[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Rules and Regulations]
[Pages 23170-23272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09667]



[[Page 23169]]

Vol. 84

Tuesday,

No. 98

May 21, 2018

Part II





Department of Health and Human Services





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45 CFR Part 88





Protecting Statutory Conscience Rights in Health Care; Delegations of 
Authority; Final Rule

  Federal Register / Vol. 84 , No. 98 / Tuesday, May 21, 2018 / Rules 
and Regulations  

[[Page 23170]]


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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.

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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.\1\
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    \1\ 83 FR 3880 (Jan. 26, 2018).
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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

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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.\2\ 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.
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    \2\ 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).
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    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.\3\
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    \3\ 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.
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    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).

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    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 Sec.  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),\4\ are members of an exempt 
religious organization or division,\5\ or participate in a ``health 
care sharing ministry.'' \6\ See also 26 U.S.C. 5000A(d)(2). Under 
section 1311(d)(4)(H) of the ACA, 42 U.S.C. 18031(d)(4)(H), health 
benefit exchanges are responsible for issuing certificates of exemption 
consistent with the Secretary's determinations under section 1411 of 
the ACA.
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    \4\ See Guidance on Hardship Exemptions from the Individual 
Shared Responsibility Provision for Persons Experiencing Limited 
Issuer Options or Other Circumstances, Center for Consumer 
Information and Insurance Oversight, Centers for Medicare & Medicaid 
Services (CMS), April 9, 2018. https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/2018-Hardship-Exemption-Guidance.pdf. As discussed in the description of Sec.  88.3(g) 
below, Congress reduced the penalty in 26 U.S.C. 5000A for a lack of 
minimum essential coverage to $0. SUPPORT for Patients and 
Communities Act, Public Law 115-271, section 4003, 26 U.S.C. 
5000A(d)(2) (2018).
    \5\ Organizations that are religiously exempt include those with 
established tenets or teachings in opposition to acceptance of the 
benefits of any private or public insurance. 26 U.S.C. 1402(g)(1).
    \6\ A ``health care sharing ministry'' is an organization, 
described in section 501(c)(3) and taxed under section 501(a) of the 
Internal Revenue Code, comprising members who share a common set of 
ethical or religious beliefs and who share medical expenses among 
members in accordance with those beliefs without regard to the State 
in which a member resides or is employed. 26 U.S.C. 5000A(d)(2)(B).
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    Other Protections Related to the Performance of Advance Directives 
or Assisted Suicide. Before passage of section 1553 of the ACA, 
Congress had passed other conscience protections related to assisted 
suicide. Section 7 of the Assisted Suicide Funding Restriction Act of 
1997 (Pub. L. 105-12, 111 Stat. 23) clarified that the Patient Self-
Determination Act's provisions stating that Medicare and Medicaid 
beneficiaries have certain self-determination rights do not (1) require 
any provider, organization, or any employee of such provider or 
organization participating in the Medicare or Medicaid program to 
inform or counsel any individual about a right to any item or service 
furnished for the purpose of causing or assisting in causing the death 
of such individual, such as assisted suicide, euthanasia, or mercy 
killing; or (2) apply to or affect

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any requirement with respect to a portion of an advance directive that 
directs the purposeful causing of, or assistance in causing, the death 
of an individual, such as by assisted suicide, euthanasia, or mercy 
killing. 42 U.S.C. 14406 (by cross-reference to 42 U.S.C. 1395cc(f) 
(Medicare) and 1396a(w) (Medicaid)); see also 42 U.S.C. 1395cc(f)(4) 
(by cross-reference to 42 U.S.C. 14406); 1396a(w)(3), 1396a(a)(57); 
1396b(m)(1)(A); and 1396r(c)(2)(E).\7\ Those protections extend to 
Medicaid and Medicare providers, such as hospitals, skilled nursing 
facilities, home health or personal care service providers, hospice 
programs, Medicaid managed care organizations, health maintenance 
organizations, Medicare+Choice (now Medicare Advantage) organizations, 
and prepaid organizations.
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    \7\ Similar protections exist under the Department's regulations 
applicable to hospitals, nursing facilities, and other medical 
facilities, See, e.g., 42 CFR 489.102(c)(2); Medicare Advantage, 42 
CFR 422.128(b)(2)(ii); and Medicare Health Maintenance Organizations 
and Comprehensive Medical Plans, 42 CFR 417.436 (such organizations, 
plans, and their agents are not required to implement advance 
directives if the provider cannot do so ``as a matter of 
conscience'' and State law allows such conscientious objection).
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    Protections Related to Counseling and Referrals Under Medicare 
Advantage Plans, Medicaid Plans, and Managed Care Organizations. 
Certain Federal protections prohibit organizations offering 
Medicare+Choice (now Medicare Advantage) plans and Medicaid managed 
care organizations from being compelled under certain circumstances to 
provide, reimburse for, or cover, any counseling or referral service in 
plans over an objection on moral or religious grounds. 42 U.S.C. 1395w-
22(j)(3)(B) (Medicare+Choice); 42 U.S.C. 1396u-2(b)(3)(B) (Medicaid 
managed care organization). Department regulations provide that this 
conscience provision for managed care organizations also applies to 
prepaid inpatient health plans and prepaid ambulatory health plans 
under the Medicaid program. 42 CFR 438.102(a)(2).
    Federal Conscience and Anti-Discrimination Protections Applying to 
Global Health Programs. The Department administers certain programs 
under the President's Emergency Plan for AIDS Relief (PEPFAR), to which 
additional conscience protections apply. Specifically, recipients of 
foreign assistance funds for HIV/AIDS prevention, treatment, or care 
authorized by section 104A of the Foreign Assistance Act of 1961 (22 
U.S.C. 2151b-2), 22 U.S.C. 7601-7682, or under any amendment made by 
the Tom Lantos and Henry J. Hyde United States Global Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 
(Pub. L. 110-293), cannot be required, as a condition of receiving such 
funds, (1) to ``endorse or utilize a multisectoral or comprehensive 
approach to combating HIV/AIDS,'' or (2) to ``endorse, utilize, make a 
referral to, become integrated with, or otherwise participate in any 
program or activity to which the organization has a religious or moral 
objection.'' 22 U.S.C. 7631(d)(1)(B). The government also cannot 
discriminate against such recipients in the solicitation or issuance of 
grants, contracts, or cooperative agreements for the recipients' 
refusal to do any such actions. 22 U.S.C. 7631(d)(2).
    Exemptions from Compulsory Medical Screening, Examination, 
Diagnosis, or Treatment. This rule incorporates four statutory 
provisions that protect parents who, on the basis of conscience, object 
to their children being forced to receive certain treatments or health 
interventions. First, under the Public Health Service Act, certain 
suicide prevention programs are not to be construed to require 
``suicide assessment, early intervention, or treatment services for 
youth'' if their parents or legal guardians have religious or moral 
objections to such services. 42 U.S.C. 290bb-36(f); section 3(c) of the 
Garrett Lee Smith Memorial Act (Pub. L. 108-355, 118 Stat. 1404, 
reauthorized by Pub. L. 114-255 at sec. 9008). Second, authority to 
issue certain grants through the Health Resources and Services 
Administration (HRSA), Centers for Disease Control and Prevention 
(CDC), and the National Institutes of Health (NIH) may not be construed 
to preempt or prohibit State laws which do not require hearing loss 
screening for newborn, infants or young children whose parents object 
to such screening based on religious beliefs. 42 U.S.C. 280g-1(d). 
Third, certain State and local child abuse prevention and treatment 
programs funded by HHS are not to be construed as creating a Federal 
requirement that a parent or legal guardian provide a child any medical 
service or treatment against the religious beliefs of that parent or 
legal guardian. 42 U.S.C. 5106i(a). Fourth, in providing pediatric 
vaccines funded by Federal medical assistance programs, providers must 
comply with any State laws relating to any religious or other 
exemptions. 42 U.S.C. 1396s(c)(2)(B)(ii).
    Conscience Clauses Related to Religious Nonmedical Health Care. 
Since 1965, Congress has provided accommodations in Medicare and 
Medicaid for persons and institutions objecting to the acceptance or 
provision of medical care or services based on a belief in a religious 
method of healing through approval of religious nonmedical health care 
institutions (RNHCIs). RNHCIs do not provide standard medical 
screenings, examination, diagnosis, prognosis, treatment, or the 
administration of medications. 42 U.S.C. 1395x(ss)(1). Instead, RNHCIs 
furnish nonmedical items and services such as room and board, 
unmedicated wound dressings, and walkers,\8\ and they provide care 
exclusively through nonmedical nursing personnel assisting with 
nutrition, comfort, support, moving, positioning, ambulation, and other 
activities of daily living.\9\
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    \8\ https://www.medicare.gov/coverage/rnhci-items-and-services.html.
    \9\ https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/RNHCIs.html.
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    Congress has acknowledged RNHCIs through several statutes. For 
example, although such institutions would not otherwise meet the 
medical criteria for Medicare providers, see 42 U.S.C. 1395x(e) 
(definition of ``hospital''), 1395x(y)(1) (definition of ``skilled 
nursing facility''), 1395x(k), and 1320c-11 (exemptions from other 
medical criteria and standards), Congress expressly included them 
within the definition of designated Medicare providers. Congress 
prohibited States from excluding RNHCIs from licensure through 
implementation of State definitions of ``nursing home'' and ``nursing 
home administrator,'' 42 U.S.C. 1396g(e), and Congress exempted RNHCIs 
from certain Medicaid requirements for medical criteria and standards. 
42 U.S.C. 1396a(a) (exempting RNHCIs from 42 U.S.C. 1396a(a)(9)(A), 
1396a(a)(31), 1396a(a)(33), and 1396b(i)(4)). Finally, Congress 
permitted patients at RNHCIs to file an election with HHS stating that 
they are ``conscientiously opposed to acceptance of'' medical 
treatment, that is neither received involuntarily nor required under 
Federal or State law or the law of a political subdivision of a State, 
on the basis of ``sincere religious beliefs,'' yet remain eligible for 
the nonmedical care and services ordinarily covered under Medicare, 
Medicaid, and CHIP. See, e.g., 42 U.S.C. 1395x(e), 1395x(y), and 1395i-
5 (Medicare provisions). Federal courts have upheld the 
constitutionality of such religious accommodations. See, e.g., Kong v. 
Scully, 341 F.3d 1132 (9th Cir. 2003); Children's Healthcare v. Min De 
Parle, 212 F.3d 1084 (8th Cir. 2000).

[[Page 23174]]

    Congress has also provided particular accommodations for persons 
and institutions that object to medical services and items. Section 
6703(a) of the Elder Justice Act of 2009 (Pub. L. 111-148, 124 Stat. 
119) provides that Elder Justice and Social Services Block Grant 
programs may not interfere with or abridge an elder person's ``right to 
practice his or her religion through reliance on prayer alone for 
healing,'' when the preference for such reliance is contemporaneously 
expressed, previously set forth in a living will or similar document, 
or unambiguously deduced from such person's life history. 42 U.S.C. 
1397j-1(b). Additionally, the Child Abuse Prevention and Treatment Act 
(CAPTA) specifies that it does not require (though it also does not 
prevent) a State finding of child abuse or neglect in cases in which a 
parent or legal guardian relies solely or partially upon spiritual 
means rather than medical treatment, in accordance with religious 
beliefs. 42 U.S.C. 5106i(a)(2).

B. Regulatory History

    The Department engaged in rulemaking to enforce some of these 
Federal conscience and anti-discrimination laws on previous occasions: 
In the 2008 final rule at 45 CFR part 88 (the ``2008 Rule,'' 73 FR 
78072, 78074 (Dec. 19, 2008)), in the revocation and replacement of 
that Rule in 2011 (the ``2011 Rule''), and in existing CMS regulations 
at 42 CFR parts 422 and 438, which implement 1395w-22(j)(3)(b) and 
1396u-2(b)(3)(B), respectively.\10\ This section of the preamble 
briefly summarizes the first two actions.
---------------------------------------------------------------------------

    \10\ For instance, the prohibition against coercion in 42 U.S.C. 
1395w-22(j)(3) (section 1852 of the Social Security Act) is 
regulated within the Medicare Program at 42 CFR 422.206(b), (d).
---------------------------------------------------------------------------

    2008 Rule. The Department issued a notice of proposed rulemaking in 
2008 to enforce, and clarify the applicability of, the Church, Coats-
Snowe, and Weldon Amendments. 73 FR 50274 (Aug. 26, 2008) (August 2008 
Proposed Rule). That proposed rule recognized (1) inconsistent 
awareness of Federal conscience and anti-discrimination protections 
among federally funded recipients and protected persons and entities; 
and (2) the need for greater enforcement mechanisms to ensure that 
Department funds do not support morally coercive or discriminatory 
policies or practices in violation of Federal law.
    The Department received a ``large volume'' of comments on the 
August 2008 Proposed Rule. See 73 FR at 78074. Comments came from a 
wide variety of individuals and organizations, including private 
citizens, individual and institutional health care providers, religious 
organizations, patient advocacy groups, professional organizations, 
universities and research institutions, consumer organizations, and 
State and Federal agencies and representatives. Comments dealt with a 
range of issues surrounding the proposed rule, including whether the 
rule was needed, what individuals would be protected by the proposed 
rule, what services would be covered by the proposed rule, whether 
health care workers would use the regulation to discriminate against 
patients, what significant implementation issues could be associated 
with the rule, what legal arguments could be made for and against the 
rule, and what cost impacts of the proposed rule could be anticipated. 
Many comments confirmed the need to promulgate a regulation to raise 
awareness of Federal conscience and anti-discrimination protections and 
provide for their enforcement.
    The Department responded to those substantive comments and issued a 
final rule on December 19, 2008, codifying the rule at 45 CFR part 88 
(``2008 Rule''), which consisted of six sections:
    Section 88.1 stated that the purpose of the 2008 Rule was ``to 
provide for the implementation and enforcement'' of the Church, Coats-
Snowe, and Weldon Amendments. It specified that those Amendments and 
the implementing regulations ``[we]re to be interpreted and implemented 
broadly to effectuate their protective purposes.''
    Section 88.2 of the 2008 Rule defined several terms used in part 88 
and applicable to various provider nondiscrimination protections, 
namely, the terms ``Assist in the Performance,'' ``Entity,'' ``Health 
Care Entity,'' ``Health Service Program,'' ``Individual,'' 
``Instrument,'' ``Recipient,'' ``Sub-recipient,'' and ``Workforce.''
    Section 88.3 of the 2008 Rule set forth the scope of applicability 
of the sections and paragraphs of part 88 as they related to each 
conscience law implemented in the 2008 Rule.
    Section 88.4 of the 2008 Rule set forth the substantive 
requirements and applications of the Church, Coats-Snowe, and the 
Weldon Amendments.
    Section 88.5 of the 2008 Rule required covered federally funded 
entities to provide written certification of compliance with the laws 
encompassed by the 2008 Rule.
    Section 88.6 of the 2008 Rule designated HHS OCR to receive 
complaints based on the three specified Federal conscience and anti-
discrimination laws, and directed OCR to coordinate handling those 
complaints with the Departmental components from which the covered 
entity receives funding.
    Proposed Changes in 2009 Resulting in New Final Rule in 2011. On 
March 10, 2009, with the advent of a new Administration, the Department 
proposed to rescind, in its entirety, the 2008 Rule. 74 FR 10207 (Mar. 
10, 2009) (2009 Proposed Rule). The Department declared that certain 
comments on the August 2008 Proposed Rule raised a number of questions 
warranting further review of the 2008 Rule to ensure its consistency 
with that Administration's policy. The Department invited further 
comments to reevaluate the necessity for regulations implementing the 
Federal conscience and anti-discrimination laws. In response to the 
proposal to rescind the 2008 Rule, for which the Department received 
supporting comments, the Department also received comments stating that 
health care workers should not be required to violate their religious 
beliefs or moral convictions; expressing concern that health care 
providers would be coerced into violating their consciences; and 
identifying the 2008 Rule as protecting First Amendment religious 
freedom rights, the capacity to uphold the tenets of the Hippocratic 
Oath, and the ethical integrity of the medical profession. Numerous 
commenters identified concerns that there would be no regulatory scheme 
to protect the legal rights afforded to health care providers, 
including medical students. 76 FR 9968, 9971 (Feb. 23, 2011) (2011 
Rule).
    On February 23, 2011, the Department rescinded most of the 2008 
Rule and finalized a new rule. 76 FR 9968. The 2011 Rule left in place 
section ``88.1 Purpose,'' but removed the word ``implementation,'' 
describing the 2011 Rule's purpose as ``provid[ing] for the 
enforcement'' of the Church, Coats-Snowe, and Weldon Amendments. It 
then removed the 2008 Rule's sections 88.2 through 88.5, redesignated 
the 2008 Rule's Sec.  88.6 as Sec.  88.2, and modified that section to 
consist of two sentences, stating that OCR is designated to receive 
complaints based on the Federal health care provider conscience 
protection statutes, and will coordinate the handling of complaints 
with the Departmental funding component(s) from which the entity with 
respect to which a complaint has been filed, receives funding.
    The preamble to the 2011 Rule stated, ``The Department supports 
clear and strong conscience protections for health care providers who 
are opposed to performing abortions.'' 76 FR at 9969. The Department 
recognized, ``The

[[Page 23175]]

comments received suggested that there is a need to increase outreach 
efforts to make sure providers and grantees are aware of these 
statutory protections. It is also clear that the Department needs to 
have a defined process for health care providers to seek enforcement of 
these protections.'' 76 FR at 9969. Accordingly, the summary of the 
2011 Rule stated that ``enforcement of the Federal statutory health 
care provider conscience protections will be handled by the 
Department's Office for Civil Rights, in conjunction with the 
Department's funding components.'' 76 FR at 9968. The Department 
announced that OCR was beginning to lead ``an initiative designed to 
increase the awareness of health care providers about the protections 
provided by the health care provider conscience statutes, and the 
resources available to providers who believe their rights have been 
violated.'' 76 FR at 9969. The 2011 Rule provided that OCR would 
``collaborate with the funding components of the Department to 
determine how best to inform health care providers and grantees about 
health care conscience protections, and the new process for enforcing 
those protections.'' Id.

II. Overview of the Final Rule

A. Overview of Reasons for the Final Rule

    After reviewing the previous rulemakings, comments from the public, 
and OCR's enforcement activities, the Department has concluded that 
there is a significant need to amend the 2011 Rule to ensure knowledge 
of, compliance with, and enforcement of, Federal conscience and anti-
discrimination laws. The 2011 Rule created confusion over what is and 
is not required under Federal conscience and anti-discrimination laws 
and narrowed OCR's enforcement processes. Since November 2016, there 
has been a significant increase in complaints filed with OCR alleging 
violations of the laws that were the subject of the 2011 Rule, compared 
to the time period between the 2009 proposal to repeal the 2008 Rule 
and November 2016. The increase underscores the need for the Department 
to have the proper enforcement tools available to appropriately enforce 
all Federal conscience and anti-discrimination laws.\11\
---------------------------------------------------------------------------

    \11\ Since 2011, conscience and coercion in health care have 
been the subjects of significant litigation at the State and local 
level. Recently, the Supreme Court held that the State of California 
likely violated the Free Speech rights of prolife pregnancy resource 
centers that do not provide information about where to obtain 
abortions by adopting a statute that required them, among other 
things, to post notices to which they objected. See Nat'l Inst. of 
Family and Life Advocates v. Becerra, 138 S. Ct. 2361 (Jun. 26, 
2018).
---------------------------------------------------------------------------

    Allegations and Evidence of Discrimination and Coercion Have 
Existed Since the 2008 Rule and Increased Over Time. The 2008 Rule 
sought to address an environment of discrimination toward, and 
attempted coercion of, those who object to certain health care 
procedures based on religious beliefs or moral convictions.\12\ Yet in 
February 2009, the Department announced its intent to rescind the 2008 
Rule just one month after its effective date.\13\ It completed that 
rescission in 2011, despite significant evidence of an environment of 
discrimination and coercion, including thousands of public comments 
during the rulemakings that led to the 2008 and 2011 Rules describing 
that environment. For example, a 2009 article in the New England 
Journal of Medicine argued, ``Qualms about abortion, sterilization, and 
birth control? Do not practice women's health.'' \14\ In a 2009 survey 
of 2,865 members of faith-based medical associations, 39% reported 
having faced pressure or discrimination from administrators or faculty 
based on their moral, ethical, or religious beliefs.\15\ Additionally, 
32% of the survey respondents reported having been pressured to refer a 
patient for a procedure to which they had moral, ethical, or religious 
objections. Some 20% of medical students in that poll said that they 
would not pursue a career in obstetrics or gynecology because of 
perceived discrimination and coercion in that specialty against their 
beliefs. In total, 91% of respondents reported that they ``would rather 
stop practicing medicine altogether than be forced to violate [their] 
conscience.''
---------------------------------------------------------------------------

    \12\ 73 FR at 78073.
    \13\ Rob Stein, ``Obama Plans to Roll Back `Conscience' Rule 
Protecting Health Care Of Workers Who Object to Some Types of 
Care,'' The Washington Post (Feb. 28, 2009) http://www.washingtonpost.com/wp-dyn/content/article/2009/02/27/AR2009022701104.html (writing that ``The administration's plans, 
revealed quietly with a terse posting on a Federal website, 
unleashed a flood of heated reaction'').
    \14\ Julie D. Cantor, M.D., J.D., ``Conscientious Objection Gone 
Awry--Restoring Selfless Professionalism in Medicine,'' 360 New 
England J. Med. 1484-85 (April 9, 2009).
    \15\ The Polling Company, Inc./WomanTrend, Highlights of The 
Polling Company, Inc. Phone Survey of the American Public, fielded 
March 31, 2009 through April 3, 2009), https://www.cmda.org/library/doclib/pollingsummaryhandout.pdf (last visited Jan. 18, 2018); see 
also Public Comment from Jonathan Imbody, Christian Medical 
Association, (``CMA Comment''), available at https://www.regulations.gov/document?D=HHS-OCR-2018-0002-64461.
---------------------------------------------------------------------------

    Comments received during the rulemaking that led to the 2011 Rule 
were consistent with this survey. Multiple commenters reported that 
some hospitals had forced health care providers to sign affidavits 
agreeing to participate in abortions if asked.\16\ One obstetrician/
gynecologist commented that he had been pressured to participate in 
abortions and abortion counseling during his entire time in health 
care--from medical school, through his residency, and during private 
practice.\17\ Medical and nursing students, in twenty-five comments, 
expressed their reluctance to enter the health care field as a whole, 
and particularly specialties such as obstetrics, family medicine, and 
elder care, where their objections to abortion or euthanasia might not 
be respected.\18\ At least ninety commenters said that, if forced to 
choose between their careers or violating their conscience, they would 
quit their jobs.\19\ Tens of

[[Page 23176]]

thousands of comments to the 2009 proposed rule expressed concern that, 
without robust enforcement of Federal conscience and anti-
discrimination laws, individuals with conscientious objections simply 
would not enter the health care field, or would leave the profession, 
and hospitals would shut down, contributing to the shortage of health 
care providers or affecting the quality of care provided.\20\ Thousands 
also feared personnel with objections would be terminated or otherwise 
unable to find employment, training, or opportunities to advance in 
their fields.\21\
---------------------------------------------------------------------------

    \16\ Comment Nos. HHS-OPHS-2009-0001-0739, -52648, -52677.
    \17\ Comment No. HHS-OPHS-2009-0001-0868.
    \18\ Comment Nos. HHS-OPHS-2009-0001-0026, -1035, -10522, -
12117, -14427, -34439, -11404 (``future physician'' concerned about 
shortages), -35236 (granddaughter entering the medical profession 
will change career path), -11579 (son entering the medical 
profession), -14435 (concerned mother of medical student), -18783 
(spoke to student who is distraught and may leave), -5571, -41431 
(sister is a medical student), -5638, -0068, -1791 (student would 
quit job), -2750 (exacerbates healthcare issues), -5255 (opposed and 
has used exemption), -7058, -7276, -7671, -5270 (has already seen 
others leave the profession over pressure for their beliefs), -5638, 
-5566 (nurse who chose not to specialize in obstetrics and 
gynecology for fear of pressure), -5566 (nurse who chose not to 
enter obstetrics and gynecology because of pressure to perform 
abortions).
    \19\ Almost 90 comments are cited here, but this is merely a 
sample of the total. See Comment Nos. HHS-OPHS-2009-0001-0540, -
0017, -0264, -0350, -0356, -0485, -0540, -0880, -0881, -0902, -0917, 
-0932, -10154, -15148, -20381 (woman in California whose daughter is 
a nurse), -23290 (already left the profession), -32951, -9188, -
47007 (patient's doctor said he would retire), -14287, -19128, -
9873, -29603 (physician stating many will retire), -50498 (patient's 
doctor said he would retire), -27384, -44458, -18837, -14216, -
18015, -18015, -34140 (already retired but would have retired 
earlier), -32593, -15341, -14837, -8582, -16541, -11579 (patient's 
doctor said he would retire), -0229, -51896 (children would be 
forced to leave), -32009 (other physicians will be driven out), -
10280 (physician with objections), -19029, -33116, -50663, -3675, -
24456, -11327, -19221, -34888 (nurse saying others will leave), -
14535 (daughter will leave the profession), -21679 (four members in 
the family who may leave), -0283, -0340, -0905, -9272, -0055 (will 
give up serving underserved population), -10862 (two sisters who are 
nurses will leave, hospital shut down), -17401, -29674 (son who is a 
physician will be forced out), -26795 (physician who says doctors 
will be forced out), -25742, -49731, -15087, -13138, -17563, -0006 
(refuse to accept violation of beliefs in practice), -0815, -7665, -
8091, -2598 (private family physician who intentionally avoided 
obstetrics because it was made clear that ``pro-life candidates need 
not apply''; also cites strong pressure in universities and 
organizations in favor of abortion provision, and is concerned 
physicians will leave the practice more), -3564, -0199, -5230 
(discrimination already present), -6603, -1397 (nurse who has been 
forced to do things against her conscience in the past before the 
2008 Rule came into effect, and who will quit if put in that 
scenario again), -1100 (nurse who says others will leave the 
practice), -6669, -0272, -0925, -0125, -4668, -6709, -7900, -2544, -
3535, -1852, -7684, -1381.
    \20\ Comment Nos. HHS-OPHS-2009-0001-20613, -43039, -27699, -
42804, -6001, -10850, -27147, -50621, -52878, -19586, -40775, -4824, 
27384, -11138, -52997, -53001, -4460, -12878, -12575, -43364, -
27262, -42942, -26426, -38158, -43672, -52381, -32173, -16541, -
19751, -2697, -52935, -6369, -44571, -53022, -48387, -21990, -50837, 
-42069, -14662, -51974, -45449, -17364, -5370, -2922, -15005, -
18783, -23376, -50685, -17401, -52946, -11206, -33828, -38997, -
3925, -21036, -50894, -27155, -10529, -47113, -7266, -22291, -4016, 
-0204, -8788, -25608, -52932, -39199, -12340, -52950 (form letter 
with 1,916 copies), -31897, -52984 (form letter with 62 copies), -
53081 (form letter with 22 copies), -52968 (form letter with 9,532 
copies), -52961 (patients concerned about access to pro-life 
doctors: Form letter with 3,272 copies), -53098 (patients concerned 
effort to push people out: Form letter with 976 copies), -52977 
(form letter with 3,516 copies), -53021 (form letter with 4,842 
copies), -52949 (form letter with 688 copies), -53039 (form letter 
with 742 copies), -0476.
    \21\ Comment Nos. HHS-OPHS-2009-0001-0558, -10144, -53026 
(claims documentation of unaddressed discrimination), -52985 (claims 
documentation of unaddressed discrimination), -52960 (claims 
documentation of unaddressed discrimination), -52735 (lack of 
knowledge about rights), -53048 (evidence of discrimination), -53047 
(evidence of discrimination: Form letter with 3,196 copies), -52960 
(evidence of discrimination: Form letter with 1,685 copies), -53028 
(evidence of discrimination: Form letter with 2,002 copies).
---------------------------------------------------------------------------

    Commenters also identified a culture of hostility to conscience 
concerns in health care.\22\ Some expressed concern that the rescission 
of the 2008 Rule would contribute to these problems by inappropriately 
politicizing, and interfering in, the practice of medicine and 
individual providers' judgment.\23\ Thousands of comments from medical 
personnel stated their disagreement with the rescission, often stating 
that they had requested exemptions in the past and were concerned 
rescission would make it harder to request exemptions in the 
future.\24\ Hundreds of commenters expressed concern over the exclusion 
and marginalization of health care entities and employees holding 
religious beliefs or moral convictions, and fears that the moral agency 
of the medical profession was eroding.\25\
---------------------------------------------------------------------------

    \22\ Comment Nos. HHS-OPHS-2009-0001-0739, -52677, -26812, -
53013 (form letter with 8,472 copies).
    \23\ Comment No. HHS-OPHS-2009-0001-10280, -2486, -46903, -
19125, -36940, -12020, -41551.
    \24\ Comment Nos. HHS-OPHS-2009-0001-3107, -15617, -19496, -
27506, -9586, -35721, -49748, -1650, -19965, -18365, -23095, -6332, 
-3405, -1762, -4395, -4569, -6890, -0729, -0943, -1490, -2994, -
3248, -3419, -5341, -6479, -7079, -4525, -7093, -2486, -2039, -7750, 
-6270, -1903, -3293, -3405, -1127, -5505, -1823, -4939, -5881, -
4529, -5829, -1773, -2220, -2345, -3089, -7163, -7471, -3840, -0389, 
-1933, -3493, -3088, -5088, -5702.
    \25\ Comment Nos. HHS-OPHS-2009-0001-52974 (form letter with 428 
copies).
---------------------------------------------------------------------------

    According to news reports, in 2010, Nassau University Medical 
Center disciplined eight nurses when they raised objections to 
assisting in the performance of abortions.\26\ Nurses in Illinois and 
New York filed lawsuits against private hospitals alleging they had 
been coerced to participate in abortions. Mendoza v. Martell, No. 2016-
6-160 (Ill. 17th Jud. Cir. June 8, 2016); Cenzon-DeCarlo v. Mount Sinai 
Hosp., 626 F.3d 695 (2d Cir. 2010). A nurse-midwife in Florida alleged 
she had been denied the ability to apply for a position at a federally 
qualified health center due to her objections to prescribing hormonal 
contraceptives. Hellwege v. Tampa Family Health Ctrs., 103 F. Supp. 3d 
1303 (M.D. Fla. 2015). Twelve nurses in New Jersey sued a public 
hospital over a policy allegedly requiring them to assist in abortions 
and for disciplining one nurse who raised a conscientious objection to 
the same. Complaint, Danquah v. University of Medicine and Dentistry of 
New Jersey, No. 2:11-cv-6377 (D.N.J. Oct. 31, 2011). Many religious 
health care personnel and faith-based medical entities have further 
alleged that health care personnel are being targeted for their 
religious beliefs.\27\
---------------------------------------------------------------------------

    \26\ LI Hospital issues abortion apology to nurses, N.Y. Post 
(Apr. 28, 2010), http://nypost.com/2010/04/28/li-hospital-issues-abortion-apology-to-nurses.
    \27\ See, e.g., Roman Catholic Diocese of Albany v. Vullo, No. 
02070-16 (N.Y. Albany County S. Ct. May 4, 2016); Means v. U.S. 
Conference of Catholic Bishops, No. 1:15-CV-353, 2015 WL 3970046 
(W.D. Mich. 2015); ACLU v. Trinity Health Corporation, 178 F. Supp. 
3d 614 (E.D. Mich. 2016); Minton v. Dignity Health, No. 17-558259 
(Calif. Super. Ct. Apr. 19, 2017); Chamorro v. Dignity Health, No. 
15-549626 (Calif. Super. Ct. Dec. 28, 2015). 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.'' \28\
---------------------------------------------------------------------------

    \28\ 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 
v. Becerra, No. 16-1140, 585 U.S. __, 138 S. Ct. 2361 (Jun. 26, 2018) 
(``NIFLA'').\29\
---------------------------------------------------------------------------

    \29\ 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.

---------------------------------------------------------------------------

[[Page 23177]]

    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. v. 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. v. 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 v. 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 v. 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 v. 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 v. Rauner, No. 
3:16-cv-50310 (N.D. Ill. Sept. 29, 2016) (preliminary injunction 
entered on free speech grounds); Calvary Chapel Pearl Harbor v. 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 v. Harris, No. 
5:16-cv-00119 (C.D. Cal. July 8, 2016) (denying preliminary 
injunction); A Woman's Friend Pregnancy Resource Clinic v. Harris, 153 
F. Supp. 3d 1168 (E.D. Cal. Dec. 21, 2015); Livingwell Medical Clinic 
v. 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.\30\ 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.'' \31\
---------------------------------------------------------------------------

    \30\ 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.
    \31\ Id. at 9.
---------------------------------------------------------------------------

    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.'' \32\ 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.'' \33\ 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.\34\
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    \32\ 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).
    \33\ 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).
    \34\ 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.
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    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).\35\ 
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 v. Rouillard, 2:15-cv-02165-KJM-EFB, 2016 WL 3688422 (E.D. Cal. 
July 11, 2016); Skyline Wesleyan Church v. 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 v. Vullo, No. 02070-16 (N.Y. Albany County 
Sup. Ct. May 4, 2016).
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    \35\ 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. v. 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.\36\
---------------------------------------------------------------------------

    \36\ 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.

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[[Page 23178]]

    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. See Means v. U.S. Conference of Catholic Bishops, No. 1:15-CV-
353, 2015 WL 3970046 (W.D. Mich. 2015) (abortion); ACLU v. Trinity 
Health Corp., 178 F.Supp.3d 614 (E.D. Mich. 2016) (abortion); Minton v. 
Dignity Health, No. 17-558259 (Cal. Super. Ct. Apr. 19, 2017) 
(hysterectomy); Chamorro v. 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 v. 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 v. 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 v. 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 v. 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, v. 
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

[[Page 23179]]

the State of California filed in 2014.\37\ 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.\38\ 
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.\39\
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    \37\ OCR Complaint Nos. 14-193604, 15-193782, and 15-195665.
    \38\ Letter from OCR Director to Complainants (June 21, 2016) 
available at http://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf.
    \39\ 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.
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    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.'' \40\
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    \40\ 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 v. 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

[[Page 23180]]

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).\41\ 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.
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    \41\ 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.
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    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.\42\ 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.\43\ 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.\44\
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    \42\ 73 FR at 78080-81 (Dec. 19, 2008).
    \43\ 73 FR at 78081.
    \44\ Id.
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    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.\45\ 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.
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    \45\ 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.'').
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    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

[[Page 23181]]

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.\46\ 
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.
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    \46\ 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,\47\ 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.
---------------------------------------------------------------------------

    \47\ 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.\48\ 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.
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    \48\ 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.'' \49\ 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.
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    \49\ 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/.
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    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

[[Page 23182]]

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.\50\ 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.
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    \50\ 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.'').
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    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

[[Page 23183]]

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 \51\ 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.
---------------------------------------------------------------------------

    \51\ 73 FR at 78087-88.
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    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

[[Page 23184]]

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

[[Page 23185]]

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,\52\ and Qualified Health Plans offering individual market 
coverage on State exchanges.
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    \52\ 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)].
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    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 Sec.  6.4 (4th ed. 2002). This rule does 
not substantively alter or amend the obligations of the respective 
statutes, JEM Broad. v. FCC, 22 F.3d 320 (D.C. Cir. 1994), and the 
definitions offered in this rule are reasonably drawn from the existing 
statutes. Hoctor v. 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

[[Page 23186]]

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 53
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    \53\ Unless indicated otherwise, the Department adopts the 
regulation text as proposed.
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Purpose (Sec.  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 Sec.  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 \54\ 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 Sec.  88.3 
of this part.''
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    \54\ 83 FR 3880, 3892.
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Definitions (Sec.  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

[[Page 23187]]

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.\55\ 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.
---------------------------------------------------------------------------

    \55\ 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

[[Page 23188]]

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'' \56\ 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.\57\ 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.\58\
---------------------------------------------------------------------------

    \56\ 42 U.S.C. 1395dd(a).
    \57\ 42 CFR 489.24(b)(3) and (4).
    \58\ Morales v. 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 v. 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,\59\ and many hospitals and 
health care facilities likely require some kind of counseling as a 
prerequisite to abortion of their own accord.
---------------------------------------------------------------------------

    \59\ 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

[[Page 23189]]

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 \60\ 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.''
---------------------------------------------------------------------------

    \60\ 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 \61\ and above, the Department adopts the definition of 
``Department'' as proposed.
---------------------------------------------------------------------------

    \61\ 83 FR 3880, 3892.
---------------------------------------------------------------------------

    Discriminate or Discrimination. The Department proposed 
``discriminate or discrimination,'' 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

[[Page 23190]]

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.
    Response: Discrimination standards usually do not limit themselves 
to an exclusive list of discriminatory actions, because adverse action 
based on prohibited grounds can take various forms depending on the 
facts and circumstances of the case. This rule encompasses several 
statutes barring discrimination. As such, the Department believes it is 
appropriate for this definition to encompass an array of actions that 
might be taken against a person on the basis of such person's exercise 
of the rights protected by Federal conscience and anti-discrimination 
laws. On the other hand, the Department agrees in part with commenters 
that the language ``any activity reasonably regarded as 
discrimination'' does not provide precise guidance on the scope of the 
definition. Therefore the Department will finalize the definition of 
``discriminate or discrimination'' by deleting proposed paragraph (4). 
The Department will also change the word ``means'' to ``includes'' in 
the opening phrase of the discrimination definition, and change the 
phrase ``as permitted by the applicable statute'' to ``to the extent 
permitted by the applicable statute.'' This will maintain the 
definition's description of types of discrimination, and ensure that 
the definition only applies to the extent it is authorized by the 
applicable statute, while also rendering the descriptions in the 
definition non-exclusive, so OCR can consider other actions that might 
constitute discrimination in violation of an applicable Federal 
conscience and anti-discrimination law to which this part applies.
    Any allegation of discrimination under the laws to which this part 
applies will be considered in light of a reasonable interpretation of 
applicable law and an application of that law to the facts. By making 
the definition inclusive, instead of exclusive, by use of the word 
``includes,'' the definition will not exclude the types of actions that 
constitute discrimination but might not fall squarely into one of the 
descriptions set forth in paragraphs (1) to (3) of the definition. 
Additionally, in light of the language added to address concerns with 
respect to how this definition interacts with reasonable 
accommodations, the Department believes that making the definition 
inclusive, while eliminating proposed paragraph (4), ensures that the 
definition is not overly broad.
    Comment: The Department received comments stating that the proposed 
definition of ``discriminate or discrimination'' conflicts with or is 
inconsistent with other Federal laws such as Title VII of the Civil 
Rights Act and Title X of the Public Health Service Act.
    Response: The Department disagrees that these regulations conflict 
with statutes applicable to the Title X family planning program under 
the Public Health Service Act. The Department agrees that regulations 
finalized in 2000 governing the Title X program, which in some cases 
required referrals, information, and counseling about abortion, 
conflicted with certain Federal conscience and anti-discrimination laws 
and, consequently, with this rule. The Department acknowledged this 
conflict in the preamble to the 2008 Rule (73 FR at 78087), in the 
preamble to the notice of proposed rulemaking for the Title X 
regulations in 2018 (83 FR 25502, 25506 (June 1, 2018)), and in the 
preamble to the Title X final rule published in 2019 (84 FR 7714, 7716 
(March 4, 2019)). In all three instances the Department stated it would 
operate the Title X program in compliance with Federal conscience and 
anti-discrimination laws, notwithstanding the language of the 2000 
Title X regulations.\62\ The

[[Page 23191]]

recently published Title X final rule revised the 2000 Title X 
regulations to eliminate that conflict and achieve consistency with 
Federal conscience statutes. Nothing in the Title X statute itself or 
in appropriations restrictions applicable to Title X funding requires 
abortion referrals, counseling, or information. This includes 
Congress's directive that, in Title X programs, ``all pregnancy 
counseling shall be nondirective.'' \63\ That provision does not 
address referrals or information, only counseling, and does not require 
pregnancy counseling, but merely specifies that, if pregnancy 
counseling occurs, it shall be nondirective--and now the regulation 
permits, but does not require abortion counseling and information (and 
bars abortion referrals). Accordingly, this rule is consistent with 
both Title X and the Federal conscience and anti-discrimination 
laws.\64\
---------------------------------------------------------------------------

    \62\ In addition, in the preamble to the 2000 Title X 
regulations, the Department acknowledged the implications of the 
Church Amendment when it addressed a comment that the requirement to 
provide options counseling ``should not apply to employees of a 
grantee who object to providing such counseling on moral or 
religious grounds,'' and rejected it, contending that it is not 
necessary because, under the Church Amendments, ``grantees may not 
require individual employees who have such objections to provide 
such counseling,'' but ``in such cases the grantees must make other 
arrangements to ensure that the service is available to Title X 
clients who desire it.'' 65 FR 41270, 41274 (July 3, 2000). At the 
time, the Department apparently did not consider the implications of 
the Coats-Snowe Amendment, adopted in 1996, with respect to Title X 
grantees and applicants; the Weldon Amendment was adopted 
subsequently.
    \63\ See 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, 132 Stat. 
2981, 3070-71.
    \64\ The Department acknowledges that, as of the date of 
publication of this final rule, several district courts have issued 
preliminary injunctions, on a nationwide basis, against the 
enforcement or implementation of the 2019 Title X final rule, and 
requiring the Title X program to maintain the status quo under the 
2000 Title X regulations. Those injunctions do not purport to 
otherwise enjoin the Department's enforcement of the Federal 
conscience and anti-discrimination laws. Since at least 2008, under 
the 2000 Title X regulations, the Department has recognized that it 
cannot, by regulation, require abortion counseling or referral by a 
Title X applicant, grantee, project, clinic, or provider where such 
requirement would constitute a violation of one or more of the 
Federal conscience and anti-discrimination laws, and the Department 
has stated that it operates the Title X program accordingly. The 
2019 Title X final rule memorialized HHS's longstanding recognition 
that Federal conscience and anti-discrimination laws bar enforcement 
of certain requirements of the 2000 Title X regulations, but the 
2019 Title X final rule did not alter HHS's preexisting policy 
dating back at least to 2008 of not enforcing requirements of the 
2000 regulations where they may conflict with the Federal conscience 
statutes as explained in this rule. This rule, similarly, does not 
alter that status quo, but sets forth general processes for 
enforcement of the Federal conscience and anti-discrimination laws. 
The Department will implement all of its programs consistent with 
the Federal conscience and anti-discrimination laws and with any 
applicable court orders.
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    With respect to Title VII, the Department agrees with some 
commenters that the definition of ``discriminate or discrimination'' as 
proposed does not function in the same way as the approach set forth in 
Title VII, specifically regarding parts of the reasonable accommodation 
of religion standard set forth under Title VII. The Department believes 
components of that approach are appropriate in this context and is 
therefore adding a new paragraph (4) to the definition of 
``discriminate or discrimination'' to properly recognize that the 
voluntary acceptance of an effective accommodation of protected 
conduct, religious beliefs, or moral convictions, will not, by itself, 
constitute discrimination. Further, the Department will take into 
account an entity's adoption and implementation of policies to 
accommodate objecting persons in making determinations of 
discrimination. The Department finds this approach appropriate because 
it is generally consistent with the text and intent of Federal 
conscience and anti-discrimination laws to respect objections based on 
religious beliefs by accommodating them. The Department's approach will 
differ from Title VII, however, by not incorporating the additional 
concept of an ``undue hardship'' exception for reasonable 
accommodations under Title VII. Despite having previously enacted Title 
VII, Congress did not adopt an undue hardship exception for the 
protections found in Federal conscience and anti-discrimination laws 
that are the subject of this rule. The Department believes Congress's 
decision to take a different approach in Title VII as compared to 
Federal conscience and anti-discrimination laws is consistent with the 
fact that Title VII's comprehensive regulation of American employers 
applies in far more contexts, and is more vast, variable, and 
potentially burdensome (and, therefore, warranting of greater 
exceptions) than the more targeted conscience statutes that are the 
subject of this rule, which are health care specific, and often 
procedure specific, and which are specific to the exercise of 
Congress's Spending Clause authority. Therefore, the Department deems 
it appropriate to recognize that, when appropriate accommodations are 
made for objections protected by Federal conscience and anti-
discrimination laws, those accommodations do not themselves constitute 
discrimination. The Department also finds it appropriate not to adopt 
the undue hardship exception for enforcing Federal conscience and anti-
discrimination laws because Congress chose not to place that limitation 
on the protections set forth in the Federal conscience and anti-
discrimination laws.
    Comment: The Department received comments expressing concern that 
the proposed definition of ``discriminate or discrimination'' would 
prohibit employers from accommodating religious objections by placing 
the conscientious objector in a different position, potentially 
requiring the double-staffing of certain positions.
    Response: The Department agrees with this concern in part. As 
discussed above, the Department is adding language in response to 
public comments to acknowledge the reasonable accommodations that 
entities make for persons protected by Federal conscience and anti-
discrimination laws. In this way, the Department recognizes that 
staffing arrangements can be acceptable accommodations in certain 
circumstances. The Department has addressed this through the addition 
of a new paragraph (4) in the definition of ``discriminate or 
discrimination'' that recognizes the effective and timely accommodation 
of an employee (which may include non-retaliatory staff rotations) as 
not constituting discrimination. Additionally, to address concerns 
raised by these commenters, the Department is adding new paragraphs (5) 
and (6) to clarify that, within limits, employers may require a 
protected employee to inform them of objections to referring for, 
participating, or assisting in the performance of specific procedures, 
programs, research, counseling, or treatments to the extent there is a 
reasonable likelihood \65\ that the protected entity or invidivdual may 
be asked in good faith to refer for, participate in, or assist in the 
performance of such conduct, and that the employer may use alternate 
staff or methods to provide or further any objected-to conduct, subject 
to certain limitations designed to protect the objecting person.
---------------------------------------------------------------------------

    \65\ For example, nurses assigned exclusively to nursing homes 
for elderly patients would not be expected to refer or assist in the 
performance of any sterilization procedures or abortions, and, thus, 
it would be inappropriate for an entity subject to the prohibitions 
in this rule to require such nurses to disclose whether or not they 
have any objections to referring or assisting in such procedures.
---------------------------------------------------------------------------

    On the other hand, as a general matter, it is not an acceptable 
practice under Federal conscience and anti-discrimination laws for 
covered entities to deem persons with religious or moral objections to 
covered practices, such as abortion, to be disqualified for certain job 
positions on that basis. For example, a hospital receiving Public 
Health Service Act funds could not deem a doctor or a nurse with a 
religious objection to performing abortions to be ineligible to 
practice obstetrics and gynecology on that basis. An important purpose 
of laws such as the Church Amendments is to prevent fields such as

[[Page 23192]]

obstetrics and gynecology from being purged of pro-life personnel just 
because abortion is legal and some health care entities perform them. 
In this sense, the Department disagrees with commenters who essentially 
contend that pro-life medical personnel can be placed outside of 
women's health positions for that reason. The Department need not 
address in this rule whether a covered entity could disqualify a person 
with religious or moral objections to covered practices if such covered 
practices made up the primary or substantial majority of the duties of 
the position, as the Department is not aware of any instances in which 
individuals with religious or moral objections to such practices have 
sought out such jobs.
    Overall, under new paragraph (6) of the definition, taking steps to 
use alternate staff or methods to provide for or further the objected-
to conduct would not run afoul of the definition of discrimination, or 
constitute a prohibited referral, if the employer or program does not 
require any additional action by the objecting individual or health 
care entity and if such methods do not exclude individuals from areas 
or fields of practice on the basis of their protected objections. The 
employer may also inform the public of the availability of alternate 
staff or methods to provide or further the objected-to conduct, if 
doing so does not constitute retaliation or other adverse action 
against the objecting individual or health care entity. For example, an 
employer may post such a notice and a phone number in a reception area 
or at a point of sale, but may not list staff with conscientious 
objections by name if such singling out constitutes retaliation.
    The definition also clarifies that employers cannot use information 
gained from this process to discriminate against any protected entity 
or employee, and any attempts to, for example, ask questions of 
prospective employees or grant applicants concerning potential 
objections before hiring or a grant award will require a persuasive 
justification because of the risk of unlawful but difficult-to-detect 
``screening'' of applicants.
    The Department believes these modifications to the scope of 
prohibited discrimination under this final rule strike the right 
balance by respecting the interests of employers and entities that wish 
to provide services allowed by their consciences; respecting the 
interests, privacy, and conscience of patients and customers; and 
respecting the conscience of employees and health care entities 
protected by the laws passed by Congress that are the subject of this 
rule.
    Comment: The Department received comments stating that the proposed 
definition of ``discriminate or discrimination'' would turn any adverse 
action taken against a protected party for any reason into per se 
unlawful discrimination.
    Response: The Department disagrees. The definition of 
``discriminate or discrimination'' does not trigger violations based on 
any adverse action whatsoever, but must be read in the context of each 
underlying statute at issue, any other related provisions of the rule, 
and the facts and circumstances. In this rule, the prohibition on 
discrimination is always conditioned on, and applied in the context of, 
violating a specific right or protection, and each protected right is 
typically associated with a particular Federal funding stream or 
streams. For example, in Sec.  88.3(c)(2), ``discrimination'' is 
unlawful when done ``on the basis that the health care entity''--the 
protected entity in the provision--``does not provide, pay for, provide 
coverage of, or refer for, abortion.'' Thus, an adverse action taken 
for reasons wholly unrelated to abortion or the health care entity's 
actions or beliefs objecting to abortion would not constitute a 
violation under this provision. In addition, as noted above, whether an 
action is regarded as adverse is subject to a standard of 
reasonableness.
    Comment: The Department received comments suggesting that the 
definition of ``discriminate or discrimination'' should not include 
elements of disparate impact. Because circuit courts of appeals handle 
disparate impact analysis differently, its inclusion here will lead to 
confusion and differing outcomes depending on the circuit in which the 
conduct occurred, and including elements of disparate impact would 
create incentives to manipulate data in order to bring illegitimate 
complaints.
    Response: The Department agrees in part and disagrees in part. 
Because there is uncertainty about which laws, or parts of laws, 
implemented by this rule may or may not support a disparate impact 
claim, the Department is choosing to finalize the rule without 
explicitly including terms traditionally associated with disparate 
impact theories. It is specifically replacing the phrase ``adverse 
effects'' with ``adverse treatment'' and is deleting ``otherwise,'' 
``tends to,'' and ``defeats or substantially impairs accomplishment of 
a health program or activity'' as elements of the definition of 
``discrimination.'' However, because the definition of 
``discrimination'' as adopted in this final rule is non-exclusive, as 
discussed above, OCR is not prejudging any complaints of violations of 
part 88 that are based on a claim of disparate impact, and will 
consider the circumstances of each complaint and apply each statute 
according to its text and any applicable court precedents.
    Comment: The Department received comments stating that the proposed 
definition of ``discriminate or discrimination'' is either 
unconstitutional or violates precedential definitions of what 
constitutes discrimination.
    Response: The Department disagrees that the definition of 
``discriminate or discrimination'' finalized in this rule generally 
violates legal standards, constitutional or otherwise, as to what 
constitutes discrimination. There is no universal definition of 
discrimination that governs all Federal statutes. Discrimination can 
take different forms depending on the particular context and language 
of each statute prohibiting it. The Department nevertheless has drawn 
substantially from definitions and interpretations of 
``discrimination'' found in other anti-discrimination statutes and case 
law, and has made various changes in response to public comments. The 
Department believes that the definition finalized here reasonably 
describes forms and methods of discrimination that are likely to be 
encountered in the context of the Federal conscience and anti-
discrimination laws at issue in this rule, and that are encompassed by 
the protections set forth in those statutes and this rule.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \66\ and above, and considering the comments received, 
the Department finalizes the definition of ``discriminate or 
discrimination'' (with additional minor changes for accuracy and 
clarity); changing ``means'' to ``includes;'' limiting the definition 
``to the extent'' permitted by the statute; changing ``exclude'' to 
``exclude from;'' deleting ``otherwise'' from paragraphs (1) and (2); 
adding ``or impose any penalty'' to the end of paragraph (2); in 
paragraph (3), deleting ``defeating or substantially impairing 
accomplishment of a health program or activity,'' changing ``tends to 
subject'' to ``subjects,'' and adding ``on grounds prohibited under an 
applicable statute encompassed by this part;'' deleting the proposed 
paragraph (4) and

[[Page 23193]]

adding new paragraph (4) as described above regarding entities that 
``shall not be regarded as having engaged in discrimination;'' adding 
paragraph (5) as described above allowing an entity subject to any 
prohibition in this part to ``require a protected entity to inform them 
of objections;'' and adding paragraph (6) as described above addressing 
what actions by the entity subject to this part ``would not, by itself, 
constitute discrimination.''
---------------------------------------------------------------------------

    \66\ 83 FR 3880, 3892-93 (stating the reasons for the proposed 
definition of ``discriminate or discrimination,'' except for the 
modifications adopted herein).
---------------------------------------------------------------------------

    Entity. The Department proposed that ``Entity means a `person' as 
defined in 1 U.S.C. 1; or a State, political subdivision of any State, 
instrumentality of any State or political subdivision thereof, or any 
public agency, public institution, public organization, or other public 
entity in any State or political subdivision of any State.'' The 
Department received comments on this definition.
    Comment: The Department received comments requesting that the 
definition of ``entity'' include non-profit religious corporations as 
well.
    Response: Non-profit religious corporations are already encompassed 
by the definition of ``person'' in 1 U.S.C. 1. See Burwell v. Hobby 
Lobby Stores, Inc., 134 S. Ct. 2751, 2768 (2014).
    Comment: The Department received a comment noting that the 
definition of ``entity'' does not mention foreign governments, the 
United Nations, and related bodies. The comment proposed explicitly 
excluding foreign governments and the United Nations from the 
definition of ``entity'' because of sovereignty concerns.
    Response: The Department agrees that the term ``entity'' should 
address foreign governments, foreign nongovernmental organizations, 
intergovernmental organizations (such as the United Nations), and 
related bodies, but the Department disagrees that they should be 
explicitly excluded. Some of the Federal conscience statutes to be 
enforced by the Department may implicate foreign entities,\67\ but 
Congress did not exempt certain kinds of foreign entities that would 
otherwise be covered. Accordingly, the definition of ``entity'' is 
modified to clarify that ``entity'' may include a foreign government, 
foreign nongovernmental organization, or intergovernmental organization 
(including the United Nations and its affiliated agencies). The Federal 
statutes at issue apply their protections to the funds at issue, 
regardless of whether those funds are awarded to domestic or foreign 
entities. If foreign entities wish not to be bound by these conscience 
protections, they may choose not to accept the relevant funds.
---------------------------------------------------------------------------

    \67\ Such as funds administered by the Secretary of Health and 
Human Services under section 104A of the Foreign Assistance Act of 
1961 (22 U.S.C. 2151b-2); under Chapter 83 of Title 22 of the U.S. 
Code; or under the Tom Lantos and Henry J. Hyde United States Global 
Leadership Against HIV/AIDS, Tuberculosis, and Malaria 
Reauthorization Act of 2008.
---------------------------------------------------------------------------

    Comment: The Department received a comment stating that the 
definition of ``entity'' would permit any employer to deny its 
employees coverage for abortion or other objected-to services, even if 
otherwise required by law. Other comments expressed concern that 
defining ``entity'' to include State or local governments expands 
covered entities beyond the health care industry.
    Response: The Department disagrees. The definition section must be 
read in conjunction with other sections of the rule when determining 
whether any particular entity must comply with any particular provision 
of the rule. For example, the fact that private employers are a type of 
organization that falls under the definition of ``entity'' does not 
make every private employer in America automatically subject to the 
Federal protection statutes for which this rule provides enforcement 
mechanisms. Similarly, the fact that natural persons fall under the 
definition of entity does not mean that every person in America is 
automatically granted protection under the rule. Rather, obligations 
and protections apply only to those entities that are subject to a 
relevant provision of a statute under the rule. Each provision in this 
final rule that addresses a Federal conscience statute has a paragraph 
titled ``Applicability'' (see Sec.  88.3), which specifies whether an 
entity is subject to any given provision of a Federal statute at issue. 
For some statutes or some portions of statutes, the Applicability 
paragraph by its own terms may only implicate certain types of entities 
or only entities receiving certain types of funding.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \68\ and above, and considering the comments received, 
the Department finalizes the definition of ``entity'' by including 
``or, as applicable, a foreign government, foreign nongovernmental 
organization, or intergovernmental organization (such as the United 
Nations or its affiliated agencies).'' The Department also adds the 
term ``the Department'' to the definition of ``entity,'' for clarity.
---------------------------------------------------------------------------

    \68\ 83 FR 3880, 3893 (stating the reasons for the proposed 
definition of ``entity,'' except for the modifications adopted 
herein).
---------------------------------------------------------------------------

    As described further below, to ensure uniformity, the Department 
also modifies the definitions of ``recipient'' and ``sub-recipient'' to 
include, as applicable, a foreign government, foreign nongovernmental 
organization, or intergovernmental organization (such as the United 
Nations or its affiliated agencies).
    Federal financial assistance. The Department proposed that Federal 
financial assistance align with the definition of this term in the 
Department's regulations implementing Title VI of the Civil Rights Act 
of 1964 at 45 CFR 80.13, which includes the provision of assistance of 
Federal funds and non-cash assistance, such as the detail of Federal 
personnel. The Department received comments on this term.
    Comment: The Department received a comment stating that the uses of 
the word ``arrangement'' and the ``provision of assistance'' were 
difficult to interpret, and that the definition of ``Federal financial 
assistance'' should clarify whether it ``includes any claim for 
payment, payments in exchange for health care services, or applications 
to participate in a Federal program through which payment would be 
made.''
    Response: The Department disagrees. The proposed definition of 
``Federal financial assistance'' mirrors the definition used in the 
Department's regulations implementing Title VI and is intended to carry 
the same meaning as it has traditionally been understood to carry in 
the application of those regulations. See 45 CFR 80.13(f). The 
Department believes that entities subject to this regulation will be 
sufficiently familiar with that meaning to understand its application 
in this final rule. Further, numerous Federal courts have recognized 
that Federal financial assistance encompasses subsidies, but not fair 
market value compensation paid in return for services. See, e.g., Jarno 
v. Lewis, 256 F. Supp. 2d 499, 504 (E.D. Va. 2003); DeVargas v. Mason & 
Hanger-Silas Mason Co., 911 F.2d 1377, 1382 (10th Cir. 1990); Cook v. 
Budget Rent-a-Car, 502 F. Supp. 494 (S.D.N.Y. 1980); Shotz v. American 
Airlines, 420 F.3d 1332 (11th Cir. 2005); Venkatraman v. REI Systems, 
417 F.3d 418 (4th Cir. 2005). In light of the comments, the Department 
finalizes this definition with a minor clarifying change to avoid a 
circular definition, by replacing ``funds, support, or aid'' with 
``subsidy'' in paragraph (5) of the definition.
    Summary of Regulatory Changes: For the reasons described in the 
proposed

[[Page 23194]]

rule \69\ and above, and considering the comments received, the 
Department finalizes the definition of ``Federal financial assistance'' 
as proposed, with a modification in paragraph (5) to remove references 
to a ``Federal'' agreement and ``arrangement'' so that the text now 
refers to ``any agreement or other contract between the Federal 
government and a recipient,'' and to clarify the terminology by 
referring to ``provision of a subsidy to the recipient'' to avoid a 
circular definition related to the provision of ``assistance.''
---------------------------------------------------------------------------

    \69\ 83 FR 3880, 3893 (stating the reasons for the proposed 
definition of ``Federal financial assistance,'' except for the 
modifications adopted herein).
---------------------------------------------------------------------------

    Health care entity. The Department proposed that ``health care 
entity'' includes an individual physician or other health care 
professional; health care personnel; a participant in a program of 
training in the health professions; an applicant for training or study 
in the health professions; a post-graduate physician training program; 
a hospital; a laboratory; an entity engaging in biomedical or 
behavioral research; a provider-sponsored organization; a health 
maintenance organization; a health insurance plan (including group or 
individual plans); a plan sponsor, issuer, or third-party 
administrator; or any other kind of health care organization, facility, 
or plan. The Department also proposed that the term may also include 
components of State or local governments. The Department proposed a 
single definition of the term ''health care entity,'' a term used in 
the Weldon Amendment, the Coats-Snowe Amendment, and ACA section 1553. 
The Department received comments on this definition.
    Comment: The Department received a comment stating that ``health 
care entity'' should include social workers and schools of social work.
    Response: The Department declines to make an explicit inclusion of 
social workers and schools of social work to the definition of health 
care entity. It is unclear in many circumstances that such entities 
deliver health care. The Department's intention in this definition is 
to provide a non-exclusive list of entities Congress has intended to 
include as a health care entity. Because the list is non-exclusive, 
there may be circumstances where a social worker is considered a health 
care entity under a Federal conscience or anti-discrimination law, but 
that will depend on the facts and the circumstances in each case as 
they arise.
    Comment: The Department received comments questioning how entities 
that are not natural persons can hold moral or religious beliefs.
    Response: Federal law routinely recognizes corporations, 
organizations, or other non-natural persons as holders of legal rights 
and subject to legal obligations. The Federal Government has long 
recognized the Free Speech and Free Exercise rights of non-profit 
organizations with charitable missions related to the religious beliefs 
or moral convictions of its members, and has recognized the Free Speech 
rights of public corporations. Citizens United v. FEC, 558 U.S. 310, 
365 (2010). The definition of ``person'' that is protected under the 
Religious Freedom Restoration Act includes both natural and non-natural 
persons (corporations, partnerships, etc.).\70\ In Hobby Lobby, having 
found that the text of the Religious Freedom Restoration Act, 42 U.S.C. 
2000bb-2000bb-4 (``RFRA''), does not preclude its application to 
corporations, the Supreme Court held that a closely held for-profit 
corporation can assert the religious beliefs of its owners. More 
specifically, from the enactment of the first paragraph of the Church 
Amendments in 1973, Federal conscience and anti-discrimination laws 
have recognized that entities such as hospitals can possess ``religious 
beliefs or moral convictions'' when prohibiting their facilities from 
being used for abortions or sterilizations. In addition, the Coats-
Snowe and Weldon Amendments, and ACA section 1553, protect 
organizations or institutions as ``health care entities'' when they 
object to certain activities concerning abortion or assisted suicide 
without regard to the motivation for the objection. Both the Coats-
Snowe and Weldon Amendments contain definitions of ``health care 
entity'' that include, as examples, both natural persons and corporate 
persons. The same is true of the definition of ``health care entity'' 
in ACA section 1553.
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    \70\ See, e.g., 42 U.S.C. 2000bb-1 (``Government shall not 
substantially burden a person's exercise of religion even if the 
burden results from a rule of general applicability, except as 
provided in subsection (b).''); 1 U.S.C. 1 (``In determining the 
meaning of any Act of Congress, unless the context indicates 
otherwise . . . the words ``person'' and ``whoever'' include 
corporations, companies, associations, firms, partnerships, 
societies, and joint stock companies, as well as individuals.''); 
Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2768 (2014) 
(``We see nothing in RFRA that suggests a congressional intent to 
depart from the Dictionary Act definition . . . .'').
---------------------------------------------------------------------------

