- The Department quantitatively industry, among other types of bound to cover 62.5 percent of the estimated those persons and entities information. For instance, a hospital industry on average. In its notice of covered by the final rule by relying system that has common ownership and proposed rulemaking, the Department primarily on the latest data available control over multiple hospital facilities sought comment on this methodology, from the U.S. Census Bureau’s Statistics is a firm, and each hospital facility is an but received no comments providing a of U.S. Businesses supplemented establishment. superior method of generating these with other sources. The Department For the vast majority of the recipient estimates. invited public comment on the and sub-recipient types, the Department The Department assumes some proposed rule’s methodology and assumed that only a portion of the portion of the social service industry solicited ideas on whether there are industry captured in the Statistics of will be covered by the rule, given the other methodologies that the U.S. Businesses receives Federal funds scope of the 2011 Rule and thereby this Department could consider to refine the to trigger coverage by this rule (e.g., rule. For instance, entities that carry out scope of persons and entities affected by ‘‘Federal financial assistance . . . from social services programs and activities this rule. The Department received one the Department or a component of the may do so in the context of health comment suggesting that the Department, or who otherwise receives service programs or research activities Department’s methodology was flawed Federal funds directly from the funded in whole or in part under for failing to include an estimate of the Department or a component of the programs administered by the Secretary, number of consumers of health care Department’’). For instance, not all or may receive funding through affected, i.e., patients, and thus did not physician offices receive FFA or programs administered by the Secretary, consider consumers of health care in the otherwise receive Federal funds as a as well as by grants or other list of persons and entities shown infra recipient or sub-recipient. In fact, about mechanisms under the PHS Act or at Table 2. The purpose of Table 2 is to 68.9 percent of physician offices the Developmental Disabilities identify regulated entities, not accepted new Medicaid patients based Assistance and Bill of Rights Act of consumers of health care. An analysis of on 2013 data from the National 2000 within the scope of the Church this rule’s impact on persons, entities, Electronic Health Records Survey. Amendment’s application. and health care entities is included in Approximately 83.7 percent of To estimate the number of local the rule’s analysis of benefits, infra at physicians accepted new Medicare governments and educational part IV.C.4. The final rule’s methods for patients based on the same data. institutions, the Department relied on quantifying the persons and entities Because OCR interprets the 2011 Rule to data from other U.S. Census Bureau impacted are the same methods from the apply to physicians receiving statistical programs or available award proposed rule, which the Department reimbursement for Medicare Part B, data available through the HHS determined was the most reasonable which is a ‘‘health service program . . . Tracking Accountability in Government and reliable approach. funded in whole or in part under a Grants System (TAGGS). For The U.S. Census Bureau’s Statistics of program administered by the Secretary instance, in estimating the number of U.S. Businesses is based on the North of Health and Human Services’’, the counties nationwide, the Department American Industry Classification Department assumed that the lower of relied on the U.S. Census Bureau’s 2010 System (NAICS). The NAICS these two percentages (69 percent) Census Geographic Entity Tallies by classifies all economic activity into 20 represents the lower-bound of State and Type to identify the total sectors and breaks that information physicians nationwide subject to the counties and equivalent areas for the down into sub-sectors and industries. 2011 Rule. In the absence of evidence U.S., Puerto Rico, the U.S. Territories, Essentially, the NAICS groups physical with which to generate a refined upper- and the Island Areas. business establishments together based As another example, the Department bound estimate, the Department on how similar the locations’ processes relied on data from TAGGS to derive a assumed that the 2011 Rule covers all are for producing goods or services. lower-bound percentage of colleges and physicians nationwide as the upper- The NAICS provides information on universities that are recipients. (The how many singular physical locations bound. upper-bound assumes all educational The Department used this same exist for a particular business or institutions industry-wide are percentage range (69 to 100 percent) in recipients.) Although most colleges and estimating the coverage for other health https://www.census.gov/data/datasets/2015/ universities receive Federal financial care industry sector types, such as econ/susb/2015-susb.html. The Department relied assistance from the U.S. Department of on the data file titled ‘‘U.S. & State, NAICS, detailed hospitals and various outpatient care Education, not all universities are employment sizes (U.S., 6-digit and States, NAICS facilities. For the social services and recipients of HHS funds; thus, the sectors).’’ The latest data available is from 2015 that education industries, which generally the Bureau made available in September of 2017, Department adopted a lower-bound and this data relied on the 2012 NAICS codes, id., have principal purposes other than estimate to reflect that assumption. which are described at https://www.census.gov/eos/ Using the ‘‘Advanced Search’’ www/naics/2012NAICS/2012_Definition_File.pdf. https://www.census.gov/eos/www/naics/faqs/ See 83 FR 3880, 3907 (describing various faqs.html#q2. function in TAGGS, HHS identified all sources of data considered and reasons for rejecting awards to Junior Colleges, Colleges, and 2 https://www.census.gov/glossary/#term_Firm. S

E other approaches).

L Esther Hing, et al., Nat’l Ctr. For Health U

R https://www.census.gov/programs-surveys/ Statistics, Centers for Disease Control and The PHS Act contains thirty titles and h t i susb/technical-documentation/methodology.html. Prevention, U.S. Dep’t of Health and Human Servs., authorizes dozens of programs. w

D FAQ 5, https://www.census.gov/eos/www/ Acceptance of New Patients with Public and Private http://taggs.hhs.gov (last visited Aug. 24, O

R naics/faqs/faqs.html#q5. Insurance by Office-Based Physicians: United 2017). P 2

8 FAQ 1, https://www.census.gov/eos/www/ States, 2013, Data Brief No. 195, 1 (Mar. 2015). https://www.census.gov/geo/maps-data/data/ 0 Q

L naics/faqs/faqs.html#q1. Id. tallies/all_tallies.html. G 3 K S D n o l l e

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Universities for FY 2016 and de- Businesses. This ratio is 51.32 Because there is uncertainty as to the duplicated the results to obtain a percent (2,457 firms/ 4,788 universe of actual persons and entities singular list of unique awardees from establishments). The Department covered, Table 2 captures this the Department, which totaled 615. applied that ratio to the total number of uncertainty by reflecting estimated Because these awardees included Junior Colleges, Colleges, and recipients as a range with a lower and satellite campuses of college or Universities that received HHS funding an upper-bound. The footnotes detail university systems, the total awardee as ‘‘establishments’’ (0.5132 × 615 the assumptions and calculations for number was akin to the number of awardee establishments) to get an each line of the table and assume ‘‘establishments’’ rather than ‘‘firms’’ as estimate of 316 firms. Despite this coverage for 69–100 percent of the those terms are used in the U.S. Census method’s potential complexity, the industry unless otherwise noted. The Bureau’s Statistics of U.S. Businesses. Department found it the most Department has made a technical Similar to how an ‘‘establishment’’ is a reasonable method for estimating the correction to Table 2 to include the lower-bound number of colleges and location of a ‘‘firm’’ that has common number of offices of miscellaneous universities that are Department health practitioners (e.g., clinical ownership and control over at least one recipients. pharmacists, dieticians, registered establishment, a satellite campus is one practical or licensed nurses’ offices, location of a university system with (iv) Quantitative Estimate of Persons and Entities Covered by This Rule Christian Science practitioners’ offices) common ownership and control over who operate private or group practices multiple campus locations. Table 2 lists each estimated type of in their own centers or clinics or in the To derive an estimate of educational recipient and the estimated number of facilities of others, such as hospitals. institutions at the ‘‘firm’’ level, the recipients that this final rule covers. Department computed the ratio between See the industry description for offices of firms and establishments from the U.S. See U.S. Census Bureau, Statistics of U.S. miscellaneous health practitioners, NAICS code Businesses, 2015, NAICS code 611310 (Colleges, 921399, https://www.census.gov/cgi-bin/sssd/naics/ Census Bureau’s Statistics of U.S. Universities, and Professional Schools) (identifying naicsrch?code=621399&search=2012 NAICS 2,457 firms and 4,788 establishments nationwide). Search. 2 S E L U R h t i w

D O R P 2 8 0 Q L G 3 K S D n o l l e

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TABLE 2—ESTIMATED NUMBER OF PERSONS AND ENTITIES COVERED BY THIS FINAL RULE

Covered by Type 45 CFR 88 in Covered by Estimate Estimate 2011 Rule? final rule? (low) (high)

1. State and Territorial Governments ...... Yes ...... Yes ...... 58 58 2. Federally recognized Tribes ...... Yes ...... Yes ...... 573 573 3. Counties ...... Yes ...... Yes ...... 3,234 3,234

Hospitals

4. General & Medical Surgical Hospitals ...... Yes ...... Yes ...... 1,859 2,694 5. Specialty Hospitals (e.g., psychiatric, substance abuse, rehabilitation, cancer, maternity) .. Yes ...... Yes ...... 553 801

Nursing and Residential Care Facilities

6. Skilled Nursing Facilities ...... Yes ...... Yes ...... 6,316 9,153 7. Residential Intellectual and Developmental Disability Facilities ...... Yes ...... Yes ...... 4,310 6,246 8. Continuing Care Retirement Communities ...... Yes ...... Yes ...... 2,605 3,775 9. Other Residential Care Facilities (e.g., group homes) ...... Yes ...... Yes ...... 2,247 3,256

Entities Providing Ambulatory Health Care Services

10. Entities providing Home Health Care Services ...... Yes ...... Yes ...... 15,062 21,829 11. Offices of Physicians (except Mental Health Specialists) ...... Yes ...... Yes ...... 115,673 167,642 12. Offices of Physicians (Mental Health Specialists) ...... Yes ...... Yes ...... 7,324 10,614 13. Offices of Mental Health Practitioners (except Physicians) ...... Yes ...... Yes ...... 14,340 20,782 14. Offices of Dentists ...... Yes ...... Yes ...... 86,874 125,904 15. Offices of Chiropractors ...... Yes ...... Yes ...... 26,725 38,732 16. Offices of Optometrists ...... Yes ...... Yes ...... 13,775 19,964 17. Offices of Physical, Occupational and Speech Therapists, and Audiologists ...... Yes ...... Yes ...... 17,623 25,540 18. Offices of Podiatrists ...... Yes ...... Yes ...... 5,314 7,701 19. Offices of All Other Misc. Health Practitioners ...... Yes ...... Yes ...... 11,502 16,670 20. Family Planning Centers ...... Yes ...... Yes ...... 999 1,448 21. Freestanding Ambulatory Surgical and Emergency Centers ...... Yes ...... Yes ...... 2,908 4,214 22. HMO Medical Centers ...... Yes ...... Yes ...... 78 113 23. Kidney Dialysis Centers ...... Yes ...... Yes ...... 305 442 24. Outpatient Mental Health and Substance Abuse Centers ...... Yes ...... Yes ...... 3,776 5,472 25. Diagnostic Imaging Centers ...... Yes ...... Yes ...... 3,209 4,651 26. Medical Laboratories ...... Yes ...... Yes ...... 2,278 3,302 27. Ambulance Services ...... Yes ...... Yes ...... 2,185 3,167 28. All Other Outpatient Care Centers (e.g., centers and clinics for pain therapy, community Yes ...... Yes ...... 3,880 5,623 health, and sleep disorders) . 29. Entities Providing All Other Ambulatory Health Care Services (health screening, smoking Yes ...... Yes ...... 2,391 3,465 cessation, hearing testing, blood banks) .

Insurance Carriers

30. Direct Health and Medical Insurance Carriers ...... Yes ...... Yes ...... 607 880

Entities Providing Social Assistance Services

31. Entities Serving the Elderly and Persons with Disabilities (provision of nonresidential social Yes ...... Yes ...... 9,051 36,205 assistance services to improve quality of life) . 32. Entities Providing Other Individual Family Services (e.g., marriage counseling, crisis inter- Yes ...... Yes ...... 5,310 21,240 vention centers, suicide crisis centers) .

Assumes coverage of the 50 States, DC, Puerto Id. (relying on the nationwide count of firms Id. (nationwide count of firms for NAICS Code Rico, 6 U.S. Territories, and the Island Areas. for NAICS Code 623110). 621391). Assumes all federally recognized Tribes get Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code HHS funds. Indian Health Service, FY 2019 623210). 621399). Justification of Estimates for Appropriations Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Committees CJ–1 (2018), https://www.ihs.gov/ 623311). 621410). budgetformulation/includes/themes/responsive Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code 2017/display_objects/documents/FY2019 623990). 621493). CongressionalJustification.pdf. Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code U.S. Census Bureau, 2010 Census Geographic 621610). 621491). Entity Tallies by State and Type, https:// Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code www.census.gov/geo/maps-data/data/tallies/all_ 621111). 621492). tallies.html (total counties and equivalent areas for Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code the U.S., Puerto Rico, the U.S. Territories, and the 621112). 621420). Island Areas). The Department assumed that every Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code county receives Federal funds as a recipient or a 621330). 621512). sub-recipient. Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code 2 S

E U.S. Census Bureau, Statistics of U.S. 621210). 621511). L

U Businesses, 2015 (released Sept. 2017), https://

R Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code h t i www.census.gov/data/datasets/2015/econ/susb/ 621310). 621910). w

D 2015-susb.html (nationwide count of firms for Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code O

R NAICS Code 622110). 621320). 621498). P 2

8 Id. (sum of the nationwide count of firms for Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code 0 Q

L NAICS Codes 622210 and 622310). 621340). 62199). G 3 K S D n o l l e

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TABLE 2—ESTIMATED NUMBER OF PERSONS AND ENTITIES COVERED BY THIS FINAL RULE—Continued

Covered by Type 45 CFR 88 in Covered by Estimate Estimate 2011 Rule? final rule? (low) (high)

33. Entities Providing Child and Youth Services (e.g., adoption agencies, foster care placement Yes ...... Yes ...... 2,169 8,674 services) . 34. Temporary Shelters (e.g., short term emergency shelters for victims of domestic violence, Yes ...... Yes ...... 805 3,219 sexual assault, or child abuse; runaway youth; and families caught in medical crises) . 35. Emergency and Other Relief Services (e.g., medical relief, resettlement, and counseling to Yes ...... Yes ...... 169 675 victims of domestic or international disasters or conflicts) .

Other Entities

36. Pharmacies and Drug Stores ...... Yes ...... Yes ...... 13,490 19,550 37. Research and Development in Biotechnology ...... Yes ...... Yes ...... 2,347 3,402 38. Colleges, Universities, & Professional Schools ...... Yes ...... Yes ...... 316 2,457

Subtotal, subject to part 88 in 2011 Rule ...... 392,236 613,367

39. HHS awarded funds appropriated to the U.S. Dept. of State & USAID ...... No ...... Yes ...... 65 130

Subtotal, incremental increase in entities ...... 65 130

TOTAL, estimated entities subject to this rule ...... 392,301 613,497

Approximately 392,236 to 613,367 may add 65 to 130 new persons and recipients but not sub-recipients, noting persons and entities were subject to part entities to the coverage of 45 CFR part that the proposed rule took this 88 in effect based on the 2011 Rule by 88. With this incremental increase, approach to reduce the burden on small virtue of the Weldon, Coats-Snowe and this final rule covers an average of entities. The Department did not receive Church Amendments. The Department 502,899 entities, which is the mid-point comments addressing this question. One estimated that the number of entities of the low (392,301 entities) and high- commenter, however, raised the that this final rule covers that are end (613,497 entities). question that, if the proposed rule’s subject to 22 U.S.C. 7631(d) and (A) Estimated Persons and Entities policy was to exempt clinicians who are 2151b(f), but not paragraph (d) of the Required To Sign an Assurance and part of State Medicaid programs, then Church Amendments is small and, Certification of Compliance the proposed rule did not exclude such possibly, non-existent because clinicians from § 88.4. However, paragraph (d) of the Church Relative to the persons and entities clinicians who receive reimbursement Amendments does not tie funding to a shown in Table 2, a smaller subset is through a State Medicaid program are particular appropriation or financial subject to § 88.4, which requires certain sub-recipients of the Department (i.e., stream. Consequently, this final rule recipients to submit an assurance and recipients of the State, which is the certification of compliance and exempts recipient in relationship to the Id. (nationwide count of firms for NAICS Code others. The Department calculated the Department). Under a Medicaid fee-for- 524114). subset of persons and entities subject to service model, the State pays the Id. (nationwide count of firms for NAICS Code § 88.4 by (1) removing estimated sub- clinicians directly, and under the 624120). recipients from the total because § 88.4 Id. (nationwide count of firms for NAICS Code managed care model, a State pays a fee 624190). applies to recipients, not sub-recipients, to a managed care plan, which in turn Id. (nationwide count of firms for NAICS Code and (2) removing the estimated pays the clinician for the services a 624110). As described supra at part IV.C.2.iii recipients exempted from § 88.4, as beneficiary may require that are within (methodology), for entities whose principal purpose identified in § 88.4(c)(1) through (4). the managed care plan’s contract with is not health care, the Department assumes 25%– Infra at Table 3 shows this calculation. 100% of industry is covered. the State to serve Medicaid Id. (nationwide count of firms for NAICS Code Calculating Estimated Sub-Recipients beneficiaries. As sub-recipients, these 624221). As described supra at part IV.C.2.iii clinicians that accept Medicaid are not (methodology), for entities whose principal purpose The Department sought comment on is not health care, the Department assumes 25%– the policy for § 88.4 to apply to subject to § 88.4, unless they become 100% of industry is covered. recipients from HHS Federal financial Id. (nationwide count of firms for NAICS Code (TAGGS) http://taggs.hhs.gov (last visited Dec. 19, assistance or other Federal funds from a 624230). As described supra at part IV.C.2.iii 2017). HHS identified unique awardees for FY 2017 non-exempt HHS program (i.e., a (methodology), for entities whose principal purpose from HHS PEPFAR implementing agencies (CDC, is not health care, the Department assumes 25%– program not captured in § 88.4(c)(2) HRSA, SAMHSA, NIH, FDA) to foreign nonprofits, through (4)). 100% of industry is covered. foreign governments, and international Id. (nationwide count of firms for NAICS Code organizations and used this number as a lower- In the proposed rule, OCR explained 44610). bound. Because the Department also receives funds that it had not found a reliable way to Id. (nationwide count of firms for NAICS Code appropriated to USAID through one or more calculate the number of sub-recipients 541711). reimbursable agreements, the Department assumed Id. (nationwide count of firms for NAICS Code that there could be twice as many recipients and of this rule. The Department assumed 611310). As described supra at part IV.C.2.iii sub-recipients after considering the awardees from entities in supra at Table 2 were all (methodology), the Department assumes 13%– these reimbursable agreements and thus multiplied recipients except for counties, which

2 100% of institutions of higher-education are and lower-bound by two. S the Department assumed were sub- E

L covered. See supra at XI.C.2.iii for a detailed The text of paragraph (d) states that its U recipients for the purpose of this R explanation for how the Department supplemented protection applies for health service program and h t i Statistics of U.S. Businesses data with award data research activities ‘‘funded in whole or part under w

D from the Department’s Tracking Accountability in a program administered by the [HHS] Secretary.’’ See, e.g., Provider Payment and Delivery O

R Government Grants System. Systems, MACPAC, https://www.macpac.gov/ P But see supra at part IV.C.2.ii (discussing the 2

8 U.S. Dep’t of Health & Human Servs., Tracking application of paragraph (d) of the Church medicaid-101/provider-payment-and-delivery- 0 Q

L Accountability in Government Grants System Amendments to such grantees). systems/ (last visited Jan. 29, 2019). G 3 K S D n o l l e

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calculation. The Department received The Department assumed that all assumed that all persons and entities no comments regarding information, physicians’ offices would meet the that provide child and youth services data sources, studies, or reports that criteria in § 88.4(c)(1) and subtracted out (such as adoption and foster care) would could assist the Department in 255,684 to 370,557 entities, which fall into this exemption. The improving its approach. represents the lower and upper-bounds Department also reasonably assumed To refine the estimates, the of all physicians’ offices. If some that all entities providing services for Department reconsidered the proposed physicians’ offices are recipients the elderly and persons with disabilities rule’s blanket assumption that all through an instrument other than (by providing nonresidential social counties are sub-recipients for purposes Medicare Part B reimbursement, then assistance services to improve quality of of this calculation. Using the the Department overestimated the life) would fall within this exemption. ‘‘Advanced Search’’ function in TAGGS, number of physicians’ offices exempted The Department did not subtract out the the Department identified the total due to § 88.4(c)(1). The Department does entities providing ‘‘Other Individual number of county awardees and de- not have the necessary data to estimate Family Services’’ (e.g., marriage duplicated the results to obtain one list the impact of the final rule’s new counseling, crisis intervention centers, of unique county awardees from the exemption for pharmacies and suicide crisis centers) because there is a Department for FY 2017. This approach pharmacists that receive Medicare Part significant likelihood of referral for the identified 625 counties (19 percent) B because the Department does not provision of health care at crisis receiving funding directly from HHS as know whether such pharmacies or intervention centers and suicide crisis recipients. Assuming that all counties pharmacists exempted under § 88.4(c)(1) centers. are HHS recipients or sub-recipients, the are Department recipients (as opposed The Department subtracted out 230 remaining of 2,609 counties (81 percent) to sub-recipients) of HHS Federal Tribes and Tribal Organizations for the would be sub-recipients that are not financial assistance or other Federal exemption in § 88.4(c)(4). This number subject to § 88.4’s application. This funds from a non-exempt HHS program represents the total Tribes and Tribal method is a more accurate proxy for (i.e., a program not captured in Organizations that operate contracts estimating the number of sub-recipient § 88.4(c)(2) through (4)). under Title I of the ISDEA Act. This counties. If some entities (other than The Department subtracted out 11,220 final rule revises the requirements for counties) in Table 2 are sub-recipients to 44,879 persons and entities that meet federally recognized Indian tribes, tribal rather than recipients, then the the criteria in § 88.4(c)(2) and (3) organizations, or urban Indian Department overestimated the scope of regarding the exemption for recipients organizations who are recipients by entities subject to § 88.4’s application of grant programs administered by the virtue of grants or cooperative that are not exempted. Administration for Children and agreements under 42 U.S.C. 290bb–36, Families or the Administration for removing the requirement that such Calculating Exempted Recipients in Community Living. The exemption entities comply with § 88.4. The § 88.4(c)(1) Through (4) applies if the program meets certain Department does not have the data The Department received no regulatory criteria indicating that its necessary to estimate the number of comments regarding the methods used purpose is unrelated to health care and such entities who are recipients of funds to estimate the scope of exempted certain types of research, does not via such grants or cooperative recipients under § 88.4(c)(1) through (4). involve health care providers, and does agreements that are not already captured Therefore, the Department maintains the not involve referral for the provision of within the scope of the exemption in proposed rule’s methods. health care. The Department reasonably § 88.4(c)(4).

TABLE 3—ESTIMATED RANGE OF RECIPIENTS SUBJECT TO THE ASSURANCE AND CERTIFICATION REQUIREMENTS (§ 88.4)

Low-end Upper-bound estimate estimate

Persons or Entities Subject to This Final Rule ...... 392,301 613,497 Sub-Recipients to which § 88.4 Does Not Apply ...... ¥2,609 ¥2,609 Range of Recipients Exempted from § 88.4 ...... ¥267,134 ¥415,666

Total, Recipients Subject to § 88.4 ...... 122,558 195,222

(B) Estimated Number of Recipients and anti-discrimination laws. The rule The Department expects that some Incentivized To Provide Voluntarily a intends to accomplish this goal by regulated recipients and Department Notice of Rights (§ 88.5) providing that OCR will consider a components will voluntarily post the notice through one of the methods The proposed rule contained a recipient’s posting of a notice as non- freestanding notice provision with dispositive evidence of compliance with specified. Because recipients are the mandatory and discretionary elements. this rule in any investigation or primary entities responsible for As finalized in this rule, the notice compliance review pursuant to this rule, compliance under this rule, the provisions are no longer mandatory. to the extent such notices are provided Department assumes that sub-recipients Section 88.5 incentivizes recipients and according to the provisions of this will not be induced by the rule to post a notice on their own accord. 2 the Department to provide notice to section and are relevant to the particular S E L persons, entities, and health care investigation or compliance review. The proposed rule did not permit U R h t entities concerning Federal conscience recipients to modify the pre-written i w

D O

R Sum of rows 11, 12, 14–16, and 18 of Table Indian Health Service, FY 2019 Justification of includes/themes/responsive2017/display_objects/ P 2

8 2. Estimates for Appropriations Committees CJ–243 documents/FY2019CongressionalJustification.pdf. 0 Q

L Sum of rows 31 and 33 of Table 2. (2018), https://www.ihs.gov/budgetformulation/ G 3 K S D n o l l e

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notice in appendix A. As discussed in pre-written notice likely will do so at to them (in relation to, for example, the preamble for § 88.5, supra at part the firm level (i.e., corporate level) abortion). The sum of the low-end and II.B, public comments asked for rather than the establishment level (i.e., high-end estimates of firms associated flexibility to modify the notice’s content at each facility). For instance, a with these eighteen recipient types is as applied to recipients. Paragraph (c) in company with common ownership and 225,751 (low-end) and 332,707 (high- § 88.5 of the final rule provides greater control over multiple facilities would end), providing an average of 279,229 flexibility by stating that the recipient modify the notice at its corporate firms. Given the discretionary nature of and the Department should consider (‘‘firm’’) level but would post the notice provision, the Department using the model text provided in substantially the same physical notices adjusts the range of firms downward by appendix A for the notice, but may at each facility (‘‘establishment’’) where 50 percent for the purpose of this tailor the content to address the laws notices are customarily posted to permit calculation to derive the values shown that apply to the recipient or ready observation for members of the in infra at Table 4: 112,876 firms (low- Department under the rule and the workforce or for the public. end) and 166,354 firms (high-end) for a recipient’s or Department’s particular The Department estimates that mid-point of 139,615 firms likely to circumstances. Accordingly, the eighteen recipient types, such as modify the pre-written notice in Department assumes that some medical specialists, elder care appendix A. To the extent that recipient recipients that voluntarily post notices providers, and entities providing types other than those listed in Table 4 will modify the pre-written notice in primarily social services, are likely to modify the notice, the Department has appendix A. Recipients that modify the modify the pre-written notice as applied underestimated the scope of impact. TABLE 4—ESTIMATED NUMBER OF FIRMS ASSOCIATED WITH EACH RECIPIENT TYPE LIKELY TO MODIFY THE NOTICE OF RIGHTS IN APPENDIX A (§ 88.5)

Type Estimate Estimate (low) (high)

1. Skilled Nursing Facilities ...... 3,158 4,577 2. Residential Intellectual and Developmental Disability Facilities ...... 2,155 3,123 3. Continuing Care Retirement Communities ...... 1,302 1,888 4. Other Residential Care Facilities (e.g., group homes) ...... 1,123 1,628 5. Entities providing Home Health Care Services ...... 7,531 10,915 6. Offices of Physicians, Mental Health Specialists ...... 3,662 5,307 7. Offices of Mental Health Practitioners (except Physicians) ...... 7,170 10,391 8. Offices of Dentists ...... 43,437 62,952 9. Offices of Chiropractors ...... 13,363 19,366 10. Offices of Optometrists ...... 6,888 9,982 11. Offices of Physical, Occupational and Speech Therapists, and Audiologists ...... 8,811 12,770 12. Offices of Podiatrists ...... 2,657 3,851 13. Offices of All Other Miscellaneous Health Practitioners ...... 5,751 8,335 14. Kidney Dialysis Centers ...... 152 221 15. Outpatient Mental Health and Substance Abuse Centers ...... 1,888 2,736 16. Diagnostic Imaging Centers ...... 1,605 2,326 17. Medical Laboratories ...... 1,139 1,651 18. Entities Providing Child and Youth Services (e.g., adoption agencies, foster care placement services) ...... 1,084 4,337

Total, Firms Likely to Modify Pre-Written Notice Text ...... 112,876 166,354

The Department assumes that, for all for each line and assume 69–100 values derived from this calculation posting methods, recipients will execute percent of the industry as covered appear infra at in Table 5: 261,735 the posting at the establishment level. unless otherwise noted, which parallels establishments (low-end) and 408,918 Using the range of firms subject to this the assumptions for Table 2. establishments (high-end) for a mid- rule as a foundation, the range of Because there is a high degree of point of 335,327 establishments. The establishments associated with those uncertainty as to the proportion of Department adjusts downward the range recipients is shown infra at in Table 5. recipients that will voluntarily post of establishments that would voluntarily Table 5 employs the methodology used notices through one or more of the provide notices of rights in years two for calculating the number of persons methods specified in § 88.5 in the first through five by 25 percent, relative to and entities shown in Table 2, but uses year of the rule’s implementation, the year one, to reflect attrition: 196,301 the U.S. Census Bureau’s Statistics of Department adjusts the range of establishments (low-end) and 306,689 U.S. Businesses data for establishments establishments associated with covered establishments (high-end) for a mid- rather than firms. The footnotes recipients downward by 50 percent for point of 251,495 establishments. detail the assumptions and calculations the purpose of this calculation. The 2 S E L U R h t i w

D O

R https://www.census.gov/data/datasets/2015/ employment sizes (U.S., 6-digit and States, NAICS the Bureau made available in September of 2017, P 2

8 econ/susb/2015-susb.html. The Department relied

0 sectors).’’ The latest data available is from 2015 that and this data relied on the 2012 NAICS codes. Id. Q

L on the data file titled ‘‘U.S. & State, NAICS, detailed G 3 K S D n o l l e

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TABLE 5—NUMBER OF PHYSICAL ESTABLISHMENTS OF EACH RECIPIENT TYPE ESTIMATED TO VOLUNTARILY PROVIDE NOTICE OF RIGHTS IN YEAR 1 (§ 88.5)

Establishments assoc. with cov- Establishments assoc. with covered recipients Type ered recipients that would voluntarily post notices in Year 1 (Low) (High) (Low) (High) Mid-point

