Protecting Statutory Conscience Rights in Health Care; Delegations of Authority

Federal RegisterMay 21, 2019

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 88

RIN 0945-AA10

Protecting Statutory Conscience Rights in Health Care; Delegations of Authority

AGENCY:

Office for Civil Rights (OCR), Office of the Secretary, HHS.

ACTION:

Final rule.

SUMMARY:

The United States has a long history of providing protections in health care for individuals and entities on the basis of religious beliefs or moral convictions. Congress has passed many such laws applicable to the Department of Health and Human Services (“HHS” or the “Department”) and the programs or activities it funds or administers, some of which are the subject of existing HHS regulations. This final rule revises existing regulations to ensure vigorous enforcement of Federal conscience and anti-discrimination laws applicable to the Department, its programs, and recipients of HHS funds, and to delegate overall enforcement and compliance responsibility to the Department's Office for Civil Rights (“OCR”). In addition, this final rule clarifies OCR's authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by the Department and its components, and use enforcement tools otherwise available in existing regulations to address violations and resolve complaints. In order to ensure that recipients of Federal financial assistance and other Department funds comply with their legal obligations, this final rule requires certain recipients to maintain records; cooperate with OCR's investigations, reviews, or other proceedings; and submit written assurances and certifications of compliance to the Department. The final rule also encourages the recipients of HHS funds to provide notice to individuals and entities about their right to be free from coercion or discrimination on account of religious beliefs or moral convictions.

DATES:

This rule is effective July 22, 2019.

FOR FURTHER INFORMATION CONTACT:

Sarah Bayko Albrecht at (800) 368-1019 or (800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION:

Electronic Access

This

Federal Register

document is also available from the

Federal Register

online database through

http://www.govinfo.gov,

a service of the U.S. Government Publishing Office.

I. Background

This document adopts as final, with changes in response to public comments, a revised part 88, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority. This preamble to the final rule provides a brief background of the rule, summarizes the final rule provisions, and discusses in detail the comments received on the proposed rule.

83 FR 3880 (Jan. 26, 2018).

A. Statutory History

The freedoms of conscience and of religious exercise are foundational rights protected by the Constitution and numerous Federal statutes. Congress has acted to protect these freedoms with particular force in the health care context, and it is these laws that are the subject of this final rule. Specifically, this final rule concerns Federal laws that provide:

• Conscience protections related to abortion, sterilization, and certain other health services applicable to the Department of Health and Human Services and recipients of certain Federal funds encompassed by 42 U.S.C. 300a-7 (the “Church Amendments”);

• Conscience protections for health care entities related to abortion provision or training, referral for such abortion or training, or accreditation standards related to abortion (the “Coats-Snowe Amendment,” 42 U.S.C. 238n);

• Protections from discrimination for health care entities that do not provide, pay for, provide coverage of, or refer for abortions under programs funded by the Department's appropriations acts (

e.g.,

Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019, Div. B., sec. 507(d), Public Law 115-245, 132 Stat. 2981 (Sept. 28, 2018) (the “Weldon Amendment”);

id.,

sec. 209);

• Protections from discrimination under the Patient Protection and Affordable Care Act (“ACA”) for health care entities that do not provide any health care item or service furnished for the purpose of causing, or for the purpose of assisting in causing, the death of any individual, such as by assisted suicide, euthanasia, or mercy killing, applicable to the Federal Government and any State or local government that receives Federal financial assistance (42 U.S.C. 18113); and conscience protections for providers, organizations, or their employees regarding counseling regarding the same (42 U.S.C. 14406(1));

• Conscience protections regarding exemptions applicable to the ACA's individual mandate (26 U.S.C. 5000A; 42 U.S.C. 18081);

• Conscience protections under the ACA for qualified health plans related to coverage of abortion, and for individual health care providers and health care facilities that do not provide, pay for, provide coverage of, or refer for abortions (42 U.S.C. 18023(b)(1)(A) and (b)(4));

• Conscience protections for Medicare Advantage organizations and Medicaid managed care organizations with moral or religious objections to counseling or referral for certain services (42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B));

• Conscience protections related to the performance of advanced directives (42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406(2));

• Conscience and nondiscrimination protections for organizations related to Global Health Programs, to the extent such funds are administered by the Secretary of HHS (the “Secretary”) (22 U.S.C. 7631(d));

• Conscience protections attached to Federal funding, to the extent such funding is administered by the Secretary, regarding abortion and involuntarily sterilization (22 U.S.C. 2151b(f),

see, e.g.,

the Consolidated Appropriations Act, 2019, Pub. L. 116-6, Div. F, sec. 7018 (the “Helms, Biden, 1978, and 1985 Amendments”));

• Conscience protections from compulsory health care or services generally (42 U.S.C. 1396f and 5106i(a)), and under specific programs for hearing screening (42 U.S.C. 280g-1(d)), occupational illness testing (29 U.S.C. 669(a)(5)); vaccination (42 U.S.C. 1396s(c)(2)(B)(ii)), and mental health treatment (42 U.S.C. 290bb-36(f)); and

• Protections for religious nonmedical health care providers and their patients from certain requirements under Medicare and Medicaid that may burden their exercise of their religious beliefs regarding medical treatment (

e.g.,

42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395x(e), 1395x(y)(1), 1396a(a), and 1397j-1(b)).

For purposes of this final rule, these laws will be collectively referred to as “Federal conscience and anti-discrimination laws.”

Congress has recognized that modern health care practices may give rise to conflicts with the religious beliefs and moral convictions of payers, providers, and patients alike. The existence of

moral and ethical objections on the part of health care clinicians about participating in, assisting with, referring for, or otherwise being complicit in certain procedures is well documented by ethicists.

Religious institutions and entities, too, have expressed objections to the provision of or participation in insurance coverage for certain procedures or services, such as abortion, sterilization, and assisted suicide. To address these problems, Congress has repeatedly legislated conscience protections for individuals and institutions providing health care to the American public, as outlined below.

See, e.g.,

Farr A. Curlin M.D., et al.,

Religion, Conscience, and Controversial Clinical Practices,

New Eng. J. Med. 593-600 (2007); Stephen J. Genuis & Chris Lipp,

Ethical Diversity and the Role of Conscience in Clinical Medicine,

2013 Int'l. J. Family Med. 1, 9 (2013); Harris, et al.,

Obstetrician-Gynecologists' Objections to and Willingness to Help Patients Obtain an Abortion

118 Obstet. & Gyn. 905 (2011); Armand H. Matheny Antommaria,

Adjudicating Rights or Analyzing Interests: Ethicists' Role in the Debate Over Conscience in Clinical Practice,

29 Theor. Med. Bioeth. 201, 206 (2008); William W. Bassett,

Private Religious Hospitals: Limitations Upon Autonomous Moral Choices in Reproductive Medicine,

17 J. Contemp. Health L. & Pol'y 455, 529 (2001); Peter A. Clark,

Medical Ethics at Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty,

34 J.L. Med. & Ethics 570 (2006).

The Church Amendments.

The Church Amendments were enacted at various times during the 1970s in response to debates over whether judicially recognized rights to abortions, sterilizations, or related practices might lead to the requirement that individuals or entities participate in activities to which they have religious or moral objections. The Church Amendments consist of five provisions, codified at 42 U.S.C. 300a-7, that protect those who hold religious beliefs or moral convictions regarding certain health care procedures from discrimination by entities that receive certain Federal funds, and in health service programs and research activities funded by HHS. Notably, the Church Amendments contain provisions explicitly protecting the rights of both individuals and entities.

First, paragraph (b) of the Church Amendments provides, with regard to individuals, that no court, public official, or other public authority can use an individual's receipt of certain Federal funding as grounds to require the individual to perform, or assist in, sterilization procedures or abortions, if doing so would be contrary to his or her religious beliefs or moral convictions. 42 U.S.C. 300a-7(b)(1). Paragraph (b) further prohibits those public authorities from requiring an entity, based on the entity's receipt of Federal funds under certain HHS programs, (1) to permit sterilizations or abortions in the entity's facilities if the performance of such procedures there violates the entity's religious beliefs or moral convictions, or (2) to make its personnel available for such procedures if contrary to the personnel's religious beliefs or moral convictions. 42 U.S.C. 300a-7(b)(2). The individuals and entities protected by this provision are recipients of grants, contracts, loans, or loan guarantees under the Public Health Service Act (42 U.S.C. 201

et seq.

), and those entities' personnel.

The Church Amendments also reference the Community Mental Health Centers Act, Public Law 88-164, 77 Stat. 282 (1963), and the Developmental Disabilities Services and Facilities Construction Amendments of 1970, Public Law 91-517, 84 Stat. 1316 (1970). However, those statutes were repealed by subsequent statute and, accordingly, are not referenced here.

Second, paragraph (c)(1) of the Church Amendments applies to decisions on employment, promotion, or termination of employment, as well as extension of staff or other privileges with respect to physicians and other health care personnel. 42 U.S.C. 300a-7(c)(1). This paragraph prohibits certain entities from discriminating in these decisions based on an individual declining to perform or assist in an abortion or sterilization because of that individual's religious beliefs or moral convictions. 42 U.S.C. 300a-7(c)(1). It also prohibits those entities from discriminating in such decisions based on an individual's performance of a lawful abortion or sterilization procedure, or on an individual's religious beliefs or moral convictions about such procedures more generally.

Id.

Like paragraph (b), any recipients of a grant, contract, loan, or loan guarantee under the Public Health Service Act must comply with paragraph (c)(1).

Third, paragraph (c)(2) of the Church Amendments applies to the recipients of the Department's grants or contracts for biomedical or behavioral research under any program administered by the Secretary. 42 U.S.C. 300a-7(c)(2). This paragraph prohibits discrimination by such entity against physicians or other health care personnel in employment, promotion, or termination of employment, as well as discrimination in the extension of staff or other privileges, because of an individual's performance or assistance in any lawful health service or research activity, declining to perform or assist in any such service or activity based on religious beliefs or moral convictions, or the individual's religious beliefs or moral convictions respecting such services or activities more generally. 42 U.S.C. 300a-7(c)(2).

Fourth, paragraph (d) of the Church Amendments applies to any part of a health service program or research activity funded in whole or in part under a program administered by the Secretary. For these health service programs or research activities, no individual shall be required to perform or assist in the performance of any part of the program or research activity if doing so would be contrary to his or her religious beliefs or moral convictions. 42 U.S.C. 300a-7(d).

Fifth, paragraph (e) of the Church Amendments applies to health care training or study programs, including internships and residencies. Paragraph (e) prohibits any entity receiving certain funds from denying admission to, or otherwise discriminating against, applicants for training or study based on the applicant's reluctance or willingness to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to, or consistent with, the applicant's religious beliefs or moral convictions. 42 U.S.C. 300a-7(e). Any recipient of a grant, contract, loan, loan guarantee, or interest subsidy under the Public Health Service Act or the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001

et seq.

) must comply with paragraph (e).

The Coats-Snowe Amendment.

Enacted in 1996, section 245 of the Public Health Service Act (also known as the “Coats-Snowe Amendment” or “Coats-Snowe”) applies nondiscrimination requirements to the Federal government, and to State or local governments receiving Federal financial assistance. 42 U.S.C. 238n. Such governments may not discriminate against any health care entity that refuses to undergo training in, require or provide training in, or perform abortions; refer for abortions or abortion training; or make arrangements for any of those activities. 42 U.S.C. 238n(a)(1)-(2). Furthermore, those governments may not discriminate against a health care entity because the entity attends or attended a health care training program that does not (or did not) perform abortions; require, provide, or refer for training in the performance of abortions; or make arrangements for any such training. 42 U.S.C. 238n(a)(3). The law defines the term “health care entity” as including (and, therefore, not limited to) an individual physician, a postgraduate physician training program, and a participant in a program of training in the health professions. 42 U.S.C. 238n(c)(2).

