3880 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 

1U.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. 

2See 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). 

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. 

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 antidiscrimination 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 

http://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 http://

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 http://

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: 

• 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 CoatsSnowe 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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3See 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). 

5See 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.’’). 

6See, 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 

Continued 

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 antidiscrimination 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

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 


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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). 

7The 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. 

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. 

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

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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8Similar 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). 

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 providersponsored 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 AntiDiscrimination 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 selfdetermination 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 crossreference 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. 

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 


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9https://www.medicare.gov/coverage/rnhciitems-and-services.html]. 

10https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/Certificationand

Complianc/RNHCIs.html. 

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 AntiDiscrimination 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

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 


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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,’’ ‘‘Subrecipient,’’ 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, CoatsSnowe, 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 


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11After 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). 

12OCR Complaint No. 10–109676. 

13OCR Complaint No. 11–122388; OCR 

Complaint No. 11–122387. 

14OCR Complaint No. 14–193604; OCR 

Complaint No. 15–193782; OCR Complaint No. 15– 

195665. 

15Letter from OCR Director to Complainants (June 

21, 2016), http://www.adfmedia.org/files/ 

CDMHCInvestigationClosureLetter.pdf. 

16Letter from Reps. John Fleming, M.D., Diane 

Black, et al. to HHS Secretary Kathleen Sebelius 

(Nov. 25, 2014). 

17House Majority Whip Kevin McCarthy, et al., 

Letter to Secretary Sebelius (June 22, 2016). 

18OCR Complaint No. 15–238113. 

19OCR Complaint No. 17–259696. 

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. 

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 nonobjecting 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. 

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. 

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

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

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. 

Of the ten complaints filed before 

November 2016, two (one filed August 


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20Since 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). 

21 73 FR 78072, 78073 (Dec. 19, 2008) (2008 Rule). 

22Rob 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) http://

www.washingtonpost.com/wp-dyn/content/article/ 

2009/02/27/AR2009022701104.html (writing that 

‘‘The administration’s plans, revealed quietly with 

a terse posting on a Federal website, unleashed a 

flood of heated reaction’’). 

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). 

24The 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). 

25Comment Nos. HHS–OPHS–2009–0001–0739, 

–52648, –52677. 

26Comment No. HHS–OPHS–2009–0001–0868. 

27Comment 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). 

28Almost 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. 

29Comment 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 

Continued 

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 antidiscrimination 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 antidiscrimination laws.20

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.’’ 

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 


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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. 

30Comment 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). 

31Comment Nos. HHS–OPHS–2009–0001–0739, 

–52677, –26812, –53013 (form letter with 8,472 

copies). 

32Comment No. HHS–OPHS–2009–0001–10280, 

–2486, –46903, –19125, –36940, –12020, –41551. 

33Comment 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. 

34Comment Nos. HHS–OPHS–2009–0001–52974 

(form letter with 428 copies). 

35 LI Hospital issues abortion apology to nurses, 

N.Y. Post (Apr. 28, 2010), http://nypost.com/2010/ 

04/28/li-hospital-issues-abortion-apology-to-nurses. 

36See, 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). 

37https://www.acog.org/Clinical-Guidance-andPublications/Committee-Opinions/Committee-onEthics/The-Limits-of-Conscientious-Refusal-inReproductive-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. 

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

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

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

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 


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38https://www.dmhc.ca.gov/Portals/0/ 

082214letters/abc082214.pdf. 

39Bob Egelko, California’s assisted-dying 

loophole: Some doctors won’t help patients die, San 

Francisco Chronicle (Aug. 12, 2017), http://

www.sfchronicle.com/news/article/California-sassisted-dying-loophole-Some-11761312.php. 

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). 

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. § 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

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 antidiscrimination 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 antidiscrimination 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’’ antidiscrimination 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 antidiscrimination 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 


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40OCR Complaint Nos. 14–193604, 15–193782, 

and 15–195665. 41Letter from OCR Director to Complainants (June 

21, 2016) available at http://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. 

43HHS 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. 

