Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act, 57592-57631 [2018-24514]
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Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD–9841]
RIN 1545–BN91
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2590
RIN 1210–AB84
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 147
[CMS–9925–F]
RIN 0938–AT46
Moral Exemptions and
Accommodations for Coverage of
Certain Preventive Services Under the
Affordable Care Act
Internal Revenue Service,
Department of the Treasury; Employee
Benefits Security Administration,
Department of Labor; and Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services.
ACTION: Final rules.
AGENCY:
These rules finalize, with
changes based on public comments, the
interim final rules issued in the Federal
Register on October 13, 2017 concerning
moral exemptions and accommodations
regarding coverage of certain preventive
services. These rules finalize expanded
exemptions to protect moral beliefs for
certain entities and individuals whose
health plans are subject to a mandate of
contraceptive coverage through
guidance issued pursuant to the Patient
Protection and Affordable Care Act.
These rules do not alter the discretion
of the Health Resources and Services
Administration, a component of the U.S.
Department of Health and Human
Services, to maintain the guidelines
requiring contraceptive coverage where
no regulatorily recognized objection
exists. These rules also leave in place an
optional ‘‘accommodation’’ process for
certain exempt entities that wish to use
it voluntarily. These rules do not alter
multiple other federal programs that
provide free or subsidized
contraceptives for women at risk of
unintended pregnancy.
DATES: Effective date: These regulations
are effective on January 14, 2019.
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SUMMARY:
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Jeff Wu at (301) 492–4305 or
marketreform@cms.hhs.gov for the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services (HHS).
Amber Rivers or Matthew Litton at (202)
693–8335 for Employee Benefits
Security Administration (EBSA),
Department of Labor (DOL).
William Fischer at (202) 317–5500 for
Internal Revenue Service, Department
of the Treasury.
Customer Service Information:
Individuals interested in obtaining
information from the Department of
Labor concerning employment-based
health coverage laws may call the EBSA
Toll-Free Hotline at 1–866–444–EBSA
(3272) or visit DOL’s website
(www.dol.gov/ebsa). Information from
HHS on private health insurance
coverage can be found on CMS’s website
(www.cms.gov/cciio), and information
on health care reform can be found at
www.HealthCare.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary and Background
A. Executive Summary
1. Purpose
2. Summary of the Major Provisions
3. Summary of Costs, Savings and Benefits
of the Major Provisions
B. Background
II. Overview of the Final Rules and Public
Comments
A. Moral Exemptions and Accommodation
in General
1. The Departments’ Authority to Mandate
Coverage or Provide Exemptions
2. Congress’s History of Protecting Moral
Convictions
a. The Church Amendments’ Protection of
Moral Convictions
b. Court Precedents Relevant to These
Expanded Exemptions
c. Conscience Protections in Other Federal
and State Contexts
d. Founding Principles
e. Executive Orders Relevant to These
Expanded Exemptions
f. Litigation Concerning the Mandate
3. Whether Moral Exemptions Should
Exist, and Whom They Should Cover
4. The Departments’ Rebalancing of
Government Interests
5. Burdens on Third Parties
6. Interim Final Rulemaking
7. Health Effects of Contraception and
Pregnancy
8. Health and Equality Effects of
Contraceptive Coverage Mandates
9. Other General Comments
B. Text of the Final Rules
1. Restatement of Statutory Requirements
of Section 2713(a) and (a)(4) of the PHS
Act (26 CFR 54.9815–2713(a)(1) and
(a)(1)(iv), 29 CFR 2590.715–2713(a)(1)
and (a)(1)(iv), and 45 CFR 147.130(a)(1)
and (a)(1)(iv)).
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2. Exemption for Objecting Entities Based
on Moral Convictions (45 CFR
147.133(a))
3. Exemption for Certain Plan Sponsors (45
CFR 147.133(a)(1)(i))
a. Plan sponsors in general (45 CFR
147.133(a)(1)(i) prefatory text)
b. Nonprofit organizations (45 CFR
147.133(a)(1)(i)(A))
c. For-Profit Entities (45 CFR
147.133(a)(1)(i)(B))
4. Institutions of Higher Education (45 CFR
147.133(a)(1)(ii))
5. Health Insurance Issuers (45 CFR
147.133(a)(1)(iii))
6. Description of the Moral Objection (45
CFR 147.133(a)(2))
7. Individuals (45 CFR 147.133(b))
8. Accommodation (45 CFR 147.131, 26
CFR 54.9815–2713A, 29 CFR 2590.715–
2713A)
9. Definition of Contraceptives for the
Purpose of These Final Rules
10. Severability
C. Other Public Comments
1. Items Approved as Contraceptives But
Used to Treat Existing Conditions
2. Comments Concerning Regulatory
Impact
III. Economic Impact and Paperwork Burden
A. Executive Orders 12866 and 13563—
Department of HHS and Department of
Labor
1. Need for Regulatory Action
2. Anticipated Effects
B. Special Analyses—Department of the
Treasury
C. Regulatory Flexibility Act
D. Paperwork Reduction Act—Department
of Health and Human Services
E. Paperwork Reduction Act—Department
of Labor
F. Regulatory Reform Executive Orders
13765, 13771 and 13777
G. Unfunded Mandates Reform Act
H. Federalism
IV. Statutory Authority
I. Executive Summary and Background
A. Executive Summary
1. Purpose
The primary purpose of these final
rules is to finalize, with changes in
response to public comments, the
interim final regulations with requests
for comments (IFCs) published in the
Federal Register on October 13, 2017
(82 FR 47838), ‘‘Moral Exemptions and
Accommodations for Coverage of
Certain Preventive Services Under the
Affordable Care Act’’ (the Moral IFC).
The rules are necessary to protect
sincerely held moral objections of
certain entities and individuals. The
rules, thus, minimize the burdens
imposed on their moral beliefs, with
regard to the discretionary requirement
that health plans cover certain
contraceptive services with no costsharing, which was created by HHS
through guidance promulgated by the
Health Resources and Services
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Administration (HRSA), pursuant to
authority granted by the ACA in section
2713(a)(4) of the Public Health Service
Act. In addition, the rules finalize
references to these moral exemptions in
the previously created accommodation
process that permit entities with certain
objections voluntarily to continue to
object while the persons covered in
their plans receive contraceptive
coverage or payments arranged by their
issuers or third party administrators.
The rules do not remove the
contraceptive coverage requirement
generally from HRSA’s guidelines. The
changes to the rules being finalized will
ensure clarity in implementation of the
moral exemptions so that proper respect
is afforded to sincerely held moral
convictions in rules governing this area
of health insurance and coverage, with
minimal impact on HRSA’s decision to
otherwise require contraceptive
coverage.
2. Summary of the Major Provisions
a. Moral Exemptions
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These rules finalize exemptions
provided in the Moral IFC for the group
health plans and health insurance
coverage of various entities and
individuals with sincerely held moral
convictions opposed to coverage of
some or all contraceptive or sterilization
methods encompassed by HRSA’s
guidelines. As in the Moral IFC, the
exemptions include plan sponsors that
are nonprofit organization plan sponsors
or for-profit entities that have no
publicly traded ownership interests
(defined as any class of common equity
securities required to be registered
under section 12 of the Securities
Exchange Act of 1934). The exemptions
also continue to include institutions of
higher education in their arrangement of
student health insurance coverage;
health insurance issuers (but only with
respect to plans that are otherwise also
exempt under the rules); and objecting
individuals with respect to their own
coverage, where their health insurance
issuer and plan sponsor, as applicable,
are willing to provide coverage
complying with the individual’s moral
objection. After considering public
comments, the Departments have
decided not to extend the moral
exemptions to non-federal governmental
entities at this time, although
individuals receiving employersponsored insurance from a
governmental entity may use the
individual exemption if the other terms
of the individual exemption apply,
including that their employer is willing
to offer them a plan consistent with
their moral objection.
In response to public comments,
various changes are made to clarify the
intended scope of the language in the
Moral IFC’s exemptions. The prefatory
exemption language is clarified to
ensure exemptions apply to a group
health plan established or maintained
by an objecting organization, or health
insurance coverage offered or arranged
by an objecting organization, to the
extent of the objections. The
Departments add language to specify
that the exemption for institutions of
higher education applies to nongovernmental entities. The Departments
also modified language describing the
moral objection applicable to the
exemptions, to specify that the entity
objects, based on its sincerely held
moral convictions, to its establishing,
maintaining, providing, offering, or
arranging for (as applicable) either:
Coverage or payments for some or all
contraceptive services; or a plan, issuer,
or third party administrator that
provides or arranges such coverage or
payments.
The Departments also clarify language
in the exemption applicable to plans of
objecting individuals. The clarification
is made to ensure that the HRSA
guidelines do not prevent a willing
health insurance issuer offering group or
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individual health insurance coverage,
and as applicable, a willing plan
sponsor of a group health plan, from
offering a separate policy, certificate or
contract of insurance or a separate group
health plan or benefit package option, to
any group health plan sponsor (with
respect to an individual) or individual,
as applicable, who objects to coverage or
payments for some or all contraceptive
services based on sincerely held moral
convictions. The exemption adds that, if
an individual objects to some but not all
contraceptive services, but the issuer,
and as applicable, plan sponsor, are
willing to provide the plan sponsor or
individual, as applicable, with a
separate policy, certificate or contract of
insurance or a separate group health
plan or benefit package option that
omits all contraceptives, and the
individual agrees, then the exemption
applies as if the individual objects to all
contraceptive services.
b. References to Moral Exemptions in
Accommodation Regulations and in
Regulatory Restatement of Statutory
Language
These rules finalize without change
the references to the moral exemptions
that were inserted by the Moral IFC into
the rules that regulatorily restate the
statutory language from section 2713(a)
and (a)(4) of the Public Health Service
Act. Similarly, these rules finalize
without change from the Moral IFC
references to the moral exemptions that
were inserted into the regulations
governing the optional accommodation
process. These references operationalize
the effect of the moral exemptions rule,
and they allow contraceptive services to
be made available to women if any
employers with non-religious moral
objections to contraceptive coverage
choose to use the optional
accommodation process.
3. Summary of Costs, Savings and
Benefits of the Major Provisions
Provision
Savings and Benefits
Costs
Finalizing insertion of references to moral exemptions into restatement of
statutory language from
section 2713(a) and (a)(4)
of the Public Health Service Act.
These provisions, finalized without change, are for the
purpose of inserting references to the moral exemptions into the regulatory restatement of section
2713(a) and (a)(4) of the Public Health Service Act,
which already references the religious exemptions.
This operationalizes the moral exemptions in each of
the tri-agencies’ rules. We estimate no economic
savings or benefit from finalizing this part of the rule,
but consider it a deregulatory action to minimize the
regulatory impact beyond the scope set forth in the
statute.
We estimate no costs from finalizing this part of the
rule.
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Provision
Savings and Benefits
Costs
Finalized moral exemptions
The moral exemptions to the contraceptive coverage
requirement are finalized with technical changes.
Their purpose is to relieve burdens that some entities
and individuals experience from being forced to
choose between, on the one hand, complying with
their moral beliefs and facing penalties from failing to
comply with the contraceptive coverage requirement,
and on the other hand, providing (or, for individuals,
obtaining) contraceptive coverage in violation of their
sincerely held moral beliefs.
Finalizing insertion of references to moral exemptions into optional accommodation regulations.
These provisions, finalized without change, will allow
organizations with moral objections to contraceptive
coverage on the basis of sincerely held moral convictions to use the accommodation as an optional process. These provisions will allow contraceptive coverage to be made available to women covered by
plans of employers that object to contraceptive coverage but do not object to their issuers or third party
administrators arranging for such coverage to be provided to persons covered by their plans.
We estimate there will be only a small amount of costs
for these exemptions, because they will primarily be
used by organizations and individuals that do not
want contraceptive coverage. To the extent some
other employers will use the exemption where there
will be transfer costs for women previously receiving
contraceptive coverage who will no longer receive
that coverage, we expect those costs to be minimal
due to the small number of entities expected to use
the exemptions with non-religious moral objections.
We estimate the transfer costs will amount to $8,760.
We do not estimate any entities with non-religious
moral objections to use the accommodation process
at this time.
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B. Background
Over many decades, Congress has
protected conscientious objections
including based on moral convictions in
the context of health care and human
services, and including health coverage,
even as it has sought to promote access
to health services.1 In 2010, Congress
1 See, for example, 42 U.S.C. 300a–7 (protecting
individuals and health care entities from being
required to provide or assist sterilizations,
abortions, or other lawful health services if it would
violate their ‘‘religious beliefs or moral
convictions’’); 42 U.S.C. 238n (protecting
individuals and entities that object to abortion);
Consolidated Appropriations Act, 2018, Div. H, Sec.
507(d) (Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act), Public
Law 115–141, 132 Stat. 348, 764 (Mar. 23, 2018)
(protecting any ‘‘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’’ in objecting to
abortion for any reason); Id. at Div. E, Sec. 726(c)
(Financial Services and General Government
Appropriations Act) (protecting individuals who
object to prescribing or providing contraceptives
contrary to their ‘‘religious beliefs or moral
convictions’’); Id. at Div. E, Sec. 808 (regarding any
requirement of ‘‘the provision of contraceptive
coverage by health insurance plans’’ in the District
of Columbia, ‘‘it is the intent of Congress that any
legislation enacted on such issue should include a
‘conscience clause’ which provides exceptions for
religious beliefs and moral convictions.’’); Id. at
Div. K, Title III (Department of State, Foreign
Operations, and Related Programs Appropriations
Act) (protecting applicants for family planning
funds based on their ‘‘religious or conscientious
commitment to offer only natural family
planning’’); 42 U.S.C. 290bb–36 (prohibiting the
statutory section from being construed to require
suicide related treatment services for youth where
the parents or legal guardians object based on
‘‘religious beliefs or moral objections’’); 42 U.S.C.
1395w–22(j)(3)(B) (protecting against forced
counseling or referrals in Medicare+Choice, now
Medicare Advantage, managed care plans with
respect to objections based on ‘‘moral or religious
grounds’’); 42 U.S.C. 1396a(w)(3) (ensuring
particular Federal law does not infringe on
‘‘conscience’’ as protected in State law concerning
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enacted the Patient Protection and
Affordable Care Act (PPACA) (Pub. L.
111–148) (March 23, 2010). Congress
enacted the Health Care and Education
Reconciliation Act of 2010 (HCERA)
(Pub. L. 111–152) on March 30, 2010,
which, among other things, amended
PPACA. As amended by HCERA,
PPACA is known as the Affordable Care
Act (ACA).
The ACA reorganized, amended, and
added to the provisions of part A of title
XXVII of the Public Health Service Act
(PHS Act) relating to group health plans
and health insurance issuers in the
group and individual markets. The ACA
added section 715(a)(1) to the Employee
Retirement Income Security Act of 1974
(ERISA) and section 9815(a)(1) to the
Internal Revenue Code (Code), in order
to incorporate the provisions of part A
of title XXVII of the PHS Act into ERISA
and the Code, and to make them
applicable to group health plans and
advance directives); 42 U.S.C. 1396u–2(b)(3)
(protecting against forced counseling or referrals in
Medicaid managed care plans with respect to
objections based on ‘‘moral or religious grounds’’);
42 U.S.C. 2996f(b) (protecting objection to abortion
funding in legal services assistance grants based on
‘‘religious beliefs or moral convictions’’); 42 U.S.C.
14406 (protecting organizations and health
providers from being required to inform or counsel
persons pertaining to assisted suicide); 42 U.S.C.
18023 (blocking any requirement that issuers or
exchanges must cover abortion); 42 U.S.C. 18113
(protecting health plans or health providers from
being required to provide an item or service that
helps cause assisted suicide); see also 8 U.S.C.
1182(g) (protecting vaccination objections by
‘‘aliens’’ due to ‘‘religious beliefs or moral
convictions’’); 18 U.S.C. 3597 (protecting objectors
to participation in Federal executions based on
‘‘moral or religious convictions’’); 20 U.S.C. 1688
(prohibiting sex discrimination law to be used to
require assistance in abortion for any reason); 22
U.S.C. 7631(d) (protecting entities from being
required to use HIV/AIDS funds contrary to their
‘‘religious or moral objection’’).
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health insurance issuers providing
health insurance coverage in connection
with group health plans. The sections of
the PHS Act incorporated into ERISA
and the Code are sections 2701 through
2728.
In section 2713(a)(4) of the PHS Act
(hereinafter ‘‘section 2713(a)(4)’’),
Congress provided administrative
discretion to require that certain group
health plans and health insurance
issuers cover certain women’s
preventive services, in addition to other
preventive services required to be
covered in section 2713. Congress
granted that discretion to the Health
Resources and Services Administration
(HRSA), a component of the U.S.
Department of Health and Human
Services (HHS). Specifically, section
2713(a)(4) allows HRSA discretion to
specify coverage requirements, ‘‘with
respect to women, such additional
preventive care and screenings as
provided for in comprehensive
guidelines supported’’ by HRSA (the
‘‘Guidelines’’).
Since 2011, HRSA has exercised that
discretion to require coverage for,
among other things, certain
contraceptive services.2 In the same
2 The references in this document to
‘‘contraception,’’ ‘‘contraceptive,’’ ‘‘contraceptive
coverage,’’ or ‘‘contraceptive services’’ generally
include all contraceptives, sterilization, and related
patient education and counseling, required by the
Women’s Preventive Guidelines, unless otherwise
indicated. The Guidelines issued in 2011 referred
to ‘‘Contraceptive Methods and Counseling’’ as
‘‘[a]ll Food and Drug Administration approved
contraceptive methods, sterilization procedures,
and patient education and counseling for all women
with reproductive capacity.’’ https://www.hrsa.gov/
womens-guidelines/. The Guidelines as
amended in December 2016 refer, under the header
‘‘Contraception,’’ to: ‘‘the full range of femalecontrolled U.S. Food and Drug Administrationapproved contraceptive methods, effective family
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time period, the administering
agencies—HHS, the Department of
Labor, and the Department of the
Treasury (collectively, ‘‘the
Departments’’ 3)—exercised discretion
to allow exemptions to those
requirements by issuing rulemaking
various times, including issuing and
finalizing three interim final regulations
prior to 2017.4 In those regulations, the
Departments crafted exemptions and
accommodations for certain religious
objectors where the Guidelines require
coverage of contraceptive services,
changed the scope of those exemptions
and accommodations, and solicited
public comments on a number of
occasions. Public comments were
submitted on various iterations of the
regulations issued before 2017, and
some of those comments supported
expanding the exemptions to include
those who oppose the contraceptive
coverage mandate for either religious
‘‘or moral’’ reasons, consistent with
various state laws (such as in
Connecticut or Missouri) that protect
objections to contraceptive coverage
based on moral convictions.5
planning practices, and sterilization procedures,’’
‘‘contraceptive counseling, initiation of
contraceptive use, and follow-up care (e.g.,
management, and evaluation as well as changes to
and removal or discontinuation of the contraceptive
method),’’ and ‘‘instruction in fertility awarenessbased methods, including the lactation amenorrhea
method.’’ https://www.hrsa.gov/womens-guidelines2016/.
3 Note, however, that in sections under headings
listing only two of the three Departments, the term
‘‘Departments’’ generally refers only to the two
Departments listed in the heading.
4 Interim final regulations on July 19, 2010, at 75
FR 41726 (July 2010 interim final regulations);
interim final regulations amending the July 2010
interim final regulations on August 3, 2011, at 76
FR 46621; final regulations on February 15, 2012,
at 77 FR 8725 (2012 final regulations); an advance
notice of proposed rulemaking (ANPRM) on March
21, 2012, at 77 FR 16501; proposed regulations on
February 6, 2013, at 78 FR 8456; final regulations
on July 2, 2013, at 78 FR 39870 (July 2013 final
regulations); interim final regulations on August 27,
2014, at 79 FR 51092 (August 2014 interim final
regulations); proposed regulations on August 27,
2014, at 79 FR 51118 (August 2014 proposed
regulations); final regulations on July 14, 2015, at
80 FR 41318 (July 2015 final regulations); and a
request for information on July 26, 2016, at 81 FR
47741 (RFI), which was addressed in an FAQ
document issued on January 9, 2017, available at:
https://www.dol.gov/sites/default/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part36.pdf and https://www.cms.gov/CCIIO/Resources/
Fact-Sheets-and-FAQs/Downloads/ACA-FAQsPart36_1-9-17-Final.pdf.
5 See, for example, Denise M. Burke, Re: file code
CMS–9968–P, Regulations.gov (posted May 5,
2013), https://www.regulations.gov/
#!documentDetail;D=CMS-2012-0031-79115;
Comment, Regulations.gov (posted Oct. 26, 2016),
https://www.regulations.gov/document?D=CMS2016-0123-54142; David Sater, Re: CMS–9931–NC:
Request for Information, Regulations.gov (posted
Oct. 26, 2016), https://www.regulations.gov/
document?D=CMS-2016-0123-54218; Comment,
Regulations.gov (posted Oct. 26, 2016), https://
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During the period when the
Departments were publishing and
modifying the regulations, organizations
and individuals filed dozens of lawsuits
challenging the contraceptive coverage
requirement and regulations
(hereinafter, the ‘‘contraceptive
Mandate,’’ or the ‘‘Mandate’’). Plaintiffs
included religious nonprofit
organizations, businesses run by
religious families, individuals, and
others, including several non-religious
organizations that opposed coverage of
certain contraceptives under the
Mandate on the basis of non-religious
moral convictions. For-profit entities
with religious objections won various
court decisions leading to the Supreme
Court’s ruling in Burwell v. Hobby
Lobby Stores, Inc. 134 S. Ct. 2751
(2014). The Supreme Court ruled against
the Departments and held that, under
the Religious Freedom Restoration Act
of 1993 (RFRA), the Mandate could not
be applied to the closely held for-profit
corporations before the Court because
their owners had religious objections to
providing such coverage.6 Later, a
second series of legal challenges were
filed by religious nonprofit
organizations that stated the
accommodation impermissibly
burdened their religious beliefs because
it utilized their health plans to provide
services to which they objected on
religious grounds, and it required them
to submit a self-certification or notice.
On May 16, 2016, the Supreme Court
issued a per curiam decision, vacating
the judgments of the Courts of
Appeals—most of which had ruled in
the Departments’ favor—and remanding
the cases ‘‘in light of the substantial
clarification and refinement in the
positions of the parties’’ that had been
filed in supplemental briefs. Zubik v.
Burwell, 136 S. Ct. 1557, 1560 (2016).
The Court stated that it anticipated that,
on remand, the Courts of Appeals would
‘‘allow the parties sufficient time to
resolve any outstanding issues between
them.’’ Id.
Beginning in 2015, lawsuits
challenging the Mandate were also filed
by various non-religious organizations
with moral objections to contraceptive
coverage. These organizations stated
that they believe some methods
classified by the Food and Drug
Administration (FDA) as contraceptives
may have an abortifacient effect and,
therefore, in their view, are morally
equivalent to abortion to which they
www.regulations.gov/document?D=CMS-2016-012346220.
6 The Supreme Court did not decide whether
RFRA would apply to publicly traded for-profit
corporations. See 134 S. Ct. at 2774.
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have a moral objection. Under
regulations preceding October 2017,
these organizations neither received an
exemption from the Mandate nor
qualified for the accommodation. For
example, March for Life filed a
complaint claiming that the Mandate
violated the equal protection component
of the Due Process Clause of the Fifth
Amendment, and was arbitrary and
capricious under the Administrative
Procedure Act (APA). Citing, for
example, 77 FR 8727, March for Life
argued that the Departments’ stated
interests behind the Mandate were only
advanced among women who ‘‘want’’
the coverage so as to prevent
‘‘unintended’’ pregnancy. March for Life
contended that, because it only hires
employees who publicly advocate
against abortion, including what they
regard as abortifacient contraceptive
items, the Departments’ interests were
not rationally advanced by imposing the
Mandate upon it and its employees.
Accordingly, March for Life contended
that applying the Mandate to it (and
other similarly situated organizations)
lacked a rational basis and, therefore,
was arbitrary and capricious in violation
of the APA. March for Life further
contended that, because the
Departments concluded the
government’s interests were not
undermined by exempting houses of
worship and integrated auxiliaries
(based on the assumption that such
entities are relatively more likely than
other nonprofits with religious
objections to have employees that share
their views against certain
contraceptives), applying the Mandate
to March for Life or similar
organizations that definitively hire only
employees who oppose certain
contraceptives lacked a rational basis
and, therefore, violated their right of
equal protection under the Due Process
Clause.
March for Life’s employees, who
stated they were personally religious
(although personal religiosity was not a
condition of their employment), also
sued as co-plaintiffs. They contended
that the Mandate violated their rights
under RFRA by making it impossible for
them to obtain health coverage
consistent with their religious beliefs,
either from the plan March for Life
wanted to offer them, or in the
individual market, because the
Departments offered no exemptions in
either circumstance. Another nonreligious nonprofit organization that
opposed the Mandate’s requirement to
provide certain contraceptive coverage
on moral grounds also filed a lawsuit
challenging the Mandate. Real
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Alternatives, Inc. v. Burwell, 150 F.
Supp. 3d 419 (M.D. Pa. 2015).
Challenges by non-religious nonprofit
organizations led to conflicting opinions
among the federal courts. A district
court agreed with the March for Life
plaintiffs on the organization’s equal
protection claim and the employees’
RFRA claims, while not specifically
ruling on the APA claim, and issued a
permanent injunction against the
Departments that is still in place. March
for Life v. Burwell, 128 F. Supp. 3d 116
(D.D.C. 2015). The appeal in March for
Life is pending and has been stayed
since early 2016. In another case, federal
district and appellate courts in
Pennsylvania disagreed with the
reasoning in March for Life, and ruled
against claims brought by a similarly
non-religious nonprofit employer and
its religious employees. Real
Alternatives, 150 F. Supp. 3d 419,
affirmed by 867 F.3d 338 (3d Cir. 2017).
One member of the appeals court panel
in Real Alternatives v. Sec’y of HHS
dissented in part, stating he would have
ruled in favor of the individual
employee plaintiffs under RFRA. 867
F.3d 338, 367 (3d Cir. 2017) (Jordan, J.,
dissenting).
The Departments most recently
solicited public comments on these
issues again in two interim final
regulations with request for comments
published in the Federal Register on
October 13, 2017: The regulations (82
FR 47838) (the Moral IFC) that are being
finalized with changes here, and the
regulations (82 FR 47792) (the Religious
IFC) published on the same day as the
Moral IFC, which are being finalized
with changes in the companion final
rules published elsewhere in today’s
Federal Register.
In the preamble to the Moral IFC, the
Departments explained several reasons
why, after exercising our discretion to
reevaluate the exemptions and
accommodations for the contraceptive
Mandate, we sought public comment on
whether to protect moral convictions in
the Moral IFC and these final rules. The
Departments noted that we considered,
among other things, Congress’s history
of providing protections for moral
convictions regarding certain health
services (including contraception,
sterilization, and items or services
believed to involve abortion); the text,
context, and intent of section 2713(a)(4)
and the ACA; Executive Order 13798,
‘‘Promoting Free Speech and Religious
Liberty’’ (May 4, 2017); previously
submitted public comments; and the
extensive litigation over the
contraceptive Mandate. The
Departments concluded that it was
appropriate that HRSA take into account
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the moral convictions of certain
employers, individuals and health
insurance issuers where the coverage of
contraceptive services is concerned.
Comments were requested on the
interim final regulations.
After consideration of the comments
and feedback received from
stakeholders, the Departments are
finalizing the Moral IFC, with changes
based on comments as indicated
herein.7
II. Overview of the Final Rules and
Public Comments
During the 60-day comment period for
the Moral IFC, which closed on
December 5, 2017, the Departments
received over 54,000 public comment
submissions, which are posted to
www.regulations.gov.8 Below, the
Departments provide an overview of the
final rules and address the issues raised
in the comments we received.
A. Moral Exemptions and
Accommodation in General
These rules expand exemptions to
protect certain entities and individuals
with moral convictions that oppose
contraception whose health plans are
subject to a mandate of contraceptive
coverage through guidance issued
pursuant to the ACA. These rules do not
alter the discretion of HRSA, a
component of HHS, to maintain the
Guidelines requiring contraceptive
coverage where no regulatorily
recognized objection exists. These rules
also make available to exempt
organizations the accommodation
process, which was previously
established in response to some
objections of religious organizations, as
an optional process for exempt entities
that wish to use it voluntarily. These
rules do not alter multiple other federal
programs that provide free or subsidized
contraceptives or related education and
7 The Department of the Treasury and Internal
Revenue Service published proposed and
temporary regulations as part of the joint
rulemaking of the Moral IFC. The Departments of
Labor and HHS published their respective rules as
interim final rules with request for comments and
are finalizing their interim final rules in these final
rules. The Department of the Treasury and Internal
Revenue Service are finalizing their regulations.
8 See Regulations.gov at https://
www.regulations.gov/searchResults?rpp=25&so=
DESC&sb=postedDate&po=0&cmd=
12%7C05%7C17-12%7C05%7C17&dktid=CMS2017-0133 and https://www.regulations.gov/
docketBrowser?rpp=25&so=ASC&sb=posted
Date&po=100&D=IRS-2017-0015. Some of those
submissions included form letters or attachments
that, while not separately tabulated at
regulations.gov, together included comments from,
or were signed by, possibly over a hundred
thousand separate persons. The Departments
reviewed all of the public comments and
attachments.
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counseling for women at risk of
unintended pregnancy.9
1. The Departments’ Authority To
Mandate Coverage or Provide
Exemptions
The Departments received conflicting
comments on their legal authority to
provide exemptions and
accommodations to the Mandate. Some
commenters agreed that the
Departments are legally authorized to
provide expanded exemptions and an
accommodation for moral convictions,
noting that there was no requirement of
contraceptive coverage in the ACA and
no prohibition on providing moral
exemptions in Guidelines issued under
section 2713(a)(4). Other commenters,
however, asserted that the Departments
have no legal authority to provide any
exemptions to the contraceptive
Mandate, contending, based on
statements in the ACA’s legislative
history, that the ACA requires
contraceptive coverage. Still other
commenters contended that the
Departments are legally authorized to
provide the religious exemptions that
existed prior to the 2017 IFCs, but not
to protect moral convictions.
The Departments conclude that we
are legally authorized to provide the
exemption and accommodation for
moral convictions set forth in the Moral
IFC and these final rules. These rules
concern section 2713 of the PHS Act, as
incorporated into ERISA and the Code.
Congress has granted the Departments
legal authority, collectively, to
administer these statutes. (26 U.S.C.
9833; 29 U.S.C. 1191c; 42 U.S.C. 300gg–
92).
Where it applies, section 2713(a)(4)
requires coverage without cost sharing
for ‘‘such additional’’ women’s
preventive care and screenings ‘‘as
provided for’’ and ‘‘supported by’’
guidelines developed by HHS acting
through HRSA. When Congress enacted
this provision, those Guidelines did not
exist. And nothing in the statute
mandated that the Guidelines had to
include contraception, let alone for all
types of employers with covered plans.
Instead, section 2713(a)(4) provided a
9 See, for example, Family Planning grants in 42
U.S.C. 300, et seq.; the Teenage Pregnancy
Prevention Program, Public Law 112–74 (125 Stat
786, 1080); the Healthy Start Program, 42 U.S.C.
254c–8; the Maternal, Infant, and Early Childhood
Home Visiting Program, 42 U.S.C. 711; Maternal
and Child Health Block Grants, 42 U.S.C. 703; 42
U.S.C. 247b–12; Title XIX of the Social Security
Act, 42 U.S.C. 1396, et seq.; the Indian Health
Service, 25 U.S.C. 13, 42 U.S.C. 2001(a), & 25 U.S.C.
1601, et seq.; Health center grants, 42 U.S.C.
254b(e), (g), (h), & (i); the NIH Clinical Center, 42
U.S.C. 248; and the Personal Responsibility
Education Program, 42 U.S.C. 713.
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positive grant of authority for HSRA to
develop those Guidelines, thus
delegating authority to HHS to shape
that development, as the administering
agency of HRSA, and to all three
agencies as the administering agencies
of the statutes by which the Guidelines
are enforced. See 26 U.S.C. 9833; 29
U.S.C. 1191(c), 42 U.S.C. 300gg–92. That
is especially true for HHS, as HRSA is
a component of HHS that was
unilaterally created by the agency and
thus is subject to the agency’s general
supervision, see 47 FR 38409 (August
31, 1982). Thus, nothing prevented
HRSA from creating an exemption from
otherwise-applicable guidelines or
prevented HHS and the other agencies
from directing that HRSA create such an
exemption.
Congress did not specify the extent to
which HRSA must ‘‘provide for’’ and
‘‘support’’ the application of Guidelines
that it chooses to adopt. HRSA’s
authority to support ‘‘comprehensive
guidelines’’ involves determining both
the types of coverage and scope of that
coverage. Section 2714(a)(4) requires
coverage for preventive services only
‘‘as provided for in comprehensive
guidelines supported by [HRSA].’’ That
is, services are required to be included
in coverage only to the extent that the
Guidelines supported by HRSA provide
for them. Through use of the word ‘‘as’’
in the phrase ‘‘as provided for,’’ it
requires that HRSA support how those
services apply—that is, the manner in
which the support will happen, such as
in the phrase ‘‘as you like it.’’ 10 When
Congress means to require certain
activities to occur in a certain manner,
instead of simply authorizing the agency
to decide the manner in which they will
occur, Congress knows how to do so.
See for example, 42 U.S.C. 1395x (‘‘The
Secretary shall establish procedures to
make beneficiaries and providers aware
of the requirement that a beneficiary
complete a health risk assessment prior
to or at the same time as receiving
personalized prevention plan services.’’)
(emphasis added). Thus, the inclusion
of ‘‘as’’ in section 300gg–13(a)(3), and its
absence in similar neighboring
provisions, shows that HRSA has
discretion whether to support how the
preventive coverage mandate applies—it
does not refer to the timing of the
promulgation of the Guidelines.
Nor is it simply a textual aberration
that the word ‘‘as’’ is missing from the
other three provisions in section 2713(a)
of the PHS Act. Rather, this difference
10 See As (usage 2), Oxford English Dictionary
Online (Feb. 2018) (‘‘[u]sed to indicate by
comparison the way something happens or is
done’’).
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mirrors other distinctions within that
section that demonstrate that Congress
intended HRSA to have the discretion
the Agencies invoke. For example,
sections (a)(1) and (a)(3) require
‘‘evidence-based’’ or ‘‘evidenceinformed’’ coverage, while section (a)(4)
does not. This difference suggests that
the Agencies have the leeway to
incorporate policy-based concerns into
their decision-making. This reading of
section 2713(a)(4) also prevents the
statute from being interpreted in a
cramped way that allows no flexibility
or tailoring, and that would force the
Departments to choose between ignoring
religious objections in violation of
RFRA or else eliminating the
contraceptive coverage requirement
from the Guidelines altogether. The
Departments instead interpret section
2713(a)(4) as authorizing HRSA’s
Guidelines to set forth both the kinds of
items and services that will be covered,
and the scope of entities to which the
contraceptive coverage requirement in
those Guidelines will apply.
The moral objections at issue here,
like the religious objections prompting
exemptions dating back to the inception
of the Mandate in 2011, may, consistent
with the statutory provision,
permissibly inform what HHS, through
HRSA, decides to provide for and
support in the Guidelines. Since the
first rulemaking on this subject in 2011,
the Departments have consistently
interpreted the broad discretion granted
to HRSA in section 2713(a)(4) as
including the power to reconcile the
ACA’s preventive-services requirement
with sincerely held views of conscience
on the sensitive subject of contraceptive
coverage—namely, by exempting
churches and their integrated auxiliaries
from the contraceptive-coverage
Mandate. (See 76 FR at 46623.) As the
Departments explained at that time, the
HRSA Guidelines ‘‘exist solely to bind
non-grandfathered group health plans
and health insurance issuers with
respect to the extent of their coverage of
certain preventive services for women,’’
and ‘‘it is appropriate that HRSA . . .
takes into account the effect on the
religious beliefs of [employers] if
coverage of contraceptive services were
required in [their] group health plans.’’
Id. Consistent with that longstanding
view, Congress’s grant of discretion in
section 2713(a)(4), and the lack of a
mandate that contraceptives be covered
or that they be covered without any
exemptions or exceptions, lead the
Departments to conclude that we are
legally authorized to exempt certain
entities or plans from a contraceptive
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57597
Mandate if HRSA decides to otherwise
include contraceptives in its Guidelines.
The Departments’ conclusions are
consistent with our interpretation of
section 2713 of the PHS Act since 2010,
when the ACA was enacted, and since
the Departments started to issue interim
final regulations implementing that
section. The Departments have
consistently interpreted section
2713(a)(4) to grant broad discretion to
decide the extent to which HRSA will
provide for, and support, the coverage of
additional women’s preventive care and
screenings, including the decision to
exempt certain entities and plans, and
not to provide for or support the
application of the Guidelines with
respect to those entities or plans. The
Departments created an exemption to
the contraceptive Mandate when that
Mandate was announced in 2011, and
then amended and expanded the
exemption and added an
accommodation process in multiple
rulemakings thereafter. The
accommodation process requires the
provision of coverage or payments for
contraceptives to plan participants in an
eligible organization’s health plan by
the organization’s insurer or third party
administrator. However, the
accommodation process itself, in some
cases, failed to require contraceptive
coverage for many women, because—as
the Departments acknowledged at the
time—the enforcement mechanism for
that process, section 3(16) of ERISA,
does not provide a means to impose an
obligation to provide contraceptive
coverage on the third party
administrator of self-insured church
plans (see 80 FR 41323). Non-exempt
employers participate in many church
plans. Therefore, in both the previous
exemption, and in the previous
accommodation’s application to selfinsured church plans, the Departments
have been choosing not to require
contraceptive coverage for certain kinds
of employers since the Guidelines were
adopted. In doing so, the Departments
have been acting contrary to
commenters who contended the
Departments had no authority to create
exemptions under section 2713 of the
PHS Act, or its incorporation into
ERISA and the Code, and who
contended instead that the Departments
must enforce Guidelines on the broadest
spectrum of group health plans as
possible, even including churches (see,
for example, 2012 final regulations at 77
FR 8726).
The Departments’ interpretation of
section 2713(a)(4) is confirmed by the
ACA’s statutory structure. Congress did
not intend to require entirely uniform
coverage of preventive services (see for
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example, 76 FR 46623). On the contrary,
Congress carved out an exemption from
section 2713 of the PHS Act (and from
several other provisions) for
grandfathered plans. In contrast, the
grandfathering exemption is not
applicable to many of the other
provisions in Title I of the ACA—
provisions previously referred to by the
Departments as providing ‘‘particularly
significant protections.’’ (75 FR 34540).
Those provisions include (from the PHS
Act) section 2704, which prohibits
preexisting condition exclusions or
other discrimination based on health
status in group health coverage; section
2708, which prohibits excessive waiting
periods (as of January 1, 2014); section
2711, which relates to lifetime dollar
limits; section 2712, which generally
prohibits rescission of health coverage;
section 2714, which extends dependent
child coverage until the child turns 26;
and section 2718, which imposes a
minimum medical loss ratio on health
insurance issuers in the individual and
group markets (for insured coverage),
and requires them to provide rebates to
policyholders if that medical loss ratio
is not met. (75 FR 34538, 34540, 34542).
Consequently, of the 150 million
nonelderly people in America with
employer-sponsored health coverage,
approximately 25.5 million are
estimated to be enrolled in
grandfathered plans not subject to
section 2713.11 Some commenters assert
the exemptions for grandfathered plans
are temporary, or were intended to be
temporary, but as the Supreme Court
observed, ‘‘there is no legal requirement
that grandfathered plans ever be phased
out.’’ Burwell v. Hobby Lobby Stores,
Inc., 134 S. Ct. 2751, 2764 n.10 (2014).
