[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Proposed Rules]
[Pages 820-830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 88

RIN 0945-AA18


Safeguarding the Rights of Conscience as Protected by Federal 
Statutes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The Department proposes 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''). The 
Department also proposes to retain, with some modifications, certain 
provisions of the 2019 Final Rule regarding federal conscience 
protections but eliminate others because they are redundant or 
confusing, because they undermine the balance Congress struck between 
safeguarding conscience rights and protecting access to health care 
access, or because significant questions have been raised as to their 
legal authorization. Further, the Department seeks to determine what 
additional regulations, if any, are necessary to implement certain 
conscience protection laws. The Department is seeking public comment on 
the proposal to retain certain provisions of the 2019 Final Rule, 
including on any alternative approaches for ensuring compliance with 
the conscience protection laws.

DATES: Written comments must be received on or before March 6, 2023.

ADDRESSES: You may submit comments, identified by the Regulatory 
Information Number (RIN) [RIN 0945-AA18] by any of the following 
methods. The first is the preferred method. Please submit your comments 
in only one of these ways to minimize the receipt of duplicate 
submissions.
    1. Federal eRulemaking Portal. You may submit comments 
electronically to https://www.regulations.gov. Submit

[[Page 821]]

your comments as an attachment to your message or cover letter. 
[Attachments should be in Microsoft Word, WordPerfect, or Excel; 
however, Microsoft Word is preferred.] Follow the instructions for 
sending comments contained in the website link ``Comment or 
Submission'' and enter the keywords, ``Conscience Recission NPRM.''
    2. By regular, express or overnight mail. You may mail written 
comments to the following address only: U.S. Department of Health and 
Human Services, Office for Civil Rights, Attention: Conscience NPRM, 
RIN 0945-AA18, Hubert H. Humphrey Building, Room 509F, 200 Independence 
Avenue SW, Washington, DC 20201. Please allow sufficient time for 
mailed comments to be received before the close of the comment period.
    3. Delivery by hand (in person or by courier). If you prefer, you 
may deliver your written comments before the close of the comment 
period to the same address: U.S. Department of Health and Human 
Services, Office for Civil Rights, Attention: Conscience NPRM, RIN 
0945-AA18, Hubert H. Humphrey Building, Room 509F, 200 Independence 
Avenue SW, Washington, DC 20201.
    Because of staffing and resource limitations, and to ensure that no 
comments are misplaced, the agency cannot accept comments by facsimile 
(FAX) transmission. All comments received on a timely basis will be 
posted without change to https://www.regulations.gov, including any 
personal information provided.
    Docket: For complete access to the docket to read background 
documents or comments received, go to https://www.regulations.gov and 
search for Docket ID number HHS-OCR-0945-AA18.

FOR FURTHER INFORMATION CONTACT: Pamela Barron at (800) 368-1019 or 
(800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) urges all interested parties to examine this regulatory proposal 
carefully and to share your views with us, including any data to 
support your positions. If you have questions before submitting 
comments, please see FOR FURTHER INFORMATION CONTACT for the name and 
contact information of the Office for Civil Rights point of contact for 
this proposed regulation.
    If you are a person with a disability and/or a user of assistive 
technology who has difficulty accessing this document, please contact 
the Office for Civil Rights using the name and contact information 
provided in FOR FURTHER INFORMATION CONTACT to obtain this information 
in an accessible format. Please visit https://www.HHS.gov/regulations 
for more information on HHS rulemaking and opportunities to comment on 
proposed and existing rules.

I. Background

Statutory Background

    Several provisions of Federal law prohibit recipients of certain 
Federal funds from coercing individuals and entities in the health care 
field into participating 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 at 
various times during the 1970s in response to debates over whether 
receipt of Federal funds required the recipients of such funds to 
perform abortions or sterilizations. The first conscience provision in 
the Church Amendments, 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 conscience provision in the Church Amendments, 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 religious beliefs or moral 
convictions, or because of his religious beliefs or moral convictions 
respecting sterilization procedures or abortions.''
    The third conscience provision, contained in 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 conscience 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 final conscience provision contained in the Church Amendments, 
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 [42 U.S.C. 238n] (Coats-Snowe 
Amendment)

    Enacted in 1996, section 245 of the Public Health Service Act (PHS 
Act) prohibits the Federal Government and

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any State or local government 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 government 
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 include certain conscience 
provisions as well. In particular, the Balanced Budget Act of 1997, 
Public Law 105-33, 111 Stat. 251 (1997), prohibits Medicaid managed 
care-managed organizations and Medicare Advantage plans from 
prohibiting or restricting a physician from informing a patient about 
his or her health and full range of treatment options. See id. 
40011852(j)(3)(A), 111 Stat. at 295 (codified at 42 U.S.C. 1395w-
22(j)(3)(A)) (Medicare Advantage); id. 4704(b)(3)(A), 111 Stat. at 496 
(codified at 42 U.S.C. 1396u-2(b)(3)(A)) (Medicaid managed care). 
However, it also provides that Medicaid managed care-managed 
organizations and Medicare Advantage plans are not required to provide, 
reimburse for, or cover a counseling or referral service if the 
organization or plan objects to the service on moral or religious 
grounds. See id. 40011852(j)(3)(B), 111 Stat. at 295 (codified at 42 
U.S.C. 1395w-22(j)(3)(B)) (Medicare Advantage); id. 4704(b)(3)(B), 111 
Stat. at 496-97 (codified at 42 U.S.C. 1396u-2(b)(3)(B)) (Medicaid). 
The organization or plan must, however, provide sufficient notice of 
its moral or religious objections to prospective enrollees. 42 U.S.C. 
1395w-22(j)(3)(B)(ii) (Medicare Advantage), 1396u-2(b)(3)(B)(ii) 
(Medicaid managed care).
    These Medicare and Medicaid statutes also contain conscience 
provisions related to the performance of advanced directives. See 42 
U.S.C. 1395cc(f), 1396a(w)(3), and 14406(2). And finally, 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).