44As seen by the compilation of the Federal 

health care conscience and associated antidiscrimination laws that are the subject of this 

proposed Rule, Congress uses the phrase ‘‘religious 

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 subregulatory 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

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 providersponsored 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 nonexhaustive 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.’’). 

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 


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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). 

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 prochoice and supportive of Roe v. Wade, 

but would rather not perform abortions 

themselves.45

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 AntiDiscrimination 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 antidiscrimination 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, CoatsSnowe, 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 antidiscrimination 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 


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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.’’ 


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(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 antidiscrimination 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 § 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 providersponsored 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, healthrelated 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 


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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’’). 

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 


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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. 

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 subrecipient, 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. 


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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 antidiscrimination 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 antidiscrimination 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 antidiscrimination 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 antidiscrimination 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 antidiscrimination 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 § 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 

§ 88.4(a)(2), proposed § 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 antidiscrimination 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, § 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 


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certification, OCR, in coordination with 

the relevant Department component, 

may effect compliance by any of the 

remedies provided in § 88.7. 

While both recipients and subrecipients, as defined herein, must 

comply with the substantive 

requirements of Federal health care 

conscience and associated antidiscrimination laws, as applicable, subrecipients 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 subrecipients. 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 

§ 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 antidiscrimination statutes and this 

regulation. 

For consistency with other notice 

requirements in civil rights regulations, 

paragraph (a) of § 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 § 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 § 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 


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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 antidiscrimination 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 antidiscrimination laws, the recipient or 

sub-recipient must inform any 

Departmental funding component of 

such review, investigation, or 

complaint. The recipient or subrecipient 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, CoatsSnowe, 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 § 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 antidiscrimination 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, subrecipients, 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 

§ 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 


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47See, 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, § 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. § 5/356m(b)(2) 

(2017); 720 Ill. Comp. Stat. § 510/13 (2017); 745 Ill. 

Comp. Stat. § 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. § 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, § 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. § 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 § 79–i 

(McKinney 2017); N.Y. Ins. Law 3221(l)(16)(A), 

4303(cc)(1) (McKinney 2017); N.C. Gen. Stat. § 14– 

45.1(e)–(f), 58–3–178(e) (2017); N.D. Cent. Code 

§ 23–16–14 (2017); Ohio Rev. Code Ann. § 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). 

appropriate to require remedies against 

a recipient for the violations of a subrecipient, 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. 

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 antidiscrimination 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 


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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 readerfriendly 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 


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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 antidiscrimination 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 CoatsSnowe 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 antidiscrimination 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 antidiscrimination 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 antidiscrimination 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 subrecipient, 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 


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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 antidiscrimination 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 

discount rate 

(millions of 2016 dollars) 

Annualized value over 5 years 

by discount rate 

(millions of 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. 


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48See Kevin Theriot & Ken Connelly, Free to Do 

No Harm: Conscience Protections for Healthcare 

Professionals, 49 Ariz. St. L.J. 549, 550–51 (2017). 

49As 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. 

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 antidiscrimination 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

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 antidiscrimination 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 antidiscrimination laws. See supra Part V 

(identifying when OCR complaints were 

received). 

(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 


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50E.g., Consolidated Appropriations Act, 2017, 

Public Law 115–31, Div. H, Tit. V, sec. 507(d), 131 

Stat. 135, 562 (May 5, 2017). 

51See id. 

52 42 U.S.C. 300a–7(c)(2) and (d). 

53https://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/ffe.html. 

54https://www.medicare.gov/. 

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 antidiscrimination 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 antidiscrimination 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. 

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: 

• 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 

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 


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55Public 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 

57Public 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). 

59 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 . . . .’’). 

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 . . . .’’). 

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

64E.g., https://www.acl.gov/node/110. https://

www.acl.gov/sites/default/files/about-acl/2017-12/ 

DDC-2017.pdf. 

65E.g., https://www.acl.gov/sites/default/files/ 

about-acl/2017-06/PADD-2017.pdf. 

(ISDEAA),55 as amended, which allows 

Tribes and Tribal Organizations to 

assume control and management of 

health care that IHS would otherwise 

provide.56

(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 CoatsSnowe 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 healthrelated activities.’’ 58

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

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 subrecipients 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

The broad array of recipients and subrecipients 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 

• State Councils on Developmental 

Disabilities 64 and States’ Protection and 

Advocacy Systems that receive funds to 

implement the DD Act.65

(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 


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66https://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. 