Some commenters argue that
Executive Order 13535’s reference to
implementing the ACA consistent with
certain conscience laws does not justify
creating exemptions to contraceptive
coverage in the Guidelines, because
those laws do not specifically require
exemptions in the Guidelines. The
Departments, however, believe that they
are acting consistent with Executive
Order 13535 by creating exemptions
using HRSA’s authority under section
2713(a)(4), and the Departments’
administrative authority over the
implementation of section 2713(a) of the
PHS Act. Executive Order 13535, issued
upon the signing of the ACA, specified
that ‘‘longstanding Federal laws to
protect conscience . . . remain intact,’’
11 Kaiser Family Foundation & Health Research &
Educational Trust, ‘‘Employer Health Benefits, 2017
Annual Survey,’’ Henry J Kaiser Family Foundation
(Sept. 19, 2017), https://files.kff.org/attachment/
Report-Employer-Health-Benefits-Annual-Survey2017.
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including laws that protect holders of
religious beliefs or moral convictions
from certain requirements in health care
contexts. Although the text of Executive
Order 13535 does not require the
expanded exemptions confirmed in
these final rules, the expanded
exemptions are, as explained below,
consistent with longstanding federal
laws to protect conscience objections,
based on religious beliefs or moral
convictions regarding certain health
matters, and are consistent with the
intent that the ACA be implemented in
accordance with the conscience
protections set forth in those laws.
Some commenters contended that,
even though Executive Order 13535
refers to the Church Amendments, the
intention of those statutes is narrow,
should not be construed to extend to
entities instead of to individuals, and
should not be construed to prohibit
procedures. But those comments
mistake the Departments’ position. The
Departments are not construing the
Church Amendments to require these
exemptions, nor do the exemptions
prohibit any procedures. Instead,
through longstanding federal conscience
statutes, Congress has established
consistent principles concerning respect
for sincerely held moral convictions in
sensitive healthcare contexts.12 Under
those principles, and absent any
contrary requirement of law, the
Departments are offering exemptions for
sincerely held moral convictions to the
extent the Departments otherwise
impose a contraceptive Mandate. These
exemptions do not prohibit any
services, nor authorize employers to
prohibit employees from obtaining any
services. The exemptions in the Moral
IFC and these final rules simply refrain
from imposing a federal mandate that
employers cover contraceptives in their
health plans even if they have sincerely
held moral convictions against doing so.
Some commenters stated that the
Supreme Court ruled that the
exemptions provided for houses of
worship and integrated auxiliaries were
required by the First Amendment. From
this, commenters concluded that the
exemptions for houses of worship and
integrated auxiliaries are legally
authorized, but that exemptions beyond
those are not. But the Supreme Court
did not rule on the question whether the
12 The Departments note that the Church
Amendments are the subject of another, ongoing
rulemaking process. See Protecting Statutory
Conscience Rights in Health Care; Delegations of
Authority, 83 FR 3880 (NPRM Jan. 26, 2018). Since
the Departments are not construing the
Amendments to require the religious exemptions,
we defer issues regarding the scope, interpretation,
and protections of the Amendments to HHS in that
rulemaking.
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exemptions provided for houses of
worship and integrated auxiliaries were
required by the First Amendment, and
the Court did not say the Departments
must apply the contraceptive Mandate
unless RFRA prohibits us from doing so.
The appropriateness of including
exemptions to protect moral convictions
is informed by Congress’s long history
of providing exemptions for moral
convictions, especially in certain health
care contexts.
2. Congress’s History of Protecting
Moral Convictions
The Department received numerous
comments about its decision in the
Moral IFC to exercise its discretion to
provide moral exemptions to, and an
accommodation under, the
contraceptive Mandate. Some
commenters agreed with the
Departments’ decision in the Moral IFC,
arguing that it is appropriate to exercise
the Departments’ discretion to protect
moral convictions in light of Congress’s
history of protecting moral convictions
in various contexts, especially
concerning health care. Other
commenters disagreed, saying that
existing conscience statutes protecting
moral convictions do not require these
exemptions and, therefore, the
exemptions should not be offered. Some
commenters stated that because
Congress has provided conscience
protections, but did not specifically
provide them in section 2713(a)(4),
conscience protections are
inappropriate in the implementation of
that section. Still other commenters
went further, disagreeing with
conscience protections regarding
contraceptives, abortions, or health care
in general.
In deciding the most appropriate way
to exercise our discretion in this
context, the Departments draw on the
most recent statements of Congress,
along with nearly 50 years of statutes
and Supreme Court precedent
discussing the protection of moral
convictions in certain circumstances—
particularly in the context of health care
and health coverage. Most recently,
Congress expressed its intent on the
matter of Government-mandated
contraceptive coverage when it
declared, with respect to the possibility
that the District of Columbia would
require contraceptive coverage, that ‘‘it
is the intent of Congress that any
legislation enacted on such issue should
include a ‘conscience clause’ which
provides exceptions for religious beliefs
and moral convictions.’’ Consolidated
Appropriations Act, 2018, Div. E,
section 808, Public Law 115–141, 132
Stat. 348, 603 (Mar. 23, 2018); see also
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Consolidated Appropriations Act, 2017,
Div. C, section 808, Public Law 115–31
(May 5, 2017). The Departments
consider it significant that Congress’s
most recent statements on the prospect
of Government-mandated contraceptive
coverage specifically intend that a
conscience clause be included to protect
moral convictions.
The Departments also consider
significant the many statutes listed
above, in section I—Background
footnote 1, that show Congress’s
consistent protection of moral
convictions alongside religious beliefs
in the federal regulation of health care.
These include laws such as the Church
Amendments (dating back to 1973),
which we discuss at length below, to the
2018 Consolidated Appropriations Act
discussed above. Notably among those
laws, and in addition to the Church
Amendments, Congress has enacted
protections for health plans or health
care organizations in Medicaid or
Medicare Advantage to object ‘‘on moral
or religious grounds’’ to providing
coverage of certain counseling or
referral services. 42 U.S.C. 1395w–
22(j)(3)(B) (protecting against forced
counseling or referrals in Medicare +
Choice (now Medicare Advantage)
managed care plans with respect to
objections based on ‘‘moral or religious
grounds’’); 42 U.S.C. 1396u–2(b)(3)
(protecting against forced counseling or
referrals in Medicaid managed care
plans with respect to objections based
on ‘‘moral or religious grounds’’).
Congress has also protected individuals
who object to prescribing or providing
contraceptives contrary to their
‘‘religious beliefs or moral convictions.’’
Consolidated Appropriations Act, 2018,
Public Law 115–141, Division E, section
726(c); see also Consolidated
Appropriations Act of 2017, Division C,
Title VII, Sec. 726(c) (Financial Services
and General Government
Appropriations Act), Public Law 115–
31.13
The Departments disagree with
commenters that suggested we should
not consider Congress’s history of
protecting moral objections in certain
health care contexts due to Congress’s
failure to explicitly include exemptions
in section 2713(a)(4) itself. The
argument by these commenters proves
too much, since Congress also did not
13 The
Departments also note that, in protecting
those individual and institutional health care
entities that object to certain abortion-related
services and activities regardless of the basis for
such objection, the Coats-Snowe Amendment, PHS
Act section 245 (42 U.S.C. 238n), and the Weldon
Amendment, Consolidated Appropriations Act,
2018, Div. H, Sec. 507(d), Public Law 115–141,
protect those whose objection is based on moral
conviction.
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specifically require contraceptive
coverage in section 2713 of the PHS Act.
This argument would also negate not
just these expanded exemptions, but the
previous exemptions provided for
houses of worship and integrated
auxiliaries, and the indirect exemption
for self-insured church plans that use
the accommodation. Where Congress
left so many matters concerning section
2713(a)(4) to agency discretion, the
Departments consider it appropriate to
implement these expanded exemptions
in light of Congress’s long history of
respecting moral convictions in the
context of certain federal health care
requirements.
a. The Church Amendments’ Protection
of Moral Convictions
One of the most important and wellestablished federal statutes respecting
conscientious objections in specific
health care contexts was enacted over
the course of several years beginning in
1973, initially as a response to court
decisions raising the prospect that
entities or individuals might be required
to facilitate abortions or sterilizations
because they had received federal funds.
These sections of the U.S. Code are
known as the Church Amendments,
named after their primary sponsor,
Senator Frank Church (D-Idaho). The
Church Amendments specifically
provide conscience protections based on
sincerely held moral convictions, not
just religious beliefs. Among other
things, the amendments protect the
recipients of certain federal health funds
from being required to perform, assist,
or make their facilities available for
abortions or sterilizations if they object
‘‘on the basis of religious beliefs or
moral convictions,’’ and they prohibit
recipients of certain federal health funds
from discriminating against any
personnel ‘‘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’’ (42 U.S.C. 300a–7(b),
(c)(1)). Later additions to the Church
Amendments protect other
conscientious objections, including
some objections on the basis of moral
conviction to ‘‘any lawful health
service,’’ or to ‘‘any part of a health
service program.’’ (42 U.S.C. 300a–
7(c)(2), (d)). In contexts covered by
those sections of the Church
Amendments, the provision or coverage
of certain contraceptives, depending on
the circumstances, could constitute
‘‘any lawful health service’’ or a ‘‘part of
a health service program.’’ As such, the
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protections provided by those
provisions of the Church Amendments
would encompass moral objections to
contraceptive services or coverage.
The Church Amendments were
enacted in the wake of the Supreme
Court’s decision in Roe v. Wade, 410
U.S. 113 (1973). Although the Court in
Roe required abortion to be legal in
certain circumstances, Roe did not
include, within that right, the
requirement that other citizens facilitate
its exercise. Indeed, Roe favorably
quoted the proceedings of the American
Medical Association House of Delegates
220 (June 1970), which declared,
‘‘Neither physician, hospital, nor
hospital personnel shall be required to
perform any act violative of personallyheld moral principles.’’ 410 U.S. at 144
& n.38 (1973). Likewise, in Roe’s
companion case, Doe v. Bolton, the
Court observed that, under state law, ‘‘a
physician or any other employee has the
right to refrain, for moral or religious
reasons, from participating in the
abortion procedure.’’ 410 U.S. 179, 197–
98 (1973). The Court said that these
conscience provisions ‘‘obviously . . .
afford appropriate protection.’’ Id. at
198. As an Arizona court later put it, ‘‘a
woman’s right to an abortion or to
contraception does not compel a private
person or entity to facilitate either.’’
Planned Parenthood Ariz., Inc. v. Am.
Ass’n of Pro-Life Obstetricians &
Gynecologists, 257 P.3d 181, 196 (Ariz.
Ct. App. 2011).
The Congressional Record contains
discussions that occurred when the
protection for moral convictions was
first proposed in the Church
Amendments. When Senator Church
introduced the first of those
amendments in 1973, he cited not only
Roe v. Wade, but also an instance where
a federal court had ordered a Catholic
hospital to perform sterilizations. 119
Congr. Rec. S5717–18 (Mar. 27, 1973).
After his opening remarks, Senator
Adlai Stevenson III (D–IL) rose to ask
that the amendment be changed to
specify that it also protects objections to
abortion and sterilization based on
moral convictions on the same terms as
it protects objections based on religious
beliefs. The following excerpt of the
Congressional Record records this
discussion:
Mr. STEVENSON. Mr. President, first of all
I commend the Senator from Idaho for
bringing this matter to the attention of the
Senate. I ask the Senator a question.
One need not be of the Catholic faith or
any other religious faith to feel deeply about
the worth of human life. The protections
afforded by this amendment run only to
those whose religious beliefs would be
offended by the necessity of performing or
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participating in the performance of certain
medical procedures; others, for moral
reasons, not necessarily for any religious
belief, can feel equally as strong about human
life. They too can revere human life.
As mortals, we cannot with confidence say,
when life begins. But whether it is life, or the
potentiality of life, our moral convictions as
well as our religious beliefs, warrant
protection from this intrusion by the
Government. Would, therefore, the Senator
include moral convictions?
Would the Senator consider an amendment
on page 2, line 18 which would add to
religious beliefs, the words ‘‘or moral’’?
Mr. CHURCH. I would suggest to the
Senator that perhaps his objective could be
more clearly stated if the words ‘‘or moral
conviction’’ were added after ‘‘religious
belief.’’ I think that the Supreme Court in
considering the protection we give religious
beliefs has given comparable treatment to
deeply held moral convictions. I would not
be averse to amending the language of the
amendment in such a manner. It is consistent
with the general purpose. I see no reason
why a deeply held moral conviction ought
not be given the same treatment as a religious
belief.
Mr. STEVENSON. The Senator’s suggestion
is well taken. I thank him.
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119 Congr. Rec. S5717–18
As the debate proceeded, Senator
Church went on to quote Doe v. Bolton’s
reliance on a Georgia statute that stated
‘‘a physician or any other employee has
the right to refrain, for moral or religious
reasons, from participating in the
abortion procedure.’’ 119 Congr. Rec.
S5722 (quoting 410 U.S. at 197–98).
Senator Church added, ‘‘I see no reason
why the amendment ought not also to
cover doctors and nurses who have
strong moral convictions against these
particular operations.’’ Id. Considering
the scope of the protections, Senator
Gaylord Nelson (D–WI) asked whether,
‘‘if a hospital board, or whatever the
ruling agency for the hospital was, a
governing agency or otherwise, just
capriciously—and not upon the
religious or moral questions at all—
simply said, ‘We are not going to bother
with this kind of procedure in this
hospital,’ would the pending
amendment permit that?’’ 119 Congr.
Rec. S5723. Senator Church responded
that the amendment would not
encompass such an objection. Id.
Senator James L. Buckley (C–NY),
speaking in support of the amendment,
added the following perspective:
Mr. BUCKLEY. Mr. President, I
compliment the Senator from Idaho for
proposing this most important and timely
amendment. It is timely in the first instance
because the attempt has already been made
to compel the performance of abortion and
sterilization operations on the part of those
who are fundamentally opposed to such
procedures. And it is timely also because the
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recent Supreme Court decisions will likely
unleash a series of court actions across the
United States to try to impose the personal
preferences of the majority of the Supreme
Court on the totality of the Nation.
I believe it is ironic that we should have
this debate at all. Who would have predicted
a year or two ago that we would have to
guard against even the possibility that
someone might be free [sic] 14 to participate
in an abortion or sterilization against his
will? Such an idea is repugnant to our
political tradition. This is a Nation which has
always been concerned with the right of
conscience. It is the right of conscience
which is protected in our draft laws. It is the
right of conscience which the Supreme Court
has quite properly expanded not only to
embrace those young men who, because of
the tenets of a particular faith, believe they
cannot kill another man, but also those who
because of their own deepest moral
convictions are so persuaded.
I am delighted that the Senator from Idaho
has amended his language to include the
words ‘‘moral conviction,’’ because, of
course, we know that this is not a matter of
concern to any one religious body to the
exclusion of all others, or even to men who
believe in a God to the exclusion of all
others. It has been a traditional concept in
our society from the earliest times that the
right of conscience, like the paramount right
to life from which it is derived, is sacred.
119 Congr. Rec. S5723
In support of the same protections
when they were debated in the U.S.
House, Representative Margaret Heckler
(R–MA) 15 likewise observed that ‘‘the
right of conscience has long been
recognized in the parallel situation in
which the individual’s right to
conscientious objector status in our
selective service system has been
protected’’ and ‘‘expanded by the
Supreme Court to include moral
conviction as well as formal religious
belief.’’ 119 Congr. Rec. H4148–49 (May
31, 1973). Rep. Heckler added, ‘‘We are
concerned here only with the right of
moral conscience, which has always
been a part of our national tradition.’’
Id. at 4149.
These first sections of the Church
Amendments, codified at 42 U.S.C.
300a–7(b) and (c)(1), passed the House
372–1, and were approved by the Senate
94–0. 119 Congr. Rec. at H4149; 119
Congr. Rec. S10405 (June 5, 1973). The
subsequently adopted provisions that
comprise the Church Amendments
similarly extend protection to those
organizations and individuals who
object to the provision of certain
services on the basis of their moral
convictions, as well as those who object
14 The Senator might have meant ‘‘[forced] . . .
against his will.’’
15 Rep. Heckler later served as the 15th Secretary
of HHS, from March 1983 to December 1985.
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to such services on the basis of religious
beliefs. And, as noted above, subsequent
statutes add protections for moral
objections in many other situations.
These include, for example:
• Protections for individuals and
entities that object to abortion. See 42
U.S.C. 238n; 42 U.S.C. 18023; 42 U.S.C.
2996f(b); Consolidated Appropriations
Act, 2018, Div. H, Sec. 507(d), Public
Law 115–141.
• Protections for entities and
individuals that object to providing or
covering contraceptives. See id. at Div.
E, Sec. 808; id. at Div. E, Sec. 726(c)
(Financial Services and General
Government Appropriations Act); id. at
Div. K, Title III.
• Protections for entities and
individuals that object to performing,
assisting, counseling, or referring as
pertains to suicide, assisted suicide, or
advance directives. See 42 U.S.C.
290bb–36; 42 U.S.C. 1396a(w)(3); 42
U.S.C. 14406; 42 U.S.C. 18113 (adopted
as part of the ACA).
The Departments believe that the
intent behind Congress’s protection of
moral convictions in certain health care
contexts, especially to protect entities
and individuals from governmental
coercion, supports the Departments’
decision in the Moral IFC and these
final rules to protect sincerely held
moral convictions from governmental
compulsion threatened by the
contraceptive Mandate.
b. Court Precedents Relevant to These
Expanded Exemptions
As reflected in the legislative history
of the first Church Amendments, the
Supreme Court has long afforded
protection to moral convictions
alongside religious beliefs. Indeed,
Senator Church cited Doe v. Bolton, 410
U.S. 179, as a parallel instance of
conscience protection and spoke of the
Supreme Court generally giving
‘‘comparable treatment to deeply held
moral convictions.’’ Both Senator
Buckley and Rep. Heckler specifically
cited the Supreme Court’s protection of
moral convictions in laws governing
military service. Those legislators
appear to have been referencing cases
such as Welsh v. United States, 398 U.S.
333 (1970), which the Supreme Court
had decided just three years earlier.
Welsh involved what is perhaps the
Government’s paradigmatic compelling
interest—the need to defend the nation
by military force. The Court stated that,
where the Government protects
objections to military service based on
‘‘religious training and belief,’’ that
protection would also extend to
avowedly non-religious objections to
war held with the same moral strength.
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Id. at 343. The Court declared, ‘‘[i]f an
individual deeply and sincerely holds
beliefs that are purely ethical or moral
in source and content but that
nevertheless impose upon him a duty of
conscience to refrain from participating
in any war at any time, those beliefs
certainly occupy in the life of that
individual ‘a place parallel to that filled
by . . . God’ in traditionally religious
persons. Because his beliefs function as
a religion in his life, such an individual
is as much entitled to a ‘religious’
conscientious objector exemption . . .
as is someone who derives his
conscientious opposition to war from
traditional religious convictions.’’
In the context of this particular
Mandate, it is also worth noting that, in
Hobby Lobby, Justice Ginsburg (joined,
in this part of the opinion, by Justices
Breyer, Kagan, and Sotomayor), cited
Justice Harlan’s opinion in Welsh, 398
U.S. at 357–58, in support of her
statement that ‘‘[s]eparating moral
convictions from religious beliefs would
be of questionable legitimacy.’’ 134 S.
Ct. at 2789 n.6. In quoting this passage,
the Departments do not mean to suggest
that all laws protecting only religious
beliefs constitute an illegitimate
‘‘separat[ion]’’ of moral convictions, nor
do the Departments assert that moral
convictions must always be protected
alongside religious beliefs; we also do
not agree with Justice Harlan that
distinguishing between religious and
moral objections would violate the
Establishment Clause. Instead, the
Departments believe that, in the specific
health care context implicated here,
providing respect for moral convictions
parallel to the respect afforded to
religious beliefs is appropriate, draws
from long-standing Federal Government
practice, and shares common ground
with Congress’s intent in the Church
Amendments and in later federal
statutes that provide protections for
moral convictions alongside religious
beliefs in other health care contexts.
c. Conscience Protections in Other
Federal and State Contexts
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The tradition of protecting moral
convictions in certain health contexts is
not limited to laws passed by Congress.
Multiple federal regulations protect
objections based on moral convictions
in such contexts.16 Other federal
16 See, for example, 42 CFR 422.206 (declaring
that the general Medicare Advantage rule ‘‘does not
require the MA plan to cover, furnish, or pay for
a particular counseling or referral service if the MA
organization that offers the plan—(1) Objects to the
provision of that service on moral or religious
grounds.’’); 42 CFR 438.102 (declaring that
information requirements do not apply ‘‘if the
MCO, PIHP, or PAHP objects to the service on
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regulations have also applied the
principle of respecting moral
convictions alongside religious beliefs
in particular circumstances. The Equal
Employment Opportunity Commission
has consistently protected ‘‘moral or
ethical beliefs as to what is right and
wrong which are sincerely held with the
strength of traditional religious views’’
alongside religious views under the
‘‘standard [ ] developed in United States
v. Seeger, 380 U.S. 163 (1965) and
[Welsh].’’ 29 CFR 1605.1. The
Department of Justice has declared that,
in cases of capital punishment, no
officer or employee may be required to
attend or participate if doing so ‘‘is
contrary to the moral or religious
convictions of the officer or employee,
or if the employee is a medical
professional who considers such
participation or attendance contrary to
medical ethics.’’ 28 CFR 26.5.17
Forty-five states have health care
conscience protections covering
objections to abortion; several of these
also cover sterilization or
contraception.18 Most of those state laws
protect objections based on ‘‘moral,’’
‘‘ethical,’’ or ‘‘conscientious’’ grounds in
addition to ‘‘religious’’ grounds.
Particularly in the case of abortion,
some federal and state conscience laws
do not require any specified motive for
the objection. 42 U.S.C. 238n;
Consolidated Appropriations, 2018,
Public Law 115–141, Div. H, section
507(d).
These various statutes and regulations
reflect an important governmental
interest in protecting moral convictions
in appropriate health contexts. The
contraceptive Mandate implicates that
governmental interest. Many persons
and entities object to the Mandate in
part because they consider some forms
of FDA-approved contraceptives to be
moral or religious grounds’’); 48 CFR 1609.7001
(‘‘health plan sponsoring organizations are not
required to discuss treatment options that they
would not ordinarily discuss in their customary
course of practice because such options are
inconsistent with their professional judgment or
ethical, moral or religious beliefs.’’); 48 CFR
352.270–9 (‘‘Non-Discrimination for Conscience’’
clause for organizations receiving HIV or Malaria
relief funds).
17 See also 18 CFR 214.11 (where a law
enforcement agency (LEA) seeks assistance in the
investigation or prosecution of trafficking of
persons, the reasonableness of the LEA’s request
will depend in part on ‘‘[c]ultural, religious, or
moral objections to the request’’).
18 According to the Guttmacher Institute, 45 states
have conscience statutes pertaining to abortion (43
of which cover institutions), 18 have conscience
statutes pertaining to sterilization (16 of which
cover institutions), and 12 have conscience statutes
pertaining to contraception (8 of which cover
institutions). ‘‘Refusing to Provide Health Services,’’
The Guttmacher Institute (June 1, 2017), https://
www.guttmacher.org/state-policy/explore/refusingprovide-health-services.
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57601
morally equivalent to abortion due to
the possibility that such items may
prevent the implantation of a human
embryo after fertilization.19 The
Supreme Court, in describing family
business owners with religious
objections, explained that ‘‘[t]he owners
of the businesses have religious
objections to abortion, and according to
their religious beliefs the four
contraceptive methods at issue are
abortifacients. If the owners comply
with the HHS mandate, they believe
they will be facilitating abortions.’’
Hobby Lobby, 134 S. Ct. at 2751. Based
on pleadings in the litigation, all of the
litigants challenging the Mandate and
asserting purely non-religious objections
share this view. And as Congress has
implicitly recognized in providing
health care conscience protections
pertaining to sterilization,
contraception, and other health care
services and practices, individuals or
entities may have additional moral
objections to contraception.20
d. Founding Principles
The Departments also look to
guidance from, and draw support for the
Moral IFC and these final rules from, the
broader history of respect for conscience
in the laws and founding principles of
the United States. Members of Congress
specifically relied on the American
tradition of respect for conscience when
they decided to protect moral
convictions in health care. In supporting
the protection of conscience based on
non-religious moral convictions,
Senator Buckley declared ‘‘[i]t has been
a traditional concept in our society from
the earliest times that the right of
conscience, like the paramount right to
life from which it is derived, is sacred.’’
Representative Heckler similarly stated
that ‘‘the right of moral conscience . . .
has always been a part of our national
tradition.’’ This tradition is reflected, for
example, in a letter President George
Washington wrote saying that ‘‘[t]he
Citizens of the United States of America
have a right to applaud themselves for
having given to mankind examples of an
enlarged and liberal policy: A policy
worthy of imitation. All possess alike
liberty of conscience and immunities of
19 FDA, ‘‘Birth Control,’’ U.S. Food and Drug
Administration (Mar. 6, 2018), https://www.fda.gov/
forconsumers/byaudience/forwomen/
freepublications/ucm313215.htm (various approved
contraceptives, including Levonorgestrel, Ulipristal
Acetate, and IUDs, work mainly by preventing
fertilization, but ‘‘may also work . . . by preventing
attachment (implantation) to the womb (uterus)’’ of
a human embryo after fertilization).
20 See supra note 1.
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citizenship.’’ 21 Thomas Jefferson
similarly declared that ‘‘[n]o provision
in our Constitution ought to be dearer to
man than that which protects the rights
of conscience against the enterprises of
the civil authority.’’ 22 Although these
statements by Presidents Washington
and Jefferson were spoken to religious
congregations, and although religious
and moral conscience were tightly
intertwined for the Founders, they both
reflect a broad principle of respect for
conscience against government
coercion. James Madison likewise called
conscience ‘‘the most sacred of all
property,’’ and proposed that the Bill of
Rights should guarantee, in addition to
protecting religious belief and worship,
that ‘‘the full and equal rights of
conscience [shall not] be in any manner,
or on any pretext infringed.’’ 23
These Founding Era statements of
general principle do not specify how
they would be applied in a particular
health care context, and the
Departments do not suggest that the
specific protections offered in the Moral
IFC and these final rules would be
required or necessarily appropriate in
any other context that does not raise the
specific concerns implicated by this
Mandate. These final rules do not
address in any way how the
Government would balance its interests
with respect to other health services not
encompassed by the contraceptive
Mandate.24 Instead, the Departments
highlight this tradition of respect for
conscience from the Nation’s Founding
Era to provide background support for
the Departments’ decision to implement
section 2713(a)(4), while protecting
conscience in the exercise of moral
convictions. The Departments believe
that these final rules are consistent both
with the American tradition of respect
for conscience and with Congress’s
history of providing conscience
protections in the kinds of health care
matters involved in this Mandate.
21 Letter from George Washington to the Hebrew
Congregation in Newport, Rhode Island (Aug. 18,
1790) (available at https://founders.archives.gov/
documents/Washington/05-06-02-0135).
22 Letter to the Society of the Methodist Episcopal
Church at New London, Connecticut (February 4,
1809) (available at https://founders.archives.gov/
documents/Jefferson/99-01-02-9714).
23 James Madison, ‘‘Essay on Property’’ (March
29, 1792); First draft of the First Amendment, 1
Annals of Congress 434 (June 8, 1789).
24 As the Supreme Court stated in Hobby Lobby,
the Court’s decision concerns only the
contraceptive Mandate, and should not be
understood to hold that all insurance-coverage
mandates, for example, for vaccinations or blood
transfusions, must necessarily fail if they conflict
with an employer’s religious beliefs. Nor does the
Court’s opinion provide a shield for employers who
might cloak illegal discrimination as a religious (or
moral) practice. 134 S. Ct. at 2783.
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e. Executive Orders Relevant to These
Expanded Exemptions
Protecting moral convictions, as set
forth in these expanded exemptions and
accommodation in these final rules, is
consistent with recent executive orders.
President Trump’s Executive Order
concerning this Mandate directed the
Departments to consider providing
protections, not specifically for
‘‘religious’’ beliefs, but for
‘‘conscience.’’ We interpret that term to
include both religious beliefs and moral
convictions. Moreover, President
Trump’s first Executive Order, E.O.
13765, declared that ‘‘the Secretary of
Health and Human Services (Secretary)
and the heads of all other executive
departments and agencies (agencies)
with authorities and responsibilities
under the [ACA] shall exercise all
authority and discretion available to
them to waive, defer, grant exemptions
from, or delay the implementation of
any provision or requirement of the Act
that would impose a fiscal burden on
any state or a cost, fee, tax, penalty, or
regulatory burden on individuals,
families, healthcare providers, health
insurers, patients, recipients of
healthcare services, purchasers of health
insurance, or makers of medical devices,
products, or medications.’’ The
exemption and accommodation adopted
in these final rules relieves a regulatory
burden imposed on entities with moral
convictions opposed to providing
certain contraceptive coverage and is
therefore consistent with both Executive
Orders.
f. Litigation Concerning the Mandate
The Departments have further taken
into consideration the litigation
surrounding the Mandate in exercising
their discretion to adopt the exemption
in these final rules. Among the lawsuits
challenging the Mandate, two have been
filed based in part on non-religious
moral convictions. In one case, the
Departments are subject to a permanent
injunction requiring us to respect the
non-religious moral objections of an
employer. See March for Life v. Burwell,
128 F. Supp. 3d 116 (D.D.C. 2015). In
the other case, an appeals court affirmed
a district court ruling that allows the
previous regulations to be imposed in a
way that affects the moral convictions of
a small nonprofit pro-life organization
and its employees. See Real Alternatives
v. Sec’y, Dep’t of Health & Human
Servs., 867 F.3d 338 (3d Cir. 2017). The
Departments’ litigation of these cases
has thus led to inconsistent court
rulings, consumed substantial
governmental resources, and created
uncertainty for objecting organizations,
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issuers, third party administrators, and
employees and beneficiaries. The
organizations that have sued seeking a
moral exemption have adopted
longstanding moral tenets opposed to
certain FDA-approved contraceptives,
and hire only employees who share this
view. As a result, it is reasonable to
conclude that employees of these
organizations would not benefit from
the Mandate. Thus, subjecting this
subset of organizations to the Mandate
does not advance any governmental
interest. The need to resolve this
litigation and the potential concerns of
similar entities, as well as the legal
requirement to comply with permanent
injunctive relief currently imposed in
March for Life, provide substantial
reasons for the Departments to protect
moral convictions through these final
rules. Although, as discussed below, the
Departments assume the number of
entities and individuals that may seek
exemption from the Mandate on the
basis of moral convictions, as these two
sets of litigants did, will be small, the
Departments know from the litigation
that it will not be zero. As a result, the
Departments have taken these types of
objections into consideration in
reviewing our regulations. Having done
so, the Departments consider it
appropriate to issue the protections set
forth in these final rules. Just as
Congress, in adopting the early
provisions of the Church Amendments,
viewed it as necessary and appropriate
to protect those organizations and
individuals with objections to certain
health care services on the basis of
moral convictions, so the Departments,
too, believe that ‘‘our moral convictions
as well as our religious beliefs, warrant
protection from this intrusion by the
Government’’ in this situation. See 119
Congr. Rec. S5717–18.
The litigation concerning the Mandate
has also underscored how important it
is for the Government to tread carefully
when engaging in regulation concerning
sensitive health care areas. As
demonstrated by the litigation, as well
as the public comments, various citizens
sincerely hold moral convictions, which
are not necessarily religious, against
providing or participating in coverage of
contraceptive items included in the
Mandate, and some believe that certain
contraceptive items may cause early
abortions. Providing conscience
protections advances the ACA’s goal of
expanding health coverage among
entities and individuals that might
otherwise be reluctant to participate in
the market. For example, the Supreme
Court in Hobby Lobby declared that, if
HHS requires owners of businesses to
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cover procedures that the owners
‘‘could not in good conscience’’ cover,
such as abortion, ‘‘HHS would
effectively exclude these people from
full participation in the economic life of
the Nation.’’ 134 S. Ct. at 2783. That sort
of outcome is one the Departments wish
to avoid. The Departments wish to
implement the contraceptive coverage
Guidelines issued under section
2713(a)(4) in a way that respects the
moral convictions of Americans so that
they are freer to engage in ‘‘full
participation in the economic life of the
Nation.’’ The exemptions in these final
rules do so by removing an obstacle that
might otherwise lead entities or
individuals with moral objections to
contraceptive coverage to choose not to
sponsor or participate in health plans if
they include such coverage.
3. Whether Moral Exemptions Should
Exist, and Whom They Should Cover
As noted above, the Department
received comments expressing diverse
views as to whether exemptions based
on moral convictions should exist and,
if so, whom they should cover.
Some commenters supported the
expanded exemptions and
accommodation in the Moral IFC, and
the choice of entities and individuals to
which they applied. They stated the
expanded exemptions and
accommodation would be an
appropriate exercise of discretion and
would be consistent with moral
exemptions Congress has provided in
many similar contexts. Similarly,
commenters stated that the
accommodation would be an inadequate
means to resolve moral objections and
that the expanded exemptions are
needed. They contended that the
accommodation process was
objectionable because it was another
method of complying with the Mandate,
its self-certification or notice involved
triggering the very contraceptive
coverage that organizations objected to,
and the coverage for contraceptive
services ‘‘hijacked’’ or flowed in
connection with the objecting
organizations’ health plans. The
commenters contended that the
seamlessness cited by the Departments
between contraceptive coverage and an
accommodated plan gives rise to moral
objections that organizations would not
have with an expanded exemption.
Commenters also stated that, with
respect to non-profit organizations that
have moral objections and only hire
persons who agree with those
objections, the Mandate serves no
legitimate government interest because
the mandated coverage is neither
wanted nor used and, therefore, would
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yield no benefits—it would only
suppress the existence of non-profit
organizations holding those views.
Several other commenters stated that
the exemptions were still too narrow.
They asked that the exemptions set forth
in these final rules be as broad as the
exemptions set forth in the Religious
IFC concerning sincerely held religious
beliefs. Some of these commenters also
asked that HHS withdraw its Mandate of
contraceptive coverage from the
Guidelines entirely. They contended
that fertility and pregnancy are
generally healthy conditions, not
diseases that are appropriately the target
of a preventive health service; that
contraceptives can pose medical risks
for women; and that studies do not
show that contraceptive programs
reduce abortion rates or unintended
pregnancies. Some commented that
many women report that they sought an
abortion because their contraception
failed. Some other commenters
contended that, to the extent the
Guidelines require coverage of certain
drugs and devices that may prevent
implantation of an embryo after
fertilization, they require coverage of
items that are abortifacient and,
therefore, violate federal conscience
protections such as the Weldon
Amendment, Consolidated
Appropriations Act, 2017, Public Law
115–31, Div. H, § 507(d).
Other commenters contended that the
exemptions in the Moral IFC were too
broad. Some of these commenters
expressed concern about the prospect of
publicly traded for-profit entities also
being afforded a moral exemption. One
such commenter commented that
allowing publicly traded for-profit
entities a moral exemption could cause
instability and confusion, as leadership
changes at such a corporation may
effectively change the corporation’s
eligibility for a moral exemption. Still
others stated that the Departments
should not exempt various kinds of
entities such as businesses, issuers, or
nonprofit entities, arguing that only
individuals, not entities, can possess
moral convictions. Some commenters
were concerned that providing moral
exemptions would contribute to
population growth and related societal
woes. Other commenters contended the
exemptions and accommodation should
not be expanded, but should remain the
same as they were in the July 2015 final
regulations (80 FR 41318), which did
not encompass moral convictions. Other
commenters stated that the Departments
should not provide exemptions, but
merely an accommodation process, to
resolve moral objections to the Mandate.
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Some commenters objected to
providing any exemption or
accommodation for moral objections at
all. Some of these commenters
contended that even the previous
regulations allowing an exemption and
accommodation were too broad and that
no exemptions to the Mandate should
exist, in order that contraceptive
coverage would be provided to as many
women as possible. Other commenters
did not go that far, but rejected the idea
of exemptions or an accommodation
based on moral convictions, contending
that such exemptions or accommodation
would contribute to population growth
and related social woes. Some of these
commenters also contended that the
exemption in the Moral IFC would
constitute an exemption covering every
business and non-profit organization.
After considering these comments,
and although the previous
Administration declined to afford any
exemption based on moral convictions,
the Departments have concluded that it
is appropriate to provide moral
exemptions and access to the
accommodation, as set forth in these
final rules. Congress did not mandate
contraceptive coverage, nor provide any
explicit guidance about incorporating
conscience exemptions into the
Guidelines. But as noted above, it is a
long-standing Congressional practice to
provide consistent exemptions for both
religious beliefs and moral convictions
in many federal statutes in the health
care context, and specifically
concerning issues such as abortion,
sterilization, and contraception. It is not
clear to the Departments that, if
Congress had expressly mandated
contraceptive coverage in the ACA, it
would have done so without providing
for similar exemptions. Therefore, the
Departments consider it appropriate, to
the extent we impose a contraceptive
Mandate by the exercise of agency
discretion, that we also include an
exemption for the protection of moral
convictions in certain cases. The
exemptions finalized in these final rules
are generally consistent with the scope
of exemptions that Congress has
established in similar contexts. As noted
above, the Departments consider the
exemptions in these final rules
consistent with the intent of Executive
Order 13535. The Departments also
wish to avoid the stark disparity that
may result from respecting religious
objections to providing contraceptive
coverage among certain entities and
individuals, but not respecting parallel
objections for moral convictions
possessed by any entities and
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individuals at all because those
objections are not specifically religious.
In addition, the Departments note that
a significant majority of states either
impose no contraceptive coverage
requirement or offer broader exemptions
than the exemption contained in the
July 2015 final regulations.25 Although
the practice of states is by no means a
limit on the discretion delegated to
HRSA by the ACA, nor a statement
about what the Federal Government
may do consistent with other limitations
in federal law, such state practices can
inform the Departments’ view that it is
appropriate to provide conscience
protections when exercising agency
discretion.
The Departments decline to use these
final rules to remove the contraceptive
Mandate altogether, such as by
declaring that HHS acting through
HRSA shall not include contraceptives
in the list of women’s preventive
services in Guidelines issued under
section 2713(a)(4). HRSA’s Guidelines
were not issued, ratified, or updated
through the regulations that preceded
the Moral IFC and these final rules.
Those Guidelines were issued in
separate processes in 2011 and 2016,
directly by HRSA, after consultation
with external organizations that
operated under cooperative agreements
with HRSA to consider the issue, solicit
public comment, and provide
recommendations. The regulations
preceding these final rules attempted
only to restate the statutory language of
section 2713 in regulatory form, and
delineate what exemptions and
accommodations would apply if HRSA
listed contraceptives in its Guidelines.
We decline to use these final rules to
direct the separate process that HRSA
uses to determine what specific services
are listed in the Guidelines generally.
Some commenters stated that if
contraceptives are not removed from the
Guidelines entirely, entities or
individuals with moral objections might
not qualify for the exemptions or
accommodation. As discussed below,
however, the exemptions in these rules
include a broad range of entities and
individuals of whom we have notice
may object based on moral convictions.
The Departments are not aware of
specific employers or individuals whose
moral convictions would still be
violated by compliance with the
Mandate after the issuance of the Moral
IFC and these final rules.
25 See ‘‘Insurance Coverage of Contraceptives,’’
The Guttmacher Institute (June 11, 2018), https://
www.guttmacher.org/state-policy/explore/
insurance-coverage-contraceptives.
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Some commenters stated that HRSA
should remove contraceptives from the
Guidelines because the Guidelines have
not been subject to the notice and
comment process under the
Administrative Procedure Act. Some
commenters also contended that the
Guidelines should be amended to omit
items that may prevent (or possibly
dislodge) the implantation of a human
embryo after fertilization, in order to
ensure consistency with conscience
provisions that prohibit requiring plans
to pay for or cover abortions. Whether
and to what extent the Guidelines
continue to list contraceptives, or items
considered to prevent implantation of
an embryo, for entities not subject to
exemptions and an accommodation, and
what process is used to include those
items in the Guidelines, is outside the
scope of these final rules. These final
rules focus on what moral exemptions
and accommodation shall apply if
Guidelines issued under section
2713(a)(4) include contraceptives or
items considered to be abortifacient.
Members of the public that support or
oppose the inclusion of some or all
contraceptives in the Guidelines, or
wish to comment concerning the
content and process of developing and
updating the Guidelines, are welcome to
communicate their views to HRSA, at
wellwomancare@hrsa.gov.
