2078 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 88 

RIN 0945–AA18 

Safeguarding the Rights of Conscience 

as Protected by Federal Statutes 

AGENCY: Office for Civil Rights (OCR), 

Office of the Secretary, HHS. 

ACTION: Final rule 

SUMMARY: The Department of Health and 

Human Services (HHS or the 

Department) is issuing this final rule to 

partially rescind the May 21, 2019, final 

rule entitled, ‘‘Protecting Statutory 

Conscience Rights in Health Care; 

Delegations of Authority’’ (‘‘2019 Final 

Rule’’), while leaving in effect the 

framework created by the February 23, 

2011, final rule entitled, ‘‘Regulation for 

the Enforcement of Federal Health Care 

Provider Conscience Protection Laws’’ 

(‘‘2011 Final Rule’’), which has been in 

effect continuously since March 25, 

2011. Though the 2019 Final Rule never 

took effect, the Department also retains, 

with some modifications, certain 

provisions of the 2019 Final Rule 

regarding federal conscience 

protections, but eliminates others that 

are redundant or confusing, that 

undermine the clarity of the statutes 

Congress enacted to both safeguard 

conscience rights and protect access to 

health care, or because significant 

questions have been raised as to their 

legality. 

DATES: This rule is effective March 11, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Office for Civil Rights: David 

Christensen, Supervisory Policy 

Advisor, and Gabriela Weigel, Policy 

Advisor, HHS Office for Civil Rights, 

(202) 795–7830 or (800) 537–7697 

(TDD), or via email at consciencerule@

hhs.gov. 

Assistance to Individuals with 

Disabilities in Reviewing the 

Rulemaking Record: Upon request, the 

Department will provide an 

accommodation or auxiliary aid to an 

individual with a disability who needs 

assistance to review the comments or 

other documents in the public 

rulemaking record for the final rule. To 

schedule an appointment for this type of 

accommodation or auxiliary aid, please 

call (202) 795–7830 or (800) 537–7697 

(TDD) for assistance or email 

consciencerule@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

This Federal Register document is 

also available from the Federal Register 

online database through http://

www.govinfo.gov, a service of the U.S. 

Government Publishing Office. 

Table of Contents 

Contents 

I. Background ...................................................................................................................................................................................................... 900 

A. Statutory Background ............................................................................................................................................................................. 900 

B. Regulatory Background .......................................................................................................................................................................... 907 

C. Litigation ................................................................................................................................................................................................. 910 

D. The Proposed Rule ................................................................................................................................................................................. 911 

II. Comments on the Proposed Rule .................................................................................................................................................................. 913 

A. General Comments ................................................................................................................................................................................. 914 

B. Comments Addressing Sections 88.1–88.4 of the Proposed Rule ....................................................................................................... 916 

C. Comments Addressing the Proposed Rule’s Requests for Comment ................................................................................................... 941 

III. Statutory Authority ....................................................................................................................................................................................... 971 

IV. Overview and Section-by-Section Description of the Final Rule .............................................................................................................. 972 

V. Regulatory Impact Analysis .......................................................................................................................................................................... 975 

A. Introduction ............................................................................................................................................................................................ 975 

B. Requests for Comment ............................................................................................................................................................................ 976 

C. Detailed Economic Analysis .................................................................................................................................................................. 981 

D. Summary of Impacts .............................................................................................................................................................................. 989 

E. Regulatory Flexibility Analysis .............................................................................................................................................................. 990 

Rule Text ............................................................................................................................................................................................................. 993 

I. Background 

A. Statutory Background 

Several provisions of Federal law 

protect the conscience rights of certain 

federally funded health care entities and 

prohibit recipients of certain Federal 

funds from requiring individuals and 

entities to participate in actions they 

find religiously or morally 

objectionable. They include the 

following provisions: 

The Church Amendments [42 U.S.C. 

300a–7] 

The conscience provisions contained 

in 42 U.S.C. 300a–7 (collectively known 

as the ‘‘Church Amendments’’) were 

enacted in the 1970s in response to 

debates over whether receipt of Federal 

funds required those recipients to 

perform abortion or sterilization 

procedures. The Church Amendments 

consist of five conscience provisions. 

The first provision, 42 U.S.C. 300a–7(b), 

provides that ‘‘[t]he receipt of any grant, 

contract, loan, or loan guarantee under 

[certain statutes implemented by the 

Department of Health and Human 

Services] by any individual or entity 

does not authorize any court or any 

public official or other public authority 

to require’’ (1) the individual to perform 

or assist in a sterilization procedure or 

an abortion, if it would be contrary to 

their religious beliefs or moral 

convictions; (2) the entity to make its 

facilities available for sterilization 

procedures or abortions, if the 

performance of sterilization procedures 

or abortions in the facilities is 

prohibited by the entity on the basis of 

religious beliefs or moral convictions; or 

(3) the entity to provide personnel for 

the performance or assistance in the 

performance of sterilization procedures 

or abortions, if it would be contrary to 

the religious beliefs or moral 

convictions of such personnel. 

The second provision, 42 U.S.C. 

300a–7(c)(1), prohibits any entity that 

receives a grant, contract, loan, or loan 

guarantee under certain Departmentimplemented statutes from 

discriminating against any physician or 

other health care personnel in 

employment, promotion, termination of 

employment, or the extension of staff or 

other privileges because the individual 

‘‘performed or assisted in the 

performance of a lawful sterilization 

procedure or abortion, because he 

refused to perform or assist in the 

performance of such a procedure or 

abortion on the grounds that his 

performance or assistance in the 

performance of the procedure or 

abortion would be contrary to his 


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religious beliefs or moral convictions, or 

because of his religious beliefs or moral 

convictions respecting sterilization 

procedures or abortions.’’ 

The third provision, 42 U.S.C. 300a– 

7(c)(2), prohibits any entity that receives 

a grant or contract for biomedical or 

behavioral research under any program 

administered by the Department from 

discriminating against any physician or 

other health care personnel in 

employment, promotion, termination of 

employment, or extension of staff or 

other privileges ‘‘because he performed 

or assisted in the performance of any 

lawful health service or research 

activity, because he refused to perform 

or assist in the performance of any such 

service or activity on the grounds that 

his performance or assistance in the 

performance of such service or activity 

would be contrary to his religious 

beliefs or moral convictions, or because 

of his religious beliefs or moral 

convictions respecting any such service 

or activity.’’ 

The fourth provision, 42 U.S.C. 300a– 

7(d), provides that ‘‘[n]o 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 

Department] if his performance or 

assistance in the performance of such 

part of such program or activity would 

be contrary to his religious beliefs or 

moral convictions.’’ 

The fifth provision, 42 U.S.C. 300a– 

7(e), prohibits any entity that receives a 

grant, contract, loan, loan guarantee, or 

interest subsidy under certain 

Departmentally implemented statutes 

from denying admission to, or otherwise 

discriminating against ‘‘any applicant 

(including applicants for internships 

and residencies) for training or study 

because of the applicant’s reluctance, or 

willingness, to counsel, suggest, 

recommend, assist, or in any way 

participate in the performance of 

abortions or sterilizations contrary to or 

consistent with the applicant’s religious 

beliefs or moral convictions.’’ 

Public Health Service Act Sec. 245, The 

Coats-Snowe Amendment [42 U.S.C. 

238n] 

Enacted in 1996, section 245 of the 

Public Health Service Act (PHS Act) 

prohibits the Federal Government and 

any State or local governments receiving 

Federal financial assistance from 

discriminating against any health care 

entity on the basis that the entity (1) 

‘‘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;’’ (2) refuses to make 

arrangements for such activities; or (3) 

‘‘attends (or attended) a post-graduate 

physician training program, or any other 

program of training in the health 

professions, that does not (or did not) 

perform induced abortions or require, 

provide, or refer for training in the 

performance of induced abortions, or 

make arrangements for the provision of 

such training.’’ For the purposes of this 

protection, the statute defines ‘‘financial 

assistance’’ as including ‘‘with respect 

to a government program,’’ 

‘‘governmental payments provided as 

reimbursement for carrying out healthrelated activities.’’ In addition, PHS Act 

Sec. 245 requires that, in determining 

whether to grant legal status to a health 

care entity (including a State’s 

determination of whether to issue a 

license or certificate), the federal 

government and any State or local 

governments receiving Federal financial 

assistance shall deem accredited any 

post-graduate physician training 

program that would be accredited, but 

for the reliance on an accrediting 

standard that, regardless of whether 

such standard provides exceptions or 

exemptions, requires an entity: (1) to 

perform induced abortions; or (2) to 

require, provide, or refer for training in 

the performance of induced abortions, 

or make arrangements for such training. 

Medicaid and Medicare 

The Medicaid and Medicare statutes 

also include certain conscience 

provisions. The Balanced Budget Act of 

1997, Public Law 105–33, 111 Stat. 251 

(1997), provides that Medicaid managed 

care-managed organizations and 

Medicare Advantage plans are not 

required to provide, reimburse for, or 

cover a counseling or referral service if 

the organization or plan objects to the 

service on moral or religious grounds. 

See id. 40011852(j)(3)(B), 111 Stat. at 

295 (codified at 42 U.S.C. 1395w– 

22(j)(3)(B)) (Medicare Advantage); id. 

§ 4704(b)(3)(B), 111 Stat. at 496–97 

(codified at 42 U.S.C. 1396u–2(b)(3)(B)) 

(Medicaid). The organization or plan 

must, however, provide sufficient notice 

of its moral or religious objections to 

prospective enrollees. 42 U.S.C. 1395w– 

22(j)(3)(B)(ii) (Medicare Advantage), 

1396u–2(b)(3)(B)(ii) (Medicaid managed 

care). 

These Medicare and Medicaid statutes 

also contain conscience provisions 

related to the performance of advanced 

directives. See 42 U.S.C. 1395cc(f), 

1396a(w)(3), and 14406(2). 

Additionally, they contain provisions 

related to religious nonmedical health 

care providers and their patients. See 42 

U.S.C. 1320a–1(h), 1320c–11, 1395i–5, 

1395x(e), 1395x(y)(1), 1396a(a) and 

1397j–1(b). For example, Congress 

prohibited States from excluding 

Religious Nonmedical Health Care 

Institutions (RNHCIs) from licensure 

through implementation of State 

definitions of ‘‘nursing home’’ and 

‘‘nursing home administrator,’’ 42 

U.S.C. 1396g(e), and Congress exempted 

RNHCIs from certain Medicaid 

requirements for medical criteria and 

standards. 42 U.S.C. 1396a(a) 

(exempting RNHCIs from 42 U.S.C. 

1396a(a)(9)(A), 1396a(a)(31), 

1396a(a)(33), and 1396b(i)(4)). 

Additionally, section 6703(a) of the 

Elder Justice Act of 2009 (Pub. L. 111– 

148, 124 Stat. 119) provides that Elder 

Justice and Social Services Block Grant 

programs may not interfere with or 

abridge an elder person’s ‘‘right to 

practice his or her religion through 

reliance on prayer alone for healing,’’ 

when the preference for such reliance is 

contemporaneously expressed, 

previously set forth in a living will or 

similar document, or unambiguously 

deduced from such person’s life history. 

42 U.S.C. 1397j–1(b). 

The Weldon Amendment 

The Weldon Amendment, originally 

adopted as section 508(d) of the LaborHHS Division (Division F) of the 2005 

Consolidated Appropriations Act, 

Public Law 108–447, 118 Stat. 2809, 

3163 (Dec. 8, 2004), has been readopted 

(or incorporated) in each subsequent 

legislative measure appropriating funds 

to HHS. See, e.g., Consolidated 

Appropriations Act, 2023, Public Law 

117–328, div. H, title V General 

Provisions, section 507(d)(1) (Dec 29, 

2022). 

The Weldon Amendment provides 

that ‘‘[n]one of the funds made available 

in this Act [making appropriations for 

the Departments of Labor, Health and 

Human Services, and Education] 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.’’ It also 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.’’ 


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1 In 2017 Congress effectively eliminated the 

penalty for noncompliance by reducing it to zero. 

See Tax Cuts and Jobs Act of 2017, Public Law 115– 

97, 11081, 131 Stat. 2092 (codified in 26 U.S.C. 

5000A(c)). 

The Affordable Care Act 

Passed in 2010, the Patient Protection 

and Affordable Care Act (ACA), Public 

Law 111–148, 124 Stat. 119 (2010) 

(codified at 42 U.S.C. 18001, et seq.), 

includes certain conscience provisions 

in sections 1553, 1303(b)(1)(A), (b)(4), 

and (c)(2)(A), and 1411(b)(5)(A). 

Section 1553 prohibits the Federal 

government, any state or local 

government, and any health care 

provider that receives Federal funding 

under the ACA, or any health plan 

created under the ACA, from subjecting 

an individual or health care entity to 

discrimination on the ground that the 

individual or entity does not provide 

services for the purpose of causing or 

assisting in the death of any individual, 

including through assisted suicide, 

euthanasia, and mercy killing. See 42 

U.S.C. 18113(a). Section 1553 provides 

that the Department’s Office for Civil 

Rights (‘‘OCR’’) will receive complaints 

of discrimination related to that section. 

Id. 18113(d). 

Section 1303(b)(1)(A) provides that 

issuers of qualified health plans shall 

determine whether or not the plan 

provides coverage of abortion services. 

Id. 18023(b)(1)(A)(ii). Additionally, 

Section 1303(b)(4) states that ‘‘[n]o 

qualified health plan offered through an 

Exchange may discriminate against any 

health care provider or health care 

facility because of its unwillingness to 

provide, pay for, provide coverage of, or 

refer for abortions.’’ Id. 18023(b)(4). 

Additionally, Section 1303(c) states that 

nothing in the ACA will be understood 

to preempt or otherwise effect State 

laws ‘‘regarding the prohibition of (or 

requirement of) coverage, funding, or 

procedural requirements on abortions, 

including parental notification or 

consent for the performance of an 

abortion on a minor,’’ 42 U.S.C. 

18023(c)(1). Section 1303(c) also states 

that nothing in the ACA will be 

understood to have any effect on 

Federal laws that protect conscience; 

that regard the willingness or refusal to 

provide abortion; and that regard 

‘‘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.’’ Id. 18023(c)(2). 

Section 1303(d) further states that 

‘‘Nothing in this Act shall be construed 

to relieve any health care provider from 

providing emergency services as 

required by State or Federal law,’’ 

including the Emergency Medical 

Treatment and Labor Act. Id. 18023(d). 

Section 1411(b)(5)(A) addresses 

exemptions to the ACA’s ‘‘individual 

responsibility requirement.’’ 42 U.S.C. 

18081(b)(5)(A).1 Under this section, the 

Department may grant exemptions 

based on hardship (which the 

Department has stated includes an 

individual’s inability to secure 

affordable coverage that does not 

provide for abortions (84 FR 23172), 

membership in a particular religious 

organization, or membership in a 

‘‘health care sharing ministry’’). 

Federal Conscience and AntiDiscrimination Protections Applying to 

Global Health Programs 

The Department administers certain 

programs under the President’s 

Emergency Plan for AIDS Relief 

(PEPFAR), to which additional 

conscience protections apply. 

Specifically, recipients of foreign 

assistance funds for HIV/AIDS 

prevention, treatment, or care 

authorized by section 104A of the 

Foreign Assistance Act of 1961 (22 

U.S.C. 2151b–2), 22 U.S.C. 7601–7682, 

or under any amendment made by the 

Tom Lantos and Henry J. Hyde United 

States Global Leadership Against HIV/ 

AIDS, Tuberculosis, and Malaria 

Reauthorization Act of 2008 (Pub. L. 

110–293), cannot be required, as a 

condition of receiving such funds, (1) to 

‘‘endorse or utilize a multisectoral or 

comprehensive approach to combating 

HIV/AIDS,’’ or (2) to ‘‘endorse, utilize, 

make a referral to, become integrated 

with, or otherwise participate in any 

program or activity to which the 

organization has a religious or moral 

objection.’’ 22 U.S.C. 7631(d)(1)(B). The 

government cannot discriminate against 

such recipients in the solicitation or 

issuance of grants, contracts, or 

cooperative agreements for the 

recipients’ refusal to do any such 

actions. 22 U.S.C. 7631(d)(2). In 

addition, recipients of foreign assistance 

funds under the Foreign Assistance Act 

of 1961 are prohibited from using those 

funds for performance or research 

respecting abortions or involuntary 

sterilization or to motivate or coerce any 

person to practice abortions or to coerce 

or provide any financial incentive to 

any person to undergo sterilization. 22 

U.S.C. 2151b(f). 

Exemptions From Compulsory Medical 

Screening, Examination, Diagnosis, or 

Treatment 

Additional provisions relating to 

conscience have also been the subject of 

previous HHS rulemaking. These 

include provisions related to mental 

health treatment, hearing screening 

programs, vaccination programs, 

occupational illness testing, and 

compulsory health care services 

generally. First, under the Public Health 

Service Act, certain suicide prevention 

programs are not to be construed to 

require ‘‘suicide assessment, early 

intervention, or treatment services for 

youth’’ if their parents or legal 

guardians have religious or moral 

objections to such services. 42 U.S.C. 

290bb–36(f); section 3(c) of the Garrett 

Lee Smith Memorial Act (Pub. L. 108– 

355, 118 Stat. 1404, reauthorized by 

Pub. L. 114–255 at sec. 9008). Second, 

authority to issue certain grants through 

the Health Resources and Services 

Administration (HRSA), Centers for 

Disease Control and Prevention (CDC), 

and the National Institutes of Health 

(NIH) may not be construed to preempt 

or prohibit State laws which do not 

require hearing loss screening for 

newborn, infants or young children 

whose parents object to such screening 

based on religious beliefs. 42 U.S.C. 

280g–1(d). Third, in providing pediatric 

vaccines funded by Federal medical 

assistance programs, providers must 

comply with any State laws relating to 

any religious or other exemptions. 42 

U.S.C. 1396s(c)(2)(B)(ii). Fourth, the 

provisions of the Occupational Safety 

and Health Act of 1970 are not to be 

construed to ‘‘authorize or 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). Fifth, 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), and Medicaid and 

CHIP programs are not to 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, with 

limited exceptions, 42 U.S.C. 1396(f). 

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). 


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B. Regulatory Background 

No statute requires the promulgation 

of rules to implement the conscience 

provisions outlined above. On August 

26, 2008, however, the Department 

exercised its discretion and issued a 

proposed rule entitled ‘‘Ensuring that 

Department of Health and Human 

Services Funds Do Not Support 

Coercive or Discriminatory Policies or 

Practices in Violation of Federal Law’’ 

(73 FR 50274) (2008 Final Rule) to 

address the conscience provisions in 

effect at that time. In the preamble to the 

2008 Final Rule, the Department 

concluded that regulations were 

necessary in order to: 

1. Educate the public and health care 

providers on the obligations imposed, and 

protections afforded, by Federal law; 

2. Work with state and local governments 

and other recipients of funds from the 

Department to ensure compliance with the 

nondiscrimination requirements embodied in 

the Federal health care provider conscience 

protection statutes; 

3. When such compliance efforts prove 

unsuccessful, enforce these 

nondiscrimination laws through the various 

Department mechanisms, to ensure that 

Department funds do not support coercive or 

discriminatory practices, or policies in 

violation of Federal law; and 

4. Otherwise take an active role in 

promoting open communication within the 

health care industry, and between providers 

and patients, fostering a more inclusive, 

tolerant environment in the health care 

industry than may currently exist. 

‘‘Ensuring That Department of Health 

and Human Services Funds Do Not 

Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law,’’ 73 FR 78072, 78074. 

The rule went into effect on January 

20, 2009, except for a certification 

requirement that never took effect, as it 

was subject to the information 

collection approval process under the 

Paperwork Reduction Act, which was 

never completed. 

On March 10, 2009, the Department 

proposed rescinding, in its entirety, the 

2008 Final Rule, and sought public 

comment to determine whether or not to 

rescind the 2008 Final Rule in part or 

in its entirety (74 FR 10207). On 

February 23, 2011, the Department 

issued a final rule entitled ‘‘Regulation 

for the Enforcement of Federal Health 

Care Provider Conscience Protection 

Laws’’ (2011 Final Rule) (76 FR 9968). 

Concluding that parts of the 2008 Final 

Rule were unclear and potentially 

overbroad in scope, the 2011 Final Rule 

rescinded much of the 2008 Final Rule, 

including provisions defining certain 

terms used in one or more of the 

conscience provisions and requiring 

entities that received Department funds, 

both as recipients and subrecipients, to 

provide a written certificate of 

compliance with the 2008 Final Rule. 

The 2011 Final Rule retained a 

provision designating OCR to receive 

and coordinate the handling of 

complaints of violations of the three 

conscience provisions that were the 

subject of the 2008 Final Rule: the 

Church Amendments, the Weldon 

Amendment, and the Coats-Snowe 

Amendment. 

On January 26, 2018, the Department 

issued a new proposed rule entitled 

‘‘Protecting Statutory Conscience Rights 

in Health Care; Delegations of 

Authority’’ (83 FR 3880) (2018 proposed 

rule). Citing a desire to ‘‘enhance the 

awareness and enforcement of Federal 

health care conscience and associated 

nondiscrimination 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,’’ the 2018 

proposed rule proposed reinstating 

several rescinded provisions of the 2008 

Final Rule, while also expanding upon 

that rule in a number of respects. 

Among other things, the 2018 proposed 

rule added a number of additional 

statutes and a detailed provision that 

would apply to alleged violations of any 

of the statutes covered by the rule. 

In response to the 2018 proposed rule, 

the Department received over 242,000 

comments from a wide variety of 

individuals and organizations, health 

care providers, faith-based 

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 the 

Department’s authority to issue the rule, 

the need for the rule, what kinds of 

workers would be protected by the 

proposed rule, the rule’s relationship to 

Title VII of the Civil Rights Act and 

other statutes and protections, what 

services are covered by the rule, 

whether the regulation might be used to 

discriminate against patients, how the 

rule would affect access to care, legal 

arguments, and the cost impacts and 

public health consequences of the rule. 

On May 21, 2019, the Department 

issued a final rule (84 FR 23170) (2019 

Final Rule). The Department concluded 

that the withdrawal of the 2008 Final 

Rule had created confusion about the 

various conscience provisions, citing 

what the Department determined was a 

significant increase in complaints 

alleging violations of a conscience 

provision that it had received since 

November 2016. The Department 

consequently reinstated the 2008 Final 

Rule while revising and expanding on 

its provisions, including by (1) adding 

additional statutory provisions to the 

rule’s enforcement scheme; (2) adopting 

definitions of various statutory terms; 

(3) imposing assurance and certification 

requirements; (4) reaffirming OCR’s 

enforcement authority; (5) imposing 

record-keeping and cooperation 

requirements; (6) establishing 

enforcement provisions and penalties; 

and (7) adopting a voluntary notice 

provision. 

C. Litigation 

Following issuance of the 2019 Final 

Rule, a number of States, localities, and 

non-governmental parties filed lawsuits 

challenging the rule in the Southern 

District of New York, the Northern 

District of California, the Eastern 

District of Washington, and the District 

of Maryland. Before the rule took effect, 

the New York, California, and 

Washington district courts granted 

summary judgment to the respective 

plaintiffs and vacated the rule in its 

entirety nationwide. See Washington v. 

Azar, 426 F. Supp. 3d 704 (E.D. Wash. 

2019), appeal pending, No. 20–35044 

(9th Cir.); San Francisco v. Azar, 411 F. 

Supp. 3d 1001 (N.D. Cal. 2019), appeal 

pending, Nos. 20–15398 et al. (9th Cir.); 

New York v. HHS, 414 F. Supp. 3d 475 

(S.D.N.Y. 2019), appeal dismissed 

without prejudice, Nos. 19–4254 et al. 

(2d Cir.). 

The courts’ rationales for vacating the 

2019 Final Rule were not identical, but 

each concluded that the rule was 

defective in a number of respects. One 

or more courts held that the 2019 Final 

Rule: (i) exceeded the Department’s 

authority; (ii) was inconsistent in 

certain respects with the conscience 

statutes or other statutes, including the 

Emergency Medical Treatment & Labor 

Act (EMTALA) and Title VII of the Civil 

Rights Act; (iii) was arbitrary and 

capricious in its evaluation of the 

record, its treatment of the Department’s 

conclusions underlying the 2011 Final 

Rule and reliance interests of funding 

recipients, and its consideration of 

certain issues relating to access to care 

and medical ethics raised by 

commenters; (iv) contained a particular 

definitional provision that was not 

promulgated in compliance with the 

notice-and-comment requirements of 

the Administrative Procedure Act 

(APA); and (v) had penalties for noncompliance with conscience provisions 

that violated the separation of powers 

and the Spending Clause. 

Because the 2019 Final Rule never 

took effect: (1) HHS has been 


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continuously operating under the 2011 

Final Rule; (2) HHS currently accepts, 

investigates, and processes complaints 

under the framework created by the 

2011 Final Rule; (3) There are no 

significant reliance interests stemming 

from the 2019 Final Rule; (4) No person 

or entity could have therefore 

reasonably relied on the 2019 Final 

Rule’s provisions; and (5) Health care 

providers or individuals have 

continuously and reasonably relied on 

the 2011 Final Rule because it has 

remained operational throughout. 

