[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Rules and Regulations]
[Pages 2078-2109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00091]



[[Page 2077]]

Vol. 89

Thursday,

No. 8

January 11, 2024

Part IV





Department of Health and Human Services





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





45 CFR Part 88





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





Safeguarding the Rights of Conscience as Protected by Federal Statutes; 
Final Rule

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

[[Page 2078]]


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

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 
<a href="/cdn-cgi/l/email-protection#c5a6aaabb6a6aca0aba6a0b7b0a9a085adadb6eba2aab3"><span class="__cf_email__" data-cfemail="82e1edecf1e1ebe7ece1e7f0f7eee7c2eaeaf1ace5edf4">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#9af9f5f4e9f9f3fff4f9ffe8eff6ffdaf2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="5b3834352838323e35383e292e373e1b333328753c342d">[email protected]</span></a>.

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        916
     Rule........................................................
    C. Comments Addressing the Proposed Rule's Requests for          941
     Comment.....................................................
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 
Department-implemented 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

[[Page 2079]]

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 health-related 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. Sec.  
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 
Labor-HHS 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 provider-sponsored organization, a health maintenance 
organization, a health insurance plan, or any other kind of health care 
facility, organization, or plan.''

[[Page 2080]]

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'').
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

Federal Conscience and Anti-Discrimination Protections Applying to 
Global Health Programs
    The Department administers certain programs under the President's 
Emergency Plan for AIDS Relief (PEPFAR), to which additional conscience 
protections apply. Specifically, recipients of foreign assistance funds 
for HIV/AIDS prevention, treatment, or care authorized by section 104A 
of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b-2), 22 U.S.C. 
7601-7682, or under any amendment made by the Tom Lantos and Henry J. 
Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, 
and Malaria Reauthorization Act of 2008 (Pub. L. 110-293), cannot be 
required, as a condition of receiving such funds, (1) to ``endorse or 
utilize a multisectoral or comprehensive approach to combating HIV/
AIDS,'' or (2) to ``endorse, utilize, make a referral to, become 
integrated with, or otherwise participate in any program or activity to 
which the organization has a religious or moral objection.'' 22 U.S.C. 
7631(d)(1)(B). The government 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).

[[Page 2081]]

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 non-compliance 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

[[Page 2082]]

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 sub-regulatory 
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 Sec.  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 non-profits, 
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

[[Page 2083]]

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.
---------------------------------------------------------------------------

    \2\ See ``Nondiscrimination in Health Programs and Activities,'' 
87 FR 47824 (Aug. 4, 2022).
    \3\ See lengthier discussion of this principle on pages 40-41, 
below.
---------------------------------------------------------------------------

B. Comments Addressing Sec. Sec.  88.1-88.4 of the Proposed Rule

1. Comments Addressing Sec.  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 Sec.  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, Coats-Snowe, 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.
---------------------------------------------------------------------------

    \4\ For 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).
---------------------------------------------------------------------------

    Comment: Some commenters, including professional health care

[[Page 2084]]

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.''
---------------------------------------------------------------------------

    \5\ The 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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

    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 case-by-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

[[Page 2085]]

example, contains its own religious and conscience exemption process at 
proposed Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  88.1 of the 2019 Final Rule in support of its view 
that that rule was substantive.
---------------------------------------------------------------------------

    \7\ 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.
---------------------------------------------------------------------------

    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 Sec.  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 Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \8\ ``Protecting Statutory Conscience Rights in Health Care; 
Delegations of Authority,'' 83 FR 3880, 3901 (Jan. 26, 2018)
---------------------------------------------------------------------------

2. Comments Addressing Sec.  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,

[[Page 2086]]

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 Sec.  88.2(a)(4) in 
conjunction with proposed Sec.  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 Sec.  
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 Sec.  88.2(a)(2) and 
a new Sec.  88.2(c). The Department also notes OCR's authority in Sec.  
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 Sec.  88.2(d), now Sec.  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 Sec.  
88.1. Finally, the Department is also adding in Sec.  88.2(a)(8) a 
reference to, and a new paragraph in Sec.  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 Sec.  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 anti-religious 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 over-regulating 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

[[Page 2087]]

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-by-case 
basis. This approach creates a more efficient and powerful method for 
ensuring compliance with the various statutes.
---------------------------------------------------------------------------

    \9\ See 45 CFR 160.304.
    \10\ See 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.
---------------------------------------------------------------------------