The Departments also conclude that it
would be inadequate to merely attempt
to amend or expand the accommodation
process to account for moral objectors,
instead of providing the exemptions. In
the past, the Departments stated in our
regulations and court briefs that the
previous accommodation required
contraceptive coverage in a way that is
‘‘seamless’’ with the coverage provided
by the objecting employer. As a result,
in significant respects, the
accommodation process did not actually
accommodate the objections of many
entities, as indicated by many entities
with religious objections. The
Departments have attempted to identify
an accommodation that would eliminate
the religious plaintiffs’ objections,
including seeking public comment
through a Request For Information, 81
FR 47741 (July 26, 2016), but stated in
January 2017 that we were unable to
develop such an approach at that time.26
26 See Departments of Labor, Health and Human
Services, and the Treasury, FAQs About Affordable
Care Act Implementation Part 36, (Jan. 9, 2017),
https://www.dol.gov/sites/default/files/ebsa/aboutebsa/our-activities/resource-center/faqs/aca-part36.pdf and https://www.cms.gov/CCIIO/Resources/
Fact-Sheets-and-FAQs/Downloads/ACA-FAQsPart36_1-9-17-Final.pdf (‘‘the comments reviewed
by the Departments in response to the RFI indicate
that no feasible approach has been identified at this
time that would resolve the concerns of religious
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Just as the Departments continue to
believe merely amending the
accommodation process would not
adequately address religious objections
to compliance with the Mandate, we do
not believe doing so would adequately
address similar moral objections.
Furthermore, the few litigants raising
non-religious moral objections have
been non-profit organizations that assert
they only hire persons who share the
employers’ objection to contraceptive
coverage. Consequently, the
Departments conclude that the most
appropriate approach to resolve these
concerns is to provide the exemptions
set forth in the Moral IFC and these final
rules. These final rules also finalize the
modifications to the accommodation
process to make it available to entities
with moral objections, without forcing
such entities to choose between
compliance with either the Mandate or
the accommodation.
Some commenters expressed concern
over the lack of a definition of ‘‘moral
convictions’’ in the Moral IFC, arguing
that, without a definition, any objection
could be encompassed by the
exemptions even if it is not based on
moral convictions. The Departments did
not adopt a regulatory definition of
‘‘moral convictions’’ in the Moral IFC,
and have decided not to adopt such a
definition in response to public
comments at this time. Nevertheless, the
Departments look to the description of
moral convictions in Welsh to help
explain the scope of the protection
provided in the Moral IFC and these
final rules. Neither these final rules or
the Moral IFC, nor the Church
Amendments or other Federal health
care conscience statutes, define ‘‘moral
convictions’’ (nor do they define
‘‘religious beliefs’’). But in issuing these
final rules, we adopt the same
background understanding of that term
that is reflected in the Congressional
Record in 1973, in which legislators
referenced cases such as Welsh to
support the addition of language
protecting moral convictions. In
protecting moral convictions in parallel
to religious beliefs, Welsh describes
moral convictions warranting such
protection as ones: (1) That the
‘‘individual deeply and sincerely
holds’’; (2) ‘‘that are purely ethical or
moral in source and content’’; (3) ‘‘but
that nevertheless impose upon him a
duty’’; (4) and that ‘‘certainly occupy in
the life of that individual a place
parallel to that filled by . . . God’ in
traditionally religious persons,’’ such
objectors, while still ensuring that the affected
women receive full and equal health coverage,
including contraceptive coverage’’).
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that one could say ‘‘his beliefs function
as a religion in his life.’’ 398 U.S. at
339–40. As recited above, Senators
Church and Nelson agreed that
protections for such moral convictions
would not encompass an objection that
an individual or entity raises
‘‘capriciously.’’ Instead, along with the
requirement that protected moral
convictions must be ‘‘sincerely held,’’
this understanding cabins the protection
of moral convictions in contexts where
they occupy a place parallel to that
filled by sincerely held religious beliefs
in religious persons and organizations.
While moral convictions are the sort
of principles that, in the life of an
individual, occupy a place parallel to
religion, sincerely held moral
convictions can also be adopted by
corporate bodies, not merely by
individuals. Senators Church and
Nelson, while discussing the fact that
opposition to abortion or sterilization on
the basis of ‘‘moral questions’’ does not
include capricious opposition to
abortion for no reason at all, were
specifically talking about opposition to
abortion by corporate entities: A
‘‘hospital board, or whatever the ruling
agency for the hospital was, a governing
agency or otherwise.’’ 27 Corporate
bodies operate by the decision-making
actions of individuals. Thus, if
individuals act in the governance of a
corporate body so as to adopt a position
for that body of adopting moral
convictions against coverage of
contraceptives, such an entity can be
considered to have an objection to
contraceptive coverage on the basis of
sincerely held moral convictions.
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4. The Departments’ Rebalancing of
Government Interests
The Departments also received
comments on their rebalancing of
interests as expressed and referenced in
the Moral IFC. Some public commenters
agreed with the Departments’
27 Nor was this recognition of the need to protect
organizations that object to performance of certain
health care procedures on the basis of moral
conviction limited to the Church Amendments’
legislative history. The first of the Church
Amendments provides, in part, that the receipt of
certain federal funds ‘‘by any individual or entity
does not authorize any court or any public official
or other public authority to require— . . . (2) such
entity to—(A) make its facilities available for the
performance of any sterilization procedure or
abortion if the performance of such procedure or
abortion in such facilities is prohibited by the entity
on the basis of religious beliefs or moral
convictions, or (B) provide any personnel for the
performance or assistance in the performance of any
sterilization procedure or abortion if the
performance or assistance in the performance of
such procedures or abortion by such personnel
would be contrary to the religious beliefs or moral
convictions of such personnel.’’ 42 U.S.C. 300a–
7(b).
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conclusion that our interest in ensuring
contraceptive coverage does not
preclude the Departments from offering
exemptions and an accommodation for
entities, plans, and individuals with a
qualifying objection to contraceptive
coverage based on moral convictions.
Some public commenters pointed out
that protecting moral convictions serves
to respect not only the interests of
certain persons to access contraceptives,
but also the interests of other persons to
participate in a health coverage market
consistent with their moral convictions.
Other commenters disagreed with this
rebalancing, and contended that the
interest of women in receiving
contraceptive coverage without costsharing is so great that it overrides
private interests to the contrary, such
that the government should or must
force private entities to provide this
coverage to other private citizens.
The Departments agree with the
commenters who stated that the
governmental interest in requiring
contraceptive coverage does not
override the interest in protecting moral
convictions and does not make these
expanded exemptions inappropriate.
For additional discussion of the
Government’s balance of interests as
applicable to religious beliefs, see
section II.C.2.b. of the companion final
rules concerning religious exemptions
published by the Departments
contemporaneously with these final
rules elsewhere in today’s Federal
Register. There, and in the Religious
and Moral IFCs, the Departments
acknowledged the reasons why the
Departments have changed the policies
and interpretations previously adopted
with respect to the Mandate and the
governmental interests underlying it.
For parallel reasons, the Departments
believe the Government’s legitimate
interests in providing for contraceptive
coverage do not require the Departments
to violate sincerely held moral
convictions while implementing the
Guidelines. The Departments likewise
believe Congress did not set forth
interests that require us to violate
sincerely held moral convictions if we
otherwise require contraceptive
coverage in our discretionary
implementation of the women’s
preventive services Guidelines under
section 2713(a)(4).
The Departments acknowledge that
coverage of contraception is an
important and highly controversial
issue, implicating many different views,
as reflected for example in the public
comments received on multiple
rulemakings over the course of
implementation of section 2713(a)(4),
added to the PHS Act in 2010. The
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Departments’ expansion of conscience
protections for moral convictions,
similar to protections contained in
numerous statutes governing health care
regulation, is not taken lightly.
However, after considering public
comments on various sides of the issue,
and reconsidering the interests served
by the Mandate in this particular
context, the objections raised, and the
relevant federal law, the Departments
have determined that affording the
exemptions to protect moral convictions
is a more appropriate administrative
response than continuing to refuse to
extend the exemptions and
accommodations to certain entities and
individuals for whom the Mandate
violates their sincerely held moral
convictions. Although the number of
organizations and individuals that may
seek to invoke these exemptions and
accommodation may be small, the
Departments believe that it is important
to provide such protection, given the
long-standing recognition of such
protections in law and regulation in the
health care and health insurance
contexts. The Moral IFC and these final
rules leave unchanged HRSA’s authority
to decide whether to include
contraceptives in the women’s
preventive services Guidelines for
entities that are not exempted by law,
regulation, or the Guidelines. These
rules also do not change the many other
mechanisms by which the Government
advances contraceptive coverage,
particularly for low-income women,
including through such programs as
Medicaid and Title X. The Departments
also note that the exemptions created
here, like the exemptions created by the
previous Administration, do not burden
third parties to a degree that counsels
against providing the exemptions, as
discussed below.
5. Burdens on Third Parties
The Department received a variety of
comments about the effect that the
exemptions and accommodation based
on moral convictions would have on
third parties. Some commenters stated
that the exemptions and
accommodation do not impose an
impermissible or unjustified burden on
third parties, including on women who
might otherwise receive contraceptive
coverage with no cost sharing. Other
commenters disagreed, asserting that the
exemptions unacceptably burden
women who might lose contraceptive
coverage as a result. They contended the
exemptions may remove contraceptive
coverage, causing women to have higher
contraceptive costs, fewer contraceptive
options, less ability to use
contraceptives more consistently, more
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unintended pregnancies,28 births spaced
more closely, and workplace, economic,
or societal inequality. Still other
commenters took the view that other
laws or protections, such as in the First
or Fifth Amendments, prohibit the
expanded exemptions, which those
commenters view as prioritizing
conscientious objection of exempted
entities over the conscience, choices, or
religious liberty of women who would
not receive contraceptive coverage
where an exemption is used. Some
commenters disagreed and said the
exemptions do not violate laws and
constitutional protections, nor do they
inappropriately prioritize the
conscience of exempted entities over
those of third parties.
The Departments note that the
exemptions in the Moral IFC and these
final rules, like the exemptions created
by the previous Administration, do not
impermissibly burden third parties.
Initially, the Departments observe that
these rules do not create a governmental
burden; rather, they relieve a
governmental burden. The ACA did not
impose a contraceptive coverage
requirement. Agency discretion was
exercised to include contraceptives in
the Guidelines issued under section
2713(a)(4). That decision is what created
and imposed a governmental burden.
These rules simply relieve part of that
governmental burden. If some third
parties do not receive contraceptive
coverage from private parties whom the
government chooses not to coerce, that
result exists in the absence of
governmental action—it is not a result
the government has imposed. Calling
that result a governmental burden rests
on an incorrect presumption: That the
government has an obligation to force
private parties to benefit those third
parties, and that the third parties have
a right to those benefits. Congress did
not create a right to receive
contraceptive coverage from other
private citizens through section 2713 of
the PHS Act, other portions of the ACA,
or any other statutes it has enacted.
Although some commenters also
contended such a right might exist
under treaties the Senate has ratified or
the Constitution, the Departments are
not aware of any source demonstrating
that the Constitution or a treaty ratified
by the Senate creates a right to receive
contraceptive coverage from other
private citizens.
The fact that the government at one
time exercised its administrative
28 Some commenters attempted to quantify the
costs of unintended pregnancy, but were unable to
provide estimates with regard to the number of
women that this exemption may affect.
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discretion to require private parties to
provide coverage to which they morally
object, to benefit other private parties,
does not prevent the government from
relieving some or all of the burden of
that Mandate. Otherwise, any
governmental coverage requirement
would be a one-way ratchet. In the
Moral IFC and these final rules, the
government has simply restored a zone
of freedom where it once existed. There
is no statutory or constitutional obstacle
to the government doing so, and the
doctrine of third party burdens should
not be interpreted to impose such an
obstacle. Such an interpretation would
be especially problematic given the
millions of women, in a variety of
contexts, whom the Mandate does not
ultimately benefit, notwithstanding any
expanded exemptions—including
through the grandfathering of plans, the
previous religious exemptions, and the
failure of the accommodation to require
delivery of contraceptive coverage in
various self-insured church plan
contexts.
In addition, the Government is under
no constitutional obligation to fund
contraception. Cf. Harris v. McRae, 448
U.S. 297 (1980) (holding that, although
the Supreme Court has recognized a
constitutional right to abortion, there is
no constitutional obligation for
government to pay for abortions). Even
more so may the government refrain
from requiring private citizens, in
violation of their moral convictions, to
cover contraception for other citizens.
Cf. Rust v. Sullivan, 500 U.S. 173, 192–
93 (1991) (‘‘A refusal to fund protected
activity, without more, cannot be
equated with the imposition of a
‘penalty’ on that activity.’’). The
constitutional rights of liberty and
privacy do not require the government
to force private parties to provide
contraception to other citizens and do
not prohibit the government from
protecting moral objections to such
governmental mandates, especially
where, as here, the Mandate is not an
explicit statutory requirement.29 The
Departments do not believe that the
Constitution prohibits offering the
expanded exemptions in these rules.
Some commenters objected that the
exemptions would violate the
Establishment Clause of the First
Amendment. The Moral IFC and these
final rules create exemptions for moral
convictions, not religious beliefs, and
they do so for the same neutral purposes
29 See, for example, Planned Parenthood Ariz.,
Inc. v. Am. Ass’n of Pro-Life Obstetricians &
Gynecologists, 257 P.3d 181, 196 (Ariz. Ct. App.
2011) (‘‘[A] woman’s right to an abortion or to
contraception does not compel a private person or
entity to facilitate either.’’).
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for which Congress has created similar
exemptions for over four decades. Not
only do these final rules not violate the
Establishment Clause, but the
Departments’ decision to provide the
exemptions and accommodation for
moral convictions, instead of limiting
the exemptions to identical objections
based on religious beliefs, further
demonstrates that neither the purpose
nor the effect of these exemptions is to
establish religion. The Establishment
Clause does not force the Department to
impose a contraceptive Mandate in
violation of the moral convictions of
entities and individuals protected by
these rules.
American governmental bodies have,
in many instances, refrained from
requiring certain private parties to cover
contraceptive services for other private
parties. From 1789 through 2012 (when
HRSA’s Guidelines went into effect),
there was no federal women’s
preventive services coverage mandate
imposed nationally on health insurance
and group health plans. The ACA did
not require contraceptives to be
included in HRSA’s Guidelines, and it
did not require any preventive services
required under section 2713 of the PHS
Act to be covered by grandfathered
plans. Many states do not impose
contraceptive coverage mandates, or
they offer religious, and in some cases
moral, exemptions to the requirements
of such coverage mandates—exemptions
that have not been invalidated by
federal or state courts. The Departments,
in previous regulations, exempted
houses of worship and integrated
auxiliaries from the Mandate. The
Departments then issued a temporary
enforcement safe harbor allowing
religious nonprofit groups to not
provide contraceptive coverage under
the Mandate for almost two additional
years. The Departments further
expanded the houses of worship and
integrated auxiliaries exemption
through definitional changes. And the
Departments created an accommodation
process under which many women in
self-insured church plans may not
ultimately receive contraceptive
coverage. The Departments are not
aware of federal courts declaring that
the exemptions, safe harbor, or
accommodations gave rise to third party
burdens that required the government to
mandate contraceptive coverage by
entities eligible for an exemption or
accommodation. In addition, many
organizations have not been subject to
the Mandate in practice because of
injunctions they received through
litigation, protecting them from federal
imposition of the Mandate, including
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under several recently entered
permanent injunctions that will apply
regardless of the issuance of these final
rules.
Commenters offered various
assessments of the impact these rules
might have on state or local
governments. Some commenters stated
that the expanded exemptions will not
burden state or local governments, or
that such burdens should not prevent
the Departments from offering those
exemptions. Others commenters stated
that if the Departments provide
expanded exemptions, states or local
jurisdictions may face higher costs in
providing birth control to women
through government programs. The
Departments consider it appropriate to
offer expanded exemptions,
notwithstanding the objection of some
state or local governments. Until 2012,
there was no federal mandate of
contraceptive coverage across health
insurance and health plans nationwide.
The ACA did not require a
contraceptive Mandate, and its
discretionary creation by means of
HRSA’s Guidelines does not translate to
a benefit that the federal government
owes to state or local governments. The
various situations recited in the
previous paragraph, in which the
federal government has not imposed
contraceptive coverage, have not been
deemed to cause a cognizable injury to
state or local governments. The
Departments find no legal prohibition
on finalizing these final rules based on
the allegation of an impact on state or
local governments, and disagree with
the suggestion that once having
exercised our discretion to deny
exemptions—no matter how recently or
incompletely—the Departments cannot
change course if some state and local
governments believe they are receiving
indirect benefits from the previous
decision.
In addition, the exemptions at issue
here are available only to a tiny fraction
of entities to which the Mandate would
otherwise apply—those with qualifying
moral objections. Public comments did
not provide reliable data on how many
entities would use these expanded
moral exemptions, in which states
women in those plans would reside,
how many of those women would
qualify for or use state and local
government subsidies of contraceptives
as a result, or in which states such
women, if they are low income, would
go without contraceptives and
potentially experience unintended
pregnancies that state Medicaid
programs would potentially have to
cover. As noted below, at least one
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study 30 has concluded the Mandate
caused no clear increase in
contraceptive use; one explanation
proposed by the authors of the study is
that women eligible for family planning
from safety net programs were already
receiving free or subsidized
contraceptive access through them,
notwithstanding the Mandate’s effects
on the overall market. Some
commenters who opposed the
exemptions admitted that this
information is unclear at this stage;
other commenters that estimated
considerably more individuals and
entities would seek an exemption also
admitted the difficulty of quantifying
estimates. In addition, the only entities
that have brought suit based on their
moral objections to the Mandate are
non-profit entities that have said they
only hire persons who share their
objections and do not use the
contraceptives to which their employers
object, so it is unlikely that exemptions
for those entities would have any
impact on safety net programs. Below,
we predict that a small number of
additional nonprofit and closely held
for-profit entities will use the
exemptions based on moral convictions.
In light of the limited evidence of third
party or state and local government
impact of these final rules, the
Departments consider it an appropriate
policy option to provide the
exemptions.
Some commenters contended that the
exemptions would constitute unlawful
sex discrimination, such as under
section 1557 of the Affordable Care Act,
Title VII of the Civil Rights Act of 1964,
Title IX of the Education Amendments
of 1972, or the Fifth Amendment. Some
commenters suggested the expanded
exemptions would discriminate on
bases such as race, disability, or LGBT
status, or that they would
disproportionately burden certain
persons in such categories.
But these rules do not discriminate or
draw any distinctions on the basis of
sex, pregnancy, race, disability, socioeconomic class, LGBT status, or
otherwise, nor do they discriminate on
any unlawful grounds. The exemptions
in these rules do not authorize entities
to comply with the Mandate for one
person, but not for another person,
based on that person’s status as a
member of a protected class. Instead,
they allow entities that have sincerely
held moral objections to providing some
30 M.L. Kavanaugh et al., ‘‘Contraceptive method
use in the United States: trends and characteristics
between 2008, 2012 and 2014,’’, 97 Contraception
14, 14–21 (2018), available at https://
www.contraceptionjournal.org/article/S00107824(17)30478-X/pdf.
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or all contraceptives included in the
Mandate to not be forced to provide
coverage of those items to anyone.
Those commenters’ contentions about
discrimination are unpersuasive for still
additional reasons. First, Title VII is
applicable to discrimination committed
by employers, and these final rules have
been issued in the government’s
capacity as a regulator of group health
plans and group and individual health
insurance, not in its capacity as an
employer. See also In Re Union Pac.
R.R. Emp’t Practices Litig., 479 F.3d 936,
940–42 & n.1 (8th Cir. 2007) (holding
that Title VII ‘‘does not require coverage
of contraception because contraception
is not a gender-specific term like
potential pregnancy, but rather applies
to both men and women’’). Second,
these rules create no disparate impact.
The women’s preventive service
mandate under section 2713(a)(4), and
the contraceptive Mandate promulgated
under such preventive services
mandate, already inure to the specific
benefit of women—men are denied any
benefit from section 2713(a)(4). Both
before and after these rules are in effect,
section 2713(a)(4) and the Guidelines
issued under that section treat women’s
preventive services in general, and
female contraceptives specifically, more
favorably than they treat male
preventive services or contraceptives.
It is simply not the case that the
government’s implementation of section
2713(a)(4) is discriminatory against
women because exemptions encompass
moral objections. The previous rules, as
discussed elsewhere herein, do not
require contraceptive coverage in a host
of plans, including grandfathered plans,
plans of houses of worship and
integrated auxiliaries, and—through
inability to enforce the accommodation
on certain third party administrators—
plans of many religious non-profits in
self-insured church plans. Below, the
Departments estimate that nearly all
women of childbearing age in the
country will be unaffected by these
exemptions. In this context, the
Departments do not believe that an
adjustment to discretionary Guidelines
for women’s preventive services
concerning contraceptives constitutes
unlawful sex discrimination. Otherwise,
anytime the government exercises its
discretion to provide a benefit that is
specific to women (or specific to men),
it would constitute sex discrimination
for the government to reconsider that
benefit. Under that theory, Hobby Lobby
itself, and RFRA (on which Hobby
Lobby’s holding was based), which
provided a religious exemption to this
Mandate for many businesses, would be
deemed discriminatory against women
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because the underlying women’s
preventive services requirement is a
benefit for women, not for men. Such
conclusions are not consistent with
legal doctrines concerning sex
discrimination.
It is not clear that these expanded
exemptions will significantly burden
women most at risk of unintended
pregnancies. Some commenters stated
that contraceptives are often readily
accessible at relatively low cost. Other
commenters disagreed. Some
commenters objected that the Moral
IFC’s estimate of a $584 yearly cost of
contraceptives for women was too low.
But some of those same commenters
provided similar estimates, citing
sources claiming that birth control pills
can cost up to $600 per year, and stated
that IUDs, which can last 3 to 6 years
or more,31 can cost $1,100 (that is, less
than $50 per month over the duration of
use). Some commenters stated that, for
lower income women, contraceptives
and related education and counseling
can be available at free or low cost
through government programs (federal
programs offering such services include,
for example, Medicaid, Title X,
community health center grants, and
Temporary Assistance for Needy
Families (TANF)). Other commenters
contended that many women in
employer-sponsored coverage might not
qualify for those programs, although
that sometimes occurs because their
incomes are above certain thresholds or
because the programs were not intended
to absorb privately covered individuals.
Some commenters observed that
contraceptives may be available through
other sources, such as a plan of another
family member, and that the expanded
exemptions will not likely encompass a
very large segment of the population
otherwise benefitting from the Mandate.
Other commenters disagreed,
emphasizing that income and eligibility
thresholds could prevent some women
from receiving contraceptives through
certain government programs if they
were no longer covered in their group
health plans or health insurance plans.
The Departments do not believe that
such differences make it inappropriate
to issue the expanded exemptions set
forth in these rules. As explained more
fully below, the Departments estimate
that nearly all women of childbearing
age in the country will be unaffected by
these exemptions. Moreover, the
Departments note that the HHS Office of
Population Affairs, within the Office of
the Assistant Secretary for Health, has
31 See, for example, ‘‘IUD,’’ Planned Parenthood,
https://www.plannedparenthood.org/learn/birthcontrol/iud.
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recently issued a proposed rule to
amend the regulations governing its
Title X family planning program. The
proposed rule would amend the
definition of ‘‘low income family’’—
individuals eligible for free or low cost
contraceptive services—to include
women who are unable to obtain certain
family planning services under their
employer-sponsored health coverage
due to their employers’ religious beliefs
or moral convictions. (83 FR 25502). If
that rule is finalized as proposed, it
would further reduce any potential
effect of these final rules on women’s
access to contraceptives.
Some commenters stated that the
expanded exemptions would violate
section 1554 of the ACA. That section
says the Secretary of HHS ‘‘shall not
promulgate any regulation’’ that
‘‘creates any unreasonable barriers to
the ability of individuals to obtain
appropriate medical care,’’ ‘‘impedes
timely access to health care services,’’
‘‘interferes with communications
regarding a full range of treatment
options between the patient and the
provider,’’ ‘‘restricts the ability of health
care providers to provide full disclosure
of all relevant information to patients
making health care decisions,’’ ‘‘violates
the principles of informed consent and
the ethical standards of health care
professionals,’’ or ‘‘limits the
availability of health care treatment for
the full duration of a patient’s medical
needs.’’ 42 U.S.C. 18114. Such
commenters urged, for example, that the
Moral IFC created unreasonable barriers
to the ability of individuals to obtain
appropriate medical care, particularly in
areas they said may have a
disproportionately high number of
entities likely to take advantage of the
exemption.
The Departments disagree with these
comments about section 1554 of the
ACA. The Departments issued previous
exemptions and accommodations that
allowed various plans to not provide
contraceptive coverage on the basis of
religious objections; multiple courts
considered those regulations; and while
many ruled that entities did not need to
provide contraceptive coverage, none
ruled that the exemptions or
accommodations in the regulations
violated section 1554 of the ACA.
Moreover, the decision not to impose a
governmental mandate is not the
creation of a ‘‘barrier,’’ especially when
that mandate requires private citizens to
provide services to other private
citizens. This would turn the
assumptions of the United States’
system of government on its head. See,
for example, U.S. Constitution, Ninth
Amendment. Section 1554 of the ACA
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likewise does not require the
Departments to require coverage of, or to
keep in place a requirement to cover,
certain services, including
contraceptives, that was issued pursuant
to HHS’s exercise of discretion under
section 2713(a)(4). Nor does section
1554 of the ACA prohibit the
Departments from providing exemptions
to relieve burdens on moral convictions,
or as is the case here, from refraining to
impose the Mandate in cases where
moral convictions would be burdened
by the Mandate. Moral exemptions from
federal mandates in certain health
contexts, including sterilization,
contraception, or items believed to be
abortifacient, have existed in federal
laws for decades. Some of those laws
were referenced by President Obama in
signing Executive Order 13535. In light
of that Executive Order and Congress’s
long history of providing exemptions for
moral convictions in the health context,
providing moral exemptions is a
reasonable administrative response to
this federally mandated burden,
especially since the burden itself is a
subregulatory creation that does not
apply in various contexts.
In short, we do not believe sections
1554 or 1557 of the ACA, other
nondiscrimination statutes, or any
constitutional doctrines, create an
affirmative obligation to create,
maintain, or impose a Mandate that
forces covered entities to provide
coverage of preventive contraceptive
services in health plans. The ACA’s
grant of authority to HRSA to provide
for, and support, the Guidelines is not
transformed by any of the laws cited by
commenters into a requirement that,
once those Guidelines exist, they can
never be reconsidered, or amended
because doing so would only affect
women’s coverage or would allegedly
impact particular populations
disparately.
In summary, members of the public
have widely divergent views on whether
the exemptions in the Moral IFC and
these final rules are good public policy.
Some commenters stated that the
exemptions would burden workers,
families, and the economic and social
stability of the country, and interfere
with the physician-patient relationship.
Other commenters disagreed, favoring
the public policy behind the exemption,
and arguing that the exemption would
not interfere with the physician-patient
relationship. The Departments have
determined that these final rules are an
appropriate exercise of public policy
discretion. Because of the importance of
the moral convictions being
accommodated, the limited impact of
these final rules, and uncertainty about
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the impact of the Mandate overall
according to some studies, the
Departments do not believe these final
rules will have any of the drastic
negative consequences on third parties
or society that some opponents of these
rules have suggested.
6. Interim Final Rulemaking
The Departments received several
comments about the decision to issue
the Moral IFC as interim final rules with
request for comments, instead of as a
notice of proposed rulemaking. Several
commenters asserted that the
Departments had the authority to issue
the Moral IFC in that way, agreeing with
the Departments that there was explicit
statutory authority to do so, good cause
under the APA, or both. Other
commenters held the opposite view,
contending that there was neither
statutory authority to issue the rules on
an interim final basis, nor good cause
under the APA to make the rules
immediately effective.
The Departments continue to believe
authority existed to issue the Moral IFC
as interim final rules. Section 9833 of
the Code, section 734 of ERISA, and
section 2792 of the PHS Act authorize
the Secretaries of the Treasury, Labor,
and HHS (collectively, the Secretaries)
to promulgate any interim final rules
that they determine are appropriate to
carry out the provisions of chapter 100
of the Code, part 7 of subtitle B of title
I of ERISA, and part A of title XXVII of
the PHS Act, which include sections
2701 through 2728 of that Act, and the
incorporation of those sections into
section 715 of ERISA and section 9815
of the Code. The Religious and Moral
IFCs fall under those statutory
authorizations for the use of interim
final rulemaking. Prior to the Moral IFC,
the Departments issued three interim
final regulations implementing this
section of the PHS Act because of the
needs of covered entities for immediate
guidance and the weighty matters
implicated by the HRSA Guidelines,
including issuance of new or revised
exemptions or accommodations. (75 FR
41726; 76 FR 46621; 79 FR 51092). The
Departments also had good cause to
issue the Moral IFC as interim final
rules, for the reasons discussed therein.
In any event, the objections of some
commenters to the issuance of the Moral
IFC as interim final rules with request
for comments does not prevent the
issuance of these final rules. These final
rules were issued after receiving and
thoroughly considering public
comments as requested in the Moral
IFC. These final rules therefore comply
with the APA’s notice and comment
requirements.
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7. Health Effects of Contraception and
Pregnancy
The Departments received numerous
comments on the health effects of
contraception and pregnancy. As noted
above, some commenters supported the
expanded exemptions, and others urged
that contraceptives be removed from the
Guidelines entirely, based on the view
that pregnancy and the unborn children
resulting from conception are not
diseases or unhealthy conditions that
are properly the subject of preventive
care coverage. Such commenters further
contended that hormonal contraceptives
may present health risks to women. For
example, they contended that studies
show certain contraceptives cause, or
are associated with, an increased risk of
depression,32 venous thromboembolic
disease,33 fatal pulmonary embolism,34
thrombotic stroke and myocardial
infarction (particularly among women
who smoke, are hypertensive, or are
32 Commenters cited Charlotte Wessel Skovlund,
et al., ‘‘Association of Hormonal Contraception with
Depression,’’ JAMA Psychiatry 1154, 1154
(published online Sept. 28, 2016) (‘‘Use of
hormonal contraception, especially among
adolescents, was associated with subsequent use of
antidepressants and a first diagnosis of depression,
suggesting depression as a potential adverse effect
of hormonal contraceptive use.’’).
33 Commenters cited the Practice Committee of
the American Society for Reproductive Medicine,
‘‘Hormonal Contraception: Recent Advances and
Controversies,’’ 82 Fertility and Sterility S26, S30
(2004); V.A. Van Hylckama et al., ‘‘The Venous
Thrombotic Risk of Oral Contraceptives, Effects of
Estrogen Dose and Progestogen Type: Results of the
MEGA Case-Control Study,’’ 339 Brit. Med. J. b2921
(2009); Y. Vinogradova et al., ‘‘Use of Combined
Oral Contraceptives and Risk of Venous
Thromboembolism: Nested Case-Control Studies
Using the QResearch and CPRD Databases,’’ 350
Brit. Med. J. h2135 (2015) (‘‘Current exposure to any
combined oral contraceptive was associated with an
increased risk of venous thromboembolism . . .
compared with no exposure in the previous year.’’);
;. Lidegaard et al., ‘‘Hormonal contraception and
risk of venous thromboembolism: national followup study,’’ 339 Brit. Med. J. b2890 (2009): M. de
Bastos et al., ‘‘Combined oral contraceptives:
venous thrombosis,’’ Cochrane Database Syst. Rev.,
Mar. 3, 2014. doi: 10.1002/
14651858.CD010813.pub2, available at https://
www.ncbi.nlm.nih.gov/pubmed?term=24590565;
L.J. Havrilesky et al., ‘‘Oral Contraceptive User for
the Primary Prevention of Ovarian Cancer,’’ Agency
for Healthcare Research and Quality, Report No.
13–E002–EF (June 2013), available at https://
archive.ahrq.gov/research/findings/evidence-basedreports/ocusetp.html; and Robert A. Hatcher et al.,
Contraceptive Technology, 405–07 (Ardent Media
18th rev. ed. 2004).
34 Commenters cited N.R. Poulter, ‘‘Risk of Fatal
Pulmonary Embolism with Oral Contraceptives,’’
355 Lancet 2088 (2000).
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older),35 hypertension,36 HIV–1
acquisition and transmission,37 and
breast, cervical, and liver cancers.38
Some commenters also stated that
fertility awareness based methods of
birth spacing are free of similar health
risks since they do not involve ingestion
of chemicals. Some commenters
contended that it is not the case that
contraceptive access reduces
unintended pregnancies or abortions.
Other commenters disagreed, citing a
variety of studies they contend show
health benefits caused by, or associated
35 Commenters cited ;. Lidegaard et al.,
‘‘Thrombotic Stroke and Myocardial Infarction with
Hormonal Contraception, 366 N. Engl. J. Med. 2257,
2257 (2012) (risks ‘‘increased by a factor of 0.9 to
1.7 with oral contraceptives that included ethinyl
estradiol at a dose of 20 mg and by a factor of 1.3
to 2.3 with those that included ethinyl estradiol at
a dose of 30 to 40 mg’’); Practice Committee of the
American Society for Reproductive Medicine,
‘‘Hormonal Contraception’’; M. Vessey et al.,
‘‘Mortality in Relation to Oral Contraceptive Use
and Cigarette Smoking,’’ 362 Lancet 185, 185–91
(2003); WHO Collaborative Study of Cardiovascular
Disease and Steroid Hormone Contraception,
‘‘Acute Myocardial Infarction and Combined Oral
Contraceptives: Results of an International
Multicentre Case-Control Study,’’ 349 Lancet 1202,
1202–09 (1997); K.M. Curtis et al., ‘‘Combined Oral
Contraceptive Use Among Women With
Hypertension: A Systematic Review,’’ 73
Contraception 179, 179–188 (2006); L.A. Gillum et
al., ‘‘Ischemic stroke risk with oral contraceptives:
A meta analysis,’’ 284 JAMA 72, 72–78 (2000),
available at https://www.ncbi.nlm.nih.gov/pubmed/
10872016; and Robert A. Hatcher et al.,
Contraceptive Technology, 404–05, 445 (Ardent
Media 18th rev. ed. 2004).
36 Commenters cited Robert A. Hatcher et al.,
Contraceptive Technology, 407, 445 (Ardent Media
18th rev. ed. 2004).
37 Commenters cited Renee Heffron et al., ‘‘Use of
Hormonal Contraceptives and Risk of HIV–1
Transmission: A Prospective Cohort Study,’’ 12
Lancet Infectious Diseases 19, 24 (2012) (‘‘Use of
hormonal contraceptives was associated with a twotimes increase in the risk of HIV–1 acquisition by
women and HIV–1 transmission from women to
men.’’); and ‘‘Hormonal Contraception Doubles HIV
Risk, Study Suggests,’’ Science Daily (Oct. 4, 2011),
https://www.sciencedaily.com/releases/2011/10/
111003195253.htm.
38 Commenters cited ‘‘Oral Contraceptives and
Cancer Risk,’’ National Cancer Institute (Mar. 21,
2012), https://www.cancer.gov/about-cancer/
causes-prevention/risk/hormones/oralcontraceptives-fact-sheet; L.J Havrilesky et al.,
‘‘Oral Contraceptive User for the Primary
Prevention of Ovarian Cancer,’’ Agency for
Healthcare Research and Quality, Report No. 13–
E002–EF (June 2013), available at https://
archive.ahrq.gov/research/findings/evidence-basedreports/ocusetp.html; S. N. Bhupathiraju et al.,
‘‘Exogenous hormone use: Oral contraceptives,
postmenopausal hormone therapy, and health
outcomes in the Nurses’ Health Study,’’ 106 Am. J.
Pub. Health 1631, 1631–37 (2016); The World
Health Organization Department of Reproductive
Health and Research, ‘‘Carcinogenicity of Combined
Hormonal Contraceptives and Combined
Menopausal Treatment,’’ (Sept. 2005), available at
https://www.who.int/reproductivehealth/topics/
ageing/cocs_hrt_statement.pdf; and the American
Cancer Society, ‘‘Known and Probably Human
Carcinogens,’’ American Cancer Society (rev. Nov.
3, 2016), https://www.cancer.org/cancer/cancercauses/general-info/known-and-probable-humancarcinogens.html.
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with, contraceptive use or the
prevention of unintended pregnancy.
Commenters cited, for example, the
2011 Report of the Institute of Medicine
(IOM), ‘‘Clinical Preventive Services for
Women: Closing the Gaps,’’ in its
discussion of the negative effects
associated with unintended
pregnancies, as well as other studies.
Such commenters contended that, by
reducing unintended pregnancy,
contraceptives reduce the risk of
unaddressed health complications, low
birth weight, preterm birth, infant
mortality, and maternal mortality.
Commenters also stated that studies
show contraceptives are associated with
a reduced risk of conditions such as
ovarian cancer, colorectal cancer, and
endometrial cancer, and that
contraceptives treat such conditions as
endometriosis, polycystic ovarian
syndrome, migraines, pre-menstrual
pain, menstrual regulation, and pelvic
inflammatory disease.39 Some
commenters stated that pregnancy
presents various health risks, such as
blood clots, bleeding, anemia, high
blood pressure, gestational diabetes, and
death. Some commenters also
contended that increased access to
contraception reduces abortions.
Some commenters stated that, in the
Moral IFC, the Departments relied on
incorrect statements concerning
scientific studies. For example, some
commenters stated that there is no
proven increased risk of breast cancer or
other risks among contraceptive users.
They criticized the Departments for
citing studies, including one previewed
in the 2011 IOM Report itself (Agency
for Healthcare Research and Quality,
Report No. 13–E002–EF (June 2013)
(cited above)), discussing an association
between contraceptive use and
increased risks of breast and cervical
cancer, and concluding there are no net
cancer-reducing benefits of
contraceptive use. As described in the
Religious IFC, 82 FR 47804, the 2013
Agency for Healthcare Research and
Quality study, and other sources, reach
conclusions with which these
commenters appear to disagree. The
Departments consider it appropriate to
consider these studies, as well as the
studies cited by commenters who
disagree with those conclusions.
Some commenters further criticized
the Departments for saying two studies
cited by the 2011 IOM Report, which
asserted an associative relationship
between contraceptive use and
decreases in unintended pregnancy, did
39 To the extent that contraceptives are prescribed
to treat health conditions, and not for preventive
purposes, the Mandate would not be applicable.
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not on their face establish a causal
relationship between a broad coverage
mandate and decreases in unintended
pregnancy. In this respect, as noted in
the Religious IFC,40 the purpose for the
Departments’ reference to such studies
was to highlight the difference between
a causal relationship and an associative
one, as well as the difference between
saying contraceptive use has a certain
effect and saying a contraceptive
coverage mandate (or part of that
mandate affected by certain exemptions)
will necessarily have (or negate,
respectively) such an effect.
Commenters disagreed about the
effects of some FDA-approved
contraceptives on embryos. Some
commenters agreed with the quotation,
in the Moral IFC, of FDA materials 41
that indicate that some items it has
approved as contraceptives may prevent
the implantation of an embryo after
fertilization. Some of those commenters
cited additional scientific sources to
argue that certain approved
contraceptives may prevent
implantation, and that, in some cases,
some contraceptive items may even
dislodge an embryo shortly after
implantation. Other commenters
disagreed with the sources cited in the
Moral IFC and cited additional studies
on that issue. Some commenters further
criticized the Departments for asserting
in the Moral IFC that some persons
believe those possible effects are
‘‘abortifacient.’’