State and Territorial Governments ...... 58 58 29 29 29 Federally recognized Tribes ...... 573 573 287 287 287 Counties ...... 625 625 313 313 313 General and Medical Surgical Hospitals ...... 3,699 5,361 1,850 2,681 2,265 Specialty Hospitals (e.g., psychiatric, substance abuse, re- habilitation, cancer, maternity) ...... 1,139 1,651 570 826 698 Skilled Nursing Facilities ...... 11,789 17,085 5,894 8,543 7,218 Residential Intellectual & Developmental Disability Facili- ties ...... 22,611 32,770 11,306 16,385 13,845 Continuing Care Retirement Communities ...... 3,668 5,316 1,834 2,658 2,246 Other Residential Care Facilities (e.g., group homes) ... 3,627 5,256 1,813 2,628 2,221 Entities providing Home Health Care Services ...... 21,377 30,981 10,688 15,491 13,089 Offices of Physicians (except Mental Health Special- ists) ...... 147,817 214,228 73,909 107,114 90,511 Offices of Physicians (Mental Health Specialists) ...... 7,498 10,867 3,749 5,434 4,591 Offices of Mental Health Practitioners (except Physi- cians) ...... 15,022 21,771 7,511 10,886 9,198 Offices of Dentists ...... 92,895 134,631 46,448 67,316 56,882 Offices of Chiropractors ...... 26,999 39,129 13,500 19,565 16,532 Offices of Optometrists ...... 15,101 21,885 7,550 10,943 9,246 Offices of Physical, Occupational & Speech Therapists, & Audiologists ...... 25,213 36,541 12,607 18,271 15,439 Offices of Podiatrists ...... 5,769 8,361 2,885 4,181 3,533 Offices of All Other Misc. Health Practitioners ...... 12,731 18,450 6,365 9,225 7,795 Family Planning Centers ...... 1,584 2,295 792 1,148 970 Freestanding Ambulatory Surgical & Emergency Ctrs. .. 4,609 6,679 2,304 3,340 2,822 HMO Medical Centers ...... 560 812 280 406 343 Kidney Dialysis Centers ...... 5,144 7,455 2,572 3,728 3,150 Outpatient Mental Health & Substance Abuse Ctrs...... 7,227 10,474 3,614 5,237 4,425 Diagnostic Imaging Centers ...... 4,553 6,598 2,276 3,299 2,788 Medical Laboratories ...... 7,360 10,667 3,680 5,334 4,507

Assumes coverage of the 50 States, DC, Puerto Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Rico, 6 U.S. Territories, and the Island Areas. 621112). 62199). Assumes all federally recognized Tribes get Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code HHS funds. Indian Health Service, FY 2019, 621330). 524114). Justification of Estimates for Appropriations Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Committees, CJ–243 (2018), https://www.ihs.gov/ 621210). 624120). budgetformulation/includes/themes/ Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code responsive2017/display_objects/documents/ 624190). FY2019CongressionalJustification.pdf. 621310). U.S. Census Bureau, 2010 Census Geographic Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Entity Tallies by State and Type, https:// 621320). 624110). As described supra at part IV.C.2.iii www.census.gov/geo/maps-data/data/tallies/all_ Id. (nationwide count of firms for NAICS Code (methodology), for entities whose principal purpose tallies.html (total counties and equivalent areas for 621340). is not health care, the Department assumes 25%– the U.S., Puerto Rico, the U.S. Territories, and the Id. (nationwide count of firms for NAICS Code 100% of industry is covered. Island Areas). The values estimate the number of 621391). Id. (nationwide count of firms for NAICS Code recipient counties and exclude estimated sub- Id. (nationwide count of firms for NAICS Code 624221). As described supra at part IV.C.2.iii recipients. 621399). (methodology), for entities whose principal purpose U.S. Census Bureau, Statistics of U.S. is not health care, the Department assumes 25%– Id. (nationwide count of firms for NAICS Code Businesses, 2015 (released Sept. 2017), https:// 100% of industry is covered. 621410). www.census.gov/data/datasets/2015/econ/susb/ Id. (nationwide count of firms for NAICS Code 2015-susb.html (nationwide count of firms for Id. (nationwide count of firms for NAICS Code 624230). As described supra at part IV.C.2.iii NAICS Code 622110). 621493). (methodology), for entities whose principal purpose Id. (sum of the nationwide count of firms for Id. (nationwide count of firms for NAICS Code is not health care, the Department assumes 25%– NAICS Codes 622210 and 622310). 621491). 100% of industry is covered. Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code 623110). 621492). 44611). Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code 623210). 621420). 541711). Id. (nationwide count of firms for NAICS Code 2 Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code S

E 623311). 621512). 611310). As described at part IV.C.2.iii L supra

U Id. (nationwide count of firms for NAICS Code R Id. (nationwide count of firms for NAICS Code (methodology), the Department assumes 13%-100% h t i 623990). 621511). of institutions of higher-education are covered. w

D Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code U.S. Dep’t of Health & Human Servs., Tracking O

R 621610). 621910). Accountability in Government Grants System P 2

8 Id. (nationwide count of firms for NAICS Code Id. (nationwide count of firms for NAICS Code (TAGGS) http://taggs.hhs.gov (last visited Dec. 19, 0 Q

L 621111). 621498). 2017). G 3 K S D n o l l e

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TABLE 5—NUMBER OF PHYSICAL ESTABLISHMENTS OF EACH RECIPIENT TYPE ESTIMATED TO VOLUNTARILY PROVIDE NOTICE OF RIGHTS IN YEAR 1 (§ 88.5)—Continued

Establishments assoc. with cov- Establishments assoc. with covered recipients Type ered recipients that would voluntarily post notices in Year 1 (Low) (High) (Low) (High) Mid-point

Ambulance Services ...... 3,271 4,740 1,635 2,370 2,003 All Other Outpatient Care Centers (e.g., centers & clinics for pain therapy, community health, & sleep dis- orders) ...... 8,054 11,672 4,027 5,836 4,931 Entities Providing All Other Ambulatory Health Care Serv- ices (health screening, smoking cessation, hearing test- ing, blood banks) ...... 3,670 5,319 1,835 2,660 2,247 Direct Health & Medical Insurance Carriers ...... 3,712 5,379 1,856 2,690 2,273 Entities Serving the Elderly and Persons with Disabilities (provision of nonresidential social assistance services to improve quality of life) ...... 10,475 41,899 5,237 20,950 13,093 Entities providing Other Individual Family Services (e.g., marriage counseling, crisis intervention centers, suicide crisis centers) ...... 7,184 28,736 3,592 14,368 8,980 Entities providing Child & Youth Services (e.g., adoption agencies, foster care placement services) ...... 2,901 11,604 1,451 5,802 3,626 Temporary Shelters (e.g., short-term emergency shelters for victims of domestic violence, sexual assault, or child abuse; runaway youth; and families caught in medical crises) ...... 1,013 4,053 507 2,027 1,267 Emergency & Other Relief Services (e.g., medical relief, resettlement, & counseling to victims of disasters or conflicts) ...... 309 1,236 155 618 386 Pharmacies and Drug Stores ...... 30,450 44,130 15,225 22,065 18,645 Research and Development in Biotechnology ...... 2,505 3,631 1,253 1,816 1,534 Colleges, Universities, & Professional Schools ...... 615 4,788 308 2,394 1,351 HHS awarded funds appropriated to the U.S. Department of State & USAID ...... 65 130 33 65 49

Total ...... 523,470 817,836 261,735 408,918 335,327

3. Estimated Burdens and their employers, the Department providers, the Department agrees that There are five categories of estimated agrees with the potential effect these this rule will result in more providers monetized burdens for this final rule as commenters predict: That some entities exercising conscientious objections to summarized in Table 6, as well as will change their behavior to come into participating in services requested by burdens that cannot be fully monetized. compliance, or improve compliance, patients, and that such objections may No commenters provided alternate with Federal conscience and anti- give rise to lawsuits by patients. reliable methodologies for monetizing discrimination laws. Indeed, the However, the Department is unaware of the rule’s burden. Potential burdens proposed rule’s RIA and this RIA any reliable basis for estimating the associated with access to care and estimate the burden associated with frequency or cost of such lawsuits. health outcomes are discussed infra at such voluntary behavior changes. However, whether entities take such Public comments regarding general part IV.C.4.vii. burdens are integrated throughout the Several comments argued that the rule action because of the risk of litigation is would impose costs on entities too speculative and uncertain for RIA. Public comments regarding the associated with the increased risk of calculation in the RIA. Further, some burden, if any, that may result from litigation over incidents of providers’ courts have held that there is no private secondary effects of this rule, such as exercise of conscience, both between right of action under the Coats-Snowe the monetary impact of certain health patients and providers and between and Church Amendments, excluding outcomes that may arise from increased individual providers and their litigation as a viable alternative for conscience protection, are discussed in employers. individuals. the rule’s analysis of benefits, infra at Regading an increase in risk for Regarding an increase in risk for IV.C.4. litigation between individual providers litigation between patients and 2 S E L U R h t i w

D See, e.g., Vermont All. for Ethical Healthcare, Order at 4, National Institute of Family and Life The totals in Table 6: Cost Summary of the O

R Inc. v. Hoser, 274 F. Supp. 3d 227, 240 (D. Vt. Advocates, et al. v. Rauner, No. 3:16–cv–50310 (N. P Final Rule may not appear to add correctly, but that 2

8 2017); Hellwege v. Tampa Family Health Centers, D. Ill. July 19, 2017), ECF No. 65. See also supra 0 is due to rounding. Q

L 103 F. Supp. 3d 1303, 1311–12 (M.D. Fla. 2015); at part II.A (describing the lack of private remedies). G 3 K S D n o l l e

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TABLE 6—COST SUMMARY OF THE FINAL RULE (Discounted 3% and 7% in millions)

Total Year 1 Year 2 Year 3 Year 4 Year 5 (for undiscounted) annualized (for discount’d.)

Familiarization (undiscounted) ...... $135 $¥ $¥ $¥ $¥ $135 Familiarization (3%) ...... 120 ...... 120 Familiarization (7%) ...... 103 ...... 103 Assurance & Certification (undiscounted) ...... 156 142 142 142 142 724 Assurance & Certification (3%) ...... 138 123 119 116 112 608 Assurance & Certification (7%) ...... 119 101 95 89 83 486 Voluntary Notice (undiscounted) ...... 93 14 14 14 14 150 Voluntary Notice (3%) ...... 83 12 12 11 11 130 Voluntary Notice (7%) ...... 71 10 9 9 8 108 Voluntary Remedial Efforts (undisc.) ...... 7 7 7 7 7 36 Voluntary Remedial Efforts (3%) ...... 6 6 6 6 6 31 Voluntary Remedial Efforts (7%) ...... 6 5 5 5 4 24 OCR Enforcement Costs (undisc.) ...... 3 3 3 3 3 15 OCR Enforcement Costs (3%) ...... 3 3 2 2 2 12 OCR Enforcement Costs (7%) ...... 2 2 2 2 2 10 Total Costs (undiscounted) ...... 394 167 167 167 167 1,061 Total Costs (3%) ...... 350 144 140 135 131 901 Total Costs (7%) ...... 301 119 111 104 97 731

In this impact analysis, the entities to familiarize themselves with applicable Federal conscience and anti- Department calculates labor costs using the rule. The proposed rule estimated discrimination laws and this rule. the mean hourly wage (including that on average, each person and entity The burden to recipients not benefits and overhead) for a: would spend one hour for exempted from § 88.4 is the opportunity • Lawyer at $134.50 per hour ($67.25 familiarization. The Department cost of recipient staff time (1) to review per hour × 2), received comments arguing that this the assurance and certification language • Executive at $186.88 ($93.44 per estimate fell short of the time needed to and the requirements of the Federal hour x 2), accomplish the goal of familiarization. conscience and anti-discrimination laws • Administrative assistant at $38.78 In light of these comments, the referenced or incorporated, (2) to review per hour ($19.39 per hour 2), × Department increased the estimate from recipient-wide policies and procedures • Web developer at $69.38 per hour one hour to two hours. This increase or take other actions to self-assess ($34.69 per hour × 2), and compliance with applicable Federal • Paralegal at $51.84 per hour ($25.92 reflects persons’ and entities’ familiarization of the rule’s conscience and anti-discrimination per hour × 2). laws, and (3) to implement any actions requirements and procedures, including These calculations reflect the necessary to come into compliance. the changes from the proposed rule. Department’s standard practice of Infra at Table 7 summarizes these costs. calculating a fully loaded mean hourly The burden is a one-time opportunity The Department estimates that each wage (i.e., wage including benefits and cost of staff time (a lawyer) to review the recipient not exempted from § 88.4 will overhead) by multiplying the hourly rule. The labor cost is approximately spend an average of 4 hours annually pre-tax wage by two. $135.3 million in the first year ($134.50 reviewing the assurance and (i) Familiarization Burden per hour × 2 hours × 502,899 entities certification language and the Federal (the average of the low and high-end conscience protection and associated The Department estimates a one-time range in Table 2)) and zero dollars in anti-discrimination laws and the rule. In burden for regulated persons and years two through five. This estimated the 2008 Rule, the Department burden represents the average burden; estimated that it would take 30 minutes Bureau of Labor Statistics, Occupational and to certify compliance with three laws: Employment Statistics, Occupational Employment some persons and entities may spend and Wages, May 2016, https://www.bls.gov/oes/ substantially more time than two hours The Church, Weldon, and Coats-Snowe current/oes_nat.htm (occupation code 23–1011). on familiarization, and others may Amendments. In this rule, there are Id. (occupation code 11–1011). spend less time. 22 additional statutory provisions Id. (occupation code 43–6010). covered. Citations for each law are Id. (occupation code 15–11134). (ii) Burden Associated With Assurance clearly listed in the rule, the texts of the Id. (occupation code 23–2011). & Certification (§ 88.4) statutes are easily found online. For ‘‘Guidance for Regulatory Impact Analysis,’’ many entities, it will be immediately Office of the Assistant Secretary for Planning and As a condition of the approval, Evaluation, U.S. Department of Health and Human clear when a law that this rule Services, 2016, at 28; see, e.g., 81 FR 31451 (2016) renewal, or extension of any Federal implements and enforces does not apply (‘‘We note that one commenter suggested that we financial assistance or Federal funds to those entities. The Department use a factor higher than 100% to adjust wages for from the Department, § 88.4 requires 2

S overhead and benefits. However, the commenter’s

E every application for Federal financial L argument is based on Federal overhead rates for 73 FR 78072, 78095 (2008 Rule). U R

contracts, and not evidence of the resource costs assistance or Federal funds from the For example, provisions applicable to h t i

w associated with reallocating employee time. As a Medicaid recipients would not apply to entities that

Department to which the rule applies to

D result, we do not adopt the commenter’s do not receive Medicaid and, presumably, most O provide, contain, or be accompanied by R

P recommendation, and we continue to use the entities readily know if they receive Medicaid 2

8 Department’s standard of 100% for overhead and an assurance and a certification that the reimbursements as a result of providing care to 0 Q

L fringe benefits.’’). applicant or recipient will comply with Medicaid beneficiaries. G 3 K S D n o l l e

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estimates each recipient will take 10 25,145 recipients in year one and 2,514 magnitude of the exemption, § 88.4 does minutes per law on average, yielding an recipients annually in years two through not unduly burden persons and entities additional 3.5 hours on average to five. The Department estimates that subject to the rule. Where the exemption review the applicability of the these recipients would spend 4 hours does not apply, the burdens arising from additional laws that this rule proposes annually, on average, to take remedial assurances and certifications are fully to enforce, for a total burden of 4 hours efforts. The Department estimates that justified, as they are with every other per recipient, per year, for the first five recipients will spend an average of 4 anti-discrimination law that requires a years. Some recipients may spend hours to update policies and similar assurance or certification. considerably less time; others may procedures, implement staffing or Moreover, the Department is spend considerably more time. scheduling practices that respect an committed to ensuring that a health care The labor cost is a function of a exercise of conscience rights under provider’s assurance and certification of lawyer spending 3 hours reviewing the Federal law, or disseminate the compliance with Federal conscience assurance and certification and an recipient’s policies and procedures. The and anti-discrimination laws does not executive spending one hour to review labor cost is a function of a lawyer unduly burden small health care and sign, as § 88.4(b)(2) requires a spending 3 hours and an executive providers in their delivery of health care signature by an individual authorized to spending one hour, which produces a services to the community. As bind the recipient. The weighted mean weighted mean hourly wage of $147.60 explained in the Paperwork Reduction hourly wage (including benefits and per hour. The labor cost is $14.8 million Act analysis for § 88.4, the Department overhead) is $147.60 per hour. The in year one ($147.60 per hour × 4 hours is leveraging existing grant, contract, labor cost is $93.8 million each year for × 25,145 entities) and approximately and other Departmental forms and the first five years ($147.60 per hour × $1.5 million annually for years two government-wide systems, consistent 4 hours × 158,890 recipients ). through five ($147.60 per hour × 4 hours with OMB’s government-wide effort to The Department estimates that 79,445 × 2,514 entities). reduce recipient burden. recipients, which is half of recipients If entities were already fully taking Finally, the Department has made required to assure and certify steps to be educated on, and comply efforts to reduce the frequency of compliance (158,890 recipients/ 2), will with, all the laws that are the subject of information collected. Paragraph (b)(6) spend 4 hours reviewing policies and this rule, there would likely not be any in § 88.4 allows an applicant or procedures or taking other actions to costs within the first five years of recipient to incorporate the assurances self-assess compliance with applicable publication for remedial efforts and certification by reference in Federal conscience and anti- associated with a recipient’s subsequent applications to the discrimination laws each year for the commitment to assure and certify Department or Department component if prior assurances or certifications are first five years after publication of the compliance in § 88.4. However, the fact initially provided in the same year. This rule. Some entities will spend more that there would be such costs is wholly approach is consistent with the HHS time and others will spend less time. consistent with the Department’s stated Grants Policy Statement. Because The Department reasonably estimates justifications for the rule (i.e., lack of recipients file an assurance of such action because § 88.4(b)(4) states knowledge of, and compliance with, the compliance form ‘‘for the organization that the submission of an assurance and laws). Several commenters expressed and . . . not . . . for each application,’’ certification will not relieve a recipient concern with the possible burden on a recipient with a signed assurance on of the obligation to come into health care providers resulting from the file assures through its signature on the compliance prior to or after submission requirements to assure and certify award application that it has a signed of such assurance or certification. A first compliance with Federal conscience Form 690 on file. step to such actions may be to review and anti-discrimination laws. In drafting Paragraph (b)(1) in § 88.4 requires organization-wide safeguards (or best the rule, the Department considered the submission more frequently than the practices), such as policies and possible burden on health providers and time of application if the applicant or procedures, that may be, or should be, exempted certain classes of recipients recipient fails to meet a requirement of in place. The labor cost is a function of from § 88.4. The impact of the the rule, or OCR or the relevant a lawyer spending 3 hours and an exemption means that, unless such Department component has reason to executive spending one hour, which exempted persons or entities are suspect or cause to investigate the produces the a weighted mean hourly recipients of Federal financial assistance possibility of such failure. The ability to wage of $147.60 per hour. The labor cost or other Federal funds from the require assurances outside of the for self-assessing compliance is a total of Department through another instrument, application process permits OCR and $46.9 million annually for the first five program, or mechanism, approximately the Department to ensure that the years ($147.60 per hour × 4 hours × 70 percent of recipients do not have to Federal financial assistance or other 79,445 entities). comply with the assurance and Federal funds that the Department The Department estimates that certification requirement. Given the awards are used in a manner compliant approximately 5 percent of entities (or with Federal conscience and anti- 16 percent of those subject to § 88.4) The average between the lower-bound discrimination laws and the final rule. will take an organization-wide action to (267,134) and upper-bound (415,666) of recipients As this is a new requirement, OCR has improve compliance in the first year exempted is 341,400 recipients, which represents 68 percent of the estimated total 500,290 recipients and 0.5 percent of entities (1.6 percent of the rule (which is the result of 502,899 entities Exec. Office of the President, Memorandum of those subject to § 88.4) will take a minus the estimated 2,609 counties that are from Mick Mulvaney, Dir., Office of Management & similar action annually in years two estimated for the purposes of this rule as sub- Budget to Heads of Executive Departments and

2 Agencies, Strategies to Reduce Grant Recipient

S recipients). If fewer recipients are impacted by the

E through five. This percentage equates to Reporting Burden, at 2 (Sept. 5, 2018), L exemptions in § 88.4(c)(1) through (4) than https:// U

R www.whitehouse.gov/wp-content/uploads/2018/09/ estimated, and if such recipients do not receive h t i Sum of ($134.50 × .75) and ($186.88 × .25). M-18-24.pdf.

w HHS Federal financial assistance or other Federal

D This estimate is the average of the low and funds from a non-exempted HHS program, then the See HHS Grants Policy Statement (Jan. 2007), O

R high-end estimates in supra at Table 3. As https://www.hhs.gov/sites/default/files/grants/ P Department overestimated the percent of recipients 2

8 explained supra at part IV.C.2.iv.A, sub-recipients that do not have to comply with the assurance and grants/policies-regulations/hhsgps107.pdf. 0 Q

L are not subject to this requirement. certification requirement. Id. at I–31. G 3 K S D n o l l e

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not yet gained the experience to know required by OCR or a Department needed basis outside of the application how many recipients, if any, would be component to sign assurances on an as- process.

TABLE 7—SUMMARY OF ASSURANCE AND CERTIFICATION COSTS

Total costs Cost categories Annually Year 1 Years 2–5

Review and Sign ...... $93.8 $93.8 Review Policies & Procedures ...... 46.9 46.9 Update or Disseminate Policies & Procedures ...... 14.8 1.5

Total Costs ...... 155.6 142.2

(iii) Burden Associated With Voluntary • At physical locations, may take an administrative assistant Actions To Provide Notices of Rights • On their websites, and longer to perform his or her respective (§ 88.5) • In two publications, such as a functions; for other establishments, it personnel manual or other substantially As explained supra at in part may take less time. As shown in Table IV.C.2.iv.B, the Department assumes similar document for members of the 5, 335,327 establishments is the average that some recipients and Department recipient’s workforce; in an application in the range of estimated establishments components will voluntarily post and for membership in the recipient’s associated with covered recipients that distribute a notice of rights through one workforce or for participation in a would voluntarily post notices in the of the methods specified in § 88.5. The service, benefit or other program, first year after the rule’s publication. expected cost to recipients and the including for training or study; or in a The estimated labor cost is $4.3 million Department is $93.4 million in the first student handbook or other substantially ( / hour × $38.78 per hour × 335,327 year of the rule’s implementation and similar document for students establishments). $14.1 million annually in years two participating in a program for training or A key uncertainty is the total number through five. The cost to the Department study, including for post-graduate of locations per establishment where makes up a miniscule portion of the interns, residents, and fellows. recipients commonly post notices; the cost—about 0.04 percent in the first year One commenter suggested that the per-establishment total will vary based and 0.10 percent annually in years two final rule should permit the notice on multiple factors. These factors through five. requirement to be posted electronically include the type of recipient, floor plans As explained supra at part IV.C.2.iv.B, only, and not in paper form. Because the of the building, the square footage of the the Department assumes that an rule does not require recipients to common areas, the square footage of the estimated 139,615 recipients (the provide notices of rights, recipients are building, the number of floors, the size average of the low-end and high-end free to provide notice in electronic form of the workforce, and the number of estimates shown in Table 4) will likely only and have such action considered ultimate beneficiaries, among other modify the pre-written notice in by OCR as non-dispositive evidence of variables. The Department assumes that Appendix A as applied to them. compliance with the substantive the average establishment will print and Because the scope of such modifications provisions of the rule, to the extent such post five notices in physical locations would likely be limited, the Department notices are otherwise provided where notices are customarily posted; estimates that modifying the notice according to § 88.5 and relevant to the larger recipients might post more and constitutes a minimal opportunity cost particular OCR investigation or smaller recipients might post fewer. The of 20 minutes of a lawyer’s time for compliance review. Department assumes that the cost of drafting and 10 minutes of an For recipients that voluntarily post materials (paper and ink) is $0.05 per executive’s time to provide final notices through any of the methods in page. Based on this assumption, the approval. For some recipients, § 88.5, the Department assumes that the first-year cost to post 5 notices across all modifying the notice will take more of recipients will act by the end of the first establishments would be $83,832 the lawyer’s or executive’s time; for year after the rule’s implementation. An (335,327 establishments × $.05 per page other recipients, it will take less time. entity that posts on its website and in × 5 pages). Because the Department The weighted mean hourly wage a physical location will incur a one-time assumes that this cost is a one-time cost (including benefits and overhead) of burden. A recipient that includes an during the first year of this rule’s these two occupations is $151.79 per insert in a publication may incur an implementation, the cost will not recur hour. The one-time labor cost is $10.6 annual burden represented by the costs in years two through five. The total million in the first year ($151.79 per of labor, materials (paper and ink for labor and materials costs for 335,327 hour × 0.5 hours × 139,615 recipients). hard-copy publication), and in some establishments to post notices in There is uncertainty regarding how cases, postage. physical locations is $4.4 million ($4.3 million in labor costs and $83,832 for many recipients will voluntarily post Burden for Voluntary Posting in notices and which method or methods materials) in year one with zero Physical Locations in § 88.5 they will employ. For the recurring costs. The Department estimates that it will 2 purposes of this calculation, the S Burden for Web Posting E take / of an hour for an administrative L Department erred on the side of U R

assistant to print notice(s) and post To post the notice on the web, the

h overestimating the burden and assumes t i w that recipients likely to provide notice them in physical locations of the Department estimates that it will take 2 D

O establishment where notices are hours for a web developer to execute the R will do so: P 2

8 customarily posted to permit ready design and technical elements for 0 Q

L Sum of ($134.50 × .67) and ($186.88 × .33). observation. For some establishments, it posting. A key uncertainty is whether G 3 K S D n o l l e

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each recipient maintains separate distribute the publications via U.S. mail marginal cost of postage per ounce of websites for each facility, and if so, where the weight of the notice $0.15, an annual number of mailings whether those websites are maintained incrementally increases the postage of 100 pages per establishment, average at the corporate (i.e., firm) level or costs. annual labor cost for mailing of $38.78 facility (i.e., establishment) level. In the The Department assumes that, within per hour, and an average number of proposed rule, the Department erred on the first year after the rule’s publication, labor hours per mailing of 0.25 hours, the side of overestimating the burden each recipient voluntarily posting the total costs due to the voluntary and assumed that recipients maintained notices in publications would identify mailing of notices are $4.1 million in separate websites for each of their the two publications in which to year one and $3.1 million annually facilities at the establishment level. include the notice, revising the in years two through five. Finally, the Thus, a web developer at each documents or their layouts to include annual cost of printed materials for recipient’s physical location would post the notice, or otherwise printing an notices (both mailed and hand the notice on the web. For some insert to include with hard copies of the distributed) is $1.7 million (335,327 establishments, it may take web publication. A recipient that adds the establishments × 100 pages × $.05 per developers longer to perform their notice to a publication disseminated page) in year one and $1.3 million respective functions; for other only online that is not disseminated in annually in years two through five establishments, it may take less time. hard copy will incur a one-time labor (251,495 establishments × 100 pages × This labor cost is approximately $46.5 cost with zero costs for materials. In $.05 per page). million (2 hours × $69.38 per hour × contrast, recipients that add the notice In sum, the burden to recipients 335,327 establishments). to a publication disseminated via hard related to the voluntary posting and If, however, recipients maintain one copy may incur the annual cost of distributions of notices that § 88.5 website at the corporate level for all of materials or incremental postage, or incentivizes is $93.4 million in the first their facilities, a web developer at the both, as well as the associated labor year and $14.1 million annually in years firm-level, rather than at each cost. For instance, a recipient that is two through five. establishment, would bear the burden. unable to add the notice to the back Burden to the Federal Government In contrast to recipients bearing the cost page of an existing publication might Federal agencies are encouraged to across 335,327 facilities, about 250,145 add the notice as a separate page to the identify costs and savings to recipients at the firm-level would each underlying publication or may print government agencies where bear this cost, which equals $34.7 notices annually to include as inserts significant. The burden of § 88.5 to million (2 hours $69.38 per hour with the hard-copy publications. A × × the Federal government is the cost 250,145 firms). Thus, if recipients recipient that does so and disseminates the publication via U.S. mail might associated with the Department’s voluntarily post notices on their components posting the notice websites, and if they do so at their incur incremental postage costs if the incremental weight of the notice places voluntarily. Although this burden is not corporate level for all sites including significant, the RIA monetizes the facility-specific websites, recipients the total weight of the mailing in the next bracket of postage costs. burden for completeness. would save on average about 25 percent The Department uses a framework for These assumptions may differ from of their labor costs to execute web estimating its burden that is similar to recipients’ implementation experiences. posting in this manner. the framework used to estimate the Some recipients may distribute fewer burden to recipients. For instance, the Burden for Posting in Two Publications than 100 hard-copy notices with Department assumes that half of its relevant publications while others will The Department did not receive components will post notices of rights distribute more than 100. Some specific comments estimating the voluntarily in the first year of the rule’s recipients that mail relevant annual costs of labor or materials that publication (i.e., 10 of the 20 HHS publications with notices of rights may may be incurred by entities that include Operating and Staff Divisions will post not experience any incremental postage notices in relevant publications as set online). Because of attrition in costs if the total weight of the mailings forth in the proposed rule (which compliance, 75 percent of that number with notices does not place the mailing remain voluntary under the final rule). will continue posting annually in in the next postage bracket. Given the key uncertainties in how certain publications in years two Notwithstanding these uncertainties, the recipients will disseminate the notices through five. As a proxy for that Department sets forth the following of rights, as explained in subsequent assumption to enable monetization of monetization as its best estimate of the paragraphs, the Department assumes the physical posting, the Department burden based on its assumptions. that: (1) Establishments that include assumes that staff at half of 533 physical notices of rights in publications will The Department assumes an administrative assistant would spend an most often do so in online publications in year one will continue to do so in out years and or in hard-copy publications hand- average of two hours in year one and there will be lower attrition compared to the distributed, where the notice’s inclusion one hour annually in years two through estimate provided in the proposed rule. results in an additional 100 hard copy five to execute the activities except for See U.S. Postal Service Postage Rates, https:// notices per establishment per year, and mailing. The average labor cost, www.stamps.com/usps/current-postage-rates/. excluding mailing-related labor costs, is Sum of incremental postage of $2.5 million (2) half of the establishments associated ($0.15 per mailing × 100 mailings × 167,663 with covered recipients voluntarily $26.0 million in year one ($38.78 per establishments) and incremental labor of $1.6 providing hard-copy notices (i.e., hour × 2 hours × 335,327 million ($38.78 per hour × 0.25 hours × 167,663 167,663 establishments in year one and establishments) and $9.8 million establishments).

