Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, 3880-3931 [2018-01226]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Proposed Rules]
[Pages 3880-3931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01226]



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Vol. 83

Friday,

No. 18

January 26, 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; Proposed Rule

Federal Register / Vol. 83 , No. 18 / Friday, January 26, 2018 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 88

[Docket No.: HHS-OCR-2018-0002]
RIN 0945-ZA03


Protecting Statutory Conscience Rights in Health Care; 
Delegations of Authority

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

ACTION: Proposed rule.

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SUMMARY: In the regulation of health care, the United States has a long 
history of providing conscience-based protections for individuals and 
entities with objections to certain activities based on religious 
belief and moral convictions. Multiple such statutory protections apply 
to the Department of Health and Human Services (HHS, or the Department) 
and the programs or activities it funds or administers. The Department 
proposes to revise regulations previously promulgated to ensure that 
persons or entities are not subjected to certain practices or policies 
that violate conscience, coerce, or discriminate, in violation of such 
Federal laws. Through this rulemaking, the Department proposes to grant 
overall responsibility to its Office for Civil Rights (OCR) for 
ensuring that the Department, its components, HHS programs and 
activities, and those who participate in HHS programs or activities 
comply with Federal laws protecting the rights of conscience and 
prohibiting associated discriminatory policies and practices in such 
programs and activities. In addition to conducting outreach and 
providing technical assistance, OCR will have the authority to initiate 
compliance reviews, conduct investigations, supervise and coordinate 
compliance by the Department and its components, and use enforcement 
tools otherwise available in civil rights law 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, the Department will require certain recipients to maintain 
records; cooperate with OCR's investigations, reviews, or other 
enforcement actions; submit written assurances and certifications of 
compliance to the Department; and provide notice to individuals and 
entities about their conscience and associated anti-discrimination 
rights, as applicable.

DATES: Submit comments on or before March 27, 2018.

ADDRESSES: You may send comments, identified by RIN 0945-ZA03 or Docket 
HHS-OCR-2018-0002, by any of the following methods:
     Federal eRulemaking Portal. You may submit electronic 
comments at https://www.regulations.gov by searching for the Docket ID 
number HHS-OCR-2018-0002. Follow the instructions for sending comments.
     Regular, Express, or Overnight Mail: U.S. Department of 
Health and Human Services, Office for Civil Rights, Attention: 
Conscience NPRM, RIN 0945-ZA03, Hubert H. Humphrey Building, Room 509F, 
200 Independence Avenue SW, Washington, DC 20201.
     Hand Delivery/Courier: Department of Health and Human 
Services, Office for Civil Rights, Attention: Conscience NPRM, RIN 
0945-ZA03, Hubert H. Humphrey Building, Room 509F, 200 Independence 
Avenue SW, Washington, DC 20201.
    Instructions: All submissions received must include ``Department of 
Health and Human Services, Office for Civil Rights RIN 0945-ZA03'' for 
this rulemaking. All comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided. Further instructions are available under PUBLIC 
PARTICIPATION.
    Docket: For complete access to the docket to read background 
documents or comments received, go to https://www.regulations.gov and 
search for Docket ID number HHS-OCR-2018-0002.

FOR FURTHER INFORMATION CONTACT: Sarah Bayko Albrecht at (800) 368-1019 
or (800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION:

I. Introduction

    The freedoms of conscience and of religious exercise are 
foundational rights protected by the First Amendment to the U.S. 
Constitution and by Federal statutes. These laws ensure, for example, 
that Americans are not compelled to speak, to salute the flag, to join 
a national church, or to vote for a particular candidate.\1\ They also 
ensure that, as a general matter, the Federal government may not 
discriminate against its citizens for the views they hold.\2\ Congress 
has passed laws protecting conscience and religious freedom with 
particular force in the health care context, and it is these statutes 
that are the subject of this proposed rule. Specifically, this proposed 
rule concerns Federal laws that provide:
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    \1\ U.S. Const., amend. I; see also, e.g., West Virginia State 
Board of Education v. Barnette, 319 U.S. 624 (1943); 18 U.S.C. 594.
    \2\ See e.g., Turner Broad. Sys. Inc. v. FCC, 512 U.S. 622 
(1994); Rust v. Sullivan, 500 U.S. 173 (1991); Kingsley Int'l Corp. 
v. Regents of the Univ. of N.Y., 360 U.S. 684 (1954).
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     Conscience protections related to abortion, sterilization, 
and certain other health services to participants in programs--and 
their personnel--funded by the Department (the Church Amendments, 42 
U.S.C. 300a-7);
     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 
and individuals who object to furthering or participating in abortion 
under programs funded by the Department's yearly appropriations acts 
(e.g., Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. H, 
Tit. V, sec. 507(d) (the Weldon Amendment) and at Div. H, Tit. II, sec. 
209);
     Conscience protections under the Patient Protection and 
Affordable Care Act (ACA) 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) and 
(b)(4));
     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));
     Conscience protections related to the performance of 
advanced directives (42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406);
     Conscience protections related to Global Health Programs 
to the extent administered by the Secretary (22 U.S.C. 7631(d); 
Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. J, Tit. 
VII, sec. 7018 (Helms Amendment));
     Exemptions 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 (e.g., 42 
U.S.C. 1320a-1, 1320c-11, 1395i-5 and 1397j-1(b)).
    (These laws will be collectively referred to as ``Federal health 
care conscience and associated anti-discrimination laws'' for purposes 
of this Notice of Proposed Rulemaking.).

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    With this proposed regulation, the Department seeks to more 
effectively and comprehensively enforce Federal health care conscience 
and associated anti-discrimination laws. Specifically, the Department 
proposes to grant its Office for Civil Rights (OCR) overall 
responsibility for ensuring that the Department, its components, HHS 
programs and activities, and those who participate in HHS programs or 
activities comply with these Federal laws. In addition to conducting 
outreach and providing technical assistance, OCR will have the 
authority to initiate compliance reviews, conduct investigations, 
supervise and coordinate compliance by the Department and its 
component(s), and use enforcement tools comparable to those available 
under other civil rights laws to more effectively address violations 
and resolve complaints. In order to ensure that recipients of 
Department funds comply with their legal obligations, as it does with 
other civil rights laws within its purview, the Department will require 
certain funding recipients to maintain records; cooperate with OCR's 
investigations, reviews, or enforcement actions; submit written 
assurances and certifications of compliance to the Department; and 
provide notice to individuals and entities about conscience and 
associated anti-discrimination rights (as applicable).

II. America's Tradition of Conscience Protection, Religious Freedom, 
and the Right to be Free From Unlawful Discrimination

    Congress has a long history of protecting conscience, religious 
beliefs, and moral convictions in law in a variety of contexts. See, 
e.g., 1864 Draft Act, 13 Stat. 9 (exempting religious objectors opposed 
to bearing arms from military service); 50 U.S.C. 3806(j) (exempting 
conscientious objectors from combat training or military service); 18 
U.S.C. 3597(b) (exempting law enforcement employees from participating 
in executions ``if such participation is contrary to the moral or 
religious convictions of the employee''); 20 U.S.C. 1681(a)(3) 
(exempting educational institutions from sex discrimination bans under 
Title IX of the Education Amendments of 1972 where such ban ``would not 
be consistent with the religious tenets'' of the institution); 42 
U.S.C. 300a-8 (prohibiting the coercion of persons to undergo abortion 
or sterilization procedures by threatening loss of benefits and 
attaching a criminal punishment of a fine of not more than $1000, 
imprisonment for not more than one year, or both, to violations of that 
prohibition); see also the Religious Freedom Restoration Act, 42 U.S.C. 
2000bb et seq. (preventing the Federal government from imposing 
substantial burdens on religious exercise absent a compelling 
government interest pursued in the manner least restrictive of that 
exercise).
    The need and justification for these types of laws was aptly 
explained by the Supreme Court in 1965:

    [B]oth 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.

United States v. Seeger, 380 U.S. 163, 170 (1965), quoting Harlan Fiske 
Stone, The Conscientious Objector, 21 Col. Univ. Q. 253, 269 (1919).
    For decades,\3\ Congress has also respected the conscience of 
taxpayers who object to paying for abortion by legislating prohibitions 
on the Federal funding of abortion. Specifically, the Hyde Amendment, 
which Congress has routinely attached to appropriations acts, generally 
prohibits Federal funding of abortion.\4\ See, e.g., Consolidated 
Appropriations Act, 2017, Public Law 115-31, Div. H, sec. 506, 507, 131 
Stat. 562 (May 5, 2017). See also id. at Div. E, sec. 613, 131 Stat. 
372 (using Hyde language to prohibit funding of abortions through 
Federal employee health benefits or coverage); id. at Div. E, sec. 810, 
131 Stat. 393 (applying Hyde language to the District of Columbia); and 
20 U.S.C. 1688 (including language in Title IX to prohibit recipients 
of Federal education funding from requiring any person, or public or 
private entity, to pay for any benefit or service, including the use of 
facilities, related to an abortion).\5\
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    \3\ See E.O. 13535, 75 FR 15599 (Mar. 29, 2010) (establishing 
enforcement mechanism to ``ensure that Federal funds are not used 
for abortion services (except in cases of rape or incest, or when 
the life of the woman would be endangered), consistent with a 
longstanding Federal statutory restriction that is commonly known as 
the Hyde Amendment'').
    \4\ In Harris v. McRae, 448 U.S. 297, 315 (1980), the Supreme 
Court held that Congress has the power to limit or prohibit the 
funding of abortion. In Maher v. Roe, 432 U.S. 464, 474 (1977), the 
court held that the Constitution empowers Congress to make a ``value 
judgment favoring childbirth over abortion'' that it may implement 
``by the allocation of public funds.'' See also Rust v. Sullivan, 
500 U.S. 173, 192-193, 201 (1991).
    \5\ See Mark L. Rienzi, The Constitutional Right Not to Kill, 62 
Emory L.J. 121, 152 (2012) (``[L]egislators acted quickly, 
decisively, and at times nearly unanimously to protect conscience 
rights in the wake of Roe. . . . The speedy passage and near 
ubiquity of these laws demonstrate that a great majority of 
Americans at the time--regardless of their famously intense disputes 
as to the merits of the underlying abortion question--agreed that 
the government should not have the power to compel participation in 
abortions by unwilling individuals and institutions.'').
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    In a May 4, 2017, Executive Order entitled ``Promoting Free Speech 
and Religious Liberty,'' the President declared that the Executive 
Branch will ``vigorously enforce Federal law's robust protections for 
religious freedom.'' E.O. 13798, 82 FR 21675 (May 8, 2017). Pursuant to 
that Executive Order, the Attorney General of the United States issued 
guidance on religious liberty clarifying that Federal law ``protects 
not just the right to believe or the right to worship; it protects the 
right to perform or abstain from performing certain physical acts in 
accordance with one's beliefs.'' Memorandum from the Attorney General, 
Federal Law Protections for Religious Liberty at 2 (Oct. 6, 2017) 
(emphasis added). Pursuant to the President's Executive Order and 
Executive Branch policy, and in keeping with the Attorney General's 
religious liberty guidance, HHS proposes this rule to enhance the 
awareness and enforcement of Federal health care conscience and 
associated anti-discrimination laws, to further conscience and 
religious freedom, and to protect the rights of individuals and 
entities to abstain from certain activities related to health care 
services without discrimination or retaliation.

III. The Federal Health Care Conscience and Associated Anti-
Discrimination Laws Applicable to Government, Providers, Patients, 
Insurers, and Other Entities That Benefit From or Administer Federally 
Funded Health Care Programs or Activities

    As noted above, Congress has recognized that modern health care 
practices may give rise to conflicts with the religious beliefs and 
moral convictions of providers and patients alike. The existence of 
moral and ethical qualms on the part of health care clinicians about 
participating in, assisting, referring for, or otherwise being morally 
complicit in certain procedures is well documented by ethicists.\6\ 
Religious institutions and

[[Page 3882]]

entities, too, have expressed qualms about the provision of, 
participation in, or provision of insurance coverage for, certain 
procedures or services. To address these problems, Congress has 
repeatedly legislated conscience protections for the institutions and 
individuals providing health care to the American public, as outlined 
below.
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    \6\ See, e.g., Stephen J. Genuis & Chris Lipp, Ethical Diversity 
and the Role of Conscience in Clinical Medicine, 2013 Int'l. J. 
Family Med. 1, 9 (2013); 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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A. 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 or sterilizations 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 respecting certain health care 
procedures from discrimination by entities that receive Federal 
funding.
    First, subsection (b) of the Church Amendments provides 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, sterilizations 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). Subsection (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 
entity otherwise prohibits the performance of such procedures on the 
basis of 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)(A) and 
(b)(2)(B). The individuals and entities protected by this provision are 
recipients of a grant, contract, loan, or loan guarantee under the 
Public Health Service Act (42 U.S.C. 201 et seq.) and their 
personnel.\7\
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    \7\ 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), were repealed by subsequent statute and 
accordingly are not referenced here.
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    Second, subsection (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)(A)-
(B). This subsection prohibits certain entities from discriminating in 
these decisions based on an individual's refusal to perform or assist 
in an abortion or sterilization because of 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 subsection (b), recipients of a 
grant, contract, loan, or loan guarantee under the Public Health 
Service Act must comply with subsection (c)(1).
    Third, subsection (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 of 
Health and Human Services. 42 U.S.C. 300a-7(c)(2). This subsection 
prohibits discrimination 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, refusal 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)(A)-(B).
    Fourth, subsection (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 programs, 
no individual shall be required to perform or assist in the performance 
of 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, subsection (e) of the Church Amendments applies to health 
care training or study, such as internships and residencies. Subsection 
(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). Recipients 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 subsection (e). Notably, the 
Church Amendments contain provisions protecting the rights of 
individuals and entities explicitly.

B. The Coats-Snowe Amendment (Section 245 of the Public Health Service 
Act)

    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 Federal, State, or local governments 
receiving Federal financial assistance. 42 U.S.C. 238n. As a condition 
of receiving such funding, those governments may not discriminate 
against ``health care entities,'' including individual physicians; 
participants in programs of training in the health professions; and 
postgraduate physician training programs, including residency training 
programs, that refuse 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).
    In addition, Coats-Snowe applies to accreditation of postgraduate 
physician training programs. Therefore, governments receiving the 
specified Federal funds may not deny a legal status (including a 
license or certificate) or financial assistance, services, or other 
benefits to a health care entity (which, as defined in 42 U.S.C. 
238n(c)(2), includes individual physicians, postgraduate physician 
training programs, and participants in programs of training in the 
health professions) 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

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make arrangements for such training. 42 U.S.C. 238n(b)(1).

C. 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., Consolidated Appropriations 
Act, 2017, Public Law 115-31, Div. H, sec. 507(d), 131 Stat. 135. 
Weldon provides that ``[n]one of the funds made available in this Act 
may 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.'' Consolidated Appropriations Act, 
2017, Public Law 115-31, Div. H, sec. 507(d)(1), 131 Stat. 135. Weldon 
defines ``health care entity'' to ``include[ ] 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. at sec. 507(d)(2).

D. Conditions on Federally Appropriated Funds Requiring Compliance With 
Federal Health Care Conscience and Associated Anti-Discrimination Laws

    In addition to Weldon, the Consolidated Appropriations Act of 2017 
includes other health care conscience protections. For example, a 
provision, using the same language as the Weldon Amendment, prohibits 
the Department from denying participation in Medicare Advantage to an 
otherwise eligible health care entity, such as a provider-sponsored 
organization, on the basis that the health care entity does not 
provide, pay for, provide coverage of, or refer for abortion. 
Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, sec. 
209, 131 Stat. 135.

E. 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 Federal, State, or local 
governments; health care providers that receive Federal financial 
assistance under the ACA; and 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 the HHS Office for Civil Rights (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).
    Finally, Internal Revenue Code sec. 5000A, as added by section 1501 
of the ACA, provides a religious conscience exemption from the 
individual mandate to maintain minimum essential coverage (and avoid 
its corresponding tax penalty) for any member of an exempt religious 
organization or division or for a ``health care sharing ministry.'' 26 
U.S.C. 5000A(d)(2). Exempt religious organizations or individuals are 
those who adhere to established tenets or teachings in opposition to 
acceptance of the benefits of any private or public insurance. 26 
U.S.C. 1402(g)(1). 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). 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 or the 
associated tax penalties imposed under Internal Revenue Code sec. 
5000A, including when such individuals are exempt by reason of 
membership in an exempt religious organization or health care sharing 
ministry. 42 U.S.C. 18081(a)(4), (b)(5).

F. Other Protections Related to the Performance of Advance Directives 
or Assisted Suicide

    Even before the ACA, Congress had passed conscience protections 
related to assisting or causing death. 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 death, such as assisted suicide, euthanasia, or mercy 
killing; or (2) apply to or affect 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. 1396a(w)(3), 1396a(a)(57); 
1396b(m)(1)(A); 1396r(c)(2)(E); and 1395cc(f)(4) (by cross-reference to 
42 U.S.C. 14406).\8\ Those protections extend to Medicaid and Medicare 
providers, such as hospitals, 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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    \8\ Similar protections exist under the Department's regulations 
applicable to hospitals, nursing facilities, and other medical 
facilities, 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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G. Protections Related to Counseling and Referrals Under Medicare 
Advantage Plans, Medicaid Plans, and Managed Care Organizations

    Certain Federal protections extend beyond the context of advance

[[Page 3884]]

directives. For example, Federal law prohibits organizations offering 
Medicare+Choice (now Medicare Advantage) plans and Medicaid managed 
care organizations from being compelled 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).

H. Conscience and Associated Anti-Discrimination Protections Applying 
to Global Health Programs

    The Department administers certain programs under the President's 
Emergency Program 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 agreements for the recipients' refusal to do any 
such actions. 22 U.S.C. 7631(d)(2).

I. Exemptions From Compulsory Medical Screening, Examination, 
Diagnosis, or Treatment

    In addition to these provider protections, multiple Federal health 
programs contain conscience protections for patients and parents of 
children who have objections to certain tests or treatments. Congress 
provided, for example, that neither Medicaid nor the Children's Health 
Insurance Program (CHIP) should be interpreted to require any State 
``to compel any person to undergo any medical screening, examination, 
diagnosis, or treatment'' against their religious objection. 42 U.S.C. 
1396f. Similarly, 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).
    As relevant here, four other statutory provisions protect parents 
who conscientiously 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, 
Health Resources and Services Administration (HRSA) grants may not be 
used to preempt or prohibit State laws, including laws which do not 
require hearing loss screening for newborn infants or young children 
where their parents object to such screening based on religious belief. 
42 U.S.C. 280g-1(d). Third, providers of pediatric vaccines funded by 
Federal medical assistance programs must comply with any State laws 
relating to any religious or other exemptions. 42 U.S.C. 
1396s(c)(2)(B)(ii). Fourth, 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)(1).

J. 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 object to providing many standard medical 
items and services, such as 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,\9\ 
and they provide care exclusively through nonmedical nursing personnel 
assisting with nutrition, comfort, support, moving, positioning, 
ambulation, and other activities of daily living.\10\
---------------------------------------------------------------------------

    \9\ https://www.medicare.gov/coverage/rnhci-items-and-services.html].
    \10\ https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/RNHCIs.html.
---------------------------------------------------------------------------

    Congress has supported RNCHIs 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 1320cb-11 (exemptions from other 
medical criteria and standards), Congress expressly included them 
within the definition of designated Medicare providers. Congress 
prohibited States from excluding RNCHIs 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)(83) (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 
on the basis of ``sincere religious beliefs'' (42 U.S.C. 1395ib-5) yet 
will remain eligible for the nonmedical care and services ordinarily 
covered under Medicare, Medicaid, and CHIP. 42 U.S.C. 1395x(e), 
1395x(y), and 1396g(e). Federal courts have upheld the 
constitutionality of such religious accommodations. See e.g., 
Children's Healthcare v. Min De Parle, 212 F.3d 1084 (8th Cir. 2000) 
and Kong v. Min De Parle, No. C 00-4285 CRB, 2001 WL 1464549 (N.D.Cal. 
Nov. 13, 2001).
    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 a person's ``right to 
practice his or her religion through reliance on

[[Page 3885]]

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 the elder'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).

IV. The Original Version and Current Version of the Rule

    The Department has engaged in rulemaking to enforce some of these 
Federal health care conscience and associated anti-discrimination 
provisions on two previous occasions: in the 2008 Federal Health Care 
Conscience Rule, and in the revocation and replacement of that Rule in 
2011. This Part briefly summarizes each action.

A. 2008 Federal Health Care Conscience Rule

    The Department issued a notice of proposed rulemaking in 2008 to 
clarify and enforce the Church, Coats-Snowe, and Weldon Amendments. 73 
FR 50274 (Aug. 26, 2008). That notice recognized: (1) The inconsistent 
awareness of Federal health care nondiscrimination protections among 
Federally funded recipients and protected persons and entities; and (2) 
the unavailability of remedies for victims of discrimination under the 
above-referenced Amendments.
    The Department received a ``large volume'' of comments on the 2008 
proposed rule. See 73 FR 78072, 78074 (2008 Rule). 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 nondiscrimination protections and provide for 
their enforcement.
    The Department responded to those substantive comments and issued a 
final rule on December 19, 2008, 45 CFR part 88, consisting 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 subsections of Part 88 as they related to each 
conscience law subject to the 2008 Rule.
    Section 88.4 of the 2008 Rule set forth the substantive 
requirements and applications of the Church Amendments, Coats-Snowe, 
and the Weldon Amendment.
    Section 88.5 of the 2008 Rule required covered Federally funded 
entities to provide written certification of compliance with the laws 
on conscience protection subject to the 2008 Rule.
    Section 88.6 of the 2008 Rule designated HHS OCR to receive 
complaints based on the provider conscience laws and directed OCR to 
coordinate handling those complaints with the Departmental components 
with respect to which the covered entity receives funding.

B. 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 conscience protection and provider nondiscrimination 
laws. In response to the proposal to rescind the 2008 Rule, the 
Department received comments stating that health care workers should 
not be required to violate their religious 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 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 the present rule. 76 FR 9968 (Feb. 23, 2011) (2011 
Rule). The 2011 Rule left in place section ``88.1 Purpose,'' but 
removed the word ``implementation,'' describing the 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 section 88.6 as section 
88.2, and modified that section to read, in its entirety: ``The Office 
for Civil Rights (OCR) of the Department of Health and Human Services 
is designated to receive complaints based on the Federal health care 
provider conscience protection statutes. OCR will coordinate the 
handling of complaints with the Departmental funding component(s) from 
which the entity, 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 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

[[Page 3886]]

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.

V. History of OCR Enforcement of Federal Health Care Conscience Laws

    Since the designation of OCR as the agency with authority to 
enforce Federal health care conscience laws in 2008, OCR has received a 
total of forty-four complaints, the large majority of which (thirty-
four) were filed since the November 2016 election.\11\ Of these forty-
four complaints, thirty-five currently remain open. OCR closed six of 
the complaints after investigation and three on administrative grounds.
---------------------------------------------------------------------------

    \11\ After OCR proposed rescission of the 2008 Rule, forty-six 
members of Congress, including the Chairman of the House Energy and 
Commerce Committee with oversight over HHS, raised concerns about 
whether HHS was fully enforcing the Federal health care conscience 
laws. See Rep. Mike Pence, House Energy and Commerce Committee 
Chairman Joseph Pitts, et al., Letter to HHS Secretary Kathleen 
Sebelius (Feb. 11, 2011).
---------------------------------------------------------------------------

    The first of the closed complaints, filed on March 8, 2010,\12\ by 
a nurse at a private hospital, alleged that the hospital had forced her 
to assist in an abortion in 2009 in violation of the Church Amendments. 
OCR conducted an investigation and closed the complaint less than a 
year later after OCR determined that the hospital had agreed to 
sufficient corrective action in a resolution agreement. The hospital 
had agreed to: (1) Comply with the Church Amendments; (2) continue to 
make best efforts to ensure that non-objecting health care personnel 
are available to perform job duties with respect to abortion 
procedures, including any abortion procedures that occur over the 
weekend; (3) revise its human resources policy concerning 
nondiscrimination as set forth in subsection (c)(1) of the Church 
Amendments; (4) continue to post notices of that policy on the 
hospital's intranet and on the operating room notice board; and (5) 
train personnel about the hospital's obligations under the Church 
Amendments to ensure proper recording of staff's objecting or non-
objecting status. In addition, the hospital incorporated technical 
assistance from OCR regarding its process for identifying employees' 
objection status and the hospital's grievance procedures. OCR directed 
the hospital to ensure that no adverse action was taken against the 
complainant or others for participating in the investigation.
---------------------------------------------------------------------------

    \12\ OCR Complaint No. 10-109676.
---------------------------------------------------------------------------

    In January 2011,\13\ OCR closed two other complaints alleging that 
a university violated the Church Amendments by requiring applicants to 
a nurse residency program to sign a form agreeing to assist in abortion 
procedures. Specifically, the application form declared, ``If you are 
chosen for the Nurse Residency Program in the Women's Health track, you 
will be expected to care for women undergoing termination of pregnancy. 
. . . If you feel you cannot provide care to women during this type of 
event, we encourage you to apply to a different track of the Nurse 
Residency Program to explore opportunities that may best fit your 
skills and career goals.'' The form further provided, ``By signing this 
letter, I acknowledge that I am aware that I may be providing nursing 
care for women who are having the procedures listed above.'' OCR closed 
these two complaints after it determined that the university had 
engaged in adequate corrective action--which included a public 
announcement that the university would no longer require an applicant 
to the nursing program to sign the form if doing so would be 
inconsistent with the applicant's religious or moral beliefs.
---------------------------------------------------------------------------

    \13\ OCR Complaint No. 11-122388; OCR Complaint No. 11-122387.
---------------------------------------------------------------------------

    Members of Congress raised concerns following OCR's closure of 
three additional complaints filed on September 10, October 1, and 
October 9, 2014,\14\ alleging that the State of California violated the 
Weldon Amendment by requiring insurance plans to cover elective 
abortions. Those complaints were filed by eighteen different 
complainants: one religious organization, seven churches, one church 
school, two religiously affiliated universities, and seven employees of 
one of those universities who participated in the university's health 
plan. Each complaint alleged that the California Department of Managed 
Health Care (CDMHC) had contacted seven insurers offering plans without 
abortion coverage on August 22, 2014, and stated that those insurers 
were required to include abortion coverage in order to maintain 
certification as insurance companies in California. All seven insurers 
changed their policies in response to the letter. OCR closed the 
complaints on the stated ground that the seven insurers did not object 
to providing abortion coverage on religious or moral grounds and that 
the Weldon Amendment required such objection.\15\
---------------------------------------------------------------------------

    \14\ OCR Complaint No. 14-193604; OCR Complaint No. 15-193782; 
OCR Complaint No. 15-195665.
    \15\ Letter from OCR Director to Complainants (June 21, 2016), 
https://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf.
---------------------------------------------------------------------------

    OCR at that time took the view that a protected entity must assert 
a religious or moral objection in order to merit protection under the 
Weldon Amendment, although the express language of the law does not 
require that a health care entity claim a religious or moral objection 
to merit protection. OCR's closures prompted 133 Members of Congress to 
express concern to the HHS Secretary that the Department failed to 
enforce the Weldon Amendment.\16\ Senior leaders of the House of 
Representatives also scheduled a meeting with the HHS Secretary and OCR 
Director to request information from OCR about these closures.\17\
---------------------------------------------------------------------------

    \16\ Letter from Reps. John Fleming, M.D., Diane Black, et al. 
to HHS Secretary Kathleen Sebelius (Nov. 25, 2014).
    \17\ House Majority Whip Kevin McCarthy, et al., Letter to 
Secretary Sebelius (June 22, 2016).
---------------------------------------------------------------------------

    Since that time, OCR has closed three more complaints on 
administrative grounds. The first, filed on May 5, 2016, alleged that a 
hospital center violated the Church Amendments by discriminating 
against a health care professional who performed and supported the 
performance of abortions,\18\ but the complainant withdrew that 
complaint nine months later. The second, filed October 25, 2016, 
alleged a covered entity discriminated against the complainant when it 
refused to perform a sterilization procedure. Though technically not a 
conscience complaint itself, the covered entity's answer, filed before 
OCR undertook any investigation, raised conscience-based defenses, 
specifically citing the Church Amendments. Following the complainant's 
request to withdraw the complaint, OCR administratively closed the 
case. The third, filed on January 17, 2017, concerned literature the 
complainant received from his employer's pharmacy benefit management 
company, and to which the employee had a religious or moral 
objection.\19\ OCR determined that the complainant had failed to raise 
sufficient facts to support a claim under the Federal health care 
conscience and anti-discrimination laws.
---------------------------------------------------------------------------

    \18\ OCR Complaint No. 15-238113.
    \19\ OCR Complaint No. 17-259696.
---------------------------------------------------------------------------

    Of the ten complaints filed before November 2016, two (one filed 
August

[[Page 3887]]

15, 2014 and the other filed November 4, 2015) remain open. Although 
OCR received on average only approximately 1.25 complaints per year 
from the 2008 Rule until November 2016, OCR has received thirty-four 
complaints between November 2016 and mid-January 2018.