    Finally, religious faith and moral convictions are often the 
organizing principle for entities covered in this rule, and natural 
persons form these organizations for the purpose of asserting their 
faith or convictions more forcefully and effectively in the public 
realm. As the Supreme Court has recognized, there is nothing about 
organizing in a group that diminishes the rights they would enjoy as 
individuals.\71\ Therefore, the Department considers it appropriate to 
finalize the definition of health care entities to include non-natural 
persons.
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    \71\ See, e.g., Hobby Lobby, 134 S. Ct. at 2768 (``When rights, 
whether constitutional or statutory, are extended to corporations, 
the purpose is to protect the rights of these people [who constitute 
the corporation] . . . And protecting the free-exercise rights of 
corporations like Hobby Lobby . . . protects the religious liberty 
of the humans who own and control those companies.''); Citizens 
United, 558 U.S. at 391-93 (Roberts, C.J., concurring) (``[T]he 
individual person's right to speak includes the right to speak in 
association with other individual persons . . . [The First 
Amendment's] text offers no foothold for excluding any category of 
speaker, from single individuals to partnerships of individuals, to 
unincorporated associations of individuals, to incorporated 
associations of individuals.'').
---------------------------------------------------------------------------

    Comment: The Department received comments stating that the proposed 
definition of ``health care entity'' exceeds the Department's statutory 
authority under the Weldon Amendment and the Coats-Snowe Amendment.
    Response: The Weldon and Coats-Snowe Amendments and ACA section 
1553 each provide a definition of ``health care entity'' that contains 
a non-exhaustive list of entities that are ``health care entities.'' 
The Coats-Snowe Amendment says that ``health care entity'' ``includes 
an individual physician, a postgraduate physician training program, and 
a participant in a program of training in the health professions.'' The 
Weldon Amendment and ACA section 1553 state that the term ``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.'' All three laws use the word ``includes,'' 
which means the lists of such entities in the definitions are non-
exhaustive, and other entities could also be ``health care entities'' 
under the plain meaning of the term as used in those statutes. The 
Coats-Snowe Amendment also uses a catch-all phrase for entities in 
``any other program of training in the health professions.'' The Weldon 
Amendment and ACA section 1553 likewise include catch-all provisions 
such as ``other health care professional'' and ``any other kind of 
health care facility, organization, or plan.'' Thus, in defining the 
term for purposes of this rule, it is consistent with the statutory 
text to list certain entities that are not explicitly

[[Page 23195]]

mentioned in the statutes, because the statutory lists are non-
exhaustive; including those entities is consistent with the plain 
meaning of the terms set forth in those statutes. As explained in the 
following discussion, however, the Department is finalizing the 
definition of health care entity to better conform the definition to 
the varying texts of the specific Federal conscience and anti-
discrimination laws that use the term.
    Comment: The Department received comments stating that the 
inclusion of ``a plan sponsor'' in the definition of ``health care 
entity'' would subject all employers who sponsor group health plans to 
the conscience statutes using that term. Other commenters contended the 
laws using those terms did not intend to protect plan sponsors that are 
not otherwise health care entities. Other commenters suggest that the 
term ``health care entity'' should not be the same for the Coats-Snowe 
Amendment, the Weldon Amendment, and ACA section 1553.
    The Department received other comments supporting the inclusion of 
``plan sponsor'' and ``third party administrator'' in the definition of 
``health care entity.'' One comment expressed that faith-based 
organizations that fund health plans should not be required to fund 
services or procedures that violate their religious beliefs.
    Response: Commenters contending that including particular types of 
entities in the definition of ``health care entity'' would require such 
entities to comply with the Coats-Snowe Amendment, the Weldon 
Amendment, or ACA section 1553 are incorrect. The term ``health care 
entity'' is used in those statutes--and in this final rule--to specify 
not which entity must comply with the statute, but which kinds of 
entities are protected from discrimination. Thus, including an entity 
in the term ``health care entity'' under those statutes does not expand 
or affect which governmental or non-governmental fund recipients must 
comply with those statutes.
    The Department concludes it is appropriate to include ``a plan 
sponsor'' in the definition ``health care entity'' for purposes of the 
Weldon Amendment and ACA section 1553. The Weldon Amendment explicitly 
protects entities that do not pay for or provide coverage of abortions, 
and includes ``health insurance plans, or any other kind of health care 
facility, organization, or plan'' within its own illustrative list of 
protected health care entities. ACA section 1553 applies to government 
entities receiving Federal financial assistance under the ACA, and any 
health plan created under the ACA. It uses the same definition of 
``health care entity'' as the Weldon Amendment, in specifying that 
health care entities cannot be subject to discrimination for choosing 
not to provide certain items or services related to assisted suicide. 
Because the focus of both laws includes protection of health plans, it 
is consistent with their language and scope to include ``a plan 
sponsor'' as a protected ``heath care entity.'' In the action of 
sponsoring a health plan or health coverage, the plan sponsor engages 
in an important function with respect to health care. Although the 
sponsor, the plan, and the issuer are all distinct entities, sponsoring 
a plan and paying for coverage (by an issuer, in the case of a fully 
insured plan) or for health care services (in the case of a self-
insured plan) are part and parcel of the provision of health coverage 
under a group health plan. The Weldon Amendment is written to prohibit 
discrimination against, among others, entities that do not provide 
abortion in health coverage; ACA section 1553 is similarly written to 
protect entities from being required to provide certain health care 
items or services in connection with health plans and the ACA. Both 
laws define health care entity to include the catch-all phrase ``any 
other kind of health care facility, organization, or plan,'' in order 
to protect a broad range of entities that might be engaged in providing 
coverage or services and subject to discrimination for not providing or 
covering abortion or assisted suicide, respectively. Therefore, 
treating a plan sponsor as a protected health care entity is consistent 
with the text of the Weldon Amendment and ACA section 1553.
    In further consideration of public comments, however, the 
Department has concluded that the definition of ``health care entity'' 
should be different for the Coats-Snowe Amendment than for the Weldon 
Amendment and ACA section 1553, including with respect to whether to 
include a plan sponsor. The Coats-Snowe Amendment, while providing a 
non-exclusive list of entities and individuals included in the term 
``health care entity,'' contains a different list of entities and 
individuals than that set forth in the Weldon Amendment and ACA section 
1553. Moreover, the nature and scope of protections set forth in the 
Coats-Snowe Amendment--which can assist in understanding the intended 
range of protected health care entities--also differ. The Coats-Snowe 
Amendment focuses generally on the performance of, training for, and 
referral for abortions, whereas the Weldon Amendment focuses more 
broadly on not just providing and referring for, but also providing 
coverage of, and payment for, abortions. Similar to the Weldon 
Amendment, and unlike the Coats-Snowe Amendment, ACA section 1553 
focuses on the context of health plans and coverage in addition to the 
provision of items and services. Consequently, the Department concludes 
that it is appropriate to finalize a definition of health care entity 
for the Coats-Snowe Amendment that is somewhat different from the 
definition applicable to the Weldon Amendment and ACA section 1553, and 
to not include in the definition for purposes of the Coats-Snowe 
Amendment entities pertaining specifically to the health insurance and 
coverage context, namely, a provider-sponsored organization, a health 
maintenance organization, a health insurance plan (including group or 
individual plans), a plan sponsor, an issuer, or a third-party 
administrator. Likewise, the Department deems it appropriate not to 
list in the definition applicable to the Coats-Snowe Amendment the 
catch-all phrase that is in the statutory text of the Weldon Amendment 
and ACA section 1553: ``or third-party administrator; or any other kind 
of health care organization, facility, or plan.''
    Otherwise, the Department deems it appropriate to include in both 
definitions of health care entity the proposed rule's non-exhaustive 
enumeration of various individual and organizational entities that 
engage in health care practices or services: ``an individual physician 
or other health care professional; health care personnel; a participant 
in a program of training in the health professions; an applicant for 
training or study in the health professions; a post-graduate physician 
training program; a hospital; a medical laboratory; [or] an entity 
engaging in biomedical or behavioral research.'' \72\ Because the 
Department intended these entities to be health care entities, and the 
term ``laboratory'' could be interpreted to include laboratories that 
are not related to health care, the Department finalizes the term 
``laboratory'' in these definitions to add the word ``medical'' to 
clarify its health care scope.
---------------------------------------------------------------------------

    \72\ That is not to say that certain types of health plans could 
not also be health care providers, e.g., staff model health 
maintanence organizations.
---------------------------------------------------------------------------

    These entities are health care entities under the ordinary meaning 
of that term because they are engaged in health care practices, 
training, or research. They are also similar to the types of 
individuals and entities listed in the non-exclusive lists of health 
care entities in the Coats-

[[Page 23196]]

Snowe Amendment, the Weldon Amendment, and ACA section 1553. All three 
statutes list individuals and personnel in the health professions, not 
just corporate entities. This demonstrates that Congress explicitly 
intended the term health care entity in all three to protect 
individuals, not just organizational entities. All three definitions 
also list organizational entities, and of course they all contain the 
basic term ``health care entity,'' which must be interpreted to 
encompass terms included in its ordinary meaning.
    Finally, the proposed definition of ``health care entity'' 
concludes by specifying that it ``may also include components of State 
or local governments.'' To clarify the meaning of this sentence, the 
Department finalizes it with a change in each definition of ``health 
care entity,'' to read: ``As applicable, components of State or local 
governments may be health care entities under'' the Coats-Snowe 
Amendment, the Weldon Amendment, and ACA section 1553.
    Comment: The Department received a comment stating that pharmacies 
and pharmacists are sometimes not understood to be health care 
providers and asking that pharmacists and pharmacies be included in the 
provisions of this rule.
    Response: The Department accepts this recommendation and is 
including pharmacies and pharmacists in the definitions of ``health 
care entity.'' A pharmacy is a health care entity, considering the 
ordinary meaning of that term, because it provides pharmaceuticals and 
information, which are health care items and services. Regarding 
pharmacists, because Congress specified that the term ``health care 
entity'' in the Coats-Snowe Amendment, the Weldon Amendment, and ACA 
section 1553, includes certain individuals in the health professions, 
and does not provide an exclusive definition, the Department deems it 
appropriate to include pharmacists, who are also health care 
professionals. Whether a particular protection in those three laws 
applies to a pharmacist or pharmacy in a particular case, or whether it 
applies to any of the examples in these definitions, is a separate 
question that will be determined in the context of the factual and 
legal issues applicable to the situation. For the purpose of specifying 
whether a pharmacist or pharmacy could possibly be covered by the term 
health care entity in these three laws, depending on the circumstances, 
the Department deems it appropriate to include them in the list of 
individuals and entities set forth in these definitions.
    Comment: The Department received comments suggesting that ``health 
care entity'' should include public school districts that provide on-
campus medical care or manage vaccination records.
    Response: The definition specifies that ``health care entity'' also 
includes components of State or local governments. The Department does 
not believe the definitions need to specify further that public school 
districts providing on-campus medical care are included. The Department 
will evaluate the applicability of the rule to public school entities 
with health care functions according to the facts and circumstances of 
each case as they arise and the applicable laws.
    Comment: The Department received a comment proposing that ``health 
care entity'' exclude occupational therapists.
    Response: To the extent that occupational therapists are health 
care personnel qualifying as ``other health care professionals,'' the 
Department disagrees that they would be necessarily excluded from 
protection. While some questions concerning who qualifies for 
protection in a particular circumstance are relatively straightforward, 
such as physicians under certain conscience protection laws, some 
questions are closer and depend on the facts and the applicable law. 
The Department, therefore, declines to make explicit exclusions, such 
as for occupational therapists, to the definitions of health care 
professionals, and will instead consider individual cases based on the 
facts and circumstances presented in each case as they arise and the 
applicable law.
    Comment: The Department received comments stating that the 
inclusion of ``health care personnel'' exceeds the definition of 
``health care entity'' under the Weldon Amendment or other laws using 
that term.
    Response: The Department disagrees. The list of individuals, 
persons and entities included as a ``health care entity'' in the Weldon 
Amendment and ACA section 1553 includes ``an individual physician,'' 
and also the catch-all phrases ``or other health care professional.'' 
The Coats-Snowe Amendment says the term includes ``individual 
physician'' and ``a participant in a program of training in the health 
professions.'' Because the term ``health care entity'' includes 
individuals, and the definitions are non-exclusive, the Department 
deems it appropriate to include other individuals who are health care 
personnel. Including ``health care personnel'' and/or ``health care 
professional'' in the definition of ``health care entity'' is, 
therefore, consistent with Congress's explicit inclusion of individual 
persons in the health care field. Doing so effectuates the remedial 
purposes of the Coats-Snowe Amendment, the Weldon Amendment, and ACA 
section 1553, and is consistent with their texts.
    Comment: The Department received comments requesting that ``health 
care professional'' and ``health care personnel'' be defined terms.
    Response: The Department declines to define these terms. The 
Department believes it is appropriate to determine remaining potential 
questions about the scope and application of the term ``health care 
entity'' based on an analysis of facts and circumstances presented in 
each case as they arise. Regarding health care professionals, State and 
local law might also be relevant concerning which persons are 
considered health care professionals. Because those laws differ, the 
Department considers it appropriate not to specify a single definition 
of health care professional or health care personnel in this rule. 
Parts of the Church Amendments use the terms ``personnel'' and ``health 
care personnel,'' but do not define those terms. Although this rule 
also does not define those terms, the Department believes this rule 
provides some additional clarity to the application of Federal 
conscience and anti-discrimination laws.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \73\ and above, and considering the comments received, 
the Department finalizes the definition of ``health care entity'' with 
changes to bifurcate the definition into two: One applicable for 
purposes of the Coats-Snowe Amendment, and the other applicable for 
purposes of the Weldon Amendment and ACA section 1553. Both definitions 
add pharmacies and pharmacists. Both add the word ``medical'' before 
the term ``laboratory'' to more clearly describe its health care scope, 
and both note that ``as applicable, components of State or local 
governments may be health care entities.'' The definition applicable to 
the Coats-Snowe Amendment omits the terms ``a provider-sponsored 
organization; a health maintenance organization; a health insurance 
plan (including group or individual plans); a plan sponsor, issuer, or 
third-party administrator; or any other kind of

[[Page 23197]]

health care organization, facility, or plan.''
---------------------------------------------------------------------------

    \73\ 83 FR 3880, 3893 (stating the reasons for the proposed 
definition of ``health care entity,'' except for the modifications 
adopted herein).
---------------------------------------------------------------------------

    Health program or activity. The Department proposed that ``Health 
program or activity'' includes the provision or administration of any 
health-related services, health service programs and research 
activities, health-related insurance coverage, health studies, or any 
other service related to health or wellness, whether directly through 
payments, grants, contracts, or other instruments, through insurance, 
or otherwise.
    Under the proposed rule the terms ``health program or activity'' 
and ``health service program'' differed mainly in that the former 
included ``the provision or administration of any health-related 
services,'' while the latter included any ``plan or program that 
provides health benefits.'' Because ``health service program'' could be 
seen as narrower, the phrase health program or activity incorporated 
``health service program'' explicitly as part of its definition. The 
Department asked for comment ``on whether the terms mean the same thing 
and should or could be defined interchangeably for purposes of this 
regulation.'' \74\
---------------------------------------------------------------------------

    \74\ 83 FR 3880, 3894.
---------------------------------------------------------------------------

    The Department did not receive specific comments on this question, 
but the comments received regarding the two definitions generally 
treated the two phrases as identical. Upon further consideration the 
Department has concluded that there are insufficient grounds for 
defining such similar terms differently under the rule.
    The Department is finalizing the rule without defining ``health 
program or activity'' because other revisions have eliminated the use 
of the phrase in the regulation text as finalized. However, for reasons 
explained below, the Department adopts (with minor edits) the 
definition proposed for ``health program or activity'' as the 
definition for ``health service program.'' All questions and responses 
to comments concerning ``health program or activity'' apply fully and 
``transfer'' to ``health service program.''
    Comment: The Department received comments stating that the 
definition of ``health program or activity'' should explicitly include 
vaccination programs or the processing of vaccination records.
    Response: Because of the broad scope of what could constitute a 
``health program or activity'' (now ``health service program''), the 
Department declines to attempt a comprehensive listing of examples of 
such programs or activities and instead relies on the general standard 
proposed. The Department believes vaccination programs would reasonably 
be considered a health program or activity (or a health service 
program) and notes that one of the statutes that is the subject of this 
rule concerns vaccination explicitly (42 U.S.C. 1396s(c)(2)(B)(ii)).
    Comment: The Department received comments stating that the 
definition of ``health program or activity'' (now ``health service 
program''), when combined with the definition of ``assist in the 
performance'' and ``refer,'' could result in disparate impact against 
women, LGBT persons, and religious minorities.
    Response: The Department disagrees. This rule implements underlying 
statutory requirements and prohibitions set forth by Congress. The 
terms defined in this rule do not apply to women, LGBT persons, or 
religious minorities in any way that differs from how Congress applied 
the terms in the statutes it adopted. To the extent commenters contend 
that some Federal conscience and anti-discrimination laws themselves 
adversely impact women because they concern abortion, the Department 
disagrees, but is in any event required to implement and enforce 
Federal conscience and anti-discrimination laws as Congress wrote them.
    Comment: The Department received comments stating that the 
definition of the term ``health program or activity'' (now ``health 
service program''), is overly broad; and, when combined with section 
104A of the Foreign Assistance Act of 1961, could result in otherwise 
unauthorized discrimination against minority groups or persons in sex 
trafficking in programs funded under section 104A.
    Response: The Department disagrees. The relevant language of 
section 104A, ``any program or activity'' (22 U.S.C. 7631(d)(1)(B)), is 
broader than, and clearly includes, any ``health service program.'' As 
the Department only administers section 104A funds (as relevant to this 
rule) with respect to health, the definition of ``health program or 
activity'' is not intended to limit, and in no way limits, any 
protection from discrimination provided in section 104A of the Foreign 
Assistance Act of 1961. Additionally, nothing in 22 U.S.C. 
7631(d)(1)(B) exempts certain programs or activities from its 
conscience protections.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule,\75\ above and below, and considering the comments 
received, the Department adopts the definition of ``health program or 
activity'' as proposed as the definition of ``health service program,'' 
except makes a technical edit for clarity by replacing commas with 
semicolons after ``directly,'' the phrase ``through payments, grants, 
contracts, or other instruments,'' and after ``through insurance.'' 
Additionally, it deletes the reference to ``health service program'' 
from the proposed definition as circular.
---------------------------------------------------------------------------

    \75\ 83 FR 3880, 3893-94 (stating the reasons for the proposed 
definition of ``health program or activity,'' except for the 
modifications adopted herein).
---------------------------------------------------------------------------

    Health service program. The Department proposed that ``Health 
service program includes any plan or program that provides health 
benefits, whether directly, through insurance, or otherwise, and is 
funded, in whole or part, by the Department. It may also include 
components of State or local programs.'' The Department received 
comments on this definition.
    Comment: The Department received comments stating that the 
definition of ``health service program'' expands the scope of the 
Federal conscience and anti-discrimination laws ``to include virtually 
any medical treatment or service, biomedical and behavioral research, 
and health insurance.''
    Response: The Department disagrees. Among the statutes that are the 
subject of this rule, the phrase ``health service program'' appears 
only once, in paragraph (d) of the Church Amendments. That paragraph 
addresses the right of persons to decline to ``perform or assist in the 
performance'' of ``any part'' of a health service program or research 
activity funded in whole or in part under a program administered by the 
Secretary of HHS if such performance or assistance would be contrary to 
the person's religious beliefs or moral convictions. Many commenters' 
objections to this definition are fundamentally objections to the text 
of paragraph (d) of the Church Amendments as passed by Congress. The 
Department believes that other 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. Many medical 
treatments and services performed by health care providers are not 
``part of'' a health service program receiving funding from HHS. In 
such

[[Page 23198]]

circumstances, paragraph (d) would not apply.
    This distinction can be illustrated by considering the parallel 
term used in paragraph (d), ``research activity.'' For example, if an 
entity receives a grant from a program administered by HHS to conduct 
research on a new cancer treatment, paragraph (d) of the Church 
Amendments would protect individuals involved in the performance of any 
part of that research activity. But if the entity engages in other 
research activities that are not funded by HHS (i.e., not related to 
the cancer treatment for which the research grant was issued in this 
example), paragraph (d) would not apply to those other activities. This 
would hold true even if other statutory provisions that are the subject 
of this rule would apply to those other research activities.
    Similarly, Medicaid is funded in whole or in part under a program 
administered by the Department. Nevertheless, if a health care provider 
receives Medicaid reimbursements for some medical treatments, but is 
providing other medical treatments that are not being reimbursed by 
Medicaid or otherwise funded by the Department, the provider--with 
respect to the non-Medicaid treatment--is not performing ``part of a 
health service program'' funded by a program administered by HHS. 
Because Medicaid generally provides reimbursements for particular 
treatments, not for a medical practice overall, providing a treatment 
not reimbursed by Medicaid would generally not be ``part of a health 
service program . . . funded in whole or in part under'' Medicaid for 
the purposes of paragraph (d) of the Church Amendments, even if the 
overall medical practice also receives Medicaid reimbursements for 
other treatments.
    The Department intends to enforce paragraph (d) of the Church 
Amendments consistent with the text of the statute. It would be 
inappropriate for the Department to define ``health service program'' 
to exclude programs that involve health services and that are funded 
(in whole or in part) under a program administered by HHS, when 
Congress specified that paragraph (d) of the Church Amendments covers 
such programs. The Department believes that the specific limitations in 
paragraph (d) concerning the circumstances in which it applies has 
already (under the statute) prevented the realization of many 
overbreadth concerns raised by commenters, and will continue to do so 
under this rule, notwithstanding the plainly broad meaning of the term 
``health service program'' itself.
    Comment: The Department received a comment stating that the 
definition of ``health service program'' should only apply in the 
context of biomedical research.
    Response: The Department disagrees. Congress used the disjunctive 
phrase ``health service program or research activity'' in paragraph (d) 
of the Church Amendments. Nothing in the phrase or its context (the 
surrounding text) indicates that the protection provided by Congress is 
limited only to biomedical research. If ``health service program'' 
meant only research activities, then Congress's addition of ``or 
research activity'' would be superfluous. Further, in a separate 
provision of the Church Amendments enacted at the same time as 
paragraph (d), paragraph (c)(2), Congress provided specific 
prohibitions for entities that receive grants or contracts ``for 
biomedical or behavioral research'' alone, without including health 
service programs. This demonstrates that Congress's inclusion or 
omission of ``health service program'' was a considered decision 
intended to have substantive effect.
    Summary of Regulatory Changes: The Department asked for comment on 
whether ``health program or activity'' and ``health service program'' 
should or could be defined interchangeably for purposes of this 
regulation \76\ but received no specific comments on the question. Upon 
further consideration the Department has concluded that there are 
insufficient grounds for defining such similar terms differently under 
the rule.
---------------------------------------------------------------------------

    \76\ 83 FR 3880, 3894.
---------------------------------------------------------------------------

    The Department's definition for ``health service program'' in the 
proposed rule mirrored the definition of the term in the 2008 Rule.\77\ 
The 2008 Rule, in turn, incorporated the phrase ``health benefits'' 
into the definition of ``health service program'' by borrowing from 
Section 1128B(f)(1) of the Social Security Act's (42 U.S.C. 1320a-
7b(f)(1)) definition of ``Federal health care program''--the rationale 
being that ``Federal health care program'' was similar enough to 
``health service program,'' to warrant the borrowing. With respect to 
the inclusion of ``health benefits,'' in the definition of ``health 
service program,'' this was appropriate because the Federal health 
service programs implemented under the Social Security Act are programs 
administered by the Secretary--and, thus, consistent with the language 
of the Church Amendment. However, the Social Security Act is not (and 
was not) the exclusive basis for defining the scope of ``health service 
program.'' The Department believes that it is also appropriate to 
consider the Public Health Service Act (PHSA) as a source for defining 
the term ``health service program'' because, (1) the Church Amendments 
themselves cite the PHSA to help establish what programs are covered 
and (2) the PHSA uses the phrase ``health service program'' and 
``health services'' numerous times. For example, the PHSA provides 
grant authority to assist States and other public entities ``in meeting 
the costs of establishing and maintaining preventive health service 
programs'' (42 U.S.C. 247b), and grants the Secretary permission to 
enter into contracts to ``furnish health services to eligible Indians'' 
(42 U.S.C. 238m).
---------------------------------------------------------------------------

    \77\ Id.
---------------------------------------------------------------------------

    The terms ``health services'' and ``health service program,'' as 
used by the PHSA, clearly include the provision of health care or 
health benefits, but they also include health-related services. For 
example, the PHSA uses the phrase ``environmental health services'' to 
describe programs that deal with the detection and alleviation of 
``unhealthful conditions'' associated with water supply, chemical and 
pesticide exposures, air quality or exposure to lead. 42 U.S.C. 
254b(b)(2)(C). These are health-related programs. Moreover, the PHSA 
uses the phrase ``health service programs'' explicitly and includes 
``preventive'' programs within its ambit including--for example, 
programs for ``the control of rodents'' and ``for community and school-
based fluoridation programs.'' 42 U.S.C. 300w-3(a)(1)(B). These are 
health-related programs.
    In light of the above, and for the sake of consistency and to avoid 
confusion, the Department finalizes the term ``health service program'' 
as equivalent to ``health program or activity'' (with minor changes). 
The Department is no longer including a definition of ``health program 
or activity'' but in light of public comments, is finalizing a 
definition of ``health service program'' with changes that incorporate 
some of the elements of both terms, based on concerns raised about both 
definitions in the public comments. The finalized definition states 
that ``health service program includes the provision or administration 
of any health or health-related services or research activities, health 
benefits, health or health-related insurance coverage, health studies, 
or any other service related to health or wellness, whether directly; 
through payments, grants, contracts, or other instruments; through 
insurance; or otherwise.''

[[Page 23199]]

    Individual. The Department proposed that ``Individual means a 
member of the workforce of an entity or health care entity.'' The 
Department received comments on this definition.
    Comment: The Department received a comment stating that the 
definition of ``individual'' should include ``persons exercising their 
right of informed consent to decline a healthcare service on the basis 
of religion or conscience.''
    Response: Upon considering this comment and reviewing the use of 
the word ``individual'' throughout the proposed rule, the Department 
agrees that the term has multiple meanings depending on the context of 
its use in the rule and in applicable statutes. Sometimes it refers to 
members of the workforce of an entity or health care entity, and other 
times it refers to persons who are not health care providers and yet 
are protected by the Federal conscience and anti-discrimination laws at 
issue in this rule, such as an individual who makes use of a religious 
nonmedical health care institution or an individual who ``is 
conscientiously opposed to acceptance of the benefits of any private or 
public insurance.'' Because ``individual'' has multiple meanings 
throughout the rule, and the meaning of ``individual'' is clear in each 
instance from its context, the inclusion of a definition for 
``individual'' introduces unnecessary confusion. Consequently, the 
Department is deciding not to finalize the proposed definition, or any 
definition, of the word ``individual'' in the final rule. As 
``individual'' is no longer a defined term, additional comments on the 
definition of the word ``individual'' are either addressed by that 
change, or not necessary to address further.
    Summary of Regulatory Changes: For the reasons described above, and 
considering the comments received, the Department does not finalize the 
proposed definition of ``individual'' and removes the word 
``individual'' and its definition from the list of defined terms.
    Instrument. The Department proposed that ``Instrument is the means 
by which Federal funds are conveyed to a recipient, and includes 
grants, cooperative agreements, contracts, grants under a contract, 
memoranda of understanding, loans, loan guarantees, stipends, and any 
other funding or employment instrument or contract.'' The Department 
did not receive comments on this definition.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \78\ and above, the Department adopts the definition of 
``instrument'' as proposed.
---------------------------------------------------------------------------

    \78\ 83 FR 3880, 3894.
---------------------------------------------------------------------------

    OCR. The Department proposed that OCR means the Office for Civil 
Rights of the Department of Health and Human Services. The Department 
did not receive comments on this definition.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \79\ and above, the Department adopts the definition of 
``OCR'' as proposed.
---------------------------------------------------------------------------

    \79\ 83 FR 3880, 3894.
---------------------------------------------------------------------------

    Recipient. The Department proposed that ``Recipient means any 
State, political subdivision of any State, instrumentality of any State 
or political subdivision thereof, and any person or any public or 
private agency, institution, organization, or other entity in any State 
including any successor, assign, or transferee thereof, to whom Federal 
financial assistance is extended directly from the Department or a 
component of the Department, or who otherwise receives Federal funds 
directly from the Department or a component of the Department, but such 
term does not include any ultimate beneficiary. The term may include 
foreign or international organizations (such as agencies of the United 
Nations).'' The Department received comments on this definition.
    Comment: The Department received a comment stating that while the 
proposed definition of ``recipient'' recognizes that an individual or 
organization must comply with the provider conscience regulations if 
the individual or organization receives funds ``directly from the 
Department or component of the Department' to carry out a project or 
program,'' the proposed rule does not explain how ``compliance with the 
regulations would not be required for products or services offered by 
the individual or organization that are unrelated to the Federal 
funding.''
    Response: Fitting within the definition of a ``recipient'' alone 
does not necessarily subject an entity to all of the requirements of 
the statutes implemented through this rule. In each paragraph of Sec.  
88.3 of this rule, there is an ``Applicability'' paragraph and a 
``Requirements and prohibitions'' paragraph that describe, in more 
particularity for each Federal conscience and anti-discrimination law 
being implemented by the paragraph, the scope of the statute and, thus, 
this regulation.
    As discussed concerning the definition of the term ``entity,'' the 
Department is finalizing the terms ``entity,'' ``recipient,'' and 
``sub-recipient'' with parallel language to clarify that they all may 
encompass ``a foreign government, foreign nongovernmental organization, 
or intergovernmental organization (such as the United Nations or its 
affiliated agencies).''
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \80\ and above, and considering the comments received, 
the Department finalizes the definition of ``recipient'' with a change 
to the last sentence, so that rather than referring only to ``foreign 
or international organizations,'' it reads ``The term may include a 
foreign government, foreign nongovernmental organization, or 
intergovernmental organization (such as the United Nations or its 
affiliated agencies).''
---------------------------------------------------------------------------

    \80\ 83 FR 3880, 3894 (stating the reasons for the proposed 
definition of ``recipient,'' except for the modifications adopted 
herein).
---------------------------------------------------------------------------

    Referral or refer for. The Department proposed that ``Referral or 
refer for'' be defined as including the provision of any information 
(including but not limited to name, address, phone number, email, 
website, instructions, or description) by any method (including but not 
limited to notices, books, disclaimers or pamphlets online or in 
print), pertaining to a health care service, activity, or procedure, 
including related to availability, location, training, information 
resources, private or public funding or financing, or directions that 
could provide any assistance in a person obtaining, assisting, training 
in, funding, financing, or performing a particular health care service, 
activity, or procedure, when the entity or health care entity making 
the referral sincerely understands that particular health care service, 
activity, or procedure to be a purpose or possible outcome of the 
referral. The Department received comments on this definition, 
including general comments in support of and opposition to the proposed 
definition.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' should be maintained as it 
appropriately allows healthcare professionals to abide by their own 
professional and ethical judgments.
    Response: The Department agrees that the definition of ``referral 
or refer for'' is appropriate, except for the addition of relatively 
minor narrowing and clarifying changes as discussed below.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' exceeds the scope of the Weldon 
Amendment or the Coats-Snowe Amendment.

[[Page 23200]]

    Response: The Department disagrees. Neither the Weldon nor Coats-
Snowe Amendment defines ``referral'' or ``refer for.'' The definition 
is a reasonable interpretation of these terms and faithfully 
effectuates the text and structure of Congress's protection of health 
care professionals and entities from being coerced or compelled to 
facilitate conduct (with respect to Weldon and Coats-Snowe, concerning 
abortion) that may violate their legally protected rights through the 
forced provision of referrals. For example, in the Weldon Amendment and 
section 1303 of the ACA, Congress did not merely protect the action of 
declining to refer to an abortion provider, but of declining to refer 
``for'' abortions generally. This more broadly protects a decision not 
to provide contact information or guidance likely to assist a patient 
in obtaining an abortion elsewhere.
    The rule's definition of ``referral'' or ``refer for'' also 
comports with dictionary definitions of the word ``refer,'' such as the 
Merriam-Webster's definition of ``to send or direct for treatment, aid, 
information, or decision.'' Refer, Merriam-Webster.com, available at 
https://www.merriam-webster.com/dictionary/refer (last accessed April 
9, 2019) (emphasis added); see also Refer, Dictionary.com, available at 
https://www.dictionary.com/browse/refer (last accessed April 9, 2019) 
(defining refer as ``to direct for information or anything required'' 
and ``to hand over or submit for information, consideration, decision, 
etc.'').
    This interpretation properly serves the remedial purposes of these 
protections. Recent attempts at coerced referrals for abortion, such as 
California's Reproductive FACT Act, have taken the form of compelled 
display of information discussing the availability of State-subsidized 
abortions. The purpose, design, and effect of such displays of 
information is precisely to assist patients in obtaining abortions if 
they so choose. As discussed elsewhere in this rule, OCR found that the 
FACT Act's compelled display of such information to members of the 
public is a type of referring or referral ``for'' abortion that 
Congress prohibited in the Weldon and Coats-Snowe Amendments.\81\
---------------------------------------------------------------------------

    \81\ 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.
---------------------------------------------------------------------------

    Nevertheless, the Department has made significant modifications to 
the definition of ``discrimination'' that address the concerns raised 
by commenters concerning the definition of referral. Specifically, the 
Department recognizes greater latitude for accommodation procedures by 
employers and entities and has added additional exclusions and 
exemptions under the rule. In doing so, the rule narrows the scope of 
possible bases of a violation under the rule.
    For example, the rule allows an employer, when there is a 
reasonable likelihood it may ask its employees in good faith to refer 
for, participate in, or assist in the performance of potentially 
objected to conduct, to require its employee to inform it of any 
objections. Thus, a hospital that regularly performs elective abortions 
may ask a nurse hired to work in the OB/GYN department if he or she 
anticipates having any objections to assisting in the performance of 
elective abortions to allow the hospital to make appropriate, non-
discriminatory staffing arrangements. Barring other facts, if the nurse 
refuses to answer, the Department would not treat any resultant adverse 
action by the employer against the nurse as ``discrimination'' under 
the rule.
    These significant changes to the rule's definition of 
discrimination respect the laws provided by Congress and the interests 
of all parties--employers, health care entities, and individual 
physicians--who wish to provide services allowed by law according to 
their consciences.
    Additionally, the Department agrees that some proposed terms in the 
definition of refer or referral were unnecessarily broad, and therefore 
the Department finalizes the definition with narrowing edits as set 
forth in response to comments regarding specific phrases discussed 
below.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' would interfere with legal and 
ethical duties of doctors to provide information to their patients.
    Response: The Department disagrees. The rules do not prohibit any 
doctor or health care entity from providing information to their 
patients--or referring for a medical service or treatment--if they feel 
they have a medical, legal, ethical, or other duty to do so. The rules 
simply enforce existing laws that prevent doctors or other protected 
entities from being forced to refer for abortions against their will or 
judgment. The rule's definition of ``referral or refer for'' ensures 
that doctors can use their own professional, medical, and ethical 
judgment without being coerced by entities receiving Federal funds to 
violate their moral or religious convictions. To the extent a State 
subject to this rule (under, for example, the Coats-Snowe Amendment or 
the Weldon Amendment) legally mandates that protected individuals and 
entities refer for abortion, Congress has indicated such mandates are 
inconsistent with Federal law.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' would violate the requirement 
that patients receive informed consent before performing treatments.
    Response: A similar objection is discussed above concerning the 
definition of ``assist in the performance'' and its inclusion of 
referrals. The Department disagrees with the objection. Federal 
conscience and anti-discrimination laws specifically shield certain 
persons and entities from being required to provide referrals for 
abortion. Indeed, 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 date to the era of Roe v. Wade and Doe v. Bolton, violates or 
undermines the principles of informed consent. This final rule will not 
change existing laws requiring doctors to secure informed consent from 
patients before performing medical procedures.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' conflicts with Title X of the 
Public Health Service Act.
    Response: As discussed above, the Department concluded in 2008 and 
again in the preamble to the proposed rule in this rulemaking that the 
2000 Regulations governing the Title X program, which required Title X 
projects and providers to provide abortion counseling, information and 
referrals in certain circumstances, conflict with certain Federal 
conscience and anti-discrimination laws. Notably, that requirement was 
imposed by the Department, not by Congress in Title X itself, which has 
long prohibited the use of Title X funds ``in programs where abortion 
is a method of family planning.'' 42 U.S.C. 300a-6. The Department has 
amended the Title X regulations to remove the requirements for abortion 
counseling, information, and referrals, while permitting the provision 
of nondirective counseling on, and information about, abortion. Under 
the 2019 final rule governing the Title X program, the Title X 
regulations no longer conflict with Federal conscience and anti-
discrimination laws or this final rule. Regardless, as the Department

[[Page 23201]]

recognized in the 2008 Rule, a Federal regulatory requirement that a 
Title X applicant, grantee, program, or clinic--a recipient of Federal 
funds in carrying out a HHS program--provide abortion counseling, 
information, and referrals cannot be enforced against such entities 
whose refusal to do so is protected by applicable Federal conscience 
and related nondiscrimination statutes.
    Comment: The Department received comments stating that including 
``the provision of any information . . . by any method'' in the 
definition ``referral'' or ``refer for'' goes beyond the meaning of 
those words in the statutes.
    Response: The definition's breadth reflects the fact that 
conscientious objections to, or the nonperformance of, acts that 
facilitate the conduct of a third party may take many forms and occur 
in many contexts. Nevertheless, the Department agrees that the phrases 
``any information'' and ``any method'' as well as ``any assistance'' 
are unnecessarily broad, and therefore deletes the three appearances of 
the word ``any'' from the definition. The rule instead relies on the 
non-exhaustive list of illustrations to guide the scope of the 
definition. Additionally, the rule permits the description of specific 
methods of transmitting information, namely, ``any method (including 
but not limited to notices, books, disclaimers or pamphlets, online or 
in print),'' and replaces the list with the clearer and more concise 
statement of ``in oral, written, or electronic form.''
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' could permit a provider to turn 
away a patient experiencing complications from an objected-to medical 
drug, device, or service without providing any information.
    Response: To the extent the comments concern providers that decline 
to volunteer certain information or make referrals to other providers, 
the applicability of the rule would turn on the individual facts and 
circumstances of each case. In making a determination, the Department 
will consider the relationship between the treatment subject to a 
referral request and the underlying service or procedure giving rise to 
the request. The Department, however, is not aware of any providers 
that would refuse to treat or refer a person with unforeseen and 
unintended complications arising from, for example, an abortion 
procedure that the provider would not perform.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' could result in a health care 
professional refusing to refer a woman for treatment of ovarian cancer 
because sterilization would be a ``possible outcome of the referral.''
    Response: The Department agrees that ``possible outcome of the 
referral'' is unnecessarily broad. The Department is therefore changing 
the word ``possible'' to ``reasonably foreseeable,'' which still 
recognizes robust protection to conscientious objectors as provided by 
Congress, but requires a stronger connection between the referral and 
the objected-to activity or result. The Department also finalizes the 
definition with a change to eliminate subjective language concerning 
what an entity ``sincerely understands'' out of similar concerns about 
overbreadth.
    Comment: The Department received a comment suggesting that 
``referral or refer for'' should be defined as ``active facilitation of 
access.''
    Response: The Department disagrees and believes such a definition 
would risk improperly narrowing the protections provided by Congress. 
For example, California's Reproductive FACT Act (which the Supreme 
Court ruled in NIFLA likely violates the Constitution, 138 S. Ct. at 
2371-76), involved a requirement that health care facilities opposed to 
abortion tell women that the State may provide free or low cost 
abortion, and provide the women a phone number for further information 
on how to access those abortions. After investigating complaints 
related to the FACT Act, the Department found that mandating the 
communication of such information to members of the public is a type of 
referring or referral ``for'' abortion that Congress prohibited in 
conscience protection statutes.\82\ Narrowing the definition to the 
``active facilitation of access'' may subject many health care 
providers to coercive requirements that the Department has already 
found violate the law. The definition finalized here better includes 
the full range of referral activities protected by Congress.
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    \82\ 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.
---------------------------------------------------------------------------

    Comment: The Department received comments stating that the 
definition of ``referral or refer for,'' when applied to employees of 
health plans, could hinder people who are attempting to determine what 
services are covered by their insurance plans and what doctors are in 
their plans or could be used to not process claims for objected-to 
services under a health plan. The comments suggested limiting 
conscience protections to health plans themselves rather than including 
the plans' employees, exempting administrative tasks performed by a 
health plan's employees, or limiting the definition of ``referral or 
refer for'' to not include health plans or their employees.
    Response: The Department replaced paragraph (4) to the definition 
of ``discriminate or discrimination'' to make clear that employers can 
use, and are encouraged to pursue, accommodation procedures with 
protected employees. Additionally, the Department added paragraphs (5) 
and (6) to the definition of discrimination to clarify that, within 
limits, employers may require protected employees to inform them of 
objections to referring for, participating in, or assisting in the 
performance of specific procedures, programs, research, counseling, or 
treatments to the extent there is a reasonable likelihood \83\ that the 
protected entity or member may be asked in good faith to refer for, 
participate in, or assist in the performance of such conduct.
---------------------------------------------------------------------------

    \83\ For example, nurses assigned exclusively to nursing homes 
for elderly patients would not be expected to refer or assist in the 
performance of any sterilization procedures or abortions, and thus, 
it would be inappropriate for an entity subject to the prohibitions 
in this rule to require such nurses to disclose whether or not they 
have any objections to referring or assisting in such procedures.
---------------------------------------------------------------------------

    Consistent with the terms of paragraphs (5) and (6) of the 
definition of discrimination regarding advance notice by an employee of 
the potential for a conscientious objection, an employer may similarly 
require an employee to notify them in a timely manner of an actual 
conscientious objection that the employee has to a specific act, in the 
day-to-day course of work, that the employee would otherwise be 
expected to perform.\84\
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    \84\ The Department notes material legal and factual 
distinctions between, on the one hand, an employer requiring an 
employee to notify it of a conscientious objection covered by this 
rule and, on the other, the accommodation process for religious 
employers in the Department's previous regulations mandating 
employer coverage of contraception and sterilization. 80 FR 41318 
(July 14, 2015). Numerous religious organizations brought challenges 
under RFRA concerning the ``accommodation'' process promulgated 
under those rules. RFRA prevents the Federal Government from 
substantially burdening a person's religious exercise unless in 
furtherance of a compelling governmental interest and in the manner 
least restrictive of that exercise. Under the accommodation, 
objecting religious organizations that self-insured would have been 
required to notify either the third-party administrator of their 
health plan, via a certain prescribed form, or HHS, via a letter 
containing certain prescribed information, of their objection to 
including contraception and sterilization in their health plans. 
Plaintiffs in those cases argued that providing such notice would 
itself have violated their religious beliefs. But a crucial element 
of the plaintiffs' argument in the context of self-insured plans was 
that the notice, via either method, was a prerequisite without which 
the plan's third-party administrator would lack legal authority to 
deliver the objected-to coverage. ``If a self-insured religious 
organization uses Form 700, the form becomes `an instrument under 
which the plan is operated [and is] treated as a designation of the 
[third-party administrator] as the plan administrator under section 
3(16) of ERISA[, 29 U.S.C. 1002(33),] for any contraceptive services 
required to be covered. 29 CFR 2510.3-16(b). Form 700 authorizes the 
[third-party administrator] to `provide or arrange payments for 
contraceptive services . . . 29 CFR 2590.715-2713A(b)(2) . . . If 
the self-insured religious organization instead self-certifies by 
HHS Notice, DOL's ensuing notification to the [third-party 
administrator] also operates to `designate' the [third-party 
administrator] `as plan administrator' under ERISA for contraceptive 
benefits. 79 FR at 51095; see also 29 CFR 2510.3-16(b).'' Sharpe 
Holdings v. U.S. Dept. of Health & Human Services, 801 F.3d 927, 935 
(8th Cir. 2015). The provision of notice triggered coverage of the 
objected-to contraceptives by the religious employer's third party 
administrator, thus--in the eyes of the objecting religious 
employers--making them complicit in a grave wrong.
     The provision of notice by an employee to her employer differs 
from the accommodation's notice requirement in key respects. First, 
absent unusual circumstances, burdens placed by a private employer 
on an employee's religious exercise would not be subject to the 
stringent demands of RFRA. Second, under the accommodation, the 
third-party administrator of an objecting employer's self-insured 
plan would have had no legal obligation to provide the objected-to 
coverage absent the employer's provision of notice, but if under 
this rule an objecting employee refuses to provide her employer with 
notice of her objection, her employer would nevertheless retain its 
authority and ability to provide the objected-to service without the 
employee's involvement.

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[[Page 23202]]

    Employers and programs that subsequently take steps to use 
alternate staff or methods to provide for or further the objected-to 
conduct would not be considered to engage in discrimination--nor would 
the requirement for the objecting entity to provide notice to the 
employer or program be considered a referral--if the employer or 
program does not take any adverse action against the objecting person 
or entity, if such methods do not exclude persons from fields of 
practice on the basis of their protected objections, and if the 
employer or program does not require any additional action by the 
objecting person or entity beyond the provision of notice discussed 
above. The employer may also inform the public of the availability of 
alternate staff or methods to provide or further the objected-to 
conduct if it does not constitute taking any adverse action against the 
objecting person or entity.
    The Department believes that incorporating these significant 
limitations to the scope of discrimination and, thus, addressing issues 
that may arise for an employer when a health care entity objects to 
making a referral, solves concerns such as those raised by this 
comment.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for,'' because it applies to public 
notices, would prohibit California's Reproductive FACT Act, ``which 
requires facilities specializing in pregnancy-related care to 
disseminate notices to all clients about the availability of public 
programs that provide free or subsidized family planning services, 
including prenatal care and abortion.''
    Response: As discussed above, the Department has already found that 
the FACT Act violated the Weldon and Coats-Snowe Amendments, and the 
Supreme Court, in NIFLA, 138 S. Ct. at 2371-76, ruled that it likely 
violates the First Amendment's free speech protections for targeting 
pro-life health care entities and compelling them to provide 
information about how to obtain abortions.
    Comment: The Department received comments stating that the proposed 
definition of ``referral or refer for'' conflicts with the DeConcini 
Amendment, which states, ``[I]n order to reduce reliance on abortion in 
developing nations, funds [to carry out the provisions of chapters 1 
and 10 of part I of the Foreign Assistance Act of 1961] shall be 
available only to voluntary family planning projects which offer, 
either directly or through referral to, or information about access to, 
a broad range of family planning methods and services'' (Consolidated 
Appropriations Act, 2019, Public Law 116-6, Div. F, sec. 7018).
    Response: The Department disagrees. The DeConcini Amendment's 
reference to ``a broad range of family planning methods and services'' 
does not include abortion. Rather, the amendment itself contrasts 
abortion with that broad range of family planning methods and services 
and excludes abortion as a method of family planning. Another proviso 
bars the use of ``funds made available under this Act . . . to pay for 
the performance of abortion as a method of family planning or to 
motivate or coerce any person to practice abortions'' and ``[t]hat 
nothing in this paragraph shall be construed to alter any existing 
statutory prohibitions against abortion under section 104 of the 
Foreign Assistance Act of 1961.'' The Department believes the best 
reading of that amendment is that the broad range of family planning 
methods and services is viewed as an alternative to abortion, not that 
the amendment mandates referrals for abortion as if they are part of 
family planning. In the context of foreign assistance, since the 1980s, 
four different presidential administrations have implemented policies 
to prohibit foreign assistance for family planning to go to entities 
that perform or actively promote abortion as a method of family 
planning, and Congress has been aware of those policies.\85\ 
Furthermore, the DeConcini Amendment's discussion of a broad range of 
family planning methods and services is nearly identical to the scope 
of the Title X statute, 42 U.S.C. 300. In that context, Congress made 
clear that it does not consider abortion to be a method of family 
planning and, in fact, prohibits the use of Federal funds in programs 
where abortion is a method of family planning. See 42 U.S.C. 300-6.
---------------------------------------------------------------------------

    \85\ U.S. Policy Statement for the International Conference on 
Population, 10 Population & Dev. Rev. 574, 578 (1984) (reproducing 
the Policy Statement of the United States of America at the United 
Nations International Conference on Population, also known as the 
Mexico City Policy).
---------------------------------------------------------------------------

    Comment: The Department received comments stating that the 
definition of ``referral or refer for'' could permit a health care 
provider to refuse to ever refer a patient to an OB/GYN for any reason 
because a future possible outcome of such a referral could be that the 
patient seeks an abortion or sterilization from the OB/GYN, even though 
the direct referral is not for such service.
    Response: The commenters' concerns seem far-fetched, but are, 
nevertheless, addressed by the change from the word ``possible 
outcome'' to ``reasonably foreseeable outcome,'' which requires a 
stronger connection between the referral and the objected-to conduct. 
The Department does not find there to be reason to foresee that 
objectors would use the Weldon or Coats-Snowe Amendments or these rules 
to refuse to refer women to every OB/GYN.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \86\ and above, and considering the comments received, 
the Department finalizes the definition of ``referral or refer for'' 
with changes as described above. The comments lead the Department to 
believe the text as originally proposed was unduly long, confusing, and 
repetitive and therefore finalizes the definition with numerous 
stylistic changes and deletions and nonsubstantive reordering of text 
to substantially improve readability. The Department also finalizes the 
rule to clarify that assistance related to a ``program'' is also 
encompassed by the definition in order to track the use of that phrase 
in statutes, including the Weldon and Coats-Snowe Amendments,

[[Page 23203]]

that protect against forced referrals in certain programs. The revised 
definition includes the provision of information in oral, written, or 
electronic form (including names, addresses, phone numbers, email or 
web addresses, directions, instructions, descriptions, or other 
information resources), where the purpose or reasonably foreseeable 
outcome of provision of the information is to assist a person in 
receiving funding or financing for, training in, obtaining, or 
performing a particular health care service, program, activity, or 
procedure.
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    \86\ 83 FR 3880, 3894-95 (stating the reasons for the proposed 
definition of ``referral or refer for,'' except for the 
modifications adopted herein).
---------------------------------------------------------------------------

    State. The Department proposed that ``State includes, in addition 
to the several States, the District of Columbia. For those provisions 
related to or relying upon the Public Health Service Act, the term 
`State' includes the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Northern Mariana Islands, the 
U.S. Virgin Islands, American Samoa, and the Trust Territory of the 
Pacific Islands. For those provisions related to or relying upon the 
Social Security Act, such as Medicaid or the Children's Health 
Insurance Program, the term `State' follows the definition of, State, 
found at 42 U.S.C. 1301.'' The Department did not receive comments on 
this definition.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \87\ and above, the Department adopts the definition of 
``State'' with one change, omitting ``follows'' and replacing it with 
``shall be defined in accordance with.''
---------------------------------------------------------------------------

    \87\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    Sub-recipient. The Department proposed that sub-recipient means any 
State, political subdivision of any State, instrumentality of any State 
or political subdivision thereof, and any person or any public or 
private agency, institution, organization, or other entity in any State 
including any successor, assign, or transferee thereof, to whom Federal 
financial assistance is extended through a recipient or another sub-
recipient, or who otherwise receives Federal funds from the Department 
or a component of the Department indirectly through a recipient or 
another sub-recipient, but such term does not include any ultimate 
beneficiary. The term may include foreign or international 
organizations (such as agencies of the United Nations). The Department 
received comments on this definition.
    Comment: The Department received a comment stating that the 
proposed definition of ``sub-recipient'' is overly broad and could be 
read to include every contracting party with a recipient of Federal 
financial assistance. The commenter proposes that ``sub-recipient'' 
should be limited ``to those for whom there is a direct pass-through of 
Federal financial assistance and who are identified as sub-recipients 
of such dollars in contracts with the direct recipient.''
    Response: The Department agrees that the definition should be 
clarified so that it does not include every entity that contracts with 
a recipient of Federal financial assistance. The Department, therefore, 
finalizes this definition with a change to the definition of ``sub-
recipient'' replacing the phrase ``to whom Federal financial assistance 
is extended through a recipient or another sub-recipient,'' with ``to 
whom there is a pass-through of Federal financial assistance through a 
recipient or another sub-recipient.'' The Department disagrees, 
however, that a sub-recipient must be explicitly declared as a sub-
recipient in a contract (or a grant). Requiring explicit designation as 
a sub-recipient could permit sub-recipients in fact to avoid such 
designation by contracting around such designation.
    As discussed concerning the term ``entity,'' the Department is 
finalizing the terms ``entity,'' ``recipient,'' and ``sub-recipient'' 
with parallel language to clarify that they all may encompass ``a 
foreign government, foreign nongovernmental organization, or 
intergovernmental organization (such as the United Nations or its 
affiliated agencies).''
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \88\ and above, and considering the comments received, 
the Department finalizes the definition of ``sub-recipient'' changing 
``and'' to ``or,'' replacing the phrase ``to whom Federal financial 
assistance is extended through a recipient or another sub-recipient, or 
who otherwise receives Federal funds from the Department or a component 
of the Department indirectly through a recipient or another sub-
recipient'' with ``to whom there is a pass-through of Federal financial 
assistance or Federal funds from the Department through a recipient or 
another sub-recipient,'' and to change the last sentence previously 
referring to ``foreign or international organizations'' to read, ``The 
term may include a foreign government, foreign nongovernmental 
organization, or intergovernmental organization (such as the United 
Nations or its affiliated agencies).''
---------------------------------------------------------------------------

    \88\ 83 FR 3880, 3895 (stating the reasons for the proposed 
definition of ``sub-recipient,'' except for the modifications 
adopted herein).
---------------------------------------------------------------------------

    Workforce. The Department proposed that workforce means employees, 
volunteers, trainees, contractors, and other persons whose conduct, in 
the performance of work for an entity or health care entity, is under 
the direct control of such entity or health care entity, whether or not 
they are paid by the entity or health care entity, as well as health 
care providers holding privileges with the entity or health care 
entity. The Department received comments on this definition.
    Comment: The Department received comments stating that the 
inclusion of volunteers, trainees, and contractors within the 
definition of ``workforce'' is too broad.
    Response: The Department does not agree. Under the revised rule 
text adopted in this final rule, the defined term ``workforce'' is used 
in a limited number of places and for limited purposes related to 
voluntary notice provisions in this rule. Limiting ``workforce'' to 
employees fails to acknowledge the complexity of the health care 
system. The Department adapted the proposed definition from the 
definition of ``workforce'' in the regulations implementing the HIPAA 
administrative simplification provisions, including the HIPAA Privacy 
Rule. See 45 CFR 160.103 (definition of ``workforce''). That definition 
has worked well to ensure, among other things, the protection of the 
privacy and security of protected health information. Just as is the 
case with the HIPAA Rules, compliance with Federal conscience and anti-
discrimination laws would not be appropriately comprehensive if only 
the employees of covered entities were protected, or if institutional 
entities chose to avoid providing notice to contractors, volunteers, 
and trainees.
    Comment: The Department received a comment suggesting that 
volunteers and contractors be included in the definition of 
``workforce'' only if they are performing or assisting in the 
performance of health care activities.
    Response: The Department disagrees. As stated above, the defined 
term ``workforce'' is used in only a limited number of places and for 
limited purposes under the rule. Generally, the statutes enforced under 
these rules apply to health care activities and entities, but where 
they do not, the terms of the statute govern.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \89\ and above, and considering the comments received, 
the Department

[[Page 23204]]

adopts the definition of ``workforce'' as proposed.
---------------------------------------------------------------------------

    \89\ 83 FR 3880, 3895.
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Applicable Requirements and Prohibitions (Sec.  88.3)
    The Department proposed a statute-by-statute recapitulation of the 
substantive provisions of each statute that is the subject of this 
rule, and of the applicability and scope of requirements and 
prohibitions of each such statute. The proposed ``Applicability'' 
provisions outlined the specific requirements of the Federal conscience 
and anti-discrimination laws that apply to various persons and 
entities. These provisions were taken from the relevant statutory 
language and would direct covered entities to the appropriate sections 
that contain the relevant requirements that form the basis of this 
regulation.
    The ``Requirements and Prohibitions'' provisions explained the 
obligations that the Federal conscience and anti-discrimination laws 
impose on the Department and on entities that receive applicable 
Federal financial assistance and other Federal funding from the 
Department. These provisions were taken from the relevant statutory 
language. The Department received comments on this section. The 
responses to comments are provided below following the proposed 
applicability and requirements and prohibitions provisions for each 
Federal conscience and anti-discrimination law.
    One conforming revision to the proposed rule that the Department 
has made throughout the ``Requirements and Prohibitions'' provisions is 
to remove Sec.  88.5 of 45 CFR part 88 (provision of notice) from the 
list of sections with which applicable persons and entities must 
comply. As described in the section-by-section analysis for Sec.  88.5 
of this rule, the provision of a notice of rights of Federal conscience 
and anti-discrimination laws is no longer a requirement for the 
Department and recipients.
    Another conforming revision to the proposed rule that the 
Department has made throughout the ``Requirements and Prohibitions'' 
provisions is to modify the phrase ``entities to whom'' various 
paragraphs apply '' to ``entities to which.'' The Department believes 
the word ``which'' avoids confusion regarding the nature and scope of 
entities to whom the rule applies.
    88.3(a). The Church Amendments. The Department received comments 
generally supportive of the Church Amendments and supportive of the 
inclusion of the Church Amendments in the rule, as well as comments 
opposed to the Church Amendments themselves or to the Department's 
enforcement of them.
    Comment: The Department received comments stating that the proposed 
rule only protects health care providers who hold moral or religious 
convictions against the provision of abortion or sterilization, but 
provides no protection for health care providers whose moral or 
religious convictions motivate them to provide abortions or 
sterilizations.
    Response: To the extent the commenters' concerns reflect an 
accurate reading of the Church Amendments, these concerns raised by the 
commenters are a result of choices Congress itself made. This final 
rule reasonably interprets the protections that Congress established, 
but it can neither eliminate nor transform the policy judgments 
embedded in the text of the Church Amendments or of any other 
applicable law. To the extent the Church Amendments apply because 
someone performed or assisted in the performance of a lawful 
sterilization procedure or abortion, this rule would enforce those 
provisions to the extent consistent with other statutory and 
constitutional requirements. See, e.g., Sec.  88.3(a)(2)(iv), (v), and 
(vii).
    Comment: The Department received comments stating that proposed 
Sec.  88.3(a)(2)(v) and (vi), which apply 42 U.S.C. 300a-7(c)(2) and 
(d), are too broad, and that 42 U.S.C. 300a-7(d) should be or has been 
interpreted to provide protections only for participation in abortion 
or sterilization procedures.
    Response: The Department disagrees that these paragraphs should be 
limited to situations involving abortion and sterilization. Paragraphs 
(b), (c)(1), and (e) of the Church Amendments clearly specify they 
apply concerning abortions or sterilizations. But paragraphs (c)(2) and 
(d) do not use that language; instead, as Congress specified, they 
encompass ``any lawful health service or research activity'' or ``any 
part of a health service program or research activity,'' respectively. 
The Department is required to implement the statutes as written by 
Congress. Reading paragraphs (c)(2) and (d) to address only abortion 
and sterilization procedures would narrow the scope of those statutory 
provisions in contravention of the clear text of the statute. 
Furthermore, court opinions interpreting 42 U.S.C. 300a-7(d) have 
varied in their interpretations, but recognize that it applies to more 
than abortion or sterilization procedures.\90\
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    \90\ See, e.g., Vt. Alliance for Ethical Healthcare, Inc. v. 
Hoser, 274 F. Supp. 3d 227, 232 (D. Vt. 2017) (``Section 300a-7(d) 
is one of several so-called Church Amendments. It excuses 
individuals engaged in health care or research from any obligation 
to perform abortions or other procedures which may violate religious 
beliefs or moral convictions.'' (emphasis added)); Franciscan 
Alliance, Inc. v. Burwell, 227 F. Supp. 3d 660, 683 (Dec. 31, 2016) 
(``The Church Amendment forbids requiring any individual `to perform 
or assist in the performance of any part of a health service program 
. . . if his performance or assistance in the performance of such 
part of such program . . . would be contrary to his religious 
beliefs or moral convictions.' '' (alterations)).
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    Regarding the breadth and accuracy of Sec.  88.3 overall, however, 
the Department finalizes the paragraph with changes to more accurately 
reflect the statutory text. With respect to Sec.  88.3(a)(2)(v), 
however, the Department agrees that the proposed rule was imprecise in 
omitting one limiting phrase that Congress had included in paragraph 
(c)(2) of the Church Amendments. The proposed rule ended Sec.  
88.3(a)(2)(v) with, ``because of his or her religious beliefs or moral 
convictions,'' while the statute reads, ``because of his religious 
beliefs or moral convictions respecting any such service or activity.'' 
The Department finalizes this paragraph to add the phrase ``respecting 
any such service or activity'' that Congress included in this part of 
the statute.
    Comment: The Department received a comment stating that the rule 
should clarify that the protections provided by Congress under 42 
U.S.C. 300a-7(b) and (c) apply only to abortions and sterilizations in 
the circumstances provided for in the statute.
    Response: Paragraphs (b) and (c)(1) of the Church Amendments 
specify that they apply in the context of abortion and sterilization 
procedures specifically. Paragraph (c)(2) has a broader reach, 
encompassing ``any lawful health service or research activity.'' As 
discussed in response to the similar comment asking that (c)(2) and (d) 
be interpreted to encompass only abortion and sterilizations, Congress 
limited paragraphs (b), (c)(1), and (e) to abortions and 
sterilizations, but used different language in paragraphs (c)(2) and 
(d). The rule tracks the text of paragraphs (b) and (c)(1) accordingly, 
as established by Congress. Paragraphs (a)(2)(i) through (iv) and (vii) 
in Sec.  88.3 of the rule explicitly relate to abortions or 
sterilizations,\91\ while Sec.  88.3(a)(2)(v) through (vi) relate to 
any lawful health service or research activity.\92\
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    \91\ Paragraph 88.3(a)(2)(i) implements subparagraph (b)(1) of 
the Church Amendments; paragraphs 88.3(a)(2)(ii) and (iii) implement 
paragraph (b)(2) of the Church Amendments; and paragraph 
88.3(a)(2)(iv) implements paragraph (c)(1) of the Church Amendments.
    \92\ Paragraph 88.3(a)(2)(v) implements subparagraph (c)(2) of 
the Church Amendment.