67https://www.census.gov/programs-surveys/ 

susb/technical-documentation/methodology.html. 

68FAQ 5, https://www.census.gov/eos/www/ 

naics/faqs/faqs.html#q5. 

69FAQ 1, https://www.census.gov/eos/www/ 

naics/faqs/faqs.html#q1. 

70https://www.census.gov/eos/www/naics/faqs/ 

faqs.html#q2. 

71https://www.census.gov/glossary/#term_Firm. 

72Esther 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. 

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 nonmedical 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 subrecipients 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. 

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 subsectors 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. 

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. 

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 


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74http://taggs.hhs.gov (last visited Aug. 24, 2017). 75https://www.census.gov/geo/maps-data/data/ 

tallies/all_tallies.html. 

76U.S. Census Bureau, Statistics of U.S. 

Businesses, 2015, NAICS code 611310 (Colleges, 

Universities, and Professional Schools). 

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

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 deduplicated 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 × 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. 

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 

Type 

Covered by 

current 

45 CFR 88? 

Covered by 

NPRM? 

Estimated 

number 

(low) 

Estimated 

number 

(high) 

1 ..................... State and Territorial Governments 77 .................................. Yes ................. Yes ................. 58 58 

2 ..................... Federally recognized Tribes 78 ............................................ Yes ................. Yes ................. 567 567 

3 ..................... Counties 79 .......................................................................... Yes ................. Yes ................. 3,234 3,234 

Hospitals: 

4 ..................... General and Medical Surgical Hospitals 80 ......................... Yes ................. Yes ................. 1,859 2,694 

5 ..................... Specialty Hospitals (e.g., psychiatric, substance abuse, 

rehabilitation, cancer, maternity) 81.

Yes ................. Yes ................. 553 801 

Nursing and Residential Care Facilities: 


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TABLE 1—ESTIMATED NUMBER OF PERSONS AND ENTITIES COVERED BY NPRM—Continued 

Type 

Covered by 

current 

45 CFR 88? 

Covered by 

NPRM? 

Estimated 

number 

(low) 

Estimated 

number 

(high) 

6 ..................... Skilled Nursing Facilities 82 ................................................. Yes ................. Yes ................. 6,316 9,153 

7 ..................... Residential Intellectual and Developmental Disability Facilities 83.Yes ................. Yes ................. 4,310 6,246 

8 ..................... Continuing Care Retirement Communities 84 ..................... Yes ................. Yes ................. 2,605 3,775 

9 ..................... Other Residential Care Facilities (e.g., group homes) 85 ... Yes ................. Yes ................. 2,247 3,256 

10 ................... Entities providing Home Health Care Services 86 .............. Yes ................. Yes ................. 15,062 21,829 

Entities Providing Ambulatory Health Care Services: 

11 ................... Offices of Physicians (except Mental Health Specialists) 87 Yes ................. Yes ................. 115,673 167,642 

12 ................... Offices of Physicians (Mental Health Specialists) 88 .......... Yes ................. Yes ................. 7,324 10,614 

13 ................... Offices of Mental Health Practitioners (except Physicians) 89.Yes ................. Yes ................. 14,340 20,782 

14 ................... Offices of Dentists 90 ........................................................... Yes ................. Yes ................. 86,874 125,904 

15 ................... Offices of Chiropractors 91 .................................................. Yes ................. Yes ................. 26,725 32,535 

16 ................... Offices of Optometrists 92 ................................................... Yes ................. Yes ................. 13,775 19,964 

17 ................... Offices of Physical, Occupational and Speech Therapists, 

and Audiologists 93.