D. The Proposed Rule 

On January 5, 2023, the Department 

issued a notice of proposed rulemaking 

entitled, ‘‘Safeguarding the Rights of 

Conscience as Protected by Federal 

Statutes.’’ 88 FR 820 (2023 proposed 

rule). The Department proposed to 

partially rescind the 2019 Final Rule 

entitled ‘‘Protecting Statutory 

Conscience Rights in Health Care; 

Delegations of Authority,’’ 84 FR 23170 

(May 21, 2019) by: (1) leaving in effect 

the framework created by the 2011 Final 

Rule (76 FR 9968) and (2) retaining, 

with some modifications, certain 

provisions of the 2019 Final Rule. The 

Department solicited public comment to 

aid in its proposed rulemaking, 

specifically seeking comments 

addressing the following: 

1. Information, including specific 

examples where feasible, addressing the 

scope and nature of the problems giving 

rise to the need for rulemaking, and 

whether those problems could be 

addressed by different regulations than 

those adopted in 2019 or by subregulatory guidance; 

2. Information, including specific 

examples where feasible, supporting or 

refuting allegations that the 2019 Final 

Rule hindered, or would hinder, access 

to information and health care services, 

particularly sexual and reproductive 

health care and other preventive 

services; 

3. Information, including specific 

examples where feasible, regarding 

complaints of discrimination on the 

basis that an individual or health care 

entity did not provide services for the 

purpose of causing or assisting in the 

death of any individual, including 

through assisted suicide, euthanasia, 

and mercy killing, as described in 

section 1553 of the ACA, and comments 

on whether additional regulations under 

this authority are necessary; 

4. Information, including specific 

examples where feasible, regarding 

complaints of discrimination by a 

qualified health plan under the ACA on 

the basis that a health care provider or 

facility refused to provide, pay for, 

cover, or refer for abortions, as 

described in section 1303 of the ACA 

and comments on whether additional 

regulations under this authority are 

necessary; 

5. Information, including specific 

examples where feasible, from health 

care providers regarding alleged 

violations of the conscience provisions 

provided for in the Medicaid and 

Medicare statutes, including the 

provisions codified at 42 U.S.C. 1320a– 

1(h), 1320c–11, 1395i–5, 1395w– 

22(j)(3), 1395x(e), 1395x(y)(1), 1395cc(f), 

1396a(a), 1396a(w)(3), 1396u–2(b)(3), 

1397j–1(b), and 14406(2) and comments 

on whether additional regulations under 

these authorities are necessary; 

6. Information, including specific 

examples where feasible, regarding 

alleged violations of any of the other 

authorities that appeared in the 2019 

Final Rule but not the 2011 Final Rule; 

7. Comment on whether the 2019 

Final Rule provided sufficient clarity to 

minimize the potential for harm 

resulting from any ambiguity and 

confusion that may exist because of the 

rule, and whether any statutory terms 

require additional clarification; 

8. Comment on whether the 

provisions added by the 2019 Final Rule 

are necessary, collectively or with 

respect to individual provisions, to 

serve the statutes’ or the rule’s 

objectives, including with regard to 

whether the Department accurately 

evaluated the need for additional 

regulation in the 2019 Final Rule, and 

whether those provisions should be 

modified, or whether the rule’s 

objectives may also be accomplished 

through alternative means, such as 

outreach and education; 

9. Comment on the proposal to retain 

a voluntary notice provision, including 

comments on whether such notice 

should be mandatory, and what a model 

notice should include; and 

10. Comment on the proposal to retain 

portions of the 2019 Final Rule’s 

enforcement provisions in the proposed 

§ 88.2. 

II. Comments on the Proposed Rule 

The Department received more than 

48,000 comments addressing the 2023 

proposed rule. A wide range of 

individuals and organizations submitted 

comments, including private citizens, 

health care workers and institutions, 

faith-based organizations, patient 

advocacy groups, civil rights 

organizations, professional associations, 

state and local government and elected 

officials, and members of Congress. 

These comments covered a variety of 

issues and points of view responding to 

the Department’s requests for 

comments, and the Department 

reviewed and analyzed all of the 

comments. Most commenters supported 

the Department’s proposed rule. The 

overwhelming majority of comments 

were individual comments associated 

with form letter campaigns from various 

groups and individuals. 

Numerous commenters, including 

civil rights organizations, health 

organizations, legal associations, and 

individual commenters, supported the 

proposed rule as written, while some 

commenters, including some faith-based 

organizations, supported the proposed 

rule as an improvement over the 2011 

Final Rule. Some others supportive of 

the proposed rule, including certain 

legal associations, faith-based 

organizations, and individual 

commenters, requested the Department 

incorporate additional provisions from 

the 2019 Final Rule that were not at 

issue in the litigation over that rule. Still 

other commenters said they generally 

supported the proposal to rescind the 

2019 Final Rule. 

Commenters also expressed 

opposition to the proposed rule for a 

variety of reasons. Numerous 

commenters, including some nonprofits, legal organizations, faith-based 

organizations, and individuals opposed 

this rule because they would like the 

Department to retain the 2019 Final 

Rule. Other commenters, including a 

professional health care organization, a 

legal organization, and a local 

Department of Health, opposed the 

proposed rule on the grounds that they 

would like the Department to return to 

the 2011 Final Rule completely. 

Numerous commenters said they 

believed that the proposed rule would 

remove conscience protections, 

undermine the diversity of views in 

health care, and cause health care 

professionals to exit the profession. 

The Department thanks commenters 

for sharing their views on the proposed 

rule. Because the 2019 Final Rule never 

went into effect, the 2011 Final Rule has 

been in effect since its enactment. This 

final rule builds on the 2011 Final Rule 

and does not remove provisions from it. 

The Department therefore disagrees that 

employees would decide to leave the 

workforce in response to this final rule. 

The Department responds in greater 

detail in the following sections to 

comments requesting additions to the 

proposed rule text and other comments 

raising specific points of support for or 

opposition to this rule. 

This final rule responds to comments 

as follows. Subpart A addresses 

comments expressing concern over 

access to care; Subpart B addresses 

comments received on specific sections 


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2See ‘‘Nondiscrimination in Health Programs and 

Activities,’’ 87 FR 47824 (Aug. 4, 2022). 

3See lengthier discussion of this principle on 

pages 40–41, below. 

4For example, 42 U.S.C. 300a–7(b) regards the 

receipt of Public Health Service Act funds which 

are administered by HHS agencies such as the 

Substance Abuse and Mental Health Services 

Administration (SAMHSA), the Agency for 

Healthcare Research and Quality (AHRQ), and the 

National Institutes of Health (NIH)); 42 U.S.C. 280g– 

1(d) regards funds for hearing screening which are 

awarded through the Health Resources and Services 

Administration (HRSA); 42 U.S.C. 1395w– 

22(j)(3)(B) and 1396u–2(b)(3)(B) are rules of 

construction expressly applying to Medicare 

Advantage and Medicaid Managed Care 

Organizations which the Department oversees 

through the Centers for Medicare and Medicaid 

Services (CMS). 

of the proposed rule; and Subpart C 

addresses comments in response to the 

Department’s requests for comments in 

the proposed rule. 

A. General Comments 

Concerns Over Access to Care 

Comment: The Department received 

numerous comments that raised 

concerns over access to health care 

generally. For example, commenters, 

including reproductive health 

organizations and major professional 

health care associations, discussed the 

negative impact that refusals of care 

have on people of certain genders, 

sexes, ages, or races, and individuals 

with disabilities. The commenters 

further explained that these refusals 

exist against the backdrop of barriers 

many patients already face, especially 

among Black, Indigenous, and other 

people of color. These disparities are 

heightened for individuals living in 

rural areas, religious minorities, and 

people with disabilities. Some 

commenters said that conscience-based 

refusals to provide certain forms of 

health care block access to such care 

and endanger patient’s lives. Many 

reproductive health organizations, 

individuals and other commenters, 

discussed the impact on reproductive 

health care after Dobbs vs. Jackson 

Women’s Health Organization, 142 S. 

Ct. 2228 (2022), and the confusion for 

providers and patients that they 

contended that decision caused, 

especially in states that have banned, or 

attempted to ban, abortion. Commenters 

gave various examples of pregnant 

women being denied medical treatment 

for miscarriage management and 

sterilization procedures. Others were 

denied, or delayed in obtaining, 

medications, including emergency 

contraception. Many commenters, 

including reproductive health groups, 

reported that women were forced to 

wait extended periods or travel across 

state lines to obtain health care. 

Others said conscience-based refusals 

to provide certain kinds of care have 

negatively impacted the LGBTQI+ 

community, especially older LGBTQI+ 

adults. Many of these commenters also 

cited what they said were specific 

examples of such denials of care that 

constituted discrimination against 

LGBTQI+ individuals, including 

patients being shamed by doctors for 

taking pre-exposure prophylaxis (PrEP) 

medication; denials of gender-affirming 

care at hospitals; denials of emergency 

room care; refusals to provide 

prescription refills for gender dysphoria 

medication by pharmacists; and refusals 

of requests from persons with HIV to 

process lab specimens. Also, a 

professional health care organization 

urged the Department to ensure that its 

efforts to protect conscience not further 

reduce availability of abortion care, 

especially in areas where providers 

retain the ability under state law to 

provide those services. The organization 

recommended that while HHS permits 

individual providers to abide by their 

conscience, providers should do so in a 

way that is consistent with patients’ 

immediate needs. 

Response: The Department thanks 

commenters for sharing this 

information. The Department is 

committed to protecting access to health 

care and protecting conscience rights as 

set forth in Federal statutes.2 OCR works 

to advance access to health care by 

enforcing federal civil rights laws, the 

Health Insurance Portability and 

Accountability Act (HIPAA) Privacy, 

Security, and Breach Notification Rules, 

the Patient Safety Act and Rule, and 

Federal health care conscience statutes, 

which together protect fundamental 

rights of nondiscrimination, health 

information privacy, and conscience. 

The Federal health care conscience 

protection statutes represent Congress’ 

attempt to strike a careful balance 

between maintaining access to health 

care on the one hand and honoring 

religious beliefs and moral convictions 

on the other.3 Some doctors, nurses, and 

hospitals, for example, object for 

religious or moral reasons to providing 

or referring for abortions or assisted 

suicide, among other procedures. 

Respecting such objections honors 

liberty and human dignity. Patients also 

have rights and health needs, sometimes 

urgent ones. The Department will 

continue to respect the balance Congress 

struck, work to ensure individuals 

understand their conscience rights, and 

enforce the law. 

B. Comments Addressing §§ 88.1–88.4 of 

the Proposed Rule 

1. Comments Addressing § 88.1 

General Support and Opposition 

Comment: Numerous commenters 

including some non-profit, legal, and 

faith-based organizations, supported the 

inclusion of the statutory authorities 

contained in § 88.1 of the 2019 Final 

Rule, and that are maintained in the 

proposed rule, because their inclusion 

provides clarity and awareness of the 

various conscience protections and 

ensures all federal conscience 

protections follow one clear and 

transparent process. 

Response: The Department 

appreciates the commenters’ views. We 

will finalize and include in this final 

rule all the authorities providing for 

conscience protections that were 

contained in the 2019 Final Rule. 

Comment: Two reproductive health 

groups stated that the proposed rule 

properly relies on HHS’s Housekeeping 

Authority under 5 U.S.C. 301 to create 

internal processes and guidelines 

‘‘rather than impose substantial burdens 

on those regulated by the Church, CoatsSnowe, and Weldon Amendments, 

which HHS lacks the authority to do.’’ 

Another commenter argued that the 

Department’s interpretation of the 

Federal conscience statutes is not 

entitled to deference given that ‘‘nothing 

in the Church, Coats-Snowe, and 

Weldon Amendments suggest that HHS 

is ‘charged with administering’ them.’’ 

Other individual commenters noted that 

the 2019 Final Rule was justified under 

the Housekeeping Authority. Two 

commenters suggested that, in order to 

be consistent in noting the limited 

nature of the Housekeeping Authority 

for this rule, the Department must 

rescind other rules that exceed the 

bounds of that authority. 

Response: The Department thanks the 

commenters for their views on the scope 

of the Department’s authority, including 

under the Housekeeping Authority. The 

Department agrees that it is authorized 

under its Housekeeping Authority, 5 

U.S.C. 301, to establish internal 

processes for handling complaints 

raised under the conscience statutes. 

HHS is obligated to ensure compliance 

with these statutes because they apply 

to certain HHS programs and specific 

funding streams that HHS is expressly 

charged with administering.4 Finally, 

whether any HHS rules outside of the 

context of the rulemakings for the 

Federal conscience statutes should be 

rescinded as beyond the Housekeeping 

Authority is beyond the scope of this 

rulemaking. 

Comment: Some commenters, 

including professional health care 


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5The statutes added by the 2019 Final Rule and 

retained in this final rule are: 42 U.S.C. 18113; 42 

U.S.C. 14406(1)) 26 U.S.C. 5000A; 42 U.S.C. 18081; 

42 U.S.C. 18023(b)(1)(A) and (b)(4); 42 U.S.C. 

1395w–22(j)(3)(B) and 1396u–2(b)(3)(B); 42 U.S.C. 

1395cc(f), 1396a(w)(3), and 14406(2); 22 U.S.C. 

7631(d); 22 U.S.C. 2151b(f), see, e.g., the 

Consolidated Appropriations Act, 2019, Public Law 

116–6, Div. F, sec. 7018 (the ‘‘Helms, Biden, 1978, 

and 1985 Amendments’’); 42 U.S.C. 1396f and 

5106i(a); 42 U.S.C. 280g–1(d); 29 U.S.C. 669(a)(5); 

42 U.S.C. 1396s(c)(2)(B)(ii); 42 U.S.C. 290bb–36(f); 

42 U.S.C. 1320a–1(h), 1320c–11, 1395i–5, 1395x(e), 

1395x(y)(1), 1396a(a), and 1397j–1(b)). 84 FR 23170, 

23170 (May 2019). 

6 In 2017 Congress effectively eliminated the 

penalty for noncompliance by being reducing it to 

zero. See Tax Cuts and Jobs Act of 2017, Public Law 

115–97, 11081, 131 Stat. 2092 (codified in 26 U.S.C. 

5000A(c)). 

organizations and a local governmental 

entity, expressed opposition to the 

inclusion of statutes in the 2019 Final 

Rule that were not in the 2011 Final 

Rule.5 The commenters argued: (1) HHS 

does not adequately justify why it is 

necessary to reference these statutes; (2) 

including these statutes will have 

negative consequences, such as 

undermining patients’ access to medical 

care and information, imposing barriers 

to physicians’ and health care 

institutions’ ability to provide 

treatment, legitimizing discrimination 

against underserved and vulnerable 

patients, especially as regards abortion 

and gender-affirming care, and creating 

confusion and uncertainty among 

physicians, other health care 

professionals, and health care 

institutions about their legal and ethical 

obligations to treat patients; (3) HHS has 

not demonstrated that the public lacks 

awareness about these statutes; and (4) 

no influx of relevant complaints justifies 

the inclusion of the statutes. Another 

commenter noted that many of the 

conscience provisions have not been 

traditionally overseen by OCR, meaning 

they do not share the well-developed 

body of legal guidance applicable to 

civil rights complaints and it is 

therefore unclear which, if any, of the 

traditional safeguards for civil rights 

complainants, such as anti-retaliation 

protection, are available to 

complainants that refuse to engage in 

certain activities due to their religious 

or moral beliefs. Another commenter 

suggested HHS should not frame the 

statutes as conscience statutes and 

instead ‘‘accurately describe the scope 

of possible exemptions, including both 

religious and secular exemptions’’ or 

remove certain provisions from the rule. 

For example, 42 U.S.C. 18081 covers 

individuals seeking an exemption ‘‘as 

an Indian, or as an individual eligible 

for a hardship exemption’’; 22 U.S.C. 

7631 prevents aid from being provided 

with a condition that the recipient 

‘‘endorse or utilize a multisectoral or 

comprehensive approach to combating 

HIV/AIDS’’; 29 U.S.C. 669 prevents that 

chapter from being ‘‘deemed to 

authorize or require medical 

examination.’’ 

Response: The Department 

appreciates the concerns raised by 

commenters. First, the Department notes 

that this rule clarifies the Department’s 

processes for handling the Federal 

health care conscience statutes. Second, 

the Department agrees that access to 

health care is a significant concern, 

especially for patients with urgent 

health care needs or marginalized 

populations whose care is facing 

restrictions across the country. As stated 

in the proposed rule, the Federal health 

care conscience protection statutes 

represent Congress’ attempt to strike a 

careful balance. The Department is 

obligated to ensure compliance with the 

Federal conscience statutes set forth in 

this rule and is committed to doing so. 

At the same time, the Department, 

through OCR, also enforces civil rights 

laws that prohibit recipients of HHS 

federal financial assistance from 

discriminating on the basis of race, 

color, national origin, disability, age, 

sex, and religion in the provision of 

health care services. In addition to 

exhibiting the Department’s 

commitment to patient access to care, 

this guidance is an example of OCR’s 

role in coordinating compliance across 

various authorities. As explained in the 

proposed rule, retaining these 

provisions as part of the rule, and 

maintaining OCR as the centralized 

HHS office tasked with receiving and 

investigating complaints under these 

provisions, is consistent with OCR’s 

existing role and delegations and will 

aid the public by: (1) increasing 

awareness of the rights protected by the 

various statutes, and (2) providing clear 

direction on where to file complaints 

alleging violations of those rights, even 

where the public is already aware of 

these authorities. Rather than requiring 

an affected party to determine which 

HHS component was responsible for the 

stream of funding connected to a 

potential problem, and how to raise 

their concerns, the rule creates a single 

intake point for anyone who believes 

their federally protected conscience 

rights may have been violated in the 

context of HHS programs. The 

Department disagrees that it should not 

retain the additional conscience statutes 

from the 2019 Final Rule in this final 

rule. 

In addition, the Department disagrees 

that 42 U.S.C. 18081, 22 U.S.C. 7631(d), 

and 29 U.S.C. 669(a)(5) are unrelated to 

conscience and do not belong in this 

rule. As with each of the other Federal 

health care conscience statutes, each of 

the provisions referenced by the 

commenter provides exemptions for or 

prohibits discrimination based on an 

individual or entity’s religious or moral 

(or other) objection to a health care 

method or service. First, as noted in the 

proposed rule, 42 U.S.C. 18081(b)(5)(A) 

addresses exemptions to the ACA’s 

‘‘individual responsibility 

requirement.’’ 6 Under this section, the 

Department may grant exemptions 

based on hardship, which the 

Department has stated includes an 

individual’s inability to secure 

affordable coverage that does not 

provide for abortions (84 FR 23172), 

membership in a particular religious 

organization, or membership in a 

‘‘health care sharing ministry.’’ Second, 

the provisions at 22 U.S.C. 7631(d) state 

that a faith-based organization or other 

organization is not required in order to 

receive such assistance to ‘‘endorse or 

utilize a multisectoral or comprehensive 

approach to combating HIV/AIDS;’’ or 

‘‘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.’’ Finally, the 

relevant provision at 29 U.S.C. 669(a)(5) 

clarifies that nothing in that chapter will 

be deemed to ‘‘authorize or require 

medical examination, immunization, or 

treatment for those who object thereto 

on religious grounds.’’ The text of these 

statutes makes it clear that these 

provisions relate to protections for 

conscience, and so the Department 

declines to remove them from this rule. 

Comment: Some commenters, 

including a health care organization, 

requested that the Department ensure 

the conscience statutes are properly 

enforced even in the context of 

enforcing other recent proposed HHS 

regulations, such as the Section 1557 

notice of proposed rulemaking, 87 FR 

47824, so that there is not an increase 

in instances where religious adherents 

are required to engage in conduct that 

violates their religious beliefs. These 

commenters suggested that the 

Department clarify how they planned to 

enforce the conscience statutes in light 

of these other regulations. 

Response: The final rule will maintain 

the general framework that OCR has 

been employing since 2011—enforcing 

the listed conscience statutes on a caseby-case basis, which respects the 

balance Congress sought to achieve 

through these statutes. The Section 1557 

proposed rule is beyond the scope of 

this rulemaking. We note, however, that 

the proposed rule for Section 1557, for 


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7See U.S. Dep’t of Health and Human Servs., Off. 

for Civil Rights, Conscience and Religious 

Nondiscrimination, https://www.hhs.gov/ 

conscience/conscience-protections/index.html. 

8 ‘‘Protecting Statutory Conscience Rights in 

Health Care; Delegations of Authority,’’ 83 FR 3880, 

3901 (Jan. 26, 2018) 

example, contains its own religious and 

conscience exemption process at 

proposed § 92.302 for how to raise such 

claims in the context of that rulemaking, 

87 FR 47885–47886. 

Requests for Technical Changes 

Comment: Some commenters, 

including members of Congress, stated 

§ 88.1’s list of citations is incomplete 

without additional context like that 

provided in the 2019 Final Rule, making 

it harder for covered entities to have a 

full understanding of the implications of 

the law and how they will be applied 

and enforced. These commenters 

suggest that the rule ‘‘should include 

the full list of laws with their 

applicability, requirements, and 

prohibitions explained, as included in 

the 2019 rule at 88.3.’’ A commenter 

argued it would be unlawful for HHS 

not to retain language from § 88.1 of the 

2019 Final Rule, given this rule’s 

purpose of protecting conscience rights 

and preventing non-discrimination. 

Response: The Department thanks the 

commenters for their views. We have 

added explanatory text to the preamble 

of this final rule to elaborate on the full 

list of the laws included in this final 

rule. However, we are finalizing this 

rule without the additional information 

drawn from § 88.3 of the 2019 Final 

Rule because, in the Department’s view, 

that explanatory language is not 

necessary to accomplish the goal of this 

section, namely clarifying which 

conscience statutes OCR enforces. We 

have added the full list of the laws 

covered by this final rule in the model 

notice. Additionally, the Department 

maintains information about the Federal 

conscience statutes on OCR’s website, 

and has included a link to this web page 

in the model notice text in Appendix A 

of this final rule.7 Moreover, a purpose 

provision similar to § 88.1 of the 2019 

Final Rule is unnecessary given the 

procedural nature of this final rule. We 

note in this regard that the court in New 

York v. U.S. Dep’t of Health & Human 

Servs., 414 F. Supp. 3d 475, 513–14, 523 

(S.D.N.Y. 2019), cited language used in 

the purpose provision of § 88.1 of the 

2019 Final Rule in support of its view 

that that rule was substantive. 

Comment: Two commenters requested 

that the Department correct an error in 

the preamble of the proposed rule that 

improperly paraphrased a provision of 

Section 1303 of the ACA, 42 U.S.C. 

18023. The commenters pointed out 

that, when paraphrasing one provision 

of Section 1303 of the ACA, 42 U.S.C. 

18023(c)(1), the language in the 

proposed rule did not mirror the 

language of the statute because the 

NPRM stated the provision discussed 

preemption of state laws about 

conscience, rather than lack of 

preemption of certain state laws about 

abortion. 

Response: OCR has made the noted 

corrections. Section 1303(c)(1) states 

that ‘‘Nothing in this Act shall be 

construed to preempt or otherwise have 

any effect on State laws regarding the 

prohibition of (or requirement of) 

coverage, funding, or procedural 

requirements on abortions, including 

parental notification or consent for the 

performance of an abortion on a minor.’’ 

42 U.S.C. 18203(c)(1). The preamble of 

the final rule uses that language. 

Comment: A commenter suggested 

that § 88.1 should explicitly state that 

the Department’s goal is to balance the 

interests of providers and patients. 

Another commenter argued that the 

freedom of conscience and religion 

should not be extended to facilities or 

institutions, such as hospital systems or 

universities, but only to individual 

providers. 

Response: The Department maintains 

that Congress sought to balance provider 

and patient rights through a variety of 

statutes and, as we noted in the 

proposed rule, the Department respects 

that balance. The Department declines 

to make changes to the final rule 

recommended by the commenter but 

discusses the issue of balancing these 

rights in greater detail in response to 

other comments infra at pages 42–43. 

Finally, regarding facilities or 

institutions, the Department will refer to 

each individual conscience statute in 

determining whether a particular statute 

applies to a particular entity. 

Comment: Noting that some of the 

statutory provisions do not apply to 

only health care providers, a commenter 

suggested changing the collective 

reference to the statutory authorities in 

§ 88.1 and throughout the rule from 

‘‘health care provider conscience 

protection statutes’’ to ‘‘health care 

conscience statutory protections.’’ 

Response: The Department agrees 

with the commenter’s concern. For 

example, 42 U.S.C. 280g–1(d) protects 

parents of newborns, infants, and young 

children who object to hearing 

screenings based on religious beliefs. 

Likewise, 29 U.S.C. 669(a)(5) protects 

employees who object to ‘‘medical 

examination, immunization, or 

treatment . . . on religious grounds.’’ 

The Department will revise this 

provision in the final rule to refer to the 

statutes as the ‘‘Federal health care 

conscience protection statutes.’’ 

Comment: A commenter requested 

that reference be made to 42 U.S.C. 

1395x(ss) within the reference to 

‘‘certain Medicare and Medicaid 

provisions’’ in the list of statutory 

authorities in § 88.1. 

Response: OCR has been delegated 

multiple authorities that relate to 

protecting Religious Nonmedical Health 

Care Institutions (RNHCIs), five of 

which reference 42 U.S.C. 1395x(ss)(1), 

which defines RNHCIs. Section 

1395x(ss)(1) contains the definition of 

RNHCIs, Section 1395x(ss)(2) covers 

accreditation of RNHCIs, and Section 

1395x(ss)(3) contains a conscience 

provision that restricts the Secretary 

from requiring patients of RNHCIs to 

undergo certain medical services, such 

as medical screenings and treatment, 

against their religious beliefs, or from 

requiring RNHCIs and their personnel 

from undergoing medical supervision, 

regulation, or control, against their 

religious beliefs. Section 1395x(ss) was 

not delegated to OCR in the 2018 

proposed rule’s Delegations of 

Authority.8 The Department declines to 

include 1395x(ss) in this final rule but 

is taking this comment under 

consideration outside this rulemaking 

process. 