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[[Page 23205]]

    Comment: The Department received comments asking for clarification 
whether the provisions in Sec.  88.3(a) that relate to sterilization 
include only intentional sterilizations, or whether they also include 
procedures or services that have sterilization as a side effect, such 
as hysterectomies performed for reasons other than sterilization, or 
chemotherapy.
    Response: Congress did not provide a definition of sterilization in 
the Church Amendments, or further specify the scope of objections under 
those statutes, but provided broad protections for religious and moral 
objections to sterilization procedures. Generally speaking, the 
Department understands the term ``sterilization'' as used in the Church 
Amendments to encompass the ordinary meaning of that term, and does not 
understand the term to include treatment of a physical disease where 
sterilization is an unintended side effect of the treatment, such as 
chemotherapy to treat uterine cancer or testicular cancer. To the 
extent that a Church Amendment complaint with respect to sterilization 
is filed, the Department would examine the facts and circumstances of 
each such claim to determine whether an act falls within the scope of 
the statute and these regulations.
    Comment: The Department received comments asking for clarification 
about whether provisions in Sec.  88.3(a) apply to sterilizations 
performed in the context of gender dysphoria.
    Response: The Department is aware of three cases brought at least 
in part under the Church Amendments, in which the claimants argued that 
the Church Amendments' sterilization provisions protect the claimants' 
conscientious objections to performing gender dysphoria related 
surgery. In one case, Franciscan Alliance, Inc. v. Burwell, 227 F. 
Supp. 3d 660 (Dec. 31, 2016), enforcement of the challenged regulation, 
which plaintiffs contended would have required the performance of 
procedures such as hysterectomies to treat gender dysphoria, was 
preliminarily enjoined on other grounds. In the other two, consolidated 
as Religious Sisters of Mercy, et al., v. Burwell, No. 3:16-cv-386 
(D.N.D. 2017), which challenged the same regulation, the court issued 
an order staying enforcement of the regulation in light of the 
nationwide preliminary injunction issued in Franciscan Alliance. In the 
event the Department receives any such complaints, the Department will 
consider them on a case-by-case basis.
    Comment: The Department received comments contending that the 
paragraphs of the rule concerning the Church Amendments were too broad 
or did not faithfully apply the statutory text.
    Response: The Department intended Sec.  88.3 to faithfully apply 
the text of applicable statutes, including the Church Amendments. As a 
result of comments, the Department became aware of instances in which 
the proposed rule text did not accurately reflect the content of the 
statute. Accordingly, the Department finalizes the rule with changes to 
more accurately reflect the statute. Specifically, in Sec.  
88.3(a)(2)(ii) and (iii), concerning paragraphs (b)(2)(A) and (B) of 
the Church Amendments, the Department finalizes the rule by changing 
the phrase ``entities to whom this paragraph . . . applies shall not 
require any entity funded under the Public Health Service Act'' to 
``the receipt of a grant, contract, loan, or loan guarantee under the 
Public Health Service Act by any entity does not authorize entities to 
which this paragraph . . . applies to require such entity to . . . .''
    The Department also finalizes Sec.  88.3(a)(1)(vi) by changing 
``Any entity that carries out'' to ``Any entity that receives funds for 
any health service program or research activity under any program 
administered by the Secretary of Health and Human Services.'' The 
Department makes this change to provide clarity regarding which 
entities are required to comply with paragraph (d) of the Church 
Amendments.
    Comment: The Department received a comment stating that the rule 
should clarify that the protections provided by Congress under 42 
U.S.C. 300a-7(d) apply only to individuals.
    Response: The rule tracks the statutory language. Namely, Sec.  
88.3(a)(2)(vi) states that covered entities ``shall not require any 
individual . . . '' (emphasis added) to act contrary to their religious 
beliefs or moral convictions in the performance of certain health 
service programs or research activities. The Department maintains such 
language in this final rule.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \93\ and above, and considering the comments received, 
the Department makes certain changes in this paragraph in this final 
rule. The Department finalizes Sec.  88.3(a)(1)(vi) by changing ``Any 
entity that carries out'' to ``Any entity that receives funds for any 
health service program or research activity under any program 
administered by the Secretary of Health and Human Services.'' The 
Department finalizes Sec.  88.3(a)(2)(ii) and (iii) by changing the 
word ``entity'' to ``recipient'' where applicable, in order to avoid 
confusion potentially created by the use of the word ``entity'' to 
refer both to protected entities and entities obligated to comply with 
88.3(a). Additionally, in Sec.  88.3(a)(2)(i) through (vii), concerning 
paragraphs and paragraphs of the Church Amendments, the Department 
finalizes paragraphs (a)(2)(i) through (vii) by changing the language 
of each paragraph to adopt the statutory text as closely as possible in 
relevant part, including by adding the words ``respecting any such 
service or activity'' to the end of Sec.  88.3(a)(2)(v); amending Sec.  
88.3(a)(2)(i) to clarify that the statute enforces a rule of 
construction regarding the receipt of certain Federal financial 
assistance; by rephrasing the requirements to state that the receipt of 
relevant funds ``does not authorize entities to which this paragraph [ 
] applies to require'' practices specified by 42 U.S.C. 300a-7(b); 
adding in the parenthetical from the statute, ``(including applicants 
for internships and residencies)'', to Sec.  88.3(a)(2)(vii); and 
replacing short form descriptions of the statutory text with the full 
statutory text, such as by changing the words ``doing so'' in Sec.  
88.3(a)(2)(v) to ``his performance or assistance in the performance of 
such service or activity.'' The Department also eliminates some 
articles and terms, like ``the'' and ``or her,'' and replaces the term 
``whom'' with the term ``which'' for readability and accuracy.
---------------------------------------------------------------------------

    \93\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(a), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(b). Coats-Snowe Amendment. The Department received comments 
generally supportive of the Coats-Snowe Amendment and supportive of the 
inclusion of the Coats-Snowe Amendment in the rule, as well as comments 
opposed to the Coats-Snowe Amendment or the rule's implementation of 
that statute.
    Comment: The Department received comments on the definition of 
terms used by the Coats-Snowe Amendment, such as what constitutes a 
``health care entity.'' All such comments are addressed in the 
responses to comments on definitions under Sec.  88.2.
    Comment: The Department received a comment stating that the Coats-
Snowe Amendment was only a ``narrow response to a specific problem''--
correcting a loophole that could have conditioned Federal financial 
assistance on the provision of abortions indirectly through the 
Accrediting Council on Graduate Medical Education's accreditation 
standards for obstetrics and gynecology graduate programs--not

[[Page 23206]]

a pronouncement of new national policy and ``cannot justify the 
rulemaking authority the Department claims in the NPRM.''
    Response: The Department disagrees. While the Coats-Snowe Amendment 
may have been motivated by the situation involving the Accrediting 
Council on Graduate Medical Education's accreditation standards for 
obstetrics and gynecology graduate medical education programs and 
standards for the receipt of Federal financial assistance based on 
accreditation, the plain language of the text of the Coats-Snowe 
Amendment is broader than that situation. While paragraph (b) of the 
Coats-Snowe Amendment addresses the accreditation and treatment of 
postgraduate physician training programs (and physicians trained in 
such programs) that are or are not accredited by accrediting agencies 
that require the performance and training in the performance of induced 
abortions, paragraph (a) of the Coats-Snowe Amendment establishes far 
broader protections for health care entities that refuse, among other 
things, to provide or undergo training in the performance of induced 
abortions, to perform such abortions, or to provide referrals for such 
training or such abortions. The Amendment was, thus, drafted with 
separate language to provide both general protections, relating to the 
training, performance of, and referral for abortions, and specific 
protections, relating to governmental treatment of physicians and 
physician training programs where the accreditation agency had 
accreditation standards that requires performance or training in the 
performance of induced abortion.
    This rule must be governed by the text of the law, not legislative 
intent or legislative history that may or may not have been reflected 
in the text passed by Congress and signed by the President. The 
Department finds it appropriate for this rule to follow the text of the 
Coats-Snowe Amendment, and not to narrow its scope based on what may 
have been the impetus for the introduction, passage or enactment of the 
statute. The Department intends to provide enforcement mechanisms for 
the protections that Congress actually enacted.
    Comment: The Department received comments stating that the Coats-
Snowe Amendment only provides protections for entities that object to 
abortions for religious or moral reasons.
    Response: The Department disagrees. As the text of the Church 
Amendments makes clear, when Congress wants to limit a protection to 
situations in which the protected party acts or refuses to act on the 
basis of religious beliefs or moral convictions specifically (as 
distinct from other reasons), it explicitly includes such a limitation. 
The text of the Coats-Snowe Amendment, unlike the text of the Church 
Amendments, does not include any such limitation. It encompasses 
objections concerning such activities as training, performing, 
providing referrals for, or making arrangements for referrals for 
abortions or abortion training, without specifying that the objections 
are only protected if they are based on religious beliefs or moral 
convictions. Limiting the application of the Coats-Snowe Amendment to 
only situations in which the protected entity is acting on the basis of 
religious beliefs or moral convictions would be to add narrowing 
language to the Coats-Snowe Amendment that Congress did not include.
    Comment: The Department received a comment stating that parts of 
proposed Sec.  88.3 could affect the ability of independent 
institutions to set standards for accreditation or licensure.
    Response: The Department agrees in part. As other commenters have 
noted, one purpose leading to enactment of the Coats-Snowe Amendment 
was to prevent States from basing their accreditation or licensure 
decisions on grounds that eliminate medical schools or their graduates 
from the medical profession on the basis that they refuse to be 
involved in abortion. The Coats-Snowe Amendment prevents States that 
receive Federal financial assistance from engaging in discrimination 
that would, for example, refuse accreditation to medical schools, or 
licensure to physicians or nurses, because they did not provide 
training for, train on, or perform, abortions. The Amendment does not 
directly regulate any non-governmental entity. The amendment, however, 
would preclude a State from relying on a private entity's refusal to 
accredit on the bases just described in order to, among other things, 
deny recognition to the medical school as a medical school, or to deny 
recognition of the medical degree of a graduate of that school.
    The Department finalizes Sec.  88.3 with other changes from the 
proposed rule to include language from the statute as follows. 
Specifically, the proposed rule did not reflect, as set forth in 
paragraph (b)(1) of the statute, that ``the government involved,'' 
meaning Federal, State, or local, ``shall formulate such regulations or 
other mechanisms, or enter into such agreements with accrediting 
agencies, as are necessary to comply with this subsection.'' In 
response to comments, the Department has included language at the end 
of Sec.  88.3(b)(2)(ii) reflecting this relevant statutory text.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \94\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(b) with the following changes.
---------------------------------------------------------------------------

    \94\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(b), except for the modifications adopted herein).
---------------------------------------------------------------------------

    Further consideration led the Department to determine that the 
proposed text of Sec.  88.3(b)(1)(i) presented concerns regarding the 
scope of entities to which the proposed Sec.  88.3(b) would apply. 
Accordingly, the Department is finalizing Sec.  88.3(b)(1)(i) to read 
``The Department is required to comply with'' in lieu of the proposed 
rule's statement that ``The Federal government, including the 
Department, is required to comply with.''
    The Department removes references to ``individual or 
institutional'' in Sec.  88.3(b)(2)(i), in order to avoid confusion 
regarding the definition of the term ``health care entity.'' While the 
Department makes this change, it is not intended to change the scope of 
protection provided by the Coats-Snowe Amendment (and this final 
rule)--namely, both individuals and organizations (or institutions) 
that constitute health care entities. The Department also removes a 
reference to ``require attendees to'' in (b)(2)(i)(C) in order to more 
accurately track the language of the statute. The Department finalizes 
Sec.  88.3(b)(2)(ii) by changing ``an accreditation standard or 
standards'' to ``accreditation standards'' and changing ``such standard 
provides'' to ``such standards provide;'' and adding ``that require an 
entity to'' in order to more clearly articulate the requirements of the 
statute. Finally, in order to fully incorporate the text of the Coats-
Snowe Amendment, the Department also adds the sentence ``Entities to 
which this paragraph (b)(2)(ii) applies and which are involved in such 
matters shall formulate such regulations or other mechanisms, or enter 
into such agreements with accrediting agencies, as are necessary to 
comply with this paragraph.''
    Additionally, the Department removes the Federal government from 
the applicability section in Sec.  88.3(b)(1)(i) but leaves ``the 
Department.'' Although the relevant statutory provision applies to the 
Federal government, this rule concerns the activities and programs 
funded or administered by the

[[Page 23207]]

Department rather than the entire Federal Government.
    88.3(c). Weldon Amendment. The Department received comments on this 
paragraph, including comments generally supportive of the Weldon 
Amendment and supportive of the inclusion of the Weldon Amendment in 
the proposed rule, as well as comments opposed to the Weldon Amendment 
itself or the proposed rule's implementation of the Amendment.
    Comment: The Department received comments on the definition of 
terms used by the Weldon Amendment, such as what constitutes a ``health 
care entity.'' All such comments are addressed above in the responses 
to comments on definitions under Sec.  88.2.
    Comment: The Department received comments stating that the Weldon 
Amendment does not provide authority for the Department to impose any 
burdens or obligations on health care entities, such as the requirement 
of an assurance of compliance and the notice requirement.
    Response: Assurance requirements to remedy past discrimination or 
prevent future discrimination are common regulatory features of anti-
discrimination laws like those that are the subject of this rule and 
such authority has been affirmed by the Supreme Court. See Grove City 
College v. Bell, 465 U.S. 555 (1984) (affirming partial termination of 
institution's Federal funds for refusing to sign a Title IX assurance 
of compliance form). In response to comments, the Department has 
revised the proposed notice provisions from being a requirement to 
being one factor that OCR considers in its determinations as to whether 
a covered entity is in violation of this part. Comments concerning 
assurance and notice provisions are discussed in more detail below in 
Sec. Sec.  88.4 and 88.5, proposing to impose those provisions.
    Comment: The Department received comments stating that the proposed 
rule impermissibly extends the Weldon Amendment to apply to non-
governmental entities, and that the proposed rule disagrees with the 
position taken by the government in National Family Planning and 
Reproductive Health Association v. Gonzales, 391 F. Supp. 2d 200 
(D.D.C. 2005), regarding whether the Weldon Amendment extends to non-
governmental entities through those entities' receipt of Federal 
financial assistance.
    Response: The Department agrees that, as proposed, Sec.  88.3 was 
worded to extend the Weldon Amendment to non-governmental entities in 
ways not encompassed by the text of the Amendment as written. This was 
due to the inclusion of paragraph (c)(1)(iii) in that section, which 
required compliance with the Weldon Amendment by ``any entity'' that 
receives funds to which the Weldon Amendment applies. This paragraph 
would render superfluous paragraphs (c)(1)(i) and (ii), which require 
compliance with the Weldon Amendment by the Department and its programs 
and by any State or local government that receives funds to which the 
Weldon Amendment applies. The Department is therefore finalizing Sec.  
88.3(c)(1) by removing paragraph (c)(1)(iii).
    The Department notes, however, that the conduct and activities of 
contractors engaged by the Department, a Departmental program, or a 
State or local government is attributable to such Department, program, 
or government for purposes of enforcement or liability under the Weldon 
amendment.
    Comment: The Department received comments stating that the 
Department cannot engage in permanent rulemaking based on an annual 
appropriations amendment that may or may not be reenacted with each 
appropriations act.
    Response: The Department disagrees. The Department has outlined, 
above, the authority that it relies upon to promulgate regulations 
containing the substantive requirements established in the Weldon 
Amendment. The Department further notes that it has promulgated rules 
based on the Weldon Amendment in 2008 and 2011 and has operated under 
such rules based in part on the annual appropriations amendment cited. 
The Department has similarly issued regulations to implement annual 
appropriations amendments, such as the Hyde Amendment.\95\ Paragraphs 
(c)(1)(i) and (ii) in Sec.  88.3 of this rule specify that compliance 
is only effective ``under an appropriations act . . . that contains the 
Weldon Amendment.'' Therefore, the provisions of this rule enforcing 
the Weldon Amendment will only be applicable to a State or local 
government that receives funds subject to such appropriation. If 
Congress were to substantially change or not renew the Weldon 
Amendment, the final rule would not apply to that extent.
---------------------------------------------------------------------------

    \95\ See, e.g., 42 CFR 441.202, 441.203, 441.206 (prohibiting 
the use of Federal funds under Medicaid to pay for abortions except 
when continuation of the pregnancy would endanger the mother's 
life).
---------------------------------------------------------------------------

    Comment: The Department received comments stating that the Weldon 
Amendment cannot be interpreted to prevent States from requiring 
abortion coverage, because the Affordable Care Act, at 42 U.S.C. 
18023(c)(1), states, ``Nothing in this Act shall be construed to 
preempt or otherwise have any effect on State laws regarding the 
prohibition of (or requirement of) coverage, funding, or procedural 
requirements on abortions.''
    Response: The Weldon Amendment is not part of the Affordable Care 
Act. Therefore, 42 U.S.C. 18023(c)(1), which states, ``[n]othing in 
this Act'' shall be construed to have an effect on State laws requiring 
abortion coverage, does not apply to the Weldon Amendment. More 
importantly, ACA section 1303 also provides that ``[n]othing in this 
Act shall be construed to have any effect on 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). In addition, the Weldon Amendment has been renewed more 
recently than Congress enacted the Affordable Care Act, and therefore 
is generally owed deference if the two laws did conflict, which they do 
not.
    Comment: The Department received comments stating that the Weldon 
Amendment, as evidenced by its legislative history, does not apply to 
refusals unrelated to conscience-based (that is, religious or moral) 
objections, such as purely financial or operational motives.
    Response: The Department disagrees, for similar reasons described 
above in response to comments arguing for a narrow interpretation of 
the Coats-Snowe Amendment. As the text of the Church Amendments makes 
clear, when Congress wants to limit a protection to situations in which 
the protected party acts or refuses to act on the basis of religious 
beliefs or moral convictions, it explicitly includes such limitation in 
the text of the statute. The text of the Weldon Amendment, unlike the 
text of the Church Amendments, does not include any such limitation. On 
its face, the Weldon Amendment encompasses a decision by a health care 
entity not to provide, pay for, provide coverage of, or refer for 
abortions, without specifying that such decisions must be based on 
religious, moral, conscientious, or any other particular motive. 
Limiting the application of the Weldon Amendment only to situations in 
which the health care entity is acting on the basis of conscientious, 
moral or religious convictions would be to refuse to apply the Weldon 
Amendment according to the text enacted by Congress.
    Comment: The Department received comments asking for clarification 
that

[[Page 23208]]

the Weldon Amendment only applies with respect to abortions.
    Response: The Department agrees with the commenter. The text of the 
proposed rule already makes clear that, as stated in the text of the 
Weldon Amendment and as described in this rule, the Weldon Amendment 
only protects against discrimination on the basis that a health care 
entity does not provide, pay for, provide coverage of, or refer for 
abortions.
    Comment: The Department received a comment stating that the 
proposed rule would impermissibly extend the Weldon Amendment's 
protection beyond the abortion context to protect refusals to provide, 
pay for, provide coverage of, or refer for ``any lawful health 
service.''
    Response: The Department disagrees. Nothing in the proposed rule or 
in this final rule extends protections under the Weldon Amendment 
outside of the abortion context. As Sec.  88.3(c)(2) states, ``The 
entities to whom this paragraph (c)(2) applies shall not subject 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, abortion'' (emphasis added). The regulatory 
provision in the proposed rule and in this final rule that makes 
reference to ``any lawful health service'' addresses and would 
implement paragraph (c)(2) of the Church Amendments, which prohibits 
certain discrimination against a physician or other health care 
personnel because, among other things, ``he performed or assisted in 
the performance of any lawful health service or research activity.'' 
\96\
---------------------------------------------------------------------------

    \96\ See 42 U.S.C. 300a-7(c)(2); compare 45 CFR 88.3(a)(2)(v) 
(implementing Church (c)(2) with 45 CFR 88.3(c) (implementing Weldon 
Amendment).
---------------------------------------------------------------------------

    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \97\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(c) as proposed, except for changes 
to the citation to the most current Public Law where the Weldon 
Amendment may be found, and the removal of proposed paragraph 
(c)(1)(iii). Additionally, the Department is adding the phrase ``and 
its programs'' after ``the Department'' to track the statutory language 
more closely.
---------------------------------------------------------------------------

    \97\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(c), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(d). Medicare Advantage, 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. The Department did not receive comments on this paragraph. The 
Department has updated the title of this paragraph for the most recent 
appropriations rider for the current fiscal year. For clarity and 
accuracy, in paragraph (d)(1), the Department changed ``under the 
Medicare Advantage program'' to read ``with respect to the Medicare 
Advantage program,'' and updated the citation therein.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \98\ and above, the Department finalizes Sec.  88.3(d) 
primarily as proposed, but updates the header and citations in 
paragraph (d)(1) to reflect the citation for this appropriations ride 
for FY 2019, and replaced ``under,'' and adds ``informs the Secretary 
that it'' for clarity in paragraph (d)(2).
---------------------------------------------------------------------------

    \98\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(e). Section 1553 of the Affordable Care Act, 42 U.S.C. 18113. 
The Department received comments on this paragraph, including comments 
generally supportive of section 1553 of the Affordable Care Act and 
supportive of the inclusion of section 1553 in the rule, as well as 
comments opposing that section and the Department's enforcement of it.
    Comment: The Department received comments stating that section 1553 
cannot allow a health care professional to omit information about ``all 
choices'' available at end-of-life because a patient has a right to be 
informed.
    Response: The Department disagrees with this comment. Congress 
specified in section 1553 that a health care entity is protected in its 
decision not to provide ``any health care item or service furnished for 
the purposes of causing, or for the purpose of assisting in causing'' 
assisted suicide, euthanasia, or mercy killing. The Department is 
unaware of any Federal requirement that an individual or health care 
entity provide information about a service that it does not provide. 
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 date to the era of 
Roe v. Wade and Doe v. Bolton, violates or undermines the principles of 
informed consent. In fact, in Roe the Supreme Court favorably cited an 
American Medical Association resolution on abortion affirming ``[t]hat 
no physician or other professional personnel shall be compelled to 
perform any act which violates his good medical judgment. Neither 
physician, hospital, nor hospital personnel shall be required to 
perform any act violative of personally-held moral principles.'' \99\ 
Similarly, in Doe the Court spoke favorably about Georgia's statutory 
language giving a hospital the freedom not to admit a patient for an 
abortion, and protecting a physician or other hospital employee ``for 
moral or religious reasons'' from participating in an abortion 
procedure.\100\ The Department interprets section 1553 as specifically 
encompassing the decision by a health care entity not to provide 
information about, or referrals for, assisted suicide.\101\
---------------------------------------------------------------------------

    \99\ 410 U.S. at 143-44.
    \100\ 410 U.S. at 197-98.
    \101\ A referral is a health care service, and the phrase 
``assisting in causing'' is reasonably interpreted to carry the same 
meaning as ``assisting in performing,'' which the Department 
interprets to include the act of referring.
---------------------------------------------------------------------------

    Comment: The Department received a comment stating that, while 
Congress explicitly granted the Department the authority to promulgate 
regulations to implement section 1557 of the ACA, Congress did not 
provide such a grant for section 1553, but only gave the Department the 
authority to ``receive complaints of discrimination'' under section 
1553.
    Response: As discussed supra at part III.A, multiple statutes and 
regulations authorize the Department to issue these rules--including 
with respect to ACA section 1553--to ensure that the Department and 
covered entities comply with Federal conscience and anti-discrimination 
laws that apply to certain Federal funding. With respect to section 
1553 specifically, that section imposes specific provisions, including 
construction provisions, and mandates that the Department's Office for 
Civil Rights implement section 1553 by receiving complaints. This rule 
follows that language and provides Departmental mechanisms for acting 
upon complaints under section 1553. Such authority is implicit in the 
authority to receive complaints set forth in 1553. If that were not the 
case, OCR would not be able to comply with Congress's direction under 
section 1553 to handle and respond to complaints it receives, making 
the authority designated to OCR in section 1553 mere surplusage, 
hollow, or inoperative.\102\
---------------------------------------------------------------------------

    \102\ See Hibbs v. Winn, 542 U.S. 88, 101 (2004) (statutes 
should be construed so as to avoid rendering superfluous any 
statutory language; ``statute should be construed so that effect is 
given to all its provisions, so that no part will be inoperative or 
superfluous, void or insignificant. . . .'').
---------------------------------------------------------------------------

    The fact that section 1557 of the Affordable Care Act specifically 
authorized, but did not require, the Department to issue regulations to

[[Page 23209]]

implement that section, does not negate the authority Congress provided 
the Secretary under 5 U.S.C. 301 and the other statutory and regulatory 
authorities cited supra at part III.A to carry out the duties Congress 
designated to OCR under section 1553 of the ACA. In particular, as 
discussed above, section 1321(a) of the ACA authorizes the Department 
to ``issue regulations setting standards for meeting the requirements 
under [title I of the ACA] with respect to . . . the offering of 
qualified health plans through such Exchanges . . . and . . . such 
other requirements as the Secretary determines appropriate.'' Section 
1321(a), thus, provides the Department with the authority to issue 
regulations setting setting standard for meeting the requirements 
established in section 1553, which is part of title 1 of the ACA.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \103\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(e) as proposed with minor technical 
changes for clarity and adherence to the text of section 1553 of the 
ACA, for example changing ``any amendment'' to ``an amendment'' and 
clarifying that ``the Act'' refers to the ``Patient Protection and 
Affordable Care Act.'' Paragraph (e)(1)(iv) clarifies that the 
amendment would have been ``made by the Patient Protection and 
Affordable Care Act,'' and paragraph (e)(2) deletes ``provided, that.''
---------------------------------------------------------------------------

    \103\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(f). Section 1303 of the Affordable Care Act, 42 U.S.C. 18023. 
The Department received comments on this paragraph, including comments 
generally supportive of section 1303 of the Affordable Care Act and 
supportive of the inclusion of section 1303 in the rule, as well as 
comments critical of this proposed paragraph.
    Comment: The Department received a comment stating that the 
inclusion of section 1303 of the ACA in this rule is redundant, as the 
conscience protections provided for in section 1303 are also provided 
by other conscience protection statutes, and by the Religious Freedom 
Restoration Act, 42 U.S.C. 2000bb et seq.
    Response: The Department disagrees. Section 1303 contains several 
distinct provisions relating to conscience and conscience protections, 
in section 1303. While section 1303(c)(2) references and preserves the 
applicability of Federal laws regarding conscience protection,\104\ 
section 1303(b)(1) and (b)(4) provide standalone conscience protections 
that are independent of other Federal conscience protection provisions. 
While the language used in section 1303(b)(1) and (b)(4) is similar to 
other conscience protection statutes, these provisions provide 
independent conscience protections both with respect to governmental 
requirements of qualified health plans, and with respect to qualified 
health plans' discrimination against individual health care providers 
and health care facilities. Additionally, were other Federal conscience 
and anti-discrimination laws to be revoked, the conscience protections 
in section 1303(b)(1) and (b)(4) of the ACA could remain in effect. The 
Department does not presume that separate Federal conscience and anti-
discrimination laws enacted by Congress are redundant. It is a 
principle of statutory construction that effect should be given to 
overlapping statutes as long as there is no ``positive repugnance'' 
between them. See, e.g., Connecticut Nat'l Bank v. Germain, 503 U.S. 
249, 253 (1992). And there is no such positive repugnance here.
---------------------------------------------------------------------------

    \104\ 42 U.S.C. 18023(c)(2) (``[n]othing in this Act shall be 
construed to have any effect on 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'').
---------------------------------------------------------------------------

    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \105\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(f) as proposed, with a technical 
correction to reflect that 42 U.S.C. 18023(b)(1)(A) is a rule of 
construction regarding Title I of the Patient Protection and Affordable 
Care Act, rather than a substantive prohibition. In paragraph 
(f)(2)(i), the Department clarifies that the entities shall not 
``construe anything in Title I of the Patient Protection and Affordable 
Care Act (or any amendment made by Title I of the Patient Protection 
and Affordable Care Act) to.''
---------------------------------------------------------------------------

    \105\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(g). Section 1411 of the Affordable Care Act, 42 U.S.C. 18081. 
The Department did not receive comments on this paragraph.
    The Department intended Sec.  88.3 to faithfully apply the text of 
applicable statutes, including section 1411 of the Affordable Care Act, 
while at the same time, providing clarity to regulated persons and 
entities. To this end, the final rule clarifies in Sec.  88.3(g)(2) 
that the Department is required not only to provide a certification 
documenting a religious exemption from the individual responsibility 
requirement and penalty under the Affordable Care Act, which appeared 
in the proposed rule, but also to coordinate with State Health Benefit 
Exchanges (State Exchanges) in the implementing of the certification 
requirements of 42 U.S.C. 18031(d)(4)(H)(ii) where applicable. The 
Department works closely with State Exchanges to implement the 
Affordable Care Act, and for clarity, the final rule reflects that 
coordination. For similar reasons, the Department modified Sec.  
88.3(g)(2)(i) to reflect changes Congress made to 26 U.S.C. 5000A 
through section 4003 of the SUPPORT for Patients and Communities Act, 
which became law October 24, 2018.\106\ Those changes retained a 
reference in 26 U.S.C. 5000A to 26 U.S.C. 1402(g)(1), which sets out 
various conditions for eligibility for the conscience exemption from 
the individual responsibility requirement. Among those conditions is a 
requirement that the religious sect or division thereof to which the 
applicant for the exemption belongs must have been in existence at all 
times since December 31, 1950. The Department has omitted this 
particular requirement from Sec.  88.3(g)(2)(i) out of concern that it 
may conflict with the Establishment Clause.
---------------------------------------------------------------------------

    \106\ SUPPORT for Patients and Communities Act, Public Law 115-
271, sec. 4003, 26 U.S.C. 5000A(d)(2) (2018).
---------------------------------------------------------------------------

    The Department understands that Public Law 115-97 (December 22, 
2017) reduced the penalty in 26 U.S.C. 5000A for a lack of minimum 
essential coverage to zero dollars,\107\ and that the implications of 
this law is the subject of substantial litigation. The Department, 
nevertheless, believes it is prudent to implement the certification 
requirements as proposed because we understand the law still requires 
individuals to submit proof of essential coverage or be certified as 
exempt despite the penalty being zeroed out.
---------------------------------------------------------------------------

    \107\ Budget Fiscal Year, 2018, Public Law 115-97, Part VIII, 
sec. 11081, 131 Stat. 2092 (Dec. 22, 2017).
---------------------------------------------------------------------------

    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \108\ and above, the Department finalizes Sec.  88.3(g) 
as proposed, with technical corrections to reflect that the individuals 
to whom the Department grants certifications under 42 U.S.C. 18081 are 
individuals who have applied for such certifications and to ensure the 
language follows that of the statute, a typographical correction to 
change the reference to ``5000A(2)(B)(ii)'' to ``5000A(d)(2)(B)(i),'' 
modifications to comport with Congress's revisions to 42 U.S.C. 
5000A(d) through the October 24, 2018, enactment of the SUPPORT for 
Patients and Communities Act, which broadens the application of the 
exemption and discusses exclusions regarding what constitutes medical

[[Page 23210]]

health services, and the Department adds clarification for the 
Department to comply with the applicable prohibitions in coordination 
with State Exchanges.
---------------------------------------------------------------------------

    \108\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(h). Counseling and referral provisions of 42 U.S.C. 1395w-
22(j)(3)(B) and 1396u-2(b)(3)(B). The Department received comments on 
this paragraph.
    Comment: The Department received a comment stating that, while the 
statutory text of 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B) 
established rules of construction, the proposed rule converted these 
statutes into freestanding exemptions.
    Response: The Department agrees that the proposed rule is worded 
imprecisely to treat 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B) 
as freestanding exemptions, rather than as rules of construction as set 
forth in the statutory text. The Department, therefore, modifies the 
final rule accordingly to conform to the statutory text.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \109\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(h)(2)(i) by referring to 
regulations that also implement the statutes containing the 
requirements and prohibitions, for example by adding ``construe 42 
U.S.C. 1395w-22(j)(3)(A) or 42 CFR 422.206(a) to,''; by deleting 
``offer a plan that provides, reimburses for, or provides'' and replace 
it with ``provide, reimburse for, or provide,''; inserting ``offering 
the plan'' to the end of paragraph (h)(2)(i); and adding paragraph 
(h)(2)(i)(B) regarding making information available to prospective 
enrollees and enrollees. The Department also made changes to paragraph 
(h)(2)(ii) by changing the phrase ``shall not require a Medicaid 
managed care organization to provide'' to ``shall not construe 42 
U.S.C. 1396u-2(b)(3)(A) or 42 CFR 438.102(a)(1) to require,''; deleting 
``objects to the provision of such service on moral or religious 
grounds,''; and adding paragraphs (h)(2)(ii)(A) and (B), (A) stating 
the organization objects on moral or religious grounds and (B) 
regarding the policies to prospective enrollees and enrollees.
---------------------------------------------------------------------------

    \109\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(h), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(i). Advance Directives, 42 U.S.C. 1395cc(f), 1396a(w)(3), and 
14406. The Department received comments on this paragraph.
    Comment: The Department received a comment stating that 42 U.S.C. 
1395cc(f) requires that certain entities maintain written policies and 
procedures to inform patients of their ``individual rights under State 
law to make decisions concerning such medical care, including the right 
to accept or refuse medical or surgical treatment and the right to 
formulate advanced directives,'' but the proposed rule ``attempt[s] to 
rewrite this provision by prohibiting this statute from being construed 
to require covered entities to provide full information to patients 
about services to which they may object.''
    Response: The Department disagrees. This final rule provides for 
the enforcement of 42 U.S.C. 14406, which states, ``. . . section 
1395cc(f) . . . shall not be construed (1) to require any provider or 
organization, or any employee of such a provider or organization, to 
inform or counsel any individual regarding any right to obtain an item 
or service furnished for the purpose of causing, or the purpose of 
assisting in causing, the death of the individual, such as by assisted 
suicide, euthanasia, or mercy killing. . . .'' This statutory language 
is adopted almost verbatim into Sec.  88.3(i)(2)(i). Far from 
``attempt[ing] to rewrite this provision,'' this rule merely adopts 
Congress's rule of construction provision as Congress enacted it.
    Comment: The Department received comments stating that advance 
directives should be followed regardless of a physician's personal 
objections.
    Response: Paragraph (i) in Sec.  88.3 provides for the 
implementation and enforcement of provisions at 42 U.S.C. 1395cc(f), 
1396a(w)(3), and 14406, which assure that applicable Federal laws 
(relating to Medicare and Medicaid) are not used contrary to statute to 
prohibit health care providers from exercising their rights of 
conscience with respect to advance directives, including with respect 
to assisted suicide. This provision does not affect State laws 
governing the enforceability of advance directives. But, in general, 
the Department believes that protecting health care providers' rights 
of conscience with respect to advance directives ensures that doctors, 
nurses, and other persons in the health care industry are not forced to 
choose between continuing to serve as health care providers and 
remaining faithful to their deepest convictions. Such conscience 
protection ensures diversity in the health care industry and maximizes 
the number of health care professionals in the United States, which 
helps all patients.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \110\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(i) with a change to correct a 
typographical error in Sec.  88.3(i)(2)(i), where ``1395a(w)'' should 
instead read ``1396a(w)(3).''
---------------------------------------------------------------------------

    \110\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(j). Global Health Programs, 22 U.S.C. 7631(d). The Department 
received comments on this paragraph.
    Comment: The Department received comments in opposition to the 
Department's enforcement of Federal conscience and anti-discrimination 
laws outside of the United States, because populations served by U.S. 
foreign aid often have less financial resources and access to fewer 
medical providers than persons in the United States.
    Response: The Department disagrees with the underlying premise of 
this comment. As described above, the Department believes that 
enforcing statutory conscience rights will increase, not decrease, the 
availability of quality medical care because it will prevent the 
exclusion of health care professionals motivated by deep religious 
beliefs or moral convictions to serve others, often the most 
underprivileged. Moreover, this rule merely provides for the 
enforcement of laws enacted by Congress that, by their own terms, may 
apply abroad.
    Comment: The Department received a comment stating that the 
provisions with respect to foreign policy may lead to confusion as to 
which laws properly govern foreign aid.
    Response: Upon reviewing the text of this paragraph, the Department 
has revised the language to make it clearer to which entities the 
requirements apply, and the circumstances in which they apply, and to 
more closely track the language enacted by Congress. The proposed rule 
would have applied the requirements of this paragraph to the Department 
and recipients of relevant Federal financial assistance. However, 22 
U.S.C. 7631(d) does not impose requirements on what recipients of 
assistance can and cannot do; rather, it imposes requirements on the 
conditions that may be placed on receipt of assistance. The statute 
does not provide a description of the entities that the statute 
governs--i.e., entities that are in a position to place conditions on 
the receipt of assistance of assistance. The Department believes that 
class of entities is best described as those that are authorized to 
obligate the assistance. Accordingly, the Department is modifying Sec.  
88.3(j)(1) to apply to the Department and entities that are authorized 
by statute, regulation, or agreement to obligate Federal financial

[[Page 23211]]

assistance under section 104A of the Foreign Assistance Act of 1961 (22 
U.S.C. 2151b-2), under Chapter 83 of Title 22 of the U.S. Code or under 
the Tom Lantos and Henry J. Hyde United States Global Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 
2008, to the extent such Federal financial assistance is administered 
by the Secretary, and is deleting the reference regarding the Federal 
financial assistance being ``for HIV/AIDS prevention, treatment, or 
care to the extent administered by the Secretary.''
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \111\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(j) with technical changes 
clarifying the language regarding to which entities the requirements 
apply, and the circumstances in which they apply, to more closely 
follow the language of such statutes and amendments as enacted by 
Congress, eliminating in paragraph (j)(2)(i) ``To the extent 
administered by the Secretary'' and inserting ``Require an 
organization, including a faith-based organization, that is otherwise 
eligible to receive assistance,'' deleting ``require applicants for'' 
and replacing it with ``to the extent such assistance is administered 
by the Secretary, . . . as a condition of such assistance.'' The 
Department also changed ``applicant'' to ``organization'' and removed 
``as a condition of assistance'' in (j)(2)(i)(B), and made significant 
edits to paragraph (j)(2)(ii) for accuracy regarding the statutory text 
and references to other paragraphs of this part.
---------------------------------------------------------------------------

    \111\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(j), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(k). The Helms, Biden, 1978, and 1985 Amendments, 22 U.S.C. 
2151b(f); e.g., Consolidated Appropriations Act, 2019, Public Law 116-
6, Div. F, sec. 7018. The Department received comments on this 
paragraph.
    Comment: The Department received a comment stating that the 
provisions with respect to foreign policy may lead to confusion as to 
which laws properly govern foreign aid.
    Response: Upon reviewing the text of this paragraph, the Department 
has revised the language to make it clearer as to which laws and 
amendments are implicated by this paragraph, and to more closely track 
the statutory language enacted by Congress. For clarity, the heading of 
the paragraph has been revised to refer to each of the four separate 
statutory provisions implemented by the paragraph, rather than only to 
the Helms Amendment. For consistency with the statute, the paragraph 
includes a new paragraph in the ``Applicability'' paragraph identifying 
as a distinct class of covered entities those entities that are 
authorized to obligate or expend the Federal financial assistance in 
question, separate from entities that merely receive such Federal 
financial assistance. The paragraph also now specifies that the Federal 
financial assistance in question for this paragraph is that which is 
appropriated for the purposes of carrying out part I of the Foreign 
Assistance Act of 1961.
    The proposed rule would have applied the requirements of this 
paragraph to the Department and recipients of relevant Federal 
financial assistance. However, 22 U.S.C. 2151b(f) and section 7018 of 
the Consolidated Appropriations Act of 2019 impose both requirements on 
what recipients of assistance can and cannot do and also requirements 
on the entities providing that assistance to recipients. The statute 
does not provide a description of the entities that provide assistance 
to recipients. The Department believes that class of entities is best 
described as those that are authorized to obligate the assistance. 
Accordingly, the Department is modifying Sec.  88.3(k)(1) to apply to 
the Department, to recipients of relevant assistance, and to entities 
that are authorized by statute, regulation, or agreement to obligate 
the relevant assistance. Additionally, considering that the 1985 
Amendment \112\ has been included in annual appropriations acts rather 
than codified as a statute, the Department is modifying the description 
of covered entities' obligations under Sec.  88.3(k)(2) to clarify that 
the rule's provisions regarding the 1985 Amendment apply only to funds 
under an appropriations act containing the 1985 Amendment.
---------------------------------------------------------------------------

    \112\ See, e.g., the Consolidated Appropriations Act, 2019, 
Public Law 116-6, Div. F, sec. 7018 (``None of the funds made 
available to carry out part I of the Foreign Assistance Act of 1961, 
as amended, may be obligated or expended for any country or 
organization if the President certifies that the use of these funds 
by any such country or organization would violate any of the above 
provisions related to abortions or involuntary sterilizations.'')
---------------------------------------------------------------------------

    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \113\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(k) with technical changes 
clarifying the citations and language as to which statutes and 
amendments are referenced, and to more closely follow the language of 
such statutes and amendments as enacted by Congress, and adding clarity 
through citations to paragraphs within this part.
---------------------------------------------------------------------------

    \113\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(l). Newborn and Infant Hearing Loss Screening, 42 U.S.C. 280g-
1(d). The Department received comments on this paragraph.
    Comment: The Department received a comment asking that the rule 
interpret 42 U.S.C. 280g-1(d) to provide an affirmative conscience 
exemption for parents who do not want their children to receive a 
hearing loss screening.
    Response: 42 U.S.C. 280g-1(d) is a rule of construction that the 
Department is unable to convert into an affirmative exemption. The 
Department can, however, enforce such rules to assure that entities 
administering the statute do not misapply the statute to the detriment 
of the conscience rights of parents and their children.
    Comment: The Department received comments stating that the proposed 
rule would endanger public health by providing conscience protections 
for parents to object to compulsory medical procedures such as hearing 
loss screenings.
    Response: The Department disagrees. 42 U.S.C. 280g-1(d) is a rule 
of construction, and this final rule does not convert it into an 
affirmative Federal exemption. This rule's enforcement provisions do 
not create a right for parents to object to a hearing loss screening 
for their children generally or as against other State or Federal laws. 
Rather, they only prevent interpreting this Federal law to override 
State laws that already provide a religious exemption regarding the 
screening at issue.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \114\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(l) with minor changes to ensure 
clarity and consistency with the statute, for example by deleting 
``newborn infants or young,'' changing articles, and making other minor 
changes.
---------------------------------------------------------------------------

    \114\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(m). Medical Screening, Examination, Diagnosis, Treatment, or 
Other Health Care or Services, 42 U.S.C. 1396f. The Department received 
comments on this paragraph.
    Comment: The Department received numerous comments supporting the 
rule's provision of enforcement mechanisms for 42 U.S.C. 1396f.
    Other commenters opposed the enforcement mechanisms, alleging they 
create an affirmative mandate that a State agency that administers a 
State Medicaid Plan may not compel any

[[Page 23212]]

person to undergo any medical screening, examination, diagnosis, or 
treatment if such person objects on religious grounds.
    Response: The Department disagrees with commenters opposing the 
paragraph. 42 U.S.C. 1396f is a rule of construction, and this rule 
does not convert it into an affirmative Federal exemption. This rule's 
enforcement provisions do not create a freestanding right for persons 
or their families to be free to decline certain medical screenings or 
treatments. Rather, they only prevent an interpretation of 42 U.S.C. 
1396f as requiring States to compel the acceptance of such screening or 
treatment when the Medicaid statute has no such requirement.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \115\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(m) as proposed.
---------------------------------------------------------------------------

    \115\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(n). Occupational Illness Examinations and Tests, 29 U.S.C. 
669(a)(5).
    Comment: The Department received comments generally supporting the 
concept of conscience protections for occupational medical 
examinations, immunizations, and treatments, and other comments 
generally opposing that concept. The Department did not receive 
specific comments on Sec.  88.3(n) or its implementation of the rule of 
construction described in 29 U.S.C. 669(a)(5).
    Response: Although Congress granted HHS authority to conduct 
research, experiments, and demonstrations related to occupational 
illnesses in the Occupational Safety and Health Act of 1970, such 
authority did not include the power to require ``medical examination, 
immunization, or treatment for those who object thereto on religious 
grounds, except where such is necessary for the protection of the 
health or safety of others.'' 29 U.S.C. 669(a)(5). The Department is 
required to abide by this limitation, and considers it appropriate to 
issue a final rule ensuring compliance.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \116\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(n) with minor changes, for example, 
deleting ``With respect to occupational illness examinations and tests, 
the entities'' and replacing it with ``Entities.''
---------------------------------------------------------------------------

    \116\ 83 FR 3880, 3895.
---------------------------------------------------------------------------

    88.3(o). Vaccination, 42 U.S.C. 1396s(c)(2)(B)(ii). The Department 
received comments on this paragraph.
    Comment: The Department received comments suggesting that the scope 
of this paragraph be expanded beyond pediatric vaccines to encompass 
all vaccines, or that it should be expanded to create a personal right 
to decline vaccinations based on moral or religious objections.
    Response: The Department is aware of complaints asserting religious 
or moral objections to administering or receiving vaccines, including, 
for example, objections to administering or receiving vaccines derived 
from aborted fetal tissue. Because Sec.  88.3(o) of the rule provides 
enforcement mechanisms for 42 U.S.C. 1396s, it is therefore limited to 
the scope of 42 U.S.C. 1396s. As 42 U.S.C. 1396s applies only to the 
pediatric vaccine program under Medicaid (the Vaccines for Children 
Program), the Department is unable to expand the scope of this 
paragraph beyond such programs. Likewise, as 42 U.S.C. 1396s requires 
compliance with religious or other exemptions under State law with 
respect to pediatric vaccines, the Department is unable to expand this 
rule provision to preempt State laws that do not provide such 
conscience protections.
    Comment: The Department received comments asking for clarification 
as to how the proposed Sec.  88.3(o) interacts with State laws such as 
school immunization requirements.
    Response: Upon reviewing the proposed Sec.  88.3(o), the Department 
agrees that the language can be clarified regarding how the paragraph 
might interact with State law. The Department therefore finalizes Sec.  
88.3(o) to more accurately reflect the text of 42 U.S.C. 
1396s(c)(2)(B)(ii) by changing the applicability of the requirement of 
Sec.  88.3(o)(2) to reflect the statute's requirement that, under any 
State-administered pediatric vaccine distribution program, the provider 
agreement executed by any provider registered to participate in the 
program includes the requirement that the program-registered provider 
comply with applicable State law, including any such law relating to 
any religious or other exemption. In order to further clarify the scope 
of Sec.  88.3(o), the Department finalizes this paragraph to specify 
that applicable State ``law'' may include State statutory, regulatory, 
or constitutional protections for conscience and religious freedom, 
where applicable.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \117\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(o) with changes to ensure it 
follows the language of 42 U.S.C. 1396s(c)(2)(B)(ii), which applies to 
program-registered providers of pediatric vaccines, not to States 
generally, and to specify that applicable State law may include State 
statutory, regulatory, or constitutional protections for conscience and 
religious freedom, where applicable.
---------------------------------------------------------------------------

    \117\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(o), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(p). Specific Assessment, Prevention and Treatment Services, 42 
U.S.C. 290bb-36(f), 5106i(a).
    Comment: The Department received comments on this paragraph 
expressing concern that the provision of conscience protections for 
parents who object to youth suicide assessments for their children 
should be balanced with the risk to the child's life.
    Response: Paragraph (p) in Sec.  88.3 is a rule of construction 
that prevents persons or entities administering programs under 42 
U.S.C. 290bb-36 or 42 U.S.C. 5106i(a) from relying on the particular 
statutes at issue to require assessments or treatments that conflict 
with religious belief. The provisions in this rule related to these 
statutes do not, however, prevent or interfere with any other State or 
Federal law that reaches a different (or the same) conclusion on these 
questions.
    In reviewing this paragraph in light of the comments received on 
it, however, the Department has determined that paragraph (p)(2)(iii) 
needs to be modified to more closely track the statutory language, in 
order to ensure it operates as a rule of construction consistent with 
42 U.S.C. 290bb-36(f).
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \118\ and above, and considering the comments received, 
the Department finalizes Sec.  88.3(p) with changes to paragraph 
(p)(2)(iii) to more closely track the language of 42 U.S.C. 290bb-
36(f), which establishes it as a rule of construction.
---------------------------------------------------------------------------

    \118\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(p), except for the modifications adopted herein).
---------------------------------------------------------------------------

    88.3(q). Religious nonmedical health care, 42 U.S.C. 1320a-1, 
1320c-11, 1395i-5, 1395x(e), 1395x(y)(1), 1396a(a), and 1397j-1(b). The 
Department received comments on this paragraph.
    Comment: The Department received comments opposed to the provision 
of Federal funds to religious nonmedical health care facilities because 
such funding could be interpreted as legitimating such facilities, 
resulting in

[[Page 23213]]

patients of such facilities not seeking other treatment options.
    Response: Whether to permit Federal funds to be used to pay 
religious nonmedical health care facilities for particular services 
provided to Medicare or Medicaid beneficiaries has been determined by 
Congress through 42 U.S.C. 1320a-1, 1320c-11, 1395i-5, 1395x(e), 
1395x(y)(1), 1396a(a), and 1397j-1(b), and the Department is unable to 
alter that decision. The purpose of including these provisions in the 
proposed rule and this final rule is only to provide enforcement 
mechanisms for the determination of Congress with respect to funding of 
religious nonmedical health care facilities. Nevertheless, the 
Department believes that most if not all persons who make use of 
religious nonmedical health care facilities do so because they hold 
religious objections to the receipt of medical care and would be 
unwilling to seek other treatment options regardless of the religious 
nonmedical health care facilities' funding status.
    Comment: The Department received comments expressing concern that 
providing conscience protections for attendees of religious nonmedical 
health care facilities could prevent people, particularly children, 
from accessing necessary medical health care.
    Response: This rule only provides for enforcement mechanisms for 
conscience protection statutes that Congress has enacted, and 
determinations of policy matters raised by these comments are outside 
the scope of this rulemaking to the extent they conflict with decisions 
made by Congress. That said, this provision regarding religious 
nonmedical health care does not prevent people from accessing care, but 
rather, has a role in enabling people to access care that does not 
violate their religious beliefs, which will benefit all patient 
populations, including children.
    Comment: The Department received a comment stating that exempting 
religious nonmedical health care facilities from State standards for 
cleanliness and quality of care potentially threatens the quality of 
care that attendees of such facilities receive. The commenter proposed 
striking these provisions from the rule and ensuring that religious 
nonmedical health care facilities adhere to the same standards as other 
skilled nursing facilities and providers.
    Response: Requiring religious nonmedical health care facilities to 
adhere to the same standards as other skilled nursing facilities and 
providers would contradict Congress's determination to exempt religious 
nonmedical health care facilities, as provided for in 42 U.S.C. 
1396a(a) and as upheld in Children's Healthcare Is a Legal Duty, Inc. 
v. Min De Parle, 212 F.3d 1084 (8th Cir. 2000) (``[S]tate plans may not 
establish State agency oversight of the quality of care provided in 
RNCHIs [sic].''). The Department, therefore, rejects this proposal.
    Nonetheless, the Department recognizes that the structure and 
description of the relevant exemptions in Sec.  88.3(q) was unclear in 
many respects, and so the Department makes substantial changes to the 
``Requirements and prohibitions'' to correct and clarify Sec.  88.3(q) 
to more accurately describe the activities from which the applicable 
covered entities are required to exempt religious nonmedical health 
care institutions, including a change to more fully incorporate the 
exemption established in 42 U.S.C. 1396(a)(31).
    Comment: The Department received a comment requesting that the 
exemptions for religious nonmedical health care facilities concerning 
Medicare Part A funding be explicitly applied to Medicare Advantage as 
well because, while Medicare Advantage is required to provide coverage 
for all services that are covered by Medicare Part A and Part B, many 
Medicare Advantage organizations do not recognize religious nonmedical 
health care.
    Response: As noted by the commenter, because Medicare Advantage 
organizations are required to cover services covered by Medicare Parts 
A and B pursuant to 42 U.S.C. 1395w-22(a)(1)(A), the exemptions for 
religious nonmedical health care facilities related to Medicare Part A 
funding apply to Medicare Advantage as well. Because the applicability 
paragraphs of Sec.  88.3(q) follow the statutory language concerning 
religious nonmedical health care exemptions, the Department declines to 
adopt the commenter's suggested modification.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \119\ and above, and considering the comments received, 
the Department made significant changes to the structure of Sec.  
88.3(q) to clarify applicable statutes and paragraphs, correct 
typographical errors, and more closely track the statutory language. 
The Department more clearly articulates which paragraphs are applicable 
to different entities by, for example, changing ``(q)(2)(i) through 
(iii)'' so that it now clearly states ``(q)(2)(i), (ii), (iii), and 
(iv).'' The Department added ``(h)'' to the reference to 42 U.S.C. 
1320a-1 to clarify the particular paragraph containing relevant 
information. The Department clarified in paragraph (q)(1)(ii) that some 
State agencies are required to comply, in paragraph (q)(1)(iii) that 
entities receiving Federal financial assistance from Medicare have 
compliance obligations, and in paragraph (q)(1)(iv) that entities 
including States that receive Federal financial assistance from 
Medicaid have compliance obligations, and in paragraph (q)(1)(v) 
clarified the authority related to an elder's right to practice his or 
her religion through reliance on prayer alone is subtitle B of Title XX 
of the Social Security Act (42 U.S.C. 1397j-1397m-5) and eliminated 
what was the last paragraph regarding the Elder Justice Block Grants. 
The paragraph incorporates multiple references to 42 U.S.C. 
1395x(ss)(1), which defines a religious nonmedical health care 
institution, to add clarity to the regulation. The paragraph clarifies 
the application of various provisions to entities that make an 
agreement with the Secretary of the Department pursuant to 42 U.S.C. 
1320a-1(b), or receive Federal financial assistance from Medicare, 
Medicaid, or Subtitle B of Title XX of the Social Security Act (42 
U.S.C. 1397j-397m-5). Last, the Department removed the references 
requiring compliance with Sec.  88.5, as compliance with that section 
is now voluntary.
---------------------------------------------------------------------------

    \119\ 83 FR 3880, 3895 (stating the reasons for the proposed 
Sec.  88.3(q), except for the modifications adopted herein).
---------------------------------------------------------------------------

Assurance and Certification of Compliance Requirements (Sec.  88.4)
    In the ``Assurance and Certification of Compliance'' section of the 
proposed rule, the Department proposed to require certain recipients of 
Federal financial assistance or other Federal funds from the Department 
or that the Department administers to submit written assurances and 
certifications of compliance with the Federal conscience and anti-
discrimination laws, as applicable, as part of the terms and conditions 
of acceptance of Federal financial assistance or other Federal funding 
from the Department. The Department stated its belief that both an 
assurance and a certification provide important protections to persons 
and entities under these laws and would be consistent with requirements 
under other civil rights laws. The Department noted its concern that 
there is a lack of knowledge on the part of States, local governments, 
the health care industry, and the public of the rights of protected 
persons and entities, and the corresponding obligations on covered 
entities provided by Federal conscience and anti-discrimination laws.

[[Page 23214]]

    Section 88.4 proposed to require certain applicants for Federal 
financial assistance or other Federal funds from the Department to 
which this part applies to submit assurances and certifications of 
compliance with Federal conscience and anti-discrimination laws and 
this part. The Department proposed that covered applicants 
operationalize the assurance and certification requirement by filing 
revised versions of applicable civil rights forms, such as the HHS-690 
Assurance of Compliance Form once per year and incorporate such filing 
by reference in all other applications submitted that year, rather than 
for every application that year. To this end, and as consistent with 
other civil rights regulations requiring assurances or certifications, 
the Department proposed in Sec.  88.4(b)(6) to permit an applicant to 
incorporate the assurance by reference in subsequent applications to 
the Department. The proposed rule explained that both the assurance and 
certification would constitute a condition of continued receipt of 
Federal financial assistance or other Federal funds from the 
Department. With respect to the certification required in proposed 
Sec.  88.4(a)(2), proposed Sec.  88.4(b)(7) clarified that, as with 
other anti-discrimination laws, a violation of the requirements of the 
certification may result in enforcement by the Department, as provided 
in Sec.  88.7 of this part.
    Noting the need to increase public awareness of Federal conscience 
and anti-discrimination laws, the Department solicited public comment 
on the various options available for public education and outreach.
    Proposed paragraph (b) identified specific requirements for the 
proposed assurance and compliance requirements: (b)(1) Addressed the 
timing to submit the assurance for current applicants or recipients as 
of the effective date of this part; (b)(2) addressed the form and 
manner of such submittals; and (b)(3) addressed the duration of 
obligations for both the assurance and certification.
    Proposed Sec.  88.4(b)(2) explained that applicants would submit 
assurance and certification forms in an efficient manner specified by 
OCR, in coordination with the relevant Department component, or 
alternatively in a separate writing.
    The Department proposed that its components be given discretion to 
phase in the written assurance and certification requirement by no 
later than the beginning of the next fiscal year following the 
effective date of the regulation. The Department stated its intent to 
work with recipients of Federal financial assistance or other Federal 
funds from the Department to ensure compliance with the requirements or 
prohibitions promulgated in this regulation. If the applicant or 
recipient would fail or refuse to furnish a required assurance or 
certification, the Department proposed that OCR, in coordination with 
the relevant Department component, would be authorized to effect 
compliance by any of the remedies provided in Sec.  88.7. See Grove 
City College, 465 U.S. 555 (affirming partial termination of 
institution's Federal funds for refusing to sign a Title IX assurance 
of compliance form).
    The Department also proposed that, while both recipients and sub-
recipients, as defined herein, must comply with the substantive 
requirements of Federal conscience and anti-discrimination laws, as 
applicable, sub-recipients would not be subject to the requirements of 
Sec.  88.4 regarding assurance and certifications of compliance. The 
Department invited comment on whether this approach strikes the 
appropriate balance between achievement of this rulemaking's policy 
objectives and avoidance of undue burden on the health care industry.
    Proposed Sec.  88.4(c) also contained several important exceptions 
from the proposed requirements for written assurance and certification 
of compliance, including (1) physicians, physician offices, and other 
health care practitioners participating only in Part B of the Medicare 
program; (2) recipients of Federal financial assistance or other 
Federal funds from the Department awarded under certain grant programs 
currently administered by the Administration for Children and Families, 
whose purpose is unrelated to health care provision as specified; (3) 
recipients of Federal financial assistance or other Federal funds from 
the Department awarded under certain grant programs currently 
administered by the Administration on Community Living, whose purpose 
is unrelated to health care provision as specified; and (4) Indian 
Tribes and Tribal Organizations when contracting with the Indian Health 
Service under the Indian Self-Determination and Education Assistance 
Act. The Department sought public comment on whether further exceptions 
should be made to the requirements of Sec.  88.4 in contexts where the 
requirements would be unduly burdensome or in contexts unrelated to 
health care or medical research. The Department received comments on 
this section, including general comments in support of this section.
    Comment: The Department received comments requesting that 
exemptions for religious beliefs or moral convictions, such as for 
vaccinations, be included in form HHS-690.
    Response: The Department's implementation of the assurance and 
certification of compliance will address the Federal conscience and 
anti-discrimination laws implicated by this rule. Because none of the 
statutes that this rule implements create across-the-board exemptions 
on the basis of religious beliefs or moral convictions to vaccination 
requirements, the assurance and certification of compliance requirement 
does not either.
    Comment: The Department received comments requesting that any 
assurance of compliance be acquired through form HHS-690 to avoid the 
increased administrative burden of adding new forms or procedures.
    Response: The Department agrees with this proposal and is working 
to obtain Paperwork Reduction Act clearance for updates to the HHS-690 
form entitled Assurance of Compliance, which previously had OMB PRA 
clearance as OMB No. 0945-0006. (The Department's operationalization of 
the certification of compliance required in Sec.  88.4(a)(1) is 
described in the RIA and PRA portions of this rule.)
    The HHS-690 form enables an applicant to provide an assurance that 
it will comply with certain Federal civil rights laws and regulations 
``in consideration of and for the purpose of obtaining Federal grants, 
loans, contracts, property, discounts, or other Federal financial 
assistance'' from the Department.\120\ By signing the assurance of 
compliance, the applicant ``agrees that compliance with this assurance 
constitutes a condition of continued receipt of Federal financial 
assistance, and that it is binding upon the Applicant, its successors, 
transferees and assignees for the period during which such assistance 
is provided.'' \121\
---------------------------------------------------------------------------

    \120\ U.S. Dep't of Health & Human Servs., Assurance of 
Compliance, HHS 690, https://www.hhs.gov/sites/default/files/hhs-690.pdf.
    \121\ Id.
---------------------------------------------------------------------------

    As finalized, Sec.  88.4(b)(1) requires entities that are already 
recipients as of the effective date of the rule and applicants to 
submit the assurance and the certification as a condition of any 
application or reapplication for funds to which the rule applies. 
Pursuant to the finalized Sec.  88.4(b)(6), it would be permissible to 
incorporate assurances and certifications by reference in subsequent 
applications, which is consistent with the Department's Grants Policy 
Statement, which states that

[[Page 23215]]

because recipients file an assurance of compliance form ``for the 
organization and . . . not . . . for each application,'' a recipient 
with a signed assurance on file assures through its signature on the 
award application that it has a signed Form 690 on file.\122\
---------------------------------------------------------------------------

    \122\ U.S. Dep't of Health & Human Serv., HHS Grants Policy 
Statement, I-31 (Jan. 2007), https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
---------------------------------------------------------------------------

    The Department proposed to add a provision to Sec.  88.4(b)(1) that 
would require submission of the assurance more frequently than at the 
time of application if the applicant or recipient fails to meet a 
requirement of the rule, or if OCR or the relevant Department component 
has reason to suspect or cause to investigate the possibility of such 
failure. For instance, OCR may have reason to suspect through its 
investigations or the number of complaints received that a particular 
recipient is not complying with the Federal conscience and anti-
discrimination laws or the rule and consequently asks the recipient to 
sign an assurance of compliance form offcycle from the normal grants 
process. To forgo as-needed assurances outside of the application 
process jeopardizes OCR's and the Department's flexibility to ensure 
that the Federal financial assistance or other Federal funds that the 
Department awards are used in a manner compliant with Federal 
conscience and anti-discrimination laws and this rule.
    Comment: The Department received a comment requesting that the 
certification of compliance contain additional language, such as 
explicit protections for LGBT patients.
    Response: The scope of this rule and the certifications of 
compliance sought herein are limited to the Federal conscience and 
anti-discrimination laws. Certifications with respect to other topics 
or laws not the subject of this rule are outside the scope of this 
rulemaking.
    Comment: The Department received a comment stating that 
conditioning receipt of Federal financial assistance or Federal funds 
on receipt of an assurance and certification is unnecessary in light of 
the proposed enforcement mechanisms provided by Sec.  88.7.
    Response: The Department does not agree. This collection of 
assurances and certifications would facilitate the Department's 
obligation to ensure that the Federal financial assistance or other 
Federal funds that the Department awards are used in a manner that 
complies with Federal conscience and anti-discrimination laws and this 
rule. The Department is accountable to the American public for 
protecting the integrity of Federal financial assistance and other 
Federal funds that the Department awards. The Department's 
administration of a requirement for a person or entity at the time of 
application or reapplication to assure and certify compliance with 
Federal conscience and anti-discrimination laws and the final rule 
demonstrates that the person or entity was aware of its obligations 
under those laws and the rule.
    In addition, this collection of assurances and certifications would 
operationalize the obligations of persons and entities to comply with 
applicable Federal conscience and anti-discrimination laws. As 
discussed above, the Department has the authority to place terms and 
conditions with respect to the Federal conscience and anti-
discrimination laws in any instrument HHS issues or to which it is a 
party (e.g., grants, contracts, or other HHS agreements). A Department 
component extending an award must communicate and incorporate statutory 
and public policy requirements and obligate the recipient to comply 
with Federal statues and ``public policy requirements, including . . . 
those . . . prohibiting discrimination.'' \123\ More specifically, the 
Department component ``must communicate . . . all relevant public 
policy requirements, including those in general appropriations 
provisions, and incorporate them either directly or by reference in the 
terms and conditions of the Federal award.'' \124\ To execute this 
obligation, the Departmental component may require a recipient ``to 
submit certifications and representations required by Federal statutes, 
or regulations . . . .'' \125\
---------------------------------------------------------------------------

    \123\ 45 CFR 75.300(a).
    \124\ Id.
    \125\ Id. sec. 75.208.
---------------------------------------------------------------------------

    Furthermore, the proposed requirements of Sec.  88.4 are consistent 
with the requirements of other Federal civil rights laws and would 
bring Federal conscience and anti-discrimination laws into parity with 
those other civil rights laws. Although instituting an enforcement 
action against an entity is effective in ensuring that the enforced-
against entity is aware of its requirements under the statutes 
implemented through this rule, the requirement of an assurance and 
certification of compliance would ensure that such awareness is shared 
by entities subject to proposed Sec.  88.4 before violations occur and 
may help prevent them.
    Comment: The Department received a comment stating that the 
requirement that covered entities provide assurances and certifications 
of compliance could lead to third-party qui tam lawsuits parallel to 
the Department's enforcement actions.
    Response: Whether a third-party may bring or prevail in a qui tam 
lawsuit with respect to an assurance or certification required by this 
rule is a legal question dependent on statutes and precedent governing 
qui tam lawsuits and is beyond the scope of this rulemaking. The 
Department does not consider the possibility that such laws may apply 
as a sufficient reason not to require assurance or certification of 
compliance with Federal conscience and anti-discrimination laws in 
order to achieve the goals described in this Final Rule for requiring 
such assurance or certification.
    Comment: The Department received a comment stating that the 
proposed rule is unclear as to whether a person that falls within one 
of the exempt categories described in Sec.  88.4(c)(1) and (2) remains 
exempt if such person receives Federal funds under a separate agency or 
program.
    Response: The Department does not agree that the proposed rule is 
unclear as to whether such a person would remain exempt. Proposed Sec.  
88.4(c) states that certain persons or entities shall not be required 
to comply with paragraphs (a)(1) and (2) of Sec.  88.4 ``provided that 
such persons or entities are not recipients of Federal financial 
assistance or other Federal funds from the Department through another 
instrument, program, or mechanism, other than those set forth in 
paragraphs (c)(1) through (4) of this paragraph.'' Therefore, a person 
who would be exempt under one of these provisions, but receives Federal 
financial assistance or other Federal funds from a non-exempt HHS 
program, is no longer exempt.
    ``Federal financial assistance'' as used in the phrase ``Federal 
financial assistance or other Federal funds from the Department'' 
should be read to mean such assistance from the Department. Therefore, 
a person that falls within one of the exempt categories described in 
Sec.  88.4(c)(1) and (2) remains exempt if such person receives Federal 
financial assistance from an agency or department other than HHS.
    Comment: The Department received a comment stating that the 
proposed rule is unclear because, while the rule states that it is 
appropriate to exempt clinicians who are part of State Medicaid 
programs, such clinicians are not included in the exemptions of Sec.  
88.4(c).