2 Sum of incremental postage of $1.9 million S 125,747 establishments annually in annually in years two through five E

L ($0.15 per mailing × 100 mailings × 125,747 U years two through five) will ($38.78 per hour × 1 hour × 251,495 R establishments) and incremental labor of $1.2 h t i establishments). Based on the million ($38.78 per hour × 0.25 hours × 125,747 w

D Product of 335,327 establishments times 50 establishments). O

R percent for year one. Product of 251,495 Under the final rule, because all the notice OMB Circular A–4, Regulatory Analysis 37 P 2

8 establishments times 50 percent for years two provisions are voluntary, the Department assumes (2003), https://www.whitehouse.gov/sites/ 0 Q

L through five. that 75% of entities that voluntarily provide notices whitehouse.gov/files/omb/circulars/A4/a-4.pdf. G 3 K S D n o l l e

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locations owned or leased by the year and $2,785 annually in years compliance review, investigation, or Department (277 physical locations) two through five. In sum, the burden to complaint under 45 CFR part 88 over a would post an average of five hard-copy the Federal government associated with five-year period as such incidents arise notices per physical location and would § 88.5 is $36,677 in the first year and and in any application for new or post in certain publications. In years $13,660 annually in years two through renewed Federal financial assistance or two through five, 75 percent of the 277 five. Departmental funding. The Department received numerous comments that locations (207 locations) would post in (iv) Record-Keeping (§ 88.6(b)) certain publications. The Department stated this requirement was too Paragraph (b) in § 88.6 of the final rule assumes that the duration of the burdensome. requires recipients and sub-recipients to Accordingly, the Department has anticipated activities ( downloading, e.g., maintain records evidencing their significantly revised § 88.6(d). printing, and posting the notice) would compliance with this part. In the Recipients and sub-recipients would no take Department staff the same time as proposed rule, the Department did not longer have to report a compliance it would take recipient staff. Similarly, identify record-keeping as a separate review, investigation, or complaint the Department assumes that half of the burden because it assumed that against them as it arises. Moreover, physical locations associated with HHS recipients and sub-recipients already recipients and sub-recipients would components voluntarily providing hard maintain records in the course of only be required to disclose the copy notices (i.e., 138 locations in year evidencing compliance with the terms existence of a determination by OCR of one and 104 locations annually in years and conditions of a Federal award, noncompliance with this rule in any two through five) will distribute the which would include not only financial application for new or renewed Federal publications via U.S. mail where the management requirements but all financial assistance or Departmental weight of the notice incrementally applicable Federal laws, including funding (rather than reporting increases the postage costs. Federal conscience and anti- compliance reviews, investigations, or discrimination laws. The Department complaints). Recipients would be The methods diverge in how the web requested comment on that assumption. responsible for disclosing any OCR posting is implemented (by each HHS The Department received numerous determinations of non-compliance made Operating and Staff Division but not by comments stating that the record- against their sub-recipients. Finally, the each facility owned or leased) and in the keeping requirements in § 88.6(b) were final rule shortens the reporting period average hourly wage rate used: A GS–7 too vague and requesting clarity on what from five to three years following an step 5, which, adjusted upward for kinds of records must be maintained. OCR determination of noncompliance. benefits and overhead, equals $47.44 However, the Department received no Given the revisions to § 88.6(d), the per hour ($23.72 per hour × 2). comments contradicting its assumption Department has revisited its Based on these assumptions, the total that recipients and sub-recipients methodology for estimating the costs labor cost is $5,277 in the first year: already follow record-keeping practices imposed by § 88.6(d). The Department ($47.44 per hour × / hour × 277 that suffice to document compliance estimates that the burden is the locations) + ($47.44 per hour × 2 hours with Federal civil rights laws. opportunity cost for recipients and sub- recipients who have had OCR determine × 10 Departmental components). Cost Therefore, because the Department that they are noncompliant with this for materials for the notice is $1,452 understands that recipients and sub- rule to retrieve information from their dollars in the first year after recipients must document such compliance in the course of receiving a records systems and enter in the publication of the final rule and $1,037 application basic identifying annually in years two through five. Federal award, any potential marginal increase in the cost of information regarding the Finally, the cost associated with the maintaining records according to the determination. The components to portion of Department locations that clarity set forth in § 88.6(b) would be de monetize this burden include: (1) The mail notices of rights with certain minimis. time spent for a staff member to execute publications is $3,713 in the first the reporting functions and that (v) Reporting a Finding of person’s fully loaded mean hourly wage, Obtained from U.S. General Services Noncompliance (§ 88.6(d)) (2) the number of times a recipient or Administration on October 30, 2018 (on file with Paragraph (d) in § 88.6 of the sub-recipient applies for new or HHS OCR). proposed rule would have required renewed funding administered by the Product of 277 locations times 50 percent for recipients and sub-recipients to report Department annually, and (3) the year one. Product of 207 locations times 50 percent to the relevant Departmental funding number of recipients and sub-recipients for years two through five. component the existence of an OCR that OCR finds noncompliant with this The hourly wage rates of staff are likely to vary part annually. from a GS–3 to a GS–11. The Department uses the The Department estimates it would mid-point GS-level and step and relies on hourly Sum of incremental postage of $2,074 ($0.15 per mailing × 100 mailings × 138 facilities) and wage rates for the locality salary adjustment for the take a records custodian at the incremental labor of $1,640 ($47.44 per hour × 0.25 District of Columbia and surrounding geographic experience level of a paralegal about 15 hours × 138 facilities). area. minutes to retrieve the relevant Sum of incremental postage of $1,555 ($0.15 https://www.opm.gov/policy-data-oversight/ per mailing × 100 mailings × 104 facilities) and information (such as date of the OCR pay-leave/salaries-wages/salary-tables/pdf/2016/ incremental labor of $1,230 ($47.44 per hour × 0.25 determination of noncompliance and DCB_h.pdf. Executive Order 13771 requires hours × 104 facilities). the OCR ‘‘transaction number’’ (i.e., case agencies to estimate costs in 2016 dollars. See 45 CFR 75.302 (regarding the sufficiency number)) from the recipient’s or sub- Sum of costs for materials to post in physical of an HHS awardee’s financial management system, recipient’s records and an 2 including ‘‘records documenting compliance with S locations (5 pages × $0.05 per page × 277 locations) E administrative assistant 15 minutes to L Federal statutes, regulations, and the terms and

U plus costs for materials to post in certain R

conditions of the Federal award’’). See also id. enter the information in the application h

t publications (100 pages × $0.05 per page × 277 i section 75.361 (requiring an HHS awardee to w locations). for Federal financial assistance or other D maintain records for three years from the date of the O Federal funds from the Department. The R Costs for materials to post in certain final expenditure report or from the date the P 2

8 publications (100 pages × $0.05 per page × 207 awardee submits its quarterly or annual financial mean weighted hourly wage for the 0 Q

L locations). report). paralegal and administrative assistant is G 3 K S D n o l l e

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$45.31. The Department estimates complaints alleging conscience of the final rule. The Department that a recipient would bear this labor violations. Given this variable expects this increase from the cost at the firm level for every award posture at this stage of the Department’s synergistic impact of persons’ increased action the recipient applied, including renewed efforts on conscience and awareness of rights; increased new funding opportunities, religious freedom, the Department confidence in the Department’s ability supplemental funding, and non- cannot reliably predict the number of and willingness to address those rights competing continuations, among others. OCR determinations of noncompliance through the administrative complaint Because OCR had no publicly to monetize this burden, but estimates process; and an increase in the number available or reliable data source to that, for those to whom it applies, the of Federal conscience and anti- estimate how many total applications related reporting cost is about $45,310 discrimination laws that the rule for new or renewed funding in a fiscal per year per entity with the highest proposes to enforce. Indeed, since year a recipient might make to the number of applications for HHS during FY 2018, the most recently Department or its component, actual funding. completed fiscal year for which data are award data from HHS TAGGS was used available, OCR received 343 complaints (vi) Voluntary Remedial Efforts as a proxy. The Department considered alleging conscience violations. the number of award actions the The proposed rule noted that the The impact of the rule on OCR is the Department and its components made to Department anticipates that some opportunity cost of about 12 FTEs to State agencies and State universities in recipients will institute a grievance or perform investigative responsibilities FY 2017 to inform the estimate. Award similar process to handle internal and coordinate enforcement with HHS data in HHS TAGGS for FY 2017 complaints raised to the recipient’s or components, as set forth in § 88.7, indicated that some State universities sub-recipient’s attention. The rule does which is an increase of 7.5 FTEs from receive less than 100 awards per fiscal not require such a process, but in HHS the proposed rule’s estimate. These year and others receive nearly 2,000 OCR’s enforcement experience, informal responsibilities include receiving and awards. Some State agencies receive one resolution of matters at the recipient or handling complaints, initiating or two awards per fiscal year and others sub-recipient level may effectively compliance reviews, conducting receive 80 awards per fiscal year. resolve a beneficiary’s or employee’s investigations, coordinating compliance Consequently, a recipient or sub- concern. The Department received no within the Department, and performing recipient found in violation of this part, comments regarding the proposed rule’s other associated activities as part of its on the extreme end, would expend methodology for estimating these costs. program to promote widespread $45,310 per year in labor costs at the The Department anticipates 0.5 percent voluntary compliance of Federal firm level (2,000 applications per year × of entities, or 2,514 entities, would conscience and anti-discrimination $45.31 per hour × 0.5 hours). conduct such internal investigations laws. The Department anticipates that The most significant uncertainty for should complaints come to the the 12 FTEs consist of a member of the monetizing the burden of § 88.6(d) is the recipient’s or sub-recipient’s attention Senior Executive Service, four GS–15 number of recipients and sub-recipients or would undertake remedial efforts to employees, three GS–14 employees, two that OCR will determine as resolve complaints. GS–13 employees, and two GS–12 noncompliant with this rule. OCR The burden is the opportunity cost of employees, each paid a mid-level salary employs a range of fact-finding methods staff time to handle internal for the DC area. The fully loaded and evaluates each complaint based on investigations and take remedial action. labor cost (including benefits and the relevant facts, circumstances, and Uncertainty exists as to how many overhead) for those twelve employees is law at issue, which is an approach that hours annually a recipient or sub- estimated to be $3 million annually. The this rule codifies in § 88.7(d). OCR is recipient would devote to this effort. On difference between the proposed rule’s gaining experience in handling the average, the Department anticipates estimate for OCR’s enforcement costs complexity and volume of complaints entities spending 20 hours annually: 16 and this estimate is primarily the result received alleging violations of the hours of a lawyer’s time and 4 hours of of the increase in the number of FTEs. Weldon Amendment, Church an executive’s time. The weighted mean This increase is informed by OCR’s hourly wage (including benefits and Amendment, Coats-Snowe Amendment, experience since publication of the overhead) is $144.98 per hour. The and section 1553 of the Affordable Care proposed rule, which has demonstrated labor cost is $7.3 million ($144.98 per Act. Most of the statutes that are the that OCR will need to devote greater hour 20 hours 2,514 entities). Some subject of the rule have no case law × × resources to the area of conscience recipients may spend more than 20 interpreting them. In addition, protections than OCR had anticipated at hours on voluntary remedial efforts, and compared to OCR’s experience handling the time of publication of the proposed complex cases for other civil rights and if this is the case, the labor cost will be greater. Other recipients may spend less health information privacy matters, Complaint data based on OCR’s system of there is little institutional history of than 20 hours, and if this is the case, the records as of December 20, 2018. OCR enforcement of the Weldon labor cost will be lower. Using the locality salary adjustment for the Amendment, Church Amendments, District of Columbia and surrounding geographic (vii) OCR Enforcement and Associated area, the annual salaries adjusted upward for Coats-Snowe Amendment, and section Costs benefits and overhead are as follows: $290,324 for 1553 of the Affordable Care Act. Indeed, The Department anticipates a GS–15 step 5 (145,162 × 2); $246,812 for GS–14 step OCR was receiving only approximately 5 ($123,406 × 2); $208,866 for GS–13 step 5 1.25 complaints per year alleging such temporary increase in investigation and ($104,433 × 2); and $175,642 for GS–12 step 5 violations during the eight years enforcement costs to OCR over the five ($87,821 × 2). See https://www.opm.gov/policy- years immediately following publication data-oversight/pay-leave/salaries-wages/salary- 2 preceding the change in Administration. tables/16Tables/html/DCB.aspx. The mid-level S E

L However, during FY 2018, the most salary adjusted for benefits and overhead for a U

R Complaint data based on OCR’s system of

Senior Executive is $308,275 ($154,138 × 2), which h recently completed fiscal year for which t i records as of December 20, 2018. is the average of the minimum and maximum salary w data are available, OCR received 343 D Product of 0.005 × 502,899 recipients. for agencies with a certified SES performance O

R Sum of ($67.25 .80) + ($93.44 .20) and appraisal system. See https://www.opm.gov/policy- P × × 2

8 Sum of (0.5 × $38.78 per hour) and (0.5 × multiplied by two to adjust upward for overhead data-oversight/pay-leave/salaries-wages/salary- 0 Q

L $51.84 per hour). and benefits. tables/16Tables/exec/html/ES.aspx. G 3 K S D n o l l e

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rule. This estimate also has been it is unrealistic to expect them to have The analysis demonstrates that the rule adjusted upwards based on the method loyalty and fidelity to their professional creates and secures significant benefits. of calculating the wages of the FTEs. responsibilities.’’ (i) Historical Support for Conscience The proposed rule assumed a fully Third, the rule is expected to decrease Protections loaded wage for each of the 4.5 FTEs at the harm that providers suffer when $201,000, but the final rule estimates they are forced to violate their The people of the United States of the cost of the 12 FTEs based on various consciences, with attending America have valued conscience GS levels and therefore relies upon the improvements to patient health. protections since the country’s founding fully loaded wage using the estimated Scholars have observed that era. Madison said that ‘‘[c]onscience is hourly salaries of employees under the ‘‘[a]bandoning the right to conscience of the most sacred of all property; . . . the GS schedule. the medical practitioner not only harms exercise of that, being a natural and One commenter stated that the costs the individual practitioner but also unalienable right. To guard a man’s associated with OCR’s enforcement threatens harm to his patients as well— house as his castle, to pay public and efforts would double to the extent that the harms, however paradoxical it might enforce private debts with the most both a provider and a patient file a seem, are actually inseparable from one exact faith, can give no title to invade complaint over the same matter. The another.’’ a man’s conscience which is more commenter did not provide an example Fourth, by providing for OCR sacred than his castle.’’ George of a scenario where such ‘‘double filing’’ investigation and HHS enforcement of Washington wrote, ‘‘Government being, would occur. The Department believes Federal conscience and anti- among other purposes, instituted to that such scenarios, if they occur at all, discrimination laws, this final rule is protect the Persons and Consciences of would constitute a de minimis expected to decrease unlawful men from oppression, it certainly is the proportion of complaints received by discrimination, thereby permitting duty of Rulers, not only to abstain from OCR and would not involve increased greater personal freedom. The rule will it themselves, but according to their or doubled costs, as resources for promote protection of religious beliefs Stations, to prevent it in others, . . . resolution of the two complaints would and moral convictions, which is a [and] the Consciencious [sic] scruples of be shared through investigation of societal good based on fundamental all men should be treated with great similar matters. rights. As James Madison, often hailed delicacy & tenderness.’’ Some 4. Estimated Benefits as the ‘‘father of the Constitution,’’ scholars have argued that the right to wrote, conscience was a hallmark of our The Department expects this final rule The Religion then of every man must be founding and in fact, ‘‘[p]rotection for to produce a net increase in access to individual exercise of rights of health care, improve the quality of care left to the conviction and conscience of every man; and it is the right of every man to conscience was one of the essential that patients receive, and secure societal exercise it as these may dictate . . . . It is the purposes for the founding of the United goods that extend beyond health care. duty of every man to render to the Creator States of America and one of the great These effects will occur primarily via such homage, and such only, as he believes motivations for the drafting of the Bill four mechanisms. to be acceptable to him. of Rights.’’ First, this rule is expected to remove The Department received comments barriers to the entry of certain health (ii) Expected Postive Impact on the arguing that the proposed rule did not professionals, and to delay the exit of Recruitment and Maintenance of Health provide a sufficient articulation of the certain health professionals from the Care Professionals field, by reducing discrimination or benefits that this rule would create or secure. In addition to analyses provided Numerous studies and comments coercion that health professionals show that the failure to protect anticipate or experience. Comments elsewhere in this preamble where germane, the Department’s analysis of conscience is a barrier to careers in the received by the Department demonstrate health care field. that a lack of conscience protections the rule’s benefits responds to those comments and reflects a review of A 2009 survey found that 82% of diminishes the availability of qualified responding faith-based health care health care providers. For example, in a academic literature on the benefits of conscience protections in health care. providers said it was either ‘‘very’’ or survey of providers belonging to faith- ‘‘somewhat’’ likely that they personally based provider organizations, over nine would limit the scope of their practice in ten (91 percent) agreed with the D. White and B. Brody, Would Accommodating Some Conscientious Objections by of medicine if conscience rules were not statement, ‘‘I would rather stop Physicians Promote Quality in Medical Care?, 305 in place. This was true of 81% of practicing medicine altogether than be J. Am. Med. Assoc., May 4, 2011, at 1804–1805 medical professionals who practice in forced to violate my conscience.’’ (arguing that prohibiting conscience-based refusals Second, in supporting a more diverse ‘‘may negatively influence the type of persons who rural areas and 86% who work full-time enter medicine[,] . . . may negatively influence serving poor and medically-underserved medical field, the rule will benefit how practicing physicians attend to professional patients by improving doctor-patient populations . . . 91% agreed, ‘‘I would obligation[,] . . . [may cause] higher levels of rather stop practicing medicine relationships and quality of care. callousness [by physicians] toward patients[,] . . . Academic literature supports the [and] may reciprocally diminish physicians’ willingness to be sympathetic to and James Madison, ‘‘Property’’, in The Founders’ proposition that prohibiting the exercise accommodating of patients’ diverse moral beliefs’’). Constitution, http://press-pubs.uchicago.edu/ of conscience rights in medicine Kevin Theriot & Ken Connelly, Free to Do No founders/documents/v1ch16s23.html. decreases the quality of care that Harm: Conscience Protections for Healthcare Letter from George Washington, to The Society patients receive. As one article noted, Professionals, 49 Ariz. St. L.J. 549, 565 (2017); see of Quakers (October 13, 1789), https:// ‘‘[I]f physicians do not have loyalty and also J. McCarthy & C. Gastmans (2015). Moral founders.archives.gov/documents/Washington/05-

2 distress: A review of the argument-based nursing 04-02-0188. S

E fidelity to their own core moral beliefs,

L ethics literature, Nursing Ethics, 22(1), 131–152 Kevin Theriot & Ken Connelly, Free to Do No U

R (finding a consensus in academic literature that Harm: Conscience Protections for Healthcare h t i Christian Medical Association & moral distress involves suffering that is Professionals, 49 Ariz. St. L.J. 549, 561 (2017) w

D Freedom2Care summary of polls conducted April, psychological, emotional, and physiologic). (citing Lynn Wardle, Protection of Health-Care O

R 2009 and May, 2011, available at https:// James Madison, ‘‘Memorial and Remonstrance Providers’ Rights of Conscience in American Law: P 2

8 docs.wixstatic.com/ugd/809e70_7ddb46110dde46 Against Religious Assessments’’, in 2 The Writings Present, Past, and Future, 9 Ave Maria L. Rev. 1, 0 Q

L cb961ef3a678d7e41c.pdf. of James Madison 183, 184 (G. Hunt ed. 1901) 78 (2010)). G 3 K S D n o l l e

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altogether than be forced to violate my there is an unmet need for health care care, commenters who raised the claim conscience.’’ providers in the United States, the that the rule would exacerbate current The Department expects this rule to Department assumes that an increase in barriers to accessing health care failed to remove barriers to entry into the health the number of people willing to enter provide data that the Department care professions and into certain the health care profession (or a certain believes enables a reliable quantification specializations within the health care specialization within the health care of the effect of the rule on access to profession that arise from anticipated profession) will result in an increase in providers and to care. For the reasons or experienced discrimination against the number of providers. Similarly, a explained in this analysis, the such persons’ religious beliefs or moral certain proportion of decisions by Department disagrees with those convictions. The Department also currently practicing health providers to commenters and believes it is more expects this rule to delay the exit of leave the profession are motivated by likely that removing the barriers to entry certain types of health professionals coercion or discrimination based on that may exist due to insufficient who are considering leaving the field in providers’ religious beliefs or moral enforcement of conscience laws will order to avoid such coercion or convictions, so the Department result in an overall increase in access to discrimination. Although the rule anticipates that this rule’s protections care. Again, however, the Department is does not create substantive protections will decrease such departures from the not aware of data that allows for an beyond those in existing law, the field. Several commenters agreed estimate of the effect of this rule on Department believes that greater anecdotally, stating that without the access to services. awareness and enforcement of those rule, access to medical care will suffer, laws will help promote compliance and because pro-life and faith-based medical (iii) Expected Postive Impact on Patient provide these follow-on effects. The providers will leave the profession. Care by Religious Health Care Department has a significant interest in The Department anticipates that this Professionals and Organizations removing unlawful barriers to careers in effect will also occur at the macro-scale Many comments discussed the subject the health care field. in the health industry. For example, of the management of miscarriages in The American Association of Pro-Life religiously-operated hospitals or health Catholic hospitals, alleging that Catholic Obstetricians and Gynecologists care systems, being granted greater hospitals’ adherence to the Ethical and (AAPLOG), which represents 2,500 security to practice medicine consistent Religious Directives (ERDs), a document members and associates, wrote in with their religious beliefs, may find it that expresses the teaching of the 2009, ‘‘Like pro-life physicians worthwhile to hire more providers to Catholic Church on matters of health generally, AAPLOG members serve more people, or to serve new care, risks harm to women undergoing overwhelmingly would leave the populations (geographic, etc.), and will a miscarriage. Approximately forty-three medical profession—or relocate to a have a larger pool of medical public comment submissions (each of more conscience-friendly jurisdiction— professionals to choose from. The which may represent more than one before they would accept coercion to Department is not aware, however, of comment per submission) cited the participate or assist in procedures that data enabling it to quantify any effect article ‘‘When There’s a Heartbeat: violate their consciences.’’ the rule may have on increasing the Miscarriage Management in Catholic- AAPLOG’s members and associates number of health care providers or the Owned Hospitals,’’ which describes represent 13 percent of OB/ GYNs in the possible result of increasing access to experiences of a handful of physicians United States. Yet, as explained care. The Department instead believes it across the nation’s Catholic health care above, the Department has received is reasonable to conclude that the rule facilities that adhered to ERDs. The significant anecdotal evidence of will increase, or at least not decrease, article relays anecdotes and quotes from violations of the very conscience laws access to health care providers and six physicians out of the thirteen that Congress has enacted to protect services. interviewed by the authors. The authors such providers. Several commenters stated that do not state why the article omits quotes Because the rule is expected to permitting or honoring conscientious from the other seven providers, nor does remove a barrier to entry into the health objections, especially objections to it highlight anecdotes from positive or care profession, the rule is expected to referring for a health service, will neutral experiences with facilities’ engender more people to be willing to exacerbate current lack of access to adherence to ERDs. The authors use the enter the health care profession. Since health care caused by the existing anecdotes and quotes as support for the shortage of health care providers. This idea that adherence to ERDs creates Christian Medical & Dental Association argument appears to not adequately take summary of Key Findings on Conscience Rights into account how greater awareness and actual, potential, or perceived Polling conducted April, 2009, available at https:// deficiencies in the facilities’ docs.wixstatic.com/ugd/809e70_2f66d15b88a0476 enforcement of conscience rights will (1) remove a barrier to entry for certain management of miscarriagesy Catholic e96d3b8e3b3374808.pdf. health care facilities. Anecdotal Id. (finding that 20% of responding faith-based individuals and institutions into the medical students chose not to pursue a career in health care field, and (2) encourage accounts of such a limited nature do not obstetrics/ gynecology because of perceived coercion provide the Department with a robust and discrimination in that field). individuals and institutions with religious beliefs and moral convictions basis for estimating the rule’s impact on Id. the management of miscarriages. About Us, American Association of Pro-Life currently in the health care field that Obstetricians and Gynecologists, http://aaplog.org/ may be thinking about leaving the field Twenty-four public comment about-us. to remain, thereby creating net benefits. submissions (each of which may Letter from Lawrence J. Joseph, on behalf of As described in the analysis below on represent more than one comment per the American Association of Pro-Life Obstetricians the effects of this final rule on access to submission) discussed the case of 2 & Gynecologists, to the Office of Public Health & S Tamesha Means, who was treated for a E

L Science, Dep’t of Health & Human Servs. 2 (Apr. 9,

U miscarriage by a Catholic hospital in R 2009), http://downloads.frc.org/EF/EF09D50.pdf. Christian Medical Association & h t i Compare id., with Occupational Employment Freedom2Care summary of Online Survey of Faith- w

D Statistics: Occupational Employment and Wages, Based Medical Professionals polls conducted April, Lori R. Freedman, When There’s a Heartbeat: O

R May 2017 (March 30, 2018), https://www.bls.gov/ 2009 and May, 2011, available at https:// Miscarriage Management in Catholic-Owned P 2

8 oes/current/oes291064.htm (calculation assumes all docs.wixstatic.com/ugd/809e70_7ddb46110dde Hospitals, AM. J. PUB. HEALTH (2008), https:// 0 Q

L AAPLOG members are OB/ GYNs). 46cb961ef3a678d7e41c.pdf. www.ncbi.nlm.nih.gov/pmc/articles/PMC2636458/. G 3 K S D n o l l e

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Michigan, as an example of the harm to accounts may not be indicative of a III.A., and as observed in the analysis patient health caused by the faith-based widespread pattern.’’ below on the effects of this final rule on practices of Catholic hospitals. Ms. Additionally, Catholic and other access to care, the Department Means subsequently brought a lawsuit religiously affiliated health care concludes that the relationship between claiming that the hospital’s adherence to providers play a major role in the enforcement of Federal conscience and the ERDs constituted negligence. Yet the delivery of health care to residents of anti-discrimination laws through this U.S. Court of Appeals for the Sixth the United States, including to rule and the impact on access to care is Circuit ruled that Ms. Means had not underserved or underprivileged more complicated than suggested by alleged any harm or injury that could communities in particular, and are commenters who claim this rule will sustain her claim. Means v. U.S. Conf. motivated by their beliefs to serve such decrease access. The Department of Catholic Bishops, No. 15–1779 (6th communities. As some commenters believes the rule is just as, or more, Cir. 2016). noted, that role may explain the likely to result in a net increase access The rule does not incorporate ERDs, disproportionately large share of to care because religious or other and it does not enforce them. Nothing charitable care and service given by conscientiously objecting providers are in the rule requires any individual or religious providers to underserved already more likely to serve institutional provider to abide by any communities. For example, Ascension, underserved communities; imposing religious belief or moral conviction in the nation’s largest religiously affiliated violations on their conscience may lead his or her practice of medicine, and this non-profit health care system, had an to them limiting their practices rather rule does not take a position on whether annual operating revenue in 2016 that than providing services in violation of any facility should or should not adhere was about one-third the size of the their beliefs; and in some underserved to ERDs. Instead, the rule provides annual operating revenue for Kaiser communities patients may have a mechanisms for the enforcement for Permanente, the nation’s largest non- proportionate likelihood to agree with Federal conscience laws and anti- profit health care system that is not religious providers on controversial discrimination statutes, which are very religiously affiliated. However, both services such as abortion. The different from ERDs in their text, organizations provided approximately Department believes that, in passing structure, and legal significance. $2 billion in care and other benefit Federal conscience and anti- discrimination laws, Congress likely Numerous commenters also cited programming to underserved communities in 2017. intended to protect objecting providers statistics demonstrating that women of precisely to prevent them from limiting color are disproportionately served by As the Department discusses above in response to comments, supra at part their practices, especially to Catholic hospitals. These commenters underserved communities, so as not to argued that, because ERDs prohibit Hill, et al., Reproductive Health Care in exacerbate shortages to those Catholic hospitals from performing Catholic-Owned Hospitals, NBER Working Paper communities. elective abortions, sterilizations, and No. 23768 (2017), at 4 (emphasis added). In light of the demonstrated other procedures that are counter to Ascension, RE: Docket HHS–OCR–2018–0002, commitment that religious health care Catholic beliefs, women of color would Protecting Statutory Conscience Rights in Health providers have to caring for those for be disproportionately harmed by Care; Delegations of Authority (Mar. 27, 2018) (‘‘As the largest non-profit health system in the U.S. and whom it may not always be profitable to exercises of religious belief protected by the world’s largest Catholic health system, care, it likely would harm the rule. Ascension is committed to delivering underprivileged populations if the The question of the ultimate effect of compassionate, personalized care to all, with Department did not provide special attention to persons living in poverty and Catholic hospitals’ adherence to ERDs those most vulnerable. In FY2017, Ascension enforcement mechanisms and certain on general access to reproductive health provided more than $1.8 billion in care of persons procedural and administrative care, or access by any particular living in poverty and other community benefit requirements, as the alternative status population, is outside the scope of this programs.’’); Catholic Health Association, REF: RIN quo risks driving such entities out of 0945–ZA 03 Protecting Statutory Conscience Rights rule, but appears to be less settled than in Health Care; Delegations of Authority: Proposed underserved communities altogether. many commenters portray it to be. A Rule, 83 FR 3880, January 26, 2018 (Mar. 27, 2018) Again, however, the Department is not metastudy in 2019 found a surprising (‘‘As a Catholic health ministry, our mission and aware of data either in its possession, paucity of data on the issue, stating that our ethical standards in health care are rooted in from commenters, or from the public, and inseparable from the Catholic Church’s ‘‘Although many may assume that teachings about the dignity of each and every that would enable the Department to institutional restrictions cause harm, human person, created in the image of God. Access reliably estimate what the impact of this our current understanding demonstrates to health care is essential to promote and protect rule would be on increasing, or that the landscape of provision [of the inherent and inalienable worth and dignity of allegedly decreasing, access to providers every individual. These values form the basis for reproductive health care services] is our steadfast commitment to the compelling moral or services. The Department, instead, wide-ranging and complex in implications of our heath care ministry and have concludes that enforcing Federal nature.’’ On the subject of driven CHA’s long history of insisting on and conscience and anti-discrimination laws miscarriages in particular, another study working for the right of everyone to affordable, is an appropriate implementation of accessible health care.’’). observed that ‘‘Anecdotal reports have Congressional intent, and is more likely Compare Kaiser Foundation Health Plan and suggested that Catholic hospitals are Hospitals Report: 2017 Financial Results, Kaiser overall to lead to net benefits, and putting women in danger due to the Permanente (Feb. 9, 2018), https:// possibly to an increase in, health care restrictions on miscarriage management. share.kaiserpermanente.org/article/kaiser- provider and services access, than to foundation-health-plan-hospitals-report-2017- lead to its reduction. Contrary to these reports, we find some financial-results/ (last visited Dec. 3, 2018), with evidence that Catholic ownership is in Our One Ascension Journey: Year in Review, (iv) Expected Reduction in the Moral