2. Comments Addressing § 88.2 

Requests for Clarification 

Comment: Many commenters, 

including legal organizations and 

reproductive health groups, asked OCR 

to clarify that its enforcement authority 

is limited to existing provisions—such 

as those in the proposed rule and HHS’s 

Uniform Administrative Requirements 

(UAR)—and clarify that it is not creating 

new mechanisms under this provision. 

Many commenters asked for 

clarification regarding the terms 

‘‘relevant funding’’ and ‘‘appropriate 

action,’’ as well as the scope of the 

terms regarding violations of the 

proposed rule. Specifically, some 

commenters urged HHS to clarify that 

‘‘appropriate action’’ relates to the 

enforcement tools of existing regulations 

(such as the UAR) and suggested 

establishing a limiting principle for 

‘‘relevant funding’’ so that it cannot 

include all the funds available to an 

entity. 

One commenter expressed support for 

the proposed rule because they believed 

it removed the authority to initiate 

compliance reviews, make enforcement 

referrals to the Department of Justice, 


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9See 45 CFR 160.304. 

10See 28 CFR 42.411 (‘‘Effective enforcement of 

title VI requires that agencies take prompt action to 

achieve voluntary compliance in all instances in 

which noncompliance is found.’’ (emphasis 

added)). Many of the other authorities OCR 

enforces, such as Title IX, Section 1557, Section 

504, and the Age Discrimination Act, contain 

identical requirements. 

and claw back relevant funding. The 

commenter argued that these 

enforcement tools went beyond the 

existing regulations for enforcement that 

should be used when handling and 

investigating complaints. Another 

commenter indicated that in their view, 

proposed § 88.2(a)(4) in conjunction 

with proposed § 88.2(d) removes OCR’s 

ability to undertake involuntary 

enforcement measures. The commenter 

approved of this perceived change and 

what they understood in the proposed 

rule to be a clarification that 

enforcement will be a voluntary process 

with flexibility for recipients to work 

with OCR to correct any findings of 

violations of the proposed rule. Other 

commenters asked the Department to 

modify the proposed rule to clarify that 

the scope of OCR’s authority is limited 

to seeking voluntary resolution of 

complaints. Other commenters stated 

that the Department should not wait for 

a complaint in order to ensure 

compliance with the conscience 

statutes, and so should include the 

authority to initiate compliance reviews. 

Additional commenters argued that 

OCR should release formal findings of 

fact in any investigation before 

reconciliation is attempted and that the 

rule should state that complainants 

should be informed of other possible 

avenues for seeking relief when their 

complaint is resolved. 

Response: The Department thanks 

commenters for their views. As noted in 

the proposed rule, 45 FR 820, 825, the 

Department decided to retain certain 

provisions of the 2019 Final Rule with 

modifications and not to retain others in 

order to address various concerns, 

including concerns raised in litigation 

regarding the lawfulness of certain 

provisions of the 2019 Final Rule. The 

Department clarifies, however, that, 

where authorized by the funding at 

issue, OCR may initiate compliance 

reviews when it determines to do so in 

its enforcement discretion and may refer 

items to the Department of Justice for 

appropriate proceedings. Additionally, 

the provisions included under this rule 

maintain the authority to seek voluntary 

compliance. Specifically, the rule 

provides that matters of noncompliance 

will, when possible, be resolved using 

informal means. This does not preclude 

the Department from using relevant 

enforcement regulations, including, 

when necessary, formal means of 

achieving compliance. These existing 

enforcement regulations could include, 

for example, the Department’s authority 

under the Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements For HHS Awards 

(UAR; 45 CFR part 75). We also note 

that ‘‘relevant funding’’ as referenced in 

§ 88.2(c) of the proposed rule is defined 

by the terms of the Federal conscience 

statutes. The Department makes several 

changes to the rule text to clarify its 

authority. The Department is adding 

reference to OCR’s authority to initiate 

compliance reviews in § 88.2(a)(2) and a 

new § 88.2(c). The Department also 

notes OCR’s authority in § 88.2(a)(7) to 

coordinate additional remedial action as 

the Department determines to be both 

necessary and allowed by applicable 

law and regulation. Additionally, the 

Department is adding a new paragraph 

(3) to proposed § 88.2(d), now § 88.2(g) 

in this final rule, to specify that where 

a matter is not able to be resolved by 

informal means, OCR will coordinate 

with the relevant Departmental 

component to (1) utilize enforcement 

regulations, such as those existing 

applicable to grants, contracts, or other 

programs and services, or (2) withhold 

funding as authorized and relevant 

under the statutes listed in § 88.1. 

Finally, the Department is also adding 

in § 88.2(a)(8) a reference to, and a new 

paragraph in § 88.2(g)(4) regarding, 

OCR’s ability to refer enforcement items 

to the Department of Justice. 

Comment: Many commenters, 

including some non-profits, elected 

officials, and legal organizations, 

suggested that the provisions in 

proposed § 88.2 are not strong enough. 

Specifically, commenters were 

concerned that this rule does not 

include certain enforcement provisions 

from the 2019 Final Rule and were 

concerned with the statement that 

matters ‘‘will be resolved by informal 

means whenever possible.’’ Some asked 

the Department to define ‘‘informal 

means’’ and explain how that will deter 

future violations of the conscience 

statutes or prevent retaliation. One 

commenter stated that HHS should 

incorporate a formal resolution process 

in the rule in order to ensure conscience 

rights are not treated differently than 

other civil rights. Two commenters 

stated that the proposed rule was at risk 

of being unlawful because the 

Department failed to explain its 

rationale for not maintaining a formal 

resolution process similar to the 2019 

Final Rule or because the rule was 

removing additional protections for 

conscience rights. Another commenter 

stated that the lack of effective and 

reasonable enforcement mechanisms 

would be an obstacle to ensuring 

compliance with the law. 

Several commenters stated that the 

proposed rule’s removal of enforcement 

provisions from the 2019 Final Rule, 

including the requirement that HHS 

respond to and resolve conscience 

complaints, demonstrates clear antireligious and anti-conscience bias and 

treats conscience rights as ‘‘less-than’’ or 

demonstrates ‘‘overt hostility on the part 

of the administration to both conscience 

rights and to religious liberty of health 

care professionals.’’ Many commenters 

raised the Department’s investigation of 

the University of Vermont Medical 

Center, the California Department of 

Managed Health Care, and other recent 

decisions by the Department as 

examples of the need for additional 

provisions to ensure the final rule is 

adequate for consistently enforcing the 

Federal health care conscience statutes. 

Another commenter argued that the 

enforcement provisions retained in the 

proposed rule lacked an articulable 

standard against which any 

investigation will be conducted. The 

commenter stated that providers will be 

uncertain with respect to complaint 

investigations in this area, but that such 

uncertainty is preferable to overregulating in the form of attempting to 

define violations without sufficiently 

stated guidance. Other commenters also 

claimed that the proposed rule will 

make it harder for any further 

discrimination claims to be filed, 

investigated, and remedied. 

Commenters made various additional 

requests, including for the rule to 

contain more rigorous enforcement 

protections, the explanatory provisions 

and enforcement mechanisms from the 

2019 Final Rule, and clear protections 

against retaliation. 

Response: OCR works to achieve 

voluntary compliance with all the 

authorities it is delegated to enforce and 

has found this to be an effective means 

of ensuring compliance. This includes 

OCR’s approach to enforcement of the 

HIPAA Privacy, Security, Breach 

Notification, and Enforcement Rules, to 

the extent practicable and consistent 

with law,9 and Title VI.10 The 

Department’s approach to the Federal 

conscience statutes is consistent with 

this approach. OCR further notes that 

applying a single ‘‘articulable standard,’’ 

as requested by a commenter, may not 

be appropriate given the breadth and 

variety of conscience statutes OCR is 

delegated to enforce. Rather than 

provide a one-size-fits-all standard, OCR 

will investigate complaints based on the 

relevant statute at issue. This rule 


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11See Press Release, The White House, Fact 

Sheet: Biden-Harris Administration Releases FirstEver U.S. National Strategy to Counter 

Antisemitism (May 25, 2023), https://

www.whitehouse.gov/briefing-room/statementsreleases/2023/05/25/fact-sheet-biden-harrisadministration-releases-first-ever-u-s-nationalstrategy-to-counter-antisemitism/. 

12See Bulletin, U.S. Dep’t of Health and Human 

Servs., Off. for Civil Rights, Fact Sheet: Protecting 

Patients and Recipients of Human Services from 

Discrimination Based on Actual or Perceived 

Shared Ancestry or Ethnic Characteristics (Sept. 28, 

2023), https://www.hhs.gov/civil-rights/forindividuals/special-topics/shared-ancestry-orethnic-characteristics-discrimination/index.html. 

13See Off. of Intergovernmental and External 

Affairs, Ctr. for Faith-based and Neighborhood 

Partnerships (Partnership Center) Homepage, 

(updated as of September 21, 2023), https://

www.hhs.gov/about/agencies/iea/partnerships/ 

index.html. 

14 45 CFR part 87. 

clarifies that OCR is the central office to 

receive and handle complaints related 

to the conscience statutes and will 

coordinate complaints with partner 

agencies as appropriate on a case-bycase basis. This approach creates a more 

efficient and powerful method for 

ensuring compliance with the various 

statutes. 

Further, the Department is making 

several additions to the rule text, similar 

to procedures contained in the 2019 

Final Rule, in response to comments. As 

discussed in response to other 

comments, the Department is adding 

reference to OCR’s authority to initiate 

compliance reviews in § 88.2(a) and a 

new § 88.2(c). The Department also 

notes OCR’s authority in § 88.2(a)(7) to 

coordinate other remedial action as the 

Department deems appropriate and 

necessary and as allowed by law and 

applicable regulation. The Department 

is adding a new paragraph (3) to 

proposed § 88.2(d), now § 88.2(g) in this 

final rule, to specify that where a matter 

is not able to be resolved by informal 

means, OCR will coordinate and consult 

with the relevant Departmental 

component to either utilize enforcement 

regulations, such as those that existing 

applicable to grants, contracts, or other 

programs and services, or withhold 

funding as authorized and relevant 

under the statutes listed under § 88.1. 

Finally, the Department notes its 

authority in § 88.2(a)(8) to make 

enforcement referrals to the Department 

of Justice, and is adding a new 

paragraph (4) to proposed § 88.2(d), now 

§ 88.2(g) in this final rule, to specify that 

OCR may, in coordination with the 

Office of the General Counsel, refer a 

matter that cannot be resolved 

informally to the Department of Justice 

to enforce the Federal health care 

conscience protection statutes as 

authorized by law. 

The Department takes seriously its 

obligations to comply with the Federal 

health care conscience protection 

statutes and has taken numerous actions 

to defend religious freedom rights, 

including by supporting the right to 

exercise faith freely. For example, the 

Department is participating in the 

National Strategy to Counter AntiSemitism, including by providing 

ongoing OCR trainings on 

antidiscrimination laws, including the 

Federal health care conscience statutes, 

to medical students nationwide and 

holding listening sessions with 

chaplains on religious discrimination in 

healthcare settings.11 As part of this 

same initiative, OCR recently released a 

bulletin on countering antisemitism 

which explains that, depending on the 

factual context, Title VI of the Civil 

Rights Act of 1964 and Section 1557 of 

the Affordable Care Act may prohibit 

discrimination against individuals who 

are or are perceived to be Jewish, 

Christian, Muslim, Sikh, Hindu, 

Buddhist, or of another religion, if the 

discrimination is based on their 

ancestry or ethnic characteristics.12

Also, the Department, through the 

longstanding operation of the HHS 

Center for Faith-Based and 

Neighborhood Partnerships, continues 

efforts to build and support partnerships 

with faith-based and community 

organizations in order to better serve 

individuals, families and communities 

in need.13 The Department’s regulations 

state that faith-based organizations are 

eligible, on the same basis as any other 

organization, to participate in agency 

programs and services.14

Comment: One commenter requested 

that the Department specifically clarify 

OCR’s process for handling complaints 

and the potential involvement of state 

health agencies as mentioned in 

proposed § 88.2(b). Other commenters 

requested OCR limit the extent to which 

OCR is permitted to rely on state 

agencies due to concerns about state 

laws and policies related to abortion 

and gender-affirming care potentially 

interfering with an accurate evaluation 

of the complaint under applicable 

federal law, especially where the state 

health departments involved have a 

record of hostility towards those seeking 

reproductive health care and genderaffirming care. They requested that OCR 

implement protections for the 

information gathered in the 

investigative process and clarify which 

state agencies may provide assistance, 

whether these agencies will make 

recommendations regarding resolution 

of the investigation, and when OCR will 

engage in independent fact finding. 

Another commenter suggested that HHS 

work to implement privacy protections 

ensuring state agencies cannot 

weaponize any collected information 

against any patients. 

Response: Where appropriate, OCR 

may coordinate the handling of 

complaints related to the Federal 

conscience statutes with State agencies. 

However, authority for making 

determinations about the Department’s 

or another entity’s compliance with the 

Federal conscience statutes as it relates 

to HHS programs and funding 

ultimately rests with the Department, 

which will consider all relevant facts 

and use its independent judgment in 

making its determination. 

Comment: Some commenters noted 

that the proposed rule does not obligate 

OCR to evaluate every complaint or 

assure the public of the prompt, 

transparent, thorough, and reasonable 

handling of complaints, which 

undercuts the effectiveness of the 

proposed rule. In addition, some 

commenters said the rule should be 

modified to ‘‘permit OCR to adopt a 

negative inference against an 

investigated entity for any factual 

question to which the entity fails to 

respond.’’ A couple of commenters 

questioned whether OCR was truly an 

independent factfinder without conflicts 

of interests and argued that more 

enforcement or compliance tools are 

needed to demonstrate independence. 

Response: The Department agrees 

with the commenters’ recommendation 

on the prompt handling of complaints 

and has determined to retain, at 

proposed § 88.2(b), now § 88.2(d) of this 

final rule, text from § 88.7(d) of the 2019 

Final Rule stating that ‘‘OCR shall make 

a prompt investigation’’ of conscience 

complaints. Additionally, OCR reviews 

all complaints it receives and takes into 

consideration a covered entity’s 

response to questions and data requests 

to assess if a violation has taken place, 

or technical assistance can help the 

entity comply with the law. To clarify 

this, the Department is finalizing this 

final rule with the addition of a new 

§ 88.2(e) that notes that, OCR may adopt 

a negative inference if, absent good 

cause, an entity that is subject to the 

Federal health care conscience 

protection statutes fails to respond to a 

request for information or to a data or 

document request within a reasonable 

timeframe. As noted in the proposed 

rule, the Department remains committed 

to educating patients, providers, and 

other covered entities about their rights 

and obligations under the conscience 

statutes and using its independent 

judgment to ensure compliance. 


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2088 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 

15See, e.g., U.S. Dep’t of Health and Human 

Servs., Off. for Civil Rights, Complaint Portal 

Assistant, https://ocrportal.hhs.gov/ocr/ 

smartscreen/main.jsf. 

16See lengthier discussion of this principle on 

pages 40–41, below. 17 76 FR 9968, 9973–74 (2011). 

Comment: One commenter 

recommended that to reduce confusion, 

the Department should use different 

forms to collect information on 

violations of the proposed rule than 

those used to collect civil rights 

complaints because conscience claims 

are legally distinct from civil rights 

complaints and will likely require 

different data and information during 

intake. 

Response: The Department thanks the 

commenter for their suggestion. 

However, OCR’s intake forms are 

beyond the scope of this rulemaking. 

Comment: Some commenters 

requested that the rule state that 

complainants may be represented by 

legal counsel. 

Response: OCR’s website states that a 

complaint may be filed on behalf of 

someone else.15 We agree that legal 

counsel may file a complaint on behalf 

of their client and represent their client 

throughout the complaint investigation 

process. The Department is finalizing 

this final rule with the addition of a new 

§ 88.2(b) which explains that any entity 

or individual may file a complaint with 

OCR alleging a potential violation of 

Federal health care conscience 

protection statutes, and the entity or 

individual filing does not have to be the 

entity or individual whose rights have 

been violated. 

Interpretation of Federal Health Care 

Conscience Statutes 

Comment: Numerous commenters 

provided their views on the proper 

interpretation of the Federal health care 

conscience statutes with many 

requesting substantive guidance in the 

final rule on how OCR will interpret 

and apply the various statutes included 

in § 88.1. Two commenters stated that 

even if the Department lacks authority 

to issue substantive regulations 

interpreting any or all of the Federal 

health care conscience statutes, it 

cannot pretend that it will not engage in 

some interpretation of the meaning of 

those statutes in the course of its 

enforcement efforts. The commenters 

argued that therefore, the proposed rule 

should set out, for internal 

administrative purposes, and in at least 

general terms, principles governing how 

the Department will interpret the federal 

health care conscience statutes in 

relation to other laws. In the absence of 

definitions, the commenters argued that 

such a provision would provide some 

guidance to covered entities about how 

the Department understands the statutes 

subject to the proposed rule. 

Response: We appreciate these 

comments. The Department is 

committed to applying the relevant 

conscience statutes on a case-by-case 

basis, which respects the balance 

Congress sought to achieve through 

these statutes.16 The Department 

appreciates the recommendation to 

issue additional guidance outside of this 

rulemaking and takes these comments 

under advisement, but it does not agree 

that there is a need for additional 

language as to the Department’s 

interpretation of the statutes in this rule 

at this time given the Department’s 

intended case-by-case approach to 

enforcing the conscience statutes. The 

Department consequently declines to 

add language interpreting the provisions 

of the conscience statutes to the rule 

text as it is unnecessary to include such 

information to clarify OCR’s processes 

by which it enforces these statutes or to 

enforce the conscience statutes on a 

case-by-case basis. Additionally, this 

final rule encompasses a variety of 

statutes such that certain ‘‘general 

principles,’’ may not apply to all the 

statutes contained in this rulemaking. 

Comment: Many commenters, 

including some faith-based 

organizations, legal organizations, and 

non-profits, stated the federal 

conscience rights should not be 

balanced against other competing 

interests and that HHS was not 

delegated authority to balance these 

interests, especially as against access to 

abortion. These commenters also 

expressed concern that a balancing test 

could result in different levels of 

protection for different providers based 

on factors like their geographic location 

or otherwise result in the arbitrary 

handling of conscience complaints. 

Another commenter said it was 

confusing to speak about a balance 

between the federal health care 

conscience statutes and other interests, 

as the proposed rule did, noting that the 

conscience statutes set forth absolute 

protections. The commenter went on to 

say that the courts that vacated the 2019 

rule incorrectly held that the rule’s 

broad construction of the federal health 

care statutes unlawfully displaced Title 

VII’s application to employment-related 

religious exercise claims in the health 

care setting. 

Another commenter also emphasized 

that conscience statutes ‘‘are themselves 

a subset of nondiscrimination law.’’ At 

the same time, this commenter stressed 

that it agreed ‘‘that patients’ autonomy 

and religious moral convictions must be 

respected’’ too. 

Response: As noted in the proposed 

rule, the Federal health care conscience 

protection statutes represent Congress’ 

attempt to strike a careful balance 

between the rights of both providers and 

patients, and the Department intends to 

respect that balance. This statement 

reflects the balance Congress struck, not 

the legal requirements specific to each 

conscience statute set forth in this rule. 

Each of those conscience statutes 

contain particular legal requirements 

that must be met in order for them to 

apply to any given set of facts, and any 

determination regarding their 

application will be made based upon 

each statute. 

The Department wishes to affirm that 

conscience statutes are a subset of 

nondiscrimination law and to clarify 

that it understands that the text of the 

conscience statutes themselves 

generally does not contain balancing 

tests. At the same time, these statutes 

co-exist with others protecting rights of 

access to health care. As it did in the 

preamble to the 2011 final rule, the 

Department continues to affirm that 

health care entities must comply with 

the long-established requirements of 

statutes governing Departmental 

programs. These statutes strike a careful 

balance between the rights of patients to 

access needed health care, and the 

conscience rights of health care 

providers. Many of the conscience laws 

in this rule and the other federal statues 

have operated side by side, often for 

many decades. As the 2011 Final Rule 

stated, ‘‘repeals by implication are 

disfavored and laws are meant to be 

read in harmony.’’ The Department will 

continue to enforce all the laws it has 

been charged with administering. At the 

same time, entities must continue to 

comply with their Title X, Section 330, 

EMTALA, Medicaid obligations and the 

federal health care provider conscience 

protection statutes.17

The Department will bear these points 

in mind in its investigation of any 

complaints it may receive. 

Comment: Many commenters, 

including professional health care 

associations and reproductive health 

groups, stated that the government 

should ensure that patients’ access to 

care is a top priority and should be 

appropriately balanced with the needs 

of health care providers. Another 

commenter stated that it is important to 

ensure an exhaustive good faith effort is 

made to connect patients with care. 

Response: The Department thanks 

commenters for raising these concerns 


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Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 2089 

and agrees that patients’ access to care 

is a top priority. Protecting the rights of 

conscience, as directed by Congress in 

federal statutes, is also a top priority, 

which the Department is committed to 

safeguarding as well. As noted 

elsewhere, the Department will handle 

complaints related to conscience on a 

case-by-case basis which respects the 

balance Congress sought to achieve 

through these statutes. 

Comment: One commenter requested 

that HHS focus its resources on civil 

rights complaints rather than conscience 

complaints because, compared to civil 

rights complaints, violations of 

conscience rights occur less frequently 

and rarely result in adverse medical 

outcomes for the provider. The 

commenter said that patients who 

encounter denial of care may be unable 

to find a suitable provider if they face 

a denial of care and may suffer adverse 

health consequences or death due to the 

denial. On the other hand, the 

commenter said providers seeking to 

deny care or that were prevented from 

denying care are unlikely to face the 

medical complications or death that can 

result from denial of care. 

Response: OCR reviews all the 

complaints it receives and will continue 

to do so for each of the authorities it is 

delegated to enforce. 

Comment: One commenter 

recommended that HHS include a 

provision that states no one served by 

HHS programs will be denied medically 

indicated care and impose a penalty for 

institutions and providers that deny 

necessary services under the ‘‘pretext’’ 

of religious freedom. The commenter 

noted, however, that HHS should 

restore the enforcement provisions from 

the 2019 Final Rule to avoid making 

providers feel they must choose 

between their religion and livelihood 

and facing retaliation. 

Response: The Department thanks the 

commenter for sharing its views. As 

discussed in response to other 

comments, the Department is adding 

provisions to this final rule similar to 

some of the enforcement provisions of 

the 2019 Final Rule. These include: 

reference to OCR’s authority to initiate 

compliance reviews in § 88.2(a) and a 

new § 88.2(c); noting OCR’s authority in 

§ 88.2(a)(7) to ‘‘coordinate other 

appropriate remedial action as the 

Department deems necessary and as 

allowed by law and applicable 

regulation’’; new paragraphs (3) and (4) 

to proposed § 88.2(d), now § 88.2(g) in 

this final rule, to specify formal means 

of enforcement, which may include the 

withholding of funds and referrals to the 

Department of Justice. 

Comment: One commenter 

recommended requiring that providers, 

grantees, and other entities subject to 

the proposed rule ensure patients are 

able to obtain care, including by being 

made aware of the treatments and 

procedures a provider refuses to 

provide, informed of alternative 

providers, and referred to alternative 

providers when failing to do so would 

harm the patient. 

Response: The Department agrees that 

patients should be able to make 

informed choices about which providers 

to seek care from, access care broadly, 

and receive the best care possible. This 

final rule clarifies OCR’s existing 

authority and process for handling 

complaints under the conscience 

statutes. Adding a substantive provision 

in line with the commenter’s request is 

beyond the scope of this rulemaking. 

The Department notes, however, that 

patients will also benefit from 

awareness of the Federal conscience 

statutes generated by entities posting a 

voluntary notice as outlined in this final 

rule. 

Comment: Several commenters, 

including professional health care 

organizations and a think tank, 

addressed the importance of having 

sufficient enforcement provisions in the 

proposed rule because courts have held 

that conscience statutes do not contain 

or imply a private right of action, 

meaning the government has the central 

role in enforcing Federal conscience 

laws and protecting providers from 

discrimination. 

Response: The Department agrees 

with commenters regarding the 

importance of the Department’s role 

with respect to the Federal conscience 

statutes. As stated in the proposed rule, 

45 FR 820, 826, the Department remains 

committed to educating patients, 

providers, and other covered entities 

about their rights and obligations under 

the conscience statutes and remains 

committed to ensuring compliance. As 

mentioned in response to other 

comments, this rule is being finalized 

with additional provisions from the 

2019 Final Rule as well as all the 

authorities that the proposed rule 

previously incorporated from the 2019 

Final Rule to allow for consistent and 

effective enforcement of the Federal 

conscience statutes. We believe that this 

rule simplifies, and therefore 

strengthens, the Department’s approach 

to ensuring compliance with the 

underlying statutes. It provides clarity 

to providers and patients about where 

and how they may register their 

concerns. And it provides the 

Department the ability to apply the 

specific legal standards and 

enforcement mechanisms that 

correspond to the statute at issue. This, 

in turn, allows the Department to better 

achieve outcomes consistent with the 

statutory protections Congress enacted. 