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 by reference) in each subsequent legislative 
measure appropriating funds to HHS. See, e.g., Consolidated 
Appropriations Act, 2022, Public Law 117-103, div. H, title V General 
Provisions, section 507(d)(1) (Mar.15, 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.''

Affordable Care Act

    In 2010, Congress passed 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.). This statute also includes certain other 
provisions including specific conscience provisions in sections 1553, 
1303(a)(3)-(b)(2), and 1411(b)(5)(A).
    Section 1553 provides that 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, may 
not subject 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 provides that a State may choose to prohibit abortion 
coverage in its qualified health plans, 42 U.S.C. 18023(a)(1), and that 
such a plan is not required to provide abortion coverage as part of its 
``essential health benefits,'' id. 18023(b)(1)(A)(i). However, a 
qualified health plan that declines to provide abortion coverage must 
provide notice of this exclusion to potential enrollees. Id. 
18023(b)(3)(A). And no qualified health plan may discriminate against 
any health care provider or facility because it refuses to provide, pay 
for, cover, or refer for abortions. Id. 18023(b)(4). Section 1303 
states that nothing in the ACA shall be construed to preempt state laws 
on abortion or federal laws on conscience protection, willingness or 
refusal to provide abortion, and discrimination based on that 
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)(1)-(2), or to relieve health care providers of their 
obligations to provide emergency services under federal or state laws, 
including the Emergency Medical Treatment and Labor Act, id. 18023(d). 
Section 1303 also states that it does not ``alter the rights and 
obligations of employees and employers'' under Title VII. See id. 
18023(c)(3).
    Section 1411 addresses exemptions to the ACA's ``individual 
responsibility requirement.'' 42 U.S.C. 18081(b)(5)(A). 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

[[Page 823]]

organization, or membership in a ``health care sharing ministry.'' \1\
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    \1\ In 2017 Congress effectively nullified the practical effect 
of this provision by setting the related payment associated with 
noncompliance to $0. 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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Other Provisions

    A number of additional provisions relating to conscience and 
religious liberty have also been the subject of previous HHS 
rulemaking. These include provisions related to compulsory health care 
services generally (42 U.S.C. 1396f and 5106i(a)), under hearing 
screening programs (42 U.S.C. 280g-1(d)), occupational illness testing 
(29 U.S.C. 699(a)(5)), vaccination programs (42 U.S.C. 
1396s(c)(2)(B)(ii)), and mental health treatment (42 U.S.C. 290bb-
36(f)). These also include conscience and nondiscrimination provisions 
tied to certain funding in global health programs and other funds 
administered by the Secretary. See 22 U.S.C. 7631(d) and 22 U.S.C. 
2151b(f).

Rulemaking

    No statutory provision 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) 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 final rule went into effect on January 20, 2009, except that a 
certification requirement it imposed 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, after receiving more than 
300,000 comments, 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 rule 
proposed reinstating several rescinded provisions of the Final 2008 
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 more 
than 242,000 comments, from a wide variety of individuals and 
organizations, including private citizens, individual and institutional 
health care providers, religious organizations, patient advocacy 
groups, professional organizations, universities and research 
institutions, consumer organizations, and State and Federal agencies 
and representatives. Comments dealt with a range of issues surrounding 
the proposed rule, including 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 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.
    Following the issuance of the 2019 Final Rule, a number of States, 
localities, and non-governmental parties filed suit 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 and on a nationwide 
basis. See Washington v. Azar, 426 F. Supp. 3d 704 (E.D. Wash. 2019), 
appeal pending, No. 20-35044 (9th Cir.); City & Cnty. of

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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 pending, Nos. 19-4254 et al. (2d 
Cir.).\2\ The courts' rationales were not identical, but they 
collectively concluded that the rule was defective in a number of 
respects. One or more courts held that: (i) the rule exceeded the 
Department's authority; (ii) its provisions were 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) the rule 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) a particular definitional provision of the rule was 
not promulgated in compliance with the notice-and-comment requirements 
of the Administrative Procedure Act; and (v) the rule's penalties for 
non-compliance with conscience provisions violated the separation of 
powers and the Spending Clause.
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    \2\ Each court held that the portions of the rule deemed 
unlawful were so intertwined with any lawful portions that the 
entire rule would be vacated, rather than individual provisions. See 
City & Cnty. of San Francisco v. Azar, 411 F. Supp. 3d at 1024-25 
(``When a rule is so saturated with error, as here, there is no 
point in trying to sever the problematic provisions. The whole rule 
must go.''); New York v. HHS., 414 F. Supp. 3d at 577 (``[T]he 
rulemaking exercise here was sufficiently shot through with glaring 
legal defects as to not justify a search for survivors.'').
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    Because the 2019 Final Rule never took effect, HHS has been 
operating under the 2011 Final Rule continuously since it was 
finalized. It currently accepts, investigates, and processes complaints 
under the framework created by the 2011 Final Rule. There are no 
significant reliance interests stemming from the 2019 Final Rule 
because the rule was vacated before it became effective. Because the 
2019 Final Rule never went into effect, no person or entity could have 
reasonably relied on its provisions. It is possible that health care 
providers or individuals have reasonably relied on the 2011 Final Rule 
because it has remained operational.
    As part of this proposed rulemaking, HHS seeks comments on the 
approach contemplated by the 2019 Final Rule as well as comments on the 
general framework that OCR has been employing since 2011--applying the 
plain text of the underlying statutes to the facts at issue on a case-
by-case basis.