2 fact associated with a reduction in Ascension, https://ascension.org/about/community- S Distress That Individual Providers E L miscarriages that involve a and-investor-relations/year-in-review (last visited U Experience R Dec. 3, 2018).

h suggesting that anecdotal t complication, i Facts and Stats, Ascension, https:// w

The Department anticipates that this D ascension.org/About/Facts-and-Stats (last visited O final rule will reduce the incidence of R Thorne, et al., Reproductive Health Care in Dec. 3, 2018); Thrive: Give Back, Kaiser P 2

8 Catholic Facilities: A Scoping Review, Obstet. Permanente, https://thrive.kaiserpermanente.org/ the harm that being forced to violate 0 Q

L Gynecol. 2019;133:105–15, at 114. thrive-together/give-back (last visited Dec. 3, 2018). one’s conscience inflicts on providers. G 3 K S D n o l l e

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Substantial academic literature decisions relating to her fertility and Commentary on the concept of moral documents the existence among health reproductive choices. Open distress among providers also expresses care providers of ‘‘moral distress,’’ communication in the doctor-patient concern over how a degraded moral which is ‘‘a sense of complicity in doing relationship will foster better overall culture in health care can jeopardize wrong’’ and ‘‘a deep anguish that comes care for patients. patients’ health. As one review of from the nature of those circumstances The benefit of open and honest literature on moral distress in nursing [of the provider’s work environment] as communication between a patient and found, ‘‘There is also a general systemic, persistently recurrent, and her doctor is difficult to quantify. One consensus among the reviews that pervasively productive of crises of study showed that even ‘‘the quality of [moral distress] arises from a number of conscience.’’ Moral distress communication [between the physician different sources, and that it (mostly) functions as a pressure on providers to and patient] affects outcomes . . . [and] impacts negatively on nurses’ personal leave the health care profession: influences how often, and if at all, a and professional lives and, ultimately, ‘‘Prolonging these conditions can lead to patient will return to that same harms patients.’’ Similarly, exhaustion of their resistance resources physician.’’ But poor communication allowance for the exercise of conscience and cause dissatisfaction with the negatively affects continuity of care and rights may promote ethical behavior by workplace. Those who continue to work undermines the patient’s health providers more broadly, preserve a despite these conditions experience goals. When conscience protections preferable model of health care stress and burnout along with are robust, both patients and their practice, and improve the doctor- dissatisfaction.’’ physicians can communicate openly patient relationship. It is difficult to quantify the impact of and honestly with one another at the the psychological trauma that results outset of their relationship. Josh Hyatt, Recognizing Moral Disengagement from moral distress. The strength of the Facilitating open communication and Its Impact on Patient Safety, J. of Nursing provider’s moral objection may vary between providers and their patients Regulation, 7:4, 18 (‘‘Perhaps, patients experience the most significant and dangerous consequences of based on the facts and circumstances of also helps to eliminate barriers to care, moral distress and moral disengagement . . . As each case, including the service in particularly for people of faith, and health care providers reduce their communications question. especially in migrant communities with patients, patients may feel less safe and less where culturally competent care matters satisfied with their medical experiences, and their (v) Expected Patient Benefits From This clinical progress may be hindered. Further, if health Rule greatly. Because positions of conscience care providers avoid patients or distance are often grounded in religious themselves from patients emotionally, they To the extent the rule supports a more influence, ‘‘[d]enying the aspect of minimize their ability to advocate for their patients’ diverse medical field, the rule would welfare. Providers’ emotional transition can also spirituality and religion for some . . . manifest as frustration toward patients, which may create positive effects for patients. The patients can act as a barrier. These impair the quality of care. If health care providers rule could assist patients in seeking influences can greatly affect the well- do not fulfill their commitments or perform at a counselors and other health care being of people. They were reported to mediocre level, patient care can become inadequate providers who share their deeply held or inappropriate . . . Lower quality of care leads to be an essential element in the lives of several costs for the patient. Patients may have to convictions. Some patients appreciate certain migrant women which enabled stay longer in the hospital or may miss care. Patient the ability to speak frankly about their them to face life with a sense of autonomy may also be threatened, and patients can own convictions concerning questions equality.’’ It is important for patients be more likely to be coerced into pursuing therapeutic options they would otherwise decide that touch upon life and death and seeking care to feel assured that their treatment options and preferences with against. Care can then become less patient centered religious beliefs and their moral and more paternalistic, a structure associated with a doctor best suited to provide such convictions will be honored. This will worse health outcomes.’’ (citations omitted)). treatment. A pro-life woman may seek a ensure that they feel they are being J. McCarthy & C. Gastmans (2015). Moral pro-life OB/ GYN to advise her on distress: A review of the argument-based nursing treated fairly. And for some, being ethics literature, Nursing Ethics, 22(1), 150. able to find health care providers that Christy A. Rentmeester, Moral Damage to White and Brody, supra at note 120; Stephen Health Care Professionals and Trainees: Legalism share the same moral convictions can be J. Genuis and Chris Lipp, Ethical Diversity and the and Other Consequences for Patients and a source of personal healing. Role of Conscience in Clinical Medicine, 2013 Int’l. Colleagues, Journal of Medicine and Philosophy, As mentioned above, academic J. Fam. Med. 587541 (2013), 5 (‘‘Compromise of 33: 27–43, 2008, p. 37 (elaborating that ‘‘[M]oral literature supports the proposition that personal moral integrity, of any kind or nature, will distress is a sense of complicity in doing wrong. inevitably lead to an erosion of ethical behavior— This sense of complicity does not come from prohibiting the exercise of conscience a prospect not conducive to the optimal provision uncertainty about what is right but from the rights in medicine may decrease the of healthcare.’’). experience that one’s power to resist participation quality of care that patients receive. Kevin Theriot & Ken Connelly, Free to Do No in doing wrong is severely restricted by one’s work Harm: Conscience Protections for Healthcare environment and from the experience that resisting Professionals, 49 Ariz. St. L.J. 549, 565–66 (2017) Fallon E. Chipidza, et al., Impact of the participation in doing wrong exposes one to harm. (‘‘[T]he ‘public utility’ model of medicine is not Doctor-Patient Relationship, 17(5) The Primary Care Moral distress is generated in the health care work only a ‘challenge [to] a conscientious physician’s Companion for CNS Disorders (2015), https:// environment when a practitioner is aware that he integrity as a physician,’ it also ‘depreciates his is acting other than how he is motivated to act, but www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308/. expertise, reduces his discretionary latitude in he believes that he cannot act as he is motivated Id. decisionmaking, and makes him a technical to act without suffering some morally significant Emmanuel Scheppers, et al., Potential Barriers instrument of another person’s wishes,’ thereby harm . . . A number of situations can generate to the Use of Health Services Among Ethnic ‘subvert[ing] the healing purpose for which moral distress. Broad systemic changes in the recent Minorities: A Review, 23 Family Practice 325, 343 medicine is intended in the first place.’ The myopic past in health care—in how health care institutions (2006), https://academic.oup.com/fampra/article/ view of medicine that views a medical practitioner are organized, how health care is financed, and how 23/3/325/475515. as a mere service provider ‘can redound to the health care resources are managed, for example— Id. patient’s harm by undermining the physician’s have de facto demanded that individual Stephen J. Genuis and Chris Lipp, Ethical moral obligation to provide sound advice and

2 practitioners adjust to being treated more like Diversity and the Role of Conscience in Clinical sound practice and to avoid medically useless or S E

L laborers than autonomous professionals and less Medicine, 2013 Int’l. J. Fam. Med. 587541(2013), 4– futile treatments.’ ’’ (citations omitted)). U

R like trusted fiduciaries than like employees with 5 (arguing that ‘‘if successive physicians lose Genuis & Lipp, at 5 (arguing that ‘‘[freedom of h t i suspicious conflicts of interest.’’) (emphasis added). individual liberty of conscience and are morally conscience] promotes open, transparent physician- w

D Borhani et al., The relationship between moral compromised because of authoritarian dictates, the patient relationships and engenders patient O

R distress, professional stress, and intent to stay in the end result [may] be a diminishing of collective advocacy . . . It is unlikely that individual patients P 2

8 nursing profession, J. Med. Ethics Hist. Med. 2014; professionalism and physician morale, leading to or society would support a situation in which 0 Q

L 7: 3. inadequate patient care.’’). Continued G 3 K S D n o l l e

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As noted above, the Department these mechanisms will contribute to the violation of the conscience of the individual assumes that this rule will increase the general public’s knowledge and will not in fact ultimately lose it by the overall number of providers because (1) appreciation of the foundational nature process. it will reduce barriers to entry into the of these rights, as well as the protections To protect the rights of conscience is to health care field (and reduce pressure to afforded by Federal law. protect personal and interpersonal leave the field) for individuals and Fostering respect for the existing goods that permit peaceful and fulfilling organizations with religious beliefs or Federal conscience and anti- lives. moral convictions, and (2) there exists discrimination laws also fosters an unmet demand for more providers. If lawfulness more generally. As one (vii) Analysis of Expected Effects of This the Department is incorrect in assuming author stated, Final Rule on Access to Care that the rule will increase the overall [L]aw and conscience are deeply intertwined. The Department solicited information number of providers—i.e., if health care . . . But the phenomenon of conscience isn’t on costs that may arise as secondary employers and medical training important only to legal experts. Just as effects of this rule, such as those programs do not increase their hiring conscience helps explain why people follow associated with changes in health rates and the size of their programs, legal rules, it helps explain why people outcomes arising from increased respectively, despite an increase in follow other types of rules as well, such as protection of conscience for health care applicants—then the rule will increase employers’ rules for employees, parents’ providers, as well as information about the quality of the average provider, rules for children, and schools’ and whether the existence or expansion of universities’ rules for students. It may also because the increase in the pool of help explain why people adhere to difficult- rights to exercise religious beliefs or available professionals will result in the to-enforce ethical rules and to the sorts of moral convictions in health care selection of better providers overall. An cultural rules (‘‘social norms’’) that make improves or worsens patient outcomes increase in the quality of providers will communal life bearable. . . . Twenty-first and access to health care. The increase the quality of care that patients century Americans still enjoy a remarkably Department also requested comment on receive. The Department is not, cooperative, law-abiding culture. the related question of whether this however, aware of data that provides a Because fostering conscience in final rule would result in unjustified basis for quantifying these effects. individuals—and compliance with limitations on access to health care. The questions of access to care and of (vi) Expected Societal Benefits From Federal conscience laws—contribute to health outcomes are largely This Rule a more lawful and virtuous society, governments and their subdivisions interdependent; access to care matters The rule will also yield lasting have a significant interest in because of its effects on health societal benefits. The rule mitigates encouraging expressions of, and fidelity outcomes, and the discussion in the current misunderstanding about what to, conscience. public comments on health outcomes in conduct the Federal government is the context of this rule were typically legally able to support and fund, and Forcing religious believers to violate their consciences involves harms that go beyond framed as a consequence of changes in educates individuals about their Federal these individuals and their communities. access to care. Many comments the conscience rights. By requiring When an individual is forced to act in ways Department received argued that the certifications and assurances (with some that they view as deeply wrong, indeed as rule would decrease access to care and excemptions), this rule provides a prohibited by the ultimate power responsible harm patient health outcomes, and most mechanism by which regulated entities for everything that exists, moral habits such comments focused on the potential will learn about—and, thus, be more essential for democratic citizenship are that providers would decline to perform likely to comply with—Federal undermined. a particular service for a patient. conscience and anti-discrimination Governments also have an interest in Generally, however, instead of laws. The rule also provides a ensuring the implementation and attempting to answer the difficult centralized office within the Department enforcement of existing laws, as part of question of how this rule would affect for individuals and institutions to file the greater virtue of the rule of law. access to care and health outcomes, and complaints with the Department when It is difficult to monetize the benefits how to quantify those effects, such such individuals and institutions of respect for conscience to the comments argued that significant believe that their rights have been individual and society as a whole, but discrimination against some segments of infringed. The Department expects that, they are clearly significant. As the the population in health care exists and as a result of this rule, more individuals, Supreme Court has said: is per se proof that the rule would result having been apprised of those rights, Both morals and sound policy require that in harm. The comments made this will assert them. The combination of the state should not violate the conscience of argument without establishing a causal the individual. All our history gives relationship between this rule and how physicians were being coerced to hide their confirmation to the view that liberty of it would affect health care access, and convictions, making decisions they felt were conscience has a moral and social value morally wrong or unethical, or failing to act in what without providing any data the they perceived to be their patients’ best interests’’); which makes it worthy of preservation at the Department believes enables a reliable Christian Medical Association & Freedom2Care hands of the state. So deep in its significance quantification of the effect of the rule on summary of polls conducted April, 2009 and May, and vital, indeed, is it to the integrity of access to providers and to care. 2011, available at https://docs.wixstatic.com/ugd/ man’s moral and spiritual nature that nothing 809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf short of the self-preservation of the state (‘‘77% of American adults surveyed said it is either should warrant its violation; and it may well United States v. Seeger, 380 U.S. 163, 169 ‘very’ or ‘somewhat’ important to them that ‘that be questioned whether the state which (1965) quoting Harlan Fisk Stone, The Conscientious Objector, 21 Col. Univ. Q. 253, 269 healthcare professionals in the U.S. are not forced preserves its life by a settled policy of 2 to participate in procedures or practices to which (1919). S E

L they have moral objections;’ ’’ ‘‘88% of American Christopher C. Lund, Religion Is Special U

R Lynn Stout, Cultivating Conscience: How adults surveyed said it is either ‘very’ or ‘somewhat’ Enough, 103 Va. L. Rev. 481, 504 (2017) (‘‘Freedom h t i important to them that they share a similar set of Good Laws Make Good People 17 (2011). of moral conscience, it turns out, serves many of the w

D morals as their doctors, nurses, and other healthcare Kathleen A. Brady, The Disappearance of same values served by freedom of religion—among O

R providers’’). Comments received by the Department Religion from Debates about Religious other things, it can serve to ameliorate P 2

8 supported the finding that patients prefer providers Accommodation, 20 Lewis & Clark L. Rev. 1093, psychological distress, reduce civil strife, and 0 Q

L who share their general belief system. 1110 (2017). preserve individual identity.’’). G 3 K S D n o l l e

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Other comments focused on whether access to particular procedures as a also want to force unwilling providers health disparities exist among result of enforcement of the law are to provide it in violation of their demographics that tend to utilize health really objections to policy decisions consciences. services that may be the subject of made by the people’s representatives in Lastly, numerous comments focused conscientious objections protected by Congress in enacting the Federal on the potential for a patient to feel this final rule, but again without conscience and anti-discrimination laws insulted or emotionally distressed establishing a causal link between the in the first place, rather than to this because of a perception that a provider, provisions of this rule and the predicted rule’s mechanisms for implementing in declining for reasons of religious or speculated effects. and enforcing those laws. belief or moral conviction to perform an Many comments observed that An analysis of any change in access objected-to service or procedure, is various demographic groups—women, to care caused by this final rule is not expressing disapprobation of the LGBT people, immigrants and refugees, the same as an analysis of the total patient, especially regarding his or her people of color, people living with HIV/ impact of the exercise of religious belief personal identity or personal AIDS, people with language barriers, and moral conviction on access to care. conceptions of morality. Although the people living in poverty, people with Nor is it the same as estimating the total Department does not understand such disabilities, and people living in rural impact of discrimination against conscientious objections to be areas—already face barriers to access to women, LGBT individuals, or necessarily intended to convey such care and therefore would be individuals in any other population disapprobation, the Department disproportionately harmed by any demographic on access to care. Rather, recognizes that, in some circumstances, additional barriers to access to care. The the question involves isolating the some patients do experience emotional Department does not dispute that impact of the exercises of religious distress as a consequence of providers’ people in such demographic categories belief or moral conviction attributable to exercise of religious beliefs or moral face health care disparities of various this final rule specifically, over and convictions. However, Congress, in forms. The Department does disagree, above whatever impact is attributable to considering the statutes enforced by this however, with these comments’ the pre-existing base rate of exercise of rule, did not establish balancing tests conclusions that the rule will create any religious belief or moral conviction. that weigh such emotional distress negative effect on access to care that Different types of harm can result against the right to abide by one’s cannot be otherwise addressed, or that from denial of a particular procedure conscience. is not outweighed by gains in overall based on an exercise of such belief or On the other side of the equation, public health, overall access to care due conviction. First, the patient’s health those who suffer discrimination on the to the removal of barriers for providers, might be harmed if an alternative is not basis of their religious beliefs or moral or the benefits of compliance with the readily found, depending on the convictions, or those coerced to violate law and respect for conscience and condition. Second, there may be search those convictions, may themselves religious freedom. In fact, as the costs for finding an alternative. Third, experience emotional distress, as well as Department discusses supra at part the patient may experience distress economic harms such as job loss or IV.C.4.iii and infra, the Department associated with not receiving a rejection from admission into a training expects the rule to specifically benefit procedure he or she seeks. These three program. underserved populations. potential harms, however, would also be There appears to be no empirical data A common sentiment expressed in applicable for denials of care based on, on how previous legislative or comments was that conscience for example, inability to pay the regulatory actions to protect conscience protections for providers are only requested amount. Fourth, there may be rights have affected access to care or appropriate to the extent they do not a harm resulting from a conscientious health outcomes. In fact, studies have interfere with, impose upon, or in any objection to referring for a health specifically found that there is way result in others feeling harmed. service, distinct from the harm of the insufficient evidence to conclude that This type of objection is not accepted initial objection to performing the conscience protections have negative for any other anti-discrimination law. service. Fifth, some commentators allege effects on access to care. For example, the Fair Housing Act and others in the community to which the Many commenters reasoned that, the Americans with Disabilities Act, patient belongs may be less willing to despite this lack of empirical evidence, under certain circumstances, require seek medical care. the rule would cause an increase in building and apartment owners to incur On the other hand, it is important not denials of care. For example, one costs to ensure that facilities are to assume that every patient who wants comment cited various statistics on the accessible to persons with disabilities. a particular service is offended by a rates of discrimination against LGBT These statutes impose costs, but provider’s unwillingness to provide that individuals, but those statistics were Congress and several Presidents have service, or wishes that the provider general in nature and did not assist the deemed it important to remove barriers would do so against his or her religious to full participation in economic and beliefs or moral convictions. Some See Chavkin et al., Conscientious objection social life for persons with disabilities. persons, out of respect for the beliefs of and refusal to provide reproductive healthcare: A Similarly, America has since the providers, may want a service but not White Paper examining prevalence, health consequences, and policy responses, 123 Int’l J. founding recognized that Free Speech take any offense, nor deem it any Gynecol. & Obstet. 3 (2013), S41–S56 (‘‘[I]t is results in harm and hurt feelings burden on themselves, for the provider difficult to disentangle the impact of conscientious (sometimes extraordinarily so) for many to not provide that service to them. objection when it is one of many barriers to Americans, yet it is deemed a price Some patients may even value the reproductive healthcare. . . . [C]onscientious worth paying. Conscience protection health care provider’s willingness to objection to reproductive health care has yet to be 2 rigorously studied.’’); K. Morrell & W. Chavkin, S

E obey his or her conscience, because the L should be not be a special exception to Conscientious objection to abortion and U R the principle that fundamental rights do patient feels that provider can be trusted reproductive healthcare: a review of recent h t i literature and implications for adolescents, 27 Curr. w not depend on there being zero conflicts to act with integrity in other matters as D Opin. Obstet. Gynecol. 5 (2015), 333–338 (‘‘[T]he O well. The Department does not believe R or disagreements in their exercise. degree to which conscientious objection has P 2

8 In any event, the objections based on it is appropriate to assume that all compromised sexual and reproductive healthcare 0 Q

L potential (often temporary) lack of patients who want a particular service for adolescents is unknown.’’). G 3 K S D n o l l e

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Department in estimating what degree health outcomes, and associated their practices because of threats to their may be attributable to the lawful concerns. consciences expand them because of exercise of religious beliefs or moral The Department attempted to quantify this rule, those would not be instances convictions. The comment also the impact of this rule on access to care of a reduction in the provision of identified numerous health disparities but determined that there is not enough services to which they object, but of an between LGBT individuals and non- reliable data, and that the analysis was increase in other services. However, the LGBT individuals, but did not explain subject to too many confounding Department was unable to find reliable the extent to which such disparities are variables, for the Department to arrive at data on this question, and concluded the product of the lawful exercise of a useful estimate. For instance, the that no useful quantitative estimate of religious beliefs or moral convictions. Department is not aware of a source for this impact was feasible. The comment then concluded that data on the percentages of providers The impact on health outcomes from ‘‘discrimination and related health who have religious beliefs or moral the exercise of conscientious objections disparities facing the LGBT population convictions against each particular to particular services and procedures stand to worsen if health care providers service or procedure that is the subject also resisted a useful quantitative are authorized to refuse to serve LGBT of this rule. estimate. Without data—to inform an people.’’ Likewise, the Department is not aware estimate of the quantity of such The same comment attached an of data on the actual rate of providers’ objections that would be attributable amicus brief that cited two studies on exercise of conscientious objections to this rule, the number of those objections how State laws affect health disparities performing such services or procedures. that led to providers offering services to among LGBT populations—one study Some providers who have a religious or which they object rather than limiting on States that either did not include moral objection to performing a service their practices, the number of persons sexual orientation as a protected or procedure may nonetheless perform who left or did not enter certain fields category in its hate crimes statute or did it for one reason or another, such as fear or practices altogether because not prohibit employment discrimination of legal reprisal. Others may respond to conscience laws were insufficiently on the basis of sexual orientation, and pressure to violate their consciences by enforced, the market effect of providers another on States that had constitutional limiting their practices, rather than expanding or moving into different amendments banning gay marriage on providing the service to which they areas because conscience laws are object. Commenters who contend the the ballot in 2004 and 2005. Neither enforced, and the overall resulting rule will reduce access to care seem to study provides a reliable basis for availability of access, both to objected- assume all providers with conscientious inferring an answer to the questions at to services and to other health care objections that are not being honored issue here. overall—the Department lacks the are providing those services anyway, so predicate for estimating the impact on Another comment cited to a 2018 that the rule will reduce their provision health outcomes of any change in the report on anecdotal experiences of of those services. The Department does availability of services. The analysis on discrimination among LGBT individuals not believe that assumption is correct. this point is also generally subject to the in eight States where laws had been The Department considered methods for same confounding factors discussed passed to protect religious freedom. The estimating the increase in the rate of below regarding the impact of report itself includes a citation to one such exercise of conscientious conscientious objections to providing study finding that awareness of objections that may occur as a result of referrals. legislation prohibiting discrimination this rule, but determined that no reliable The Department expects any on the basis of sexual orientation is method was available. The Department decreases in access to care to be associated with a decrease in the rate of likewise considered whether providers outweighed by significant overall such discrimination in interpersonal who, for reasons of religious beliefs or increases in access generated by this employment contexts. While analogous, moral convictions, have left the practice rule. If the laws that are the subject of such a finding is not the same as a of medicine or limited their scope of this rule are not enforced, many of the finding that the awareness of legislation practice may reenter the field or resume exact same people who would face a protecting conscience rights increases their previous scope of practice, given burden from a denial of access to a the rates of discriminatory conduct by the rule’s expanded enforcement of particular procedure from a particular people with religious beliefs or moral protections for religious beliefs or moral doctor or provider would face the convictions. The report provides convictions. If providers who limited potential of receiving no health care at anecdotal accounts of discrimination all from that doctor or provider because from LGBT residents of those States. For instance, even in the case of abortion, for such providers may limit, or leave, their However, the report does not attempt to which some data on the rates of providers’ practices if unable to comply with their determine if the laws passed by those objections actually exists, those rates vary religious beliefs or moral convictions. States played any causal role in the significantly based on the facts and circumstances of the scenario presented, confounding an attempt The absence or departure of those discrimination experienced by the to produce a single measure of providers’ rate of providers from the health field does not respondents, e.g., via comparison to objection to abortion in general. See Harris, et al., clearly lead to any increase in other LGBT individuals’ experiences in States Obstetrician-Gynecologists’ Objections to and providers who are willing to offer where no such laws had been passed. Willingness to Help Patients Obtain an Abortion 118 OBSTETRICS & GYNECOLOGY 905 (2011) services that are the subject of Federal Multiple comments provided lists of (‘‘These data suggest that ob-gyns also consider conscience and anti-discrimination various incidents in which providers contextual factors, including risk of physical harm laws, but is more likely to simply declined to participate in a service or to the woman by continuing pregnancy (breast diminish the overall availability of procedure to which they had a religious cancer, cardiopulmonary disease), the health care services. The burden of not 2 circumstances of the sexual encounter that resulted S

E or moral objection. Such lists offer no L in pregnancy (rape), the impact abortion may have being able to receive any health care U R suitable data for estimating the impact on pregnancy outcome (selective reduction), the clearly outweighs the burden of not h t i potential for fetal anomaly (diabetes), and the w of this rule. being able to receive a particular D duration of pregnancy (second versus first O No comment attempted a detailed R trimester) . . . Among ob-gyns, support for abortion treatment. P 2

8 description of the actual impact varies widely depending on the context in which For example, after the Department 0 Q

L expected from the rule on access to care, abortion is sought and physician characteristics.’’). proposed in 2009 to rescind the 2008 G 3 K S D n o l l e

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rule providing conscience protections protections to ensuring patient access’’ procedure. For instance, any pregnant for providers, a survey found that 81 for ‘‘patients who want access to woman is almost certainly aware of the percent of faith-based health care physicians of conscience,’’ to result in existence and purpose of abortion, and professionals working in rural areas and an increase in access to care. the extensive efforts of pro-choice 86 percent of faith-based health care groups to facilitate women’s access to The Effect of the Rule’s Protection of professionals working full-time in abortion make information about how to Refusals To Refer for Services service to underserved communities obtain an abortion relatively easy to said that they were either ‘‘very’’ or As with the analysis in the above find. So the effect of a provider’s ‘‘somewhat’’ likely to limit the scope of factors, there exists some baseline rate refusal to refer for an abortion is their practice if the 2008 rule was of exercise of conscientious objection to mitigated by the patient’s own rescinded. For such providers who referring for a service to which the knowledge and the widespread did not in fact limit their scope of provider morally objects. A significant availability of information about practice, this rule will help to prevent percentage of providers believe that they abortion access on the internet and future situations in which they feel are not obligated to refer for a service to elsewhere. forced to do so. For those who did, this which they morally object. It is The Change in the Number of Patients rule provides protections that may reasonable to assume that the rates of Who Delay or Forgo Health Care for Fear induce them to resume their previous exercise of the right not to refer will of Being Denied a Health Service scope of practice. In this sense the increase under the rule, but it is difficult Department believes the rule will both to determine by how much. It is As numerous public comments preserve and expand access to health likewise difficult to estimate what part demonstrate, certain minority groups care generally. of the baseline instances of already experience significant health Furthermore, as one academic article conscientious objection manifest care disparities. Commenters state that observed, ‘‘[P]atients choose not merely themselves in providers providing the negative health outcomes from some particular services, but particular kinds referrals in violation of their objections, demographics are due to fear of of professionals.’’ As noted earlier in instead of limiting their practices so as discrimination leading to avoidance of this section, a survey of patients found to avoid the conflict. seeking health care. However, the that 88 percent would prefer that their First, it is unclear how many Department is not aware of any data providers share their moral beliefs. providers understand their existing right establishing what, if any, part of this Another survey conducted by a former to decline to refer, whether grounded in avoidance phenomenon is attributable Chair of Bioethics of the National ethics or the law, to be coextensive with to the exercise of conscientious Institutes of Health Clinical Center the freedom that the rule reflects. For objections protected by this rule or by ‘‘reinforces the existence of patient example, a provider who objects to implementation of the enforcement preference for physicians with shared performing sterilizations may feel mechanisms of this rule. ethically obligated to inform a patient values . . . [finding] that nearly one- Other Comments on Access to Care fifth of [cancer] patients surveyed where vasectomies are locally ‘thought they would change physicians available—an act that the rule may Many of the comments that claimed if their physician told them he or she allow the provider to abstain from—but that the rule would result in more ‘had provided euthansia [sic] or assisted may not feel obligated to provide the frequent denials of service to patients suicide’ for other patients.’ ’’ The patient any further information about also argued that the rule is unnecessary Department, accordingly, expects this how to obtain that procedure. Research because there is no current problem rule, through its recognition of the suggests that providers may often draw with health care providers being ‘‘fundamental necessity of conscience such a distinction. coerced into violating their consciences. It is also difficult to estimate what These arguments are contradictory. If, Christian Medical Association & actual impact the increase in refusals to under the final rule, a provider exercises Freedom2Care summary of polls conducted April, refer would have. One confounding a right protected by the rule to decline 2009 and May, 2011, available at https:// to perform a service that he had been docs.wixstatic.com/ugd/809e70_7ddb46110dde factor is that the practical effect of a 46cb961ef3a678d7e41c.pdf. provider’s exercise of conscientious performing prior to this rule, his M. Bowman & C. Schandevel, The Harmony objection to providing a referral may previous performances of the service between Professional Conscience Rights and vary greatly depending on the particular would likely have been contrary to his Patients’ Right of Access, 6 Phoenix L. Rev. 31 facts and circumstances of the case. conscience. (2012) at 56 (‘‘First, a patient who chooses a pro- Many commenters observed that, in life physician is not merely choosing a physician Public knowledge of the availability of who does not do something. She is choosing a certain medical services may be rural areas, if a provider were to decline physician who affirmatively practices medicine extensive or minimal depending on the on religious or moral grounds to provide according to principles that unconditionally value a particular service or procedure, there human life, whether in the context of the preborn, may not be alternative providers within the born, the disabled, or the terminally ill . . . Id. at 36. Second, patients seek physicians not only for Combs et al., Conscientious refusals to refer: a feasible distance of the patient. The discrete services, but even more so for relationships findings from a national physician survey, J. Med. Department does not dispute that of trust.’’) Ethics 2011;37:397–401, 399 (‘‘[43%] of physicians patients in rural areas are more likely Christian Medical Association & in this present study . . . did not agree that than patients in urban areas to suffer physicians are obligated to make referrals that they Freedom2Care summary of polls conducted April, adverse health outcomes as a result of 2009 and May, 2011, available at https:// believe are immoral.’’). docs.wixstatic.com/ugd/809e70_7ddb46110dde Farr A. Curlin M.D., et al., Religion, being denied care. That is why 46cb961ef3a678d7e41c.pdf (‘‘88% of American Conscience, and Controversial Clinical Practices, enforcement of Federal conscience and adults surveyed said it is either ‘very’ or ‘somewhat’ NEW ENG. J. MED. 593–600, 593 (2007) available anti-discrimination laws to prevent

2 important to them that they share a similar set of at http://www.ncbi.nlm.nih.gov/pmc/articles/ S

E health care providers from being

L morals as their doctors, nurses, and other healthcare PMC2867473/ (finding that some providers will U

R unlawfully driven out of business,

providers’’). inform patients of options but not refer for such h t i options) (‘‘Most [providers] also believe that

w Bowman & Schandevel, citing Ezekiel J.