We also note that in the proposed rule 

for Section 1557, the Department 

provided an additional process at 

proposed § 92.302 for individuals to 

raise requests for a conscience or 

religious freedom exemption, 87 FR 

47885–47886. 

3. Comments Addressing § 88.3 

General Support 

Comment: Many commenters, 

including a national association of faithbased medical and dental providers and 

a national hospital association of faithbased providers, expressed support for 

the voluntary nature of the rule’s notice 

provision. Additionally, a couple of 

commenters supported the proposed 

rule for allowing entities to tailor the 

voluntary notice to ‘‘particular 

circumstances and communities’’ and 

combine the notice with other notices. 

A couple of commenters also supported 

the proposed rule’s inclusion of a 

recognition that some entities will have 

a conscience-based objection to posting 

details about alternative providers that 

offer services that the posting entity 

objects to providing. Commenters stated 

the proposed voluntary notice provision 

appropriately promotes compliance 

without undue burden. 

Response: The Department 

appreciates the commenters’ support. 

The Department includes the voluntary 

notice provision, including the 

provision recognizing that some entities 

will have a conscience-based objection 

to posting details about alternative 

providers in the final rule. 

Requests for Changes to Rule Text 

Comment: A commenter argued that 

the proposed rule does not incentivize 

entities to post a voluntary notice. This 

commenter suggested that certain 

compliance requirements from § 88.6 of 

the 2019 Final Rule and the provision 

from § 88.5 of the 2019 Final Rule, 

which noted that posting the voluntary 

notice would constitute ‘‘nondispositive evidence of compliance’’ 

and support the Department’s goal of 

clarifying what an entity must do to 

comply with the federal conscience 

statutes. 

Response: As noted in the proposed 

rule, while the Department considers 

posting a notice to be a best practice and 

encourages covered entities to post the 

model notice included in this 

regulation, this alone does not satisfy 

the substantive obligations imposed on 


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18See U.S. Dep’t of Health and Human Servs., 

Off. for Civil Rights, Conscience and Religious 

Nondiscrimination, https://www.hhs.gov/ 

conscience/conscience-protections/index.html. 

a covered entity by the underlying 

statutes. The proposed rule and this 

final rule modify § 88.5 of the 2019 

Final Rule to avoid implying that 

covered entities can substantively 

comply with the underlying statute by 

simply posting a notice because such an 

implication could undermine the 

conscience protections provided by the 

underlying statutes themselves, and 

therefore the goal of this rule. While the 

Department does not adopt § 88.5 of the 

2019 Final Rule, the Department is 

finalizing § 88.3 with additional 

statements that the Department 

considers posting a notice to be a best 

practice ‘‘towards achieving compliance 

with and educating the public about the 

Federal health care conscience statutes’’ 

and that ‘‘OCR will consider posting a 

notice as a factor in any investigation or 

compliance review’’ to emphasize the 

importance of posting the voluntary 

notice. 

The Department declines, however, to 

maintain all the compliance 

requirements from § 88.6 of the 2019 

Final Rule. Some commenters raised 

concerns in response to both the 2018 

Proposed Rule and the proposed rule for 

this rulemaking that the compliance 

requirements at § 88.6 were overly 

burdensome on covered entities, 

especially the record keeping 

requirements, and not authorized by the 

conscience statutes. In the Department’s 

view, these concerns raised by 

commenters warrant additional 

consideration. Even though the 

Department declines to maintain the 

duty to cooperate as specified in 

§ 88.6(c) of the 2019 Final Rule, 

however, this final rule includes a 

notice to covered entities in § 88.2(e) 

that OCR will adopt a negative inference 

if, absent good cause, an entity that is 

subject to the Federal health care 

conscience protection statutes fails to 

respond to a request for information or 

to a data or document request within a 

reasonable timeframe. In the 

Department’s view, this requirement 

will encourage compliance without 

creating additional regulatory burden. 

Comment: One commenter requested 

that HHS require that notices related to 

conscience exceptions also be required 

to comply with the Section 1557 

language access and auxiliary aids and 

services requirements. 

Response: The Department 

appreciates this comment. Covered 

entities are required to comply fully 

with all applicable language access 

requirements found in statute or 

regulation, regardless of whether the 

requirements overlap with the topics of 

this regulation. 

Language of the Notice 

Comment: Some commenters stated 

that the model notice should be the 

same as the model notice proposed in 

the 2019 Final Rule because it provided 

more clarity. Other commenters 

recommended more specific and clear 

language generally. A commenter said 

that, while they supported aspects of the 

proposed notice, such as listing the 

relevant statutes and dropping the 

implication that posting the notice 

would be some evidence of substantive 

compliance with the underlying statute, 

the commenter urged HHS to include in 

the notice a general description of the 

types of protections these statutes 

provide. 

Response: The Department 

appreciates the commenters’ 

recommendations and has included the 

following text in the model notice text 

in response to commenter requests for 

more clarity: ‘‘You may have rights as a 

provider, patient, or other individual 

under these Federal statutes, which 

prohibit coercion or other 

discrimination on the basis of 

conscience in certain circumstances.’’ 

The Department also notes that § 88.3(d) 

states that an entity ‘‘may tailor its 

notice to address its particular 

circumstances and to more specifically 

address the conscience laws covered by 

this rule that apply to it.’’ Finally, the 

Department has included in the model 

notice a list of the federal health care 

conscience protection statutes and a 

link to the HHS web page where 

additional resources can be accessed for 

covered entities and the public to better 

understand their obligations and rights 

under the Federal health care 

conscience statutes.18

Comment: A commenter argued that 

the following language in proposed 

§ 88.3(d) was improper: ‘‘where 

possible, and where the recipient does 

not have a conscience-based objection to 

doing so, the notice should include 

information about alternative providers 

that may offer patients services the 

recipient does not provide for reasons of 

conscience.’’ This commenter 

maintained that the language is 

improper because the Coats-Snowe 

Amendment prohibits a covered entity 

from requiring a physician or certain 

other individuals to refer patients, 

which may be the case where a covered 

employer does not object to the 

inclusion of information about 

alternative providers, but their 

employee physician does. Another 

commenter argued that this language 

was ‘‘a prudent observance of the 

Supreme Court’s decision in NIFLA v. 

Becerra.’’ 

Response: The Department disagrees 

that the challenged language is 

improper. The provision identified by 

the commenter does not require 

recipients to provide information about 

alternative providers in any notice, nor 

does it suggest that any recipient may 

require a health care provider (e.g., a 

doctor) to post this information in 

violation of their rights under applicable 

health care conscience protection 

statutes or the Constitution. 

Comment: A few commenters 

requested additional language in the 

voluntary notice that would focus on 

protecting patients from negative 

impacts caused by a denial of care 

under the conscience statutes. These 

commenters suggested that the 

voluntary notice provision has two 

target audiences: employees of 

providers and members of the public, 

and so there should be two separate 

notice provisions for each group, and 

they should be posted on the health care 

provider’s website. 

Response: The Department agrees that 

patients should also be the focus of the 

voluntary notice and notes that the text 

of § 88.3 addresses this concern. Section 

88.3(d) states that ‘‘[w]here possible, 

and where the recipient does not have 

a conscience-based objection to doing 

so, the notice should include 

information about alternative providers 

that may offer patients services the 

recipient does not provide for reasons of 

conscience,’’ which gives entities the 

opportunity to include additional 

information for the consideration of 

patients about access to certain health 

care services. Additionally, the 

Department in § 88.3(d) states that an 

entity ‘‘may tailor its notice to address 

its particular circumstances and to more 

specifically address the conscience laws 

covered by this rule that apply to it.’’ 

The Department is also adding text to 

the voluntary notice to make clear that 

the Federal health care conscience 

statutes also provide certain conscience 

protections for patients. Finally, the 

Department notes that § 88.3(b)(1) of 

both the proposed rule and this final 

rule recommends the model notice be 

posted on provider’s websites, where 

both patients and providers may view it. 

4. Comments Addressing Section 88.4 

Comment: A commenter noted that 

the preamble to the proposed rule stated 

that it was repealing the severability 

provision, but that the provision is 

retained in the regulation text at § 88.4. 


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19U.S. Dep’t of Health and Human Servs., Off. for 

Civil Rights, ‘‘Guidance on Nondiscrimination 

Protections under the Church Amendments’’ 

(Content last reviewed Feb. 3, 2023), https://

www.hhs.gov/conscience/conscience-protections/ 

guidance-church-amendments-protections/ 

index.html. 

Response: The Department thanks the 

commenter. The statement that OCR 

was removing the severability provision 

was a typographical error at 88 FR 820, 

825. The error is corrected in this final 

rule. This rule provides meaningful 

tools for OCR to enforce the Federal 

health care conscience protection 

statutes. Section 88.4 ensures that 

portions of this rule not found to be 

unlawful would remain in effect even if 

a court were to strike down some 

provision of this final rule. The various 

complaint handling and investigating 

provisions at § 88.2, for instance, 

operate independently of each other. 

Likewise, the notice provision at § 88.3 

can operate independently of the rest of 

the rule. 

C. Comments Addressing the Proposed 

Rule’s Requests for Comment 

1. Information, Including Specific 

Examples Where Feasible, Addressing 

the Scope and Nature of the Problems 

Giving Rise to the Need for Rulemaking, 

and Whether Those Problems Could Be 

Addressed by Different Regulations 

Than Those Adopted in 2019 or by SubRegulatory Guidance 

Comments Addressing the Scope and 

Nature of the Problems Giving Rise to 

the Need for Rulemaking 

Comment: In support of the need for 

rulemaking, one legal organization 

provided court cases related to the 

Religious Freedom Restoration Act. 

Another individual commenter cited her 

own published work which suggests 

that nurses and nursing students are 

under the impression that they must set 

aside their conscientious views to be a 

nurse. Other commenters highlighted 

that their religious beliefs and moral 

convictions are what motivate them to 

be in the health care field and help them 

to relate to the spiritual needs of 

patients who desire a religious 

perspective. 

Response: The Department 

appreciates the concerns raised by the 

commenters regarding the need for this 

rulemaking. While the Department does 

not opine here on any of the cases raised 

by the commenters, the comments help 

illustrate that finalizing this rule will 

provide further clarity about OCR’s 

enforcement authority and processes 

related to the Federal health care 

conscience statutes. The Department is 

committed to applying the text of the 

relevant conscience statutes on a caseby-case basis, which respects the 

balance Congress sought to achieve 

through these statutes, and that 

commitment is evidenced in part 

through this new rulemaking. The 

Department has also taken steps to 

ensure that the public is aware of the 

protections under the conscience 

statutes beyond this rulemaking, 

including by issuing guidance on the 

Church Amendments.19 The 

Department encourages anyone who 

believes the Federal health care 

conscience statutes have been violated 

to file a complaint with OCR. For 

detailed instructions on how to file a 

complaint or to download a complaint 

form, please visit OCR’s website at 

www.hhs.gov/ocr/complaints. 

Whether the Problems Giving Rise to 

Rulemaking Could Be Addressed by 

Different Regulations or by SubRegulatory Guidance 

Comment: A commenter proposed a 

new framework for evaluating 

conscience complaints, revolving 

around requiring objections to be stated 

in advance, increasing staffing to 

accommodate objections, and requiring 

health care entities that object to 

providing procedures to either (1) 

facilitate and pay for transferring 

patients to hospitals that provide 

procedures or (2) limit their services to 

patients who share their beliefs and 

divest facilities where there is no 

similar sized health care entity within a 

30 minute drive that provides all 

needed services. Another commenter 

similarly commented that any 

exceptions based on the Church 

Amendments should not apply if the 

provider’s refusal to provide care results 

in serious harm to the patient, and the 

patient could not schedule another innetwork provider. 

Response: The Department thanks the 

commenters. We decline to implement 

the commenters’ recommendations in 

this final rule as they are beyond the 

scope of this rulemaking. The 

Department will adhere to the Federal 

health care conscience statutes and 

apply them on a case-by-case basis. 

Comment: Given the lack of explicit 

enforcement mechanisms in the existing 

statutes, one commenter urged the 

Department to consider what additional 

regulatory language or subsequent 

guidance it can provide consistent with 

its authority to ensure that the 

conscience laws are fully and effectively 

enforced when violations of conscience 

rights are found. 

Response: The Department thanks the 

commenter for recommending that the 

Department consider additional 

regulatory language and subsequent 

guidance. As discussed in response to 

other comments, the Department is 

adding regulatory language to clarify the 

Department’s and OCR’s authority to 

enforce the Federal health care 

conscience statutes, including through 

compliance reviews (§ 88.2(a) and a new 

§ 88.2(c)), coordinating other 

appropriate remedial action (§ 88.2(a)), 

and OCR’s authority to utilize existing 

enforcement regulations or withhold 

relevant funding to the extent 

authorized under the Federal health 

care conscience statutes where a matter 

cannot be resolved by informal means 

(§ 88.2(g)(3)). The commenter did not 

provide any recommendations on what 

that guidance should include, but the 

Department will continue to consider 

whether additional guidance under the 

conscience statutes is warranted. 

2. Information, Including Specific 

Examples Where Feasible, Supporting 

or Refuting Allegations That the 2019 

Final Rule Hindered, or Would Hinder, 

Access to Information and Health Care 

Services, Particularly Sexual and 

Reproductive Health Care and Other 

Preventive Services 

Comment: Some commenters, 

including reproductive health groups, 

claimed that the 2019 Final Rule 

generally would have had a negative 

effect on patients by restricting access to 

care and increasing denials of care. 

Commenters stated that barriers to 

health care are compounded in health 

systems that refuse to provide certain 

types of care due to religious or moral 

objections. These commenters said 

patients do not necessarily know about 

such limits on care. The commenters 

further said this occurs more often in 

rural areas where there are often no 

alternative providers, impacts those 

with lower incomes, and impacts 

pregnant women of color who 

disproportionately give birth at 

hospitals that object to abortion and 

contraception. 

Numerous commenters, including 

reproductive health groups and 

LGBTQI+ rights groups discussed the 

2019 Final Rule’s potential impact on 

services and access to care for groups of 

marginalized or underserved 

populations, including but not limited 

to women, older Americans, LGBTQI+ 

people, people with disabilities, people 

living in rural areas, Black, Indigenous, 

and people of color, immigrants, lowincome communities, people with HIV, 

and people with substance use disorder. 

Numerous commenters discussed 

general health disparities and 

heightened discrimination against 

LGBTQI+ individuals, including access 


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to reproductive health care and 

technology, that they claimed would 

have occurred because of the 2019 Final 

Rule. One commenter tied the fact that 

LGBTQI+ individuals already 

experience significant health inequities 

due to refusals to provide certain forms 

of care and stated LGBTQI+ individuals 

often suffer from ‘‘health care 

avoidance’’ due to facing discrimination 

in a number of services, including 

reproductive services, adoption and 

foster care services, childcare, homeless 

shelters, and transportation services—as 

well as physical and mental health care 

services. A commenter stated the 2019 

Final Rule would have allowed 

providers to object to providing care, 

especially emergency services, which 

would disproportionately affect 

transgender people because of their 

struggle to access care. Another 

commenter argued the 2019 Final Rule 

would have harmed older adults by 

authorizing discrimination and 

increasing disparities in Medicare and 

Medicaid, especially for transgender 

older adults that would be at the mercy 

of Medicare Advantage plans hoping the 

plan contracts with providers who will 

not refuse them treatment. Additionally, 

a commenter discussed refusals to 

provide care that are based on religious 

or moral objections as particularly 

impactful to transgender individuals. 

Numerous commenters described the 

types of services that they believed the 

2019 Final Rule would have negatively 

impacted, such as contraception, end-oflife care, vaccination, pregnancy and 

reproductive services, counseling and 

behavioral health, infertility treatment, 

pre-exposure prophylaxis (PrEP) and 

HIV treatment, among others. One 

commenter said the 2019 Final Rule 

could have allowed providers to refuse 

cancer treatment or reproductive 

services for pregnant individuals. 

Another commenter discussed the 

importance of family planning under 

the Title X program, stating that they 

believed the 2019 Final Rule would 

have reduced access to such ‘‘sexuality 

education’’ and family planning care 

and would have made it difficult for 

Title X facilities to hire employees 

willing to perform core job functions. 

Other commenters said that by further 

restricting access, the 2019 Final Rule 

would have exacerbated existing racial 

and socio-economic health disparities. 

A few commenters, including 

reproductive health organizations, noted 

that immigrants, ethnic minorities, and 

LGBTQI+ individuals faced 

disproportionate barriers accessing 

reproductive health care before the 

Dobbs v. Jackson Women’s Health 

Organization, 142 S. Ct. 2228 (2022), 

decision and the 2019 Final Rule would 

have increased those barriers. One 

commenter stated that the 2019 Final 

Rule targeted people seeking 

reproductive health care, but even 

before the 2019 Final Rule, people cited 

religious beliefs to deny access to 

services such as abortion, sterilization, 

certain infertility treatments, and 

miscarriage management. A commenter 

stated there are serious physical and 

socioeconomical impacts on patients 

who experience discrimination when 

seeking abortion care, and refusals to 

provide such care can have profound 

health consequences for women. Two 

commenters stated that this partial 

recission of the 2019 Final Rule comes 

at an important time in the wake of the 

Dobbs decision, as abortion services are 

harder to obtain. 

Several commenters, including a 

reproductive health group, stated that 

the 2019 Final Rule upset the careful 

balance in Federal laws between patient 

needs and conscience rights, and that 

the proposed rule appropriately resets 

that balance. A professional health care 

association stated that in the balance 

between conscience rights and patients’ 

rights, patients’ rights must come first as 

the patient is in the more vulnerable 

position, meaning there is a duty to refer 

on the part of the objecting provider. A 

few commenters argued that the 

proposed rule is needed to ensure 

LGBTQI+ patients have access to care, 

free from discrimination. Two 

commenters stated that the proposed 

rule would minimize the frequency of 

refusals to provide abortions, which 

especially burden the most vulnerable 

in our society. The commenter also 

stated that physicians should have some 

discretion if they truly believe 

performing an abortion in certain cases 

would violate their duties as medical 

professionals, but those who would be 

unwilling to perform abortion under any 

circumstance are not well suited for 

reproductive health care. 

Numerous commenters, including a 

reproductive health organization, urged 

the Department to eliminate the 2019 

Final Rule because it would have 

allowed almost any worker in a health 

care facility, insurance plan, or hospital 

to delay or block patients from getting 

care because of who they are or the kind 

of care they seek, including individuals 

indirectly involved in the provision of 

health care. One commenter stated that 

the 2019 Final Rule would have caused 

massive disruptions to large provider 

networks because costs of compliance 

with the 2019 Final Rule would have 

been astronomical, since losing federal 

funding for failure to comply would 

have led to the discontinuation of 

essential services and even closures. 

One commenter stated that the 2019 

Final Rule failed to account for health 

care providers who have moral beliefs 

that motivate them to treat and provide 

health care, especially abortion, end-oflife care, and gender-affirming care, to 

patients. 

Response: The Department thanks 

commenters for sharing their views. The 

Department appreciates the concern that 

patients have full access to health care 

and as the proposed rule stated, 88 FR 

820, 826, the Department maintains that 

our health care systems must effectively 

deliver services to all who need them in 

order to protect patients’ health and 

dignity. The Department is engaging in 

this rulemaking in part to address the 

concerns raised by commenters about 

the impact of the 2019 Final Rule. The 

Department reiterates its commitment to 

ensuring that patients are not 

discriminated against, including by 

being denied health care on the various 

bases protected under civil rights laws. 

In addition, the Department is 

committed to ensuring compliance with 

the conscience statutes, including those 

provisions under the Church 

Amendments that offer protections for 

physicians or certain other individuals 

in certain federally funded health, 

training, or research programs who have 

performed or assisted in the 

performance of, or who are willing to 

perform or assist in the performance of, 

a lawful sterilization procedure or 

abortion. 

3. Information, Including Specific 

Examples Where Feasible, Regarding 

Complaints of Discrimination on the 

Basis That an Individual or Health Care 

Entity Did Not Provide Services for the 

Purpose of Causing or Assisting in the 

Death of Any Individual, Including 

Through Assisted Suicide, Euthanasia, 

and Mercy Killing, as Described in 

Section 1553 of the ACA, and 

Comments on Whether Additional 

Regulations Under This Authority Are 

Necessary 

General Support for Conscience 

Protections 

Comment: Some commenters 

requested that conscience protections 

for assisted suicide be strengthened due 

to a recent rise in conscience objections. 

Some commenters referenced various 

examples, including cases and state 

laws from Vermont, Maine, California, 

and New Mexico and stated that since 

state laws protect conscience rights to a 

lesser degree than Section 1553, the 

Department must ensure compliance 

with Section 1553 to protect the 


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20 ‘‘The Federal Government, and any State or 

local government or health care provider that 

receives Federal financial assistance under this Act 

(or under an amendment made by this Act) or any 

health plan created under this Act (or under an 

amendment made by this Act), may 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.’’ 42 U.S.C. 18113(a). 

conscience rights of those providers 

who object to taking human life. 

Response: The Department 

appreciates commenters providing their 

views regarding conscience rights 

related to assisted suicide. The 

Department remains committed to 

educating patients, providers, and other 

covered entities about their rights and 

obligations under the conscience 

statutes and remains committed to 

ensuring compliance, including with 

Section 1553 of the Affordable Care Act. 

Comment: A commenter noted that 

assisted suicide or medical aid in dying 

is not necessary, life-preserving, or 

lifesaving, so there should be no issue 

with permitting health care entities to 

refuse to perform such services for 

moral or religious objections. A 

commenter stated that conscientious 

objections are from the perspective of 

the objector, meaning it is immaterial 

how a state defines the ‘‘practice’’ of 

assisted suicide or whether it disagrees 

that abortion is a procedure that takes 

the life of a separate, unique, human 

being. 

Response: Each of the conscience 

statutes contains particular 

requirements that must be met in order 

for them to apply to a given set of facts. 

The Department remains committed to 

faithfully applying each statute as 

drafted by Congress on a case-by-case 

basis. 

Requests for Technical Changes 

Comment: One end-of-life patient 

advocacy group raised concerns about 

the proposed rule using the term 

‘‘assisted suicide’’ as opposed to 

‘‘medical aid in dying,’’ arguing that 

using that term in conjunction with 

citing Section 1553 of the Affordable 

Care Act would create barriers 

preventing terminally ill patients from 

accessing their right to ‘‘medical aid in 

dying’’ in states that authorize it and 

consider it as distinct from assisted 

suicide. The commenter argued that 

medical aid in dying is a medical 

procedure in which a physician writes 

a prescription for medication for a 

mentally capable, terminally ill adult 

who can then decide if they want to 

self-administer the medication if their 

suffering becomes too great. The 

commenter contrasted that with assisted 

suicide, which it defined as a criminal 

act in which someone encourages and 

facilitates the self-inflicted death of an 

individual irrespective of their life 

expectancy. The commenter 

recommended the Department use the 

term ‘‘medical aid in dying’’ to ensure 

that patients are informed of the option, 

and to distinguish between the duty to 

share information about medical options 

at the end of life from the act of 

participating in a medical procedure to 

which a provider objects. 

Response: The Department 

appreciates this comment. The 

Department notes that the final rule 

includes reference to Section 1553 of 

the Affordable Care Act, which uses the 

terms ‘‘assisted suicide,’’ ‘‘euthanasia,’’ 

and ‘‘mercy killing.’’ 20 The Department 

declines, however, to incorporate 

additional language in the rule text 

regarding the definition of ‘‘assisted 

suicide’’ or the other terms in the statute 

as it is unnecessary to include such 

language to clarify OCR’s processes by 

which it enforces this statute or to 

enforce it on a case-by-case basis. 

4. Information, Including Specific 

Examples Where Feasible, Regarding 

Complaints of Discrimination by a 

Qualified Health Plan Under the ACA 

on the Basis That a Health Care Provider 

or Facility Refused To Provide, Pay for, 

Cover, or Refer for Abortions, as 

Described in Section 1303 of the ACA 

and Comments on Whether Additional 

Regulations Under This Authority Are 

Necessary 

Comment: The Department received a 

comment in response to this question, 

but did not receive information 

regarding complaints of discrimination 

by a qualified health plan. The 

commenter expressed concern that 

patients can either choose their 

employer’s insurance plan or an 

Affordable Care Act plan but stated that 

neither type of insurance plan should be 

allowed to deny care under the federal 

conscience statutes. The commenter 

stated that health insurance plans, and 

hospitals as well, are not people with 

rights that can be infringed. 

Response: The Department thanks the 

commenters for sharing their views, but 

notes that each of the conscience 

statutes contains particular 

requirements and prohibitions that were 

put in place by Congress. Any 

determination regarding their 

application will be made based upon 

the specifics of each statute. 