In addition, Coats-Snowe applies to accreditation of postgraduate physician training programs. Therefore, the Federal government, and State or local governments receiving Federal financial assistance, may not deny a legal status (including a license or certificate) or financial assistance, services, or other benefits to a health care entity based on an applicable physician training program's lack of accreditation due to the accrediting agency's requirements that a health care entity perform induced abortions; require, provide, or refer for training in the performance of induced abortions; or make arrangements for such training, regardless of whether such standard provides exceptions or exemptions. 42 U.S.C. 238n(b)(1). Additionally, the statute requires the government involved to formulate regulations or other mechanisms, or enter into agreements with accrediting agencies, as are necessary to comply with this accreditation provision of Coats-Snowe.

Id.

The Weldon Amendment.

The Weldon Amendment (or “Weldon”) was originally adopted in 2004 and has been readopted (or incorporated by reference) in each subsequent appropriations act for the Departments of Labor, Health and Human Services, and Education.

See, e.g.,

Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing Appropriations Act, 2019, Public Law 115-245, Div. B., sec. 507(d). Weldon provides that none of the funds made available in the applicable Labor, HHS, and Education appropriations act be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions.

E.g.,

Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing Appropriations Act, 2019, Public Law 115-245, Div. B., sec. 507(d). Weldon states that the term “health care entity” includes an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.

Id.

Conditions on Federally Appropriated Funds Requiring Compliance with Federal Conscience and Anti-Discrimination Laws.

In addition to Weldon, current appropriations acts include other health care conscience protections. For example, one provision, using language similar to the Weldon Amendment, prohibits the Department from denying participation in Medicare Advantage to an otherwise eligible entity, such as a provider-sponsored organization, because the entity informs the Secretary it will not provide, pay for, provide coverage of, or provide referrals for abortions. Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019, Public Law 115-245, Div. B, sec. 209, 132 Stat. 2981.

The Patient Protection and Affordable Care Act's Conscience and Associated Anti-Discrimination Protections.

Passed in 2010, the Patient Protection and Affordable Care Act (ACA) also includes several conscience and associated anti-discrimination protections.

Section 1553 of the ACA prohibits the Federal government, and any State or local government or health care provider that receives Federal financial assistance under the ACA, or any ACA health plans, from discriminating against an individual or institutional health care entity because of the individual or entity's objection to providing any health care items or service for the purpose of causing or assisting in causing death, such as by assisted suicide, euthanasia, or mercy killing. 42 U.S.C. 18113. Section 1553 designates OCR to receive complaints of discrimination on that basis.

Id.

Section 1303 declares that the ACA does not require health plans to provide coverage of abortion services as part of “essential health benefits for any plan year.” 42 U.S.C. 18023(b)(1)(A). Furthermore, no qualified health plan offered through an ACA exchange may discriminate against any individual health care provider or health care facility because of the facility or provider's unwillingness to provide, pay for, provide coverage of, or refer for abortions. 42 U.S.C. 18023(b)(4). And section 1303 of the ACA makes clear that nothing in that Act should be construed to undermine Federal laws regarding—(i) conscience protection; (ii) willingness or refusal to provide abortion; and (iii) discrimination on the basis of the willingness or refusal to provide, pay for, cover, or refer for abortion or to provide or participate in training to provide abortion. 42 U.S.C. 18023(c)(2)(A)(i)-(iii). Qualified health plans, as defined under 42 U.S.C. 18021, offered on any Exchange created under the ACA, are required to comply with § 88.3(f)(2)(i) and (ii), which faithfully applies the plain text of section 1303 of the ACA. 42 U.S.C. 18023.

Finally, under section 1411 of the ACA, 42 U.S.C. 18081, HHS is responsible for issuing certifications to individuals who are entitled to an exemption from the individual responsibility requirement imposed under Internal Revenue Code sec. 5000A, including when such individuals are exempt based on a hardship (such as the inability to secure affordable coverage without abortion),

are members of an exempt religious organization or division,

or participate in a “health care sharing ministry.”

See also

U.S. Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Services (Nov. 17, 2009) (identifying Catholic objections to performing abortions, tubal ligations, and hysterectomies).

In 2016, the American Congress of Obstetricians and Gynecologists (ACOG) reaffirmed a prior ethics opinion that recommended, “Physicians and other health care professionals have the duty to refer patients in a timely manner to other providers if they do not feel that they can in conscience provide the standard reproductive services that their patients request,” and “In resource-poor areas . . . [p]roviders with moral or religious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place so that patients have access to the service that the physician does not wish to provide.”

https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Ethics/The-Limits-of-Conscientious-Refusal-in-Reproductive-Medicine

(reaffirming ACOG, “The Limits of Conscientious Refusal in Medicine,” Committee Opinion No. 385, 110 Obstet Gyn. 1479 (2007)) The 2007 ACOG opinion had, at least in part, prompted the 2008 Rule. Then-HHS Secretary Leavitt wrote to ACOG and the American Board of Obstetrics and Gynecology (ABOG) and noted that the interaction between the ACOG opinion and ABOG certification requirements could constitute a violation of Federal conscience and anti-discrimination laws.

Public comments received on the proposed rule published in January 2018 shared additional anecdotes of coercion, discriminatory conduct, or other actions potentially in violation of Federal conscience and anti-discrimination laws. Commenters also shared their assessments of the knowledge, or lack thereof, among the general public, health care field, health care insurance industry, and employment law field of the rights and obligations that this rule implements and enforces. Examples are detailed in the Regulatory Impact Analysis as part of the Department's analysis under Executive Orders 12,866 and 13,563 regarding the need for this rule.

Recently Enacted State and Local Government Health Care Laws and Policies Have Resulted in Numerous Lawsuits by Conscientious Objectors.

The Department has also witnessed an increase in lawsuits against State and local laws that plaintiffs allege violate conscience or unlawfully discriminate. For example, many State and local governments have enacted legislation requiring health care providers offering pregnancy resources as an alternative to abortion to post notices related to abortion, to which plaintiffs objected on First Amendment and analogous grounds. The Supreme Court held that California's version of such a law likely violated the First Amendment free speech rights of centers that object to abortion in

National Institute of Family and Life Advocates

Becerra,

No. 16-1140, 585 U.S. __, 138 S. Ct. 2361 (Jun. 26, 2018) (“

NIFLA”

On January 18, 2019, OCR issued a Notice of Violation to the State of California for OCR Complaint Nos. 16-224756 and 18-292848, finding that California's version of such a law violated the

Weldon and Coats-Snowe Amendments, as discussed

infra.

Courts have also enjoined similar ordinances in New York City; Austin, Texas; Montgomery County, Maryland; Baltimore, Maryland; Illinois; and Hawaii.

Greater Baltimore Center for Pregnancy Concerns, Inc.

Mayor and City Council of Baltimore,

879 F.3d 101, 105 (4th Cir. 2018),

cert. denied,

138 S. Ct. 2710, (2018) (holding that Baltimore ordinance requiring pregnancy resource center to State abortion services are not available in their facilities violated the Free Speech Clause);

Evergreen Ass'n, Inc.

City of New York,

740 F.3d 233 (2d Cir. 2014) (affirming an injunction, based on the First Amendment, of ordinance provisions requiring disclosures about whether pregnancy resource centers refer for abortion and conveying city health department's recommendation to consult a licensed medical provider);

Austin LifeCare

City of Austin,

No. 1:11-cv-00875-LY (W.D. Tex. Jun. 23, 2014) (permanently enjoining enforcement of ordinance as void for vagueness);

Centro Tepeyac

Montgomery County,

5 F. Supp. 3d 745 (D. Md. Mar. 7, 2014) (applying strict scrutiny in finding that ordinance violated pregnancy resource center's First Amendment rights);

Pregnancy Care Center of Rockford

Rauner,

No. 2016-MR-741 (Ill. 17th Jud. Cir. Dec. 20, 2016) (preliminary injunction entered on free speech grounds);

Prelim. Inj., Nat'l Instit. of Family and Life Advocates

Rauner,

No. 3:16-cv-50310 (N.D. Ill. Sept. 29, 2016) (preliminary injunction entered on free speech grounds);

Calvary Chapel Pearl Harbor

Chin,

No. 1:17-cv-00326-DKW-KSC (D. Haw. Sept. 20, 2018) (permanent injunction and final judgment).

Before

NIFLA,

several courts had rejected challenges to California's law.

See, e.g., Mountain Right to Life

Harris,

No. 5:16-cv-00119 (C.D. Cal. July 8, 2016) (denying preliminary injunction);

A Woman's Friend Pregnancy Resource Clinic

Harris,

153 F. Supp. 3d 1168 (E.D. Cal. Dec. 21, 2015);

Livingwell Medical Clinic

Harris,

No. 3:15-cv-04939, 2015 WL 13187682 (N.D. Cal. Dec. 18, 2015).

Some of the plaintiffs in these lawsuits also filed complaints with OCR alleging that the State laws violate the Weldon, Coats-Snowe, and/or Church Amendments. Complaints filed with OCR against the State of California, alleging California's Reproductive Freedom, Accountability, Comprehensive Care, and Transparency Act (FACT Act) (Cal. Health & Safety Code Ann. sections 123470,

et seq.

) violated Federal conscience and anti-discrimination laws, were recently resolved with a finding by OCR that the State of California violated the Weldon and Coats-Snowe Amendments.

OCR determined that “California's enactment of the FACT Act violate[d] the Weldon and Coats-Snowe Amendments by discriminating against health care entities that object to referring for, or making arrangements for, abortion.”

Letter from Roger T. Severino, Dir., Dep't of Health & Human Serv's. Office for Civil Rights, to Xavier Becerra, Att'y. Gen., State of Cal. (Jan. 18, 2019),

available at https://www.hhs.gov/sites/default/files/california-notice-of-violation.pdf.

Id. at

Complaints filed with OCR against the State of Hawaii, alleging Hawaii Revised Statute section 321-561(b)-(c) violated Federal conscience and anti-discrimination laws, were recently satisfactorily resolved when Hawaii Attorney General Clare E. Connors issued a Memorandum to the Department of the Attorney General for the State of Hawaii stating, “the Department will not enforce section 321-561(b)-(c), HRS, against any limited service pregnancy centers, as defined in section 321-561(a), HRS;” the memorandum also stated that it “shall remain in effect indefinitely or until such time as there is a change in the laws discussed above warranting reconsideration.”

In her letter to OCR regarding the Memorandum, Attorney General Connors also said that “the Department will advise the Hawai'i Legislature of its decision not to enforce section 321-561(b)-(c), HRS, against any limited service pregnancy center.”

Attorney General Connors took appropriate corrective action in Hawaii to assure current and future compliance with the Weldon and Coats-Snowe Amendments, as they apply to Hawaii Revised Statute section 321-561(b)-(c), and the complaints regarding this provision were resolved without having to find Hawaii in violation of Federal conscience and anti-discrimination laws.

Memorandum from Haw. Att'y. Gen. Clare E. Connors to the Dep't. of the Att'y. Gen., State of Haw. 2 (Mar. 15, 2019) (on file with HHS OCR).

Letter from Haw. Att'y. Gen. Clare E. Connors, to Luis E. Perez, Deputy Dir. of the Conscience & Religious Freedom Div., Office for Civil Rights, U.S. Dep't of Health & Human Servs. (Mar. 15, 2019) (on file with HHS OCR).

Letter from Roger T. Severino, Dir., Dep't of Health & Human Serv's. Office for Civil Rights, to Clare E. Connors, Att'y. Gen., State of Haw. (Mar. 21, 2019),

available at https://www.hhs.gov/sites/default/files/hawaii-ocr-notice-of-resolution-final.pdf.

Some States have also sought to require health insurance plans to cover abortions, triggering additional conscience-related lawsuits. California, for example, sent a letter to seven insurance companies seeking to enforce a California legal requirement that the insurers include abortion coverage in plans used by persons who objected to such coverage.

See

Letter from California Department of Managed Health Care,

Re: Limitations or Exclusions of Abortion Services

(Aug. 22, 2014) (interpreting State statutes, regulations, and court decisions).

The State of California estimates that at least 28,000 individuals subsequently lost their abortion-free health plans, and houses of worship have challenged California's policy in court.