VI. Reasons for the Proposed 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, 
compliance, and enforcement of the Federal health care conscience and 
associated anti-discrimination laws. The 2011 Rule created confusion 
over what is and is not required under Federal health care conscience 
laws and narrowed OCR's enforcement authority. Since November 2016, 
there has been a significant increase in complaints filed with OCR 
alleging violations of these conscience and associated anti-
discrimination laws. The increase underscores the need for the 
Department to have the proper enforcement tools available to 
appropriately enforce Federal health care conscience and associated 
anti-discrimination laws.\20\
---------------------------------------------------------------------------

    \20\ Since 2011, conscience and coercion in health care have 
been the subjects of significant litigation on the State and local 
level. Recently, the Supreme Court agreed to determine whether 
certain disclosures required by a state law violate the Free Speech 
rights of pregnancy resource centers that do not refer for 
abortions. See National Institute of Family and Life Advocates v. 
Becerra, No. 16-1140 (certiorari granted November 13, 2017).
---------------------------------------------------------------------------

A. 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 or moral convictions.\21\ Yet in 
February 2009, the Department announced its intent to rescind the 2008 
Rule just one month after its effective date.\22\ And it completed that 
rescission in 2011 despite significant evidence of an environment of 
discrimination and coercion, including thousands of public comments 
during the 2008 and 2011 rulemakings describing the same. Indeed, a 
2009 article in the New England Journal of Medicine argued, ``Qualms 
about abortion, sterilization, and birth control? Do not practice 
women's health.'' \23\ 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.\24\ Additionally, 32% of 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/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.''
---------------------------------------------------------------------------

    \21\ 73 FR 78072, 78073 (Dec. 19, 2008) (2008 Rule).
    \22\ Rob Stein, Obama Plans to Roll Back `Conscience' Rule 
Protecting Health Care Qf Workers Who Object to Some Types of Care, 
The Washington Post (Feb. 28, 2009) https://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'').
    \23\ 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).
    \24\ The Polling CompanyTM, 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 Memorandum from Jonathan Imbody, Christian Medical Association, 
Vice President for Government Relations to Office of Public Health 
and Science, Department of Health and Human Services (Apr. 9, 2009).
---------------------------------------------------------------------------

    Comments received during the 2011 rulemaking 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.\25\ One obstetrician/gynecologist commented 
that, during his entire time in health care--from medical school, 
through his residency, and to private practice--he had been pressured 
to participate in abortions and abortion counseling.\26\ 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.\27\ At 
least ninety commenters said that, if forced to choose between their 
careers or violating their conscience, they would quit their jobs.\28\ 
Tens of thousands of comments to the proposed 2011 Rule expressed 
concern that, without robust enforcement of Federal health care 
conscience laws, individuals with conscientious objections simply would 
not enter the health care field at all 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.\29\ Thousands 
also feared

[[Page 3888]]

personnel with objections would be terminated or otherwise unable to 
find employment, training, or opportunities to advance in their 
field.\30\ Commenters identified a culture of hostility to conscience 
concerns in health care.\31\ 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.\32\ 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.\33\ Hundreds of commenters expressed concern over the exclusion 
and marginalization of health care entities and employees holding 
religious or moral convictions, and fears that the moral agency of the 
medical profession was eroding.\34\
---------------------------------------------------------------------------

    \25\ Comment Nos. HHS-OPHS-2009-0001-0739, -52648, -52677.
    \26\ Comment No. HHS-OPHS-2009-0001-0868.
    \27\ 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).
    \28\ 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. 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.
    \29\ 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.
    \30\ 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).
    \31\ Comment Nos. HHS-OPHS-2009-0001-0739, -52677, -26812, -
53013 (form letter with 8,472 copies).
    \32\ Comment No. HHS-OPHS-2009-0001-10280, -2486, -46903, -
19125, -36940, -12020, -41551.
    \33\ 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.
    \34\ 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.\35\ 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 (Winnebago County Cir. Ill. June 8, 2016); Cenzon-DeCarlo v. 
Mount Sinai Hospital, 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 hospital due to her objections to prescribing certain medications. 
Hellwege v. Tampa Family Health Centers, 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. 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.\36\
---------------------------------------------------------------------------

    \35\ LI Hospital issues abortion apology to nurses, N.Y. Post 
(Apr. 28, 2010), https://nypost.com/2010/04/28/li-hospital-issues-abortion-apology-to-nurses.
    \36\ 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, ``[i]n an 
emergency in which referral is not possible or might negatively affect 
a patient's physical or mental health, providers have an obligation to 
provide medically indicated and requested care regardless of the 
provider's personal moral objections.'' \37\
---------------------------------------------------------------------------

    \37\ 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 combination of the ACOG opinion and ABOG 
certification requirements could constitute a violation of Federal 
health care conscience laws.
---------------------------------------------------------------------------

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

    The Department has witnessed an increase in lawsuits against State 
and local laws that complainants allege violate conscience. For 
example, many State and local governments have enacted legislation 
requiring pregnancy resource centers to post notices related to 
abortion that plaintiffs have objected to on First Amendment and 
analogous grounds. Courts preliminarily or permanently enjoined 
ordinances in New York City, Austin, Montgomery County, Baltimore, and 
Illinois. Greater Baltimore Center for Pregnancy Concerns, Inc. v. 
Mayor and City Council of Baltimore, No. 16-2325 (4th Cir. Jan. 5, 
2018) (affirming freedom of speech claim to strike down Baltimore 
ordinance requiring pregnancy resource center to state abortion 
services are not available in their facilities); Evergreen Association, 
Inc. v. City of New York, 740 F.3d 233 (2d Cir. 2014) (striking down 
under the First Amendment 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); National Institute of Family and Life 
Advocates v. Rauner, No. 3:16-cv-50310 (N.D. Ill. filed Sept. 29, 2016) 
(preliminary injunction entered on free speech grounds). But litigation 
continues in a case filed against Hawaii. See Calvary Chapel Pearl 
Harbor v. Chin, No. 1:17-cv-00326-DKW-KSC (D. Haw., filed July 12, 
2017) (stayed pending Supreme Court's review of NIFLA v. Becerra). And 
several courts rejected challenges to California's law, see, e.g., 
Mountain Right to Life v. Harris, No. 5:16-cv-00119 (C.D. Calif. 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 these ordinances also require that pregnancy resource 
centers or medical professionals provide information about where 
abortion services can be obtained or whether facilities have licensed 
medical staff. The Supreme Court issued a writ of certiorari in one 
such case challenging California's A.B. 775 on free speech grounds. See 
NIFLA v. Becerra, No. 16-1140 (Nov. 13, 2017).
    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

[[Page 3889]]

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).\38\ 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). The New York State Department 
of Financial Services required individual and small group employers, 
irrespective of the number of employees or any religious affiliation, 
to provide insurance coverage for abortions, see New York Department of 
Financial Services, Outpatient and Professional Services Model 
Language, Section IX[M], prompting additional lawsuits, see, e.g., 
Roman Catholic Diocese of Albany v. Vullo, No. 02070-16 (N.Y. Albany 
County S. Ct. May 4, 2016).
---------------------------------------------------------------------------

    \38\ 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 also 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''). Act 39 states that health care professionals must 
inform patients ``of all available options related to terminal care.'' 
18 Vt. Stat. Ann. Sec.  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. 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 elder abuse 
because the cancer patient died after the oncologists on staff declined 
to participate in assisted suicide and before she could obtain a new 
physician.\39\
---------------------------------------------------------------------------

    \39\ Bob Egelko, California's assisted-dying loophole: Some 
doctors won't help patients die, San Francisco Chronicle (Aug. 12, 
2017), https://www.sfchronicle.com/news/article/California-s-assisted-dying-loophole-Some-11761312.php.
---------------------------------------------------------------------------

    Finally, some States have passed laws requiring health care 
professionals to provide referrals for implementation of advance 
directives. See Iowa Code Ann. section 144D.3(5) (2012) (requiring that 
provider 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'').
    The Department has not opined on or judged the legal merits or 
sufficiency of any of the above-cited lawsuits or challenged laws. They 
are discussed here only to illustrate that recent disputes alleging 
violations of conscience, broadly understood, by state and local 
governments exist to a notable degree, and to illustrate the need for 
greater clarity concerning the scope and operation of the Federal 
conscience and associated anti-discrimination laws that are the subject 
of this regulation. The Department anticipates that the proposed 
regulation will result in greater public familiarity with Federal 
health care conscience and associated anti-discrimination protections 
and may inform both potential plaintiffs and future State and local 
legislators.

C. Confusion Exists About Conscience Laws' Scope and Applicability

    Even though Federal health care conscience and associated 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 health care 
conscience protections 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 associated 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 Corporation, 178 F.Supp.3d 614 (E.D. Mich. 2016) 
(abortion); Minton v. Dignity Health, No. 17-558259 (Calif. Super. Ct. 
Apr. 19, 2017) (hysterectomy); Chamorro v. Dignity Health, No. 15-
549626 (Calif. Super. Ct. Dec. 28, 2015) (tubal ligation). A patient 
also recently 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. Public 
Hospital 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 for respect of 
conscience, and such conscience conditions supersede conflicting 
provisions of State law and must be harmonized and given effect with 
``cross-cutting'' anti-discrimination laws, as in many other contexts. 
See e.g., Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et 
seq. The Department seeks to clarify the scope and application of 
Federal health care conscience and associated anti-discrimination laws 
in the proposed rule.

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

    In lawsuits filed by health care providers for alleged violations 
of certain Federal health care conscience and associated anti-
discrimination laws, courts have held that such laws do not contain an 
implied private right of action to seek relief from such violations by 
non-governmental covered entities. Adequate governmental enforcement 
mechanisms are therefore 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 698-699. 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 Hospital, 962 N.Y.S.2d 
845 (S. Ct. Kings County 2010). The nurse then filed a complaint with 
OCR on January 1, 2011, and, as discussed above, OCR resolved the 
complaint when the hospital

[[Page 3890]]

changed its written policy for health care professionals going forward.
    Similar results were obtained in a Federal lawsuit brought by a 
nurse in 2014, alleging that a health center had violated subsection 
(d) of 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 did not confer a remedy to bring suit against a private entity in 
Federal court. Id. at 1310. In July of this year, 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. National Institute of Family 
and Life Advocates, et al. v. Rauner, No. 3:16-cv-50310, at 4 (N.D. 
Ill. July 19, 2017).

E. Addressing Confusion Caused by OCR Sub-Regulatory Guidance

    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 health care conscience and associated 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.
    This proposed regulation intends to clear up confusion caused by 
OCR sub-regulatory guidance issued through OCR's high-profile closing 
of three Weldon Amendment complaints against the state of California 
filed in 2014.\40\ 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.\41\ 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, because none of the complainants were 
insurance issuers, the letter concluded that none qualified as an 
entity or person protected under the Weldon Amendment. Relying on 
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,'' as 
opposed to some other reason for refusing to facilitate 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 the Constitution's prohibition on the 
Federal government infringing State sovereignty through its Spending 
Clause power.\42\
---------------------------------------------------------------------------

    \40\ OCR Complaint Nos. 14-193604, 15-193782, and 15-195665.
    \41\ Letter from OCR Director to Complainants (June 21, 2016) 
available at https://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf.
    \42\ In reaching this conclusion, the letter cited advice from 
``HHS' Office of General Counsel, after consulting with the 
Department of Justice,'' but HHS believes this advice may have been 
relayed orally as it has not located any written legal analysis from 
either the HHS Office of the General Counsel or the Department of 
Justice despite a diligent search.
---------------------------------------------------------------------------

    The Department does not opine upon, and has not made a judgment on, 
the compatibility of California's policy with the Weldon Amendment. But 
clarifications are in order with respect to the general interpretations 
of the Weldon Amendment offered in OCR's previous closure of complaints 
against California's abortion coverage requirement. The Department has 
engaged in further consideration of these general matters and has also 
further reviewed the Federal health care conscience statutes, the 
legislative history, and the record of rulemaking and public comments 
under Part 88. Based on this review, the Department has concluded that 
the above-mentioned sub-regulatory guidance issued by OCR with respect 
to interpretation of the Weldon Amendment no longer reflects the 
current position of HHS, OCR, or the HHS Office of the General Counsel.
    Specifically, and first, HHS does not believe that the 
``potential'' constitutional concerns cited in the letter relieve HHS 
of the obligations Congress imposed on it to not make certain funding 
available to covered entities that discriminate in violation of the 
Weldon Amendment. Instead, HHS must diligently enforce the Weldon 
Amendment according to its text and to the extent allowed by the 
Constitution. It is a bedrock principle that the Federal government is 
to presume that statutes passed by Congress are constitutional. 
Additionally, if conflicts with the Constitution are clearly present, 
saving constructions should be employed to avoid interpreting statutes 
as dead letters. The Weldon Amendment's funding remedies in cases of 
violation can and should be read and applied consistently with the 
Constitution.
    Second, in contrast to OCR's previous position, HHS concludes that 
the Weldon Amendment's protection for health insurance and any other 
kind of plans is not a protection that may only be invoked or 
complained of by issuers.\43\ Per the amendment, ``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.'' Consolidated 
Appropriations Act, 2017, Public Law 115-31, Div. H, Tit. V, sec. 
507(d) (emphasis added). The amendment's broad and non-exhaustive 
definition indicates that the amendment takes an inclusive approach 
with respect to the health care entities it protects and should not be 
interpreted narrowly. Because the Weldon Amendment protects not only 
the health insurance issuer, but also the health plan itself, it can 
also be raised, at minimum, by the plan sponsor on behalf of the plan, 
as well as by the issuer. Such an interpretation is not foreclosed by 
either the statute or the regulation. Cf. Department of Justice Title 
VI Legal Manual (``The financial assistance does not have to relate to 
a program in which the complainant participates or seeks to participate 
or [to a program] used for the complainant's benefit. Rather, an agency 
only has to prove that the entity received Federal financial assistance 
when the alleged discrimination occurred.'').
---------------------------------------------------------------------------

    \43\ HHS believes health insurance issuers are health care 
entities by that term's plain meaning in the Weldon Amendment. But, 
notably, while the Weldon Amendment explicitly protects plans, it 
does not explicitly mention issuers. This further undermines OCR's 
previous conclusion that the amendment protects issuers, but not 
plans distinct from issuers.
---------------------------------------------------------------------------

    Finally, the plain text of the Weldon Amendment prohibits 
discrimination against protected individuals and entities for being 
unwilling to take certain actions or to provide certain support in 
relation to abortion without requiring a specifically religious or 
moral motive for that decision or position.\44\ The Weldon Amendment

[[Page 3891]]

states that funding shall not be available to an agency, program, or 
government if that ``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.'' See, e.g., Consolidated 
Appropriations Act, 2017, Public Law 115-31, sec. 507(d). While Weldon 
certainly protects objections based on conscience or religion, nothing 
in the text limits its protection to those contexts. The legislative 
history of the Weldon Amendment cannot be used to contradict or limit 
the plain text of the statute. In any event, the legislative history in 
the form of a floor statement from the Amendment's sponsor, 
Representative Dave Weldon, reinforces the plain meaning of the 
amendment. Representative Weldon stated that his amendment ``simply 
states you cannot force the unwilling'' to participate in abortion, and 
that it protects those ``who choose not to provide abortion services,'' 
including health professionals who say they are pro-choice and 
supportive of Roe v. Wade, but would rather not perform abortions 
themselves.\45\
---------------------------------------------------------------------------

    \44\ As seen by the compilation of the Federal health care 
conscience and associated anti-discrimination laws that are the 
subject of this proposed Rule, Congress uses the phrase ``religious 
or moral convictions'' (or an equivalent) when it wants to exempt 
only persons asserting those motivations, and does not include such 
language when it wants to exempt persons and institutions without 
any inquiry into their motivation. See, e.g., 42 U.S.C. 238n (Coats-
Snowe Amendment).
    \45\ 150 Cong. Rec. H10090 (Statement of Rep. Weldon) (Nov. 20, 
2004); 151 Cong. Rec. H177 (Statement of Rep. Weldon) (Jan. 25, 
2005).
---------------------------------------------------------------------------

    The Department is concerned that segments of the public have been 
dissuaded from complaining about religious discrimination in the health 
care setting to OCR, at least in part, as the result of these previous 
unduly narrow interpretations of the Weldon Amendment. For example, 
Foothill Church 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 health care 
conscience laws. See Foothill Church v. Rouillard, No. 2:15-cv-02165-
KJM-EFB, 2016 WL 3688422 (E.D. Calif. July 11, 2016).
    With the proposed 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 and 
moral convictions to enter, or remain in, the health care industry; 
and, by clarifying the Department's general views regarding the 
operation and applicability of the Weldon Amendment, to prevent others 
from being similarly dissuaded from filing complaints due to OCR sub-
regulatory guidance that is no longer reflective of the views of the 
Department.

F. Additional Federal Health Care Conscience and Associated Anti-
Discrimination Laws

    Finally, in addition to all of the concerns discussed above that 
support the proposed rulemaking, the Department proposes to use this 
rulemaking to address various other Federal health care conscience and 
associated anti-discrimination laws not discussed in the 2008 and 2011 
Rules. These provisions include the Consolidated Appropriations Act, 
2017, Public Law 115-31, Div. H, sec. 209; Id., Div. E, sec. 726 and 
808; 22 U.S.C. 7631(d); 29 U.S.C. 669(a)(5); 42 U.S.C. 1396f, 
5106i(a)(1) and (2), 280g-1(d), 290bb-36(f), 1396s(c)(2)(B)(ii), 1395w-
22(j)(3)(B), 1396u-2(b)(3)(B), 1395cc(f), 1396a(w)(3), 1320a-1, 1320c-
11, 1395i-5, 1395x(e), 1395x(y)(1), 1396a(a), 1397j-1(b), and 14406. 
Some of these provisions were enacted after 2008. All provide 
additional protections for health care providers, patients, 
beneficiaries of human services, or providers of human services from 
coercion and discrimination because of moral convictions or religious 
beliefs.

VII. Summary of the Proposed Rule

    This proposed rule would generally reinstate the structure of the 
2008 Rule, supplemented with further definition of Federal health care 
conscience and associated anti-discrimination laws and robust notice 
and enforcement provisions. Specifically, the proposed rule would 
require certain recipients of Federal financial assistance from the 
Department or of Federal funds from the Department to both notify 
individuals and entities who are protected under the Federal health 
care conscience and associated anti-discrimination laws (such as 
employees, applicants, or students) of their rights and also to assure 
and certify to the Department their compliance with the requirements of 
these laws. It would also set forth in more detail the investigative 
and enforcement responsibility of OCR, along with the tools at OCR's 
disposal in carrying out its responsibility with respect to those 
Federal health care conscience and associated anti-discrimination laws.
    By virtue of Congress's enactment of all the Federal health care 
conscience and associated anti-discrimination laws cited herein, the 
Department is required to ensure its own compliance with those 
statutes, 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 Departmental components that provide 
Federal financial assistance. Congress later designated OCR as having 
enforcement authority 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. With the publication of this 
proposed rule in the Federal Register, the Secretary thus provides 
notice of the delegation to OCR of full enforcement authority over a 
significantly larger universe of Federal statutes compared to the 2008 
and 2011 Rules.
    The compliance and enforcement sections specify in much greater 
detail than either the 2008 or 2011 Rule how OCR will enforce the 
Federal health care and associated anti-discrimination laws beyond the 
receipt and handling of complaints and the coordination with other 
Department components. Implementation of the requirements set forth in 
this proposed rule would 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 would be based on complaints, 
referrals, news reports, and OCR-initiated compliance reviews and 
communications activities. If OCR were to become aware of a potential 
violation of Federal health care conscience and associated anti-
discrimination laws, OCR would assist or require such government or 
entity to come into compliance. If, despite the Department's 
assistance, compliance were not achieved, the Department would consider 
all legal options available to overcome the effects of such 
discrimination or violations. Enforcement mechanisms would include 
termination of relevant funding in whole or in part, claw backs, 
referral to the Department of Justice, or other measures. This proposed 
rule clarifies that recipients are liable for their own compliance with 
Federal health care conscience and associated anti-discrimination laws 
and implementing regulations, as well as for ensuring their sub-
recipients comply with these laws. The rule also clarifies that parties 
subject to OCR investigation have a duty to cooperate and preserve 
documents

[[Page 3892]]

and to report that they if they are subject to an OCR enforcement 
action or investigation to their funding agency. Finally, the rule 
grants OCR authority to remedy claims of intimidation and retaliation 
against those who file a complaint or assist in an OCR investigation.

VIII. Section-by-Section Descriptions of the Proposed Rule

Proposed Section 88.1 Purpose

    The ``Purpose'' section of the regulation sets forth the objective 
that the proposed regulation would, when finalized, provide for the 
implementation and enforcement of Federal health care conscience and 
associated anti-discrimination laws. It also states that the statutory 
provisions and regulations contained in this part are to be interpreted 
and implemented broadly to effectuate their protective purposes.

Proposed Section 88.2 Definitions

    Administered by the Secretary: The Department proposes 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.'' This term was used but not defined in the 2008 
Rule, and is defined here in order to add clarity.
    Assist in the Performance: The Department proposes that ``assist in 
the performance'' means ``to participate in any activity with an 
articulable connection to a procedure, health service or health service 
program, or research activity, so long as the individual involved is a 
part of the workforce of a Department-funded entity. This includes 
counseling, referral, training, and other arrangements for the 
procedure, health service, or research activity.'' This definition 
mirrors the definition used for this term in the 2008 Rule.
    In interpreting the term ``assist in the performance,'' the 
Department seeks to provide broad protection for individuals, 
consistent with the plain meaning of the statutes. The Department 
believes that a more narrow definition of the statutory term ``assist 
in the performance,'' such as a definition restricted to those 
activities that constitute direct involvement with a procedure, health 
service, or research activity, would fall short of implementing the 
protections Congress provided. But the Department acknowledges that the 
rights in the statutes are not unlimited, and it proposes to limit the 
definition of ``assist in the performance'' to activities with an 
articulable connection to the procedure, health service, health service 
program, or research activity in question.
    Department: The Department proposes to define ``the Department'' to 
mean the U.S. Department of Health and Human Services and any component 
thereof.
    Discriminate or Discrimination: The Department proposes to define 
``discriminate'' or ``discrimination'' to mean, as applicable and as 
permitted by the applicable statute, (1) to withhold, reduce, exclude, 
terminate, restrict, or otherwise 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, 
terminate, restrict, or otherwise make unavailable or deny any benefit 
or privilege; (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 tends to subject individuals or 
entities protected under this part to any adverse effect described in 
this definition, or to have the effect of defeating or substantially 
impairing accomplishment of a health program or activity with respect 
to individuals, entities, or conduct protected under this part; or (4) 
to otherwise engage in any activity reasonably regarded as 
discrimination, including intimidating or retaliatory action. The 2008 
Rule did not define this term--it is defined here in order to provide 
clearer notice to the public about what sort of conduct certain 
provisions of this proposed rule would prohibit.
    A functional concept of ``discrimination'' in this context must 
account for the various forms that violations of the right of 
conscience can take. One way Federal law prohibits such violations is 
by requiring that religious individuals or institutions be allowed a 
level playing field, and that their beliefs not be held to disqualify 
them from participation in a program or benefit. For example, a medical 
school that receives a grant under the Public Health Service Act may 
not deny admission to an applicant based on that applicant's 
conscientious objection to participating in an abortion. 42 U.S.C. 
300a-7(e). This form of discrimination, broadly conceived--denial of 
participation in a program, service, or benefit--parallels the type of 
discrimination typically prohibited with respect to other protected 
characteristics such as race, color, or national origin. See 45 CFR 
80.3 (HHS regulations implementing Title VI nondiscrimination 
requirements and prohibiting, inter alia, ``Deny[ing] an individual any 
service . . .'', ``Subject[ing] an individual to segregation or 
separate treatment . . .'', ``Treat[ing] an individual differently from 
others in determining whether he satisfies any admission . . . 
requirement . . .'', etc., on the basis of race, color, or national 
origin). HHS believes it appropriate to apply the general principles of 
nondiscrimination enshrined in Title VI with full force to 
discrimination on the basis of religious belief or moral conviction.
    Freedom from discrimination on the basis of religious belief or 
moral conviction, however, does not just mean the right not to be 
treated differently or adversely; it also means being free not to act 
contrary to one's beliefs. To that end, Federal law carves out 
exemptions based on religious and/or conscientious objection to 
otherwise generally applicable requirements that compel certain 
conduct. For instance, as discussed infra, although the ACA's 
individual mandate compels, via force of a tax penalty, the purchase of 
minimum essential health coverage, that mandate exempts certain 
religious organizations and individuals who conscientiously oppose 
acceptance of the benefits of any private or public insurance. 26 
U.S.C. 1402(g)(1). OCR solicits comments regarding the impact on the 
proposed regulation of the planned elimination of the penalty for 
failure to carry ACA-mandated health insurance as set forth in the 
major tax reform legislation passed at the end of 2017.
    The intersection of religion and health care may also create the 
more unusual and insidious circumstance in which governmental 
authorities unlawfully seek to target religious organizations or 
individuals for additional legal or regulatory burdens, precisely 
because of their exercise of a particular religious belief or moral 
conviction. See Church of the Lukumi Babalu Aye, Inc. v. Hialeah, 508 
U.S. 520 (1993) (striking down facially neutral ordinance gerrymandered 
to apply only to religiously motivated conduct). The Supreme Court has 
made clear that governmental burdens on speech targeting particular 
viewpoints are presumptively unconstitutional. Matal v. Tam, 137 S.Ct. 
1744, 1766 (2017) (``A law found to discriminate based on viewpoint is 
an egregious form of content discrimination, which is presumptively 
unconstitutional.''