[[Page 23216]]

    Response: The exclusion in Sec.  88.4(c) does not need to 
explicitly exempt State Medicaid program clinicians because such 
participants are already excluded from Sec.  88.4's application by 
virtue of being sub-recipients of the Department, not recipients. 
States are the direct recipients of Medicaid funding from the 
Department, and States may offer Medicaid benefits on a fee-for-service 
(FFS) basis, through managed care plans, or both. Regardless of the 
model that the States use, clinicians are sub-recipients as this term 
is used in this rule. Under the fee-for-service model, the State pays 
the clinicians directly and under the managed care model, a State pays 
a fee to a managed care plan, which in turn pays the clinician for the 
services a beneficiary may require that are within the managed care 
plan's contract with the State to serve Medicaid beneficiaries.\126\ 
The 2008 Rule expressly exempted State Medicaid program clinicians 
because the certification requirement applied to recipients and sub-
recipients; \127\ in contrast, the certification requirement in this 
rule applies to recipients only.\128\
---------------------------------------------------------------------------

    \126\ See, e.g., Provider Payment and Delivery Systems, MACPAC, 
https://www.macpac.gov/medicaid-101/provider-payment-and-delivery-systems/ (last visited Jan. 29, 2019).
    \127\ 73 FR at 78101.
    \128\ Compare 2008 Rule, 73 FR at 78098 (requiring sub-
recipients to provide the Certification of Compliance set out in the 
rule as part of the sub-recipient's original agreement with the 
recipient) with Sec.  88.4(a)(1)-(2) infra (requiring an applicant 
or recipient to submit an assurance and certification).
---------------------------------------------------------------------------

    Comment: The Department received a comment stating that, while some 
pharmacies and pharmacists participate in Medicare Part B, the 
exemption for health care practitioners in Sec.  88.4(c) does not 
explicitly include pharmacists and pharmacies, and ``health care 
practitioners'' may not be understood to include pharmacists or 
pharmacies.
    Response: The Department agrees with the commenter's observation 
and, accordingly, will finalize Sec.  88.4(c)(1) to explicitly include 
pharmacists and pharmacies within the exemption if they participate in 
Medicare Part B and are not otherwise subject to this part.
    Comment: The Department received a comment asking that the 
exemption in Sec.  88.4(c) be expanded to include participants in 
Medicare Part C as well as Part B.
    Response: In contrast to doctors and other health care 
practitioners who participate in Medicare Part B and are considered 
recipients under this rule because these providers receive direct 
payments from the Centers for Medicare & Medicaid Services, Medicare 
Part C (Medicare Advantage) providers are not recipients, as defined by 
this rule, but instead are sub-recipients. Under the Medicare Part C 
program, HHS makes payments to the private plan, which is the recipient 
for the purpose of Medicare Part C, and the plan pays the provider, 
which under this rule would be considered a sub-recipient.\129\ 
Therefore, Sec.  88.4(c) does not need to exempt Medicare Part C 
providers because, as a threshold manner, the assurances and 
certifications requirement of Sec.  88.4 do not apply to providers 
participating in Medicare Part C. The same is true of participants in 
Medicare Part D.\130\
---------------------------------------------------------------------------

    \129\ See Medicare Advantage Program Payment System, MEDPAC 1 
(Oct. 2016), http://www.medpac.gov/docs/default-source/payment-basics/medpac_payment_basics_16_ma_final.pdf (describing the payment 
system).
    \130\ See id.
---------------------------------------------------------------------------

    Comment: The Department received a comment asking that the 
assurance and certification of compliance provisions become effective 
one year after the final rule is published or provide a one-year safe 
harbor to entities that make a good faith effort to inform their 
employees about the Federal conscience and anti-discrimination laws and 
come into compliance.
    Response: Although ultimate responsibility for compliance resides 
with covered entities, OCR plans to do significant outreach and public 
education to inform covered entities of their obligations and 
timelines. Recipients are also free to inform their employees about 
Federal conscience and anti-discrimination laws through policies and 
procedures or internal communications efforts, such as by posting 
notices of rights under Federal conscience and anti-discrimination 
laws, using the model in appendix A to 45 CFR part 88. Section 88.5 of 
this rule no longer requires recipients to post notices, but OCR will 
consider the posting of notices as non-dispositive evidence of 
compliance if OCR were to investigate the recipients' compliance with 
Federal conscience and anti-discrimination laws. Because the notice 
provision is being finalized as a voluntary best practice that serves 
as non-dispositive evidence of compliance, there is no deadline for 
posting of notices.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \131\ and above, and considering the comments received, 
the Department finalizes Sec.  88.4 with the following changes: A 
change to paragraph (b)(1), deleting ``applicants or recipients'' and 
replacing with ``entities'' for accuracy; a change to paragraph (b)(1) 
to insert ``or any applicants'' and to insert ``application or'' to 
clarify that new applicants are included; a change to paragraph (b)(1), 
regarding timing, to clarify that submission of assurance and 
certifications may be required on a more frequent basis if ``OCR or the 
relevant Department component has reason to suspect or cause to 
investigate the possibility of [a] failure'' to meet a requirement of 
this part; changes to paragraph (b)(6) to clarify that both prior 
assurances and certifications may be incorporated by reference; a 
change to the end of paragraph (b)(7) by adding the phrase ``including 
by referral to the Department of Justice, in coordination with the 
Department's Office of General Counsel, where appropriate'' as 
discussed above; a change to paragraph (b)(8) to replace ``remedies'' 
with ``mechanisms'' for accuracy; and a change to paragraph (c)(1) to 
include pharmacies and pharmacists in the list of Medicare Part B 
exclusions.
---------------------------------------------------------------------------

    \131\ 83 FR 3880, 3896-3897 (stating the reasons for the 
proposed Sec.  88.4, except for the modifications adopted herein).
---------------------------------------------------------------------------

Notice of Rights Under Federal Conscience and Anti-Discrimination Laws 
(Sec.  88.5)
    The NPRM proposed requiring the Department and recipients to notify 
the public, patients, and workforce, which may include students or 
applicants for employment or training, of their protections under the 
Federal conscience and anti-discrimination laws and this rule.
    For consistency with other notice requirements in civil rights 
regulations, paragraph (a) of Sec.  88.5 proposed to require the 
Department and recipients to post the notice provided in Appendix A of 
the proposed rule within 90 days of the effective date of this part. 
This proposed notice would advise persons and entities about their 
rights and the Department's and/or recipients' obligations under 
Federal conscience and anti-discrimination laws. The notice would 
provide information about how to file a complaint with OCR. The 
Department sought comment on whether there are categories of recipients 
that should be exempted from this requirement to post such notices. The 
proposed rule did not propose to require sub-recipients to post the 
notice.
    The proposed rule would require all Department components and 
recipients to use the notice text in appendix A of the proposed rule. 
The Department invited comment on whether the proposed rule should 
permit recipients to draft their own notices for which the content 
meets certain criteria and does not compromise the intent of Sec.  
88.5.
    Proposed paragraph (b) set forth two categories of locations where 
the notice

[[Page 23217]]

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

[[Page 23218]]

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

[[Page 23219]]

into consideration in investigations and compliance reviews. The notice 
provisions under this final rule provide appropriate suggestions for 
effective placement while still acknowledging that not all 
circumstances are identical.
    Comment: The Department received comments stating that there should 
be no exceptions to the notice requirement in Sec.  88.5.
    Response: The Department appreciates the comments, but has decided 
not to finalize the notice provision as a requirement. The notice 
provision is being finalized as a voluntary best practice that the 
Department will consider in complaint investigation and compliance 
reviews.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \132\ and above, and considering the comments received, 
the Department finalizes Sec.  88.5 with changes so that notices are 
not required, but will be a voluntary best practice that may 
demonstrate compliance in any OCR investigation. The rule specifies 
that OCR may, in investigating complaints and conducting compliance 
reviews, consider the extent to which covered entities post notices 
according to the rule's notice provisions as non-dispositive evidence 
of compliance with substantive provisions of the rule applicable to 
covered entities. The section also now permits recipients to draft 
their own version of the notice, or to combine the notice with other 
non-discrimination notices, to allow greater accuracy, flexibility, and 
tailoring to their particular circumstances. The Department also 
changes the section to reflect that, while guidance regarding 
particular placement of notices remains a factor for compliance 
consideration purposes, all notice placement provisions may not be 
applicable or appropriate to all covered entities. The Department also 
changes the section to remove the requirement that the notice be posted 
within 90 days of the publishing of the rule, or, with respect to new 
recipients, within 90 days of becoming a recipient, to reflect that 
posting of the notice is voluntary and that there is no mandated time 
frame within which a notice must be posted. The Department also changes 
the section to include, in paragraphs (b)(3) and (4), ``the 
Department'' in addition to recipients, for additional clarity. 
Finally, the Department makes a technical change to relocate the 
proposed rule's provision regarding the readability of the notice text 
from paragraph (b)(2) in the proposed rule to paragraph (b)(6) in the 
final rule.
---------------------------------------------------------------------------

    \132\ 83 FR 3880, 3897-98 (stating the reasons for the proposed 
Sec.  88.5, except for the modifications adopted herein).
---------------------------------------------------------------------------

Compliance Requirements (Sec.  88.6)
    This section of the proposed rule identified specific requirements 
for compliance with the Federal conscience and anti-discrimination 
laws. The Department proposed to subject recipients to the imposition 
of funding restrictions and other appropriate remedies if they or a 
sub-recipient is found to have violated a Federal conscience and anti-
discrimination law. The Department proposed to require recipients, sub-
recipients, and agency components to maintain records evidencing 
compliance with these laws and the proposed rule and to require such 
entities to cooperate with any OCR compliance review or investigation 
(including by producing documents or participating in interviews). The 
proposed rule further would require recipients and sub-recipients to 
inform any Departmental funding component, and to disclose, on 
applications for Departmental funding, the existence of any OCR 
compliance review, investigation, or complaint under the rule. This 
section also addressed claims in the event a covered entity intimidates 
or retaliates against those who complain to OCR or participate in or 
assist in an OCR enforcement action. The Department received comments 
suggesting improvements to this section, as well as comments generally 
supporting proposed Sec.  88.6.
    Comment: The Department received comments stating that it is unduly 
burdensome and unnecessary to require recipients to report to the 
Department funding component all compliance reviews, investigations, 
and complaints when they occur and to disclose any compliance review, 
investigation, or complaint for five years prior in any application for 
new or renewed Federal financial assistance or Departmental funding. 
Commenters noted that such requirements are burdensome on the covered 
entities, are unnecessary if an investigation found no violation, and 
require the covered entity to provide the Department with information 
that the Department should already have.
    Response: The Department agrees that such reporting requirements 
are unnecessary in situations in which an investigation has found no 
violation. The Department also agrees that the provision of such 
reports to funding components of the Department for already awarded 
Federal financial assistance or Departmental funding is unnecessary 
because the Office for Civil Rights can notify such funding components 
at the time such a determination of violation is made. The Department 
disagrees that such records of violations are unnecessary as to future 
awards of Federal financial assistance or Departmental funding, because 
the Department does not maintain records of all such findings in a 
manner that is generally accessible to funding components across the 
Department.
    Therefore, the Department is revising the reporting requirements 
under Sec.  88.6 to reduce the burden on covered entities and to 
eliminate the reporting requirements in situations in which such 
reports are unnecessary or redundant with actions that will be taken by 
the Department. The final rule retains the requirement that recipients 
or sub-recipients subject to a determination by OCR of noncompliance 
with this part must, in any application for new or renewed Federal 
financial assistance or Departmental funding following such 
determination, disclose the determination of noncompliance. The rule 
also clarifies that applicants must also disclose OCR determinations 
made against their sub-recipients under previous or existing contracts, 
grants, or other instruments providing Federal financial assistance. 
Sub-recipients would only have to disclose findings made against them 
if they are seeking new or renewed funding as recipients of HHS funds 
or Federal financial assistance. The final rule shortens the period for 
reporting from five years to three years.
    Comment: The Department received comments stating that none of the 
Federal conscience and anti-discrimination laws authorize the 
Department to require record-keeping, conduct compliance reviews, or 
investigate complaints.
    Response: As discussed supra at part III.A, various statutes and 
regulations authorize the Department to issue these regulations. The 
Department, and entities to which this rule applies, are required by 
statute to comply with various Federal conscience and anti-
discrimination laws. Inherent in Congress's adoption of the statutes 
that require the recipients of Federal funds from the Department to 
comply with certain Federal health conscience statutes is the authority 
of the Department to take measures to ensure compliance. Further, 
complaint investigation, compliance reviews, and record-keeping are 
standard measures that the Department employs with respect to the 
grants and contracts that it issues--to ensure compliance with 
requirements imposed by Congress with respect to particular programs 
and on

[[Page 23220]]

recipients of Federal funds, including statutory non-discrimination 
requirements. Below, the Department discusses in more detail objections 
to the Department's authority to conduct compliance reviews.
    Issuing this rule as finalized provides for the application and 
imposition of standard Departmental terms, conditions, and procedures 
to ensure compliance by recipients with statutory non-discrimination 
requirements, pursuant to the Department's authorities discussed supra 
at part III.A. Those authorities allow, among other things, the 
imposition of terms and conditions on grant awards, contracts, and 
other funding instruments, and authorize the Department to require 
certain information from entities applying for such funds.
    Comment: The Department received comments requesting more 
specificity as to how long records should be maintained, in what form 
or manner they should be maintained, and what content such records 
should include.
    Response: The Department agrees that greater specificity as to the 
records that should be maintained, how long such records should be 
maintained, and in what format such records should be kept is 
appropriate. Therefore the Department will finalize the rule with 
modifications specifying that records (1) shall be maintained for a 
period of three years from the date the record was created, was last in 
force, or was obtained, by the recipient or sub-recipient; (2) shall 
contain any information maintained by the recipient or sub-recipient 
that pertains to discrimination on the basis of religious belief or 
moral conviction, including any complaints; statements, policies, or 
notices concerning discrimination on the basis of religious belief or 
moral conviction; procedures for accommodating employees' or other 
protected individuals' religious beliefs or moral convictions; and 
records of requests for such religious or moral accommodation and the 
recipient or sub-recipient's response to such requests; and (3) may be 
maintained in any form and manner that affords OCR with reasonable 
access to them in a timely manner. These modifications are consistent 
with recordkeeping requirements employed in other civil rights 
regulations. For example, the Department of Justice imposed three-year 
record maintenance for self-evaluations \133\ required under 
regulations implementing section 504 of the Rehabilitation Act, and the 
Department or the Department of Justice imposed similar requirements in 
regulations under Title II of the Americans with Disabilities Act, the 
Age Discrimination Act of 1975, and Title IX of the Education 
Amendments of 1972.\134\ And HHS regulations under Title VI, Age 
Discrimination Act of 1975, and Titles VI and XVI of the Public Health 
Service Act generally require that a recipient maintain records 
necessary to determine whether the recipient has complied with the 
law.\135\
---------------------------------------------------------------------------

    \133\ See, e.g., ``A public entity shall, within one year of the 
effective date of this part, evaluate its current services, 
policies, and practices, and the effects thereof, that do not or may 
not meet the requirements of this part and, to the extent 
modification of any such services, policies, and practices is 
required, the public entity shall proceed to make the necessary 
modifications.'' 28 CFR 35.105(a).
    \134\ See 45 CFR 84.6(c) and 85.11(c), 28 CFR 35.105(c), 45 CFR 
90.43(b), and 45 CFR 86.3(d), respectively.
    \135\ See 45 CFR 80.6(b), 45 CFR 90.42(a) and 91.31, and 42 CFR 
124.605(b), respectively.
---------------------------------------------------------------------------

    Comment: The Department received a comment requesting that the 
requirements of Sec.  88.6 not go into effect until at least one year 
after the publication of the final rule.
    Response: The Department believes that covered entities will have 
sufficient time to begin abiding by the requirements of Sec.  88.6 60 
days after the publication of this final rule. To the extent that 
entities have specific reasons why they cannot comply within that 
timeframe, the Department will consider exercising enforcement 
discretion and take those reasons into consideration during any 
investigation of complaints that may arise.
    Comment: The Department received comments requesting that the 
imposition of funding restrictions or other remedies on recipients 
based on their sub-recipients' violations of Federal conscience and 
anti-discrimination laws be made discretionary instead of mandatory 
because some recipients may have limited control over their sub-
recipients.
    Response: As with other anti-discrimination regulations OCR 
enforces, such as the Age Discrimination Act (45 CFR 90), Title IX (45 
CFR 86), and Title VI (45 CFR 80), this rule assures that Federal funds 
channeled from recipients to sub-recipients do not become immune to the 
protections provided by conscience and associated anti-discrimination 
laws. The Department, however, agrees that the rule should reflect 
greater enforcement discretion, and will finalize Sec.  88.6(a) by 
changing ``shall'' with respect to the imposition of funding 
restrictions ``and'' other remedies to read ``may'' and ``or,'' 
respectively.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \136\ and above, and considering the comments received, 
the Department finalizes Sec.  88.6 with substantial changes as 
described above, by making a technical correction to provide OCR with 
greater enforcement discretion concerning the responsibility of 
recipients for violations of the rule by sub-recipients, by changing 
``shall'' to ``may'' in paragraph (a); by providing greater specificity 
as to the records covered entities are required to maintain and for how 
long in paragraphs (b)(1) through (3); by making a technical correction 
to provide greater clarity on how a covered entity's failure to 
cooperate may result in an OCR referral to the Department of Justice by 
inserting ``in coordination with the Department's Office of General 
Counsel'' in paragraph (c); by making a technical correction, in 
keeping with the Department's intent for Sec.  88.6 to mirror Title VI 
enforcement regulations where applicable, to add a provision regarding 
the time and manner of OCR's access to records, and the applicability 
of confidentiality and privacy concerns to OCR's access in paragraph 
(c); by shortening from five years to three years in paragraph (d) the 
period for disclosing in any application for new or renewed Federal 
financial assistance or Departmental funding any determination by OCR 
of noncompliance to reduce the burden on covered entities; by revising 
reporting requirements in paragraph (d) to reduce the burden on covered 
entities by eliminating reporting requirements in situations in which 
such reports are unnecessary or redundant with actions taken by the 
Department, such as disclosing the existence of complaints, compliance 
reviews, or investigations in any application for new or renewed 
Federal financial assistance or Departmental funding; and by making a 
technical correction at the end of paragraph (d) to clarify that 
recipients disclose any OCR determinations made against their sub-
recipients.
---------------------------------------------------------------------------

    \136\ 83 FR 3880, 3898 (stating the reasons for the proposed 
Sec.  88.6, except for the modifications adopted herein).
---------------------------------------------------------------------------

Enforcement Authority (Sec.  88.7)
    This section of the proposed rule reaffirmed the delegation to OCR 
of the Department's authority to enforce the Federal conscience and 
anti-discrimination laws, in collaboration with the relevant Department 
components. The Department also noted that OCR has been expressly 
delegated the authority to enforce the Church, Coats-Snowe, and Weldon 
Amendments

[[Page 23221]]

since the 2008 Rule, which was reaffirmed in the 2011 Rule. Enforcement 
of section 1553 is also expressly delegated to OCR in the ACA. The NPRM 
provided notice that the Secretary delegated to OCR the authority to 
enforce all Federal conscience and anti-discrimination laws that were 
the subject of the proposed rule.
    This section also proposed to specify that OCR's enforcement 
authority would include the authority to handle complaints, perform 
compliance reviews, investigate, and seek appropriate action (in 
coordination with the leadership of any relevant HHS component) that 
the Director deems necessary to remedy the violation of Federal 
conscience and anti-discrimination laws and the proposed regulation, as 
allowed by law. The proposed text of Sec.  88.7 of this part would 
provide OCR discretion in choosing the means of enforcement, from 
informal resolution to more rigorous enforcement leading to, for 
example, funding termination, as appropriate to the particular facts, 
law, and availability of resources.
    The Department also proposed to explicitly establish its authority 
to investigate and handle (a) alleged violations and conduct compliance 
reviews whether or not a formal complaint has been filed, and (b) 
``whistleblower'' complaints, or complaints made on behalf of others, 
whether or not the particular complainant is a person or entity 
protected by Federal conscience and anti-discrimination laws.
    In this section of the proposed rule, the Department proposed to 
adopt the enforcement procedures for other civil rights laws, such as 
Title VI and section 504 of the Rehabilitation Act, for the Federal 
conscience and anti-discrimination laws. The Department solicited 
comments on what administrative procedures or opportunities for due 
process the Department should, as a matter of policy, or must, as a 
matter of law, provide (1) with respect to the remedial and enforcement 
measures that the Department may consider imposing or utilizing in 
response to a failure or threatened failure to comply with Federal 
conscience and anti-discrimination laws or this part, (2) before the 
Department may terminate Federal financial assistance or other Federal 
funds from the Department, or (3) before the Department may implement 
any or all of the remedial measures identified in Sec.  88.7(i)(3) of 
the proposed rule. For example, comment was requested on whether the 
proposed rule should establish notice, hearing, and appeal procedures 
similar to those established in the Department's regulations 
implementing Title VI of the Civil Rights Act of 1964, at 45 CFR 80.8-
80.10. The Department also requested comment on whether and in what 
circumstances it would be appropriate to require remedies against a 
recipient for the violations of a sub-recipient, or against entities' 
subsidiaries that are found to be in violation of any Federal 
conscience and anti-discrimination law or the proposed regulation.
    The Department received comments on this section, including those 
generally supporting the proposed Sec.  88.7.
    Comment: The Department received comments stating that the Federal 
conscience and anti-discrimination laws do not provide the Department 
with the authority to conduct compliance reviews under these statutes 
or to engage in the investigatory actions provided for in Sec.  88.7. 
The Department also received a comment stating that conducting a 
compliance review without having received a complaint is unreasonable.
    Response: Inherent in Congress's adoption of the statutes that 
require the recipients of Federal funds from the Department to comply 
with certain Federal health conscience statutes is the authority of the 
Department to take measures to ensure compliance. This is especially 
true in light of the fact that courts have refused to recognize private 
rights of action under certain statutes that are the subject of this 
rule, thus leaving victims of unlawful discrimination with no possible 
remedy without the Department's intervention. Further, under the 
various statutes and regulations governing HHS grants, contracts and 
other programs discussed in part III.A above concerning the authority 
to issue this rule, the Department has authority to ensure that both 
it, and covered entities, are spending Federal funds and operating 
programs consistent with Federal laws applicable to those funds and 
programs. The Secretary similarly has authority under 5 U.S.C. 301 to 
prescribe regulations for the government of the Department and the 
distribution and performance of its business. Providing for 
Departmental procedures to ensure compliance, including to undertake 
compliance reviews, falls under such authorities.
    As for their reasonableness, compliance reviews are a standard tool 
for ensuring compliance with Federal nondiscrimination statutes, 
despite the fact that most Federal nondiscrimination statutes, such as 
Title VI of the Civil Rights Act of 1964, do not explicitly mention 
them. Executive Order 12250 directed the Attorney General to implement 
regulations that addressed investigations and compliance reviews for 
the Federal nondiscrimination statutes. The order also directed 
agencies administering Federal nondiscrimination statutes to implement 
directives, via either policy guidance or regulations, consistent with 
the Attorney General's regulations. Regulations subsequently 
promulgated by the Department of Justice regarding coordination of 
Title VI compliance, pursuant to Executive Order 12250, interpret Title 
VI as authorizing Federal agencies to conduct compliance reviews for 
Title VI enforcement. See, e.g., 28 CFR 42.407(c)(1) (``Federal 
agencies shall establish and maintain an effective program of post-
approval compliance reviews regarding approved new applications (see 28 
CFR 50.3(c) II A), applications for continuation or renewal of 
assistance (28 CFR 50.3(c) II B) and all other federally assisted 
programs.'').
    Nevertheless, in order to address these concerns, the Department is 
finalizing Sec.  88.7(c) with certain changes to clarify that OCR may 
conduct compliance reviews based on information from a complaint or 
other source that causes OCR to suspect non-compliance by an entity 
subject to the rule.
    Comment: The Department received comments stating that, to provide 
clarity for covered entities and to ensure fairness of enforcement, 
potential penalties set forth in the rule should be clear and uniform.
    Response: The Department agrees with this comment in part. 
Potential penalties vary among the Federal conscience and anti-
discrimination laws as set by Congress. In addition, to the extent 
penalties may be imposed involuntarily, regulations such as those that 
apply to HHS grants, contracts, and CMS programs discussed above 
provide a well-established process for enforcing compliance with the 
terms and conditions of grants and contracts and programmatic 
regulations that require compliance with certain non-discrimination 
provisions. Consequently, in order to increase the clarity and 
uniformity of involuntary remedial processes applied through this rule, 
the Department has concluded that penalties imposed involuntarily under 
this rule will be imposed through those applicable regulations, such as 
45 CFR part 75, or the FAR and HHSAR. This is preferable both to an 
independent framework mirroring those of Title VI

[[Page 23222]]

and section 504 of the Rehabilitation Act, as the Department had 
proposed, and to a new set of uniform penalties as the commenter may 
have been proposing. Under this rule, in the event the Department deems 
that involuntary remedies may be appropriate, OCR will coordinate with 
the relevant funding component(s) of HHS in pursuing such remedies.
    Comment: The Department received a comment stating that conducting 
a compliance review without having received a complaint is 
unreasonable.
    Response: The Department disagrees. The Department's Office for 
Civil Rights routinely conducts compliance reviews to ensure covered 
entities follow the requirements of other Federal civil rights laws, as 
well as the Health Insurance Portability and Accountability Act of 1996 
and its associated regulations.\137\ Providing for compliance reviews 
to ensure that Federal conscience and anti-discrimination laws are not 
violated brings the Department's ability to enforce such laws into 
parity with other civil rights laws that the Department enforces.
---------------------------------------------------------------------------

    \137\ 45 CFR 160.308.
---------------------------------------------------------------------------

    Comment: The Department received comments stating that proposed 
Sec.  88.7 does not provide for adequate due process.
    Response: The Department agrees in part, and is finalizing the rule 
to make use of remedial processes under other existing HHS regulations. 
As clarified herein, where OCR is not able to reach a voluntary 
resolution of a complaint with a covered entity, involuntary 
enforcement will occur by the mechanisms established in the 
Department's existing regulations, such as those that apply to grants, 
contracts, or CMS programs, with OCR coordinating with the relevant 
funding component(s) of HHS. In those instances, the due process 
available under the applicable regulations will be available to covered 
entities. For example, 45 CFR 75.374 provides for opportunities for 
grantees to object, obtain hearings, and seek appeals when the 
Department or a component take a remedy for grantee non-compliance. 
Consistent with this approach, the language of Sec.  88.7(a) is 
finalized with changes to clarify that the Director of OCR is 
authorized to pursue voluntary resolutions of complaints, and that 
remedial action beyond that will occur through coordination of OCR with 
funding components, consistent with applicable laws and regulations.
    Comment: The Department received a comment stating that the 
proposed penalties violate the Spending Clause of the Constitution 
because, for Congress to place a condition on receipt of Federal funds 
by a State, the condition placed on the State must be unambiguous, and 
the amount in question cannot be so great that it can be considered 
coercive to the State's acceptance of the condition.
    Response: The Department disagrees. The substantive requirements of 
laws enforced by this rule were set forth by Congress, and the 
Department is not aware of any successful Spending Clause challenge to 
such laws, even though some of those laws have existed for decades. The 
Department believes the conditions and requirements imposed on the 
States by the Federal conscience and anti-discrimination laws are 
unambiguous, and that these rules, in mirroring those requirements, are 
similarly clear. The Department has provided a clear description of 
entities to which each such statute applies, and of what is required of 
each entity in Sec.  88.3 of this rule and elsewhere. Only after a 
violation has been found should the question of the appropriate remedy 
available under the law be answered.
    It is the consistent policy of the Federal government to presume 
that statutes passed by Congress and signed by the President are 
constitutional. Funding remedies in cases of violations under this rule 
will be applied consistently with the Constitution and relevant case 
law. The Department's decision to finalize this section to make use of 
existing remedial mechanisms under longstanding HHS regulations 
applicable to certain funding instruments, with OCR coordinating with 
HHS funding components, will also ensure that remedies imposed will be 
consistent with any constitutional concerns.
    Comment: The Department received a comment stating that referral to 
the Department of Justice for additional enforcement is not provided 
for in any of the Federal conscience and anti-discrimination laws.
    Response: The Department of Justice acts as the Department's 
representative in court, and the Department routinely refers matters 
that require litigation on its behalf, or on behalf of the United 
States, to the Department of Justice including laws enforced by OCR. 
Furthermore, entities that make assurances or certifications of 
compliance under Sec.  88.4, or that make other statements or 
productions to the Department under this part, do so under penalty of 
18 U.S.C. 1001 (prohibiting materially false statements regarding an 
agency matter), violations of which may warrant referral to the 
Department of Justice. Additionally, the Department of Justice would be 
the appropriate party to receive referrals of potential violations of 
42 U.S.C. 300a-8 which imposes criminal penalties on any officer or 
employee of the United States, or of any entity that administers 
federally funded programs (including States), and on any person 
receiving Federal financial assistance, who coerces or endeavors to 
coerce any person to undergo an abortion or sterilization procedure by 
threatening such person with the loss of, or disqualification for the 
receipt of, any benefit or service under a program receiving Federal 
financial assistance. As a result, the Department finalizes the rule by 
amending Sec.  88.7(i) (renumbered as Sec.  88.7(h)) to clarify that 
possible appropriate referrals to the Department of Justice include 
potential violations of 42 U.S.C. 300a-8 and 18 U.S.C. 1001.
    Comment: The Department received comments stating that health care 
entities should not be subject to the mechanisms in Sec.  88.7 unless a 
discriminated-against employee had provided prior notice to the entity 
of the employee's religious beliefs or moral convictions.
    Response: While the Department encourages employers and employees 
to openly discuss religious and moral convictions that may impact which 
services or tasks the employer may ask of employees, where Federal 
conscience and anti-discrimination laws do not require prior notice of 
religious beliefs or moral convictions, neither does this rule. In 
other situations involving religious accommodations, the Supreme Court 
has held that notice is not required.\138\ Nevertheless, during 
complaint investigations and compliance reviews, the Department takes 
into consideration facts such as whether the covered entity knew or 
should have known about the objection.
---------------------------------------------------------------------------

    \138\ See, e.g., EEOC v. Abercrombie & Fitch Stores, Inc., 135 
S. Ct. 2028, 2033 (2015) (stating that importation of a notice 
requirement would ``add words to the law'' and that a prior request 
for accommodation ``may make it easier to infer motive, but is not a 
necessary condition of liability.'').
---------------------------------------------------------------------------

    Comment: The Department received a comment stating that imposing 
the penalties described in Sec.  88.7(j)(3) (renumbered as Sec.  
88.7(i)(3)) on the basis of a ``threatened failure'' to comport with 
the Federal conscience and anti-discrimination laws is excessive.
    Response: The Department agrees and is removing the phrase 
``threatened failure'' from Sec.  88.7(j)(3) (renumbered as Sec.  
88.7(i)(3)).
    Comment: The Department received a comment stating that Sec.  88.7 
threatens all

[[Page 23223]]

funding streams for any violation of the Federal conscience and anti-
discrimination laws.
    Response: The Department disagrees. The only funding streams 
threatened by a violation of the Federal conscience and anti-
discrimination laws are the funding streams that such statutes directly 
implicate. The Department cannot terminate funding for violation of a 
Federal conscience or anti-discrimination law unless Congress has 
applied that law to that funding. Section 88.7 is intended to provide a 
general description of the range of possible enforcement mechanisms 
available to the Department, not an exhaustive list of actions to be 
taken for each violation or prescribed amounts. Termination of funding 
as a possible remedy is a necessary corollary of Congressional 
requirements that certain funding not be provided to entities that 
engage in impermissible discrimination. Nevertheless, OCR commonly 
investigates complaints under civil rights laws that permit termination 
of funding on a finding of a violation, and yet OCR only rarely imposes 
termination of funding as a penalty for such violations. For example, 
under HIPAA, civil monetary penalties are not uncommon, although they 
still represent the minority of resolutions to cases where a violation 
was found to the satisfaction of the Department. In civil rights cases, 
complaint investigations in which OCR finds a violation are usually 
resolved by corrective action. What specific remedy is appropriate in 
the case of a particular violation depends on the facts and 
circumstances, and OCR does not prejudge those facts in this rule to 
suggest termination of funding will be either a common or an uncommon 
outcome. The Department simply observes that, just because the rule 
provides for termination of funding as a possible corrective action, 
does not mean that funding, either in whole or in part, will be 
terminated in all or even most cases. It would be premature and 
contrary to the history of OCR enforcement to deem this rule as a 
requirement that OCR terminate all, or even some, funding of all 
entities found to have committed a violation.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \139\ and above, and considering the comments received, 
the Department finalizes Sec.  88.7 by making the changes discussed 
above, which include clarifying that OCR will serve a coordinating role 
with other Department components when remedial actions are pursued, and 
such remedies will be pursued under regulations applicable to relevant 
funding instruments, rather than under an independent enforcement 
framework set forth in this rule as had been proposed. Consistent with 
changes made to the definition of ``discrimination'' regarding the 
applicability of disparate impact analysis, the Department deletes the 
phrase ``to overcome the effects of violations of Federal conscience 
and anti-discrimination laws and this part'' from Sec.  88.7(a)(8). The 
Department deletes the phrase ``from time to time'' from Sec.  88.7(c) 
and, in place of the sentence ``OCR may conduct these reviews in the 
absence of a complaint,'' adds the sentence ``OCR may initiate a 
compliance review of an entity subject to this part based on 
information from a complaint or other source that causes OCR to suspect 
non-compliance by such entity with this part or the laws implemented by 
this part.'' The Department also adds certain criminal statutes as 
possible bases of referrals to the Department of Justice under Sec.  
88.7(h); and removes the phrase ``threatened failure'' from Sec.  
88.7(j)(3) of the proposed rule (renumbered as Sec.  88.7(i)(3) in this 
final rule). The Department also makes a technical correction, in order 
to maintain consistency of terminology, to replace the phrase ``cash 
payments'' with ``Federal financial assistance'' in Sec.  88.7(j)(3)(i) 
of the proposed rule (renumbered Sec.  88.7(i)(3)(i) in this final 
rule); makes technical changes to Sec.  88.7(a); adds reference to 
coordination with the Department's Office of General Counsel to Sec.  
88.7(a)(6) and (h); makes a stylistic change to Sec.  88.7(d), 
including the deletion of ``health care,'' ``associated,'' ``the,'' and 
``but not limited to;'' removes proposed Sec.  88.7(e), which discussed 
destruction of evidence; makes an edit for clarity and readability to 
relocate the phrase ``in whole or in part'' within paragraph (i)(3)(v); 
for greater accuracy replaces ``created by Federal law'' with ``under 
Federal law or this part'' in paragraph (i)(3)(vi); and inserts a new 
Sec.  88.7(j) to specifically address handling of noncompliance with 
assurances and certifications, as discussed above.
---------------------------------------------------------------------------

    \139\ 83 FR 3880, 3898-3899 (stating the reasons for the 
proposed Sec.  88.7, except for the modifications adopted herein).
---------------------------------------------------------------------------

Relationship to Other Laws Sec.  88.8
    This section would clarify the relationship between this part and 
other Federal, State, and local laws that protect religious freedom and 
moral convictions. In the proposed rule, the preamble for this section 
acknowledged that many State laws provide additional conscience 
protections for providers who have objections to abortion, fertility 
treatments, sterilization, assisted suicide, and euthanasia, among 
others. The Department proposed to uphold the maximum protection for 
the rights of conscience and the broadest prohibition on discrimination 
provided by Federal, State, or local law, as consistent with the 
Constitution. Where a State or local law provides as much or greater 
protection than Federal law for religious freedom and moral 
convictions, the Department proposed not to construe Federal law to 
preempt or impair the application of that law, unless expressly 
provided.
    The Department noted that the proposed rule would not relieve OCR 
of its obligation to enforce other civil rights authorities, such as 
Title VI of the Civil Rights Act of 1964, Title IX of the Education 
Amendments of 1972, the Age Discrimination Act of 1975, section 504 of 
the Rehabilitation Act of 1973, and the Americans with Disabilities Act 
of 1990. The Department affirmed that OCR would enforce all civil 
rights laws consistent with the Constitution and the statutory 
language. The Department received comments on this section.
    Comment: The Department received comments stating that the proposed 
rule conflicted with other Federal laws, such as Title X of the Public 
Health Service Act, that were raised in comments related to other 
provisions of the proposed rule.
    Response: Issues of potential statutory conflict have already been 
raised by other comments and answered in responses set forth above, so 
they are not repeated here.
    Comment: The Department received comments stating that the proposed 
rule violates 42 U.S.C. 18114, a section of the ACA that states that, 
notwithstanding any other provision of ACA, the Secretary shall not 
promulgate any regulation that creates any unreasonable barriers to the 
ability of individuals to obtain appropriate medical care, impedes 
timely access to health care services, interferes with communications 
regarding a full range of treatment options between the patient and the 
provider, restricts the ability of health care providers to provide 
full disclosure of all relevant information to patients making health 
care decisions, violates the principles of informed consent and the 
ethical standards of health care professionals, or limits the 
availability of health care treatment for the full duration of a 
patient's medical needs. Such comments argued that the proposed rule 
would violate this section by permitting providers to observe their 
consciences when responding to a patient's request for a particular 
medical

[[Page 23224]]

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

[[Page 23225]]

and religious liberty.\140\ When the Senate ratified the ICCPR, 
however, it did so subject to a declaration ``[t]hat it is the view of 
the United States that States Party to the Covenant should wherever 
possible refrain from imposing any restrictions or limitations on the 
exercise of the rights recognized and protected by the Covenant, even 
when such restrictions and limitations are permissible under the terms 
of the Covenant.'' \141\ Additionally, the Senate ratified the ICCPR 
with the understanding that the ICCPR is not self-executing.\142\
---------------------------------------------------------------------------

    \140\ See, e.g., International Covenant on Civil and Political 
Rights arts. 18-19, adopted Dec. 19, 1966, 999 U.N.T.S. 171.
    \141\ Senate Comm. on Foreign Relations, Report on the 
International Covenant on Civil and Political Rights, S. Exec. Rep. 
No. 23, 23 (102d Sess. 1992)
    \142\ Id.
---------------------------------------------------------------------------

    The Department also disagrees that the proposed rule conflicts with 
the ICESCR. First, the description of the ICESCR provided by the 
commenter is incorrect. The ICESCR simply requires that ``States 
Parties to the present Covenant recognize the right of everyone to the 
enjoyment of the highest attainable standard of physical and mental 
health.'' \143\ Additionally, the United States has not ratified the 
ICESCR; thus, it is not binding. Nevertheless, because the Department 
believes, as described elsewhere in this preamble, that this rule will 
increase access to and quality of health care in America, this rule 
furthers the goals of the ICESCR.
---------------------------------------------------------------------------

    \143\ International Covenant on Economic, Cultural and Social 
Rights art. 12, adopted Dec. 16, 1966, 993 U.N.T.S. 3. (The ICECSR 
states that the ``steps to be taken by the States Parties to the 
present Covenant to achieve the full realization of this right shall 
include those necessary for: (a) The provision for the reduction of 
the stillbirth-rate and of infant mortality and for the healthy 
development of the child; (b) The improvement of all aspects of 
environmental and industrial hygiene; (c) The prevention, treatment 
and control of epidemic, endemic, occupational and other diseases; 
(d) The creation of conditions which would assure to all medical 
service and medical attention in the event of sickness.'' Id.)
---------------------------------------------------------------------------

    Comment: The Department received a comment stating that the 
proposed rule violated the Eighth Amendment to the U.S. Constitution 
because the proposed rule would reduce access to care in prisons.
    Response: The Department disagrees. First, as noted above, the 
Department believes that this rule will result in greater access to 
health care or greater options from a wider and more diverse pool of 
medical professionals. Additionally, the finalized definition of 
``discriminate or discrimination'' ensures that a facility that must 
respect conscience can use alternative staff to accommodate an objector 
without violating this rule.
    Comment: The Department received comments stating that the proposed 
rule could harm efforts to assist persons with substance use disorder 
because a health care provider may hold a religious or moral conviction 
that drug use should be treated as a moral or criminal matter instead 
of a medical matter.
    Response: This rule does not conflict with any Federal statutes 
that would require the treatment of persons suffering from substance 
use disorder, because no regulation can, of its own force, supersede 
statutes enacted by Congress. This rule merely provides the Department 
with the means to adequately enforce the Federal conscience and anti-
discrimination laws to the extent permissible under the laws of the 
United States and the Constitution. The Department is unaware of any 
faith community that holds the views identified by the commenter. To 
the contrary, the Department's experience reveals that many members of 
the faith community are actively involved and voluntarily play an 
important role in efforts to help address the opioid crisis and other 
substance use disorders.
    Comment: The Department received comments stating that the proposed 
rule would violate the Equal Protection Clause of the Constitution by 
permitting discrimination against women seeking abortion.
    Response: The Department disagrees. Nothing in this rule permits 
the Federal government to discriminate against a person on the basis of 
such person's membership in a suspect class. Neither the equal 
protection doctrine nor any other constitutional doctrine negates any 
of the Federal conscience and anti-discrimination laws pertaining to 
abortion that this rule enforces. On the contrary, the Supreme Court 
has upheld laws limiting Federal funding of abortions, even of those 
deemed to be medically necessary, against equal protection challenges. 
See Harris v. McRae, 448 U.S. 917 (1980) (upholding the Hyde Amendment 
against a challenge under the Equal Protection Clause because the Hyde 
Amendment is rationally related to the legitimate governmental interest 
in preserving the life of the unborn); Maher v. Roe, 432 U.S. 464 
(1977) (holding that government may legitimately favor childbirth over 
abortion through public funding); Rust v. Sullivan, 500 U.S. 173 (1991) 
(same). Roe v. Wade and Doe v. Bolton both explicitly affirmed the 
appropriateness of conscience protections,\144\ and, therefore, the 
scope of rights defined by either case cannot be read to conflict with 
conscience protections relating to abortion. This rule, additionally, 
furthers the legitimate governmental interest in ensuring a large and 
diverse pool of health care providers by removing obstacles to persons 
who are interested in serving as health care providers but might be 
unwilling to do so for fear of being coerced to violate their religious 
beliefs or moral convictions.
---------------------------------------------------------------------------

    \144\ 410 U.S. at 143-44; 410 U.S. at 197-98.
---------------------------------------------------------------------------

    Comment: The Department received comments stating the proposed rule 
would violate the Establishment Clause by providing for an affirmative 
accommodation for religious beliefs that burden a third party.
    Response: The Department disagrees that religious accommodations 
such as those provided by Congress and enforced by this rule violate 
the Establishment Clause. Congress began enacting laws such as the 
Church Amendments in 1973, and none of them have been invalidated under 
the Establishment Clause. As the Supreme Court recognized in 
Corporation of Presiding Bishop of the Church of Jesus Christ of 
Latter-day Saints v. Amos, ``the government may (and sometimes must) 
accommodate religious practices and . . . it may do so without 
violating the Establishment Clause.'' 483 U.S. 327, 334 (1987) (quoting 
Hobbie v. Unemployment Appeals Comm'n of Fla., 480 U.S. 136, 144-45 
(1987)). As one commenter noted, in Burwell v. Hobby Lobby Stores, 
Inc., 134 S. Ct. 2751, 2781 (2014), the Supreme Court held that the 
Department's regulation mandating group health plans to cover 
contraceptives violated the Religious Freedom Restoration Act by 
failing to provide an exemption for Hobby Lobby to exercise its 
sincerely held religious beliefs. The Supreme Court also observed that 
any burden on third parties could be addressed in other ways, including 
through the establishment of a new governmental program if necessary. 
The Court held that Hobby Lobby itself did not have to bear a religious 
burden merely because its religious accommodation may burden a third 
party.
    Furthermore, this rule merely provides for the enforcement of the 
Federal conscience and anti-discrimination laws as Congress enacted 
them. These protections are limited to particular programs, particular 
governmental involvement, and particular funding streams, as Congress 
determined necessary to ensure that conscience rights are respected and 
that

[[Page 23226]]

health care entities with moral or religious objections to certain 
medical services or certain aspects of health service programs or 
research activities are not driven from the health care industry.
    Comment: The Department received comments stating that the proposed 
rule will conflict with various State laws and medical standards.
    Response: This rule does not establish new Federal law, but 
provides for the enforcement of laws enacted by Congress. To the extent 
State or local laws or standards conflict with the Federal laws that 
are the subject of this rule, the Federal conscience and 
antidiscrimination laws preempt such laws and standards with respect to 
funded entities and activities, in accordance with the terms of such 
Federal laws. With respect to States, States can decline to accept 
Federal funds that are conditioned on respecting Federal conscience 
rights and protections.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \145\ and above, and considering the comments received, 
the Department finalizes Sec.  88.8 without change, beyond global edits 
to the rule as a whole.
---------------------------------------------------------------------------

    \145\ 83 FR 3880, 3899.
---------------------------------------------------------------------------

Rule of Construction Sec.  88.9
    This section proposed that the protections for religious freedom 
and moral conviction for which enforcement mechanisms are provided by 
this part would be construed broadly and to the maximum extent 
permitted by law and the Constitution. The Department received comments 
on this section, including comments in general support of the proposed 
section.
    Comment: The Department received a comment stating that Sec.  88.9 
could be more clearly stated as follows: ``This part shall be construed 
in favor of a broad protection of free exercise of religious beliefs 
and moral convictions, to the maximum extent permitted by the 
Constitution and the terms of the Federal conscience protection and 
associated anti-discrimination statutes.''
    Response: The Department agrees that this proposed language is 
clearer and is modifying Sec.  88.9 to so read, with some stylistic 
changes to the proposed text, characterizing the Federal laws in 
question as ``Federal conscience and anti-discrimination laws.''
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \146\ and above, and considering the comments received, 
the Department finalizes Sec.  88.9 by rephrasing it to add clarity so 
that it now says, ``This part shall be construed in favor of a broad 
protection of the free exercise of religious beliefs and of moral 
convictions, to the maximum extent permitted by the Constitution and 
the terms of the Federal conscience protection and associated anti-
discrimination statutes.''
---------------------------------------------------------------------------

    \146\ 83 FR 3880, 3899 (stating the reasons for the proposed 
Sec.  88.9, except for the modifications adopted herein).
---------------------------------------------------------------------------

Severability Sec.  88.10
    In Sec.  88.10, the Department proposed a severability provision 
that would govern the Department's interpretation and implementation of 
45 CFR part 88 if any section of part 88 should be held invalid or 
unenforceable, either facially or as applied. In the event this occurs, 
the Department proposed that the provision in question be construed in 
a manner that gives maximum extent to the force of the provision as 
permitted by law. For instance, a provision held to be unenforceable as 
applied to a particular circumstance should be construed so as to 
continue the application of the provision to dissimilar circumstances. 
Proposed Sec.  88.10 would provide that if the provision is held to be 
utterly invalid or unenforceable, the provision in question shall be 
severable from part 88, and the remainder of part 88 should remain in 
full force and effect to the maximum extent permitted by law. The 
Department received a comment on this section.
    Comment: The Department received a comment stating that a 
severability clause is unnecessary because, following consideration of 
public comments to the proposed rule, the Department should be aware of 
any portions of the rule that are invalid or unenforceable.
    Response: The Department does not agree that the severability 
clause is inappropriate. The Department considers all the provisions of 
this final rule as being legally supported, has fully considered all 
comments received, and has made appropriate modifications, additions, 
and deletions. Nevertheless, as a general matter, severability 
represents the Department's intention regarding whether the rule should 
go into effect if parts of it are held invalid or enjoined by a court. 
The Department deems it appropriate to maintain the severability clause 
as proposed, so that this rule will remain in place to the maximum 
extent allowable in the event of adverse court action. In addition, 
future additions to statutes enforced by this rule could render parts 
of the rule inapplicable, and it is the Department's intention that 
such changes will not invalidate parts of the rule that remain 
statutorily supported.
    Summary of Regulatory Changes: For the reasons described in the 
proposed rule \147\ and above, and considering the comments received, 
the Department finalizes Sec.  88.10 without change.
---------------------------------------------------------------------------

    \147\ 83 FR 3880, 3899.
---------------------------------------------------------------------------

Appendix A to Part 88--Notice of Rights Under Federal Conscience and 
Anti-Discrimination Laws
    The Department received comments on appendix A to part 88, which 
were responded to above, with the comments to Sec.  88.5.
    Summary of Regulatory Changes: For the reasons described above, and 
considering the comments received, the Department finalizes appendix A 
to part 88 to provide a more accurate notice as to the protections 
provided by the Federal conscience and anti-discrimination laws. For 
instance, the Department replaces proposed text stating that the entity 
``does not'' engage in certain acts with language stating that entity 
``complies with'' laws prohibiting certain acts. The Department also 
modifies the notice text to say that ``You may have the right'' instead 
of ``You have the right,'' and replaces ``participate in'' with 
``perform, assist in the performance of.'' The Department also makes 
stylistic changes to the heading and certain portions of the body text 
of the model notice in appendix A.

IV. Regulatory Impact Analysis

A. Introduction and Summary

    The Department has examined the impacts of this final rule as 
required under Executive Order 12866 on Regulatory Planning and Review 
(September 30, 1993), Executive Order 13563 on Improving Regulation and 
Regulatory Review (January 18, 2011), Executive Order 13771 on Reducing 
Regulation and Controlling Regulatory Costs (January 30, 2017), the 
Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354, 5 
U.S.C. 601-612), section 202 of the Unfunded Mandates Reform Act of 
1995 (March 22, 1995, Pub. L. 104-04), Executive Order 13132 on 
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 
804(2)), the Assessment of Federal Regulation and Policies on Families 
(Pub. L. 105-277, sec. 654, 5 U.S.C. 601 (note)), and the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520).
    This rule revises the regulation that allows OCR to accept and 
coordinate the handling of complaints alleging violations of the 
Weldon, Coats-Snowe and Church Amendments, three Federal

[[Page 23227]]

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

                         Table 1--Accounting Table of Benefits and Costs of All Changes
----------------------------------------------------------------------------------------------------------------
                                                  Present value over 5 years  by   Annualized value over 5 years
                                                    discount rate (millions of    by discount rate  (millions of
                                                           2016 dollars)                   2016 dollars)
                                                 ---------------------------------------------------------------
                                                     3 Percent       7 Percent       3 Percent       7 Percent
----------------------------------------------------------------------------------------------------------------
Benefits:
    Quantified Benefits.........................  ..............  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
Non-quantified Benefits: Compliance with the law; protection of conscience rights, the free exercise of religion
  and moral convictions; more diverse and inclusive providers and health care professionals; improved provider-
 patient relationships that facilitate improved quality of care; equity, fairness, nondiscrimination; increased
                                                 access to care.
----------------------------------------------------------------------------------------------------------------
Costs:
    Quantified Costs............................           900.7           731.5           214.9           218.5
----------------------------------------------------------------------------------------------------------------
 Non-quantified Costs: Compliance procedures (recordkeeping and compliance reporting) and seeking of alternative
                        providers of certain objected-to medical services or procedures.
----------------------------------------------------------------------------------------------------------------

Analysis of Economic Impacts: Executive Orders 12866 and 13563
    HHS has examined the economic implications of this final rule as 
required by Executive Orders 12866 and 13563. Executive Orders 12866 
and 13563 direct agencies to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects; distributive 
impacts; and equity). The Department estimates that the benefits of 
this rule, although not always quantifiable or monetized, justify the 
burdens of the regulatory action.

B. Executive Order 12866

    Section 6(3)(C) of Executive Order 12866 requires agencies to 
prepare a regulatory impact analysis (RIA) for major rules that are 
significant. Section 3(f) of Executive Order 12866 defines a regulatory 
action as significant if it is likely to result in a rule that meets 
one of four conditions: (1) Is economically significant, (2) creates a 
serious inconsistency or otherwise interferes with an action taken or 
planned by another agency, (3) materially alters the budgetary impacts 
of entitlement grants, user fees, or loan programs or the rights and 
obligations of the recipients of these grants and programs, or (4) 
raises novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in Executive Order 
12866. A rule is likely to be economically significant where the agency 
estimates that it will (a) have an annual effect on the economy of $100 
million or more in any one year, or (b) adversely and materially affect 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local, or tribal 
governments or communities. The Department has determined that this 
rule will have an annual effect on the economy of $100 million or more 
in one year and, thus, is economically significant. The rule also 
furthers a presidential priority of protecting conscience and religious 
freedom. Executive Order 13798, 82 FR 21675 (May 4, 2017).

C. Executive Order 13563

    Executive Order 13563 supplements and reaffirms the principles of 
Executive Order 12866. Section 1(b) of Executive Order 13563 requires 
agencies to:
     ``propose or adopt a regulation only upon a reasoned 
determination that its benefits justify its costs,''
     ``tailor its regulations to impose the least burden on 
society,''
     ``select . . . regulatory approaches that maximize net 
benefits,''
     ``[as] feasible, specify performance objectives, rather 
than specifying the behavior or manner of compliance that regulated 
entities must adopt,'' and
     ``identify and assess available alternatives to direct 
regulation, including providing economic incentives to encourage the 
desired behavior . . . or providing information upon which the public 
can make choices.''
    Executive Order 13563 encourages agencies to promote innovation; 
avoid creating redundant, inconsistent, or overlapping requirements 
applicable to already highly regulated industries and sectors; and 
consider approaches that maintain flexibility and freedom of choice for 
the public. Finally, Executive Order 13563 requires that agencies use 
the best reasonably obtainable scientific, technical, and economic 
information available in evaluating the burdens and benefits of a 
regulatory action.
    The Department considered these objectives and used the best 
reasonably obtainable technical and economic information to determine 
that this final rule creates net benefits, is tailored to impose the 
least burden on society, incentivizes the desired behavior, and 
maximizes flexibility. This impact analysis also strives to promote 
transparency in how the Department derived the estimates. To this end, 
this RIA notes the extent to which key uncertainties in the data and 
assumptions affect the Department's analytic conclusions.