D Emanuel et al., Euthanasia and Physician-Assisted physicians are obligated to present all options See, e.g., https://prochoice.org/think-youre- O

R (86%) and to refer the patient to another clinician P Suicide: Attitudes and Experiences of Oncology pregnant/find-a-provider/ (first result for Google 2

8 Patients, Oncologists, and the Public, 347 Lancet who does not object to the requested procedure search of phrase ‘‘find abortion clinic near me’’ 0 Q

L 1805, 1808 (1996). (71%)’’). performed 10/ 17/ 18). G 3 K S D n o l l e

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especially in rural areas, is of 5. Analysis of Regulatory Alternatives Federal government frameworks to paramount importance. Instead of a The Department carefully considered enforce Federal conscience and anti- decrease in access to a particular alternatives to this final rule. The discrimination laws and (2) inadequate procedure from a particular doctor or Department determined that no information and understanding about provider, the residents of a rural area alternative could achieve appropriately the obligations of regulated persons and would face the potential of receiving no robust enforcement of, and respect for, entities and the rights of persons, health care at all from that doctor or Federal conscience and anti- entities, and health care entities under provider because such providers may discrimination laws without unduly the Federal conscience and anti- leave the practice if unable to practice burdening covered persons and entities discrimination laws. State action cannot medicine according to their religious subject to those laws and this rule. The correct these deficiencies at the Federal beliefs or moral convictions. In following alternatives represent the level. Furthermore, the Department addition, as discussed in response to major approaches the Department could not, in good faith, choose to rely comments supra at part III.A., some considered, including how burden on States to promote conscience polls show populations in rural reduction was a consideration in protection policies, knowing that some communities may be more likely to constructing this rule. States have adopted laws that are agree with providers in objecting to The Department considered inconsistent with, or have otherwise expressed indifference towards, the certain procedures encompassed by preserving the status quo by rights protected by the laws that part 88 Federal conscience and anti- maintaining 45 CFR part 88 without (as written in the 2011 Rule) discrimination laws. This implies that change from the 2011 Rule. Under this implements—the Weldon, Church, and the demand for such services may not approach, the Department would largely defer to the States to enforce their Coats-Snowe Amendments. exist (or be as great) in such Additionally, as noted more communities, partially offsetting the respective conscience laws or to enact new laws to fill gaps in the landscape extensively in the preamble’s summary impact of a higher number of of regulatory history, supra at part I, conscientious objections that may be of Federal and State conscience protection and associated anti- many commenters have pointed out the effectuated because of the rule. Persons mutually reinforcing inadequate in urban areas, in contrast, may feel less discrimination rights and their enforcement, continue with the current circumstances of the status quo effect from an increase in conscientious contribute to the critical need for this inadequate enforcement scheme, and objections because of the relatively final rule, including a conspicuously provide no meaningful enforcement of greater availability of alternative minimalistic regulatory scheme the conscience and associated anti- providers as compared to rural areas. (compared to regulations implementing discrimination laws that were not part other civil rights laws OCR enforces); a One commenter noted that of the 2011 Rule. The Department lack of recognition by courts of a private individuals whose health insurance received comments advocating this right of action under certain Federal does not provide financially adequate approach since, in commenters’ views, conscience and anti-discrimination coverage for a large enough number of State law, in conjunction with Federal laws; and hostility to conscience providers may similarly face a lack of law, already provides adequate protections in some portion of the alternative providers in the event one accommodation of religious beliefs. population and in certain State and provider exercises a conscientious Furthermore, some commenters stated local governments. Maintaining the objection to a desired service. The that the stringent protections for status quo leaves a gap where HHS has Department regards its analysis herein conscience established by the statutes a responsibility to coordinate regarding rural areas to be applicable to implemented by this rule are in tension compliance with, and enforcement of, such situations as well. with State nondiscrimination laws, Federal conscience protection and anti- State pharmaceutical dispensing laws, Just as the consequences of denials of discrimination laws but does not have and State immunization laws that offer care may in some cases be magnified in the regulatory scheme to accomplish employers greater leeway in handling rural areas, so too may be the that goal. The Department consequently situations in which an employee asserts consequences of forcing a rural health promulgates this final rule to eliminate a conscientious objection. As stated care provider to violate her conscience. that gap. First, the provider may limit her elsewhere in response to similar The Department considered practice or exit the field, harming health comments, the Department disagrees maintaining the status quo, but care access in a significant way. Second, with these arguments. As described dramatically increasing its outreach. if the provider continues to practice, the above and further in the rule’s Numerous commenters asserted the Federalism analysis, to eliminate or stress of having to violate her strong need for outreach to combat bias reduce any tension between this rule’s conscience may detract from the quality and animus in the health care sector application of Federal statutes and State of care the provider delivers to her against individuals with religious law, the final rule narrows the scope of patients in general, who have no beliefs or moral convictions, to raise the definitions of ‘‘discrimination’’ and alternative provider. awareness of the conscience rights of ‘‘referral’’ in § 88.2. individuals, entities, and health care Additionally, if a provider is in an The Department also disagrees that entities, and to clarify the legal area where the majority of the maintaining the status quo is preferable obligations of regulated persons and population shares the provider’s belief to this rule. Deference to States would entities. Commenters suggested a range system, and if the provider leaves the perpetuate the current circumstances area due to inability to exercise necessitating Federal regulation, which

2 See supra at part II.A (discussing laws and S

E protected beliefs, many in the include (1) inadequate to non-existent

L policies that some States have adopted). U R

community may lose the ability to have See, e.g., Cenzon-DeCarlo v. Mount Sinai h t i These comments paralleled the concerns, Hospital, 626 F.3d 695 (2d Cir. 2010); Hellwege v. w

a provider with values they share, thus

D described supra at part III.B, raised by commenters Tampa Family Health Centers, 103 F. Supp. 3d O negatively impacting the delivery of R who argued that this rule conflicts with other 1303 (M.D. Fla. 2015); National Institute of Family P 2

8 health care and the doctor-patient Federal statutes like Title VII of the Civil Rights Act and Life Advocates, et al. v. Rauner, No. 3:16–cv– 0 Q

L relationship. of 1964. 50310, at 4 (N.D. Ill. July 19, 2017). G 3 K S D n o l l e

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of ideas, including that the Department conscience and anti-discrimination laws discounted relative to year 2016, over a publish educational materials for and this rule. perpetual time horizon. academic medical institutions to As discussed above, the Department One commenter argued that the final educate students about their protected considered requiring recipients to post rule violates Executive Order 13771 notices of nondiscrimination in various conscience rights and the obligation of because it imposes costs but does not physical locations and online, but has regulated entities to comply with identify what other burdens imposed by chosen to make the notice provisions Federal conscience and anti- other regulations are being eliminated. voluntary, in part to reduce burden. The discrimination laws; that HHS partner Although each agency must identify final rule allows recipients and sub- with State institutions regulating health offsetting deregulatory actions for each professions; and that HHS create an recipients flexibility to decide what measures will best ensure compliance new regulatory burden, OMB does not advisory team with diverse members to interpret Executive Order 13771 to develop a plan for extensive outreach to with Federal conscience and anti- discrimination laws and this rule, while require each regulation that imposes combat ignorance about Federal costs to cite the particular deregulatory conscience and anti-discrimination providing for vigorous enforcement in cases of violation. Recipients and sub- actions that offset that particular laws. burden. The Department remains committed recipients are better positioned to to robust outreach. Outreach has decide whether organization-wide E. Regulatory Flexibility Act tremendous benefits to clarify legal action is necessary, and if so, what obligations, raise awareness of OCR, and extent, content, and manner of that HHS has examined the economic elevate awareness of the importance of action is appropriate to ensure implications of this final rule as conscience protections generally. The compliance. This approach allows required by the Regulatory Flexibility Department, however, agrees with one recipients and sub-recipients to tailor Act (RFA) (5 U.S.C. 601–612). The RFA commenter who noted that, although appropriate organization-wide action requires an agency to describe the outreach is important, it is insufficient based on their type, the populations impact of a rulemaking on small entities without an enforceable rule to uphold they serve, their size, the scope of their by providing an initial regulatory the substantive protections under workforce members likely to exercise flexibility analysis unless the agency Federal law. As with every other civil protected rights under the Federal expects that the rule will not have a rights law, outreach without adequate conscience and anti-discrimination laws significant impact on a substantial and this rule, and other relevant enforcement mechanisms is not enough number of small entities, provides a considerations. This rule, therefore, to ensure appropriate compliance. factual basis for this determination, and permits recipient employers to establish to certify the statement. 5 U.S.C. 603(a), The Department considered a their own policies and procedures for regulatory scheme that was more 605(b). If an agency must provide an how they will handle individuals’ initial regulatory flexibility analysis, prescriptive than this rule by requiring objections to certain procedures, such as all recipients and sub-recipients to this analysis must address the abortion, sterilization, or assisted consideration of regulatory options that establish policies and procedures for suicide, and recognizes the availability accommodating workforce members would lessen the economic effect of the of appropriate accommodation rule on small entities. For purposes of who objected to certain services based procedures. In addition, this rule on moral convictions or religious the RFA, small entities include small permits recipient employers who do businesses, nonprofit organizations, and beliefs; to address certain substantive have institution-wide objections to elements in their policies and small governmental jurisdictions. HHS performing certain procedures, such as considers a rule to have a significant procedures; and to require the sterilization, but that do not object to impact on a substantial number of small dissemination of information to referring for such procedures, to entities if it has at least a three percent workforce members about Federal establish referral systems with nearby impact of revenue on at least five conscience and anti-discrimination institutions that do not have objections percent of small entities. laws, this rule, or the recipient’s and to such procedures to facilitate the sub-recipient’s policies and procedures. delivery of the services or programs. Based on its examination, the The burden under this option across Department has concluded that this rule 502,899 entities (the mid-point of the D. Executive Order 13771 does not have a significant economic range shown in supra at Table 2) is the Executive Order 13771 (January 30, impact on a substantial number of small labor of a lawyer’s time (3 hours) and an 2017) requires that the costs associated entities. The entities that would be executive’s time (1 hour). Using the with significant new regulations ‘‘to the affected by this final rule, in industries mean hourly wages for these extent permitted by law, be offset by the described in detail in the RIA, are occupations adjusted upward for elimination of existing costs associated considered small by virtue of either benefits and overhead, the annual with at least two prior regulations.’’ The nonprofit status or having revenues of average burden would be $297 Department believes that this final rule less than between $7.5 million and million. is a significant regulatory action as $38.5 million in average annual The Department rejected this defined by section 3(f) of Executive revenue, with the threshold varying by alternative, but estimates supra at part Order 12866. This rule is also IV.C.3.ii that five percent of entities in considered a regulatory action under Office of Management & Budget, Guidance year one and 0.5 percent of entities Executive Order 13771. Excluding any Implementing Executive Order 13771, Titled annually in years two through five negative externalities attributed to this Reducing Regulation and Controlling Regulatory rule in the form of health outcomes or Costs, at 16 (Apr. 5, 2017), https:// 2 would voluntarily update policies and www.whitehouse.gov/sites/whitehouse.gov/files/ S

E other effects not compensated by L procedures or disseminate them to staff omb/memoranda/2017/M-17-21-OMB.pdf (stating U R as a by-product of assuring and positive health or other externalities in the answer to question 37 that ‘‘[w]hile each h t i Federal Register notice should identify whether the w certifying compliance with Federal from protecting conscience rights, the D regulation is an E.O. 13771 regulatory action, there O Department estimates that this rule will R is no need to discuss specific offsetting E.O. 13771 P 2

8 Product of weighted mean hourly wage of generate $148.2 million in annualized deregulatory actions within the same Federal 0 Q

L $147.60 per hour × 4 hours × 502,899 entities. costs at a 7 percent discount rate, Register entry.’’). G 3 K S D n o l l e

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industry. Persons and States are not significant impact on a substantial Under the Supremacy and Spending included in the definition of a small number of small entities. Clauses of the Constitution, States and entity. The Department assumes that their political subdivisions are subject F. Unfunded Mandates Reform Act most of the entities affected meet the to Acts of Congress, and Federal threshold of a small entity. The Department similarly concludes conscience and anti-discrimination laws Although this final rule will apply to that the requirements of the Unfunded are no exception. This rule holds States and, thus, affect small entities, this Mandates Reform Act of 1995 are not and local governments accountable for rule’s per-entity effects are relatively triggered by this final rule. Section compliance with these laws by setting small. The Department estimates that 202(a) of that Act requires the forth mechanisms for OCR investigation this rule would impose an average cost Department to prepare a written and HHS enforcement related to those of $778 per entity in the first year of statement, including an assessment of requirements. The rule does not change compliance and about $325.30 per anticipated costs and benefits, before the substantive conscience protections year in years two through five. issuing ‘‘any rule that includes any or anti-discrimination requirements of Furthermore, these costs would Federal mandate that may result in the these statutes. generally be proportional to the size of expenditure by State, local, and tribal The Department received comments an entity, so that the smallest affected governments, in the aggregate, or by the arguing that the enforcement of this rule entities will face lower average costs. private sector, of $100,000,000 or more through § 88.7 could infringe on State Given the thresholds discussed in the (adjusted annually for inflation) in any sovereignty, in violation of the limits of preceding paragraphs, the average costs one year.’’ The current threshold after the Spending Clause power afforded by are below those required to have a adjustment for inflation is $150 million, the U.S. Constitution to Congress. The significant impact on a substantial using the most current (2016) Implicit Federal government presumes the number of small entities, within the Price Deflator for the Gross Domestic constitutionality of statutes that meaning of the RFA. Product. As discussed in this RIA, this Congress enacts. Congress has exercised Furthermore, the rule attempts to rule will not result in an expenditure in the broad authority afforded to it under minimize costs imposed on small any year that meets or exceeds that the Spending Clause to attach clear entities. For example, the assurance and amount with regard to State, local, or conditions on Federal funds to secure certification requirements in § 88.4 tribal governments, but will exceed that conscience protection and associated contain exceptions to relieve many amount with regard to the private anti-discrimination rights. In cases of small entities of the requirement to sector. An in-depth analysis of the rule violation of the Federal conscience and submit an assurance and certification. with respect to State and local anti-discrimination laws, the Approximately 70 percent of recipients governments specifically appears in the Department intends to interpret and are exempted from the assurance and following section of this RIA regarding apply the remedies that § 88.7 sets forth certification requirement, assuming that Executive Order 13132 (Federalism). in a manner consistent with the those exempted do not receive HHS particular Federal law(s) at issue and funding through a non-exempt G. Executive Order 13132—Federalism; the U.S. Constitution, and, as discussed program. Given the magnitude and Executive Order 13175—Impact on in response to earlier comments, will type of entities granted the exception, Tribal Entities comply with relevant Supreme Court § 88.4 should not be understood as Federalism precedents concerning federalism. unduly burdening small entities subject Some commenters argued that the to the rule. The Secretary has determined that rule implicates the requirements of The Department has further this final rule comports with Executive Executive Order 13132 and committed to leveraging existing grant, Order 13132. Executive Order 13132 unconstitutionally impedes the ability contract, and other Departmental forms aims to ‘‘guarantee the division of of States to exercise power in areas where possible to implement § 88.4, governmental responsibilities between traditionally reserved to them, such as rather than create additional, separate the national government and the States health, safety, and welfare. Commenters forms for recipients to sign. Similarly, that was intended by the Framers of the also raised concerns that the rule may § 88.5 no longer requires recipients to Constitution . . . [and] ensure that the inhibit States from implementing their provide notices of conscience rights, but principles of federalism . . . guide the own conscience protections. The incentivizes recipients to voluntarily executive departments and agencies in Department disagrees with these provide such notices. In light of this the formulation and implementation of concerns. The Department promulgates determination, the Secretary certifies policies.’’ Some of the Federal laws this rule under longstanding Federal that this rule will not result in a that this rule implements and enforces, laws that leave ample room for State such as the Weldon and Coats-Snowe activity. States are free to enact their U.S. Small Business Administration, Table of Amendments, directly regulate States own conscience protection and anti- Small Business Size Standards Marched to North and local governments that receive discrimination laws that consider their American Industry Classification System Codes Federal funding by conditioning the own respective needs, populations, and (Oct. 1, 2017), https://www.sba.gov/sites/default/ receipt of such funding on the prerogatives. Indeed, all fifty States have files/files/Size_Standards_Table_2017.pdf (identifying the size standards by NAICS code for governments’ commitments to refrain some protections in place for the health care and social service industries). from discrimination on certain bases or conscientious objectors to certain health Result of $391.5 million in first year costs to by imposing certain requirements on or medical services and several non-HHS entities divided by 502,899 entities. States and local governments that provisions of this rule explicitly apply Result of $163.6 million annually to non-HHS to reinforce and respect State entities in years two through five divided by receive Federal funding. This impact, conscience protections. States are 2 502,899 entities. however, is a result of the statutory S E

L The average between the lower-bound prohibitions and requirements U

R Id. section 2(d). (267,134) and upper-bound (415,666) of recipients themselves, and are not due to the h t i exempted is 341,400 recipients, which represents See supra at part III.B (section-by-section w mechanisms provided by this rule. D 68 percent of the estimated total 500,290 recipients analysis for § 88.7) and part I.B (this regulation’s O

R of the rule (excluding the estimated 2,609 counties history) for further discussion of this matter. P 2

8 that for the purpose of this rule are estimated to be E.O. 13132, 64 FR 43255 (Aug. 4, 1999). See Kevin Theriot & Ken Connelly, Free to Do 0 Q

L sub-recipients). Id. No Harm: Conscience Protections for Healthcare G 3 K S D n o l l e

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free to experiment with various provision of abortion coverage, (OIRA) of the Office of Management and approaches to promote respect of, and employer protections, counseling Budget finds has resulted in or is likely tolerance for, the exercise of conscience related to assisted suicide, or employers to result in—(A) an annual effect on the rights, and this final rule respects that being able to accommodate objectors economy of $100,000,000 or more; (B) a prerogative. States are also free to reject with alternative arrangements. These major increase in costs or prices for Federal funding if they object to comments paralleled the concerns consumers, individual industries, conditions required by any of the laws already addressed above. In short, the Federal, State, or local government that are the subject of this rule. Department finalizes the rule to agencies, or geographic regions; or (C) Section 88.8 of the rule makes clear recognize forms of accommodation and significant adverse effects on that the rule is not intended to interfere to eliminate or reduce such tension competition, employment, investment, with the operation of State law. For between applicable statutes or between productivity, innovation, or on the State laws equally or more protective of this final rule and State laws. ability of United States-based religious freedom and moral convictions Accordingly, the final rule narrows the enterprises to compete with foreign- than this rule, § 88.8 of this rule states scope of the definitions of based enterprises in domestic and that nothing in the rule ‘‘shall be ‘‘discrimination’’ and ‘‘referral’’ in export markets.’’ 5 U.S.C. 804(2). Based construed to preempt’’ such State or § 88.2. on the analysis of this final rule under local law. Section 88.8 also declares that The impact of § 88.4 is minimal in Executive Order 12866, the Office of nothing in the rule ‘‘shall be construed terms of the added labor costs for State Management and Budget has to narrow the meaning or application of and local government staff to assure and determined that this rule is a major rule any State . . . law protecting free certify compliance. Additionally, the for purposes of the Congressional exercise of religious beliefs or moral rule relies on enforcement mechanisms Review Act. convictions.’’ already available to HHS for grants and Some statutes that the rule other forms of financial assistance. I. Assessment of Federal Regulation and implements, such as 42 U.S.C. In light of the above, the rule cannot Policies on Families 1396s(c)(2)(B)(ii), require providers to be properly understood to impose In the proposed rule, the Department comply ‘‘with applicable State law, substantial direct effects on States or included a discussion of section 654 of including any law relating to any their political subdivisions, their the Treasury and General Government religious or other exemption’’ as a relationship with the Federal Appropriations Act of 1999, Public Law condition of participation in the Government, or the distribution of 105–277, sec. 654, 112 Stat. 2681 (1998) program that the statute authorizes (in power among the various levels of as amended by Public Law 108–271, this example, the Federal pediatric government. sec. 654, 118 Stat. 814 (2004), which vaccine program). Other laws that this One comment noted that it ‘‘does not required Federal departments and rule implements, such as 42 U.S.C. threaten principles of federalism [to] agencies to determine whether a policy 280g–1(d), clarify that Federal requir[e] respect for constitutionally- or regulation could affect family well- assistance for newborn and infant protected conscience rights as a being. These provisions are codified as hearing screening programs do not condition of receiving Federal funds.’’ a ‘‘note’’ to 5 U.S.C. 601. Because preempt or prohibit any State law The Department agrees. The Department Congress did not renew these protections for parents to assert has not identified any Federal laws or requirements in the most recent religious objections to such screenings. jurisprudence that indicates that merely appropriations act applicable to the Similarly, 42 U.S.C. 1396f clarifies that implementing and enforcing Federal Department, the Department believes nothing requires a State to compel a laws as written violates constitutional it is not obligated to conduct an analysis person to undergo medical screenings, principles of federalism. of potential impact on family well-being examination, diagnosis, treatment, Impact on Tribal Entities before finalizing regulations. health care or services if a person Additionally, OMB Circular A–4 does objects on religious grounds, with One comment stated that the not require such an analysis. limited exceptions. Department would be required to engage Nevertheless, out of an abundance of This rule’s requirements and in tribal consultation regarding the rule caution, the Department conducts such prohibitions do not impose substantial as required under Executive Order an analysis below. direct effects on States and their 13175. However, because the final rule Section 601 (note) of 5 U.S.C. required political subdivisions, modify the removes the requirement in the agencies to assess whether a regulatory relationship between the Federal proposed § 88.3(p)(1)(iii) that certain action (1) impacts the stability or safety government and the States, or alter the federally recognized Indian tribes or of the family, particularly in terms of distribution of power and tribal organizations and urban Indian marital commitment; (2) impacts the responsibilities among the various organizations comply with sections 88.4 authority of parents in the education, levels of government. and 88.6 of the rule, the Department nurture, and supervision of their Some commenters argued that this believes that the rule does not have children; (3) helps the family perform rule, or the statutes that the rule tribal implications as defined in its functions; (4) affects disposable implements, conflict with State and Executive Order 13175, and that tribal income or poverty of families and local laws regarding student and health consultation regarding the rule was, children; (5) if the regulatory action provider immunizations, mandated therefore, not necessary. which financially impacts families, is H. Congressional Review Act justified; (6) may be carried out by State Professionals, 49 Ariz. St. L.J. 549, 575–76, 587–600 or local government or by the family;

2 (2017) (summarizing State laws). The Congressional Review Act defines S and (7) establishes a policy concerning E

L E.O. 13132, section 1(a). Executive Order a ‘‘major rule’’ as ‘‘any rule that the U the relationship between the behavior R

13132 requires an agency to meet certain h Administrator of the Office of t i requirements when it promulgates a rule with w Information and Regulatory Affairs D ‘‘policies that have federalism implications.’’ Id. Department of Defense and Labor, Health and O

R sections 2–3, 6(b)–(c) (identifying federalism Human Services, and Education Appropriations P 2

8 principles, policymaking criteria, and consultation See supra at part IV.C.2.vi of this RIA Act, 2019 and Continuing Appropriations Act, 0 Q

L requirements). estimating the rule’s burden. 2019, Public Law 115–245, 132 Stat. 2981 (2018). G 3 K S D n o l l e

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and personal responsibility of youth and disseminated by or for the Federal compliance requirement in § 88.4(a)(2) the norms of society. government’’ and to minimize the by updating the HHS form 5161–1, but The Department received comments burden of this collection. 44 U.S.C. this form is only used by two HHS stating that it did not adequately assess 3501(2). As defined in 5 CFR 1320.3(c), components rather than by all or most the impact on families in the proposed ‘‘collection of information’’ comprises HHS operating or staff divisions. The rule and reached an incorrect reporting, record-keeping, monitoring, Department also explored updating the conclusion in determining that it is posting, labeling, and other similar Assurances for Non-Construction unlikely that this rule will negatively actions. The Department sought Programs (SF–424B), which, despite its impact factors (1)–(4), with respect to comments regarding the burden name, enables the authorized the stability of the family, parental estimates and the information representative of the applicant to certify authority, or the disposable income or collections generally. Some comments up to nineteen paragraphs of agency and poverty of families and children. Other are discussed supra at part IV.C.3.ii–vi program-specific laws and regulations, comments referenced concerns about and others discussed in the following such as housing, environmental, and how delays or refusals in treatment or sections. The collections of information labor laws and regulations. Pursuant in the transmission of information could required by this final rule relate to to an OMB directive, ‘‘[e]ffective affect factor (5): The emotional and §§ 88.4 (Assurance and Certification), January 1, 2019, the SF–424B will financial well-being of families. The 88.5 (Voluntary Posting of Notice of become optional and agencies shall Department did not receive comments Rights), and 88.6(d) (Compliance make plans to phase out use in Funding addressing factors (6) or (7). In response Requirements). Opportunity Announcements.’’ to these comments, the Department Given this directive, the Department did notes that these concerns do not 1. Information Collection for § 88.4 not further explore updating the SF– constitute an impact on the well-being (Assurance and Certification) 424B. of the family within the meaning of 5 (i) Summary of the Collection of The Department is seeking PRA U.S.C. 601 (note) and that, in any event, Information clearance to operationalize the the objections are to the underlying This final rule requires each recipient certification of compliance requirement statutes that are the subject of the rule, (or applicant to become a recipient), during calendar year 2019 through the not the mechanisms provided by the with limited exceptions, to assure and existing signature block of the rule itself. With regard to factor (5), the certify compliance with Federal government-wide Application for prospect of a person losing their job, conscience and anti-discrimination Federal Assistance (SF–424) or, for thus affecting the emotional and laws. Specifically, § 88.4(a)(1) and (2) research or related grants, through the financial well-being of their family, is requires each recipient or applicant to Application for Federal Assistance for greater if conscience laws are not include in its application for Federal Research and Related (R&R) Series (SF– enforced as people of faith and moral funds, or accompany its application 424 R&R). The signature block for conviction risk being driven out of the with, an assurance and a certification both applications contains the following health care field as discussed above. statement: that it will operate applicable projects or Further discussion on the impact of this programs in compliance with applicable By signing this application, I certify (1) to rule on patients and individuals can be Federal conscience and anti- the statements contained in the list of found in part IV.C.4 (Estimated discrimination laws and this rule. certifications ** and (2) that the statements Benefits). herein are true, complete and accurate to the As the Department noted in the Operationalizing the Assurance of best of my knowledge. I also provide the proposed rule, the action taken in this Compliance Requirement required assurances ** and agree to comply with any resulting terms if I accept an award. rule cannot be carried out by State or To operationalize the requirement in local governments or by the family on I am aware that any false, fictitious, or § 88.4(a)(1) for a recipient or applicant fraudulent statements or claims may subject their own (factor (6)) because the rule to sign an assurance of compliance, the me to criminal, civil, or administrative pertains to enforcement of certain Department is seeking clearance under penalties. (U.S. Code, Title 18, Section 1001). Federal laws. Additionally, by the PRA to update the HHS–690 form, ———— protecting parents’ ability to assert which is entitled ‘‘Assurance of ** The list of certifications and assurances, or an internet site where you may obtain this conscience rights on behalf of their Compliance’’ and is described in the children, the rule clearly enhances list, is contained in the announcement or section-by-section analysis of the agency specific instructions. parental authority under factor (2). None preamble for § 88.4. The new language In calendar year 2020 and the of the rule’s provisions impact factors that the Department is adding to the (1), (3)–(5), or (7) to the degree outyears, the Department is seeking PRA HHS–690 form identifies the major contemplated by 5 U.S.C. 601 (note). Federal conscience and anti- Assurances for Non-Construction Programs, Accordingly, this rule will not discrimination laws by their popular negatively affect family well-being SF–424B, (OMB #4040–0007) https:// titles and their U.S. Code provisions (if apply07.grants.gov/apply/forms/sample/SF424B- within the meaning of 5 U.S.C. 601 codified) and directs the reader to OCR’s V1.1.pdf (last visited Apr. 11, 2019). (note) in the event such provisions Conscience and Religious Freedom web Exec. Office of the President, Memorandum apply. from Mick Mulvaney, Dir., Office of Management & page for a full listing of the laws. Budget to Heads of Executive Departments and J. Paperwork Reduction Act Agencies, Strategies to Reduce Grant Recipient Operationalizing the Certification of Reporting Burden, at 2 (Sept. 5, 2018), https:// This final rule requires new Compliance Requirement www.whitehouse.gov/wp-content/uploads/2018/09/ collections of information under the In response to public comments that M-18-24.pdf. Paperwork Reduction Act of 1995 (44 2 Application for Financial Assistance, SF–424,

S encouraged the Department to use

E U.S.C. 3501–3520). Congress enacted L (OMB # 4040–0004), https://apply07.grants.gov/

U existing forms, the Department explored R

the Paperwork Reduction Act of 1995 to apply/forms/sample/SF424_2_1-V2.1.pdf (last h t i operationalizing the certification of visited Apr. 11, 2019). w

‘‘maximize the practical utility and D Application for Financial Assistance, SF–424 O public benefit of the information R U.S. Dep’t of Health & Human Servs., P (R&R), (OMB # 4040–0001), https:// 2

8 created, collected, disclosed, Assurance of Compliance, HHS 690, https:// apply07.grants.gov/apply/forms/sample/RR_SF424_ 0 Q

L maintained, used, shared and www.hhs.gov/sites/default/files/hhs-690.pdf. 2_0-V2.0.pdf (last visited Apr. 11, 2019). G 3 K S D n o l l e