II. Proposed Rule

    The Department is proposing to partially rescind 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), while leaving in effect the framework created 
by the February 23, 2011, Final Rule and retaining, with some 
modifications, certain provisions of the 2019 Final Rule.
    Though the Department received comments supporting and opposing the 
2018 Proposed Rule (the basis for the 2019 Final Rule), the 
overwhelming majority of comments were in opposition to the rule.
    Groups supporting the 2018 Proposed Rule said it would provide 
needed clarity and strengthen protections for conscience rights in 
health care. For example, a comment jointly filed by the U.S. 
Conference of Catholic Bishops, the National Association of 
Evangelicals, the Southern Baptist Ethics & Religious Liberty 
Commission, the Christian Legal Society, the Catholic Medical 
Association, and the Family Research Council commended the Department 
on the breadth of the proposed regulations, saying they would ``provide 
much needed guidance as to the meaning of the conscience statutes.'' 
\3\ The Catholic Health Association (CHA) filed a separate comment 
supporting the proposed rule, noting its belief that ``[a]ccess to 
health care is essential to promote and protect the inherent and 
inalienable worth and dignity of every individual,'' and that 
``organizations and individuals should not be required to participate 
in, pay for, provide coverage for or refer for services that directly 
contradict their deeply held religious or moral beliefs and 
convictions.'' \4\ According to CHA, ``[t]he lack of implementing 
regulations and of clarity concerning enforcement mechanisms for these 
laws has stymied their effectiveness.'' Thus, CHA welcomed the proposed 
rule, saying it ``effectively reflects the intent and content of the 
underlying laws. . . .'' \5\
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    \3\ Letter from USCCB, NAE, CMA, CLS, ELRC, and FRC to HHS (Mar. 
16, 2018) available at https://www.regulations.gov/comment/HHS-OCR-2018-0002-27795. The American Association of Pro-Life Obstetricians 
and Gynecologists also filed comments in support of the proposed 
rule. Letter from AAPLOG to HHS (Mar. 26, 2018), available at 
https://www.regulations.gov/comment/HHS-OCR-2018-0002-67019.
    \4\ Letter from the Catholic Health Association to HHS (Mar. 27, 
2018), available at https://www.regulations.gov/comment/HHS-OCR-2018-0002-70534.
    \5\ Id.
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    Other commenters opposed to the 2018 Proposed Rule raised a number 
of concerns, including that the rule would create confusion, place 
unnecessary burdens on covered entities, limit access to patient care, 
and result in individuals being denied access to services, with 
vulnerable populations being particularly affected. The American 
Medical Association, for example, commented that the proposed rule 
would undermine patients' access to care and information, impede 
research, and create confusion among providers about their legal and 
ethical obligations to treat patients.\6\ The American Academy of 
Family Physicians, American Nurses Association, American Academy of 
Nursing, American Congress of Obstetricians and Gynecologists, American 
College of Emergency Physicians and American Academy of Pediatrics, 
similarly raised concerns about the rule's effect on patients' 
abilities to access critical care.\7\ The American Psychological 
Association raised concerns about the rule's potential harm to women 
and sexual and gender minorities.\8\ The Association of American 
Medical Colleges commented that the rule was overly expansive and 
incongruous with medical professionalism, among other concerns.\9\ A 
coalition of state attorneys general commented that the rule would, 
among other things, undermine state health care laws and policies that 
protect patients, and lead to discrimination against patients.\10\ 
Several reproductive health organizations similarly commented that the 
proposed rule would upset the statutory balance between protecting 
providers' conscience rights and patients' ability to access 
reproductive care.\11\ The National Coalition for LGBTQ Health 
commented that the

[[Page 825]]

proposed rule would lead to increased discrimination and denials of 
care for vulnerable members of the LGBTQ community.\12\
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    \6\ Letter from the AMA to HHS (Mar. 27, 2018), available at 
https://www.regulations.gov/comment/HHS-OCR-2018-0002-70564.
    \7\ See Letter from AAFP to HHS (Mar. 20, 2018) available at 
https://www.regulations.gov/document/HHS-OCR-2018-0002-34646; Letter 
from ANA-AAN to HHS (Mar. 23, 2018) available at https://www.regulations.gov/document/HHS-OCR-2018-0002-55870; Letter from 
ACOG to HHS (Mar. 27, 2018) available at https://www.regulations.gov/document/HHS-OCR-2018-0002-70647; Letter from 
ACEP to HHS (Mar. 27, 2018); and Letter from AAP to HHS (Mar. 27, 
2018) available at https://www.regulations.gov/document/HHS-OCR-2018-0002-71022.
    \8\ Letter from APA to HHS (Mar. 26, 2018) available at https://www.regulations.gov/document/HHS-OCR-2018-0002-71056.
    \9\ Letter from AAMC to HHS (Mar. 26, 2018) available at https://www.regulations.gov/document/HHS-OCR-2018-0002-67592.
    \10\ Letter from Attorneys General to HHS (Mar. 27, 2018) 
available at https://www.regulations.gov/comment/HHS-OCR-2018-0002-70188.
    \11\ E.g., Letter from Nat'l Family Planning and Reproductive 
Health Assoc. to HHS (Mar. 27, 2018) available at https://www.regulations.gov/comment/HHS-OCR-2018-0002-70260.
    \12\ Letter from The Nat'l Coalition for LGBT Health to HHS 
(Mar. 27, 2018) available at https://www.regulations.gov/comment/HHS-OCR-2018-0002-71195.
---------------------------------------------------------------------------