See Foothill Church

Rouillard,

2:15-cv-02165-KJM-EFB, 2016 WL 3688422 (E.D. Cal. July 11, 2016);

Skyline Wesleyan Church

California Department of Managed Health Care,

No. 3:16-cv-00501-H-DHB (S.D. Cal. 2016). The New York State Department of Financial Services has similarly sought to require individual and small group employers, regardless of the number of employees or any religious affiliation, to provide insurance coverage for abortions, prompting additional lawsuits.

See, e.g., Roman Catholic Diocese of Albany

Vullo,

No. 02070-16 (N.Y. Albany County Sup. Ct. May 4, 2016).

https://www.dmhc.ca.gov/Portals/0/082214letters/abc082214.pdf.

Over the past several years, an increasing number of jurisdictions in the United States have legalized assisted suicide.

See

District of Columbia B21-0038 (Feb. 18, 2017), Colorado Prop. 106 (Dec. 16, 2016); California ABX2-15 (June 9, 2016); 18 Vermont Act 39 (May 20, 2013) (“Act 39”). In Vermont, for example, Act 39 states that health care professionals must inform patients “of all available options related to terminal care.” 18 Vt. Stat. Ann. section 5282. When the Vermont Department of Health construed Act 39 to require all health care professionals to counsel for assisted suicide, individual health care professionals and associations of religious health care providers sued Vermont, alleging a violation of their conscience rights. Compl.,

Vermont Alliance for Ethical Health Care, Inc.

Hoser,

No. 5:16-cv-205 (D. Vt. Apr. 5, 2017) (dismissed by consent agreement). More recently still, the family of a California cancer patient sued UCSF Medical Center for alleged elder abuse because the cancer patient died after the oncologists on staff declined to participate in assisted suicide, but before she could obtain a new physician.

Bob Egelko,

California's assisted-dying loophole: Some doctors won't help patients die,

San

Francisco Chronicle (Aug. 12, 2017),

http://www.sfchronicle.com/news/article/California-s-assisted-dying-loophole-Some-11761312.php.

Finally, some States have passed laws appearing to require health care professionals to provide referrals for implementation of advance directives without accommodation for religious belief or moral conviction.

See

Iowa Code Ann. section 144D.3(5) (2012) (requiring that providers take “all reasonable steps to transfer the patient to another health care provider, hospital, or health care facility” even when there is an objection based on “religious beliefs, or moral convictions”); Idaho Code Ann. 39-4513(2) (2012) (requiring that a provider “make[ ] a good faith effort to assist the person in obtaining the services of another physician or other health care provider who is willing to provide care for the person in accordance with the person's expressed or documented wishes”).

Since the Department issued the proposed Conscience Rule in 2018, OCR issued a Notice of Violation to the State of California for OCR Complaint Nos. 16-224756 and 18-292848, finding that California's FACT Act violated the Weldon and Coats-Snowe Amendments, as discussed

supra.

Beyond this finding, in this final rule, the Department does not opine on or judge the legal merits or sufficiency of any of the above-cited lawsuits or challenged laws. They are discussed here to illustrate a notable number of disputes about alleged violations of health care conscience, broadly understood, by State and local governments. They also illustrate the need for greater clarity concerning the scope and operation of the Federal conscience and anti-discrimination laws that are the subject of this final rule. The Department anticipates that this final rule will result in greater public familiarity with Federal conscience and anti-discrimination laws, and may inform both State and local governments and health care institutions of their obligations, and individual and institutional health care entities of their rights, under those laws.

Confusion Exists About the Scope and Applicability of Federal Conscience and Anti-Discrimination Laws.

Even though Federal conscience and anti-discrimination laws are currently in effect, the public has sometimes been confused about their applicability in relation to other Federal, State, or local laws. One of the purposes of the 2008 Rule was to address confusion about the interaction between Federal conscience and anti-discrimination laws and other Federal statutes.

For instance, some advocacy organizations have filed lawsuits claiming that Federal or State laws require private religious entities to perform abortions and sterilizations despite the existence of longstanding conscience and anti-discrimination protections on this topic. S

ee Means

U.S. Conference of Catholic Bishops,

No. 1:15-CV-353, 2015 WL 3970046 (W.D. Mich. 2015) (abortion);

ACLU

Trinity Health Corp.,

178 F.Supp.3d 614 (E.D. Mich. 2016) (abortion);

Minton

Dignity Health,

No. 17-558259 (Cal. Super. Ct. Apr. 19, 2017) (hysterectomy);

Chamorro

Dignity Health,

No. 15-549626 (Cal. Super. Ct. Dec. 28, 2015) (tubal ligation). A patient also sued a secular public hospital for accommodating doctors' and nurses' religious objections to abortion in alleged violation of a State law, Washington's Reproductive Privacy Act.

Coffey

Pub. Hosp. Dist. No. 1,

20-15-2-00217-4 (Wash. 2015).

Congress has exercised the broad authority afforded to it under the Spending Clause to attach conditions on Federal funds to protect conscience rights. Such conditions override conflicting provisions of State law for States that accept the conditioned funds according to the terms of the statutes applicable to such funding streams. States have long been able to harmonize and comply with other “cross-cutting” anti-discrimination laws imposed through such conditions on Federal financial assistance.

See, e.g.,

Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d

et seq.,

and Title IX of the Education Amendments of 1972, 20 U.S.C. 1681

et seq.

The Department seeks to clarify the scope and application of Federal conscience and anti-discrimination laws in this final rule as it has with other anti-discrimination laws.

See

45 CFR part 80 (Title VI) and part 86 (Title IX).

Courts Have Found No Alternative Private Right of Action to Remedy Violations.

The government, rather than private parties, has the central role in enforcement of Federal conscience and anti-discrimination laws. In lawsuits filed by health care providers for alleged violations of certain of these laws, courts have generally held that such laws do not contain, or imply, a private right of action to seek relief from such violations by non-governmental covered entities. Thus, adequate governmental enforcement mechanisms are critical to the enforcement of these laws.

The case of a New York nurse who alleged that a private hospital forced her to assist in an abortion over her religious objections illustrates the point. The nurse filed a lawsuit in Federal court in 2009, but her case was dismissed on the ground that she did not have a private right to file a civil action against such a hospital under the Church Amendments.

Cenzon-DeCarlo

Mount Sinai Hospital,

626 F.3d 695 (2d Cir. 2010). The Second Circuit affirmed the dismissal, holding that the Church Amendments “may be a statute in which Congress conferred an individual right,” but that Congress

had not implied a remedy

to file suit against private entities in Federal court.

Id.

at 698-99. After the dismissal of the Federal lawsuit, the nurse then filed a case in State court, but that case too was dismissed for lack of a private right of action.

Cenzon-DeCarlo

Mount Sinai Hosp.,

962 N.Y.S.2d 845 (Sup. Ct. Kings County 2010),

aff'd by

957 N.Y.S.2d 256 (App. Div. 2012). The nurse then filed a complaint with OCR on January 1, 2011, and OCR resolved the complaint after the hospital changed its written policy for health care professionals.

Similar results occurred in a Federal lawsuit brought by a nurse in 2014, alleging that a health center had violated the Church Amendments when it denied her the ability to apply for a position as a nurse because she objected to prescribing abortifacients.

Hellwege

Tampa Family Health Centers,

103 F. Supp. 3d 1303 (M.D. Fla. 2015). Like the court in New York, the court held that the Church Amendments “recognize important individual rights” but do not confer a remedy to bring suit against a private entity in Federal court.

Id.

at 1310. More recently, a Federal district court in Illinois held that there is no private right of action for a doctor who alleges that the State required her to refer for abortions in violation of the Coats-Snowe Amendment. Order at 4,

Nat'l Instit. of Family and Life Advocates,

Rauner,

No. 3:16-cv-50310 (N.D. Ill. July 19, 2017), ECF No. 65.

In light of these decisions and the increase in conscience-based challenges to State and local laws in the health care context, OCR has a singular and critical responsibility to provide clear and appropriate interpretation of Federal conscience and anti-discrimination laws, to engage in outreach to protected parties and covered entities, to conduct compliance reviews, to investigate alleged violations, and to vigorously enforce those laws.

Addressing Confusion Caused by OCR Sub-Regulatory Guidance.

This final rule also resolves confusion caused by sub-regulatory guidance issued through OCR's high-profile closure of three Weldon Amendment complaints against

the State of California filed in 2014.

On June 21, 2016, OCR declared it found no violation stemming from California's policy requiring that health insurance plans include coverage for abortion based on the facts alleged in the three complaints it had received.

OCR's closure letter concluded that the Weldon Amendment's protection of health insurance plans included issuers of health insurance plans but not institutions or individuals who purchase or are insured by those plans. Even though California's policy resulted in complainants losing abortion-free insurance that was consistent with their beliefs and that insurers were willing to provide, the letter concluded that none qualified as an entity or person protected under the Weldon Amendment because none was an insurance issuer. Relying on an interpretation of legislative history, instead of the Weldon Amendment's text, OCR also declared that health care entities are not protected under Weldon unless they possess a “religious or moral objection to abortion,” and concluded that the insurance issuers at issue did not merit protection because they had not raised any religious or moral objections. Finally, OCR called into question its ability to enforce the Weldon Amendment against a State

at all

because, according to the letter, to do so could “potentially” require the revocation of Federal funds to California in such a magnitude as to violate State sovereignty and constitute a violation of the Constitution.

OCR Complaint Nos. 14-193604, 15-193782, and 15-195665.

Letter from OCR Director to Complainants (June 21, 2016)

available at http://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf.

In reaching this conclusion, the letter cited advice from “HHS' Office of General Counsel, after consulting with the Department of Justice,” but HHS has not located any written legal analysis from either the HHS Office of the General Counsel or the Department of Justice despite a diligent search.

The Department does not opine upon, and has not yet made a judgment on, the compatibility of California's policy with the Weldon Amendment. But clarification is in order with respect to the general interpretations of the Weldon Amendment offered in OCR's closure of complaints against California's abortion coverage requirement. The Department has engaged in further consideration of this general matter and has also further reviewed Federal conscience and anti-discrimination laws, their legislative history, and the record of rulemaking and public comments. Based on this review, the Department indicated, in the preamble to the proposed rule, that the above-mentioned sub-regulatory guidance issued by OCR with respect to interpretation of the Weldon Amendment no longer reflects the Department's position on, and interpretation of, the Weldon Amendment. The Department continues to hold the views it expressed on that issue in the preamble to the proposed rule,

see

83 FR at 3890-91, and has reflected those views in its analysis contained in the Notice of Violation to the State of California for OCR Complaint Nos. 16-224756 and 18-292848, discussed

supra,

in which OCR discussed the rationale behind its determination that “California's enactment of the FACT Act violate[d] the Weldon . . . Amendment[ ] by discriminating against health care entities that object to referring for, or making arrangements for, abortion.”

Letter from Roger T. Severino, Dir., Dep't of Health & Human Serv's. Office for Civil Rights, to Xavier Becerra, Att'y. Gen., State of Cal.,

at 9

(Jan. 18, 2019),

available at https://www.hhs.gov/sites/default/files/california-notice-of-violation.pdf.

The Department is concerned that segments of the public have been dissuaded from complaining about religious discrimination in the health care setting to OCR as the result, at least in part, of these unduly narrow interpretations of the Weldon Amendment. For example, Foothill Church, located in Glen Morrow, California, expressed concern that filing a complaint with OCR about California's abortion-coverage requirement was pointless because the Department had already closed three similar complaints, finding no violation of Federal conscience and anti-discrimination laws.

See Foothill Church

Rouillard,

No. 2:15-cv-02165-KJM-EFB, 2016 WL 3688422 (E.D. Cal. July 11, 2016).

With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no longer reflect the views of the Department.

Additional Federal Conscience and Anti-Discrimination Laws.

Finally, in addition to all of the concerns discussed above, the Department is using this rulemaking to address various other conscience protection and anti-discrimination laws not discussed in the 2008 and 2011 Rules. Some of these provisions were enacted after 2008. All provide additional protections, such as for health care providers and patients, from coercion and discrimination including that stemming from moral convictions or religious beliefs.