Yes ................. Yes ................. 17,623 25,540 

18 ................... Offices of Podiatrists 94 ....................................................... Yes ................. Yes ................. 5,314 7,701 

19 ................... Family Planning Centers 95 ................................................. Yes ................. Yes ................. 999 1,448 

20 ................... Freestanding Ambulatory Surgical and Emergency Centers 96.Yes ................. Yes ................. 2,908 4,214 

21 ................... HMO Medical Centers 97 ..................................................... Yes ................. Yes ................. 78 113 

22 ................... Kidney Dialysis Centers 98 .................................................. Yes ................. Yes ................. 305 442 

23 ................... Outpatient Mental Health and Substance Abuse Centers 99.Yes ................. Yes ................. 3,776 5,472 

24 ................... Diagnostic Imaging Centers 100 .......................................... Yes ................. Yes ................. 3,209 4,651 

25 ................... Medical Laboratories 101 ..................................................... Yes ................. Yes ................. 2,278 3,302 

26 ................... Ambulance Services 102 ..................................................... Yes ................. Yes ................. 2,185 3,167 

27 ................... All Other Outpatient Care Centers (e.g., centers and clinics for pain therapy, community health, and sleep disorders) 103.Yes ................. Yes ................. 3,880 5,623 

28 ................... Entities providing All Other Ambulatory Health Care Services (health screening, smoking cessation, hearing testing, blood banks) 104Yes ................. Yes ................. 2,391 3,465 

Insurance Carriers: 

29 ................... Direct Health and Medical Insurance Carriers 105 .............. Yes ................. Yes ................. 607 880 

Entities Providing Social Assistance Services: 

30 ................... Entities Serving the Elderly and Persons with Disabilities 

(provision of nonresidential social assistance services 

to improve quality of life) 106

Yes ................. Yes ................. 9,051 36,205 

31 ................... Entities providing Other Individual Family Services (e.g., 

marriage counseling, crisis intervention centers, suicide 

crisis centers) 107

Yes ................. Yes ................. 5,310 21,240 

32 ................... Entities providing Child and Youth Services (e.g., adoption agencies, foster care placement services) 108Yes ................. Yes ................. 2,169 8,674 

33 ................... Temporary Shelters (e.g., short term emergency shelters 

for victims of domestic violence, sexual assault, or child 

abuse; runaway youth; and families caught in medical 

crises) 109.

Yes ................. Yes ................. 805 3,219 

34 ................... Emergency and Other Relief Services (e.g., medical relief, resettlement, and counseling to victims of domestic 

or international disasters or conflicts) 110

Yes ................. Yes ................. 169 675 

Other Entities: 

35 ................... Pharmacies and Drug Stores 111 ........................................ Yes ................. Yes ................. 13,490 19,550 

36 ................... Research and Development in Biotechnology 112 .............. Yes ................. Yes ................. 2,347 3,402 

37 ................... Colleges, Universities, and Professional Schools 113 ......... Yes ................. Yes ................. 316 2,457 

Subtotal, subject to current part 88 .................................................................................................................. 364,575 571,282 

38 ................... HHS awarded funds appropriated to the U.S. Department 

of State & USAID 114.

No .................. Yes ................. 65 130 

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


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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3909 

77Assumes coverage of the 50 States, DC, Puerto 

Rico, 6 U.S. Territories, and the Island Areas. 78Assumes 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/responsive

2017/display_objects/documents/FY2018

CongressionalJustification.pdf. 79U.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 subrecipient. 80U.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. 

114U.S. Dep’t of Health & Human Servs., Tracking 

Accountability in Government Grants System 

(TAGGS) http://taggs.hhs.gov (last visited Dec. 19, 

2017). HHS identified unique awardees for FY 2017 

from HHS PEPFAR implementing agencies (CDC, 

HRSA, SAMHSA, NIH, FDA) to foreign nonprofits, 

foreign governments, and international 

organizations and used this number as a lowerbound. 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. 

115But see supra Part XI.C.2.ii (discussing the 

application of paragraph (d) of the Church 

Amendments to such grantees). 

TABLE 1—ESTIMATED NUMBER OF PERSONS AND ENTITIES COVERED BY NPRM—Continued 

Type 

Covered by 

current 

45 CFR 88? 

Covered by 

NPRM? 

Estimated 

number 

(low) 

Estimated 

number 

(high) 

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

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. 