    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 Sec.  88.2(a) and a new Sec.  88.2(c). The 
Department also notes OCR's authority in Sec.  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 Sec.  88.2(d), now Sec.  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 Sec.  88.1. 
Finally, the Department notes its authority in Sec.  88.2(a)(8) to make 
enforcement referrals to the Department of Justice, and is adding a new 
paragraph (4) to proposed Sec.  88.2(d), now Sec.  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 Anti-
Semitism, 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\
---------------------------------------------------------------------------

    \11\ See Press Release, The White House, Fact Sheet: Biden-
Harris Administration Releases First-Ever U.S. National Strategy to 
Counter Antisemitism (May 25, 2023), https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/25/fact-sheet-biden-harris-administration-releases-first-ever-u-s-national-strategy-to-counter-antisemitism/.
    \12\ See 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/for-individuals/special-topics/shared-ancestry-or-ethnic-characteristics-discrimination/index.html.
    \13\ See 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.
---------------------------------------------------------------------------

    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 Sec.  
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 gender-affirming 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 Sec.  88.2(b), now Sec.  88.2(d) of this final rule, text from 
Sec.  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 Sec.  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.

[[Page 2088]]

    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 Sec.  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.
---------------------------------------------------------------------------

    \15\ See, 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.
---------------------------------------------------------------------------

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 Sec.  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.
---------------------------------------------------------------------------

    \16\ See lengthier discussion of this principle on pages 40-41, 
below.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \17\ 76 FR 9968, 9973-74 (2011).
---------------------------------------------------------------------------

    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

[[Page 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 Sec.  88.2(a) and a new 
Sec.  88.2(c); noting OCR's authority in Sec.  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 Sec.  88.2(d), now Sec.  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 Sec.  92.302 for 
individuals to raise requests for a conscience or religious freedom 
exemption, 87 FR 47885-47886.
3. Comments Addressing Sec.  88.3
General Support
    Comment: Many commenters, including a national association of 
faith-based medical and dental providers and a national hospital 
association of faith-based 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 Sec.  88.6 of the 
2019 Final Rule and the provision from Sec.  88.5 of the 2019 Final 
Rule, which noted that posting the voluntary notice would constitute 
``non-dispositive 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

[[Page 2090]]

a covered entity by the underlying statutes. The proposed rule and this 
final rule modify Sec.  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 Sec.  88.5 of the 2019 Final Rule, the 
Department is finalizing Sec.  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 Sec.  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 
Sec.  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 Sec.  88.6(c) of the 
2019 Final Rule, however, this final rule includes a notice to covered 
entities in Sec.  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 Sec.  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\
---------------------------------------------------------------------------

    \18\ 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.
---------------------------------------------------------------------------

    Comment: A commenter argued that the following language in proposed 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  88.4.

[[Page 2091]]

    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 Sec.  88.2, 
for instance, operate independently of each other. Likewise, the notice 
provision at Sec.  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 Sub-Regulatory 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 case-by-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.
---------------------------------------------------------------------------

    \19\ U.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.
---------------------------------------------------------------------------

Whether the Problems Giving Rise to Rulemaking Could Be Addressed by 
Different Regulations or by Sub-Regulatory 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 in-network 
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 (Sec.  88.2(a) and a new Sec.  
88.2(c)), coordinating other appropriate remedial action (Sec.  
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 (Sec.  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, low-
income communities, people with HIV, and people with substance use 
disorder. Numerous commenters discussed general health disparities and 
heightened discrimination against LGBTQI+ individuals, including access

[[Page 2092]]

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-of-life 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-of-life 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

[[Page 2093]]

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

[[Page 2094]]

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 Sec.  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

[[Page 2095]]

to virtually any other person in the health care setting.
---------------------------------------------------------------------------

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

    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 Sec.  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\
---------------------------------------------------------------------------

    \22\ The 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.
---------------------------------------------------------------------------

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

[[Page 2096]]

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.
---------------------------------------------------------------------------

    \23\ See 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/hhs-announces-new-divisions-within-office-civil-rights-better-address-growing-need-enforcement-recent-years.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

    Comment: Some commenters, including a faith-based organization, 
expressed opposition to the removal of the compliance requirements at 
Sec.  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 fact-intensive 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 Sec.  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 Sec.  88.3 and the compliance requirements at Sec.  88.6. 
Specifically, the applicable requirements and prohibitions that 
appeared at Sec.  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 
Sec.  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.
---------------------------------------------------------------------------

    \25\ The 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.
    \26\ See 84 FR 23170, 23219 (May 21, 2019).
---------------------------------------------------------------------------