5. Information, Including Specific 

Examples Where Feasible, From Health 

Care Providers Regarding Alleged 

Violations of the Conscience Provisions 

Provided for in the Medicaid and 

Medicare Statutes, Including the 

Provisions Codified at 42 U.S.C. 1320a– 

1(h), 1320c–11, 1395i–5, 1395w– 

22(j)(3), 1395x(e), 1395x(y)(1), 1395cc(f), 

1396a(a), 1396a(w)(3), 1396u–2(b)(3), 

1397j–1(b), and 14406(2) and Comments 

on Whether Additional Regulations 

Under These Authorities Are Necessary 

Comment: A patient advocacy group 

generally discussed the importance of 

advance directives as a health care 

planning tool for end-of-life medical 

care. The commenter stated that the 

Medicare and Medicaid provisions 

regarding advanced directives should 

not be construed to allow entities and 

providers to fail to provide complete 

information to patients about end-of-life 

care and advance directives, pointing 

out that under many state laws 

providers may refuse to follow advance 

directives for religious or moral beliefs 

so long as the physician informs the 

patient and in many cases assists in the 

transfer to another provider who will 

honor the patient’s wishes. 

Another commenter stated that the 

Department failed to articulate a 

sufficient reason for expanding the 

proposed rule to include these Medicare 

and Medicaid provisions. The 

commenter stated the proposed rule 

invalidates the inherent authority of 

advance directives by allowing 

providers to ignore these documents if 

they disagree. The commenter asserted 

that Section 1395cc(f) and CMS 

implementing regulations (See 42 CFR 

489.102(a)(1)(ii) (2018); 42 CFR 

418.52(a)(2) (2018)) require facilities to 

inform patients and residents of their 

rights to have completed advance 

directives, and that facilities should 

provide their patients and residents 

with written information about whether 

or not the provider objects on 

conscience grounds to honoring the 

directive. The commenter recommended 

that the Department require health care 

entities to provide accessible and 

prominent notice about all information 

the health care entity or provider refuses 

to offer and urged the Department to 

ensure patients are still timely 

transferred if a health care provider 

objects to honoring an advance 

directive. 

Response: As the proposed rule 

stated, retaining the Federal conscience 

provisions as a part of the rule and 

maintaining OCR as the centralized 

HHS office tasked with receiving and 

investigating complaints under these 


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21 142 Cong. Rec. 5,158 (1996) (statement of Sen. 

Coats). 

provisions will aid the public by 

increasing awareness of the rights 

protected by these statutes and where to 

file complaints alleging violations of 

those rights. The Department declines to 

include provisions beyond the text of 

the conscience statutes in this 

procedural rule as recommended by the 

commenter or to require entities to post 

information about services to which 

they have a conscience objection. The 

Department notes, however, that the 

voluntary notice provision of this final 

rule states that, where possible, and 

where the recipient does not have a 

conscience-based objection to doing so, 

the notice should include information 

about alternative providers that may 

offer patients services the recipient does 

not provide for reasons of conscience. 

Comment: One commenter referenced 

the Department’s request for comment 

for examples from providers about 

discrimination in violation of 

conscience provisions in the Medicaid 

and Medicare statutes without directly 

providing such examples. The 

commenter stated that public and 

private insurance should safeguard 

existing benefits for children and should 

include reproductive health and related 

services. The commenter urged HHS to 

ensure no individuals receiving care 

through public health insurance are 

denied access to care or willing 

providers. 

Response: The Department thanks the 

commenter for sharing their concern. 

Providing such substantive provisions, 

however, is beyond the scope of this 

rulemaking. 

6. Information, Including Specific 

Examples Where Feasible, Regarding 

Alleged Violations of Any of the Other 

Authorities That Appeared in the 2019 

Final Rule But Not the 2011 Final Rule 

Comment: The Department only 

identified one comment in response to 

this question. A commenter offered 

suggestions on ‘‘other relevant 

authorities’’ (without citation) in 

reference to this request for comment 

and urged HHS to support only 

organizations that advocate in favor of 

childhood vaccination and not to make 

policy changes to weaken measures to 

immunize health care personnel. 

Response: The Department thanks the 

commenter for their response. This final 

rule clarifies OCR’s existing authorities 

over the Federal conscience statutes in 

§ 88.1, which includes a provision 

regarding pediatric vaccines (42 U.S.C. 

1396s(c)(2)(B)(ii)). 

7. Comment on Whether the 2019 Final 

Rule Provided Sufficient Clarity To 

Minimize the Potential for Harm 

Resulting From Any Ambiguity and 

Confusion That May Exist Because of 

the Rule, and Whether Any Statutory 

Terms Require Additional Clarification 

Whether the 2019 Final Rule Provided 

Sufficient Clarity To Minimize the 

Potential for Harm 

Comment: Numerous commenters, 

including reproductive health 

organizations and legal organizations, 

generally expressed support for the 

rescission of 2019 Final Rule provisions, 

stating that the 2019 Final Rule was 

confusing and redundant, unlawful, 

overbroad, discriminatory, and ripe for 

abuse. Many of these commenters also 

stated that rescinding the 2019 Final 

Rule would restore OCR’s appropriate 

scope of enforcement. One commenter 

stated that the proposed rule reflected 

the appropriate balance between 

providing reasonable accommodations 

for providers who cannot perform 

certain services in good conscience and 

obligations to patients and providing the 

care they need—a balance that hospitals 

already have vast experience in 

addressing. 

Two commenters stated that for many 

major medical providers, including their 

own, the threat of loss of federal funding 

is a threat to the facilities’ existence, 

meaning the 2019 Final Rule would 

have skewed health systems against 

patient care and in favor of refusals to 

provide certain services based on 

religious or moral objections. Three 

commenters stated that the 2019 Final 

Rule would have aggravated health 

disparities, contrary to the mission of 

HHS and OCR. One commenter 

expressed their support for the proposed 

rule because it declined to retain the 

provisions in the 2019 Final Rule that 

appeared to give OCR the authority to 

withhold federal financial assistance 

and suspend award activities based on 

‘‘threatened violations’’ alone, without 

first allowing for the completion of an 

informal resolution process. A couple of 

commenters stated that they support the 

proposed rule for removing onerous 

reporting requirements that the 2019 

Final Rule would have imposed. 

Other commenters discussed 

physicians’ duties to patients, with one 

commenter asking that the Department 

clarify that the Federal government’s 

stance is that providers cannot refuse to 

serve patients due to personal beliefs. 

Another commenter supported the 

proposed rule out of concern that the 

2019 Final Rule would have negatively 

impacted the field of pediatrics and the 

care and well-being of children in 

particular. 

Many commenters, including legal 

organizations and reproductive health 

organizations, argued that the sweeping 

language of the 2019 Final Rule 

definitions exceeded statutory and 

constitutional authority by abandoning 

the long-standing balancing framework 

under Title VII of the Civil Rights Act 

of 1964 or violating the Establishment 

Clause, especially the definitions of 

‘‘referral/refer’’ and ‘‘assist in the 

performance.’’ Many of these 

commenters said the 2019 Final Rule 

definitions would have allowed 

providers to violate principles of 

medical ethics and informed consent by 

refraining from informing patients about 

treatment options that they find 

objectionable and referring the patient 

to another provider, even in an 

emergency. These commenters said that 

this would have weakened the integrity 

of key HHS programs and the quality of 

U.S. health care by disregarding 

evidence-based standards of care. One 

legal organization asserted that the 2019 

Rule’s definition of ‘‘discrimination’’ 

contrasted with prior case law regarding 

the Weldon and Coats-Snowe 

Amendments and the reasonableness of 

accommodations. Several commenters, 

including state attorneys general, a legal 

organization, and a reproductive health 

organization, argued that the definition 

of ‘‘health care entity’’ in the 2019 Rule 

would have exceeded the reach of the 

Weldon and Coats-Snowe Amendments 

by including dozens of new entities 

under their protection, such as 

employers that provide health benefits, 

pharmacists, and medical laboratories. 

One of these commenters elaborated 

that in the Coats-Snowe Amendment, 

Congress chose to focus on a select 

group of individuals involved in the 

abortion training context in its 

definition of ‘‘health care entity,’’ and 

cited to contemporary statements by 

Senator Coats that the statute was meant 

to ‘‘simply address the question of 

training for induced abortions.’’ 21 The 

commenter likewise cited floor 

statements by Representative Weldon to 

show that the Weldon Amendment was 

meant to apply to a limited group of 

entities. Additional commenters argued 

the 2019 Final Rule would have made 

it exceedingly difficult for health care 

providers to interview, hire, or respond 

to accommodation requests, and to 

continue to provide essential services to 

their patients since the rule would have, 

in their view, impermissibly broadened 

the right to object based on conscience 


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22The Department notes that the model notice 

text includes a link to the HHS web page where 

additional resources can be accessed for covered 

entities and the public to better understand their 

obligations and rights under the Federal health care 

conscience statutes. See U.S. Dep’t of Health and 

Human Servs., Off. for Civil Rights, Conscience and 

Religious Nondiscrimination, https://www.hhs.gov/ 

conscience/conscience-protections/index.html. As 

noted elsewhere in this preamble, the Department 

agrees it is important to ensure the public is aware 

of the Federal conscience statutes and remains 

committed to educating patients, providers, and 

other covered entities about their rights and 

obligations under the conscience statutes, including 

through education and outreach efforts. 

to virtually any other person in the 

health care setting. 

Response: The Department thanks the 

commenters for sharing their views on 

the 2019 Rule. As stated in the proposed 

rule, the Federal health care conscience 

protection statutes represent Congress’ 

attempt to strike a careful balance, 

which the Department will respect. 

Some doctors, nurses, and hospitals, for 

example, object for religious or moral 

reasons to providing or referring for 

abortions or assisted suicide, among 

other procedures. Respecting such 

objections honors liberty and human 

dignity. It also redounds to the benefit 

of the medical profession. Patients also 

have autonomy, rights, and moral and 

religious convictions. And they have 

health needs, sometimes urgent ones. 

Our health care systems must effectively 

deliver services to all who need them in 

order to protect patients’ health and 

dignity. The Department maintains that 

this final rule appropriately addresses 

the concerns raised by commenters and 

three separate district courts about the 

2019 Final Rule, and in particular, its 

definitions, and allows the Department 

to faithfully apply each statute on a 

case-by-case basis. 

Whether Any Statutory Terms Require 

Additional Clarification 

Comment: Several commenters, 

including local governments, legal 

organizations, and others, generally 

expressed opposition to the rescission of 

the definitions that appeared at § 88.2 of 

the 2019 Final Rule on the grounds that 

those definitions provide more clarity 

regarding conscience protection 

statutes, that some of the definitions 

were not redundant, unlawful, or 

unnecessary, and that the definitions 

would ensure adequate enforcement and 

prevent arbitrary determinations by 

OCR. One commenter stated that the 

Department has failed to provide an 

adequate justification for why the 

removal of all definitions improves the 

application or interpretation of laws 

regarding conscience protections, while 

another commenter requested that the 

Department replace the allegedly 

confusing definitions of the rule with 

new definitions. A few commenters said 

that the 2019 Final Rule’s definitions 

upheld the balance between conscience 

protection and patient rights and 

appropriately reflected the breadth of 

the underlying statutes. 

Response: The Department thanks the 

commenters for sharing their concerns 

regarding the 2019 Final Rule’s 

definitions and clarifying certain 

statutory terms. The Department is 

declining to include certain portions of 

the 2019 Final Rule, including the 

definitions mentioned by commenters, 

because questions have been raised as to 

their clarity and legality, including 

whether they undermine the balance 

Congress struck between safeguarding 

conscience rights and protecting access 

to health care. In response to the 2018 

Proposed Rule, the Department received 

numerous comments about the clarity 

and scope of the proposed definitions. 

See, 84 FR 23170, 23186–23204 (May 

21, 2019). While the Department 

finalized the definitions in the 2019 

Final Rule with changes to address 

these concerns, the district court for the 

Southern District of New York found 

that the 2019 Final Rule’s definitions of 

‘‘discrimination,’’ ‘‘assist in the 

performance,’’ ‘‘referral,’’ and ‘‘health 

care entity,’’ in the court’s view, 

impermissibly broaden the conscience 

statutes beyond the balance struck by 

Congress. New York, 414 F. Supp. 3d at 

523. The district court for the Northern 

District of California similarly found 

that the 2019 Final Rule, including the 

definitions and enforcement provisions, 

were not ‘‘mere housekeeping.’’ San 

Francisco, 411 F. Supp. 3d at 1023. In 

the court’s view, the ‘‘expansive 

definitions,’’ which departed from the 

federal statutes, coupled with the 

termination of all HHS funding as a 

consequence of noncompliance, 

rendered the rule ‘‘undoubtedly 

substantive.’’ Id. In response to the 

proposed rule, the Department received 

comments again raising concerns about 

the clarity and scope of the 2019 Final 

Rule’s definitions. Taken together, the 

Department determined that the 

questions raised about the definitions in 

the 2019 Final Rule by commenters and 

the courts warrant additional careful 

consideration. Finally, as noted 

elsewhere, the Department declines to 

add language interpreting the provisions 

of the conscience statutes to the rule 

text as it is unnecessary to include such 

language to clarify OCR’s processes by 

which it enforces these statutes or to 

enforce them on a case-by-case basis.22

8. Comment on Whether the Provisions 

Added by the 2019 Final Rule Are 

Necessary, Collectively or With Respect 

to Individual Provisions, To Serve the 

Statutes’ or the Rule’s Objectives, 

Including With Regard to Whether the 

Department Accurately Evaluated the 

Need for Additional Regulation in the 

2019 Final Rule, and Whether Those 

Provisions Should Be Modified, or 

Whether the Rule’s Objectives May Also 

Be Accomplished Through Alternative 

Means, Such as Outreach and Education 

Whether the Provisions Added by the 

2019 Final Rule Are Necessary and 

Whether the Department Accurately 

Evaluated the Need for Additional 

Regulation in the 2019 Final Rule 

Comment: Some commenters, 

including a reproductive health group, 

stated that the Department did not 

accurately evaluate the need for 

additional regulation in its 

promulgation of the 2019 Final Rule, 

stating that the paucity of data on 

conscience complaints or allegations of 

conscience statute violations, and the 

decision by three federal district courts 

to vacate the 2019 Final Rule, illustrates 

that the provisions of the 2019 Final 

rule were not actually necessary. One 

legal organization agreed that the 2019 

Final Rule made significant changes to 

the conscience statutes and argued the 

Department did not need to engage in 

rulemaking given that there were less 

than a dozen conscience complaints 

filed with OCR between 2011 and 2017 

and instances in which providers are 

required to violate their conscience are 

rare. Some commenters noted that, as 

the Southern District of New York 

found, the number of conscience 

complaints received by OCR was 

significantly less than the 2019 Final 

Rule stated, which undermined one key 

argument for it. These commenters said 

that this lack of data means HHS has no 

justification for the assertion in the 2019 

Final Rule that HHS otherwise lacks the 

capacity to enforce the provisions of the 

Federal conscience statutes. These 

commenters stated that the provisions of 

the 2019 Final Rule are not necessary 

because (1) Congress did not delegate to 

HHS rulemaking authority to 

promulgate the substantive components 

of the 2019 Final Rule and (2) Congress 

did not delegate to OCR the ultimate 

enforcement power to cut off all of a 

recipient’s funding for the breach of a 

conscience provision. 

Response: The Department 

acknowledges that the litigation 

surrounding the 2019 Final Rule raised 

questions regarding the complaints of 

statutory violations that served as a 

predicate for the 2019 Final Rule, and 


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23See Press Release, U.S. Dep’t of Health and 

Human Servs., Off. for Civil Rights, HHS 

Announces New Divisions Within the Office for 

Civil Rights to Better Address Growing Need of 

Enforcement in Recent Years (Feb. 27, 2023), 

https://www.hhs.gov/about/news/2023/02/27/hhsannounces-new-divisions-within-office-civil-rightsbetter-address-growing-need-enforcement-recentyears.html. 

24 Id. 

25The Department notes that the model notice 

text includes a link to the HHS web page where 

additional resources can be accessed for covered 

entities and the public to better understand their 

obligations and rights under the Federal health care 

conscience statutes. See U.S. Dep’t of Health and 

Human Servs., Off. for Civil Rights, Conscience and 

Religious Nondiscrimination, https://www.hhs.gov/ 

conscience/conscience-protections/index.html. As 

noted elsewhere in this preamble, the Department 

agrees it is important to ensure the public is aware 

of the Federal conscience statutes and remains 

committed to educating patients, providers, and 

other covered entities about their rights and 

obligations under the conscience statutes, including 

through education and outreach efforts. 

26See 84 FR 23170, 23219 (May 21, 2019). 

thanks the commenters for sharing their 

other thoughts regarding this issue. The 

Department notes that OCR’s overall 

caseload has multiplied in recent years, 

increasing to over 51,000 complaints in 

2022—an increase of 69 percent 

between 2017 and 2022—with 27 

percent of those complaints alleging 

violations of civil rights, 66 percent 

alleging violations of health information 

privacy and security laws, and 7 percent 

alleging violations of conscience/ 

religious freedom laws.23 The 

Department has concluded that this 

final rule will enable OCR to effectively 

process and resolve complaints related 

to the Federal health care conscience 

statutes. 

Comment: One commenter stated that 

the 300 complaints filed with OCR 

within a month of the announcement of 

the new Conscience and Religious 

Freedom Division within OCR are 

evidence of the need for broader 

conscience protections, and another 

commenter defended the 2019 Final 

Rule in part due to an increase in 

complaints filed with OCR. 

Response: Among other things, the 

litigation over the 2019 Final Rule 

raised significant questions regarding 

the complaints of statutory violations 

that served as a predicate for the 2019 

Final Rule. As noted above, OCR’s 

caseload has increased,24 but the 

Department has concluded that this 

final rule will enable OCR to effectively 

process and resolve complaints related 

to the Federal health care conscience 

statutes. 

Comment: Some commenters, 

including a faith-based organization, 

expressed opposition to the removal of 

the compliance requirements at § 88.6 of 

the 2019 Final Rule, stating that removal 

of these requirements is contradictory to 

the stated goal of protecting conscience 

rights and will hinder the Department’s 

ability to prevent discrimination. 

Commenters explained that compliance 

requirements would provide clarity on 

how conscience rights are expected to 

be enforced, would aid in the factintensive investigations conscience 

complaints can require, and would fit in 

with the general practices for other for 

civil rights laws. One commenter 

elaborated that in the absence of these 

requirements, recipients may under- or 

over-record, incurring laborious 

administrative costs and enormous legal 

fees. Additionally, some commenters 

expressed opposition to the rescission of 

the applicable requirements and 

prohibitions that appeared at § 88.3 in 

the 2019 Final Rule because this 

rescission creates issues with 

enforcement. Without this provision’s 

language, several commenters said that 

the rule fails to provide information to 

covered entities about which statutes 

apply to them, removes helpful context, 

and imposes increased costs on covered 

entities who now have to research over 

two dozen separate statutes instead of 

having one place to learn about them. 

Response: The Department thanks the 

commenters for their recommendations. 

The Department declines to retain, 

among other provisions, the applicable 

requirements and prohibitions that 

appeared at § 88.3 and the compliance 

requirements at § 88.6. Specifically, the 

applicable requirements and 

prohibitions that appeared at § 88.3 

were unnecessary because they simply 

repeated the language of the underlying 

statutes.25 Some commenters also raised 

concerns in response to both the 2018 

Proposed Rule 26 and the proposed rule 

for this rulemaking that the compliance 

requirements at § 88.6 were overly 

burdensome on covered entities and not 

authorized by the conscience statutes. 

The concerns raised by commenters 

highlight significant questions that 

warrant additional consideration, and in 

the Department’s view, these provisions 

are not necessary to clarify OCR’s 

processes by which it enforces these 

statutes. This final rule specifies the 

Department’s procedures for handling 

conscience complaints in a manner that 

allows the Department to address 

conscience complaints on a case-by-case 

basis to ensure the balance struck by 

Congress is respected. Finally, the 

Department notes, as it has already 

elsewhere, that in response to comments 

received on the proposed rule, this rule 

is being finalized with additional 

enforcement provisions similar to 

provisions in the 2019 Final Rule that 

did not raise the same issues as were 

raised by the other provisions noted 

above. 

Comment: One commenter stated that 

the potential withdrawal of federal 

funds or the potential for a lawsuit 

needs to remain in the rule to ensure 

that there is effective enforcement; and 

that requirements for reporting 

incidents of discrimination from § 88.6 

of the 2019 Final Rule need to be left in 

place. One commenter said, ‘‘The courts 

that vacated the 2019 Final Rule did not 

find that the use of such formal means 

was impermissible per se, but only that 

the 2019 rule’s text deviated from those 

existing frameworks in specific ways.’’ 

The commenter also said that the final 

rule should therefore retain OCR’s 

authority to pursue formal as well as 

informal means of enforcing the 

conscience statutes. 

Response: As discussed in response to 

other comments, the Department is 

adding regulatory language to clarify the 

Department’s and OCR’s authority to 

enforce the Federal health care 

conscience statutes, including through 

compliance reviews (§ 88.2(a) and a new 

§ 88.2(c)), coordinating other 

appropriate remedial action (§ 88.2(a)), 

and OCR’s authority to utilize existing 

enforcement regulations, such as those 

that apply to grants, contracts, or other 

programs and services, or withhold 

relevant funding to the extent 

authorized under the Federal health 

care conscience statutes where a matter 

cannot be resolved by informal means 

(§ 88.2(g)(3)). 

As the Department has already noted 

in response to other comments, the 

Department determined not to retain, 

among other provisions, compliance 

requirements at § 88.6. In the 

Department’s view, this provision is not 

necessary to clarify OCR’s processes by 

which it enforces these statutes. The 

Department has concluded that the final 

rule’s enforcement provisions, which set 

out procedures for the Department to 

handle conscience complaints on a caseby-case basis as they arise, appropriately 

permit the Department to ensure 

compliance with the conscience statutes 

without raising certain potential 

concerns commenters identified in 

connection with compliance provisions 

included in the 2019 final rule. 

Comment: Some commenters, 

including several faith-based 

organizations and a couple non-profits, 

expressed concern regarding the 

rescission of the rule of construction 

and severability provisions at § 88.9 and 

§ 88.10 of the 2019 Final Rule, arguing 

that they provided much needed clarity 

as to the Department’s interpretation 

and enforcement of the conscience 


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27The Department notes that the model notice 

text includes a link to the HHS web page where 

additional resources can be accessed for covered 

entities and the public to better understand their 

obligations and rights under the Federal health care 

conscience statutes. See U.S. Dep’t of Health and 

Human Servs., Off. for Civil Rights, Conscience and 

Religious Nondiscrimination, https://www.hhs.gov/ 

conscience/conscience-protections/index.html. As 

noted elsewhere in this preamble, the Department 

agrees it is important to ensure the public is aware 

of the Federal conscience statutes and remains 

committed to educating patients, providers, and 

other covered entities about their rights and 

obligations under the conscience statutes, including 

through education and outreach efforts. 

28See U.S. Dep’t of Health and Human Servs., 

Off. for Civil Rights, ‘‘Assurance of Compliance,’’ 

HHS Form 690, OMB Control Number 0945–0008 

(Last updated Nov. 2019), https://www.hhs.gov/ 

sites/default/files/form-hhs690.pdf. 

protection laws. Three commenters 

cited caselaw to elaborate that courts 

and administrative agencies have long 

recognized that non-discrimination laws 

should be construed broadly to give full 

effect to their remedial purposes, and so 

it would be entirely appropriate for HHS 

to announce a rule of broad construction 

in the final rule. 

Response: The Department notes that 

the language from the severability 

provision from § 88.10 of the 2019 Final 

Rule is retained at § 88.4 of the 

proposed rule and in this final rule. 

Additionally, as noted in the proposed 

rule, the enactment of the Federal health 

care conscience protection statutes 

represents Congress’ attempt to strike a 

careful balance, and the Department 

will respect that balance. The 

conscience statutes each contain 

particular requirements that must be 

met in order for them to apply. The 

Department is committed to meeting its 

obligations and ensuring compliance 

with all relevant federal law, including 

under the Federal conscience statutes. 

Comment: One commenter stated that 

the proposed rule does not provide any 

justification for rescinding the 2019 

Final Rule other than by citing New 

York v. U.S. Dep’t of Health & Human 

Servs., 414 F. Supp. 3d 475, 513–14, 535 

(S.D.N.Y. 2019), without explaining 

why HHS is deferring to the court’s 

decision. Many other commenters 

argued that the Department should not 

rely on the New York decision because 

the district court’s ruling was based on 

an incomplete and incorrect 

understanding of the underlying 

legislation. Other commenters 

maintained that, because only certain 

provisions of the 2019 Final Rule were 

held unlawful, the proposed rule overrelied on the finding of the court as to 

the other provisions in the 2019 Final 

Rule and did not clearly articulate the 

reasoning for rescissions in general to 

specific rescinded provisions. 

Response: The Department 

respectfully disagrees with commenters 

that the sole proffered justification for 

rescinding the 2019 Final Rule was the 

New York decision. As the Department 

noted in the proposed rule, 88 FR 820, 

825–26, ‘‘[t]he Department proposes to 

rescind the other portions of the 2019 

Final Rule because those portions are 

redundant, unlawful, confusing or 

undermine the balance Congress struck 

between safeguarding conscience rights 

and protecting access to health care, or 

because significant questions have been 

raised as to their legal authorization.’’ 