    Comments received on the 2018 Proposed Rule made valuable points 
about the importance of federal conscience protections as well as the 
importance of access to care free from discrimination. For this and 
other reasons, the Department is proposing to retain certain provisions 
from the 2019 Final Rule with modifications while rescinding others, 
and generally reinstating 2011 framework that has been in effect for 
some time.
    The Department proposes to retain three aspects of the 2019 Final 
Rule: (1) the application to statutes first referenced in the 2019 
Final Rule; (2) several enforcement provisions; and (3) a voluntary 
notice provision. The provisions proposed to be retained have been 
modified to address concerns raised by many of the commenters--and 
echoed in federal district court decisions--about the Department's 
underlying rulemaking authority.\13\ The new proposed rule relies on 
the Department's housekeeping authority under 5 U.S.C. 301, which 
permits the Department to issue regulations concerning its own internal 
procedures and operations, and therefore allows for the modifications 
in this proposed rule.
---------------------------------------------------------------------------

    \13\ See, e.g., New York v. United States Dep't of Health & Hum. 
Servs., 414 F. Supp. 3d 475, 521-22 (S.D.N.Y. 2019) (neither 
housekeeping authority nor general compliance powers are a basis for 
substantive rulemaking).
---------------------------------------------------------------------------

    First, the Department proposes to expand the category of ``federal 
health care provider conscience protection statutes'' covered by the 
rule to include the statutes that HHS added to Sec.  88.3 in the 2019 
Final Rule. Those statutes, which are described above, include 
conscience protections embedded in a wide range of Department programs, 
including Medicare and Medicaid, the administration of the Affordable 
Care Act, global health programs, health screenings, and more. 
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, 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.
    Second, the Department proposes to retain a number of provisions 
from the 2019 Final Rule related to complaint handling and 
investigations. In the proposed Sec.  88.2, the Department expands upon 
the 2011 Final Rule's description of complaint handling and 
investigation. Paragraph (a) describes OCR's authority to receive and 
handle complaints, seek voluntary compliance, and work with relevant 
Department components to ensure compliance through existing enforcement 
mechanisms. Paragraph (b) describes how OCR will conduct 
investigations. Paragraph (c) describes how OCR will proceed if an 
investigation reveals a violation of a federal health care provider 
conscience protection statute, and paragraph (d) provides that OCR will 
seek voluntary resolution of violations and will inform relevant 
parties if it has found no violation.
    Finally, the Department proposes to retain the 2019 Final Rule's 
voluntary notice provisions, with some modifications to address 
concerns identified above. Notice of conscience protections and 
nondiscrimination laws under those provisions is an important means of 
promoting compliance. Such notices inform the public, patients, and 
workforce, which may include students or applicants for employment or 
training, of protections under the Federal conscience and 
nondiscrimination laws and this rule.
    This proposed notice would advise persons and covered entities 
about their rights and the Department's and/or recipients' obligations 
under Federal conscience and nondiscrimination laws. The notice may 
also provide information about how to file a complaint with OCR if an 
individual believes that these laws have been violated, and may provide 
additional information to the patient on how to seek care.
    Proposed paragraph (b) sets forth locations where the notice should 
appear: on the Department's and recipient's website(s), and in a 
physical location of each Department and recipient establishment where 
notices to the public and notices to their workforce are customarily 
posted. Proposed paragraph (c) would encourage covered entities to 
utilize the model notice and, if the recipient does not have a 
conscience-based objection to doing so, to provide information about 
alternative providers that may offer patients services the recipient 
does not provide for reasons of conscience. The Department proposes 
that recipients should be permitted to tailor their notice to their 
particular circumstances and communities, and paragraph (d) of Sec.  
88.3 proposes to permit recipients to combine the text of the notice 
specified in paragraph (a) with other notices.
    The 2019 Final Rule, at Sec.  88.5(A), provided that the OCR 
director would consider whether a covered entity posted OCR's model 
notice as non-dispositive evidence of compliance with the underlying 
federal conscience protection statute where relevant. This proposed 
rule modifies that provision to avoid implying that covered entities 
can substantively comply with the underlying statute by simply posting 
a notice. The Department believes such an implication could undermine 
the conscience and nondiscrimination protections provided by the 
underlying statutes themselves, and therefore the goal of this rule. 
While the Department considers posting a notice to be a best practice 
and encourages covered entities to post the model notice included in 
the proposed rule, we wish to avoid the implication that a covered 
entity can satisfy the substantive obligations imposed upon it by the 
underlying statutes by taking an action that none of the underlying 
statues designates as a method of demonstrating compliance with their 
substantive provisions.with. Covered entities must comply with the 
requirements of each of the federal health care provider conscience 
protection statutes identified in Sec.  88.1 of the proposed rule, 
regardless of whether the notice is posted. We solicit comments on 
these voluntary notice provisions and specifically seek comment on 
whether posting a notice should be mandatory as contemplated by the 
2018 Proposed Rule.
    We encourage any relevant comments, including those that will 
assist the Department in assessing alternatives and reevaluating the 
necessity for additional regulations implementing the statutory 
requirements.
    The 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. This 
includes the purpose provision at Sec.  88.1, the definitions that 
appeared at Sec.  88.2, the applicable requirements and prohibitions 
that appeared at Sec.  88.3, the assurance and certification 
requirements at Sec.  88.4, compliance requirements at Sec.  88.6, the 
relationship to other laws provision at Sec.  88.8, and the rule of 
construction and severability provisions at Sec.  88.9 and Sec.  88.10. 
Those portions of the 2019 Rule were either: (1) redundant and 
unnecessary, because they simply repeated the language of the 
underlying statute; (2) have been deemed unlawful in district court 
decisions that raise