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clearance to operationalize the applicable, that the final rule final rule demonstrates that the person certification of compliance requirement implements. or entity was aware of its obligations through the government-wide System Another statement conveys that the under those laws and the rule. for Award Management (SAM) authorized representative certifies that it In addition, HHS has the authority to because this system, pursuant to an ‘‘[w]ill comply with all applicable place terms and conditions consistent OMB directive, ‘‘will become the central requirements of all other Federal laws, with those statutes in any instrument repository for common government- executive orders, regulations, and HHS issues or to which it is a party (e.g., wide certifications and representations policies government financial assistance grants, contracts or other HHS required of Federal grants awards and any financial assistance instruments). A Department component recipients.’’ The certifications and project covered by this certification extending an award must communicate representations through SAM replace document.’’ The Department and incorporate statutory and public the government-wide assurances construes this catch-all statement as policy requirements and obligate the contained in the Assurances for Non- incorporating the Federal conscience recipient to comply with Federal statues Construction Programs (SF–424B). and anti-discrimination laws, as and ‘‘public policy requirements, In submitting the general applicable, and the final rule. including . . . those . . . prohibiting certifications and representations discrimination.’’ More specifically, (ii) Need for Information through SAM, the authorized the Department component ‘‘must representative certifies to several Requiring certain recipients and communicate . . . all relevant public statements, two of which the applicants to assure and certify policy requirements, including those in Department interprets as compliance serves two purposes. First, general appropriations provisions, and operationalizing § 88.4(b). First, the through the act of reading and reviewing incorporate them either directly or by authorized representative certifies that it the statutory requirements to which reference in the terms and conditions of ‘‘[w]ill comply with U.S. statutory and recipients or applicants assure and the Federal award.’’ The public policy requirements which certify compliance, recipients would be Departmental component may require a prohibit discrimination, including but apprised of their obligations under the recipient ‘‘to submit certifications and not limited to[]’’ certain Federal civil applicable Federal conscience and anti- representations required by Federal rights statutes. The Federal discrimination laws and this rule. statutes, or regulations . . .’’ conscience and anti-discrimination laws Second, a recipient’s or applicant’s are not listed because the general awareness of its obligations would (iii) Use of Information certifications and representations increase the likelihood that it would The Department and its components identified in SAM are government-wide, comply with such laws and, awarding Federal funds and OCR will rather than agency or multi-agency consequently, afford entities and use the signed assurance and specific. However, the Department individuals protection of their certification as documentation of (1) a construes the non-exhaustive list as conscience rights and protection from recipient’s or applicant’s awareness of incorporating the Federal conscience coercion or discrimination. its obligations under the Federal and anti-discrimination laws, as In the proposed rule, the Department conscience and anti-discrimination laws requested comment on whether the and this rule, and (2) a recipient’s or U.S. Gen. Servs. Admin., System for Award collection of information is necessary applicant’s binding agreement to abide Management, Home, https://www.sam.gov/SAM/ pages/public/index.jsf (last visited Apr. 11, 2019). for the proper performance of the by such obligations. This use would Exec. Office of the President, Memorandum Department’s functions to enforce most likely occur during an OCR from Mick Mulvaney, Dir., Office of Management & Federal laws on which Federal funding investigation of the recipient’s Budget to Heads of Executive Departments and is conditioned. At least one commenter compliance with Federal conscience Agencies, Strategies to Reduce Grant Recipient encouraged the Department to add the Reporting Burden, at 2 (Sept. 5, 2018), https:// and anti-discrimination laws and this www.whitehouse.gov/wp-content/uploads/2018/09/ assurance and certification requirements rule, and as part of an entity’s record M-18-24.pdf. in § 88.4 because of the ‘‘surge in keeping obligations under this rule. See id. (‘‘[R]egistration in SAM is required for harassment and coercion of medical eligibility for a Federal award and registration must providers of faith.’’ Other commenters (iv) Description of the Respondents be updated annually . . . . Federal agencies will use SAM information to comply with award stated that assurance and certification The respondents are applicants or requirements and avoid increased burden and costs was unnecessary because recipients recipients for Federal financial of separate requests for such information, unless the already must certify compliance with assistance or Federal funds from the recipient fails to meet a Federal award requirement, Federal law upon the receipt of Federal Department as set forth in § 88.3, which or there is a need to make updates to their SAM registration for other purposes.’’). funds. identifies the applicability of this rule U.S. Gen. Servs. Admin., System for Award This collection of information for each of the underlying statutes that Management, SAM Release Notes Build 2019–02– facilitates the Department’s obligation to would be implemented and enforced. 01, at 3 (Feb. 2, 2019), https://www.sam.gov/SAM/ ensure that the Federal financial Respondents include hospitals, research transcript/SAM_Release_Notes_2019_02_01.pdf (describing under ‘‘enhancements’’ that SAM has ‘‘a assistance or other Federal funds that institutions, health professions training new government-wide Financial Assistance the Department awards are used in a programs, qualified health plan issuers, Representations and Certifications module within manner compliant with Federal Health Insurance Marketplaces, home the SAM entity management registration’’ and ‘‘[a]ll conscience and anti-discrimination laws health agencies, community mental non-federal registrants in SAM will be required to certify to the new Financial Assistance Reps & Certs and the final rule. The Department’s health centers, and skilled nursing as part of their registration’’). administration of a requirement for an facilities. The certifications and representations are not entity at the time of application or (v) Number of Respondents

2 publicly available until an individual creates an

S reapplication to assure and certify E

L account. The list of certifications and The Department estimates the number

U compliance with Federal conscience

R representations were obtained from staff at

h of respondents at 158,890 persons or t i Grants.gov on March 19, 2019, and are on file with and anti-discrimination laws and the w

D OCR. O

R Financial Assistance General Certifications Financial Assistance General Certifications 45 CFR 75.300(a). P 2

8 and Representations, at 2, para. 9 (on file with and Representations, at 1, para. 7 (on file with Id. 0 Q

L OCR). OCR). Id. at § 75.208. G 3 K S D n o l l e

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entities, which is the average between • Whether the exception for Indian recipient is otherwise free to draft its the low (122,558) and high (195,222) Tribes and tribal Organizations in own notices tailored to its specific estimates of entities required to sign an proposed 45 CFR 88.4(c)(vi) avoids circumstances and applicable laws assurance or a certification. These ‘‘tribal implications’’ and does not under the rule. figures appear supra at Table 3, part ‘‘impose substantial direct compliance (ii) Need for Information IV.C.2.iv.A. Respondents are a subset of costs on Indian Tribal governments’’ as the recipients because § 88.4(c)(1) stated in Executive Order 13175, The Department incentivizes through (4) excludes certain categories Consultation and Coordination with recipients and Department components of recipients. The rule excludes Indian Tribal Governments, sec. 5(b) to provide notice of rights because physicians, as defined in 42 U.S.C. (Nov. 9, 2000); notice serves three primary purposes. 1395x(r), physician offices, other health • Whether assuring compliance with First, individuals become apprised of care practitioners or pharmacists who the Federal conscience protection and their rights under applicable Federal are recipients in the form of associated anti-discrimination statutes conscience and anti-discrimination reimbursements for services provided to would constitute a burden exempt from laws, including the right to file a beneficiaries under Medicare Part B. See the Paperwork Reduction Act as a usual complaint with HHS OCR. Second, an § 88.4(c)(1). The rule also exempts and customary business practice individual’s awareness of his or her recipients of certain grant programs incurred by recipients during the rights increases the likelihood that the administered by the Administration for ordinary course of business; individual will exercise those rights. Children and Families or the • How the quality, utility, and clarity Third, recipients and their managers Administration for Community Living of the information to be collected may and employees will be more likely to be when the program’s purpose is be enhanced; and reminded, and be made aware, of their unrelated to health care and certain • How the manner of compliance own obligations under these laws. types of research, does not involve with the assurance and certification health care providers, and does not requirements could be improved, (iii) Use of Information involve any significant likelihood of including through use of automated Individuals, entities, and health care referral for the provision of health care. collection techniques or other forms of entities will use the information to See § 88.4(c)(2) and (3). Finally, this information technology. increase their awareness of their rights final rule excludes Indian Tribes and The Department received public and file complaints with OCR if they Tribal Organizations when contracting comments expressing concern with the believe their rights have been violated. with the Indian Health Service under possible burden on health care Entities required to comply will have an the Indian Self-Determination and providers resulting from § 88.4, which is increased likelihood of understanding Education Assistance Act. See discussed supra at part IV.C.3.ii. In their obligations to thus act accordingly § 88.4(c)(4). addition, as explained in the summary to fulfill them. During OCR of this Paperwork Reduction Act investigation or compliance review of a (vi) Burden of Response analysis, the Department is leveraging recipient, OCR will consider as non- The Paperwork Reduction Act burden existing grant, contract, and other dispositive evidence of compliance is the opportunity cost of recipient staff Departmental forms and government- whether and how the recipient posted a time to review the assurance and wide systems, consistent with OMB’s notice according to § 88.5. certification language as well as the government-wide effort to reduce requirements of the underlying Federal recipient burden. (iv) Description of the Respondents conscience and anti-discrimination laws 2. Information Collection for § 88.5 The respondents are recipients as referenced or incorporated. The (Notice) defined in this rule at § 88.2. methods that the Department uses are Respondents include, but are not outlined supra at part IV.C.3.ii, and the (i) Summary of the Collection of limited to, States, hospitals, research mean hourly wage is adjusted Information institutions, and skilled nursing downward to exclude benefits and Under this rule as finalized, § 88.5 facilities. overhead. does not mandate the provision of (v) Number of Respondents The labor cost is a function of a notice, but rather incentivizes recipients lawyer spending 3 hours reviewing the and Department components to provide The number of respondents is assurance and certification and an notice concerning Federal conscience estimated at 335,327 recipients at the executive spending one hour to review and anti-discrimination laws. The rule establishment-level in year one and 75 and sign, as § 88.4(b)(2) requires a intends to accomplish this goal by percent of that amount in years two signature by an individual authorized to considering a recipient’s or a through five (i.e., 251,495 bind the recipient. The weighted mean Department component’s posting of the establishments). This estimate hourly wage (not including benefits and notice as non-dispositive evidence of represents the average between the overhead) of these two occupations is compliance with the rule when OCR lower and upper-bound estimates of $73.80 per hour. The labor cost is investigates or initiates a compliance how many recipient establishments will $46.9 million each year ($73.80 per hour review of a recipient or Department voluntarily post notices through one of × 4 hours × 158,890 entities). component. If recipients voluntarily more of the methods in § 88.5 in years The Department asked for public provide notice to implement § 88.5, one and annually in years two through comment on the information collection recipients are encouraged to use the pre- five. A subset of respondents, about under § 88.4. Several specific questions written notice in appendix A. The 139,615 recipients at the firm level, will that the Department posed received no

2 likely modify the pre-written notice in S

E comments:

L Exec. Office of the President, Memorandum appendix A. U R

from Mick Mulvaney, Dir., Office of Management & h t i Sum of ($67.25 × .75) and ($93.44 × .25). Budget to Heads of Executive Departments and (vi) Burden of Response w

D This total differs from the burden in the RIA Agencies, Strategies to Reduce Grant Recipient O Even though the notice provision of R Reporting Burden, at 2 (Sept. 5, 2018), https:// P because a fully-loaded wage that is adjusted 2

8 upwards for benefits and overhead must be used in www.whitehouse.gov/wp-content/uploads/2018/09/ the final rule is entirely voluntary, the 0 Q

L the RIA. M-18-24.pdf. Department expects that some segment G 3 K S D n o l l e

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of the recipients and Department associated with voluntary posting in Acknowledging the uncertainties components that this rule regulates will physical locations by 180,331 outlined supra at part IV.C.3.iii, the choose to post the notice through one of establishments is $1.2 million ($1.2 Department estimates the annual costs the methods specified. The burden is million in labor costs and $45,083 for of labor, material, and postage according mix of labor, materials, and in some materials) in the first year of to the following assumptions. The cases, postage costs. The methods and implementation with zero recurring Department assumes that (1) assumptions that the Department uses costs. establishments that include notices of are outlined supra at part IV.C.3.iii, and One commenter raised concerns with rights in publications will most often do the mean hourly wage is adjusted the notice requirement being overly so in online publications or in hard- downward to exclude benefits and broad because it would require a multi- copy publications hand-distributed, overhead. Unlike the burden estimated State health care entity to post notices where the notice’s inclusion results in in the RIA of the rule, the PRA burden at every location where workforce an additional 100 hard copy notices per associated with § 88.5 excludes the costs notices are customarily posted to permit establishment per year, and (2) half of of posting the notice for those entities ready observation, even if the particular the establishments associated with that post it verbatim because the location had no connection to the covered recipients voluntarily providing Department is supplying the language funding or activity giving rise to the hard copy notices (i.e., 90,166 for the notice for the purpose of obligation to post the notice. The final establishments in year one and 67,624 disclosure to the public, under 5 CFR rule’s modification of the notice from establishments annually in years two 1320.3(c)(2). mandatory to voluntary should resolve through five) will mail the Assuming that 139,615 recipients at this concern. Additionally, the rule publications for which the weight of the the firm level alter the text of the notice provides for posting in locations as notice incrementally increases the in appendix A, these recipients will, on ‘‘applicable and appropriate.’’ postage costs. These assumptions may average, bear a minimal opportunity One commenter expressed concern differ from the actual experience of cost of / hour of a lawyer’s time for that the Department’s estimate of time recipients’ implementation, as described drafting and ten minutes of an that an administrative assistant would supra at part IV.C.3.iii. executive’s time to provide final sign- spend to post the notice did not take Using the model, hourly estimates, off. The weighted mean hourly wage into account the multiple facilities and other assumptions described supra (excluding benefits and overhead) of owned by a corporate entity. The at part IV.C.3.iii, the average labor cost, these two occupations is $75.89 per estimates for the Paperwork Reduction excluding mailing-related labor costs, hour. The one-time labor cost is $5.3 Act and in the RIA, however, do take resulting from including notices in million in the first year ($75.89 per hour this into account because the relevant publications is $7.0 million in × 0.5 hours × 139,615 recipients). Department multiplied the per facility year one ($19.39 per hour × 2 hours × The assumptions regarding the timing labor and materials costs by the number 180,331 establishments) and $2.6 of providing notices of rights and the of facilities (i.e., establishments) over million annually in years two through various uncertainties inherent in the which a corporate entity (i.e., firm) five ($19.39 per hour × 1 hour × 135,249 implementation of § 88.5 described in exercises common ownership and establishments). Based on the detail in the RIA supra at part IV.C.3.iii control. marginal cost of postage per ounce of $0.15, an annual number of mailings apply to this analysis, too, such as the (viii) Burden for Voluntary Web Posting number of locations where notices are of 100 pages per establishment, average customarily posted, and the length of To post the notice on the web, the annual labor cost for mailing of $19.39 time it may take an administrative Department estimates that it will take 2 per hour, and an average number of assistant or web developer to perform hours for a web developer at each labor hours per mailing of 0.25 hours, their respective functions. recipient’s physical location to execute the total costs due to the voluntary the design and technical elements for mailing of notices is $1.8 million in (vii) Burden for Voluntary Posting in posting. This labor cost is year one and $1.3 million annually Physical Locations approximately $12.5 million (2 hours × in years two through five. Finally, the The Department estimates that it will $34.69 per hour × 180,337 take / of an hour for an administrative establishments) in the first year of in year one will continue to do so in out years and assistant to print notice(s) and post implementation with zero recurring there will be lower attrition compared to the them in physical locations of the costs. estimate provided in the proposed rule. Product of 180,331 establishments times 50 establishment where notices are (ix) Burden for Voluntary Posting in percent for year one. Product of 135,249 customarily posted. The 139,615 Two Publications establishments times 50 percent for years two recipients at the firm level estimated to through five. alter the notice are associated with The Department assumes that, within These totals differ from the estimate of the the first year after the rule’s publication, burden in the RIA because the RIA uses a fully 180,331 establishments. Assuming that loaded wage rate (i.e., including benefits and about 180,331 facilities at the each recipient voluntarily posting overhead) not employed here. establishment level choose voluntarily notices in publications would identify See U.S. Postal Service Postage Rates, https:// to post notices in physical locations, the two publications in which to include www.stamps.com/usps/current-postage-rates/. estimated labor cost is $1.2 million ( / the notice, revising the document or its Sum of incremental postage of $1.4 million hour × $19.39 per hour × 180,331 layout to include the notice, or ($0.15 per mailing × 100 mailings × 90,166 otherwise printing an insert to include establishments) and incremental labor of $437,078 establishments). The cost to post 5 ($19.39 per hour × 0.25 hours × 90,166 notices across all establishments would with hard copies of the publication. establishments).

2 Sum of incremental postage of $1.0 million

S be $45,083 (180,331 establishments × E

L This total differs from the estimate of the ($0.15 per mailing × 100 mailings × 67,624

U $.05 per page (paper and ink) × 5 pages).

R burden in the RIA because the RIA uses a fully establishments) and incremental labor of $327,809 h t i The total labor and materials costs loaded wage rate (i.e., including benefits and ($19.39 per hour × 0.25 hours × 67,624 w

D overhead) not employed here. establishments). O

R This total differs from the burden in the RIA Under the final rule, because all the notice This total differs from the estimate of the P 2

8 because a fully loaded wage that is adjusted provisions are voluntary, the Department assumes burden in the RIA because the RIA uses a fully 0 Q

L upwards for benefits and overhead must be used. that 75% of entities that voluntarily provide notices Continued G 3 K S D n o l l e

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annual cost of printed materials for improved, including through the use of assumptions supra at part IV.C.3.v, the notices (both mailed and hand automated collection techniques or Department assumes that a recipient, at distributed) is $0.9 million (180,331 other forms of information technology. the highest end, would submit 2,000 establishments × 100 pages × $.05 per applications each year for new funding 3. Compliance Procedures (§ 88.6(d)) page) in year one and $676,243 annually opportunities, supplemental funding, in years two through five (135,249 (i) Summary of the Collection of and non-competing continuations, establishments × 100 pages × $.05 per Information among others. The mean weighted page). Paragraph 88.6(d) requires any hourly wage for the paralegal and In sum, the total expected cost of recipient or sub-recipient that is subject administrative assistant is $22.66, activities related to the voluntary to a determination by OCR of which excludes benefits and overhead. posting and distributions of notices that noncompliance with this part Each recipient or sub-recipient found in § 88.5 incentivizes is $28.7 million in concerning Federal conscience and anti- violation of the rule would expend on the first year and $4.6 million annually discrimination laws to report this fact in the highest end, $22,655 per year in in years two through five. any application for new or renewed labor costs at the firm level ($22.66 per (x) Burden to the Federal Government Federal financial assistance or hour × 2,000 applications × 0.5 hours). Unlike the burden estimated in the Departmental funding in the three years following the determination of Commenters stated that the version of RIA of the rule, the PRA burden to the this requirement in the proposed rule Department associated with § 88.5 noncompliance. This includes a requirement that recipients disclose any was redundant and duplicative. The excludes the costs of posting the notice Department agrees. The final rule and for those HHS components that post it OCR determinations made against their sub-recipients. this information collection has been verbatim because the Department is modified substantially to require supplying the language of the notice for (ii) Need for Information recipients and sub-recipients to notify the purpose of disclosure to the public, The information alerts applicable the Departmental components from under 5 CFR 1320.3(c)(2). Because the Departmental components of OCR’s which the recipient or sub-recipient Department components will likely post determination of noncompliance on the receives Federal funds in the three years the notice from Appendix A verbatim, part of the recipient or sub-recipient, to following a determination of all costs to the Department under the ensure appropriate coordination within noncompliance with Federal conscience PRA for § 88.5 are excluded. the Department during OCR’s and anti-discrimination laws and this The remaining issue raised by final rule by OCR. commenters is whether the rule requires enforcement of Federal conscience and translation of the notice into non- anti-discrimination laws, and to inform List of Subjects in 45 CFR Part 88 funding decision-making. English languages. Under the Abortion, Adult education, Advanced conscience protection and associated (iii) Use of Information directives, Assisted suicide, Authority anti-discrimination laws and this rule, This requirement puts the delegations, Childbirth, Civil rights, translation or posting of translated Departmental component on notice of Coercion, Colleges and universities, notices is not independently required. OCR’s determination of noncompliance Community facilities, Contracts, However, recipients subject to this rule to inform a component’s decision Educational facilities, Employment, may also have independent obligations whether to approve, renew, or modify Euthanasia, Family planning, Federal- to provide language assistance services Federal funding to the recipient. This State relations, Government contracts, and meaningful access to individuals requirement also facilitates coordination Government employees, Grant with limited English proficiency when between the component and OCR on the programs-health, Grants administration, abiding by the prohibition of national status of the recipient or sub-recipient’s Health care, Health facilities, Health origin discrimination in Federal civil compliance status. insurance, Health professions, rights laws that OCR enforces. Hospitals, Immunization, Indian Tribes, The Department asked for public (iv) Description of the Respondents Insurance, Insurance companies, comment on the following issues and The respondents are recipients and Laboratories, Manpower training received no comments: sub-recipients that HHS OCR has found programs, Maternal and child health, • Whether the proposed collection of noncompliant with this final rule. information is necessary for the proper Medicaid, Medical and dental schools, performance of the Department’s (v) Number of Respondents Medical research, Medicare, Mental functions to enforce Federal laws on health programs, Mercy killing, Moral As explained, supra at part IV.C.3.v, convictions, Nondiscrimination, which Federal funding is conditioned, the Department cannot predict the including whether the information will Nursing homes, Nursing schools, number of entities that OCR will find Occupational safety and health, have practical utility; noncompliant with the rule. • Whether the public had feedback on Occupational training, Physicians, the assumptions that formed the basis of (vi) Burden of Response Prescription drugs, Public assistance programs, Public awareness, Public the cost estimates for the notice The Department estimates it would health, Religious discrimination, provision; and take a records custodian at the • How the manner of compliance Religious beliefs, Religious liberties, experience level of a paralegal about 15 Religious nonmedical health care with the notice provision could be minutes to retrieve the relevant institutions, Reporting and information (such as date of the recordkeeping requirements, Rights of loaded wage rate (i.e., including benefits and violation finding and the OCR 2 overhead) not employed here.

S conscience, Scholarships and

E ‘‘transaction number’’ (e.g., case L E.g., 42 U.S.C. 2000d (Title VI of the Civil

U fellowships, Schools, Scientists, State R

Rights Act of 1964); 45 CFR part 80 (HHS number)) from the recipient’s or sub- h t i implementing regulations); Guidance to Federal and local governments, Sterilization, w

recipient’s records and an

D Financial Assistance Recipients Regarding Title VI O administrative assistant 15 minutes to R Prohibition Against National Origin Discrimination This total differs from the burden in the RIA P 2

8 Affecting Limited English Proficient Persons, 68 FR enter the information on the because a fully loaded wage that is adjusted 0 Q

L 47311, 47313 (Aug. 8, 2003). application. Based on the methods and upwards for benefits and overhead must be used. G 3 K S D n o l l e

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Students, Technical assistance, Tribal care or services over their conscientious whether any entity has engaged in Organizations. objection. Consistent with their discriminatory action with respect to For the reasons set forth in the objective to protect the conscience and any complaint or compliance review preamble, the Department of Health and associated anti-discrimination rights of under this part, OCR will take into Human Services revises 45 CFR part 88 individuals, entities, and health care account the degree to which an entity to read as follows: entities, the statutory provisions and the had implemented policies to provide regulatory provisions contained in this effective accommodations for the PART 88—PROTECTING STATUTORY part are to be interpreted and exercise of protected conduct, religious CONSCIENCE RIGHTS IN HEALTH implemented broadly to effectuate their beliefs, or moral convictions under this CARE; DELEGATIONS OF AUTHORITY protective purposes. part and whether or not the entity took any adverse action against a protected Sec. § 88.2 Definitions. entity on the basis of protected conduct, 88.1 Purpose. For the purposes of this part: beliefs, or convictions before the 88.2 Definitions. Assist in the performance means to provision of any accommodation. 88.3 Applicable requirements and take an action that has a specific, (5) Notwithstanding paragraphs (1) prohibitions. reasonable, and articulable connection through (3) of this definition, an entity 88.4 Assurance and certification of to furthering a procedure or a part of a compliance requirements. subject to any prohibition in this part 88.5 Notice of rights under Federal health service program or research may require a protected entity to inform conscience and anti-discrimination laws. activity undertaken by or with another it of objections to performing, referring 88.6 Compliance requirements. person or entity. This may include for, participating in, or assisting in the 88.7 Enforcement authority. counseling, referral, training, or performance of specific procedures, 88.8 Relationship to other laws. otherwise making arrangements for the programs, research, counseling, or 88.9 Rule of construction. procedure or a part of a health service treatments, but only to the extent that 88.10 Severability. program or research activity, depending there is a reasonable likelihood that the Appendix A to Part 88—Model Text: Notice on whether aid is provided by such protected entity may be asked in good of Rights Under Federal Conscience and actions. Anti-Discrimination Laws faith to perform, refer for, participate in, Department means the Department of or assist in the performance of, any act Authority: 42 U.S.C. 300a–7 (the Church Health and Human Services and any or conduct just described. Such inquiry Amendments); 42 U.S.C. 238n (Coats-Snowe component thereof. may only occur after the hiring of, Amendment); the Weldon Amendment (e.g., Discriminate or discrimination contracting with, or awarding of a grant Pub. L. 115–245, Div. B, sec. 507(d)); 42 includes, as applicable to, and to the U.S.C. 18113 (Section 1553 of the Affordable or benefit to a protected entity, and once Care Act); Medicare Advantage (e.g., Pub. L. extent permitted by, the applicable per calendar year thereafter, unless 115–245, Div. B, sec. 209); the Helms, Biden, statute: supported by a persuasive justification. 1978, and 1985 Amendments, 22 U.S.C. (1) To withhold, reduce, exclude (6) The taking of steps by an entity 2151b(f) (e.g., Pub. L. 116–6, Div. F, sec. from, terminate, restrict, or make subject to prohibitions in this part to use 7018); 22 U.S.C. 7631(d); 29 U.S.C. 669(a)(5); unavailable or deny any grant, contract, alternate staff or methods to provide or 42 U.S.C. 300gg–92; 42 U.S.C. 1302(a); 42 subcontract, cooperative agreement, further any objected-to conduct U.S.C. 18041(a) (Section 1321 of the loan, license, certification, identified in paragraph (5) of this Affordable Care Act); 42 U.S.C. 18081 accreditation, employment, title, or definition would not, by itself, (Section 1411 of the Affordable Care Act); 42 other similar instrument, position, or constitute discrimination or a U.S.C. 18023 (Section 1303 of the Affordable status; prohibited referral, if such entity does Care Act); 26 U.S.C. 5000A(d)(2); 42 U.S.C. (2) To withhold, reduce, exclude 18031; 42 U.S.C. 280g–1(d); 42 U.S.C. 290bb– not require any additional action by, or 36(f); 42 U.S.C. 1315; 42 U.S.C. 1315a; 42 from, terminate, restrict, or make does not take any adverse action against, U.S.C. 1320a–1; 42 U.S.C. 1320c–11; 42 unavailable or deny any benefit or the objecting protected entity (including U.S.C. 1395cc(f); 42 U.S.C. 1395i–3; 42 U.S.C. privilege or impose any penalty; or individuals or health care entities), and 1395i–5; 42 U.S.C. 1395w–22(j)(3)(B); 42 (3) To utilize any criterion, method of if such methods do not exclude U.S.C. 1395w–26; 42 U.S.C. 1395w–27; 42 administration, or site selection, protected entities from fields of practice U.S.C. 1395x; 42 U.S.C. 1396a; 42 U.S.C. including the enactment, application, or on the basis of their protected 1396a(w)(3); 42 U.S.C. 1396f; 42 U.S.C. enforcement of laws, regulations, objections. Entities subject to 1396r; 42 U.S.C. 1396s(c)(2)(B)(ii); 42 U.S.C. policies, or procedures directly or prohibitions in this part may also 1396u–2(b)(3)(B); 42 U.S.C. 1397j–1(b); 42 through contractual or other inform the public of the availability of U.S.C. 5106i(a); 42 U.S.C. 14406; 5 U.S.C. 301; 40 U.S.C. 121(c); 42 U.S.C. 263a(f)(1)(E); arrangements, that subjects individuals alternate staff or methods to provide or 45 CFR parts 75 and 96; 48 CFR chapter 1; or entities protected under this part to further the objected-to conduct, but 48 CFR parts 300 thru 370; 2 CFR part 376. any adverse treatment with respect to such entity may not do so in a manner individuals, entities, or conduct that constitutes adverse or retaliatory § 88.1 Purpose. protected under this part on grounds action against an objecting entity. The purpose of this part is to provide prohibited under an applicable statute Entity means a ‘‘person’’ as defined in for the implementation and enforcement encompassed by this part. 1 U.S.C. 1; the Department; a State, of the Federal conscience and anti- (4) Notwithstanding paragraphs (1) political subdivision of any State, discrimination laws listed in § 88.3. through (3) of this definition, an entity instrumentality of any State or political Such laws, for example, protect the subject to any prohibition in this part subdivision thereof; any public agency, rights of individuals, entities, and shall not be regarded as having engaged public institution, public organization, health care entities to refuse to perform, in discrimination against a protected or other public entity in any State or 2 S

E assist in the performance of, or undergo entity where the entity offers and the political subdivision of any State; or, as L U R

certain health care services or research protected entity voluntarily accepts an applicable, a foreign government, h t i w

activities to which they may object for effective accommodation for the foreign nongovernmental organization, D

O religious, moral, ethical, or other exercise of such protected entity’s or intergovernmental organization (such R P 2

8 reasons. Such laws also protect patients protected conduct, religious beliefs, or as the United Nations or its affiliated 0 Q

L from being subjected to certain health moral convictions. In determining agencies). G 3 K S D n o l l e