B. Structure of the Final Rule

This final rule generally reinstates the structure of the 2008 Rule, includes further definitions of terms, and provides robust certification and enforcement provisions comparable to provisions found in OCR's other civil rights regulations.This final rule also encourages certain recipients of Federal financial assistance from the Department or of Federal funds from the Department to notify individuals and entities protected under Federal conscience and anti-discrimination laws (such as employees, applicants, or students) of their Federal conscience rights. In addition, this final rule requires certain such entities to assure and certify to the Department their compliance with the requirements of these laws. It also sets forth in more detail the investigative and enforcement responsibility of OCR, along with the tools at OCR's disposal for carrying out its responsibility with respect to these laws.

Congress has imposed obligations on the Department and funding recipients through these statutes, and the Department is, therefore, required to ensure its own compliance and the compliance of its funding recipients. In 2008 and 2011, the Secretary delegated to OCR the authority to receive complaints of discrimination under the Church, Coats-Snowe, and Weldon Amendments, in coordination with Department components that provide Federal financial assistance. Congress later designated OCR as responsible for receiving complaints under section 1553 of the ACA. Many of the remaining statutes that are the subject of the proposed rule do not have any implementing regulations. To the extent not already delegated to OCR, the Secretary is, therefore, delegating to OCR enforcement authority—that is, the authority to receive complaints, and, in consultation and coordination with the funding components of the Department, investigate alleged violations and take appropriate enforcement action—over those additional Federal statutes as well as the statutes covered by the 2008 and 2011 Rules.

The compliance and enforcement sections specify in much greater detail than either the 2008 Rule or 2011 Rule how OCR will, in consultation and coordination with HHS funding components, enforce the Federal conscience and anti-discrimination laws. Implementation of the requirements set forth in this final rule

will be conducted in the same way that OCR implements other civil rights requirements (such as the prohibition of discrimination on the basis of race, color, or national origin), which includes outreach, investigation, compliance, technical assistance, and enforcement practices. Enforcement will be based on complaints, referrals, and other information OCR may receive about potential violations, such as news reports and OCR-initiated compliance reviews and communications activities if facts suffice to support an investigation. If OCR becomes aware of a potential violation of Federal conscience and anti-discrimination laws, OCR will investigate, in coordination with the Department component providing Federal financial assistance or Federal funds to the investigated entity. If OCR concludes an entity is not in compliance, OCR, in consultation and coordination with the Department funding component(s), will assist covered entities with corrective action or compliance, or require violators to come into compliance. If, despite the Department's assistance, corrective action is not satisfactory or compliance is not achieved, OCR, in coordination with the funding component, may consider all legal options available to the Department, to overcome the effects of such discrimination or violations. Enforcement mechanisms where voluntary resolution cannot be reached include termination of relevant funding, either in whole or in part, funding claw backs to the extent permitted by law, voluntary resolution agreements, referral to the Department of Justice (in consultation and coordination with the Department's Office of the General Counsel), or other measures, as set forth in applicable regulations, procedures, and funding instruments. This final rule clarifies that recipients are responsible for their own compliance with Federal conscience and anti-discrimination laws and implementing regulations, as well as for ensuring their sub-recipients comply with these laws. This final rule also clarifies that parties subject to OCR investigation have a duty to cooperate and preserve documents and to report to their Department funding component(s) if they are subject to a determination by OCR of noncompliance. Finally, this final rule specifies that OCR may remedy claims of intimidation and retaliation against those who file a complaint or assist in an OCR investigation.

III. Analysis and Response to Public Comments on the Proposed Rule

HHS received over 242,000 comments in response to the notice of proposed rulemaking (NPRM).

HHS considered all comments filed in accordance with the Administrative Procedure Act and the instructions provided in the NPRM published in the

Federal Register

on January 26, 2018.

The comments are available at

https://www.regulations.gov/docket?D=HHS-OCR-2018-0002.

While

Regulations.gov

shows 72,417 public submissions were received, many comment submissions attached hundreds or thousands of individual comments, resulting in over 242,000 actual comments.

The Department's evaluation of the comments led to a number of changes between the NPRM and this final rule. The public comments and the changes made in issuing this final rule are discussed below.

A. General Comments

The Department received many comments on the proposed rule that expressed general support or opposition and did not include substantive or technical commentary upon the rule.

Comment:

The Department received comments expressing concern about the impact of the rule on access to care in rural communities, underprivileged communities, or other communities that are primarily served by religious healthcare providers or facilities.

Response:

Access to care is a critical concern of the Department. The Department does not believe this rule will harm access to care. When the Department promulgated the 2008 Rule protecting conscience rights in health care, it addressed comments about the rule's impact on access to care.

In that response, the Department stated that the regulation did not expand the scope of existing Federal conscience and anti-discrimination laws, and noted that implementation and enforcement of such laws would help alleviate the country's shortage of health care providers.

The Department also observed that it was contradictory to argue, as many commenters did, both that the rule would decrease access to care and that the then-current conscience protections for providers were sufficient: If the Department's new rule would decrease access to care because of an increase in providers' exercise of conscientious objections, it would seem that the statutory protections that existed before the regulation did not result in providers fully exercising their consciences as protected by law.

73 FR at 78080-81 (Dec. 19, 2008).

73 FR at 78081.

Id.

The Department agrees with its previous response. The Federal conscience and anti-discrimination laws pre-exist these regulations. They provide rights and protections to health care providers, including in rural communities, underprivileged communities, or other communities that are primarily served by religious healthcare providers or facilities (together, “underserved communities”).

There appears to be no empirical data, however, on how previous legislative or regulatory actions to protect conscience rights have affected access to care or health outcomes. Studies have specifically found that there is insufficient evidence to conclude that conscience protections have negative effects on access to care.

The Department is not aware of data in its possession, in the public comments, or in the public domain that provides a way to estimate how many health care providers either in general or in underserved communities are—and are not—exercising their conscience rights and protections, even though they are encompassed by Federal conscience and anti-discrimination laws, nor is the Department aware of data to determine how many providers, among those, would exercise their conscience rights and protections once this rule is finalized, and because it is finalized.

See

Chavkin et al., “Conscientious objection and refusal to provide reproductive healthcare: A White Paper examining prevalence, health consequences, and policy responses,” 123 Int'l J. Gynecol. & Obstet. 3 (2013), S41-S56 (“[I]t is difficult to disentangle the impact of conscientious objection when it is one of many barriers to reproductive healthcare. . . . [C]onscientious objection to reproductive health care has yet to be rigorously studied.”); K. Morrell & W. Chavkin, “Conscientious objection to abortion and reproductive healthcare: A review of recent literature and implications for adolescents,” 27 Curr. Opin. Obstet. Gynecol. 5 (2015), 333-38 (“[T]he degree to which conscientious objection has compromised sexual and reproductive healthcare for adolescents is unknown.”).

Because enforcement of the rule will remove barriers to entry into the health care professions, it is reasonable to assume that the rule may, in fact, induce more people and entities to enter or remain in the health care field. On a broad level, this effect is reasonably likely to increase, not decrease, access to care, including—and perhaps especially—in underserved communities. The Department is not aware of data, including from public commenters, that would provide a useful basis for a quantitative estimate of how many more providers would enter the health care field, or serve

underserved communities, as a result of this rule, nor what the corresponding increase of access to care might be. However, no public commenter provided any data that undermines the reasoning that leads the Department to believe that the rule will have such an effect. And several factors support the Department's position.

First, predictions that the rule will reduce services in underserved communities may be based on incorrect assumptions. As the Department has made clear, the rule does not expand the substantive protections of Federal conscience and anti-discrimination laws. Thus, to the extent commenters believe the rule would reduce services in underserved communities, that would seem to be based on an assumption that there are health care providers in underserved communities who are protected by these laws but are offering services to which they object anyway (for example, abortions or abortion referrals) because the laws are inadequately enforced. That is not necessarily a correct assumption. Such health care providers might be responding to a threat to their conscientious practice, not by offering the services despite their objections, but by leaving the health care field or a particular practice area involving that service. One poll suggests that over 80% of religious health care providers in underserved communities would likely limit their scope of practice if they were required to participate in practices and procedures to which they have moral, ethical, or religious objections, rather than provide the services.

If that is correct, improving enforcement of Federal conscience and anti-discrimination laws might reduce infringement of conscience protections, not by reducing the availability of services such as abortion, but by increasing the availability of other services by encouraging providers not to self-limit their practices in underserved communities.

The CMA comment cited poll data from 2009 and 2011, which found that 82% of medical professionals “said it was either `very' or `somewhat' likely that they personally would limit the scope of their practice of medicine if conscience rules were not in place. This was true of 81% of medical professionals who practice in rural areas and 86% who work full-time serving poor and medically-underserved populations . . . 91% agreed, `I would rather stop practicing medicine altogether than be forced to violate my conscience.' ”

Second, and relatedly, the rule might result in an increase in the number of providers overall, or in certain specialties within the health care field. Individuals and entities may have chosen not to enter the health care field because they anticipated they would be pressured to violate their consciences. In some cases, that decision may be the result of discrimination occurring during medical training, such as medical students' experiences of discrimination on the basis of their religious beliefs or moral convictions,

or by pressures faced by institutions because of their religious identity or moral convictions. Reducing that discrimination and pressure may lead to more individual and institutional health care providers overall, which could help increase, rather than decrease, services for underserved communities. Another way this effect may manifest itself is if the average facility has access to more highly qualified candidates because there is a larger pool of medical professionals from which to choose. Having more providers overall, so that the field as a whole provides a wide and diverse range of services, is preferable to having fewer providers, particularly with respect to underserved areas.

The CMA comment cited a poll finding that twenty percent of responding faith-based medical students chose not to pursue a career in obstetrics/gynecology because of perceived coercion and discrimination in that field.

Third, the rule may prevent some health care providers from leaving the field. A certain proportion of decisions by currently practicing health providers to leave the profession may be motivated by such pressure.

With the rule's added emphasis on enforcing protections for rights of conscience, fewer individuals may leave the profession, and in turn they may help meet unmet needs for care. In addition, in some instances where a provider objects, based on conscience, to providing a service, there may be some underserved communities where other providers who have no such objections are available to provide the service. By contrast, without enforcement of Federal conscience and anti-discrimination laws, some providers with religious beliefs or moral convictions could close their doors (rather than violate their consciences), leaving a community even more underserved than if the provider were in practice.

The Christian Medical Association and Freedom2Care poll of May 3, 2011, found that 82% of medical professionals “said it was either `very' or `somewhat' likely that they personally would limit the scope of their practice of medicine if conscience rules were not in place. This was true of 81% of medical professionals who practice in rural areas and 86% who work full-time serving poor and medically-underserved populations . . . 91% agreed, `I would rather stop practicing medicine altogether than be forced to violate my conscience.' ”

The rule might allow an increase in the provision of health care by religious institutions as well, not just individuals. Religious hospitals or clinics, for example, if they are assured greater enforcement of their rights to practice medicine consistent with their religious beliefs, may find it worthwhile to expand to serve more people, including in underserved communities. Some commenters contend this could lead religious hospitals to move into underserved communities and crowd out other providers who might not have objections to certain services. The Department is not, however, aware of data demonstrating that the expansion of health care services by religious providers, particularly in underserved communities, would crowd out other providers who perform services that they do not, and market forces ordinarily would not dictate that result. Again, the Department is not aware of data demonstrating the dire results predicted by some commenters.

In addition, the relationship between religious or other conscientiously objecting providers and underserved communities may be far more complex than assumed by the prediction that this rule will decrease services. There are reasons to believe that many persons who might make use of protections under Federal conscience and anti-discrimination laws are already more likely to be located in certain underserved areas, and that their patients are similarly likely to share their views on issues such as abortion. According to the Pew Research Center, for example, “urban dwellers are far more likely than their rural counterparts to say abortion should be legal in all or most cases.”