[[Page 23228]]

1. Need for the Rule
(i) Problems That This Rule Seeks To Address
    In developing regulatory actions, ``[e]ach agency shall identify 
the problem that it intends to address (including . . . the failures of 
private markets or public institutions . . .) as well as assess the 
significance of the problem.'' E.O. 12866, sec. 1(b)(1). In identifying 
the problem warranting agency regulatory action, ``[e]ach agency shall 
examine whether existing regulations (or other law) have created, or 
contributed to, the problem . . . .'' E.O. 12866, sec. 1(b)(2).
    This rule seeks to address two categories of problems: (1) 
Inadequate enforcement tools to address unlawful discrimination and 
coercion faced by protected persons, entities, or health care entities, 
and (2) lack of awareness, and, to the extent there is awareness, 
confusion, concerning Federal conscience protection obligations and 
associated anti-discrimination rights, of covered entities and 
individuals and organizations, respectively, leading to possible 
violations of law. The array of issues described in supra at part I.B 
(describing the final rule's regulatory history) fall into one or both 
of these categories.
    The first category--inadequate enforcement tools to address 
unlawful discrimination and coercion--stems from inadequate to non-
existent regulatory frameworks to enforce existing Federal conscience 
and anti-discrimination laws. The absence of adequate Federal governing 
frameworks to remedy discrimination may have undermined incentives for 
covered persons and entities to institute proactive measures to protect 
conscience, prohibit coercion, and promote nondiscrimination. Although 
some public comments argued that existing law is sufficient to protect 
conscience and religious freedom, the Department disagrees, given the 
mutually reinforcing deficiencies at the Federal level, which include:
     An inadequate, minimalistic regulatory scheme set forth in 
the Department's 2011 Rule that rescinded the comprehensive 2008 Rule, 
which addressed three of the 25 statutory provisions that are the 
subject of this rule. See supra at part I (describing existing and 
prior versions of the rule and identifying confusion about the scope 
and applicability of Federal conscience and anti-discrimination laws);
     An unduly narrow Departmental interpretation of the Weldon 
Amendment adopted by OCR in connection with the 2011 Rule that limited 
the scope of prohibited discrimination, contrary to the language that 
Congress passed, see supra at part I.B (addressing confusion caused by 
OCR sub-regulatory guidance); and
     A lack of strategic coordination across the Department to 
promote awareness of Federal protections for conscience and religious 
freedom in health care, and to address the enforcement of Federal 
conscience and anti-discrimination laws set forth in authorizing 
statutes of programs conducted or administered by Departmental 
components. See supra at part I.A (identifying additional Federal 
conscience and anti-discrimination laws).
    The second category of problems--lack of awareness and, where there 
is awareness, confusion concerning Federal conscience protection 
obligations and associated anti-discrimination rights, of covered 
entities and individuals and entities, respectively--stems from 
inadequate information and understanding about such Federal law, 
leading to possible violations of law. Relevant situations where 
persons, entities, and health care entities with religious beliefs or 
moral convictions may be coerced or suffer discrimination include:
     Being required to perform, participate in, pay for, 
provide coverage for, counsel or refer for abortion, sterilization, 
euthanasia, or other health services; \148\
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    \148\ California, for example, sent a letter to seven insurance 
companies requiring insurers to 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). The State of 
California estimates that at least 28,000 individuals subsequently 
lost their abortion-free health plans, and multiple churches have 
challenged California's policy in court. See Foothill Church v. 
Rouillard, 2:15-cv-02165-KJM-EFB, 2016 WL 3688422 (E.D. Calif. July 
11, 2016); Skyline Wesleyan Church v. California Department of 
Managed Health Care, No. 3:16-cv-00501-H-DHB (S.D. Calif. 2016).
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     participating in health professional training that 
pressures students, residents, fellows, etc., to perform, assist in the 
performance of, refer for, or counsel for, abortion or sterilization;
     being steered away from a career in obstetrics, family 
medicine, or geriatric medicine, when one has a religious or moral 
objection, as applicable, to abortion, sterilization, physician-
assisted suicide or euthanasia;
     being asked to perform or assist in certain services 
within the scope of one's employment but contrary to one's religious 
beliefs or moral convictions.
    Comments received in support of the proposed rule demonstrated that 
persons who are unlawfully coerced to violate their consciences, or 
otherwise discriminated against because they have acted in accord with 
their moral convictions or religious beliefs, may experience real harms 
that are significant and sometimes devastating psychologically, 
emotionally, and/or financially.\149\ This can include loss of jobs, 
loss of promotion possibilities, ``blackballing'' in the medical 
community, denial of acceptance into or graduation from a medical 
school, denial of board certification, stigmatization, shunning by 
peers, and trauma and stress from forced violations of the Hippocratic 
Oath. Commenters shared anecdotes of the occurrence and nature of 
coercion, discriminatory conduct, or other actions potentially in 
violation of Federal conscience and anti-discrimination laws. 
Commenters also shared their assessment 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 follow.
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    \149\ See. e.g., Compl. Cenzon-DeCarlo v. Mount Sinai Hosp., No: 
09-3120 (E.D.N.Y. Jul. 21, 2009) at 15 (``Being forced to assist in 
this abortion has caused Mrs. DeCarlo extreme emotional, 
psychological, and spiritual suffering.'') (dismissed on other 
grounds).
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     Numerous commenters shared anecdotes of bias and animus in 
the health care sector against individuals with religious beliefs or 
moral convictions with respect to abortion.
     Employees shared that they experienced discrimination 
based on their objections to prescribing abortifacients or 
participating in abortion or assisted suicide.
     Commenters stated that many health care professionals' 
careers are jeopardized because entities are completely unaware or 
willfully dismissive of applicable Federal law that protects 
conscience, prohibits coercion, or requires nondiscrimination.
     Students, fellows, and residents shared being forced out 
of residency programs or fields of medicine because of their beliefs 
about abortion or contraception.
     Commenters shared that they considered avoiding obstetrics 
and gynecology programs for fear of discrimination and shared polling 
data, which the RIA's benefits section describes infra at part IV.C.4, 
documenting discrimination experienced by medical students on the basis 
of their religious beliefs or moral convictions.
     Commenters expressed concern that States are coercing 
persons and entities

[[Page 23229]]

to violate their religious beliefs or moral convictions through laws 
mandating health coverage for abortion.
     One commenter noted that academic medical institutions are 
not self-policing compliance with, or educating students on, applicable 
Federal conscience and anti-discrimination laws.
     Commenters shared barriers to obtaining coverage by 
Medicare Advantage plans for care provided by RNHCIs.\150\ Commenters 
shared that plans justified the denials of coverage and 
preauthorization requests because medical professionals did not provide 
the care (even though by definition, an RNHCI provides nonmedical 
care).
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    \150\ RNHCIs can participate in Medicare and Medicaid as long as 
they meet the requisite conditions of coverage and participation. 
See supra at part I.A (summarizing the history of statutory 
provisions regarding RNHCIs, among other provisions, which this rule 
implements and enforces). See also https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/RNHCIs.html.
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    Some commenters have suggested that the thirty-four complaints that 
OCR received between November 2016 and January 2018 that allege 
coercion, violation of conscience, or discrimination do not necessitate 
this final rule.\151\ These commenters misconstrue the reasons for this 
rule; the increase in complaints received by OCR is one of the many 
metrics used to demonstrate the importance of this rule. During FY 
2018, the most recently completed fiscal year for which data are 
available, OCR received 343 complaints alleging conscience 
violations.\152\ Some complaints raise issues that affect more than one 
aggrieved person, entity or health care entity; therefore, although one 
person may have filed the complaint, the complaint may represent the 
concerns and objections of all nurses at a hospital, multiple pregnancy 
care facilities or providers in a State, or entire populations (or 
subpopulations) of States or communities.
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    \151\ See 83 FR 3880, 3886 (proposed Jan. 26, 2018) (to be 
codified at 45 CFR pt. 88) (summarizing the history of OCR 
enforcement of conscience laws).
    \152\ Complaint data based on OCR's system of records as of 
December 20, 2018.
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(ii) How the Rule Seeks To Address the Problems
    This rule corrects those problems. First, the Department revises 45 
CFR part 88 from a minimal regulatory scheme to one comparable to the 
regulatory schemes implementing other civil rights laws. Such schemes 
typically include a dozen provisions, addressing a range of conduct. 
These provisions typically restate the substantive requirements and 
obligations of the laws and often set forth procedural requirements 
(e.g., assurances of compliance, recordkeeping of compliance, etc.) to 
advance compliance with substantive rights and obligations. In 
addition, the regulatory schemes outline the enforcement procedures to 
provide regulated entities notice of the enforcement tools available to 
HHS and the type of remedies HHS may seek. Part 88 in effect as a 
result of the 2011 Rule, by contrast, was only three sentences long and 
provided considerably less notice and clarity about the conduct 
prohibited under Federal law and the enforcement mechanisms available 
to HHS.
    This rule confirms HHS will have the authority to initiate 
compliance reviews where it believes compliance issues have arisen, 
conduct investigations, resolve complaints, and supervise and 
coordinate appropriate action(s) with the relevant Department 
component(s) to assure compliance. Under this rule, certain persons and 
entities must maintain records regarding compliance with part 88; 
cooperate with OCR investigations, compliance reviews, interviews, or 
other parts of OCR's investigative process; and submit written 
assurances and certifications of compliance to the Department. These 
procedural and administrative requirements are similar to those in 
other civil rights regulations that promote compliance with, and 
enforcement of, the Federal civil rights laws that the regulations 
implement. Finally, by expanding the scope of part 88 to cover the 25 
statutory conscience and anti-discrimination laws applicable to HHS 
that are the subject of this rule, the rule supports the Department's 
strategic coordination with respect to compliance with, and enforcement 
of, these laws across the Department, as well as providing one location 
that identifies all of the health care related conscience protections 
and associated anti-discrimination laws enforced by the Department so 
that regulated entities have clear knowledge of the applicable 
conscience requirements.
    The investigative and enforcement processes set forth by the rule 
are vital because other avenues of relief are inadequate or 
unavailable. The Department solicited comment on whether alternate 
remedies, such as pursuing litigation, have been sufficient to address 
discrimination, coercion, or other treatment that the laws that are the 
subject of this rule prohibit. Many commenters stated that litigation 
was an inadequate option because several courts have declined to 
recognize a private right of action, such as under the Coats-Snowe and 
Church Amendments, and have concluded that persons must rely on OCR's 
administrative complaint process to secure relief.\153\ Some commenters 
also viewed litigation as unviable given the high economic costs of 
litigation, which may be against well-funded States or medical 
providers.
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    \153\ See, e.g., Vermont All. for Ethical Healthcare, Inc. v. 
Hoser, 274 F. Supp. 3d 227, 240 (D. Vt. 2017); Hellwege v. Tampa 
Family Health Centers, 103 F. Supp. 3d 1303, 1311-12 (M.D. Fla. 
2015); Order at 4, National Institute of Family and Life Advocates, 
et al. v. Rauner, No. 3:16-cv-50310 (N. D. Ill. July 19, 2017), ECF 
No. 65. See also supra at part II.A (describing the lack of private 
remedies).
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    Second, this rule promotes voluntary compliance with laws governing 
the ability of health care entities to act in accord with their legally 
protected religious beliefs or moral convictions by ensuring that 
health care entities are aware of, and understand, Federal conscience 
and anti-discrimination laws. The rule incentivizes entities to provide 
notice of rights and obligations under the rule by identifying the 
provision of notice as non-dispositive evidence of compliance that OCR 
will consider if an entity is subject to an OCR investigation or 
compliance review. Entities will be more likely to accommodate 
conscience and associated anti-discrimination rights if entities 
understand that they are legally obligated to do so. Entities will also 
be in a better position to accommodate these rights if they understand 
these rights are akin to other civil rights protecting people from 
discrimination on the basis of race, national origin, disability, 
etc.--rights for which entities already provide notice and are familiar 
with respecting.
    In addition, as described infra at part IV.C.3.i, the Department 
anticipates that a subset of recipients that assure and certify 
compliance in accordance with Sec.  88.4 will take organization-wide 
action, such as to update policies and procedures, implement staffing 
or scheduling practices that respect the exercise of conscience rights 
under Federal law, or take steps to disseminate the recipient's 
policies and procedures concerning these laws. Greater transparency of 
practices through open communication of recipient and sub-recipient 
policies ``should strengthen relationships between . . . entities and 
their . . . [workforce members].'' \154\
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    \154\ 73 FR 78074, 78074 (2008 Rule).
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    Protection of religious beliefs and moral convictions serves not 
only individual rights, but also society as a whole. Protections for 
conscience help ensure a society free from discrimination and more 
respectful of personal freedom and fundamental

[[Page 23230]]

rights enshrined in the First Amendment and Federal law. The Department 
shares the anticipation of many commenters who reasoned that the rule 
will promote a culture of respect for rights of conscience and 
religious freedom in health care that is currently lacking. The 
boundaries of protection for conscience may be tested when protections 
for religious beliefs and moral convictions appear to impose a cost or 
compete with other public purposes.\155\ However, as with other civil 
rights laws, it is in those cases where fidelity to the law becomes of 
paramount importance.
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    \155\ See Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 550-51 (2017) (``[T]he growing acceptance of this `public 
utility' model of medicine means in practice that extant Federal and 
State laws protecting conscience--most of which cover only a limited 
range of procedures and medical practitioners, lack meaningful 
enforcement mechanisms, and . . . are inadequate to the task of 
protecting the right to conscience[] . . .'' (citations omitted)).
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2. Affected Persons and Entities
    The final rule affects (1) persons and entities already obligated 
to comply with the Weldon Amendment, Coats-Snowe Amendment, or Church 
Amendments (or a combination thereof) under the 2008 and 2011 Rules; 
and (2) persons and entities obligated to comply with at least one of 
the other Federal statutory provisions that this rule implements.
(i) Scope of Persons and Entities Covered by 45 CFR Part 88 in 2011 
Rule
    Depending on the operation and applicability of the underlying 
statutes, the 2011 Rule, i.e., 45 CFR part 88 as currently in effect, 
extended, and continues to extend, broadly. As explained below, the 
diversity of entities estimated as covered is due to the applicability 
of the Church Amendments, which applies to non-governmental (as well as 
governmental) entities that operate ``any part of a health service 
program or research activity funded in whole or in part under a program 
administered by the Secretary''; \156\ or receive a grant, contract, 
loan, or loan guarantee under the Public Health Service (PHS) Act,\157\ 
which contains thirty titles and authorizes dozens of programs, or 
under the Developmental Disabilities Assistance and Bill of Rights Act 
of 2000 (DD Act), or receive an interest subsidy under the DD Act.\158\
---------------------------------------------------------------------------

    \156\ 42 U.S.C. 300a-7(d).
    \157\ 42 U.S.C. 300a-7(c).
    \158\ 42 U.S.C. 300a-7(e).
---------------------------------------------------------------------------

(A) The Department
    As a result of the 2011 Rule, 45 CFR part 88 applied, and still 
applies, to the Department because the Weldon and Coats-Snowe 
Amendments, as well as specific parts of the Church Amendments, apply 
to the Department.
    The Weldon Amendment states that ``[n]one of the funds made 
available in [the Departments of Labor, Health and Human Services, and 
Education, and Related Agencies Appropriations Act, 2019] may be made 
available to a Federal agency or program . . . if such agency [or] 
program . . . subjects any institutional or individual health care 
entity to discrimination . . . .'' \159\ The Department is a Federal 
agency that receives substantial funds made available in the Department 
of Defense and Labor, Health and Human Services, and Education 
Appropriations Act, 2019 and Continuing Appropriations Act, 2019, which 
are the funds addressed in Weldon.\160\ The Department must comply with 
the Weldon Amendment.
---------------------------------------------------------------------------

    \159\ 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), 
132 Stat. 2981, 3118 (September 28, 2018).
    \160\ Id.
---------------------------------------------------------------------------

    The Coats-Snowe Amendment states that ``[t]he Federal Government . 
. . may not subject any health care entity to discrimination on the 
[bases]'' listed in paragraphs (a)(1)-(3) of 42 U.S.C. 238n. The 
Department, as part of the Federal Government, must comply with the 
Coats-Snowe Amendment in its operations.
    Paragraphs (d) and (c)(2) of the Church Amendments apply to certain 
programs administered by the Secretary. Paragraph (d) applies to all 
health service programs or research activities funded in whole or part 
under programs administered by the Secretary, regardless of the source 
of funding. Paragraph (c)(2) applies to entities that receive grants or 
contracts ``for biomedical or behavioral research under any program 
administered by the Secretary.'' \161\ The requirements would, thus, 
apply to such programs or research activities conducted by, or funded 
by or through, the Department.
---------------------------------------------------------------------------

    \161\ 42 U.S.C. 300a-7(c)(2) and (d).
---------------------------------------------------------------------------

(B) State and Local Governments
    As a result of the 2008 and 2011 Rules, 45 CFR part 88 applied, and 
will continue to apply, to all State and local governments that receive 
HHS Federal financial assistance by virtue of several statutory 
provisions. First, the Weldon Amendment applies to State and local 
governments that receive funds made available in the annual Labor, 
Health and Human Services, and Education Appropriations Act.\162\ 
Second, the Coats-Snowe Amendment applies to State and local 
governments that receive Federal financial assistance, including 
Federal financial assistance from the Department (without restriction 
to any particular funding stream), ``includ[ing] governmental payments 
provided as reimbursement for carrying out health-related activities.'' 
\163\ Third, several paragraphs of the Church Amendments apply to State 
and local governments. Paragraph (b) of the Church Amendments prohibits 
coercion by a ``public authority,'' and thereby includes States and 
local governments. Paragraphs (c) and (e) of the Church Amendments 
apply to State and local governments to the extent that such 
governments receive funds to implement programs authorized in the 
public laws cited in such paragraphs. Finally, paragraph (d) of the 
Church Amendments applies to a State or local government (or a 
component thereof) to the extent that such State or local government 
receives funding under any program administered by the Secretary.\164\
---------------------------------------------------------------------------

    \162\ See, e.g., Public Law 115-245, Div. B, section 507(d), 132 
Stat. 2981, 3118 (``None of the funds made available in [the 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 2019] may be made available to 
a . . . State or local government[ ] if such . . . government . . . 
.'').
    \163\ 42 U.S.C. 238n(a), (c)(1).
    \164\ Id. section 300a-7(d) (``No individual shall be required 
to perform or assist in the performance of any part of a health 
service program or research activity funded in whole or in part 
under a program administered by the Secretary of Health and Human 
Services . . . .'').
---------------------------------------------------------------------------

    State and local governments (such as counties or cities) and 
instrumentalities of governments (such as State health and human 
services agencies) receive Federal financial assistance or Federal 
funds from the Department from a variety of financing streams as 
recipients or sub-recipients. Examples of programs and activities for 
which State and local governments (in some cases, not exclusively) 
receive Federal financial assistance or Federal funds from the 
Department may include Medicaid and the Children's Health Insurance 
Program; Title X programs, public health and prevention programs, HIV/
AIDS and STD prevention and education, and substance abuse screening; 
biomedical and behavioral research at State institutions of higher 
education; services for older Americans; medical assistance to 
refugees; and adult protection services to combat elder abuse.

[[Page 23231]]

(C) Persons and Entities
    As a result of the 2008 and 2011 Rules, 45 CFR part 88 applied, and 
still applies, to recipients and sub-recipients that operate ``any part 
of a health service program or research activity funded in whole or in 
part under a program administered by the Secretary'' \165\; or receive 
a grant, contract, loan, or loan guarantee under the Public Health 
Service (PHS) Act \166\ or the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000 (DD Act), or receive an interest subsidy 
under the DD Act.
---------------------------------------------------------------------------

    \165\ 42 U.S.C. 300a-7(d).
    \166\ The PHS Act contains thirty titles and authorizes dozens 
of programs.
---------------------------------------------------------------------------

    Examples of recipients and sub-recipients may include:
     Health facilities, including hospitals, federally 
qualified health centers, community health centers, and mental health 
clinics;
     Health-related schools and other education entities that 
provide health professions training for medicine, oral health, 
behavioral health, geriatric care, nursing, etc.;
     Community-based organizations that provide substance abuse 
screening, HIV/AIDS prevention and treatment, and domestic violence 
screening;
     Title X-funded family planning clinics;
     Private non-profit and for-profit agencies that provide 
medical care to unaccompanied minors;
     Interdisciplinary university centers or public or 
nonprofit entities associated with universities that receive financial 
assistance to implement the DD Act \167\; and
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    \167\ E.g., https://www.acl.gov/node/466.
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     State Councils on Developmental Disabilities \168\ and 
States' Protection and Advocacy Systems that receive funds to implement 
the DD Act.\169\
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    \168\ E.g., https://www.acl.gov/node/110.https://www.acl.gov/sites/default/files/about-acl/2017-12/DDC-2017.pdf.
    \169\ E.g., https://www.acl.gov/sites/default/files/about-acl/2017-06/PADD-2017.pdf.
---------------------------------------------------------------------------

    Several statutory provisions support this application. First, 
paragraphs (c)(1) and (2) of the Church Amendments apply to entities 
that receive a ``grant, contract, loan, or loan guarantee under the 
[PHS Act],'' or a ``grant or contract for biomedical or behavioral 
research.'' Second, paragraph (e) of the Church Amendments applies to 
entities that receive a ``grant, contract, loan, or loan guarantee, or 
interest subsidy'' under the PHS Act or the DD Act.\170\ Third, 
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 of Health and Human 
Services.'' \171\ Paragraph (d) of the Church Amendment does not tie 
the funding source to a particular appropriation, instrument, or 
authorizing statute, nor does the receipt of funds under Church (d) 
automatically trigger coverage of all of an entity's operations.
---------------------------------------------------------------------------

    \170\ Id. 300a-7(c)(1)(B) (``No entity which receives a grant, 
contract, loan, or loan guarantee under the Public Health Service 
Act . . . .''); 300a-7(e) (``No entity which receives . . . any 
grant, contract, loan, [or] loan guarantee . . . under the Public 
Health Service Act . . . or the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000 may . . . .''). In 
addition to the PHS Act, paragraphs (c)(1) and (e) of the Church 
Amendments apply to entities that receive funding under the 
Community Mental Health Centers Act, 42 U.S.C. 2689 et seq. 
Paragraph (c)(1) of the Church Amendments additionally applies to 
entities that receive funding under the Developmental Disabilities 
Services and Facilities Construction Act, 42 U.S.C. 6000 et seq. 
Congress repealed both of these laws. See Omnibus Reconciliation Act 
of 1981, Public Law 97-35, Title IX, sec. 902(e)(2)(B), 95 Stat. 560 
(1981); Developmental Disabilities Assistance and Bill of Rights Act 
of 2000, Public Law 106-402, Title IV, sec. 401(a), 114 Stat. 1737 
(2000). Thus, there are no entities receiving funds under programs 
authorized by these statutes to consider in this RIA.
    \171\ Id. section 300a-7(d) (``No individual shall be required 
to perform or assist in the performance of any part of a health 
service program or research activity funded in whole or in part 
under a program administered by the Secretary of Health and Human 
Services . . . .'').
---------------------------------------------------------------------------

(ii) Persons and Entities Obligated To Comply With Additional Federal 
Laws That This Rule Implements and Enforces
    This rule only affects persons and entities obligated to comply 
with at least one of the Federal statutory provisions that this rule 
implements and enforces. There is substantial overlap between persons 
and entities currenty obligated to comply with 45 CFR part 88, as based 
on the 2011 Rule and persons and entities subject to at least one of 
the additional Federal laws that this final rule enforces. This overlap 
occurs because such persons and entities largely were, and continue to 
be, subject to 45 CFR part 88 by virtue of the Church Amendments, but 
also the Weldon Amendment and the Coats-Snowe Amendment, as explained 
above. Because of this substantial overlap, the Department estimated in 
the proposed rule that OCR's authority to enforce the following 
statutory provisions would not add any new persons and entities to the 
coverage of this rule:
     Provisions protecting health care entities and individuals 
from discrimination who object to furthering or participating in 
abortion under Medicare Advantage, e.g. Public Law 115-245, Div. B, 
Tit. II, sec. 209, 132 Stat. 2981, 3090 (2018);
     Provisions of the Affordable Care Act related to assisted 
suicide (42 U.S.C. 18113), the ACA individual mandate (26 U.S.C. 
5000A(d)(2)), and other matters of conscience (42 U.S.C. 
18023(c)(2)(A)(i)-(iii), (b)(1)(A) & (b)(4));
     Provisions regarding conscience protections for objections 
to counseling and referral for certain services in Medicaid or Medicare 
Advantage (42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B));
     Provisions regarding conscience protections related to the 
performance of advanced directives (42 U.S.C. 1395cc(f), 1396a(w)(3), 
and 14406);
     Provisions exempting individuals from compulsory health 
care or services generally (42 U.S.C. 1396f & 5106i(a)(1)) 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 relating 
to health facility review (42 U.S.C. 1320a-1), peer review (42 U.S.C. 
1320c-11), certain health standards (42 U.S.C. 1396a(a)(9)(A)), medical 
evaluation (42 U.S.C. 1396a(a)(31)), medical licensing review (42 
U.S.C. 1396a(a)(33)), and utilization review plan requirements (42 
U.S.C. 1396b(i)(4)), and by protecting the exercise of religious 
nonmedical health care in the Elder Justice Block Grant Program (42 
U.S.C. 1397j-1(b)) and in the Child Abuse Prevention and Treatment Act 
(42 U.S.C. 5106i(a)(2)).
    In the proposed rule, the Department estimated that the OCR 
enforcement of the following Federal statutory provisions could add new 
persons and entities to the coverage of 45 CFR part 88:
     Global Health Programs for HIV/AIDS Prevention, Treatment, 
or Care (22 U.S.C. 7631(d)), and
     The Helms, Biden, 1978, and 1985 Amendments, 22 U.S.C. 
2151b(f), e.g., Consolidated Appropriations Act, 2019, Public Law 116-
6, Div. F, sec. 7018.
    However, the proposed rule explained that because paragraph (d) of 
the Church Amendments does not require that the funding for the health 
service program or research activity be appropriated to HHS, but only 
that it be ``funded in whole or part under a program administered by 
the [HHS] Secretary,'' funding appropriated to other Federal 
Departments, but awarded by HHS in its administration of certain global 
health programs would be covered by paragraph (d) of the Church 
Amendments. Consequently, HHS's

[[Page 23232]]

implementation of 22 U.S.C. 2151b(f) and 7631(d) may not expand the 
scope of persons and entities covered by this part.
(iii) Methodology
    The Department quantitatively estimated those persons and entities 
covered by the final rule by relying primarily on the latest data 
available from the U.S. Census Bureau's Statistics of U.S. Businesses 
\172\ supplemented with other sources. The Department invited public 
comment on the proposed rule's methodology and solicited ideas on 
whether there are other methodologies that the Department could 
consider to refine the scope of persons and entities affected by this 
rule. The Department received one comment suggesting that the 
Department's methodology was flawed for failing to include an estimate 
of the number of consumers of health care affected, i.e., patients, and 
thus did not consider consumers of health care in the list of persons 
and entities shown infra at Table 2. The purpose of Table 2 is to 
identify regulated entities, not consumers of health care. An analysis 
of this rule's impact on persons, entities, and health care entities is 
included in the rule's analysis of benefits, infra at part IV.C.4. The 
final rule's methods for quantifying the persons and entities impacted 
are the same methods from the proposed rule, which the Department 
determined was the most reasonable and reliable approach.\173\
---------------------------------------------------------------------------

    \172\ https://www.census.gov/data/datasets/2015/econ/susb/2015-susb.html. The Department relied on the data file titled ``U.S. & 
State, NAICS, detailed employment sizes (U.S., 6-digit and States, 
NAICS sectors).'' The latest data available is from 2015 that the 
Bureau made available in September of 2017, and this data relied on 
the 2012 NAICS codes, id., which are described at https://www.census.gov/eos/www/naics/2012NAICS/2012_Definition_File.pdf.
    \173\ See 83 FR 3880, 3907 (describing various sources of data 
considered and reasons for rejecting other approaches).
---------------------------------------------------------------------------

    The U.S. Census Bureau's Statistics of U.S. Businesses is based on 
the North American Industry Classification System (NAICS).\174\ The 
NAICS classifies all economic activity into 20 sectors and breaks that 
information down into sub-sectors and industries.\175\ Essentially, the 
NAICS groups physical business establishments together based on how 
similar the locations' processes are for producing goods or 
services.\176\ The NAICS provides information on how many singular 
physical locations exist for a particular business or industry (called 
an ``establishment''),\177\ how many of those establishments are under 
common ownership or control of a business organization or entity 
(called a ``firm''),\178\ and the number of people who work in a 
particular business or industry, among other types of information. For 
instance, a hospital system that has common ownership and control over 
multiple hospital facilities is a firm, and each hospital facility is 
an establishment.
---------------------------------------------------------------------------

    \174\ https://www.census.gov/programs-surveys/susb/technical-documentation/methodology.html.
    \175\ FAQ 5, https://www.census.gov/eos/www/naics/faqs/faqs.html#q5.
    \176\ FAQ 1, https://www.census.gov/eos/www/naics/faqs/faqs.html#q1.
    \177\ https://www.census.gov/eos/www/naics/faqs/faqs.html#q2.
    \178\ https://www.census.gov/glossary/#term_Firm.
---------------------------------------------------------------------------

    For the vast majority of the recipient and sub-recipient types, the 
Department assumed that only a portion of the industry captured in the 
Statistics of U.S. Businesses receives Federal funds to trigger 
coverage by this rule (e.g., ``Federal financial assistance . . . from 
the Department or a component of the Department, or who otherwise 
receives Federal funds directly from the Department or a component of 
the Department''). For instance, not all physician offices receive FFA 
or otherwise receive Federal funds as a recipient or sub-recipient. In 
fact, about 68.9 percent of physician offices accepted new Medicaid 
patients based on 2013 data from the National Electronic Health Records 
Survey.\179\ Approximately 83.7 percent of physicians accepted new 
Medicare patients based on the same data.\180\ Because OCR interprets 
the 2011 Rule to apply to physicians receiving reimbursement for 
Medicare Part B, which is a ``health service program . . . funded in 
whole or in part under a program administered by the Secretary of 
Health and Human Services'', the Department assumed that the lower of 
these two percentages (69 percent) represents the lower-bound of 
physicians nationwide subject to the 2011 Rule. In the absence of 
evidence with which to generate a refined upper-bound estimate, the 
Department assumed that the 2011 Rule covers all physicians nationwide 
as the upper-bound.
---------------------------------------------------------------------------

    \179\ Esther Hing, et al., Nat'l Ctr. For Health Statistics, 
Centers for Disease Control and Prevention, U.S. Dep't of Health and 
Human Servs., Acceptance of New Patients with Public and Private 
Insurance by Office-Based Physicians: United States, 2013, Data 
Brief No. 195, 1 (Mar. 2015).
    \180\ Id.
---------------------------------------------------------------------------

    The Department used this same percentage range (69 to 100 percent) 
in estimating the coverage for other health care industry sector types, 
such as hospitals and various outpatient care facilities. For the 
social services and education industries, which generally have 
principal purposes other than health and patient care, the Department 
adopted ranges more appropriate for those industries. For the social 
services industries, the Department adopted a range with 25 percent as 
the lower-bound and 100 percent as the upper-bound to cover 62.5 
percent of the industry on average. In its notice of proposed 
rulemaking, the Department sought comment on this methodology, but 
received no comments providing a superior method of generating these 
estimates.
    The Department assumes some portion of the social service industry 
will be covered by the rule, given the scope of the 2011 Rule and 
thereby this rule. For instance, entities that carry out social 
services programs and activities may do so in the context of health 
service programs or research activities funded in whole or in part 
under programs administered by the Secretary, or may receive funding 
through programs administered by the Secretary, as well as by grants or 
other mechanisms under the PHS Act \181\ or the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 within the scope 
of the Church Amendment's application.
---------------------------------------------------------------------------

    \181\ The PHS Act contains thirty titles and authorizes dozens 
of programs.
---------------------------------------------------------------------------

    To estimate the number of local governments and educational 
institutions, the Department relied on data from other U.S. Census 
Bureau statistical programs or available award data available through 
the HHS Tracking Accountability in Government Grants System 
(TAGGS).\182\ For instance, in estimating the number of counties 
nationwide, the Department relied on the U.S. Census Bureau's 2010 
Census Geographic Entity Tallies by State and Type to identify the 
total counties and equivalent areas for the U.S., Puerto Rico, the U.S. 
Territories, and the Island Areas.\183\
---------------------------------------------------------------------------

    \182\ http://taggs.hhs.gov (last visited Aug. 24, 2017).
    \183\ https://www.census.gov/geo/maps-data/data/tallies/all_tallies.html.
---------------------------------------------------------------------------

    As another example, the Department relied on data from TAGGS to 
derive a lower-bound percentage of colleges and universities that are 
recipients. (The upper-bound assumes all educational institutions 
industry-wide are recipients.) Although most colleges and universities 
receive Federal financial assistance from the U.S. Department of 
Education, not all universities are recipients of HHS funds; thus, the 
Department adopted a lower-bound estimate to reflect that assumption.
    Using the ``Advanced Search'' function in TAGGS, HHS identified all 
awards to Junior Colleges, Colleges, and

[[Page 23233]]

Universities for FY 2016 and de-duplicated the results to obtain a 
singular list of unique awardees from the Department, which totaled 
615. Because these awardees included satellite campuses of college or 
university systems, the total awardee number was akin to the number of 
``establishments'' rather than ``firms'' as those terms are used in the 
U.S. Census Bureau's Statistics of U.S. Businesses. Similar to how an 
``establishment'' is a location of a ``firm'' that has common ownership 
and control over at least one establishment, a satellite campus is one 
location of a university system with common ownership and control over 
multiple campus locations.
    To derive an estimate of educational institutions at the ``firm'' 
level, the Department computed the ratio between firms and 
establishments from the U.S. Census Bureau's Statistics of U.S. 
Businesses.\184\ This ratio is 51.32 percent (2,457 firms/4,788 
establishments). The Department applied that ratio to the total number 
of Junior Colleges, Colleges, and Universities that received HHS 
funding as ``establishments'' (0.5132 x 615 awardee establishments) to 
get an estimate of 316 firms. Despite this method's potential 
complexity, the Department found it the most reasonable method for 
estimating the lower-bound number of colleges and universities that are 
Department recipients.
---------------------------------------------------------------------------

    \184\ See U.S. Census Bureau, Statistics of U.S. Businesses, 
2015, NAICS code 611310 (Colleges, Universities, and Professional 
Schools) (identifying 2,457 firms and 4,788 establishments 
nationwide).
---------------------------------------------------------------------------

(iv) Quantitative Estimate of Persons and Entities Covered by This Rule
    Table 2 lists each estimated type of recipient and the estimated 
number of recipients that this final rule covers. Because there is 
uncertainty as to the universe of actual persons and entities covered, 
Table 2 captures this uncertainty by reflecting estimated recipients as 
a range with a lower and an upper-bound. The footnotes detail the 
assumptions and calculations for each line of the table and assume 
coverage for 69-100 percent of the industry unless otherwise noted. The 
Department has made a technical correction to Table 2 to include the 
number of offices of miscellaneous health practitioners (e.g., clinical 
pharmacists, dieticians, registered practical or licensed nurses' 
offices, Christian Science practitioners' offices) who operate private 
or group practices in their own centers or clinics or in the facilities 
of others, such as hospitals.\185\
---------------------------------------------------------------------------

    \185\ See the industry description for offices of miscellaneous 
health practitioners, NAICS code 921399, https://www.census.gov/cgi-bin/sssd/naics/naicsrch?code=621399&search=2012 NAICS Search.

---------------------------------------------------------------------------

[[Page 23234]]

     
---------------------------------------------------------------------------

    \186\ Assumes coverage of the 50 States, DC, Puerto Rico, 6 U.S. 
Territories, and the Island Areas.
    \187\ Assumes all federally recognized Tribes get HHS funds. 
Indian Health Service, FY 2019 Justification of Estimates for 
Appropriations Committees CJ-1 (2018), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.
    \188\ U.S. Census Bureau, 2010 Census Geographic Entity Tallies 
by State and Type, https://www.census.gov/geo/maps-data/data/tallies/all_tallies.html (total counties and equivalent areas for 
the U.S., Puerto Rico, the U.S. Territories, and the Island Areas). 
The Department assumed that every county receives Federal funds as a 
recipient or a sub-recipient.
    \189\ U.S. Census Bureau, Statistics of U.S. Businesses, 2015 
(released Sept. 2017), https://www.census.gov/data/datasets/2015/econ/susb/2015-susb.html (nationwide count of firms for NAICS Code 
622110).
    \190\ Id. (sum of the nationwide count of firms for NAICS Codes 
622210 and 622310).
    \191\ Id. (relying on the nationwide count of firms for NAICS 
Code 623110).
    \192\ Id. (nationwide count of firms for NAICS Code 623210).
    \193\ Id. (nationwide count of firms for NAICS Code 623311).
    \194\ Id. (nationwide count of firms for NAICS Code 623990).
    \195\ Id. (nationwide count of firms for NAICS Code 621610).
    \196\ Id. (nationwide count of firms for NAICS Code 621111).
    \197\ Id. (nationwide count of firms for NAICS Code 621112).
    \198\ Id. (nationwide count of firms for NAICS Code 621330).
    \199\ Id. (nationwide count of firms for NAICS Code 621210).
    \200\ Id. (nationwide count of firms for NAICS Code 621310).
    \201\ Id. (nationwide count of firms for NAICS Code 621320).
    \202\ Id. (nationwide count of firms for NAICS Code 621340).
    \203\ Id. (nationwide count of firms for NAICS Code 621391).
    \204\ Id. (nationwide count of firms for NAICS Code 621399).
    \205\ Id. (nationwide count of firms for NAICS Code 621410).
    \206\ Id. (nationwide count of firms for NAICS Code 621493).
    \207\ Id. (nationwide count of firms for NAICS Code 621491).
    \208\ Id. (nationwide count of firms for NAICS Code 621492).
    \209\ Id. (nationwide count of firms for NAICS Code 621420).
    \210\ Id. (nationwide count of firms for NAICS Code 621512).
    \211\ Id. (nationwide count of firms for NAICS Code 621511).
    \212\ Id. (nationwide count of firms for NAICS Code 621910).
    \213\ Id. (nationwide count of firms for NAICS Code 621498).
    \214\ Id. (nationwide count of firms for NAICS Code 62199).

                  Table 2--Estimated Number of Persons and Entities Covered by This Final Rule
----------------------------------------------------------------------------------------------------------------
                                     Covered by 45 CFR 88    Covered by  final                       Estimate
               Type                     in  2011 Rule?             rule?          Estimate (low)      (high)
----------------------------------------------------------------------------------------------------------------
1. State and Territorial            Yes..................  Yes..................              58              58
 Governments\186\.
2. Federally recognized Tribes      Yes..................  Yes..................             573             573
 \187\.
3. Counties \188\.................  Yes..................  Yes..................           3,234           3,234
----------------------------------------------------------------------------------------------------------------
                                                    Hospitals
----------------------------------------------------------------------------------------------------------------
4. General & Medical Surgical       Yes..................  Yes..................           1,859           2,694
 Hospitals \189\.
5. Specialty Hospitals (e.g.,       Yes..................  Yes..................             553             801
 psychiatric, substance abuse,
 rehabilitation, cancer,
 maternity) \190\.
----------------------------------------------------------------------------------------------------------------
                                     Nursing and Residential Care Facilities
----------------------------------------------------------------------------------------------------------------
6. Skilled Nursing Facilities       Yes..................  Yes..................           6,316           9,153
 \191\.
7. Residential Intellectual and     Yes..................  Yes..................           4,310           6,246
 Developmental Disability
 Facilities \192\.
8. Continuing Care Retirement       Yes..................  Yes..................           2,605           3,775
 Communities \193\.
9. Other Residential Care           Yes..................  Yes..................           2,247           3,256
 Facilities (e.g., group homes)
 \194\.
----------------------------------------------------------------------------------------------------------------
                               Entities Providing Ambulatory Health Care Services
----------------------------------------------------------------------------------------------------------------
10. Entities providing Home Health  Yes..................  Yes..................          15,062          21,829
 Care Services \195\.
11. Offices of Physicians (except   Yes..................  Yes..................         115,673         167,642
 Mental Health Specialists) \196\.
12. Offices of Physicians (Mental   Yes..................  Yes..................           7,324          10,614
 Health Specialists) \197\.
13. Offices of Mental Health        Yes..................  Yes..................          14,340          20,782
 Practitioners (except Physicians)
 \198\.
14. Offices of Dentists \199\.....  Yes..................  Yes..................          86,874         125,904
15. Offices of Chiropractors \200\  Yes..................  Yes..................          26,725          38,732
16. Offices of Optometrists \201\.  Yes..................  Yes..................          13,775          19,964
17. Offices of Physical,            Yes..................  Yes..................          17,623          25,540
 Occupational and Speech
 Therapists, and Audiologists
 \202\.
18. Offices of Podiatrists \203\..  Yes..................  Yes..................           5,314           7,701
19. Offices of All Other Misc.      Yes..................  Yes..................          11,502          16,670
 Health Practitioners \204\.
20. Family Planning Centers \205\.  Yes..................  Yes..................             999           1,448
21. Freestanding Ambulatory         Yes..................  Yes..................           2,908           4,214
 Surgical and Emergency Centers
 \206\.
22. HMO Medical Centers \207\.....  Yes..................  Yes..................              78             113
23. Kidney Dialysis Centers \208\.  Yes..................  Yes..................             305             442
24. Outpatient Mental Health and    Yes..................  Yes..................           3,776           5,472
 Substance Abuse Centers \209\.
25. Diagnostic Imaging Centers      Yes..................  Yes..................           3,209           4,651
 \210\.
26. Medical Laboratories \211\....  Yes..................  Yes..................           2,278           3,302
27. Ambulance Services \212\......  Yes..................  Yes..................           2,185           3,167
28. All Other Outpatient Care       Yes..................  Yes..................           3,880           5,623
 Centers (e.g., centers and
 clinics for pain therapy,
 community health, and sleep
 disorders) \213\.
29. Entities Providing All Other    Yes..................  Yes..................           2,391           3,465
 Ambulatory Health Care Services
 (health screening, smoking
 cessation, hearing testing, blood
 banks) \214\.
----------------------------------------------------------------------------------------------------------------
                                               Insurance Carriers
----------------------------------------------------------------------------------------------------------------
30. Direct Health and Medical       Yes..................  Yes..................             607             880
 Insurance Carriers \215\.
----------------------------------------------------------------------------------------------------------------
                                  Entities Providing Social Assistance Services
----------------------------------------------------------------------------------------------------------------
31. Entities Serving the Elderly    Yes..................  Yes..................           9,051          36,205
 and Persons with Disabilities
 (provision of nonresidential
 social assistance services to
 improve quality of life) \216\.
32. Entities Providing Other        Yes..................  Yes..................           5,310          21,240
 Individual Family Services (e.g.,
 marriage counseling, crisis
 intervention centers, suicide
 crisis centers) \217\.

[[Page 23235]]

 
33. Entities Providing Child and    Yes..................  Yes..................           2,169           8,674
 Youth Services (e.g., adoption
 agencies, foster care placement
 services) \218\.
34. Temporary Shelters (e.g.,       Yes..................  Yes..................             805           3,219
 short term emergency shelters for
 victims of domestic violence,
 sexual assault, or child abuse;
 runaway youth; and families
 caught in medical crises) \219\.
35. Emergency and Other Relief      Yes..................  Yes..................             169             675
 Services (e.g., medical relief,
 resettlement, and counseling to
 victims of domestic or
 international disasters or
 conflicts) \220\.
----------------------------------------------------------------------------------------------------------------
                                                 Other Entities
----------------------------------------------------------------------------------------------------------------
36. Pharmacies and Drug Stores      Yes..................  Yes..................          13,490          19,550
 \221\.
37. Research and Development in     Yes..................  Yes..................           2,347           3,402
 Biotechnology \222\.
38. Colleges, Universities, &       Yes..................  Yes..................             316           2,457
 Professional Schools \223\.
----------------------------------------------------------------------------------------------------------------
    Subtotal, subject to part 88    .....................  .....................         392,236         613,367
     in 2011 Rule.
----------------------------------------------------------------------------------------------------------------
39. HHS awarded funds appropriated  No...................  Yes..................              65             130
 to the U.S. Dept. of State &
 USAID \224\.
----------------------------------------------------------------------------------------------------------------
    Subtotal, incremental increase  .....................  .....................              65             130
     in entities.
----------------------------------------------------------------------------------------------------------------
        TOTAL, estimated entities   .....................  .....................         392,301         613,497
         subject to this rule.
----------------------------------------------------------------------------------------------------------------

    Approximately 392,236 to 613,367 persons and entities were subject 
to part 88 in effect based on the 2011 Rule by virtue of the Weldon, 
Coats-Snowe and Church Amendments. The Department estimated that the 
number of entities that this final rule covers that are subject to 22 
U.S.C. 7631(d) and 2151b(f), but not paragraph (d) of the Church 
Amendments is small and, possibly, non-existent because paragraph (d) 
of the Church Amendments does not tie funding to a particular 
appropriation or financial stream.\225\ Consequently, this final rule 
may add 65 to 130 new persons and entities to the coverage of 45 CFR 
part 88.\226\ With this incremental increase, this final rule covers an 
average of 502,899 entities, which is the mid-point of the low (392,301 
entities) and high-end (613,497 entities).
---------------------------------------------------------------------------

    \215\ Id. (nationwide count of firms for NAICS Code 524114).
    \216\ Id. (nationwide count of firms for NAICS Code 624120).
    \217\ Id. (nationwide count of firms for NAICS Code 624190).
    \218\ Id. (nationwide count of firms for NAICS Code 624110). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \219\ Id. (nationwide count of firms for NAICS Code 624221). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \220\ Id. (nationwide count of firms for NAICS Code 624230). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \221\ Id. (nationwide count of firms for NAICS Code 44610).
    \222\ Id. (nationwide count of firms for NAICS Code 541711).
    \223\ Id. (nationwide count of firms for NAICS Code 611310). As 
described supra at part IV.C.2.iii (methodology), the Department 
assumes 13%-100% of institutions of higher-education are covered. 
See supra at XI.C.2.iii for a detailed explanation for how the 
Department supplemented Statistics of U.S. Businesses data with 
award data from the Department's Tracking Accountability in 
Government Grants System.
    \224\ U.S. Dep't of Health & Human Servs., Tracking 
Accountability in Government Grants System (TAGGS) http://taggs.hhs.gov (last visited Dec. 19, 2017). HHS identified unique 
awardees for FY 2017 from HHS PEPFAR implementing agencies (CDC, 
HRSA, SAMHSA, NIH, FDA) to foreign nonprofits, foreign governments, 
and international organizations and used this number as a lower-
bound. Because the Department also receives funds appropriated to 
USAID through one or more reimbursable agreements, the Department 
assumed that there could be twice as many recipients and sub-
recipients after considering the awardees from these reimbursable 
agreements and thus multiplied and lower-bound by two.
    \225\ The text of paragraph (d) states that its protection 
applies for health service program and research activities ``funded 
in whole or part under a program administered by the [HHS] 
Secretary.''
    \226\ But see supra at part IV.C.2.ii (discussing the 
application of paragraph (d) of the Church Amendments to such 
grantees).
---------------------------------------------------------------------------

(A) Estimated Persons and Entities Required To Sign an Assurance and 
Certification of Compliance
    Relative to the persons and entities shown in Table 2, a smaller 
subset is subject to Sec.  88.4, which requires certain recipients to 
submit an assurance and certification of compliance and exempts others. 
The Department calculated the subset of persons and entities subject to 
Sec.  88.4 by (1) removing estimated sub-recipients from the total 
because Sec.  88.4 applies to recipients, not sub-recipients, and (2) 
removing the estimated recipients exempted from Sec.  88.4, as 
identified in Sec.  88.4(c)(1) through (4). Infra at Table 3 shows this 
calculation.
Calculating Estimated Sub-Recipients
    The Department sought comment on the policy for Sec.  88.4 to apply 
to recipients but not sub-recipients, noting that the proposed rule 
took this approach to reduce the burden on small entities. The 
Department did not receive comments addressing this question. One 
commenter, however, raised the question that, if the proposed rule's 
policy was to exempt clinicians who are part of State Medicaid 
programs, then the proposed rule did not exclude such clinicians from 
Sec.  88.4. However, clinicians who receive reimbursement through a 
State Medicaid program are sub-recipients of the Department (i.e., 
recipients of the State, which is the recipient in relationship to the 
Department). Under a Medicaid fee-for-service model, the State pays the 
clinicians directly, and under the managed care model, a State pays a 
fee to a managed care plan, which in turn pays the clinician for the 
services a beneficiary may require that are within the managed care 
plan's contract with the State to serve Medicaid beneficiaries.\227\ As 
sub-recipients, these clinicians that accept Medicaid are not subject 
to Sec.  88.4, unless they become recipients from HHS Federal financial 
assistance or other Federal funds from a non-exempt HHS program (i.e., 
a program not captured in Sec.  88.4(c)(2) through (4)).
---------------------------------------------------------------------------

    \227\ See, e.g., Provider Payment and Delivery Systems, MACPAC, 
https://www.macpac.gov/medicaid-101/provider-payment-and-delivery-systems/ (last visited Jan. 29, 2019).
---------------------------------------------------------------------------

    In the proposed rule, OCR explained that it had not found a 
reliable way to calculate the number of sub-recipients of this rule. 
The Department assumed entities in supra at Table 2 were all recipients 
except for counties, which the Department assumed were sub-recipients 
for the purpose of this

[[Page 23236]]

calculation. The Department received no comments regarding information, 
data sources, studies, or reports that could assist the Department in 
improving its approach.
    To refine the estimates, the Department reconsidered the proposed 
rule's blanket assumption that all counties are sub-recipients for 
purposes of this calculation. Using the ``Advanced Search'' function in 
TAGGS, the Department identified the total number of county awardees 
and de-duplicated the results to obtain one list of unique county 
awardees from the Department for FY 2017. This approach identified 625 
counties (19 percent) receiving funding directly from HHS as 
recipients. Assuming that all counties are HHS recipients or sub-
recipients, the remaining of 2,609 counties (81 percent) would be sub-
recipients that are not subject to Sec.  88.4's application. This 
method is a more accurate proxy for estimating the number of sub-
recipient counties. If some entities (other than counties) in Table 2 
are sub-recipients rather than recipients, then the Department 
overestimated the scope of entities subject to Sec.  88.4's application 
that are not exempted.
Calculating Exempted Recipients in Sec.  88.4(c)(1) Through (4)
    The Department received no comments regarding the methods used to 
estimate the scope of exempted recipients under Sec.  88.4(c)(1) 
through (4). Therefore, the Department maintains the proposed rule's 
methods.
    The Department assumed that all physicians' offices would meet the 
criteria in Sec.  88.4(c)(1) and subtracted out 255,684 to 370,557 
entities, which represents the lower and upper-bounds of all 
physicians' offices.\228\ If some physicians' offices are recipients 
through an instrument other than Medicare Part B reimbursement, then 
the Department overestimated the number of physicians' offices exempted 
due to Sec.  88.4(c)(1). The Department does not have the necessary 
data to estimate the impact of the final rule's new exemption for 
pharmacies and pharmacists that receive Medicare Part B because the 
Department does not know whether such pharmacies or pharmacists 
exempted under Sec.  88.4(c)(1) are Department recipients (as opposed 
to sub-recipients) of HHS Federal financial assistance or other Federal 
funds from a non-exempt HHS program (i.e., a program not captured in 
Sec.  88.4(c)(2) through (4)).
---------------------------------------------------------------------------

    \228\ Sum of rows 11, 12, 14-16, and 18 of Table 2.
---------------------------------------------------------------------------

    The Department subtracted out 11,220 to 44,879 persons and entities 
that meet the criteria in Sec.  88.4(c)(2) and (3) regarding the 
exemption for recipients of grant programs administered by the 
Administration for Children and Families or the Administration for 
Community Living.\229\ The exemption applies if the program meets 
certain regulatory criteria indicating that its purpose is unrelated to 
health care and certain types of research, does not involve health care 
providers, and does not involve referral for the provision of health 
care. The Department reasonably assumed that all persons and entities 
that provide child and youth services (such as adoption and foster 
care) would fall into this exemption. The Department also reasonably 
assumed that all entities providing services for the elderly and 
persons with disabilities (by providing nonresidential social 
assistance services to improve quality of life) would fall within this 
exemption. The Department did not subtract out the entities providing 
``Other Individual Family Services'' (e.g., marriage counseling, crisis 
intervention centers, suicide crisis centers) because there is a 
significant likelihood of referral for the provision of health care at 
crisis intervention centers and suicide crisis centers.
---------------------------------------------------------------------------

    \229\ Sum of rows 31 and 33 of Table 2.
---------------------------------------------------------------------------

    The Department subtracted out 230 Tribes and Tribal Organizations 
for the exemption in Sec.  88.4(c)(4). This number represents the total 
Tribes and Tribal Organizations that operate contracts under Title I of 
the ISDEA Act.\230\ This final rule revises the requirements for 
federally recognized Indian tribes, tribal organizations, or urban 
Indian organizations who are recipients by virtue of grants or 
cooperative agreements under 42 U.S.C. 290bb-36, removing the 
requirement that such entities comply with Sec.  88.4. The Department 
does not have the data necessary to estimate the number of such 
entities who are recipients of funds via such grants or cooperative 
agreements that are not already captured within the scope of the 
exemption in Sec.  88.4(c)(4).
---------------------------------------------------------------------------

    \230\ Indian Health Service, FY 2019 Justification of Estimates 
for Appropriations Committees CJ-243 (2018), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.

   Table 3--Estimated Range of Recipients Subject to the Assurance and
                Certification Requirements (Sec.   88.4)
------------------------------------------------------------------------
                                              Low-end       Upper-bound
                                             estimate        estimate
------------------------------------------------------------------------
Persons or Entities Subject to This              392,301         613,497
 Final Rule.............................
Sub-Recipients to which Sec.   88.4 Does          -2,609          -2,609
 Not Apply..............................
Range of Recipients Exempted from Sec.          -267,134        -415,666
 88.4...................................
                                         -------------------------------
    Total, Recipients Subject to Sec.            122,558         195,222
     88.4...............................
------------------------------------------------------------------------

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

[[Page 23237]]

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

    \231\ https://www.census.gov/data/datasets/2015/econ/susb/2015-susb.html. The Department relied on the data file titled ``U.S. & 
State, NAICS, detailed employment sizes (U.S., 6-digit and States, 
NAICS sectors).'' The latest data available is from 2015 that the 
Bureau made available in September of 2017, and this data relied on 
the 2012 NAICS codes. Id.

 Table 4--Estimated Number of Firms Associated With Each Recipient Type
    Likely To Modify the Notice of Rights in Appendix A (Sec.   88.5)
------------------------------------------------------------------------
                                                             Estimate
                  Type                    Estimate (low)      (high)
------------------------------------------------------------------------
1. Skilled Nursing Facilities...........           3,158           4,577
2. Residential Intellectual and                    2,155           3,123
 Developmental Disability Facilities....
3. Continuing Care Retirement                      1,302           1,888
 Communities............................
4. Other Residential Care Facilities               1,123           1,628
 (e.g., group homes)....................
5. Entities providing Home Health Care             7,531          10,915
 Services...............................
6. Offices of Physicians, Mental Health            3,662           5,307
 Specialists............................
7. Offices of Mental Health                        7,170          10,391
 Practitioners (except Physicians)......
8. Offices of Dentists..................          43,437          62,952
9. Offices of Chiropractors.............          13,363          19,366
10. Offices of Optometrists.............           6,888           9,982
11. Offices of Physical, Occupational              8,811          12,770
 and Speech Therapists, and Audiologists
12. Offices of Podiatrists..............           2,657           3,851
13. Offices of All Other Miscellaneous             5,751           8,335
 Health Practitioners...................
14. Kidney Dialysis Centers.............             152             221
15. Outpatient Mental Health and                   1,888           2,736
 Substance Abuse Centers................
16. Diagnostic Imaging Centers..........           1,605           2,326
17. Medical Laboratories................           1,139           1,651
18. Entities Providing Child and Youth             1,084           4,337
 Services (e.g., adoption agencies,
 foster care placement services)........
                                         -------------------------------
    Total, Firms Likely to Modify Pre-           112,876         166,354
     Written Notice Text................
------------------------------------------------------------------------

    The Department assumes that, for all posting methods, recipients 
will execute the posting at the establishment level. Using the range of 
firms subject to this rule as a foundation, the range of establishments 
associated with those recipients is shown infra at in Table 5. Table 5 
employs the methodology used for calculating the number of persons and 
entities shown in Table 2, but uses the U.S. Census Bureau's Statistics 
of U.S. Businesses data for establishments rather than firms.\231\ The 
footnotes detail the assumptions and calculations for each line and 
assume 69-100 percent of the industry as covered unless otherwise 
noted, which parallels the assumptions for Table 2.
    Because there is a high degree of uncertainty as to the proportion 
of recipients that will voluntarily post notices through one or more of 
the methods specified in Sec.  88.5 in the first year of the rule's 
implementation, the Department adjusts the range of establishments 
associated with covered recipients downward by 50 percent for the 
purpose of this calculation. The values derived from this calculation 
appear infra at in Table 5: 261,735 establishments (low-end) and 
408,918 establishments (high-end) for a mid-point of 335,327 
establishments. The Department adjusts downward the range of 
establishments that would voluntarily provide notices of rights in 
years two through five by 25 percent, relative to year one, to reflect 
attrition: 196,301 establishments (low-end) and 306,689 establishments 
(high-end) for a mid-point of 251,495 establishments.

[[Page 23238]]

     
---------------------------------------------------------------------------

    \232\ Assumes coverage of the 50 States, DC, Puerto Rico, 6 U.S. 
Territories, and the Island Areas.
    \233\ Assumes all federally recognized Tribes get HHS funds. 
Indian Health Service, FY 2019, Justification of Estimates for 
Appropriations Committees, CJ-243 (2018), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.
    \234\ U.S. Census Bureau, 2010 Census Geographic Entity Tallies 
by State and Type, https://www.census.gov/geo/maps-data/data/tallies/all_tallies.html (total counties and equivalent areas for 
the U.S., Puerto Rico, the U.S. Territories, and the Island Areas). 
The values estimate the number of recipient counties and exclude 
estimated sub-recipients.
    \235\ U.S. Census Bureau, Statistics of U.S. Businesses, 2015 
(released Sept. 2017), https://www.census.gov/data/datasets/2015/econ/susb/2015-susb.html (nationwide count of firms for NAICS Code 
622110).
    \236\ Id. (sum of the nationwide count of firms for NAICS Codes 
622210 and 622310).
    \237\ Id. (nationwide count of firms for NAICS Code 623110).
    \238\ Id. (nationwide count of firms for NAICS Code 623210).
    \239\ Id. (nationwide count of firms for NAICS Code 623311).
    \240\ Id. (nationwide count of firms for NAICS Code 623990).
    \241\ Id. (nationwide count of firms for NAICS Code 621610).
    \242\ Id. (nationwide count of firms for NAICS Code 621111).
    \243\ Id. (nationwide count of firms for NAICS Code 621112).
    \244\ Id. (nationwide count of firms for NAICS Code 621330).
    \245\ Id. (nationwide count of firms for NAICS Code 621210).
    \246\ Id. (nationwide count of firms for NAICS Code 621310).
    \247\ Id. (nationwide count of firms for NAICS Code 621320).
    \248\ Id. (nationwide count of firms for NAICS Code 621340).
    \249\ Id. (nationwide count of firms for NAICS Code 621391).
    \250\ Id. (nationwide count of firms for NAICS Code 621399).
    \251\ Id. (nationwide count of firms for NAICS Code 621410).
    \252\ Id. (nationwide count of firms for NAICS Code 621493).
    \253\ Id. (nationwide count of firms for NAICS Code 621491).
    \254\ Id. (nationwide count of firms for NAICS Code 621492).
    \255\ Id. (nationwide count of firms for NAICS Code 621420).
    \256\ Id. (nationwide count of firms for NAICS Code 621512).
    \257\ Id. (nationwide count of firms for NAICS Code 621511).
    \258\ Id. (nationwide count of firms for NAICS Code 621910).
    \259\ Id. (nationwide count of firms for NAICS Code 621498).
    \260\ Id. (nationwide count of firms for NAICS Code 62199).
    \261\ Id. (nationwide count of firms for NAICS Code 524114).
    \262\ Id. (nationwide count of firms for NAICS Code 624120).
    \263\ Id. (nationwide count of firms for NAICS Code 624190).
    \264\ Id. (nationwide count of firms for NAICS Code 624110). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
---------------------------------------------------------------------------

     
---------------------------------------------------------------------------

    \265\ Id. (nationwide count of firms for NAICS Code 624221). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \266\ Id. (nationwide count of firms for NAICS Code 624230). As 
described supra at part IV.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \267\ Id. (nationwide count of firms for NAICS Code 44611).
    \268\ Id. (nationwide count of firms for NAICS Code 541711).
    \269\ Id. (nationwide count of firms for NAICS Code 611310). As 
described supra at part IV.C.2.iii (methodology), the Department 
assumes 13%-100% of institutions of higher-education are covered.
    \270\ U.S. Dep't of Health & Human Servs., Tracking 
Accountability in Government Grants System (TAGGS) http://taggs.hhs.gov (last visited Dec. 19, 2017).

  Table 5--Number of Physical Establishments of Each Recipient Type Estimated to Voluntarily Provide Notice of
                                         Rights in Year 1 (Sec.   88.5)
----------------------------------------------------------------------------------------------------------------
                                    Establishments assoc. with     Establishments assoc. with covered recipients
                                        covered recipients         that would voluntarily post notices in Year 1
              Type               -------------------------------------------------------------------------------
                                       (Low)          (High)           (Low)          (High)         Mid-point
----------------------------------------------------------------------------------------------------------------
State and Territorial                         58              58              29              29              29
 Governments \232\..............
Federally recognized Tribes                  573             573             287             287             287
 \233\..........................
Counties \234\..................             625             625             313             313             313
General and Medical Surgical               3,699           5,361           1,850           2,681           2,265
 Hospitals \235\................
Specialty Hospitals (e.g.,                 1,139           1,651             570             826             698
 psychiatric, substance abuse,
 rehabilitation, cancer,
 maternity) \236\...............
Skilled Nursing Facilities \237\          11,789          17,085           5,894           8,543           7,218
Residential Intellectual &                22,611          32,770          11,306          16,385          13,845
 Developmental Disability
 Facilities \238\...............
Continuing Care Retirement                 3,668           5,316           1,834           2,658           2,246
 Communities \239\..............
Other Residential Care                     3,627           5,256           1,813           2,628           2,221
 Facilities (e.g., group homes)
 \240\..........................
Entities providing Home Health            21,377          30,981          10,688          15,491          13,089
 Care Services \241\............
Offices of Physicians (except            147,817         214,228          73,909         107,114          90,511
 Mental Health Specialists)
 \242\..........................
Offices of Physicians (Mental              7,498          10,867           3,749           5,434           4,591
 Health Specialists) \243\......
Offices of Mental Health                  15,022          21,771           7,511          10,886           9,198
 Practitioners (except
 Physicians) \244\..............
Offices of Dentists \245\.......          92,895         134,631          46,448          67,316          56,882
Offices of Chiropractors \246\..          26,999          39,129          13,500          19,565          16,532
Offices of Optometrists \247\...          15,101          21,885           7,550          10,943           9,246
Offices of Physical,                      25,213          36,541          12,607          18,271          15,439
 Occupational & Speech
 Therapists, & Audiologists
 \248\..........................
Offices of Podiatrists \249\....           5,769           8,361           2,885           4,181           3,533
Offices of All Other Misc.                12,731          18,450           6,365           9,225           7,795
 Health Practitioners \250\.....
Family Planning Centers \251\...           1,584           2,295             792           1,148             970
Freestanding Ambulatory Surgical           4,609           6,679           2,304           3,340           2,822
 & Emergency Ctrs. \252\........
HMO Medical Centers \253\.......             560             812             280             406             343
Kidney Dialysis Centers \254\...           5,144           7,455           2,572           3,728           3,150
Outpatient Mental Health &                 7,227          10,474           3,614           5,237           4,425
 Substance Abuse Ctrs. \255\....
Diagnostic Imaging Centers \256\           4,553           6,598           2,276           3,299           2,788
Medical Laboratories \257\......           7,360          10,667           3,680           5,334           4,507

[[Page 23239]]

 
Ambulance Services \258\........           3,271           4,740           1,635           2,370           2,003
All Other Outpatient Care                  8,054          11,672           4,027           5,836           4,931
 Centers (e.g., centers &
 clinics for pain therapy,
 community health, & sleep
 disorders) \259\...............
Entities Providing All Other               3,670           5,319           1,835           2,660           2,247
 Ambulatory Health Care Services
 (health screening, smoking
 cessation, hearing testing,
 blood banks) \260\.............
Direct Health & Medical                    3,712           5,379           1,856           2,690           2,273
 Insurance Carriers \261\.......
Entities Serving the Elderly and          10,475          41,899           5,237          20,950          13,093
 Persons with Disabilities
 (provision of nonresidential
 social assistance services to
 improve quality of life) \262\.
Entities providing Other                   7,184          28,736           3,592          14,368           8,980
 Individual Family Services
 (e.g., marriage counseling,
 crisis intervention centers,
 suicide crisis centers) \263\..
Entities providing Child & Youth           2,901          11,604           1,451           5,802           3,626
 Services (e.g., adoption
 agencies, foster care placement
 services) \264\................
Temporary Shelters (e.g., short-           1,013           4,053             507           2,027           1,267
 term emergency shelters for
 victims of domestic violence,
 sexual assault, or child abuse;
 runaway youth; and families
 caught in medical crises) \265\
Emergency & Other Relief                     309           1,236             155             618             386
 Services (e.g., medical relief,
 resettlement, & counseling to
 victims of disasters or
 conflicts) \266\...............
Pharmacies and Drug Stores \267\          30,450          44,130          15,225          22,065          18,645
Research and Development in                2,505           3,631           1,253           1,816           1,534
 Biotechnology \268\............
Colleges, Universities, &                    615           4,788             308           2,394           1,351
 Professional Schools \269\.....
HHS awarded funds appropriated                65             130              33              65              49
 to the U.S. Department of State
 & USAID \270\..................
                                 -------------------------------------------------------------------------------
    Total.......................         523,470         817,836         261,735         408,918         335,327
----------------------------------------------------------------------------------------------------------------

3. Estimated Burdens
    There are five categories of estimated monetized burdens for this 
final rule as summarized in Table 6, as well as burdens that cannot be 
fully monetized. No commenters provided alternate reliable 
methodologies for monetizing the rule's burden. Potential burdens 
associated with access to care and health outcomes are discussed infra 
at part IV.C.4.vii.
    Several comments argued that the rule would impose costs on 
entities associated with the increased risk of litigation over 
incidents of providers' exercise of conscience, both between patients 
and providers and between individual providers and their employers.
    Regading an increase in risk for litigation between individual 
providers and their employers, the Department agrees with the potential 
effect these commenters predict: That some entities will change their 
behavior to come into compliance, or improve compliance, with Federal 
conscience and anti-discrimination laws. Indeed, the proposed rule's 
RIA and this RIA estimate the burden associated with such voluntary 
behavior changes. However, whether entities take such action because of 
the risk of litigation is too speculative and uncertain for calculation 
in the RIA. Further, some courts have held that there is no private 
right of action under the Coats-Snowe and Church Amendments, excluding 
litigation as a viable alternative for individuals.\271\
---------------------------------------------------------------------------

    \271\ See, e.g., Vermont All. for Ethical Healthcare, Inc. v. 
Hoser, 274 F. Supp. 3d 227, 240 (D. Vt. 2017); Hellwege v. Tampa 
Family Health Centers, 103 F. Supp. 3d 1303, 1311-12 (M.D. Fla. 
2015); Order at 4, National Institute of Family and Life Advocates, 
et al. v. Rauner, No. 3:16-cv-50310 (N. D. Ill. July 19, 2017), ECF 
No. 65. See also supra at part II.A (describing the lack of private 
remedies).
---------------------------------------------------------------------------

    Regarding an increase in risk for litigation between patients and 
providers, the Department agrees that this rule will result in more 
providers exercising conscientious objections to participating in 
services requested by patients, and that such objections may give rise 
to lawsuits by patients. However, the Department is unaware of any 
reliable basis for estimating the frequency or cost of such lawsuits.
    Public comments regarding general burdens are integrated throughout 
the RIA. Public comments regarding the burden, if any, that may result 
from secondary effects of this rule, such as the monetary impact of 
certain health outcomes that may arise from increased conscience 
protection, are discussed in the rule's analysis of benefits, infra at 
IV.C.4.
---------------------------------------------------------------------------

    \272\ The totals in Table 6: Cost Summary of the Final Rule may 
not appear to add correctly, but that is due to rounding.

