Proposed Rule2022-28505
Safeguarding the Rights of Conscience as Protected by Federal Statutes
Primary source
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Published
January 5, 2023
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, including any
personal information provided.
Docket: For complete access to the docket to read background
documents or comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.HHS.gov/regulations">https://www.HHS.gov/regulations</a>
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
[[Page 822]]
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
[[Page 824]]
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 <a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-27795">https://www.regulations.gov/comment/HHS-OCR-2018-0002-27795</a>. 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
<a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-67019">https://www.regulations.gov/comment/HHS-OCR-2018-0002-67019</a>.
\4\ Letter from the Catholic Health Association to HHS (Mar. 27,
2018), available at <a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-70534">https://www.regulations.gov/comment/HHS-OCR-2018-0002-70534</a>.
\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
<a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-70564">https://www.regulations.gov/comment/HHS-OCR-2018-0002-70564</a>.
\7\ See Letter from AAFP to HHS (Mar. 20, 2018) available at
<a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-34646">https://www.regulations.gov/document/HHS-OCR-2018-0002-34646</a>; Letter
from ANA-AAN to HHS (Mar. 23, 2018) available at <a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-55870">https://www.regulations.gov/document/HHS-OCR-2018-0002-55870</a>; Letter from
ACOG to HHS (Mar. 27, 2018) available at <a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-70647">https://www.regulations.gov/document/HHS-OCR-2018-0002-70647</a>; Letter from
ACEP to HHS (Mar. 27, 2018); and Letter from AAP to HHS (Mar. 27,
2018) available at <a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-71022">https://www.regulations.gov/document/HHS-OCR-2018-0002-71022</a>.
\8\ Letter from APA to HHS (Mar. 26, 2018) available at <a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-71056">https://www.regulations.gov/document/HHS-OCR-2018-0002-71056</a>.
\9\ Letter from AAMC to HHS (Mar. 26, 2018) available at <a href="https://www.regulations.gov/document/HHS-OCR-2018-0002-67592">https://www.regulations.gov/document/HHS-OCR-2018-0002-67592</a>.
\10\ Letter from Attorneys General to HHS (Mar. 27, 2018)
available at <a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-70188">https://www.regulations.gov/comment/HHS-OCR-2018-0002-70188</a>.
\11\ E.g., Letter from Nat'l Family Planning and Reproductive
Health Assoc. to HHS (Mar. 27, 2018) available at <a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-70260">https://www.regulations.gov/comment/HHS-OCR-2018-0002-70260</a>.
\12\ Letter from The Nat'l Coalition for LGBT Health to HHS
(Mar. 27, 2018) available at <a href="https://www.regulations.gov/comment/HHS-OCR-2018-0002-71195">https://www.regulations.gov/comment/HHS-OCR-2018-0002-71195</a>.
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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.
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\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).
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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 <a href="https://ocrportal.hhs.gov/ocr/portal/lobby.jsf">https://ocrportal.hhs.gov/ocr/portal/lobby.jsf</a>
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 <a href="https://www.hhs.gov/conscience">https://www.hhs.gov/conscience</a>.
* * * * *
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
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