This objection on this issue appears to
be partially one of semantics. People
disagree about whether to define
‘‘conception’’ or ‘‘pregnancy’’ to occur
at fertilization, when the sperm and
ovum unite, or days later at
implantation, when that embryo has
undergone further cellular development,
travelled down the fallopian tube, and
implanted in the uterine wall. This
question is independent of the question
of what mechanisms of action FDAapproved or cleared contraceptives may
have. It is also a separate question from
whether members of the public assert,
or believe, that it is appropriate to
consider the items ‘‘abortifacient’’—that
is, a kind of abortion, or a medical
product that causes an abortion—
because they believe abortion means to
cause the demise of a post-fertilization
40 82
FR at 47803–04.
guide ‘‘Birth Control’’ specifies that
various approved contraceptives, including
Levonorgestrel, Ulipristal Acetate, and IUDs, work
mainly by preventing fertilization and ‘‘may also
work . . . by preventing attachment (implantation)
to the womb (uterus)’’ of a human embryo after
fertilization. Available at https://www.fda.gov/
forconsumers/byaudience/forwomen/
freepublications/ucm313215.htm.
41 FDA’s
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embryo inside the mother’s body.
Commenters referenced scientific
studies and sources on both sides of the
issue of whether certain contraceptives
prevent implantation. Commenters and
litigants have positively stated that
some of them view certain
contraceptives as abortifacients, for this
reason. See also Hobby Lobby, 134 U.S.
at 2765 (‘‘The Hahns have accordingly
excluded from the group-healthinsurance plan they offer to their
employees certain contraceptive
methods that they consider to be
abortifacients.’’).
The Departments do not take a
position on the scientific, religious, or
moral debates on this issue by
recognizing that some people have
sincere moral objections to providing
contraception coverage on this basis.
The Supreme Court has already
recognized that such a view can form
the basis of an objection based on
sincerely held religious belief under
RFRA.42 Several litigants have
separately raised non-religious moral
objections to contraceptive coverage
based on the same basic rationale. Even
though there is a plausible scientific
argument against the view that certain
contraceptives have mechanisms of
action that may prevent implantation,
there is also a plausible scientific
argument in favor of it—as
demonstrated, for example, by FDA’s
statement that some contraceptives may
prevent implantation and by some
scientific studies cited by commenters.
The Departments believe in this context
we have a sufficient rationale to offer
moral exemptions with respect to this
Mandate.
The Departments also received
comments about their discussion,
located in the Religious IFC but partly
relied upon in the Moral IFC,
concerning uncertainty about the effects
the Mandate’s expanded exemptions
might have on teen sexual activity. In
this respect, the Departments stated,
‘‘With respect to teens, the Santelli and
Melnikas study cited by IOM 2011
42 ‘‘Although many of the required, FDAapproved methods of contraception work by
preventing the fertilization of an egg, four of those
methods (those specifically at issue in these cases)
may have the effect of preventing an already
fertilized egg from developing any further by
inhibiting its attachment to the uterus. See Brief for
HHS in No. 13–354, pp. 9–10, n. 4; FDA, Birth
Control: Medicines to Help You.’’ Hobby Lobby, 134
S. Ct. at 2762–63. ‘‘The Hahns have accordingly
excluded from the group-health-insurance plan they
offer to their employees certain contraceptive
methods that they consider to be
abortifacients. . . . Like the Hahns, the Greens
believe that life begins at conception and that it
would violate their religion to facilitate access to
contraceptive drugs or devices that operate after
that point.’’ Id. at 2765–66.
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observes that, between 1960 and 1990,
as contraceptive use increased, teen
sexual activity outside of marriage
likewise increased (although the study
does not assert a causal relationship).
Another study, which proposed an
economic model for the decision to
engage in sexual activity, stated that
‘[p]rograms that increase access to
contraception are found to decrease teen
pregnancies in the short run but
increase teen pregnancies in the long
run.’ ’’ 43 Some commenters agreed with
this discussion, while other commenters
disagreed. Commenters who supported
the expanded exemptions cited these
and similar sources suggesting that
limiting the exemptions to the Mandate
to those that existed prior to the
Religious and Moral IFCs is not tailored
towards advancing the Government’s
interests in reducing teen pregnancy.
Instead they suggested there are means
of reducing teen pregnancy that are less
burdensome on conscientious
objections.44 Some commenters
opposing the expanded exemptions
stated that school-based health centers
provide access to contraceptives, thus
increasing use of contraceptives by
sexually active students. They also cited
studies concluding that certain
decreases in teen pregnancy are
attributable to increased contraceptive
use.45
Many commenters opposing the moral
exemptions misunderstood the
Departments’ discussion of this issue.
Teens are a significant part, though not
the entirety, of women the IOM
identified as being most at risk of
unintended pregnancy. The
43 Citing J.S. Santelli & A.J. Melnikas, ‘‘Teen
fertility in transition: recent and historic trends in
the United States,’’ 31 Ann. Rev. Pub. Health 371,
375–76 (2010), and Peter Arcidiacono et al., Habit
Persistence and Teen Sex: Could Increased Access
to Contraception Have Unintended Consequences
for Teen Pregnancies? (2005), available at https://
public.econ.duke.edu/∼psarcidi/addicted13.pdf.
See also K. Buckles & D. Hungerman, ‘‘The
Incidental Fertility Effects of School Condom
Distribution Programs,’’ Nat’l Bureau of Econ.
Research Working Paper No. 22322 (June 2016),
available at https://www.nber.org/papers/w22322
(‘‘access to condoms in schools increases teen
fertility by about 10 percent’’ and increased
sexually transmitted infections).
44 See Helen Alvare
´ , ‘‘No Compelling Interest:
The ‘Birth Control’ Mandate and Religious
Freedom,’’ 58 Vill. L. Rev. 379, 400–02 (2013)
(discussing the Santelli & Melnikas study and the
Arcidiacono study cited above, and other research
that considers the extent to which reduction in teen
pregnancy is attributable to sexual risk avoidance
rather than to contraception access).
45 See, e.g., Lindberg L., Santelli J.,
‘‘Understanding the Decline in Adolescent Fertility
in the United States, 2007–2012,’’ 59 J. Adolescent
Health 577–83 (Nov. 2016), https://doi.org/10.1016/
j.jadohealth.2016.06.024; see also Comment of The
Colorado Health Foundation, submission ID CMS–
2014–0115–19635, www.regulations.gov (discussing
teen pregnancy data from Colorado).
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Departments do not take a position on
the empirical question of whether
contraception has caused certain
reductions in teen pregnancy. Rather,
the Departments note that studies
suggesting various causes of teen
pregnancy and unintended pregnancy in
general make it difficult to establish
causation between exemptions to the
contraceptive Mandate, and an increase
in teen pregnancies in particular, or
unintended pregnancies in general. For
example, a 2015 study investigating the
decline in teen pregnancy since 1991
attributed it to multiple factors
(including, but not limited to, reduced
sexual activity, falling welfare benefit
levels, and expansion of family
planning services in Medicaid, with the
latter accounting for less than 13
percent of the decline). It concluded
that ‘‘that none of the relatively easy,
policy-based explanations for the recent
decline in teen childbearing in the
United States hold up very well to
careful empirical scrutiny.’’ 46 One
study found that, during the teen
pregnancy decline between 2007
through 2012, teen sexual activity was
also decreasing.47 One study concluded
that falling unemployment rates in the
1990s accounted for 85 percent of the
decrease in rates of first births among 18
to 19 year-old African Americans.48
Another study found that the
representation of African-American
teachers was associated with a
significant reduction in the AfricanAmerican teen pregnancy rate.49 One
study concluded that an ‘‘increase in the
price of the Pill on college campuses
. . . did not increase the rates of
unintended pregnancy.’’ 50 Similarly,
46 Kearney MS and Levine PB, ‘‘Investigating
recent trends in the U.S. birth rate,’’ 41 J. Health
Econ. 15–29 (2015), available at https://
www.sciencedirect.com/science/article/abs/pii/
S0167629615000041.
47 See, e.g., K. Ethier et al., ‘‘Sexual Intercourse
Among High School Students—29 States and
United States Overall, 2005–2015,’’ 66 CDC Morb.
Mortal. Wkly Report 1393, 1393–97 (Jan. 5, 2018),
available at https://dx.doi.org/10.15585/
mmwr.mm665152a1 (‘‘Nationwide, the proportion
of high school students who had ever had sexual
intercourse decreased significantly overall . . . .’’).
48 Colen CG, Geronimus AT, and Phipps MG,
‘‘Getting a piece of the pie? The economic boom of
the 1990s and declining teen birth rates in the
United States,’’ 63 Social Science & Med. 1531–45
(Sept. 2006), available at https://
www.sciencedirect.com/science/article/pii/
S027795360600205X.
49 Atkins DN and Wilkins VM, ‘‘Going Beyond
Reading, Writing, and Arithmetic: The Effects of
Teacher Representation on Teen Pregnancy Rates,’’
23 J. Pub. Admin. Research & Theory 771–90 (Oct.
1, 2013), available at https://academic.oup.com/
jpart/article-abstract/23/4/771/963674.
50 E. Collins & B. Herchbein, ‘‘The Impact of
Subsidized Birth Control for College Women:
Evidence from the Deficit Reduction Act,’’ U. Mich.
Pop. Studies Ctr. Report 11–737 (May 2011),
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one study from England found that,
where funding for teen pregnancy
prevention was reduced, there was no
evidence that the reduction led to an
increase in teen pregnancies.51 Some
commenters also cited studies—which
are not limited to the issue of teen
pregnancy—that have found that many
women who have abortions report that
they were using contraceptives when
they became pregnant.52
As the Departments stated in the
Religious IFC, we do not take a position
on the variety of empirical questions
discussed above. Likewise, these rules
do not address the substantive question
of whether HRSA should include
contraceptives in the women’s
preventive services Guidelines issued
under section 2713(a)(4). Rather,
reexamination of the record and review
of public comments has reinforced the
Departments’ view that the uncertainty
surrounding these weighty and
important issues makes it appropriate to
provide the moral exemptions and
accommodation if and for as long as
HRSA continues to include
contraceptives in the Guidelines. The
federal government has a long history,
particularly in certain sensitive and
multi-faceted health issues, of providing
moral exemptions from governmental
mandates. These final rules are
consistent with that history and with
the discretion Congress vested in the
Departments to implement the ACA.
8. Health and Equality Effects of
Contraceptive Coverage Mandates
The Departments also received
comments about the health and equality
effects of the Mandate more broadly.
Some commenters contended that the
contraceptive Mandate promoted the
health and equality of women,
especially low income women, and
promoted female participation and
available at https://www.psc.isr.umich.edu/pubs/
pdf/rr11-737.pdf (‘‘[I]ncrease in the price of the Pill
on college campuses . . . did not increase the rates
of unintended pregnancy or sexually transmitted
infections for most women’’).
51 See D. Paton & L. Wright, ‘‘The effect of
spending cuts on teen pregnancy,’’ 54 J. Health
Econ. 135, 135–46 (2017), available at https://
www.sciencedirect.com/science/article/abs/pii/
S0167629617304551 (‘‘Contrary to predictions
made at the time of the cuts, panel data estimates
provide no evidence that areas which reduced
expenditure the most have experienced relative
increases in teenage pregnancy rates. Rather,
expenditure cuts are associated with small
reductions in teen pregnancy rates’’).
52 Commenters cited, for example, Guttmacher
Institute, ‘‘Fact Sheet: Induced Abortion in the
United States’’ (Jan. 2018) (‘‘Fifty-one percent of
abortion patients in 2014 were using a
contraceptive method in the month they became
pregnant’’), available at https://
www.guttmacher.org/sites/default/files/factsheet/
fb_induced_abortion.pdf.
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equality in the workforce. Other
commenters contended there was
insufficient evidence showing that the
expanded exemptions would harm
those interests. Some of those
commenters further questioned whether
there was evidence to show that broad
health coverage mandates of
contraception lead to increased
contraceptive use, reductions in
unintended pregnancies, or reductions
in negative effects said to be associated
with unintended pregnancies. In
particular, some commenters discussed
a study published and revised by the
Guttmacher Institute in October 2017,
concluding that ‘‘[b]etween 2008 and
2014, there were no significant changes
in the overall proportion of women who
used a contraceptive method both
among all women and among women at
risk of unintended pregnancy.’’ 53 This
timeframe includes the first two years of
the contraceptive Mandate’s
implementation. Despite some changes
in the use of various methods of
contraceptives, the study concluded
that, ‘‘[f]or the most part, women are
changing method type within the group
of most or moderately effective methods
and not shifting from less effective to
more effective methods.’’ Regarding the
effect of this Mandate in particular, the
authors concluded that ‘‘[t]he role that
the contraceptive coverage guarantee
played in impacting use of
contraception at the national level
remains unclear, as there was no
significant increase in the use of
methods that would have been covered
under the ACA (most or moderately
effective methods) during the most
recent time period (2012–2014)
excepting small increases in implant
use.’’ The authors observed that other
‘‘[s]tudies have produced mixed
evidence regarding the relationship
between the implementation of the ACA
and contraceptive use patterns.’’ In
explaining some possible reasons or no
clear effect on contraceptive use, the
authors suggested that ‘‘existence of
these safety net programs [publicly
funded family planning centers and
Medicaid] may have dampened any
impact that the ACA could have had on
contraceptive use,’’ ‘‘cost is not the only
barrier to accessing a full range of
method options,’’ and ‘‘access to
affordable and/or free contraception
made possible through programs such as
Title X’’ may have led to income not
being associated with the use of most
53 M.L. Kavanaugh et al., ‘‘Contraceptive method
use in the United States: trends and characteristics
between 2008, 2012 and 2014,’’ 97 Contraception
14, 14–21 (2018), available at https://
www.contraceptionjournal.org/article/S00107824(17)30478-X/pdf.
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contraceptive methods.54 In addition,
commenters noted that in the 29 states
where contraceptive coverage mandates
have been imposed statewide,55 those
mandates have not necessarily lowered
rates of unintended pregnancy (or
abortion) overall.56
Other commenters, however, disputed
the significance of these state statistics,
noting that, of the 29 states with
contraceptive coverage mandates, only
four states have laws that match the
federal requirements in scope. Some
also observed that, even in states with
state contraceptive coverage mandates,
self-insured group health plans might
escape those requirements, and some
states do not mandate the contraceptives
to be covered at no out-of-pocket cost to
the beneficiary.
The Departments have considered
these experiences as relevant to the
effect the exemption in these rules
might have on the Mandate more
broadly. The state mandates of
contraceptive coverage still apply to a
very large number of plans and plan
participants notwithstanding ERISA
preemption, and public commenters did
not point to studies showing those state
mandates reduced unintended
pregnancies. The federal contraceptive
Mandate, likewise, applies to a broad,
but not entirely comprehensive, number
of employers. For example, to the extent
that houses of worship and integrated
auxiliaries may have self-insured to
avoid state health insurance
contraceptive coverage mandates or for
other reasons, those groups were already
exempt from the federal Mandate prior
to the 2017 Religious and Moral IFCs.
The exemptions as set forth in the Moral
IFC and in these final rules leave the
contraceptive Mandate in place for
nearly all entities and plans to which
the Mandate has applied. The
Departments are not aware of data
showing that these expanded
exemptions would negate any reduction
in unintended pregnancies that might
result from the contraceptive Mandate
here.
Some commenters took a view that
appears to disagree with the assertion in
54 Id.
55 See Guttmacher Institute, ‘‘Insurance Coverage
of Contraceptives’’ (June 11, 2018); ‘‘State
Requirements for Insurance Coverage of
Contraceptives,’’ Henry J. Kaiser Family Foundation
(Jan. 1, 2018), https://www.kff.org/other/stateindicator/state-requirements-for-insurancecoverage-of-contraceptives/?currentTimeframe=
0&sortModel=%7B%22colId%22:%22Location%22,
%22sort%22:%22asc%22%7D.
56 See Michael J. New, ‘‘Analyzing the Impact of
State Level Contraception Mandates on Public
Health Outcomes,’’ 13 Ave Maria L. Rev. 345 (2015),
available at https://avemarialaw-lawreview.avemarialaw.edu/Content/articles/
vXIII.i2.new.final.0809.pdf.
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the 2017 Guttmacher study, that ‘‘[t]he
role that the contraceptive coverage
guarantee played in impacting use of
contraception at the national level
remains unclear, as there was no
significant increase in the use of
methods that would have been covered
under the ACA.’’ These commenters
instead observed that, under the
Mandate, more women have coverage of
contraceptives and contraception
counseling and that more contraceptives
are provided without co-pays than
before. Still others argued that the
Mandate, or other expansions of
contraceptive coverage, have led women
to increase their use of contraception in
general, or to change from less effective,
less expensive contraceptive methods to
more effective, more expensive
contraceptive methods. Some
commenters pointed to studies cited in
the 2011 IOM Report recommending
contraception be included in the
Guidelines and argued that certain
women will go without certain health
care, or contraception specifically,
because of cost. They contended that a
smaller percentage of women delay or
forego health care overall under the
ACA 57 and that, according to studies,
coverage of contraceptives without costsharing has increased use of
contraceptives in certain circumstances.
Some commenters also stated that
studies show that decreases in
unintended pregnancies are due to
broader access to contraceptives.
Finally, some commenters also stated
that birth control access generally has
led to social and economic equality for
women.
The Departments have reviewed the
comments, including studies submitted
by commenters either supporting or
opposing these expanded exemptions.
Based on that review, it is not clear that
merely offering the exemption in these
rules will have a significant effect on
contraceptive use and health, or
workplace equality, for the vast majority
of women benefitting from the Mandate.
There is conflicting evidence regarding
whether the Mandate alone, as distinct
from contraceptive access more
generally, has caused increased
contraceptive use, reduced unintended
pregnancies, or eliminated workplace
disparities, where all other women’s
preventive services were covered
without cost sharing. Without taking a
definitive position on those evidentiary
issues, however, the Departments
57 Citing, for example, Adelle Simmons et al.,
‘‘The Affordable Care Act: Promoting Better Health
for Women,’’ Table 1, ASPE (June 14, 2016), https://
aspe.hhs.gov/system/files/pdf/205066/
ACAWomenHealthIssueBrief.pdf.
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conclude that the Moral IFC and these
final rules—which merely withdraw the
Mandate’s requirement from what
appears to be a small number of newly
exempt entities and plans—are not
likely to have negative effects on the
health or equality of women
nationwide. The Departments also
conclude that the expanded exemptions
are an appropriate policy choice left to
the agencies under the relevant statutes,
and, thus, an appropriate exercise of the
Departments’ discretion.
Moreover, the Departments conclude
that the best way to balance the various
policy interests at stake in the Moral IFC
and these final rules is to provide the
exemptions set forth herein, even if
certain effects may occur among the
populations actually affected by the
employment of these exemptions. These
rules provide tangible conscience
protections for moral convictions, and
impose fewer governmental burdens on
various entities and individuals, some
of whom have contended for several
years that denying them an exemption
from the contraceptive Mandate
imposes a burden on their moral
convictions. The Departments view the
provision of those protections to
preserve conscience in this health care
context as an appropriate policy option,
notwithstanding the widely divergent
effects that public commenters have
predicted based on different studies
they cited. Providing the protections for
moral convictions set forth in the Moral
IFC and these final rules is not
inconsistent with the ACA, and brings
this Mandate into better alignment with
various other federal conscience
protections in health care, some of
which have been in place for decades.
9. Other General Comments
Some commenters expressed the view
that the exemptions afforded in the
Moral IFC and herein violate the RFRA
rights of women who might not receive
contraceptive coverage as the result of
these final rules, by allowing their
employers to impose their moral
convictions on them by removing
contraceptive coverage through use of
the exemption. Still other commenters
stated that employer payment of
insurance premiums is part of any
employee’s compensation package, the
benefits of which employers should not
be able to limit. In the Departments’
view, the expanded exemptions in these
final rules do not prohibit employers
from providing contraceptive coverage.
Instead, they lift a government burden
that was imposed on some employers to
provide contraceptive coverage to their
employees in violation of those
employers’ moral convictions. The
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Departments do not believe RFRA
requires, or has ever required, the
federal government to force employers
to provide contraceptive coverage. The
federal government’s decision to exempt
some entities from a requirement to
provide no-cost-sharing services to
private citizens does not constitute a
federal government-imposed burden on
the latter under RFRA.
Some commenters asked the
Departments to discuss the interaction
between these rules and state laws that
either require contraceptive coverage or
provide exemptions from those and
other requirements. Some commenters
argue that providing the exemptions in
these rules would negate state
contraceptive requirements or narrower
state exemptions. Some commenters
asked that the Departments specify that
these exemptions do not apply to plans
governed by state laws that require
contraceptive coverage.
The Departments agree that these
rules only concern the applicability of
the federal contraceptive Mandate
imposed pursuant to section 2713(a)(4).
They do not regulate state contraceptive
mandates or state exemptions. If a plan
is exempt under the Moral IFC and
these final rules, that exemption does
not necessarily exempt the plan or other
insurance issuer from state laws that
may apply to it. The previous
regulations, which offered exemptions
for houses of worship and integrated
auxiliaries, did not include regulatory
language negating the exemptions in
states that require contraceptive
coverage, although the Departments
discussed the issue to some degree in
various preambles of those previous
regulations. The Departments do not
consider it appropriate or necessary in
the regulatory text of the moral
exemption rules to declare whether the
federal contraceptive Mandate would
still apply in states that have a state
contraceptive mandate, since these rules
do not purport to regulate the
applicability of state contraceptive
mandates.58
Some commenters observed that,
through ERISA, some entities may avoid
state laws that require contraceptive
58 Some commenters also asked that these final
rules specify that exempt entities must comply with
other applicable laws concerning such things as
notice to plan participants or collective bargaining
agreements. These final rules relieve the application
of the federal contraceptive Mandate under section
2713(a)(4) to qualified exempt entities; they do not
affect the applicability of other laws. In the
preamble to the companion final rules concerning
religious exemptions published elsewhere in
today’s Federal Register, the Departments provide
guidance applicable to notices of revocation and
changes that an entity may seek to make during its
plan year.
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coverage by self-insuring. This is a
result of the application of the
preemption and savings clauses
contained in ERISA to state insurance
regulation. See 29 U.S.C. 1144(a) &
(b)(1).
These final rules cannot change
statutory ERISA provisions, and do not
change the standards applicable to
ERISA preemption. To the extent
Congress has decided that ERISA
preemption includes preemption of
state laws requiring contraceptive
coverage, that decision occurred before
the ACA and was not negated by the
ACA. Congress did not mandate in the
ACA that any Guidelines issued under
section 2713(a)(4) must include
contraceptives, nor that the Guidelines
must force entities with moral
objections to cover contraceptives.
Finally, some commenters expressed
concern that providing moral
exemptions to the mandate that private
parties provide contraception may lead
to exemptions regarding other
medications or services, like vaccines.
The exemptions provided in these rules,
however, do not apply beyond the
contraceptive coverage requirement
implemented through section
2713(a)(4). Specifically, section
2713(a)(2) of the PHS Act requires
coverage of ‘‘immunizations,’’ and these
exemptions do not encompass that
requirement. The fact that the
Departments have exempted houses of
worship and integrated auxiliaries from
the contraceptive Mandate since 2011
did not lead to those entities receiving
exemptions under section 2713(a)(2)
concerning vaccines. In addition,
hundreds of entities have sued the
Departments over the implementation of
section 2713(a)(4), leading to two
decisions of the U.S. Supreme Court,
but no similar wave of lawsuits has
challenged section 2713(a)(2). The
expanded exemptions in these final
rules are consistent with a long history
of statutes protecting moral convictions
from certain health care mandates
concerning issues such as sterilization,
abortion and birth control.
B. Text of the Final Rules
In this section, the Departments
describe the regulations from the Moral
IFC, public comments in response to the
specific regulatory text set forth in the
IFC, the Departments’ response to those
comments, and, in consideration of
those comments, the regulatory text as
finalized in this final rule. We also note
the regulatory text as it existed prior to
the Religious and Moral IFCs, as
appropriate. The Departments consider
the exemptions finalized here to be an
appropriate and permissible policy
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choice in light of various interests at
stake and the lack of a statutory
requirement for the Departments to
impose the Mandate on entities and
plans that qualify for these exemptions.
As noted above, various members of
the public provided comments that were
supportive, or critical, of the regulations
overall, or of significant policies
pertaining to the regulations. To the
extent those comments apply to the
following regulatory text, the
Departments have responded to them
above. This section of the preamble
responds to comments that pertain more
specifically to particular regulatory text.
1. Restatement of Statutory
Requirements of Section 2713(a) and
(a)(4) of the PHS Act (26 CFR 54.9815–
2713(a)(1) and (a)(1)(iv), 29 CFR
2590.715–2713(a)(1) and (a)(1)(iv), and
45 CFR 147.130(a)(1) and (a)(1)(iv))
The previous regulations restated the
statutory requirements of section
2713(a) and (a)(4) of the PHS Act, at 26
CFR 54.9815–2713(a)(1) and (a)(1)(iv),
29 CFR 2590.715–2713(a)(1) and
(a)(1)(iv), and 45 CFR 147.130(a)(1) and
(a)(1)(iv). The Religious IFC modified
those restatements to more closely align
them with the text of section 2713(a)
and (a)(4) of the PHS Act. Those
sections cross-reference the other
sections of the Departments’ rules that
provide exemptions to the contraceptive
Mandate. After the Religious IFC
changed those sections, the Moral IFC
inserted, within those cross-references,
references to the new § 147.133, which
contains the text of the moral
exemptions. The insertions correspond
to the cross-references to the religious
exemptions added by the Religious IFC.
The Departments finalize these parts of
the Moral IFC without change.
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2. Exemption for Objecting Entities
Based on Moral Convictions (45 CFR
147.133(a))
The previous regulations contained
no exemption concerning moral
convictions, as distinct from religious
beliefs. Instead, at 45 CFR 147.131(a),
they offered an exemption for houses of
worship and integrated auxiliaries. In
the remaining part of § 147.131, the
previous regulations described the
accommodation process for
organizations with religious objections.
The Religious IFC moved the religious
exemption to a new section 45 CFR
147.132, and expanded its scope. The
Moral IFC created a new section 45 CFR
147.133, providing exemptions for
moral convictions similar to, but not
exactly the same as, the exemptions for
religious beliefs set forth in § 147.132.
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The prefatory language of § 147.133(a)
not only specifies that certain entities
are ‘‘exempt,’’ but also explains that the
Guidelines shall not support or provide
for an imposition of the contraceptive
coverage requirement to such exempt
entities. This is an acknowledgement
that section 2713(a)(4) requires women’s
preventive services coverage only ‘‘as
provided for in comprehensive
guidelines supported by the Health
Resources and Services
Administration.’’ To the extent the
HRSA Guidelines do not provide for, or
support, the application of such
coverage to certain entities or plans, the
Affordable Care Act does not require the
coverage. Those entities or plans are
‘‘exempt’’ by not being subject to the
requirements in the first instance.
Therefore, in describing the entities or
plans as ‘‘exempt,’’ and in referring to
the ‘‘exemption’’ encompassing those
entities or plans, the Departments also
affirm the non-applicability of the
Guidelines to them.
The Departments wish to make clear
that the expanded exemption set forth
in § 147.133(a) applies to several
distinct entities involved in the
provision of coverage to an objecting
employer’s employees. This explanation
is consistent with how prior regulations
have worked by means of similar
language. When § 147.133(a)(1) and
(a)(1)(i) specify that ‘‘[a] group health
plan,’’ ‘‘health insurance coverage
provided in connection with a group
health plan,’’ and ‘‘health insurance
coverage offered or arranged by an
objecting organization’’ are exempt ‘‘to
the extent’’ of the objections ‘‘as
specified in paragraph (a)(2),’’ that
language exempts the group health
plans of the sponsors that object, and
their health insurance issuers in
providing the coverage in those plans
(whether or not the issuers have their
own objections). Consequently, with
respect to Guidelines issued under
§ 147.130(a)(1)(iv) (and as referenced by
the parallel provisions in 26 CFR
54.9815 through 2713(a)(1)(iv) and 29
CFR 2590.715 through 2713(a)(1)(v)),
the plan sponsor, issuer, and plan
covered in the exemption of that
paragraph would face no penalty as a
result of omitting contraceptive
coverage from the benefits of the plan
participants and beneficiaries. However,
while a plan sponsor’s or arranger’s
objection removes penalties from that
group health plan’s issuer, it only does
so with respect to that group health
plan—it does not affect the issuer’s
coverage for other group health plans
where the plan sponsor has no
qualifying objection. More information
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on the effects of the objection of a health
insurance issuer in § 147.133(a)(1)(iii) is
included below.
The exemptions in § 147.133(a)(1)
apply ‘‘to the extent’’ of the objecting
entities’ sincerely held moral
convictions. Thus, entities that hold a
requisite objection to covering some, but
not all, contraceptive items would be
exempt with respect to the items to
which they object, but not with respect
to the items to which they do not object.
Some commenters stated it was unclear
whether the plans of entities or
individuals that morally object to some
but not all contraceptives would be
exempt from being required to cover just
the contraceptive methods as to which
there is an objection, or whether the
objection to some contraceptives leads
to an exemption from that plan being
required to cover all contraceptives. The
Departments intend that a requisite
moral objection to some, but not all,
contraceptives would lead to an
exemption only to the extent of that
objection: That is, the exemption would
encompass only the items to which the
relevant entity or individual objects and
would not encompass contraceptive
methods to which the objection does not
apply. To make this clearer, in these
final rules the Departments finalize the
prefatory language of § 147.133(a) so
that the first sentence of that paragraph
states that an exemption shall be
included, and the Guidelines must not
provide for contraceptive coverage, ‘‘to
the extent of the objections specified
below.’’ The Departments have made
corresponding changes to language
throughout the regulatory text, to
describe the exemptions as applying ‘‘to
the extent’’ of the objection(s).
The exemptions contained in
previous regulations, at § 147.131(a), did
not require an exempt entity to submit
any particular self-certification or
notice, either to the government or to
the entity’s issuer or third party
administrator, in order to obtain or
qualify for their exemption. Similarly,
under the expanded exemptions in
§ 147.133, the Moral IFC did not require
exempt entities to comply with a selfcertification process. We finalize that
approach without change. Although
exempt entities do not need to file
notices or certifications of their
exemption, and these final rules do not
impose any new notice requirements on
them, existing ERISA rules governing
group health plans require that, with
respect to plans subject to ERISA, a plan
document must include a
comprehensive summary of the benefits
covered by the plan and a statement of
the conditions for eligibility to receive
benefits. Under ERISA, the plan
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document identifies what benefits are
provided to participants and
beneficiaries under the plan; if an
objecting employer would like to
exclude all or a subset of contraceptive
services, it must ensure that the
exclusion is clear in the plan document.
Moreover, if there is a reduction in a
covered service or benefit, the plan has
to disclose that change to plan
participants.59 Thus, where an
exemption applies and all (or a subset
of) contraceptive services are omitted
from a plan’s coverage, otherwise
applicable ERISA disclosures must
reflect the omission of coverage in
ERISA plans. These existing disclosure
requirements serve to help provide
notice to participants and beneficiaries
of what ERISA plans do and do not
cover.
Some commenters supported this
approach, while others did not. Those
in favor suggested that self-certification
forms for an exemption are not
necessary, could add burdens to exempt
entities beyond those imposed by the
previous exemption, and could give rise
to objections to the self-certification
process itself. Commenters also stated
that requiring an exemption form for
exempt entities could cause additional
operational burdens for plans that have
existing processes in place to handle
exemptions. Other commenters favored
including a self-certification process for
exempt entities. They suggested that
entities might abuse the availability of
an exemption or use their exempt status
insincerely if no self-certification
process exists, and that the Mandate
might be difficult to enforce without a
self-certification process.
After considering the comments, the
Departments continue to believe it is
appropriate to not require exempt
entities to submit a self-certification or
notice. The previous exemption did not
require a self-certification or notice, and
the Departments did not collect a list of
all entities that used the exemption,
although there may have been
thousands of houses of worship and
integrated auxiliaries covered by the
previous exemption and the
Departments think it likely that only a
small number of entities will use the
moral exemption. Adding a selfcertification or notice to the exemption
would impose an additional paperwork
burden on exempt entities that the
previous regulations did not impose,
and would also involve additional
59 See, for example, 29 U.S.C. 1022, 1024(b), 29
CFR 2520.102–2, 2520.102–3, & 2520.104b-3(d), and
29 CFR 2590.715–2715. See also 45 CFR 147.200
(requiring disclosure of the ‘‘exceptions, reductions,
and limitations of the coverage,’’ including group
health plans and group & individual issuers).
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public costs if those certifications or
notices are to be reviewed or kept on file
by the government.
The Departments are not aware of
instances where the lack of a selfcertification under the previous
exemption led to abuses or to an
inability to engage in enforcement. The
Mandate is enforceable through various
mechanisms in the PHS Act, the Code,
and ERISA. Entities that insincerely or
otherwise improperly operate as if they
are exempt would do so at the risk of
enforcement and accountability under
such mechanisms. The Departments are
not aware of sufficient reasons to
believe those measures and mechanisms
would fail to deter entities from
improperly operating as if they are
exempt. Moreover, as noted above,
ERISA and other plan disclosure
requirements governing group health
plans require provision of a
comprehensive summary of the benefits
covered by the plan and disclosure of
any reductions in covered services or
benefits, so beneficiaries will know
whether their health plan claims a
contraceptive Mandate exemption and
will be able to raise appropriate
challenges to such claims. As a
consequence, the Departments believe it
is an appropriate balance of various
concerns expressed by commenters for
these final rules to continue to not
require notices or self-certifications for
using the exemption.
Some commenters asked the
Departments to add language indicating
that an exemption cannot be invoked in
the middle of a plan year, nor should it
be used to the extent inconsistent with
laws that apply to, or state approval of,
fully insured plans. None of the
previous iterations of the exemption
regulations included such provisions,
and the Departments do not consider
them necessary in these final rules. The
exemptions in these final rules only
purport to exempt plans and entities
from the application of the federal
contraceptive coverage requirement of
the Guidelines issued under section
2713(a)(4). They do not purport to
exempt entities or plans from state laws
concerning contraceptive coverage, or
laws governing whether an entity can
make a change (of whatever kind)
during a plan year. Final rules
governing the accommodation likewise
do not purport to obviate the need to
follow otherwise applicable rules about
making changes during a plan year. (In
the companion rules concerning
religious beliefs published elsewhere in
today’s Federal Register, the
Departments discuss in more detail the
accommodation and when an entity
seeking to revoke it would be able to do
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57615
so or to notify plan participants of the
revocation.)
Commenters also asked that clauses
be added to the regulatory text holding
issuers harmless where exemptions are
invoked by plan sponsors. As discussed
above, the exemption rules already
specify that where an exemption applies
to a group health plan, it encompasses
both the group health plan and health
insurance coverage provided in
connection with the group health plan,
and therefore encompasses any impact
on the issuer of the contraceptive
coverage requirement with respect to
that plan. In addition, as discussed in
the companion religious final rule
published elsewhere in today’s Federal
Register, the Departments have added
language from the previous regulations,
in § 147.131(f), to protect issuers that act
in reliance on certain representations
made in the accommodation process. To
the extent that commenters seek
language offering additional protections
for other incidents that might occur in
connection with the invocation of an
exemption, the previous exemption
regulations did not include such
provisions, and the Departments do not
consider them necessary in these final
rules. As noted above, the expanded
exemptions in these final rules simply
remove or narrow the contraceptive
Mandate contained in, and derived
from, the Guidelines for certain plans.
The previous regulations included a
reliance clause in the accommodation
provisions, but did not specify further
details regarding the relationship
between exempt entities and their
issuers or third party administrators.
The Departments do not believe it
necessary to do so in these final rules.
Commenters disagreed about the
likely effects of the moral exemptions
on the health coverage market. Some
commenters stated that expanding the
exemptions to encompass moral
convictions would not cause
complications in the market, while
others said that it could, due to such
causes as a lack of uniformity among
plans, or permitting multiple risk pools.
The Departments note that the extent to
which plans cover contraception under
the prior regulations is already far from
uniform. Congress did not require all
entities to comply with section 2713 of
the PHS Act (under which the Mandate
was promulgated)—most notably by
exempting grandfathered plans.
Moreover, under the previous
regulations, issuers were already able to
offer plans that omit contraceptives—or
only some contraceptives—to houses of
worship and integrated auxiliaries, and
some commenters and litigants said that
issuers were doing so. These cases
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where plans did not need to comply
with the Mandate, and the Departments’
previous accommodation process which
had the effect of allowing coverage not
to be provided in certain self-insured
church plans, together show that the
importance of a uniform health coverage
system is not significantly harmed by
allowing plans to omit contraception in
some contexts.60
Concerning the prospect raised by
some commenters of different risk pools
between men and women, section
2713(a) of the PHS Act itself provides
for some preventive services coverage
that applies to both men and women,
and some that would apply only to
women. With respect to the latter, it
does not specify what, if anything,
HRSA’s Guidelines for women’s
preventives services would cover, or if
contraceptive coverage will be required.
The Moral IFC and these final rules do
not require issuers to offer health
insurance products that satisfy morally
objecting entities, they simply make it
legal to do so. The Mandate has been
imposed only relatively recently, and
the contours of its application to
objecting entities has been in continual
flux, due to various rulemakings and
court orders. Overall, concerns raised by
some public commenters have not led
the Departments to consider it likely
that offering these expanded exemptions
will cause any injury to the uniformity
or operability of the health coverage
market.
3. Exemption for Certain Plan Sponsors
(45 CFR 147.133(a)(1)(i))
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The exemption in § 147.133(a)(1)(i) of
the Moral IFC covers a group health
plan and health insurance coverage for
non-governmental plan sponsors that
object as specified in paragraph (a)(2),
and that are either nonprofit
organizations, or are for-profit entities
that have no publicly traded ownership
interests (defined as any class of
common equity securities required to be
registered under section 12 of the
Securities Exchange Act of 1934). The
Departments finalize this paragraph
without change, and discuss each part
of the paragraph in turn.
60 See also Real Alternatives, 867 F.3d 338, 389
(3d Cir. 2017) (Jordan, J., concurring in part and
dissenting in part) (‘‘Because insurance companies
would offer such plans as a result of market forces,
doing so would not undermine the government’s
interest in a sustainable and functioning market.
. . . Because the government has failed to
demonstrate why allowing such a system (not
unlike the one that allowed wider choice before the
ACA) would be unworkable, it has not satisfied
strict scrutiny.’’ (citation and internal quotation
marks omitted)).
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a. Plan Sponsors in General (45 CFR
147.133(a)(1)(i) Prefatory Text)
Under the plan sponsor exemption in
§ 147.132(a)(1)(i), the prefatory text in
that paragraph specifies that it
encompasses group health plans, and
health insurance coverage provided in
connection with such group health
plans, that are sponsored by certain
kinds of entities, namely, nonprofit
organizations or for-profit entities that
have no publicly traded ownership
interests.
Such plan sponsors, if they are
otherwise nonprofit organizations or forprofit entities that have no publicly
traded ownership interests, can include
entities that are not employers (for
example, a union, or a sponsor of a
multiemployer plan), where the plan
sponsor objects based on sincerely held
moral convictions to coverage of
contraceptives or sterilization. Plan
sponsors encompassed by the
exemption can also include employers,
and consistent with the definition of
‘‘employer’’ in 29 CFR 2510.3–5, can
include association health plans, where
the plan sponsor is a nonprofit
organization or a for-profit entity that
has no publicly traded ownership
interests.
Some commenters objected to
extending the exemption to plan
sponsors that are not single employers,
arguing that they could not have the
same kind of moral objection that a
single employer might have. Other
commenters supported the protection of
any plan sponsor with the requisite
moral objection. The Departments
conclude that it is appropriate, where a
plan sponsor of a multiemployer plan or
multiple employer plan adopts a moral
objection using the same procedures
that such a plan sponsor might use to
make other decisions, to respect that
decision by providing an exemption
from the Mandate.
The plans of governmental employers
are not covered by the plan sponsor
exemption in § 147.133(a)(1)(i), which
instead limits the moral exemptions to
‘‘non-governmental plan sponsors.’’ As
noted above, the Departments sought
public comment on whether to extend
the exemptions to non-federal
governmental plan sponsors. Some
commenters suggested that the moral
exemptions should include government
entities because other conscience laws
can include government entities, such
as when they oppose offering abortions.
Others disagreed, contending that
governmental entities should not or
cannot object based on moral
convictions, or that it would be
unlawful for them to do so.