[[Page 23240]]



                                     Table 6--Cost Summary of the Final Rule
                                    (Discounted 3% and 7% in millions) \272\
----------------------------------------------------------------------------------------------------------------
                                                                                                  Total  (for
                                                                                                 undiscounted)
                                 Year 1       Year 2       Year 3       Year 4       Year 5     annualized (for
                                                                                                  discount'd.)
----------------------------------------------------------------------------------------------------------------
Familiarization                      $135           $-           $-           $-           $-               $135
 (undiscounted).............
    Familiarization (3%)....          120  ...........  ...........  ...........  ...........                120
    Familiarization (7%)....          103  ...........  ...........  ...........  ...........                103
Assurance & Certification             156          142          142          142          142                724
 (undiscounted).............
    Assurance &                       138          123          119          116          112                608
     Certification (3%).....
    Assurance &                       119          101           95           89           83                486
     Certification (7%).....
Voluntary Notice                       93           14           14           14           14                150
 (undiscounted).............
    Voluntary Notice (3%)...           83           12           12           11           11                130
    Voluntary Notice (7%)...           71           10            9            9            8                108
Voluntary Remedial Efforts              7            7            7            7            7                 36
 (undisc.)..................
    Voluntary Remedial                  6            6            6            6            6                 31
     Efforts (3%)...........
    Voluntary Remedial                  6            5            5            5            4                 24
     Efforts (7%)...........
OCR Enforcement Costs                   3            3            3            3            3                 15
 (undisc.)..................
    OCR Enforcement Costs               3            3            2            2            2                 12
     (3%)...................
    OCR Enforcement Costs               2            2            2            2            2                 10
     (7%)...................
Total Costs (undiscounted)..          394          167          167          167          167              1,061
    Total Costs (3%)........          350          144          140          135          131                901
    Total Costs (7%)........          301          119          111          104           97                731
----------------------------------------------------------------------------------------------------------------

    In this impact analysis, the Department calculates labor costs 
using the mean hourly wage (including benefits and overhead) for a:
     Lawyer at $134.50 per hour ($67.25 per hour x 2),\273\
---------------------------------------------------------------------------

    \273\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm (occupation code 23-1011).
---------------------------------------------------------------------------

     Executive at $186.88 ($93.44 per hour x 2),\274\
---------------------------------------------------------------------------

    \274\ Id. (occupation code 11-1011).
---------------------------------------------------------------------------

     Administrative assistant at $38.78 per hour ($19.39 per 
hour x 2),\275\
---------------------------------------------------------------------------

    \275\ Id. (occupation code 43-6010).
---------------------------------------------------------------------------

     Web developer at $69.38 per hour ($34.69 per hour x 
2),\276\ and
---------------------------------------------------------------------------

    \276\ Id. (occupation code 15-11134).
---------------------------------------------------------------------------

     Paralegal at $51.84 per hour ($25.92 per hour x 2).\277\
---------------------------------------------------------------------------

    \277\ Id. (occupation code 23-2011).

These calculations reflect the Department's standard practice of 
calculating a fully loaded mean hourly wage (i.e., wage including 
benefits and overhead) by multiplying the hourly pre-tax wage by 
two.\278\
---------------------------------------------------------------------------

    \278\ ``Guidance for Regulatory Impact Analysis,'' Office of the 
Assistant Secretary for Planning and Evaluation, U.S. Department of 
Health and Human Services, 2016, at 28; see, e.g., 81 FR 31451 
(2016) (``We note that one commenter suggested that we use a factor 
higher than 100% to adjust wages for overhead and benefits. However, 
the commenter's argument is based on Federal overhead rates for 
contracts, and not evidence of the resource costs associated with 
reallocating employee time. As a result, we do not adopt the 
commenter's recommendation, and we continue to use the Department's 
standard of 100% for overhead and fringe benefits.'').
---------------------------------------------------------------------------

(i) Familiarization Burden
    The Department estimates a one-time burden for regulated persons 
and entities to familiarize themselves with the rule. The proposed rule 
estimated that on average, each person and entity would spend one hour 
for familiarization. The Department received comments arguing that this 
estimate fell short of the time needed to accomplish the goal of 
familiarization. In light of these comments, the Department increased 
the estimate from one hour to two hours. This increase reflects 
persons' and entities' familiarization of the rule's requirements and 
procedures, including the changes from the proposed rule.
    The burden is a one-time opportunity cost of staff time (a lawyer) 
to review the rule. The labor cost is approximately $135.3 million in 
the first year ($134.50 per hour x 2 hours x 502,899 entities (the 
average of the low and high-end range in Table 2)) and zero dollars in 
years two through five. This estimated burden represents the average 
burden; some persons and entities may spend substantially more time 
than two hours on familiarization, and others may spend less time.
(ii) Burden Associated With Assurance & Certification (Sec.  88.4)
    As a condition of the approval, renewal, or extension of any 
Federal financial assistance or Federal funds from the Department, 
Sec.  88.4 requires every application for Federal financial assistance 
or Federal funds from the Department to which the rule applies to 
provide, contain, or be accompanied by an assurance and a certification 
that the applicant or recipient will comply with applicable Federal 
conscience and anti-discrimination laws and this rule.
    The burden to recipients not exempted from Sec.  88.4 is the 
opportunity cost of recipient staff time (1) to review the assurance 
and certification language and the requirements of the Federal 
conscience and anti-discrimination laws referenced or incorporated, (2) 
to review recipient-wide policies and procedures or take other actions 
to self-assess compliance with applicable Federal conscience and anti-
discrimination laws, and (3) to implement any actions necessary to come 
into compliance. Infra at Table 7 summarizes these costs.
    The Department estimates that each recipient not exempted from 
Sec.  88.4 will spend an average of 4 hours annually reviewing the 
assurance and certification language and the Federal conscience 
protection and associated anti-discrimination laws and the rule. In the 
2008 Rule, the Department estimated that it would take 30 minutes to 
certify compliance with three laws: The Church, Weldon, and Coats-Snowe 
Amendments.\279\ In this rule, there are 22 additional statutory 
provisions covered. Citations for each law are clearly listed in the 
rule, the texts of the statutes are easily found online. For many 
entities, it will be immediately clear when a law that this rule 
implements and enforces does not apply to those entities.\280\ The 
Department

[[Page 23241]]

estimates each recipient will take 10 minutes per law on average, 
yielding an additional 3.5 hours on average to review the applicability 
of the additional laws that this rule proposes to enforce, for a total 
burden of 4 hours per recipient, per year, for the first five years. 
Some recipients may spend considerably less time; others may spend 
considerably more time.
---------------------------------------------------------------------------

    \279\ 73 FR 78072, 78095 (2008 Rule).
    \280\ For example, provisions applicable to Medicaid recipients 
would not apply to entities that do not receive Medicaid and, 
presumably, most entities readily know if they receive Medicaid 
reimbursements as a result of providing care to Medicaid 
beneficiaries.
---------------------------------------------------------------------------

    The labor cost is a function of a lawyer spending 3 hours reviewing 
the assurance and certification and an executive spending one hour to 
review and sign, as Sec.  88.4(b)(2) requires a signature by an 
individual authorized to bind the recipient. The weighted mean hourly 
wage (including benefits and overhead) is $147.60 per hour.\281\ The 
labor cost is $93.8 million each year for the first five years ($147.60 
per hour x 4 hours x 158,890 recipients \282\).
---------------------------------------------------------------------------

    \281\ Sum of ($134.50 x .75) and ($186.88 x .25).
    \282\ This estimate is the average of the low and high-end 
estimates in supra at Table 3. As explained supra at part 
IV.C.2.iv.A, sub-recipients are not subject to this requirement.
---------------------------------------------------------------------------

    The Department estimates that 79,445 recipients, which is half of 
recipients required to assure and certify compliance (158,890 
recipients/2), will spend 4 hours reviewing policies and procedures or 
taking other actions to self-assess compliance with applicable Federal 
conscience and anti-discrimination laws each year for the first five 
years after publication of the rule. Some entities will spend more time 
and others will spend less time. The Department reasonably estimates 
such action because Sec.  88.4(b)(4) states that the submission of an 
assurance and certification will not relieve a recipient of the 
obligation to come into compliance prior to or after submission of such 
assurance or certification. A first step to such actions may be to 
review organization-wide safeguards (or best practices), such as 
policies and procedures, that may be, or should be, in place. The labor 
cost is a function of a lawyer spending 3 hours and an executive 
spending one hour, which produces the a weighted mean hourly wage of 
$147.60 per hour. The labor cost for self-assessing compliance is a 
total of $46.9 million annually for the first five years ($147.60 per 
hour x 4 hours x 79,445 entities).
    The Department estimates that approximately 5 percent of entities 
(or 16 percent of those subject to Sec.  88.4) will take an 
organization-wide action to improve compliance in the first year and 
0.5 percent of entities (1.6 percent of those subject to Sec.  88.4) 
will take a similar action annually in years two through five. This 
percentage equates to 25,145 recipients in year one and 2,514 
recipients annually in years two through five. The Department estimates 
that these recipients would spend 4 hours annually, on average, to take 
remedial efforts. The Department estimates that recipients will spend 
an average of 4 hours to update policies and procedures, implement 
staffing or scheduling practices that respect an exercise of conscience 
rights under Federal law, or disseminate the recipient's policies and 
procedures. The labor cost is a function of a lawyer spending 3 hours 
and an executive spending one hour, which produces a weighted mean 
hourly wage of $147.60 per hour. The labor cost is $14.8 million in 
year one ($147.60 per hour x 4 hours x 25,145 entities) and 
approximately $1.5 million annually for years two through five ($147.60 
per hour x 4 hours x 2,514 entities).
    If entities were already fully taking steps to be educated on, and 
comply with, all the laws that are the subject of this rule, there 
would likely not be any costs within the first five years of 
publication for remedial efforts associated with a recipient's 
commitment to assure and certify compliance in Sec.  88.4. However, the 
fact that there would be such costs is wholly consistent with the 
Department's stated justifications for the rule (i.e., lack of 
knowledge of, and compliance with, the laws).
    Several commenters expressed concern with the possible burden on 
health care providers resulting from the requirements to assure and 
certify compliance with Federal conscience and anti-discrimination 
laws. In drafting the rule, the Department considered the possible 
burden on health providers and exempted certain classes of recipients 
from Sec.  88.4. The impact of the exemption means that, unless such 
exempted persons or entities are recipients of Federal financial 
assistance or other Federal funds from the Department through another 
instrument, program, or mechanism, approximately 70 percent of 
recipients do not have to comply with the assurance and certification 
requirement.\283\ Given the magnitude of the exemption, Sec.  88.4 does 
not unduly burden persons and entities subject to the rule. Where the 
exemption does not apply, the burdens arising from assurances and 
certifications are fully justified, as they are with every other anti-
discrimination law that requires a similar assurance or certification.
---------------------------------------------------------------------------

    \283\ The average between the lower-bound (267,134) and upper-
bound (415,666) of recipients exempted is 341,400 recipients, which 
represents 68 percent of the estimated total 500,290 recipients of 
the rule (which is the result of 502,899 entities minus the 
estimated 2,609 counties that are estimated for the purposes of this 
rule as sub-recipients). If fewer recipients are impacted by the 
exemptions in Sec.  88.4(c)(1) through (4) than estimated, and if 
such recipients do not receive HHS Federal financial assistance or 
other Federal funds from a non-exempted HHS program, then the 
Department overestimated the percent of recipients that do not have 
to comply with the assurance and certification requirement.
---------------------------------------------------------------------------

    Moreover, the Department is committed to ensuring that a health 
care provider's assurance and certification of compliance with Federal 
conscience and anti-discrimination laws does not unduly burden small 
health care providers in their delivery of health care services to the 
community. As explained in the Paperwork Reduction Act analysis for 
Sec.  88.4, the Department is leveraging existing grant, contract, and 
other Departmental forms and government-wide systems, consistent with 
OMB's government-wide effort to reduce recipient burden.\284\
---------------------------------------------------------------------------

    \284\ Exec. Office of the President, Memorandum from Mick 
Mulvaney, Dir., Office of Management & Budget to Heads of Executive 
Departments and Agencies, Strategies to Reduce Grant Recipient 
Reporting Burden, at 2 (Sept. 5, 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/M-18-24.pdf.
---------------------------------------------------------------------------

    Finally, the Department has made efforts to reduce the frequency of 
information collected. Paragraph (b)(6) in Sec.  88.4 allows an 
applicant or recipient to incorporate the assurances and certification 
by reference in subsequent applications to the Department or Department 
component if prior assurances or certifications are initially provided 
in the same year. This approach is consistent with the HHS Grants 
Policy Statement.\285\ Because recipients file an assurance of 
compliance form ``for the organization and . . . not . . . for each 
application,'' a recipient with a signed assurance on file assures 
through its signature on the award application that it has a signed 
Form 690 on file.\286\
---------------------------------------------------------------------------

    \285\ See HHS Grants Policy Statement (Jan. 2007), https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
    \286\ Id. at I-31.
---------------------------------------------------------------------------

    Paragraph (b)(1) in Sec.  88.4 requires submission more frequently 
than the time of application if the applicant or recipient fails to 
meet a requirement of the rule, or OCR or the relevant Department 
component has reason to suspect or cause to investigate the possibility 
of such failure. The ability to require assurances outside of the 
application process permits OCR and the Department to ensure that the 
Federal financial assistance or other Federal funds that the Department 
awards are used in a manner compliant with Federal conscience and anti-
discrimination laws and the final rule. As this is a new requirement, 
OCR has

[[Page 23242]]

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

          Table 7--Summary of Assurance and Certification Costs
------------------------------------------------------------------------
                                                    Total costs
                                         -------------------------------
             Cost categories                              Annually Years
                                              Year 1            2-5
------------------------------------------------------------------------
Review and Sign.........................           $93.8           $93.8
Review Policies & Procedures............            46.9            46.9
Update or Disseminate Policies &                    14.8             1.5
 Procedures.............................
                                         -------------------------------
    Total Costs.........................           155.6           142.2
------------------------------------------------------------------------

(iii) Burden Associated With Voluntary Actions To Provide Notices of 
Rights (Sec.  88.5)
    As explained supra at in part IV.C.2.iv.B, the Department assumes 
that some recipients and Department components will voluntarily post 
and distribute a notice of rights through one of the methods specified 
in Sec.  88.5. The expected cost to recipients and the Department is 
$93.4 million in the first year of the rule's implementation and $14.1 
million annually in years two through five. The cost to the Department 
makes up a miniscule portion of the cost--about 0.04 percent in the 
first year and 0.10 percent annually in years two through five.
    As explained supra at part IV.C.2.iv.B, the Department assumes that 
an estimated 139,615 recipients (the average of the low-end and high-
end estimates shown in Table 4) will likely modify the pre-written 
notice in Appendix A as applied to them. Because the scope of such 
modifications would likely be limited, the Department estimates that 
modifying the notice constitutes a minimal opportunity cost of 20 
minutes of a lawyer's time for drafting and 10 minutes of an 
executive's time to provide final approval. For some recipients, 
modifying the notice will take more of the lawyer's or executive's 
time; for other recipients, it will take less time. The weighted mean 
hourly wage (including benefits and overhead) of these two occupations 
is $151.79 per hour.\287\ The one-time labor cost is $10.6 million in 
the first year ($151.79 per hour x 0.5 hours x 139,615 recipients).
---------------------------------------------------------------------------

    \287\ Sum of ($134.50 x .67) and ($186.88 x .33).
---------------------------------------------------------------------------

    There is uncertainty regarding how many recipients will voluntarily 
post notices and which method or methods in Sec.  88.5 they will 
employ. For the purposes of this calculation, the Department erred on 
the side of overestimating the burden and assumes that recipients 
likely to provide notice will do so:
     At physical locations,
     On their websites, and
     In two publications, such as a personnel manual or other 
substantially similar document for members of the recipient's 
workforce; in an application for membership in the recipient's 
workforce or for participation in a service, benefit or other program, 
including for training or study; or in a student handbook or other 
substantially similar document for students participating in a program 
for training or study, including for post-graduate interns, residents, 
and fellows.
    One commenter suggested that the final rule should permit the 
notice requirement to be posted electronically only, and not in paper 
form. Because the rule does not require recipients to provide notices 
of rights, recipients are free to provide notice in electronic form 
only and have such action considered by OCR as non-dispositive evidence 
of compliance with the substantive provisions of the rule, to the 
extent such notices are otherwise provided according to Sec.  88.5 and 
relevant to the particular OCR investigation or compliance review.
    For recipients that voluntarily post notices through any of the 
methods in Sec.  88.5, the Department assumes that the recipients will 
act by the end of the first year after the rule's implementation. An 
entity that posts on its website and in a physical location will incur 
a one-time burden. A recipient that includes an insert in a publication 
may incur an annual burden represented by the costs of labor, materials 
(paper and ink for hard-copy publication), and in some cases, postage.
Burden for Voluntary Posting in Physical Locations
    The Department estimates that it will take \1/3\ of an hour for an 
administrative assistant to print notice(s) and post them in physical 
locations of the establishment where notices are customarily posted to 
permit ready observation. For some establishments, it may take an 
administrative assistant longer to perform his or her respective 
functions; for other establishments, it may take less time. As shown in 
Table 5, 335,327 establishments is the average in the range of 
estimated establishments associated with covered recipients that would 
voluntarily post notices in the first year after the rule's 
publication. The estimated labor cost is $4.3 million (\1/3\ hour x 
$38.78 per hour x 335,327 establishments).
    A key uncertainty is the total number of locations per 
establishment where recipients commonly post notices; the per-
establishment total will vary based on multiple factors. These factors 
include the type of recipient, floor plans of the building, the square 
footage of the common areas, the square footage of the building, the 
number of floors, the size of the workforce, and the number of ultimate 
beneficiaries, among other variables. The Department assumes that the 
average establishment will print and post five notices in physical 
locations where notices are customarily posted; larger recipients might 
post more and smaller recipients might post fewer. The Department 
assumes that the cost of materials (paper and ink) is $0.05 per page. 
Based on this assumption, the first-year cost to post 5 notices across 
all establishments would be $83,832 (335,327 establishments x $.05 per 
page x 5 pages). Because the Department assumes that this cost is a 
one-time cost during the first year of this rule's implementation, the 
cost will not recur in years two through five. The total labor and 
materials costs for 335,327 establishments to post notices in physical 
locations is $4.4 million ($4.3 million in labor costs and $83,832 for 
materials) in year one with zero recurring costs.
Burden for Web Posting
    To post the notice on the web, the Department estimates that it 
will take 2 hours for a web developer to execute the design and 
technical elements for posting. A key uncertainty is whether

[[Page 23243]]

each recipient maintains separate websites for each facility, and if 
so, whether those websites are maintained at the corporate (i.e., firm) 
level or facility (i.e., establishment) level. In the proposed rule, 
the Department erred on the side of overestimating the burden and 
assumed that recipients maintained separate websites for each of their 
facilities at the establishment level. Thus, a web developer at each 
recipient's physical location would post the notice on the web. For 
some establishments, it may take web developers longer to perform their 
respective functions; for other establishments, it may take less time. 
This labor cost is approximately $46.5 million (2 hours x $69.38 per 
hour x 335,327 establishments).
    If, however, recipients maintain one website at the corporate level 
for all of their facilities, a web developer at the firm-level, rather 
than at each establishment, would bear the burden. In contrast to 
recipients bearing the cost across 335,327 facilities, about 250,145 
recipients at the firm-level would each bear this cost, which equals 
$34.7 million (2 hours x $69.38 per hour x 250,145 firms). Thus, if 
recipients voluntarily post notices on their websites, and if they do 
so at their corporate level for all sites including facility-specific 
websites, recipients would save on average about 25 percent of their 
labor costs to execute web posting in this manner.
Burden for Posting in Two Publications
    The Department did not receive specific comments estimating the 
annual costs of labor or materials that may be incurred by entities 
that include notices in relevant publications as set forth in the 
proposed rule (which remain voluntary under the final rule). Given the 
key uncertainties in how recipients will disseminate the notices of 
rights, as explained in subsequent paragraphs, the Department assumes 
that: (1) Establishments that include notices of rights in publications 
will most often do so in online publications or in hard-copy 
publications hand-distributed, where the notice's inclusion results in 
an additional 100 hard copy notices per establishment per year, and (2) 
half of the establishments associated with covered recipients 
voluntarily providing hard-copy notices (i.e., 167,663 establishments 
in year one and 125,747 establishments annually in years two through 
five) \288\ will distribute the publications via U.S. mail where the 
weight of the notice incrementally increases the postage costs.
---------------------------------------------------------------------------

    \288\ Product of 335,327 establishments times 50 percent for 
year one. Product of 251,495 establishments times 50 percent for 
years two through five.
---------------------------------------------------------------------------

    The Department assumes that, within the first year after the rule's 
publication, each recipient voluntarily posting notices in publications 
would identify the two publications in which to include the notice, 
revising the documents or their layouts to include the notice, or 
otherwise printing an insert to include with hard copies of the 
publication. A recipient that adds the notice to a publication 
disseminated only online that is not disseminated in hard copy will 
incur a one-time labor cost with zero costs for materials. In contrast, 
recipients that add the notice to a publication disseminated via hard 
copy may incur the annual cost of materials or incremental postage, or 
both, as well as the associated labor cost. For instance, a recipient 
that is unable to add the notice to the back page of an existing 
publication might add the notice as a separate page to the underlying 
publication or may print notices annually to include as inserts with 
the hard-copy publications. A recipient that does so and disseminates 
the publication via U.S. mail might incur incremental postage costs if 
the incremental weight of the notice places the total weight of the 
mailing in the next bracket of postage costs.
    These assumptions may differ from recipients' implementation 
experiences. Some recipients may distribute fewer than 100 hard-copy 
notices with relevant publications while others will distribute more 
than 100. Some recipients that mail relevant publications with notices 
of rights may not experience any incremental postage costs if the total 
weight of the mailings with notices does not place the mailing in the 
next postage bracket. Notwithstanding these uncertainties, the 
Department sets forth the following monetization as its best estimate 
of the burden based on its assumptions.
    The Department assumes an administrative assistant would spend an 
average of two hours in year one and one hour annually in years two 
through five to execute the activities except for mailing. The average 
labor cost, excluding mailing-related labor costs, is $26.0 million in 
year one ($38.78 per hour x 2 hours x 335,327 establishments) and $9.8 
million annually in years two through five ($38.78 per hour x 1 hour x 
251,495 establishments).\289\ Based on the marginal cost of postage per 
ounce of $0.15,\290\ an annual number of mailings of 100 pages per 
establishment, average annual labor cost for mailing of $38.78 per 
hour, and an average number of labor hours per mailing of 0.25 hours, 
the total costs due to the voluntary mailing of notices are $4.1 
million in year one \291\ and $3.1 million annually in years two 
through five.\292\ Finally, the annual cost of printed materials for 
notices (both mailed and hand distributed) is $1.7 million (335,327 
establishments x 100 pages x $.05 per page) in year one and $1.3 
million annually in years two through five (251,495 establishments x 
100 pages x $.05 per page).
---------------------------------------------------------------------------

    \289\ Under the final rule, because all the notice provisions 
are voluntary, the Department assumes that 75% of entities that 
voluntarily provide notices in year one will continue to do so in 
out years and there will be lower attrition compared to the estimate 
provided in the proposed rule.
    \290\ See U.S. Postal Service Postage Rates, https://www.stamps.com/usps/current-postage-rates/.
    \291\ Sum of incremental postage of $2.5 million ($0.15 per 
mailing x 100 mailings x 167,663 establishments) and incremental 
labor of $1.6 million ($38.78 per hour x 0.25 hours x 167,663 
establishments).
    \292\ Sum of incremental postage of $1.9 million ($0.15 per 
mailing x 100 mailings x 125,747 establishments) and incremental 
labor of $1.2 million ($38.78 per hour x 0.25 hours x 125,747 
establishments).
---------------------------------------------------------------------------

    In sum, the burden to recipients related to the voluntary posting 
and distributions of notices that Sec.  88.5 incentivizes is $93.4 
million in the first year and $14.1 million annually in years two 
through five.
Burden to the Federal Government
    Federal agencies are encouraged to identify costs and savings to 
government agencies where significant.\293\ The burden of Sec.  88.5 to 
the Federal government is the cost associated with the Department's 
components posting the notice voluntarily. Although this burden is not 
significant, the RIA monetizes the burden for completeness.
---------------------------------------------------------------------------

    \293\ OMB Circular A-4, Regulatory Analysis 37 (2003), https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf.
---------------------------------------------------------------------------

    The Department uses a framework for estimating its burden that is 
similar to the framework used to estimate the burden to recipients. For 
instance, the Department assumes that half of its components will post 
notices of rights voluntarily in the first year of the rule's 
publication (i.e., 10 of the 20 HHS Operating and Staff Divisions will 
post online). Because of attrition in compliance, 75 percent of that 
number will continue posting annually in certain publications in years 
two through five. As a proxy for that assumption to enable monetization 
of the physical posting, the Department assumes that staff at half of 
533 physical

[[Page 23244]]

locations owned or leased by the Department \294\ (277 physical 
locations) would post an average of five hard-copy notices per physical 
location and would post in certain publications. In years two through 
five, 75 percent of the 277 locations (207 locations) would post in 
certain publications. The Department assumes that the duration of the 
anticipated activities (e.g., downloading, printing, and posting the 
notice) would take Department staff the same time as it would take 
recipient staff. Similarly, the Department assumes that half of the 
physical locations associated with HHS components voluntarily providing 
hard copy notices (i.e., 138 locations in year one and 104 locations 
annually in years two through five) \295\ will distribute the 
publications via U.S. mail where the weight of the notice incrementally 
increases the postage costs.
---------------------------------------------------------------------------

    \294\ Obtained from U.S. General Services Administration on 
October 30, 2018 (on file with HHS OCR).
    \295\ Product of 277 locations times 50 percent for year one. 
Product of 207 locations times 50 percent for years two through 
five.
---------------------------------------------------------------------------

    The methods diverge in how the web posting is implemented (by each 
HHS Operating and Staff Division but not by each facility owned or 
leased) and in the average hourly wage rate used: A GS-7 step 5,\296\ 
which, adjusted upward for benefits and overhead, equals $47.44 per 
hour ($23.72 per hour x 2).\297\
---------------------------------------------------------------------------

    \296\ The hourly wage rates of staff are likely to vary from a 
GS-3 to a GS-11. The Department uses the mid-point GS-level and step 
and relies on hourly wage rates for the locality salary adjustment 
for the District of Columbia and surrounding geographic area.
    \297\ https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/DCB_h.pdf. Executive Order 
13771 requires agencies to estimate costs in 2016 dollars.
---------------------------------------------------------------------------

    Based on these assumptions, the total labor cost is $5,277 in the 
first year: ($47.44 per hour x \1/3\ hour x 277 locations) + ($47.44 
per hour x 2 hours x 10 Departmental components). Cost for materials 
for the notice is $1,452 dollars \298\ in the first year after 
publication of the final rule and $1,037 annually \299\ in years two 
through five. Finally, the cost associated with the portion of 
Department locations that mail notices of rights with certain 
publications is $3,713 in the first year \300\ and $2,785 \301\ 
annually in years two through five. In sum, the burden to the Federal 
government associated with Sec.  88.5 is $36,677 in the first year and 
$13,660 annually in years two through five.
---------------------------------------------------------------------------

    \298\ Sum of costs for materials to post in physical locations 
(5 pages x $0.05 per page x 277 locations) plus costs for materials 
to post in certain publications (100 pages x $0.05 per page x 277 
locations).
    \299\ Costs for materials to post in certain publications (100 
pages x $0.05 per page x 207 locations).
    \300\ Sum of incremental postage of $2,074 ($0.15 per mailing x 
100 mailings x 138 facilities) and incremental labor of $1,640 
($47.44 per hour x 0.25 hours x 138 facilities).
    \301\ Sum of incremental postage of $1,555 ($0.15 per mailing x 
100 mailings x 104 facilities) and incremental labor of $1,230 
($47.44 per hour x 0.25 hours x 104 facilities).
---------------------------------------------------------------------------

(iv) Record-Keeping (Sec.  88.6(b))
    Paragraph (b) in Sec.  88.6 of the final rule requires recipients 
and sub-recipients to maintain records evidencing their compliance with 
this part. In the proposed rule, the Department did not identify 
record-keeping as a separate burden because it assumed that recipients 
and sub-recipients already maintain records in the course of evidencing 
compliance with the terms and conditions of a Federal award, which 
would include not only financial management requirements but all 
applicable Federal laws, including Federal conscience and anti-
discrimination laws. The Department requested comment on that 
assumption. The Department received numerous comments stating that the 
record-keeping requirements in Sec.  88.6(b) were too vague and 
requesting clarity on what kinds of records must be maintained. 
However, the Department received no comments contradicting its 
assumption that recipients and sub-recipients already follow record-
keeping practices that suffice to document compliance with Federal 
civil rights laws. Therefore, because the Department understands that 
recipients and sub-recipients must document such compliance in the 
course of receiving a Federal award,\302\ any potential marginal 
increase in the cost of maintaining records according to the clarity 
set forth in Sec.  88.6(b) would be de minimis.
---------------------------------------------------------------------------

    \302\ See 45 CFR 75.302 (regarding the sufficiency of an HHS 
awardee's financial management system, including ``records 
documenting compliance with Federal statutes, regulations, and the 
terms and conditions of the Federal award''). See also id. section 
75.361 (requiring an HHS awardee to maintain records for three years 
from the date of the final expenditure report or from the date the 
awardee submits its quarterly or annual financial report).
---------------------------------------------------------------------------

(v) Reporting a Finding of Noncompliance (Sec.  88.6(d))
    Paragraph (d) in Sec.  88.6 of the proposed rule would have 
required recipients and sub-recipients to report to the relevant 
Departmental funding component the existence of an OCR compliance 
review, investigation, or complaint under 45 CFR part 88 over a five-
year period as such incidents arise and in any application for new or 
renewed Federal financial assistance or Departmental funding. The 
Department received numerous comments that stated this requirement was 
too burdensome.
    Accordingly, the Department has significantly revised Sec.  
88.6(d). Recipients and sub-recipients would no longer have to report a 
compliance review, investigation, or complaint against them as it 
arises. Moreover, recipients and sub-recipients would only be required 
to disclose the existence of a determination by OCR of noncompliance 
with this rule in any application for new or renewed Federal financial 
assistance or Departmental funding (rather than reporting compliance 
reviews, investigations, or complaints). Recipients would be 
responsible for disclosing any OCR determinations of non-compliance 
made against their sub-recipients. Finally, the final rule shortens the 
reporting period from five to three years following an OCR 
determination of noncompliance.
    Given the revisions to Sec.  88.6(d), the Department has revisited 
its methodology for estimating the costs imposed by Sec.  88.6(d). The 
Department estimates that the burden is the opportunity cost for 
recipients and sub-recipients who have had OCR determine that they are 
noncompliant with this rule to retrieve information from their records 
systems and enter in the application basic identifying information 
regarding the determination. The components to monetize this burden 
include: (1) The time spent for a staff member to execute the reporting 
functions and that person's fully loaded mean hourly wage, (2) the 
number of times a recipient or sub-recipient applies for new or renewed 
funding administered by the Department annually, and (3) the number of 
recipients and sub-recipients that OCR finds noncompliant with this 
part annually.
    The Department estimates it would take a records custodian at the 
experience level of a paralegal about 15 minutes to retrieve the 
relevant information (such as date of the OCR determination of 
noncompliance and the OCR ``transaction number'' (i.e., case number)) 
from the recipient's or sub-recipient's records and an administrative 
assistant 15 minutes to enter the information in the application for 
Federal financial assistance or other Federal funds from the 
Department. The mean weighted hourly wage for the paralegal and 
administrative assistant is

[[Page 23245]]

$45.31.\303\ The Department estimates that a recipient would bear this 
labor cost at the firm level for every award action the recipient 
applied, including new funding opportunities, supplemental funding, and 
non-competing continuations, among others.
---------------------------------------------------------------------------

    \303\ Sum of (0.5 x $38.78 per hour) and (0.5 x $51.84 per 
hour).
---------------------------------------------------------------------------

    Because OCR had no publicly available or reliable data source to 
estimate how many total applications for new or renewed funding in a 
fiscal year a recipient might make to the Department or its component, 
actual award data from HHS TAGGS was used as a proxy. The Department 
considered the number of award actions the Department and its 
components made to State agencies and State universities in FY 2017 to 
inform the estimate. Award data in HHS TAGGS for FY 2017 indicated that 
some State universities receive less than 100 awards per fiscal year 
and others receive nearly 2,000 awards. Some State agencies receive one 
or two awards per fiscal year and others receive 80 awards per fiscal 
year. Consequently, a recipient or sub-recipient found in violation of 
this part, on the extreme end, would expend $45,310 per year in labor 
costs at the firm level (2,000 applications per year x $45.31 per hour 
x 0.5 hours).
    The most significant uncertainty for monetizing the burden of Sec.  
88.6(d) is the number of recipients and sub-recipients that OCR will 
determine as noncompliant with this rule. OCR employs a range of fact-
finding methods and evaluates each complaint based on the relevant 
facts, circumstances, and law at issue, which is an approach that this 
rule codifies in Sec.  88.7(d). OCR is gaining experience in handling 
the complexity and volume of complaints received alleging violations of 
the Weldon Amendment, Church Amendment, Coats-Snowe Amendment, and 
section 1553 of the Affordable Care Act. Most of the statutes that are 
the subject of the rule have no case law interpreting them. In 
addition, compared to OCR's experience handling complex cases for other 
civil rights and health information privacy matters, there is little 
institutional history of OCR enforcement of the Weldon Amendment, 
Church Amendments, Coats-Snowe Amendment, and section 1553 of the 
Affordable Care Act. Indeed, OCR was receiving only approximately 1.25 
complaints per year alleging such violations during the eight years 
preceding the change in Administration. However, during FY 2018, the 
most recently completed fiscal year for which data are available, OCR 
received 343 complaints alleging conscience violations.\304\ Given this 
variable posture at this stage of the Department's renewed efforts on 
conscience and religious freedom, the Department cannot reliably 
predict the number of OCR determinations of noncompliance to monetize 
this burden, but estimates that, for those to whom it applies, the 
related reporting cost is about $45,310 per year per entity with the 
highest number of applications for HHS funding.
---------------------------------------------------------------------------

    \304\ Complaint data based on OCR's system of records as of 
December 20, 2018.
---------------------------------------------------------------------------

(vi) Voluntary Remedial Efforts
    The proposed rule noted that the Department anticipates that some 
recipients will institute a grievance or similar process to handle 
internal complaints raised to the recipient's or sub-recipient's 
attention. The rule does not require such a process, but in HHS OCR's 
enforcement experience, informal resolution of matters at the recipient 
or sub-recipient level may effectively resolve a beneficiary's or 
employee's concern. The Department received no comments regarding the 
proposed rule's methodology for estimating these costs. The Department 
anticipates 0.5 percent of entities, or 2,514 entities,\305\ would 
conduct such internal investigations should complaints come to the 
recipient's or sub-recipient's attention or would undertake remedial 
efforts to resolve complaints.
---------------------------------------------------------------------------

    \305\ Product of 0.005 x 502,899 recipients.
---------------------------------------------------------------------------

    The burden is the opportunity cost of staff time to handle internal 
investigations and take remedial action. Uncertainty exists as to how 
many hours annually a recipient or sub-recipient would devote to this 
effort. On average, the Department anticipates entities spending 20 
hours annually: 16 hours of a lawyer's time and 4 hours of an 
executive's time. The weighted mean hourly wage (including benefits and 
overhead) is $144.98 per hour.\306\ The labor cost is $7.3 million 
($144.98 per hour x 20 hours x 2,514 entities). Some recipients may 
spend more than 20 hours on voluntary remedial efforts, and if this is 
the case, the labor cost will be greater. Other recipients may spend 
less than 20 hours, and if this is the case, the labor cost will be 
lower.
---------------------------------------------------------------------------

    \306\ Sum of ($67.25 x .80) + ($93.44 x .20) and multiplied by 
two to adjust upward for overhead and benefits.
---------------------------------------------------------------------------

(vii) OCR Enforcement and Associated Costs
    The Department anticipates a temporary increase in investigation 
and enforcement costs to OCR over the five years immediately following 
publication of the final rule. The Department expects this increase 
from the synergistic impact of persons' increased awareness of rights; 
increased confidence in the Department's ability and willingness to 
address those rights through the administrative complaint process; and 
an increase in the number of Federal conscience and anti-discrimination 
laws that the rule proposes to enforce. Indeed, since during FY 2018, 
the most recently completed fiscal year for which data are available, 
OCR received 343 complaints alleging conscience violations.\307\
---------------------------------------------------------------------------

    \307\ Complaint data based on OCR's system of records as of 
December 20, 2018.
---------------------------------------------------------------------------

    The impact of the rule on OCR is the opportunity cost of about 12 
FTEs to perform investigative responsibilities and coordinate 
enforcement with HHS components, as set forth in Sec.  88.7, which is 
an increase of 7.5 FTEs from the proposed rule's estimate. These 
responsibilities include receiving and handling complaints, initiating 
compliance reviews, conducting investigations, coordinating compliance 
within the Department, and performing other associated activities as 
part of its program to promote widespread voluntary compliance of 
Federal conscience and anti-discrimination laws. The Department 
anticipates that the 12 FTEs consist of a member of the Senior 
Executive Service, four GS-15 employees, three GS-14 employees, two GS-
13 employees, and two GS-12 employees, each paid a mid-level salary for 
the DC area.\308\ The fully loaded labor cost (including benefits and 
overhead) for those twelve employees is estimated to be $3 million 
annually. The difference between the proposed rule's estimate for OCR's 
enforcement costs and this estimate is primarily the result of the 
increase in the number of FTEs. This increase is informed by OCR's 
experience since publication of the proposed rule, which has 
demonstrated that OCR will need to devote greater resources to the area 
of conscience protections than OCR had anticipated at the time of 
publication of the proposed

[[Page 23246]]

rule. This estimate also has been adjusted upwards based on the method 
of calculating the wages of the FTEs. The proposed rule assumed a fully 
loaded wage for each of the 4.5 FTEs at $201,000, but the final rule 
estimates the cost of the 12 FTEs based on various GS levels and 
therefore relies upon the fully loaded wage using the estimated hourly 
salaries of employees under the GS schedule.
---------------------------------------------------------------------------

    \308\ Using the locality salary adjustment for the District of 
Columbia and surrounding geographic area, the annual salaries 
adjusted upward for benefits and overhead are as follows: $290,324 
for GS-15 step 5 (145,162 x 2); $246,812 for GS-14 step 5 ($123,406 
x 2); $208,866 for GS-13 step 5 ($104,433 x 2); and $175,642 for GS-
12 step 5 ($87,821 x 2). See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/16Tables/html/DCB.aspx. The mid-level salary adjusted for benefits and overhead 
for a Senior Executive is $308,275 ($154,138 x 2), which is the 
average of the minimum and maximum salary for agencies with a 
certified SES performance appraisal system. See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/16Tables/exec/html/ES.aspx.
---------------------------------------------------------------------------

    One commenter stated that the costs associated with OCR's 
enforcement efforts would double to the extent that both a provider and 
a patient file a complaint over the same matter. The commenter did not 
provide an example of a scenario where such ``double filing'' would 
occur. The Department believes that such scenarios, if they occur at 
all, would constitute a de minimis proportion of complaints received by 
OCR and would not involve increased or doubled costs, as resources for 
resolution of the two complaints would be shared through investigation 
of similar matters.
4. Estimated Benefits
    The Department expects this final rule to produce a net increase in 
access to health care, improve the quality of care that patients 
receive, and secure societal goods that extend beyond health care. 
These effects will occur primarily via four mechanisms.
    First, this rule is expected to remove barriers to the entry of 
certain health professionals, and to delay the exit of certain health 
professionals from the field, by reducing discrimination or coercion 
that health professionals anticipate or experience. Comments received 
by the Department demonstrate that a lack of conscience protections 
diminishes the availability of qualified health care providers. For 
example, in a survey of providers belonging to faith-based provider 
organizations, over nine in ten (91 percent) agreed with the statement, 
``I would rather stop practicing medicine altogether than be forced to 
violate my conscience.'' \309\
---------------------------------------------------------------------------

    \309\ Christian Medical Association & Freedom2Care summary of 
polls conducted April, 2009 and May, 2011, available at https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.
---------------------------------------------------------------------------

    Second, in supporting a more diverse medical field, the rule will 
benefit patients by improving doctor-patient relationships and quality 
of care. Academic literature supports the proposition that prohibiting 
the exercise of conscience rights in medicine decreases the quality of 
care that patients receive. As one article noted, ``[I]f physicians do 
not have loyalty and fidelity to their own core moral beliefs, it is 
unrealistic to expect them to have loyalty and fidelity to their 
professional responsibilities.'' \310\
---------------------------------------------------------------------------

    \310\ D. White and B. Brody, Would Accommodating Some 
Conscientious Objections by Physicians Promote Quality in Medical 
Care?, 305 J. Am. Med. Assoc., May 4, 2011, at 1804-1805 (arguing 
that prohibiting conscience-based refusals ``may negatively 
influence the type of persons who enter medicine[,] . . . may 
negatively influence how practicing physicians attend to 
professional obligation[,] . . . [may cause] higher levels of 
callousness [by physicians] toward patients[,] . . . [and] may 
reciprocally diminish physicians' willingness to be sympathetic to 
and accommodating of patients' diverse moral beliefs'').
---------------------------------------------------------------------------

    Third, the rule is expected to decrease the harm that providers 
suffer when they are forced to violate their consciences, with 
attending improvements to patient health. Scholars have observed that 
``[a]bandoning the right to conscience of the medical practitioner not 
only harms the individual practitioner but also threatens harm to his 
patients as well--the harms, however paradoxical it might seem, are 
actually inseparable from one another.'' \311\
---------------------------------------------------------------------------

    \311\ Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 565 (2017); see also J. McCarthy & C. Gastmans (2015). 
Moral distress: A review of the argument-based nursing ethics 
literature, Nursing Ethics, 22(1), 131-152 (finding a consensus in 
academic literature that moral distress involves suffering that is 
psychological, emotional, and physiologic).
---------------------------------------------------------------------------

    Fourth, by providing for OCR investigation and HHS enforcement of 
Federal conscience and anti-discrimination laws, this final rule is 
expected to decrease unlawful discrimination, thereby permitting 
greater personal freedom. The rule will promote protection of religious 
beliefs and moral convictions, which is a societal good based on 
fundamental rights. As James Madison, often hailed as the ``father of 
the Constitution,'' wrote,

    The Religion then of every man must be left to the conviction 
and conscience of every man; and it is the right of every man to 
exercise it as these may dictate . . . . It is the duty of every man 
to render to the Creator such homage, and such only, as he believes 
to be acceptable to him.\312\
---------------------------------------------------------------------------

    \312\ James Madison, ``Memorial and Remonstrance Against 
Religious Assessments'', in 2 The Writings of James Madison 183, 184 
(G. Hunt ed. 1901)

    The Department received comments arguing that the proposed rule did 
not provide a sufficient articulation of the benefits that this rule 
would create or secure. In addition to analyses provided elsewhere in 
this preamble where germane, the Department's analysis of the rule's 
benefits responds to those comments and reflects a review of academic 
literature on the benefits of conscience protections in health care. 
The analysis demonstrates that the rule creates and secures significant 
benefits.
(i) Historical Support for Conscience Protections
    The people of the United States of America have valued conscience 
protections since the country's founding era. Madison said that 
``[c]onscience is the most sacred of all property; . . . the exercise 
of that, being a natural and unalienable right. To guard a man's house 
as his castle, to pay public and enforce private debts with the most 
exact faith, can give no title to invade a man's conscience which is 
more sacred than his castle.'' \313\ George Washington wrote, 
``Government being, among other purposes, instituted to protect the 
Persons and Consciences of men from oppression, it certainly is the 
duty of Rulers, not only to abstain from it themselves, but according 
to their Stations, to prevent it in others, . . . [and] the 
Consciencious [sic] scruples of all men should be treated with great 
delicacy & tenderness.'' \314\ Some scholars have argued that the right 
to conscience was a hallmark of our founding and in fact, 
``[p]rotection for individual exercise of rights of conscience was one 
of the essential purposes for the founding of the United States of 
America and one of the great motivations for the drafting of the Bill 
of Rights.'' \315\
---------------------------------------------------------------------------

    \313\ James Madison, ``Property'', in The Founders' 
Constitution, http://press-pubs.uchicago.edu/founders/documents/v1ch16s23.html.
    \314\ Letter from George Washington, to The Society of Quakers 
(October 13, 1789), https://founders.archives.gov/documents/Washington/05-04-02-0188.
    \315\ Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 561 (2017) (citing Lynn Wardle, Protection of Health-Care 
Providers' Rights of Conscience in American Law: Present, Past, and 
Future, 9 Ave Maria L. Rev. 1, 78 (2010)).
---------------------------------------------------------------------------

(ii) Expected Postive Impact on the Recruitment and Maintenance of 
Health Care Professionals
    Numerous studies and comments show that the failure to protect 
conscience is a barrier to careers in the health care field.
    A 2009 survey found that 82% of responding faith-based health care 
providers 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

[[Page 23247]]

altogether than be forced to violate my conscience.'' \316\
---------------------------------------------------------------------------

    \316\ Christian Medical & Dental Association summary of Key 
Findings on Conscience Rights Polling conducted April, 2009, 
available at https://docs.wixstatic.com/ugd/809e70_2f66d15b88a0476e96d3b8e3b3374808.pdf.
---------------------------------------------------------------------------

    The Department expects this rule to remove barriers to entry into 
the health care professions and into certain specializations within the 
health care profession \317\ that arise from anticipated or experienced 
discrimination against such persons' religious beliefs or moral 
convictions. The Department also expects this rule to delay the exit of 
certain types of health professionals who are considering leaving the 
field in order to avoid such coercion or discrimination.\318\ Although 
the rule does not create substantive protections beyond those in 
existing law, the Department believes that greater awareness and 
enforcement of those laws will help promote compliance and provide 
these follow-on effects. The Department has a significant interest in 
removing unlawful barriers to careers in the health care field.
---------------------------------------------------------------------------

    \317\ Id. (finding that 20% of responding faith-based medical 
students chose not to pursue a career in obstetrics/gynecology 
because of perceived coercion and discrimination in that field).
    \318\ Id.
---------------------------------------------------------------------------

    The American Association of Pro-Life Obstetricians and 
Gynecologists (AAPLOG), which represents 2,500 members and 
associates,\319\ wrote in 2009, ``Like pro-life physicians generally, 
AAPLOG members overwhelmingly would leave the medical profession--or 
relocate to a more conscience-friendly jurisdiction--before they would 
accept coercion to participate or assist in procedures that violate 
their consciences.'' \320\ AAPLOG's members and associates represent 13 
percent of OB/GYNs in the United States.\321\ Yet, as explained above, 
the Department has received significant anecdotal evidence of 
violations of the very conscience laws that Congress has enacted to 
protect such providers.
---------------------------------------------------------------------------

    \319\ About Us, American Association of Pro-Life Obstetricians 
and Gynecologists, http://aaplog.org/about-us.
    \320\ Letter from Lawrence J. Joseph, on behalf of the American 
Association of Pro-Life Obstetricians & Gynecologists, to the Office 
of Public Health & Science, Dep't of Health & Human Servs. 2 (Apr. 
9, 2009), http://downloads.frc.org/EF/EF09D50.pdf.
    \321\ Compare id., with Occupational Employment Statistics: 
Occupational Employment and Wages, May 2017 (March 30, 2018), 
https://www.bls.gov/oes/current/oes291064.htm (calculation assumes 
all AAPLOG members are OB/GYNs).
---------------------------------------------------------------------------

    Because the rule is expected to remove a barrier to entry into the 
health care profession, the rule is expected to engender more people to 
be willing to enter the health care profession. Since there is an unmet 
need for health care providers in the United States, the Department 
assumes that an increase in the number of people willing to enter the 
health care profession (or a certain specialization within the health 
care profession) will result in an increase in the number of providers. 
Similarly, a certain proportion of decisions by currently practicing 
health providers to leave the profession are motivated by coercion or 
discrimination based on providers' religious beliefs or moral 
convictions,\322\ so the Department anticipates that this rule's 
protections will decrease such departures from the field. Several 
commenters agreed anecdotally, stating that without the rule, access to 
medical care will suffer, because pro-life and faith-based medical 
providers will leave the profession.
---------------------------------------------------------------------------

    \322\ Christian Medical Association & Freedom2Care summary of 
Online Survey of Faith-Based Medical Professionals polls conducted 
April, 2009 and May, 2011, available at https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.
---------------------------------------------------------------------------

    The Department anticipates that this effect will also occur at the 
macro-scale in the health industry. For example, religiously-operated 
hospitals or health care systems, being granted greater security to 
practice medicine consistent with their religious beliefs, may find it 
worthwhile to hire more providers to serve more people, or to serve new 
populations (geographic, etc.), and will have a larger pool of medical 
professionals to choose from. The Department is not aware, however, of 
data enabling it to quantify any effect the rule may have on increasing 
the number of health care providers or the possible result of 
increasing access to care. The Department instead believes it is 
reasonable to conclude that the rule will increase, or at least not 
decrease, access to health care providers and services.
    Several commenters stated that permitting or honoring conscientious 
objections, especially objections to referring for a health service, 
will exacerbate current lack of access to health care caused by the 
existing shortage of health care providers. This argument appears to 
not adequately take into account how greater awareness and enforcement 
of conscience rights will (1) remove a barrier to entry for certain 
individuals and institutions into the health care field, and (2) 
encourage individuals and institutions with religious beliefs and moral 
convictions currently in the health care field that may be thinking 
about leaving the field to remain, thereby creating net benefits. As 
described in the analysis below on the effects of this final rule on 
access to care, commenters who raised the claim that the rule would 
exacerbate current barriers to accessing health care failed to provide 
data that the Department believes enables a reliable quantification of 
the effect of the rule on access to providers and to care. For the 
reasons explained in this analysis, the Department disagrees with those 
commenters and believes it is more likely that removing the barriers to 
entry that may exist due to insufficient enforcement of conscience laws 
will result in an overall increase in access to care. Again, however, 
the Department is not aware of data that allows for an estimate of the 
effect of this rule on access to services.
(iii) Expected Postive Impact on Patient Care by Religious Health Care 
Professionals and Organizations
    Many comments discussed the subject of the management of 
miscarriages in Catholic hospitals, alleging that Catholic hospitals' 
adherence to the Ethical and Religious Directives (ERDs), a document 
that expresses the teaching of the Catholic Church on matters of health 
care, risks harm to women undergoing a miscarriage. Approximately 
forty-three public comment submissions (each of which may represent 
more than one comment per submission) cited the article ``When There's 
a Heartbeat: Miscarriage Management in Catholic-Owned Hospitals,'' 
which describes experiences of a handful of physicians across the 
nation's Catholic health care facilities that adhered to ERDs.\323\ The 
article relays anecdotes and quotes from six physicians out of the 
thirteen interviewed by the authors. The authors do not state why the 
article omits quotes from the other seven providers, nor does it 
highlight anecdotes from positive or neutral experiences with 
facilities' adherence to ERDs. The authors use the anecdotes and quotes 
as support for the idea that adherence to ERDs creates actual, 
potential, or perceived deficiencies in the facilities' management of 
miscarriagesy Catholic health care facilities. Anecdotal accounts of 
such a limited nature do not provide the Department with a robust basis 
for estimating the rule's impact on the management of miscarriages.
---------------------------------------------------------------------------

    \323\ Lori R. Freedman, When There's a Heartbeat: Miscarriage 
Management in Catholic-Owned Hospitals, AM. J. PUB. HEALTH (2008), 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636458/.
---------------------------------------------------------------------------

    Twenty-four public comment submissions (each of which may represent 
more than one comment per submission) discussed the case of Tamesha 
Means, who was treated for a miscarriage by a Catholic hospital in

[[Page 23248]]

Michigan, as an example of the harm to patient health caused by the 
faith-based practices of Catholic hospitals. Ms. Means subsequently 
brought a lawsuit claiming that the hospital's adherence to the ERDs 
constituted negligence. Yet the U.S. Court of Appeals for the Sixth 
Circuit ruled that Ms. Means had not alleged any harm or injury that 
could sustain her claim. Means v. U.S. Conf. of Catholic Bishops, No. 
15-1779 (6th Cir. 2016).
    The rule does not incorporate ERDs, and it does not enforce them. 
Nothing in the rule requires any individual or institutional provider 
to abide by any religious belief or moral conviction in his or her 
practice of medicine, and this rule does not take a position on whether 
any facility should or should not adhere to ERDs. Instead, the rule 
provides mechanisms for the enforcement for Federal conscience laws and 
anti-discrimination statutes, which are very different from ERDs in 
their text, structure, and legal significance.
    Numerous commenters also cited statistics demonstrating that women 
of color are disproportionately served by Catholic hospitals. These 
commenters argued that, because ERDs prohibit Catholic hospitals from 
performing elective abortions, sterilizations, and other procedures 
that are counter to Catholic beliefs, women of color would be 
disproportionately harmed by exercises of religious belief protected by 
the rule.
    The question of the ultimate effect of Catholic hospitals' 
adherence to ERDs on general access to reproductive health care, or 
access by any particular population, is outside the scope of this rule, 
but appears to be less settled than many commenters portray it to be. A 
metastudy in 2019 found a surprising paucity of data on the issue, 
stating that ``Although many may assume that institutional restrictions 
cause harm, our current understanding demonstrates that the landscape 
of provision [of reproductive health care services] is wide-ranging and 
complex in nature.'' \324\ On the subject of miscarriages in 
particular, another study observed that ``Anecdotal reports have 
suggested that Catholic hospitals are putting women in danger due to 
the restrictions on miscarriage management. Contrary to these reports, 
we find some evidence that Catholic ownership is in fact associated 
with a reduction in miscarriages that involve a complication, 
suggesting that anecdotal accounts may not be indicative of a 
widespread pattern.'' \325\
---------------------------------------------------------------------------

    \324\ Thorne, et al., Reproductive Health Care in Catholic 
Facilities: A Scoping Review, Obstet. Gynecol. 2019;133:105-15, at 
114.
    \325\ Hill, et al., Reproductive Health Care in Catholic-Owned 
Hospitals, NBER Working Paper No. 23768 (2017), at 4 (emphasis 
added).
---------------------------------------------------------------------------

    Additionally, Catholic and other religiously affiliated health care 
providers play a major role in the delivery of health care to residents 
of the United States, including to underserved or underprivileged 
communities in particular, and are motivated by their beliefs to serve 
such communities.\326\ As some commenters noted, that role may explain 
the disproportionately large share of charitable care and service given 
by religious providers to underserved communities. For example, 
Ascension, the nation's largest religiously affiliated non-profit 
health care system, had an annual operating revenue in 2016 that was 
about one-third the size of the annual operating revenue for Kaiser 
Permanente, the nation's largest non-profit health care system that is 
not religiously affiliated.\327\ However, both organizations provided 
approximately $2 billion in care and other benefit programming to 
underserved communities in 2017.\328\
---------------------------------------------------------------------------

    \326\ Ascension, RE: 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.'').
    \327\ Compare Kaiser Foundation Health Plan and Hospitals 
Report: 2017 Financial Results, Kaiser Permanente (Feb. 9, 2018), 
https://share.kaiserpermanente.org/article/kaiser-foundation-health-plan-hospitals-report-2017-financial-results/ (last visited Dec. 3, 
2018), with Our One Ascension Journey: Year in Review, Ascension, 
https://ascension.org/about/community-and-investor-relations/year-in-review (last visited Dec. 3, 2018).
    \328\ Facts and Stats, Ascension, https://ascension.org/About/Facts-and-Stats (last visited Dec. 3, 2018); Thrive: Give Back, 
Kaiser Permanente, https://thrive.kaiserpermanente.org/thrive-together/give-back (last visited Dec. 3, 2018).
---------------------------------------------------------------------------

    As the Department discusses above in response to comments, supra at 
part III.A., and as observed in the analysis below on the effects of 
this final rule on access to care, the Department concludes that the 
relationship between enforcement of Federal conscience and anti-
discrimination laws through this rule and the impact on access to care 
is more complicated than suggested by commenters who claim this rule 
will decrease access. The Department believes the rule is just as, or 
more, likely to result in a net increase access to care because 
religious or other conscientiously objecting providers are already more 
likely to serve underserved communities; imposing violations on their 
conscience may lead to them limiting their practices rather than 
providing services in violation of their beliefs; and in some 
underserved communities patients may have a proportionate likelihood to 
agree with religious providers on controversial services such as 
abortion. The Department believes that, in passing Federal conscience 
and anti-discrimination laws, Congress likely intended to protect 
objecting providers precisely to prevent them from limiting their 
practices, especially to underserved communities, so as not to 
exacerbate shortages to those communities.
    In light of the demonstrated commitment that religious health care 
providers have to caring for those for whom it may not always be 
profitable to care, it likely would harm underprivileged populations if 
the Department did not provide enforcement mechanisms and certain 
procedural and administrative requirements, as the alternative status 
quo risks driving such entities out of underserved communities 
altogether. Again, however, the Department is not aware of data either 
in its possession, from commenters, or from the public, that would 
enable the Department to reliably estimate what the impact of this rule 
would be on increasing, or allegedly decreasing, access to providers or 
services. The Department, instead, concludes that enforcing Federal 
conscience and anti-discrimination laws is an appropriate 
implementation of Congressional intent, and is more likely overall to 
lead to net benefits, and possibly to an increase in, health care 
provider and services access, than to lead to its reduction.
(iv) Expected Reduction in the Moral Distress That Individual Providers 
Experience
    The Department anticipates that this final rule will reduce the 
incidence of the harm that being forced to violate one's conscience 
inflicts on providers.

[[Page 23249]]

Substantial academic literature documents the existence among health 
care providers of ``moral distress,'' which is ``a sense of complicity 
in doing wrong'' and ``a deep anguish that comes from the nature of 
those circumstances [of the provider's work environment] as systemic, 
persistently recurrent, and pervasively productive of crises of 
conscience.'' \329\ Moral distress functions as a pressure on providers 
to leave the health care profession: ``Prolonging these conditions can 
lead to exhaustion of their resistance resources and cause 
dissatisfaction with the workplace. Those who continue to work despite 
these conditions experience stress and burnout along with 
dissatisfaction.'' \330\
---------------------------------------------------------------------------

    \329\ Christy A. Rentmeester, Moral Damage to Health Care 
Professionals and Trainees: Legalism and Other Consequences for 
Patients and Colleagues, Journal of Medicine and Philosophy, 33: 27-
43, 2008, p. 37 (elaborating that ``[M]oral distress is a sense of 
complicity in doing wrong. This sense of complicity does not come 
from uncertainty about what is right but from the experience that 
one's power to resist participation in doing wrong is severely 
restricted by one's work environment and from the experience that 
resisting participation in doing wrong exposes one to harm. Moral 
distress is generated in the health care work environment when a 
practitioner is aware that he is acting other than how he is 
motivated to act, but he believes that he cannot act as he is 
motivated to act without suffering some morally significant harm . . 
. A number of situations can generate moral distress. Broad systemic 
changes in the recent past in health care--in how health care 
institutions are organized, how health care is financed, and how 
health care resources are managed, for example--have de facto 
demanded that individual practitioners adjust to being treated more 
like laborers than autonomous professionals and less like trusted 
fiduciaries than like employees with suspicious conflicts of 
interest.'') (emphasis added).
    \330\ Borhani et al., The relationship between moral distress, 
professional stress, and intent to stay in the nursing profession, 
J. Med. Ethics Hist. Med. 2014; 7: 3.
---------------------------------------------------------------------------

    It is difficult to quantify the impact of the psychological trauma 
that results from moral distress. The strength of the provider's moral 
objection may vary based on the facts and circumstances of each case, 
including the service in question.
(v) Expected Patient Benefits From This Rule
    To the extent the rule supports a more diverse medical field, the 
rule would create positive effects for patients. The rule could assist 
patients in seeking counselors and other health care providers who 
share their deeply held convictions. Some patients appreciate the 
ability to speak frankly about their own convictions concerning 
questions that touch upon life and death and treatment options and 
preferences with a doctor best suited to provide such treatment. A pro-
life woman may seek a pro-life OB/GYN to advise her on decisions 
relating to her fertility and reproductive choices. Open communication 
in the doctor-patient relationship will foster better overall care for 
patients.
    The benefit of open and honest communication between a patient and 
her doctor is difficult to quantify. One study showed that even ``the 
quality of communication [between the physician and patient] affects 
outcomes . . . [and] influences how often, and if at all, a patient 
will return to that same physician.'' \331\ But poor communication 
negatively affects continuity of care and undermines the patient's 
health goals.\332\ When conscience protections are robust, both 
patients and their physicians can communicate openly and honestly with 
one another at the outset of their relationship.
---------------------------------------------------------------------------

    \331\ Fallon E. Chipidza, et al., Impact of the Doctor-Patient 
Relationship, 17(5) The Primary Care Companion for CNS Disorders 
(2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308/.
    \332\ Id.
---------------------------------------------------------------------------

    Facilitating open communication between providers and their 
patients also helps to eliminate barriers to care, particularly for 
people of faith, and especially in migrant communities where culturally 
competent care matters greatly. Because positions of conscience are 
often grounded in religious influence, ``[d]enying the aspect of 
spirituality and religion for some . . . patients can act as a barrier. 
These influences can greatly affect the well-being of people. They were 
reported to be an essential element in the lives of certain migrant 
women which enabled them to face life with a sense of equality.'' \333\ 
It is important for patients seeking care to feel assured that their 
religious beliefs and their moral convictions will be honored. This 
will ensure that they feel they are being treated fairly.\334\ And for 
some, being able to find health care providers that share the same 
moral convictions can be a source of personal healing.
---------------------------------------------------------------------------

    \333\ Emmanuel Scheppers, et al., Potential Barriers to the Use 
of Health Services Among Ethnic Minorities: A Review, 23 Family 
Practice 325, 343 (2006), https://academic.oup.com/fampra/article/23/3/325/475515.
    \334\ Id.
---------------------------------------------------------------------------

    As mentioned above, academic literature supports the proposition 
that prohibiting the exercise of conscience rights in medicine may 
decrease the quality of care that patients receive.\335\ Commentary on 
the concept of moral distress among providers also expresses concern 
over how a degraded moral culture in health care can jeopardize 
patients' health.\336\ As one review of literature on moral distress in 
nursing found, ``There is also a general consensus among the reviews 
that [moral distress] arises from a number of different sources, and 
that it (mostly) impacts negatively on nurses' personal and 
professional lives and, ultimately, harms patients.'' \337\ Similarly, 
allowance for the exercise of conscience rights may promote ethical 
behavior by providers more broadly,\338\ preserve a preferable model of 
health care practice,\339\ and improve the doctor-patient 
relationship.\340\
---------------------------------------------------------------------------

    \335\ Stephen J. Genuis and Chris Lipp, Ethical Diversity and 
the Role of Conscience in Clinical Medicine, 2013 Int'l. J. Fam. 
Med. 587541(2013), 4-5 (arguing that ``if successive physicians lose 
individual liberty of conscience and are morally compromised because 
of authoritarian dictates, the end result [may] be a diminishing of 
collective professionalism and physician morale, leading to 
inadequate patient care.'').
    \336\ Josh Hyatt, Recognizing Moral Disengagement and Its Impact 
on Patient Safety, J. of Nursing Regulation, 7:4, 18 (``Perhaps, 
patients experience the most significant and dangerous consequences 
of moral distress and moral disengagement . . . As health care 
providers reduce their communications with patients, patients may 
feel less safe and less satisfied with their medical experiences, 
and their clinical progress may be hindered. Further, if health care 
providers avoid patients or distance themselves from patients 
emotionally, they minimize their ability to advocate for their 
patients' welfare. Providers' emotional transition can also manifest 
as frustration toward patients, which may impair the quality of 
care. If health care providers do not fulfill their commitments or 
perform at a mediocre level, patient care can become inadequate or 
inappropriate . . . Lower quality of care leads to several costs for 
the patient. Patients may have to stay longer in the hospital or may 
miss care. Patient autonomy may also be threatened, and patients can 
be more likely to be coerced into pursuing therapeutic options they 
would otherwise decide against. Care can then become less patient 
centered and more paternalistic, a structure associated with worse 
health outcomes.'' (citations omitted)).
    \337\ J. McCarthy & C. Gastmans (2015). Moral distress: A review 
of the argument-based nursing ethics literature, Nursing Ethics, 
22(1), 150.
    \338\ White and Brody, supra at note 120; Stephen J. Genuis and 
Chris Lipp, Ethical Diversity and the Role of Conscience in Clinical 
Medicine, 2013 Int'l. J. Fam. Med. 587541 (2013), 5 (``Compromise of 
personal moral integrity, of any kind or nature, will inevitably 
lead to an erosion of ethical behavior--a prospect not conducive to 
the optimal provision of healthcare.'').
    \339\ Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 565-66 (2017) (``[T]he `public utility' model of medicine 
is not only a `challenge [to] a conscientious physician's integrity 
as a physician,' it also `depreciates his expertise, reduces his 
discretionary latitude in decisionmaking, and makes him a technical 
instrument of another person's wishes,' thereby `subvert[ing] the 
healing purpose for which medicine is intended in the first place.' 
The myopic view of medicine that views a medical practitioner as a 
mere service provider `can redound to the patient's harm by 
undermining the physician's moral obligation to provide sound advice 
and sound practice and to avoid medically useless or futile 
treatments.' '' (citations omitted)).
    \340\ Genuis & Lipp, at 5 (arguing that ``[freedom of 
conscience] promotes open, transparent physician-patient 
relationships and engenders patient advocacy . . . It is unlikely 
that individual patients or society would support a situation in 
which physicians were being coerced to hide their convictions, 
making decisions they felt were morally wrong or unethical, or 
failing to act in what they perceived to be their patients' best 
interests''); Christian Medical Association & Freedom2Care summary 
of polls conducted April, 2009 and May, 2011, available at https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf 
(``77% of American adults surveyed said it is either `very' or 
`somewhat' important to them that `that healthcare professionals in 
the U.S. are not forced to participate in procedures or practices to 
which they have moral objections;' '' ``88% of American adults 
surveyed said it is either `very' or `somewhat' important to them 
that they share a similar set of morals as their doctors, nurses, 
and other healthcare providers''). Comments received by the 
Department supported the finding that patients prefer providers who 
share their general belief system.