This suggests that the enforcement of Federal conscience and anti-discrimination laws is not likely to be the cause of religious and other objecting providers being located in rural communities, but that such providers are already in those communities, and Congress passed these laws to protect them, among other individuals and entities, from being driven out of practice, which could exacerbate the lack of access to health care overall in those communities.

Pew Research Center, “What Unites and Divides Urban, Suburban, and Ruran Communities” (May 22, 2018), available at

https://www.pewsocialtrends.org/2018/05/22/what-unites-and-divides-urban-suburban-and-rural-communities/.

There is also reason to believe that religious institutions and individuals are disposed to serve in underserved communities because of elements of their religious mission besides objections protected by Federal conscience and anti-discrimination laws. For example, various commenters

contend the reason why Catholic hospitals are overrepresented in serving certain underserved populations is because the hospitals are motivated by their Catholic beliefs to serve unserved, underserved, underprivileged, or minority communities, and these commenters argue that Catholic hospitals (and, by extension, other religious providers) provide an overall benefit to underserved communities.

This overall benefit is consistent with Congress's apparent intent, in the Federal conscience and anti-discrimination laws, to ensure that the health care system remains open to the vibrant participation of religious and other providers, without barriers that can be created by discrimination against them, or infringements of their conscientious beliefs. Any loss of such providers because of the lack of enforcement of Federal conscience and anti-discrimination laws could decrease access to care for underserved communities. Therefore, when other commenters contend that women of color would be disproportionately harmed by this rule due to the significant services provided by Catholic hospitals, they do not seem to account for the fact that, without those hospitals' overall ability to exercise their religious mission, they would not be providing health care services to those communities in the first place.

Ascension, REF: Docket HHS-OCR-2018-0002, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority (Mar. 27, 2018) (“As the largest non-profit health system in the U.S. and the world's largest Catholic health system, Ascension is committed to delivering compassionate, personalized care to all, with special attention to persons living in poverty and those most vulnerable. In FY2017, Ascension provided more than $1.8 billion in care of persons living in poverty and other community benefit programs.”); Catholic Health Association, REF: RIN 0945-ZA 03 Protecting Statutory Conscience Rights in Health Care; Delegations of Authority: Proposed Rule, 83 FR 3880, January 26, 2018 (Mar. 27, 2018) (“As a Catholic health ministry, our mission and our ethical standards in health care are rooted in and inseparable from the Catholic Church's teachings about the dignity of each and every human person, created in the image of God. Access to health care is essential to promote and protect the inherent and inalienable worth and dignity of every individual. These values form the basis for our steadfast commitment to the compelling moral implications of our heath care ministry and have driven CHA's long history of insisting on and working for the right of everyone to affordable, accessible health care.”).

The Department also disagrees with the assumption that the rule's enforcement of Federal conscience and anti-discrimination laws will result in harm, or in more harm than the benefits that derive from implementing Federal laws. As explained in the Regulatory Impact Analysis,

infra

at part IV.C.3.vii, the Department expects the rule to enhance, not impede, access to care in areas with fewer providers, such as rural communities. The Department is not aware of data establishing the views of commenters who say the rule will reduce services in underserved communities, or of data establishing quantitatively how much the rule will increase and enhance access to health care services in underserved communities. The Department concludes, instead, that it is reasonable to agree with commenters who believe the rule will not decrease access to care, and may increase it.

The Department finds that finalizing the rule is appropriate without regard to whether data exists on the competing contentions about its effect on access to services. Most significantly, finalizing the rule is appropriate because it enforces Federal conscience and anti-discrimination laws, which represent Congress's considered judgment that these rights are worth protecting even if they impact overall or individual access to a particular service, such as abortion. But finalizing the rule is also appropriate because the Department's belief that the rule will enhance access to care is based on reasonable, informed assumptions unrebutted by public comments submitted in opposition to the rule. Ultimately, the Department believes that this rule will result in more health care provider options and, thus, better health care for all Americans. The Department thus believes that it is appropriate to finalize this rule to enforce Federal conscience and anti-discrimination laws, even though the Department and commenters do not have data capable of quantifying all of its effects on the availability of care.

Comment:

The Department received comments stating that protecting health care professionals' moral and religious convictions places health care providers above patients.

Response:

The Department disagrees. First, this final rule provides for the enforcement of protections established by the people's representatives in Congress; the Department has no authority to override Congress's balancing of the protections. Second, protecting health care providers' rights of conscience ensures that health care providers with deeply held religious beliefs or moral convictions are not driven out of the health care industry—and, therefore, made unavailable to serve any patients and provide any health care services—because of their refusal to participate in certain objected-to activities, such as abortion, sterilization, or assisted suicide. Third, the Department believes the provider-patient relationship is best served by open communication of conscience issues surrounding the provision of health care services, including any conscientious objections providers or patients may have to providing, assisting, participating in, or receiving certain services or procedures. By protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions.

Comment:

The Department received comments expressing concern that the proposed rule would expand Federal conscience and anti-discrimination statutes to cover areas beyond the scope of the statutes. Several commenters raised concerns about expanding protection to HIV treatment, pre-exposure prophylaxis, and infertility treatment.

Response:

The Department drafted the proposed rule to track the scope of each statute's covered activities as Congress drafted them, without being unduly broad or unduly narrow. For example, where the scope of laws that are the subject of this regulation is limited to certain enumerated procedures, the final rule makes clear that OCR will only pursue enforcement under those laws with respect to those enumerated procedures.

The Department is unaware of any cases claiming denial of service regarding these procedures brought under any of the statutes implemented by this rule. Public comments received by the Department did not cite such cases. In the event that the Department receives a complaint with respect to HIV treatment, pre-exposure prophylaxis, or infertility treatment, the Department would examine the facts and circumstances of the complaint to determine whether it falls within the scope of the statute in question and these regulations.

Discussion of this rule's potential application with regard to gender dysphoria is located in the section-by-section analysis regarding comments on the Church Amendments,

infra

at part III.B.

Comment:

The Department received many comments expressing confusion or concern as to how the proposed rule would interact with or be in conflict with other Federal laws, such as the

Emergency Medical Treatment and Active Labor Act (EMTALA) and Federal anti-discrimination statutes (such as section 1557 of the ACA).

Response:

This final rule provides the Department with the means to enforce Federal conscience and anti-discrimination laws in accordance with their terms and to the extent permitted under the laws of the United States and the Constitution. This final rule, like the 2008 Rule and the 2011 Rule, does not go into detail as to how its provisions may or may not interact with other statutes or in all scenarios, but OCR intends to read every law passed by Congress in harmony to the fullest extent possible so that there is maximum compliance with the terms of each law. With respect to EMTALA, the Department generally agrees with its explanation in the preamble to the 2008 Rule

that the requirement under EMTALA that certain hospitals treat and stabilize patients who present in an emergency does not conflict with Federal conscience and anti-discrimination laws. The Department intends to give all laws their fullest possible effect.

73 FR at 78087-88.

Comment:

The Department received comments stating that the Department should withhold Federal financial assistance from any State that does not provide for religious exemptions to vaccination.

Response:

This rule is only intended to provide enforcement mechanisms for the Federal conscience and anti-discrimination laws that Congress has enacted. The creation of a new substantive conscience protection is outside of the scope of this rulemaking. With respect to vaccination in particular, this rule provides for enforcement of 42 U.S.C. 1396s(c)(2)(B)(ii), which requires providers of pediatric vaccines funded by Federal medical assistance programs to comply with any State laws relating to any religious or other exemptions. Under the statute's plain text, this protection applies only to the extent a State already provides (or, in the future, chooses to provide) such an accommodation, and does not require a State to adopt such an accommodation.

Comment:

The Department received comments stating that the proposed rule's enforcement mechanisms will not meaningfully further conscience protection because existing laws protecting religious beliefs or moral convictions are sufficient.

Response:

The Department disagrees, and believes that the rule would make a meaningful difference in terms of compliance, as compared to the status quo. This rule provides appropriate enforcement mechanisms in response to a significant increase in complaints alleging violations of Federal conscience and anti-discrimination laws. Each law that is the subject of this rule meaningfully differs from the next. Moreover, the Department believes some laws have never been enforced, not necessarily because of widespread compliance with other overlapping laws, but because the Department has devoted no meaningful attention to those laws, has not conducted outreach to the public on them, and has not adopted regulations with enforcement procedures for them.

Comment:

The Department received a comment requesting that the Department clarify that health care providers may establish systems to help meet patients' health care needs when a provider holds a religious belief or moral conviction that may affect the service or procedure that a patient is seeking.

Response:

Nothing in the rule prohibits an entity from providing a lawful service it wants to provide, even as it respects the rights of personnel who may be protected by Federal laws from being required to provide, or assist in, the service. As discussed later in this preamble, the rule provides incentives for (but does not mandate) notices that parallel notice provisions under other anti-discrimination regulations. The Department believes that the provider-patient relationship is best served by open communication of conscience issues surrounding the provision of health care services, so that the consciences of patients, providers, and employees are respected whenever possible or required. Nothing in the rule precludes such communication or systems that encourage such communication. For example, providers may include notices in patient intake materials notifying patients that a provider's service provision is governed by certain ethical or religious principles. Providers may also encourage communication of moral or religious views by patients with respect to treatment in order to respect patients' wishes to the extent it is mutually acceptable or required. The Department declines to mandate any particular timeline or form in which a provider or patient must raise these sensitive issues. The Department encourages providers, if they are working with, or employing, health care professionals who may have religious or moral objections, especially with regard to certain procedures or treatments, to openly discuss these issues and have processes in place to identify and respect a diversity of views, further the provision of health care, and comply with the law. The final rule's modifications to the definition of “discrimination” permit employers of such personnel to accommodate the professionals' religious or moral objections, without interfering in the employer's delivery of health services.

Comment:

The Department received comments questioning whether the Department has authority to issue regulations implementing some or all of the Federal conscience and anti-discrimination laws encompassed by this rule.

Response:

The Federal conscience and anti-discrimination laws encompassed by this part, including the Church Amendments, section 245 of the Public Health Service Act, and the Weldon Amendment, require, among other things, that the Department and recipients of Department funds refrain from discriminating against institutional and individual health care entities that do not participate in certain medical procedures or services, including certain health services or research activities funded in whole or in part by the Federal government.

Compliance by the Department.

Inherent in Congress's adoption of the statutes that require compliance by the Department, by departmental programs, and by recipients of Federal funds from the Department is the authority of the Department to take measures to ensure its own compliance. As explained more fully below, compliance reviews, complaint investigation, and record-keeping are standard measures for ensuring compliance with conditions Congress has imposed upon the Department and on recipients of Federal funds, including statutory nondiscrimination requirements. Moreover, 5 U.S.C. 301 empowers the head of an Executive department to prescribe regulations “for the government of his department, the conduct of his employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.”

Compliance through funding instruments and agreements.

In large part, the rule's enforcement mechanisms concerning entities that receive funds from the Department involve placing terms and conditions that implement Federal law in contracts, grants, and other Federal funding instruments and agreements. HHS has the authority to impose terms and conditions in its grants, contracts, and other funding instruments, to ensure recipients comply with applicable law, including

the aforementioned Federal conscience and anti-discrimination laws. The Department, furthermore, will enforce such terms and conditions requiring compliance with such conscience and anti-discrimination law in accordance with existing statutes, regulations and policies that govern such instruments, such as the Federal Acquisition Regulation; the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (HHS UAR), 45 CFR part 75; regulations applicable to CMS programs; the associated regulations relating to suspension and debarment; as well as any other regulations or procedures that govern the Department's ability to impose and enforce terms and conditions on funding recipients to comply with Federal requirements.

Grants and cooperative agreements.

With respect to grants and cooperative agreements, the HHS UAR, 45 CFR part 75, requires adherence by award recipients to all applicable Federal statutes and regulations. For example, section 75.300(a) requires that the Department administer Federal awards to ensure that Federal funding and associated programs “are implemented in full accordance with U.S. statutory and public policy requirements: Including, but not limited to, those protecting public welfare, the environment, and prohibiting discrimination.” The regulation also requires the Department to communicate to non-Federal entities all policy requirements and include them in the conditions of the award. 45 CFR 75.300(a).