[[Page 826]]

significant questions as to whether they exceed the scope of the 
Department's housekeeping authority; or (3) created confusion or harm 
by undermining the balance struck by Congress in the statutes 
themselves. For example, the district court for the Southern District 
of New York found that the 2019 Final Rule's purpose, definitions, and 
assurance and certification requirements ``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 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.'' City and Cty. 
of San Francisco, 411 F. Supp. 3d at 1023. The ``expansive 
definitions,'' which departed from the federal statutes, coupled with 
the termination of all HHS funding as a consequence of noncompliance, 
deemed the rule ``undoubtedly substantive.'' Id.
    The proposed partial rescission n is informed by the three district 
court decisions that vacated the 2019 Final Rule prior to it taking 
effect and identified a number of serious questions that warrant 
additional careful consideration. Among other things, the litigation 
has raised significant questions regarding the complaints of statutory 
violations that served as a predicate for the 2019 Final Rule.
    The Federal health conscience protection and nondiscrimination 
statutes represent Congress' attempt to strike a careful balance. 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, sometime urgent ones. Our 
health care systems must effectively deliver services--including safe 
legal abortions--to all who need them in order to protect patients' 
health and dignity.
    Congress sought to balance these considerations through a variety 
of statutes. The Department will respect that balance. 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 light of the 
decisions discussed above, issues raised by commenters, and concerns 
about how the 2019 Final Rule approached the balance struck by Congress 
in the underlying statutes, the Department proposes to partially 
rescind the 2019 Final Rule, while maintaining some of its provisions, 
but otherwise preserve the status quo from 2011, which continues to be 
in effect. We solicit public comment to aid our consideration of the 
many complex questions surrounding the issue and the need for 
regulation in this area.

III. Statutory Authority

    The Secretary proposes to partially rescind 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 proposed 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 his employees, the distribution and performance of its 
business, and the custody, use, and preservation of its records, 
papers, and property.''

IV. Request for Comment

    The Department seeks comments in order to determine whether or not 
to rescind the 2019 Final Rule in part or in its entirety or to modify 
that rule or parts of it, as well as to determine whether or not to 
leave in place the framework created by 2011 Final Rule, with 
additional authorities added to that framework, or otherwise to modify 
it. In particular, the Department seeks 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;

[[Page 827]]

    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.

V. Preliminary Regulatory Impact Analysis

Introduction

    We have examined the impacts of the proposed 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 us 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). We 
believe that this proposed rule is an economically significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this proposed rule would result in either a small 
reduction in costs to small entities or no impact on costs to small 
entities, we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
This finding is consistent with the regulatory flexibility analysis of 
the final rule that would be partially rescinded by this regulatory 
action, which ``concluded that this rule does not have a significant 
economic impact on a substantial number of small entities'' (84 FR 
23255).
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us 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 one year.'' The current threshold after adjustment 
for inflation is $165 million, using the most current (2021) 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.

Detailed Economic Analysis

    HHS considered several policy alternatives, in addition to the 
approach of the proposed 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 the proposed rule, which partially rescinds the 2019 Final 
Rule, and modifies other provisions; and (3) adopting the approach of 
the proposed 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 proposed 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 the 
anticipated impacts of the 2019 Final Rule. For the purposes of this 
economic analysis, we provisionally adopt the characterization and 
quantification of these impacts that were presented in the regulatory 
impact analysis (RIA) of the 2019 Final Rule. The potential impacts 
identified and estimated in the RIA covered a five-year time horizon 
following the effective date of the 2019 Final Rule. However, because 
the 2019 Final Rule has been vacated by three federal district courts, 
these impacts have mostly not occurred and are not likely to occur. The 
litigation status of the 2019 Final Rule introduces substantial 
analytic uncertainty into any characterization of the baseline scenario 
of no further regulatory action. We address this uncertainty directly 
by analyzing the potential impacts of Policy Option 1 under two 
discrete baseline scenarios. First, for the purposes of this economic 
analysis, we adopt a primary baseline scenario that the 2019 Final Rule 
would take effect. Second, we adopt an alternative baseline scenario 
that the 2019 Final Rule would never take effect, even without any 
subsequent regulatory action.
    Under our primary baseline scenario, Policy Option 1 would entirely 
reverse the impacts of the 2019 Final Rule. To analyze the impacts of 
Policy Option 1 under this scenario, we provisionally adopt the 
estimates of the likely impacts of the 2019 Final Rule in its RIA, 
although we understand that commenters raised questions whether, for 
example, certain of the non-quantified benefits that the 2019 Final 
Rule anticipated would in fact be realized. The RIA identified five 
categories of quantified costs: (1) familiarization; (2) assurance and 
certification; (3) voluntary actions to provide notices of rights; (4) 
voluntary remedial efforts; and (5) OCR enforcement and associated 
costs. The narrative of the RIA described an approach for estimating 
each of these costs, and Table 6 of the RIA summarized the timing and 
magnitude of these quantified costs (84 FR 23240). In addition to 
identifying quantified costs, the RIA identified non-quantified costs 
associated with compliance procedures and non-quantified costs 
associated with seeking alternative providers of certain objected to 
medical services or procedures. The RIA did not identify any quantified 
benefits, but identified non-quantified benefits associated with 
compliance with the law; protection of conscience rights, the free 
exercise of religion and moral convictions; more diverse and inclusive 
providers and health care professionals; improved provider-patient 
relationships that facilitate improved quality of care; equity, 
fairness, nondiscrimination; increased access to care. We request 
public comment on whether the non-quantified benefits and costs 
identified in the 2019 Final Rule's RIA would likely be realized, 
absent any further regulatory action.
    Table 1 of the 2019 Final Rule's RIA reported the present value and 
annualized value of the quantified costs and summarized the non-
quantified costs and benefits of the 2019 Final Rule (84 FR 23227). 
That RIA reported estimates of the present value of the total costs 
over a 5-year time horizon of $900.7 million using a 3-percent discount 
rate and $731.5 million using a 7-percent discount rate. That RIA also 
reported annualized estimates of the costs of $214.9 million under a 3-
percent discount rate and $218.5 million using a 7-percent discount 
rate. Both sets of these cost estimates were