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[[Page 23250]]

    As noted above, the Department assumes that this rule will increase 
the overall number of providers because (1) it will reduce barriers to 
entry into the health care field (and reduce pressure to leave the 
field) for individuals and organizations with religious beliefs or 
moral convictions, and (2) there exists an unmet demand for more 
providers. If the Department is incorrect in assuming that the rule 
will increase the overall number of providers--i.e., if health care 
employers and medical training programs do not increase their hiring 
rates and the size of their programs, respectively, despite an increase 
in applicants--then the rule will increase the quality of the average 
provider, because the increase in the pool of available professionals 
will result in the selection of better providers overall. An increase 
in the quality of providers will increase the quality of care that 
patients receive. The Department is not, however, aware of data that 
provides a basis for quantifying these effects.
(vi) Expected Societal Benefits From This Rule
    The rule will also yield lasting societal benefits. The rule 
mitigates current misunderstanding about what conduct the Federal 
government is legally able to support and fund, and educates 
individuals about their Federal conscience rights. By requiring 
certifications and assurances (with some excemptions), this rule 
provides a mechanism by which regulated entities will learn about--and, 
thus, be more likely to comply with--Federal conscience and anti-
discrimination laws. The rule also provides a centralized office within 
the Department for individuals and institutions to file complaints with 
the Department when such individuals and institutions believe that 
their rights have been infringed. The Department expects that, as a 
result of this rule, more individuals, having been apprised of those 
rights, will assert them. The combination of these mechanisms will 
contribute to the general public's knowledge and appreciation of the 
foundational nature of these rights, as well as the protections 
afforded by Federal law.
    Fostering respect for the existing Federal conscience and anti-
discrimination laws also fosters lawfulness more generally. As one 
author stated,

[L]aw and conscience are deeply intertwined. . . . But the 
phenomenon of conscience isn't important only to legal experts. Just 
as conscience helps explain why people follow legal rules, it helps 
explain why people follow other types of rules as well, such as 
employers' rules for employees, parents' rules for children, and 
schools' and universities' rules for students. It may also help 
explain why people adhere to difficult-to-enforce ethical rules and 
to the sorts of cultural rules (``social norms'') that make communal 
life bearable. . . . Twenty-first century Americans still enjoy a 
remarkably cooperative, law-abiding culture.\341\
---------------------------------------------------------------------------

    \341\ Lynn Stout, Cultivating Conscience: How Good Laws Make 
Good People 17 (2011).

    Because fostering conscience in individuals--and compliance with 
Federal conscience laws--contribute to a more lawful and virtuous 
society, governments and their subdivisions have a significant interest 
---------------------------------------------------------------------------
in encouraging expressions of, and fidelity to, conscience.

    Forcing religious believers to violate their consciences 
involves harms that go beyond these individuals and their 
communities. When an individual is forced to act in ways that they 
view as deeply wrong, indeed as prohibited by the ultimate power 
responsible for everything that exists, moral habits essential for 
democratic citizenship are undermined.\342\
---------------------------------------------------------------------------

    \342\ Kathleen A. Brady, The Disappearance of Religion from 
Debates about Religious Accommodation, 20 Lewis & Clark L. Rev. 
1093, 1110 (2017).

Governments also have an interest in ensuring the implementation and 
enforcement of existing laws, as part of the greater virtue of the rule 
of law.
    It is difficult to monetize the benefits of respect for conscience 
to the individual and society as a whole, but they are clearly 
significant. As the Supreme Court has said:

    Both morals and sound policy require that the state should not 
violate the conscience of the individual. All our history gives 
confirmation to the view that liberty of conscience has a moral and 
social value which makes it worthy of preservation at the hands of 
the state. So deep in its significance and vital, indeed, is it to 
the integrity of man's moral and spiritual nature that nothing short 
of the self-preservation of the state should warrant its violation; 
and it may well be questioned whether the state which preserves its 
life by a settled policy of violation of the conscience of the 
individual will not in fact ultimately lose it by the process.\343\
---------------------------------------------------------------------------

    \343\ United States v. Seeger, 380 U.S. 163, 169 (1965) quoting 
Harlan Fisk Stone, The Conscientious Objector, 21 Col. Univ. Q. 253, 
269 (1919).

To protect the rights of conscience is to protect personal and 
interpersonal goods that permit peaceful and fulfilling lives.\344\
---------------------------------------------------------------------------

    \344\ Christopher C. Lund, Religion Is Special Enough, 103 Va. 
L. Rev. 481, 504 (2017) (``Freedom of moral conscience, it turns 
out, serves many of the same values served by freedom of religion--
among other things, it can serve to ameliorate psychological 
distress, reduce civil strife, and preserve individual identity.'').
---------------------------------------------------------------------------

(vii) Analysis of Expected Effects of This Final Rule on Access to Care
    The Department solicited information on costs that may arise as 
secondary effects of this rule, such as those associated with changes 
in health outcomes arising from increased protection of conscience for 
health care providers, as well as information about whether the 
existence or expansion of rights to exercise religious beliefs or moral 
convictions in health care improves or worsens patient outcomes and 
access to health care. The Department also requested comment on the 
related question of whether this final rule would result in unjustified 
limitations on access to health care.
    The questions of access to care and of health outcomes are largely 
interdependent; access to care matters because of its effects on health 
outcomes, and the discussion in the public comments on health outcomes 
in the context of this rule were typically framed as a consequence of 
changes in access to care. Many comments the Department received argued 
that the rule would decrease access to care and harm patient health 
outcomes, and most such comments focused on the potential that 
providers would decline to perform a particular service for a patient.
    Generally, however, instead of attempting to answer the difficult 
question of how this rule would affect access to care and health 
outcomes, and how to quantify those effects, such comments argued that 
significant discrimination against some segments of the population in 
health care exists and is per se proof that the rule would result in 
harm. The comments made this argument without establishing a causal 
relationship between this rule and how it would affect health care 
access, and without providing any data the Department believes enables 
a reliable quantification of the effect of the rule on access to 
providers and to care.

[[Page 23251]]

    Other comments focused on whether health disparities exist among 
demographics that tend to utilize health services that may be the 
subject of conscientious objections protected by this final rule, but 
again without establishing a causal link between the provisions of this 
rule and the predicted or speculated effects.
    Many comments observed that various demographic groups--women, LGBT 
people, immigrants and refugees, people of color, people living with 
HIV/AIDS, people with language barriers, people living in poverty, 
people with disabilities, and people living in rural areas--already 
face barriers to access to care and therefore would be 
disproportionately harmed by any additional barriers to access to care. 
The Department does not dispute that people in such demographic 
categories face health care disparities of various forms. The 
Department does disagree, however, with these comments' conclusions 
that the rule will create any negative effect on access to care that 
cannot be otherwise addressed, or that is not outweighed by gains in 
overall public health, overall access to care due to the removal of 
barriers for providers, or the benefits of compliance with the law and 
respect for conscience and religious freedom. In fact, as the 
Department discusses supra at part IV.C.4.iii and infra, the Department 
expects the rule to specifically benefit underserved populations.
    A common sentiment expressed in comments was that conscience 
protections for providers are only appropriate to the extent they do 
not interfere with, impose upon, or in any way result in others feeling 
harmed. This type of objection is not accepted for any other anti-
discrimination law. For example, the Fair Housing Act and the Americans 
with Disabilities Act, under certain circumstances, require building 
and apartment owners to incur costs to ensure that facilities are 
accessible to persons with disabilities. These statutes impose costs, 
but Congress and several Presidents have deemed it important to remove 
barriers to full participation in economic and social life for persons 
with disabilities. Similarly, America has since the founding recognized 
that Free Speech results in harm and hurt feelings (sometimes 
extraordinarily so) for many Americans, yet it is deemed a price worth 
paying. Conscience protection should be not be a special exception to 
the principle that fundamental rights do not depend on there being zero 
conflicts or disagreements in their exercise.
    In any event, the objections based on potential (often temporary) 
lack of access to particular procedures as a result of enforcement of 
the law are really objections to policy decisions made by the people's 
representatives in Congress in enacting the Federal conscience and 
anti-discrimination laws in the first place, rather than to this rule's 
mechanisms for implementing and enforcing those laws.
    An analysis of any change in access to care caused by this final 
rule is not the same as an analysis of the total impact of the exercise 
of religious belief and moral conviction on access to care. Nor is it 
the same as estimating the total impact of discrimination against 
women, LGBT individuals, or individuals in any other population 
demographic on access to care. Rather, the question involves isolating 
the impact of the exercises of religious belief or moral conviction 
attributable to this final rule specifically, over and above whatever 
impact is attributable to the pre-existing base rate of exercise of 
religious belief or moral conviction.
    Different types of harm can result from denial of a particular 
procedure based on an exercise of such belief or conviction. First, the 
patient's health might be harmed if an alternative is not readily 
found, depending on the condition. Second, there may be search costs 
for finding an alternative. Third, the patient may experience distress 
associated with not receiving a procedure he or she seeks. These three 
potential harms, however, would also be applicable for denials of care 
based on, for example, inability to pay the requested amount. Fourth, 
there may be a harm resulting from a conscientious objection to 
referring for a health service, distinct from the harm of the initial 
objection to performing the service. Fifth, some commentators allege 
others in the community to which the patient belongs may be less 
willing to seek medical care.
    On the other hand, it is important not to assume that every patient 
who wants a particular service is offended by a provider's 
unwillingness to provide that service, or wishes that the provider 
would do so against his or her religious beliefs or moral convictions. 
Some persons, out of respect for the beliefs of providers, may want a 
service but not take any offense, nor deem it any burden on themselves, 
for the provider to not provide that service to them. Some patients may 
even value the health care provider's willingness to obey his or her 
conscience, because the patient feels that provider can be trusted to 
act with integrity in other matters as well. The Department does not 
believe it is appropriate to assume that all patients who want a 
particular service also want to force unwilling providers to provide it 
in violation of their consciences.
    Lastly, numerous comments focused on the potential for a patient to 
feel insulted or emotionally distressed because of a perception that a 
provider, in declining for reasons of religious belief or moral 
conviction to perform an objected-to service or procedure, is 
expressing disapprobation of the patient, especially regarding his or 
her personal identity or personal conceptions of morality. Although the 
Department does not understand such conscientious objections to be 
necessarily intended to convey such disapprobation, the Department 
recognizes that, in some circumstances, some patients do experience 
emotional distress as a consequence of providers' exercise of religious 
beliefs or moral convictions. However, Congress, in considering the 
statutes enforced by this rule, did not establish balancing tests that 
weigh such emotional distress against the right to abide by one's 
conscience.
    On the other side of the equation, those who suffer discrimination 
on the basis of their religious beliefs or moral convictions, or those 
coerced to violate those convictions, may themselves experience 
emotional distress, as well as economic harms such as job loss or 
rejection from admission into a training program.
    There appears to be no empirical data on how previous legislative 
or regulatory actions to protect conscience rights have affected access 
to care or health outcomes. In fact, studies have specifically found 
that there is insufficient evidence to conclude that conscience 
protections have negative effects on access to care.\345\
---------------------------------------------------------------------------

    \345\ 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), 333-338 (``[T]he degree to which conscientious objection has 
compromised sexual and reproductive healthcare for adolescents is 
unknown.'').
---------------------------------------------------------------------------

    Many commenters reasoned that, despite this lack of empirical 
evidence, the rule would cause an increase in denials of care. For 
example, one comment cited various statistics on the rates of 
discrimination against LGBT individuals, but those statistics were 
general in nature and did not assist the

[[Page 23252]]

Department in estimating what degree may be attributable to the lawful 
exercise of religious beliefs or moral convictions. The comment also 
identified numerous health disparities between LGBT individuals and 
non-LGBT individuals, but did not explain the extent to which such 
disparities are the product of the lawful exercise of religious beliefs 
or moral convictions. The comment then concluded that ``discrimination 
and related health disparities facing the LGBT population stand to 
worsen if health care providers are authorized to refuse to serve LGBT 
people.''
    The same comment attached an amicus brief that cited two studies on 
how State laws affect health disparities among LGBT populations--one 
study on States that either did not include sexual orientation as a 
protected category in its hate crimes statute or did not prohibit 
employment discrimination on the basis of sexual orientation, and 
another on States that had constitutional amendments banning gay 
marriage on the ballot in 2004 and 2005. Neither study provides a 
reliable basis for inferring an answer to the questions at issue here.
    Another comment cited to a 2018 report on anecdotal experiences of 
discrimination among LGBT individuals in eight States where laws had 
been passed to protect religious freedom. The report itself includes a 
citation to one study finding that awareness of legislation prohibiting 
discrimination on the basis of sexual orientation is associated with a 
decrease in the rate of such discrimination in interpersonal employment 
contexts. While analogous, such a finding is not the same as a finding 
that the awareness of legislation protecting conscience rights 
increases the rates of discriminatory conduct by people with religious 
beliefs or moral convictions. The report provides anecdotal accounts of 
discrimination from LGBT residents of those States. However, the report 
does not attempt to determine if the laws passed by those States played 
any causal role in the discrimination experienced by the respondents, 
e.g., via comparison to LGBT individuals' experiences in States where 
no such laws had been passed.
    Multiple comments provided lists of various incidents in which 
providers declined to participate in a service or procedure to which 
they had a religious or moral objection. Such lists offer no suitable 
data for estimating the impact of this rule.
    No comment attempted a detailed description of the actual impact 
expected from the rule on access to care, health outcomes, and 
associated concerns.
    The Department attempted to quantify the impact of this rule on 
access to care but determined that there is not enough reliable data, 
and that the analysis was subject to too many confounding variables, 
for the Department to arrive at a useful estimate. For instance, the 
Department is not aware of a source for data on the percentages of 
providers who have religious beliefs or moral convictions against each 
particular service or procedure that is the subject of this rule.\346\
---------------------------------------------------------------------------

    \346\ For instance, even in the case of abortion, for which some 
data on the rates of providers' objections actually exists, those 
rates vary significantly based on the facts and circumstances of the 
scenario presented, confounding an attempt to produce a single 
measure of providers' rate of objection to abortion in general. See 
Harris, et al., Obstetrician-Gynecologists' Objections to and 
Willingness to Help Patients Obtain an Abortion 118 OBSTETRICS & 
GYNECOLOGY 905 (2011) (``These data suggest that ob-gyns also 
consider contextual factors, including risk of physical harm to the 
woman by continuing pregnancy (breast cancer, cardiopulmonary 
disease), the circumstances of the sexual encounter that resulted in 
pregnancy (rape), the impact abortion may have on pregnancy outcome 
(selective reduction), the potential for fetal anomaly (diabetes), 
and the duration of pregnancy (second versus first trimester) . . . 
Among ob-gyns, support for abortion varies widely depending on the 
context in which abortion is sought and physician 
characteristics.'').
---------------------------------------------------------------------------

    Likewise, the Department is not aware of data on the actual rate of 
providers' exercise of conscientious objections to performing such 
services or procedures. Some providers who have a religious or moral 
objection to performing a service or procedure may nonetheless perform 
it for one reason or another, such as fear of legal reprisal. Others 
may respond to pressure to violate their consciences by limiting their 
practices, rather than providing the service to which they object. 
Commenters who contend the rule will reduce access to care seem to 
assume all providers with conscientious objections that are not being 
honored are providing those services anyway, so that the rule will 
reduce their provision of those services. The Department does not 
believe that assumption is correct. The Department considered methods 
for estimating the increase in the rate of such exercise of 
conscientious objections that may occur as a result of this rule, but 
determined that no reliable method was available. The Department 
likewise considered whether providers who, for reasons of religious 
beliefs or moral convictions, have left the practice of medicine or 
limited their scope of practice may reenter the field or resume their 
previous scope of practice, given the rule's expanded enforcement of 
protections for religious beliefs or moral convictions. If providers 
who limited their practices because of threats to their consciences 
expand them because of this rule, those would not be instances of a 
reduction in the provision of services to which they object, but of an 
increase in other services. However, the Department was unable to find 
reliable data on this question, and concluded that no useful 
quantitative estimate of this impact was feasible.
    The impact on health outcomes from the exercise of conscientious 
objections to particular services and procedures also resisted a useful 
quantitative estimate. Without data--to inform an estimate of the 
quantity of such objections that would be attributable this rule, the 
number of those objections that led to providers offering services to 
which they object rather than limiting their practices, the number of 
persons who left or did not enter certain fields or practices 
altogether because conscience laws were insufficiently enforced, the 
market effect of providers expanding or moving into different areas 
because conscience laws are enforced, and the overall resulting 
availability of access, both to objected-to services and to other 
health care overall--the Department lacks the predicate for estimating 
the impact on health outcomes of any change in the availability of 
services. The analysis on this point is also generally subject to the 
same confounding factors discussed below regarding the impact of 
conscientious objections to providing referrals.
    The Department expects any decreases in access to care to be 
outweighed by significant overall increases in access generated by this 
rule. If the laws that are the subject of this rule are not enforced, 
many of the exact same people who would face a burden from a denial of 
access to a particular procedure from a particular doctor or provider 
would face the potential of receiving no health care at all from that 
doctor or provider because such providers may limit, or leave, their 
practices if unable to comply with their religious beliefs or moral 
convictions. The absence or departure of those providers from the 
health field does not clearly lead to any increase in other providers 
who are willing to offer services that are the subject of Federal 
conscience and anti-discrimination laws, but is more likely to simply 
diminish the overall availability of health care services. The burden 
of not being able to receive any health care clearly outweighs the 
burden of not being able to receive a particular treatment.
    For example, after the Department proposed in 2009 to rescind the 
2008

[[Page 23253]]

rule providing conscience protections for providers, a survey found 
that 81 percent of faith-based health care professionals working in 
rural areas and 86 percent of faith-based health care professionals 
working full-time in service to underserved communities said that they 
were either ``very'' or ``somewhat'' likely to limit the scope of their 
practice if the 2008 rule was rescinded.\347\ For such providers who 
did not in fact limit their scope of practice, this rule will help to 
prevent future situations in which they feel forced to do so. For those 
who did, this rule provides protections that may induce them to resume 
their previous scope of practice. In this sense the Department believes 
the rule will both preserve and expand access to health care generally.
---------------------------------------------------------------------------

    \347\ Christian Medical Association & Freedom2Care summary of 
polls conducted April, 2009 and May, 2011, available at https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.
---------------------------------------------------------------------------

    Furthermore, as one academic article observed, ``[P]atients choose 
not merely particular services, but particular kinds of 
professionals.'' \348\ As noted earlier in this section, a survey of 
patients found that 88 percent would prefer that their providers share 
their moral beliefs.\349\ Another survey conducted by a former Chair of 
Bioethics of the National Institutes of Health Clinical Center 
``reinforces the existence of patient preference for physicians with 
shared values . . . [finding] that nearly one-fifth of [cancer] 
patients surveyed `thought they would change physicians if their 
physician told them he or she `had provided euthansia [sic] or assisted 
suicide' for other patients.' '' \350\ The Department, accordingly, 
expects this rule, through its recognition of the ``fundamental 
necessity of conscience protections to ensuring patient access'' for 
``patients who want access to physicians of conscience,'' to result in 
an increase in access to care.\351\
---------------------------------------------------------------------------

    \348\ M. Bowman & C. Schandevel, The Harmony between 
Professional Conscience Rights and Patients' Right of Access, 6 
Phoenix L. Rev. 31 (2012) at 56 (``First, a patient who chooses a 
pro-life physician is not merely choosing a physician who does not 
do something. She is choosing a physician who affirmatively 
practices medicine according to principles that unconditionally 
value human life, whether in the context of the preborn, the born, 
the disabled, or the terminally ill . . . Second, patients seek 
physicians not only for discrete services, but even more so for 
relationships of trust.'')
    \349\ Christian Medical Association & Freedom2Care summary of 
polls conducted April, 2009 and May, 2011, available at https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf 
(``88% of American adults surveyed said it is either `very' or 
`somewhat' important to them that they share a similar set of morals 
as their doctors, nurses, and other healthcare providers'').
    \350\ Bowman & Schandevel, citing Ezekiel J. Emanuel et al., 
Euthanasia and Physician-Assisted Suicide: Attitudes and Experiences 
of Oncology Patients, Oncologists, and the Public, 347 Lancet 1805, 
1808 (1996).
    \351\ Id. at 36.
---------------------------------------------------------------------------

The Effect of the Rule's Protection of Refusals To Refer for Services
    As with the analysis in the above factors, there exists some 
baseline rate of exercise of conscientious objection to referring for a 
service to which the provider morally objects. A significant percentage 
of providers believe that they are not obligated to refer for a service 
to which they morally object.\352\ It is reasonable to assume that the 
rates of exercise of the right not to refer will increase under the 
rule, but it is difficult to determine by how much. It is likewise 
difficult to estimate what part of the baseline instances of 
conscientious objection manifest themselves in providers providing the 
referrals in violation of their objections, instead of limiting their 
practices so as to avoid the conflict.
---------------------------------------------------------------------------

    \352\ Combs et al., Conscientious refusals to refer: findings 
from a national physician survey, J. Med. Ethics 2011;37:397-401, 
399 (``[43%] of physicians in this present study . . . did not agree 
that physicians are obligated to make referrals that they believe 
are immoral.'').
---------------------------------------------------------------------------

    First, it is unclear how many providers understand their existing 
right to decline to refer, whether grounded in ethics or the law, to be 
coextensive with the freedom that the rule reflects. For example, a 
provider who objects to performing sterilizations may feel ethically 
obligated to inform a patient where vasectomies are locally available--
an act that the rule may allow the provider to abstain from--but may 
not feel obligated to provide the patient any further information about 
how to obtain that procedure. Research suggests that providers may 
often draw such a distinction.\353\
---------------------------------------------------------------------------

    \353\ Farr A. Curlin M.D., et al., Religion, Conscience, and 
Controversial Clinical Practices, NEW ENG. J. MED. 593-600, 593 
(2007) available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2867473/ (finding that some providers will inform patients of 
options but not refer for such options) (``Most [providers] also 
believe that physicians are obligated to present all options (86%) 
and to refer the patient to another clinician who does not object to 
the requested procedure (71%)'').
---------------------------------------------------------------------------

    It is also difficult to estimate what actual impact the increase in 
refusals to refer would have. One confounding factor is that the 
practical effect of a provider's exercise of conscientious objection to 
providing a referral may vary greatly depending on the particular facts 
and circumstances of the case. Public knowledge of the availability of 
certain medical services may be extensive or minimal depending on the 
procedure. For instance, any pregnant woman is almost certainly aware 
of the existence and purpose of abortion, and the extensive efforts of 
pro-choice groups to facilitate women's access to abortion make 
information about how to obtain an abortion relatively easy to 
find.\354\ So the effect of a provider's refusal to refer for an 
abortion is mitigated by the patient's own knowledge and the widespread 
availability of information about abortion access on the internet and 
elsewhere.
---------------------------------------------------------------------------

    \354\ See, e.g., https://prochoice.org/think-youre-pregnant/find-a-provider/ (first result for Google search of phrase ``find 
abortion clinic near me'' performed 10/17/18).
---------------------------------------------------------------------------

The Change in the Number of Patients Who Delay or Forgo Health Care for 
Fear of Being Denied a Health Service
    As numerous public comments demonstrate, certain minority groups 
already experience significant health care disparities. Commenters 
state that negative health outcomes from some demographics are due to 
fear of discrimination leading to avoidance of seeking health care. 
However, the Department is not aware of any data establishing what, if 
any, part of this avoidance phenomenon is attributable to the exercise 
of conscientious objections protected by this rule or by implementation 
of the enforcement mechanisms of this rule.
Other Comments on Access to Care
    Many of the comments that claimed that the rule would result in 
more frequent denials of service to patients also argued that the rule 
is unnecessary because there is no current problem with health care 
providers being coerced into violating their consciences. These 
arguments are contradictory. If, under the final rule, a provider 
exercises a right protected by the rule to decline to perform a service 
that he had been performing prior to this rule, his previous 
performances of the service would likely have been contrary to his 
conscience.
    Many commenters observed that, in rural areas, if a provider were 
to decline on religious or moral grounds to provide a particular 
service or procedure, there may not be alternative providers within a 
feasible distance of the patient. The Department does not dispute that 
patients in rural areas are more likely than patients in urban areas to 
suffer adverse health outcomes as a result of being denied care. That 
is why enforcement of Federal conscience and anti-discrimination laws 
to prevent health care providers from being unlawfully driven out of 
business,

[[Page 23254]]

especially in rural areas, is of paramount importance. Instead of a 
decrease in access to a particular procedure from a particular doctor 
or provider, the residents of a rural area would face the potential of 
receiving no health care at all from that doctor or provider because 
such providers may leave the practice if unable to practice medicine 
according to their religious beliefs or moral convictions. In addition, 
as discussed in response to comments supra at part III.A., some polls 
show populations in rural communities may be more likely to agree with 
providers in objecting to certain procedures encompassed by Federal 
conscience and anti-discrimination laws. This implies that the demand 
for such services may not exist (or be as great) in such communities, 
partially offsetting the impact of a higher number of conscientious 
objections that may be effectuated because of the rule. Persons in 
urban areas, in contrast, may feel less effect from an increase in 
conscientious objections because of the relatively greater availability 
of alternative providers as compared to rural areas.
    One commenter noted that individuals whose health insurance does 
not provide financially adequate coverage for a large enough number of 
providers may similarly face a lack of alternative providers in the 
event one provider exercises a conscientious objection to a desired 
service. The Department regards its analysis herein regarding rural 
areas to be applicable to such situations as well.
    Just as the consequences of denials of care may in some cases be 
magnified in rural areas, so too may be the consequences of forcing a 
rural health care provider to violate her conscience. First, the 
provider may limit her practice or exit the field, harming health care 
access in a significant way. Second, if the provider continues to 
practice, the stress of having to violate her conscience may detract 
from the quality of care the provider delivers to her patients in 
general, who have no alternative provider.
    Additionally, if a provider is in an area where the majority of the 
population shares the provider's belief system, and if the provider 
leaves the area due to inability to exercise protected beliefs, many in 
the community may lose the ability to have a provider with values they 
share, thus negatively impacting the delivery of health care and the 
doctor-patient relationship.
5. Analysis of Regulatory Alternatives
    The Department carefully considered alternatives to this final 
rule. The Department determined that no alternative could achieve 
appropriately robust enforcement of, and respect for, Federal 
conscience and anti-discrimination laws without unduly burdening 
covered persons and entities subject to those laws and this rule. The 
following alternatives represent the major approaches the Department 
considered, including how burden reduction was a consideration in 
constructing this rule.
    The Department considered preserving the status quo by maintaining 
45 CFR part 88 without change from the 2011 Rule. Under this approach, 
the Department would largely defer to the States to enforce their 
respective conscience laws or to enact new laws to fill gaps in the 
landscape of Federal and State conscience protection and associated 
anti-discrimination rights and their enforcement, continue with the 
current inadequate enforcement scheme, and provide no meaningful 
enforcement of the conscience and associated anti-discrimination laws 
that were not part of the 2011 Rule. The Department received comments 
advocating this approach since, in commenters' views, State law, in 
conjunction with Federal law, already provides adequate accommodation 
of religious beliefs. Furthermore, some commenters stated that the 
stringent protections for conscience established by the statutes 
implemented by this rule are in tension with State nondiscrimination 
laws, State pharmaceutical dispensing laws, and State immunization laws 
that offer employers greater leeway in handling situations in which an 
employee asserts a conscientious objection.\355\ As stated elsewhere in 
response to similar comments, the Department disagrees with these 
arguments. As described above and further in the rule's Federalism 
analysis, to eliminate or reduce any tension between this rule's 
application of Federal statutes and State law, the final rule narrows 
the scope of the definitions of ``discrimination'' and ``referral'' in 
Sec.  88.2.
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    \355\ These comments paralleled the concerns, described supra at 
part III.B, raised by commenters who argued that this rule conflicts 
with other Federal statutes like Title VII of the Civil Rights Act 
of 1964.
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    The Department also disagrees that maintaining the status quo is 
preferable to this rule. Deference to States would perpetuate the 
current circumstances necessitating Federal regulation, which include 
(1) inadequate to non-existent Federal government frameworks to enforce 
Federal conscience and anti-discrimination laws and (2) inadequate 
information and understanding about the obligations of regulated 
persons and entities and the rights of persons, entities, and health 
care entities under the Federal conscience and anti-discrimination 
laws. State action cannot correct these deficiencies at the Federal 
level. Furthermore, the Department could not, in good faith, choose to 
rely on States to promote conscience protection policies, knowing that 
some States have adopted laws that are inconsistent with, or have 
otherwise expressed indifference towards, the rights protected by the 
laws that part 88 (as written in the 2011 Rule) implements--the Weldon, 
Church, and Coats-Snowe Amendments.\356\
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    \356\ See supra at part II.A (discussing laws and policies that 
some States have adopted).
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    Additionally, as noted more extensively in the preamble's summary 
of regulatory history, supra at part I, many commenters have pointed 
out the mutually reinforcing inadequate circumstances of the status quo 
contribute to the critical need for this final rule, including a 
conspicuously minimalistic regulatory scheme (compared to regulations 
implementing other civil rights laws OCR enforces); a lack of 
recognition by courts of a private right of action under certain 
Federal conscience and anti-discrimination laws; \357\ and hostility to 
conscience protections in some portion of the population and in certain 
State and local governments. Maintaining the status quo leaves a gap 
where HHS has a responsibility to coordinate compliance with, and 
enforcement of, Federal conscience protection and anti-discrimination 
laws but does not have the regulatory scheme to accomplish that goal. 
The Department consequently promulgates this final rule to eliminate 
that gap.
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    \357\ See, e.g., Cenzon-DeCarlo v. Mount Sinai Hospital, 626 
F.3d 695 (2d Cir. 2010); Hellwege v. Tampa Family Health Centers, 
103 F. Supp. 3d 1303 (M.D. Fla. 2015); National Institute of Family 
and Life Advocates, et al. v. Rauner, No. 3:16-cv-50310, at 4 (N.D. 
Ill. July 19, 2017).
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    The Department considered maintaining the status quo, but 
dramatically increasing its outreach. Numerous commenters asserted the 
strong need for outreach to combat bias and animus in the health care 
sector against individuals with religious beliefs or moral convictions, 
to raise awareness of the conscience rights of individuals, entities, 
and health care entities, and to clarify the legal obligations of 
regulated persons and entities. Commenters suggested a range

[[Page 23255]]

of ideas, including that the Department publish educational materials 
for academic medical institutions to educate students about their 
protected conscience rights and the obligation of regulated entities to 
comply with Federal conscience and anti-discrimination laws; that HHS 
partner with State institutions regulating health professions; and that 
HHS create an advisory team with diverse members to develop a plan for 
extensive outreach to combat ignorance about Federal conscience and 
anti-discrimination laws.
    The Department remains committed to robust outreach. Outreach has 
tremendous benefits to clarify legal obligations, raise awareness of 
OCR, and elevate awareness of the importance of conscience protections 
generally. The Department, however, agrees with one commenter who noted 
that, although outreach is important, it is insufficient without an 
enforceable rule to uphold the substantive protections under Federal 
law. As with every other civil rights law, outreach without adequate 
enforcement mechanisms is not enough to ensure appropriate compliance.
    The Department considered a regulatory scheme that was more 
prescriptive than this rule by requiring all recipients and sub-
recipients to establish policies and procedures for accommodating 
workforce members who objected to certain services based on moral 
convictions or religious beliefs; to address certain substantive 
elements in their policies and procedures; and to require the 
dissemination of information to workforce members about Federal 
conscience and anti-discrimination laws, this rule, or the recipient's 
and sub-recipient's policies and procedures. The burden under this 
option across 502,899 entities (the mid-point of the range shown in 
supra at Table 2) is the labor of a lawyer's time (3 hours) and an 
executive's time (1 hour). Using the mean hourly wages for these 
occupations adjusted upward for benefits and overhead, the annual 
average burden would be $297 million.\358\
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    \358\ Product of weighted mean hourly wage of $147.60 per hour x 
4 hours x 502,899 entities.
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    The Department rejected this alternative, but estimates supra at 
part IV.C.3.ii that five percent of entities in year one and 0.5 
percent of entities annually in years two through five would 
voluntarily update policies and procedures or disseminate them to staff 
as a by-product of assuring and certifying compliance with Federal 
conscience and anti-discrimination laws and this rule.
    As discussed above, the Department considered requiring recipients 
to post notices of nondiscrimination in various physical locations and 
online, but has chosen to make the notice provisions voluntary, in part 
to reduce burden. The final rule allows recipients and sub-recipients 
flexibility to decide what measures will best ensure compliance with 
Federal conscience and anti-discrimination laws and this rule, while 
providing for vigorous enforcement in cases of violation. Recipients 
and sub-recipients are better positioned to decide whether 
organization-wide action is necessary, and if so, what extent, content, 
and manner of that action is appropriate to ensure compliance. This 
approach allows recipients and sub-recipients to tailor appropriate 
organization-wide action based on their type, the populations they 
serve, their size, the scope of their workforce members likely to 
exercise protected rights under the Federal conscience and anti-
discrimination laws and this rule, and other relevant considerations. 
This rule, therefore, permits recipient employers to establish their 
own policies and procedures for how they will handle individuals' 
objections to certain procedures, such as abortion, sterilization, or 
assisted suicide, and recognizes the availability of appropriate 
accommodation procedures. In addition, this rule permits recipient 
employers who do have institution-wide objections to performing certain 
procedures, such as sterilization, but that do not object to referring 
for such procedures, to establish referral systems with nearby 
institutions that do not have objections to such procedures to 
facilitate the delivery of the services or programs.

D. Executive Order 13771

    Executive Order 13771 (January 30, 2017) requires that the costs 
associated with significant new regulations ``to the extent permitted 
by law, be offset by the elimination of existing costs associated with 
at least two prior regulations.'' The Department believes that this 
final rule is a significant regulatory action as defined by section 
3(f) of Executive Order 12866. This rule is also considered a 
regulatory action under Executive Order 13771. Excluding any negative 
externalities attributed to this rule in the form of health outcomes or 
other effects not compensated by positive health or other externalities 
from protecting conscience rights, the Department estimates that this 
rule will generate $148.2 million in annualized costs at a 7 percent 
discount rate, discounted relative to year 2016, over a perpetual time 
horizon.
    One commenter argued that the final rule violates Executive Order 
13771 because it imposes costs but does not identify what other burdens 
imposed by other regulations are being eliminated. Although each agency 
must identify offsetting deregulatory actions for each new regulatory 
burden, OMB does not interpret Executive Order 13771 to require each 
regulation that imposes costs to cite the particular deregulatory 
actions that offset that particular burden.\359\
---------------------------------------------------------------------------

    \359\ Office of Management & Budget, Guidance Implementing 
Executive Order 13771, Titled Reducing Regulation and Controlling 
Regulatory Costs, at 16 (Apr. 5, 2017), https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf 
(stating in the answer to question 37 that ``[w]hile each Federal 
Register notice should identify whether the regulation is an E.O. 
13771 regulatory action, there is no need to discuss specific 
offsetting E.O. 13771 deregulatory actions within the same Federal 
Register entry.'').
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E. Regulatory Flexibility Act

    HHS has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). 
The RFA requires an agency to describe the impact of a rulemaking on 
small entities by providing an initial regulatory flexibility analysis 
unless the agency expects that the rule will not have a significant 
impact on a substantial number of small entities, provides a factual 
basis for this determination, and to certify the statement. 5 U.S.C. 
603(a), 605(b). If an agency must provide an initial regulatory 
flexibility analysis, this analysis must address the consideration of 
regulatory options that would lessen the economic effect of the rule on 
small entities. For purposes of the RFA, small entities include small 
businesses, nonprofit organizations, and small governmental 
jurisdictions. HHS considers a rule to have a significant impact on a 
substantial number of small entities if it has at least a three percent 
impact of revenue on at least five percent of small entities.
    Based on its examination, the Department has concluded that this 
rule does not have a significant economic impact on a substantial 
number of small entities. The entities that would be affected by this 
final rule, in industries described in detail in the RIA, are 
considered small by virtue of either nonprofit status or having 
revenues of less than between $7.5 million and $38.5 million in average 
annual revenue, with the threshold varying by

[[Page 23256]]

industry.\360\ Persons and States are not included in the definition of 
a small entity. The Department assumes that most of the entities 
affected meet the threshold of a small entity.
---------------------------------------------------------------------------

    \360\ U.S. Small Business Administration, Table of Small 
Business Size Standards Marched to North American Industry 
Classification System Codes (Oct. 1, 2017), https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf (identifying 
the size standards by NAICS code for the health care and social 
service industries).
---------------------------------------------------------------------------

    Although this final rule will apply to and, thus, affect small 
entities, this rule's per-entity effects are relatively small. The 
Department estimates that this rule would impose an average cost of 
$778 per entity in the first year of compliance \361\ and about $325.30 
per year in years two through five.\362\ Furthermore, these costs would 
generally be proportional to the size of an entity, so that the 
smallest affected entities will face lower average costs. Given the 
thresholds discussed in the preceding paragraphs, the average costs are 
below those required to have a significant impact on a substantial 
number of small entities, within the meaning of the RFA.
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    \361\ Result of $391.5 million in first year costs to non-HHS 
entities divided by 502,899 entities.
    \362\ Result of $163.6 million annually to non-HHS entities in 
years two through five divided by 502,899 entities.
---------------------------------------------------------------------------

    Furthermore, the rule attempts to minimize costs imposed on small 
entities. For example, the assurance and certification requirements in 
Sec.  88.4 contain exceptions to relieve many small entities of the 
requirement to submit an assurance and certification. Approximately 70 
percent of recipients are exempted from the assurance and certification 
requirement, assuming that those exempted do not receive HHS funding 
through a non-exempt program.\363\ Given the magnitude and type of 
entities granted the exception, Sec.  88.4 should not be understood as 
unduly burdening small entities subject to the rule.
---------------------------------------------------------------------------

    \363\ The average between the lower-bound (267,134) and upper-
bound (415,666) of recipients exempted is 341,400 recipients, which 
represents 68 percent of the estimated total 500,290 recipients of 
the rule (excluding the estimated 2,609 counties that for the 
purpose of this rule are estimated to be sub-recipients).
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    The Department has further committed to leveraging existing grant, 
contract, and other Departmental forms where possible to implement 
Sec.  88.4, rather than create additional, separate forms for 
recipients to sign. Similarly, Sec.  88.5 no longer requires recipients 
to provide notices of conscience rights, but incentivizes recipients to 
voluntarily provide such notices. In light of this determination, the 
Secretary certifies that this rule will not result in a significant 
impact on a substantial number of small entities.

F. Unfunded Mandates Reform Act

    The Department similarly concludes that the requirements of the 
Unfunded Mandates Reform Act of 1995 are not triggered by this final 
rule. Section 202(a) of that Act requires the Department to prepare a 
written statement, including an assessment of anticipated costs and 
benefits, before issuing ``any rule that includes any Federal mandate 
that may result in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $150 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. As discussed in this RIA, this rule will not 
result in an expenditure in any year that meets or exceeds that amount 
with regard to State, local, or tribal governments, but will exceed 
that amount with regard to the private sector. An in-depth analysis of 
the rule with respect to State and local governments specifically 
appears in the following section of this RIA regarding Executive Order 
13132 (Federalism).

G. Executive Order 13132--Federalism; Executive Order 13175--Impact on 
Tribal Entities

Federalism
    The Secretary has determined that this final rule comports with 
Executive Order 13132.\364\ Executive Order 13132 aims to ``guarantee 
the division of governmental responsibilities between the national 
government and the States that was intended by the Framers of the 
Constitution . . . [and] ensure that the principles of federalism . . . 
guide the executive departments and agencies in the formulation and 
implementation of policies.'' \365\ Some of the Federal laws that this 
rule implements and enforces, such as the Weldon and Coats-Snowe 
Amendments, directly regulate States and local governments that receive 
Federal funding by conditioning the receipt of such funding on the 
governments' commitments to refrain from discrimination on certain 
bases or by imposing certain requirements on States and local 
governments that receive Federal funding. This impact, however, is a 
result of the statutory prohibitions and requirements themselves, and 
are not due to the mechanisms provided by this rule.
---------------------------------------------------------------------------

    \364\ E.O. 13132, 64 FR 43255 (Aug. 4, 1999).
    \365\ Id.
---------------------------------------------------------------------------

    Under the Supremacy and Spending Clauses of the Constitution, 
States and their political subdivisions are subject to Acts of 
Congress,\366\ and Federal conscience and anti-discrimination laws are 
no exception. This rule holds States and local governments accountable 
for compliance with these laws by setting forth mechanisms for OCR 
investigation and HHS enforcement related to those requirements. The 
rule does not change the substantive conscience protections or anti-
discrimination requirements of these statutes.
---------------------------------------------------------------------------

    \366\ Id. section 2(d).
---------------------------------------------------------------------------

    The Department received comments arguing that the enforcement of 
this rule through Sec.  88.7 could infringe on State sovereignty, in 
violation of the limits of the Spending Clause power afforded by the 
U.S. Constitution to Congress. The Federal government presumes the 
constitutionality of statutes that Congress enacts. Congress has 
exercised the broad authority afforded to it under the Spending Clause 
to attach clear conditions on Federal funds to secure conscience 
protection and associated anti-discrimination rights. In cases of 
violation of the Federal conscience and anti-discrimination laws, the 
Department intends to interpret and apply the remedies that Sec.  88.7 
sets forth in a manner consistent with the particular Federal law(s) at 
issue and the U.S. Constitution, and, as discussed in response to 
earlier comments, will comply with relevant Supreme Court precedents 
concerning federalism.\367\
---------------------------------------------------------------------------

    \367\ See supra at part III.B (section-by-section analysis for 
Sec.  88.7) and part I.B (this regulation's history) for further 
discussion of this matter.
---------------------------------------------------------------------------

    Some commenters argued that the rule implicates the requirements of 
Executive Order 13132 and unconstitutionally impedes the ability of 
States to exercise power in areas traditionally reserved to them, such 
as health, safety, and welfare. Commenters also raised concerns that 
the rule may inhibit States from implementing their own conscience 
protections. The Department disagrees with these concerns. The 
Department promulgates this rule under longstanding Federal laws that 
leave ample room for State activity. States are free to enact their own 
conscience protection and anti-discrimination laws that consider their 
own respective needs, populations, and prerogatives. Indeed, all fifty 
States have some protections in place for conscientious objectors to 
certain health or medical services and several provisions of this rule 
explicitly apply to reinforce and respect State conscience 
protections.\368\ States are

[[Page 23257]]

free to experiment with various approaches to promote respect of, and 
tolerance for, the exercise of conscience rights, and this final rule 
respects that prerogative. States are also free to reject Federal 
funding if they object to conditions required by any of the laws that 
are the subject of this rule.
---------------------------------------------------------------------------

    \368\ See Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 575-76, 587-600 (2017) (summarizing State laws).
---------------------------------------------------------------------------

    Section 88.8 of the rule makes clear that the rule is not intended 
to interfere with the operation of State law. For State laws equally or 
more protective of religious freedom and moral convictions than this 
rule, Sec.  88.8 of this rule states that nothing in the rule ``shall 
be construed to preempt'' such State or local law. Section 88.8 also 
declares that nothing in the rule ``shall be construed to narrow the 
meaning or application of any State . . . law protecting free exercise 
of religious beliefs or moral convictions.''
    Some statutes that the rule implements, such as 42 U.S.C. 
1396s(c)(2)(B)(ii), require providers to comply ``with applicable State 
law, including any law relating to any religious or other exemption'' 
as a condition of participation in the program that the statute 
authorizes (in this example, the Federal pediatric vaccine program). 
Other laws that this rule implements, such as 42 U.S.C. 280g-1(d), 
clarify that Federal assistance for newborn and infant hearing 
screening programs do not preempt or prohibit any State law protections 
for parents to assert religious objections to such screenings. 
Similarly, 42 U.S.C. 1396f clarifies that nothing requires a State to 
compel a person to undergo medical screenings, examination, diagnosis, 
treatment, health care or services if a person objects on religious 
grounds, with limited exceptions.
    This rule's requirements and prohibitions do not impose substantial 
direct effects on States and their political subdivisions, modify the 
relationship between the Federal government and the States, or alter 
the distribution of power and responsibilities among the various levels 
of government.\369\
---------------------------------------------------------------------------

    \369\ E.O. 13132, section 1(a). Executive Order 13132 requires 
an agency to meet certain requirements when it promulgates a rule 
with ``policies that have federalism implications.'' Id. sections 2-
3, 6(b)-(c) (identifying federalism principles, policymaking 
criteria, and consultation requirements).
---------------------------------------------------------------------------

    Some commenters argued that this rule, or the statutes that the 
rule implements, conflict with State and local laws regarding student 
and health provider immunizations, mandated provision of abortion 
coverage, employer protections, counseling related to assisted suicide, 
or employers being able to accommodate objectors with alternative 
arrangements. These comments paralleled the concerns already addressed 
above. In short, the Department finalizes the rule to recognize forms 
of accommodation and to eliminate or reduce such tension between 
applicable statutes or between this final rule and State laws. 
Accordingly, the final rule narrows the scope of the definitions of 
``discrimination'' and ``referral'' in Sec.  88.2.
    The impact of Sec.  88.4 is minimal in terms of the added labor 
costs for State and local government staff to assure and certify 
compliance.\370\ Additionally, the rule relies on enforcement 
mechanisms already available to HHS for grants and other forms of 
financial assistance.
---------------------------------------------------------------------------

    \370\ See supra at part IV.C.2.vi of this RIA estimating the 
rule's burden.
---------------------------------------------------------------------------

    In light of the above, the rule cannot be properly understood to 
impose substantial direct effects on States or their political 
subdivisions, their relationship with the Federal Government, or the 
distribution of power among the various levels of government.
    One comment noted that it ``does not threaten principles of 
federalism [to] requir[e] respect for constitutionally-protected 
conscience rights as a condition of receiving Federal funds.'' The 
Department agrees. The Department has not identified any Federal laws 
or jurisprudence that indicates that merely implementing and enforcing 
Federal laws as written violates constitutional principles of 
federalism.
Impact on Tribal Entities
    One comment stated that the Department would be required to engage 
in tribal consultation regarding the rule as required under Executive 
Order 13175. However, because the final rule removes the requirement in 
the proposed Sec.  88.3(p)(1)(iii) that certain federally recognized 
Indian tribes or tribal organizations and urban Indian organizations 
comply with sections 88.4 and 88.6 of the rule, the Department believes 
that the rule does not have tribal implications as defined in Executive 
Order 13175, and that tribal consultation regarding the rule was, 
therefore, not necessary.

H. Congressional Review Act

    The Congressional Review Act defines a ``major rule'' as ``any rule 
that the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) of the Office of Management and Budget finds has 
resulted in or is likely to result in--(A) an annual effect on the 
economy of $100,000,000 or more; (B) a major increase in costs or 
prices for consumers, individual industries, Federal, State, or local 
government agencies, or geographic regions; or (C) significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic and export 
markets.'' 5 U.S.C. 804(2). Based on the analysis of this final rule 
under Executive Order 12866, the Office of Management and Budget has 
determined that this rule is a major rule for purposes of the 
Congressional Review Act.

I. Assessment of Federal Regulation and Policies on Families

    In the proposed rule, the Department included a discussion of 
section 654 of the Treasury and General Government Appropriations Act 
of 1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998) as amended 
by Public Law 108-271, sec. 654, 118 Stat. 814 (2004), which required 
Federal departments and agencies to determine whether a policy or 
regulation could affect family well-being. These provisions are 
codified as a ``note'' to 5 U.S.C. 601. Because Congress did not renew 
these requirements in the most recent appropriations act applicable to 
the Department,\371\ the Department believes it is not obligated to 
conduct an analysis of potential impact on family well-being before 
finalizing regulations. Additionally, OMB Circular A-4 does not require 
such an analysis. Nevertheless, out of an abundance of caution, the 
Department conducts such an analysis below.
---------------------------------------------------------------------------

    \371\ Department of Defense and Labor, Health and Human 
Services, and Education Appropriations Act, 2019 and Continuing 
Appropriations Act, 2019, Public Law 115-245, 132 Stat. 2981 (2018).
---------------------------------------------------------------------------

    Section 601 (note) of 5 U.S.C. required agencies to assess whether 
a regulatory action (1) impacts the stability or safety of the family, 
particularly in terms of marital commitment; (2) impacts the authority 
of parents in the education, nurture, and supervision of their 
children; (3) helps the family perform its functions; (4) affects 
disposable income or poverty of families and children; (5) if the 
regulatory action which financially impacts families, is justified; (6) 
may be carried out by State or local government or by the family; and 
(7) establishes a policy concerning the relationship between the 
behavior

[[Page 23258]]

and personal responsibility of youth and the norms of society.
    The Department received comments stating that it did not adequately 
assess the impact on families in the proposed rule and reached an 
incorrect conclusion in determining that it is unlikely that this rule 
will negatively impact factors (1)-(4), with respect to the stability 
of the family, parental authority, or the disposable income or poverty 
of families and children. Other comments referenced concerns about how 
delays or refusals in treatment or in the transmission of information 
could affect factor (5): The emotional and financial well-being of 
families. The Department did not receive comments addressing factors 
(6) or (7). In response to these comments, the Department notes that 
these concerns do not constitute an impact on the well-being of the 
family within the meaning of 5 U.S.C. 601 (note) and that, in any 
event, the objections are to the underlying statutes that are the 
subject of the rule, not the mechanisms provided by the rule itself. 
With regard to factor (5), the prospect of a person losing their job, 
thus affecting the emotional and financial well-being of their family, 
is greater if conscience laws are not enforced as people of faith and 
moral conviction risk being driven out of the health care field as 
discussed above. Further discussion on the impact of this rule on 
patients and individuals can be found in part IV.C.4 (Estimated 
Benefits).
    As the Department noted in the proposed rule, the action taken in 
this rule cannot be carried out by State or local governments or by the 
family on their own (factor (6)) because the rule pertains to 
enforcement of certain Federal laws. Additionally, by protecting 
parents' ability to assert conscience rights on behalf of their 
children, the rule clearly enhances parental authority under factor 
(2). None of the rule's provisions impact factors (1), (3)-(5), or (7) 
to the degree contemplated by 5 U.S.C. 601 (note). Accordingly, this 
rule will not negatively affect family well-being within the meaning of 
5 U.S.C. 601 (note) in the event such provisions apply.

J. Paperwork Reduction Act

    This final rule requires new collections of information under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Congress enacted 
the Paperwork Reduction Act of 1995 to ``maximize the practical utility 
and public benefit of the information created, collected, disclosed, 
maintained, used, shared and disseminated by or for the Federal 
government'' and to minimize the burden of this collection. 44 U.S.C. 
3501(2). As defined in 5 CFR 1320.3(c), ``collection of information'' 
comprises reporting, record-keeping, monitoring, posting, labeling, and 
other similar actions. The Department sought comments regarding the 
burden estimates and the information collections generally. Some 
comments are discussed supra at part IV.C.3.ii-vi and others discussed 
in the following sections. The collections of information required by 
this final rule relate to Sec. Sec.  88.4 (Assurance and 
Certification), 88.5 (Voluntary Posting of Notice of Rights), and 
88.6(d) (Compliance Requirements).
1. Information Collection for Sec.  88.4 (Assurance and Certification)
(i) Summary of the Collection of Information
    This final rule requires each recipient (or applicant to become a 
recipient), with limited exceptions, to assure and certify compliance 
with Federal conscience and anti-discrimination laws. Specifically, 
Sec.  88.4(a)(1) and (2) requires each recipient or applicant to 
include in its application for Federal funds, or accompany its 
application with, an assurance and a certification that it will operate 
applicable projects or programs in compliance with applicable Federal 
conscience and anti-discrimination laws and this rule.
Operationalizing the Assurance of Compliance Requirement
    To operationalize the requirement in Sec.  88.4(a)(1) for a 
recipient or applicant to sign an assurance of compliance, the 
Department is seeking clearance under the PRA to update the HHS-690 
form, which is entitled ``Assurance of Compliance'' \372\ and is 
described in the section-by-section analysis of the preamble for Sec.  
88.4. The new language that the Department is adding to the HHS-690 
form identifies the major Federal conscience and anti-discrimination 
laws by their popular titles and their U.S. Code provisions (if 
codified) and directs the reader to OCR's Conscience and Religious 
Freedom web page for a full listing of the laws.
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    \372\ U.S. Dep't of Health & Human Servs., Assurance of 
Compliance, HHS 690, https://www.hhs.gov/sites/default/files/hhs-690.pdf.
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Operationalizing the Certification of Compliance Requirement
    In response to public comments that encouraged the Department to 
use existing forms, the Department explored operationalizing the 
certification of compliance requirement in Sec.  88.4(a)(2) by updating 
the HHS form 5161-1, but this form is only used by two HHS components 
rather than by all or most HHS operating or staff divisions. The 
Department also explored updating the Assurances for Non-Construction 
Programs (SF-424B), which, despite its name, enables the authorized 
representative of the applicant to certify up to nineteen paragraphs of 
agency and program-specific laws and regulations, such as housing, 
environmental, and labor laws and regulations.\373\ Pursuant to an OMB 
directive, ``[e]ffective January 1, 2019, the SF-424B will become 
optional and agencies shall make plans to phase out use in Funding 
Opportunity Announcements.'' \374\ Given this directive, the Department 
did not further explore updating the SF-424B.
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    \373\ Assurances for Non-Construction Programs, SF-424B, (OMB 
#4040-0007) https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf (last visited Apr. 11, 2019).
    \374\ Exec. Office of the President, Memorandum from Mick 
Mulvaney, Dir., Office of Management & Budget to Heads of Executive 
Departments and Agencies, Strategies to Reduce Grant Recipient 
Reporting Burden, at 2 (Sept. 5, 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/M-18-24.pdf.
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    The Department is seeking PRA clearance to operationalize the 
certification of compliance requirement during calendar year 2019 
through the existing signature block of the government-wide Application 
for Federal Assistance (SF-424) \375\ or, for research or related 
grants, through the Application for Federal Assistance for Research and 
Related (R&R) Series (SF-424 R&R).\376\ The signature block for both 
applications contains the following statement:

    \375\ Application for Financial Assistance, SF-424, (OMB # 4040-
0004), https://apply07.grants.gov/apply/forms/sample/SF424_2_1-V2.1.pdf (last visited Apr. 11, 2019).
    \376\ Application for Financial Assistance, SF-424 (R&R), (OMB # 
4040-0001), https://apply07.grants.gov/apply/forms/sample/RR_SF424_2_0-V2.0.pdf (last visited Apr. 11, 2019).

    By signing this application, I certify (1) to the statements 
contained in the list of certifications ** and (2) that the 
statements herein are true, complete and accurate to the best of my 
knowledge. I also provide the required assurances ** and agree to 
comply with any resulting terms if I accept an award. I am aware 
that any false, fictitious, or fraudulent statements or claims may 
subject me to criminal, civil, or administrative penalties. (U.S. 
Code, Title 18, Section 1001).
--------
    ** The list of certifications and assurances, or an internet 
site where you may obtain this list, is contained in the 
announcement or agency specific instructions.