[[Page 3893]]

(internal citations and quotations omitted)). Thus, within OCR's 
regulatory ambit, and to the extent permitted by law, OCR will regard 
as presumptively discriminatory any law, regulation, policy, or other 
such exercise of authority that has as its purpose, or explicit or 
otherwise clear application, the targeting of religious or conscience-
motivated conduct. In determining the purpose or justification of such 
an exercise of authority, OCR will consider all relevant factors and 
proposes to include in that analysis, when supported by the applicable 
statute, whether or not the exercise of authority has a disparate 
impact on religious believers or those who share a particular religious 
belief or moral conviction. The Department solicits comment on whether 
disparate impact analysis is appropriate, as a policy or legal matter, 
to apply to any of the statutes implemented by this rule; whether it is 
appropriately included in the definition of discrimination, and, if so, 
how disparate impact analysis would be best performed in the context of 
applicable Federal health care conscience and associated anti-
discrimination laws (e.g., how groups suffering the disparate impact 
can be described under the various statutes).
    Entity: The Department proposes to define the term ``entity'' 
consistent with the definition of ``person'' in 1 U.S.C. 1 and also to 
include any State, political subdivision of any State, instrumentality 
of any State or political subdivision thereof, and any public agency, 
public institution, public organization, or other public entity in any 
State or political subdivision of any State. The 2008 Rule provided 
identical definitions for both ``entity'' and ``health care entity.'' 
Here, the Department proposes this definition of ``entity,'' distinct 
from the definition of ``health care entity'' set out infra, to better 
fit the use of these terms in the statutes at issue in this proposed 
rule.
    Federal Financial Assistance: The Department proposes to define the 
term ``Federal financial assistance'' to include ``(1) the grant or 
loan of Federal funds; (2) the grant or donation 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 Federal agreement, 
arrangement, or other contract which has as one of its purposes the 
provision of assistance.'' Note that Federal financial assistance 
includes forms of non-cash assistance. The 2008 Rule did not use the 
term ``Federal financial assistance.'' It is employed here to provide 
greater clarity about what sort of Federal assistance triggers 
obligations under this part. The Department notes that this term will 
likely be familiar to much of the health care industry, and is intended 
in the proposed rule to carry its traditional meaning, such as that 
provided in the Department's regulations implementing Title VI of the 
Civil Rights Act of 1964. See 45 CFR 80.13.
    Not all of the statutes that the proposed rule would enforce use 
the term ``Federal financial assistance.'' This is reflected in the 
text of the various provisions in Sec.  88.3 of the proposed rule, 
which set out the proposed rule's terms regarding the applicability of 
the statutes being enforced. However, the proposed rule would establish 
separate requirements regarding assurance and certification of 
compliance with applicable Federal health care conscience and 
associated antidiscrimination laws, and regarding the posting of 
notices regarding those laws. The proposed rule employs the term 
``Federal financial assistance'' in order to help define who must 
comply with those separate requirements regarding assurance and 
certification of compliance and notices.
    Health Care Entity: The Department proposes to define the term 
``health care entity'' to include an individual physician or other 
health care professional, health care personnel, a participant in a 
program of training in the health professions, an applicant or 
participant for training or study in the health professions, a 
postgraduate 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. It may also include components of 
State or local governments.
    The Department's proposed definition is an illustrative, not 
exhaustive, list. Like the statutory definitions in the Weldon 
Amendment and Public Health Service Act, the Department uses the words 
``include'' and ``any other kind'' to indicate that the list is 
illustrative. Thus, the Department's proposed inclusion of the terms 
``health care professional'' and ``health care personnel'' is intended, 
for example, to cover pharmacists, nurses, occupational therapists, 
public-health workers, and technicians, as well as psychiatrists, 
psychologists, counselors, and other mental health providers, but the 
definition does not enumerate these health care job categories because 
they are reasonably included in such terms. To attempt to employ an 
exhaustive list would run the risk of inadvertently omitting certain 
types of health care professionals or health care personnel.
    With regard to the term ``health insurance plan,'' the Department 
proposes that it include the sponsors, issuers, and third-party 
administrators of health care plans or insurance. The Weldon Amendment 
specifically includes in its definition of the term ``health care 
entity'' ``a provider-sponsored organization, a health maintenance 
organization, a health insurance plan, or any other kind of . . . 
plan'' and protects such health care entities from being subject to 
discrimination on the basis that they do not provide, pay for, cover, 
or refer for abortions. Thus, to ensure that Congress's explicit 
protection for health insurance plans and health care organizations is 
fully enforced, the Department considers it appropriate to include plan 
sponsors not primarily engaged in the business of health care as 
``health care entities'' for purposes of the proposed regulation.
    We ask for comment on this proposed approach. We also ask for 
comment on whether the terms ``entity'' and ``health care entity,'' as 
we propose to employ them in relation to the various statutes that this 
rule implements, clearly and accurately reflect the intent and scope of 
each of those statutes.
    Health Program or Activity: The Department proposes to define 
``health program or activity'' to include 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. In developing an appropriate 
definition for ``health program or activity,'' HHS looked at Section 
1128B(f)(1) of the Social Security Act, 42 U.S.C. 1320a-7b(f)(1), which 
defines a similar term, ``Federal health care program,'' as ``any plan 
or program that provides health benefits, whether directly, through 
insurance, or otherwise, which is funded directly, in whole or in part, 
by the United States Government.'' This term was not used

[[Page 3894]]

in the 2008 Rule, and is added here in order that this proposed rule 
may correspond more precisely to the intended application of the 
statutes at issue, where the term ``health service program'' may not 
suffice.
    Health Service Program: For the purposes of this part, the 
Department proposes to define ``health service program'' to include 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. This definition mirrors the definition used for this term in 
the 2008 Rule.
    Because subsection (d) of the Church Amendments covers health 
service programs or research activities administered by the Secretary, 
these programs include those where the Department provides care or 
health services directly (e.g., Indian Health Service, NIH Clinical 
Center); programs administered by the Secretary that provide health 
services through grants, cooperative agreements, or otherwise (e.g., 
Administration for Children and Families programs such as the 
Unaccompanied Alien Children program, and HRSA programs such as 
community health centers); programs where the Department reimburses 
another entity that provides care (e.g., Medicare); and health 
insurance programs where Federal funds are used to provide access to 
health coverage (e.g., CHIP, Medicaid, and Medicare Advantage). It may 
also include components of State or local governments. The Department 
believes this definition would appropriately effectuate Congress's 
intent to protect health service programs and research activities 
funded in whole or in part by, and/or administered by the Secretary.
    We have proposed definitions for both ``health program or 
activity'' and ``health service program'' because the phrases are used 
in different statutes that are the subject of this proposed rule. We 
ask for comment on whether the terms mean the same thing and should or 
could be defined interchangeably for purposes of this regulation.
    Individual: For purposes of this part, the Department proposes to 
define ``individual'' as a member of the workforce of an entity or 
health care entity. The Department adopts the concept of ``workforce'' 
from the Health Insurance Portability and Accountability Act Rules, 
where it includes volunteers, trainees, or other members or agents of a 
covered entity, broadly defined, when the conduct of the person is 
under the control of such entity. This definition mirrors the 
definition used for this term in the 2008 Rule.
    Instrument: The Department proposes to define ``instrument'' to be 
the means by which Federal funds are conveyed to a recipient, and to 
include grants, cooperative agreements, contracts, grants under a 
contract, memoranda of understanding, loans, loan guarantees, stipends, 
and any other funding or employment instrument or contract. There are a 
variety of means by which the Department conveys Federal financial 
assistance or other Federal funds from the Department to organizations, 
including: Grants, cooperative agreements, contracts, grants under a 
contract, and memoranda of understanding. The definition of 
``instrument'' is intended to include all means by which the Department 
conveys funding and resources. Save for the addition of the phrase 
``loans, loan guarantees, stipends,'' this definition mirrors the 
definition used for this term in the 2008 Rule.
    OCR: The Department proposes to define OCR to signify the Office 
for Civil Rights of the Department of Health and Human Services.
    Recipient: The Department proposes to define ``recipient'' to mean 
``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 would 
include State and local governments, public and private institutions of 
higher education, public and private hospitals, commercial 
organizations, and other quasi-public and private nonprofit 
organizations such as, but not limited to, community action agencies, 
research institutes, educational associations, and health centers. The 
term may include foreign or international organizations (such as 
agencies of the United Nations). This definition differs from the 
definition used for this term in the 2008 Rule in part because this 
proposed rule employs the term ``Federal financial assistance,'' 
whereas the 2008 Rule did not. Other changes made in this definition 
are intended to provide clarity about the types of entities that may 
qualify as recipients.
    As discussed elsewhere in this notice of proposed rulemaking, 
recipients would be subject to this part's requirements regarding 
assurances and certifications of compliance. The Department seeks to 
minimize the financial and administrative burdens of the proposed rule 
by accomplishing the assurances and certifications required of 
recipients through the forms that recipients are already filing to 
assure or certify compliance with other applicable nondiscrimination 
laws. The Department anticipates that the vast majority, if not all, of 
recipients will be able to fulfill their assurance and certification 
requirements by using the modified versions of the forms already in 
use. Accordingly, if an entity is currently required to file an HHS-690 
Form, HHS-5161-1 Form, or another similar form assuring or certifying 
compliance with nondiscrimination requirements in connection with 
Federal financial assistance from or through the Department, that 
entity can reliably assume that it is a ``recipient'' for the purposes 
of this part.
    Referral or Refer for: The Department proposes to define 
``referral'' \46\ or ``refer for'' as including the provision of any 
information (including but not limited to name, address, phone number, 
email, or website) by any method (including but not limited to notices, 
books, disclaimers, or pamphlets online or in print) pertaining to a 
service, activity, or procedure, including related to availability, 
location, training, information resources, private or public funding or 
financing, or direction 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

[[Page 3895]]

service, activity, or procedure to be a purpose or possible outcome of 
the referral. This term was not used in the 2008 Rule. It is added here 
to address confusion the Department perceives among the public about 
what sorts of actions may be properly regarded as referrals for the 
purposes of protecting rights of conscience under the statutes at issue 
in this proposed rule.
---------------------------------------------------------------------------

    \46\ Various ethicists have discussed how referral constitutes 
moral cooperation with a conscientiously objected activity. See, 
e.g., William W. Bassett, Private Religious Hospitals: Limitations 
Upon Autonomous Moral Choices in Reproductive Medicine, 17 J. 
Contemp. Health L. & Pol'y 455, 529 (2001) (``The moral principle 
involved in the cooperation and referral situations is called the 
principle of moral cooperation''); 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) (``not contravening one's conscience through illicit 
cooperation is a significant interest that may obligate one to 
forego other important interests, such as one's job or even 
career''); Stephen J. Genuis & Chris Lipp, Ethical Diversity and the 
Role of Conscience in Clinical Medicine, 2013 Int'l. J. Family Med. 
1, 9 (2013) (``Facilitating a clinical course of action that the 
health provider sincerely deems to be ill-advised, unethical, or 
against the patient's best interests may compromise the integrity of 
the professional role and may violate fundamental tenets of such 
ethical codes'').
---------------------------------------------------------------------------

    The Weldon Amendment prohibits discrimination on the basis that a 
health care entity does not ``refer for abortions.'' The Coats-Snowe 
Amendment prohibits discrimination on the basis that an entity refuses 
to ``provide referrals for [induced abortions],'' ``refuses to make 
arrangements for'' such referrals, or attends a health profession 
training program that does not ``refer for training in the performance 
of induced abortions.'' Section 1303 of the ACA prohibits qualified 
health plans offered through an exchange from discriminating against 
any individual health care provider or health care facility because of 
its unwillingness to refer for abortions. 42 U.S.C. 18023(b)(4). 
Medicare Advantage contains a protection for entities that inform HHS 
that they will not provide referrals for abortions. Consolidated 
Appropriations Act of 2017, Public Law 115-31, 131 Stat. 502, Div. H, 
sec. 209 (2017). Certain recipients of funds administered by Secretary 
under the Foreign Assistance Act cannot be required to make a referral 
to a program or activity to which the recipient has a religious or 
moral objection. 22 U.S.C. 7631(d). Medicare Advantage plans and 
Medicaid managed care organizations are protected from being required 
to provide certain referral services. 42 U.S.C. 1395w-22(j)(3); 42 
U.S.C. 1396u-2.
    The Department believes that Congress provided, in these Federal 
health care statutes, protections for entities from discrimination in a 
broad way related to referring for abortions or abortion training, or, 
as specified in applicable statutes, for other kinds of services. In 
the Coats-Snowe Amendment, for example, Congress protected not only the 
refusal to provide referrals for abortion, but also the refusal to make 
arrangements to provide referrals for abortion. This protects entities 
that object not just to making referrals, but to rendering aid to 
anyone else who is reasonably likely to make an abortion referral. 
Likewise, in the Weldon Amendment and Section 1303 of the ACA, Congress 
specified that it 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.
    Under the proposed definition, to provide an abortion referral, 
refer for abortion, or make arrangements for an abortion referral, 
would include such activities as providing to a patient seeking 
abortion contact information of a physician or clinic that may provide 
an abortion, or telling a patient that funding is available for 
abortion and providing a phone number where she can be referred to 
abortion services or funding. It would include such activities by any 
method, such as orally, in writing, digitally, or through the posting 
of notices. The Department believes defining referral or refer in a 
more narrow way, for example to only mean an endorsement, 
recommendation, facilitated referral to a physician, or transfer of 
records to a specific provider, would fail to implement Congress's 
broad protection for entities unwilling to be complicit in the 
provision of items or services they cannot in good conscience 
themselves provide.
    State: The Department proposes to define ``State'' to include, in 
addition to the several States, the District of Columbia. For those 
provisions in this part related to or relying upon the Public Health 
Service Act, the term ``State'' is proposed to include the several 
States, the District of Columbia, the Commonwealth of Puerto Rico, 
Guam, the Northern Mariana Islands, the Virgin Islands, American Samoa, 
and the Trust Territory of the Pacific Islands. For those provisions in 
this part related to or relying upon the Social Security Act, the term 
``State'' is proposed to incorporate the definition of ``State'' found 
at 42 U.S.C. 1301. This term was not defined in the 2008 Rule but is 
added here to reflect that the term carries different meanings in 
certain statutes at issue in this proposed rule. The Department seeks 
comment on whether this definition fully and accurately implements the 
scope of the statutes that are the subject of this proposed rule, 
especially with regard to statutes that cover State and local 
government or other public authorities.
    Sub-recipient: The Department proposes to define ``sub-recipient'' 
to mean ``any political subdivision of any State, any 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 another 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 includes State and local governments, 
public and private institutions of higher education, public and private 
hospitals, commercial organizations, and other quasi-public and private 
nonprofit organizations such as, but not limited to, community action 
agencies, research institutes, educational associations, and health 
centers. The term may include foreign or international organizations 
(such as agencies of the United Nations). As with the definition of 
``recipient,'' this definition differs from the 2008 Rule's definition 
of this term in part because of the use of the term ``Federal financial 
assistance,'' and also in order to provide greater clarity about the 
types of potentially covered entities.
    Workforce: The Department proposes to define ``workforce'' to 
consist of 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. This definition substantially mirrors the 
definition used for this term in the 2008 Rule.

Proposed Section 88.3 Applicable Requirements and Prohibitions

    The proposed ``Applicability'' section outlines the specific 
requirements of the Federal health care conscience and associated anti-
discrimination laws that apply to various persons and entities. These 
provisions are 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'' section explains the 
obligations that the Federal health care conscience and associated 
anti-discrimination statutes impose on the Department and on entities 
that receive applicable Federal financial assistance and other Federal 
funding from the Department. These provisions are taken from the 
relevant statutory language.
    We intend for the proposed requirements and prohibitions to be 
interpreted using the definitions proposed in section 88.2.

[[Page 3896]]

Proposed Section 88.4 Assurance and Certification of Compliance 
Requirements

    In the ``Assurance and Certification of Compliance'' section, the 
Department would require certain recipients to submit written 
assurances and certifications of compliance with the Federal health 
care conscience and associated anti-discrimination laws, as applicable, 
as a condition of the terms of acceptance of the Federal financial 
assistance or other Federal funding from the Department. While the 2008 
Rule required only the submission of a certification of compliance, the 
Department believes that both an assurance and certification provide 
important protections to persons and entities under these laws and 
would be consistent with requirements under other civil rights laws. We 
are concerned that there is a lack of knowledge on the part of States, 
local governments, and the health care industry of the rights of 
protected persons and entities, and the corresponding obligations on 
covered entities provided by the Federal health care conscience and 
associated anti-discrimination laws. Certifications provide a 
demonstrable way of ensuring that applicants for such funding know of, 
and attest that they will comply with, applicable Federal health care 
conscience and associated anti-discrimination laws.
    Applicants for Department grants, loans, contracts, Federal 
financial assistance, or other Federal funds from the Department are 
currently required to sign assurances and certifications of compliance 
with several specific civil rights laws, such as Title VI of the Civil 
Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, 
Title IX of the Education Amendments of 1972, the Age Discrimination 
Act of 1975. See HHS-690 Form, OMB No. 0945-0006 (Medicare Part A); 
HHS-5161-1 Form, OMB No. 0930-0367 (HHS Grant Applications). The 
assurances and certifications of compliance required by this part would 
be accomplished via submission of modified versions of the applicable 
civil rights clearance forms, such as the HHS-5161-1 Form, HHS-690 
Form, or similar forms that may be developed and implemented in the 
future.
    The HHS-690 Form (Assurance of Compliance) briefly identifies the 
prohibited discriminatory conduct covered by each civil rights law. 
Although many Federal health care conscience and associated anti-
discrimination laws were enacted at approximately the same time as 
those other civil rights laws, such conscience laws are not 
specifically mentioned in Form HHS-690 Form or HHS-5161-1 Form. Adding 
the above-referenced laws to these forms would increase awareness of 
the Federal health care conscience and associated anti-discrimination 
laws and demonstrate the Department's commitment to consistently 
enforcing all civil rights protections on an equal basis. The 
certification form serves to provide a formal statement by the 
recipient, generally subsequent to the submission of the assurance that 
the recipient actually is currently in compliance with the referenced 
requirements.
    Given this backdrop, section 88.4 proposes 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 health care conscience and 
associated anti-discrimination provisions and this part. Consistent 
with current practice, we propose covered applicants file the HHS-690 
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, proposed Sec.  88.4(b)(6) permits an applicant to 
incorporate the assurance by reference in subsequent applications to 
the Department. The proposed rule explains that both the assurance and 
certification shall 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) clarifies that a violation 
of the requirements of the certification may result in enforcement by 
the Department, as provided in section 88.7 of this part.
    The Department believes that requiring assurances and 
certifications of compliance by applicants for and recipients of 
Federal financial assistance and other Federal funds from the 
Department would provide an important vehicle for increasing awareness 
of Federal health care conscience and associated anti-discrimination 
laws and thereby increasing compliance. While many people in the health 
care field may have general knowledge that Federal health care 
conscience and associated anti-discrimination protections exist for 
persons and health care providers, the scope of these protections is 
not always widely understood. Because Congress has enacted several 
different protections, a person or entity may be aware that, for 
instance, a physician may not be compelled to perform abortions, but 
may not be aware of other aspects of the statutes providing Federal 
health care conscience and associated anti-discrimination protections. 
Others may become aware of these laws, at least in detail, only when a 
dispute arises and a person, provider, or entity attempts to assert 
their Federal health care conscience rights, and there may be 
subsequent disagreement over the nature of the rights asserted.
    The Department recognizes that it needs to undertake significant 
outreach efforts in order for the rule to be maximally effective. Thus, 
the Department will consider all avenues available for increasing 
public awareness of Federal health care conscience laws. The Department 
welcomes public comment on the various options available for public 
education and outreach.
    Paragraph (b) identifies specific requirements for the proposed 
assurance and compliance requirements: (b)(1) Addresses the timing to 
submit the assurance for current applicants or recipients as of the 
effective date of this part; (b)(2) addresses the form and manner of 
such submittals; and (b)(3) addresses the duration of obligations for 
both the assurance and certification. In regard to the form and manner 
of the submission, the Department is committed to leveraging existing 
grant, contract, and other Departmental forms where possible rather 
than creating additional, separate forms for recipients to sign. To 
this end, Sec.  88.5(4)(2) explains that applicants shall 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. Such certifications should be 
clearly written so that applicants and recipients know, by means of the 
certification, which provisions they must comply with based on the 
nature of the recipient or the funding mechanism through which it 
receives funds.
    Department components will 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 intends 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 fails or refuses to 
furnish a required assurance or

[[Page 3897]]

certification, OCR, in coordination with the relevant Department 
component, may effect compliance by any of the remedies provided in 
Sec.  88.7.
    While both recipients and sub-recipients, as defined herein, must 
comply with the substantive requirements of Federal health care 
conscience and associated anti-discrimination laws, as applicable, sub-
recipients are not subject to the requirements of section 88.4 
regarding assurance and certifications of compliance. This approach 
departs from the 2008 Rule, which required certifications of compliance 
to be submitted by both recipients and sub-recipients. By exempting 
sub-recipients from this requirement, the Department seeks to cut down 
on administrative burdens. The Department invites 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.
    Section 88.4(c) also contains 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 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.
    Requiring the large number of entities in these four categories to 
submit assurance and certification requirements would pose significant 
implementation hurdles for Departmental components, programs, and 
services. Furthermore, the Department believes that, due primarily to 
their generally smaller size, several of the excepted categories of 
recipients of Federal financial assistance or other Federal funds from 
the Department are less likely to encounter the types of issues sought 
to be addressed in this regulation. For example, State Medicaid 
programs are already responsible for ensuring the compliance of their 
sub-recipients as part of ensuring that the State Medicaid program is 
operated consistently with applicable nondiscrimination provisions. 
Similarly, certain programs currently administered by the 
Administration for Children and Families and the Administration on 
Community Living involve the provision of grants to States and other 
governments, or cash assistance or vouchers rather than direct 
services, and they are not likely to involve medical research, the 
participation of health care providers, or referral to health care 
providers.
    Excepted providers, however, may become subject to the assurance 
and certification requirement if they receive Federal financial 
assistance or Federal funds from the Department through a mechanism or 
in a manner not excepted by this section. For example, a physician 
office participating in Medicare Part B may become subject to the 
written certification requirement by receiving Department funds to 
conduct clinical research. And it is important to emphasize that no 
exemption from the requirements of this regulation regarding notice, 
assurances, or certifications relieves the Department, recipients, or 
sub-recipients, and State and local governments, of their obligations 
to comply with these longstanding Federal health care conscience laws.
    The Department seeks 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.

Proposed Section 88.5 Notice Requirement

    The proposed rule adds a ``Notice'' section that was not contained 
in the 2008 Rule. This section requires the Department and recipients 
to notify the public, patients, and employees, which may include 
students or applicants for employment or training, of their protections 
under the Federal health care conscience and associated anti-
discrimination statutes and this regulation.
    For consistency with other notice requirements in civil rights 
regulations, paragraph (a) of Sec.  88.5 proposes to require the 
Department and recipients to post the notice in Appendix A within 90 
days of the effective date of this part. This notice advises persons 
and entities about their rights and the Department's and recipients' 
obligations under Federal health care conscience and associated anti-
discrimination laws. The notice provides information about how to file 
a complaint with OCR. We seek comment on whether there are categories 
of recipients that should be exempted from this requirement to post 
such notices.
    The proposed rule requires all Department components and recipients 
to use the notice text in Appendix A. This approach maximizes 
efficiency and economies of scale by enabling recipients to leverage 
the text of an HHS-authored notice. We invite 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) sets forth two categories of locations where 
the notice must 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) imposes readability requirements without identifying 
prescriptive font-size or other display requirements. The proposed 
readability specifications advance the goal for the notice content to 
appear sufficiently conspicuous and visible that persons observing it 
could reasonably be expected to see and be able to read the 
information.
    Proposed paragraph (c) incentivizes recipients to display the 
notice in locations other than their websites and physical 
establishments. In the event that the OCR Director, pursuant to the 
proposed enforcement authority in section 88.7 of this part, 
investigates or initiates a compliance review of a recipient, the OCR 
Director will consider as one of many factors in compliance whether the 
recipient posted the notice in the documents described in paragraphs 
(c)(1)-(3), as applicable. Because this part regulates a diverse range 
of recipients, we identified three categories of documents most common 
across all recipients. We seek comment on the proposed approach of 
paragraph (c) and on the categories of documents identified in 
paragraphs (c)(1)-(3).
    Finally, we recognize that recipients may be subject to other 
notice requirements under Federal and State law. Paragraph (d) of Sec.  
88.5 proposes to permit recipients to combine the text of the notice 
required in paragraph (a) with other notices under the condition that 
the recipient retains all of the language provided in Appendix A of 
this part in an unaltered state. Instead of regulating the manner of 
compliance, we considered permitting recipients to

[[Page 3898]]

integrate and revise the text of the notice required in paragraph (a) 
with other notices. Although this approach permits greater flexibility, 
it invites potential unintentional misrepresentation of Federal health 
care conscience and associated anti-discrimination rights. We request 
comment on whether paragraph (d) strikes the best balance based on 
recipients' experiences.

Proposed Section 88.6 Compliance Requirements

    This section identifies specific requirements for compliance with 
the Federal health care conscience and associated anti-discrimination 
laws. Recipients and other agency components must maintain records 
evidencing compliance with these laws and the proposed regulation and 
are required to cooperate with OCR in the enforcement process. If a 
recipient or sub-recipient is subject to an OCR compliance review, 
investigation, or complaint filed with OCR regarding the recipient's or 
sub-recipient's compliance with Federal health care conscience and 
associated anti-discrimination laws, the recipient or sub-recipient 
must inform any Departmental funding component of such review, 
investigation, or complaint. The recipient or sub-recipient must also, 
in any application for new or renewed Federal financial assistance or 
Departmental funding, disclose the existence of such compliance review 
or investigation, and must also report on such applications the 
existence of any complaints filed with OCR if a complaint had been 
filed in the previous five years before the recipient's or sub-
recipient's application. This section also addresses 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.

Proposed Section 88.7 Enforcement Authority

    This section reaffirms the delegation to OCR of the Department's 
authority to enforce the Federal health care conscience laws, in 
collaboration with the relevant Department components. OCR has been 
expressly delegated the authority to enforce the Church, Coats-Snowe, 
and Weldon Amendments since the 2008 Rule. Enforcement of section 1553 
is expressly delegated to OCR in the ACA. Each of the Federal health 
care conscience laws, by virtue of Congressional enactment, requires 
compliance by the Department and covered entities. This NPRM provides 
notice that the Secretary has delegated to OCR the authority to enforce 
all Federal health care conscience and associated anti-discrimination 
laws that are the subject of the proposed rule. This section also 
includes retaliation claims in the event a covered entity takes any 
such retaliatory actions against those who participate in or assist an 
OCR enforcement action.
    This section also specifies that OCR's enforcement authority 
includes 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 health care conscience and 
associated anti-discrimination laws and the proposed regulation, as 
allowed by law. The current text of Sec.  88.7 of this part grants 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 Director may, in coordination with a 
relevant Department component, restrict funds for noncompliant entities 
in whole or in part, including by limiting funds to certain programs 
and particular covered entities, or by restricting a broader range of 
funds or broader categories of covered entities, as allowed by law to 
effectuate the Federal health care conscience laws. In addition to 
withdrawal of funding, possible corrective actions include settlements 
or voluntary resolution agreements where allowed. OCR can also refer 
cases to the Department of Justice for additional enforcement, and in 
coordination with the relevant Department component.
    The proposed rule would also make explicit the Department's 
authority to investigate and handle violations and conduct compliance 
reviews whether or not a formal complaint has been filed. That language 
is consistent with OCR's enforcement practices under other civil rights 
laws, and with the Department's obligation to enforce Federal health 
care conscience and associated anti-discrimination laws. Under the 
proposed rule, OCR would also be explicitly authorized to investigate 
``whistleblower'' complaints, or complaints made on behalf of others, 
whether or not the particular complainant is a person or entity 
protected by conscience and associated antidiscrimination laws.
    This section adopts the enforcement procedures for other civil 
rights laws, such as Title VI and Section 504 of the Rehabilitation 
Act. See, e.g., 45 CFR 80.8 through 80.10 and 84.7. If the Department 
becomes aware that a State or local government or an entity may have 
undertaken activities in violation of statutory conscience and 
associated antidiscrimination laws, the Department will work with such 
government or entity to provide assistance and guidance to recipients 
to help them comply voluntarily with the law and this part. For 
compliance, recommended best practices (as identified in the 
Department's other civil rights regulations) include such procedures 
as: (1) The designation of at least one employee responsible for 
compliance, (2) the adoption of internal grievance procedures to 
provide for prompt and equitable resolution of complaints, and (3) the 
preparation of internal compliance reports by recipients, sub-
recipients, participants, and beneficiaries.
    If, despite the Department's assistance, compliance is not 
achieved, the Department will consider all legal options, up to and 
including termination of funding and return of funds, as applicable. 
Remedial measures include the temporary withholding of cash payments in 
whole or part, pending correction of the deficiency, the denial of 
funds and any applicable matching credit in whole or in part, the 
suspension or termination of the Federal award in whole or in part, the 
withholding of new Federal financial assistance or other Federal funds 
from the Department, referral of the matter to the Attorney General for 
enforcement proceedings, and any other remedies that may be legally 
available.
    The Department solicits 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 health care conscience and associated 
antidiscrimination 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(j)(3) of the proposed 
rule. For example, comment is 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. We also request 
comment on whether and in what circumstances it is

[[Page 3899]]

appropriate to require remedies against a recipient for the violations 
of a sub-recipient, or against entities whose subsidiaries are found to 
be in violation of any Federal health care conscience and associated 
antidiscrimination law or the proposed regulation.