[[Page 828]]

reported in year 2016 dollars. We updated these estimates to year 2021 
dollars using the Implicit Price Deflator for the Gross Domestic 
Product and report the present value of costs of $1,008.0 million using 
a 3-percent discount rate and $818.6 million using a 7-percent discount 
rate; and annualized costs of $240.5 million using a 3-percent discount 
rate and $244.5 million using a 7-percent discount rate. Under our 
primary baseline scenario, the impacts of Policy Option 1 would be 
approximately the inverse of the impacts contained in the 2019 Final 
Rule's RIA. Table A in this preliminary regulatory impact analysis 
reports the impacts of the Policy Option 1 under this baseline scenario 
in millions of 2021 dollars, covering a 5-year time horizon.
    Under our alternative baseline scenario, we assume that the 2019 
Final Rule would never take effect, even without any additional 
regulatory action. Under this baseline scenario, Policy Option 1 would 
maintain the current status quo, which is characterized by the 2011 
Final Rule (76 FR 9968). Thus, for this baseline scenario, we conclude 
that Policy Option 1 would result in only de minimis impacts that we do 
not quantify, such as resolving any regulatory uncertainty associated 
with the 2019 Final Rule, which has been vacated by three federal 
courts but not rescinded. We report the impacts of Policy Option 1 
under this alternative baseline scenario in Table A.

Policy Option 2: The Proposed Rule

    The proposed rule would partially rescind the 2019 Final Rule, with 
certain exceptions. Specifically, the Department proposes to retain 
three aspects of the 2019 Final Rule: (1) the addition to part 88 of 
statutes including the 2019 Final Rule; (2) several enforcement 
provisions; and (3) a voluntary notice provision. However, as described 
in greater detail in the Preamble, the Department is also proposing to 
modify each of these provisions of the 2019 Final Rule. For example, 
the voluntary notice provision in the proposed rule would clarify that 
providing these voluntary notices would not satisfy an entity's 
substantive obligations imposed upon covered entities by the underlying 
statutes.
    We considered the likely impacts of each of the three retained 
aspects of the 2019 Final Rule. We identify quantifiable impacts 
associated with retaining the aspects of the 2019 Final Rule related to 
the enforcement provisions and quantifiable impacts related to the 
voluntary notice provision. We adopt the analytic approach contained in 
the 2019 Final Rule's RIA to quantify these impacts, including an 
assumption in that RIA that about half of covered entities would 
provide notices voluntarily. For the provisions related to enforcement, 
the 2019 RIA estimated an annual impact of about $3 million in costs to 
the Department and $15 million in total costs over five years. For the 
provisions related to voluntary notices, that RIA estimated an impact 
of about $93.4 million in costs in the first year of the analysis, and 
about $14.1 million in costs in subsequent years, or about $150 million 
over five years. Combined, the 2019 RIA estimated 5-year costs for 
these two provisions of $165 million; in present value terms, these 
estimates are $142 million using a 3-percent discount rate and $118 
million using a 7-percent discount rate. The 2019 RIA reported these 
costs in 2016 dollars.
    To quantify the net impact of the proposed rule, we subtract the 
costs associated with enforcement and voluntary notice provisions from 
our earlier estimates of the total cost savings of rescinding the 2019 
Final Rule. As an intermediate step, we converted the 2016 dollar 
estimates to 2021 dollars using the Implicit Price Deflator for the 
Gross Domestic Product. Compared to our primary baseline, we estimate 
that the proposed rule, if finalized, would result in annualized cost 
savings in 2021 dollars of $202.5 million using a 3-percent discount 
rate and $205.2 million using a 7-percent discount rate. We report 
these estimates in Table A, which also reports comparable estimates 
corresponding to our alternative baseline scenario.

Policy Option 3: The Proposed Rule With an Alternative Notice Provision

    We analyzed a third policy option, which is similar to the proposed 
rule, but would further modify the notice provision by requiring 
covered entities to post these notices in designated places. The 2019 
Final Rule's RIA assumes that about half of covered entities would 
provide these notices on a voluntary basis, and we carried this 
assumption through in this analysis, including in our analysis of the 
costs of the proposed rule. Under Policy Option 3, we anticipate that 
all covered entities would provide notices, and therefore estimate that 
costs of mandatory notices would be double that of our estimates of the 
costs of voluntary notices.
    To quantify the net impact of Policy Option 3, we subtract the 
costs associated with enforcement and mandatory notice provisions from 
our earlier estimates of the total cost savings of rescinding the 2019 
Final Rule. Compared to our primary baseline, we estimate that Policy 
Option 3 would result in annualized cost savings in 2021 dollars of 
$168.0 million using a 3-percent discount rate and $169.2 using a 7-
percent discount rate. We report these estimates in Table A, which also 
reports comparable estimates corresponding to our alternative baseline 
scenario.