Furthermore, section 75.371 sets forth remedies for non-compliance where the award recipient “fails to comply with Federal statutes, regulations, or the terms and conditions of the Federal award.” These remedies include disallowance, withholding, suspension, and termination of funding. 45 CFR 75.371. The HHS UAR also contains provisions relating to recordkeeping (45 CFR 75.503) and program specific audits (45 CFR 75.507), which the Department may invoke when enforcing grant terms and conditions that operate to implement the Federal conscience and anti-discrimination laws. In addition, Federal grant recipients must also sign OMB-approved assurances which certify compliance with all Federal statutes relating to non-discrimination and all applicable requirements of all other Federal laws governing the program.

In sum, the Department's enforcement of the Federal conscience and anti-discrimination laws for grantees will be conducted through the normal grant compliance mechanisms applicable to grants or other funding instruments, with OCR coordinating its investigation and compliance activities with the funding component. If the Department becomes aware that a State or local government or a health care entity may have undertaken activities that may violate any statutory conscience protection, the Department will work to assist such government or entity to comply with, or come into compliance with, such requirements or prohibitions. If, despite the Department's assistance, compliance is not achieved, the Department will consider all legal options as may be provided under 45 CFR parts 75 (HHS UAR) and 96 (regulations addressing HHS block grant programs), as applicable.

Contracts.

With respect to Federal contracts and contractors, the Federal Property and Administrative Services Act of 1949 (“FPASA”) authorizes the promulgation of the Federal Acquisition Regulation (“FAR”). 40 U.S.C. 121(c). The FAR, in turn, authorizes agency heads to “issue or authorize the issuance of agency acquisition regulations that implement or supplement the FAR and incorporate, together with the FAR, agency policies, procedures, contract clauses, solicitation provisions, and forms that govern the contracting process or otherwise control the relationship between the agency, including any of its suborganizations, and contractors or prospective contractors.” 48 CFR 1.301-(a)(1). In addition, Federal agencies are required to prepare their solicitations and resulting contracts utilizing a uniform contract format, which permits agencies to include a clear statement of any “special contract requirements” that are not included in its standard government contract clauses or in other sections of the uniform contract format. 48 CFR 15.204-2-(h). Finally, pursuant to the FAR and other legal authorities, the Department has established the Department of Health and Human Services Acquisition Regulation (“HHSAR”) [48 CFR parts 300 through 370], which establishes uniform departmental acquisition policies and procedures that implement and supplement the FAR. The HHSAR contains departmental policies that govern the acquisition process or otherwise control acquisition relationships between the Department's contracting activities and contractors. The HHSAR contains (1) requirements of law; (2) HHS-wide policies; (3) deviations from FAR requirements; and (4) policies that have a significant effect beyond the internal procedures of the Department or a significant cost or administrative impact on contractors or offerors.

See

48 CFR 301.101(b);

see also

48 CFR 301.103(b) (“The Assistant Secretary for Financial Resources (ASFR) prescribes the HHSAR under the authority of 5 U.S.C. 301 and section 205(c) of the Federal Property and Administrative Services Act of 1949, as amended (40 U.S.C. 121(c)(2)), as delegated by the Secretary[ ].”). As a result, the Department has ample authority to include terms and conditions in its contracts consistent with the Federal conscience and anti-discrimination laws. Furthermore, the Federal Acquisition Regulation provides a variety of mechanisms that may be used to enforce such contract provisions (

e.g.,

48 CFR part 49 “Termination of Contracts”). Thus, the Department intends to implement and enforce contract terms on the Federal conscience and anti-discrimination laws through the FAR and HHSAR and other Federal laws and regulations that govern the administration and performance of Federal contracts.

Other rulemaking authorities.

Under the ACA section 1321(a), 42 U.S.C. 18041, the Department has the authority to promulgate regulations implementing the ACA conscience provisions. Section 1321(a) provides authority to the Secretary to issue regulations setting standards for meeting the requirements under Title I of the ACA, and the amendments made by Title I, with respect to the establishment and operation of Exchanges (including SHOP Exchanges), the offering of qualified health plans through such Exchanges, the establishment of the reinsurance and risk adjustment programs under part V, and such other requirements as the Secretary determines appropriate. This provision authorizes the Secretary to promulgate regulations setting standards for regulated entities to meet the conscience protection requirements in ACA sections 1303(b)(1)(A) & (b)(4), 1411, and 1553, 42 U.S.C. 18023(b)(1)(A) & (b)(4), 18081, 18113, all of which are located in Title I of the ACA.

With respect to the Medicare, Medicaid, and Children's Health Insurance Program (CHIP), section 1102 of the Social Security Act, 42 U.S.C. 1302, authorizes the Secretary to “make and publish such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions with which [he] is charged under this Act.” This provides the Secretary with authority to promulgate regulations that provide for compliance by participants in the Medicare, Medicaid, and CHIP programs, including Medicare

providers, State Medicaid and CHIP programs, etc., with applicable Federal conscience and anti-discrimination laws.

Furthermore, with respect to funding instruments administered by the Centers for Medicare & Medicaid Services (CMS), including instruments or agreements authorized by the Social Security Act and ACA, the Secretary has the authority under section 1115(a)(2) of the Social Security Act to authorize Federal matching funds in expenditures by State Medicaid agencies that would not otherwise be eligible for Federal matching in order to carry out a demonstration project that promotes the objectives of the Medicaid or CHIP programs. Under section 1115A of the Social Security Act, Federal funds are available to test innovative payment and service delivery models expected to reduce costs to Medicare, Medicaid, or CHIP, while preserving or enhancing the quality of care furnished to the beneficiaries of these programs. The Secretary has the authority to include terms and conditions addressing Federal conscience and anti-discrimination laws in certain funding instruments or agreements under these authorities. The Secretary also has the authority to impose terms and conditions in certain grant instruments under some of its grant authorities, such as the grants available to States for ACA implementation under section 2794(c)(2)(B) of the Public Health Service Act. In addition, the Secretary has the authority to include such requirements, through rulemaking, with respect to State Medicaid programs generally, Medicaid managed care organizations (section 1902(a)(4) of the Social Security Act), Medicare Advantage organizations (section 1856(b)(1) of the Social Security Act) and Medicare Part D sponsors (section 1857(e)(1) of the Social Security Act), other types of Medicare providers and suppliers of items and services,

and Qualified Health Plans offering individual market coverage on State exchanges.

Through delegation from the Secretary, CMS has statutory authority to place conditions on participation in its programs under the following authorities:

1. Skilled nursing facilities (SNFs)—section 1819(d)(4)(B) of the Act [42 U.S.C. 1395i-3(d)(4)(B)].

2. Medicaid nursing facilities (NFs)—section 1919(d)(4)(B) of the Act [42 U.S.C. 1396r(d)(4)(B)].

3. Hospitals—section 1861(e)(9) of the Act [42 U.S.C. 1395x(e)(9)].

4. Psychiatric hospitals—section 1861(f)(2) of the Act [42 U.S.C. 1395x(f)(2)], cross referencing 1861(e)(9).

5. Long term care hospitals—section 1861(ccc)(3) of the Act [42 U.S.C. 1395x(ccc)(3)], cross referencing section 1861(e).

6. Home health agencies (HHAs)—section 1861(o)(6) of the Act [42 U.S.C. 1395x(o)(6)].

7. Rehabilitation agencies and Clinics as providers of physical, occupational therapy and speech language pathology services—section 1861(p)(4)(A)(v) of the Act and 1861(p)(4)

flush language

[42 U.S.C. 1395x(p)(4)].

8. Comprehensive outpatient rehabilitation facilities (CORFs)—section 1861(cc)(2)(J) of the Act [42 U.S.C. 1395x(cc)(2)(J)].

9. Hospice—section 1861(dd)(2)(G) of the Act [42 U.S.C. 1395x(dd)(2)(G)].

10. Community mental health centers (CMHCs)—section 1861(ff)(3)(B)(iv) of the Act [42 U.S.C. 1395x(ff)(3)(B)(iv)].

11. Religious nonmedical health care institution (RNHCIs)—section 1861(ss)(1)(J) of the Act [42 U.S.C. 1395x(ss)(1)(J)].

12. Portable x-ray suppliers—1861(s)(3) of the Act [42 U.S.C. 1395x(s)(3)]

13. Independent clinical laboratories—section 353(f)(1)(E) of the Public Health Act [42 U.S.C. 263a(f)(1)(E)] (authorizing the Secretary to make additional regulations “necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures”).

14. Rural health clinics (RHCs)—section 1861(aa)(2)(K) of the Act [42 U.S.C. 1395x(aa)(2)(K)].

15. Intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs)—section 1861(e)(9) of the Act [42 U.S.C. 1395x(e)(9)].

To the extent that terms and conditions relating to Federal conscience and anti-discrimination laws are incorporated into CMS's instruments or agreements, CMS would have the authority to enforce such terms pursuant to the relevant enforcement mechanism for each instrument or agreement. For example, with respect to a special term and condition under a section 1115 demonstration, the demonstration could be terminated for a failure to comply with a term and condition. With respect to section 1115A, it would depend on the legal instrument used. For cooperative agreements, the enforcement mechanism would be Federal grants law. For addenda to existing contracts, the enforcement mechanism would be Federal procurement law. For participation agreements and regulations—through which CMMI operates most of its section 1115A models—CMS could enforce these requirements under the terms of the agreement or regulation itself (which allow CMS to take certain corrective actions, up to and including termination of a non-compliant participant from the model) and, under certain circumstances, under general CMS regulations (

e.g.,

regarding recoupments). In the case of a CMS grant program, it would depend on the terms included in the grant award, but grant funds could be subject to forfeiture in some instances. Medicaid requirements imposed through rulemaking would be enforced through a compliance action under section 1902(a)(4) of the Social Security Act. For Medicare Advantage or Part C contracts, there are intermediate sanctions, civil money penalties, and potential contract termination for violations of contract requirements. In the case of Medicare providers and suppliers, enforcement could involve loss of a provider agreement or certification.

Debarment and suspension.

Finally, the Department notes that it has the authority, where appropriate, to initiate debarment or suspension proceedings against entities that are otherwise eligible to receive Federal funding pursuant to grants and cooperative agreements, contracts and other funding instruments.

See, e.g.,

48 CFR part 9.4; 2 CFR part 376. Entities that are debarred, suspended, or proposed for debarment are also excluded from conducting business with the Government and, thus, are generally not eligible to receive Federal funds during the duration of the suspension or debarment. The Department notes that, under the FAR, an entity may be debarred for the “[c]ommission of any other offense indicating a lack of business integrity or business honesty that seriously and directly affects the present responsibility of a Government contractor or subcontractor.” 48 CFR 9.406-2(a)(5). In addition, a contractor may be debarred for a “[w]illful failure to perform in accordance with the terms of one or more contracts.” 48 CFR 9.406-2(b). Thus, the Department will consider whether suspension or debarment may be appropriate when enforcing terms and conditions implementing the Federal conscience and anti-discrimination laws.

Receipt and processing of complaints.

With regard to the receipt and processing of complaints of violations of the Federal conscience and anti-discrimination laws, it is well settled in case law that every agency has the inherent authority to issue interpretive rules and rules of agency practice and procedure. 1 Richard J. Pierce, Jr.,

Administrative Law Treatise

§ 6.4 (4th ed. 2002). This rule does not substantively alter or amend the obligations of the respective statutes,

JEM Broad.

FCC,

22 F.3d 320 (D.C. Cir. 1994), and the definitions offered in this rule are reasonably drawn from the existing statutes.

Hoctor

Dept. of Agriculture,

82 F.3d 165 (7th Cir. 1996). As a result, the Department and OCR have authority to issue interpretations regarding the Federal conscience and anti-discrimination laws, many of

which have been placed in the Department's program statutes.

Comment:

The Department received a comment requesting that long-term care and post-acute providers be exempted from the rule because such entities are already heavily regulated.