(Emphasis added). For example, the 

applicable requirements and 

prohibitions that appeared at § 88.3 

were unnecessary because they simply 

repeated the language of the underlying 

statute.27 Additionally, the Department 

received comments in response to the 

2018 Proposed Rule and the proposed 

rule for this final rule that stated that 

many of the definitions at § 88.2 were 

confusing or undermined the balance 

struck by Congress between 

safeguarding conscience rights and 

protecting access to care. Likewise, 

commenters in response to the 2018 

Proposed Rule and the proposed rule for 

this final rule stated that the assurance 

and certification requirements that 

appeared at § 88.4 were overly 

burdensome. The Department also 

determined that the requirements at 

§ 88.4 are not necessary as the 

Department has updated the HHS Form 

690 Assurance of Compliance (which 

OCR maintains) independent of the 

2019 Final Rule and this rulemaking to 

include reference to the Federal 

conscience statutes.28 Further, the 

compliance requirements at § 88.6, the 

relationship to other laws provision at 

§ 88.8, and rule of construction at § 88.9 

(which was echoed in § 88.1) were 

flagged by commenters to both the 2018 

Proposed Rule and the proposed rule for 

this final rule as, in their view, unlawful 

or having created confusion or risk of 

harm by undermining the balance struck 

by Congress. Finally, as noted in the 

proposed rule, in the view of the court 

in the New York decision, the purpose 

provision at § 88.1, several of the 

definitions at § 88.2, and the assurance 

and certification requirements at § 88.4 

were found to be unlawful since the 

court understood them to impose new 

substantive duties on regulated entities 

in the health care sector, beyond the 

Department’s Housekeeping Authority. 

The district court decisions overlapped 

with concerns raised by commenters 

regarding the provisions at § 88.1, 

several of the definitions at § 88.2, and 

the assurance and certification 

requirements at § 88.4, and so the 

Department determined these concerns 

warrant additional consideration. In the 

current instance, however, the 

Department does not view these 

provisions as necessary to clarify OCR’s 

processes by which it enforces these 

statutes. This final rule specifies the 

Department’s procedures for handling 

conscience complaints in a manner that 

allows the Department to address 

conscience complaints on a case-by-case 

basis to ensure the balance struck by 

Congress is respected. 

The Department notes as well, as it 

has already elsewhere, that in response 

to comments received on the proposed 

rule, this rule is being finalized with 

additional enforcement provisions 

similar to provisions in the 2019 Final 

Rule that did not raise the same issues 

as were raised by the other provisions 

noted above. 

Comment: One commenter argued 

that the specified reasons for the 

removal of § 88.4 are not rational and 

weaken the argument proffered by the 

Department that the proposed rule 

strengthens conscience rights. Some 

commenters requested that the 

Department maintain assurance and 

certification requirements in the final 

rule as it is a common mechanism for 

preventing discrimination used in civil 

rights regulations. Another commenter 

argued that HHS, at a minimum, must 

replace the assurance and certification 

requirements with a requirement that 

the names of all conscience statutes that 

a grantee may be subject to be included 

in the terms of any grant agreements. 

One commenter argued that the purpose 

provision of the 2019 Final Rule was 

necessary evidence of the Department’s 

commitment to ensuring that conscience 

rights are respected and protected to the 

furthest extent of the law, and that the 

rule in general was a vital expression of 

the need to protect conscience rights in 

health care, where, in the commenter’s 

view, discrimination against ‘‘pro-life’’ 

persons is evident. 

Response: The Department believes 

the final rule clearly demonstrates the 

Department’s commitment to ensuring 

that the federal conscience statutes are 

given full effect. The Department 

determined that the requirements at 

§ 88.4 are not necessary as the 

Department has updated the HHS Form 

690 Assurance of Certification (which 

OCR maintains) independent of the 

2019 Final Rule and this rulemaking to 

include reference to the Federal 

conscience statutes. The purpose 

provision from § 88.1 of the 2019 Final 

Rule similarly is not necessary for this 

rule as this rule is not intended to 

‘‘implement’’ the conscience statutes. 

The final rule is the result of the 

Department’s careful efforts to design an 


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effective system of enforcement that is 

fully supported by the authority 

Congress has granted the Department, 

and these determinations likewise avoid 

potential concerns raised by the court 

decisions and commenters regarding 

§§ 88.4 and 88.1 of the 2019 rule. As 

noted in the proposed rule, the district 

court for the Southern District of New 

York found that, in its view, the 2019 

Final Rule’s purpose and assurance and 

certification requirements, among 

others, ‘‘impose[d] new substantive 

duties on regulated entities in the health 

care sector’’ and did not fall within the 

agency’s Housekeeping Authority. New 

York, 414 F. Supp. 3d at 523.The court’s 

decision raised similar concerns as 

those raised by commenters in response 

to both the 2018 Proposed Rule and the 

proposed rule for this final rule, who 

stated concerns that those provisions 

were overly burdensome or overly 

broad. 

Comment: Two commenters noted 

that HHS has explicit rulemaking 

authority to engage in substantive 

rulemaking on the conscience 

protections set out in Sections 1303, 

1411, and 1553 of the Affordable Care 

Act, 42 U.S.C. 18023, 18081, and 18113; 

and certain Medicare and Medicaid 

provisions, 42 U.S.C. 1320a–1(h), 

1320c–11, 1395i–5, 1395w–22(j)(3)(B), 

1395x(e), 1395x(y)(1), 1395cc(f), 

1396a(a), 1396a(w)(3), 1396u–2(b)(3)(B), 

1397j–1(b), and 14406. The commenters 

argued that the Department should 

retain as applicable to those statutes the 

provisions of the 2019 Final Rule 

requiring assurances and certifications 

of compliance, establishing compliance 

requirements comparable to those 

applicable to other civil rights laws, and 

defining terms. 

Response: The Department has 

carefully considered these comments 

but declines to make these substantive 

changes in this final rule at this time. 

This rule addresses statutes beyond 

those mentioned by the commenters, 

and none of the statutes mentioned by 

the commenters requires the 

Department to enact regulations for the 

respective statute’s implementation. The 

Department maintains that addressing 

all of the statutes listed in § 88.1 

uniformly under this rule outweighs the 

benefits of including piecemeal 

provisions for certain statutes but not 

others. The Department will consider, 

however, whether further rulemaking on 

the statutes recommended by 

commenters is needed. 

Whether the Rule’s Objectives May Also 

Be Accomplished Through Alternative 

Means, Such as Outreach and Education 

Comment: One professional health 

care organization stated that they 

believe physicians are aware of their 

legal obligations under the conscience 

statutes, and so the proposed rule is not 

necessary to enforce the conscience 

provisions under existing law. A few 

commenters urged HHS to pursue 

education and outreach to entities and 

individuals instead, with some 

commenters requesting the Department 

do so as an alternative to rulemaking 

and others requesting that the 

Department do so in addition to 

rulemaking. Commenters stated that 

such efforts would ensure that 

physicians and other providers and 

health care entities are fully aware of 

their rights and responsibilities under 

the numerous federal conscience 

protection laws, especially in light of 

the proposal to remove the assurance of 

compliance requirement and to only 

require voluntary notice. 

Response: The Department thanks the 

commenters for their recommendations. 

The Department agrees it is important to 

ensure the public is aware of the Federal 

conscience statutes and remains 

committed to educating patients, 

providers, and other covered entities 

about their rights and obligations under 

the conscience statutes, including 

through education and outreach efforts. 

The Department looks forward to 

working with covered entities and 

stakeholders to increase outreach 

activities and ensure awareness. The 

Department notes as well that it has 

updated the HHS Form 690 Assurance 

of Certification (which OCR maintains) 

to include reference to the Federal 

conscience statutes as another means of 

increasing awareness. The Department 

maintains that that this rule is also an 

important component of educating the 

public about these statutes. 

9. Comment on the Proposal To Retain 

a Voluntary Notice Provision, Including 

Comments on Whether Such Notice 

Should Be Mandatory, and What a 

Model Notice Should Include 

Opposition To Retention of Voluntary 

Notice 

Comment: One local government 

agency argued that having a voluntary 

notice provision was inconsistent with 

the scope of the Housekeeping 

Authority as explained in City and 

County of San Francisco v. Azar, 411 F. 

Supp. 3d 1001 (N.D. Cal. 2019), and 

argued in favor of returning to the 2011 

Final Rule in full. A commenter that 

provides Skilled Nursing & Assisted 

Living services opposed the rule’s 

inclusion of a voluntary notice, arguing 

that there is already overregulation, and 

adding additional notices would only 

add confusion and increase anxiety. 

Response: While the court in San 

Francisco v. Azar determined that some 

provisions in the 2019 Final Rule were 

‘‘substantive’’ provisions that were not 

authorized by the Department’s 

Housekeeping Authority, it did not 

address that rule’s voluntary notice 

provision. 411 F. Supp. 3d at 1023. This 

rule lacks the provisions that the San 

Francisco v. Azar court identified as 

substantive, and, as the notice is 

voluntary, the rule does not impose new 

responsibilities on health care 

providers. The Department maintains 

that providing notice is an important 

way for covered entities to promote 

compliance and ensure the public, 

patients, and workforce, which may 

include students or applicants for 

employment or training, are aware of 

their rights under the health care 

conscience protection statutes. The 

Department declines to remove the 

voluntary notice provision on the bases 

cited by the commenters and encourages 

all covered entities to provide the 

voluntary notice. As stated in this final 

rule, the Department will consider 

posting a notice as a factor in an 

investigation or compliance review. 

Whether the Notice Should Be 

Mandatory 

Comment: Some commenters, 

including some faith-based 

organizations, elected officials, and 

professional health care organizations, 

argued that the voluntary notice 

provision should be mandatory instead, 

citing a variety of reasons. A couple of 

commenters argued that making the 

notice mandatory would increase 

awareness of the conscience statutes. 

Another commenter relied on the 

concept of notice in many other areas of 

law to argue that a mandatory notice 

provision should be applied here. Other 

commenters, including a professional 

health care organization, argued that a 

mandatory notice would increase access 

to services that providers might object to 

and supported changes that would 

ensure that the notice offered 

information about access to such 

services. A commenter proposed the 

notice should include the words 

‘‘religious and moral beliefs’’ along with 

‘‘conscience.’’ 

Response: The Department declines to 

make the notice mandatory, and notes 

that the 2019 Final Rule notice was also 

voluntary. The Department also notes 

that the wide variety of entities subject 

to the Federal health care conscience 


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29Section 88.2(a)(5) of the proposed rule stated, 

‘‘Consult and coordinate with the relevant 

Departmental funding component, and utilize 

existing regulations enforcement.’’ (emphasis 

added). 88 FR 820, 829. This typo has been 

corrected in this final rule to ‘‘enforcement 

regulations’’ instead. 

protection statutes would make it 

difficult to mandate a notice with text 

that would be relevant to each of those 

entities. In the Department’s view, a 

voluntary notice with recommended 

text does a better job of giving covered 

entities the flexibility to post a notice 

that is relevant to their obligations 

without increasing regulatory burden on 

the Department and covered entities. 

The Department nonetheless is 

clarifying in the rule text that posting a 

notice will be considered as a factor in 

any relevant OCR investigation or 

compliance review. Lastly, in response 

to the commenter’s request, the 

Department has added ‘‘religious beliefs 

or moral convictions’’ in the model 

notice. 

10. Comment on the Proposal To Retain 

Portions of the 2019 Final Rule’s 

Enforcement Provisions in the Proposed 

§ 88.2 

General Support 

Comment: Numerous commenters, 

including some faith-based 

organizations, expressed general 

support for retaining the complaint 

handling and investigation provisions in 

§ 88.2 on the grounds that it is an 

improvement over the 2011 Final Rule, 

noting that OCR is best equipped to be 

the central HHS office for receiving and 

investigating complaints. 

Response: The Department thanks the 

commenters for sharing their views and 

agrees that maintaining OCR as the 

centralized HHS office tasked with 

receiving and investigating complaints 

under these provisions will aid the 

public by increasing awareness of the 

rights protected by the various statutes 

and where to file complaints alleging 

violations of those rights. 

Requests for Clarification 

Comment: Many commenters, 

including reproductive health 

organizations and legal organizations, 

expressed support for the rescission of 

several portions of the 2019 Final Rule, 

especially what they characterized as 

overly broad enforcement provisions, 

but urged HHS to provide more clarity 

on the limits of the retained 

enforcement provisions and on OCR’s 

enforcement authority generally. Some 

commenters recommended that the 

Department provide a more detailed 

justification for the proposal to retain 

procedural elements from the 2019 

Final Rule’s § 88.7, which includes the 

authority to conduct interviews and 

issue ‘‘written data or discovery 

requests.’’ 88 FR at 829–30. 

Response: The Department thanks the 

commenters for sharing their views. 

Section 88.2(a)(5) makes clear that 

OCR’s authority is to ‘‘[c]onsult and 

coordinate with the relevant 

Departmental funding component, and 

utilize existing enforcement 

regulations.’’ 29 These existing 

enforcement regulations could include, 

for example, the Department’s authority 

under the Uniform Administrative 

Requirements, Cost Principles, And 

Audit Requirements for HHS Awards 

(UAR; 45 CFR part 75). Second, the 

ability to conduct interviews and issue 

written data requests are standard 

components of OCR’s function as an 

enforcement agency. The Department 

considers these elements to be part and 

parcel of the Department’s compliance 

powers, and, as the commenter notes, 

procedural elements that fall within the 

Department’s Housekeeping Authority. 

As with its other authorities, OCR may 

also use the provision of technical 

assistance or voluntary resolution 

agreements in an effort to achieve 

voluntary compliance. The 

Department’s approach to enforcing the 

Federal health care conscience statutes 

will continue to rely on the 

Department’s existing compliance and 

enforcement authority. Finally, the 

Department notes that, as discussed in 

response to other comments, the 

Department is adding regulatory 

language to clarify the Department’s and 

OCR’s authority to enforce the Federal 

health care conscience statutes, 

including through compliance reviews 

(§ 88.2(a) and a new § 88.2(c)), 

coordinating other appropriate remedial 

action (§ 88.2(a)), and OCR’s authority to 

utilize existing enforcement regulations 

or withhold relevant funding to the 

extent authorized under the Federal 

health care conscience statutes 

(§ 88.2(g)(3)) or to refer to the Attorney 

General (§ 88.2(g)(4)) where a matter 

cannot be resolved by informal means. 

Comment: Many commenters 

expressed concern that the 

modifications to § 88.7 of the 2019 Final 

Rule (§ 88.2 of the proposed rule) 

remove assurances that OCR will 

conduct a prompt investigation of 

complaints and investigate complaints 

involving a potential or threatened 

failure to comply with the conscience 

statutes. One individual commenter 

specifically pointed to the change of 

verb from ‘‘should’’ to ‘‘may’’ with 

regard to the investigatory and factfinding methods the proposed rule 

stated OCR would employ, which the 

commenter felt left the Department with 

too much discretion in the complaint 

handling process. The commenter stated 

that the proposed rule fails to clarify 

which, if any, complaints are accepted, 

and fails to clarify how complaints are 

to be handled by OCR, making it 

uncertain who is allowed to file a 

complaint. 

Response: OCR reviews all complaints 

received as a matter of course in its 

normal business operations and may use 

some or all of the investigatory tools 

outlined in § 88.2 in evaluating and 

investigating a complaint. As noted in 

the proposed rule, the Department 

remains committed to educating 

patients, providers, and other covered 

entities about their rights and 

obligations under the conscience 

statutes and remains committed to 

ensuring compliance. In addition, the 

Department is finalizing proposed 

§ 88.2(b) as § 88.2(d) with a revision to 

state that OCR shall make a prompt 

investigation of a complaint alleging 

failure to comply with the Federal 

health care conscience protection 

statutes, and adding a new § 88.2(b) 

explaining that any entity or individual 

may file a complaint with OCR alleging 

a potential violation of Federal health 

care conscience protection statutes, and 

that the entity filing does not have to be 

the entity whose rights have been 

violated. The Department declines to 

modify the language of § 88.2(d) to 

mandate the use of certain investigation 

methods as not all the investigatory and 

fact-finding methods available to OCR 

are appropriate or necessary to be used 

in all cases. Any relevant complaints 

filed with the Department will be routed 

to OCR if they are not initially filed 

directly with OCR, and OCR will review 

all received complaints and make a 

determination regarding the allegations 

raised. 

Comment: Numerous commenters 

criticized the proposed rule and HHS 

for rescinding portions of the 2019 Final 

Rule’s enforcement provisions and only 

retaining some, stating it would make it 

difficult for HHS to protect conscience 

rights and would lead to discrimination 

against health care entities and 

individual providers. Many 

commenters, including a professional 

health care organization and a think 

tank, requested the Department include 

explicit authority for OCR to pursue 

formal rather than just informal 

enforcement and a clear statement on 

how the Department will interpret the 

conscience laws in relation to other 

laws, similar to the language provided 

in §§ 88.7 and 88.8 of the 2019 Final 

Rule. 


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30See 45 CFR 160.304. 31See 28 CFR 42.411 (‘‘Effective enforcement of 

title VI requires that agencies take prompt action to 

achieve voluntary compliance in all instances in 

which noncompliance is found.’’ (emphasis 

added)). 

Response: OCR works to achieve 

voluntary compliance with all of its 

authorities, including HIPAA Privacy, 

Security, Breach Notification, and 

Enforcement Rules 30 and Title VI.31 As 

finalized in this rule, the Department 

states that matters of noncompliance 

will ‘‘be resolved by informal means 

whenever possible.’’ (Emphasis added). 

This is consistent with OCR’s approach 

to enforcement across the authorities it 

has been delegated and does not 

preclude the Department from using 

appropriate formal means at its disposal 

to achieve compliance whenever it is 

not possible to resolve a matter through 

informal means. As well, as discussed 

in response to other comments, the 

Department is adding regulatory 

language to clarify the Department’s and 

OCR’s processes and authority to 

enforce the Federal health care 

conscience statutes, including through 

compliance reviews (§ 88.2(a) and a new 

§ 88.2(c)), coordinating other 

appropriate remedial action (§ 88.2(a)), 

and OCR’s authority to utilize existing 

enforcement regulations or withhold 

relevant funding to the extent 

authorized under the Federal health 

care conscience statutes where a matter 

cannot be resolved by informal means 

(§ 88.2(g)(3)). The Department declines, 

however, to add § 88.8 from the 2019 

Final Rule into this rule as this is a 

procedural rule that does not address 

the scope of any substantive right, and 

thus there is no need to clarify how the 

rule interacts with laws that do establish 

protections for religious freedom or 

moral convictions. Moreover, in the 

Department’s view, it is appropriate to 

proceed with case-by-case enforcement 

of the conscience statutes. The 

Department has determined therefore 

that additional guidance is not 

necessary at this point. 

III. Statutory Authority 

The Secretary is partially rescinding 

the May 21, 2019, Final Rule entitled 

‘‘Protecting Statutory Conscience Rights 

in Health Care; Delegations of 

Authority.’’ As discussed above, the 

Church Amendments, section 245 of the 

PHS Act, the Weldon Amendment, and 

the Affordable Care Act require, among 

other things, that the Department and 

recipients of Department funds 

(including State and local governments) 

refrain from discriminating against 

institutional and individual health care 

entities for their participation in, 

abstention from, or objection to certain 

medical procedures or services, 

including certain health services, or 

research activities funded in whole or in 

part by the federal government. No 

statutory provision, however, requires 

promulgation of regulations for their 

interpretation or implementation. This 

rule is being issued pursuant to the 

authority of 5 U.S.C. 301, which 

empowers the head of an Executive 

department to prescribe regulations ‘‘for 

the government of his department, the 

conduct of its employees, the 

distribution and performance of its 

business, and the custody, use, and 

preservation of its records, papers, and 

property.’’ 

IV. Overview and Section-by-Section 

Description of the Final Rule 

Section 88.1 describes the purpose of 

the Final Rule. The language is revised 

from the 2019 Final Rule, and states that 

the purpose of this Part 88 is to provide 

for the enforcement of the Church 

Amendments, 42 U.S.C. 300a–7; the 

Coats-Snowe Amendment, section 245 

of the Public Health Service Act, 42 

U.S.C. 238n; the Weldon Amendment, 

e.g., Consolidated Appropriations Act, 

2023, Public Law 117–328, div. H, title 

V General Provisions, section 507(d)(1) 

(Dec. 29, 2022); Sections 1303(b)(1)(A), 

(b)(4), and (c)(2)(A), and 1411(b)(5)(A), 

and 1553 of the ACA, 42 U.S.C. 

18023(b)(1)(A), (b)(4), and (c)(2)(A), 

18081(b)(5)(A), and 18113; certain 

Medicare and Medicaid provisions, 42 

U.S.C. 1320a–1(h), 1320c–11, 1395i–5, 

1395w–22(j)(3)(B), 1395x(e) 1395x(y)(1), 

1395cc(f), 1396a(a), 1396a(w)(3), 1396u– 

2(b)(3)(B), 1397j–1(b), and 14406; the 

Helms, Biden, 1978, and 1985 

Amendments, 22 U.S.C. 2151b(f); 

accord., e.g., Consolidated 

Appropriations Act, 2023, Public Law 

117–328, div. H, section 209, div. K, 

title VII, section 7018 (Dec. 29, 2022); 22 

U.S.C. 7631(d42 U.S.C. 280g–1(d), 

290bb–36(f), 1396f, 1396s(c)(2)(B)(ii); 

5106i(a); and 29 U.S.C. 669(a)(5), 

referred to collectively as the ‘‘Federal 

health care conscience protection 

statutes.’’ The Department is finalizing 

this provision with two changes. First, 

in response to a comment, the 

Department is removing the word 

‘‘provider’’ from the proposed rule’s 

collective reference of the ‘‘federal 

health care conscience protection 

statutes.’’ Second, the Department 

identified and corrected an error in the 

citations to the Medicare and Medicaid 

statutes. The proposed rule cites 42 

U.S.C. 1395w–22(j)(3)(A) and 1396u– 

2(b)(3)(A) as conscience provisions 

when 42 U.S.C. 1395w–22(j)(3)(B) and 

1396u–2(b)(3)(B) are the relevant 

conscience provisions. 

Sections 88.2 through 88.4 of the 2019 

Final Rule have been removed. The 

language of § 88.7 of the 2019 Final Rule 

has been revised and redesignated as 

§ 88.2 in this final rule. Section 88.2 in 

this final rule states under paragraph (a) 

that OCR has been delegated the 

authority to facilitate and coordinate the 

Department’s enforcement of the 

Federal health care provider conscience 

protection statutes and includes a list of 

related authorities. This includes three 

authorities that did not appear in the 

proposed rule, but which the 

Department is finalizing at § 88.2(a)(2), 

(7), and (8) addressing OCR’s authority 

to initiate compliance reviews, 

‘‘coordinate other appropriate remedial 

action as the Department deems 

necessary and as allowed by law and 

applicable regulation,’’ and ‘‘make 

enforcement referrals to the Department 

of Justice.’’ In response to comments, 

the Department is finalizing this rule 

with a new § 88.2(b) and (c) to clarify 

OCR’s authority to conduct compliance 

reviews and to clarify who may file a 

complaint with OCR regarding the 

Federal health care conscience 

protection statutes. Section 88.2(b) of 

the proposed rule has been redesignated 

in this final rule as § 88.2(d) and 

describes OCR’s investigation process. 

In response to comments, the 

Department is finalizing § 88.2(d) with a 

revision to state that OCR shall make a 

prompt investigation of a complaint 

alleging failure to comply with the 

Federal health care conscience 

protection statutes. The Department is 

also making a technical edit to remove 

the term ‘‘discovery’’ from § 88.2(d) as 

that term is generally used in litigation, 

but is keeping the term ‘‘data request.’’ 

The Department is also finalizing this 

rule with a new § 88.2(e) that did not 

appear in the proposed rule, but which 

now notes that, ‘‘OCR may adopt a 

negative inference if, absent good cause, 

an entity that is subject to the Federal 

health care conscience protection 

statutes fails to respond to a request for 

information or to a data or document 

request within a reasonable timeframe.’’ 

Proposed § 88.2(c) has been 

redesignated as § 88.2(f) and describes 

OCR’s role in providing supervision and 

coordination of compliance where OCR 

makes a determination as a result of an 

investigation that an entity is not 

compliant with their responsibilities 

under the Federal health care 

conscience protection statutes. Proposed 

§ 88.2(d) has been redesignated as 

§ 88.2(g) and describes OCR’s process 

for achieving resolution of matters. In 


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response to comments, the Department 

is finalizing § 88.2(g) with a new 

paragraph (3) that describes OCR’s 

authority to ‘‘coordinate with the 

relevant Departmental component to (1) 

utilize existing enforcement regulations, 

such as those that apply to grants, 

contracts, or other programs and 

services, or (2) withhold relevant 

funding to the extent authorized under 

the statutes listed under § 88.1’’ where 

informal means of achieving compliance 

have failed to resolve a given matter. In 

response to comments, the Department 

is also finalizing § 88.2(g) with a new 

paragraph (4) that describes OCR’s 

authority to ‘‘in coordination with the 

Office of the General Counsel, refer the 

matter to the Department of Justice for 

proceedings to enforce the statutes 

listed under § 88.1’’ where informal 

means of achieving compliance have 

failed to resolve a given matter. 

Section 88.5 of the 2019 Final Rule 

has been revised and redesignated as 

§ 88.3 of this final rule. In response to 

comments, section 88.3(a) in this final 

rule now states that OCR considers the 

posting of a notice consistent with this 

part ‘‘as a best practice towards 

achieving compliance with and 

educating the public about the Federal 

health care conscience protection 

statutes, and encourages all entities 

subject to the Federal health care 

conscience protection statutes to post 

the model notice provided in Appendix 

A.’’ In addition, we have also added to 

section 88.3(a) language to explain that 

‘‘OCR will consider posting a notice as 

a factor in any investigation or 

compliance review under this rule.’’ 