Proposed Section 88.8 Relationship to Other Laws

    This section clarifies the relationship between this part and other 
Federal, State, and local laws that protect religious freedom and moral 
convictions. Many State laws provide additional conscience protections 
for providers who have objections to abortion, fertility treatments, 
sterilization, capital punishment, assisted suicide, and 
euthanasia.\47\ The Department proposes 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 will not construe Federal law to preempt or 
impair the application of that law, unless expressly provided.
---------------------------------------------------------------------------

    \47\ See, e.g., Ala. Code 15-18-82.1(i) (2017); Alaska Stat. 
18.16.010(b), 13.52.060(e) (2017); Ariz. Rev. Stat. Ann. 20-826(Z), 
20-1057.08(B), 20-1402(M), 20-1404(V), 20-2329(B), 20-2329(C), 36-
3205(C)(1), 36-2154 (2017); Ark. Code Ann. 20-13-1403(b), 20-16-
304(4)-(5), 20-16-601, 23-79-1103(b), 23-79-1104(b)(3) (2017); Cal. 
Prob. Code 4734 (West 2017); Cal. Penal Code 3605(c) (West 2017); 
Cal. Bus. & Prof. Code 733(b)(3) (West 2017); Cal. Health & Safety 
Code 443.14(b), (e), 443.15, 1367.25(c), 1374.55(e)-(f), 123420 
(West 2017); Cal. Ins. Code 10119.6(d)-(e), 10123.196(e) (West 
2017); Colo. Rev. Stat. 25-6-102(9), 25-6-207, 25-3-110(3) (2017); 
Conn. Gen. Stat. 38a-503e(b), (e), 38a-536(c), 38a-509(c), 38a-
530e(b), (e), (2017); Del. Code Ann. tit. 24, 1791, tit. 18, Sec.  
3559(d) (2017); Fla. Stat. 381.0051(5), 390.0111(8), 409.973(1)(h), 
765.1105, 922.105(9) (2017); Ga. Code Ann. 16-12-142, 17-10-38(d), 
31-20-6, 49-7-6 (2017); Haw. Rev. Stat. 431:10A-116.7, 453-16(e), 
327E-7(e) (2017); Idaho Code Ann. 18-611, 18-612, 39-3915 (2017); 
745 Ill. Comp. Stat. 70/1-70/14 (2017); 215 Ill. Comp. Stat. Sec.  
5/356m(b)(2) (2017); 720 Ill. Comp. Stat. Sec.  510/13 (2017); 745 
Ill. Comp. Stat. Sec.  30/1 (2017); Ind. Code 16-34-1-3 to -7 
(2017); Iowa Code 146.1-.2 (2017); Kan. Stat. Ann. 65-443, -444, 65-
446, -447, 65-1637(n), 65-6737 (2017); Ky. Rev. Stat. Ann. Sec.  
311.800(3)-(5) (West 2017); La. Rev. Stat. Ann. 15:569(C), 
15:570(C), 40:1061.2-.3, 40:1061.4(C), 40:1061.20 (2017); Me. Rev. 
Stat. tit. 18-A, 5-807(e), tit. 32, 13795(2-3), tit. 22, 1591-1592, 
1903(4), tit. 24, 2332-J(2), tit. 24-A, 2756(2), 2847-G(2), 4247(2), 
tit. 34-B, Sec.  7016 (2017); Md. Code Ann., Health-Gen. 20-214 
(West 2017); Md. Code Ann., Ins. 15-810(i), 15-826(c) (West 2017); 
Mass. Gen. Laws ch. 112, 12I, ch. 272, 21B, ch. 175, 47W(f), ch. 
176A, 8W(f), ch. 176B, 4W(f), ch. 176G, 4O(c) (2017); Mich. Comp. 
Laws Serv. 333.20181 to 333.20184 (2017); Minn. Stat. 145.414, 
145.42, 145.925(6) (2017); Miss. Code Ann. 41-41-215(5), 41-107-5 to 
-9 (2017); Mo. Rev. Stat. 188.105-.110, 191.724, 197.032, 338.255 
(2017); Mont. Code Ann. Sec.  50-20-111, 50-5-502 to -505 (2017); 
Neb. Rev. Stat. 28-337 to -341 (2017); Nev. Rev. Stat. 449.191, 
632.475, 689A.0415(5), 689A.0417(5), 689B.0376(5), 689B.0377(5), 
695B.1916(5), 695B.1918(5), 695C.1694(5), 695C.1695(5) (2017); N.J. 
Stat. Ann. 2A:65A-1, to -3, 17B:27-46.1x(b), 17:48A-7w(b), 17:48-
6x(b), 17:48E-35.22(b), 26:2J-4.23(b), 17:48-6ee, 17:48A-7bb, 
17:48E-35.29, 17B:27-46.1ee, 17B:26-2.1y, 26:2J-4.30, 17B:27A-19.15, 
17:48F-13.2, 17B:27A-7.12 (West 2017); N.M. Stat. Ann. 24-8-6(A)(2), 
24-7A-7(E), 30-5-2, 59A-22-42(D), 59A-46-44(C) (2017); N.Y. Civ. 
Rights Law Sec.  79-i (McKinney 2017); N.Y. Ins. Law 3221(l)(16)(A), 
4303(cc)(1) (McKinney 2017); N.C. Gen. Stat. Sec.  14-45.1(e)-(f), 
58-3-178(e) (2017); N.D. Cent. Code Sec.  23-16-14 (2017); Ohio Rev. 
Code Ann. Sec.  4731.91 (West 2017); Okla. Stat. tit. 63, 1-568, 1-
728c to -728f, 1-741 (2017); Or. Rev. Stat. 127.625, 127.885, 
435.225, 435.475, 435.485 (2017); 43 Pa. Cons. Stat. 955.2 (2017); 
18 Pa. Cons. Stat. 3213(d) (2017); R.I. Gen. Laws 23-17-11, 27-18-
57, 27-19-48, 27-20-43, 27-41-59 (2017); S.C. Code Ann. 44-41-40, 
44-41-50 (2017); S.D. Codified Laws 34-23A-11 to -14, 36-11-70 
(2017); Tenn. Code Ann. 39-15-204 to -205, 68-34-104(5) (2017); Tex. 
Ins. Code Ann. 1271.007, 1366.006, 1369.108 (West 2017); Tex. Occ. 
Code Ann. 103.001-.004 (West 2017); Utah Code Ann. sec. 76-7-306 
(West 2017); Vt. Stat. Ann. tit. 18, 5285-5286 (2017); Va. Code Ann. 
sec. 32.1-134, 18.2-75, 54.1-2957.21 (2017); Wash. Rev. Code Ann. 
9.02.150, 48.43.065(2), 70.47.160(2), 70.245.190 (2017); W. Va. Code 
16-2B-4, 16-11-1, 16-30-12 (2017); Wis. Stat. 253.07(3)(b), 253.09, 
441.06(6), 448.03(5)(A) (2017); Wyo. Stat. Ann. 42-5-101(d)-102, 35-
6-105 to-106 (2017).
---------------------------------------------------------------------------

    This section is new to this proposed rule with no analog in the 
2008 Rule.
    The proposed rule does 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. OCR will enforce 
all civil rights laws consistent with the Constitution and the 
statutory language.

Proposed Section 88.9 Rule of Construction

    This section ensures that the protections for religious freedom and 
moral conviction provided by this part shall be construed broadly and 
to the maximum extent permitted by law and the Constitution.

Proposed Section 88.10 Severability

    This section is a ``severability clause'' for the proposed 
regulation that provides that, if any provision or part of a provision 
of the proposed regulation is held to be invalid or unenforceable, 
either facially or as applied, the provision in question will be 
construed in a manner that allows it to remain in force to the maximum 
extent permitted by law. Furthermore, if a provision of the proposed 
regulation is held to be invalid or unenforceable, that provision is 
severable from the rest of the proposed regulation, which remains in 
full force and effect to the maximum extent permitted by law. A severed 
provision shall not affect the remainder of the proposed regulation, 
and where possible the severed provision remains in effect as applied 
to other persons or situations not similarly situated, or to other 
dissimilar circumstances.

IX. Request for Comment

    In addition to the requests for comments mentioned elsewhere in 
this notice of proposed rulemaking, the Department, in order to draft 
its final rule to best reflect the experiences and concerns of those 
most impacted, seeks comment on this Proposed Rule. In particular, the 
Department seeks the following:
     Comment on all issues raised by the proposed regulation.
     Information, including any facts, surveys, audits, or 
reports, about the occurrence or nature of coercion, discriminatory 
conduct, or other violations of the Federal health care conscience and 
associated anti-discrimination laws.
     Information, including any facts, surveys, audits, or 
reports, with regard to the general knowledge, or lack thereof, of the 
protections established by the Federal health care conscience and 
associated anti-discrimination provisions among the general public, as 
well as within the health care field, health care insurance industry, 
and employment law field.
     Information, including any facts, surveys, audits, or 
reports, on whether public authorities continue to claim that the 
receipt of Federal funds is a sufficient basis for entities to be 
required to participate in abortions or sterilizations. If so, comment 
on how the Department should address this problem.
     Information, including any facts, surveys, audits, or 
reports, about whether parents or legal guardians are discriminated 
against based on objections to testing or treatment of their minor 
children.
     Information, including any facts, surveys, audits, or 
reports, about whether individuals or entities have been coerced or 
discriminated against based on their religious or moral objection to 
counseling or referral.
     Information, including any facts, surveys, audits, or 
reports, about whether health care insurers, health plan sponsors, and 
health plan participants have religious or moral objections to certain 
health insurance coverage.
     Information, including any facts, surveys, audits, or 
reports, about whether applicants for Federal financial assistance from 
the Department, who

[[Page 3900]]

would otherwise been eligible for such assistance, have been 
discriminated against based on their religious or moral objections.
     Information, including any facts, surveys, audits, or 
reports, about whether individuals did not enter a health care field or 
a certain specialty because of concerns that their conscientious 
objections would not be accommodated.
     Information, including any facts, surveys, audits, or 
reports, about whether certain populations in the health care field, 
such as students or nurses, face or are vulnerable to discrimination in 
violation of the Federal health care conscience and associated anti-
discrimination laws, and how outreach and enforcement might be tailored 
to respond to those needs.
     Information, including any facts, surveys, audits, or 
reports, about the occurrence of coercion or discrimination against 
health care practitioners or professionals related to the 
implementation of advance directives.
     Information, including any facts, surveys, audits, or 
reports, about coercion or discrimination against religious nonmedical 
health care institutions and their patients.
     Information, including any facts, surveys, audits, or 
reports, 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.
     Comment on whether particular circumstances might exist 
that present a higher risk of undetected unlawful discrimination, such 
as the medical residency application process, and how the rule might 
address such problems.
     Comment on whether the voicing of health care conscience 
and associated anti-discrimination objections protected by Federal law 
is chilled by State laws, State agency action, lack of perceived 
remedies, threat of litigation, or threat of losing legal status, such 
as a medical license.
     Comment on whether the definition of ``individual'' in 
relation to ``workforce'' artificially circumscribes the scope of 
protections afforded by the Church Amendments that protect individuals 
and individual rights.
     Comment on whether the definition of ``recipient'' 
appropriately defines the scope of entities that should be subject to 
the rule's requirements regarding notice and assurances or 
certifications, including whether those requirements should be extended 
to sub-recipients.
     Comment on whether the definition of ``referral or refer 
for'' appropriately defines the scope of activities that should be 
encompassed by the rule's protections.
     Comment on whether the definition of ``assist in the 
performance'' appropriately defines the scope of activities that should 
be encompassed by the rule's protections.
     Comment on whether written certifications of compliance 
with nondiscrimination laws should contain additional language.
     Comment on the appropriateness of exceptions to the 
certification requirements.
     Comment on what constitutes the most effective method of 
educating recipients of Department funds and their employees about the 
protections of the Federal health care conscience and associated anti-
discrimination laws.
     Comment on what constitutes the most effective method for 
recipients of Department funds to provide notice about the requirements 
and prohibitions in the Federal health care conscience and associated 
anti-discrimination laws to employees, students, applicants, and sub-
recipients.
     Comment on whether State or local government laws, 
policies, or enforcement activities conflict with or make it difficult 
to ensure compliance with Federal health care conscience and associated 
anti-discrimination laws.
     Comment on whether policies and practices at covered 
entities appear to conflict with the health care conscience and 
associated anti-discrimination laws or make it difficult to ensure 
compliance with those laws.
     Comment on whether the rule provides adequate clarity 
regarding the respective obligations of recipients and sub-recipients, 
and regarding the potential consequences of noncompliance with those 
obligations.
     Comment on whether the exemptions in section 88.4(c) for 
certain grant programs currently administered by the Administration for 
Children and Families and the Administration for Community Living are 
meaningful given the requirement that the grant program involve no 
significant likelihood of referral for the provision of health care.
     Comment on whether, and how, the proposed rule should 
address the scheduled elimination of the penalty under the Patient 
Protection and Affordable Care Act for an individual's failure to carry 
minimum essential health coverage.
     Comment on whether alternate remedies, such as lawsuits, 
have been sufficient to protect individuals and entities from 
discrimination, coercion, or other treatment prohibited by the health 
care conscience and associated anti-discrimination laws.
     Comment on whether any provisions in the proposed rule 
would result in an unjustified limitation on access to health care or 
treatments.
     Comment on which enforcement tools OCR, as a policy 
matter, ought to employ, such as compliance reviews, investigations, 
and alternate disbursal of funds.
     Comment on whether the proposed rule 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), and whether the rule clearly and 
appropriately addresses its application to Federal funds that are 
contracted or compacted out to tribal nations.
     Comment on whether Urban Indian organizations, as defined 
by 25 U.S.C. 1603(29), operating a Title V Urban Indian Health Program 
that currently has a grant or contract with the IHS under Title V of 
the Indian Health Care Improvement Act, (Pub. L. 93-437), should be 
exempted from the proposed rule's requirements regarding assurances and 
certifications of compliance.
     Comment on whether the proposed rule should apply to 
Tribes, which are recipients of Federal financial assistance through 
compact agreements or are awarded Federal contracts. Furthermore, the 
Department requests comment on exemptions for any Indian Tribes under 
the notice and certification requirements. Additionally, the Department 
solicits comment on the rule's impact on Tribal sovereignty.
     Comment on whether the notice text provided in Appendix A 
to this rule strikes the appropriate balance between, on the one hand, 
affirming rights of conscience in a simple and reader-friendly manner, 
in general terms suitable for use by all recipients; and on the other, 
reflecting the complexities and variations in the application of 
Federal health care conscience and associated anti-discrimination laws 
to different covered entities and protected parties in different 
contexts.
     Consistent with the Paperwork Reduction Act, comments 
regarding the burden of the requirement for covered entities to report 
if they are the subject of an OCR investigation the Department in any 
requests for new or renewed Federal financial assistance or Federal 
funds in the five years subsequent to the filing of the relevant OCR 
complaint.
     Consistent with the Paperwork Reduction Act, comments 
regarding the

[[Page 3901]]

burden and cost estimates, or regarding any other aspect of the 
collection of information proposed in this rule as discussed below.

X. Public Participation

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments that are 
received by the date and time specified in the DATES section of the 
Preamble.
    Written comments mailed or hand delivered must include one original 
and two copies. Mailed comments may be subject to security delays due 
to security procedures. Please allow sufficient time for mailed 
comments to be timely received in the event of delivery delays. Because 
access to the interior of the Hubert H. Humphrey Building is not 
readily available to persons without Federal government identification, 
commenters are encouraged to leave their comments in the mail drop 
slots located in the lobby of the building. Electronic comments with 
attachments should be in Microsoft Word or Excel; however, we prefer 
Microsoft Word. Please note that comments submitted by fax or email and 
those submitted after the comment period will not be accepted.

XI. Delegations of Authority

    Notice is hereby given that I have delegated to the Director of the 
Office for Civil Rights (OCR), with authority to redelegate, the 
authority to enforce the following Federal health care conscience and 
associated anti-discrimination laws:
     Conscience protections related to abortion, sterilization, 
and other lawful health services among recipients of funds and 
participants in programs, and their personnel, where funded by the 
Department (the Church Amendments, 42 U.S.C. 300a-7);
     Conscience protections for health care entities related to 
abortion, training, or accreditation (the Coats-Snowe Amendment, 
section 245 of the Public Health Service Act, 42 U.S.C. 238n);
     Provisions protecting health care entities and individuals 
that do not act to further abortion or other practices from 
discrimination by recipients of funding under the Department's annual 
appropriations acts (e.g., Consolidated Appropriations Act, 2017, Pub. 
L. 115-31, Div. H, sec. 507(d) (the Weldon Amendment); Div. H, sec. 
209);
     Patient Protection and Affordable Care Act protections 
related to assisted suicide (42 U.S.C. 18113), the requirement to issue 
certifications of exemption from the individual mandate with respect to 
membership in exempt religious sects or divisions or health care 
sharing ministries (26 U.S.C. 5000A(d)(2)), and the conscience 
provisions with respect to abortion (42 U.S.C. 18023(c)(2)(A), 
(b)(1)(A), and (b)(4));
     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));
     Protections related to the performance of advanced 
directives in Medicare and Medicaid (42 U.S.C. 1395cc(f), 1396a(w)(3), 
and 14406);
     Protections related to Global Health Programs to the 
extent administered by the Secretary (22 U.S.C. 7631(d); Consolidated 
Appropriations Act, 2017, Pub. L. 115-31, Div. J, sec. 7018 (Helms 
Amendment));
     Exemptions 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 care in the Medicare, 
Medicaid, and CHIP programs (42 U.S.C. 1320a-1; 1320c-11; 1395i-5; 
1395x(e); 1395x(y)(1); 1396a(a); 1396b(i)(4); 1397j-1(b); and 
5106i(a)(2)).
    Pursuant to these delegations, the OCR Director shall have the 
authority:
    To receive and handle complaints of discrimination or any other 
potential violation of the Federal health care conscience and 
associated anti-discrimination laws and/or these regulations at 45 CFR 
part 88 by recipients, sub-recipients, or Department components;
    To initiate and conduct compliance reviews and investigate 
incidents of discrimination or any other potential violation of the 
Federal health care conscience and associated anti-discrimination laws 
and/or these regulations by recipients, sub-recipients, or Department 
components;
    To supervise and coordinate OCR's investigations or compliance 
reviews with the relevant Department components;
    To delegate responsibilities to other officials of the Department 
in connection with the effectuation of Federal health care conscience 
and associated anti-discrimination laws and these regulations, 
including the achievement of effective coordination and maximum 
uniformity within the Department; and
    To take remedial action as the Director of OCR deems necessary and 
as allowed by law to overcome the effects of violations of Federal 
health care conscience and associated anti-discrimination laws and this 
part, in coordination with the relevant component or components of the 
Department.
    If there appears to be a failure or threatened failure to comply 
with Federal health care conscience and associated 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 
funding component:
    Temporarily withholding cash payments, in whole or in part, pending 
correction of the deficiency;
    Denying use of Federal financial assistance or other Federal funds 
from the Department, including any applicable matching credit, in whole 
or in part;
    Wholly or partly suspending award activities;
    Terminating Federal financial assistance or other Federal funds 
from the Department, in whole or in part;
    Withholding new Federal financial assistance or other Federal funds 
from the Department, in whole or in part, 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;
    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, created by Federal law; and
    Taking any other remedies that may be legally available.
    This delegation is effective upon signature. I hereby affirm and 
ratify any actions taken by the OCR Director or the Director's 
subordinates which involved the exercise of the authorities delegated 
herein from April 1, 2017, to the effective date of this delegation.

XII. Regulatory Impact Analysis

A. Introduction and Summary

    The Department has examined the impacts of the proposed 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

[[Page 3902]]

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, 
section 654, 5 U.S.C. 601 (note)), and the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3520).
    This rule proposes to revise the regulation that allows OCR to 
accept and coordinate the handling of complaints alleging violations of 
the Weldon, Church, and Coats-Snowe Amendments 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, the 
proposed rule:
    (1) Aligns the regulation's scope to comport with the full panoply 
of Federal health care conscience and associated anti-discrimination 
laws that exist across the Department and that the Secretary has 
delegated to OCR to enforce,
    (2) Expands the scope of enforcement mechanisms available to OCR to 
be consistent with mechanisms used by OCR to enforce similar civil 
rights laws, as appropriate,
    (3) Requires certain persons and entities covered by this proposed 
rule to adhere to certain procedural and administrative requirements 
that aim to elevate awareness of Federal health care conscience and 
associated anti-discrimination rights and certain obligations of 
persons and entities.

                     Table 1--Accounting Table of Benefits and Costs of All Proposed 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: Balance of personal freedom and moral commitment; more diverse and inclusive
 workforces; improved provider patient relationships; equity, fairness, nondiscrimination.
----------------------------------------------------------------------------------------------------------------
Costs:
    Quantified Costs............................           692.1           562.7           165.1           168.1
----------------------------------------------------------------------------------------------------------------
Non-quantified Costs: Any ancillary costs resulting from a protection of conscience rights......................
----------------------------------------------------------------------------------------------------------------

    The Department estimates that the benefits of this rule, although 
not quantifiable or monetized, justify the burdens of the regulatory 
action. The Department estimates that implementation of this rule will, 
on average, cost $312.3 million in year one and $125.5 million annually 
in years two through five. Considering the number of entities affected 
and excluding the costs to OCR, this rule is estimated to cost each 
affected person, entity, and health care entity, on average, $665 in 
year one, which drops by 60% to about $266 annually in years two 
through five.
Analysis of Economic Impacts: Executive Orders 12866 and 13563
    HHS has examined the economic implications of this proposed 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).

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.

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.

[[Page 3903]]

    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.
    As discussed throughout this impact analysis, the Department 
considered these objectives in its analyses of this proposed rule. In 
doing so, the Department used the best reasonably obtainable technical 
and economic information to determine that this proposed 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.
1. Need for the Proposed Rule
(i) Problems That the Proposed 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 proposed rule seeks to address two categories of problems: (1) 
Inadequate enforcement tools to address discrimination and coercion 
associated with conscience objections by persons, entities, or health 
care entities, and (2) intolerance for certain Federal health care 
conscience and associated anti-discrimination rights, in part due to 
confusion about the law, leading to possible violations of law and 
increased complaints. The array of issues described supra in Parts IV 
(The Original Version and Current Version of the Rule) and Part VI 
(Reasons for the Proposed Rule) fall into one or both of these two 
overarching categories.
    Protection of religious beliefs and moral convictions not only 
serves individual rights, it serves society as a whole. Protections for 
conscience help ensure a society free from discrimination and more 
respectful of personal freedom. Although the boundaries of protection 
for conscience may be tested when that protection appears to impede 
other public goods, it is in those cases where fidelity to the law 
becomes paramount.\48\
---------------------------------------------------------------------------

    \48\ See Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 550-51 (2017).
---------------------------------------------------------------------------

    Despite the longstanding nature of the Federal health care 
conscience and associated anti-discrimination laws that this rule 
proposes to enforce, discrimination and coercion continue to occur. 
Relevant situations where persons, entities, and health care entities 
with religious beliefs or moral convictions may be coerced or suffer 
discrimination include:
     Being asked to perform, participate in, pay for, counsel 
or refer for abortion, sterilization, euthanasia, or other health 
services;
     engaging in health professions training that pressures 
students, residents, fellows, etc., to perform, assist in the 
performance of, or counsel for abortion;
     considering a career in obstetrics, family medicine, or 
elder care, when one has a religious or moral objection to abortion, 
sterilization, or euthanasia;
     raising religious or moral objections to participating in 
certain services within the scope of one's employment; and,
     being required to administer or receive certain 
vaccinations derived from aborted fetal tissues as a condition of work 
or receipt of educational services.
    Discrimination, coercion, and intolerance for religious beliefs or 
moral convictions continue to occur due to (1) the poor functioning of 
Federal government frameworks to enforce Federal health care conscience 
and associated anti-discrimination laws and (2) inadequate information 
and understanding about the obligations of persons and entities and the 
rights of persons, entities, and health care entities under these laws. 
These deficiencies in Federal governing frameworks include:
    An inadequate, minimalistic regulatory scheme at part 88 of 45 CFR 
due to the Department's 2011 Rule that rescinded the comprehensive 2008 
Rule, see supra Part IV.A-B (describing content of the existing and 
prior versions of the rule) and Part VI.C (identifying confusion about 
conscience laws' scope and applicability);
    An unduly narrow Departmental interpretation of the Weldon 
Amendment adopted by OCR in connection with the 2011 Rule that limited 
the scope of discrimination contrary to the language that Congress 
passed, see supra Part VI.E (addressing confusion caused by OCR sub-
regulatory guidance); and
    A lack of strategic coordination across the Department to address 
the enforcement of Federal health care conscience and associated anti-
discrimination laws set forth in authorizing statutes of programs that 
the Department's components conduct, see supra Part III.F (identifying 
additional Federal health care conscience and associated anti-
discrimination laws).
    The absence of adequate Federal governing frameworks to remedy 
discrimination may have undermined incentives for covered persons and 
entities proactively to institute measures to protect conscience, 
prohibit coercion, and promote nondiscrimination.
    OCR is aware 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 
experience real harm that is significant psychologically, emotionally, 
and financially. Such persons claim that their harm amounts to an 
actionable violation of the Federal health care conscience and 
associated anti-discrimination laws that OCR can remedy through 
administrative enforcement.\49\ Indeed, since November of 2016, OCR has 
received thirty-four complaints concerning Federal health care 
conscience and associated anti-discrimination laws. See supra Part V 
(identifying when OCR complaints were received).
---------------------------------------------------------------------------

    \49\ As discussed earlier, several courts have declined to 
recognize a private right of action for persons protected under 
certain Federal health care conscience and associated anti-
discrimination laws. In such cases, persons must rely on OCR for 
enforcement.
---------------------------------------------------------------------------

(ii) How the Proposed Rule Seeks To Address Those Problems
    This proposed regulatory action corrects those problems. First, the 
Department proposes to revise 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 impose 
procedural requirements (e.g., assurances of compliance, notices to the 
public) to further compliance with those substantive rights and 
obligations. In addition, such schemes outline the enforcement 
procedures to provide regulated entities notice of the enforcement 
tools available to OCR and the type of remedies OCR may seek. Part 88, 
by contrast, is currently only three sentences long and therefore 
provides

[[Page 3904]]

considerably less notice and clarity about the conduct prohibited under 
Federal law and the enforcement mechanisms available to OCR.
    Department components, recipients, and sub-recipients must comply 
with the Federal laws that are the subject of this proposed rulemaking. 
In addition to conducting outreach and providing technical assistance, 
OCR would have the authority to initiate compliance reviews, conduct 
investigations, and supervise and coordinate appropriate action with 
the relevant Department component to assure compliance.
    To assist OCR in ensuring compliance with and enforcement of the 
Federal health care conscience and associated anti-discrimination laws, 
the proposed rule would require certain persons and entities: To 
maintain records; cooperate with OCR investigations, reviews, 
interviews, or other parts of OCR's enforcement process; submit written 
assurances and certifications of compliance to the Department; and 
provide notice to persons, entities, and health care entities about 
Federal health care conscience and associated anti-discrimination 
protections, as applicable. These procedural and administrative 
requirements are similar to those in other civil rights regulations and 
have a proven record of improving compliance with, and enforcement of, 
other Federal civil rights laws. Together, these requirements would 
support the Department's renewed effort for strategic coordination with 
respect to the compliance and enforcement of the Federal health care 
conscience and associated anti-discrimination laws that exist across 
the Department.
    Second, this proposed rule seeks to promote voluntary compliance 
with laws governing the ability of persons, entities, and health care 
entities to act in accord with their religious beliefs or moral 
convictions by ensuring that persons and entities are aware of and 
understand Federal health care conscience and associated anti-
discrimination laws. Persons and entities would be more likely to 
accommodate conscience and associated anti-discrimination rights if 
persons and entities understand that they are legally obligated to do 
so. Persons and entities would also be in a better position to 
accommodate these rights if they understand these rights to be akin to 
other civil rights to be free from discrimination on the basis of race, 
national origin, disability, etc.--rights that recipients and sub-
recipients are already familiar with respecting.
    The Department anticipates, as anticipated with the 2008 Rule, that 
this proposed rule would promote accommodation of protected persons, 
entities, and health care entities. See e.g., 73 FR 78074, 78081 (2008 
Rule). Greater transparency of practices through open communication of 
recipient and sub-recipient policies ``should strengthen relationships 
between patients and providers, as well as those between entities and 
their . . . [workforce members].'' Id. at 78074. The Department intends 
that OCR's outreach and guidance, investigations, compliance reviews, 
and enforcement actions, would provide institutions with an incentive 
to review their compliance with Federal health care conscience and 
associated anti-discrimination laws, as applicable, resulting in 
increased voluntary compliance.
2. Affected Persons and Entities
    The proposed rule affects: (1) Persons and entities obligated to 
comply with 45 CFR part 88 because they are subject to the Weldon 
Amendment, Coats-Snowe Amendment, or Church Amendments (or a 
combination thereof); and (2) persons and entities obligated to comply 
with at least one of the nearly two dozen Federal laws that this 
revision of part 88 proposes to enforce.
(i) Scope of Persons and Entities That 45 CFR Part 88 Covers
    This proposed rule affects persons and entities obligated to comply 
with the Weldon, Church, and Coats-Snowe Amendments of which 45 CFR 
part 88 provides for the enforcement.
    Current part 88 extends:
     To almost every program and activity administered by the 
Secretary;
     To all State and local governments that receive Federal 
financial assistance as recipients or sub-recipients; and
     To recipients that operate a health service program or 
research activity or biomedical or behavioral research administered by 
the Secretary, or for the implementation of programs or activities 
authorized in the Public Health Service Act (``PHS Act'') or the 
Developmental Disabilities Assistance and Bill of Rights Act of 2000 
(``DD Act'') through specified instruments. As described in the 
following paragraphs, the current part 88 thus covers a synthesis of 
actors subject to the Church, Coats-Snowe, and Weldon Amendments.
(A) The Department
    Part 88 applies to the Department because the Weldon and Coats-
Snowe Amendments, as well as specific paragraphs of the Church 
Amendments, apply to the Department.
    The Weldon Amendment states that ``[n]one of the funds made 
available in this Act 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 . . . 
.'' \50\ The Department is a Federal agency that receives substantial 
funds made available in the Departments of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act 
(``Labor/HHS/Education Appropriation''), which are the funds addressed 
in Weldon.\51\ To continue to receive those funds, the Department 
cannot discriminate on a basis prohibited by Weldon.
---------------------------------------------------------------------------

    \50\ E.g., Consolidated Appropriations Act, 2017, Public Law 
115-31, Div. H, Tit. V, sec. 507(d), 131 Stat. 135, 562 (May 5, 
2017).
    \51\ See 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 all of the Department's 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.'' \52\ The Department administers many 
such programs, either directly or through its components. Examples 
include:
---------------------------------------------------------------------------

    \52\ 42 U.S.C. 300a-7(c)(2) and (d).
---------------------------------------------------------------------------

     The Health Resources and Services Administration (HRSA) 
administers grant programs, such as the operation of a grant program 
for community health centers,
     The National Institute of Health operates grant programs 
to fund research,
     The Centers for Medicare & Medicaid Services (CMS) 
administers Medicare and Federally-facilitated Health Insurance 
Marketplaces,\53\ and CMS jointly administers Medicaid with States,\54\ 
and
---------------------------------------------------------------------------

    \53\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/ffe.html.
    \54\ https://www.medicare.gov/.
---------------------------------------------------------------------------

    The Indian Health Service (IHS) operates a system of direct health 
care for certain Tribes and Tribal organizations and also administers 
contracts and self-governance compacts under the Indian Self-
Determination and Education Assistance Act

[[Page 3905]]

(ISDEAA),\55\ as amended, which allows Tribes and Tribal Organizations 
to assume control and management of health care that IHS would 
otherwise provide.\56\
---------------------------------------------------------------------------

    \55\ Public Law 93-638, 88 Stat. 2203 (Jan. 4, 1975).
    \56\ IHS FY 2018 Congressional Justification of Estimates to the 
Appropriations Committees 199, 203 (2017), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2018CongressionalJustification.pdf
---------------------------------------------------------------------------

(B) State and Local Governments
    Part 88 applies 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 Labor/HHS/Education 
Appropriation.\57\ Second, the Coats-Snowe Amendment applies to State 
and local governments that receive HHS Federal financial assistance 
(regardless of funding source), ``includ[ing] governmental payments 
provided as reimbursement for carrying out health-related activities.'' 
\58\
---------------------------------------------------------------------------