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The Departments are sympathetic to
the arguments of commenters that favor
including government entities in the
exemption for moral convictions. The
protections outlined in the first
paragraph of the Church Amendments
for entities that object based on moral
convictions to making their facilities or
personnel available to assist in the
performance of abortions or
sterilizations do not turn on the nature
of the entity, whether public, private,
nonprofit, for-profit, or governmental.
(42 U.S.C. 300a–7(b)). Both the Weldon
and Coats-Snowe Amendments also
protect state and local government
entities from providing, promoting, or
paying for abortions in particular
ways.61 Congress has generally not
limited protections for conscience based
on the nature of an entity—even in the
case of governmental entities.
At the same time, the Departments do
not at this time have information
suggesting that an exemption for
governmental entities is needed or
desired. The Departments have not been
sued by any governmental entities
raising objections to the Mandate based
on non-religious moral convictions.
Although the Departments sought
public comment on the issue, the
Departments received no public
comments identifying governmental
entities that need or desire such an
exemption. Rather, the Departments are
aware of governmental entities that,
despite not possessing their own
objections to contraceptive coverage,
have acted to protect their employees
who have conscientious objections to
receiving contraceptive coverage in their
employer-provided health insurance
plans. See Wieland v. U.S. Dep’t of
Health & Human Servs., 196 F. Supp.
1010, 1015–16 (E.D. Mo. 2016) (quoting
Mo. Rev. Stat. 191.724). The individual
exemption adopted in these rules will
ensure the Mandate is not an obstacle to
those efforts.
Thus, in light of the balance of public
comments, the Departments decline to
extend the moral convictions exemption
to governmental entities. As is the case
with the Departments’ decision not to
extend the moral exemption to publicly
traded for-profit entities, this decision
does not reflect a disagreement with the
various conscience statutes that provide
exemptions for moral convictions
61 Consolidated Appropriations Act, 2018, Div. H,
Sec. 507(d), 132 Stat. at 764 (protecting any
‘‘hospital, a provider-sponsored organization, a
health maintenance organization, a health
insurance plan, or any other kind of health care
facility, organization, or plan’’ in objecting to
abortion); 42 U.S.C. 238n (protecting entities that
object to abortion, including, but not limited to, any
‘‘postgraduate physician training program’’).
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without categorically excluding
governmental entities. The Departments
remain open to the possibility of future
rulemaking on this issue if the
Departments become aware of a
governmental entity seeking to be
exempt from the contraceptive Mandate.
b. Nonprofit Organizations (45 CFR
147.133(a)(1)(i)(A))
As discussed above, some
commenters opposed offering
exemptions based on moral convictions
to any plan sponsors, and/or objected to
doing so for nonprofit organizations, on
various grounds, including but not
limited to arguments that the benefits of
contraception access should override
moral objections, entities cannot assert
moral objections, and moral objections
burden third parties. Other commenters
supported the exemptions, generally
defending the interest of nonprofit
organizations not to be forced to violate
their moral convictions, supporting the
history of government protection of
moral convictions in similar contexts,
and disputing the claims of opponents
of the exemptions.
The Departments are aware, through
litigation, of only two non-religious
nonprofit organizations with moral
objections to the contraceptive Mandate.
Many more nonprofit religious
organizations have sued suggesting—as
discussed below—that the effect of this
exemption for non-religious nonprofit
objections to the Mandate will be far
less significant than commenters who
oppose the exemption believe it will.
The two non-religious nonprofit
organizations that challenged the
Mandate in court provide a good
illustration of the reasons why the
Department has decided to provide this
exemption to nonprofit organizations.
Both organizations have said in court
they oppose certain contraceptives on
non-religious moral grounds as being
abortifacient and state that they only
hire employees who share that view.
Public comments and litigation reflect
that many nonprofit organizations
publicly describe their beliefs and
convictions. Government records and
many of those groups’ websites also
often reflect those groups’ religious or
moral character, as the case may be. If
a person who desires contraceptive
coverage works at a nonprofit
organization, the Departments view it as
sufficiently likely that the person would
know, or would know to ask, whether
the organization offers such coverage.
The Departments are not aware of
federal laws that would require a
nonprofit organization that opposes
contraceptive coverage to hire a person
who disagrees with the organization’s
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view on contraceptive coverage. Instead,
nonprofit organizations generally have
access to a First Amendment right of
expressive association to choose to hire
persons (or, in the case of students, to
admit them) based on whether they
share, or at least will be respectful of,
their beliefs.62
The Departments agree with
commenters who support offering the
exemption to nonprofit organizations
and believe that doing so is an
appropriate protection and is not likely
to have a significant impact on women
who want contraceptive coverage.
57617
With respect to for-profit
organizations addressed in
§ 147.133(a)(1)(i)(B), in the Moral IFC,
the Departments did not limit the
exemption to nonprofit organizations,
but also included some for-profit
entities. Some commenters supported
including for-profit entities in the
exemption, saying owners of such
entities exercise their moral convictions
through their businesses, and that such
owners should not be burdened by a
federal governmental contraceptive
Mandate. Other commenters opposed
extending the exemption to closely held
for-profit entities, saying the entities
cannot exercise moral convictions or
should not have their moral opposition
to contraceptive coverage protected by
the exemption. Some commenters stated
that the entities should not be able to
impose their beliefs about contraceptive
coverage on their employees and that
doing so constitutes discrimination.
The Departments agree with
commenters who support including
some for-profit entities in the
exemption. Many of the federal health
care conscience statutes cited above
offer protections for the moral
convictions of entities, without regard to
whether they operate as nonprofit
organizations or for-profit entities. In
addition, nearly half of the states either
impose no contraceptive coverage
requirement or offer ‘‘an almost
unlimited’’ exemption encompassing
both ‘‘religious and secular
organizations.’’ 63 States also generally
protect moral convictions in other
health care conscience laws whether or
not an entity operates as a nonprofit.64
Extending the exemption to certain
for-profit entities is also consistent with
the Supreme Court’s ruling in Hobby
Lobby, which declared that a corporate
entity is capable of possessing and
pursuing non-pecuniary goals (in Hobby
Lobby, the pursuit of religious beliefs),
regardless of whether the entity operates
as a nonprofit organization and rejected
the Departments’ argument to the
contrary. 134 S. Ct. at 2768–75. The
mechanisms by which a for-profit
company makes decisions of
conscience, or resolves disputes on
those issues among their owners, are
problems that ‘‘state corporate law
provides a ready means’’ of solving. Id.
at 2774–75. Some reports and industry
experts have indicated that few forprofit entities beyond those that had
originally challenged the Mandate have
sought relief from it after Hobby
Lobby.65 Because all of those appear to
be informed by religious beliefs,
extending the exemption to entities with
non-religious moral convictions would
seem to have an even smaller impact on
access to contraceptive coverage.
The Moral IFC only extended the
exemption covering for-profit entities to
those that are closely held, not to forprofit entities that are publicly traded,
but asked for comment on whether
publicly traded entities should be
included in the moral exemption. In this
way the Moral IFC differed from the
exemption provided to plan sponsors
with objections based on sincerely held
religious beliefs set forth in the
Religious IFC, at § 147.132(a)(1),
finalized in companion rules published
elsewhere in today’s Federal Register.
Some commenters supported
including publicly traded entities in the
moral exemption, contending that
publicly traded entities have historically
taken various positions on important
public concerns beyond merely seeking
the company’s own profits, and that
nothing in principle would preclude
them from using the same mechanisms
of corporate decision-making to
establish and exercise moral convictions
against contraceptive coverage. They
observed that large publicly traded
entities are exempt from the
contraceptive Mandate by means of the
grandfathering provision of the ACA, so
62 Notably, ‘‘the First Amendment simply does
not require that every member of a group agree on
every issue in order for the group’s policy to be
‘expressive association.’ ’’ Boy Scouts of America v.
Dale, 530 U.S. 640, 655 (2000).
63 ‘‘Insurance Coverage of Contraceptives,’’ The
Guttmacher Institute (June 11, 2018), https://
www.guttmacher.org/state-policy/explore/
insurance-coverage-contraceptives.
64 See, e.g., ‘‘Refusing to Provide Health
Services,’’ The Guttmacher Institute (June 1, 2018),
https://www.guttmacher.org/state-policy/explore/
refusing-provide-health-services.
65 See Jennifer Haberkorn, ‘‘Two years later, few
Hobby Lobby copycats emerge,’’ Politico (Oct. 11,
2016), https://www.politico.com/story/2016/10/
obamacare-birth-control-mandate-employers229627.
c. For-Profit Entities (45 CFR
147.133(a)(1)(i)(B))
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that it is inappropriate to refuse to
exempt publicly traded entities that
actually have sincerely held moral
convictions against compliance with the
Mandate. They further argued that in
some instances there are closely held
companies that are as large as publicly
traded companies of significant size.
They also stated that other protections
for moral convictions in certain federal
health care conscience statutes do not
preclude the application of such
protections to certain entities on the
basis that they are not closely held, and
federal law defines ‘‘persons’’ to include
all forms of corporations, not just
closely held corporations, at 1 U.S.C. 1.
Additionally, some commenters were
concerned that not providing a moral
exemption for publicly traded for-profit
entities but allowing a religious
exemption for publicly traded for-profit
entities (as was allowed in the Religious
IFC, and as is allowed in the companion
religious final rules published
elsewhere in today’s Federal Register),
may raise Establishment Clause
questions, may cause confusion to the
public, and may make the exemptions
more difficult for the Departments and
enforcing agencies to administer. They
stated that it is incongruous to include
publicly traded entities in the
exemption for religious beliefs, but
exclude them from the exemption for
moral convictions.
Other commenters opposed including
publicly traded companies in these
moral exemptions. Some stated that
such companies could not exercise
moral convictions and opposed the
effects on women if they would. They
also objected that including such
companies, along with closely held
businesses, would extend the
exemptions to all or virtually all
companies. Some commenters stated
that many publicly traded companies
would use a moral exemption if
available to them, because many closely
held for-profit businesses expressed
religious objections to the Mandate, or
availed themselves of the religious
accommodation.
As is the case for non-federal
governmental employers, the
Departments are sympathetic to the
arguments of commenters that favor
including publicly traded entities in the
exemption for moral convictions. In the
case of particularly sensitive health care
matters, several significant federal
health care conscience statutes protect
entities’ moral objections without regard
to their ownership status. For example,
the first paragraph of the Church
Amendments provides certain
protections for entities that object based
on moral convictions to making their
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facilities or personnel available to assist
in the performance of abortions or
sterilizations; the protections of the
Church Amendments do not turn on the
nature of the entity, whether public,
private, nonprofit, for-profit, or
governmental. (42 U.S.C. 300a–7(b)).
Thus, under section 300a–7(b), a
hospital in a publicly traded health
system, or a local governmental
hospital, could adopt sincerely held
moral convictions by which it objects to
providing facilities or personnel for
abortions or sterilizations, and if the
entity receives relevant funds from HHS
specified by section 300a–7(b), the
protections of that section would apply.
Other federal conscience protections in
the health sector apply in the same
manner:
• The Coats-Snowe Amendment (42
U.S.C. 238n) provides certain
protections for health care entities and
postgraduate physician training
programs that, among other things,
choose not to perform, refer for, or
provide training for, abortions.
• The Weldon Amendment 66
provides certain protections for health
care entities, hospitals, providersponsored organizations, health
maintenance organizations, and health
insurance plans that do not provide, pay
for, provide coverage of, or refer for
abortions.
• The ACA provides certain
protections for any institutional health
care entity, hospital, provider-sponsored
organization, health maintenance
organization, health insurance plan, or
any other kind of health care facility,
that does not provide any health care
item or service furnished for the
purpose of causing or assisting in
causing assisted suicide, euthanasia, or
mercy killing. (42 U.S.C. 18113).67
• Social Security Act sections
1852(j)(3)(B) (Medicare) and
1932(b)(3)(B) (Medicaid), 42 U.S.C.
1395w–22(j)(3)(B) and 1396u–2(b)(3)(B),
provide protections so that the statutes
cannot be construed to require
organizations that offer Medicare
Advantage and Medicaid managed care
plans in certain contexts to provide,
reimburse for, or provide coverage of a
counseling or referral service if they
object to doing so on moral grounds.
• Congress’s most recent statement on
contraceptive coverage specified that, if
the District of Columbia requires ‘‘the
66 See Consolidated Appropriations Act, 2018,
Public Law 115–141, Div. H, Sec. 507(d) (Mar.
2018).
67 The lack of the limitation in this provision may
be particularly relevant since it was enacted in the
same statute, the ACA, as the provision under
which the Mandate—and these exemptions to the
Mandate—were promulgated.
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provision of contraceptive coverage by
health insurance plans,’’ ‘‘it is the intent
of Congress that any legislation enacted
on such issue should include a
‘conscience clause’ which provides
exceptions for religious beliefs and
moral convictions.’’ Consolidated
Appropriations Act, 2018, Public Law
115–141, Div. E, Sec. 808.
In all of these instances, Congress did
not limit the protection for conscience
based on the nature of the entity—and
did not exclude publicly traded entities
from protection.
At the same time, as stated in the
Moral IFC, the Departments continue to
lack significant information about
whether there is a need to extend the
expanded exemption to publicly traded
entities. The Departments have been
sued by nonprofit entities expressing
objections to the Mandate based on nonreligious moral convictions, as well as
by closely held for-profit entities
expressing religious objections, but not
by any publicly traded entities. In
addition, the Departments sought public
comments on whether publicly traded
entities might benefit from extending
the moral exemption to them. No such
entities were brought to the attention of
the Department through the comment
process. The Supreme Court concluded
it is improbable that publicly traded
companies with numerous ‘‘unrelated
shareholders—including institutional
investors with their own set of
stakeholders—would agree to run a
corporation under the same religious
beliefs.’’ Hobby Lobby, 134 S. Ct. at
2774. It would appear to be even less
probable that publicly traded entities
would adopt that view based on nonreligious moral convictions.
In light of the balance of public
comments, the Departments decline to
extend the moral convictions exemption
to publicly traded entities. Because the
Departments are aware of so many
closely-held for-profit entities with
religious objections to contraceptive
coverage, and of some nonprofit entities
with non-religious moral objections to
contraceptive coverage, the Departments
believe it is reasonably possible that
closely held for-profit entities with nonreligious moral objections to
contraceptive coverage might exist or
come into being. The Departments have
also concluded that it is reasonably
possible, even if improbable, that
publicly traded entities with religious
objections to contraceptive coverage
might exist or come into being. But the
Departments conclude there is not a
similar probability that publicly traded
for-profit entities with non-religious
moral objections to contraceptive
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coverage may exist and need to be
included in these expanded exemptions.
The decision to not extend the moral
exemption to publicly traded for-profit
entities in these rules does not reflect a
disagreement with the various
conscience statutes that provide
exemptions for moral convictions
without categorically excluding publicly
traded entities. The Departments remain
open to the possibility of future
rulemaking on this issue, if we become
aware of the need to expand the
exemptions to publicly traded
corporations with non-religious moral
objections to all (or a subset of)
contraceptives.
In contrast, the Departments finalize,
without change, the Moral IFC’s
extension of the exemptions in these
rules to closely held for-profit entities
with moral convictions opposed to
offering coverage of some or all
contraceptives. The Departments
conclude that it is sufficiently likely
that closely held for-profit entities exist
or may come into being and may
maintain moral objections to certain
contraceptives, so as to support
including them in these expanded
exemptions. The Departments seek to
remove an obstacle that might prevent
individuals with moral objections from
forming or maintaining such small or
closely held businesses and providing
health coverage to their employees in
accordance with their moral
convictions.
In defining what constitutes a closely
held for-profit entity to which these
exemptions extend, the Moral IFC used
language derived from the July 2015
final regulations. Those regulations, in
offering the accommodation (not an
exemption) to religious (not moral)
closely held for-profit entities, did so by
attempting to positively define what
constitutes a closely held entity,
formulating a multi-factor, and partially
open-ended, definition for that purpose.
(80 FR 41313). Any such positive
definition runs up against the myriad
state differences in defining such
entities and potentially intrudes into a
traditional area of state regulation of
business organizations. Instead of
attempting to positively define closely
held businesses in the Moral IFC,
however, the Departments considered it
much clearer, effective, and preferable
to define the category negatively, by
reference to one element of the previous
definition: that the entity has no
publicly traded ownership interest (that
is, any class of common equity
securities required to be registered
under section 12 of the Securities
Exchange Act of 1934).
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4. Institutions of Higher Education (45
CFR 147.133(a)(1)(ii))
The previous regulations did not
exempt plans arranged by institutions of
higher education, although they did
include, in the accommodation, plans
arranged by institutions of higher
education similarly to the way in which
the regulations provided the
accommodation to plans of nonprofit
religious employers. (See 80 FR 41347).
The Moral IFC provided an exemption,
in § 147.133(a)(1)(ii), encompassing
institutions of higher education that
arrange student health insurance
coverage, and stating the exemption
would operate in a manner comparable
to the exemption for employers with
respect to plans they sponsor. In these
final rules, the Departments finalize
§ 147.133(a)(1)(ii) with one change.
These rules treat the health plans of
institutions of higher education that
arrange student health insurance
coverage similarly to the way in which
the rules treat the plans of employers.
The rules do so by making such student
health plans eligible for the expanded
exemptions, and by permitting them the
option of electing to utilize the
accommodation process. Thus, these
rules specify, in § 147.133(a)(1)(ii), that
the exemption is extended, in the case
of institutions of higher education (as
defined in 20 U.S.C. 1002) with
objections to the Mandate based on
sincerely held moral convictions, to
their arrangement of student health
insurance coverage, in a manner
comparable to the exemption for group
health insurance coverage provided in
connection with a group health plan
established or maintained by a plan
sponsor.
Some commenters supported
including, in the exemptions,
institutions of higher education that
provide health coverage for students
through student health plans but have
moral objections to providing certain
contraceptive coverage. They stated that
moral exemptions allow freedom for
certain institutions of higher education
to exist, and this in turn gives students
the choice of institutions that hold
different views on important issues such
as contraceptives and abortifacients.
Other commenters opposed including
the exemption, asserting that expanding
the exemption would negatively impact
female students because institutions of
higher education might not cover
contraceptives in student health plans,
women enrolled in those plans would
not receive access to birth control, and
an increased number of unintended
pregnancies would result.
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57619
In the Departments’ view, the reasons
for extending the exemption to
institutions of higher education are
similar to the reasons, discussed above,
for extending the exemption to other
nonprofit organizations. The
Departments are not aware of any
institutions of higher education that
arrange student health insurance
coverage and object to the Mandate
based on non-religious moral
convictions. But because the
Departments have been sued by several
institutions of higher education that
arrange student health insurance
coverage and object to the Mandate
based on religious beliefs and by several
nonprofit organizations with moral
objections, the Departments believe the
existence of institutions of higher
education with non-religious moral
objections, or the possible formation of
such entities in the future, is sufficiently
possible to justify including protections
for such entities in these final rules.
The Departments conclude that this
aspect of the exemption is likely to have
a minimal impact on contraceptive
coverage for women at institutions of
higher education. As noted above, the
Departments are not aware of any
institutions of higher education that
would currently qualify for the
objection. In addition, only a minority
of students in higher education receive
health insurance coverage from plans
arranged by their colleges or
universities, as opposed to from other
sources, and an even smaller number
receive such coverage from schools
objecting to contraceptive coverage.
Exempting institutions of higher
education that object to contraceptive
coverage based on moral convictions
does not affect student health insurance
contraceptive coverage at the vast
majority of institutions of higher
education. The exemption simply makes
it legal under federal law for institutions
to adhere to moral convictions that
oppose contraception, without facing
penalties for non-compliance that could
threaten their existence. This removes a
possible barrier to diversity in the
nation’s higher education system,
because it makes it easier for students to
attend institutions of higher education
that hold those views, if the institutions
exist or come into being and students
choose to attend them. Moreover,
because institutions of higher education
have no legal obligation to sponsor
student health insurance coverage,
providing this moral exemption
removes an obstacle to such institutions
sponsoring student health insurance
coverage, thus possibly encouraging
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more widespread health insurance
coverage.
As noted above, after seeking public
comment on whether the final moral
exemptions rules should be extended to
include non-federal governmental
entities, the Departments have
concluded they should only include
non-governmental entities. For the same
reasons, the Departments are inserting a
reference into § 147.133(a)(1)(ii)
specifying that it includes an institution
of higher education ‘‘which is nongovernmental.’’ This language is parallel
to the same limiting phrase used in the
religious exemptions rule governing
institutions of higher education, at
§ 147.132(a)(1)(ii). Thus, the first
sentence of § 147.133(a)(1)(ii) is
finalized to read: ‘‘An institution of
higher education as defined in 20 U.S.C.
1002, which is non-governmental, in its
arrangement of student health insurance
coverage, to the extent that institution
objects as specified in paragraph (a)(2)
of this section.’’ The remaining text of
§ 147.133(a)(1)(ii) is finalized without
change.
5. Health Insurance Issuers (45 CFR
147.133(a)(1)(iii))
The Moral IFC extended the
exemption, in § 147.133(a)(1)(iii), to
health insurance issuers offering group
or individual health insurance coverage
that sincerely hold their own moral
convictions opposed to providing
coverage for contraceptive services. The
issuer exemption only applied to the
group health plan if the plan itself was
also exempt under an exemption for the
plan sponsor or individuals. In these
final rules, the Departments finalize
§ 147.133(a)(1)(iii) without change.
As discussed above, where the
exemption for plan sponsors or
institutions of higher education applies,
issuers are exempt under those sections
with respect to providing contraceptive
coverage in those plans. The issuer
exemption in § 147.133(a)(1)(iii) adds to
that protection, but the additional
protection operates in a different way
than the plan sponsor exemption
operates. The only plan sponsors—or in
the case of individual insurance
coverage, individuals—who are eligible
to purchase or enroll in health
insurance coverage offered by an
exempt issuer that does not cover some
or all contraceptive services, are plan
sponsors or individuals who themselves
object and whose plans are otherwise
exempt based on that objection. An
exempt issuer can then offer an exempt
product to an entity or individual that
is exempt based on either the moral
exemptions for entities and individuals,
or the religious exemptions for entities
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and individuals. Thus, the issuer
exemption specifies that, where a health
insurance issuer providing group health
insurance coverage is exempt under
paragraph (a)(1)(iii), the plan remains
subject to any requirement to provide
coverage for contraceptive services
under Guidelines issued under
§ 147.130(a)(1)(iv), unless the plan is
otherwise exempt from that
requirement. Accordingly, the only plan
sponsors, or in the case of individual
insurance coverage, individuals, who
are eligible to purchase or enroll in
health insurance coverage offered by an
exempt issuer under this paragraph
(a)(1)(iii) that does not include some or
all contraceptive services, are plan
sponsors or individuals who themselves
object and are exempt.
Under these rules, issuers that hold
their own objections based on sincerely
held moral convictions could issue
policies that omit contraception to plan
sponsors or individuals that are
otherwise exempt based on their moral
convictions, or if they are exempt based
on their religious beliefs under the
companion final rules published
elsewhere in today’s Federal Register.
Likewise, issuers with sincerely held
religious beliefs, that are exempt under
those companion final rules, could
likewise issue policies that omit
contraception to plan sponsors or
individuals that are otherwise exempt
based on either their religious beliefs or
their moral convictions.
Some commenters supported
including this exemption for issuers in
these rules, both to protect the moral
convictions of issuers, and so that, in
the future, issuers would be free to
organize that may wish to specifically
serve plan sponsors and individuals that
object to contraception based on
religious or moral reasons. Other
commenters objected to including an
exemption for issuers. Some
commenters stated that issuers cannot
exercise moral convictions, while others
stated that exempting issuers would
threaten contraceptive coverage for
women. Some commenters stated that it
was arbitrary and capricious for the
Departments to provide an exemption
for issuers if they do not know that
issuers with qualifying moral objections
exist.
The Departments consider it
appropriate to provide this exemption
for issuers. Because the issuer
exemption only applies where an
independently exempt policyholder
(entity or individual) is involved, the
issuer exemption will not serve to
remove contraceptive coverage
obligations from any plan or plan
sponsor that is not also exempt, nor will
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it prevent other issuers from being
required to provide contraceptive
coverage in individual or group
insurance coverage.
The issuer exemption serves several
interests, even though the Departments
are not currently aware of existing
issuers that would use it. As noted by
some commenters, allowing issuers to
be exempt, at least with respect to plan
sponsors, plans, and individuals that
independently qualify for an exemption,
will remove a possible obstacle to
issuers with moral convictions being
organized in the future to serve entities
and individuals that want plans that
respect their religious beliefs or moral
convictions. Furthermore, permitting
issuers to object to offering
contraceptive coverage based on
sincerely held moral convictions will
allow issuers to continue to offer
coverage to plan sponsors and
individuals, without subjecting them to
liability under section 2713(a)(4), or
related provisions, for their failure to
provide contraceptive coverage. In this
way, the issuer exemption serves to
protect objecting issuers both from being
required to issue policies that cover
contraception in violation of the issuers’
sincerely held moral convictions and
from being asked or required to issue
policies that omit contraceptive
coverage to non-exempt entities or
individuals, thus subjecting the issuers
to potential liability if those plans are
not exempt from the Guidelines.
The Departments reject the
proposition that issuers cannot exercise
moral convictions. Many federal health
care conscience laws and regulations
protect issuers or plans specifically. For
example, as discussed above, 42 U.S.C.
1395w–22(j)(3)(B) and 1396u–2(b)(3)
protect plans or managed care
organizations in Medicare Advantage or
Medicaid. The Weldon Amendment
specifically protects, among other
entities, HMOs, health insurance plans,
and ‘‘any other kind of health care
facility[ies], organization[s] or plan[s]’’
as a ‘‘health care entity’’ from being
required to provide coverage of, or pay
for, abortions. See, for example,
Consolidated Appropriations Act, 2018,
Public Law 115–141, Div. H, Sec.
507(d).68 The most recently enacted
Consolidated Appropriations Act
declares that Congress supports a
68 ACA section 1553 protects an identically
defined group of ‘‘health care entities,’’ including
provider-sponsored organizations, HMOs, health
insurance plans, and ‘‘any other kind of . . . plan,’’
from being subject to discrimination on the basis
that it does not provide any health care item or
service furnishing for the purpose of assisted
suicide, euthanasia, mercy killing, and the like.
ACA section 1553, 42 U.S.C. 18113.
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‘‘conscience clause’’ to protect moral
convictions concerning ‘‘the provision
of contraceptive coverage by health
insurance plans.’’ See id. at Div. E, Sec.
808.
The issuer exemption does not
specifically include third party
administrators, for the reasons
discussed in the companion Religious
IFC and final rules concerning religious
beliefs issued contemporaneously with
these final rules and published
elsewhere in today’s Federal Register.69
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6. Description of the Moral Objection
(45 CFR 147.133(a)(2))
The Moral IFC set forth the scope of
the moral objection of objecting entities
in § 147.133(a)(2), so that it applies to
the extent an entity described in
paragraph (a)(1), based on sincerely held
moral convictions, objects to
‘‘establishing, maintaining, providing,
offering, or arranging’’ either ‘‘coverage
or payments’’ for contraceptives, or ‘‘for
a plan, issuer, or third party
administrator that provides or arranges
such coverage or payments.’’ The
Departments are finalizing this
exemption with structural changes
separating the second half of the
sentence into separate subparagraphs, so
as to more clearly specify, as set forth
in the Moral IFC text, that the objection
may pertain either to coverage or
payments for contraceptives, or to a
plan, issuer, or third party administrator
that provides or arranges such coverage
or payments.
Some commenters observed that, by
allowing exempt plan sponsors to object
to ‘‘some or all’’ contraceptives, this
might yield a cafeteria-style approach
where different plan sponsors choose
various combinations of contraceptives
that they wish to cover. Some
commenters further observed that this
might create a burden on issuers or third
party administrators.
The Departments have concluded,
however, that just as the previous
exemption rules allowed certain
religious plan sponsors to object to some
or all contraceptives, it is appropriate to
maintain that flexibility for entities
covered by the expanded exemption.
These rules do not require any issuer or
69 The exemption for issuers, as outlined here,
does not make a distinction among issuers based on
whether they are publicly traded, unlike the plan
sponsor exemption for employers. Because the
issuer exemption operates more narrowly than the
exemption for plan sponsors operates, in the ways
described here (i.e., the issuer exemption does not
operate unless the plan sponsor or individual, as
applicable, is also exempt), and exists in part to
help preserve market options for objecting plan
sponsors and individuals, the Departments consider
it appropriate to not draw such a distinction among
issuers.
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third party administrator to contract
with an exempt entity or individual if
the issuer or third party administrator
does not wish to do so, including
because the issuer or third party
administrator does not wish to offer an
unusual plan variation. These rules
simply remove the federal Mandate, in
some cases, where it could have led to
penalties on an employer, issuer, or
third party administrator if they wished
to sponsor, provide, or administer a
plan that omits contraceptive coverage
in the presence of a qualifying moral
objection. That approach is consistent
with the approach under the previous
regulations, which did not require
issuers and third party administrators to
contract with exempt plans of houses of
worship or integrated auxiliaries if they
did not wish to do so.
The definition does not specify that
the moral convictions that can support
an exemption need to be non-religious
moral convictions. We find it
unnecessary to limit the definition in
that way. Even though moral
convictions need not be based on
religious beliefs, religious beliefs can
have a moral component. It is not
always clear whether a moral conviction
is based on religious tenets. As noted in
Welsh, a moral conviction can be
‘‘purely ethical or moral in source and
content but that nevertheless . . .
occupy in the life of that individual a
place parallel to that filled by God [and]
function as a religion in his life.’’ 398
U.S at 340. One reason for providing
exemptions for moral convictions is so
that the government need not engage in
the potentially difficult task of parsing
which convictions are religious and
which are not. If sincerely held moral
convictions supporting an exemption
are religious, they will be encompassed
by the exemption for sincerely held
religious beliefs. If the moral
convictions are not also religious, or if
their religious quality is unclear but
they are ethical or moral, they can
qualify as sincerely held moral
convictions under these rules if the
other requirements of these rules are
met.
The Departments are not aware of any
entities that qualify for an exemption
under the religious exemptions finalized
elsewhere in today’s Federal Register,
but not under the moral exemptions
finalized here, such as publicly traded
entities. If publicly traded entities object
to the Mandate, it seems unlikely their
objection is based on moral convictions
and not religious beliefs, given that
many more objections to the Mandate
have been based on religious beliefs.
Thus, the Departments find it unlikely
that they would be faced with a
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57621
situation where a publicly traded entity,
for example, has an objection to the
contraceptive Mandate, but it is not
clear whether that objection is based on
sincerely held religious beliefs or
merely based on sincerely held moral
convictions.
7. Individuals (45 CFR 147.133(b))
The previous regulations did not
provide an exemption for objecting
individuals. The Moral IFC provided
such an exemption for objecting
individuals (referred to here as the
‘‘individual exemption’’), using the
following language at § 147.133(b):
‘‘Objecting individuals’’. Guidelines
issued under § 147.130(a)(1)(iv) by the
Health Resources and Services
Administration must not provide for or
support the requirement of coverage or
payments for contraceptive services
with respect to individuals who object
as specified in this paragraph (b), and
nothing in § 147.130(a)(1)(iv), 26 CFR
54.9815–2713(a)(1)(iv), or 29 CFR
2590.715–2713(a)(1)(iv) may be
construed to prevent a willing health
insurance issuer offering group or
individual health insurance coverage,
and as applicable, a willing plan
sponsor of a group health plan, from
offering a separate policy, certificate or
contract of insurance or a separate group
health plan or benefit package option, to
any individual who objects to coverage
or payments for some or all
contraceptive services based on
sincerely held moral convictions.’’
The Departments finalize this
language, with changes in response to
public comments in some of the text
and in a new sentence at the end of the
paragraph that clarify how the
exemption applies.
Section 147.133(b) sets forth a special
rule pertaining to individuals (referred
to here as the ‘‘individual exemption’’).
This rule exempts plans of certain
individuals with moral objections to
contraceptive coverage where the plan
sponsor and, as applicable, issuer is
willing to provide a plan compliant
with the individuals’ objections to such
plan sponsors or individuals, as
applicable.
Some commenters supported this
exemption as providing appropriate
protections for the moral convictions of
individuals who obtain their insurance
coverage in such places as the
individual market or exchanges, or who
obtain coverage from a group health
plan sponsor that does not object to
coverage of contraceptives but is willing
(and, as applicable, the issuer is also
willing) to provide coverage consistent
with an individual’s moral objections.
They commented that this exemption
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would free individuals from having
their moral convictions placed in
tension with their desire for health
coverage. They also contended that the
individual exemption would not
undermine any government interests
behind the contraceptive Mandate, since
the individuals would be choosing not
to have the coverage. Some commenters
also observed that, by specifying that
the individual exemption only operates
where the plan sponsor and issuer, as
applicable, are willing to provide
coverage that is consistent with the
objection, the exemption would not
impose burdens on the insurance
market because the possibility of such
burdens would be factored into the
willingness of an employer or issuer to
offer such coverage.
Other commenters disagreed and
contended that allowing the individual
exemption would cause burden and
confusion in the insurance market.
Some commenters also suggested that
the individual exemption should not
allow the offering of a separate group
health plan because doing so could
cause various administrative burdens.
The Departments agree with the
commenters who suggested the
individual exemption will not burden
the insurance market, and, therefore,
conclude that it is appropriate to
provide the individual exemption where
a plan sponsor and, as applicable, issuer
are willing to cooperate in doing so. The
Departments note that this individual
exemption only operates in the case
where the issuer is willing to provide
the separate option; in the case of
coverage provided by a group health
plan sponsor, where the plan sponsor is
willing; or in the case where both a plan
sponsor and issuer are involved, both
are willing. The Departments conclude
that it is appropriate to provide the
individual exemption so that the
Mandate will not serve as an obstacle
among these various options. Practical
difficulties that may be implicated by
one option or another will likely be
factored into whether plan sponsors and
issuers are willing to offer particular
options in individual cases. But the
Departments do not wish to pose an
obstacle to the offering of such coverage.
The Departments note that their
decision is consistent with the decision
by Congress to provide protections in
certain contexts for individuals who
object to prescribing or providing
contraceptives contrary to their moral
convictions. See, for example,
Consolidated Appropriations Act of
2018, Div. E, Sec. 726(c) (Mar. 23, 2018).
While some commenters argued that
such express protections are narrow,
Congress likewise provided that, if the
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District of Columbia requires ‘‘the
provision of contraceptive coverage by
health insurance plans,’’ ‘‘it is the intent
of Congress that any legislation enacted
on such issue should include a
‘conscience clause’ which provides
exceptions for religious beliefs and
moral convictions’’. Id. at Div. E, Sec.
808. A moral exemption for individuals
would not be effective if the government
did not, at the same time, permit issuers
and group health plans to provide
individuals with policies that comply
with their moral convictions.
The individual exemption extends to
the coverage unit in which the plan
participant, or subscriber in the
individual market, is enrolled (for
instance, to family coverage covering
the participant and his or her
beneficiaries enrolled under the plan),
but does not relieve the plan’s or
issuer’s obligation to comply with the
Mandate with respect to the group
health plan generally, or, as applicable,
to any other individual policies the
issuer offers. Thus, this individual
exemption allows plan sponsors and
issuers that do not specifically object to
contraceptive coverage to offer morally
acceptable coverage to their participants
or subscribers who do object, while
offering coverage that includes
contraception to participants or
subscribers who do not object. The July
2013 regulations stated that, because
employees of objecting houses of
worship and integrated auxiliaries are
relatively likely to oppose
contraception, exempting those
organizations ‘‘does not undermine the
governmental interests furthered by the
contraceptive coverage requirement.’’
(78 FR 39874). For parallel reasons, as
the Departments stated in the Moral IFC
(83 FR at 47853 through 47854), this
individual exemption does not
undermine the governmental interests
furthered by the contraceptive coverage
requirement, because, when the
exemption is applicable, the individual
does not want the coverage, and
therefore would not use the
objectionable items even if they were
covered.
This individual exemption can apply
with respect to individuals in plans
sponsored by private employers or
governmental employers. For example,
in one case brought against the
Departments, the State of Missouri
enacted a law under which the state is
not permitted to discriminate against
insurance issuers that offer group health
insurance policies without coverage for
contraception based on employees’
religious beliefs ‘‘or moral convictions,’’
or against the individual employees
who accept such offers. See Wieland,
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196 F. Supp. 3d at 1015–16 (quoting
Mo. Rev. Stat. 191.724). Under the
individual exemption in these rules,
employers sponsoring governmental
plans would be free to honor the moral
objections of individual employees by
offering them plans that omit
contraceptive coverage, even if those
governmental entities do not object to
offering contraceptive coverage in
general.
In the separate companion IFC to the
Moral IFC—the Religious IFC—the
Departments, at § 147.133(b), provided a
similar individual exemption, but we
used slightly different operative
language. Where the Moral IFC said a
willing issuer and plan sponsor may
offer ‘‘a separate policy, certificate or
contract of insurance or a separate group
health plan or benefit package option, to
any individual who objects’’ under the
individual exemption, the Religious IFC
described what may be offered to
objecting individuals as ‘‘a separate
benefit package option, or a separate
policy, certificate or contract of
insurance.’’ Some commenters observed
this difference and asked whether the
language was intended to encompass
the same options. The Departments
intended these descriptions to include
the same scope of options. Some
commenters suggested that the
individual exemption should not allow
the offering of ‘‘a separate group health
plan,’’ because doing so could cause
various administrative burdens. The
Departments disagree, since group
health plan sponsors and group and
individual health insurance issuers
would be free to decline to provide that
option, including because of
administrative burdens. In addition, the
Departments wish to clarify that, where
an employee claims the exemption, a
willing issuer and a willing employer
may, where otherwise permitted, offer
the employee participation in a group
health insurance policy or benefit
option that complies with the
employee’s objection. Consequently,
these rules finalize the individual
exemption by making a technical
change to the language to adopt the
formulation, ‘‘a separate policy,
certificate or contract of insurance or a
separate group health plan or benefit
package option, to any group health
plan sponsor (with respect to an
individual) or individual, as applicable,
who objects.’’
This individual exemption cannot be
used to force a plan (or its sponsor) or
an issuer to provide coverage omitting
contraception, or, with respect to health
insurance coverage, to prevent the
application of state law that requires
coverage of such contraceptives or
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sterilization. Nor can the individual
exemption be construed to require the
guaranteed availability of coverage
omitting contraception to a plan sponsor
or individual who does not have a
sincerely held moral objection. This
individual exemption is limited to the
requirement to provide contraceptive
coverage under section 2713(a)(4), and
does not affect any other federal or state
law governing the plan or coverage.
Thus, if there are other applicable laws
or plan terms governing the benefits,
these rules do not affect such other laws
or terms.
The Departments received numerous
comments about the administrative
burden from the potential variations in
moral convictions held by individuals.
Some commenters welcomed the ability
of individuals covered by the individual
exemption to be able to assert an
objection to either some or all
contraceptives, while others expressed
concern that the variations in the kinds
of contraceptive coverage to which
individuals object might make it
difficult for willing plan sponsors and
issuers to provide coverage that
complies with the moral convictions of
an exempt individual.
If an individual only objects to some
contraceptives, and the individual’s
issuer and, as applicable, plan sponsor
are willing to provide the individual a
package of benefits omitting such
coverage, but for practical reasons can
only do so by providing the individual
with coverage that omits all—not just
some—contraceptives, the Departments
believe that it favors individual freedom
and market choice, and does not harm
others, to allow the issuer and plan
sponsor to provide, in that case, a plan
omitting all contraceptives if the
individual is willing to enroll in that
plan. The language of the individual
exemption set forth in the Moral IFC
implied this conclusion by specifying
that the Guidelines requirement of
contraceptive coverage did not apply
where the individual objected to some
or all contraceptives. Notably, that
language differed from the language
applicable to the exemptions under
§ 147.133(a), which specifies that those
exemptions apply ‘‘to the extent’’ of the
moral objections, so that, as discussed
above, they include only those
contraceptive methods to which the
objection applied. In response to
comments suggesting the language of
the individual exemption was not
sufficiently clear on this distinction,
however, the Departments in these rules
finalize the individual exemption at
§ 147.133(b), with the following change,
by adding the following sentence at the
end of the paragraph: ‘‘Under this
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exemption, if an individual objects to
some but not all contraceptive services,
but the issuer, and as applicable, plan
sponsor, are willing to provide the plan
sponsor or individual, as applicable,
with a separate policy, certificate or
contract of insurance or a separate group
health plan or benefit package option
that omits all contraceptives, and the
individual agrees, then the exemption
applies as if the individual objects to all
contraceptive services.’’