Section 88.3(b) describes places where 

the model notice in Appendix A should 

be posted. Section 88.3(c) describes the 

format of the notice. Section 88.3(d) 

describes the content of the notice text. 

Section 88.3(e) provides that the 

Department and each recipient may post 

the notice text along with the content of 

other notices (such as other 

nondiscrimination notices). The 

language from Appendix A to Part 88 in 

the 2019 Final Rule has been revised but 

is still designated as Appendix A to Part 

88 in this final rule. The Department is 

finalizing the text of Appendix A with 

one change in response to commenters 

to include a statement for clarity that 

‘‘You may have rights as a provider, 

patient, or other individual under these 

Federal statutes, which prohibit 

coercion or other discrimination on the 

basis of conscience in certain 

circumstances.’’ 

V. Regulatory Impact Analysis 

A. Introduction 

The Department has examined the 

impacts of this Final Rule under 

Executive Order 12866, Executive Order 

13563, the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). 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, 

and other advantages; distributive 

impacts; and equity). The Office of 

Information and Regulatory Affairs has 

designated this final rule significant 

under Section 3(f)(1) of Executive Order 

12866, as amended by Executive Order 

14094. The Department addresses the 

Regulatory Flexibility Act below. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires 

agencies to prepare a written statement, 

which includes an assessment of 

anticipated costs and benefits, before 

proposing ‘‘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 

1 year.’’ The current threshold after 

adjustment for inflation is 

approximately $177 million, using the 

most current (2022) Implicit Price 

Deflator for the Gross Domestic Product. 

This proposed rule would not create an 

unfunded mandate under the Unfunded 

Mandates Reform Act because it does 

not impose any new requirements 

resulting in unfunded expenditures by 

state, local, and tribal governments, or 

by the private sector. 

Congress enacted the Paperwork 

Reduction Act of 1995 to ‘‘maximize the 

utility of information created, collected, 

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). This final rule does not require 

new collections of information under 

the Paperwork Reduction Act of 1995. 

See generally 44 U.S.C. 3501–3520. 

The Department made several changes 

to this Regulatory Impact Analysis (RIA) 

in response to public comment to the 

RIA that was published with the 

proposed rule in January 2023. In 

response to multiple comments 

regarding potential cost savings against 

a baseline of the 2019 Final Rule, the 

Department reviewed all RIA cost 

categories from the 2019 Final Rule to 

determine if they will be potentially 

recoverable by virtue of the recission of 

the 2019 Final Rule. The Department 

concluded that regulatory 

familiarization costs likely happened 

immediately following the publication 

of the 2019 Final Rule and would not be 

recoverable as a result of this final rule. 

The Department determined that all 

other cost categories might be 

considered as potential savings in a 

rescission scenario. We also added 

regulatory familiarization costs in 

response to concerns about the need of 

various stakeholders to review the 

provisions of this rule. Finally, the 

Department addressed comments about 

the impacts to small businesses by 

including a separate regulatory 

flexibility analysis section. 

B. Requests for Comment 

The Department solicited comments 

on the proposed rule’s RIA, including 

whether the non-quantified impacts 

identified in the 2019 Final Rule’s RIA 

would likely be realized, absent any 

further regulatory action. The 

Department responds to those 

comments here. 

Comment: A commenter said that the 

2019 Final Rule would have been 

burdensome because providers would 

have had to: obtain legal counsel to 

determine whether and how policies 

must be altered; revise employment 

manuals and training programs; 

maintain the records the Rule requires; 

and provide the mandated assurances 

and certifications. 

Response: The Department thanks the 

commenter for insight into potential 

burdens. 

Comment: A commenter stated that 

HHS did not ‘‘adequately or accurately’’ 

consider the costs of the proposed 

rulemaking. The commenter elaborated 

that the RIA did not show that the 

proposed rule is justified ‘‘when 

evaluated reasonably,’’ stating that the 

primary baseline used is ‘‘irrational and 

self-contradictory.’’ The commenter 

disagreed that the Department’s 

explanation of the proposed rescissions 

of the 2019 Final Rule could be 

considered a savings, since the rule was 

not put into effect. The commenter 

stated that HHS should use its 

alternative baseline scenario, which 

assumes the 2019 Final Rule to be 

unimplemented, instead of the primary 

baseline to avoid arbitrariness. The 

commenter also said that the 

Department underestimates the impact 

of the proposed rule because the 

calculations under the alternative 

baseline in the RIA leave out the 

familiarization costs included with the 

2019 Final Rule’s RIA. 


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Response: The Department 

acknowledges the commenter’s concern. 

The two baselines in question—the 

primary baseline that the 2019 Final 

Rule would go into effect and the 

alternative baseline that it would never 

go into effect—involve different ways of 

looking at the economic impact of the 

rule, not the justification for the rule. 

The Department continues to use the 

primary baseline but presents the 

alternative baseline as well. 

Comment: A commenter stated that 

the RIA published with the proposed 

rule excludes the impact of the 

rulemaking on voluntary remedial 

efforts. The commenter cited the 2019 

Final Rule’s RIA statement that ‘‘some 

recipients will institute a grievance or 

similar process to handle internal 

complaints raised to the recipient’s or 

sub-recipient’s attention,’’ and 

concluded that ‘‘an additional 

undiscounted 5-year cost of $36 million 

at minimum must be added to the total 

cost of the proposed rule.’’ The 

commenter stated that there is no reason 

to suggest that the proposed rule will 

not cause adoption of the same number 

of grievance processes as the 2019 Final 

Rule would have. 

Response: The Department has 

reviewed this comment and disagrees. 

The commenter did not provide any 

new data to support the argument that 

the Department should adopt a 

particular view regarding how many 

entities will adopt a grievance or other 

remedial process. The Department does 

have reason to disagree with the 

remedial costs being identical, as 

significant provisions from the 2019 

Final Rule that would likely have 

incentivized entities to voluntarily 

adopt grievance processes are removed. 

The rule rescinds significant portions of 

the 2019 Final Rule including required 

assurance and compliance provisions. 

Absent new data, the Department 

continues to believe that the recissions 

in this final rule will generate $8.3 

million per year in savings through less 

grievance costs. 

Comment: One commenter claimed 

that if the assurance and certification 

requirements of the 2019 Final Rule 

were ‘‘redundant and unnecessary’’ as 

HHS described them in the proposed 

rule, then ‘‘there would likely not be 

any costs within the first five years of 

publication’’ since ‘‘entities were 

already fully taking steps to be educated 

on, and comply with, all the laws that 

are the subject of this rule,’’ as stated in 

the 2019 Final Rule’s RIA. Given this 

assumption, the commenter continued, 

then the impact of the 2019 Final Rule 

should be reduced by the $255.3 million 

in assurance and certification impact, 

bringing the total undiscounted cost of 

the 2019 Final Rule to $769.7 million. 

The commenter argued that this ‘‘overall 

lack of consideration of cost itself’’ 

constitutes a failure to meet the 

demands of Michigan v. EPA. 

Response: The commenter quotes 

from the 2019 Final Rule’s RIA’s 

statement that there would likely not be 

‘‘any costs within the first five years of 

publication’’ for remedial efforts taken 

by a recipient to meet the assurance and 

certification requirements in § 88.4 if 

‘‘entities were already fully taking steps 

to be educated on, and comply with, all 

the laws that are the subject of this 

rule[.]’’ In other words, the costs of 

these remedial efforts would be zero if 

entities were taking these steps. But this 

conclusion cannot be extrapolated to the 

assurance and compliance requirements 

more generally. Section 88.4(b)(6) of the 

2019 Final Rule required annual 

assurance and certification to OCR. 

These assurance and certification costs 

were projected to occur regardless of 

whether entities were already educated 

about the health care conscience 

protection statutes. 

Comment: Some commenters 

suggested that, because a pandemic has 

occurred since the 2019 Final Rule, 

various estimates in the RIA are 

unreliable because of the strain on the 

health care community, including from 

loss of staffing. 

Response: The Department agrees 

with the commenter that the impact 

estimates of the final rule are subject to 

several sources of uncertainty, including 

any impacts of the COVID–19 pandemic 

on covered entities. However, the 

comment did not provide any new data 

to explain which numbers in the 2019 

RIA should be changed because of the 

noted strain due to the pandemic. The 

comment also did not provide a 

recommended approach for projecting 

these impacts over the 5-year time 

horizon of the analysis of the final rule. 

The Department notes that, while the 

analysis does not modify its estimates 

based on impacts related to the COVID– 

19 pandemic, it does address 

uncertainty, including by assessing a 

secondary baseline scenario. 

Comment: Several commenters urged 

HHS to consider additional costs in the 

calculation of the final rule. These 

included: the impact of turnover, 

increased agency costs, increased 

litigation, and risk management costs; 

the costs of potential increased 

conscience and religious freedom 

complaints; the Federalism implications 

associated with impacts on state 

hospitals, medical facilities, and 

insurance plans, as well as the 

interaction with state and local laws 

regarding conscience and religious 

freedom; specific costs, such as: the 

stresses placed on the nation’s 

infrastructure of health care as a whole, 

and the public health consequences of 

‘‘conscientious providers’’ leaving the 

workforce; the loss of access to certain 

providers; the costs that may result from 

companies that choose to ignore 

conscience protections, and thus lose 

employees and patients as a result; the 

compound effect of the rule’s impact on 

existing labor shortages, among others. 

Response: The Department is unable 

to quantify most of these costs, as the 

necessary data are not provided by the 

commenter and are not available in any 

data sources that the Department has 

reviewed. This approach is consistent 

with the 2019 Final Rule, in which 

these potential effects were discussed 

qualitatively but were also not 

quantified. 

In response to the concerns about 

federalism, some of the Federal laws 

that this rule implements and enforces, 

such as the Weldon and Coats-Snowe 

Amendments, directly regulate States 

and local governments that receive 

Federal funding by conditioning the 

receipt of such funding on the 

governments’ commitments to refrain 

from discrimination on certain bases or 

by imposing certain requirements on 

States and local governments that 

receive Federal funding. This impact, 

however, is a result of the statutory 

prohibitions and requirements 

themselves and are not due to the 

mechanisms provided by this rule. 

Comment: A commenter pointed out 

that a premise of the 2019 Final Rule 

was that the 2019 Final Rule would 

expand access to health care, 

specifically by reducing barriers to the 

entry of certain health professionals and 

delaying the exit of certain health 

professionals from the field, by reducing 

discrimination or coercion that health 

professionals anticipate or experience. 

The commenter suggested that the 

proposed rule’s disagreement with this 

conclusion means the Department 

(which continues to rely on the 2019 

RIA) now underestimates the effects of 

reversing the 2019 Final Rule, as the 

commenter agrees with the 2019 Final 

Rule’s assessment of its effects. 

Response: The Department has 

reviewed this comment and found that 

it does not provide any new data or 

other actionable information relevant to 

the economic analysis. Consistent with 

numerous comments received on the 

2018 proposed rule, the Department has 

no reason to conclude that the 2019 

Rule would have resulted in more 

providers entering the workforce or 


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would have resulted in greater patient 

access to care. 

Comment: Commenters had varying 

views regarding what percent of 

providers would post the voluntary 

notice. One commenter, who suspected 

the percent of covered entities posting 

voluntary notices would be minimal, 

requested that OCR better estimate the 

percentage of entities that will comply 

with the proposed posting notice on a 

voluntary basis. Another commenter 

suggested it would be reasonable for the 

Department to assume that all entities 

will provide voluntary notices, and, 

therefore, the overall cost to covered 

entities from posting the voluntary 

notices will be higher than the RIA 

states. 

Response: The Department has 

reviewed this issue but disagrees that 

nearly all entities will post a voluntary 

notice. No commenter provided data to 

support their assertion that all covered 

entities or else a minimal number of 

covered entities will post the voluntary 

notice. After consideration, the 

Department in this final rule maintains 

the 2019 Final Rule RIA’s estimate that 

half of all entities would post a 

voluntary notice in this final rule. If all 

entities posted a voluntary notice, the 

costs associated would be equivalent to 

the costs of a mandatory notice 

summarized in Policy Option 3 (this 

final rule, modified to include a 

mandatory notice). This final rule 

adopts a voluntary notice provision, and 

the cost is the same as the cost of the 

2019 Final Rule’s voluntary notice 

provision summarized in Policy Option 

2 (this final rule). 

C. Detailed Economic Analysis 

HHS considered several policy 

alternatives, in addition to the approach 

of this final rule. This economic 

analysis considers the likely impacts 

associated with the following three 

policy options: (1) rescinding the 2019 

Final Rule without exceptions; (2) 

adopting the approach of this final rule, 

which partially rescinds the 2019 Final 

Rule, and modifies other provisions; 

and (3) adopting the approach of this 

final rule, except further modifying the 

notice provision to require mandatory 

notices instead of voluntary notices. To 

simplify the narrative of this RIA, we 

present the impacts of rescinding the 

2019 Final Rule in its entirety first, and 

then present the impacts of a partial 

rescission with modifications. These 

modifications correspond to the policy 

option of the final rule, and the policy 

option of mandatory notices. This RIA 

then summarizes the impacts of each 

policy option against common 

assumptions about the baseline scenario 

of no further regulatory action. 

Policy Option 1: Rescinding the 2019 

Final Rule 

Rescinding the final rule entitled 

‘‘Protecting Statutory Conscience Rights 

in Health Care; Delegations of 

Authority,’’ published in the Federal 

Register on May 21, 2019 (84 FR 23170, 

45 CFR part 88) (hereafter, ‘‘2019 Final 

Rule’’) would prevent the realization of 

many of the anticipated impacts of the 

2019 Final Rule. For the purposes of 

this economic analysis, we 

provisionally adopt the characterization 

and quantification of these impacts that 

were presented in the regulatory impact 

analysis (RIA) of the 2019 Final Rule. 

The potential impacts identified and 

estimated in the RIA covered a five-year 

time horizon following the effective date 

of the 2019 Final Rule. However, 

because the 2019 Final Rule has been 

vacated by three federal district courts, 

these impacts have mostly not occurred 

and are not likely to occur. The 

litigation status of the 2019 Final Rule 

introduces substantial analytic 

uncertainty into any characterization of 

the baseline scenario of no further 

regulatory action. We address this 

uncertainty directly by analyzing the 

potential impacts of Policy Option 1 

under two discrete baseline scenarios. 

First, for the purposes of this economic 

analysis, we adopt a primary baseline 

scenario that the 2019 Final Rule would 

take effect. Second, we adopt an 

alternative baseline scenario that the 

2019 Final Rule would never take effect, 

even without any subsequent regulatory 

action. 

Under our primary baseline scenario, 

Policy Option 1 would entirely reverse 

the impacts of the 2019 Final Rule. To 

analyze the impacts of Policy Option 1 

under this scenario, we provisionally 

adopt the estimates of the likely impacts 

of the 2019 Final Rule in its RIA, 

although we understand that 

commenters raised questions whether, 

for example, certain of the nonquantified benefits that the 2019 Final 

Rule anticipated would in fact be 

realized. The RIA identified five 

categories of quantified costs: (1) 

familiarization; (2) assurance and 

certification; (3) voluntary actions to 

provide notices of rights; (4) voluntary 

remedial efforts; and (5) OCR 

enforcement and associated costs. The 

narrative of the RIA described an 

approach for estimating each of these 

costs, and Table 6 of the RIA 

summarized the timing and magnitude 

of these quantified costs (84 FR 23240). 

In addition to identifying quantified 

costs, the RIA identified non-quantified 

costs associated with compliance 

procedures and non-quantified costs 

associated with seeking alternative 

providers of certain objected to medical 

services or procedures. 

The 2019 Final Rule’s RIA did not 

identify any quantified benefits, but 

identified non-quantified benefits 

associated with compliance with the 

law; protection of conscience rights, the 

free exercise of religion and moral 

convictions; more diverse and inclusive 

providers and health care professionals; 

improved provider-patient relationships 

that facilitate improved quality of care; 

equity, fairness, nondiscrimination; and 

increased access to care. The District 

Court in New York, however, also 

identified some non-quantified costs of 

the 2019 Final Rule, including: ‘‘that the 

Rule could potentially impose liability 

on an employer . . . for insisting that an 

ambulance driver complete a mission of 

transporting a patient to a hospital for 

an emergency procedure,’’ that the Rule 

‘‘would authorize individuals [to leave] 

the operating theater or medical 

procedure [and] withhold their 

services,’’ and other instances of failing 

to provide care in life-threatening 

situations. 414 F.Supp.3d at 539, 519, 

514 (citing Shelton v. Univ. of Med. & 

Dentistry of N.J., 223 F.3d 220, 222–23, 

224–28 (3d Cir. 2000)). The Department 

has no reason to conclude that, 

consistent with numerous comments 

received on the 2018 proposed rule, the 

2019 Rule would have resulted in more 

providers entering the workforce or 

would have resulted in greater patient 

access to care, and acknowledges the 

potential harms raised by the New York 

decision. In addition, the Department 

notes that there are non-quantifiable 

benefits of this revised rule, including 

respecting Congress’ attempt to strike a 

careful balance between patient and 

provider rights, ensuring patient access 

to health care, notifying the public of 

OCR’s existing authorities on 

conscience laws, and clarifying to the 

public what OCR’s process is for 

handling complaints under these 

authorities. 

Table 1 of the 2019 Final Rule’s RIA 

reported the present value and 

annualized value of the quantified costs 

and summarized the non-quantified 

costs and benefits of the 2019 Final Rule 

(84 FR 23227). That RIA reported 

estimates of the present value of the 

total costs over a 5-year time horizon of 

$900.7 million using a 3-percent 

discount rate and $731.5 million using 

a 7-percent discount rate. That RIA also 

reported annualized estimates of the 

costs of $214.9 million under a 3- 

percent discount rate and $218.5 

million using a 7-percent discount rate. 


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32U.S. Dep’t of Labor, Bureau of Labor Statistics, 

May 2022 State Occupational Employment and 

Wage Estimates (Last visited October 30, 2023), 

https://www.bls.gov/oes/current/oessrcst.htm; U.S. 

Dep’t of Labor, Bureau of Labor Statistics, Employer 

Costs for Employee Compensation, Quarter 1, 2023 

(Last visited October 30, 2023), https://

www.bls.gov/ecec/data.htm. 

Both sets of these cost estimates were 

reported in year 2016 dollars. We 

updated these estimates to year 2022 

dollars using the Implicit Price Deflator 

for the Gross Domestic Product. We 

removed the regulatory familiarization 

costs for the 2019 Final Rule from the 

potential costs savings, as we believe 

these were incurred in full upon 

publication of the rule and will 

therefore be non-recoverable despite the 

partial recission of the 2019 Final Rule. 

Likewise, we added regulatory 

familiarization costs for this final rule 

following the general methodology of 

the 2019 Final Rule updated with the 

most recent available data. We estimate 

that 513,627 entities will spend 2 hours 

of legal professional time to review the 

document. To determine the cost of 

legal professional time, we use the 

average wage for Lawyers (OES 23– 

1011) and load it with the factor for all 

civilian workers.32 As Table 1 notes 

below, the present value of these 

familiarization costs add up to $114 

million using a 3-percent discount rate, 

or $106 million using a 7-percent 

discount rate; they will also partially 

offset any cost savings in the first year 

of this current rule. The annualized 

costs are $24.8 million, and $23.2 

million, respectively. 

HHS next estimated the Policy Option 

1 cost savings by calculating the total 

potentially recoverable costs from fully 

rescinding the 2019 Final Rule and 

adjusting them with the new regulatory 

familiarization costs. The present value 

of potentially recoverable costs from 

fully rescinding the 2019 Final Rule is 

$1,026.0 million using a 3-percent 

discount rate and $856.8 million using 

a 7-percent discount rate; these cover 

assurance and certification, voluntary 

notice and remedial efforts, and OCR 

enforcement costs (see Table 1 below for 

detailed breakdown of individual costs), 

and annualized costs of $224.0 million 

using a 3-percent discount rate and 

$187.1 million using a 7-percent 

discount rate. Under our primary 

baseline scenario, the cost savings of 

Policy Option 1 would be 

approximately the inverse of the 

impacts contained in the 2019 

potentially recoverable costs from the 

2019 Final Rule’s RIA plus the newly 

incurred regulatory familiarization cost. 

These cost savings sum up to a total 

discounted value of $912.3 million at a 

3-percent discount rate, or $750.5 

million using a 7-percent discount rate; 

the annualized values are, $199.2 

million, and $163.9 million, 

respectively. Table A in the Summary of 

Impacts section of this preliminary 

regulatory impact analysis reports the 

summary impacts of the Policy Option 

1 under this baseline scenario in 

millions of 2022 dollars, covering a 5- 

year time horizon, including annualized 

values, and Table 1 reports the detailed 

impacts in this primary baseline 

scenario, by cost category. 

TABLE 1—COSTS AND COST SAVINGS—OPTION 1 (PRIMARY BASELINE) 

[Discounted 3% and 7% in millions] 

Year 1 Year 2 Year 3 Year 4 Year 5 Total 

Costs and Cost Savings—Option 1 

Familiarization (undiscounted) ................................................................. $117.2 $0.0 $0.0 $0.0 $0.0 $117.1 

Familiarization (3%) ................................................................................. 113.8 0.0 0.0 0.0 0.0 113.7 

Familiarization (7%) ................................................................................. 106.3 0.0 0.0 0.0 0.0 106.3 

Assurance and Certification (undiscounted) ............................................ ¥187.2 ¥171.1 ¥171.1 ¥171.1 ¥171.1 ¥871.5 

Assurance and Certification (3%) ............................................................ ¥181.7 ¥161.3 ¥156.6 ¥152.0 ¥147.6 ¥799.1 

Assurance and Certification (7%) ............................................................ ¥169.8 ¥140.8 ¥127.8 ¥116.0 ¥105.2 ¥659.6 

Voluntary Notice (undiscounted) .............................................................. ¥112.3 ¥17.0 ¥17.0 ¥17.0 ¥17.0 ¥180.3 

Voluntary Notice (3%) .............................................................................. ¥109.1 ¥16.0 ¥15.5 ¥15.1 ¥14.6 ¥170.4 

Voluntary Notice (7%) .............................................................................. ¥101.9 ¥14.0 ¥12.7 ¥11.5 ¥10.4 ¥150.6 

Voluntary Remedial Efforts (undiscounted) ............................................. ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥43.9 

Voluntary Remedial Efforts (3%) ............................................................. ¥8.5 ¥8.3 ¥8.0 ¥7.8 ¥7.6 ¥40.2 

Voluntary Remedial Efforts (7%) ............................................................. ¥8.0 ¥7.2 ¥6.6 ¥5.9 ¥5.4 ¥33.1 

OCR Enforcement Costs (undiscounted) ................................................ ¥3.6 ¥3.6 ¥3.6 ¥3.6 ¥3.6 ¥17.9 

OCR Enforcement Costs (3%) ................................................................ ¥3.5 ¥3.4 ¥3.3 ¥3.2 ¥3.1 ¥16.4 

OCR Enforcement Costs (7%) ................................................................ ¥3.3 ¥3.0 ¥2.7 ¥2.4 ¥2.2 ¥13.5 

Total Costs (undiscounted) ............................................................... ¥194.6 ¥200.4 ¥200.4 ¥200.4 ¥200.4 ¥996.4 

Total Costs (3%) ............................................................................... ¥189.0 ¥188.9 ¥183.4 ¥178.1 ¥172.9 ¥912.3 

Total Costs (7%) ............................................................................... ¥176.6 ¥165.0 ¥149.7 ¥135.8 ¥123.3 ¥750.5 

Notes: Negative costs indicate the Policy Option, if finalized would result in cost savings. 

Under our alternative baseline 

scenario, we assume that the 2019 Final 

Rule would never take effect, even 

without any additional regulatory 

action. Under this baseline scenario, 

Policy Option 1 would maintain the 

current status quo, which is 

characterized by the 2011 Final Rule (76 

FR 9968). Thus, for this baseline 

scenario, we conclude that adopting 

Policy Option 1 would result in the new 

regulatory familiarization costs 

(discussed above) plus other de minimis 

impacts that we do not quantify, such as 

resolving any regulatory uncertainty 

associated with the 2019 Final Rule, 

which has been vacated by three federal 

courts but not rescinded. We report the 

summary impacts of Policy Option 1 

under this alternative baseline scenario 

in Table A in the Impacts Summary 

section. 

Policy Option 2: The Final Rule 

The final rule partially rescinds the 

2019 Final Rule, with certain 

exceptions. Specifically, this final rule 

retains three aspects of the 2019 Final 

Rule: (1) the addition to part 88 of 

statutes included in the 2019 Final Rule; 


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33The Department also keeps the severability 

clause from the 2019 Final Rule. 

(2) several enforcement provisions; and 

(3) a voluntary notice provision.33

However, as described in greater detail 

in the Preamble, the Department is also 

modifying each of these provisions of 

the 2019 Final Rule. For example, the 

voluntary notice provision in the 

proposed rule would clarify that 

providing these voluntary notices would 

not satisfy an entity’s substantive 

obligations imposed upon covered 

entities by the underlying statutes. 