Summary of Impacts

    This analysis estimates the costs associated with the proposed rule 
and for two policy alternatives. For the proposed rule, we estimate the 
present value of the costs of -$834.2 million using a 3-percent 
discount rate and -$657.2 million using a 7-percent discount rate. 
Alternatively stated, we estimate that the proposed rule would generate 
cost savings of $834.2 million using a 3-percent discount rate and 
$657.2 million using a 7-percent discount rate. Table A reports cost 
estimates for the proposed rule and for the two policy alternatives. 
These estimates are reported in millions of 2021 dollars over a 5-year 
time horizon. Table A presents these cost estimates in present value 
terms and as annualized values for both a 3-percent and a 7-percent 
discount rate. Table A reports these estimates for our primary baseline 
scenario that the 2019 Final Rule would take effect, and for an 
alternative baseline scenario that the 2019 Final Rule would never take 
effect, even without any subsequent regulatory action. We do not 
identify any quantified benefits for the proposed rule or for the two 
policy alternatives.

[[Page 829]]



                                       Table A--Accounting Table of Costs
                              [Millions of 2021 dollars over a 5-year time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                  Present value by         Annualized value by
                                                                    discount rate             discount rate
             Baseline scenario and policy option             ---------------------------------------------------
                                                               3 Percent    7 Percent    3 Percent    7 Percent
----------------------------------------------------------------------------------------------------------------
Primary Baseline:
    Option 1................................................    -$1,008.0      -$818.6      -$240.5      -$244.5
    Option 2................................................       -834.2       -657.2       -202.5       -205.2
    Option 3................................................       -675.7       -509.6       -168.0       -169.2
Alternative Baseline:
    Option 1................................................          0.0          0.0          0.0          0.0
    Option 2................................................        173.8        161.4         37.9         39.4
    Option 3................................................        332.2        309.0         72.5         75.4
----------------------------------------------------------------------------------------------------------------
Notes: Option 2 corresponds to the Proposed Rule. Negative costs indicate the Policy Option, if finalized would
  result in cost savings.

    The RIA of the 2019 Final Rule also identified certain non-
quantifiable impacts. That RIA discussed potential impacts related to 
compliance with the law; impacts related to conscience rights; impacts 
related to the composition of providers and health care professionals; 
impacts related to provider-patient relations; impacts related to 
equity, fairness, and nondiscrimination; impacts related to access to 
care; and additional non-quantified cost savings associated with 
compliance procedures (recordkeeping and compliance reporting) and 
seeking of alternative providers of certain objected to medical 
services or procedures. We request public comment on whether the non-
quantified impacts identified in the 2019 Final Rule's RIA would likely 
be realized, absent any further regulatory action; and request comment 
on the extent to which each of the Policy Options, including the 
proposed rule, would result in comparable impacts.
    We also request comment on whether covered entities have incurred 
costs attributable to the 2019 Final Rule that would not be averted by 
the proposed rule, if it is finalized; and further request data that 
would allow us to refine our quantified cost-savings estimates. For 
example, we request information that would allow us to quantify costs 
that covered entities previously incurred and are not recoverable, such 
as the costs associated with familiarization of the 2019 Final Rule.

List of Subjects in 45 CFR Part 88

    Adult education, Authority delegations (Government agencies), Civil 
rights, Colleges and universities, Community facilities, Conflicts of 
interest, Educational facilities, Employment, Family planning, Freedom 
of information, Government contracts, Government employees, Grant 
programs-health, Grants administration, Health care, Health facilities, 
Health insurance, Health professions, Hospitals, Immunization, 
Indians--Tribal government, Insurance, Insurance companies, 
Intergovernmental relations, Laboratories, Maternal and child health, 
Medicaid, Medical and dental schools, Medical research, Medicare, 
Mental health programs, Nursing homes, Occupational safety and health, 
Prescription drugs, Public assistance programs, Public health, 
Religious discrimination, Reporting and recordkeeping requirements, 
Research, Scholarships and fellowships, Schools, Scientists.


0
For the reasons set forth in the preamble, the Department proposes to 
revise 45 CFR part 88 as follows:

PART 88--ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES 
FUNDS DO NOT SUPPORT COERCIVE OR DISCIMINATORY POLICIES OR 
PRACTICES IN VIOLATION OF FEDERAL LAW

Sec.
88.1 Purpose.
88.2 Complaint handling and investigating.
88.3 Voluntary Notice of Federal conscience and nondiscrimination 
laws.
88.4 Severability.
Appendix A to Part 88--Model Text: Notice of Rights Under Federal 
Conscience and Nondiscrimination Laws

    Authority:  5 U.S.C. 301.


Sec.  88.1  Purpose.

    The purpose of this part is to provide for the enforcement of the 
Church Amendments, 42 U.S.C. 300a-7; the Coats-Snowe Amendment, section 
245 of the Public Health Service Act, 42 U.S.C. 238n; the Weldon 
Amendment, Consolidated Appropriations Act, 2022, Pub. L. 117-103, div. 
H, title V General Provisions, section 507(d)(1) (Mar.15, 2022); 
Sections 1303, 1411, and 1553 of the ACA, 42 U.S.C. 18023, 18081, and 
18113; certain Medicare and Medicaid provisions, 42 U.S.C. 1320a-1(h), 
1320c-11, 1395i-5, 1395w-22(j)(3)(A)-(B), 1395x(e), 1395x(y)(1), 
1395cc(f), 1396a(a), 1396a(w)(3), 1396u-2(b)(3)(A)-(B), 1397j-1(b), and 
14406; Consolidated Appropriations Act, 2022, Pub. L. 115-245, div. H, 
section 209, div. K, title VII, section 7018; 22 U.S.C. 7631(d); 22 
U.S.C. 2151b(f); 42 U.S.C. 280g-1(d), 290bb-36(f), 1396f, 
1396s(c)(2)(B)(ii); 5106i(a)); and 29 U.S.C. 669(a)(5), referred to 
collectively as the ``federal health care provider conscience 
protection statutes.''