Some commenters asked for plain
language guidance and examples about
how the individual exemption might
apply in the context of employersponsored insurance. Here is one such
example. An employee is enrolled in
group health coverage through her
employer. The plan is fully insured. If
the employee has sincerely held moral
convictions objecting to her plan
including coverage for contraceptives,
she could raise this with her employer.
If the employer is willing to offer her a
plan that omits contraceptives, the
employer could discuss this with the
insurance agent or issuer. If the issuer
is also willing to offer the employer,
with respect to the employee, a group
health insurance policy that omits
contraceptive coverage, the individual
exemption would make it legal for the
group health insurance issuer to omit
contraceptives for her and her
beneficiaries under her policy, for her
employer to sponsor that plan for her,
and for the issuer to issue such a plan
to the employer, to cover that employee.
This would not affect other employees’
plans—those plans would still be
subject to the Mandate and would
continue to cover contraceptives. But if
either the employer, or the issuer, is not
willing (for whatever reason) to offer a
plan or a policy for that employee that
omits contraceptive coverage, these
rules do not require them to do so. The
employee would have the choice of
staying enrolled in a plan with its
coverage of contraceptives, not enrolling
in that plan, seeking coverage
elsewhere, or seeking employment
elsewhere.
For all these reasons, these rules
adopt the individual exemption
language from the Religious IFC with
changes, to read as follows: ‘‘(b)
Objecting individuals. Guidelines issued
under § 147.130(a)(1)(iv) by the Health
Resources and Services Administration
must not provide for or support the
requirement of coverage or payments for
contraceptive services with respect to
individuals who object as specified in
this paragraph (b), and nothing in
§ 147.130(a)(1)(iv), 26 CFR 54.9815–
2713(a)(1)(iv), or 29 CFR 2590.715–
2713(a)(1)(iv) may be construed to
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prevent a willing health insurance
issuer offering group or individual
health insurance coverage, and as
applicable, a willing plan sponsor of a
group health plan, from offering a
separate policy, certificate or contract of
insurance or a separate group health
plan or benefit package option, to any
group health plan sponsor (with respect
to an individual) or individual, as
applicable, who objects to coverage or
payments for some or all contraceptive
services based on sincerely held moral
convictions. Under this exemption, if an
individual objects to some but not all
contraceptive services, but the issuer,
and as applicable, plan sponsor, are
willing to provide the plan sponsor or
individual, as applicable, with a
separate policy, certificate or contract of
insurance or a separate group health
plan or benefit package option that
omits all contraceptives, and the
individual agrees, then the exemption
applies as if the individual objects to all
contraceptive services.’’
8. Accommodation (45 CFR 147.131, 26
CFR 54.9815–2713A, 29 CFR 2590.715–
2713A)
The previous regulations did not offer
the accommodation process to entities
with moral non-religious objections.
The Religious IFC amended the
accommodation regulations to offer it to
all entities that are exempt on the basis
of religious beliefs under § 147.132, as
an optional process in which such
entities could participate voluntarily.
The Moral IFC did not change that
accommodation process, but inserted
references in it to the new section
§ 147.133, alongside the references to
section § 147.132. These changes made
entities eligible for the voluntary
accommodation process if they are
exempt on the basis of moral
convictions. The references were
inserted in 45 CFR 147.131, 26 CFR
54.9815–2713A, and 29 CFR 2590.715–
2713A.
In these rules, the Departments
finalize, without change, the Moral
IFC’s revisions of 45 CFR 147.131, 26
CFR 54.9815–2713A, and 29 CFR
2590.715–2713A. The operation of the
accommodation process, changes made
in the Religious IFC, and public
comments concerning the
accommodation, are more fully
described in the Religious IFC, and in
the companion final rules concerning
the religious exemptions and
accommodation, published elsewhere in
today’s Federal Register. Those
descriptions are incorporated here by
reference to the extent they apply to
these rules.
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Many commenters supported
extending the accommodation process
to entities with objections based on
moral convictions. Others objected to
doing so, raising arguments parallel to
their objections to creating exemptions
for group health plan sponsors with
moral convictions. For much the same
reasons discussed above concerning
why the Departments find it appropriate
to exempt entities with moral objections
to contraceptive coverage, the
Departments find it appropriate to
extend the optional accommodation
process to these entities. The
Departments observe that, to the extent
such entities wish to use the process, it
will not be an obstacle to contraceptive
coverage, but will instead help deliver
contraceptive coverage to women who
receive health coverage from such
entities while respecting the moral
convictions of the entities. The
Departments are not aware of entities
with non-religious moral convictions
against contraceptive coverage that also
consider the accommodation acceptable
and would opt into it, but we are aware
of a small number of entities with nonreligious moral objections to the
Mandate. The Departments, therefore,
continue to consider it appropriate to
extend the optional accommodation to
such entities in case any wish to use it.
Below, albeit based on very limited
data, the Departments estimate that a
small number of entities with nonreligious moral objections may use the
accommodation process.
9. Definition of Contraceptives for the
Purpose of These Final Rules
The previous regulations did not
define contraceptive services. The
Guidelines issued in 2011 included,
under ‘‘Contraceptive methods and
counseling,’’ ‘‘[a]ll Food and Drug
Administration approved contraceptive
methods, sterilization procedures, and
patient education and counseling for all
women with reproductive capacity.’’
The previous regulations concerning the
exemption and the accommodation used
the terms ‘‘contraceptive services’’ and
‘‘contraceptive coverage’’ as catch-all
terms to encompass all of those
Guidelines requirements. The 2016
update to the Guidelines are similarly
worded. Under ‘‘Contraception,’’ they
include the ‘‘full range of contraceptive
methods for women currently identified
by the U.S. Food and Drug
Administration,’’ ‘‘instruction in
fertility awareness-based methods,’’ and
‘‘[c]ontraceptive care’’ to ‘‘include
contraceptive counseling, initiation of
contraceptive use, and follow-up care
(e.g., management, and evaluation as
well as changes to and removal or
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discontinuation of the contraceptive
method).’’ 70
To more explicitly state that the
expanded exemptions encompass any of
the contraceptive or sterilization
services, items, procedures, or related
patient education or information that
have been required under the
Guidelines, the Moral IFC included a
definition of contraceptive services,
benefits or coverage, at 45 CFR
147.133(c). These rules finalize that
definition without change.
10. Severability
The Departments finalize, without
change, the severability clause set forth
at § 147.133(d).
C. Other Public Comments
1. Items Approved as Contraceptives
But Used To Treat Existing Conditions
Some commenters noted that some
drugs included in the preventive
services contraceptive Mandate can also
be useful for treating certain existing
health conditions, and that women use
them for non-contraceptive purposes.
Certain commenters urged the
Departments to clarify that the final
rules do not permit employers to
exclude from coverage medically
necessary prescription drugs used for
non-preventive services. Some
commenters suggested that moral
objections to the Mandate should not be
permitted in cases where contraceptive
methods are used to treat such existing
medical conditions and not for
preventive purposes, even if those
contraceptive methods can also be used
for contraceptive purposes.
Section 2713(a)(4) only applies to
‘‘preventive’’ care and screenings. The
statute does not allow the Guidelines to
mandate coverage of services provided
solely for a non-preventive use, such as
the treatment of an existing condition.
The Guidelines implementing this
section of the statute are consistent with
that narrow authority. They state
repeatedly that they apply to
‘‘preventive’’ services or care.71 The
requirement in the Guidelines
concerning ‘‘contraception’’ specifies
several times that it encompasses
‘‘contraceptives,’’ that is, medical
products, methods, and services applied
for ‘‘contraceptive’’ uses. The
Guidelines do not require coverage of
care and screenings that are nonpreventive, and the contraception
portion of those Guidelines do not
require coverage of medical products,
70 ‘‘Women’s Preventive Services Guidelines,’’
HRSA (last reviewed Oct. 2017), https://
www.hrsa.gov/womens-guidelines-2016/.
71 Id.
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methods, care, and screenings that are
non-contraceptive in purpose or use.
The Guidelines’ inclusion of
contraceptive services requires coverage
of contraceptive methods as a type of
preventive service only when a drug
that FDA has approved for contraceptive
use is prescribed in whole or in part for
such purpose or intended use. Section
2713(a)(4) does not authorize the
Departments to require coverage of
drugs prescribed exclusively for a noncontraceptive and non-preventive use to
treat an existing condition.72 The extent
to which contraceptives are covered to
treat non-preventive conditions would
be determined by application of the
requirement section 1302(b)(1)(F) of the
ACA to cover prescription drugs (where
applicable), implementing regulations at
45 CFR 156.122, and 156.125, and
plans’ decisions about the basket of
medicines to cover for these conditions.
Some commenters observed that
pharmacy claims do not include a
medical diagnosis code, so that plans
may be unable to discern whether a
drug approved by FDA for contraceptive
uses is actually applied for a preventive
or contraceptive use. Section 2713(a)(4),
however, draws a distinction between
preventive and other kinds of care and
screenings. That subsection does not
authorize the Departments to impose a
coverage mandate of services that are
not at least partly applied for a
preventive use, and the Guidelines
themselves do not require coverage of
care unless it is contraceptive in
purpose. These rules do not prohibit
issuers from covering drugs and devices
that are approved for contraceptive uses
even when those drugs and devices are
72 The Departments previously cited the IOM’s
listing of existing conditions that contraceptive
drugs can be used to treat (menstrual disorders,
acne, and pelvic pain), and said of those uses that
‘‘there are demonstrated preventive health benefits
from contraceptives relating to conditions other
than pregnancy.’’ 77 FR 8727 & n.7. This was not,
however, an assertion that section 2713(a)(4) or the
Guidelines require coverage of ‘‘contraceptive’’
methods when prescribed for an exclusively noncontraceptive, non-preventive use. Instead, it was
an observation that such drugs—generally referred
to as ‘‘contraceptives’’—also have some alternate
beneficial uses to treat existing conditions. For the
purposes of these final rules, the Departments
clarify here that the previous reference to the
benefits of using contraceptive drugs exclusively for
some non-contraceptive and non-preventive uses to
treat existing conditions did not mean that the
Guidelines require coverage of such uses, and
consequently is not a reason to refrain from offering
the exemptions provided here. Where a drug
approved by the FDA for contraceptive use is
prescribed for both a contraceptive use and a noncontraceptive use, the Guidelines (to the extent they
apply) would require its coverage. Where a drug
approved by the FDA for contraceptive use is
prescribed exclusively for a non-contraceptive and
non-preventive use to treat an existing condition, it
would be outside the scope of the Guidelines and
the contraceptive Mandate.
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prescribed for non-preventive, noncontraceptive purposes. As discussed
above, these final rules do not purport
to delineate the items HRSA will
include in the Guidelines, but only
concern expanded exemptions and
accommodations that apply if the
Guidelines require contraceptive
coverage. Therefore, the Departments do
not consider it appropriate to specify in
these final rules that, under section
2713(a)(4), exempt organizations must
provide coverage for drugs or items
prescribed exclusively for a noncontraceptive and non-preventive use to
treat an existing condition.
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2. Comments Concerning Regulatory
Impact
Some commenters agreed with the
Departments’ statement in the Moral IFC
that the moral exemptions are likely to
affect only a very small number of
women otherwise receiving coverage
under the Mandate. Other commenters
disagreed, stating that the exemptions
could take contraceptive coverage away
from many or most women. Still others
opposed establishing the exemptions,
but contended that accurately
determining the number of women
affected by the exemptions is not
possible. Public comments included
various statements that these
exemptions would impact coverage for
a large number of women, while others
stated they would affect only a very
small number. But few, if any, public
commenters provided data predicting a
precise number of entities that would
make use of the exemptions for moral
convictions nor a precise number of
employees that would potentially be
affected.
After reviewing the public comments,
the Departments do not find the
suggestions of commenters who
predicted a very large impact any more
reliable than the estimates set forth in
the Religious and Moral IFCs. Therefore,
the Departments conclude that the
estimates of regulatory impact made in
the Religious and Moral IFCs are still
the best estimates available. The
Departments’ estimates are discussed in
more detail in the following section.
III. Economic Impact and Paperwork
Burden
The Departments have examined the
impacts of these final rules as required
by Executive Order 12866 on Regulatory
Planning and Review (September 30,
1993), Executive Order 13563 on
Improving Regulation and Regulatory
Review (January 18, 2011), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354,
section1102(b) of the Social Security
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Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March
22, 1995; Pub. L. 104–4), Executive
Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5
U.S.C. 804(2)) and Executive Order
13771 on Reducing Regulation and
Controlling Regulatory Costs (January
30, 2017).
A. Executive Orders 12866 and 13563—
Department of HHS and Department of
Labor
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, and public health and
safety effects; distributive impacts; and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility.
Section 3(f) of Executive Order 12866
defines a ‘‘significant regulatory action’’
as an action that is likely to result in a
regulation: (1) Having an annual effect
on the economy of $100 million or more
in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local, or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis must be
prepared for major rules with
economically significant effects ($100
million or more in any 1 year), and an
‘‘economically significant’’ regulatory
action is subject to review by OMB. As
discussed below regarding their
anticipated effects, the these final rules
are not likely to have economic impacts
of $100 million or more in any one year,
and therefore do not meet the definition
of ‘‘economically significant’’ under
Executive Order 12866. However, OMB
has determined that the actions are
significant within the meaning of
section 3(f)(4) of the Executive Order.
Therefore, OMB has reviewed these
final rules and the Departments have
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provided the following assessment of
their impact.
1. Need for Regulatory Action
The Religious IFC amended the
Departments’ July 2015 final
regulations. The Moral IFC amended
those regulations further, and added an
additional rule at 45 CFR part 147.133.
These final rules adopt as final, and
further amend, the amendments made
by the Moral IFC. The Departments do
so in conjunction with the amendments
made in the companion final rules
concerning religious beliefs published
elsewhere in today’s Federal Register.
These rules provide an exemption from
the requirement to provide coverage for
contraceptives and sterilization,
established under the HRSA Guidelines,
promulgated under section 2713(a)(4),
section 715(a)(1) of the ERISA, and
section 9815(a)(1) of the Code, for
certain entities and individuals with
objections to compliance with the
Mandate based on sincerely held moral
convictions, and they revise the
accommodation process by making the
accommodation applicable to
organizations with such convictions as
an option. The exemption applies to
certain individuals, nonprofit entities,
institutions of higher education, issuers,
and for-profit entities that do not have
publicly traded ownership interests,
that have a moral objection to some (or
all) of the contraceptive and/or
sterilization services covered by the
Guidelines. Such action has been taken
to provide for participation in the health
insurance market by certain entities or
individuals in a manner free from
penalties for violating sincerely held
moral convictions opposed to providing
or receiving coverage of contraceptive
services, to ensure the preventive
services coverage requirement is
implemented in a way consistent with
longstanding federal conscience
statutes, to prevent lawsuits of the kind
that were filed against the Departments
when the expanded exemption in these
final rules was not offered, and for the
other reasons discussed above.
2. Anticipated Effects
The Departments acknowledge that
expanding the exemption to include
objections based on moral convictions
might result in less insurance coverage
of contraception for some women who
may want the coverage. Although the
Departments do not know the exact
scope of that effect attributable to the
moral exemption in these final rules, we
believe it to be small.
With respect to the exemption for
nonprofit organizations with objections
based on moral convictions, as noted
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above, the Departments are aware of two
small nonprofit organizations that have
filed lawsuits raising non-religious
moral objections to coverage of some
contraceptives. Both of those entities
have fewer than five employees enrolled
in health coverage, and both require all
of their employees to agree with their
opposition to the nature of certain
contraceptives subject to coverage under
the Mandate.73 One of them has
obtained a permanent injunction against
any regulations implementing the
contraceptive Mandate, and so will not
be affected by these final rules. Based on
comments submitted in response to
rulemakings prior to the Moral and
Religious IFCs, the Departments believe
that at least one other similar entity
exists.74 However, the Departments do
not know how many similar entities
exist and are currently unable to
estimate the number of such entities.
Lacking other information, we assume
that the number is small. The
Departments estimate it to be less than
10 and assume the exemption will be
used by nine nonprofit entities.
The Departments also assume that
those nine entities will operate in a
fashion similar to the two similar
entities of which we are aware, so that
their employees will likely share their
views against coverage of certain
contraceptives. This is consistent with
the conclusion in previous regulations
that no significant burden or costs
would result from exempting houses of
worship and integrated auxiliaries. (See
76 FR 46625 and 78 FR 39889). The
Departments reached that conclusion
without ultimately requiring that houses
of worship and integrated auxiliaries
only hire persons who agree with their
views against contraception and without
requiring that such entities actually
oppose contraception in order to be
exempt (in contrast, the exemption here
requires the exempt entity to actually
possess sincerely held moral
convictions objecting to contraceptive
coverage). In concluding that the
exemption for houses of worship and
integrated auxiliaries would result in no
significant burden or costs, the
73 Non-religious nonprofit organizations that
engage in expressive activity generally have a First
Amendment right to hire only people who share
their moral convictions or will be respectful of
them—including their convictions on whether the
organization or others provide health coverage of
contraception, or of certain items they view as being
abortifacient.
74 See, for example, Americans United for Life
(‘‘AUL’’) Comment on CMA-9992-IFC2 at 10 (Nov.
1, 2011), available at https://www.regulations.gov/
#!documentDetail;D=HHS-OS-2011-0023-59496,
and AUL Comment on CMS-9968-P at 5 (Apr. 8,
2013), available at https://www.regulations.gov/
#!documentDetail;D=CMS-2012-0031-79115.
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Departments relied on the assumption
that the employees of exempt houses of
worship and integrated auxiliaries likely
share their employers’ opposition to
contraceptive coverage.
A similar assumption is appropriate
with respect to the expanded exemption
for nonprofit organizations with
objections based on moral convictions.
To the knowledge of the Departments,
the vast majority of organizations
objecting to the Mandate assert
objections based on religious beliefs.
The only nonprofit organizations of
which they are aware that possess nonreligious moral convictions against
some or all contraceptive methods only
hire persons who share their
convictions. It is possible that the
exemption for nonprofit organizations
with moral convictions in these final
rules could be used by a nonprofit
organization that employs persons who
do not share the organization’s views on
contraception, but it was also possible
under the Departments’ previous
regulations that a house of worship or
integrated auxiliary could employ
persons who do not share their views on
contraception.75 Although the
Departments are unable to find
sufficient data on this issue, we believe
that there are far fewer nonprofit
organizations opposed to contraceptive
coverage on the basis of moral
convictions than there are houses of
worship or integrated auxiliaries with
religious objections to such coverage.
Based on the limited data available, the
Departments believe the most likely
effect of the expanded exemption for
nonprofit entities is that it will be used
by entities similar to the two entities
that have sought an exemption through
litigation, and whose employees also
oppose certain contraceptive coverage.
Therefore, the Departments expect that
the moral exemption for nonprofit
entities will have a minimal effect of
reducing contraceptive coverage with
respect to employees who want such
coverage.
These rules extend the exemption to
include institutions of higher education
that arrange student coverage and have
non-religious moral objections to the
Mandate, and make exempt entities
with moral objections eligible to avail
themselves of the accommodation. The
Departments are not aware of any
institutions of higher education with
this kind of non-religious moral
75 Cf., for example, Frank Newport, ‘‘Americans,
Including Catholics, Say Birth Control Is Morally
OK,’’ Gallup, (May 22, 2012), https://
www.gallup.com/poll/154799/americans-includingcatholics-say-birth-control-morally.aspx (‘‘Eightytwo percent of U.S. Catholics say birth control is
morally acceptable’’).
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convictions. Moreover, the Departments
believe the overall number of entities
that would object to the Mandate based
on non-religious moral convictions is
already very small. The only entities of
which we are aware that have raised
such objections are not institutions of
higher education. Public comments did
not reveal the existence of any
institutions of higher education with
such moral convictions. Therefore, for
the purposes of estimating the
anticipated effect of these final rules on
contraceptive coverage of women who
wish to receive such coverage, the
Departments assume that—at this
time—no entities with non-religious
moral objections to the Mandate will be
institutions of higher education that
arrange student coverage, and no other
entities with non-religious moral
objections will opt into the
accommodation. We wish to make the
expanded exemption and
accommodation available to such
entities in case they do exist or might
come into existence, based on reasons
similar to those given above for why the
exemptions and accommodations are
extended to other entities.
The Departments believe that the
exemption for issuers with objections
based on moral convictions will not
result in a distinct effect on
contraceptive coverage for women who
wish to receive it, because that
exemption only applies in cases where
plan sponsors or individuals are also
otherwise exempt, and the effect of
those exemptions is discussed
elsewhere herein, or in the companion
final rules concerning religious beliefs
published elsewhere in today’s Federal
Register. The exemption for individuals
that oppose contraceptive coverage
based on sincerely held moral
convictions will provide coverage that
omits contraception for individuals that
object to contraceptive coverage.
The moral exemption will also cover
for-profit entities that do not have
publicly traded ownership interests and
that have non-religious moral objections
to the Mandate, if such entities exist.
Some commenters agreed that the
impact of these final rules would be no
more than the Departments estimated in
the Moral IFC, and some commenters
stated the impact would be much
smaller. Other commenters disagreed,
suggesting that the expanded
exemptions risked removing
contraceptive coverage from more than
55 million women receiving the benefits
of the preventive services Guidelines, or
even risked removing contraceptive
coverage from over 100 million women.
Some commenters cited studies
indicating that, nationally, unintended
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pregnancies have large public costs, and
the Mandate overall led to large out-ofpocket savings for women. These
general comments did not, however,
substantially assist the Departments in
estimating the number of women that
would potentially be affected by these
exemptions for moral convictions
specifically, or among them, how many
unintended pregnancies would result,
how many of the affected women would
nevertheless use contraceptives not
covered under the health plans of their
objecting employers and, thus, be
subject to the estimated transfer costs, or
instead, how many women might avoid
unintended pregnancies by changing
their activities in other ways besides
using contraceptives.
Some of the comments opposing these
exemptions assert that they will lead to
a large number of entities dropping
contraceptive coverage. The
Departments disagree; they are aware of
only two entities that hold non-religious
moral convictions against contraceptive
coverage. Both only hire employees that
share their beliefs, and one will not be
affected by these final rules because it
is protected by an injunction from any
regulations implementing the
contraceptive Mandate. Commenters
cited no other specific entities that
might assert these moral convictions,
and did not provide better data to
estimate how many entities might exist.
Likewise, the Departments find it
unlikely that any of the vast majority of
entities that covered contraceptives
before this Mandate was announced in
2011 would terminate such coverage
because of these exemptions based on
moral convictions. The Departments
also find it unlikely that a significant
number of for-profit entities, whose
plans include a significant number of
women, omitted contraceptive coverage
before the ACA on the basis of
objections grounded in non-religious
moral convictions, and would claim an
exemption under these final rules. No
such entities, or data concerning such
entities, were identified by public
commenters, nor are the Departments
aware of any involved in litigation over
the Mandate.
Numerous for-profit entities claiming
religious objections have filed suit
challenging the Mandate. Among the
over 200 entities that brought legal
challenges, only two entities (less than
1 percent) raised non-religious moral
objections—and both were nonprofit
organizations. Among the general
public, polls vary about religious
beliefs, but one prominent poll shows
that 89 percent of Americans say they
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believe in God.76 Among non-religious
persons, only a very small percentage of
the population appears to hold moral
objections to contraception. A recent
study found that only 2 percent of
religiously unaffiliated persons believed
using contraceptives is morally wrong.77
Combined, this suggests that 0.2 percent
of Americans at most 78 might believe
contraceptives are morally wrong based
on moral convictions but not religious
beliefs. The Departments have no
information about how many of those
persons run closely held businesses,
offer employer sponsored health
insurance, and would make use of the
expanded exemption for moral
convictions set forth in these final rules.
Given the large number of closely held
entities that challenged the Mandate
based on religious objections, the
Departments assume that some similar
for-profit entities with non-religious
moral objections exist. But the
Departments expect that it will be a
comparatively small number of entities,
since among the nonprofit litigants, only
two were non-religious. Without data
available to estimate the actual number
of entities that will make use of the
expanded exemption for for-profit
entities without publicly traded
ownership interests and with sincere
moral objections to the Mandate, the
Departments expect that fewer than 10
entities, if any, will do so—so the
Departments assume nine for-profit
entities will use the exemption in these
final rules.
The moral exemption encompassing
certain for-profit entities could result in
the removal of contraceptive coverage
from women who do not share their
employers’ views. The Departments
used data from the Current Population
Survey (CPS) and the Medical
Expenditure Panel Survey-Insurance
Component (MEPS–IC) to obtain an
estimate of the number of policyholders
that will be covered by the plans of the
nine for-profit entities we assume may
make use of these expanded
exemptions.79 The average number of
76 Frank Newport, ‘‘Most Americans Still Believe
in God,’’ Gallup (June 29, 2016), https://
www.gallup.com/poll/193271/americans-believegod.aspx.
77 Pew Research Center, ‘‘Where the Public
Stands on Religious Liberty vs.
Nondiscrimination,’’ Pew Research Center, 26
(Sept. 28, 2016), https://assets.pewresearch.org/wpcontent/uploads/sites/11/2016/09/ReligiousLiberty-full-for-web.pdf.
78 The study defined religiously ‘‘unaffiliated’’ as
agnostic, atheist or ‘‘nothing in particular’’, id. at 8,
as distinct from several versions of Protestants, or
Catholics. ‘‘Nothing in particular’’ might have
included some theists.
79 ‘‘Health Insurance Coverage Bulletin,’’ Dept. of
Labor (June 28, 2016), Table 4, page 21. Using
March 2015 Annual Social and Economic
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57627
policyholders (9) in plans with under
100 employees was obtained. It is not
known how many employees would be
employed by the for-profit employers
that might claim this exemption, but as
discussed above these final rules do not
include publicly traded companies, and
both of the two nonprofit entities that
challenged the Mandate based on moral
objections included fewer than five
policyholders in their group plans.
Therefore, the Departments assume that
the for-profit entities that may claim this
expanded exemption will have fewer
than 100 employees and an average of
9 policyholders. For 9 entities, the total
number of policyholders would be
approximately 81. DOL estimates that
for each policyholder, there is
approximately one dependent.80 This
amounts to approximately 162 covered
persons. Census data indicate that
women of childbearing age, i.e., women
aged 15 to 44, comprise 20.2 percent of
the general population.81 This amounts
to approximately 33 women of
childbearing age for this group of
individuals covered by group plans
sponsored by for-profit moral objectors.
Approximately 44.3 percent of women
currently use contraceptives covered by
the Guidelines.82 Thus, the Departments
estimate that approximately 15 women
may incur contraceptive costs due to
for-profit entities using the expanded
moral exemption provided for in these
final rules.83 In the companion final
Supplement to the Current Population Survey.
https://www.dol.gov/sites/default/files/ebsa/
researchers/data/health-and-welfare/healthinsurance-coverage-bulletin-2015.pdf. Estimates of
the number of ERISA Plans based on 2015 Medical
Expenditure Survey—Insurance.
80 ‘‘Health Insurance Coverage Bulletin’’ Dept. of
Labor’’ (June 28, 2016), Table 4, page 21. Using
March 2015 Annual Social and Economic
Supplement to the Current Population Survey.
https://www.dol.gov/sites/default/files/ebsa/
researchers/data/health-and-welfare/healthinsurance-coverage-bulletin-2015.pdf.
81 U.S. Census Bureau, ‘‘Age and Sex
Composition: 2010’’ (May 2011), available at
https://www.census.gov/prod/cen2010/briefs/
c2010br-03.pdf. The Guidelines’ requirement of
contraceptive coverage only applies ‘‘for all women
with reproductive capacity.’’ Women’s Preventive
Services Guidelines, HRSA (last reviewed Oct.
2017), https://www.hrsa.gov/womensguidelines/;
see also 80 FR 40318. In addition, studies
commonly consider the 15–44 age range to assess
contraceptive use by women of childbearing age.
See, e.g., ‘‘Contraceptive Use in the United States,’’
The Guttmacher Institute (Sept. 2016), https://
www.guttmacher.org/fact-sheet/contraceptive-useunited-states.
82 See ‘‘Contraceptive Use in the United States,’’
The Guttmacher Institute (Sept. 2016), https://
www.guttmacher.org/fact-sheet/contraceptive-useunited-states.
83 The Departments note that many non-religious
for-profit entities which sued the Departments
challenging the Mandate, including some of the
largest employers, only objected to coverage of 4 of
the 18 types of contraceptives required to be
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rules concerning religious beliefs issued
contemporaneously with these final
rules and published elsewhere in
today’s Federal Register, we estimate
that the average cost of contraception
per year per woman of childbearing age
that use contraception covered by the
Guidelines, in health plans that cover
contraception, is $584. Consequently,
the Departments estimate that the
anticipated effects attributable to the
cost of contraception from for-profit
entities using the expanded moral
exemption in these final rules is
approximately $8,760.
The Departments estimate that these
final rules will not result in any
additional burden or costs on issuers or
third party administrators. As discussed
above, we assume that no entities with
non-religious moral convictions will
avail themselves of the accommodation,
although the Departments wish to make
it available in case an entity voluntarily
opts into it in order to allow
contraceptive coverage to be provided to
its plan participants and beneficiaries.
While these final rules make it legal for
issuers to offer insurance coverage that
omits contraceptives to/for exempt
entities and individuals, these final
rules do not require issuers to do so.
Finally, because the accommodation
process was not previously available to
entities that possess non-religious moral
objections to the Mandate, the
Departments do not anticipate that these
final rules will result in any burden
from such entities acting to revoke their
accommodated status.
The Departments believe the
foregoing analysis represents a
reasonable estimate of the likely impact
under the exemptions finalized in these
final rules. The Departments
acknowledge uncertainty in the estimate
and, therefore, conducted a second
analysis using an alternative framework,
which is set forth in the companion
final rules concerning religious beliefs
issued contemporaneously with these
final rules and published elsewhere in
today’s Federal Register, with reference
to the analysis conducted in the
Religious IFC. Under either estimate,
these final rules are not deemed to be
economically significant.
covered by the Mandate—namely, those
contraceptives which they viewed as abortifacients,
and akin to abortion —and they were willing to
provide coverage for other types of contraception.
It is reasonable to assume that this would also be
the case with respect to some for-profits that object
to the Mandate on the basis of sincerely held moral
convictions. Accordingly, it is possible that even
fewer women beneficiaries under such plans would
bear out-of-pocket expenses in order to obtain
contraceptives, and that those who might do so
would bear lower costs due to many contraceptive
items being covered.
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The Departments reiterate the
rareness of instances in which we are
aware that employers assert nonreligious objections to contraceptive
coverage based on sincerely held moral
convictions, as discussed above, and
also that in the few instances where
such an objection has been raised,
employees of such employers also
opposed contraception.
B. Special Analyses—Department of the
Treasury
These regulations are not subject to
review under section 6(b) of Executive
Order 12866 pursuant to the
Memorandum of Agreement (April 11,
2018) between the Department of the
Treasury and the Office of Management
and Budget regarding review of tax
regulations.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) imposes certain
requirements with respect to federal
regulations that are subject to the notice
and comment requirements of section
553(b) of the APA (5 U.S.C. 551 et seq.)
and that are likely to have a significant
economic impact on a substantial
number of small entities. Under section
553(b) of the APA, a general notice of
proposed rulemaking is not required
when an agency, for good cause, finds
that notice and public comment thereon
are impracticable, unnecessary, or
contrary to the public interest. The
Moral IFC was a set of interim final
rules with comment, and in these final
rules, the Departments finalize the
Moral IFC with certain changes based
on public comments. The Moral IFC was
exempt from the notice and comment
requirements of the APA, both because
the PHS Act, ERISA, and the Code
contain specific provisions under which
the Secretaries may adopt regulations by
interim final rule and because the
Departments have made a good cause
finding that a general notice of proposed
rulemaking is not necessary earlier in
this preamble. Therefore, the RFA did
not apply to the Moral IFC. These final
rules are, however, issued after a notice
and comment period.
The Departments carefully considered
the likely impact of the rules on small
entities in connection with their
assessment under Executive Order
12866. The Departments do not expect
that these final rules will have a
significant economic effect on a
substantial number of small entities,
because they will not result in any
additional costs to affected entities.
Instead, by exempting from the Mandate
small businesses and nonprofit
organizations with moral objections to
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some or all contraceptives and/or
sterilization—businesses and
organizations which would otherwise be
faced with the dilemma of complying
with the Mandate (and violating their
moral convictions), or of following their
moral convictions and incurring
potentially significant financial
penalties for noncompliance—the
Departments have reduced regulatory
burden on small entities. Pursuant to
section 7805(f) of the Code, the notice
of proposed rulemaking preceding these
regulations was submitted to the Chief
Counsel for Advocacy of the Small
Business Administration for comment
on their impact on small business.
D. Paperwork Reduction Act—
Department of Health and Human
Services
Under the Paperwork Reduction Act
of 1995 (the PRA), federal agencies are
required to publish notice in the
Federal Register and solicit public
comment before a collection of
information is submitted to the Office of
Management and Budget (OMB) for
review and approval. Interested persons
are invited to send comments regarding
our burden estimates or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
The Departments estimate that these
final rules will not result in additional
burdens not accounted for as set forth in
companion final rules concerning
religious beliefs issued
contemporaneously with these final
rules and published elsewhere in
today’s Federal Register. As discussed
there, rules covering the
accommodation include provisions
regarding self-certification or notices to
HHS from eligible organizations
(§ 147.131(c)(3)), notice of availability of
separate payments for contraceptive
services (§ 147.131(e)), and notice of
revocation of accommodation
(§ 147.131(c)(4)). The burden related to
these information collection
requirements (ICRs) received emergency
review and approval under OMB
Control Number 0938–1344. They have
been resubmitted to OMB in
conjunction with this final rule and are
pending re-approval.
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As discussed above, however, the
Departments assume that no entities
with non-religious moral objections to
the Mandate will use the
accommodation. The Departments know
that no such entities were eligible for it
until now, so that no entity possesses an
accommodated status that would need
to be revoked. Therefore, the
Departments believe that the burden for
these ICRs is accounted for in the
collection approved under OMB Control
Numbers 0938–1344, as described in the
final rules concerning religious beliefs
issued contemporaneously with these
final rules.
E. Paperwork Reduction Act—
Department of Labor
Under the Paperwork Reduction Act,
an agency may not conduct or sponsor,
and an individual is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. In accordance with the
requirements of the PRA, the ICR for the
EBSA Form 700 and alternative notice
have previously been approved by OMB
under control numbers 1210–0150 and
1210–0152. In an effort to consolidate
the number of information collections
the Department is combining OMB
control numbers 1210–0150 and 1210–
0152 under OMB control number 1210–
0150 and discontinuing OMB control
number 1210–0152.
A copy of the ICR may be obtained by
contacting the PRA addressee shown
below or at https://www.RegInfo.gov.
PRA ADDRESSEE: G. Christopher
Cosby, Office of Policy and Research,
U.S. Department of Labor, Employee
Benefits Security Administration, 200
Constitution Avenue NW, Room N–
5718, Washington, DC 20210.
Telephone: (202) 693–8410; Fax: (202)
219–4745. These are not toll-free
numbers.
Consistent with the analysis in the
HHS PRA section above, although these
final rules make entities with certain
moral convictions eligible for the
accommodation, the Department
assumes (1) that no entities will use the
accommodation rather than the
exemption, and (2) entities using the
moral exemption would not have to
revoke an accommodation, because they
previously were not eligible for it.
Therefore, the Department believes
these final rules do not involve
additional burden not accounted for
under OMB control number 1210–0150,
which is published elsewhere in today’s
issue of the Federal Register in
connection with the companion
Religious Exemption and
Accommodation Preventive Health
Service final rule. The Department will
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publish a notice informing the public of
OMB’s action with respect to the
Department’s submission of the ICRs
under OMB control number 1210–0150.
F. Regulatory Reform Executive Orders
13765, 13771 and 13777
Executive Order 13765 (January 20,
2017) directs that, ‘‘[t]o the maximum
extent permitted by law, the Secretary of
Health and Human Services (Secretary)
and the heads of all other executive
departments and agencies (agencies)
with authorities and responsibilities
under the [Affordable Care] Act shall
exercise all authority and discretion
available to them to waive, defer, grant
exemptions from, or delay the
implementation of any provision or
requirement of the Act that would
impose a fiscal burden on any state or
a cost, fee, tax, penalty, or regulatory
burden on individuals, families,
healthcare providers, health insurers,
patients, recipients of healthcare
services, purchasers of health insurance,
or makers of medical devices, products,
or medications.’’ In addition, agencies
are directed to ‘‘take all actions
consistent with law to minimize the
unwarranted economic and regulatory
burdens of the [Affordable Care Act],
and prepare to afford the States more
flexibility and control to create a more
free and open healthcare market.’’ The
Moral IFC and these final rules exercise
the discretion provided to the
Departments under the Affordable Care
Act and other laws to grant exemptions
and thereby minimize regulatory
burdens of the Affordable Care Act on
the affected entities and recipients of
health care services.
Consistent with Executive Order
13771 (82 FR 9339, February 3, 2017),
the Departments have estimated the
costs and cost savings attributable to
these rules. As discussed in more detail
in the preceding analysis, these final
rules lessen incremental reporting
costs.84 However, in order to avoid
84 Other noteworthy potential impacts encompass
potential changes in medical expenditures,
including potential decreased expenditures on
contraceptive devices and drugs and potential
increased expenditures on pregnancy-related
medical services. OMB’s guidance on E.O. 13771
implementation (https://www.whitehouse.gov/thepress-office/2017/04/05/memorandumimplementing-executive-order-13771-titledreducing-regulation) states that impacts should be
categorized as consistently as possible within
Departments. The Food and Drug Administration,
within HHS, and the Occupational Safety and
Health Administration (OSHA) and Mine Safety
and Health Administration (MSHA), within DOL,
regularly estimate medical expenditure impacts in
the analyses that accompany their regulations, with
the results being categorized as benefits (positive
benefits if expenditures are reduced, negative
benefits if expenditures are raised). Following the
FDA, OSHA and MSHA accounting convention
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57629
double-counting with the Moral IFC,
which has already been tallied as an
E.O. 13771 deregulatory action, this
finalization of the IFC’s policy is not
considered a deregulatory action under
the Executive Order.
G. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (section 202(a) (Pub. L. 104–4),
requires the Departments to prepare a
written statement, which includes an
assessment of anticipated costs and
benefits, before issuing ‘‘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 million
or more (adjusted annually for inflation)
in any 1 year.’’ In 2018, that threshold
is approximately $150 million. For
purposes of the Unfunded Mandates
Reform Act, the Moral IFC and these
final rules do not include any federal
mandate that may result in expenditures
by state, local, or tribal governments,
nor do they include any federal
mandates that may impose an annual
burden of $150 million or more on the
private sector.
H. Federalism
Executive Order 13132 outlines
fundamental principles of federalism,
and requires the adherence to specific
criteria by federal agencies in the
process of their formulation and
implementation of policies that have
‘‘substantial direct effects’’ on states, the
relationship between the federal
government and states, or the
distribution of power and
responsibilities among the various
levels of government. Federal agencies
promulgating regulations that have
these federalism implications must
consult with state and local officials,
and describe the extent of their
consultation and the nature of the
concerns of state and local officials in
the preamble to the regulation.
These rules do not have any
Federalism implications, since they
only provide exemptions from the
contraceptive and sterilization coverage
requirement in HRSA Guidelines
supplied under section 2713 of the PHS
Act.