Response:

The Department declines to provide this exemption. The rule provides for appropriate enforcement of statutes protecting foundational civil rights, and Congress did not exempt long-term care or post-acute providers from these civil rights laws.

B. Section-by-Section Analysis

Unless indicated otherwise, the Department adopts the regulation text as proposed.

Purpose (§ 88.1)

In the NPRM, the Department's “Purpose” section set forth the objective that the proposed regulation would, when finalized, provide for the implementation and enforcement of Federal conscience and anti-discrimination laws. It also stated that the statutory provisions and regulations contained in this part are to be interpreted and implemented broadly to effectuate their protective purposes. The Department did not receive comments on this section beyond the general comments addressed above. Section 88.1 of the final rule reflects technical edits to replace the word “persons” with “individuals,” for clarity, and to refer to the set of statutes encompassed by this rule collectively as the “Federal conscience and anti-discrimination laws, which are listed in § 88.3 of this part.” Throughout the final rule, the Department has made changes to refer to those statutes as “Federal conscience and anti-discrimination laws,” rather than “Federal conscience protection and associated anti-discrimination laws.”

Summary of Regulatory Changes:

The Department believes, as discussed above, that there are various reasons why this rule is needed and appropriate to provide for the implementation and enforcement of Federal conscience and anti-discrimination laws. In addition, the Department believes it is appropriate to interpret the rules broadly, within the scope of the text set forth in each statute, to effectuate their protective purposes. Generally, it is appropriate to broadly interpret laws enacted to protect civil rights and prevent discrimination. For the reasons described in the proposed rule

and above, and considering the comments received, the Department finalizes this section as proposed, but with technical edits to replace the word “persons” with “individuals,” add the term “certain” in regard to health care services, remove the term “for example” and “comprehensively” in relation to the degree of the protections, for clarity, and to refer to the statutes part 88 addresses as “Federal conscience and anti-discrimination laws, which are listed in § 88.3 of this part.”

83 FR 3880, 3892.

Definitions (§ 88.2)

In the NPRM, the Department proposed definitions of various terms. The comments and the responses applicable to each definition are set forth below.

Administered by the Secretary.

The Department proposed that a federally funded program or activity is “administered by the Secretary” when it is “subject to the responsibility of the Secretary of the U.S. Department of Health and Human Services, as established via statute or regulation.” The Department did not receive comments specifically on this definition.

In proposing the definition for “administered by the Secretary,” the Department noted that the 2008 Rule had not defined the phrase, and that the proposed definition was intended to add clarity. Upon further review and in consideration of general comments received concerning whether the proposed rules are sufficiently clear, the Department has concluded that the proposed definition does not add substantial clarity to the plain meaning of the phrase “administered by the Secretary.” No commenters submitted comments on this question, which suggests that there is no confusion about the meaning of this phrase. The Department is finalizing this rule without adopting the proposed definition, or any definition, of “administered by the Secretary.” In the event that the Department is asked to consider the meaning of this phrase in its application of the rule, the Department will apply the standard canons of statutory construction.

Summary of Regulatory Changes:

For the reasons described above, the Department finalizes the rule without a definition of the phrase “administered by the Secretary.”

Assist in the Performance.

The Department proposed that “assist in the performance” means “to participate in any program or activity with an articulable connection to a procedure, health service, health program, or research activity, so long as the individual involved is a part of the workforce of a Department-funded entity.” The definition specified that “[t]his includes but is not limited to counseling, referral, training, and other arrangements for the procedure, health service, health program, or research activity.” The Department received comments on this definition, including comments generally supportive of the proposed definition and generally opposed to it. Because comments evidenced significant confusion over the proposed definition, the Department amends the definition, as described further below.

Comment:

The Department received comments suggesting that the definition of “assist in the performance” is unnecessary because employees maintain the option to seek employment elsewhere.

Response:

The Department disagrees. Congress established requirements, including the protections interpreted by this final rule, for recipients of certain Federal financial assistance or participants in certain Federal programs. Those obligations are not obviated merely because an employee who desires to make use of the protections that Congress provided could, instead, find employment elsewhere. Indeed, forcing a person to find employment elsewhere (which includes as a result of being fired), because they make certain protected objections to procedures, or because of their religious beliefs or moral convictions, is a quintessential example of the discrimination and coercion that these laws prohibit. The existence of numerous comments employing this line of reasoning provides additional evidence of the need for this final rule, so that the Department may better educate both recipients and the public on the law, and may ensure vigorous enforcement where education proves insufficient to achieve compliance.

Comment:

The Department received comments stating that the proposed “articulable connection” standard is too broad and would permit objections by persons whom certain commenters contend have only a tangential connection to the objected-to procedure or health service program or research activity. Some commenters included examples such as a person preparing a room for an abortion or scheduling an abortion.

Response:

The Department believes that the proffered examples are properly considered as within the scope of the protections enacted by Congress for those who choose to assist and those who choose not to assist in the performance of an abortion. Scheduling an abortion or preparing a room and the instruments for an abortion are necessary parts of the process of providing an abortion, and it is

reasonable to consider performing these actions as constituting “assistance.”

The definition will ensure a sufficient connection between the conduct for which (or from which) the conscientious objector is seeking relief and the protections Congress established in law. This approach would ensure that health care workers are not driven from the health care industry because of conflicts with their religious beliefs or moral convictions in connection with practices as set forth by Congress, such as abortion. It would also dissuade employers from attempting to skirt protections through improperly narrow interpretations of the term.

Nevertheless, in response to concerns about the potential overbreadth and need for increased clarity of the definition, the Department finalizes the definition with a change to the first sentence, so that it reads: To assist in the performance means “to take an action that has a specific, reasonable, and articulable connection to furthering a procedure or a part of a health service program or research activity undertaken by or with another person or entity.” The Department believes that replacing the phrase “to participate in any activity” with the phrase “to take an action” more clearly and precisely explains the conduct covered by “assist in the performance.” The phrase “undertaken by or with another person or entity” distinguishes “assisting” from “performing,” as assisting implies working with another. This change would also ensure that any articulable connection must also be “reasonable” and “specific.” It would, therefore, preclude vague or attenuated allegations that do not support a claim of assisting in a procedure or health service program or research activity. For example, a health care worker who objects to being scheduled to conduct physicals on some patients, when abortions are scheduled on the same day for unrelated patients elsewhere in the building, would not have a claim of being coerced into “assisting” with an abortion, barring additional facts. Conversely, where a provider requires the designation and availability of a backup doctor whenever an abortion is to be performed, that designation may constitute assistance in the performance of an abortion even if no complications arise requiring the backup doctor to intervene during or after an abortion in a particular instance. In addition, the Department clarifies that the activities need only to regard “part of a health service program or research activity,” in contrast to, for example, furthering the health service program as a whole.

The Department believes these changes adequately respond to commenters who contend the proposed definition of “assist in the performance” is insufficiently clear, without narrowing the definition to exclude actions that do constitute assistance in the performance. The Department believes the definition in the final rule, while still requiring OCR to weigh the facts and circumstances of each case, provides additional clarity. Congress did not define “assist in the performance.” The Department considered not finalizing a definition of “assist in the performance,” but without any definition, there may be confusion about what the term includes, with different employers interpreting it more broadly or more narrowly. For example, in the

Danquah

lawsuit, where nurses contended they were required to assist abortion cases in violation of the Church Amendments, a public hospital receiving Public Health Service Act funds filed a brief in Federal court stating that “to administer routine pre and post-operative care” to abortion patients does not constitute assisting in the performance of an abortion under the Church Amendments.

Without taking a position on the facts of that case, the Department disagrees with a narrow interpretation of assisting in the performance that excludes pre- and post-operative support to a scheduled abortion procedure. The Department believes that the confusion among covered entities and members of the public about what constitutes assistance in the performance of a health service makes it appropriate for the Department to define “assist in the performance” with the changes as set forth in this final rule.

Defs.' Brief in Opp. To Pls.' App. For Prelim. Inj. at 26,

Danquah,

No. 2:11-cv-06377-JLL-MAH, doc. # 26 (D.N.J. filed Nov. 22, 2011).

Comment:

The Department received a comment requesting that “articulable connection” be replaced with “reasonable connection” because “articulable connection” may be abused by persons articulating connections that are irrational.

Response:

The Department agrees in part, to the extent that the reasonableness standard should be included in the definition. As stated above, in response to similar concerns about potential overbreadth, the Department has modified the sentence containing the phrase, “to participate in any program or activity with an articulable connection to a procedure,” to add the word “reasonable,” and other language to limit its scope and add greater specificity. Specifically, the final rule describes “to take an action that has a specific, reasonable, and articulable connection to furthering a procedure or health service program or research activity undertaken by or with another person or entity.” This standard would preclude irrational assertions that an action constitutes assisting in the performance of a procedure, because it requires the action to have a specific, reasonable, and articulable connection to furthering the procedure. If the connection between an action and a procedure is irrational, there is no actual connection by which the action specifically furthers the procedure. The Department does not interpret the language to permit irrational applications.

Comment:

The Department received a comment suggesting that the “articulable connection” standard be replaced with a standard that connects that assistance to the clinical setting and includes a complete, not illustrative, list of activities subject to the protections.

Response:

The Department believes this concern is adequately addressed by the changes described above to clarify the definition of “assist in the performance.” The Department disagrees with the recommended approach because the statutory protections for objecting to assisting in the performance of procedures encompasses situations beyond the narrow scope proposed by the commenter. For example, an unlawfully coerced assistance in an abortion is no less unlawful if the coercion takes place outside a particular clinical setting, as opposed to within such clinical setting. Furthermore, creating an exhaustive list of potentially protected conduct does not allow for variations from State to State, or even clinic to clinic, in how procedures are handled. Such an approach also does not consider the diverse ways in which protected moral or religious objections may manifest, and would not account for changes in practices over time.

Comment:

The Department received comments stating that the scope of persons protected by the definition of “assist in the performance” is too broad because it extends beyond health care professionals and includes other members of the workforce.

Response:

The Department acknowledges that inclusion of a reference to workforce members in the definition of “assist in the performance” has caused confusion among commenters. The Department has concluded this reference is not necessary because the scope of persons and entities protected from being forced to “assist in the performance” of an

objected to procedure is already governed by provisions in the relevant law and this rule. Accordingly, the Department is finalizing the definition of “assist in the performance” to delete the reference to workforce members. Similarly, the Department is removing the reference to “any program or activity” as part of the definition of “assist in the performance” because the new language in the definition—“to take an action that has a specific articulable connection”—makes the reference to “any program or activity” unnecessary. The Department is also removing the reference to “health program or activity” because that term is no longer defined in the final rule, as discussed further below.

Comment:

The Department received comments expressing concern that the definition of “assist in the performance” would cover ambulance drivers.

Response:

EMTs and paramedics are treated like other health care professionals under this definition. Federal conscience and anti-discrimination laws would apply to them, or not, based on whether the elements of the law (and this final rule) are satisfied in a particular circumstance. To the extent the commenters contend that the kinds of actions that ambulance crews perform never count as assisting in the performance of a procedure encompassed by a Federal conscience or anti-discrimination law, the Department declines to take such a categorical approach. As discussed earlier, where EMTALA might apply in a particular case, the Department would apply both EMTALA and the relevant law under this rule harmoniously to the extent possible. EMTs and paramedics are trained medical professionals, not mere “drivers.” If commenters contend that driving a patient to a procedure should never be construed to be assisting in the performance of a procedure, the Department disagrees and believes it would depend on the facts and circumstances of each case. For example, the Department believes driving a person to a hospital or clinic for a scheduled abortion could constitute “assisting in the performance of” an abortion, as would physically delivering drugs for inducing abortion.

To the extent commenters are referring to emergency transportation of persons experiencing unforeseen complications after, for example, an abortion procedure, the Department does not believe such a scenario would implicate the definition of “assist in the performance of” an abortion, because the complications in need of treatment would be an unforeseen and unintended byproduct of a completed procedure. Further, the Department is not aware of any entities or medical professionals that would object to treating someone, or transporting someone to treatment, under these circumstances.