    \57\ Public Law 115-31, Div. H, Tit. V, sec. 507(d), 131 Stat. 
at 562 (``None of the funds made available in this Act may be made 
available to a . . . State or local government[] if such . . . 
government . . . .'').
    \58\ 42 U.S.C. 238n(a), (c)(1).
---------------------------------------------------------------------------

    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 to the extent that such State or local government 
receives partial or full funding for a health service program or 
research activity under a program administered by the Secretary.\59\
---------------------------------------------------------------------------

    \59\ Id. at Sec.  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) subject to current part 88 receive Federal financial 
assistance or Federal funds from the Department from a variety of 
financing streams as recipients or sub-recipients. Examples of these 
financing streams, which include reimbursement for health-related 
activities, include:
     Medicaid and the Children's Health Insurance Program,
     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 justice abuse.
(C) Persons and Entities
    Part 88 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;'' \60\ 
receive a grant, contract, loan, or loan guarantee under the PHS Act or 
the DD Act; or receive an interest subsidy under the DD Act. Several 
statutory provisions support this application. First, paragraphs 
(c)(1)-(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.\61\ 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.'' \62\
---------------------------------------------------------------------------

    \60\ 42 U.S.C. 300a-7(d).
    \61\ 42 U.S.C. 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; thus, there are no entities 
receiving funds under programs authorized by these statutes to 
consider in this RIA. 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).
    \62\ Id. at 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 . 
. . .'').
---------------------------------------------------------------------------

    The broad array of recipients and sub-recipients in this category 
is a function of two statutory features. First, paragraph (d) of the 
Church Amendment does not tie the funding source to a particular 
appropriation, instrument, or authorizing statute. Second, the PHS Act 
contains thirty titles and authorizes dozens of programs. Examples of 
entities that receive funds under programs authorized by the PHS Act 
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;
     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; \63\ and
---------------------------------------------------------------------------

    \63\ E.g., https://www.acl.gov/node/466.
---------------------------------------------------------------------------

     State Councils on Developmental Disabilities \64\ and 
States' Protection and Advocacy Systems that receive funds to implement 
the DD Act.\65\
---------------------------------------------------------------------------

    \64\ E.g., https://www.acl.gov/node/110. https://www.acl.gov/sites/default/files/about-acl/2017-12/DDC-2017.pdf.
    \65\ E.g., https://www.acl.gov/sites/default/files/about-acl/2017-06/PADD-2017.pdf.
---------------------------------------------------------------------------

(ii) Persons and Entities Obligated To Comply With Additional Federal 
Laws That This NPRM Proposes To Enforce
    This proposed rule would affect persons and entities obligated to 
comply with at least one of the approximately two dozen Federal laws 
that this revision of part 88 proposes to enforce. There is substantial 
overlap between persons and entities obligated to comply with the 
current part 88 and persons and entities subject to at least one of the 
additional Federal laws that this revision of part 88 proposes to 
enforce. This overlap occurs because such persons and entities should 
already be subject to 45 CFR part 88 by virtue of their coverage by the 
Weldon Amendment, Coats-Snowe Amendment, or Church Amendments (or a 
combination thereof), the coverage of which the Department explained in 
the immediately preceding part--Part XI.C.2.i. Because of this overlap, 
the Department estimates that the proposed

[[Page 3906]]

delegation of authority to OCR to enforce the following laws would not 
add any new persons and entities to the coverage of part 88:
    Provider conscience laws related to abortion (the Weldon Amendment 
for Medicare Advantage, e.g. Public Law 115-31, Div. H, sec. 209, 131 
Stat. 135, 539 (2017));
    Certain provisions of the Affordable Care Act applying Federal 
conscience protections of providers with respect to abortion (42 U.S.C. 
18023(b)(4)), regarding assisted suicide (42 U.S.C. 18113), and 
providing a conscience exemption to the individual mandate (26 U.S.C. 
5000A(d)(2));
    Certain laws governing provider counseling, referral, and 
implementation of directives (counseling and referral in Medicare 
Advantage ((42 U.S.C. 1395w-22(j)(3)(B)), counseling and referral in 
Medicaid (42 U.S.C. 1396u-2(b)(3)(B)), and performance of advanced 
directives in the Medicare and Medicaid programs (42 U.S.C. 
1396a(w)(3), and 14406));
    Laws providing for patient objections to receiving health care 
services, including medical screening, examination, diagnosis, 
treatment, or other health care (42 U.S.C. 1396f), occupational illness 
testing (29 U.S.C. 669(a)(5)), pediatric vaccination (42 U.S.C. 
1396s(c)(2)(B)(ii)), youth suicide prevention and treatment (42 U.S.C. 
290bb-36(f)), and newborn health screening (42 U.S.C. 280g-1(d)); and
    Laws protecting religious nonmedical health care, by exempting 
religious non-medical institutions from 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)).
    The Department estimates that the proposed delegation of authority 
to OCR to enforce the following laws would probably add new persons and 
entities to the coverage of part 88:
     Global Health Programs for HIV/AIDS Prevention, Treatment, 
or Care (22 U.S.C. 7631(d)), and
     The Helms Amendment (e.g., Consolidated Appropriations 
Act, 2017, Pub. L. 115-31, Div. J, sec. 7018).
    The persons and entities subject to 22 U.S.C. 7631(d) and the Helms 
Amendment may not be currently subject to part 88 because the persons 
and entities are recipients and sub-recipients of funds that HHS 
administers for Global Health programs where those funds are 
appropriated to the U.S. Department of State and USAID but awarded from 
HHS. Thus, the financing streams to which these laws apply likely do 
not overlap with the financial streams to which the Weldon, Coats-
Snowe, and Church Amendments apply. However, paragraph (d) of the 
Church Amendments applies to a ``health service program or research 
activity funded in whole or in part under a program administered by the 
Secretary.'' Paragraph (d) 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 Secretary.'' Consequently, paragraph (d) of the Church 
Amendments (and, thus, part 88) would arguably apply to recipients and 
sub-recipients of Federal funds from (or administered by) the 
Department with respect to such Global Health programs because if the 
Department administers the funds, it administers the program.
(iii) Methodology
    Although the Department has qualitatively summarized the new 
persons and entities covered by this proposed rule, the Department has 
also quantitatively estimated those persons and entities to understand 
the likely impact of the proposed rule. To do so, the Department 
primarily relied on the latest data available from the U.S. Census 
Bureau's Statistics of U.S. Businesses,\66\ supplemented with other 
sources. The Department determined that no one data source could supply 
an unduplicated count of the persons or entities that receive an award 
through an instrument covered within the scope of this proposed rule. 
But in assessing the available methodologies, the Department concluded 
that the U.S. Census Bureau data, supplemented with other sources, was 
the most reasonable way to estimate the number of persons and entities 
that this proposed rule would affect.
---------------------------------------------------------------------------

    \66\ 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.
---------------------------------------------------------------------------

    The U.S. Census Bureau's Statistics of U.S. Businesses is based on 
the North American Industry Classification System (NAICS).\67\ The 
NAICS classifies all economic activity into 20 sectors and breaks that 
information down into sub-sectors and industries.\68\ Essentially, the 
NAICS groups physical business establishments together based on how 
similar the locations' processes are for producing goods or 
services.\69\ The NAICS provides information on how many singular 
physical locations exist for a particular business or industry (called 
an ``establishment''),\70\ how many of those establishments are under 
common ownership or control of a business organization or entity 
(called a ``firm''),\71\ 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.
---------------------------------------------------------------------------

    \67\ https://www.census.gov/programs-surveys/susb/technical-documentation/methodology.html.
    \68\ FAQ 5, https://www.census.gov/eos/www/naics/faqs/faqs.html#q5.
    \69\ FAQ 1, https://www.census.gov/eos/www/naics/faqs/faqs.html#q1.
    \70\ https://www.census.gov/eos/www/naics/faqs/faqs.html#q2.
    \71\ https://www.census.gov/glossary/#term_Firm.
---------------------------------------------------------------------------

    For the vast majority of the recipient and sub-recipient types, the 
Department assumes that only a portion of the industry captured in the 
Statistics of U.S. Businesses receives Federal funds. For instance, not 
all physician offices accept Medicare, Medicaid, or both. In fact, 
about 68.9% of physician offices accepted new Medicaid patients based 
on 2013 data from the National Electronic Health Records Survey.\72\ 
Approximately 83.7% of physicians accepted new Medicare patients based 
on the same data.\73\ Because current part 88 applies to physicians 
receiving reimbursement for Medicare Part B and to physicians 
participating in Medicaid, the Department assumed that the lower of 
these two percentages (69%) represents the lower-bound of physicians 
nationwide subject to current part 88. In the absence of evidence with 
which to generate a refined upper-bound estimate, the Department 
assumed that current part 88 covers all physicians nationwide as the 
upper-bound.
---------------------------------------------------------------------------

    \72\ 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 Patience with Public and Private 
Insurance by Office-Based Physicians: United States, 2013, Data 
Brief No. 195, 1 (Mar. 2015).
    \73\ Id.
---------------------------------------------------------------------------

    The Department used this same percentage range (69% to 100%) in 
estimating the coverage for other health care industry sector types, 
such as hospitals and various outpatient care facilities. For the 
social services and

[[Page 3907]]

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% as the lower-bound and 100% as 
the upper-bound to cover 62.5% of the industry on average).
    To estimate the number of local governments and educational 
institutions, the Department supplemented its use of data from the U.S. 
Census Bureau's Statistics of U.S. Businesses with Census data from 
other statistical programs or with available award data available 
through the HHS Tracking Accountability in Government Grants System 
(TAGGS).\74\ For instance, in estimating the number of counties 
nationwide, the Department relied on 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.\75\
---------------------------------------------------------------------------

    \74\ https://taggs.hhs.gov (last visited Aug. 24, 2017).
    \75\ 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 wanted a lower-bound estimate to reflect that assumption.
    Using the ``Advanced Search'' function in TAGGS, HHS identified all 
awards to Junior Colleges, Colleges, and 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, a 
satellite campus is one location of a university system with common 
ownership and control of 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.\76\ This ratio is 51.32% (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.
---------------------------------------------------------------------------

    \76\ U.S. Census Bureau, Statistics of U.S. Businesses, 2015, 
NAICS code 611310 (Colleges, Universities, and Professional 
Schools).
---------------------------------------------------------------------------

    The Department considered other methodologies for estimating the 
number of impacted persons and entities. For instance, the Department 
considered primarily relying on award data from TAGGS in lieu of using 
it as a supplemental data source. In addition, the Department also 
considered adding together the number of awards to States, local 
governments, private entities, nonprofit entities, etc., that 
Department components commonly report on a program-by-program basis on 
the Web, in ad hoc reports on topic-specific matters, and in their 
annual Justifications of Estimates to the Appropriations Committees as 
part of the President's annual budget request to Congress.
    The Department rejected those methodological approaches. In 
particular, the Department was concerned that those approaches would 
double-count a substantial number of persons and entities that receive 
an award from more than one Department component or that receive 
multiple awards from the same component. Primarily relying on TAGGS 
would not only double-count some persons and entities but would under-
count others because TAGGS does not capture the number of sub-
recipients receiving awards from a recipient. Given these 
considerations, NAICS information, supplemented with Census data from 
other statistical programs or with publicly available award data from 
TAGGS, was the best reasonably obtainable source of economic and 
technical information on which the Department could rely.
    The Department seeks comment on the methodology used and whether 
there are other methodologies that the Department could consider to 
refine the scope of persons and entities affected by this proposed 
rule.
(iv) Quantitative Estimate of Persons and Entities Covered by NPRM
    Table 1 lists each type of recipient and the estimated number of 
recipients that this proposed rule covers. Because there is uncertainty 
as to the universe of persons and entities currently covered by 45 CFR 
part 88 and the incremental number of new persons and entities that the 
Department expects this proposed rule will cover, Table 1 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.

                        Table 1--Estimated Number of Persons and Entities Covered by NPRM
----------------------------------------------------------------------------------------------------------------
                                          Covered by current                         Estimated       Estimated
                            Type              45 CFR 88?       Covered by NPRM?    number (low)    number (high)
----------------------------------------------------------------------------------------------------------------
1.................  State and             Yes...............  Yes...............              58              58
                     Territorial
                     Governments \77\.
2.................  Federally recognized  Yes...............  Yes...............             567             567
                     Tribes \78\.
3.................  Counties \79\.......  Yes...............  Yes...............           3,234           3,234
----------------------------------------------------------------------------------------------------------------
Hospitals:
----------------------------------------------------------------------------------------------------------------
4.................  General and Medical   Yes...............  Yes...............           1,859           2,694
                     Surgical Hospitals
                     \80\.
5.................  Specialty Hospitals   Yes...............  Yes...............             553             801
                     (e.g., psychiatric,
                     substance abuse,
                     rehabilitation,
                     cancer, maternity)
                     \81\.
----------------------------------------------------------------------------------------------------------------
Nursing and Residential Care Facilities:
----------------------------------------------------------------------------------------------------------------

[[Page 3908]]

 
6.................  Skilled Nursing       Yes...............  Yes...............           6,316           9,153
                     Facilities \82\.
7.................  Residential           Yes...............  Yes...............           4,310           6,246
                     Intellectual and
                     Developmental
                     Disability
                     Facilities \83\.
8.................  Continuing Care       Yes...............  Yes...............           2,605           3,775
                     Retirement
                     Communities \84\.
9.................  Other Residential     Yes...............  Yes...............           2,247           3,256
                     Care Facilities
                     (e.g., group homes)
                     \85\.
10................  Entities providing    Yes...............  Yes...............          15,062          21,829
                     Home Health Care
                     Services \86\.
----------------------------------------------------------------------------------------------------------------
Entities Providing Ambulatory Health Care Services:
----------------------------------------------------------------------------------------------------------------
11................  Offices of            Yes...............  Yes...............         115,673         167,642
                     Physicians (except
                     Mental Health
                     Specialists) \87\.
12................  Offices of            Yes...............  Yes...............           7,324          10,614
                     Physicians (Mental
                     Health Specialists)
                     \88\.
13................  Offices of Mental     Yes...............  Yes...............          14,340          20,782
                     Health
                     Practitioners
                     (except Physicians)
                     \89\.
14................  Offices of Dentists   Yes...............  Yes...............          86,874         125,904
                     \90\.
15................  Offices of            Yes...............  Yes...............          26,725          32,535
                     Chiropractors \91\.
16................  Offices of            Yes...............  Yes...............          13,775          19,964
                     Optometrists \92\.
17................  Offices of Physical,  Yes...............  Yes...............          17,623          25,540
                     Occupational and
                     Speech Therapists,
                     and Audiologists
                     \93\.
18................  Offices of            Yes...............  Yes...............           5,314           7,701
                     Podiatrists \94\.
19................  Family Planning       Yes...............  Yes...............             999           1,448
                     Centers \95\.
20................  Freestanding          Yes...............  Yes...............           2,908           4,214
                     Ambulatory Surgical
                     and Emergency
                     Centers \96\.
21................  HMO Medical Centers   Yes...............  Yes...............              78             113
                     \97\.
22................  Kidney Dialysis       Yes...............  Yes...............             305             442
                     Centers \98\.
23................  Outpatient Mental     Yes...............  Yes...............           3,776           5,472
                     Health and
                     Substance Abuse
                     Centers \99\.
24................  Diagnostic Imaging    Yes...............  Yes...............           3,209           4,651
                     Centers \100\.
25................  Medical Laboratories  Yes...............  Yes...............           2,278           3,302
                     \101\.
26................  Ambulance Services    Yes...............  Yes...............           2,185           3,167
                     \102\.
27................  All Other Outpatient  Yes...............  Yes...............           3,880           5,623
                     Care Centers (e.g.,
                     centers and clinics
                     for pain therapy,
                     community health,
                     and sleep
                     disorders) \103\.
28................  Entities providing    Yes...............  Yes...............           2,391           3,465
                     All Other
                     Ambulatory Health
                     Care Services
                     (health screening,
                     smoking cessation,
                     hearing testing,
                     blood banks) \104\
----------------------------------------------------------------------------------------------------------------
Insurance Carriers:
----------------------------------------------------------------------------------------------------------------
29................  Direct Health and     Yes...............  Yes...............             607             880
                     Medical Insurance
                     Carriers \105\.
----------------------------------------------------------------------------------------------------------------
Entities Providing Social Assistance Services:
----------------------------------------------------------------------------------------------------------------
30................  Entities Serving the  Yes...............  Yes...............           9,051          36,205
                     Elderly and Persons
                     with Disabilities
                     (provision of
                     nonresidential
                     social assistance
                     services to improve
                     quality of life)
                     \106\
31................  Entities providing    Yes...............  Yes...............           5,310          21,240
                     Other Individual
                     Family Services
                     (e.g., marriage
                     counseling, crisis
                     intervention
                     centers, suicide
                     crisis centers)
                     \107\
32................  Entities providing    Yes...............  Yes...............           2,169           8,674
                     Child and Youth
                     Services (e.g.,
                     adoption agencies,
                     foster care
                     placement services)
                     \108\
33................  Temporary Shelters    Yes...............  Yes...............             805           3,219
                     (e.g., short term
                     emergency shelters
                     for victims of
                     domestic violence,
                     sexual assault, or
                     child abuse;
                     runaway youth; and
                     families caught in
                     medical crises)
                     \109\.
34................  Emergency and Other   Yes...............  Yes...............             169             675
                     Relief Services
                     (e.g., medical
                     relief,
                     resettlement, and
                     counseling to
                     victims of domestic
                     or international
                     disasters or
                     conflicts) \110\
----------------------------------------------------------------------------------------------------------------
Other Entities:
----------------------------------------------------------------------------------------------------------------
35................  Pharmacies and Drug   Yes...............  Yes...............          13,490          19,550
                     Stores \111\.
36................  Research and          Yes...............  Yes...............           2,347           3,402
                     Development in
                     Biotechnology \112\.
37................  Colleges,             Yes...............  Yes...............             316           2,457
                     Universities, and
                     Professional
                     Schools \113\.
----------------------------------------------------------------------------------------------------------------
    Subtotal, subject to current part 88........................................         364,575         571,282
----------------------------------------------------------------------------------------------------------------
38................  HHS awarded funds     No................  Yes...............              65             130
                     appropriated to the
                     U.S. Department of
                     State & USAID \114\.
----------------------------------------------------------------------------------------------------------------
    Subtotal, incremental increase in entities..................................              65             130
----------------------------------------------------------------------------------------------------------------

[[Page 3909]]

 
        Total, estimated entities subject to NPRM...............................         364,640         571,412
----------------------------------------------------------------------------------------------------------------

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

    \77\ Assumes coverage of the 50 States, DC, Puerto Rico, 6 U.S. 
Territories, and the Island Areas.
    \78\ Assumes all Federally-recognized Tribes get HHS funds. 
Indian Health Service, FY 2018 Justification of Estimates to the 
Appropriations Committees CJ-1 (2017), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2018CongressionalJustification.pdf.
    \79\ 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 sub-recipient.
    \80\ 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). Assumes coverage for 69%-100% of the industry.
    \81\ Id. (sum of the nationwide count of firms for NAICS Codes 
622210 and 622310). Assumes 69%-100% of industry is covered.
    \82\ Id. (relying on the nationwide count of firms for NAICS 
Code 623110). Assumes 69%-100% of industry is covered.
    \83\ Id. (nationwide count of firms for NAICS Code 623210). 
Assumes 69%-100% of industry is covered.
    \84\ Id. (nationwide count of firms for NAICS Code 623311). 
Assumes 69%-100% of industry is covered.
    \85\ Id. (nationwide count of firms for NAICS Code 623990). 
Assumes 69%-100% of industry is covered.
    \86\ Id. (nationwide count of firms for NAICS Code 621610). 
Assumes 69%-100% of industry is covered.
    \87\ Id. (nationwide count of firms for NAICS Code 621111). 
Assumes 69%-100% of industry is covered.
    \88\ Id. (nationwide count of firms for NAICS Code 621112). 
Assumes 69%-100% of industry is covered.
    \89\ Id. (nationwide count of firms for NAICS Code 621330). 
Assumes 69%-100% of industry is covered.
    \90\ Id. (nationwide count of firms for NAICS Code 621210). 
Assumes 69%-100% of industry is covered.
    \91\ Id. (nationwide count of firms for NAICS Code 621310). 
Assumes 69%-100% of industry is covered.
    \92\ Id. (nationwide count of firms for NAICS Code 621320). 
Assumes 69%-100% of industry is covered.
    \93\ Id. (nationwide count of firms for NAICS Code 621340). 
Assumes 69%-100% of industry is covered.
    \94\ Id. (nationwide count of firms for NAICS Code 621391). 
Assumes 69%-100% of industry is covered.
    \95\ Id. (nationwide count of firms for NAICS Code 621410). 
Assumes 69%-100% of industry is covered.
    \96\ Id. (nationwide count of firms for NAICS Code 621493). 
Assumes 69%-100% of industry is covered.
    \97\ Id. (nationwide count of firms for NAICS Code 621491). 
Assumes 69%-100% of industry is covered.
    \98\ Id. (nationwide count of firms for NAICS Code 621492). 
Assumes 69%-100% of industry is covered.
    \99\ Id. (nationwide count of firms for NAICS Code 621420). 
Assumes 69%-100% of industry is covered.
    \100\ Id. (nationwide count of firms for NAICS Code 621512). 
Assumes 69%-100% of industry is covered.
    \101\ Id. (nationwide count of firms for NAICS Code 621511). 
Assumes 69%-100% of industry is covered.
    \102\ Id. (nationwide count of firms for NAICS Code 621910). 
Assumes 69%-100% of industry is covered.
    \103\ Id. (nationwide count of firms for NAICS Code 621498). 
Assumes 69%-100% of industry is covered.
    \104\ Id. (nationwide count of firms for NAICS Code 62199). 
Assumes 69%-100% of the industry is covered.
    \105\ Id. (nationwide count of firms for NAICS Code 524114). 
Assumes 69%-100% of industry is covered.
    \106\ Id. (nationwide count of firms for NAICS Code 624120). 
Assumes 69%-100% of industry is covered.
    \107\ Id. (nationwide count of firms for NAICS Code 624190). 
Assumes 69%-100% of industry is covered.
    \108\ Id. (nationwide count of firms for NAICS Code 624110). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \109\ Id. (nationwide count of firms for NAICS Code 624221). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \110\ Id. (nationwide count of firms for NAICS Code 624230). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \111\ Id. (nationwide count of firms for NAICS Code 44610). 
Assumes 69%-100% of industry is covered.
    \112\ Id. (nationwide count of firms for NAICS Code 541711). 
Assumes 69%-100% of industry is covered.
    \113\ Id. (nationwide count of firms for NAICS Code 611310). As 
described supra Part XI.C.2.iii (methodology), the Department 
assumes 13%-100% of institutions of higher-education are covered. 
See supra 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.
    \114\ U.S. Dep't of Health & Human Servs., Tracking 
Accountability in Government Grants System (TAGGS) https://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.
---------------------------------------------------------------------------

    Approximately 364,575 to 571,282 persons and entities are currently 
subject to part 88 by virtue of the Weldon Amendment, the Coats-Snowe 
Amendment, and the Church Amendments. The Department estimated that the 
universe of incremental new persons and entities subject to 22 U.S.C. 
7631(d) and the Helms Amendment that this proposed rule would cover is 
small and, possibly, non-existent. This proposed rule may add 65 to 130 
new persons and entities to part 88's coverage.\115\ With this 
incremental increase, this proposed rule would cover a total of 364,640 
to 571,412 entities.
---------------------------------------------------------------------------

    \115\ But see supra Part XI.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 1, a smaller 
subset will be subject to proposed 88.4, which requires certain 
recipients to submit an assurance and certification of compliance. The 
Department began calculating that subset by removing sub-recipients 
from the total because proposed 88.4 would apply only to recipients, 
not sub-recipients. OCR has not found a reliable way to estimate the 
total number of sub-recipients. For purposes of this calculation, the 
Department assumed that every county is a sub-recipient but not a 
recipient and accordingly excluded all 3,234 counties from the total 
number that must comply with the assurance and certification of 
compliance requirement. The Department requests information, data 
sources, studies, or reports that could assist in identifying the 
number of sub-recipients under this proposed regulation excluded from 
Sec.  88.4.
    The Department next sought to estimate and remove exempted entities 
from the total. The Department assumed that all physicians would meet 
the proposed criteria for exemption from the requirement in proposed

[[Page 3910]]

Sec.  88.4(c)(1).\116\ Consequently, the Department excluded 255,684 to 
370,557 entities, representing the lower and upper-bounds, from the 
estimate. To the degree that some physicians are recipients of the 
Department through an instrument other than reimbursement for their 
participation in Medicare Part B, then the Department overestimated the 
impact of the exemption.
---------------------------------------------------------------------------

    \116\ Sum of rows 11, 12, 14-18 of Table 1.
---------------------------------------------------------------------------

    The Department removed 11,220 to 44,879 persons and entities that 
provide child and youth services and services for the elderly and 
persons with disabilities based on the proposed exemption for 
recipients awarded under grant programs administered by the 
Administration for Children and Families or the Administration for 
Community Living. 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. See proposed Sec.  88.4(c)(2)-(3).
    The Department reasonably anticipated 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 
anticipated 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 considered exempting entities providing Other 
Individual Family Services (e.g., marriage counseling, crisis 
intervention centers, suicide crisis centers), but decided not to do 
so. Although the provision of these services may not involve health 
care providers, there is a significant likelihood of referral for the 
provision of health care at crisis intervention centers and suicide 
crisis centers.
    Finally, the Department excluded 223 Tribes and Tribal 
Organizations from the total. The number reflects the proposed Tribal 
exemption. See proposed Sec.  88.4(c)(4). The Department has identified 
223 Tribes and Tribal Organizations that operate Title contracts under 
Title I of the ISDEA Act.
    The Department seeks comment on the methods used to estimate the 
scope of exempted recipients under proposed Sec.  88.4(c)(1)-(4).

   Table 2--Range of Recipients Subject to the Proposed Assurance and
                Certification Requirements (Sec.   88.4)
------------------------------------------------------------------------
                                              Low-end      Upper- bound
                                             estimate        estimate
------------------------------------------------------------------------
Range of Persons or Entities Subject to          364,640         571,412
 the NPRM...............................
Range of Recipients Excepted from               -270,361        -418,893
 Proposed Sec.   88.4...................
                                         -------------------------------
    Total, Recipients Subject to the              94,279         152,519
     Assurance and Certification
     Requirements.......................
------------------------------------------------------------------------

(B) Estimated Number of Recipients Required to Provide Notice (Sec.  
88.5)
    More persons and entities would be subject to the notice 
requirement than to the assurance and certification requirements under 
the proposed rule. Although the Department proposes to exclude certain 
recipients from the assurance and certification requirements, the 
Department proposes to require all recipients and the Department to 
comply with the notice requirement. The Department proposes this policy 
approach because persons, entities, and health care entities who do not 
know their rights may not exercise them. The notice is designed to be 
seen by workforce members of the Department or recipients, 
beneficiaries of covered programs and activities, and the public. In 
contrast, assurance and certification documents are internal facing 
documents that certain recipients would sign and the public would 
likely never see.
    In an effort to reduce the burden on sub-recipients, proposed Sec.  
88.5, similar to proposed Sec.  88.4, does not require sub-recipients 
to post a notice. The Department requests comment on whether its 
proposed policy strikes the right balance between reducing the burden 
on sub-recipients and providing notice of important rights. OCR 
employed the methods from supra Part XI.C.2.iv.A to estimate the total 
number of sub-recipients (3,234 counties) to exclude from the total 
count of persons and entities subject to the notice requirement.
    The Department counted the number of establishments associated with 
each recipient type. Unlike the assurance and certification 
requirements, which will be implemented at the ``firm'' level, the 
Department expects that the notice requirement will be implemented at 
the ``establishment'' level because proposed Sec.  88.5 requires 
recipients to post the notice in all physical locations where notices 
are commonly posted for members of the workforce or for the public. For 
instance, a hospital system that has common ownership and control over 
multiple hospital facilities (a firm) would implement Sec.  88.4 but 
each hospital facility (an establishment) would implement Sec.  88.5 to 
display physical notices.
    Table 3 employs the same methodology for calculating the number of 
entities but uses the U.S. Census Bureau's Statistics of U.S. 
Businesses data for establishments rather than firms.

   Table 3--Number of Physical Establishments of Each Recipient Type Required To Provide Notice (Sec.   88.5)
----------------------------------------------------------------------------------------------------------------
                                                                                     Estimated       Estimated
                                                             Type                  number (Low)    number (High)
----------------------------------------------------------------------------------------------------------------
1..........................................  State and Territorial Governments                58              58
                                              \117\.
2..........................................  Federally recognized Tribes \118\..             567             567
3..........................................  Counties \119\ (assumed sub-                    n/a             n/a
                                              recipient category to which the
                                              notice requirement does not apply).
4..........................................  General and Medical Surgical                  3,699           5,361
                                              Hospitals \120\.