IV. Statutory Authority
The Department of the Treasury
regulations are adopted pursuant to the
authority contained in sections 7805
and 9833 of the Code.
leads to these final rules’ medical expenditure
impacts being categorized as (positive or negative)
benefits, rather than as costs, thus placing them
outside of consideration for E.O. 13771 designation
purposes.
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The Department of Labor regulations
are adopted pursuant to the authority
contained in 29 U.S.C. 1002(16), 1027,
1059, 1135, 1161–1168, 1169, 1181–
1183, 1181 note, 1185, 1185a, 1185b,
1185d, 1191, 1191a, 1191b, and 1191c;
sec. 101(g), Public Law 104–191, 110
Stat. 1936; sec. 401(b), Public Law 105–
200, 112 Stat. 645 (42 U.S.C. 651 note);
sec. 512(d), Public Law 110–343, 122
Stat. 3881; sec. 1001, 1201, and 1562(e),
Public Law 111–148, 124 Stat. 119, as
amended by Public Law 111–152, 124
Stat. 1029; Secretary of Labor’s Order 1–
2011, 77 FR 1088 (Jan. 9, 2012).
The Department of Health and Human
Services regulations are adopted
pursuant to the authority contained in
sections 2701 through 2763, 2791, and
2792 of the PHS Act (42 U.S.C. 300gg
through 300gg–63, 300gg–91, and
300gg–92), as amended; and Title I of
the Affordable Care Act, sections 1301–
1304, 1311–1312, 1321–1322, 1324,
1334, 1342–1343, 1401–1402, and 1412,
Public Law 111–148, 124 Stat. 119 (42
U.S.C. 18021–18024, 18031–18032,
18041–18042, 18044, 18054, 18061,
18063, 18071, 18082, 26 U.S.C. 36B, and
31 U.S.C. 9701).
Dated: October 17, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: October 18, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
List of Subjects
§ 54.9815–2713A
26 CFR Part 54
■
Excise taxes, Health care, Health
insurance, Pensions, Reporting and
recordkeeping requirements.
29 CFR Part 2590
Continuation coverage, Disclosure,
Employee benefit plans, Group health
plans, Health care, Health insurance,
Medical child support, Reporting and
recordkeeping requirements.
45 CFR Part 147
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Health care, Health insurance,
Reporting and recordkeeping
requirements, State regulation of health
insurance.
Kirsten Wielobob,
Deputy Commissioner for Services and
Enforcement.
Approved: October 30, 2018.
David J. Kautter,
Assistant Secretary for Tax Policy.
Signed this 29th day of October, 2018.
Preston Rutledge,
Assistant Secretary, Employee Benefits
Security Administration, Department of
Labor.
VerDate Sep<11>2014
18:53 Nov 14, 2018
Jkt 247001
DEPARTMENT OF THE TREASURY
Internal Revenue Service
For the reasons set forth in this
preamble, 26 CFR part 54 is amended as
follows:
PART 54—PENSION EXCISE TAXES
1. The authority citation for part 54
continues to read, in part, as follows:
■
Authority: 26 U.S.C. 7805. * * *
§ 54.9815–2713
[Amended]
2. Section 54.9815–2713, as amended
elsewhere in this issue of the Federal
Register, is further amended in
paragraph (a)(1)(iv) by removing the
reference ‘‘147.131 and 147.132’’ and
adding in its place the reference
‘‘147.131, 147.132, and 147.133’’.
■
[Amended]
3. Section 54.9815–2713A, as
amended elsewhere in this issue of the
Federal Register, is further amended—
■ a. In paragraph (a)(1) by removing ‘‘or
(ii)’’ and adding in its place ‘‘or (ii), or
45 CFR 147.133(a)(1)(i) or (ii)’’;
■ b. In paragraph (a)(2) by removing the
reference ‘‘147.132(a)’’ and adding in its
place the reference ‘‘147.132(a) or
147.133(a)’’;
■ c. In paragraph (b)(1)(ii) introductory
text by removing the reference
‘‘147.132’’ and adding in its place the
reference ‘‘147.132 or 147.133’’;
■ d. In paragraph (b)(1)(ii)(B) by
removing the reference ‘‘147.132’’ and
adding in its place the reference
‘‘147.132 or 147.133’’;
■ e. In paragraph (c)(1)(ii) introductory
text by removing the reference
‘‘147.132’’ and adding in its place the
reference ‘‘147.132 or 147.133’’;
■ f. In paragraph (c)(1)(ii)(B) by
removing the reference ‘‘147.132’’ and
adding in its place the reference
‘‘147.132 or 147.133’’; and
■ g. In paragraph (c)(2) by removing the
reference ‘‘147.132’’ and adding in its
place the reference ‘‘147.132 or
147.133’’.
PO 00000
Frm 00040
Fmt 4701
Sfmt 4700
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
PART 2590—RULES AND
REGULATIONS FOR GROUP HEALTH
PLANS
For the reasons set forth in the
preamble, the Department of Labor
adopts, as final, the interim final rules
amending 29 CFR part 2590, published
October 13, 2017 (82 FR 47838), without
change.
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
For the reasons set forth in the
preamble, the Department of Health and
Human Services adopts as final the
interim final rules amending 45 CFR
part 147 published on October 13, 2017
(82 FR 47838) with the following
changes:
■
PART 147—HEALTH INSURANCE
REFORM REQUIREMENTS FOR THE
GROUP AND INDIVIDUAL HEALTH
INSURANCE MARKETS
4. The authority citation for part 147,
as revised elsewhere in this issue of the
Federal Register, continues to read as
follows:
■
Authority: 42 U.S.C. 300gg through 300gg–
63, 300gg–91, and 300gg–92, as amended.
5. Section 147.133 is amended by
revising paragraph (a)(1) introductory
text, (a)(1)(ii), (a)(2), and (b) to read as
follow:
■
§ 147.133 Moral exemptions in connection
with coverage of certain preventive health
services.
(a) * * *
(1) Guidelines issued under
§ 147.130(a)(1)(iv) by the Health
Resources and Services Administration
must not provide for or support the
requirement of coverage or payments for
contraceptive services with respect to a
group health plan established or
maintained by an objecting
organization, or health insurance
coverage offered or arranged by an
objecting organization, to the extent of
the objections specified below. Thus the
Health Resources and Service
Administration will exempt from any
guidelines’ requirements that relate to
the provision of contraceptive services:
*
*
*
*
*
(ii) An institution of higher education
as defined in 20 U.S.C. 1002, which is
non-governmental, in its arrangement of
student health insurance coverage, to
the extent that institution objects as
specified in paragraph (a)(2) of this
section. In the case of student health
E:\FR\FM\15NOR3.SGM
15NOR3
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Rules and Regulations
khammond on DSK30JT082PROD with RULES3
insurance coverage, this section is
applicable in a manner comparable to
its applicability to group health
insurance coverage provided in
connection with a group health plan
established or maintained by a plan
sponsor that is an employer, and
references to ‘‘plan participants and
beneficiaries’’ will be interpreted as
references to student enrollees and their
covered dependents; and
*
*
*
*
*
(2) The exemption of this paragraph
(a) will apply to the extent that an entity
described in paragraph (a)(1) of this
section objects, based on its sincerely
held moral convictions, to its
establishing, maintaining, providing,
offering, or arranging for (as applicable):
(i) Coverage or payments for some or
all contraceptive services; or
VerDate Sep<11>2014
18:53 Nov 14, 2018
Jkt 247001
(ii) A plan, issuer, or third party
administrator that provides or arranges
such coverage or payments.
(b) Objecting individuals. Guidelines
issued under § 147.130(a)(1)(iv) by the
Health Resources and Services
Administration must not provide for or
support the requirement of coverage or
payments for contraceptive services
with respect to individuals who object
as specified in this paragraph (b), and
nothing in § 147.130(a)(1)(iv), 26 CFR
54.9815–2713(a)(1)(iv), or 29 CFR
2590.715–2713(a)(1)(iv) may be
construed to prevent a willing health
insurance issuer offering group or
individual health insurance coverage,
and as applicable, a willing plan
sponsor of a group health plan, from
offering a separate policy, certificate or
contract of insurance or a separate group
health plan or benefit package option, to
PO 00000
Frm 00041
Fmt 4701
Sfmt 9990
57631
any group health plan sponsor (with
respect to an individual) or individual,
as applicable, who objects to coverage or
payments for some or all contraceptive
services based on sincerely held moral
convictions. Under this exemption, if an
individual objects to some but not all
contraceptive services, but the issuer,
and as applicable, plan sponsor, are
willing to provide the plan sponsor or
individual, as applicable, with a
separate policy, certificate or contract of
insurance or a separate group health
plan or benefit package option that
omits all contraceptives, and the
individual agrees, then the exemption
applies as if the individual objects to all
contraceptive services.
*
*
*
*
*
[FR Doc. 2018–24514 Filed 11–7–18; 4:15 pm]
BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P
E:\FR\FM\15NOR3.SGM
15NOR3
Agencies
[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Rules and Regulations]
[Pages 57592-57631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24514]
[[Page 57591]]
Vol. 83
Thursday,
No. 221
November 15, 2018
Part III
Department of the Treasury
-----------------------------------------------------------------------
Internal Revenue Service
Department of Labor
-----------------------------------------------------------------------
Employee Benefits Security Administration
Department of Health and Human Services
-----------------------------------------------------------------------
26 CFR Part 54
29 CFR Part 2590
45 CFR Part 147
Moral Exemptions and Accommodations for Coverage of Certain Preventive
Services Under the Affordable Care Act; Final Rule
Federal Register / Vol. 83 , No. 221 / Thursday, November 15, 2018 /
Rules and Regulations
[[Page 57592]]
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD-9841]
RIN 1545-BN91
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AB84
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS-9925-F]
RIN 0938-AT46
Moral Exemptions and Accommodations for Coverage of Certain
Preventive Services Under the Affordable Care Act
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; and Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Final rules.
-----------------------------------------------------------------------
SUMMARY: These rules finalize, with changes based on public comments,
the interim final rules issued in the Federal Register on October 13,
2017 concerning moral exemptions and accommodations regarding coverage
of certain preventive services. These rules finalize expanded
exemptions to protect moral beliefs for certain entities and
individuals whose health plans are subject to a mandate of
contraceptive coverage through guidance issued pursuant to the Patient
Protection and Affordable Care Act. These rules do not alter the
discretion of the Health Resources and Services Administration, a
component of the U.S. Department of Health and Human Services, to
maintain the guidelines requiring contraceptive coverage where no
regulatorily recognized objection exists. These rules also leave in
place an optional ``accommodation'' process for certain exempt entities
that wish to use it voluntarily. These rules do not alter multiple
other federal programs that provide free or subsidized contraceptives
for women at risk of unintended pregnancy.
DATES: Effective date: These regulations are effective on January 14,
2019.
FOR FURTHER INFORMATION CONTACT:
Jeff Wu at (301) 492-4305 or [email protected] for the Centers
for Medicare & Medicaid Services (CMS), Department of Health and Human
Services (HHS).
Amber Rivers or Matthew Litton at (202) 693-8335 for Employee Benefits
Security Administration (EBSA), Department of Labor (DOL).
William Fischer at (202) 317-5500 for Internal Revenue Service,
Department of the Treasury.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor concerning employment-based
health coverage laws may call the EBSA Toll-Free Hotline at 1-866-444-
EBSA (3272) or visit DOL's website (www.dol.gov/ebsa). Information from
HHS on private health insurance coverage can be found on CMS's website
(www.cms.gov/cciio), and information on health care reform can be found
at www.HealthCare.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary and Background
A. Executive Summary
1. Purpose
2. Summary of the Major Provisions
3. Summary of Costs, Savings and Benefits of the Major
Provisions
B. Background
II. Overview of the Final Rules and Public Comments
A. Moral Exemptions and Accommodation in General
1. The Departments' Authority to Mandate Coverage or Provide
Exemptions
2. Congress's History of Protecting Moral Convictions
a. The Church Amendments' Protection of Moral Convictions
b. Court Precedents Relevant to These Expanded Exemptions
c. Conscience Protections in Other Federal and State Contexts
d. Founding Principles
e. Executive Orders Relevant to These Expanded Exemptions
f. Litigation Concerning the Mandate
3. Whether Moral Exemptions Should Exist, and Whom They Should
Cover
4. The Departments' Rebalancing of Government Interests
5. Burdens on Third Parties
6. Interim Final Rulemaking
7. Health Effects of Contraception and Pregnancy
8. Health and Equality Effects of Contraceptive Coverage
Mandates
9. Other General Comments
B. Text of the Final Rules
1. Restatement of Statutory Requirements of Section 2713(a) and
(a)(4) of the PHS Act (26 CFR 54.9815-2713(a)(1) and (a)(1)(iv), 29
CFR 2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR 147.130(a)(1) and
(a)(1)(iv)).
2. Exemption for Objecting Entities Based on Moral Convictions
(45 CFR 147.133(a))
3. Exemption for Certain Plan Sponsors (45 CFR 147.133(a)(1)(i))
a. Plan sponsors in general (45 CFR 147.133(a)(1)(i) prefatory
text)
b. Nonprofit organizations (45 CFR 147.133(a)(1)(i)(A))
c. For-Profit Entities (45 CFR 147.133(a)(1)(i)(B))
4. Institutions of Higher Education (45 CFR 147.133(a)(1)(ii))
5. Health Insurance Issuers (45 CFR 147.133(a)(1)(iii))
6. Description of the Moral Objection (45 CFR 147.133(a)(2))
7. Individuals (45 CFR 147.133(b))
8. Accommodation (45 CFR 147.131, 26 CFR 54.9815-2713A, 29 CFR
2590.715-2713A)
9. Definition of Contraceptives for the Purpose of These Final
Rules
10. Severability
C. Other Public Comments
1. Items Approved as Contraceptives But Used to Treat Existing
Conditions
2. Comments Concerning Regulatory Impact
III. Economic Impact and Paperwork Burden
A. Executive Orders 12866 and 13563--Department of HHS and
Department of Labor
1. Need for Regulatory Action
2. Anticipated Effects
B. Special Analyses--Department of the Treasury
C. Regulatory Flexibility Act
D. Paperwork Reduction Act--Department of Health and Human
Services
E. Paperwork Reduction Act--Department of Labor
F. Regulatory Reform Executive Orders 13765, 13771 and 13777
G. Unfunded Mandates Reform Act
H. Federalism
IV. Statutory Authority
I. Executive Summary and Background
A. Executive Summary
1. Purpose
The primary purpose of these final rules is to finalize, with
changes in response to public comments, the interim final regulations
with requests for comments (IFCs) published in the Federal Register on
October 13, 2017 (82 FR 47838), ``Moral Exemptions and Accommodations
for Coverage of Certain Preventive Services Under the Affordable Care
Act'' (the Moral IFC). The rules are necessary to protect sincerely
held moral objections of certain entities and individuals. The rules,
thus, minimize the burdens imposed on their moral beliefs, with regard
to the discretionary requirement that health plans cover certain
contraceptive services with no cost-sharing, which was created by HHS
through guidance promulgated by the Health Resources and Services
[[Page 57593]]
Administration (HRSA), pursuant to authority granted by the ACA in
section 2713(a)(4) of the Public Health Service Act. In addition, the
rules finalize references to these moral exemptions in the previously
created accommodation process that permit entities with certain
objections voluntarily to continue to object while the persons covered
in their plans receive contraceptive coverage or payments arranged by
their issuers or third party administrators. The rules do not remove
the contraceptive coverage requirement generally from HRSA's
guidelines. The changes to the rules being finalized will ensure
clarity in implementation of the moral exemptions so that proper
respect is afforded to sincerely held moral convictions in rules
governing this area of health insurance and coverage, with minimal
impact on HRSA's decision to otherwise require contraceptive coverage.
2. Summary of the Major Provisions
a. Moral Exemptions
These rules finalize exemptions provided in the Moral IFC for the
group health plans and health insurance coverage of various entities
and individuals with sincerely held moral convictions opposed to
coverage of some or all contraceptive or sterilization methods
encompassed by HRSA's guidelines. As in the Moral IFC, the exemptions
include plan sponsors that are nonprofit organization plan sponsors or
for-profit entities that have no publicly traded ownership interests
(defined as any class of common equity securities required to be
registered under section 12 of the Securities Exchange Act of 1934).
The exemptions also continue to include institutions of higher
education in their arrangement of student health insurance coverage;
health insurance issuers (but only with respect to plans that are
otherwise also exempt under the rules); and objecting individuals with
respect to their own coverage, where their health insurance issuer and
plan sponsor, as applicable, are willing to provide coverage complying
with the individual's moral objection. After considering public
comments, the Departments have decided not to extend the moral
exemptions to non-federal governmental entities at this time, although
individuals receiving employer-sponsored insurance from a governmental
entity may use the individual exemption if the other terms of the
individual exemption apply, including that their employer is willing to
offer them a plan consistent with their moral objection.
In response to public comments, various changes are made to clarify
the intended scope of the language in the Moral IFC's exemptions. The
prefatory exemption language is clarified to ensure exemptions apply to
a group health plan established or maintained by an objecting
organization, or health insurance coverage offered or arranged by an
objecting organization, to the extent of the objections. The
Departments add language to specify that the exemption for institutions
of higher education applies to non-governmental entities. The
Departments also modified language describing the moral objection
applicable to the exemptions, to specify that the entity objects, based
on its sincerely held moral convictions, to its establishing,
maintaining, providing, offering, or arranging for (as applicable)
either: Coverage or payments for some or all contraceptive services; or
a plan, issuer, or third party administrator that provides or arranges
such coverage or payments.
The Departments also clarify language in the exemption applicable
to plans of objecting individuals. The clarification is made to ensure
that the HRSA guidelines do not prevent a willing health insurance
issuer offering group or individual health insurance coverage, and as
applicable, a willing plan sponsor of a group health plan, from
offering a separate policy, certificate or contract of insurance or a
separate group health plan or benefit package option, to any group
health plan sponsor (with respect to an individual) or individual, as
applicable, who objects to coverage or payments for some or all
contraceptive services based on sincerely held moral convictions. The
exemption adds that, if an individual objects to some but not all
contraceptive services, but the issuer, and as applicable, plan
sponsor, are willing to provide the plan sponsor or individual, as
applicable, with a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option
that omits all contraceptives, and the individual agrees, then the
exemption applies as if the individual objects to all contraceptive
services.
b. References to Moral Exemptions in Accommodation Regulations and in
Regulatory Restatement of Statutory Language
These rules finalize without change the references to the moral
exemptions that were inserted by the Moral IFC into the rules that
regulatorily restate the statutory language from section 2713(a) and
(a)(4) of the Public Health Service Act. Similarly, these rules
finalize without change from the Moral IFC references to the moral
exemptions that were inserted into the regulations governing the
optional accommodation process. These references operationalize the
effect of the moral exemptions rule, and they allow contraceptive
services to be made available to women if any employers with non-
religious moral objections to contraceptive coverage choose to use the
optional accommodation process.
3. Summary of Costs, Savings and Benefits of the Major Provisions
------------------------------------------------------------------------
Provision Savings and Benefits Costs
------------------------------------------------------------------------
Finalizing insertion of These provisions, We estimate no costs
references to moral finalized without from finalizing
exemptions into restatement change, are for the this part of the
of statutory language from purpose of rule.
section 2713(a) and (a)(4) inserting
of the Public Health references to the
Service Act. moral exemptions
into the regulatory
restatement of
section 2713(a) and
(a)(4) of the
Public Health
Service Act, which
already references
the religious
exemptions. This
operationalizes the
moral exemptions in
each of the tri-
agencies' rules. We
estimate no
economic savings or
benefit from
finalizing this
part of the rule,
but consider it a
deregulatory action
to minimize the
regulatory impact
beyond the scope
set forth in the
statute.
[[Page 57594]]
Finalized moral exemptions.. The moral exemptions We estimate there
to the will be only a
contraceptive small amount of
coverage costs for these
requirement are exemptions, because
finalized with they will primarily
technical changes. be used by
Their purpose is to organizations and
relieve burdens individuals that do
that some entities not want
and individuals contraceptive
experience from coverage. To the
being forced to extent some other
choose between, on employers will use
the one hand, the exemption where
complying with there will be
their moral beliefs transfer costs for
and facing women previously
penalties from receiving
failing to comply contraceptive
with the coverage who will
contraceptive no longer receive
coverage that coverage, we
requirement, and on expect those costs
the other hand, to be minimal due
providing (or, for to the small number
individuals, of entities
obtaining) expected to use the
contraceptive exemptions with non-
coverage in religious moral
violation of their objections. We
sincerely held estimate the
moral beliefs. transfer costs will
amount to $8,760.
Finalizing insertion of These provisions, We do not estimate
references to moral finalized without any entities with
exemptions into optional change, will allow non-religious moral
accommodation regulations. organizations with objections to use
moral objections to the accommodation
contraceptive process at this
coverage on the time.
basis of sincerely
held moral
convictions to use
the accommodation
as an optional
process. These
provisions will
allow contraceptive
coverage to be made
available to women
covered by plans of
employers that
object to
contraceptive
coverage but do not
object to their
issuers or third
party
administrators
arranging for such
coverage to be
provided to persons
covered by their
plans.
------------------------------------------------------------------------
B. Background
Over many decades, Congress has protected conscientious objections
including based on moral convictions in the context of health care and
human services, and including health coverage, even as it has sought to
promote access to health services.\1\ In 2010, Congress enacted the
Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-148)
(March 23, 2010). Congress enacted the Health Care and Education
Reconciliation Act of 2010 (HCERA) (Pub. L. 111-152) on March 30, 2010,
which, among other things, amended PPACA. As amended by HCERA, PPACA is
known as the Affordable Care Act (ACA).
---------------------------------------------------------------------------
\1\ See, for example, 42 U.S.C. 300a-7 (protecting individuals
and health care entities from being required to provide or assist
sterilizations, abortions, or other lawful health services if it
would violate their ``religious beliefs or moral convictions''); 42
U.S.C. 238n (protecting individuals and entities that object to
abortion); Consolidated Appropriations Act, 2018, Div. H, Sec.
507(d) (Departments of Labor, HHS, and Education, and Related
Agencies Appropriations Act), Public Law 115-141, 132 Stat. 348, 764
(Mar. 23, 2018) (protecting any ``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'' in objecting to abortion for
any reason); Id. at Div. E, Sec. 726(c) (Financial Services and
General Government Appropriations Act) (protecting individuals who
object to prescribing or providing contraceptives contrary to their
``religious beliefs or moral convictions''); Id. at Div. E, Sec. 808
(regarding any requirement of ``the provision of contraceptive
coverage by health insurance plans'' in the District of Columbia,
``it is the intent of Congress that any legislation enacted on such
issue should include a `conscience clause' which provides exceptions
for religious beliefs and moral convictions.''); Id. at Div. K,
Title III (Department of State, Foreign Operations, and Related
Programs Appropriations Act) (protecting applicants for family
planning funds based on their ``religious or conscientious
commitment to offer only natural family planning''); 42 U.S.C.
290bb-36 (prohibiting the statutory section from being construed to
require suicide related treatment services for youth where the
parents or legal guardians object based on ``religious beliefs or
moral objections''); 42 U.S.C. 1395w-22(j)(3)(B) (protecting against
forced counseling or referrals in Medicare+Choice, now Medicare
Advantage, managed care plans with respect to objections based on
``moral or religious grounds''); 42 U.S.C. 1396a(w)(3) (ensuring
particular Federal law does not infringe on ``conscience'' as
protected in State law concerning advance directives); 42 U.S.C.
1396u-2(b)(3) (protecting against forced counseling or referrals in
Medicaid managed care plans with respect to objections based on
``moral or religious grounds''); 42 U.S.C. 2996f(b) (protecting
objection to abortion funding in legal services assistance grants
based on ``religious beliefs or moral convictions''); 42 U.S.C.
14406 (protecting organizations and health providers from being
required to inform or counsel persons pertaining to assisted
suicide); 42 U.S.C. 18023 (blocking any requirement that issuers or
exchanges must cover abortion); 42 U.S.C. 18113 (protecting health
plans or health providers from being required to provide an item or
service that helps cause assisted suicide); see also 8 U.S.C.
1182(g) (protecting vaccination objections by ``aliens'' due to
``religious beliefs or moral convictions''); 18 U.S.C. 3597
(protecting objectors to participation in Federal executions based
on ``moral or religious convictions''); 20 U.S.C. 1688 (prohibiting
sex discrimination law to be used to require assistance in abortion
for any reason); 22 U.S.C. 7631(d) (protecting entities from being
required to use HIV/AIDS funds contrary to their ``religious or
moral objection'').
---------------------------------------------------------------------------
The ACA reorganized, amended, and added to the provisions of part A
of title XXVII of the Public Health Service Act (PHS Act) relating to
group health plans and health insurance issuers in the group and
individual markets. The ACA added section 715(a)(1) to the Employee
Retirement Income Security Act of 1974 (ERISA) and section 9815(a)(1)
to the Internal Revenue Code (Code), in order to incorporate the
provisions of part A of title XXVII of the PHS Act into ERISA and the
Code, and to make them applicable to group health plans and health
insurance issuers providing health insurance coverage in connection
with group health plans. The sections of the PHS Act incorporated into
ERISA and the Code are sections 2701 through 2728.
In section 2713(a)(4) of the PHS Act (hereinafter ``section
2713(a)(4)''), Congress provided administrative discretion to require
that certain group health plans and health insurance issuers cover
certain women's preventive services, in addition to other preventive
services required to be covered in section 2713. Congress granted that
discretion to the Health Resources and Services Administration (HRSA),
a component of the U.S. Department of Health and Human Services (HHS).
Specifically, section 2713(a)(4) allows HRSA discretion to specify
coverage requirements, ``with respect to women, such additional
preventive care and screenings as provided for in comprehensive
guidelines supported'' by HRSA (the ``Guidelines'').
Since 2011, HRSA has exercised that discretion to require coverage
for, among other things, certain contraceptive services.\2\ In the same
[[Page 57595]]
time period, the administering agencies--HHS, the Department of Labor,
and the Department of the Treasury (collectively, ``the Departments''
\3\)--exercised discretion to allow exemptions to those requirements by
issuing rulemaking various times, including issuing and finalizing
three interim final regulations prior to 2017.\4\ In those regulations,
the Departments crafted exemptions and accommodations for certain
religious objectors where the Guidelines require coverage of
contraceptive services, changed the scope of those exemptions and
accommodations, and solicited public comments on a number of occasions.
Public comments were submitted on various iterations of the regulations
issued before 2017, and some of those comments supported expanding the
exemptions to include those who oppose the contraceptive coverage
mandate for either religious ``or moral'' reasons, consistent with
various state laws (such as in Connecticut or Missouri) that protect
objections to contraceptive coverage based on moral convictions.\5\
---------------------------------------------------------------------------
\2\ The references in this document to ``contraception,''
``contraceptive,'' ``contraceptive coverage,'' or ``contraceptive
services'' generally include all contraceptives, sterilization, and
related patient education and counseling, required by the Women's
Preventive Guidelines, unless otherwise indicated. The Guidelines
issued in 2011 referred to ``Contraceptive Methods and Counseling''
as ``[a]ll Food and Drug Administration approved contraceptive
methods, sterilization procedures, and patient education and
counseling for all women with reproductive capacity.'' https://www.hrsa.gov/womens-guidelines/. The Guidelines as amended
in December 2016 refer, under the header ``Contraception,'' to:
``the full range of female-controlled U.S. Food and Drug
Administration-approved contraceptive methods, effective family
planning practices, and sterilization procedures,'' ``contraceptive
counseling, initiation of contraceptive use, and follow-up care
(e.g., management, and evaluation as well as changes to and removal
or discontinuation of the contraceptive method),'' and ``instruction
in fertility awareness-based methods, including the lactation
amenorrhea method.'' https://www.hrsa.gov/womens-guidelines-2016/.
\3\ Note, however, that in sections under headings listing only
two of the three Departments, the term ``Departments'' generally
refers only to the two Departments listed in the heading.
\4\ Interim final regulations on July 19, 2010, at 75 FR 41726
(July 2010 interim final regulations); interim final regulations
amending the July 2010 interim final regulations on August 3, 2011,
at 76 FR 46621; final regulations on February 15, 2012, at 77 FR
8725 (2012 final regulations); an advance notice of proposed
rulemaking (ANPRM) on March 21, 2012, at 77 FR 16501; proposed
regulations on February 6, 2013, at 78 FR 8456; final regulations on
July 2, 2013, at 78 FR 39870 (July 2013 final regulations); interim
final regulations on August 27, 2014, at 79 FR 51092 (August 2014
interim final regulations); proposed regulations on August 27, 2014,
at 79 FR 51118 (August 2014 proposed regulations); final regulations
on July 14, 2015, at 80 FR 41318 (July 2015 final regulations); and
a request for information on July 26, 2016, at 81 FR 47741 (RFI),
which was addressed in an FAQ document issued on January 9, 2017,
available at: https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/ACA-FAQs-Part36_1-9-17-Final.pdf.
\5\ See, for example, Denise M. Burke, Re: file code CMS-9968-P,
Regulations.gov (posted May 5, 2013), https://www.regulations.gov/#!documentDetail;D=CMS-2012-0031-79115; Comment, Regulations.gov
(posted Oct. 26, 2016), https://www.regulations.gov/document?D=CMS-2016-0123-54142; David Sater, Re: CMS-9931-NC: Request for
Information, Regulations.gov (posted Oct. 26, 2016), https://www.regulations.gov/document?D=CMS-2016-0123-54218; Comment,
Regulations.gov (posted Oct. 26, 2016), https://www.regulations.gov/document?D=CMS-2016-0123-46220.
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During the period when the Departments were publishing and
modifying the regulations, organizations and individuals filed dozens
of lawsuits challenging the contraceptive coverage requirement and
regulations (hereinafter, the ``contraceptive Mandate,'' or the
``Mandate''). Plaintiffs included religious nonprofit organizations,
businesses run by religious families, individuals, and others,
including several non-religious organizations that opposed coverage of
certain contraceptives under the Mandate on the basis of non-religious
moral convictions. For-profit entities with religious objections won
various court decisions leading to the Supreme Court's ruling in
Burwell v. Hobby Lobby Stores, Inc. 134 S. Ct. 2751 (2014). The Supreme
Court ruled against the Departments and held that, under the Religious
Freedom Restoration Act of 1993 (RFRA), the Mandate could not be
applied to the closely held for-profit corporations before the Court
because their owners had religious objections to providing such
coverage.\6\ Later, a second series of legal challenges were filed by
religious nonprofit organizations that stated the accommodation
impermissibly burdened their religious beliefs because it utilized
their health plans to provide services to which they objected on
religious grounds, and it required them to submit a self-certification
or notice. On May 16, 2016, the Supreme Court issued a per curiam
decision, vacating the judgments of the Courts of Appeals--most of
which had ruled in the Departments' favor--and remanding the cases ``in
light of the substantial clarification and refinement in the positions
of the parties'' that had been filed in supplemental briefs. Zubik v.
Burwell, 136 S. Ct. 1557, 1560 (2016). The Court stated that it
anticipated that, on remand, the Courts of Appeals would ``allow the
parties sufficient time to resolve any outstanding issues between
them.'' Id.
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\6\ The Supreme Court did not decide whether RFRA would apply to
publicly traded for-profit corporations. See 134 S. Ct. at 2774.
---------------------------------------------------------------------------
Beginning in 2015, lawsuits challenging the Mandate were also filed
by various non-religious organizations with moral objections to
contraceptive coverage. These organizations stated that they believe
some methods classified by the Food and Drug Administration (FDA) as
contraceptives may have an abortifacient effect and, therefore, in
their view, are morally equivalent to abortion to which they have a
moral objection. Under regulations preceding October 2017, these
organizations neither received an exemption from the Mandate nor
qualified for the accommodation. For example, March for Life filed a
complaint claiming that the Mandate violated the equal protection
component of the Due Process Clause of the Fifth Amendment, and was
arbitrary and capricious under the Administrative Procedure Act (APA).
Citing, for example, 77 FR 8727, March for Life argued that the
Departments' stated interests behind the Mandate were only advanced
among women who ``want'' the coverage so as to prevent ``unintended''
pregnancy. March for Life contended that, because it only hires
employees who publicly advocate against abortion, including what they
regard as abortifacient contraceptive items, the Departments' interests
were not rationally advanced by imposing the Mandate upon it and its
employees. Accordingly, March for Life contended that applying the
Mandate to it (and other similarly situated organizations) lacked a
rational basis and, therefore, was arbitrary and capricious in
violation of the APA. March for Life further contended that, because
the Departments concluded the government's interests were not
undermined by exempting houses of worship and integrated auxiliaries
(based on the assumption that such entities are relatively more likely
than other nonprofits with religious objections to have employees that
share their views against certain contraceptives), applying the Mandate
to March for Life or similar organizations that definitively hire only
employees who oppose certain contraceptives lacked a rational basis
and, therefore, violated their right of equal protection under the Due
Process Clause.
March for Life's employees, who stated they were personally
religious (although personal religiosity was not a condition of their
employment), also sued as co-plaintiffs. They contended that the
Mandate violated their rights under RFRA by making it impossible for
them to obtain health coverage consistent with their religious beliefs,
either from the plan March for Life wanted to offer them, or in the
individual market, because the Departments offered no exemptions in
either circumstance. Another non-religious nonprofit organization that
opposed the Mandate's requirement to provide certain contraceptive
coverage on moral grounds also filed a lawsuit challenging the Mandate.
Real
[[Page 57596]]
Alternatives, Inc. v. Burwell, 150 F. Supp. 3d 419 (M.D. Pa. 2015).
Challenges by non-religious nonprofit organizations led to
conflicting opinions among the federal courts. A district court agreed
with the March for Life plaintiffs on the organization's equal
protection claim and the employees' RFRA claims, while not specifically
ruling on the APA claim, and issued a permanent injunction against the
Departments that is still in place. March for Life v. Burwell, 128 F.
Supp. 3d 116 (D.D.C. 2015). The appeal in March for Life is pending and
has been stayed since early 2016. In another case, federal district and
appellate courts in Pennsylvania disagreed with the reasoning in March
for Life, and ruled against claims brought by a similarly non-religious
nonprofit employer and its religious employees. Real Alternatives, 150
F. Supp. 3d 419, affirmed by 867 F.3d 338 (3d Cir. 2017). One member of
the appeals court panel in Real Alternatives v. Sec'y of HHS dissented
in part, stating he would have ruled in favor of the individual
employee plaintiffs under RFRA. 867 F.3d 338, 367 (3d Cir. 2017)
(Jordan, J., dissenting).
The Departments most recently solicited public comments on these
issues again in two interim final regulations with request for comments
published in the Federal Register on October 13, 2017: The regulations
(82 FR 47838) (the Moral IFC) that are being finalized with changes
here, and the regulations (82 FR 47792) (the Religious IFC) published
on the same day as the Moral IFC, which are being finalized with
changes in the companion final rules published elsewhere in today's
Federal Register.
In the preamble to the Moral IFC, the Departments explained several
reasons why, after exercising our discretion to reevaluate the
exemptions and accommodations for the contraceptive Mandate, we sought
public comment on whether to protect moral convictions in the Moral IFC
and these final rules. The Departments noted that we considered, among
other things, Congress's history of providing protections for moral
convictions regarding certain health services (including contraception,
sterilization, and items or services believed to involve abortion); the
text, context, and intent of section 2713(a)(4) and the ACA; Executive
Order 13798, ``Promoting Free Speech and Religious Liberty'' (May 4,
2017); previously submitted public comments; and the extensive
litigation over the contraceptive Mandate. The Departments concluded
that it was appropriate that HRSA take into account the moral
convictions of certain employers, individuals and health insurance
issuers where the coverage of contraceptive services is concerned.
Comments were requested on the interim final regulations.
After consideration of the comments and feedback received from
stakeholders, the Departments are finalizing the Moral IFC, with
changes based on comments as indicated herein.\7\
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\7\ The Department of the Treasury and Internal Revenue Service
published proposed and temporary regulations as part of the joint
rulemaking of the Moral IFC. The Departments of Labor and HHS
published their respective rules as interim final rules with request
for comments and are finalizing their interim final rules in these
final rules. The Department of the Treasury and Internal Revenue
Service are finalizing their regulations.
---------------------------------------------------------------------------
II. Overview of the Final Rules and Public Comments
During the 60-day comment period for the Moral IFC, which closed on
December 5, 2017, the Departments received over 54,000 public comment
submissions, which are posted to www.regulations.gov.\8\ Below, the
Departments provide an overview of the final rules and address the
issues raised in the comments we received.
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\8\ See Regulations.gov at https://www.regulations.gov/searchResults?rpp=25&so=DESC&sb=postedDate&po=0&cmd=12%7C05%7C17-12%7C05%7C17&dktid=CMS-2017-0133 and https://www.regulations.gov/docketBrowser?rpp=25&so=ASC&sb=postedDate&po=100&D=IRS-2017-0015.
Some of those submissions included form letters or attachments that,
while not separately tabulated at regulations.gov, together included
comments from, or were signed by, possibly over a hundred thousand
separate persons. The Departments reviewed all of the public
comments and attachments.
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A. Moral Exemptions and Accommodation in General
These rules expand exemptions to protect certain entities and
individuals with moral convictions that oppose contraception whose
health plans are subject to a mandate of contraceptive coverage through
guidance issued pursuant to the ACA. These rules do not alter the
discretion of HRSA, a component of HHS, to maintain the Guidelines
requiring contraceptive coverage where no regulatorily recognized
objection exists. These rules also make available to exempt
organizations the accommodation process, which was previously
established in response to some objections of religious organizations,
as an optional process for exempt entities that wish to use it
voluntarily. These rules do not alter multiple other federal programs
that provide free or subsidized contraceptives or related education and
counseling for women at risk of unintended pregnancy.\9\
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\9\ See, for example, Family Planning grants in 42 U.S.C. 300,
et seq.; the Teenage Pregnancy Prevention Program, Public Law 112-74
(125 Stat 786, 1080); the Healthy Start Program, 42 U.S.C. 254c-8;
the Maternal, Infant, and Early Childhood Home Visiting Program, 42
U.S.C. 711; Maternal and Child Health Block Grants, 42 U.S.C. 703;
42 U.S.C. 247b-12; Title XIX of the Social Security Act, 42 U.S.C.
1396, et seq.; the Indian Health Service, 25 U.S.C. 13, 42 U.S.C.
2001(a), & 25 U.S.C. 1601, et seq.; Health center grants, 42 U.S.C.
254b(e), (g), (h), & (i); the NIH Clinical Center, 42 U.S.C. 248;
and the Personal Responsibility Education Program, 42 U.S.C. 713.
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1. The Departments' Authority To Mandate Coverage or Provide Exemptions
The Departments received conflicting comments on their legal
authority to provide exemptions and accommodations to the Mandate. Some
commenters agreed that the Departments are legally authorized to
provide expanded exemptions and an accommodation for moral convictions,
noting that there was no requirement of contraceptive coverage in the
ACA and no prohibition on providing moral exemptions in Guidelines
issued under section 2713(a)(4). Other commenters, however, asserted
that the Departments have no legal authority to provide any exemptions
to the contraceptive Mandate, contending, based on statements in the
ACA's legislative history, that the ACA requires contraceptive
coverage. Still other commenters contended that the Departments are
legally authorized to provide the religious exemptions that existed
prior to the 2017 IFCs, but not to protect moral convictions.
The Departments conclude that we are legally authorized to provide
the exemption and accommodation for moral convictions set forth in the
Moral IFC and these final rules. These rules concern section 2713 of
the PHS Act, as incorporated into ERISA and the Code. Congress has
granted the Departments legal authority, collectively, to administer
these statutes. (26 U.S.C. 9833; 29 U.S.C. 1191c; 42 U.S.C. 300gg-92).
Where it applies, section 2713(a)(4) requires coverage without cost
sharing for ``such additional'' women's preventive care and screenings
``as provided for'' and ``supported by'' guidelines developed by HHS
acting through HRSA. When Congress enacted this provision, those
Guidelines did not exist. And nothing in the statute mandated that the
Guidelines had to include contraception, let alone for all types of
employers with covered plans. Instead, section 2713(a)(4) provided a
[[Page 57597]]
positive grant of authority for HSRA to develop those Guidelines, thus
delegating authority to HHS to shape that development, as the
administering agency of HRSA, and to all three agencies as the
administering agencies of the statutes by which the Guidelines are
enforced. See 26 U.S.C. 9833; 29 U.S.C. 1191(c), 42 U.S.C. 300gg-92.