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Federal financial assistance includes: health care organization, facility, or the U.S. Virgin Islands, American (1) Grants and loans of Federal funds; plan. As applicable, components of Samoa, and the Trust Territory of the (2) The grant or loan of Federal State or local governments may be Pacific Islands. For those provisions property and interests in property; health care entities under the Weldon related to or relying upon the Social (3) The detail of Federal personnel; Amendment and Patient Protection and Security Act, such as Medicaid or the (4) The sale or lease of, and the Affordable Care Act section 1553. Children’s Health Insurance Program, permission to use (on other than a Health service program includes the the term ‘‘State’’ shall be defined in casual or transient basis), Federal provision or administration of any accordance with the definition of property or any interest in such health or health-related services or ‘‘State’’ found at 42 U.S.C. 1301. property without consideration or at a research activities, health benefits, Sub-recipient means any State, nominal consideration, or at a health or health-related insurance political subdivision of any State, consideration which is reduced for the coverage, health studies, or any other instrumentality of any State or political purpose of assisting the recipient or in service related to health or wellness, subdivision thereof, or any person or recognition of the public interest to be whether directly; through payments, any public or private agency, served by such sale or lease to the grants, contracts, or other instruments; institution, organization, or other entity recipient; and through insurance; or otherwise. in any State, including any successor, (5) Any agreement or other contract Instrument is the means by which assign, or transferee thereof, to whom between the Federal government and a Federal funds are conveyed to a there is a pass-through of Federal recipient that has as one of its purposes recipient and includes grants, financial assistance or Federal funds the provision of a subsidy to the cooperative agreements, contracts, from the Department through a recipient recipient. grants under a contract, memoranda of or another sub-recipient, but such term Health care entity includes: understanding, loans, loan guarantees, (1) For purposes of the Coats-Snowe does not include any ultimate stipends, and any other funding or beneficiary. The term may include a Amendment (42 U.S.C. 238n) and the employment instrument or contract. subsections of this part implementing foreign government, foreign OCR means the Office for Civil Rights nongovernmental organization, or that law (§ 88.3(b)), an individual of the Department of Health and Human physician or other health care intergovernmental organization (such as Services. the United Nations or its affiliated professional, including a pharmacist; Recipient means any State, political health care personnel; a participant in a agencies). subdivision of any State, Workforce means employees, program of training in the health instrumentality of any State or political professions; an applicant for training or volunteers, trainees, contractors, and subdivision thereof, and any person or other persons whose conduct, in the study in the health professions; a post- any public or private agency, graduate physician training program; a performance of work for an entity or institution, organization, or other entity health care entity, is under the direct hospital; a medical laboratory; an entity in any State, including any successor, control of such entity or health care engaging in biomedical or behavioral assign, or transferee thereof, to whom entity, whether or not they are paid by research; a pharmacy; or any other Federal financial assistance is extended the entity or health care entity, as well health care provider or health care directly from the Department or a as health care providers holding facility. As applicable, components of component of the Department, or who privileges with the entity or health care State or local governments may be otherwise receives Federal funds entity. health care entities under the Coats- directly from the Department or a Snowe Amendment; and component of the Department, but such § 88.3 Applicable requirements and (2) For purposes of the Weldon term does not include any ultimate prohibitions. Amendment (e.g., Department of beneficiary. The term may include a (a) The Church Amendments, 42 Defense and Labor, Health and Human foreign government, foreign U.S.C. 300a–7—(1) Applicability. (i) The Services, and Education Appropriations nongovernmental organization, or Department is required to comply with Act, 2019, and Continuing intergovernmental organization (such as paragraphs (a)(2)(i) through (vii) of this Appropriations Act, 2019, Pub. L. 115– the United Nations or its affiliated section and § 88.6 of this part. 245, Div. B., sec. 507(d), 132 Stat. 2981, agencies). (ii) Any State or local government or 3118 (Sept. 28, 2018)), Patient Referral or refer for includes the subdivision thereof and any other Protection and Affordable Care Act provision of information in oral, public entity is required to comply with section 1553 (42 U.S.C. 18113), and to written, or electronic form (including paragraphs (a)(2)(i) through (iii) of this sections of this part implementing those names, addresses, phone numbers, section. laws (§ 88.3(c) and (e)), an individual email or web addresses, directions, (iii) Any entity that receives a grant, physician or other health care instructions, descriptions, or other contract, loan, or loan guarantee under professional, including a pharmacist; information resources), where the the Public Health Service Act (42 U.S.C. health care personnel; a participant in a purpose or reasonably foreseeable 201 et seq.) after June 18, 1973, is program of training in the health outcome of provision of the information required to comply with paragraph professions; an applicant for training or is to assist a person in receiving funding (a)(2)(iv) of this section and §§ 88.4 and study in the health professions; a post- or financing for, training in, obtaining, 88.6 of this part. graduate physician training program; a or performing a particular health care (iv) Any entity that receives a grant or hospital; a medical laboratory; an entity service, program, activity, or procedure. contract for biomedical or behavioral engaging in biomedical or behavioral State includes, in addition to the research under any program research; a pharmacy; a provider- several States, the District of Columbia. administered by the Secretary of Health 2 S

E sponsored organization; a health For those provisions related to or L and Human Services after July 12, 1974, U R maintenance organization; a health relying upon the Public Health Service is required to comply with paragraph h t i w insurance issuer; a health insurance Act, the term ‘‘State’’ includes the (a)(2)(v) of this section and §§ 88.4 and D

O plan (including group or individual several States, the District of Columbia, R 88.6 of this part. P 2

8 plans); a plan sponsor or third-party the Commonwealth of Puerto Rico, (v) The Department and any entity 0 Q

L administrator; or any other kind of Guam, the Northern Mariana Islands, that receives funds for any health G 3 K S D n o l l e

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service program or research activity procedure or abortion, because he financial assistance, including Federal under any program administered by the refused to perform or assist in the payments provided as reimbursement Secretary of Health and Human Services performance of a lawful sterilization for carrying out health-related activities, is required to comply with paragraph procedure or abortion on the grounds is required to comply with paragraphs (a)(2)(vi) of this section and §§ 88.4 and that his performance or assistance in the (b)(2)(i) through (ii) of this section and 88.6 of this part. performance of such procedure or §§ 88.4 and 88.6 of this part. (vi) Any entity that receives, after abortion would be contrary to his (2) Requirements and prohibitions. (i) September 29, 1979, any grant, contract, religious beliefs or moral convictions, or Pursuant to 42 U.S.C. 238n(a)(1), (2), loan, loan guarantee, or interest subsidy because of his religious beliefs or moral and (3), entities to which this paragraph under the Public Health Service Act or convictions respecting sterilization (b)(2)(i) applies shall not subject any the Developmental Disabilities procedures or abortions. health care entity to discrimination on Assistance and Bill of Rights Act of (v) Pursuant to 42 U.S.C. 300a–7(c)(2), the basis that the health care entity— 2000 [42 U.S.C. 15001 et seq.] is entities to which this paragraph (a)(2)(v) (A) Refuses to undergo training in the required to comply with paragraph applies shall not discriminate against performance of induced abortions, to (a)(2)(vii) of this section and §§ 88.4 and any physician or other health care require or provide such training, to 88.6 of this part. personnel in employment, promotion, perform such abortions, or to provide (2) Requirements and prohibitions. (i) termination of employment, or referrals for such training or such Pursuant to 42 U.S.C. 300a–7(b)(1), the extension of staff or other privileges abortions; receipt of a grant, contract, loan, or loan because such physician or other health (B) Refuses to make arrangements for guarantee under the Public Health care personnel performed or assisted in any of the activities specified in Service Act by any individual does not the performance of any lawful health (b)(2)(i)(A); or authorize entities to which this service or research activity, because he (C) Attends or attended a post- paragraph (a)(2)(i) applies to require refused to perform or assist in the graduate physician training program or such individual to perform or assist in performance of any such service or any other program of training in the the performance of any sterilization activity on the grounds that his health professions that does not or did procedure or abortion if his performance performance or assistance in the not perform induced abortions or or assistance in the performance of such performance of such service or activity require, provide, or refer for training in procedure or abortion would be contrary would be contrary to his religious the performance of induced abortions, to his religious beliefs or moral beliefs or moral convictions, or because or make arrangements for the provision convictions. of his religious beliefs or moral of such training. (ii) Pursuant to 42 U.S.C. 300a– convictions respecting any such service (ii) Pursuant to 42 U.S.C. 238n(b), 7(b)(2)(A), the receipt of a grant, or activity. contract, loan, or loan guarantee under (vi) Pursuant to 42 U.S.C. 300a–7(d), entities to which this paragraph (b)(2)(ii) the Public Health Service Act by any entities to which this paragraph applies shall not, for the purposes of recipient does not authorize entities to (a)(2)(vi) applies shall not require any granting a legal status to a health care which this paragraph (a)(2)(ii) applies to individual to perform or assist in the entity (including a license or certificate), require such recipient to make its performance of any part of a health or providing such entity with financial facilities available for the performance service program or research activity assistance, services, or benefits, fail to of any sterilization procedure or funded in whole or in part under a deem accredited any postgraduate abortion if the performance of such program administered by the Secretary physician training program that would procedure or abortion in such facilities of Health and Human Services if the be accredited but for the accrediting is prohibited by the recipient on the individual’s performance or assistance agency’s reliance upon accreditation basis of religious beliefs or moral in the performance of such part of such standards that require an entity to convictions. program or activity would be contrary to perform an induced abortion or that (iii) Pursuant to 42 U.S.C. 300a– his religious beliefs or moral require an entity to require, provide, or 7(b)(2)(B), the receipt of a grant, convictions. refer for training in the performance of contract, loan, or loan guarantee under (vii) Pursuant to 42 U.S.C. 300a–7(e), induced abortions or make the Public Health Service Act by any entities to which this paragraph arrangements for such training, recipient does not authorize entities to (a)(2)(vii) applies shall not deny regardless of whether such standards which this paragraph (a)(2)(iii) applies admission to or otherwise discriminate provide exceptions or exemptions. to require such recipient to provide against any applicant (including Entities to which this paragraph personnel for the performance or applicants for internships and (b)(2)(ii) applies and which are involved assistance in the performance of any residencies) for training or study in such matters shall formulate such sterilization procedure or abortion if the because of the applicant’s reluctance or regulations or other mechanisms, or performance or assistance in the willingness to counsel, suggest, enter into such agreements with performance of such procedure or recommend, assist, or in any way accrediting agencies, as are necessary to abortion by such personnel would be participate in the performance of comply with this paragraph. contrary to the religious beliefs or moral abortions or sterilizations contrary to, or (c) Weldon Amendment (See, e.g., convictions of such personnel. consistent with, the applicant’s religious Pub. L. 115–245, Div. B, sec. 507(d))— (iv) Pursuant to 42 U.S.C. 300a– beliefs or moral convictions. (1) Applicability. (i) The Department 7(c)(1), entities to which this paragraph (b) The Coats-Snowe Amendment and its programs, while operating under (a)(2)(iv) applies shall not discriminate (Section 245 of the Public Health an appropriations act that contains the against any physician or other health —(1) Weldon Amendment, are required to

2 Service Act), 42 U.S.C. 238n S

E care personnel in employment, comply with paragraph (c)(2) of this L Applicability. (i) The Department is U R promotion, termination of employment, required to comply with paragraphs section and § 88.6 of this part. h t i w or extension of staff or other privileges (b)(2)(i) through (ii) of this section and (ii) Any State or local government that D

O because such physician or other health receives funds under an appropriations R § 88.6 of this part. P 2

8 care personnel performed or assisted in (ii) Any State or local government or act for the Department that contains the 0 Q

L the performance of a lawful sterilization subdivision thereof that receives Federal Weldon Amendment is required to G 3 K S D n o l l e

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comply with paragraph (c)(2) of this killing. Nothing in this paragraph shall information demonstrating that the section and §§ 88.4 and 88.6 of this part. be construed to apply to, or to affect, applicant: (2) Prohibition. The entities to which any limitation relating to: (A) Is an adherent of religious tenets this paragraph (c)(2) applies shall not (i) The withholding or withdrawing of or teachings by reason of which he is subject any institutional or individual medical treatment or medical care; conscientiously opposed to acceptance health care entity to discrimination on (ii) The withholding or withdrawing of the benefits of any private or public the basis that the health care entity does of nutrition or hydration; insurance which makes payments in the not provide, pay for, provide coverage (iii) Abortion; or event of death, disability, old-age, or of, or refer for, abortion. (iv) The use of an item, good, benefit, retirement or makes payments toward (d) Medicare Advantage (See, e.g., or service furnished for the purpose of the cost of, or provides services for, Pub. L. 115–245, Div. B, sec. 209)—(1) alleviating pain or discomfort, even if medical care (including the benefits of Applicability. The Department, while such use may increase the risk of death, any insurance system established by the operating under an appropriations act so long as such item, good, benefit, or Social Security Act), or that contains a provision with respect to service is not also furnished for the (B) Is an adherent of religious tenets the Medicare Advantage program as set purpose of causing, or the purpose of or teachings that are not described in forth by Public Law 115–245, Div. B, assisting in causing, death, for any paragraph (g)(2)(i)(A) of this section, sec. 209, is required to comply with reason. who relies solely on a religious method paragraph (d)(2) of this section and (f) Section 1303 of the Affordable Care of healing, and for whom the acceptance § 88.6 of this part. Act, 42 U.S.C. 18023—(1) Applicability. of medical health services would be (2) Prohibition. The entities to which (i) The Department is required to inconsistent with the religious beliefs of this paragraph (d)(2) applies shall not comply with paragraph (f)(2)(i) of this the individual, and the application for deny participation in the Medicare section and § 88.6 of this part. the certificate includes an attestation Advantage program to an otherwise (ii) Qualified health plans, as defined that the individual has not received eligible entity (including a Provider under 42 U.S.C. 18021, offered through medical health services during the Sponsored Organization) because that any Exchange created under the Patient preceding taxable year. entity informs the Secretary that it will Protection and Affordable Care Act, are (1) For purposes of this paragraph not provide, pay for, provide coverage required to comply with paragraphs (g)(2)(i)(B), ‘‘medical health services’’ of, or provide referrals for abortions. (f)(2)(i) and (ii) of this section and does not include routine dental, vision (e) Section 1553 of the Affordable §§ 88.4 and 88.6 of this part. and hearing services, midwifery Care Act, 42 U.S.C. 18113—(1) (2) Requirements and prohibitions. (i) services, vaccinations, necessary Applicability. (i) The Department is Pursuant to 42 U.S.C. 18023(b)(1)(A)(i), medical services provided to children, required to comply with paragraph entities to which this paragraph (f)(2)(i) services required by law or by a third (e)(2) of this section and § 88.6 of this applies shall not construe anything in party, and such other services as the part. Title I of the Patient Protection and Secretary may provide in implementing (ii) Any State or local government that Affordable Care Act (or any amendment section 1311(d)(4)(H) of the Patient receives Federal financial assistance made by Title I of the Patient Protection Protection and Affordable Care Act; under the Patient Protection and and Affordable Care Act) to require a and Affordable Care Act (or under an qualified health plan to provide (ii) Any applicant for such a amendment made by the Patient coverage of abortion or abortion-related certificate for any month who provides Protection and Affordable Care Act) is services as described in 42 U.S.C. information demonstrating that the required to comply with paragraph 18023(b)(1)(B)(i) or (ii) as part of its applicant is a member of a ‘‘health care (e)(2) of this section and §§ 88.4 and essential health benefits for any plan sharing ministry,’’ as defined in 26 88.6 of this part. year. U.S.C. 5000A(d)(2)(B)(ii), for the month. (iii) Any health care provider that (ii) Pursuant to 42 U.S.C. 18023(b)(4), (h) Counseling and referral provisions receives Federal financial assistance entities to which this paragraph (f)(2)(ii) of 42 U.S.C. 1395w–22(j)(3)(B) and under the Patient Protection and applies shall not discriminate against 1396u–2(b)(3)(B))—(1) Applicability. (i) Affordable Care Act (or under an any individual health care provider or The Department is required to comply amendment made by the Patient health care facility because of its with paragraphs (h)(2)(i) and (ii) of this Protection and Affordable Care Act) is unwillingness to provide, pay for, section and § 88.6 of this part. required to comply with paragraph provide coverage of, or refer for (ii) Any State agency that administers (e)(2) of this section and §§ 88.4 and abortions. a Medicaid program is required to 88.6 of this part. (g) Section 1411 of the Affordable comply with paragraph (h)(2)(ii) of this (iv) Any health plan created under the Care Act, 42 U.S.C. 18081—(1) section and §§ 88.4 and 88.6 of this part. Patient Protection and Affordable Care Applicability. The Department shall (2) Requirements and prohibitions. (i) Act (or under an amendment made by comply with paragraph (g)(2) of this Pursuant to 42 U.S.C. 1395w–22(j)(3)(B), the Patient Protection and Affordable section and § 88.6 of this part. entities to which this paragraph (h)(2)(i) Care Act) is required to comply with (2) Requirement. The Department applies shall not construe 42 U.S.C. paragraph (e)(2) of this section and shall provide a certification 1395w–22(j)(3)(A) or 42 CFR 422.206(a) §§ 88.4 and 88.6 of this part. documenting a religious exemption to require a Medicare Advantage (2) Prohibition. The entities to which from the individual responsibility organization to provide, reimburse for, this paragraph (e)(2) applies shall not requirement and penalty under the or provide coverage of, a counseling or subject an individual or institutional Patient Protection and Affordable Care referral service if the organization health care entity to discrimination on Act and shall coordinate with State 2 offering the plan: S

E the basis that the entity does not L Health Benefit Exchanges in the (A) Objects to the provision of such U R provide any health care item or service implementing of the certification service on moral or religious grounds, h t i w

furnished for the purpose of causing, or requirements of 42 U.S.C. and D

O for the purpose of assisting in causing, (B) In the manner and through the R 18031(d)(4)(H)(ii) where applicable to: P 2

8 the death of any individual, such as by (i) Any applicant for such a certificate written instrumentalities such 0 Q

L assisted suicide, euthanasia, or mercy for any month who provides organization deems appropriate, makes G 3 K S D n o l l e

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available information on its policies Department is required to comply with Department is required to comply with regarding such service to prospective paragraph (j)(2) of this section and paragraph (k)(2)(i) of this section and enrollees before or during enrollment § 88.6 of this part. § 88.6 of this part. and to enrollees within 90 days after the (ii) Any entity that is authorized by (ii) Any entity that is authorized by date that the organization adopts a statute, regulation, or agreement to statute, regulation, or agreement to change in policy regarding such a obligate Federal financial assistance obligate or expend Federal financial counseling or referral service. under section 104A of the Foreign assistance under part I of the Foreign (ii) Pursuant to 42 U.S.C. 1396u– Assistance Act of 1961 (22 U.S.C. Assistance Act of 1961, as amended (22 2(b)(3)(B), entities to which this 2151b–2), under Chapter 83 of Title 22 U.S.C. 2151b–2), to the extent paragraph (h)(2)(ii) applies shall not of the U.S. Code or under the Tom administered by the Secretary, is construe 42 U.S.C. 1396u–2(b)(3)(A) or Lantos and Henry J. Hyde United States required to comply with paragraph 42 CFR 438.102(a)(1) to require a Global Leadership Against HIV/ AIDS, (k)(2)(i) of this section and §§ 88.4 and Medicaid managed care organization to Tuberculosis, and Malaria 88.6 of this part. provide, reimburse for, or provide Reauthorization Act of 2008, to the (iii) Any entity that receives Federal coverage of, a counseling or referral extent such Federal financial assistance financial assistance under part I of the service if the organization: is administered by the Secretary, is Foreign Assistance Act of 1961, as (A) Objects to the provision of such required to comply with paragraph (j)(2) amended (22 U.S.C. 2151b–2), to the service on moral or religious grounds, of this section and §§ 88.4 and 88.6 of extent administered by the Secretary, is and this part. required to comply with paragraph (B) In the manner and through the (2) Prohibitions. The entities to which (k)(2)(ii) of this section and §§ 88.4 and written instrumentalities such this paragraph (j)(2) applies shall not: 88.6 of this part. organization deems appropriate, makes (i) Require an organization, including (2) Prohibitions. (i) The entities to available information on its policies a faith-based organization, that is which this paragraph (k)(2)(i) applies regarding such service to prospective otherwise eligible to receive assistance shall not: enrollees before or during enrollment under section 104A of the Foreign (A) Permit Federal financial and to enrollees within 90 days after the Assistance Act of 1961 (22 U.S.C. assistance identified in paragraph date that the organization adopts a 2151b–2), under Chapter 83 of Title 22 (k)(1)(ii) of this section to be used in a change in policy regarding such a of the U.S. Code, or under the Tom manner that would violate provisions in counseling or referral service. Lantos and Henry J. Hyde United States paragraphs (k)(2)(ii)(A)(1) through (5) of (i) Advance Directives, 42 U.S.C. Global Leadership Against HIV/ AIDS, this section related to abortions and 1395cc(f), 1396a(w)(3), and 14406—(1) Tuberculosis, and Malaria involuntary sterilizations. Applicability. (i) The Department is Reauthorization Act of 2008, to the (B) Obligate or expend Federal required to comply with paragraph (i)(2) extent such assistance is administered financial assistance under an of this section and § 88.6 of this part by the Secretary, for HIV/ AIDS appropriations act that contains the with respect to the Medicare and prevention, treatment, or care to, as a 1985 Amendment and identified in Medicaid programs. condition of such assistance: paragraph (k)(1)(ii) of this section for (ii) Any State agency that administers (A) Endorse or utilize a multisectoral any country or organization if the a Medicaid program is required to or comprehensive approach to President certifies that the use of these comply with paragraph (i)(2) of this combating HIV/ AIDS; or funds by any such country or section and §§ 88.4 and 88.6 of this part (B) Endorse, utilize, make a referral to, organization would violate provisions in with respect to its Medicaid program. become integrated with, or otherwise paragraphs (k)(2)(ii)(A)(1) through (5) of (2) Prohibitions. The entities to which participate in any program or activity to this section related to abortions and this paragraph (i)(2) applies shall not: which the organization has a religious involuntary sterilizations. (i) Construe 42 U.S.C. 1395cc(f) or or moral objection. (ii) The entities to which this 1396a(w)(3) to require any provider or (ii) Discriminate against an paragraph (k)(2)(ii) applies shall not: organization, or any employee of such a organization, including a faith-based (A) Use such Federal financial provider or organization, to inform or organization, that is otherwise eligible assistance identified in paragraph counsel any individual regarding any to receive assistance under section 104A (k)(1)(iii) of this section to: right to obtain an item or service of the Foreign Assistance Act of 1961 (1) Pay for the performance of furnished for the purpose of causing, or (22 U.S.C. 2151b–2), under Chapter 83 abortions as a method of family the purpose of assisting in causing, the of Title 22 of the U.S. Code, or under the planning; death of the individual, such as by Tom Lantos and Henry J. Hyde United (2) Motivate or coerce any person to assisted suicide, euthanasia, or mercy States Global Leadership Against HIV/ practice abortions; killing; or to apply to or affect any AIDS, Tuberculosis, and Malaria (3) Pay for the performance of requirement with respect to a portion of Reauthorization Act of 2008, to the involuntary sterilizations as a method of an advance directive that directs the extent such assistance is administered family planning; purposeful causing of, or the purposeful by the Secretary, for HIV/ AIDS (4) Coerce or provide any financial assisting in causing, the death of any prevention, treatment, or care, in the incentive to any person to undergo individual, such as by assisted suicide, solicitation or issuance of grants, sterilizations; or euthanasia, or mercy killing; or contracts, or cooperative agreements (5) Pay for any biomedical research (ii) Construe 42 U.S.C. 1396a to under such provisions of law for that relates in whole or in part, to prohibit the application of a State law refusing to meet any requirement methods of, or the performance of, which allows for an objection on the described in paragraph (j)(2)(i) of this abortions or involuntary sterilization as 2 S E

L basis of conscience for any health care section. a means of family planning. U R provider or any agent of such provider (k) The Helms, Biden, 1978, and 1985 (B) Obligate or expend Federal h t i w which as a matter of conscience cannot Amendments, 22 U.S.C. 2151b(f); see, financial assistance under an D

O e.g., Consolidated Appropriations Act, appropriations act that contains the R implement an advance directive. P 2

8 (j) Global Health Programs, 22 U.S.C. 2019, Public Law 116–6, Div. F, sec. 1985 Amendment and identified in 0 Q

L 7631(d)—(1) Applicability. (i) The 7018—(1) Applicability. (i) The paragraph (k)(1)(iii) of this section for G 3 K S D n o l l e

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any country or organization if the with paragraph (o)(2) of this section and (2) Requirements and prohibitions. (i) President certifies that the use of these § 88.6 of this part. Entities to which this paragraph (p)(2)(i) funds by any such country or (ii) Any State agency that administers applies shall not construe the receipt of organization would violate provisions in a pediatric vaccine distribution program funds under or anything in 42 U.S.C. paragraphs (k)(2)(ii)(A)(1) through (5) of under 42 U.S.C. 1396s is required to chapter 67, subchapters I or III as this section related to abortions and comply with paragraph (o)(2) of this establishing any Federal requirement involuntary sterilizations. section and §§ 88.4 and 88.6 of this part. that a parent or legal guardian provide (l) Newborn and Infant Hearing Loss (2) Requirement. The entities to a child any medical service or treatment Screening, 42 U.S.C. 280g–1(d)—(1) which this paragraph (o)(2) applies shall against the religious beliefs of the parent Applicability. The Department is ensure that, under any State- or legal guardian. required to comply with paragraph (l)(2) administered pediatric vaccine (ii) Entities to which this paragraph of this section and § 88.6 of this part. distribution program under 42 U.S.C. (p)(2)(ii) applies shall not construe the (2) Requirement. The Department 1396s, the provider agreement executed receipt of funds under or anything in 42 shall not construe 42 U.S.C. 280g–1 to by any program-registered provider, as U.S.C. chapter 67, subchapters I or III as preempt or prohibit any State law that defined under 42 U.S.C. 1396s(c)(1), requiring a State to find, or prohibiting does not require the screening for includes the requirement that the a State from finding, child abuse or hearing loss of children of parents who program-registered provider will neglect in cases in which a parent or object to the screening on the grounds provide pediatric vaccines in legal guardian relies solely or partially that it conflicts with the parents’ compliance with all applicable State upon spiritual means rather than religious beliefs. law relating to any religious or other medical treatment, in accordance with (m) Medical Screening, Examination, exemption. Such State law may include the religious beliefs of the parent or Diagnosis, Treatment, or Other Health State statutory, regulatory, or legal guardian. Care or Services, 42 U.S.C. 1396f—(1) constitutional protections for (iii) Entities to which this paragraph Applicability. The Department is conscience and religious freedom, (p)(2)(iii) applies shall not construe required to comply with paragraph where applicable. anything in 42 U.S.C. 290bb–36 to (m)(2) of this section and § 88.6 of this (p) Specific Assessment, Prevention require suicide assessment, early part. and Treatment Services, 42 U.S.C. intervention, or treatment services for (2) Requirements and prohibitions. youth whose parents or legal guardians The Department shall not construe 290bb–36(f), 5106i(a)—(1) Applicability. (i) The Department is required to object based on the parents’ or legal anything in 42 U.S.C. 1396 et seq. to guardians’ religious beliefs or moral require a State agency that administers comply with paragraphs (p)(2)(i) through (iii) of this section and § 88.6 of objections. a State Medicaid Plan to compel any (q) Religious nonmedical health care, this part. person to undergo any medical 42 U.S.C. 1320a–1(h), 1320c–11, 1395i– (ii) Any State, political subdivision, screening, examination, diagnosis, or 5, 1395x(e), 1395x(y)(1), 1396a(a), and public organization, private nonprofit treatment or to accept any other health 1397j–1(b)—(1) Applicability. (i) The organization, institution of higher care or services provided under such Department is required to comply with education, or tribal organization actively plan for any purpose (other than for the paragraphs (q)(2)(i) through (iv) of this involved with the State-sponsored purpose of discovering and preventing section and § 88.6 of this part. the spread of infection or contagious statewide or tribal youth suicide early (ii) Any State agency that makes an disease or for the purpose of protecting intervention and prevention strategy, agreement with the Secretary pursuant environmental health), if such person designated by a State to develop or to 42 U.S.C. 1320a–1(b) is required to objects (or, in case such person is a direct the State-sponsored Statewide comply with paragraph (q)(2)(i) of this child, his parent or guardian objects) youth suicide early intervention and section and §§ 88.4 and 88.6 of this part. thereto on religious grounds. prevention strategy under 42 U.S.C. (iii) Any entity receiving Federal (n) Occupational Illness Examinations 290bb–36 and that receives a grant or financial assistance from participating and Tests, 29 U.S.C. 669(a)(5)—(1) cooperative agreement thereunder, is in Medicare is required to comply with Applicability. (i) The Department is required to comply with paragraph paragraphs (q)(2)(ii) of this section and required to comply with paragraph (p)(2)(iii) of this section and §§ 88.4 and §§ 88.4 and 88.6 of this part. (n)(2) of this section and § 88.6 of this 88.6 of this part. (iv) Any entity, including a State, part. (iii) Any federally recognized Indian receiving Federal financial assistance (ii) Any recipient of grants or tribe or tribal organization (as defined in from participating in Medicaid, contracts under 29 U.S.C. 669, to the the Indian Self-Determination and including any entity receiving Federal extent administered by the Secretary, is Education Assistance Act (25 U.S.C. financial assistance through CHIP that is required to comply with paragraph 5301 et seq.)) or an urban Indian used to expand Medicaid, is required to (n)(2) of this section and §§ 88.4 and organization (as defined in the Indian comply with paragraphs (q)(2)(iii) of 88.6 of this part. Health Care Improvement Act (25 U.S.C. this section and §§ 88.4 and 88.6 of this (2) Requirements. Entities to which 1601 et seq.)) that is actively involved part. this paragraph (n)(2) applies shall not in the development and continuation of (v) Any entity, including a State or deem any provision of 29 U.S.C. 651 et a tribal youth suicide early intervention local government or subdivision thereof, seq. to authorize or require medical and prevention strategy under 42 U.S.C. receiving Federal financial assistance examination, immunization, or 290bb–36 and that receives a grant or under subtitle B of Title XX of the treatment, as provided under 29 U.S.C. cooperative agreement thereunder is Social Security Act (42 U.S.C. 1397j– 669, for those who object thereto on required to comply with paragraph 1397m–5) is required to comply with 2 S

E (p)(2)(iii) of this section.