    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 Sec.  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 (Sec.  88.2(a) and a new 
Sec.  88.2(c)), coordinating other appropriate remedial action (Sec.  
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 (Sec.  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 Sec.  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 case-by-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 
Sec.  88.9 and Sec.  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

[[Page 2097]]

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 Sec.  88.10 of the 2019 Final Rule is 
retained at Sec.  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 over-relied 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 Sec.  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 Sec.  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 Sec.  88.4 were overly burdensome. The Department also 
determined that the requirements at Sec.  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 Sec.  88.6, the relationship to other 
laws provision at Sec.  88.8, and rule of construction at Sec.  88.9 
(which was echoed in Sec.  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 Sec.  88.1, several of the definitions at Sec.  
88.2, and the assurance and certification requirements at Sec.  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 Sec.  88.1, several of the definitions at Sec.  88.2, and 
the assurance and certification requirements at Sec.  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.
---------------------------------------------------------------------------

    \27\ The 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.
    \28\ See 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.
---------------------------------------------------------------------------

    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 Sec.  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 Sec.  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 Sec.  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

[[Page 2098]]

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 Sec. Sec.  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 Sec.  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

[[Page 2099]]

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 Sec.  88.2
General Support
    Comment: Numerous commenters, including some faith-based 
organizations, expressed general support for retaining the complaint 
handling and investigation provisions in Sec.  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 Sec.  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 (Sec.  88.2(a) and a new Sec.  88.2(c)), 
coordinating other appropriate remedial action (Sec.  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 (Sec.  88.2(g)(3)) or to refer to the Attorney 
General (Sec.  88.2(g)(4)) where a matter cannot be resolved by 
informal means.
---------------------------------------------------------------------------

    \29\ Section 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.
---------------------------------------------------------------------------

    Comment: Many commenters expressed concern that the modifications 
to Sec.  88.7 of the 2019 Final Rule (Sec.  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 fact-finding 
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 Sec.  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 Sec.  88.2(b) as Sec.  
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 
Sec.  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 Sec.  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 Sec. Sec.  88.7 and 
88.8 of the 2019 Final Rule.

[[Page 2100]]

    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 (Sec.  88.2(a) and a new Sec.  
88.2(c)), coordinating other appropriate remedial action (Sec.  
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 (Sec.  88.2(g)(3)). The Department declines, 
however, to add Sec.  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.
---------------------------------------------------------------------------

    \30\ See 45 CFR 160.304.
    \31\ See 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)).
---------------------------------------------------------------------------

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 Sec.  88.7 of the 2019 Final Rule has been 
revised and redesignated as Sec.  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 Sec.  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 Sec.  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 Sec.  88.2(d) and describes 
OCR's investigation process. In response to comments, the Department is 
finalizing Sec.  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 
Sec.  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 Sec.  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 Sec.  88.2(c) has been redesignated as Sec.  
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 Sec.  88.2(d) has been redesignated as Sec.  88.2(g) 
and describes OCR's process for achieving resolution of matters. In

[[Page 2101]]

response to comments, the Department is finalizing Sec.  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 Sec.  88.1'' where informal 
means of achieving compliance have failed to resolve a given matter. In 
response to comments, the Department is also finalizing Sec.  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 Sec.  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 Sec.  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.

[[Page 2102]]

    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 Sec.  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

[[Page 2103]]

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 non-quantified 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.

[[Page 2104]]

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.
---------------------------------------------------------------------------

    \32\ U.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.
---------------------------------------------------------------------------

    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;

[[Page 2105]]

(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.
---------------------------------------------------------------------------

    \33\ The Department also keeps the severability clause from the 
2019 Final Rule.
---------------------------------------------------------------------------

    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

[[Page 2106]]

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]
----------------------------------------------------------------------------------------------------------------
                                                                  Present value by         Annualized value by
                                                                    discount rate             discount rate
             Baseline scenario and policy option             ---------------------------------------------------
                                                               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            -555.2       -435.9       -121.2        -95.2
     Provision).............................................
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             470.8        420.9        102.8         91.9
     Provision).............................................
----------------------------------------------------------------------------------------------------------------
Notes: Negative costs indicate the Policy Option, if finalized would result in cost savings.


[[Page 2107]]

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 health-care 
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 per-entity 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.

0
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.


Sec.  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.''


Sec.  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

[[Page 2108]]

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 fact-finding 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 Sec.  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 Sec.  88.1.


Sec.  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).


Sec.  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.

[[Page 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 <a href="/cdn-cgi/l/email-protection#bfd0dccdd2ded6d3ffd7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="58373b2a353931341830302b763f372e">[email protected]</span></a>. 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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>