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Rule2024-00091

Safeguarding the Rights of Conscience as Protected by Federal Statutes

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Published

January 11, 2024

Effective

March 11, 2024

Issuing agencies

Health and Human Services Department

Abstract

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.

Full Text

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<title>Federal Register, Volume 89 Issue 8 (Thursday, January 11, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00091]

[[Page 2077]]

Vol. 89

Thursday,

No. 8

January 11, 2024

Part IV

Department of Health and Human Services

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45 CFR Part 88

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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]]

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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

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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&#160;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&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Electronic Access

This Federal Register document is also available from the Federal
Register online database through <a href="http://www.govinfo.gov">http://www.govinfo.gov</a>, 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'').
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\1\ In 2017 Congress effectively eliminated the penalty for
noncompliance by reducing it to zero. See Tax Cuts and Jobs Act of
2017, Public Law 115-97, 11081, 131 Stat. 2092 (codified in 26
U.S.C. 5000A(c)).
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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.
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\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.
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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).
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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, <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>.
---------------------------------------------------------------------------

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.
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\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.
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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), <a href="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/">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/</a>.
\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), <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/shared-ancestry-or-ethnic-characteristics-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/shared-ancestry-or-ethnic-characteristics-discrimination/index.html</a>.
\13\ See Off. of Intergovernmental and External Affairs, Ctr.
for Faith-based and Neighborhood Partnerships (Partnership Center)
Homepage, (updated as of September 21, 2023), <a href="https://www.hhs.gov/about/agencies/iea/partnerships/index.html">https://www.hhs.gov/about/agencies/iea/partnerships/index.html</a>.
\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.
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\15\ See, e.g., U.S. Dep't of Health and Human Servs., Off. for
Civil Rights, Complaint Portal Assistant, <a href="https://ocrportal.hhs.gov/ocr/smartscreen/main.jsf">https://ocrportal.hhs.gov/ocr/smartscreen/main.jsf</a>.
---------------------------------------------------------------------------

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\
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\18\ See U.S. Dep't of Health and Human Servs., Off. for Civil
Rights, Conscience and Religious Nondiscrimination, <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>.
---------------------------------------------------------------------------

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 <a href="http://www.hhs.gov/ocr/complaints">www.hhs.gov/ocr/complaints</a>.
---------------------------------------------------------------------------

\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), <a href="https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/index.html</a>.
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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.
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\20\ ``The Federal Government, and any State or local government
or health care provider that receives Federal financial assistance
under this Act (or under an amendment made by this Act) or any
health plan created under this Act (or under an amendment made by
this Act), may not subject an individual or institutional health
care entity to discrimination on the basis that the entity does not
provide any health care item or service furnished for the purpose of
causing, or for the purpose of assisting in causing, the death of
any individual, such as by assisted suicide, euthanasia, or mercy
killing.'' 42 U.S.C. 18113(a).
---------------------------------------------------------------------------

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\
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\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, <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>. 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), <a href="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">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</a>.
---------------------------------------------------------------------------

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, <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>. 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, <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>. 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), <a href="https://www.hhs.gov/sites/default/files/form-hhs690.pdf">https://www.hhs.gov/sites/default/files/form-hhs690.pdf</a>.
---------------------------------------------------------------------------

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

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