[[Page 3911]]

 
5..........................................  Specialty Hospitals (e.g.                     1,139           1,651
                                              psychiatric, substance abuse,
                                              rehabilitation, cancer, maternity)
                                              \121\.
6..........................................  Skilled Nursing Facilities \122\...          11,789          17,085
7..........................................  Residential Intellectual and                 22,611          32,770
                                              Developmental Disability
                                              Facilities \123\.
8..........................................  Continuing Care Retirement                    3,668           5,316
                                              Communities \124\.
9..........................................  Other Residential Care Facilities             3,627           5,256
                                              (e.g., group homes) \125\.
10.........................................  Entities providing Home Health Care          21,377          30,981
                                              Services \126\.
11.........................................  Offices of Physicians (except               147,817         214,228
                                              Mental Health Specialists) \127\.
12.........................................  Offices of Physicians (Mental                 7,498          10,867
                                              Health Specialists) \128\.
13.........................................  Offices of Mental Health                     15,022          21,771
                                              Practitioners (except Physicians)
                                              \129\.
14.........................................  Offices of Dentists \130\..........          92,895         134,631
15.........................................  Offices of Chiropractors \131\.....          26,999          39,129
16.........................................  Offices of Optometrists \132\......          15,101          21,885
17.........................................  Offices of Physical, Occupational            25,213          36,541
                                              and Speech Therapists, and
                                              Audiologists \133\.
18.........................................  Offices of Podiatrists \134\.......           5,769           8,361
19.........................................  Family Planning Centers \135\......           1,584           2,295
20.........................................  Freestanding Ambulatory Surgical              4,609           6,679
                                              and Emergency Centers \136\.
21.........................................  HMO Medical Centers \137\..........             560             812
22.........................................  Kidney Dialysis Centers \138\......           5,144           7,455
23.........................................  Outpatient Mental Health and                  7,227          10,474
                                              Substance Abuse Centers \139\.
24.........................................  Diagnostic Imaging Centers \140\...           4,553           6,598
25.........................................  Medical Laboratories \141\.........           7,360          10,667
26.........................................  Ambulance Services \142\...........           3,271           4,740
27.........................................  All Other Outpatient Care Centers             8,054          11,672
                                              (e.g., centers and clinics for
                                              pain therapy, community health,
                                              and sleep disorders) \143\.
28.........................................  Entities providing All Other                  3,670           5,319
                                              Ambulatory Health Care Services
                                              (health screening, smoking
                                              cessation, hearing testing, blood
                                              banks) \144\.
29.........................................  Direct Health and Medical Insurance           3,712           5,379
                                              Carriers \145\.
30.........................................  Entities Serving the Elderly and             10,475          41,899
                                              Persons with Disabilities
                                              (provision of nonresidential
                                              social assistance services to
                                              improve quality of life) \146\.
31.........................................  Entities providing Other Individual           7,184          28,736
                                              Family Services (e.g., marriage
                                              counseling, crisis intervention
                                              centers, suicide crisis centers)
                                              \147\.
32.........................................  Entities providing Child and Youth            2,901          11,604
                                              Services (e.g., adoption agencies,
                                              foster care placement services)
                                              \148\.
33.........................................  Temporary Shelters (e.g., short               1,013           4,053
                                              term emergency shelters for
                                              victims of domestic violence,
                                              sexual assault, or child abuse;
                                              runaway youth; and families caught
                                              in medical crises) \149\.
34.........................................  Emergency and Other Relief Services             309           1,236
                                              (e.g., medical relief,
                                              resettlement, and counseling to
                                              victims of domestic or
                                              international disasters or
                                              conflicts) \150\.
35.........................................  Pharmacies and Drug Stores \151\...          30,450          44,130
36.........................................  Research and Development in                   2,505           3,631
                                              Biotechnology \152\.
37.........................................  Colleges, Universities, and                     615           4,788
                                              Professional Schools \153\.
38.........................................  HHS awarded funds appropriated to                65             130
                                              the U.S. Department of State &
                                              USAID \154\.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total, Subject to the Notice             ...................................         476,539         746,206
     Requirement.
----------------------------------------------------------------------------------------------------------------

Public Comment Requested on Scope of Entities
    Given the uncertainty as to the number of recipients covered by 
this

[[Page 3912]]

NPRM, the Department in particular seeks public comment on ways that 
HHS could improve the accuracy of the estimates contained in this RIA. 
Please specifically provide data, studies, reports, or other 
documentation to support your comments.
---------------------------------------------------------------------------

    \117\ Assumes coverage of the 50 States, DC, Puerto Rico, 6 U.S. 
Territories, and the Island Areas.
    \118\ Assumes all Federally-recognized Tribes get HHS funds. 
Indian Health Service, FY 2018 Justification of Estimates to the 
Appropriations Committees CJ-1 (2017), https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2018CongressionalJustification.pdf.
    \119\ 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 is a recipient or a sub-
recipient.
    \120\ 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). Assumes coverage for 69%-100% of the industry.
    \121\ Id. (sum of the nationwide count of firms for NAICS Codes 
622210 and 622310). Assumes 69%-100% of industry is covered.
    \122\ Id. (relying on the nationwide count of firms for NAICS 
Code 623110). Assumes 69%-100% of industry is covered.
    \123\ Id. (nationwide count of firms for NAICS Code 623210). 
Assumes 69%-100% of industry is covered.
    \124\ Id. (nationwide count of firms for NAICS Code 623311). 
Assumes 69%-100% of industry is covered.
    \125\ Id. (nationwide count of firms for NAICS Code 623990). 
Assumes 69%-100% of industry is covered.
    \126\ Id. (nationwide count of firms for NAICS Code 621610). 
Assumes 69%-100% of industry is covered.
    \127\ Id. (nationwide count of firms for NAICS Code 621111). 
Assumes 69%-100% of industry is covered.
    \128\ Id. (nationwide count of firms for NAICS Code 621112). 
Assumes 69%-100% of industry is covered.
    \129\ Id. (nationwide count of firms for NAICS Code 621330). 
Assumes 69%-100% of industry is covered.
    \130\ Id. (nationwide count of firms for NAICS Code 621210). 
Assumes 69%-100% of industry is covered.
    \131\ Id. (nationwide count of firms for NAICS Code 621310). 
Assumes 69%-100% of industry is covered.
    \132\ Id. (nationwide count of firms for NAICS Code 621320). 
Assumes 69%-100% of industry is covered.
    \133\ Id. (nationwide count of firms for NAICS Code 621340). 
Assumes 69%-100% of industry is covered.
    \134\ Id. (nationwide count of firms for NAICS Code 621391). 
Assumes 69%-100% of industry is covered.
    \135\ Id. (nationwide count of firms for NAICS Code 621410). 
Assumes 69%-100% of industry is covered.
    \136\ Id. (nationwide count of firms for NAICS Code 621493). 
Assumes 69%-100% of industry is covered.
    \137\ Id. (nationwide count of firms for NAICS Code 621491). 
Assumes 69%-100% of industry is covered.
    \138\ Id. (nationwide count of firms for NAICS Code 621492). 
Assumes 69%-100% of industry is covered.
    \139\ Id. (nationwide count of firms for NAICS Code 621420). 
Assumes 69%-100% of industry is covered.
    \140\ Id. (nationwide count of firms for NAICS Code 621512). 
Assumes 69%-100% of industry is covered.
    \141\ Id. (nationwide count of firms for NAICS Code 621511). 
Assumes 69%-100% of industry is covered.
    \142\ Id. (nationwide count of firms for NAICS Code 621910). 
Assumes 69%-100% of industry is covered.
    \143\ Id. (nationwide count of firms for NAICS Code 621498). 
Assumes 69%-100% of industry is covered.
    \144\ Id. (nationwide count of firms for NAICS Code 62199). 
Assumes 69%-100% of the industry is covered.
    \145\ Id. (nationwide count of firms for NAICS Code 524114). 
Assumes 69%-100% of industry is covered.
    \146\ Id. (nationwide count of firms for NAICS Code 624120). 
Assumes 69%-100% of industry is covered.
    \147\ Id. (nationwide count of firms for NAICS Code 624190). 
Assumes 69%-100% of industry is covered.
    \148\ Id. (nationwide count of firms for NAICS Code 624110). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \149\ Id. (nationwide count of firms for NAICS Code 624221). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \150\ Id. (nationwide count of firms for NAICS Code 624230). As 
described supra Part XI.C.2.iii (methodology), for entities whose 
principal purpose is not health care, the Department assumes 25%-
100% of industry is covered.
    \151\ Id. (nationwide count of firms for NAICS Code 44610). 
Assumes 69%-100% of industry is covered.
    \152\ Id. (nationwide count of firms for NAICS Code 541711). 
Assumes 69%-100% of industry is covered.
    \153\ Id. (nationwide count of firms for NAICS Code 611310). As 
described supra Part XI.C.2.iii (methodology), the Department 
assumes 13%-100% of institutions of higher-education are covered.
    \154\ U.S. Dep't of Health & Human Servs., Tracking 
Accountability in Government Grants System (TAGGS) https://taggs.hhs.gov (last visited Dec. 19, 2017).
---------------------------------------------------------------------------

Estimated Burdens
    There are six categories of estimated burdens for this proposed 
rule, as summarized in Table 4.

                                            Table 4--Summary of Costs
----------------------------------------------------------------------------------------------------------------
                                                       Year 1: Initial costs      Years 2 to 5: Annual recurring
                                                 --------------------------------              costs
                              Cost category                                      -------------------------------
                                                  Total cost (in   Affected (%)   Total cost (in
                                                     millions)                       millions)     Affected (%)
----------------------------------------------------------------------------------------------------------------
1.....................  Familiarization (one-              $62.9             100  ..............  ..............
                         time burden).
2.....................  Assurance and
                         Certification.
                          Signing Documents.....            72.8              26           $72.8              26
                          Reviewing Policies and            36.4              13            36.4              13
                           Procedures.
                          Update Policies,                  13.8               5             1.4             0.5
                           Procedures, Training.
----------------------------------------------------------------------------------------------------------------
    Subtotal, Assurance and Cert................           123.0  ..............           110.6  ..............
----------------------------------------------------------------------------------------------------------------
3.....................  Notice requirement......
                          Mandatory, one-time,              92.9              99
                           posting.
                          Voluntary Posting.....            25.2              50             6.7            24.9
----------------------------------------------------------------------------------------------------------------
    Subtotal, Notice............................           118.1  ..............             6.7  ..............
----------------------------------------------------------------------------------------------------------------
4.....................  Compliance Procedures...             0.6            0.01             0.6             .01
5.....................  Voluntary Remedial                   6.8             0.5             6.8             0.5
                         Efforts.
----------------------------------------------------------------------------------------------------------------
    Subtotal, Non-HHS Costs.....................           311.4  ..............           124.6  ..............
----------------------------------------------------------------------------------------------------------------
6.....................  OCR Enforcement.........             0.9             N/A             0.9             N/A
----------------------------------------------------------------------------------------------------------------
        Total...................................           312.3  ..............           125.5  ..............
----------------------------------------------------------------------------------------------------------------

Familiarization Costs
    The Department estimates that all persons and entities subject to 
the proposed rule would spend approximately one hour on average 
familiarizing themselves with the content of the proposed rule and its 
requirements. One fundamental reason that the Department publishes this 
proposed rule is the lack of awareness of obligations under Federal 
health care conscience and associated anti-discrimination laws and 
individuals' rights. This burden is a one-time opportunity cost of 
staff time to review the proposed rule. The mean hourly wage (including 
benefits and overhead) for a lawyer (occupation code 23-1011) is 
$134.50 per hour ($67.25 per hour x 2).\155\ The labor cost is 
approximately $62.9 million in the first year ($134.50 per hour x 1 
hour x 468,123 entities) and zero dollars in the out-years.
---------------------------------------------------------------------------

    \155\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------

Assurance and Certification (Proposed Sec.  88.4)
    The burden for the assurance and certification is the opportunity 
cost of

[[Page 3913]]

recipient staff time (1) to review the HHS-690 Form (assurance), and 
HHS-5161-1 Form (certification language) as well as the requirements of 
the underlying Federal health care conscience and associated 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 health care conscience and 
associated anti-discrimination laws, and (3) to implement any actions 
necessary to come into compliance. Examples of actions a recipient may 
need to take to come into compliance include updating policies and 
procedures, implementing staffing or scheduling practices that respect 
an exercise of conscience rights under Federal law, and training staff 
on relevant Federal laws or the recipient's policies and procedures. 
Table 5 infra summarizes these costs.
    The Department estimates that each recipient not excepted will 
spend an average of 4 hours reviewing the assurance and certification 
language as well as the requirements of the underlying Federal health 
care conscience and associated anti-discrimination laws referenced or 
incorporated through a Web link. 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. 73 FR 
78072, 78095 (2008 Rule). In this proposed rule, there are almost two 
dozen additional laws included. Using the rough guide of 10 minutes per 
law, the Department estimates that it would take 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.
    The labor cost is a function of a lawyer spending 3 hours reviewing 
the assurance and certification and a chief executive spending one hour 
to review and sign, as proposed Sec.  88.4(b)(2) requires a signature 
by an individual authorized to bind the recipient. The mean hourly wage 
(including benefits and overhead) for these occupations is $134.50 per 
hour for the lawyer (occupation code 23-1011) ($67.25 per hour x 2) and 
$186.88 for the chief executive (occupation code 11-1011) ($93.44 per 
hour x 2).\156\ The weighted mean hourly wage (including benefits and 
overhead) of these two occupations is $147.60 per hour ((134.50 x .75) 
+ (186.88 x .25)). The labor cost is $72.8 million each year for the 
first five years ($147.60 per hour x 4 hours x 123,302 entities).
---------------------------------------------------------------------------

    \156\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------

    The Department estimates that 61,652 recipients, which is half of 
all recipients required to assure and certify compliance (123,302 
entities/2) will review policies and procedures or take other actions 
to self-assess compliance with applicable Federal health care 
conscience and associated anti-discrimination laws each year for the 
first five years of publication. The Department reasonably estimates 
such action because Sec.  88.4(c)(4) states that the submission of an 
assurance and certification will not relieve a recipient of the 
obligation to take and complete actions to come into compliance prior 
to or after submission of such assurance or certification. The first 
step to such actions is reviewing organization-wide safeguards that 
are, or should be, in place.
    The Department estimates that recipients that review policies and 
procedures or otherwise self-assess compliance will spend an average of 
4 hours doing so. Some entities will spend more time and others will 
spend less time. The labor cost is a function of a lawyer spending 3 
hours and a chief executive spending one hour, which produces the 
weighted mean hourly wage of $147.60 per hour. The labor cost for self-
assessing compliance, such as reviewing policies and procedures, is a 
total of $36.4 million each year for the first five years ($147.60 per 
hour x 4 hours x 61,652 entities).
    The Department estimates that approximately 5% of entities will 
take an organization-wide action to improve compliance in the first 
year and 0.5% will take a similar action annually each year in years 
two through five. This percentage equates to 23,406 recipients in year 
1 and 2,341 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 
train staff on relevant Federal law or the recipient's policies and 
procedures. The labor cost is a function of a lawyer spending 3 hours 
and a chief executive spending one hour, which produces a weighted mean 
hourly wage of $147.60 per hour. The labor cost is $13.8 million in 
year one ($147.60 per hour x 4 hours x 23,406 entities) and 
approximately $1.4 million annually for years two through five ($147.60 
per hour x 4 hours x 2,341 entities).
    The Department is committed to leveraging existing grant, contract, 
and other Departmental forms where possible rather than creating 
additional, separate forms for recipients to sign. Sub-recipients are 
not subject to this requirement; as described in the preamble, the 
Department seeks comment on this approach taken to reduce burden on 
small entities.

                              Table 5--Summary of Assurance and Certification Costs
----------------------------------------------------------------------------------------------------------------
                                                       Year 1: Initial costs        Years 2-5: recurring costs
                                                 ---------------------------------------------------------------
                 Cost categories                    Total cost      Per entity      Total cost      Per entity
                                                 ---------------------------------------------------------------
                                                   (in millions)     (dollars)     (in millions)     (dollars)
----------------------------------------------------------------------------------------------------------------
Review and Sign.................................           $72.8            $590           $72.8            $590
Review Policies and Procedures..................            36.4             590            36.4             590
Update Policies and Procedures; Train Workforce.            13.8             590             1.4             590
                                                 ---------------------------------------------------------------
    Total Costs.................................           123.0             998           110.6             897
----------------------------------------------------------------------------------------------------------------


[[Page 3914]]

Notice Requirement (Proposed Sec.  88.5)
    Proposed Sec.  88.5 requires recipients and the Department to 
provide notice. Section 88.5 includes a mandatory posting requirement 
and incentives additional posting. The mandatory posting requirement is 
a one-time burden with no recurring costs. The Department does not 
intend for recipients to incur any costs in developing the notice; 
indeed, proposed Sec.  88.5 would require recipients to post the text 
of the notice in appendix A to this proposed part. This approach 
leverages economies of scale by requiring recipients to post the exact 
text from the notice in Appendix A. The Department is mindful that 
Executive Order 13562 asks agencies, if feasible, to specify 
performance objectives for persons and entities rather than the 
behavior or manner of compliance. The Department has determined that 
providing a pre-written notice is the most efficient and effective way 
to provide information to persons, entities, and health care entities 
while reducing the burden on a recipient. The Department acknowledges 
that the trade-off regarding this approach is that it limits a 
recipient's flexibility. On the other hand, the decreased flexibility 
may be a worthwhile trade-off because, with a pre-written notice from 
OCR, a recipient need not spend time with counsel or executives in 
developing the text.
    The Department estimates that the burden for the notice is 
represented in terms of opportunity costs of staff time to download, 
print, and post the notice, combined with material costs for paper and 
ink. These costs are a one-time, upfront burden in the first year of 
implementation. The Department estimates that it will take \1/3\ of an 
hour for an administrative assistant to download the notice, print 
notice(s) and post them in physical locations of the establishment 
where notices are commonly posted. 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 to post the notice online. 
For some establishments, it may take an administrative assistant or Web 
developer longer to perform this function; for other establishments, it 
may take less time. The mean hourly wage (including benefits and 
overhead) for an administrative assistant is $38.78 per hour 
(occupation code 43-6010) ($19.39 per hour x 2).\157\ The mean hourly 
wage (including benefits and overhead) for a Web developer is $69.38 
per hour (occupation code 15-11134) ($34.69 per hour x 2).\158\ This 
labor cost is approximately $92.7 million ((\1/3\ hr. x $38.78 per hour 
x 611,372 establishments) + (2 hours x $63.38 per hour x 611,372 
establishments)).
---------------------------------------------------------------------------

    \157\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
    \158\ Id.
---------------------------------------------------------------------------

    A key uncertainty with respect to this labor cost is the degree to 
which each establishment maintains its own website and thus would bear 
the labor cost for a Web developer to post the notice on the 
establishment's website. For the purpose of this RIA, the Department 
has erred on the side of overestimating the burden. Therefore, the 
Department assumed that a Web developer at each physical location will 
spend 2 hours to post the notice.
    If, however, recipients maintain one website for all of its 
establishments, a Web developer at the firm-level, rather than Web 
developers at each establishment, would bear the labor costs to post 
the notice online. In contrast to 611,372 establishments bearing the 
labor costs of the Web developer, about 464,792 recipients at the firm-
level would bear this cost. This number results from subtracting 3,324 
counties from the total number of entities on average subject to the 
NPRM (468,026 entities). For the purpose of this calculation, the 
Department assumed all counties are sub-recipients.
    The labor costs are the sum of (1) the costs for an administrative 
assistant at each establishment to post the notice in physical 
locations (\1/3\ hr. x $38.78 per hour x 611,372 establishments) and 
(2) the costs for a Web developer at each firm to post the notice on 
the entity's website (2 hours x $63.38 per hour x 464,792), which 
equals $72.4 million. This labor cost is $20 million less, or 
approximately 22% less, than the labor cost of a Web developer at each 
establishment of a recipient, rather than at the firm-level, to post 
the notice on the websites of each recipient establishment.
    Another key uncertainty with respect to the estimated burden of the 
notice requirement is the number of locations where notices are 
commonly posted in an establishment; the number will vary based on 
multiple factors. These factors may 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; larger entities might post more and 
smaller entities post fewer. The Department also 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 $152,843 (611,372 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 proposed rule's 
implementation, the cost will not recur in years 2 through 5. The total 
labor and materials costs for implementing the mandatory component of 
the notice requirement is $8 million ($7.9 million in labor costs and 
$152,843 for materials) in year one with zero recurring costs.
    Because societal goals for assuring nondiscrimination are often 
realized through individuals' persistent exercise of protected rights, 
this proposed rule's notice requirement serves as a gateway to achieve 
those goals. Section 88.5 intends to incentivize recipients to include 
the OCR-drafted notice in certain types of documents or publications by 
rendering such posting as a factor that the OCR Director would consider 
if the Director investigates or initiates a compliance review of a 
recipient.
    For instance, OCR would take into account whether a recipient has 
provided the notice in a personnel manual for the recipient's 
workforce, in applications for membership in the recipient's workforce 
or to receive a service or benefit, or in a student handbook for 
students participating in a program for training or study. Because this 
provision is permissive, the Department assumes that 305,686 
establishments will undertake such action in the first year, which is 
half of all establishments subject to the notice requirement (611,372 
establishments x 50%). Approximately 152,843 establishments (305,686 
establishments/2) will annually undertake such voluntary posting in 
years 2 through 5. The Department assumes that an administrative 
assistant paid at $19.39/hour would identify documents in which to 
include the notice, revising the documents or their layouts to include 
the notice, or otherwise printing an insert to include with paper 
documents. The assistant may spend a total of 2 hours in year one and 1 
hour annually in years 2 through 5. The labor cost, adjusted upward for 
benefits and overhead is $23.7 million (2 x $19.39 per hour x 2 hours x 
305,686 establishments) in year one and $5.9 million annually in years 
2 through 5 (2 x $19.39 x 1 x 152,843 establishments).
    The Department anticipates that there may be some additional 
printing costs

[[Page 3915]]

where inclusion of the notice adds a page to the underlying document. 
There is a high degree of uncertainty as to the average number of 
documents in which a recipient may proactively include the notice. 
There is also uncertainty as to whether a recipient would provide hard-
copy publications or house them online.
    A recipient that voluntarily includes the notice in certain 
publications probably would provide some in hard-copy and others 
online. On balance, a recipient might print approximately 100 extra 
pages. Given these assumptions, the cost of voluntarily included 
notices, as proposed Sec.  88.5(c) incentivizes, will cost 
approximately $1.5 million in the first year (305,686 entities x 100 
pages x $.05 per page) and $764,215 annually in years two through five.
    In sum, total first-year costs to implement the mandatory and 
voluntary components of the notice requirement is estimated at $118.1 
million and $6.7 million annually in years 2 through 5, which is a 94% 
decrease in cost from the one-time cost to implement the notice 
requirement in year 1.
Compliance Procedures (Sec.  88.6(d))
    The information promptly informs applicable Departmental components 
of OCR's pending investigation to ensure appropriate coordination 
within the Department during the pendency of the investigation and the 
obligation to report complaints if the Department modifies existing 
applications for grants, or in a separate writing with the 
applications, for five years. OCR estimates that there are 30 
recipients on average per year that OCR may investigate and 
investigate. Thirty recipients is the average between the lower-bound 
estimate (10 recipients) and the upper-bound estimate (50 recipients).
    The Department estimates that the burden is the opportunity cost 
that recipients and sub-recipients would incur to email the appropriate 
grants management official(s). The Department assumes that this email 
would inform the Department component and could also be used as the 
separate writing to accompany new or renewed applications. This burden 
is the labor cost associated with an administrative assistant spending 
approximately 15 minutes to draft and transmit the email. The mean 
hourly wage for the administrative assistant (occupation code 43-6010) 
($19.39 per hour) (adjusted for benefits and overhead) is $38.78 per 
hour. The Department estimates that the administrative assistant would 
incur this labor cost for each award action for which the recipients 
applied, including new funding opportunities, supplemental funding, and 
non-competing continuations, among others.
    Because OCR had no publicly available and reliable data source to 
know how many total applications for new or renewed funding in a fiscal 
year a recipient might make to the Department or its component, OCR 
used actual award data from HHS TAGGS as a proxy. The Department looked 
at 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 a couple of 
awards per fiscal year and others receive 80 awards per fiscal year.
    The Department erred on the side of overestimating the burden and 
assumed that each of the 30 recipients would apply for new or renewed 
funding 2,000 times per year. The annual labor cost is $0.6 million 
across all 30 entities (30 recipients x $39.78 per hour x 0.25 hours x 
2,000).
Voluntary Remedial Efforts
    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 proposed 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 anticipates 0.5% of entities, or 2,340 recipients or sub-
recipients, (0.005 x 468,026 recipients), would conduct such internal 
investigations should complaints come to the recipient's or sub-
recipient's attention or undertake remedial efforts.
    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 per year. On average, the Department anticipates entities 
spending 20 hours annually: 16 hours of a lawyer's time and 4 hours of 
a chief executive's time. The mean hourly wage (including benefits and 
overhead) for these occupations is $134.50 per hour for the lawyer 
(occupation code 23-1011) ($67.25 per hour x 2 to adjust upward for 
benefits and overhead) and $186.88 for the chief executive (occupation 
code 11-1011) ($93.44 per hour x 2 to adjust upward for benefits and 
overhead).\159\ The weighted mean hourly wage (including benefits and 
overhead) is $72.49 per hour (($67.25 x .80) + ($93.44 x .20)). The 
labor cost is $6.8 million ($144.98 per hour x 20 hours x 2,341 
entities).
---------------------------------------------------------------------------

    \159\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------

    Some recipients may spend more than 20 hours, 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.
OCR Enforcement
    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 to address those rights through 
the administrative complaint process; and an increase in the number of 
Federal health care conscience and associated anti-discrimination laws 
for which the rule proposes to enforce. The Department expects that 
after 5 years following publication of the final rule, the number of 
complaints probably will plateau, but uncertainty exists in this 
estimated timeframe. The Department hopes that over time, recipients' 
awareness of their obligations will equate to fewer violations of law 
and consequently fewer complaints to OCR to address such violations.
    OCR will bear the increased cost in the form of the opportunity 
cost of staff resources for enforcement. In the first five years 
following publication of the rule, the Department anticipates that the 
impact of this proposed rule on enforcement is equivalent to an 
additional 4.5 FTE. The fully loaded labor cost (which includes 
benefits and overhead) is about $201,000 per FTE. With these variables, 
the Department expects OCR's staff costs would increase by 
$904,500annually in years one through five (4.5 FTE x $201,000/FTE).
Request for Comment on Burden Analysis
    The Department seeks public comment on improving the accuracy of 
the best estimates contained in this RIA. To the extent that more 
entities are covered or an entity spends more staff time executing or 
implementing required and/or voluntary actions, the costs will be 
higher than estimated.