    In calendar year 2020 and the outyears, the Department is seeking 
PRA

[[Page 23259]]

clearance to operationalize the certification of compliance requirement 
through the government-wide System for Award Management (SAM) \377\ 
because this system, pursuant to an OMB directive, ``will become the 
central repository for common government-wide certifications and 
representations required of Federal grants recipients.'' \378\ The 
certifications and representations through SAM replace the government-
wide assurances contained in the Assurances for Non-Construction 
Programs (SF-424B).\379\
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    \377\ U.S. Gen. Servs. Admin., System for Award Management, 
Home, https://www.sam.gov/SAM/pages/public/index.jsf (last visited 
Apr. 11, 2019).
    \378\ Exec. Office of the President, Memorandum from Mick 
Mulvaney, Dir., Office of Management & Budget to Heads of Executive 
Departments and Agencies, Strategies to Reduce Grant Recipient 
Reporting Burden, at 2 (Sept. 5, 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/M-18-24.pdf.
    \379\ See id. (``[R]egistration in SAM is required for 
eligibility for a Federal award and registration must be updated 
annually . . . . Federal agencies will use SAM information to comply 
with award requirements and avoid increased burden and costs of 
separate requests for such information, unless the recipient fails 
to meet a Federal award requirement, or there is a need to make 
updates to their SAM registration for other purposes.'').
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    In submitting the general certifications and representations 
through SAM,\380\ the authorized representative certifies to several 
statements, two of which the Department interprets as operationalizing 
Sec.  88.4(b).\381\ First, the authorized representative certifies that 
it ``[w]ill comply with U.S. statutory and public policy requirements 
which prohibit discrimination, including but not limited to[]'' certain 
Federal civil rights statutes.\382\ The Federal conscience and anti-
discrimination laws are not listed because the general certifications 
and representations identified in SAM are government-wide, rather than 
agency or multi-agency specific. However, the Department construes the 
non-exhaustive list as incorporating the Federal conscience and anti-
discrimination laws, as applicable, that the final rule implements.
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    \380\ U.S. Gen. Servs. Admin., System for Award Management, SAM 
Release Notes Build 2019-02-01, at 3 (Feb. 2, 2019), https://www.sam.gov/SAM/transcript/SAM_Release_Notes_2019_02_01.pdf 
(describing under ``enhancements'' that SAM has ``a new government-
wide Financial Assistance Representations and Certifications module 
within the SAM entity management registration'' and ``[a]ll non-
federal registrants in SAM will be required to certify to the new 
Financial Assistance Reps & Certs as part of their registration'').
    \381\ The certifications and representations are not publicly 
available until an individual creates an account. The list of 
certifications and representations were obtained from staff at 
Grants.gov on March 19, 2019, and are on file with OCR.
    \382\ Financial Assistance General Certifications and 
Representations, at 2, para. 9 (on file with OCR).
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    Another statement conveys that the authorized representative 
certifies that it ``[w]ill comply with all applicable requirements of 
all other Federal laws, executive orders, regulations, and policies 
government financial assistance awards and any financial assistance 
project covered by this certification document.'' \383\ The Department 
construes this catch-all statement as incorporating the Federal 
conscience and anti-discrimination laws, as applicable, and the final 
rule.
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    \383\ Financial Assistance General Certifications and 
Representations, at 1, para. 7 (on file with OCR).
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(ii) Need for Information
    Requiring certain recipients and applicants to assure and certify 
compliance serves two purposes. First, through the act of reading and 
reviewing the statutory requirements to which recipients or applicants 
assure and certify compliance, recipients would be apprised of their 
obligations under the applicable Federal conscience and anti-
discrimination laws and this rule. Second, a recipient's or applicant's 
awareness of its obligations would increase the likelihood that it 
would comply with such laws and, consequently, afford entities and 
individuals protection of their conscience rights and protection from 
coercion or discrimination.
    In the proposed rule, the Department requested comment on whether 
the collection of information is necessary for the proper performance 
of the Department's functions to enforce Federal laws on which Federal 
funding is conditioned. At least one commenter encouraged the 
Department to add the assurance and certification requirements in Sec.  
88.4 because of the ``surge in harassment and coercion of medical 
providers of faith.'' Other commenters stated that assurance and 
certification was unnecessary because recipients already must certify 
compliance with Federal law upon the receipt of Federal funds.
    This collection of information facilitates the Department's 
obligation to ensure that the Federal financial assistance or other 
Federal funds that the Department awards are used in a manner compliant 
with Federal conscience and anti-discrimination laws and the final 
rule. The Department's administration of a requirement for an entity at 
the time of application or reapplication to assure and certify 
compliance with Federal conscience and anti-discrimination laws and the 
final rule demonstrates that the person or entity was aware of its 
obligations under those laws and the rule.
    In addition, HHS has the authority to place terms and conditions 
consistent with those statutes in any instrument HHS issues or to which 
it is a party (e.g., grants, contracts or other HHS instruments). A 
Department component extending an award must communicate and 
incorporate statutory and public policy requirements and obligate the 
recipient to comply with Federal statues and ``public policy 
requirements, including . . . those . . . prohibiting discrimination.'' 
\384\ More specifically, the Department component ``must communicate . 
. . all relevant public policy requirements, including those in general 
appropriations provisions, and incorporate them either directly or by 
reference in the terms and conditions of the Federal award.'' \385\ The 
Departmental component may require a recipient ``to submit 
certifications and representations required by Federal statutes, or 
regulations . . .'' \386\
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    \384\ 45 CFR 75.300(a).
    \385\ Id.
    \386\ Id. at Sec.  75.208.
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(iii) Use of Information
    The Department and its components awarding Federal funds and OCR 
will use the signed assurance and certification as documentation of (1) 
a recipient's or applicant's awareness of its obligations under the 
Federal conscience and anti-discrimination laws and this rule, and (2) 
a recipient's or applicant's binding agreement to abide by such 
obligations. This use would most likely occur during an OCR 
investigation of the recipient's compliance with Federal conscience and 
anti-discrimination laws and this rule, and as part of an entity's 
record keeping obligations under this rule.
(iv) Description of the Respondents
    The respondents are applicants or recipients for Federal financial 
assistance or Federal funds from the Department as set forth in Sec.  
88.3, which identifies the applicability of this rule for each of the 
underlying statutes that would be implemented and enforced. Respondents 
include hospitals, research institutions, health professions training 
programs, qualified health plan issuers, Health Insurance Marketplaces, 
home health agencies, community mental health centers, and skilled 
nursing facilities.
(v) Number of Respondents
    The Department estimates the number of respondents at 158,890 
persons or

[[Page 23260]]

entities, which is the average between the low (122,558) and high 
(195,222) estimates of entities required to sign an assurance or a 
certification. These figures appear supra at Table 3, part IV.C.2.iv.A. 
Respondents are a subset of the recipients because Sec.  88.4(c)(1) 
through (4) excludes certain categories of recipients. The rule 
excludes physicians, as defined in 42 U.S.C. 1395x(r), physician 
offices, other health care practitioners or pharmacists who are 
recipients in the form of reimbursements for services provided to 
beneficiaries under Medicare Part B. See Sec.  88.4(c)(1). The rule 
also exempts recipients of certain grant programs administered by the 
Administration for Children and Families or the Administration for 
Community Living when the program's purpose is unrelated to health care 
and certain types of research, does not involve health care providers, 
and does not involve any significant likelihood of referral for the 
provision of health care. See Sec.  88.4(c)(2) and (3). Finally, this 
final rule excludes Indian Tribes and Tribal Organizations when 
contracting with the Indian Health Service under the Indian Self-
Determination and Education Assistance Act. See Sec.  88.4(c)(4).
(vi) Burden of Response
    The Paperwork Reduction Act burden is the opportunity cost of 
recipient staff time to review the assurance and certification language 
as well as the requirements of the underlying Federal conscience and 
anti-discrimination laws referenced or incorporated. The methods that 
the Department uses are outlined supra at part IV.C.3.ii, and the mean 
hourly wage is adjusted downward to exclude benefits and overhead.
    The labor cost is a function of a lawyer spending 3 hours reviewing 
the assurance and certification and an executive spending one hour to 
review and sign, as Sec.  88.4(b)(2) requires a signature by an 
individual authorized to bind the recipient. The weighted mean hourly 
wage (not including benefits and overhead) of these two occupations is 
$73.80 per hour.\387\ The labor cost is $46.9 million each year ($73.80 
per hour x 4 hours x 158,890 entities).\388\
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    \387\ Sum of ($67.25 x .75) and ($93.44 x .25).
    \388\ This total differs from the burden in the RIA because a 
fully-loaded wage that is adjusted upwards for benefits and overhead 
must be used in the RIA.
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    The Department asked for public comment on the information 
collection under Sec.  88.4. Several specific questions that the 
Department posed received no comments:
     Whether the exception for Indian Tribes and tribal 
Organizations in proposed 45 CFR 88.4(c)(vi) avoids ``tribal 
implications'' and does not ``impose substantial direct compliance 
costs on Indian Tribal governments'' as stated in Executive Order 
13175, Consultation and Coordination with Indian Tribal Governments, 
sec. 5(b) (Nov. 9, 2000);
     Whether assuring compliance with the Federal conscience 
protection and associated anti-discrimination statutes would constitute 
a burden exempt from the Paperwork Reduction Act as a usual and 
customary business practice incurred by recipients during the ordinary 
course of business;
     How the quality, utility, and clarity of the information 
to be collected may be enhanced; and
     How the manner of compliance with the assurance and 
certification requirements could be improved, including through use of 
automated collection techniques or other forms of information 
technology.
    The Department received public comments expressing concern with the 
possible burden on health care providers resulting from Sec.  88.4, 
which is discussed supra at part IV.C.3.ii. In addition, as explained 
in the summary of this Paperwork Reduction Act analysis, the Department 
is leveraging existing grant, contract, and other Departmental forms 
and government-wide systems, consistent with OMB's government-wide 
effort to reduce recipient burden.\389\
---------------------------------------------------------------------------

    \389\ Exec. Office of the President, Memorandum from Mick 
Mulvaney, Dir., Office of Management & Budget to Heads of Executive 
Departments and Agencies, Strategies to Reduce Grant Recipient 
Reporting Burden, at 2 (Sept. 5, 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/M-18-24.pdf.
---------------------------------------------------------------------------

2. Information Collection for Sec.  88.5 (Notice)
(i) Summary of the Collection of Information
    Under this rule as finalized, Sec.  88.5 does not mandate the 
provision of notice, but rather incentivizes recipients and Department 
components to provide notice concerning Federal conscience and anti-
discrimination laws. The rule intends to accomplish this goal by 
considering a recipient's or a Department component's posting of the 
notice as non-dispositive evidence of compliance with the rule when OCR 
investigates or initiates a compliance review of a recipient or 
Department component. If recipients voluntarily provide notice to 
implement Sec.  88.5, recipients are encouraged to use the pre-written 
notice in appendix A. The recipient is otherwise free to draft its own 
notices tailored to its specific circumstances and applicable laws 
under the rule.
(ii) Need for Information
    The Department incentivizes recipients and Department components to 
provide notice of rights because notice serves three primary purposes. 
First, individuals become apprised of their rights under applicable 
Federal conscience and anti-discrimination laws, including the right to 
file a complaint with HHS OCR. Second, an individual's awareness of his 
or her rights increases the likelihood that the individual will 
exercise those rights. Third, recipients and their managers and 
employees will be more likely to be reminded, and be made aware, of 
their own obligations under these laws.
(iii) Use of Information
    Individuals, entities, and health care entities will use the 
information to increase their awareness of their rights and file 
complaints with OCR if they believe their rights have been violated. 
Entities required to comply will have an increased likelihood of 
understanding their obligations to thus act accordingly to fulfill 
them. During OCR investigation or compliance review of a recipient, OCR 
will consider as non-dispositive evidence of compliance whether and how 
the recipient posted a notice according to Sec.  88.5.
(iv) Description of the Respondents
    The respondents are recipients as defined in this rule at Sec.  
88.2. Respondents include, but are not limited to, States, hospitals, 
research institutions, and skilled nursing facilities.
(v) Number of Respondents
    The number of respondents is estimated at 335,327 recipients at the 
establishment-level in year one and 75 percent of that amount in years 
two through five (i.e., 251,495 establishments). This estimate 
represents the average between the lower and upper-bound estimates of 
how many recipient establishments will voluntarily post notices through 
one of more of the methods in Sec.  88.5 in years one and annually in 
years two through five. A subset of respondents, about 139,615 
recipients at the firm level, will likely modify the pre-written notice 
in appendix A.
(vi) Burden of Response
    Even though the notice provision of the final rule is entirely 
voluntary, the Department expects that some segment

[[Page 23261]]

of the recipients and Department components that this rule regulates 
will choose to post the notice through one of the methods specified. 
The burden is mix of labor, materials, and in some cases, postage 
costs. The methods and assumptions that the Department uses are 
outlined supra at part IV.C.3.iii, and the mean hourly wage is adjusted 
downward to exclude benefits and overhead. Unlike the burden estimated 
in the RIA of the rule, the PRA burden associated with Sec.  88.5 
excludes the costs of posting the notice for those entities that post 
it verbatim because the Department is supplying the language for the 
notice for the purpose of disclosure to the public, under 5 CFR 
1320.3(c)(2).
    Assuming that 139,615 recipients at the firm level alter the text 
of the notice in appendix A, these recipients will, on average, bear a 
minimal opportunity cost of \1/3\ hour of a lawyer's time for drafting 
and ten minutes of an executive's time to provide final sign-off. The 
weighted mean hourly wage (excluding benefits and overhead) of these 
two occupations is $75.89 per hour. The one-time labor cost is $5.3 
million in the first year ($75.89 per hour x 0.5 hours x 139,615 
recipients).
    The assumptions regarding the timing of providing notices of rights 
and the various uncertainties inherent in the implementation of Sec.  
88.5 described in detail in the RIA supra at part IV.C.3.iii apply to 
this analysis, too, such as the number of locations where notices are 
customarily posted, and the length of time it may take an 
administrative assistant or web developer to perform their respective 
functions.
(vii) Burden for Voluntary Posting in Physical Locations
    The Department estimates that it will take \1/3\ of an hour for an 
administrative assistant to print notice(s) and post them in physical 
locations of the establishment where notices are customarily posted. 
The 139,615 recipients at the firm level estimated to alter the notice 
are associated with 180,331 establishments. Assuming that about 180,331 
facilities at the establishment level choose voluntarily to post 
notices in physical locations, the estimated labor cost is $1.2 million 
(\1/3\ hour x $19.39 per hour x 180,331 establishments).\390\ The cost 
to post 5 notices across all establishments would be $45,083 (180,331 
establishments x $.05 per page (paper and ink) x 5 pages). The total 
labor and materials costs associated with voluntary posting in physical 
locations by 180,331 establishments is $1.2 million ($1.2 million in 
labor costs and $45,083 for materials) in the first year of 
implementation with zero recurring costs.
---------------------------------------------------------------------------

    \390\ This total differs from the burden in the RIA because a 
fully loaded wage that is adjusted upwards for benefits and overhead 
must be used.
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    One commenter raised concerns with the notice requirement being 
overly broad because it would require a multi-State health care entity 
to post notices at every location where workforce notices are 
customarily posted to permit ready observation, even if the particular 
location had no connection to the funding or activity giving rise to 
the obligation to post the notice. The final rule's modification of the 
notice from mandatory to voluntary should resolve this concern. 
Additionally, the rule provides for posting in locations as 
``applicable and appropriate.''
    One commenter expressed concern that the Department's estimate of 
time that an administrative assistant would spend to post the notice 
did not take into account the multiple facilities owned by a corporate 
entity. The estimates for the Paperwork Reduction Act and in the RIA, 
however, do take this into account because the Department multiplied 
the per facility labor and materials costs by the number of facilities 
(i.e., establishments) over which a corporate entity (i.e., firm) 
exercises common ownership and control.
(viii) Burden for Voluntary Web Posting
    To post the notice on the web, the Department estimates that it 
will take 2 hours for a web developer at each recipient's physical 
location to execute the design and technical elements for posting. This 
labor cost is approximately $12.5 million (2 hours x $34.69 per hour x 
180,337 establishments) in the first year of implementation with zero 
recurring costs.\391\
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    \391\ This total differs from the estimate of the burden in the 
RIA because the RIA uses a fully loaded wage rate (i.e., including 
benefits and overhead) not employed here.
---------------------------------------------------------------------------

(ix) Burden for Voluntary Posting in Two Publications
    The Department assumes that, within the first year after the rule's 
publication, each recipient voluntarily posting notices in publications 
would identify two publications in which to include the notice, 
revising the document or its layout to include the notice, or otherwise 
printing an insert to include with hard copies of the publication.\392\ 
Acknowledging the uncertainties outlined supra at part IV.C.3.iii, the 
Department estimates the annual costs of labor, material, and postage 
according to the following assumptions. The Department assumes that (1) 
establishments that include notices of rights in publications will most 
often do so in online publications or in hard-copy publications hand-
distributed, where the notice's inclusion results in an additional 100 
hard copy notices per establishment per year, and (2) half of the 
establishments associated with covered recipients voluntarily providing 
hard copy notices (i.e., 90,166 establishments in year one and 67,624 
establishments annually in years two through five) \393\ will mail the 
publications for which the weight of the notice incrementally increases 
the postage costs. These assumptions may differ from the actual 
experience of recipients' implementation, as described supra at part 
IV.C.3.iii.
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    \392\ Under the final rule, because all the notice provisions 
are voluntary, the Department assumes that 75% of entities that 
voluntarily provide notices in year one will continue to do so in 
out years and there will be lower attrition compared to the estimate 
provided in the proposed rule.
    \393\ Product of 180,331 establishments times 50 percent for 
year one. Product of 135,249 establishments times 50 percent for 
years two through five.
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    Using the model, hourly estimates, and other assumptions described 
supra at part IV.C.3.iii, the average labor cost, excluding mailing-
related labor costs, resulting from including notices in relevant 
publications is $7.0 million in year one ($19.39 per hour x 2 hours x 
180,331 establishments) and $2.6 million annually in years two through 
five ($19.39 per hour x 1 hour x 135,249 establishments).\394\ Based on 
the marginal cost of postage per ounce of $0.15,\395\ an annual number 
of mailings of 100 pages per establishment, average annual labor cost 
for mailing of $19.39 per hour, and an average number of labor hours 
per mailing of 0.25 hours, the total costs due to the voluntary mailing 
of notices is $1.8 million \396\ in year one and $1.3 million \397\ 
annually in years two through five.\398\ Finally, the

[[Page 23262]]

annual cost of printed materials for notices (both mailed and hand 
distributed) is $0.9 million (180,331 establishments x 100 pages x $.05 
per page) in year one and $676,243 annually in years two through five 
(135,249 establishments x 100 pages x $.05 per page).
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    \394\ These totals differ from the estimate of the burden in the 
RIA because the RIA uses a fully loaded wage rate (i.e., including 
benefits and overhead) not employed here.
    \395\ See U.S. Postal Service Postage Rates, https://www.stamps.com/usps/current-postage-rates/.
    \396\ Sum of incremental postage of $1.4 million ($0.15 per 
mailing x 100 mailings x 90,166 establishments) and incremental 
labor of $437,078 ($19.39 per hour x 0.25 hours x 90,166 
establishments).
    \397\ Sum of incremental postage of $1.0 million ($0.15 per 
mailing x 100 mailings x 67,624 establishments) and incremental 
labor of $327,809 ($19.39 per hour x 0.25 hours x 67,624 
establishments).
    \398\ This total differs from the estimate of the burden in the 
RIA because the RIA uses a fully loaded wage rate (i.e., including 
benefits and overhead) not employed here.
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    In sum, the total expected cost of activities related to the 
voluntary posting and distributions of notices that Sec.  88.5 
incentivizes is $28.7 million in the first year and $4.6 million 
annually in years two through five.
(x) Burden to the Federal Government
    Unlike the burden estimated in the RIA of the rule, the PRA burden 
to the Department associated with Sec.  88.5 excludes the costs of 
posting the notice for those HHS components that post it verbatim 
because the Department is supplying the language of the notice for the 
purpose of disclosure to the public, under 5 CFR 1320.3(c)(2). Because 
the Department components will likely post the notice from Appendix A 
verbatim, all costs to the Department under the PRA for Sec.  88.5 are 
excluded.
    The remaining issue raised by commenters is whether the rule 
requires translation of the notice into non-English languages. Under 
the conscience protection and associated anti-discrimination laws and 
this rule, translation or posting of translated notices is not 
independently required. However, recipients subject to this rule may 
also have independent obligations to provide language assistance 
services and meaningful access to individuals with limited English 
proficiency when abiding by the prohibition of national origin 
discrimination in Federal civil rights laws that OCR enforces.\399\
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    \399\ E.g., 42 U.S.C. 2000d (Title VI of the Civil Rights Act of 
1964); 45 CFR part 80 (HHS implementing regulations); Guidance to 
Federal Financial Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons, 68 FR 47311, 47313 (Aug. 8, 2003).
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    The Department asked for public comment on the following issues and 
received no comments:
     Whether the proposed collection of information is 
necessary for the proper performance of the Department's functions to 
enforce Federal laws on which Federal funding is conditioned, including 
whether the information will have practical utility;
     Whether the public had feedback on the assumptions that 
formed the basis of the cost estimates for the notice provision; and
     How the manner of compliance with the notice provision 
could be improved, including through the use of automated collection 
techniques or other forms of information technology.
3. Compliance Procedures (Sec.  88.6(d))
(i) Summary of the Collection of Information
    Paragraph 88.6(d) requires any recipient or sub-recipient that is 
subject to a determination by OCR of noncompliance with this part 
concerning Federal conscience and anti-discrimination laws to report 
this fact in any application for new or renewed Federal financial 
assistance or Departmental funding in the three years following the 
determination of noncompliance. This includes a requirement that 
recipients disclose any OCR determinations made against their sub-
recipients.
(ii) Need for Information
    The information alerts applicable Departmental components of OCR's 
determination of noncompliance on the part of the recipient or sub-
recipient, to ensure appropriate coordination within the Department 
during OCR's enforcement of Federal conscience and anti-discrimination 
laws, and to inform funding decision-making.
(iii) Use of Information
    This requirement puts the Departmental component on notice of OCR's 
determination of noncompliance to inform a component's decision whether 
to approve, renew, or modify Federal funding to the recipient. This 
requirement also facilitates coordination between the component and OCR 
on the status of the recipient or sub-recipient's compliance status.
(iv) Description of the Respondents
    The respondents are recipients and sub-recipients that HHS OCR has 
found noncompliant with this final rule.
(v) Number of Respondents
    As explained, supra at part IV.C.3.v, the Department cannot predict 
the number of entities that OCR will find noncompliant with the rule.
(vi) Burden of Response
    The Department estimates it would take a records custodian at the 
experience level of a paralegal about 15 minutes to retrieve the 
relevant information (such as date of the violation finding and the OCR 
``transaction number'' (e.g., case number)) from the recipient's or 
sub-recipient's records and an administrative assistant 15 minutes to 
enter the information on the application. Based on the methods and 
assumptions supra at part IV.C.3.v, the Department assumes that a 
recipient, at the highest end, would submit 2,000 applications each 
year for new funding opportunities, supplemental funding, and non-
competing continuations, among others. The mean weighted hourly wage 
for the paralegal and administrative assistant is $22.66, which 
excludes benefits and overhead. Each recipient or sub-recipient found 
in violation of the rule would expend on the highest end, $22,655 per 
year in labor costs at the firm level ($22.66 per hour x 2,000 
applications x 0.5 hours).\400\
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    \400\ This total differs from the burden in the RIA because a 
fully loaded wage that is adjusted upwards for benefits and overhead 
must be used.
---------------------------------------------------------------------------

    Commenters stated that the version of this requirement in the 
proposed rule was redundant and duplicative. The Department agrees. The 
final rule and this information collection has been modified 
substantially to require recipients and sub-recipients to notify the 
Departmental components from which the recipient or sub-recipient 
receives Federal funds in the three years following a determination of 
noncompliance with Federal conscience and anti-discrimination laws and 
this final rule by OCR.

List of Subjects in 45 CFR Part 88

    Abortion, Adult education, Advanced directives, Assisted suicide, 
Authority delegations, Childbirth, Civil rights, Coercion, Colleges and 
universities, Community facilities, Contracts, Educational facilities, 
Employment, Euthanasia, Family planning, Federal-State relations, 
Government contracts, Government employees, Grant programs-health, 
Grants administration, Health care, Health facilities, Health 
insurance, Health professions, Hospitals, Immunization, Indian Tribes, 
Insurance, Insurance companies, Laboratories, Manpower training 
programs, Maternal and child health, Medicaid, Medical and dental 
schools, Medical research, Medicare, Mental health programs, Mercy 
killing, Moral convictions, Nondiscrimination, Nursing homes, Nursing 
schools, Occupational safety and health, Occupational training, 
Physicians, Prescription drugs, Public assistance programs, Public 
awareness, Public health, Religious discrimination, Religious beliefs, 
Religious liberties, Religious nonmedical health care institutions, 
Reporting and recordkeeping requirements, Rights of conscience, 
Scholarships and fellowships, Schools, Scientists, State and local 
governments, Sterilization,

[[Page 23263]]

Students, Technical assistance, Tribal Organizations.


0
For the reasons set forth in the preamble, the Department of Health and 
Human Services revises 45 CFR part 88 to read as follows:

PART 88--PROTECTING STATUTORY CONSCIENCE RIGHTS IN HEALTH CARE; 
DELEGATIONS OF AUTHORITY

Sec.
88.1 Purpose.
88.2 Definitions.
88.3 Applicable requirements and prohibitions.
88.4 Assurance and certification of compliance requirements.
88.5 Notice of rights under Federal conscience and anti-
discrimination laws.
88.6 Compliance requirements.
88.7 Enforcement authority.
88.8 Relationship to other laws.
88.9 Rule of construction.
88.10 Severability.
Appendix A to Part 88--Model Text: Notice of Rights Under Federal 
Conscience and Anti-Discrimination Laws

    Authority: 42 U.S.C. 300a-7 (the Church Amendments); 42 U.S.C. 
238n (Coats-Snowe Amendment); the Weldon Amendment (e.g., Pub. L. 
115-245, Div. B, sec. 507(d)); 42 U.S.C. 18113 (Section 1553 of the 
Affordable Care Act); Medicare Advantage (e.g., Pub. L. 115-245, 
Div. B, sec. 209); the Helms, Biden, 1978, and 1985 Amendments, 22 
U.S.C. 2151b(f) (e.g., Pub. L. 116-6, Div. F, sec. 7018); 22 U.S.C. 
7631(d); 29 U.S.C. 669(a)(5); 42 U.S.C. 300gg-92; 42 U.S.C. 1302(a); 
42 U.S.C. 18041(a) (Section 1321 of the Affordable Care Act); 42 
U.S.C. 18081 (Section 1411 of the Affordable Care Act); 42 U.S.C. 
18023 (Section 1303 of the Affordable Care Act); 26 U.S.C. 
5000A(d)(2); 42 U.S.C. 18031; 42 U.S.C. 280g-1(d); 42 U.S.C. 290bb-
36(f); 42 U.S.C. 1315; 42 U.S.C. 1315a; 42 U.S.C. 1320a-1; 42 U.S.C. 
1320c-11; 42 U.S.C. 1395cc(f); 42 U.S.C. 1395i-3; 42 U.S.C. 1395i-5; 
42 U.S.C. 1395w-22(j)(3)(B); 42 U.S.C. 1395w-26; 42 U.S.C. 1395w-27; 
42 U.S.C. 1395x; 42 U.S.C. 1396a; 42 U.S.C. 1396a(w)(3); 42 U.S.C. 
1396f; 42 U.S.C. 1396r; 42 U.S.C. 1396s(c)(2)(B)(ii); 42 U.S.C. 
1396u-2(b)(3)(B); 42 U.S.C. 1397j-1(b); 42 U.S.C. 5106i(a); 42 
U.S.C. 14406; 5 U.S.C. 301; 40 U.S.C. 121(c); 42 U.S.C. 
263a(f)(1)(E); 45 CFR parts 75 and 96; 48 CFR chapter 1; 48 CFR 
parts 300 thru 370; 2 CFR part 376.


Sec.  88.1   Purpose.

    The purpose of this part is to provide for the implementation and 
enforcement of the Federal conscience and anti-discrimination laws 
listed in Sec.  88.3. Such laws, for example, protect the rights of 
individuals, entities, and health care entities to refuse to perform, 
assist in the performance of, or undergo certain health care services 
or research activities to which they may object for religious, moral, 
ethical, or other reasons. Such laws also protect patients from being 
subjected to certain health care or services over their conscientious 
objection. Consistent with their objective to protect the conscience 
and associated anti-discrimination rights of individuals, entities, and 
health care entities, the statutory provisions and the regulatory 
provisions contained in this part are to be interpreted and implemented 
broadly to effectuate their protective purposes.


Sec.  88.2  Definitions.

    For the purposes of this part:
    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. This may include 
counseling, referral, training, or otherwise making arrangements for 
the procedure or a part of a health service program or research 
activity, depending on whether aid is provided by such actions.
    Department means the Department of Health and Human Services and 
any component thereof.
    Discriminate or discrimination includes, as applicable to, and to 
the extent permitted by, the applicable statute:
    (1) To withhold, reduce, exclude from, terminate, restrict, or make 
unavailable or deny any grant, contract, subcontract, cooperative 
agreement, loan, license, certification, accreditation, employment, 
title, or other similar instrument, position, or status;
    (2) To withhold, reduce, exclude from, terminate, restrict, or make 
unavailable or deny any benefit or privilege or impose any penalty; or
    (3) To utilize 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 subjects individuals or 
entities protected under this part to any adverse treatment with 
respect to individuals, entities, or conduct protected under this part 
on grounds prohibited under an applicable statute encompassed by this 
part.
    (4) Notwithstanding paragraphs (1) through (3) of this definition, 
an entity subject to any prohibition in this part shall not be regarded 
as having engaged in discrimination against a protected entity where 
the entity offers and the protected entity voluntarily accepts an 
effective accommodation for the exercise of such protected entity's 
protected conduct, religious beliefs, or moral convictions. In 
determining whether any entity has engaged in discriminatory action 
with respect to any complaint or compliance review under this part, OCR 
will take into account the degree to which an entity had implemented 
policies to provide effective accommodations for the exercise of 
protected conduct, religious beliefs, or moral convictions under this 
part and whether or not the entity took any adverse action against a 
protected entity on the basis of protected conduct, beliefs, or 
convictions before the provision of any accommodation.
    (5) Notwithstanding paragraphs (1) through (3) of this definition, 
an entity subject to any prohibition in this part may require a 
protected entity to inform it of objections to performing, referring 
for, participating in, or assisting in the performance of specific 
procedures, programs, research, counseling, or treatments, but only to 
the extent that there is a reasonable likelihood that the protected 
entity may be asked in good faith to perform, refer for, participate 
in, or assist in the performance of, any act or conduct just described. 
Such inquiry may only occur after the hiring of, contracting with, or 
awarding of a grant or benefit to a protected entity, and once per 
calendar year thereafter, unless supported by a persuasive 
justification.
    (6) The taking of steps by an entity subject to prohibitions in 
this part to use alternate staff or methods to provide or further any 
objected-to conduct identified in paragraph (5) of this definition 
would not, by itself, constitute discrimination or a prohibited 
referral, if such entity does not require any additional action by, or 
does not take any adverse action against, the objecting protected 
entity (including individuals or health care entities), and if such 
methods do not exclude protected entities from fields of practice on 
the basis of their protected objections. Entities subject to 
prohibitions in this part may also inform the public of the 
availability of alternate staff or methods to provide or further the 
objected-to conduct, but such entity may not do so in a manner that 
constitutes adverse or retaliatory action against an objecting entity.
    Entity means a ``person'' as defined in 1 U.S.C. 1; the Department; 
a State, political subdivision of any State, instrumentality of any 
State or political subdivision thereof; any public agency, public 
institution, public organization, or other public entity in any State 
or political subdivision of any State; or, as applicable, a foreign 
government, foreign nongovernmental organization, or intergovernmental 
organization (such as the United Nations or its affiliated agencies).

[[Page 23264]]

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


Sec.  88.3  Applicable requirements and prohibitions.

    (a) The Church Amendments, 42 U.S.C. 300a-7--(1) Applicability. (i) 
The Department is required to comply with paragraphs (a)(2)(i) through 
(vii) of this section and Sec.  88.6 of this part.
    (ii) Any State or local government or subdivision thereof and any 
other public entity is required to comply with paragraphs (a)(2)(i) 
through (iii) of this section.
    (iii) Any entity that receives a grant, contract, loan, or loan 
guarantee under the Public Health Service Act (42 U.S.C. 201 et seq.) 
after June 18, 1973, is required to comply with paragraph (a)(2)(iv) of 
this section and Sec. Sec.  88.4 and 88.6 of this part.
    (iv) Any entity that receives a grant or contract for biomedical or 
behavioral research under any program administered by the Secretary of 
Health and Human Services after July 12, 1974, is required to comply 
with paragraph (a)(2)(v) of this section and Sec. Sec.  88.4 and 88.6 
of this part.
    (v) The Department and any entity that receives funds for any 
health

[[Page 23265]]

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

[[Page 23266]]

comply with paragraph (c)(2) of this section and Sec. Sec.  88.4 and 
88.6 of this part.
    (2) Prohibition. The entities to which this paragraph (c)(2) 
applies shall not subject 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, abortion.
    (d) Medicare Advantage (See, e.g., Pub. L. 115-245, Div. B, sec. 
209)--(1) Applicability. The Department, while operating under an 
appropriations act that contains a provision with respect to the 
Medicare Advantage program as set forth by Public Law 115-245, Div. B, 
sec. 209, is required to comply with paragraph (d)(2) of this section 
and Sec.  88.6 of this part.
    (2) Prohibition. The entities to which this paragraph (d)(2) 
applies shall not deny participation in the Medicare Advantage program 
to an otherwise eligible entity (including a Provider Sponsored 
Organization) because that entity informs the Secretary that it will 
not provide, pay for, provide coverage of, or provide referrals for 
abortions.
    (e) Section 1553 of the Affordable Care Act, 42 U.S.C. 18113--(1) 
Applicability. (i) The Department is required to comply with paragraph 
(e)(2) of this section and Sec.  88.6 of this part.
    (ii) Any State or local government that receives Federal financial 
assistance under the Patient Protection and Affordable Care Act (or 
under an amendment made by the Patient Protection and Affordable Care 
Act) is required to comply with paragraph (e)(2) of this section and 
Sec. Sec.  88.4 and 88.6 of this part.
    (iii) Any health care provider that receives Federal financial 
assistance under the Patient Protection and Affordable Care Act (or 
under an amendment made by the Patient Protection and Affordable Care 
Act) is required to comply with paragraph (e)(2) of this section and 
Sec. Sec.  88.4 and 88.6 of this part.
    (iv) Any health plan created under the Patient Protection and 
Affordable Care Act (or under an amendment made by the Patient 
Protection and Affordable Care Act) is required to comply with 
paragraph (e)(2) of this section and Sec. Sec.  88.4 and 88.6 of this 
part.
    (2) Prohibition. The entities to which this paragraph (e)(2) 
applies shall not subject an individual or institutional health care 
entity to discrimination on the basis that the entity does 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. 
Nothing in this paragraph shall be construed to apply to, or to affect, 
any limitation relating to:
    (i) The withholding or withdrawing of medical treatment or medical 
care;
    (ii) The withholding or withdrawing of nutrition or hydration;
    (iii) Abortion; or
    (iv) The use of an item, good, benefit, or service furnished for 
the purpose of alleviating pain or discomfort, even if such use may 
increase the risk of death, so long as such item, good, benefit, or 
service is not also furnished for the purpose of causing, or the 
purpose of assisting in causing, death, for any reason.
    (f) Section 1303 of the Affordable Care Act, 42 U.S.C. 18023--(1) 
Applicability. (i) The Department is required to comply with paragraph 
(f)(2)(i) of this section and Sec.  88.6 of this part.
    (ii) Qualified health plans, as defined under 42 U.S.C. 18021, 
offered through any Exchange created under the Patient Protection and 
Affordable Care Act, are required to comply with paragraphs (f)(2)(i) 
and (ii) of this section and Sec. Sec.  88.4 and 88.6 of this part.
    (2) Requirements and prohibitions. (i) Pursuant to 42 U.S.C. 
18023(b)(1)(A)(i), entities to which this paragraph (f)(2)(i) applies 
shall not construe anything in Title I of the Patient Protection and 
Affordable Care Act (or any amendment made by Title I of the Patient 
Protection and Affordable Care Act) to require a qualified health plan 
to provide coverage of abortion or abortion-related services as 
described in 42 U.S.C. 18023(b)(1)(B)(i) or (ii) as part of its 
essential health benefits for any plan year.
    (ii) Pursuant to 42 U.S.C. 18023(b)(4), entities to which this 
paragraph (f)(2)(ii) applies shall not discriminate against any 
individual health care provider or health care facility because of its 
unwillingness to provide, pay for, provide coverage of, or refer for 
abortions.
    (g) Section 1411 of the Affordable Care Act, 42 U.S.C. 18081--(1) 
Applicability. The Department shall comply with paragraph (g)(2) of 
this section and Sec.  88.6 of this part.
    (2) Requirement. The Department shall provide a certification 
documenting a religious exemption from the individual responsibility 
requirement and penalty under the Patient Protection and Affordable 
Care Act and shall coordinate with State Health Benefit Exchanges in 
the implementing of the certification requirements of 42 U.S.C. 
18031(d)(4)(H)(ii) where applicable to:
    (i) Any applicant for such a certificate for any month who provides 
information demonstrating that the applicant:
    (A) Is an adherent of religious tenets or teachings by reason of 
which he is conscientiously opposed to acceptance of the benefits of 
any private or public insurance which makes payments in the event of 
death, disability, old-age, or retirement or makes payments toward the 
cost of, or provides services for, medical care (including the benefits 
of any insurance system established by the Social Security Act), or
    (B) Is an adherent of religious tenets or teachings that are not 
described in paragraph (g)(2)(i)(A) of this section, who relies solely 
on a religious method of healing, and for whom the acceptance of 
medical health services would be inconsistent with the religious 
beliefs of the individual, and the application for the certificate 
includes an attestation that the individual has not received medical 
health services during the preceding taxable year.
    (1) For purposes of this paragraph (g)(2)(i)(B), ``medical health 
services'' does not include routine dental, vision and hearing 
services, midwifery services, vaccinations, necessary medical services 
provided to children, services required by law or by a third party, and 
such other services as the Secretary may provide in implementing 
section 1311(d)(4)(H) of the Patient Protection and Affordable Care 
Act;
    and
    (ii) Any applicant for such a certificate for any month who 
provides information demonstrating that the applicant is a member of a 
``health care sharing ministry,'' as defined in 26 U.S.C. 
5000A(d)(2)(B)(ii), for the month.
    (h) Counseling and referral provisions of 42 U.S.C. 1395w-
22(j)(3)(B) and 1396u-2(b)(3)(B))--(1) Applicability. (i) The 
Department is required to comply with paragraphs (h)(2)(i) and (ii) of 
this section and Sec.  88.6 of this part.
    (ii) Any State agency that administers a Medicaid program is 
required to comply with paragraph (h)(2)(ii) of this section and 
Sec. Sec.  88.4 and 88.6 of this part.
    (2) Requirements and prohibitions. (i) Pursuant to 42 U.S.C. 1395w-
22(j)(3)(B), entities to which this paragraph (h)(2)(i) applies shall 
not construe 42 U.S.C. 1395w-22(j)(3)(A) or 42 CFR 422.206(a) to 
require a Medicare Advantage organization to provide, reimburse for, or 
provide coverage of, a counseling or referral service if the 
organization offering the plan:
    (A) Objects to the provision of such service on moral or religious 
grounds, and
    (B) In the manner and through the written instrumentalities such 
organization deems appropriate, makes

[[Page 23267]]

available information on its policies regarding such service to 
prospective enrollees before or during enrollment and to enrollees 
within 90 days after the date that the organization adopts a change in 
policy regarding such a counseling or referral service.
    (ii) Pursuant to 42 U.S.C. 1396u-2(b)(3)(B), entities to which this 
paragraph (h)(2)(ii) applies shall not construe 42 U.S.C. 1396u-
2(b)(3)(A) or 42 CFR 438.102(a)(1) to require a Medicaid managed care 
organization to provide, reimburse for, or provide coverage of, a 
counseling or referral service if the organization:
    (A) Objects to the provision of such service on moral or religious 
grounds, and
    (B) In the manner and through the written instrumentalities such 
organization deems appropriate, makes available information on its 
policies regarding such service to prospective enrollees before or 
during enrollment and to enrollees within 90 days after the date that 
the organization adopts a change in policy regarding such a counseling 
or referral service.
    (i) Advance Directives, 42 U.S.C. 1395cc(f), 1396a(w)(3), and 
14406--(1) Applicability. (i) The Department is required to comply with 
paragraph (i)(2) of this section and Sec.  88.6 of this part with 
respect to the Medicare and Medicaid programs.
    (ii) Any State agency that administers a Medicaid program is 
required to comply with paragraph (i)(2) of this section and Sec. Sec.  
88.4 and 88.6 of this part with respect to its Medicaid program.
    (2) Prohibitions. The entities to which this paragraph (i)(2) 
applies shall not:
    (i) Construe 42 U.S.C. 1395cc(f) or 1396a(w)(3) to require any 
provider or organization, or any employee of such a provider or 
organization, to inform or counsel any individual regarding any right 
to obtain an item or service furnished for the purpose of causing, or 
the purpose of assisting in causing, the death of the individual, such 
as by assisted suicide, euthanasia, or mercy killing; or to apply to or 
affect any requirement with respect to a portion of an advance 
directive that directs the purposeful causing of, or the purposeful 
assisting in causing, the death of any individual, such as by assisted 
suicide, euthanasia, or mercy killing; or
    (ii) Construe 42 U.S.C. 1396a to prohibit the application of a 
State law which allows for an objection on the basis of conscience for 
any health care provider or any agent of such provider which as a 
matter of conscience cannot implement an advance directive.
    (j) Global Health Programs, 22 U.S.C. 7631(d)--(1) Applicability. 
(i) The Department is required to comply with paragraph (j)(2) of this 
section and Sec.  88.6 of this part.
    (ii) Any entity that is authorized by statute, regulation, or 
agreement to obligate Federal financial assistance under section 104A 
of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b-2), under 
Chapter 83 of Title 22 of the U.S. Code or under the Tom Lantos and 
Henry J. Hyde United States Global Leadership Against HIV/AIDS, 
Tuberculosis, and Malaria Reauthorization Act of 2008, to the extent 
such Federal financial assistance is administered by the Secretary, is 
required to comply with paragraph (j)(2) of this section and Sec. Sec.  
88.4 and 88.6 of this part.
    (2) Prohibitions. The entities to which this paragraph (j)(2) 
applies shall not:
    (i) Require an organization, including a faith-based organization, 
that is otherwise eligible to receive assistance under section 104A of 
the Foreign Assistance Act of 1961 (22 U.S.C. 2151b-2), under Chapter 
83 of Title 22 of the U.S. Code, or under the Tom Lantos and Henry J. 
Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, 
and Malaria Reauthorization Act of 2008, to the extent such assistance 
is administered by the Secretary, for HIV/AIDS prevention, treatment, 
or care to, as a condition of such assistance:
    (A) Endorse or utilize a multisectoral or comprehensive approach to 
combating HIV/AIDS; or
    (B) Endorse, utilize, make a referral to, become integrated with, 
or otherwise participate in any program or activity to which the 
organization has a religious or moral objection.
    (ii) Discriminate against an organization, including a faith-based 
organization, that is otherwise eligible to receive assistance under 
section 104A of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b-2), 
under Chapter 83 of Title 22 of the U.S. Code, or under the Tom Lantos 
and Henry J. Hyde United States Global Leadership Against HIV/AIDS, 
Tuberculosis, and Malaria Reauthorization Act of 2008, to the extent 
such assistance is administered by the Secretary, for HIV/AIDS 
prevention, treatment, or care, in the solicitation or issuance of 
grants, contracts, or cooperative agreements under such provisions of 
law for refusing to meet any requirement described in paragraph 
(j)(2)(i) of this section.
    (k) The Helms, Biden, 1978, and 1985 Amendments, 22 U.S.C. 
2151b(f); see, e.g., Consolidated Appropriations Act, 2019, Public Law 
116-6, Div. F, sec. 7018--(1) Applicability. (i) The Department is 
required to comply with paragraph (k)(2)(i) of this section and Sec.  
88.6 of this part.
    (ii) Any entity that is authorized by statute, regulation, or 
agreement to obligate or expend Federal financial assistance under part 
I of the Foreign Assistance Act of 1961, as amended (22 U.S.C. 2151b-
2), to the extent administered by the Secretary, is required to comply 
with paragraph (k)(2)(i) of this section and Sec. Sec.  88.4 and 88.6 
of this part.
    (iii) Any entity that receives Federal financial assistance under 
part I of the Foreign Assistance Act of 1961, as amended (22 U.S.C. 
2151b-2), to the extent administered by the Secretary, is required to 
comply with paragraph (k)(2)(ii) of this section and Sec. Sec.  88.4 
and 88.6 of this part.
    (2) Prohibitions. (i) The entities to which this paragraph 
(k)(2)(i) applies shall not:
    (A) Permit Federal financial assistance identified in paragraph 
(k)(1)(ii) of this section to be used in a manner that would violate 
provisions in paragraphs (k)(2)(ii)(A)(1) through (5) of this section 
related to abortions and involuntary sterilizations.
    (B) Obligate or expend Federal financial assistance under an 
appropriations act that contains the 1985 Amendment and identified in 
paragraph (k)(1)(ii) of this section for any country or organization if 
the President certifies that the use of these funds by any such country 
or organization would violate provisions in paragraphs (k)(2)(ii)(A)(1) 
through (5) of this section related to abortions and involuntary 
sterilizations.
    (ii) The entities to which this paragraph (k)(2)(ii) applies shall 
not:
    (A) Use such Federal financial assistance identified in paragraph 
(k)(1)(iii) of this section to:
    (1) Pay for the performance of abortions as a method of family 
planning;
    (2) Motivate or coerce any person to practice abortions;
    (3) Pay for the performance of involuntary sterilizations as a 
method of family planning;
    (4) Coerce or provide any financial incentive to any person to 
undergo sterilizations; or
    (5) Pay for any biomedical research that relates in whole or in 
part, to methods of, or the performance of, abortions or involuntary 
sterilization as a means of family planning.
    (B) Obligate or expend Federal financial assistance under an 
appropriations act that contains the 1985 Amendment and identified in 
paragraph (k)(1)(iii) of this section for

[[Page 23268]]

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

[[Page 23269]]

religious nonmedical health care institution as defined in 42 U.S.C. 
1395x(ss)(1).
    (ii) With respect to a religious nonmedical health care institution 
as defined in 42 U.S.C. 1395x(ss)(1), the entities to which this 
paragraph (q)(2)(ii) applies shall not:
    (A) Fail or refuse to make a payment under part A of subchapter 
XVIII of chapter 7 of Title 42 of the U.S. Code for inpatient hospital 
services, post-hospital extended care services, or home health services 
furnished to an individual by a religious nonmedical health care 
institution that is a hospital as defined in 42 U.S.C. 1395x(e), a 
skilled nursing facility as defined in 42 U.S.C. 1395x(y), or a home 
health agency as defined in 42 U.S.C. 1395x(aaa), respectively, if the 
condition under 42 U.S.C. 1395i-5(a)(2) is satisfied and an individual 
makes an election pursuant to 1395i-5(b) that:
    (1) Such individual is conscientiously opposed to acceptance of 
medical care or treatment other than medical care or treatment 
(including medical and other health services) that is:
    (i) Received involuntarily, or
    (ii) Required under Federal or State law or law of a political 
subdivision of a State; and
    (2) Acceptance of such medical treatment would be inconsistent with 
such individual's sincere religious beliefs, or
    (B) In administering 42 U.S.C. 1395i-5 or 1395x(ss)(1):
    (1) Require any patient of a religious nonmedical health care 
institution to undergo medical screening, examination, diagnosis, 
prognosis, or treatment or to accept any other medical health care 
service, if such patient (or legal representative of the patient) 
objects to such service on religious grounds, or
    (2) Subject a religious nonmedical health care institution or its 
personnel to any medical supervision, regulation, or control, insofar 
as such supervision, regulation, or control would be contrary to the 
religious beliefs observed by the institution or such personnel, or
    (C) Subject religious nonmedical health care institution to the 
provisions of part B of subchapter XI of Chapter 7 of Title 42 of the 
U.S. Code.
    (iii) Pursuant to 42 U.S.C. 1396a(a), the entities to which this 
paragraph (q)(2)(iii) applies shall not fail or refuse to exempt a 
religious nonmedical health care institution from the Medicaid 
requirements to:
    (A) Meet State standards described in 42 U.S.C. 1396a(a)(9)(A);
    (B) Be evaluated under 42 U.S.C. 1396a(a)(33), on the 
appropriateness and quality of care and services;
    (C) Undergo a regular program, under 42 U.S.C. 1396(a)(31), of 
independent professional review, including medical evaluation, of 
services in an intermediate care facility for persons with mental 
disabilities; and
    (D) Meet the requirements of 42 U.S.C. 1396(b)(i)(4) to establish a 
utilization review plan consistent with, or superior to, the 
utilization review plan criteria under 42 U.S.C. 1395x(k) for Medicare.
    (iv) Pursuant to 42 U.S.C. 1397j-1(b), the entities to which this 
paragraph (q)(2)(iv) applies shall not construe subtitle B of Title XX 
of the Social Security Act (42 U.S.C. 1397j-1397m-5) to interfere with 
or abridge an elder's right to practice his or her religion through 
reliance on prayer alone for healing when this choice:
    (A) Is contemporaneously expressed, either orally or in writing, 
with respect to a specific illness or injury which the elder has at the 
time of the decision by an elder who is competent at the time of the 
decision;
    (B) Is previously set forth in a living will, health care proxy, or 
other advance directive document that is validly executed and applied 
under State law; or
    (C) May be unambiguously deduced from the elder's life history.


Sec.  88.4  Assurance and certification of compliance requirements.

    (a) In general--(1) Assurance. Except for an application or 
recipient to which paragraph (c) of this section applies, every 
application for Federal financial assistance or Federal funds from the 
Department to which Sec.  88.3 of this part applies shall, as a 
condition of the approval, renewal, or extension of any Federal 
financial assistance or Federal funds from the Department pursuant to 
the application, provide, contain, or be accompanied by an assurance 
that the applicant or recipient will comply with applicable Federal 
conscience and anti-discrimination laws and this part.
    (2) Certification. Except for an application or recipient to which 
paragraph (c) of this section applies, every application for Federal 
financial assistance or Federal funds from the Department to which 
Sec.  88.3 of this part applies, shall, as a condition of the approval, 
renewal, or extension of any Federal financial assistance or Federal 
funds from the Department pursuant to the application, provide, 
contain, or be accompanied by, a certification that the applicant or 
recipient will comply with applicable Federal conscience and anti-
discrimination laws and this part.
    (b) Specific requirements--(1) Timing. Entities who are already 
recipients as of the effective date of this part or any applicants 
shall submit the assurance required in paragraph (a)(1) of this section 
and the certification required in paragraph (a)(2) of this section as a 
condition of any application or reapplication for funds to which this 
part applies, through any instrument or as a condition of an amendment 
or modification of the instrument that extends the term of such 
instrument or adds additional funds to it. Submission may be required 
more frequently if:
    (i) The applicant or recipient fails to meet a requirement of this 
part, or
    (ii) OCR or the relevant Department component has reason to suspect 
or cause to investigate the possibility of such failure.
    (2) Form and manner. Applicants or recipients shall submit the 
assurance required in paragraph (a)(1) of this section and the 
certification required in paragraph (a)(2) of this section in the form 
and manner that OCR, in coordination with the relevant Department 
component, specifies, or shall submit them in a separate writing signed 
by the applicant's or recipient's officer or other person authorized to 
bind the applicant or recipient.
    (3) Duration of obligation. The assurance required in paragraph 
(a)(1) of this section and the certification required in paragraph 
(a)(2) of this section will obligate the recipient for the period 
during which the Department extends Federal financial assistance or 
Federal funds from the Department to a recipient.
    (4) Compliance requirement. Submission of an assurance or 
certification required under this section will not relieve a recipient 
of the obligation to take and complete any action necessary to come 
into compliance with Federal conscience and anti-discrimination laws 
and this part prior to, at the time of, or subsequent to, the 
submission of such assurance or certification.
    (5) Condition of continued receipt. Provision of a compliant 
assurance and certification shall constitute a condition of continued 
receipt of Federal financial assistance or Federal funds from the 
Department and is binding upon the applicant or recipient, its 
successors, assigns, or transferees for the period during which such 
Federal financial assistance or Federal funds from the Department are 
provided.
    (6) Assurances and certifications in applications. An applicant or 
recipient may incorporate the assurances and

[[Page 23270]]

certifications by reference in subsequent applications to the 
Department or Department component if prior assurances or 
certifications are initially provided in the same fiscal or calendar 
year, as applicable.
    (7) Enforcement of assurances and certifications. The Department, 
Department components, and OCR shall have the right to seek enforcement 
of the assurances and certifications required in this section.
    (8) Remedies for failure to make assurances and certifications. If 
an applicant or recipient fails or refuses to furnish an assurance or 
certification required under this section, OCR, in coordination with 
the relevant Department component, may effect compliance by any of the 
mechanisms provided in Sec.  88.7.
    (c) Exceptions. The following persons or entities shall not be 
required to comply with paragraphs (a)(1) and (2) of this section, 
provided that such persons or entities are not recipients of Federal 
financial assistance or other Federal funds from the Department through 
another instrument, program, or mechanism, other than those set forth 
in paragraphs (c)(1) through (4) of this section:
    (1) A physician, as defined in 42 U.S.C. 1395x(r), physician 
office, pharmacist, pharmacy, or other health care practitioner 
participating in Part B of the Medicare program;
    (2) A recipient of Federal financial assistance or other Federal 
funds from the Department awarded under certain grant programs 
currently administered by the Administration for Children and Families, 
the purpose of which is either solely financial assistance unrelated to 
health care or which is otherwise unrelated to health care provision, 
and which, in addition, does not involve--
    (i) Medical or behavioral research;
    (ii) Health care providers; or
    (iii) Any significant likelihood of referral for the provision of 
health care;
    (3) A recipient of Federal financial assistance or other Federal 
funds from the Department awarded under certain grant programs 
currently administered by the Administration on Community Living, the 
purpose of which is either solely financial assistance unrelated to 
health care or which is otherwise unrelated to health care provision, 
and which, in addition, does not involve--
    (i) Medical or behavioral research;
    (ii) Health care providers; or
    (iii) Any significant likelihood of referral for the provision of 
health care.
    (4) Indian Tribes and Tribal Organizations when contracting with 
the Indian Health Service under the Indian Self-Determination and 
Education Assistance Act.


Sec.  88.5   Notice of rights under Federal conscience and anti-
discrimination laws.

    (a) In general. In investigating a complaint or conducting a 
compliance review, OCR will consider an entity's voluntary posting of a 
notice of nondiscrimination as non-dispositive evidence of compliance 
with the applicable substantive provisions of this part, to the extent 
such notices are provided according to the provisions of this section 
and are relevant to the particular investigation or compliance review.
    (b) Placement of the notice text. In evaluating the Department's or 
a recipient's compliance with this part, OCR will take into account 
whether, as applicable and appropriate, the Department or recipient has 
provided the notice under this section:
    (1) On the Department or recipient's website(s);
    (2) In a prominent and conspicuous physical location in Department 
or recipient establishments where notices to the public and notices to 
its workforce are customarily posted to permit ready observation;
    (3) In a personnel manual or other substantially similar document 
for members of the Department or recipient's workforce;
    (4) In applications to the Department or recipient for inclusion in 
the workforce or for participation in a service, benefit, or other 
program, including for training or study; and
    (5) In any student handbook or other substantially similar document 
for students participating in a program of training or study, including 
for post-graduate interns, residents, and fellows.
    (6) Such that the text of the notice is large and conspicuous 
enough to be read easily and is presented in a format, location, or 
manner that impedes or prevents the notice being altered, defaced, 
removed, or covered by other material.
    (c) Content of the notice text. The recipient and the Department 
should consider using the model text provided in Appendix A for the 
notice, but may tailor its notice to address its particular 
circumstances and to more specifically address the laws that apply to 
it under this rule.
    (d) Combined nondiscrimination notices. The Department and each 
recipient may post the notice text provided in appendix A of this part, 
or a notice it drafts itself, along with the content of other notices 
(such as other non-discrimination notices).


Sec.  88.6  Compliance requirements.

    (a) In general. The Department and each recipient has primary 
responsibility to ensure that it is in compliance with Federal 
conscience and anti-discrimination laws and this part, and shall take 
steps to eliminate any violations of the Federal conscience and anti-
discrimination laws and this part. If a sub-recipient is found to have 
violated the Federal conscience and anti-discrimination laws, the 
recipient from whom the sub-recipient received funds may be subject to 
the imposition of funding restrictions or any appropriate remedies 
available under this part, depending on the facts and circumstances.
    (b) Records and information. The Department, each recipient, and 
each sub-recipient shall maintain complete and accurate records 
evidencing compliance with Federal conscience and anti-discrimination 
laws and this part, and afford OCR, upon request, reasonable access to 
such records and information in a timely manner and to the extent OCR 
finds necessary to determine compliance with the Federal conscience and 
anti-discrimination laws and this part. Such records:
    (1) Shall be maintained for a period of three years from the date 
the record was created or obtained by the recipient or sub-recipient;
    (2) Shall contain any information maintained by the recipient or 
sub-recipient that pertains to discrimination on the basis of religious 
belief or moral conviction, including, without limitation, any 
complaints; statements, policies, or notices concerning discrimination 
on the basis of religious belief or moral conviction; procedures for 
accommodating employees' or other protected individuals' religious 
beliefs or moral convictions; and records of requests for such 
religious or moral accommodation and the recipient or sub-recipient's 
response to such requests; and
    (3) May be maintained in any form and manner that affords OCR with 
reasonable access to them in a timely manner.
    (c) Cooperation. The Department, each recipient, and each sub-
recipient shall cooperate with any compliance review, investigation, 
interview, or other part of OCR's enforcement process, which may 
include production of documents, participation in interviews, response 
to data requests, and making available of premises for inspection where 
relevant. Failure to cooperate may result in an OCR referral to the 
Department of Justice, in coordination with the Department's Office of 
the General Counsel, for

[[Page 23271]]

further enforcement in Federal court or otherwise. Each recipient or 
sub-recipient shall permit access by OCR during normal business hours 
to such of its books, records, accounts, and other sources of 
information, as well as its facilities, as may be pertinent to 
ascertain compliance with this part. Asserted considerations of privacy 
or confidentiality may not operate to bar OCR from evaluating or 
seeking to enforce compliance with this part. Information of a 
confidential nature obtained in connection with compliance reviews, 
investigations, or other enforcement activities shall not be disclosed 
except as required in formal enforcement proceedings or as otherwise 
required by law.
    (d) Reporting requirement. If a recipient or sub-recipient is 
subject to a determination by OCR of noncompliance with this part, the 
recipient or sub-recipient must, in any application for new or renewed 
Federal financial assistance or Departmental funding in the three years 
following such determination, disclose the existence of the 
determination of noncompliance. This includes a requirement that 
recipients disclose any OCR determinations made against their sub-
recipients.
    (e) Intimidating or retaliatory acts prohibited. Neither the 
Department nor any recipient or sub-recipient shall intimidate, 
threaten, coerce, or discriminate against any entity for the purpose of 
interfering with any right or privilege under the Federal conscience 
and anti-discrimination laws or this part, or because such entity has 
made a complaint or participated in any manner in an investigation or 
review under the Federal conscience and anti-discrimination laws or 
this part.


Sec.  88.7  Enforcement authority.

    (a) In general. OCR has been delegated the authority to facilitate 
and coordinate the Department's enforcement of the Federal conscience 
and anti-discrimination laws, which includes the authority to:
    (1) Receive and handle complaints;
    (2) Initiate compliance reviews;
    (3) Conduct investigations;
    (4) Coordinate compliance within the Department;
    (5) Seek voluntary resolutions of complaints;
    (6) In coordination with the relevant component or components of 
the Department and the Office of the General Counsel, make enforcement 
referrals to the Department of Justice;
    (7) In coordination with the relevant Departmental funding 
component, utilize existing regulations for involuntary enforcement, 
such as those that apply to grants, contracts, or CMS programs; and
    (8) In coordination with the relevant component or components of 
the Department, coordinate other appropriate remedial action as the 
Department deems necessary and as allowed by law and applicable 
regulation.
    (b) Complaints. Any entity, whether individually, as a member of a 
class, on behalf of others, or on behalf of an entity, may file a 
complaint with OCR alleging any potential violation of Federal 
conscience and anti-discrimination laws or this part. OCR shall 
coordinate handling of complaints with the relevant Department 
component(s). The complaint filer is not required to be the entity 
whose rights under the Federal conscience and anti-discrimination laws 
or this part have been potentially violated.
    (c) Compliance reviews. OCR may conduct compliance reviews or use 
other similar procedures as necessary to permit OCR to investigate and 
review the practices of the Department, Department components, 
recipients, and sub-recipients to determine whether they are complying 
with Federal conscience and anti-discrimination laws and this part. OCR 
may initiate a compliance review of an entity subject to this part 
based on information from a complaint or other source that causes OCR 
to suspect non-compliance by such entity with this part or the laws 
implemented by this part.
    (d) Investigations. OCR shall make a prompt investigation, whenever 
a compliance review, report, complaint, or any other information found 
by OCR indicates a threatened, potential, or actual failure to comply 
with Federal conscience and anti-discrimination laws or this part. The 
investigation should include, where appropriate, a review of the 
pertinent practices, policies, communications, documents, compliance 
history, circumstances under which the possible noncompliance occurred, 
and other factors relevant to determining whether the Department, 
Department component, recipient, or sub-recipient has failed to comply. 
OCR shall use fact-finding methods including site visits; interviews 
with the complainants, Department component, recipients, sub-
recipients, or third-parties; and written data or discovery requests. 
OCR may seek the assistance of any State agency.
    (e) Failure to respond. Absent good cause, the failure of an entity 
that is subject to this part to respond to a request for information or 
to a data or document request within 45 days of OCR's request shall 
constitute a violation of this part.
    (f) Related administrative or judicial proceeding. Consistent with 
other applicable Federal laws, testimony and other evidence obtained in 
an investigation or compliance review conducted under this part may be 
used by the Department for, and offered into evidence in, any 
administrative or judicial proceeding related to this part.
    (g) Supervision and coordination. If as a result of an 
investigation, compliance review, or other enforcement activity, OCR 
determines that a Department component appears to be in noncompliance 
with its responsibilities under Federal conscience and anti-
discrimination laws or this part, OCR will undertake appropriate action 
with the component to assure compliance. In the event that OCR and the 
Department component are unable to agree on a resolution of any 
particular matter, the matter shall be submitted to the Secretary for 
resolution. OCR may from time to time request the assistance of 
officials of the Department in carrying out responsibilities in 
connection with the enforcement of Federal conscience and anti-
discrimination laws and this part, including the achievement of 
effective coordination and maximum uniformity within the Department.
    (h) Referral to the Department of Justice. If as a result of an 
investigation, compliance review, or other enforcement activity, OCR 
determines that a recipient or sub-recipient is not in compliance with 
the Federal conscience and anti-discrimination laws or this part, OCR 
may, in coordination with the relevant Department component and the 
Office of the General Counsel, make referrals to the Department of 
Justice, for further enforcement in Federal court or otherwise. OCR may 
also make referrals to the Department of Justice, in coordination with 
the Office of the General Counsel, concerning potential violations of 
18 U.S.C. 1001 or 42 U.S.C. 300a-8 for enforcement or other appropriate 
action.
    (i) Resolution of matters. (1) If an investigation or compliance 
review reveals that no action is warranted, OCR will so inform any 
party who has been notified of the existence of the investigation or 
compliance review, if any, in writing.
    (2) If an investigation or compliance review indicates a failure to 
comply with Federal conscience and anti-discrimination laws or this 
part, OCR will so inform the relevant parties and the matter will be 
resolved by informal means whenever possible. Attempts to resolve 
matters informally shall not preclude OCR from simultaneously

[[Page 23272]]

pursuing any action described in paragraphs (a)(5) through (7) of this 
section.
    (3) If OCR determines that there is a failure to comply with 
Federal conscience and anti-discrimination laws or this part, 
compliance with these laws and this part may be effected by the 
following actions, taken in coordination with the relevant Department 
component, and pursuant to statutes and regulations which govern the 
administration of contracts (e.g., Federal Acquisition Regulation), 
grants (e.g., 45 CFR part 75) and CMS funding arrangements (e.g., the 
Social Security Act):
    (i) Temporarily withholding Federal financial assistance or other 
Federal funds, in whole or in part, pending correction of the 
deficiency;
    (ii) Denying use of Federal financial assistance or other Federal 
funds from the Department, including any applicable matching credit, in 
whole or in part;
    (iii) Wholly or partly suspending award activities;
    (iv) Terminating Federal financial assistance or other Federal 
funds from the Department, in whole or in part;
    (v) Denying or withholding, in whole or in part, new Federal 
financial assistance or other Federal funds from the Department 
administered by or through the Secretary for which an application or 
approval is required, including renewal or continuation of existing 
programs or activities or authorization of new activities;
    (vi) In coordination with the Office of the General Counsel, 
referring the matter to the Attorney General for proceedings to enforce 
any rights of the United States, or obligations of the recipient or 
sub-recipient, under Federal law or this part; and
    (vii) Taking any other remedies that may be legally available.
    (j) Noncompliance with Sec.  88.4. If a recipient of Federal 
financial assistance or applicant therefor fails or refuses to furnish 
an assurance or certification required under Sec.  88.4 or otherwise 
fails or refuses to comply with a requirement imposed by or pursuant to 
that section, OCR, in coordination with the relevant Department 
component, may effect compliance by any of the remedies provided in 
paragraph (i) of this section. The Department shall not be required to 
provide assistance in such a case during the pendency of the 
administrative proceedings brought under such paragraph.


Sec.  88.8  Relationship to other laws.

    Nothing in this part shall be construed to preempt any Federal, 
State, or local law that is equally or more protective of religious 
freedom and moral convictions. Nothing in this part shall be construed 
to narrow the meaning or application of any State or Federal law 
protecting free exercise of religious beliefs or moral convictions.


Sec.  88.9  Rule of construction.

    This part shall be construed in favor of a broad protection of the 
free exercise of religious beliefs and moral convictions, to the 
maximum extent permitted by the Constitution and the terms of the 
Federal conscience and anti-discrimination laws.


Sec.  88.10  Severability.

    Any provision of this part held to be invalid or unenforceable 
either by its terms or as applied to any entity or circumstance shall 
be construed so as to continue to give the maximum effect to the 
provision permitted by law, unless such holding shall be one of utter 
invalidity or unenforceability, in which event such provision shall be 
severable from this part, which shall remain in full force and effect 
to the maximum extent permitted by law. A severed provision shall not 
affect the remainder of this part or the application of the provision 
to other persons or entities not similarly situated or to other, 
dissimilar circumstances.

Appendix A to Part 88--Model Text: Notice of Rights Under Federal 
Conscience and Anti-Discrimination Laws

    [Name of recipient, the Department, or Department component] 
complies with applicable Federal conscience and anti-discrimination 
laws prohibiting exclusion, adverse treatment, coercion, or other 
discrimination against individuals or entities on the basis of their 
religious beliefs or moral convictions. You may have the right under 
Federal law to decline to perform, assist in the performance of, 
refer for, undergo, or pay for certain health care-related 
treatments, research, or services (such as abortion or assisted 
suicide, among others) that violate your conscience, religious 
beliefs, or moral convictions.
    If you believe that [Name of recipient, the Department, or 
Department component] has failed to accommodate your conscientious, 
religious, or moral objection, or has discriminated against you on 
those grounds, you can file a conscience and religious freedom 
complaint with the U.S. Department of Health and Human Services, 
Office for Civil Rights, electronically through the Office for Civil 
Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf or by mail or phone at: U.S. Department of Health 
and Human Services, 200 Independence Avenue SW, Room 509F, HHH 
Building Washington, DC 20201, 1-800-368-1019, 800-537-7697 (TDD). 
Complaint forms and more information about Federal conscience and 
anti-discrimination laws are available at http://www.hhs.gov/conscience.

    Dated: May 2, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-09667 Filed 5-20-19; 8:45 am]
 BILLING CODE 4153-01-P