(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 subrecipients 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 subrecipients under this proposed 

regulation excluded from § 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 


daltland on DSKBBV9HB2PROD with PROPOSALS2
3910 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 

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

§ 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. 

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 § 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 § 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 

§ 88.4(c)(1)–(4). 

TABLE 2—RANGE OF RECIPIENTS SUBJECT TO THE PROPOSED ASSURANCE AND CERTIFICATION REQUIREMENTS (§ 88.4) 

Low-end 

estimate 

Upperbound 

estimate 

Range of Persons or Entities Subject to the NPRM ............................................................................................... 364,640 571,412 

Range of Recipients Excepted from Proposed § 88.4 ............................................................................................ ¥270,361 ¥418,893 

Total, Recipients Subject to the Assurance and Certification Requirements .................................................. 94,279 152,519 

(B) Estimated Number of Recipients 

Required to Provide Notice (§ 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 § 88.5, similar 

to proposed § 88.4, does not require subrecipients 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 

§ 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 § 88.4 but each 

hospital facility (an establishment) 

would implement § 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 (§ 88.5) 

Type 

Estimated 

number 

(Low) 

Estimated 

number 

(High) 

1 ................................ State and Territorial Governments 117 .............................................................................. 58 58 

2 ................................ Federally recognized Tribes 118 ........................................................................................ 567 567 

3 ................................ Counties 119 (assumed sub-recipient category to which the notice requirement does 

not apply).

n/a n/a 

4 ................................ General and Medical Surgical Hospitals 120 ..................................................................... 3,699 5,361 


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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3911 

117Assumes coverage of the 50 States, DC, Puerto 

Rico, 6 U.S. Territories, and the Island Areas. 

118Assumes 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/responsive

2017/display_objects/documents/FY2018

CongressionalJustification.pdf. 

119U.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. 

120U.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. 

Continued 

TABLE 3—NUMBER OF PHYSICAL ESTABLISHMENTS OF EACH RECIPIENT TYPE REQUIRED TO PROVIDE NOTICE (§ 88.5)— 

Continued 

Type 

Estimated 

number 

(Low) 

Estimated 

number 

(High) 

5 ................................ Specialty Hospitals (e.g. psychiatric, substance abuse, rehabilitation, cancer, maternity) 121.1,139 1,651 

6 ................................ Skilled Nursing Facilities 122 ............................................................................................. 11,789 17,085 

7 ................................ Residential Intellectual and Developmental Disability Facilities 123 ................................. 22,611 32,770 

8 ................................ Continuing Care Retirement Communities 124 ................................................................. 3,668 5,316 

9 ................................ Other Residential Care Facilities (e.g., group homes) 125 ............................................... 3,627 5,256 

10 .............................. Entities providing Home Health Care Services 126 ........................................................... 21,377 30,981 

11 .............................. Offices of Physicians (except Mental Health Specialists) 127 .......................................... 147,817 214,228 

12 .............................. Offices of Physicians (Mental Health Specialists) 128 ...................................................... 7,498 10,867 

13 .............................. Offices of Mental Health Practitioners (except Physicians) 129 ........................................ 15,022 21,771 

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 and Speech Therapists, and Audiologists 133 ............ 25,213 36,541 

18 .............................. Offices of Podiatrists 134 ................................................................................................... 5,769 8,361 

19 .............................. Family Planning Centers 135 ............................................................................................. 1,584 2,295 

20 .............................. Freestanding Ambulatory Surgical and Emergency Centers 136 ...................................... 4,609 6,679 

21 .............................. HMO Medical Centers 137 ................................................................................................. 560 812 

22 .............................. Kidney Dialysis Centers 138 .............................................................................................. 5,144 7,455 

23 .............................. Outpatient Mental Health and Substance Abuse Centers 139 .......................................... 7,227 10,474 

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 (e.g., centers and clinics for pain therapy, community health, and sleep disorders) 143.8,054 11,672 

28 .............................. Entities providing All Other Ambulatory Health Care Services (health screening, smoking cessation, hearing testing, blood banks) 144.3,670 5,319 

29 .............................. Direct Health and Medical Insurance Carriers 145 ............................................................ 3,712 5,379 

30 .............................. Entities Serving the Elderly and Persons with Disabilities (provision of nonresidential 

social assistance services to improve quality of life) 146.