[[Page 3916]]

Similarly, to the extent that fewer persons and entities are covered, 
or an entity spends less staff time executing or implementing required 
and/or voluntary actions, the costs will be lower than estimated.
    In particular, the Department would appreciate comment on areas 
where the public has documentation, data, or other information to 
support a belief that this RIA over-estimates or under-estimates the 
implementation costs. For instance, the Department assumes that 
recipients and sub-recipients maintain records in the course of 
evidencing compliance with the terms and conditions of a Federal award, 
which would include not only financial requirements but all applicable 
Federal laws, including Federal health care conscience and associated 
anti-discrimination laws. Consequently, the Department has not 
identified record keeping as a separate burden resulting from this 
proposed rule because the Department understands that recipients and 
sub-recipients must document such compliance in the course of receiving 
a Federal award. To the extent that this assumption does not represent 
the existing record keeping requirements or practices, please provide 
comments to inform this assumption.
    Moreover, the Department would appreciate information, data, 
studies, reports, or other documentation to that support what costs, if 
any, result from ancillary effects of this proposed rule, such as the 
monetary impact of certain health outcomes that may arise from the 
increase protection of conscience of medical providers as set forth in 
the proposed rule.
Estimated Benefits
    This proposed rule is expected to remove barriers to the entry of 
certain health professionals, and to delay the exit of certain types of 
health professionals from the field, due to discrimination or coercion 
anticipated or experienced. Second, in supporting a more diverse 
medical field, the proposed rule would create ancillary benefits for 
patients. Third, the Department expects that the proposed rule would 
generate benefits by securing a public good--a society free from 
discrimination, which permits more personal freedom and removes 
unfairness. The proposed rule would promote protection of religious 
beliefs and moral convictions, which is a societal good based on 
fundamental rights.
Historical Support for Conscience Protections
    The people of the United States of America have valued conscience 
protections since the country's founding. James Madison, the fourth 
President of the United States and often hailed as the ``father of the 
Constitution'' said, ``[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.'' \160\ 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.'' 
\161\ Some scholars have argued that ``[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.'' \162\
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    \160\ James Madison, Property, The Founders' Constitution (March 
29, 1792), https://press-pubs.uchicago.edu/founders/documents/v1ch16s23.html.
    \161\ Letter from George Washington, to The Society of Quakers 
(October 13, 1789), https://founders.archives.gov/documents/Washington/05-04-02-0188.
    \162\ Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 561 (2017).
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Recruitment and Maintenance of Health Care Professionals
    This proposed rule is expected to remove barriers to the entry of 
certain health professionals, and to delay the exit of certain types of 
health professionals from the field, due to discrimination or coercion 
anticipated or experienced. The Department has a significant interest 
in removing unlawful barriers to careers in the health care field. As 
numerous studies and comments establish, failure to protect conscience 
is one such barrier.
    A 2011 study released by the American College of Obstetrics and 
Gynecology revealed that, ``while 97% of ob-gyns reported having 
encountered women seeking an abortion, only 14% said they were willing 
to perform the service.'' \163\ Only 1.2% of Evangelical Protestant, 9% 
of Catholic or Eastern Orthodox, 10.1% of Non-Evangelical Protestant, 
20% of Hindu, 26.5% with no religious affiliation, and 40.2% of Jewish 
doctors said they would provide abortion.\164\ Yet one in six patients 
is cared for in Catholic hospitals, and Catholic Hospitals employed 
523,040 full-time and 216,487 part-time workers in 2015.\165\ Another 
pro-life organization, the Christian Medical & Dental Associations 
(``CMDA''), boasts 19,000 members.\166\ And the American Association of 
Pro-Life Obstetricians and Gynecologists (``AAPLOG''), which boasts 
2,500 members and associates,\167\ 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.'' \168\
---------------------------------------------------------------------------

    \163\ Abortion is Legal, but What Percentage of Ob-Gyns Will 
Provide One?, Freakonomics (August 24, 2011, 1:57 p.m.), https://freakonomics.com/2011/08/24/abortion-is-legal-but-what-percentage-of-ob-gyns-will-provide-one/.
    \164\ Id.
    \165\ U.S. Catholic Health Care: The Nation's Largest Group of 
Not-for-Profit Health Care Providers, Catholic Health Association of 
the United States (2017), available at https://www.chausa.org/docs/default-source/default-document-library/cha_2017_miniprofile.pdf?sfvrsn=0.
    \166\ History of Our Ministry, Christian Medical & Dental 
Associations, https://www.cmda.org/library/doclib/history-of-cmda.pdf.
    \167\ About Us, American Association of Pro-Life Obstetricians 
and Gynecologists, https://aaplog.org/about-us.
    \168\ Letter from Lawrence J. Joseph, on behalf of the American 
Association of Pro-Life Obstetricians and Gynecologists, to the 
Office of Public Health & Science, Department of Health & Human 
Services 2 (April 9, 2009), available at https://downloads.frc.org/EF/EF09D50.pdf.
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    Protecting the conscience rights of persons, entities, and health 
care entities is expected to result in the recruitment of diverse 
health care professionals and the maintenance of such professionals in 
the field. The medical community and American people as a whole might 
also benefit from the willing and enthusiastic participation in the 
field of people with a variety of moral, religious, and philosophical 
backgrounds. The Department expects that its proposed rule will protect 
existing participants in the profession and promote more diverse 
participation over time as the institutional culture at health 
facilities, and in health-professions training programs, changes.
Patient Benefits From Conscience Protections
    In supporting a more diverse medical field, the proposed rule would 
create ancillary benefits for patients. The proposed rule would assist 
patients in seeking counselors and other health-care providers who 
share their deepest

[[Page 3917]]

held convictions. Some patients will appreciate the ability to speak 
frankly about their own convictions concerning questions that touch 
upon life and death and treatment 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. A pro-vaccination parent may seek a pediatrician who shares 
his views. Open communication in the doctor-patient relationship will 
foster better over-all 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.'' \169\ But poor communication 
negatively affects continuity of care and undermines the patient's 
health goals. When conscience protections are robust, both patients and 
their physicians can communicate openly and honestly with one-another 
at the outset of their relationship.
---------------------------------------------------------------------------

    \169\ Fallon E. Chipidza, et al., Impact of the Doctor-Patient 
Relationship, 17(5) The Primary Care Companion for CNS Disorders 
(2015), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308/.
---------------------------------------------------------------------------

    Facilitating open communication between providers and their 
patients also helps to eliminate barriers to care, particularly for 
minorities. 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. These influences 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.'' \170\ It is 
important for patients seeking care to feel assured that their faith, 
and the principles of conscience grounded in their faith, will be 
honored. This will ensure that they feel they are being treated 
fairly.\171\ And for some, being able to find health care providers 
that share the same moral convictions can be a source of personal 
healing. See Gonzales v. Carhart, 550 U.S. 124, 159 (2007) (``Respect 
for human life finds an ultimate expression in the bond of love the 
mother has for her child. . . . it seems unexceptionable to conclude 
some women come to regret their choice to abort the infant life they 
once created and sustained.''). The patient benefits that will accrue 
from respect for provider conscience protections may take time to 
develop, but the Department anticipates that such benefits will be 
individualized and long-lasting.
---------------------------------------------------------------------------

    \170\ Emmanuel Scheppers, et al., Potential Barriers to the Use 
of Health Services Among Ethnic Minorities: A Review, 23 Family 
Practice 325, 343 (2006), available at https://academic.oup.com/fampra/article/23/3/325/475515.
    \171\ Id.
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Societal Benefits From Conscience Protections
    The proposed rule will also yield lasting societal benefits. The 
rule will mitigate current misunderstanding about what conduct the 
Federal government is legally able to support and fund, and it will 
educate individuals about their Federal health care conscience rights. 
The proposed rule would provide an enforcement mechanism for 
individuals and institutions to file complaints with the Department 
when such individuals and institutions believe that their rights have 
been curtailed. The Department expects that, as a result of this 
proposed rule, more individuals, having been apprised of those rights, 
would assert them, and such assertions would contribute to the general 
public's knowledge and appreciation of these protections.
    Fostering respect for the existing Federal health care conscience 
and associated 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.\172\
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    \172\ Lynn Stout, Cultivating Conscience: How Good Laws Make 
Good People 17 (2011).

    Because fostering conscience in individuals contributes to a more 
lawful and virtuous society, governments and their subdivisions have a 
significant interest in encouraging expressions of, and fidelity to, 
conscience. 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 respect for conscience to the 
individual and society as a whole, but the benefit is 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.

    United States v. Seeger, 380 U.S. 163, 169 (1965) quoting Harlan 
Fisk Stone, The Conscientious Objector, 21 Col. Univ. Q. 253, 269 
(1919).
    The Department seeks comment regarding the benefits of this 
proposed rule, and how they might be quantified or monetized and 
specifically seeks supporting data, studies, reports, or other 
documentation.
Analysis of Regulatory Alternatives
    The Department carefully considered alternatives to this proposed 
rule, but concluded that none struck the appropriate balance between 
the Administration's goal of robust enforcement of existing Federal 
statutory protections for conscience in the health care field without 
unduly burdening entities in that field.
    First, the Department considered maintaining the status quo, 
enforcing part 88 as it current exists and largely deferring to States 
to enact and enforce their respective conscience laws, but such an 
approach would create a significant risk of unaddressed violations of 
the conscience rights of persons, entities, and health care entities. 
Specifically, it would leave OCR's minimal administrative enforcement 
scheme as the only remedy for alleged violations of the Weldon, Coats-
Snowe or Church Amendments. See supra Part VI (reasons for the proposed 
rule). That minimalistic scheme, so different from those that pertain 
to other civil rights laws, undermines both OCR's authority and public 
perception of the value of these protections. And it fails to allow for 
strategic coordination with respect to the compliance and enforcement 
of the many Federal health care conscience and associated anti-
discrimination protections that exist outside the Weldon, Coats-Snowe 
or Church Amendments.
    Second, the Department also considered alternative approaches to 
the policies enunciated in the proposed rule. The Department considered 
developing a rule that specifies

[[Page 3918]]

performance objectives rather than the manner of compliance to allow 
persons and entities more flexibility. For instance, instead of 
providing the text of a notice in Appendix A for recipients to post, 
the Department considered allowing recipients to develop the text of 
their own notices, so long as such notices achieved certain substantive 
objectives. But the Department was sensitive to the time it might take 
each entity to draft a notice and to obtain the proper legal 
consultation and executive sign-off. In lieu of requiring, or 
permitting, each entity to re-create the wheel, the Department proposes 
that entities use the notice in Appendix A to reduce burden. The 
Department also considered requiring fewer recipients to execute the 
assurance and certify compliance, and/or to post notices of 
individuals' conscience and anti-coercion rights and the recipients' 
corresponding obligations.
    The Department invites comment on our proposed approach, as well as 
other approaches to achieve robust enforcement of Federal health care 
conscience laws with minimal regulatory burden.
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 
proposed rule is a significant regulatory action as defined by 
Executive Order 12866. If this rule is finalized as proposed, it would 
be considered a regulatory action under Executive Order 13771. 
Excluding any ancillary costs attributed to this proposed rule that 
result from health outcomes or other effects of protecting conscience 
rights (as this RIA seeks comment on such costs, which have not yet 
been quantified), the Department estimates that this rule generates 
$112 million in annualized costs at a 7% discount rate, discounted 
relative to year 2016, over a perpetual time horizon.
Regulatory Flexibility Act
    HHS has examined the economic implications of this proposed 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 proposed 
rulemaking on small entities by providing an initial regulatory 
flexibility analysis unless the agency expects that the proposed rule 
will not have a significant impact on a substantial number of small 
entities, provides a factual basis for this determination, and proposes 
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 preliminarily 
concluded that this proposed rule does not have a significant economic 
impact on a substantial number of small entities. The entities that 
would be affected by the proposed 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 
industry.\173\ Persons and States are not included in the definition of 
a small entity. The Department assumes that most, if not all, of the 
entities affected meet the threshold of a small entity.
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    \173\ https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf.
---------------------------------------------------------------------------

    Although the proposed rule will apply to and thus affect small 
entities, the proposed rule's per-entity effects are relatively small. 
The Department estimates that this rule would impose an average cost of 
$665 in the first year of compliance following publication of the final 
rule and about $266 per year in subsequent years. Furthermore, these 
costs would generally be proportional to the size of an entity, 
suggesting that the smallest affected entities will face lower average 
costs. Given thresholds discussed above, we believe these average costs 
are well below those required to have a significant impact on a 
substantial number of small entities.
    Despite this determination, the proposed rule attempts to minimize 
costs imposed on small entities. For example, the assurance and 
certification requirements in proposed Sec.  88.4 contain exceptions to 
relieve many small entities of the requirement to submit an assurance 
and certification. 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, in an effort to reduce economic 
burden imposed by the notice requirements in proposed Sec.  88.5, HHS 
has drafted a notice in Appendix A for recipients to use so that the 
recipients do not have to bear the labor costs of consulting with 
counsel and executives. In light of this determination, the Secretary 
proposed to certify that this rule will not result in a significant 
impact on a substantial number of small entities.
Unfunded Mandates Reform Act
    HHS similarly concludes that the requirements of the Unfunded 
Mandates Reform Act of 1995 are not triggered by the proposed rule. 
Section 202(a) of that Act requires us 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 $148 million, using the most current (2016) 
Implicit Price Deflator for the Gross Domestic Product. As discussed in 
this Regulatory Impact Analysis, if finalized as proposed, this rule 
would 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.
Executive Order 13132--Federalism
    The Secretary has also preliminarily determined that this proposed 
rule does not implicate the requirements of Executive Order 13132. That 
Executive Order requires an agency to meet certain requirements when it 
promulgates a proposed rule (and subsequent final rule) that imposes 
substantial direct effects on (1) States, including political 
subdivisions thereof, (2) the relationship between the Federal 
government and the States, or (3) the distribution of power and 
responsibilities among the various levels of government. Although this 
rulemaking is expected to affect State and local governments, the 
anticipated affect is not substantial.
    First, this rulemaking does not impose substantial direct effects 
on States or political subdivisions of States. The substantive 
prohibitions and requirements in Federal health care conscience and 
associated anti-discrimination laws already apply to State and local 
governments. Moreover, State and local government agencies who are 
recipients of HHS awards must already assure compliance with applicable 
Federal laws and certify

[[Page 3919]]

compliance with them in the normal course of receiving such awards. And 
although proposed Sec.  88.5 imposes a new requirement to post a notice 
about rights and obligations under Federal health care conscience and 
associated anti-discrimination laws, this requirement involves a 
minimal one-time opportunity cost on staff time, attaches only to 
recipients, and is similar to notice requirements already in force for 
other civil rights laws. Under such circumstances, the notice 
requirement cannot be understood to impose substantial direct effects 
on States or their political subdivisions.
    Second, this proposed rulemaking does not have substantial direct 
effects on the relationship between the Federal government and the 
States. The proposed rule would be promulgated under longstanding 
Federal laws that leave room for State activity. For example, 42 U.S.C. 
280g-1(d) authorizes the Department to provide grants and cooperative 
agreements for newborn and infant hearing screening, but makes clear 
that such grants do not preempt or prohibit any State law, including 
State laws that allow parents to assert religious objections to such 
screening. Similarly, 42 U.S.C. 1396f clarifies that nothing in that 
subchapter shall be construed to require a State to compel a person to 
undergo medical screenings, examination, diagnosis, treatment, health 
care or services if a person objects on religious grounds (except for 
discovering and preventing the spread of infection or contagious 
disease or protecting environmental health). And the requirement in 42 
U.S.C. 1396s(c)(2)(B)(ii) for providers to offer pediatric vaccines is 
subject to applicable State law, including any law relating to any 
religious or other exemption. Given these provisions, it is no surprise 
that, as described supra, in Part VIII, all fifty States have some 
protections in place for conscientious objectors to certain health or 
medical services.\174\
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    \174\ See Kevin Theriot & Ken Connelly, Free to Do No Harm: 
Conscience Protections for Healthcare Professionals, 49 Ariz. St. 
L.J. 549, 575-76, app. I, 587-600 (2017) (summarizing State laws).
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    The proposed rule makes clear that it is not intended to interfere 
with the operation of State law, except as required by existing Federal 
health conscience protections. Thus, proposed Sec.  88.8 states that 
this proposed rule does not preempt any Federal, State, or local law 
that is equally as protective of the rights of conscience and against 
coercion as the regulation. And the proposed Sec.  88.7 borrows from 
enforcement mechanisms already available to OCR to enforce similar 
civil rights laws. States are familiar with such mechanisms from 
decades of investigations, compliance reviews, and remedial actions 
taken pursuant to existing civil rights laws (e.g. Title VI, Section 
504 of the Rehabilitation Act, and Title II of the Americans with 
Disabilities Act). HHS believes that this approach does not alter or 
have any substantial direct effects on the relationship between the 
Federal government and the States.
    The Department invites comments from States and local governments 
on whether provisions of this proposed rule implicate federalism 
concerns not identified and ways to minimize any such burden, 
consistent with meeting the Department's objectives of ensuring (1) 
knowledge of the obligations imposed, and the rights and protections 
afforded, by Federal health care conscience and associated anti-
discrimination laws; and (2) compliance with their nondiscrimination 
provisions.
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 proposed rule 
under Executive Order 12866, the Department deems that this proposed 
rule is a major rule for purposes of the Congressional Review Act.
Assessment of Federal Regulation and Policies on Families
    Section 654 of the Treasury and General Government Appropriations 
Act of 1999, Pub. L. 105-277, section 654, 112 Stat. 2681 (1998) 
(codified at 5 U.S.C. 601 (note)), requires Federal departments and 
agencies to determine whether a proposed policy or regulation could 
affect family well-being.\175\
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    \175\ This section discusses the assessment required in 
Executive Order 12606, The Family, which was revoked on April 21, 
1997. Memorandum from Jacob Lew, Dir., Office Of Mgmt. & Budget, 
Exec. Office of the President, To Heads of Exec. Dep'ts, Agencies, & 
Independent Establishments Assessment of Federal Regulations and 
Policies on Families (Jan. 26, 1999) https://www.fws.gov/policy/library/rglew.pdf.
---------------------------------------------------------------------------

    Agencies must assess whether the proposed 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 financially 
impacts families, are 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 and personal 
responsibility of youth and the norms of society.\176\
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    \176\ Treasury and General Government Appropriations Act of 
1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998).
---------------------------------------------------------------------------

    It is unlikely that this proposed rule will negatively impact the 
stability of the family or impact parental authority. In addition, the 
proposed rule has no bearing on the disposable income or poverty of 
families and children, and none of the rule's proposed provisions 
concern the relationship between the behavior and personal 
responsibility of youth and the norms of society. Finally, the action 
taken in this proposed rule cannot be carried out by State or local 
government or by the family because the rule pertains to the 
enforcement of certain Federal laws. Therefore, this proposed rule 
probably will have minimal to no impact on family well-being.
    If the determination is affirmative, then the Department or agency 
must prepare an impact assessment to address criteria specified in the 
law. The Secretary proposes to certify that this proposed rule has been 
assessed in accordance with Section 654 of the Treasury and General 
Government Appropriations Act of 1999, Public Law 105-277, section 654, 
112 Stat. 2681 (1998), and will not negatively affect family well-
being.
Paperwork Reduction Act
    This notice of proposed rulemaking would call for 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),

[[Page 3920]]

``collection of information'' comprises reporting, record-keeping, 
monitoring, posting, labeling, and other similar actions.
    The collections of information required by the proposed rule relate 
to Sec.  88.4 (Assurance and Certification), Sec.  88.5 (Notice), and 
Sec.  88.6(d) (Compliance Requirements).
Information Collection for Proposed Sec.  88.4 (Assurance and 
Certification)
    Summary of the Collection of Information: The proposed rule 
requires each recipient (or applicant to become a recipient), with 
limited exception, to assure and certify compliance with Federal 
conscience and associated anti-discrimination laws. Specifically, 
proposed Sec.  88.4(a) 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 health care 
conscience and associated anti-discrimination laws. The Federal laws 
with which recipients would be required to assure compliance, if 
applicable, are:
    Provider conscience laws related to abortion (the Weldon Amendment 
for Medicare Advantage, e.g. Public Law 115-31, Div. H, sec. 209, 131 
Stat. 135, 539 (2017));
    Certain provisions of the Affordable Care Act applying Federal 
conscience protections (42 U.S.C. 18023(b)(4)), regarding assisted 
suicide (42 U.S.C. 18113), and providing a conscience exemption to the 
individual mandate (26 U.S.C. 5000A(d)(2));
    Certain laws governing provider counseling, referral, and 
implementation of directives (counseling and referral in Medicare 
Advantage ((42 U.S.C. 1395w-22(j)(3)(B)), counseling and referral in 
Medicaid (42 U.S.C. 1396u-2(b)(3)(B)), and performance of advanced 
directives in the Medicare and Medicaid programs (42 U.S.C. 
1396a(w)(3), and 14406);
    Conscience and anti-coercion laws applicable to Global Health 
Programs for HIV/AIDS Prevention, Treatment, or Care (22 U.S.C. 
7631(d)) and certain funds appropriated to the U.S. Department of State 
and USAID (the Helms Amendment (e.g., Consolidated Appropriations Act, 
2017, Public Law 115-31, Div. J, sec. 7018));
    Laws providing for patient objections to receiving health care 
services, including medical screening, examination, diagnosis, 
treatment, or other health care (42 U.S.C. 1396f), occupational illness 
testing (29 U.S.C. 669(a)(5)), pediatric vaccination (42 U.S.C. 
1396s(c)(2)(B)(ii)), youth suicide prevention and treatment (42 U.S.C. 
290bb-36(f)), and newborn health screening (42 U.S.C. 280g-1(d)); and
    Laws protecting religious nonmedical health care by exempting 
religious non-medical institutions from 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 
from utilization review plan requirements (42 U.S.C. 1396b(i)(4)), and 
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)).
    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 
health care conscience and associated anti-discrimination laws. Second, 
a recipient's or applicant's awareness of its obligation 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. Because of this 
awareness, the Department anticipates that this rule may generate 
changes in the policies, procedures, and operations of the entities 
that this proposed rule covers.
    Proposed Use of Information: The Department and its components 
awarding Federal funds and OCR would use the signed assurance and 
certification as documentation of: (1) A recipient's or applicant's 
awareness of its obligations under the Federal health care conscience 
and associated anti-discrimination laws and the proposed rule, and (2) 
a recipient's commitment to comply with such statutes and the proposed 
rule. This use would most likely occur during an OCR investigation of 
the recipient's compliance with Federal health care conscience and 
associated anti-discrimination laws and this proposed rule.
    Description of the Respondents: The respondents are applicants or 
recipients for Federal financial assistance or Federal funds from the 
Department to which the proposed Sec.  88.3 applies. 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.
    Number of Respondents: The Department estimates the number of 
respondents at 123,302 persons or entities. This estimate represents 
the average between the lower-bound (94,214) and upper-bound (152,389) 
estimates of entities that will have to sign an assurance or a 
certification. These figures appear supra in Table 2.
    Respondents are a subset of the recipients subject to the relevant 
Federal health care conscience and associated anti-discrimination laws 
and the proposed rule because proposed Sec.  88.4(c)(1) through (4) 
excludes certain categories of recipients. Specifically, the proposed 
rule excludes physicians, as defined in 42 U.S.C. 1395x(r), physician 
offices, or other health care practitioners who are recipients, as 
defined in proposed Sec.  88.2, only in the form of reimbursements for 
participation Medicare Part B. See proposed Sec.  88.4(c)(1). The 
proposed 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 proposed 
Sec.  88.4(c)(2) and (3). Finally, the proposed rule excludes Indian 
Tribes and Tribal Organizations when contracting with the Indian Health 
Service under the Indian Self-Determination and Education Assistance 
Act. See proposed Sec.  88.4(c)(4).
    Burden of Response: The Department is committed to leveraging 
existing grant, contract, and other Departmental forms where possible 
rather than creating additional, separate forms for recipients to sign. 
The Department intends to update the HHS-690 Form, which includes 
several Federal civil rights authorities with which applicants and 
recipients must assurance compliance.\177\ The Department would

[[Page 3921]]

update the form to include a reference to Federal health care 
conscience and associated anti-discrimination laws, as well as a Web 
link to information about the requirements. The Department also intends 
to update HHS-5161-1 Form, OMB No. 0930-0367 (Certification of 
Compliance).
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    \177\ HHS regulations implementing each of the following civil 
rights laws require recipients to assure compliance with applicable 
implementing regulations: Title VI of the Civil Rights Act of 1964, 
Section 504 of the Rehabilitation Act of 1973, Title IX of the 
Education Amendments of 1972, the Age Discrimination Act of 1975, 
and Section 1557 of the Affordable Care Act. See 45 CFR 80.4 
(requiring recipients to assure compliance with HHS Title VI 
regulations), 84.5 (requiring recipients to assure compliance with 
HHS Section 504 regulations), 86.4 (requiring recipients to assure 
compliance with HHS Title IX regulations), 91.33 (requiring 
recipients to assure compliance with the Age Act and HHS 
implementing regulations), 92.5 (requiring recipients and entities 
created under Title I of the Affordable Care Act to assure 
compliance with Section 1557 and the HHS implementing regulation).
---------------------------------------------------------------------------

    The burden for the assurance and certification is the opportunity 
cost of recipient staff time (1) to review the assurance and 
certification language as well as the requirements of the underlying 
Federal health care conscience and associated anti-discrimination laws 
referenced or incorporated, (2) to review entity-wide policies and 
procedures or take other actions to self-assess compliance with 
applicable Federal health care conscience and associated anti-
discrimination laws, and (3) to implement any actions to come into 
compliance.
    The methods that the Department uses are outlined supra in the 
Assurance and Certification section of this RIA. The only adjustment to 
those methods for this information collection analysis is to adjust the 
mean hourly wage downward to exclude benefits and overhead. In doing 
so, the Department calculates the following labor costs.
    The labor cost is a function of a lawyer spending 3 hours reviewing 
the assurance and certification and a chief executive spending one hour 
to review and sign, as proposed Sec.  88.4(b)(2) requires a signature 
by an individual authorized to bind the recipient. The mean hourly wage 
(not including benefits and overhead) for these occupations is $67.25 
per hour for the lawyer (occupation code 23-1011) and $93.44 for the 
chief executive (occupation code 11-1011).\178\ The weighted mean 
hourly wage (not including benefits and overhead) of these two 
occupations is $73.80 per hour (($67.25 x .75) + ($93.44 x .25)). The 
labor cost is $36 million each year for the first five years ($73.80 
per hour x 4 hours x 123,302 entities).\179\
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    \178\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
    \179\ 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.
---------------------------------------------------------------------------

    The Department estimates that 61,652 recipients, which is half of 
all respondents to this information collection (123,302 entities/2) 
will review entity-wide policies and procedures or take other actions 
to self-assess compliance with applicable Federal health care 
conscience and associated anti-discrimination laws each year for the 
first five years of publication, spending an average of 4 hours doing 
so. The labor cost is a function of a lawyer spending 3 hours and a 
chief executive spending one hour, which produces the same weighted 
mean hourly wage of $73.80 per hour. The labor cost for self-assessing 
compliance, such as reviewing policies and procedures, is a total of 
$18.2 million each year for the first five years ($73.80 per hour x 4 
hours x 61,652 entities).\180\
---------------------------------------------------------------------------

    \180\ 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.
---------------------------------------------------------------------------

    The Department estimates that approximately 5% of entities will 
take an organization-wide action to improve compliance in the first 
year and 0.5% will act each year in years two through five. This 
percentage equates to 23,406 entities in year 1 and 2,341 entities 
annually in years two through five. The Department estimates that each 
year, the entities that engage in this voluntary compliance will spend 
4 hours annually, on average. The labor cost is a function of a lawyer 
spending 3 hours and a chief executive spending one hour, which 
produces a weighted mean hourly wage of $73.80 per hour. The labor cost 
is $6.9 million in year one ($73.80 x 4 x 23,406 entities) and 
approximately $690,783 annually for years two through five ($73.80 x 4 
x 2,341 entities).\181\
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    \181\ 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.
---------------------------------------------------------------------------

    The Department asks for public comment on the proposed information 
collection, including the particular issues below.
     Whether the proposed collection of information is 
necessary for the proper performance of OCR's functions and the 
Department's and its components' functions to enforce Federal laws on 
which Federal funding is conditioned, including whether the information 
will have practical utility.
     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 health care 
conscience 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.
     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.
Information Collection for Proposed Sec.  88.5 (Notice)
    Summary of the Collection of Information: Under the proposed rule, 
each recipient and the Department must post a notice that apprises 
persons, entities, and health care entities of their rights under 
Federal health care conscience and associated anti-discrimination laws 
and this proposed part.
    Need for Information: Notice serves three primary purposes. First, 
persons become apprised of their rights under the applicable Federal 
health care conscience and associated anti-discrimination laws, 
including the right to file a complaint with HHS OCR. Second, a 
person's awareness of his or her rights increases the likelihood that 
the person will exercise those rights. Third, recipients and their 
managers and employees will be reminded and be made aware of their own 
obligations under these laws.
    Proposed Use of Information: In the event that the OCR Director 
investigates or initiates a compliance review of a recipient, the OCR 
Director will consider as one of many factors whether the recipient 
posted the notice in the documents described in Sec.  88.5(c)(1) 
through (3), as applicable.
    Description of the Respondents: The respondents are recipients. 
Respondents include, but are not limited to, 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.
    Number of Respondents: The number of respondents is estimated at 
611,372 establishments. This estimate represents the average between 
the lower and upper-bound estimates of how many recipient 
establishments must post notices. Respondents are a subset (99.5%) of 
the total scope of entities subject to this proposed rule because the