L religious grounds, except where such is paragraph (q)(2)(iv) of this section and U R necessary for the protection of the (iv) Any entity that receives funds §§ 88.4 and 88.6 of this part. h t i w health or safety of others. under 42 U.S.C. chapter 67, subchapters (2) Requirements and prohibitions. (i) D

O (o) Vaccination, 42 U.S.C. I or III is required to comply with The entities to which this paragraph R P 2

8 1396s(c)(2)(B)(ii)—(1) Applicability. (i) paragraphs (p)(2)(i) and (ii) of this (q)(2)(i) applies shall not apply the 0 Q

L The Department is required to comply section and §§ 88.4 and 88.6 of this part. provisions of 42 U.S.C. 1320a–1 to a G 3 K S D n o l l e

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religious nonmedical health care (B) Be evaluated under 42 U.S.C. applicable Federal conscience and anti- institution as defined in 42 U.S.C. 1396a(a)(33), on the appropriateness discrimination laws and this part. 1395x(ss)(1). and quality of care and services; (b) Specific requirements—(1) Timing. (ii) With respect to a religious (C) Undergo a regular program, under Entities who are already recipients as of nonmedical health care institution as 42 U.S.C. 1396(a)(31), of independent the effective date of this part or any defined in 42 U.S.C. 1395x(ss)(1), the professional review, including medical applicants shall submit the assurance entities to which this paragraph (q)(2)(ii) evaluation, of services in an required in paragraph (a)(1) of this applies shall not: intermediate care facility for persons section and the certification required in (A) Fail or refuse to make a payment with mental disabilities; and paragraph (a)(2) of this section as a under part A of subchapter XVIII of (D) Meet the requirements of 42 condition of any application or chapter 7 of Title 42 of the U.S. Code U.S.C. 1396(b)(i)(4) to establish a reapplication for funds to which this for inpatient hospital services, post- utilization review plan consistent with, part applies, through any instrument or hospital extended care services, or home or superior to, the utilization review as a condition of an amendment or health services furnished to an plan criteria under 42 U.S.C. 1395x(k) modification of the instrument that individual by a religious nonmedical for Medicare. extends the term of such instrument or health care institution that is a hospital (iv) Pursuant to 42 U.S.C. 1397j–1(b), adds additional funds to it. Submission as defined in 42 U.S.C. 1395x(e), a the entities to which this paragraph may be required more frequently if: (i) The applicant or recipient fails to skilled nursing facility as defined in 42 (q)(2)(iv) applies shall not construe meet a requirement of this part, or U.S.C. 1395x(y), or a home health subtitle B of Title XX of the Social (ii) OCR or the relevant Department agency as defined in 42 U.S.C. Security Act (42 U.S.C. 1397j–1397m–5) component has reason to suspect or 1395x(aaa), respectively, if the to interfere with or abridge an elder’s cause to investigate the possibility of condition under 42 U.S.C. 1395i–5(a)(2) right to practice his or her religion such failure. is satisfied and an individual makes an through reliance on prayer alone for (2) Form and manner. Applicants or election pursuant to 1395i–5(b) that: healing when this choice: recipients shall submit the assurance (1) Such individual is conscientiously (A) Is contemporaneously expressed, required in paragraph (a)(1) of this opposed to acceptance of medical care either orally or in writing, with respect section and the certification required in or treatment other than medical care or to a specific illness or injury which the paragraph (a)(2) of this section in the treatment (including medical and other elder has at the time of the decision by form and manner that OCR, in health services) that is: an elder who is competent at the time coordination with the relevant (i) Received involuntarily, or of the decision; Department component, specifies, or (ii) Required under Federal or State (B) Is previously set forth in a living shall submit them in a separate writing law or law of a political subdivision of will, health care proxy, or other advance signed by the applicant’s or recipient’s a State; and directive document that is validly officer or other person authorized to (2) Acceptance of such medical executed and applied under State bind the applicant or recipient. treatment would be inconsistent with law; or (3) Duration of obligation. The such individual’s sincere religious (C) May be unambiguously deduced assurance required in paragraph (a)(1) of beliefs, or from the elder’s life history. this section and the certification required in paragraph (a)(2) of this (B) In administering 42 U.S.C. 1395i– § 88.4 Assurance and certification of 5 or 1395x(ss)(1): compliance requirements. section will obligate the recipient for the (1) Require any patient of a religious period during which the Department (a) In general—(1) Assurance. Except extends Federal financial assistance or nonmedical health care institution to for an application or recipient to which undergo medical screening, Federal funds from the Department to a paragraph (c) of this section applies, recipient. examination, diagnosis, prognosis, or every application for Federal financial treatment or to accept any other medical (4) Compliance requirement. assistance or Federal funds from the Submission of an assurance or health care service, if such patient (or Department to which § 88.3 of this part legal representative of the patient) certification required under this section applies shall, as a condition of the will not relieve a recipient of the objects to such service on religious approval, renewal, or extension of any grounds, or obligation to take and complete any Federal financial assistance or Federal action necessary to come into ( ) Subject a religious nonmedical 2 funds from the Department pursuant to compliance with Federal conscience health care institution or its personnel the application, provide, contain, or be and anti-discrimination laws and this to any medical supervision, regulation, accompanied by an assurance that the part prior to, at the time of, or or control, insofar as such supervision, applicant or recipient will comply with subsequent to, the submission of such regulation, or control would be contrary applicable Federal conscience and anti- assurance or certification. to the religious beliefs observed by the discrimination laws and this part. (5) Condition of continued receipt. institution or such personnel, or (2) Certification. Except for an Provision of a compliant assurance and (C) Subject religious nonmedical application or recipient to which certification shall constitute a condition health care institution to the provisions paragraph (c) of this section applies, of continued receipt of Federal financial of part B of subchapter XI of Chapter 7 every application for Federal financial assistance or Federal funds from the of Title 42 of the U.S. Code. assistance or Federal funds from the Department and is binding upon the (iii) Pursuant to 42 U.S.C. 1396a(a), Department to which § 88.3 of this part applicant or recipient, its successors, the entities to which this paragraph applies, shall, as a condition of the assigns, or transferees for the period 2 S

E (q)(2)(iii) applies shall not fail or refuse approval, renewal, or extension of any L during which such Federal financial U R to exempt a religious nonmedical health Federal financial assistance or Federal assistance or Federal funds from the h t i

w care institution from the Medicaid funds from the Department pursuant to Department are provided. D

O requirements to: the application, provide, contain, or be (6) Assurances and certifications in R P 2

8 (A) Meet State standards described in accompanied by, a certification that the applications. An applicant or recipient 0 Q

L 42 U.S.C. 1396a(a)(9)(A); applicant or recipient will comply with may incorporate the assurances and G 3 K S D n o l l e

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certifications by reference in subsequent Indian Self-Determination and § 88.6 Compliance requirements. applications to the Department or Education Assistance Act. (a) In general. The Department and Department component if prior each recipient has primary assurances or certifications are initially § 88.5 Notice of rights under Federal responsibility to ensure that it is in conscience and anti-discrimination laws. provided in the same fiscal or calendar compliance with Federal conscience year, as applicable. (a) In general. In investigating a and anti-discrimination laws and this (7) Enforcement of assurances and complaint or conducting a compliance part, and shall take steps to eliminate certifications. The Department, review, OCR will consider an entity’s any violations of the Federal conscience Department components, and OCR shall voluntary posting of a notice of and anti-discrimination laws and this have the right to seek enforcement of the nondiscrimination as non-dispositive part. If a sub-recipient is found to have assurances and certifications required in evidence of compliance with the violated the Federal conscience and this section. applicable substantive provisions of this anti-discrimination laws, the recipient (8) Remedies for failure to make part, to the extent such notices are from whom the sub-recipient received assurances and certifications. If an provided according to the provisions of funds may be subject to the imposition applicant or recipient fails or refuses to this section and are relevant to the of funding restrictions or any furnish an assurance or certification particular investigation or compliance appropriate remedies available under required under this section, OCR, in review. this part, depending on the facts and coordination with the relevant (b) Placement of the notice text. In circumstances. Department component, may effect evaluating the Department’s or a (b) Records and information. The compliance by any of the mechanisms recipient’s compliance with this part, Department, each recipient, and each provided in § 88.7. OCR will take into account whether, as sub-recipient shall maintain complete (c) Exceptions. The following persons applicable and appropriate, the and accurate records evidencing or entities shall not be required to Department or recipient has provided compliance with Federal conscience comply with paragraphs (a)(1) and (2) of the notice under this section: and anti-discrimination laws and this this section, provided that such persons (1) On the Department or recipient’s part, and afford OCR, upon request, or entities are not recipients of Federal website(s); reasonable access to such records and financial assistance or other Federal (2) In a prominent and conspicuous information in a timely manner and to funds from the Department through physical location in Department or the extent OCR finds necessary to another instrument, program, or recipient establishments where notices determine compliance with the Federal mechanism, other than those set forth in to the public and notices to its conscience and anti-discrimination laws paragraphs (c)(1) through (4) of this workforce are customarily posted to and this part. Such records: (1) Shall be maintained for a period of section: permit ready observation; three years from the date the record was (1) A physician, as defined in 42 (3) In a personnel manual or other created or obtained by the recipient or U.S.C. 1395x(r), physician office, substantially similar document for members of the Department or sub-recipient; pharmacist, pharmacy, or other health (2) Shall contain any information recipient’s workforce; care practitioner participating in Part B maintained by the recipient or sub- (4) In applications to the Department of the Medicare program; recipient that pertains to discrimination (2) A recipient of Federal financial or recipient for inclusion in the on the basis of religious belief or moral assistance or other Federal funds from workforce or for participation in a conviction, including, without the Department awarded under certain service, benefit, or other program, limitation, any complaints; statements, grant programs currently administered including for training or study; and policies, or notices concerning by the Administration for Children and (5) In any student handbook or other discrimination on the basis of religious Families, the purpose of which is either substantially similar document for belief or moral conviction; procedures solely financial assistance unrelated to students participating in a program of for accommodating employees’ or other health care or which is otherwise training or study, including for post- protected individuals’ religious beliefs unrelated to health care provision, and graduate interns, residents, and fellows. or moral convictions; and records of which, in addition, does not involve— (6) Such that the text of the notice is requests for such religious or moral (i) Medical or behavioral research; large and conspicuous enough to be accommodation and the recipient or (ii) Health care providers; or read easily and is presented in a format, sub-recipient’s response to such (iii) Any significant likelihood of location, or manner that impedes or requests; and referral for the provision of health care; prevents the notice being altered, (3) May be maintained in any form (3) A recipient of Federal financial defaced, removed, or covered by other and manner that affords OCR with assistance or other Federal funds from material. reasonable access to them in a timely the Department awarded under certain (c) Content of the notice text. The manner. grant programs currently administered recipient and the Department should (c) Cooperation. The Department, by the Administration on Community consider using the model text provided each recipient, and each sub-recipient Living, the purpose of which is either in Appendix A for the notice, but may shall cooperate with any compliance solely financial assistance unrelated to tailor its notice to address its particular review, investigation, interview, or health care or which is otherwise circumstances and to more specifically other part of OCR’s enforcement unrelated to health care provision, and address the laws that apply to it under process, which may include production which, in addition, does not involve— this rule. of documents, participation in (i) Medical or behavioral research; (d) Combined nondiscrimination interviews, response to data requests, 2 S

E (ii) Health care providers; or notices. The Department and each and making available of premises for L U R

(iii) Any significant likelihood of recipient may post the notice text inspection where relevant. Failure to h t i w

referral for the provision of health care. provided in appendix A of this part, or cooperate may result in an OCR referral D

O (4) Indian Tribes and Tribal a notice it drafts itself, along with the to the Department of Justice, in R P 2

8 Organizations when contracting with content of other notices (such as other coordination with the Department’s 0 Q

L the Indian Health Service under the non-discrimination notices). Office of the General Counsel, for G 3 K S D n o l l e

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further enforcement in Federal court or involuntary enforcement, such as those OCR’s request shall constitute a otherwise. Each recipient or sub- that apply to grants, contracts, or CMS violation of this part. recipient shall permit access by OCR programs; and (f) Related administrative or judicial during normal business hours to such of (8) In coordination with the relevant proceeding. Consistent with other its books, records, accounts, and other component or components of the applicable Federal laws, testimony and sources of information, as well as its Department, coordinate other other evidence obtained in an facilities, as may be pertinent to appropriate remedial action as the investigation or compliance review ascertain compliance with this part. Department deems necessary and as conducted under this part may be used Asserted considerations of privacy or allowed by law and applicable by the Department for, and offered into confidentiality may not operate to bar regulation. evidence in, any administrative or OCR from evaluating or seeking to (b) Complaints. Any entity, whether judicial proceeding related to this part. enforce compliance with this part. individually, as a member of a class, on (g) Supervision and coordination. If as Information of a confidential nature behalf of others, or on behalf of an a result of an investigation, compliance obtained in connection with compliance entity, may file a complaint with OCR review, or other enforcement activity, reviews, investigations, or other alleging any potential violation of OCR determines that a Department enforcement activities shall not be Federal conscience and anti- component appears to be in disclosed except as required in formal discrimination laws or this part. OCR noncompliance with its responsibilities enforcement proceedings or as shall coordinate handling of complaints under Federal conscience and anti- otherwise required by law. with the relevant Department discrimination laws or this part, OCR (d) Reporting requirement. If a component(s). The complaint filer is not will undertake appropriate action with recipient or sub-recipient is subject to a required to be the entity whose rights the component to assure compliance. In determination by OCR of under the Federal conscience and anti- the event that OCR and the Department noncompliance with this part, the discrimination laws or this part have component are unable to agree on a recipient or sub-recipient must, in any been potentially violated. resolution of any particular matter, the application for new or renewed Federal (c) Compliance reviews. OCR may matter shall be submitted to the financial assistance or Departmental conduct compliance reviews or use Secretary for resolution. OCR may from funding in the three years following other similar procedures as necessary to time to time request the assistance of such determination, disclose the permit OCR to investigate and review officials of the Department in carrying existence of the determination of the practices of the Department, out responsibilities in connection with noncompliance. This includes a Department components, recipients, and the enforcement of Federal conscience sub-recipients to determine whether requirement that recipients disclose any and anti-discrimination laws and this they are complying with Federal OCR determinations made against their part, including the achievement of conscience and anti-discrimination laws sub-recipients. effective coordination and maximum (e) Intimidating or retaliatory acts and this part. OCR may initiate a uniformity within the Department. prohibited. Neither the Department nor compliance review of an entity subject (h) Referral to the Department of any recipient or sub-recipient shall to this part based on information from Justice. If as a result of an investigation, a complaint or other source that causes compliance review, or other intimidate, threaten, coerce, or OCR to suspect non-compliance by such enforcement activity, OCR determines discriminate against any entity for the entity with this part or the laws that a recipient or sub-recipient is not in purpose of interfering with any right or implemented by this part. compliance with the Federal conscience privilege under the Federal conscience (d) Investigations. OCR shall make a and anti-discrimination laws or this and anti-discrimination laws or this prompt investigation, whenever a part, OCR may, in coordination with the part, or because such entity has made a compliance review, report, complaint, relevant Department component and the complaint or participated in any manner or any other information found by OCR Office of the General Counsel, make in an investigation or review under the indicates a threatened, potential, or referrals to the Department of Justice, for Federal conscience and anti- actual failure to comply with Federal further enforcement in Federal court or discrimination laws or this part. conscience and anti-discrimination laws otherwise. OCR may also make referrals § 88.7 Enforcement authority. or this part. The investigation should to the Department of Justice, in (a) In general. OCR has been delegated include, where appropriate, a review of coordination with the Office of the the authority to facilitate and coordinate the pertinent practices, policies, General Counsel, concerning potential the Department’s enforcement of the communications, documents, violations of 18 U.S.C. 1001 or 42 U.S.C. Federal conscience and anti- compliance history, circumstances 300a–8 for enforcement or other discrimination laws, which includes the under which the possible appropriate action. authority to: noncompliance occurred, and other (i) Resolution of matters. (1) If an (1) Receive and handle complaints; factors relevant to determining whether investigation or compliance review (2) Initiate compliance reviews; the Department, Department reveals that no action is warranted, OCR (3) Conduct investigations; component, recipient, or sub-recipient will so inform any party who has been (4) Coordinate compliance within the has failed to comply. OCR shall use fact- notified of the existence of the Department; finding methods including site visits; investigation or compliance review, if (5) Seek voluntary resolutions of interviews with the complainants, any, in writing. complaints; Department component, recipients, sub- (2) If an investigation or compliance (6) In coordination with the relevant recipients, or third-parties; and written review indicates a failure to comply component or components of the data or discovery requests. OCR may with Federal conscience and anti- 2 S

E discrimination laws or this part, OCR L Department and the Office of the seek the assistance of any State agency. U R General Counsel, make enforcement (e) Failure to respond. Absent good will so inform the relevant parties and h t i w

referrals to the Department of Justice; cause, the failure of an entity that is the matter will be resolved by informal D

O (7) In coordination with the relevant subject to this part to respond to a means whenever possible. Attempts to R P 2

8 Departmental funding component, request for information or to a data or resolve matters informally shall not 0 Q

L utilize existing regulations for document request within 45 days of preclude OCR from simultaneously G 3 K S D n o l l e

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pursuing any action described in (j) Noncompliance with § 88.4. If a extent permitted by law. A severed paragraphs (a)(5) through (7) of this recipient of Federal financial assistance provision shall not affect the remainder section. or applicant therefor fails or refuses to of this part or the application of the (3) If OCR determines that there is a furnish an assurance or certification provision to other persons or entities failure to comply with Federal required under § 88.4 or otherwise fails not similarly situated or to other, conscience and anti-discrimination laws or refuses to comply with a requirement dissimilar circumstances. or this part, compliance with these laws imposed by or pursuant to that section, Appendix A to Part 88—Model Text: and this part may be effected by the OCR, in coordination with the relevant Notice of Rights Under Federal following actions, taken in coordination Department component, may effect Conscience and Anti-Discrimination with the relevant Department compliance by any of the remedies Laws component, and pursuant to statutes provided in paragraph (i) of this section. and regulations which govern the The Department shall not be required to [Name of recipient, the Department, or administration of contracts (e.g., Federal provide assistance in such a case during Department component] complies with Acquisition Regulation), grants (e.g., 45 the pendency of the administrative applicable Federal conscience and anti- CFR part 75) and CMS funding proceedings brought under such discrimination laws prohibiting exclusion, arrangements (e.g., the Social Security paragraph. adverse treatment, coercion, or other discrimination against individuals or entities Act): § 88.8 Relationship to other laws. on the basis of their religious beliefs or moral (i) Temporarily withholding Federal convictions. You may have the right under financial assistance or other Federal Nothing in this part shall be Federal law to decline to perform, assist in funds, in whole or in part, pending construed to preempt any Federal, State, the performance of, refer for, undergo, or pay correction of the deficiency; or local law that is equally or more for certain health care-related treatments, (ii) Denying use of Federal financial protective of religious freedom and research, or services (such as abortion or assistance or other Federal funds from moral convictions. Nothing in this part assisted suicide, among others) that violate the Department, including any shall be construed to narrow the your conscience, religious beliefs, or moral applicable matching credit, in whole or meaning or application of any State or convictions. in part; Federal law protecting free exercise of If you believe that [Name of recipient, the (iii) Wholly or partly suspending religious beliefs or moral convictions. Department, or Department component] has award activities; failed to accommodate your conscientious, (iv) Terminating Federal financial § 88.9 Rule of construction. religious, or moral objection, or has discriminated against you on those grounds, assistance or other Federal funds from This part shall be construed in favor you can file a conscience and religious the Department, in whole or in part; of a broad protection of the free exercise freedom complaint with the U.S. Department (v) Denying or withholding, in whole of religious beliefs and moral of Health and Human Services, Office for or in part, new Federal financial convictions, to the maximum extent Civil Rights, electronically through the Office assistance or other Federal funds from permitted by the Constitution and the for Civil Rights Complaint Portal, available at the Department administered by or terms of the Federal conscience and https://ocrportal.hhs.gov/ocr/portal/lobby.jsf through the Secretary for which an anti-discrimination laws. or by mail or phone at: U.S. Department of application or approval is required, Health and Human Services, 200 including renewal or continuation of § 88.10 Severability. Independence Avenue SW, Room 509F, HHH existing programs or activities or Any provision of this part held to be Building Washington, DC 20201, 1–800–368– authorization of new activities; invalid or unenforceable either by its 1019, 800–537–7697 (TDD). Complaint forms terms or as applied to any entity or and more information about Federal (vi) In coordination with the Office of conscience and anti-discrimination laws are the General Counsel, referring the circumstance shall be construed so as to available at http://www.hhs.gov/conscience. matter to the Attorney General for continue to give the maximum effect to proceedings to enforce any rights of the the provision permitted by law, unless Dated: May 2, 2019. United States, or obligations of the such holding shall be one of utter Alex M. Azar II, recipient or sub-recipient, under Federal invalidity or unenforceability, in which Secretary, Department of Health and Human law or this part; and event such provision shall be severable Services. (vii) Taking any other remedies that from this part, which shall remain in [FR Doc. 2019–09667 Filed 5–20–19; 8:45 am] may be legally available. full force and effect to the maximum BILLING CODE 4153–01–P 2 S E L U R h t i w

D O R P 2 8 0 Q L G 3 K S D n o l l e

b VerDate Sep<11>2014 21:56 May 20, 2019 Jkt 247001 PO 00000 Frm 00104 Fmt 4701 Sfmt 9990 E:\FR\FM\21MYR2.SGM 21MYR2 j JS-CAND 44 (Rev. 06/17) Case 5:19-cv-02916 CIVIL Document COVER 1-2 SHEETFiled 05/28/19 Page 1 of 5 The JS-CAND 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved in its original form by the Judicial Conference of the United States in September 1974, is required for the Clerk of Court to initiate the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.) I. (a) PLAINTIFFS DEFENDANTS County of Santa Clara, Trust Women Seattle, Los Angeles LGBT Center, Whitman Walker Clinic, Inc. d/b/a U.S. Department of Heath and Human Services and Alex M. Azar, II, in his official capacity as Secretary of Whitman Walker Health, et al. (See full list of plaintiffs attached.) Health and Human Services (b) County of Residence of First Listed Plaintiff Santa Clara County County of Residence of First Listed Defendant n/a (EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY) NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE TRACT OF LAND INVOLVED.

(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known) See attached list of attorneys.

II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff (For Diversity Cases Only) and One Box for Defendant) PTF DEF PTF DEF 1 U.S. Government Plaintiff 3 Federal Question Citizen of This State 1 1 Incorporated or Principal Place 4 4 (U.S. Government Not a Party) of Business In This State Citizen of Another State 2 2 Incorporated and Principal Place 5 5 2 U.S. Government Defendant 4 Diversity (Indicate Citizenship of Parties in Item III) of Business In Another State Citizen or Subject of a 3 3 Foreign Nation 6 6 Foreign Country

IV. NATURE OF SUIT (Place an “X” in One Box Only) CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES 110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure of 422 Appeal 28 USC § 158 375 False Claims Act Property 21 USC § 881 120 Marine 310 Airplane 365 Personal Injury – Product 423 Withdrawal 28 USC 376 Qui Tam (31 USC 690 Other § 157 § 3729(a)) 130 Miller Act 315 Airplane Product Liability Liability 400 State Reapportionment 140 Negotiable Instrument 320 Assault, Libel & Slander 367 Health Care/ LABOR PROPERTY RIGHTS Pharmaceutical Personal 410 Antitrust 150 Recovery of 330 Federal Employers’ 710 Fair Labor Standards Act 820 Copyrights Overpayment Of Injury Product Liability 430 Banks and Banking Liability 720 Labor/Management 830 Patent Veteran’s Benefits 368 Asbestos Personal Injury 450 Commerce 340 Marine Relations 835 PatentņAbbreviated New 151 Medicare Act Product Liability 345 Marine Product Liability 740 Railway Labor Act Drug Application 460 Deportation 152 Recovery of Defaulted PERSONAL PROPERTY 350 Motor Vehicle 751 Family and Medical 840 Trademark 470 Racketeer Influenced & Student Loans (Excludes 370 Other Fraud Leave Act Corrupt Organizations Veterans) 355 Motor Vehicle Product SOCIAL SECURITY Liability 371 Truth in Lending 790 Other Labor Litigation 480 Consumer Credit 153 Recovery of 380 Other Personal Property 861 HIA (1395ff) 490 Cable/Sat TV Overpayment 360 Other Personal Injury 791 Employee Retirement Damage Income Security Act 862 Black Lung (923) 850 Securities/Commodities/ of Veteran’s Benefits 362 Personal Injury -Medical Malpractice 385 Property Damage Product 863 DIWC/DIWW (405(g)) Exchange 160 Stockholders’ Suits IMMIGRATION Liability 864 SSID Title XVI 890 Other Statutory Actions 190 Other Contract 462 Naturalization CIVIL RIGHTS PRISONER PETITIONS 865 RSI (405(g)) 891 Agricultural Acts 195 Contract Product Liability Application 440 Other Civil Rights HABEAS CORPUS 893 Environmental Matters 196 Franchise 465 Other Immigration FEDERAL TAX SUITS 895 Freedom of Information 441 Voting 463 Alien Detainee Actions 870 Taxes (U.S. Plaintiff or REAL PROPERTY Act 442 Employment 510 Motions to Vacate Defendant) 896 Arbitration 210 Land Condemnation 443 Housing/ Sentence 871 IRS–Third Party 26 USC 220 Foreclosure Accommodations 530 General § 7609 899 Administrative Procedure Act/Review or Appeal of 230 Rent Lease & Ejectment 445 Amer. w/Disabilities– 535 Death Penalty Employment Agency Decision 240 Torts to Land OTHER 446 Amer. w/Disabilities–Other 950 Constitutionality of State 245 Tort Product Liability 540 Mandamus & Other Statutes 448 Education 290 All Other Real Property 550 Civil Rights 555 Prison Condition 560 Civil Detainee– Conditions of Confinement

V. ORIGIN (Place an “X” in One Box Only) 1 Original 2 Removed from 3 Remanded from 4 Reinstated or 5 Transferred from 6 Multidistrict 8 Multidistrict Proceeding State Court Appellate Court Reopened Another District (specify) Litigation–Transfer Litigation–Direct File

VI. CAUSE OF Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity): Administrative Procedure Act, 5 U.S.C. § 706(2) ACTION Brief description of cause: Plaintiffs seek an injunction and declaration that the regulation entitled Protecting Statutory Conscience Rights in Health Care is unlawful and unenforceable.

VII. REQUESTED IN CHECK IF THIS IS A CLASS ACTION DEMAND $ CHECK YES only if demanded in complaint: COMPLAINT: UNDER RULE 23, Fed. R. Civ. P. JURY DEMAND: Yes No VIII. RELATED CASE(S), JUDGE Spero DOCKET NUMBER IF ANY (See instructions): 3:19-cv-02405-JCS; 3:19-cv-02769-JCS IX. DIVISIONAL ASSIGNMENT (Civil Local Rule 3-2) (Place an “X” in One Box Only) SAN FRANCISCO/OAKLAND SAN JOSE EUREKA-MCKINLEYVILLE

DATE 05/28/2019 SIGNATURE OF ATTORNEY OF RECORD /s/ Lee Rubin Case 5:19-cv-02916 Document 1-2 Filed 05/28/19 Page 2 of 5

Civil Cover Sheet for County of Santa Clara, et al, v. U.S. Department of Health and Human Services and Alex M. Azar, II Attachment 1 Answer to Question 1(a) - Plaintiffs

County Of Santa Clara Trust Women Seattle Los Angeles LGBT Center Whitman-Walker Clinic, Inc. D/B/A Whitman-Walker Health Bradbury-Sullivan LGBT Community Center Center On Halsted Hartford Gyn Center, Mazzoni Center, Medical Students For Choice, AGLP: The Association Of LGBTQ+ Psychiatrists American Association Of Physicians For Human Rights D/B/A GLMA: Health Professionals Advancing LGBTQ Equality Colleen McNicholas Robert Bolan Ward Carpenter Sarah Henn Randy Pumphrey Case 5:19-cv-02916 Document 1-2 Filed 05/28/19 Page 3 of 5

Civil Cover Sheet for County of Santa Clara, et al, v. U.S. Department of Health and Human Services and Alex M. Azar, II Attachment 2 Answer to Question 1(c) - Attorneys for Plaintiffs

For Plaintiff County of Santa Clara:

James R. Williams Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900

Greta S. Hansen Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900

Laura S. Trice Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900

Mary E. Hanna-Weir Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900

Susan P. Greenberg Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900 Case 5:19-cv-02916 Document 1-2 Filed 05/28/19 Page 4 of 5

H. Luke Edwards Office of the County Counsel, County of Santa Clara 70 West Hedding Street, East Wing, 9th Floor San José, CA 95110-1770 Tel: (408) 299-5900

For Plaintiffs Other Than County of Santa Clara:

Richard Katskee Americans United for Separation of Church and State 1310 L Street NW, Suite 200 Washington, D.C. 20005 Tel: (202) 466-3234

Kenneth D. Upton, Jr. Americans United for Separation of Church and State 1310 L Street NW, Suite 200 Washington, D.C. 20005 Tel: (202) 466-3234

Genevieve Scott Center for Reproductive Rights 199 Water Street, 22nd Floor New York, NY 10038 Tel: (917) 637-3605

Rabia Muqaddam Center for Reproductive Rights 199 Water Street, 22nd Floor New York, NY 10038 Tel: (917) 637-3605

Christine Parker Center for Reproductive Rights 199 Water Street, 22nd Floor New York, NY 10038 Tel: (917) 637-3605

Jamie A. Gliksberg Lambda Legal Defense and Education Fund, Inc. 105 West Adams, 26th Floor Chicago, IL 60603-6208 Tel: (312) 663-4413 Case 5:19-cv-02916 Document 1-2 Filed 05/28/19 Page 5 of 5

Camilla B. Taylor Lambda Legal Defense and Education Fund, Inc. 105 West Adams, 26th Floor Chicago, IL 60603-6208 Tel: (312) 663-4413

Omar Gonzalez-Pagan Lambda Legal Defense and Education Fund, Inc. 120 Wall Street, 19th Floor New York, NY 10005-3919 Tel: (212) 809-8585

For Plaintiffs County of Santa Clara, Trust Women Seattle, LA LGBT Center, Whitman-Walker, Bradbury-Sullivan Center, Center on Halsted, Hartford Gyn Center, Mazzoni Center, Medical Students for Choice, AGLP, GLMA, Ward Carpenter, Sarah Henn and Randy Pumphrey:

Lee H. Rubin Mayer Brown LLP Two Palo Alto Square, Suite 300 3000 El Camino Real Palo Alto, CA 94306-2112 Tel: (650) 331-2000

Miriam R. Nemetz Mayer Brown LLP 1999 K Street, N.W. Washington, D.C. 20006-1101 Tel: (202) 263-3000

Nicole Saharsky Mayer Brown LLP 1999 K Street, N.W. Washington, D.C. 20006-1101 Tel: (202) 263-3000