Sec.  88.2  Complaint handling and investigating.

    (a) Delegated authority. OCR has been delegated the authority to 
facilitate and coordinate the Department's enforcement of the Federal 
health care provider conscience protection statutes, which includes the 
authority to:
    (1) Receive and handle complaints;
    (2) Conduct investigations;
    (3) Consult on compliance within the Department;
    (4) Seek voluntary resolutions of complaints; and
    (5) Consult and coordinate with the relevant Departmental funding 
component, and utilize existing regulations enforcement, such as those 
that apply to grants, contracts, or other programs and services..
    (b) Investigations. An OCR investigation of a complaint alleging 
failure to comply with the Federal health care provider conscience 
protection statutes may include, a review of the pertinent practices, 
policies, communications, documents, compliance history, circumstances 
under which the possible noncompliance occurred, and other factors 
relevant to determining whether the Department, Department component, 
recipient, or sub[hyphen]recipient has failed to comply. OCR may use 
fact[hyphen]finding methods including site visits; interviews with the

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complainants, Department component, recipients, sub[hyphen]recipients, 
or third[hyphen]parties; and written data or discovery requests. OCR 
may seek the assistance of any State agency.
    (c) Supervision and coordination. If as a result of an 
investigation OCR makes a determination of noncompliance with 
responsibilities under the Federal health care provider conscience 
protection statutes, OCR will coordinate and consult with the 
Departmental component responsible for the relevant funding to 
undertake appropriate action with the component to assure compliance.
    (d) Resolution of matters. (1) If an investigation reveals that no 
action is warranted, OCR will in writing so inform any party who has 
been notified by OCR of the existence of the investigation.
    (2) If an investigation indicates a failure to comply with the 
Federal health care provider conscience protection statutes, OCR will 
so inform the relevant parties and the matter will be resolved by 
informal means whenever possible.


Sec.  88.3  Voluntary Notice of Federal conscience and 
nondiscrimination laws.

    (a) In general. OCR considers the posting of a notice consistent 
with this part as a best practice, and encourages all entities subject 
to the federal health care provider statutes to post the model notice 
provided in Appendix A.
    (b) Placement of the notice text. The model notice in Appendix A 
should be posted in the following places, where relevant:
    (1) On the Department or recipient's website(s);
    (2) In a prominent and conspicuous physical location in the 
Department's or covered entity's establishments where notices to the 
public and notices to its workforce are customarily posted to permit 
ready observation;
    (3) In a personnel manual, handbook, orientation materials, 
trainings, or other substantially similar document likely to be 
reviewed by members of the covered entity's workforce;
    (4) In employment applications to the Department or covered entity, 
or in applications for participation in a service, benefit, or other 
program, including for training or study; and
    (5) In any student handbook, orientation materials, or other 
substantially similar document for students participating in a program 
of training or study, including for postgraduate interns, residents, 
and fellows.
    (c) Format of the notice. The text of the notice should be large 
and conspicuous enough to be read easily and be presented in a format, 
location, or manner that impedes or prevents the notice being altered, 
defaced, removed, or covered by other material.
    (d) Content of the notice text. A recipient or the Department 
should consider using the model text provided in Appendix A for the 
notice, but 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. Where possible, and where the 
recipient does not have a conscience-based objection to doing so, the 
notice should include information about alternative providers that may 
offer patients services the recipient does not provide for reasons of 
conscience.
    (e) Combined nondiscrimination notices. The Department and each 
recipient may post the notice text provided in Appendix A of this part, 
or a notice it drafts itself, along with the content of other notices 
(such as other nondiscrimination notices).


Sec.  88.4  Severability.

    Any provision of this part held to be invalid or unenforceable 
either by its terms or as applied to any entity or circumstance shall 
be construed so as to continue to give the maximum effect to the 
provision permitted by law, unless such holding shall be one of utter 
invalidity or unenforceability, in which event such provision shall be 
severable from this part, which shall remain in full force and effect 
to the maximum extent permitted by law. A severed provision shall not 
affect the remainder of this part or the application of the provision 
to other persons or entities not similarly situated or to other, 
dissimilar circumstances.

Appendix A to Part 88--Model Text: Notice of Rights Under Federal 
Conscience and Nondiscrimination Laws

    [Name of entity] complies with applicable Federal health care 
provider conscience protection statutes, including [list applicable 
conscience statutes]. If you believe that [Name of entity] has 
violated any of these provisions, you can file a complaint with the 
U.S. Department of Health and Human Services, Office for Civil 
Rights, electronically through the Office for Civil Rights Complaint 
Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf 
or by mail or phone at: U.S. Department of Health and Human 
Services, 200 Independence Avenue SW, Room 509F, HHH Building 
Washington, DC 20201, 1-800-368-1019, 800-537-7697 (TDD). Complaint 
forms and more information about Federal conscience protection laws 
are available at https://www.hhs.gov/conscience.
* * * * *

    Dated: December 28, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.

[FR Doc. 2022-28505 Filed 12-30-22; 11:15 am]
BILLING CODE 4153-01-P