[[Page 3922]]

notice requirement does not apply to sub-recipients.
    Burden of Response: The Department estimates that the burden for 
the notice is represented in terms of opportunity costs of staff time 
to download, print, and post the notice, combined with material costs 
for paper and ink. These costs are a one-time burden in the first year 
of this proposed rule's implementation.
    The Department estimates that it would take \1/3\ of an hour for an 
administrative assistant to download the notice, print notice(s) and 
post them in physical locations of the establishment where notices are 
commonly posted. 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 to post the notice online. For some 
establishments, it may take an administrative assistant or Web 
developer longer to perform these functions; for other establishments, 
it may take less time.
    The Department uses the same method for calculating the cost of 
this requirement supra in the RIA but adjusts the hourly wage downward 
to exclude benefits and overhead. The mean hourly wage (not including 
benefits and overhead) for an administrative assistant is $19.39 per 
hour (occupation code 43-6010).\182\ The mean hourly wage (not 
including benefits and overhead) for a Web developer is $34.69 per hour 
(occupation code 15-11134). This labor cost is approximately $46.4 
million ((\1/3\ hour x $19.39/hr. x 611,372 establishments) + (2 hours 
x $34.69/hr. x 611,372 establishments).\183\
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    \182\ Bureau of Labor Statistics, Occupational and Employment 
Statistics, Occupational Employment and Wages, May 2016, https://www.bls.gov/oes/current/oes_nat.htm.
    \183\ 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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    The number of locations where notices are commonly posted in an 
establishment will vary based on multiple factors. The Department also 
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 (611,372 establishments x $.05 per page x 5 
pages), which amounts to about $152,843. Because the Department assumes 
that this cost is a one-time, upfront cost, it will not recur in the 
out-years.
    The proposed notice provision at Sec.  88.5(c)(1) through (3) 
includes language designed to incentivize recipients to include the 
OCR-drafted notice in certain types of documents or publications. 
Because this provision is permissive, the Department assumes that 
305,686 establishments will undertake such action in the first year, 
which is half of all establishments subject to the notice requirement 
(611,372 establishments x 50%). Approximately 152,843 establishments 
(305,686 establishments/2) will annually undertake such voluntary 
posting in years 2 through 5. The Department assumes that an 
administrative assistant paid at $19.39/hour would identify documents 
in which to include the notice, revising the documents or their layouts 
to include the notice, or otherwise printing an insert to include with 
paper documents. The assistant may spend a total of 2 hours in year one 
and 1 hour annually in years 2 through 5. The labor cost in year 1 is 
$11.9 million ($19.39 x 2 x 305,686 establishments) and $3 million 
annually in years 2 through 5 ($19.39 x 1 x 152,843 establishments).
    The Department anticipates that there may be some additional 
printing costs where inclusion of the notice adds a page to the 
underlying document. There is a high degree of uncertainty as to the 
average number of documents in which a recipient may proactively 
include the notice. There is also uncertainty as to whether a recipient 
would print the publications or house them online. The Department 
estimates that a recipient that voluntarily includes the notice in 
publications may print some publications and house others online; on 
balance, the recipient might print approximately 100 extra pages. With 
these assumptions, the cost of voluntarily included notices, as 
proposed Sec.  88.5(c) incentivizes, will cost approximately $1.5 
million in the first year (305,686 entities x 100 pages x $.05 per 
page) and $764,216 annually in years two through five.
    Total first-year costs (mandatory plus voluntary) for the notice 
requirement are estimated at $59.9 million and $3.7 million annually in 
years 2 through 5.
    The Department asks for public comment on the proposed information 
collection, including the particular issues below.
     Whether the proposed collection of information is 
necessary for the proper performance of OCR's functions and the 
Department's and its components' functions to enforce Federal laws on 
which Federal funding is conditioned, including whether the information 
will have practical utility.
     Feedback on the assumptions that form the basis of our 
cost estimates for the notice provision.
     How the manner of compliance with notice provision could 
be improved, including through the use of automated collection 
techniques or other forms of information technology.
Compliance Procedures (Sec.  88.6(d))
    Summary of the Collection of Information: Proposed Sec.  88.6(d) 
requires any recipient that receives a notice of investigation or 
compliance review letter from OCR concerning Federal health care 
conscience and associated anti-discrimination laws to report this fact 
to each of the Departmental components from which the recipient 
receives Federal funds. Additionally, this requirement applies to 
complaints filed with OCR such that the recipient must disclose to the 
applicable Departmental funding component the existence of the 
complaint for five years from the date of the filing of the complaint 
whenever it applies for new or renewed Federal financial assistance or 
other Federal funds from the Department.
    Need for Information: The information promptly informs applicable 
Departmental components of OCR's pending investigation and historical 
complaints to ensure appropriate coordination within the Department 
during the pendency of the investigation and to inform funding 
decision-making.
    Proposed Use of Information: At a minimum, this requirement puts 
the Departmental component on notice of OCR's investigation and 
facilitates coordination between the component and OCR on technical or 
factual matters underlying the recipient's or sub-recipient's extension 
of Federal funds. The Department component may also use the information 
to monitor the status of the investigation and history of complaints to 
incorporate these facts into the component's decision-making when 
deciding whether to approve or renew or modify Federal funding to the 
recipient.
    Description of the Respondents: The respondents are a subset of 
recipients and sub-recipients subject to an HHS OCR investigation of 
Federal health care conscience and associated anti-discrimination laws 
and this proposed rule. Respondents include State and local 
governments, physicians, hospitals, research institutions, health 
professions training programs, qualified health plan issuers, Health 
Insurance Marketplaces, home health agencies, educational institutions, 
community mental health centers, and skilled nursing facilities, among 
others.
    Number of Respondents: The number of respondents on average is 30

[[Page 3923]]

recipients per year, which is the average between the lower-bound (10 
recipients) and upper-bound (50 recipients) estimate.
    Burden of Response: The Department estimates that the burden is the 
opportunity cost that recipients will incur to spend 15 minutes to 
email the appropriate grants management official(s). The Department 
uses the same methodology used when calculating these costs in the RIA 
but adjusts the hourly wage down to exclude benefit and overhead. The 
mean hourly wage for the administrative assistant (not adjusted for 
benefits and overhead) is $19.39 per hour. The annual labor cost is 
$0.3 million across all 30 entities (30 entities x $19.39 per hour x 
0.25 hours x 2,000 applications or renewals).
    The Department asks for public comment on the proposed information 
collection, including the particular issues below.
     Whether the proposed collection of information is 
necessary for the proper performance of OCR's functions and the 
Department's and its components' functions to enforce Federal laws on 
which Federal funding is conditioned, including whether the information 
will have practical utility.
     Feedback on the assumptions that form the basis of our 
cost estimates.
     The automated collection techniques or other forms of 
information technology that could improve the efficiency of this 
collection of information.
    Comments regarding the collection of information proposed in this 
rule must refer to the proposed rule by name and docket number and must 
be submitted to both OMB and the Docket Management Facility where 
indicated under ADDRESSES by the date specified under DATES.
    When it issues a final rule, the Department plans to publish in the 
Federal Register the control numbers assigned by the Office of 
Management and Budget (OMB). Publication of the control numbers 
notifies the public that OMB has approved the final rule's information 
collection requirements under the Paperwork Reduction Act of 1995.

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, Students, Technical assistance, Tribal 
Organizations.

Proposed Rule

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

PART 88--ENSURING THAT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES 
DOES NOT FUND OR ADMINISTER PROGRAMS OR ACTIVITIES THAT VIOLATE 
CONSCIENCE AND ASSOCIATED ANTI-DISCRIMINATION LAWS

Sec.
88.1 Purpose.
88.2 Definitions.
88.3 Applicable requirements and prohibitions.
88.4 Assurance and certification of compliance requirements.
88.5 Notice requirement.
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--Notice Concerning Federal Health Care 
Conscience and Associated Anti-Discrimination Protections

    Authority:  The Weldon Amendment (e.g., Consolidated 
Appropriations Act, 2017, Public Law 115-31, sec. 507(d); Div. H, 
sec. 209); the Helms Amendment (e.g., Consolidated Appropriations 
Act, 2017, Public Law 115-31, Div. J, sec. 7018); 22 U.S.C. 7631(d); 
26 U.S.C. 5000A(d)(2); 29 U.S.C. 669(a)(5); 42 U.S.C. 300a-7 (the 
Church Amendments), 42 U.S.C. 238n (Coats-Snowe Amendment); 18113 
(Section 1553 of the Affordable Care Act), 18023(c)(2)(A)(i)-(iii), 
18023(b)(1)(A), 18023(b)(4); 280g-1(d)), 290bb-36(f), 1320a-1, 
1320c-11, 1395cc(f), 1395i-5, 1395w-22(j)(3)(B), 1395x(e), 
1395x(y)(1), 1396a(a), 1396a(w)(3), 1396f, 1396s(c)(2)(B)(ii), 
1396u-2(b)(3)(B), 1397j-1(b), 5106i(a), 14406.


Sec.  88.1   Purpose.

    The purpose of this part is to provide for the implementation and 
enforcement of the Federal health care conscience and associated anti-
discrimination laws. Such laws, for example, protect the rights of 
persons, entities, and health care entities to refuse to perform, 
assist in the performance of, or undergo health care services or 
research activities to which they may object for religious, moral, 
ethical, or other reasons. Such laws, for example, also protect 
patients from being subjected to certain health care or services over 
their conscientious objection. Consistent with their objective to 
comprehensively protect the conscience and associated anti-
discrimination rights of persons, 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:
    Administered by the Secretary means to be subject to the 
responsibility of the Secretary of the U.S. Department of Health and 
Human Services, as established via statute or regulation, for the 
administration of Federal funds available to any program or activity.
    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. This 
includes but is not limited to counseling, referral, training, and 
other arrangements for the procedure, health service, health program, 
or research activity.
    Department means the Department of Health and Human Services and 
any component thereof.
    Discriminate or Discrimination means, as applicable and as 
permitted by the applicable statute:
    (1) To withhold, reduce, exclude, terminate, restrict, or otherwise 
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, terminate, restrict, or otherwise 
make unavailable or deny any benefit or privilege;
    (3) To utilize any criterion, method of administration, or site 
selection,

[[Page 3924]]

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 this part to any adverse effect described in this 
definition, or have the effect of defeating or substantially impairing 
accomplishment of a health program or activity with respect to 
individuals, entities, or conduct protected under this part; or
    (4) To otherwise engage in any activity reasonably regarded as 
discrimination including intimidating or retaliatory action.
    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.
    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 Federal agreement, arrangement, or other contract which has 
as one of its purposes the provision of assistance.
    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. It may also include components of State or local governments.
    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.
    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.
    Individual means a member of the workforce of an entity or health 
care entity.
    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 foreign or international 
organizations (such as agencies of the United Nations).
    Referral or refer for includes 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, where 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.
    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.
    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).
    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. Sec.  88.5 and 88.6 of this part.
    (ii) Any State or local government or subdivision thereof and any 
other public entity are 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, 88.5, and 88.6 of this part.
    (iv) Any entity that receives a grant or contract for biomedical or 
behavioral research under any program

[[Page 3925]]

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, 88.5, and 88.6 of this part.
    (v) Any entity that carries out any part of any health service 
program or research activity funded in whole or in part under a 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, 88.5, 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, 
88.5, and 88.6 of this part.
    (2) Requirements and prohibitions. (i) Pursuant to 42 U.S.C. 300a-
7(b)(1), entities to whom this paragraph (a)(2)(i) applies shall not 
require any individual who receives a grant, contract, loan, or loan 
guarantee under the Public Health Service Act 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), entities to whom this 
paragraph (a)(2)(ii) applies shall not require any entity funded under 
the Public Health Service Act 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 entity on the basis of religious beliefs or moral 
convictions.
    (iii) Pursuant to 42 U.S.C. 300a-7(b)(2)(B), entities to whom this 
paragraph (a)(2)(iii) applies shall not require any entity funded under 
the Public Health Service Act 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 whom this 
paragraph (a)(2)(iv) applies shall not discriminate against any 
physician or other health care personnel in the employment, promotion, 
termination, or extension of staff or other privileges because such 
physician or other health care personnel performed or assisted in the 
performance, or refused to perform or assist in the performance of a 
lawful sterilization procedure or abortion on the grounds that doing so 
would be contrary to his or her religious beliefs or moral convictions, 
or because of his or her religious beliefs or moral convictions 
concerning abortions or sterilization procedures themselves.
    (v) Pursuant to 42 U.S.C. 300a-7(c)(2), entities to whom 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 or refused to perform or assist in the performance of such 
service or activity on the grounds that doing so would be contrary to 
his or her religious beliefs or moral convictions, or because of his or 
her religious beliefs or moral convictions.
    (vi) Pursuant to 42 U.S.C. 300a-7(d), entities to whom 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 if such performance or assistance would be 
contrary to the individual's religious beliefs or moral convictions.
    (vii) Pursuant to 42 U.S.C. 300a-7(e), entities to whom this 
paragraph (a)(2)(vii) applies shall not deny admission to or otherwise 
discriminate against any applicant for training or study because of 
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 Federal 
government, including the Department, is required to comply with 
paragraphs (b)(2)(i) through (ii) of this section and Sec. Sec.  88.5, 
and 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, 88.5, 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 whom this paragraph (b)(2)(i) 
applies shall not subject any individual or institutional health care 
entity to discrimination on the basis that the individual or 
institutional 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 require attendees to 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 whom 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 
an accreditation standard or standards that require an entity to 
perform an induced abortion or 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.
    (c) Weldon Amendment (See, e.g., Pub. L. 115-31, Div. H, sec. 
507(d))--(1) Applicability. (i) The Department, while operating under 
an appropriations act that contains the Weldon Amendment, is required 
to comply with paragraph (c)(2) of this section and Sec. Sec.  88.5, 
and 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 comply with paragraph (c)(2) of this section 
and Sec. Sec.  88.4, 88.5, and 88.6 of this part;
    (iii) Any entity that receives funds through a program administered 
by the Secretary or under an appropriations act for the Department that 
contains the Weldon Amendment is required to comply with paragraph 
(c)(2) of this section and Sec. Sec.  88.4, 88.5, and 88.6 of this 
part.
    (2) Prohibition. 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.

[[Page 3926]]

    (d) Medicare Advantage, Consolidated Appropriations Act of 2017, 
Public Law 115-31, Div. H, Tit. II, sec. 209--(1) Applicability. The 
Department, while operating under an appropriations act that contains a 
provision under the Medicare Advantage program as set forth by Public 
Law 115-31, Div. H, Tit. II, sec. 209, is required to comply with 
paragraph (d)(2) of this section and Sec. Sec.  88.5, and 88.6 of this 
part.
    (2) Prohibition. The entities to whom 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 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. Sec.  88.5, and 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 any amendment made by the Act) is required to comply with 
paragraph (e)(2) of this section and Sec. Sec.  88.4, 88.5, 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 any amendment made by the Act) is required to comply with 
paragraph (e)(2) of this section and Sec. Sec.  88.4, 88.5, and 88.6 of 
this part.
    (iv) Any health plan created under the Patient Protection and 
Affordable Care Act (or under any amendment) is required to comply with 
paragraph (e)(2) of this section and Sec. Sec.  88.4, 88.5, and 88.6 of 
this part.
    (2) Prohibition. The entities to whom 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; provided, that 
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. Sec.  88.5, and 88.6 of this part.
    (ii) Qualified health plans, as defined under 42 U.S.C. 18021, 
offered on any Exchange created under the Affordable Care Act, are 
required to comply with paragraph (f)(2)(ii) of this section and 
Sec. Sec.  88.4, 88.5, and 88.6 of this part.
    (2) Requirements and prohibitions. (i) Pursuant to 42 U.S.C. 
18023(b)(1)(A)(i), entities to whom this paragraph (f)(2)(i) applies 
shall not 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) as part of its essential health benefits for any plan 
year.
    (ii) Pursuant to 42 U.S.C. 18023(b)(4), entities to whom 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. Sec.  88.5, and 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 Affordable Care Act to:
    (i) Any individual who is a member of a recognized religious sect 
or division thereof and is an adherent of established tenets or 
teachings of such sect or division by reason of which he is 
conscientiously opposed to acceptance of the benefits of any private or 
public insurance which, among other things, 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); and
    (ii) Any individual for the month for which such individual is a 
member of a ``health care sharing ministry,'' as defined in 26 U.S.C. 
5000A(2)(B)(ii).
    (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) through (ii) 
of this section and Sec. Sec.  88.5 and 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, 88.5, and 88.6 of this part.
    (2) Requirements and prohibitions. (i) Pursuant to 42 U.S.C. 1395w-
22(j)(3)(B), entities to whom this paragraph (h)(2)(i) applies shall 
not require a Medicare Advantage organization to offer a plan that 
provides, reimburses for, or provides coverage of, a counseling or 
referral service if the organization objects to the provision of such 
service on moral or religious grounds.
    (ii) Pursuant to 42 U.S.C. 1396u-2(b)(3)(B), entities to whom this 
paragraph (h)(2)(ii) applies shall not require a Medicaid managed care 
organization to provide, reimburse for, or provide coverage of, a 
counseling or referral service if the organization objects to the 
provision of such service on moral or religious grounds.
    (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. Sec.  88.5 and 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, 88.5, and 88.6 of this part with respect to its Medicaid program.
    (2) Prohibitions. The entities to whom this paragraph (i)(2) 
applies shall not:
    (i) Construe 42 U.S.C. 1395cc(f) or 1395a(w) 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 any 
applicable 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

[[Page 3927]]

paragraph (j)(2) of this section and Sec. Sec.  88.5 and 88.6 of this 
part.
    (ii) Any entity that receives Federal financial assistance for HIV/
AIDS prevention, treatment, or care to the extent administered by the 
Secretary 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, is required to comply with paragraph (j)(2) of this section and 
Sec. Sec.  88.4, 88.5, and 88.6 of this part.
    (2) Prohibitions. The entities to whom this paragraph (j)(2) 
applies shall not:
    (i) To the extent administered by the Secretary 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, require 
applicants for assistance for HIV/AIDS prevention, treatment, or care 
to:
    (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 
applicant has a religious or moral objection, as a condition of 
assistance.
    (ii) Discriminate against applicants in the solicitation or 
issuance of grants, contracts, or cooperative agreements under such 
provisions of law for refusing to meet any requirement described in 
this paragraph (j)(2).
    (k) The Helms Amendment (e.g., Consolidated Appropriations Act of 
2017, Public Law 115-31, Div. J, Tit. VII, sec. 7018) (codified at 22 
U.S.C. 2151b(f))--(1) Applicability. The Department is required to 
comply with paragraph (k)(2)(i) of this section and Sec. Sec.  88.5 and 
88.6 of this part.
    (ii) 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, 
88.5, and 88.6 of this part.
    (2) Prohibitions. (i) The entities to whom this paragraph (k)(2)(i) 
applies shall not:
    (A) Permit Federal financial assistance identified in (k)(1)(ii) to 
be used in an manner that would violation 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 to 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 whom this paragraph (k)(2)(ii) applies shall 
not:
    (A) Use such Federal financial assistance identified in (k)(1)(ii) 
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 sterilization as a 
method of family planning;
    (4) Coerce or provide any financial incentive to any person to 
undergo sterilizations;
    (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 to 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. Sec.  88.5 and 88.6 of this 
part.
    (2) Requirement. The Department shall not construe 42 U.S.C. 280g-
1(d) to preempt or prohibit State laws that do not require screening 
for hearing loss of newborn infants or young children when their 
parents 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. Sec.  88.5 and 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. Sec.  88.5 and 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, 88.5, and 88.6 of 
this part.
    (2) Requirements. With respect to occupational illness examinations 
and tests, the entities to whom 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. Sec.  88.5 and 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, 88.5, and 88.6 of 
this part.
    (2) Requirement. The entities to whom this paragraph (o)(2) applies 
shall comply with applicable State law, including any such law relating 
to any religious or other exemption.
    (p) Specific Assessment, Prevention and Treatment Services, 42 
U.S.C. 290bb-36(f), 5106i--(1) Applicability. (i) The Department is 
required to comply with paragraphs (p)(2)(i) through (iii) of this 
section and Sec. Sec.  88.5 and 88.6 of this part.
    (ii) Any State; part of any State; public organization; or private 
nonprofit organization, such as a school, educational institution, 
juvenile justice system, substance use disorder program, mental health 
program, foster care system, or other child and youth support 
organization, 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

[[Page 3928]]

comply with paragraph (p)(2)(iii) of this section and Sec. Sec.  88.4, 
88.5, 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 and Sec. Sec.  88.4, 88.5, and 88.6 of this part.
    (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, 88.5, and 88.6 of this 
part.
    (2) Requirements and prohibitions. (i) Entities to whom 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 whom 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 whom this paragraph (p)(2)(iii) applies shall not 
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, 1320c-11, 
1395i-5, 1395x(e), 1395x(y)(1), 1396a(a), 1397j-1(b), and 5106i(a)(2)--
(1) Applicability. (i) The Department is required to comply with 
paragraphs (q)(2)(i), through (iii) of this section and Sec. Sec.  88.5 
and 88.6 of this part.
    (ii) Any State agency that administers a Medicaid or CHIP program 
is required to comply with paragraph (q)(2)(ii) of this section and 
Sec. Sec.  88.4, 88.5, and 88.6 of this part.
    (iii) Any entity, including a State or local government or 
subdivision thereof, receiving Federal financial assistance from Social 
Services Block Grant is required to comply with paragraphs (q)(2)(i) 
and (iv) of this section and Sec. Sec.  88.4, 88.5, and 88.6 of this 
part.
    (iv) Any entity, including a State or local government or 
subdivision thereof, receiving Federal financial assistance from the 
Elder Justice Block Grants is required to comply with paragraph 
(q)(2)(iii) of this section and Sec. Sec.  88.4, 88.5, and 88.6 of this 
part.
    (2) Requirements and prohibitions. (i) The entities to whom this 
paragraph (q)(2)(i) applies shall not fail or refuse to exempt a 
religious nonmedical health care institution from the Medicare 
requirement for peer review under 42 U.S.C. 1320cc and the Medicare 
requirements under 42 U.S.C. 1320a-1, for evaluation by advisory boards 
on capability to provide comprehensive health care services.
    (ii) The entities to whom this paragraph (q)(2)(ii) applies shall 
not fail or refuse to exempt a religious nonmedical health care 
institution from the Medicaid requirements to:
    (A) Meet State medical standards, under 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 medical 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) Establish a utilization review plan under 42 U.S.C. 1395x(k); 
or the Medicare, Medicaid, and Children's Health Insurance Program 
requirements, under 42 U.S.C. 1320a-1, for evaluation by advisory 
boards on capability to provide comprehensive health services.
    (iii) Pursuant to 42 U.S.C. 1397j-1(b), the entities to whom this 
paragraph (q)(2)(iii) applies shall not 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.
    (iv) Pursuant to 42 U.S.C. 1395i-5, the entities to whom this 
paragraph (q)(2)(iv) applies shall not prohibit coverage of inpatient 
hospital services or post-hospital extended care services furnished an 
individual in a religious nonmedical health care institution or home 
health services furnished an individual by a religious nonmedical 
health care institution if an individual makes an election providing 
that:
    (A) Such individual is conscientiously opposed to acceptance of 
conventional or unconventional medical items and services (including 
any medical screening, examination, diagnosis, prognosis, treatment, or 
the administration of drugs); and
    (B) Acceptance of such medical treatment would be inconsistent with 
such individual's sincere religious beliefs.


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 
health care conscience and associated 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 health care conscience 
and associated anti-discrimination laws and this part.
    (b) Specific requirements--(1) Timing. Applicants or recipients who 
are already recipients as of the effective date of this part 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 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

[[Page 3929]]

may be required more frequently if the applicant or recipient fails to 
meet a requirement of this part.
    (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 health care conscience and associated 
anti-discrimination laws and this part prior to, or 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 in applications. An applicant or recipient may 
incorporate the assurances by reference in subsequent applications to 
the Department or Department component if prior assurances are 
initially provided in the same year.
    (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 
remedies 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, 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 requirement.

    (a) In general. The Department and each recipient shall post the 
notice text located in Appendix A to this part in accordance with 
paragraph (b) of this section by April 26, 2018, or with respect to new 
recipients, within 90 days after becoming a recipient.
    (b) Specific requirements. The notice text required in paragraph 
(a) of this section shall appear:
    (1) On the Department's and each recipient's website(s), and
    (2) In a prominent and conspicuous physical location in every 
Department and recipient establishment where notices to the public and 
notices to their workforce are customarily posted to permit ready 
observation. The text of the notice shall be large enough to be easily 
read. The Department and each recipient shall take steps to ensure that 
such notices are not altered, defaced, or covered by other material.
    (c) Factors in evaluation of compliance. In evaluating a 
recipient's compliance with the requirements of this part, OCR will 
take into account whether the recipient has provided the notice text in 
paragraph (a) of this section:
    (1) In a personnel manual or other substantially similar document 
for members of the recipient's workforce;
    (2) In applications for membership in the recipient's workforce or 
for participation in a service, benefit, or other program, including 
for training or study; and
    (3) In a 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.
    (d) Combined nondiscrimination notices. The Department and each 
recipient may post the notice text provided in appendix A of this part 
along with the content of other notices only if it retains all of the 
language provided in appendix A of this part in an unaltered state.


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 health 
care conscience and associated anti-discrimination laws and this part, 
and shall take steps to eliminate any violations of the Federal health 
care conscience and associated anti-discrimination laws and this part. 
If a sub-recipient is found to have violated the Federal health care 
conscience and associated anti-discrimination laws, the recipient from 
whom the sub-recipient received funds shall be subject to the 
imposition of funding restrictions and other appropriate remedies 
available under this part.
    (b) Records and information. The Department, each recipient, and 
each sub-recipient shall maintain complete and accurate records 
evidencing compliance with Federal health care conscience and 
associated anti-discrimination laws and this part, and afford OCR, upon 
request, reasonable access to such records and information in a timely 
manner to the extent OCR finds necessary to determine compliance with 
the Federal health care conscience and associated anti-discrimination 
laws and this part.
    (c) Cooperation. The Department, each recipient, and each sub-
recipient

[[Page 3930]]

shall cooperate with any compliance review, investigation, interview, 
or other part of OCR's enforcement process, which may include the 
production of documents, the participation in interviews, the response 
to data requests, and the making available of premises for inspection 
where relevant. Failure to cooperate may result in an OCR referral to 
the Department of Justice for further enforcement in Federal court or 
otherwise.
    (d) Reporting requirement. If a recipient or sub-recipient is 
subject to an OCR compliance review, investigation, or complaint filed 
with OCR regarding the recipient's or sub-recipient's compliance with 
Federal health care conscience and associated anti-discrimination laws, 
the recipient or sub-recipient must inform any Departmental funding 
component of such review, investigation, or complaint and must, in any 
application for new or renewed Federal financial assistance or 
Departmental funding, disclose the existence of such compliance review 
or investigation, and must also report on such applications, or in a 
separate writing with such applications, the existence of any such 
complaints filed with OCR for five years from such complaints' filing.
    (e) Intimidating or retaliatory acts prohibited. Neither the 
Department nor any recipient or sub-recipient shall intimidate, 
threaten, coerce, or discriminate against any person, entity, or health 
care entity for the purpose of interfering with any right or privilege 
under the Federal health care conscience and associated anti-
discrimination laws or this part, or because such person, entity, or 
health care entity has made a complaint or participated in any manner 
in an investigation or review under the Federal health care conscience 
and associated anti-discrimination laws or this part.


Sec.  88.7   Enforcement authority.

    (a) In general. OCR has been delegated the authority to enforce the 
Federal health care conscience and associated anti-discrimination laws, 
which includes the authority to:
    (1) Receive and handle complaints;
    (2) Initiate compliance reviews;
    (3) Conduct investigations;
    (4) Supervise and coordinate compliance within the Department;
    (5) In coordination with the relevant component or components of 
the Department, make enforcement referrals to the Department of 
Justice; and
    (6) In coordination with the relevant component or components of 
the Department, take other appropriate remedial action as the Director 
of OCR deems necessary and as allowed by law to overcome the effects of 
violations of Federal health care conscience and associated anti-
discrimination laws and this part.
    (b) Complaints. Any entity, health care entity, or any person, 
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 health care conscience and associated anti-
discrimination laws or this part. OCR shall coordinate handling of 
complaints with the relevant Department component. The complaint filer 
is not required to be the person, entity, or health care entity whose 
rights under the Federal health care conscience and associated anti-
discrimination laws or this part have been potentially violated.
    (c) Periodic compliance reviews. OCR may from time to time 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 health care conscience and 
associated anti-discrimination laws and this part. OCR may conduct 
these reviews in the absence of a complaint.
    (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 health care conscience and associated anti-discrimination 
laws or this part. The investigation should include, where appropriate, 
a review of the pertinent practices, policies, communications, 
documents, compliance history, the 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, but not limited to, site visits, interviews with 
complainants, the Department component, recipients, sub-recipients, or 
third-parties, and written data or discovery requests. OCR may seek the 
assistance of any State agency.
    (e) Destruction of evidence. Consistent with Sec.  88.6(b) and (c), 
a Department component, recipient, or sub-recipient that knowingly or 
recklessly destroys evidence potentially relevant to an OCR 
investigation or compliance review that is ongoing or reasonably 
anticipated shall be in violation of this part.
    (f) Failure to respond. Absent good cause, a party's failure to 
respond to a request for information or a data or document request 
within 45 days of OCR's request, shall constitute a violation of this 
part.
    (g) 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.
    (h) 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 health care conscience and 
associated 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 delegate to 
officials of the Department responsibilities in connection with the 
effectuation of Federal health care conscience and associated anti-
discrimination laws and this part, including the achievement of 
effective coordination and maximum uniformity within the Department.
    (i) 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 health care conscience and associated anti-discrimination 
laws or this part, OCR may, in coordination with the relevant 
Department component make referrals to the Department of Justice for 
further enforcement in Federal court or otherwise.
    (j) Resolution of matters. (1) If an investigation or compliance 
review reveals that no action is warranted, OCR will so inform the 
subject of the complaint or review and complainant, if any, in writing.
    (2) If an investigation or compliance review indicates a failure to 
comply with Federal health care conscience and associated 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 pursuing any action described in Sec.  88.7(j)(3).

[[Page 3931]]

    (3) If there appears to be a failure or threatened failure to 
comply with Federal health care conscience and associated 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:
    (i) Temporarily withholding cash payments, 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) Withholding new Federal financial assistance or other Federal 
funds from the Department, in whole or in part, 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) 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, created by Federal law; and
    (vii) Taking any other remedies that may be legally available.


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 free 
exercise of religious beliefs and moral convictions, to the maximum 
extent permitted by the terms of the Federal health care conscience and 
associated antidiscrimination statutes implemented by the Constitution.


Sec.  88.10   Severability.

    Any provision of this part held to be invalid or unenforceable 
either by its terms or as applied to any person, 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--Notice Concerning Federal Health Care Conscience 
and Associated Anti-Discrimination Protections

    [Name of recipient, the Department, or Department component] 
complies with Federal health care conscience and associated anti-
discrimination laws and does not exclude, treat adversely, coerce, 
or otherwise discriminate against persons or entities on the basis 
of their religious beliefs or moral convictions. You have the right 
to decline to participate in, refer for, undergo, or pay for certain 
health care-related treatments, research, or services (such as 
abortion or assisted suicide, among others) which violate your 
conscience, religious beliefs, or moral convictions under Federal 
law.
    If you believe that [Name of recipient, the Department, or 
Department component] has failed to accommodate your conscientious, 
religious, or moral objection, or has unlawfully 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 
health care conscience and associated anti-discrimination laws are 
available at https://www.hhs.gov/conscience.

    Dated: January 18, 2018.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.

[FR Doc. 2018-01226 Filed 1-19-18; 11:15 am]
 BILLING CODE 4153-01-P