10,475 41,899 

31 .............................. Entities providing Other Individual Family Services (e.g., marriage counseling, crisis 

intervention centers, suicide crisis centers) 147.

7,184 28,736 

32 .............................. Entities providing Child and Youth Services (e.g., adoption agencies, foster care 

placement services) 148.

2,901 11,604 

33 .............................. Temporary Shelters (e.g., short term emergency shelters for victims of domestic violence, sexual assault, or child abuse; runaway youth; and families caught in medical 

crises) 149.

1,013 4,053 

34 .............................. Emergency and Other Relief Services (e.g., medical relief, resettlement, and counseling to victims of domestic or international disasters or conflicts) 150.309 1,236 

35 .............................. Pharmacies and Drug Stores 151 ...................................................................................... 30,450 44,130 

36 .............................. Research and Development in Biotechnology 152 ............................................................ 2,505 3,631 

37 .............................. Colleges, Universities, and Professional Schools 153 ....................................................... 615 4,788 

38 .............................. HHS awarded funds appropriated to the U.S. Department of State & USAID 154 .......... 65 130 

Total, Subject to 

the Notice Requirement.

........................................................................................................................................... 476,539 746,206 

Public Comment Requested on Scope of 

Entities 

Given the uncertainty as to the 

number of recipients covered by this 


daltland on DSKBBV9HB2PROD with PROPOSALS2
3912 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 

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. 

154U.S. Dep’t of Health & Human Servs., Tracking 

Accountability in Government Grants System 

(TAGGS) http://taggs.hhs.gov (last visited Dec. 19, 

2017). 

155Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 

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. 

Estimated Burdens 

There are six categories of estimated 

burdens for this proposed rule, as 

summarized in Table 4. 

TABLE 4—SUMMARY OF COSTS

Cost category 

Year 1: Initial 

costs 

Years 2 to 5: Annual recurring 

costs 

Total cost 

(in millions) 

Affected 

(%) 

Total cost 

(in millions) 

Affected 

(%) 

1 ...................... Familiarization (one-time burden) ....................................... $62.9 100 ........................ ........................

2 ...................... Assurance and Certification.

Signing Documents ......................................................... 72.8 26 $72.8 26 

Reviewing Policies and Procedures ............................... 36.4 13 36.4 13 

Update Policies, Procedures, Training ........................... 13.8 5 1.4 0.5 

Subtotal, Assurance and Cert .................................................................. 123.0 ........................ 110.6 ........................

3 ...................... Notice requirement.

Mandatory, one-time, posting ......................................... 92.9 99 

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 Efforts ................................................. 6.8 0.5 6.8 0.5 

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 antidiscrimination 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 × 

2).155 The labor cost is approximately 

$62.9 million in the first year ($134.50 

per hour × 1 hour × 468,123 entities) 

and zero dollars in the out-years. 

Assurance and Certification (Proposed 

§ 88.4) 

The burden for the assurance and 

certification is the opportunity cost of 


daltland on DSKBBV9HB2PROD with PROPOSALS2
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3913 

156Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 

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 antidiscrimination laws referenced or 

incorporated, (2) to review recipientwide policies and procedures or take 

other actions to self-assess compliance 

with applicable Federal health care 

conscience and associated antidiscrimination 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 antidiscrimination 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 § 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 × 2) and $186.88 for the chief 

executive (occupation code 11–1011) 

($93.44 per hour × 2).156 The weighted 

mean hourly wage (including benefits 

and overhead) of these two occupations 

is $147.60 per hour ((134.50 × .75) + 

(186.88 × .25)). The labor cost is $72.8 

million each year for the first five years 

($147.60 per hour × 4 hours × 123,302 

entities). 

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 antidiscrimination laws each year for the 

first five years of publication. The 

Department reasonably estimates such 

action because § 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 × 4 

hours × 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 × 4 hours × 23,406 

entities) and approximately $1.4 million 

annually for years two through five 

($147.60 per hour × 4 hours × 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

Cost categories 

Year 1: Initial costs Years 2–5: recurring costs 

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 


daltland on DSKBBV9HB2PROD with PROPOSALS2
3914 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 

157Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 158 Id. 