We considered the likely impacts of 

each of the three retained aspects of the 

2019 Final Rule. The Department 

estimates that maintaining the statutes 

from the 2019 Final Rule will not 

impact costs. For the remaining two 

aspects of the 2019 Final Rule, we 

identify quantifiable impacts associated 

with retaining the aspects of the 2019 

Final Rule related to the enforcement 

provisions and quantifiable impacts 

related to the voluntary notice 

provision. We adopt the analytic 

approach contained in the 2019 Final 

Rule’s RIA to quantify these impacts, 

including an assumption in that RIA 

that about half of covered entities would 

provide notices voluntarily. For the 

provisions related to enforcement, the 

2019 RIA estimated an annual impact of 

about $3 million in costs to the 

Department and $15 million in total 

costs over five years. For the provisions 

related to voluntary notices, that RIA 

estimated an impact of about $93.4 

million in costs in the first year of the 

analysis, and about $14.1 million in 

costs in subsequent years, or about $150 

million over five years. Combined, the 

2019 RIA estimated 5-year costs for 

these two provisions of $165 million; in 

present value terms, these estimates are 

$142 million using a 3-percent discount 

rate and $118 million using a 7-percent 

discount rate. The 2019 RIA reported 

these costs in 2016 dollars. 

To quantify the net impact of this 

rule, we fully remove the costs 

associated with enforcement and 

voluntary notice provisions from our 

earlier estimates of the total cost savings 

of rescinding the 2019 Final Rule. Since 

the voluntary notice requirement will 

not be rescinded, and some enforcement 

provisions will be retained, we 

anticipate that there will be no cost 

savings against the 2019 Final Rule 

under these cost categories. As an 

intermediate step, we converted the 

2016 dollar estimates from the previous 

paragraph to 2022 dollars using the 

Implicit Price Deflator for the Gross 

Domestic Product. Compared to our 

primary baseline, we estimate that over 

the first five years of this rule, this rule 

will result in total cost savings in 2022 

dollars of $725.5 million using a 3- 

percent discount rate and $586.4 

million using a 7-percent discount rate 

(as shown in Table 2); the 

corresponding annualized cost savings 

are $158.4 million using a 3-percent 

discount rate and $128.0 million using 

a 7-percent discount rate. We report 

these estimates in Table A in the 

Summary of Impacts section, which also 

reports comparable estimates 

corresponding to our alternative 

baseline scenario, and include a 

detailed breakdown of primary baseline 

costs in Table 2 below. 

TABLE 2—COSTS AND COST SAVINGS—OPTION 2 (PRIMARY BASELINE) 

[Discounted 3% and 7% in millions] 

Year 1 Year 2 Year 3 Year 4 Year 5 Total 

Costs and Cost Savings—Option 2 

Familiarization (undiscounted) ................................................................. $117.2 $0.0 $0.0 $0.0 $0.0 $117.1 

Familiarization (3%) ................................................................................. 113.8 0.0 0.0 0.0 0.0 113.7 

Familiarization (7%) ................................................................................. 106.3 0.0 0.0 0.0 0.0 106.3 

Assurance and Certification (undiscounted) ............................................ ¥187.2 ¥171.1 ¥171.1 ¥171.1 ¥171.1 ¥871.5 

Assurance and Certification (3%) ............................................................ ¥181.7 ¥161.3 ¥156.6 ¥152.0 ¥147.6 ¥799.1 

Assurance and Certification (7%) ............................................................ ¥169.8 ¥140.8 ¥127.8 ¥116.0 ¥105.2 ¥659.6 

Voluntary Notice (undiscounted) .............................................................. 0.0 0.0 0.0 0.0 0.0 0.0 

Voluntary Notice (3%) .............................................................................. 0.0 0.0 0.0 0.0 0.0 0.0 

Voluntary Notice (7%) .............................................................................. 0.0 0.0 0.0 0.0 0.0 0.0 

Voluntary Remedial Efforts (undiscounted) ............................................. ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥43.9 

Voluntary Remedial Efforts (3%) ............................................................. ¥8.5 ¥8.3 ¥8.0 ¥7.8 ¥7.6 ¥40.2 

Voluntary Remedial Efforts (7%) ............................................................. ¥8.0 ¥7.2 ¥6.6 ¥5.9 ¥5.4 ¥33.1 

OCR Enforcement Costs (undiscounted) ................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

OCR Enforcement Costs (3%) ................................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

OCR Enforcement Costs (7%) ................................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

Total Costs (undiscounted) ............................................................... ¥78.7 ¥179.8 ¥179.8 ¥179.8 ¥179.8 ¥798.2 

Total Costs (3%) ............................................................................... ¥76.4 ¥169.5 ¥164.6 ¥159.8 ¥155.1 ¥725.5 

Total Costs (7%) ............................................................................... ¥71.4 ¥148.1 ¥134.4 ¥121.9 ¥110.6 ¥586.4 

Negative costs indicate the Policy Option, if finalized would result in cost savings. 

Policy Option 3: The Final Rule With an 

Alternative Notice Provision 

The Department analyzed a third 

policy option, which is similar to the 

final rule, but would further modify the 

notice provision by requiring covered 

entities to post these notices in 

designated places. The 2019 Final 

Rule’s RIA assumes that about half of 

covered entities would provide these 

notices on a voluntary basis, and we 

carried this assumption through in this 

analysis, including in our analysis of the 

costs of the proposed rule. Under Policy 

Option 3, we anticipate that all covered 

entities would provide notices, and 

therefore estimate that the costs of 

mandatory notices would be double that 

of our estimates of the costs of voluntary 

notices. 

To quantify the net impact of Policy 

Option 3, we subtract the costs 

associated with enforcement and 

mandatory notice provisions from our 


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earlier estimates of the total cost savings 

of rescinding the 2019 Final Rule. 

Compared to our primary baseline, we 

estimate that Policy Option 3 would 

result in annualized cost savings in 

2022 dollars of $121.2 million using a 

3-percent discount rate and $95.2 

million using a 7-percent discount rate. 

We report these estimates in Table A in 

the Summary of Impacts section, which 

also includes comparable estimates 

corresponding to our alternative 

baseline scenario; a detailed breakdown 

of primary baseline impacts is included 

in Table 3 below. 

TABLE 3—COSTS AND COST SAVINGS—OPTION 3 (PRIMARY BASELINE) 

[Discounted 3% and 7% in millions] 

Year 1 Year 2 Year 3 Year 4 Year 5 Total 

Costs and Cost Savings—Option 3 

Familiarization (undiscounted) ................................................................. $117.2 $0.0 $0.0 $0.0 $0.0 $117.1 

Familiarization (3%) ................................................................................. 113.8 0.0 0.0 0.0 0.0 113.7 

Familiarization (7%) ................................................................................. 106.3 0.0 0.0 0.0 0.0 106.3 

Assurance and Certification (undiscounted) ............................................ ¥187.2 ¥171.1 ¥171.1 ¥171.1 ¥171.1 ¥871.5 

Assurance and Certification (3%) ............................................................ ¥181.7 ¥161.3 ¥156.6 ¥152.0 ¥147.6 ¥799.1 

Assurance and Certification (7%) ............................................................ ¥169.8 ¥140.8 ¥127.8 ¥116.0 ¥105.2 ¥659.6 

Mandatory Notice (undiscounted) ............................................................ 112.3 17.0 17.0 17.0 17.0 180.3 

Mandatory Notice (3%) ............................................................................ 109.1 16.0 15.5 15.1 14.6 170.4 

Mandatory Notice (7%) ............................................................................ 101.9 14.0 12.7 11.5 10.4 150.6 

Voluntary Remedial Efforts (undiscounted) ............................................. ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥8.8 ¥43.9 

Voluntary Remedial Efforts (3%) ............................................................. ¥8.5 ¥8.3 ¥8.0 ¥7.8 ¥7.6 ¥40.2 

Voluntary Remedial Efforts (7%) ............................................................. ¥8.0 ¥7.2 ¥6.6 ¥5.9 ¥5.4 ¥33.1 

OCR Enforcement Costs (undiscounted) ................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

OCR Enforcement Costs (3%) ................................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

OCR Enforcement Costs (7%) ................................................................ 0.0 0.0 0.0 0.0 0.0 0.0 

Total Costs (undiscounted) ............................................................... $33.6 ¥162.9 ¥162.9 ¥162.9 ¥162.9 ¥617.9 

Total Costs (3%) ............................................................................... $32.6 ¥153.5 ¥149.0 ¥144.7 ¥140.5 ¥555.2 

Total Costs (7%) ............................................................................... $30.5 ¥134.1 ¥121.7 ¥110.4 ¥100.2 ¥435.9 

Notes: Negative costs indicate the Policy Option, if finalized would result in cost savings. 

D. Summary of Impacts 

This analysis estimates the costs 

associated with the final rule and for 

two policy alternatives. For the final 

rule, we estimate the present value of 

the costs of ¥$725.5 million using a 3- 

percent discount rate and ¥$586.4 

million using a 7-percent discount rate. 

Alternatively stated, we estimate that 

the final rule would generate cost 

savings of $725.5 million using a 3- 

percent discount rate and $586.4 

million using a 7-percent discount rate. 

Table A reports cost estimates for the 

Final Rule and for the two policy 

alternatives. These estimates are 

reported in millions of 2022 dollars over 

a 5-year time horizon. Table A presents 

these cost estimates in present value 

terms and as annualized values for both 

a 3-percent and a 7-percent discount 

rate. Table A reports these estimates for 

our primary baseline scenario that the 

2019 Final Rule would take effect, and 

for an alternative baseline scenario that 

the 2019 Final Rule would never take 

effect, even without any subsequent 

regulatory action. We do not identify 

any quantified benefits for the Final 

Rule or for the two policy alternatives. 

The Department has selected Policy 

Option 2 despite Policy Option 1 

generating the most savings because 

Policy Option 2 both rescinds the 2019 

Final Rule and maintains several of its 

provisions. This approach better 

clarifies OCR’s existing authorities and 

processes for enforcing the conscience 

statutes, as explained above. 

TABLE A—ACCOUNTING TABLE OF COSTS

[Millions of 2022 dollars over a 5-year time horizon] 

Baseline scenario and policy option 

Present value by 

discount rate 

Annualized value by 

discount rate 

3 Percent 7 Percent 3 Percent 7 Percent 

Primary Baseline: 

Option 1 (Rescinding the 2019 Final Rule) .............................................................. ¥$912.3 ¥$750.5 ¥$199.2 ¥$163.9 

Option 2 (The Final Rule) ......................................................................................... ¥725.5 ¥586.4 ¥158.4 ¥128.0 

Option 3 (The Final Rule with an Alternative Notice Provision) .............................. ¥555.2 ¥435.9 ¥121.2 ¥95.2 

Alternative Baseline: 

Option 1 (Rescinding the 2019 Final Rule) .............................................................. 113.7 106.3 24.8 23.2 

Option 2 (The Final Rule) ......................................................................................... 300.5 270.4 65.6 59.0 

Option 3 (The Final Rule with an Alternative Notice Provision) .............................. 470.8 420.9 102.8 91.9 

Notes: Negative costs indicate the Policy Option, if finalized would result in cost savings. 


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E. Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires us to 

analyze regulatory options that would 

minimize any significant impact of a 

rule on small entities. HHS has 

examined the economic implications of 

this final rule as required by the RFA. 

The RFA requires an agency to describe 

the impact of a rulemaking on small 

entities by providing an initial 

regulatory flexibility analysis unless the 

agency expects that the rule will not 

have a significant impact on a 

substantial number of small entities, 

provides a factual basis for this 

determination, and to certify the 

statement. 5 U.S.C. 603(a), 605(b). If an 

agency must provide an initial 

regulatory flexibility analysis, this 

analysis must address the consideration 

of regulatory options that would lessen 

the economic effect of the rule on small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. HHS 

considers a rule to have a significant 

impact on a substantial number of small 

entities if it has at least a three percent 

impact of revenue on at least five 

percent of small entities. 

One commenter said that HHS also 

needs to assess and certify the impact 

on small businesses and all non-profits 

under the RFA, using the above analysis 

on costs and explaining its reasoning. 

The commenter pointed to non-profit 

organizations, including many 

religiously affiliated hospitals and 

health-care facilities, and small healthcare practitioners as entities and 

individuals affected by this rule. 

Based on its examination, the 

Department has concluded that this rule 

does not have a significant economic 

impact on a substantial number of small 

entities. The entities that would be 

affected by this final rule, in industries 

described in detail in the RIA, are 

considered small by virtue of either 

nonprofit status or having revenues of 

less than between $7.5 million and 

$38.5 million in average annual 

revenue, with the threshold varying by 

industry. Persons and States are not 

included in the definition of a small 

entity. The Department assumes that 

most of the entities affected meet the 

threshold of a small entity. 

Although this final rule will apply to 

and affect small entities, this rule’s perentity effects are relatively small. The 

Department estimates that this rule 

would result in average cost savings of 

$307 per entity in the primary baseline 

scenario, or an average cost of $129 per 

entity in the alternative baseline 

scenario, over the first five years of 

compliance (both annualized with a 3- 

percent discount rate). Furthermore, any 

costs would generally be proportional to 

the size of an entity, so that the smallest 

affected entities will face lower average 

costs. Given the thresholds discussed in 

the preceding paragraphs, the average 

costs are below the Department’s default 

threshold for significance. 

Because this final rule would result in 

either a small reduction in costs to small 

entities or minimal to no impact on 

costs to small entities, this analysis 

concludes, and the Secretary certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. This finding 

and certification is consistent with the 

regulatory flexibility analysis of the 

2019 Final Rule that would be partially 

rescinded by this regulatory action, 

which ‘‘concluded that this rule does 

not have a significant economic impact 

on a substantial number of small 

entities’’ (84 FR 23255). 

List of Subjects in 45 CFR Part 88 

Adult education, Authority 

delegations (Government agencies), 

Civil rights, Colleges and universities, 

Community facilities, Conflicts of 

interest, Educational facilities, 

Employment, Family planning, Freedom 

of information, Government contracts, 

Government employees, Grant 

programs—health, Grants 

administration, Health care, Health 

facilities, Health insurance, Health 

professions, Hospitals, Immunization, 

Indians—Tribal government, Insurance, 

Insurance companies, 

Intergovernmental relations, 

Laboratories, Maternal and child health, 

Medicaid, Medical and dental schools, 

Medical research, Medicare, Mental 

health programs, Nursing homes, 

Occupational safety and health, 

Prescription drugs, Public assistance 

programs, Public health, Religious 

discrimination, Reporting and 

recordkeeping requirements, Research, 

Scholarships and fellowships, Schools, 

Scientists. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

■ For the reasons set forth in the 

preamble, the Department revises 45 

CFR part 88 to read as follows: 

PART 88—ENSURING THAT 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES FUNDS DO NOT 

SUPPORT COERCIVE OR 

DISCIMINATORY POLICIES OR 

PRACTICES IN VIOLATION OF 

FEDERAL LAW 

Sec. 

88.1 Purpose 

88.2 Complaint handling and investigating. 

88.3 Notice of Federal conscience and 

nondiscrimination laws. 

88.4 Severability. 

Appendix A to Part 88—Model Text: Notice 

of Rights Under Federal Conscience and 

Nondiscrimination Laws 

Authority: 5 U.S.C. 301. 

§ 88.1 Purpose. 

The purpose of this part is to provide 

for the enforcement of the Church 

Amendments, 42 U.S.C. 300a–7; the 

Coats-Snowe Amendment, section 245 

of the Public Health Service Act, 42 

U.S.C. 238n; the Weldon Amendment, 

e.g., Consolidated Appropriations Act, 

2023, Public Law 117–328, div. H, title 

V General Provisions, section 507(d)(1) 

(Dec. 29, 2022); Sections 1303(b)(1)(A), 

(b)(4), and (c)(2)(A), and 1411(b)(5)(A), 

and 1553 of the ACA, 42 U.S.C. 

18023(b)(1)(A), (b)(4), and (c)(2)(A), 

18081(b)(5)(A), and 18113; certain 

Medicare and Medicaid provisions, 42 

U.S.C. 1320a–1(h), 1320c–11, 1395i–5, 

1395w–22(j)(3)(B), 1395x(e), 

1395x(y)(1), 1395cc(f), 1396a(a), 

1396a(w)(3), 1396u–2(b)(3)(B), 1397j– 

1(b), and 14406; the Helms, Biden, 1978, 

and 1985 Amendments, 22 U.S.C. 

2151b(f), accord, e.g., Consolidated 

Appropriations Act, 2023, Public Law 

117–328, div. K, title VII, section 7018 

(Dec. 29, 2022); 22 U.S.C. 7631(d); 42 

U.S.C. 280g–1(d), 290bb–36(f), 1396f, 

1396s(c)(2)(B)(ii); 5106i(a)); and 29 

U.S.C. 669(a)(5), referred to collectively 

as the ‘‘Federal health care conscience 

protection statutes.’’ 

§ 88.2 Complaint handling and 

investigating. 

(a) Delegated authority. The Office for 

Civil Rights (OCR) has been delegated 

the authority to facilitate and coordinate 

the Department’s enforcement of the 

Federal health care conscience 

protection statutes, which includes the 

authority to: 

(1) Receive and handle complaints; 

(2) Initiate compliance reviews; 

(3) Conduct investigations; 

(4) Consult on compliance within the 

Department; 

(5) Seek voluntary resolutions of 

complaints; 

(6) Consult and coordinate with the 

relevant Departmental funding 

component, and utilize existing 


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2108 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 

enforcement regulations, such as those 

that apply to grants, contracts, or other 

programs and services; 

(7) In coordination with the relevant 

component or components of the 

Department, coordinate other 

appropriate remedial action as the 

Department deems necessary and as 

allowed by law and applicable 

regulation; and 

(8) In coordination with the relevant 

component or components of the 

Department, make enforcement referrals 

to the Department of Justice. 

(b) Complaints. Any entity or 

individual may file a complaint with 

OCR alleging a potential violation of 

Federal health care conscience 

protection statutes. OCR shall 

coordinate handling of complaints with 

the relevant Department component(s). 

The complaint filer is not required to be 

the entity whose rights under the 

Federal health care conscience 

protection statutes have been potentially 

violated. 

(c) Compliance reviews. OCR may 

conduct compliance reviews of an entity 

subject to the Federal health care 

conscience protection statutes, where 

authorized for the funding at issue, to 

determine whether they are complying 

with Federal health care conscience 

protection statutes. OCR may initiate a 

compliance review of an entity subject 

to the Federal health care conscience 

protection statutes based on information 

from a complaint or other source that 

causes OCR to suspect non-compliance 

by such entity with the Federal health 

care conscience protection statutes. 

(d) Investigations. OCR shall make a 

prompt investigation of a complaint 

alleging failure to comply with the 

Federal health care conscience 

protection statutes. This investigation 

may include a review of the pertinent 

practices, policies, communications, 

documents, compliance history, 

circumstances under which the possible 

noncompliance occurred, and other 

factors relevant to determining whether 

the Department, Department 

components, recipient, or sub-recipient 

has failed to comply. OCR may use factfinding methods including site visits; 

interviews with the complainants, 

Department components, recipients, 

sub-recipients, or third parties; and 

written data requests. OCR may seek the 

assistance of any State agency. 

(e) Failure to respond. OCR will adopt 

a negative inference if, absent good 

cause, an entity that is subject to the 

Federal health care conscience 

protection statutes fails to respond to a 

request for information or to a data or 

document request within a reasonable 

timeframe. 

(f) Supervision and coordination. If, 

as a result of an investigation, OCR 

makes a determination of 

noncompliance with responsibilities 

under the Federal health care 

conscience protection statutes, OCR will 

coordinate and consult with the 

Departmental component responsible 

for the relevant funding to undertake 

appropriate action with the component 

to assure compliance. 

(g) Resolution of matters. (1) If an 

investigation reveals that no action is 

warranted, OCR will in writing so 

inform any party who has been notified 

by OCR of the existence of the 

investigation. 

(2) If an investigation indicates a 

failure to comply with the Federal 

health care conscience protection 

statutes, OCR will so inform the relevant 

parties and the matter will be resolved 

by informal means whenever possible. 

(3) If a matter cannot be resolved by 

informal means, OCR will coordinate 

with the relevant Departmental 

component to: 

(i) Utilize existing enforcement 

regulations, such as those that apply to 

grants, contracts, or other programs and 

services, or 

(ii) Withhold relevant funding to the 

extent authorized under the statutes 

listed under § 88.1. 

(4) If a matter cannot be resolved by 

informal means, OCR may, in 

coordination with the Office of the 

General Counsel, refer the matter to the 

Department of Justice to the extent 

permitted by law for proceedings to 

enforce the statutes listed under § 88.1. 

§ 88.3 Notice of Federal conscience and 

nondiscrimination laws. 

(a) In general. OCR considers the 

posting of a notice consistent with this 

part as a best practice towards achieving 

compliance with and educating the 

public about the Federal health care 

conscience protection statutes, and 

encourages all entities subject to the 

Federal health care conscience 

protection statutes to post the model 

notice provided in Appendix A to this 

part. OCR will consider posting a notice 

as a factor in any investigation or 

compliance review under this rule. 

(b) Placement of the notice text. The 

model notice in Appendix A to this part 

should be posted in the following 

places, where relevant: 

(1) On the Department or recipient’s 

website(s); 

(2) In a prominent and conspicuous 

physical location in the Department’s or 

covered entity’s establishments where 

notices to the public and notices to its 

workforce are customarily posted to 

permit ready observation; 

(3) In a personnel manual, handbook, 

orientation materials, trainings, or other 

substantially similar document likely to 

be reviewed by members of the covered 

entity’s workforce; 

(4) In employment applications to the 

Department or covered entity, or in 

applications for participation in a 

service, benefit, or other program, 

including for training or study; and 

(5) In any student handbook, 

orientation materials, or other 

substantially similar document for 

students participating in a program of 

training or study, including for 

postgraduate interns, residents, and 

fellows. 

(c) Format of the notice. The text of 

the notice should be large and 

conspicuous enough to be read easily 

and be presented in a format, location, 

and manner that impedes or prevents 

the notice being altered, defaced, 

removed, or covered by other material. 

(d) Content of the notice text. A 

recipient or the Department should 

consider using the model text provided 

in Appendix A to this part for the notice 

but may tailor its notice to address its 

particular circumstances and to more 

specifically address the Federal health 

care conscience protection statutes 

covered by this rule that apply to it. 

Where possible, and where the recipient 

does not have a conscience-based 

objection to doing so, the notice should 

include information about alternative 

providers that may offer patients 

services the recipient does not provide 

for reasons of conscience. 

(e) Combined nondiscrimination 

notices. The Department and each 

recipient may post the notice text 

provided in Appendix A of this part, or 

a notice it drafts itself, along with the 

content of other notices (such as other 

nondiscrimination notices). 

§ 88.4 Severability. 

Any provision of this part held to be 

invalid or unenforceable either by its 

terms or as applied to any entity or 

circumstance shall be construed so as to 

continue to give the maximum effect to 

the provision permitted by law, unless 

such holding shall be one of utter 

invalidity or unenforceability, in which 

event such provision shall be severable 

from this part, which shall remain in 

full force and effect to the maximum 

extent permitted by law. A severed 

provision shall not affect the remainder 

of this part or the application of the 

provision to other persons or entities 

not similarly situated or to other, 

dissimilar circumstances. 


ddrumheller on DSK120RN23PROD with RULES2
Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 2109 

Appendix A to Part 88—Model Text: 

Notice of Rights Under Federal 

Conscience and Nondiscrimination 

Laws 

[Name of entity] complies with applicable 

Federal health care conscience protection 

statutes, including the Church Amendments, 

42 U.S.C. 300a–7; the Coats-Snowe 

Amendment, section 245 of the Public Health 

Service Act, 42 U.S.C. 238n; the Weldon 

Amendment, e.g., Consolidated 

Appropriations Act, 2023, Public Law 117– 

328, div. H, title V General Provisions, 

section 507(d)(1) (Dec. 29, 2022); Sections 

1303(b)(1)(A), (b)(4), and (c)(2)(A), and 

1411(b)(5)(A), and 1553 of the ACA, 42 

U.S.C. 18023(b)(1)(A), (b)(4), and (c)(2)(A), 

18081(b)(5)(A), and 18113; certain Medicare 

and Medicaid provisions, 42 U.S.C. 1320a– 

1(h), 1320c–11, 1395i–5, 1395w–22(j)(3)(B), 

1395x(e), 1395x(y)(1), 1395cc(f), 1396a(a), 

1396a(w)(3), 1396u–2(b)(3)(B), 1397j–1(b), 

and 14406; the Helms, Biden, 1978, and 1985 

Amendments, 22 U.S.C. 2151b(f), accord, 

e.g., Consolidated Appropriations Act, 2023, 

Public Law 117–328, div. K, title VII, section 

7018 (Dec. 29, 2022); 22 U.S.C. 7631(d); 42 

U.S.C. 280g–1(d), 290bb–36(f), 1396f, 

1396s(c)(2)(B)(ii); 5106i(a)); and 29 U.S.C. 

669(a)(5). More information to help entities 

determine which statutes are applicable to 

them is available at https://www.hhs.gov/ 

conscience/conscience-protections/ 

index.html. You may have rights as a 

provider, patient, or other individual under 

these Federal statutes, which prohibit 

coercion or other discrimination on the basis 

of conscience, whether based on religious 

beliefs or moral convictions, in certain 

circumstances. If you believe that [Name of 

entity] has violated any of these provisions, 

you may file a 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://www.hhs.gov/ocr/ 

complaints/index.html 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) or by email at ocrmail@hhs.gov. 

Complaint forms and more information about 

Federal conscience protection laws are 

available at https://www.hhs.gov/conscience. 

[FR Doc. 2024–00091 Filed 1–9–24; 8:45 am] 

BILLING CODE 4153–01–P 


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