To the extent commenters are referring to emergency transportation of persons with conditions such as an ectopic pregnancy, where the potential procedures performed at the hospital may include abortion, the question of whether such transportation falls under the definition of “assist in the performance” would depend on the facts and circumstances. However, as a general matter, the Department does not believe that mere speculation that an objected-to service or procedure may occur suffices to establish a specific and reasonable connection between the objected-to service or procedure and the act of transporting the patient.

The Department's existing regulation implementing EMTALA at 42 CFR 489.24 defines EMTALA's statutory language “comes to the emergency department”

to include an individual who is en route to a hospital in an ambulance owned and operated by the hospital, with limited exceptions, as well as, in certain circumstances, an individual who is en route to a hospital in an ambulance that is not owned and operated by the hospital.

Federal Appeals Courts in the Ninth and First Circuits have examined the Department's regulatory definition of “comes to the emergency department,” and have upheld the Department's regulatory definition for EMTALA as reasonable, and have distinguished other Federal Circuits' cases interpreting EMTALA by differentiating the cases by their facts or by the nature of the courts' analyses.

42 U.S.C. 1395dd(a).

42 CFR 489.24(b)(3) and (4).

Morales

Sociedad Espanola de Auxilio Mutuo y Beneficencia,

524 F.3d 54, 60-61 (1st Cir. 2008) (holding that the HHS regulatory definition comports with EMTALA's purpose and remedial framework and distinguishing cases from the Fifth and Seventh Circuits);

Arrington

Wong,

237 F.3d 1066, 1073-74 (9th Cir. 2001) (same).

Comment:

The Department received comments stating that the inclusion of counseling and referral in the definition of “assist in the performance” was not the intent of Congress in enacting the Church Amendments. Some commenters pointed to differing language in the Church, Weldon, and Coats-Snowe Amendments to support this assertion.

Response:

Congress did not define the phrases “assist in the performance,” “counsel,” or “recommend” in the Church Amendments; “refer” or “referral” in Weldon or Coats-Snowe; or “make arrangements for” in Coats-Snowe. Some commenters contend that the meaning of these terms are completely distinct and should never be interpreted as overlapping. The Department disagrees. When Congress enacted paragraphs (b) and (c)(1) of the Church Amendments in 1973, and paragraphs (c)(2) and (d) in 1974, it used the phrase “assist in the performance” regarding certain medical procedures. Congress then enacted paragraph (e) in 1979 to protect applicants for medical training or study from discrimination based on their reluctance or willingness “to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations.”

Counseling and referral are common and well understood forms of assistance that materially help people reach desired medical ends. Indeed, because referrals are so tightly bound to the ultimate performance of medical procedures, Congress banned many forms of referral fees or “kickbacks” among providers receiving Medicare and Medicaid reimbursements.

See

the Medicare and Medicaid Patient Protection Act of 1987, as amended, 42 U.S.C. 1320a-7b (the “Anti-Kickback Statute”) and the Ethics in Patient Referrals Act of 1989, as amended, 42 U.S.C. 1395nn (the “Stark Law”). Similarly, counseling of some form regarding abortion is often

required

before the procedure can be performed, as is the case in 33 States,

and many hospitals and health care facilities likely require some kind of counseling as a prerequisite to abortion of their own accord.

Counseling and Waiting Periods for Abortion, Guttmacher Institute (Oct. 1, 2018),

https://www.guttmacher.org/state-policy/explore/counseling-and-waiting-periods-abortion.

Based on the text, structure, and purpose of the statutes at issue, the Department interprets “assist in the performance” broadly and does not believe the presence of more specific terms of assistance elsewhere in the Church Amendments, or in other laws that are the subject of this rule, narrows the meaning of the phrase. It would be contrary to the structure and history of the Church Amendments to interpret provisions protecting conscience in the

study

of abortion procedures significantly more broadly than provisions protecting conscience in the actual

performance

of an abortion procedure.

The Department, however, does not believe that every form of counseling, training, or referral (as defined under

this rule) necessarily constitutes assistance in the performance of a procedure under this rule. The Department, therefore, finalizes the definition of “assist in the performance” by changing the second sentence to read “This may include counseling, referral, training, or otherwise making arrangements for the procedure or health service program or research activity, depending on whether aid is provided by such actions.”

Comment:

The Department received comments expressing concern that the definition of “assist in the performance” combined with the language of 42 U.S.C. 300a-7(d) could impact counseling or referrals for LGBT persons.

Response:

Several provisions of statutes that are the subject of this rule are specific to abortion, sterilization, assisted suicide, or other procedures, and provide specific protections. In 42 U.S.C. 300a-7(d) (and 300a-7(c)(2)), Congress directed the protection of conscientious objections in contexts not tied to specific treatments. When the previous administration finalized 45 CFR part 88 in 2011, it affirmed its commitment to enforce Federal conscience and anti-discrimination laws, including 42 U.S.C. 300a-7(d). (76 FR at 9972). The Department continues and expands on that commitment in this rule. The Department does not pre-judge matters without the benefit of specific facts and circumstances, and particular claims under 42 U.S.C. 300a-7(d) will be evaluated on a case-by-case basis.

Nevertheless, the Department believes that some commenters may misunderstand the scope of paragraph (d). Generally, the protections of paragraph (d) follow the funds provided by any program administered by the Secretary. But paragraph (d) does not encompass every medical treatment or service performed by any entity receiving Federal funds from HHS for whatever purpose. Instead, Congress narrowly focused paragraph (d) to prohibit the coercion of persons “in performance of” health service programs funded under a program administered by the Secretary. As explained more fully in response to other comments below with respect to paragraph (d), many medical treatments and services performed by health care providers are not “part of” a health service program receiving funding from HHS. In such circumstances, paragraph (d) would not apply.

Comment:

The Department received comments expressing concern that the definition of “assist in the performance” will result in conscientious objectors refusing to provide information to patients about objected-to treatment options, potentially in violation of principles of informed consent.

Response:

The Department disagrees that the rule would violate principles of informed consent. Medical ethics have long protected rights of conscience alongside the principles of informed consent. The Department does not believe that enforcement of conscience protections, many of which have been in place for nearly fifty years, violates or undermines the principles of informed consent. This rule will not change the obligation that, absent exigent circumstances, doctors secure informed consent from patients before engaging in a medical procedure.

Summary of Regulatory Changes:

For the reasons described in the proposed rule

and above, and considering the comments received, the Department adopts the definition of “assist in the performance” with changes to read that it means “to take an action that has a specific, reasonable, and articulable connection to furthering a procedure or health service program or research activity undertaken by or with another person or entity.” The definition specifies that “[t]his may include counseling, referral, training, or otherwise making arrangements for the procedure or health service program or research activity, depending on whether aid is provided by such actions.” This new definition removes “so long as the individual involved is a part of the workforce of a Department-funded entity” for accuracy and clarity and makes other minor language changes, for example, changing “includes but is not limited to” to “may include.”

83 FR 3880, 3892 (stating the reasons for the proposed definition of “assist in the performance,” except for the modifications adopted herein).

Department.

The Department proposed that “Department means the Department of Health and Human Services and any component thereof.” The Department did not receive comments on this definition.

Summary of Regulatory Changes:

For the reasons described in the proposed rule

and above, the Department adopts the definition of “Department” as proposed.

83 FR 3880, 3892.

Discriminate

Discrimination.

The Department proposed “

discriminate

or d

iscrimination,”

to mean one of four categories of adverse actions or treatment, for which each paragraph or type of action within each paragraph would apply as permitted by the applicable statute. Paragraph (1) of the definition addressed prohibited adverse actions or treatment, as permitted by the applicable statute, as those actions relate to any grant, contract, subcontract, cooperative agreement, loan, license, certification, accreditation, employment, title, or other similar instrument, position, or status. Paragraph (2) addressed prohibited adverse actions or treatment, as permitted by the applicable statute, as those actions relate to any benefit or privilege. For both paragraphs, prohibited adverse actions or treatment included those to withhold, reduce, exclude, terminate, restrict, or otherwise make unavailable or deny the categories listed in paragraphs (1) and (2). Paragraph (3) addressed the use of any criterion, method of administration, or site selection, including the enactment, application, or enforcement of laws, regulations, policies, or procedures directly or through contractual or other arrangements, that tends to subject individuals or entities protected under the rule to any adverse effect described in this definition, or has the effect of defeating or substantially impairing accomplishment of a health program or activity with respect to individuals, entities, or conduct protected under the rule. Finally, paragraph (4) of the definition set forth a catch-all for which discriminate or discrimination means to otherwise engage in any activity reasonably regarded as discrimination, including intimidation or retaliatory action.

The Department received comments on this definition, including comments generally supporting or opposing the proposed definition.

Comment:

The Department received comments stating that the definition of “discriminate or discrimination” would encompass situations in which States apply neutral laws of general applicability that require the performance of abortion, and such commenters disagreed that a neutral law of general applicability can be deemed an act of discrimination.

Response:

The term “neutral law of general applicability” is a legal term of art that derives from case law interpreting the Free Exercise Clause of the First Amendment. What renders a law “neutral” in the Free Exercise context is that the law is not by its text, history, motive, or operation targeted at the protected activity of religious exercise. If commenters are contending that States that might otherwise be prohibited by a Federal conscience or anti-discrimination law from discriminating against doctors who refuse to perform abortions may nonetheless do so pursuant to a neutral State law of general applicability, the Department disagrees. States that accept

applicable Federal funds and thereby subject themselves to Federal conscience and anti-discrimination laws cannot evade the requirements of those laws through neutral laws of general applicability. For example, the Weldon Amendment flatly prevents State laws from discriminating against doctors because they do not perform abortions against their will regardless of whether the law is “neutrally” worded or applied. Subjecting persons to penalties or adverse treatment because they decline to perform abortions is a form of discrimination encompassed by the Weldon Amendment. Even if a State law were to impose penalties on OB/GYNs because they decline to perform any lawful procedure they are competent to perform (the Department is not aware of such a law), and that law were used to impose penalties on OB/GYNs because they do not perform abortions, that would also constitute discrimination encompassed by the Weldon Amendment. The Coats-Snowe Amendment similarly prohibits discrimination against a health care entity, such as an individual physician, who (among other things) declines to perform abortions. Additionally, under both the Coats-Snowe and Weldon Amendments, protected entities and individuals need not specify a motive, or provide a justification, for declining.

Paragraph (c)(1) of the Church Amendments provides that a covered entity cannot discriminate against any physician or other health care personnel (1) because he or she performed or assisted in the performance of a sterilization or abortion procedure, (2) because he or she refused to so perform or assist “on the grounds that” doing so “would be contrary to his [or her] religious beliefs or moral convictions,” or (3) “because of his religious beliefs or moral convictions respecting sterilization procedures or abortions.” The last provision covers circumstances where a covered entity's motive is arguably driven by anti-religious animus. But the second prohibition of discrimination does not rely on animus on the part of the entity committing the discrimination; it rests solely on whether the person refused to perform or assisted in the performance of a sterilization or abortion procedure on the grounds of the person's religious beliefs or moral convictions with respect to such procedures. Therefore, under paragraph (c)(1), a covered entity cannot discriminate against a doctor, for example, because of his or her refusal to perform abortions on the grounds of religious beliefs or moral convictions regardless of whether the covered entity's discrimination is accompanied by anti-religious animus, or whether the entity would also penalize doctors who refuse to perform abortions for non-protected reasons. Nothing in the legislative history of the Church Amendments suggests that Congress intended to permit entities receiving applicable funds to coerce religiously or morally motivated doctors to perform abortions, so long as those entities also require doctors who do not have qualms about abortions to perform them.

Consequently, the Department concludes that the concept of discrimination, as used in Federal conscience and anti-discrimination laws, can encompass a situation where a State takes adverse action against a doctor because of the doctor's refusal to perform an abortion, even under a general or “neutral” law mandating the performance of abortions.

Comment:

The Department received comments stating that the phrase “any activity reasonably regarded as discrimination” is overbroad or impermissibly vague.

Res

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