Notice Requirement (Proposed § 88.5) 

Proposed § 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 

§ 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 × 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 × 2).158 This labor cost 

is approximately $92.7 million ((1⁄3 hr. 

× $38.78 per hour × 611,372 

establishments) + (2 hours × $63.38 per 

hour × 611,372 establishments)). 

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. × $38.78 per 

hour × 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 × $63.38 per hour × 

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 × 

$.05 per page × 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 × 

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 × $19.39 

per hour × 2 hours × 305,686 

establishments) in year one and $5.9 

million annually in years 2 through 5 (2 

× $19.39 × 1 × 152,843 establishments). 

The Department anticipates that there 

may be some additional printing costs 


daltland on DSKBBV9HB2PROD with PROPOSALS2
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3915 

159Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 

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 hardcopy and others online. On balance, a 

recipient might print approximately 100 

extra pages. Given these assumptions, 

the cost of voluntarily included notices, 

as proposed § 88.5(c) incentivizes, will 

cost approximately $1.5 million in the 

first year (305,686 entities × 100 pages 

× $.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 (§ 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 × $39.78 per hour × 0.25 

hours × 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 × 

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 subrecipient 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 × 2 to adjust upward 

for benefits and overhead) and $186.88 

for the chief executive (occupation code 

11–1011) ($93.44 per hour × 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 × .80) + ($93.44 

× .20)). The labor cost is $6.8 million 

($144.98 per hour × 20 hours × 2,341 

entities). 

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 antidiscrimination 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 × $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. 


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160 James Madison, Property, The Founders’ 

Constitution (March 29, 1792), http://presspubs.uchicago.edu/founders/documents/ 

v1ch16s23.html. 

161Letter 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). 

163Abortion is Legal, but What Percentage of ObGyns Will Provide One?, Freakonomics (August 24, 

2011, 1:57 p.m.), http://freakonomics.com/2011/08/ 

24/abortion-is-legal-but-what-percentage-of-obgyns-will-provide-one/. 

164 Id. 

165U.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/defaultdocument-library/cha_2017_

miniprofile.pdf?sfvrsn=0. 

166History of Our Ministry, Christian Medical & 

Dental Associations, https://www.cmda.org/library/ 

doclib/history-of-cmda.pdf. 

167About Us, American Association of Pro-Life 

Obstetricians and Gynecologists, http://aaplog.org/ 

about-us. 

168Letter 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 http://

downloads.frc.org/EF/EF09D50.pdf. 

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 subrecipients 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

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

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 healthcare providers who share their deepest 


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169Fallon 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/. 170Emmanuel 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. 

172Lynn Stout, Cultivating Conscience: How 

Good Laws Make Good People 17 (2011). 

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 obgyn 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. 

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. 

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 difficultto-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

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 


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173https://www.sba.gov/sites/default/files/files/ 

Size_Standards_Table_2017.pdf. 

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 anticoercion 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. 

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 § 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 § 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 

§ 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 antidiscrimination 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 


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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3919 

174See 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). 

175This 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. 

176Treasury and General Government 

Appropriations Act of 1999, Public Law 105–277, 

sec. 654, 112 Stat. 2681 (1998). 

compliance with them in the normal 

course of receiving such awards. And 

although proposed § 88.5 imposes a new 

requirement to post a notice about rights 

and obligations under Federal health 

care conscience and associated antidiscrimination 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

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 

§ 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 § 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 antidiscrimination 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 foreignbased 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

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

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 wellbeing. 

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), 


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177HHS 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 

‘‘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 

§ 88.4 (Assurance and Certification), 

§ 88.5 (Notice), and § 88.6(d) 

(Compliance Requirements). 

Information Collection for Proposed 

§ 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 antidiscrimination laws. Specifically, 

proposed § 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 nonmedical 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 antidiscrimination 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 antidiscrimination 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 antidiscrimination 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 § 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 

§ 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 § 88.2, only in the form of 

reimbursements for participation 

Medicare Part B. See proposed 

§ 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 § 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 SelfDetermination and Education 

Assistance Act. See proposed 

§ 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 


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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). 

178Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 

179This total differs from the burden in the RIA 

because a fully loaded wage that is adjusted 

upwards for benefits and overhead must be used. 

180This total differs from the burden in the RIA 

because a fully loaded wage that is adjusted 

upwards for benefits and overhead must be used. 

181This total differs from the burden in the RIA 

because a fully loaded wage that is adjusted 

upwards for benefits and overhead must be used. 

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). 

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 antidiscrimination 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 antidiscrimination 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 § 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 × .75) + ($93.44 × .25)). 

The labor cost is $36 million each year 

for the first five years ($73.80 per hour 

× 4 hours × 123,302 entities).179

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 selfassess 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 selfassessing 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 × 4 hours × 

61,652 entities).180

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 × 4 × 23,406 entities) and 

approximately $690,783 annually for 

years two through five ($73.80 × 4 × 

2,341 entities).181

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 

§ 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 antidiscrimination 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 antidiscrimination 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 § 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 


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182Bureau of Labor Statistics, Occupational and 

Employment Statistics, Occupational Employment 

and Wages, May 2016, https://www.bls.gov/oes/ 

current/oes_nat.htm. 

183This total differs from the burden in the RIA 

because a fully loaded wage that is adjusted 

upwards for benefits and overhead must be used. 

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 × $19.39/hr. × 611,372 

establishments) + (2 hours × $34.69/hr. 

× 611,372 establishments).183

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 × $.05 per 

page × 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 outyears. 

The proposed notice provision at 

§ 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 × 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 × 2 × 

305,686 establishments) and $3 million 

annually in years 2 through 5 ($19.39 × 

1 × 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 § 88.5(c) incentivizes, will 

cost approximately $1.5 million in the 

first year (305,686 entities × 100 pages 

× $.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 (§ 88.6(d)) 

Summary of the Collection of 

Information: Proposed § 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 subrecipient’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 antidiscrimination 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 


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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 × $19.39 per 

hour × 0.25 hours × 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, FederalState 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 (CoatsSnowe 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. 

§ 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 antidiscrimination 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. 

§ 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, 


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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, healthrelated 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 subrecipient, or who otherwise receives 

Federal funds from the Department or a 

component of the Department indirectly 

through a recipient or another subrecipient, 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. 

§ 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 §§ 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 §§ 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 


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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 §§ 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 

§§ 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 §§ 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 

§§ 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 

§§ 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 postgraduate 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 §§ 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 §§ 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 §§ 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. 


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(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 

§§ 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 §§ 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 §§ 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 §§ 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 §§ 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 §§ 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 

§§ 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 §§ 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 §§ 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 §§ 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 §§ 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 §§ 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 


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paragraph (j)(2) of this section and 

§§ 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 §§ 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 

§§ 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 §§ 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 §§ 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 §§ 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 §§ 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 §§ 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 

§§ 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 §§ 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 §§ 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 Statesponsored 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 


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comply with paragraph (p)(2)(iii) of this 

section and §§ 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 §§ 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 §§ 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 §§ 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 §§ 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 

§§ 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 §§ 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. 

§ 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 § 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 antidiscrimination 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 § 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 antidiscrimination 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 


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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 antidiscrimination 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 § 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. 

§ 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 postgraduate 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. 

§ 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 antidiscrimination laws and this part, and 

shall take steps to eliminate any 

violations of the Federal health care 

conscience and associated antidiscrimination 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 antidiscrimination 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 antidiscrimination laws and this part. 

(c) Cooperation. The Department, 

each recipient, and each sub-recipient 


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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 subrecipient’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 antidiscrimination 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. 

§ 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 antidiscrimination 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 subrecipients to determine whether they are 

complying with Federal health care 

conscience and associated antidiscrimination 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 factfinding 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 § 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 antidiscrimination 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 antidiscrimination 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 § 88.7(j)(3). 


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(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 subrecipient, created by Federal law; and 

(vii) Taking any other remedies that 

may be legally available. 

§ 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. 

§ 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. 

§ 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 AntiDiscrimination 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 http://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 


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