That is especially true for HHS, as HRSA is a component of HHS that was
unilaterally created by the agency and thus is subject to the agency's
general supervision, see 47 FR 38409 (August 31, 1982). Thus, nothing
prevented HRSA from creating an exemption from otherwise-applicable
guidelines or prevented HHS and the other agencies from directing that
HRSA create such an exemption.
Congress did not specify the extent to which HRSA must ``provide
for'' and ``support'' the application of Guidelines that it chooses to
adopt. HRSA's authority to support ``comprehensive guidelines''
involves determining both the types of coverage and scope of that
coverage. Section 2714(a)(4) requires coverage for preventive services
only ``as provided for in comprehensive guidelines supported by
[HRSA].'' That is, services are required to be included in coverage
only to the extent that the Guidelines supported by HRSA provide for
them. Through use of the word ``as'' in the phrase ``as provided for,''
it requires that HRSA support how those services apply--that is, the
manner in which the support will happen, such as in the phrase ``as you
like it.'' \10\ When Congress means to require certain activities to
occur in a certain manner, instead of simply authorizing the agency to
decide the manner in which they will occur, Congress knows how to do
so. See for example, 42 U.S.C. 1395x (``The Secretary shall establish
procedures to make beneficiaries and providers aware of the requirement
that a beneficiary complete a health risk assessment prior to or at the
same time as receiving personalized prevention plan services.'')
(emphasis added). Thus, the inclusion of ``as'' in section 300gg-
13(a)(3), and its absence in similar neighboring provisions, shows that
HRSA has discretion whether to support how the preventive coverage
mandate applies--it does not refer to the timing of the promulgation of
the Guidelines.
---------------------------------------------------------------------------
\10\ See As (usage 2), Oxford English Dictionary Online (Feb.
2018) (``[u]sed to indicate by comparison the way something happens
or is done'').
---------------------------------------------------------------------------
Nor is it simply a textual aberration that the word ``as'' is
missing from the other three provisions in section 2713(a) of the PHS
Act. Rather, this difference mirrors other distinctions within that
section that demonstrate that Congress intended HRSA to have the
discretion the Agencies invoke. For example, sections (a)(1) and (a)(3)
require ``evidence-based'' or ``evidence-informed'' coverage, while
section (a)(4) does not. This difference suggests that the Agencies
have the leeway to incorporate policy-based concerns into their
decision-making. This reading of section 2713(a)(4) also prevents the
statute from being interpreted in a cramped way that allows no
flexibility or tailoring, and that would force the Departments to
choose between ignoring religious objections in violation of RFRA or
else eliminating the contraceptive coverage requirement from the
Guidelines altogether. The Departments instead interpret section
2713(a)(4) as authorizing HRSA's Guidelines to set forth both the kinds
of items and services that will be covered, and the scope of entities
to which the contraceptive coverage requirement in those Guidelines
will apply.
The moral objections at issue here, like the religious objections
prompting exemptions dating back to the inception of the Mandate in
2011, may, consistent with the statutory provision, permissibly inform
what HHS, through HRSA, decides to provide for and support in the
Guidelines. Since the first rulemaking on this subject in 2011, the
Departments have consistently interpreted the broad discretion granted
to HRSA in section 2713(a)(4) as including the power to reconcile the
ACA's preventive-services requirement with sincerely held views of
conscience on the sensitive subject of contraceptive coverage--namely,
by exempting churches and their integrated auxiliaries from the
contraceptive-coverage Mandate. (See 76 FR at 46623.) As the
Departments explained at that time, the HRSA Guidelines ``exist solely
to bind non-grandfathered group health plans and health insurance
issuers with respect to the extent of their coverage of certain
preventive services for women,'' and ``it is appropriate that HRSA . .
. takes into account the effect on the religious beliefs of [employers]
if coverage of contraceptive services were required in [their] group
health plans.'' Id. Consistent with that longstanding view, Congress's
grant of discretion in section 2713(a)(4), and the lack of a mandate
that contraceptives be covered or that they be covered without any
exemptions or exceptions, lead the Departments to conclude that we are
legally authorized to exempt certain entities or plans from a
contraceptive Mandate if HRSA decides to otherwise include
contraceptives in its Guidelines.
The Departments' conclusions are consistent with our interpretation
of section 2713 of the PHS Act since 2010, when the ACA was enacted,
and since the Departments started to issue interim final regulations
implementing that section. The Departments have consistently
interpreted section 2713(a)(4) to grant broad discretion to decide the
extent to which HRSA will provide for, and support, the coverage of
additional women's preventive care and screenings, including the
decision to exempt certain entities and plans, and not to provide for
or support the application of the Guidelines with respect to those
entities or plans. The Departments created an exemption to the
contraceptive Mandate when that Mandate was announced in 2011, and then
amended and expanded the exemption and added an accommodation process
in multiple rulemakings thereafter. The accommodation process requires
the provision of coverage or payments for contraceptives to plan
participants in an eligible organization's health plan by the
organization's insurer or third party administrator. However, the
accommodation process itself, in some cases, failed to require
contraceptive coverage for many women, because--as the Departments
acknowledged at the time--the enforcement mechanism for that process,
section 3(16) of ERISA, does not provide a means to impose an
obligation to provide contraceptive coverage on the third party
administrator of self-insured church plans (see 80 FR 41323). Non-
exempt employers participate in many church plans. Therefore, in both
the previous exemption, and in the previous accommodation's application
to self-insured church plans, the Departments have been choosing not to
require contraceptive coverage for certain kinds of employers since the
Guidelines were adopted. In doing so, the Departments have been acting
contrary to commenters who contended the Departments had no authority
to create exemptions under section 2713 of the PHS Act, or its
incorporation into ERISA and the Code, and who contended instead that
the Departments must enforce Guidelines on the broadest spectrum of
group health plans as possible, even including churches (see, for
example, 2012 final regulations at 77 FR 8726).
The Departments' interpretation of section 2713(a)(4) is confirmed
by the ACA's statutory structure. Congress did not intend to require
entirely uniform coverage of preventive services (see for
[[Page 57598]]
example, 76 FR 46623). On the contrary, Congress carved out an
exemption from section 2713 of the PHS Act (and from several other
provisions) for grandfathered plans. In contrast, the grandfathering
exemption is not applicable to many of the other provisions in Title I
of the ACA--provisions previously referred to by the Departments as
providing ``particularly significant protections.'' (75 FR 34540).
Those provisions include (from the PHS Act) section 2704, which
prohibits preexisting condition exclusions or other discrimination
based on health status in group health coverage; section 2708, which
prohibits excessive waiting periods (as of January 1, 2014); section
2711, which relates to lifetime dollar limits; section 2712, which
generally prohibits rescission of health coverage; section 2714, which
extends dependent child coverage until the child turns 26; and section
2718, which imposes a minimum medical loss ratio on health insurance
issuers in the individual and group markets (for insured coverage), and
requires them to provide rebates to policyholders if that medical loss
ratio is not met. (75 FR 34538, 34540, 34542). Consequently, of the 150
million nonelderly people in America with employer-sponsored health
coverage, approximately 25.5 million are estimated to be enrolled in
grandfathered plans not subject to section 2713.\11\ Some commenters
assert the exemptions for grandfathered plans are temporary, or were
intended to be temporary, but as the Supreme Court observed, ``there is
no legal requirement that grandfathered plans ever be phased out.''
Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2764 n.10 (2014).
---------------------------------------------------------------------------
\11\ Kaiser Family Foundation & Health Research & Educational
Trust, ``Employer Health Benefits, 2017 Annual Survey,'' Henry J
Kaiser Family Foundation (Sept. 19, 2017), https://files.kff.org/attachment/Report-Employer-Health-Benefits-Annual-Survey-2017.
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Some commenters argue that Executive Order 13535's reference to
implementing the ACA consistent with certain conscience laws does not
justify creating exemptions to contraceptive coverage in the
Guidelines, because those laws do not specifically require exemptions
in the Guidelines. The Departments, however, believe that they are
acting consistent with Executive Order 13535 by creating exemptions
using HRSA's authority under section 2713(a)(4), and the Departments'
administrative authority over the implementation of section 2713(a) of
the PHS Act. Executive Order 13535, issued upon the signing of the ACA,
specified that ``longstanding Federal laws to protect conscience . . .
remain intact,'' including laws that protect holders of religious
beliefs or moral convictions from certain requirements in health care
contexts. Although the text of Executive Order 13535 does not require
the expanded exemptions confirmed in these final rules, the expanded
exemptions are, as explained below, consistent with longstanding
federal laws to protect conscience objections, based on religious
beliefs or moral convictions regarding certain health matters, and are
consistent with the intent that the ACA be implemented in accordance
with the conscience protections set forth in those laws.
Some commenters contended that, even though Executive Order 13535
refers to the Church Amendments, the intention of those statutes is
narrow, should not be construed to extend to entities instead of to
individuals, and should not be construed to prohibit procedures. But
those comments mistake the Departments' position. The Departments are
not construing the Church Amendments to require these exemptions, nor
do the exemptions prohibit any procedures. Instead, through
longstanding federal conscience statutes, Congress has established
consistent principles concerning respect for sincerely held moral
convictions in sensitive healthcare contexts.\12\ Under those
principles, and absent any contrary requirement of law, the Departments
are offering exemptions for sincerely held moral convictions to the
extent the Departments otherwise impose a contraceptive Mandate. These
exemptions do not prohibit any services, nor authorize employers to
prohibit employees from obtaining any services. The exemptions in the
Moral IFC and these final rules simply refrain from imposing a federal
mandate that employers cover contraceptives in their health plans even
if they have sincerely held moral convictions against doing so.
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\12\ The Departments note that the Church Amendments are the
subject of another, ongoing rulemaking process. See Protecting
Statutory Conscience Rights in Health Care; Delegations of
Authority, 83 FR 3880 (NPRM Jan. 26, 2018). Since the Departments
are not construing the Amendments to require the religious
exemptions, we defer issues regarding the scope, interpretation, and
protections of the Amendments to HHS in that rulemaking.
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Some commenters stated that the Supreme Court ruled that the
exemptions provided for houses of worship and integrated auxiliaries
were required by the First Amendment. From this, commenters concluded
that the exemptions for houses of worship and integrated auxiliaries
are legally authorized, but that exemptions beyond those are not. But
the Supreme Court did not rule on the question whether the exemptions
provided for houses of worship and integrated auxiliaries were required
by the First Amendment, and the Court did not say the Departments must
apply the contraceptive Mandate unless RFRA prohibits us from doing so.
The appropriateness of including exemptions to protect moral
convictions is informed by Congress's long history of providing
exemptions for moral convictions, especially in certain health care
contexts.
2. Congress's History of Protecting Moral Convictions
The Department received numerous comments about its decision in the
Moral IFC to exercise its discretion to provide moral exemptions to,
and an accommodation under, the contraceptive Mandate. Some commenters
agreed with the Departments' decision in the Moral IFC, arguing that it
is appropriate to exercise the Departments' discretion to protect moral
convictions in light of Congress's history of protecting moral
convictions in various contexts, especially concerning health care.
Other commenters disagreed, saying that existing conscience statutes
protecting moral convictions do not require these exemptions and,
therefore, the exemptions should not be offered. Some commenters stated
that because Congress has provided conscience protections, but did not
specifically provide them in section 2713(a)(4), conscience protections
are inappropriate in the implementation of that section. Still other
commenters went further, disagreeing with conscience protections
regarding contraceptives, abortions, or health care in general.
In deciding the most appropriate way to exercise our discretion in
this context, the Departments draw on the most recent statements of
Congress, along with nearly 50 years of statutes and Supreme Court
precedent discussing the protection of moral convictions in certain
circumstances--particularly in the context of health care and health
coverage. Most recently, Congress expressed its intent on the matter of
Government-mandated contraceptive coverage when it declared, with
respect to the possibility that the District of Columbia would require
contraceptive coverage, that ``it is the intent of Congress that any
legislation enacted on such issue should include a `conscience clause'
which provides exceptions for religious beliefs and moral
convictions.'' Consolidated Appropriations Act, 2018, Div. E, section
808, Public Law 115-141, 132 Stat. 348, 603 (Mar. 23, 2018); see also
[[Page 57599]]
Consolidated Appropriations Act, 2017, Div. C, section 808, Public Law
115-31 (May 5, 2017). The Departments consider it significant that
Congress's most recent statements on the prospect of Government-
mandated contraceptive coverage specifically intend that a conscience
clause be included to protect moral convictions.
The Departments also consider significant the many statutes listed
above, in section I--Background footnote 1, that show Congress's
consistent protection of moral convictions alongside religious beliefs
in the federal regulation of health care. These include laws such as
the Church Amendments (dating back to 1973), which we discuss at length
below, to the 2018 Consolidated Appropriations Act discussed above.
Notably among those laws, and in addition to the Church Amendments,
Congress has enacted protections for health plans or health care
organizations in Medicaid or Medicare Advantage to object ``on moral or
religious grounds'' to providing coverage of certain counseling or
referral services. 42 U.S.C. 1395w-22(j)(3)(B) (protecting against
forced counseling or referrals in Medicare + Choice (now Medicare
Advantage) managed care plans with respect to objections based on
``moral or religious grounds''); 42 U.S.C. 1396u-2(b)(3) (protecting
against forced counseling or referrals in Medicaid managed care plans
with respect to objections based on ``moral or religious grounds'').
Congress has also protected individuals who object to prescribing or
providing contraceptives contrary to their ``religious beliefs or moral
convictions.'' Consolidated Appropriations Act, 2018, Public Law 115-
141, Division E, section 726(c); see also Consolidated Appropriations
Act of 2017, Division C, Title VII, Sec. 726(c) (Financial Services and
General Government Appropriations Act), Public Law 115-31.\13\
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\13\ The Departments also note that, in protecting those
individual and institutional health care entities that object to
certain abortion-related services and activities regardless of the
basis for such objection, the Coats-Snowe Amendment, PHS Act section
245 (42 U.S.C. 238n), and the Weldon Amendment, Consolidated
Appropriations Act, 2018, Div. H, Sec. 507(d), Public Law 115-141,
protect those whose objection is based on moral conviction.
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The Departments disagree with commenters that suggested we should
not consider Congress's history of protecting moral objections in
certain health care contexts due to Congress's failure to explicitly
include exemptions in section 2713(a)(4) itself. The argument by these
commenters proves too much, since Congress also did not specifically
require contraceptive coverage in section 2713 of the PHS Act. This
argument would also negate not just these expanded exemptions, but the
previous exemptions provided for houses of worship and integrated
auxiliaries, and the indirect exemption for self-insured church plans
that use the accommodation. Where Congress left so many matters
concerning section 2713(a)(4) to agency discretion, the Departments
consider it appropriate to implement these expanded exemptions in light
of Congress's long history of respecting moral convictions in the
context of certain federal health care requirements.
a. The Church Amendments' Protection of Moral Convictions
One of the most important and well-established federal statutes
respecting conscientious objections in specific health care contexts
was enacted over the course of several years beginning in 1973,
initially as a response to court decisions raising the prospect that
entities or individuals might be required to facilitate abortions or
sterilizations because they had received federal funds. These sections
of the U.S. Code are known as the Church Amendments, named after their
primary sponsor, Senator Frank Church (D-Idaho). The Church Amendments
specifically provide conscience protections based on sincerely held
moral convictions, not just religious beliefs. Among other things, the
amendments protect the recipients of certain federal health funds from
being required to perform, assist, or make their facilities available
for abortions or sterilizations if they object ``on the basis of
religious beliefs or moral convictions,'' and they prohibit recipients
of certain federal health funds from discriminating against any
personnel ``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'' (42 U.S.C.
300a-7(b), (c)(1)). Later additions to the Church Amendments protect
other conscientious objections, including some objections on the basis
of moral conviction to ``any lawful health service,'' or to ``any part
of a health service program.'' (42 U.S.C. 300a-7(c)(2), (d)). In
contexts covered by those sections of the Church Amendments, the
provision or coverage of certain contraceptives, depending on the
circumstances, could constitute ``any lawful health service'' or a
``part of a health service program.'' As such, the protections provided
by those provisions of the Church Amendments would encompass moral
objections to contraceptive services or coverage.
The Church Amendments were enacted in the wake of the Supreme
Court's decision in Roe v. Wade, 410 U.S. 113 (1973). Although the
Court in Roe required abortion to be legal in certain circumstances,
Roe did not include, within that right, the requirement that other
citizens facilitate its exercise. Indeed, Roe favorably quoted the
proceedings of the American Medical Association House of Delegates 220
(June 1970), which declared, ``Neither physician, hospital, nor
hospital personnel shall be required to perform any act violative of
personally-held moral principles.'' 410 U.S. at 144 & n.38 (1973).
Likewise, in Roe's companion case, Doe v. Bolton, the Court observed
that, under state law, ``a physician or any other employee has the
right to refrain, for moral or religious reasons, from participating in
the abortion procedure.'' 410 U.S. 179, 197-98 (1973). The Court said
that these conscience provisions ``obviously . . . afford appropriate
protection.'' Id. at 198. As an Arizona court later put it, ``a woman's
right to an abortion or to contraception does not compel a private
person or entity to facilitate either.'' Planned Parenthood Ariz., Inc.
v. Am. Ass'n of Pro-Life Obstetricians & Gynecologists, 257 P.3d 181,
196 (Ariz. Ct. App. 2011).
The Congressional Record contains discussions that occurred when
the protection for moral convictions was first proposed in the Church
Amendments. When Senator Church introduced the first of those
amendments in 1973, he cited not only Roe v. Wade, but also an instance
where a federal court had ordered a Catholic hospital to perform
sterilizations. 119 Congr. Rec. S5717-18 (Mar. 27, 1973). After his
opening remarks, Senator Adlai Stevenson III (D-IL) rose to ask that
the amendment be changed to specify that it also protects objections to
abortion and sterilization based on moral convictions on the same terms
as it protects objections based on religious beliefs. The following
excerpt of the Congressional Record records this discussion:
Mr. STEVENSON. Mr. President, first of all I commend the Senator
from Idaho for bringing this matter to the attention of the Senate.
I ask the Senator a question.
One need not be of the Catholic faith or any other religious
faith to feel deeply about the worth of human life. The protections
afforded by this amendment run only to those whose religious beliefs
would be offended by the necessity of performing or
[[Page 57600]]
participating in the performance of certain medical procedures;
others, for moral reasons, not necessarily for any religious belief,
can feel equally as strong about human life. They too can revere
human life.
As mortals, we cannot with confidence say, when life begins. But
whether it is life, or the potentiality of life, our moral
convictions as well as our religious beliefs, warrant protection
from this intrusion by the Government. Would, therefore, the Senator
include moral convictions?
Would the Senator consider an amendment on page 2, line 18 which
would add to religious beliefs, the words ``or moral''?
Mr. CHURCH. I would suggest to the Senator that perhaps his
objective could be more clearly stated if the words ``or moral
conviction'' were added after ``religious belief.'' I think that the
Supreme Court in considering the protection we give religious
beliefs has given comparable treatment to deeply held moral
convictions. I would not be averse to amending the language of the
amendment in such a manner. It is consistent with the general
purpose. I see no reason why a deeply held moral conviction ought
not be given the same treatment as a religious belief.
Mr. STEVENSON. The Senator's suggestion is well taken. I thank
him.
119 Congr. Rec. S5717-18
As the debate proceeded, Senator Church went on to quote Doe v.
Bolton's reliance on a Georgia statute that stated ``a physician or any
other employee has the right to refrain, for moral or religious
reasons, from participating in the abortion procedure.'' 119 Congr.
Rec. S5722 (quoting 410 U.S. at 197-98). Senator Church added, ``I see
no reason why the amendment ought not also to cover doctors and nurses
who have strong moral convictions against these particular
operations.'' Id. Considering the scope of the protections, Senator
Gaylord Nelson (D-WI) asked whether, ``if a hospital board, or whatever
the ruling agency for the hospital was, a governing agency or
otherwise, just capriciously--and not upon the religious or moral
questions at all--simply said, `We are not going to bother with this
kind of procedure in this hospital,' would the pending amendment permit
that?'' 119 Congr. Rec. S5723. Senator Church responded that the
amendment would not encompass such an objection. Id.
Senator James L. Buckley (C-NY), speaking in support of the
amendment, added the following perspective:
Mr. BUCKLEY. Mr. President, I compliment the Senator from Idaho
for proposing this most important and timely amendment. It is timely
in the first instance because the attempt has already been made to
compel the performance of abortion and sterilization operations on
the part of those who are fundamentally opposed to such procedures.
And it is timely also because the recent Supreme Court decisions
will likely unleash a series of court actions across the United
States to try to impose the personal preferences of the majority of
the Supreme Court on the totality of the Nation.
I believe it is ironic that we should have this debate at all.
Who would have predicted a year or two ago that we would have to
guard against even the possibility that someone might be free [sic]
\14\ to participate in an abortion or sterilization against his
will? Such an idea is repugnant to our political tradition. This is
a Nation which has always been concerned with the right of
conscience. It is the right of conscience which is protected in our
draft laws. It is the right of conscience which the Supreme Court
has quite properly expanded not only to embrace those young men who,
because of the tenets of a particular faith, believe they cannot
kill another man, but also those who because of their own deepest
moral convictions are so persuaded.
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\14\ The Senator might have meant ``[forced] . . . against his
will.''
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I am delighted that the Senator from Idaho has amended his
language to include the words ``moral conviction,'' because, of
course, we know that this is not a matter of concern to any one
religious body to the exclusion of all others, or even to men who
believe in a God to the exclusion of all others. It has been a
traditional concept in our society from the earliest times that the
right of conscience, like the paramount right to life from which it
is derived, is sacred.
119 Congr. Rec. S5723
In support of the same protections when they were debated in the
U.S. House, Representative Margaret Heckler (R-MA) \15\ likewise
observed that ``the right of conscience has long been recognized in the
parallel situation in which the individual's right to conscientious
objector status in our selective service system has been protected''
and ``expanded by the Supreme Court to include moral conviction as well
as formal religious belief.'' 119 Congr. Rec. H4148-49 (May 31, 1973).
Rep. Heckler added, ``We are concerned here only with the right of
moral conscience, which has always been a part of our national
tradition.'' Id. at 4149.
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\15\ Rep. Heckler later served as the 15th Secretary of HHS,
from March 1983 to December 1985.
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These first sections of the Church Amendments, codified at 42
U.S.C. 300a-7(b) and (c)(1), passed the House 372-1, and were approved
by the Senate 94-0. 119 Congr. Rec. at H4149; 119 Congr. Rec. S10405
(June 5, 1973). The subsequently adopted provisions that comprise the
Church Amendments similarly extend protection to those organizations
and individuals who object to the provision of certain services on the
basis of their moral convictions, as well as those who object to such
services on the basis of religious beliefs. And, as noted above,
subsequent statutes add protections for moral objections in many other
situations. These include, for example:
Protections for individuals and entities that object to
abortion. See 42 U.S.C. 238n; 42 U.S.C. 18023; 42 U.S.C. 2996f(b);
Consolidated Appropriations Act, 2018, Div. H, Sec. 507(d), Public Law
115-141.
Protections for entities and individuals that object to
providing or covering contraceptives. See id. at Div. E, Sec. 808; id.
at Div. E, Sec. 726(c) (Financial Services and General Government
Appropriations Act); id. at Div. K, Title III.
Protections for entities and individuals that object to
performing, assisting, counseling, or referring as pertains to suicide,
assisted suicide, or advance directives. See 42 U.S.C. 290bb-36; 42
U.S.C. 1396a(w)(3); 42 U.S.C. 14406; 42 U.S.C. 18113 (adopted as part
of the ACA).
The Departments believe that the intent behind Congress's
protection of moral convictions in certain health care contexts,
especially to protect entities and individuals from governmental
coercion, supports the Departments' decision in the Moral IFC and these
final rules to protect sincerely held moral convictions from
governmental compulsion threatened by the contraceptive Mandate.
b. Court Precedents Relevant to These Expanded Exemptions
As reflected in the legislative history of the first Church
Amendments, the Supreme Court has long afforded protection to moral
convictions alongside religious beliefs. Indeed, Senator Church cited
Doe v. Bolton, 410 U.S. 179, as a parallel instance of conscience
protection and spoke of the Supreme Court generally giving ``comparable
treatment to deeply held moral convictions.'' Both Senator Buckley and
Rep. Heckler specifically cited the Supreme Court's protection of moral
convictions in laws governing military service. Those legislators
appear to have been referencing cases such as Welsh v. United States,
398 U.S. 333 (1970), which the Supreme Court had decided just three
years earlier.
Welsh involved what is perhaps the Government's paradigmatic
compelling interest--the need to defend the nation by military force.
The Court stated that, where the Government protects objections to
military service based on ``religious training and belief,'' that
protection would also extend to avowedly non-religious objections to
war held with the same moral strength.
[[Page 57601]]
Id. at 343. The Court declared, ``[i]f an individual deeply and
sincerely holds beliefs that are purely ethical or moral in source and
content but that nevertheless impose upon him a duty of conscience to
refrain from participating in any war at any time, those beliefs
certainly occupy in the life of that individual `a place parallel to
that filled by . . . God' in traditionally religious persons. Because
his beliefs function as a religion in his life, such an individual is
as much entitled to a `religious' conscientious objector exemption . .
. as is someone who derives his conscientious opposition to war from
traditional religious convictions.''
In the context of this particular Mandate, it is also worth noting
that, in Hobby Lobby, Justice Ginsburg (joined, in this part of the
opinion, by Justices Breyer, Kagan, and Sotomayor), cited Justice
Harlan's opinion in Welsh, 398 U.S. at 357-58, in support of her
statement that ``[s]eparating moral convictions from religious beliefs
would be of questionable legitimacy.'' 134 S. Ct. at 2789 n.6. In
quoting this passage, the Departments do not mean to suggest that all
laws protecting only religious beliefs constitute an illegitimate
``separat[ion]'' of moral convictions, nor do the Departments assert
that moral convictions must always be protected alongside religious
beliefs; we also do not agree with Justice Harlan that distinguishing
between religious and moral objections would violate the Establishment
Clause. Instead, the Departments believe that, in the specific health
care context implicated here, providing respect for moral convictions
parallel to the respect afforded to religious beliefs is appropriate,
draws from long-standing Federal Government practice, and shares common
ground with Congress's intent in the Church Amendments and in later
federal statutes that provide protections for moral convictions
alongside religious beliefs in other health care contexts.
c. Conscience Protections in Other Federal and State Contexts
The tradition of protecting moral convictions in certain health
contexts is not limited to laws passed by Congress. Multiple federal
regulations protect objections based on moral convictions in such
contexts.\16\ Other federal regulations have also applied the principle
of respecting moral convictions alongside religious beliefs in
particular circumstances. The Equal Employment Opportunity Commission
has consistently protected ``moral or ethical beliefs as to what is
right and wrong which are sincerely held with the strength of
traditional religious views'' alongside religious views under the
``standard [ ] developed in United States v. Seeger, 380 U.S. 163
(1965) and [Welsh].'' 29 CFR 1605.1. The Department of Justice has
declared that, in cases of capital punishment, no officer or employee
may be required to attend or participate if doing so ``is contrary to
the moral or religious convictions of the officer or employee, or if
the employee is a medical professional who considers such participation
or attendance contrary to medical ethics.'' 28 CFR 26.5.\17\
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\16\ See, for example, 42 CFR 422.206 (declaring that the
general Medicare Advantage rule ``does not require the MA plan to
cover, furnish, or pay for a particular counseling or referral
service if the MA organization that offers the plan--(1) Objects to
the provision of that service on moral or religious grounds.''); 42
CFR 438.102 (declaring that information requirements do not apply
``if the MCO, PIHP, or PAHP objects to the service on moral or
religious grounds''); 48 CFR 1609.7001 (``health plan sponsoring
organizations are not required to discuss treatment options that
they would not ordinarily discuss in their customary course of
practice because such options are inconsistent with their
professional judgment or ethical, moral or religious beliefs.''); 48
CFR 352.270-9 (``Non-Discrimination for Conscience'' clause for
organizations receiving HIV or Malaria relief funds).
\17\ See also 18 CFR 214.11 (where a law enforcement agency
(LEA) seeks assistance in the investigation or prosecution of
trafficking of persons, the reasonableness of the LEA's request will
depend in part on ``[c]ultural, religious, or moral objections to
the request'').
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Forty-five states have health care conscience protections covering
objections to abortion; several of these also cover sterilization or
contraception.\18\ Most of those state laws protect objections based on
``moral,'' ``ethical,'' or ``conscientious'' grounds in addition to
``religious'' grounds. Particularly in the case of abortion, some
federal and state conscience laws do not require any specified motive
for the objection. 42 U.S.C. 238n; Consolidated Appropriations, 2018,
Public Law 115-141, Div. H, section 507(d).
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\18\ According to the Guttmacher Institute, 45 states have
conscience statutes pertaining to abortion (43 of which cover
institutions), 18 have conscience statutes pertaining to
sterilization (16 of which cover institutions), and 12 have
conscience statutes pertaining to contraception (8 of which cover
institutions). ``Refusing to Provide Health Services,'' The
Guttmacher Institute (June 1, 2017), https://www.guttmacher.org/state-policy/explore/refusing-provide-health-services.
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These various statutes and regulations reflect an important
governmental interest in protecting moral convictions in appropriate
health contexts. The contraceptive Mandate implicates that governmental
interest. Many persons and entities object to the Mandate in part
because they consider some forms of FDA-approved contraceptives to be
morally equivalent to abortion due to the possibility that such items
may prevent the implantation of a human embryo after fertilization.\19\
The Supreme Court, in describing family business owners with religious
objections, explained that ``[t]he owners of the businesses have
religious objections to abortion, and according to their religious
beliefs the four contraceptive methods at issue are abortifacients. If
the owners comply with the HHS mandate, they believe they will be
facilitating abortions.'' Hobby Lobby, 134 S. Ct. at 2751. Based on
pleadings in the litigation, all of the litigants challenging the
Mandate and asserting purely non-religious objections share this view.
And as Congress has implicitly recognized in providing health care
conscience protections pertaining to sterilization, contraception, and
other health care services and practices, individuals or entities may
have additional moral objections to contraception.\20\
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\19\ FDA, ``Birth Control,'' U.S. Food and Drug Administration
(Mar. 6, 2018), https://www.fda.gov/forconsumers/byaudience/forwomen/freepublications/ucm313215.htm (various approved
contraceptives, including Levonorgestrel, Ulipristal Acetate, and
IUDs, work mainly by preventing fertilization, but ``may also work .
. . by preventing attachment (implantation) to the womb (uterus)''
of a human embryo after fertilization).
\20\ See supra note 1.
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d. Founding Principles
The Departments also look to guidance from, and draw support for
the Moral IFC and these final rules from, the broader history of
respect for conscience in the laws and founding principles of the
United States. Members of Congress specifically relied on the American
tradition of respect for conscience when they decided to protect moral
convictions in health care. In supporting the protection of conscience
based on non-religious moral convictions, Senator Buckley declared
``[i]t has been a traditional concept in our society from the earliest
times that the right of conscience, like the paramount right to life
from which it is derived, is sacred.'' Representative Heckler similarly
stated that ``the right of moral conscience . . . has always been a
part of our national tradition.'' This tradition is reflected, for
example, in a letter President George Washington wrote saying that
``[t]he Citizens of the United States of America have a right to
applaud themselves for having given to mankind examples of an enlarged
and liberal policy: A policy worthy of imitation. All possess alike
liberty of conscience and immunities of
[[Page 57602]]
citizenship.'' \21\ Thomas Jefferson similarly declared that ``[n]o
provision in our Constitution ought to be dearer to man than that which
protects the rights of conscience against the enterprises of the civil
authority.'' \22\ Although these statements by Presidents Washington
and Jefferson were spoken to religious congregations, and although
religious and moral conscience were tightly intertwined for the
Founders, they both reflect a broad principle of respect for conscience
against government coercion. James Madison likewise called conscience
``the most sacred of all property,'' and proposed that the Bill of
Rights should guarantee, in addition to protecting religious belief and
worship, that ``the full and equal rights of conscience [shall not] be
in any manner, or on any pretext infringed.'' \23\
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\21\ Letter from George Washington to the Hebrew Congregation in
Newport, Rhode Island (Aug. 18, 1790) (available at https://founders.archives.gov/documents/Washington/05-06-02-0135).
\22\ Letter to the Society of the Methodist Episcopal Church at
New London, Connecticut (February 4, 1809) (available at https://founders.archives.gov/documents/Jefferson/99-01-02-9714).
\23\ James Madison, ``Essay on Property'' (March 29, 1792);
First draft of the First Amendment, 1 Annals of Congress 434 (June
8, 1789).
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These Founding Era statements of general principle do not specify
how they would be applied in a particular health care context, and the
Departments do not suggest that the specific protections offered in the
Moral IFC and these final rules would be required or necessarily
appropriate in any other context that does not raise the specific
concerns implicated by this Mandate. These final rules do not address
in any way how the Government would balance its interests with respect
to other health services not encompassed by the contraceptive
Mandate.\24\ Instead, the Departments highlight this tradition of
respect for conscience from the Nation's Founding Era to provide
background support for the Departments' decision to implement section
2713(a)(4), while protecting conscience in the exercise of moral
convictions. The Departments believe that these final rules are
consistent both with the American tradition of respect for conscience
and with Congress's history of providing conscience protections in the
kinds of health care matters involved in this Mandate.
---------------------------------------------------------------------------
\24\ As the Supreme Court stated in Hobby Lobby, the Court's
decision concerns only the contraceptive Mandate, and should not be
understood to hold that all insurance-coverage mandates, for
example, for vaccinations or blood transfusions, must necessarily
fail if they conflict with an employer's religious beliefs. Nor does
the Court's opinion provide a shield for employers who might cloak
illegal discrimination as a religious (or moral) practice. 134 S.
Ct. at 2783.
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e. Executive Orders Relevant to These Expanded Exemptions
Protecting moral convictions, as set forth in these expanded
exemptions and accommodation in these final rules, is consistent with
recent executive orders. President Trump's Executive Order concerning
this Mandate directed the Departments to consider providing
protections, not specifically for ``religious'' beliefs, but for
``conscience.'' We interpret that term to include both religious
beliefs and moral convictions. Moreover, President Trump's first
Executive Order, E.O. 13765, declared that ``the Secretary of Health
and Human Services (Secretary) and the heads of all other executive
departments and agencies (agencies) with authorities and
responsibilities under the [ACA] shall exercise all authority and
discretion available to them to waive, defer, grant exemptions from, or
delay the implementation of any provision or requirement of the Act
that would impose a fiscal burden on any state or a cost, fee, tax,
penalty, or regulatory burden on individuals, families, healthcare
providers, health insurers, patients, recipients of healthcare
services, purchasers of health insurance, or makers of medical devices,
products, or medications.'' The exemption and accommodation adopted in
these final rules relieves a regulatory burden imposed on entities with
moral convictions opposed to providing certain contraceptive coverage
and is therefore consistent with both Executive Orders.
f. Litigation Concerning the Mandate
The Departments have further taken into consideration the
litigation surrounding the Mandate in exercising their discretion to
adopt the exemption in these final rules. Among the lawsuits
challenging the Mandate, two have been filed based in part on non-
religious moral convictions. In one case, the Departments are subject
to a permanent injunction requiring us to respect the non-religious
moral objections of an employer. See March for Life v. Burwell, 128 F.
Supp. 3d 116 (D.D.C. 2015). In the other case, an appeals court
affirmed a district court ruling that allows the previous regulations
to be imposed in a way that affects the moral convictions of a small
nonprofit pro-life organization and its employees. See Real
Alternatives v. Sec'y, Dep't of Health & Human Servs., 867 F.3d 338 (3d
Cir. 2017). The Departments' litigation of these cases has thus led to
inconsistent court rulings, consumed substantial governmental
resources, and created uncertainty for objecting organizations,
issuers, third party administrators, and employees and beneficiaries.
The organizations that have sued seeking a moral exemption have adopted
longstanding moral tenets opposed to certain FDA-approved
contraceptives, and hire only employees who share this view. As a
result, it is reasonable to conclude that employees of these
organizations would not benefit from the Mandate. Thus, subjecting this
subset of organizations to the Mandate does not advance any
governmental interest. The need to resolve this litigation and the
potential concerns of similar entities, as well as the legal
requirement to comply with permanent injunctive relief currently
imposed in March for Life, provide substantial reasons for the
Departments to protect moral convictions through these final rules.
Although, as discussed below, the Departments assume the number of
entities and individuals that may seek exemption from the Mandate on
the basis of moral convictions, as these two sets of litigants did,
will be small, the Departments know from the litigation that it will
not be zero. As a result, the Departments have taken these types of
objections into consideration in reviewing our regulations. Having done
so, the Departments consider it appropriate to issue the protections
set forth in these final rules. Just as Congress, in adopting the early
provisions of the Church Amendments, viewed it as necessary and
appropriate to protect those organizations and individuals with
objections to certain health care services on the basis of moral
convictions, so the Departments, too, believe that ``our moral
convictions as well as our religious beliefs, warrant protection from
this intrusion by the Government'' in this situation. See 119 Congr.
Rec. S5717-18.
The litigation concerning the Mandate has also underscored how
important it is for the Government to tread carefully when engaging in
regulation concerning sensitive health care areas. As demonstrated by
the litigation, as well as the public comments, various citizens
sincerely hold moral convictions, which are not necessarily religious,
against providing or participating in coverage of contraceptive items
included in the Mandate, and some believe that certain contraceptive
items may cause early abortions. Providing conscience protections
advances the ACA's goal of expanding health coverage among entities and
individuals that might otherwise be reluctant to participate in the
market. For example, the Supreme Court in Hobby Lobby declared that, if
HHS requires owners of businesses to
[[Page 57603]]
cover procedures that the owners ``could not in good conscience''
cover, such as abortion, ``HHS would effectively exclude these people
from full participation in the economic life of the Nation.'' 134 S.
Ct. at 2783. That sort of outcome is one the Departments wish to avoid.
The Departments wish to implement the contraceptive coverage Guidelines
issued under section 2713(a)(4) in a way that respects the moral
convictions of Americans so that they are freer to engage in ``full
participation in the economic life of the Nation.'' The exemptions in
these final rules do so by removing an obstacle that might otherwise
lead entities or individuals with moral objections to contraceptive
coverage to choose not to sponsor or participate in health plans if
they include such coverage.
3. Whether Moral Exemptions Should Exist, and Whom They Should Cover
As noted above, the Department received comments expressing diverse
views as to whether exemptions based on moral convictions should exist
and, if so, whom they should cover.
Some commenters supported the expanded exemptions and accommodation
in the Moral IFC, and the choice of entities and individuals to which
they applied. They stated the expanded exemptions and accommodation
would be an appropriate exercise of discretion and would be consistent
with moral exemptions Congress has provided in many similar contexts.
Similarly, commenters stated that the accommodation would be an
inadequate means to resolve moral objections and that the expanded
exemptions are needed. They contended that the accommodation process
was objectionable because it was another method of complying with the
Mandate, its self-certification or notice involved triggering the very
contraceptive coverage that organizations objected to, and the coverage
for contraceptive services ``hijacked'' or flowed in connection with
the objecting organizations' health plans. The commenters contended
that the seamlessness cited by the Departments between contraceptive
coverage and an accommodated plan gives rise to moral objections that
organizations would not have with an expanded exemption. Commenters
also stated that, with respect to non-profit organizations that have
moral objections and only hire persons who agree with those objections,
the Mandate serves no legitimate government interest because the
mandated coverage is neither wanted nor used and, therefore, would
yield no benefits--it would only suppress the existence of non-profit
organizations holding those views.
Several other commenters stated that the exemptions were still too
narrow. They asked that the exemptions set forth in these final rules
be as broad as the exemptions set forth in the Religious IFC concerning
sincerely held religious beliefs. Some of these commenters also asked
that HHS withdraw its Mandate of contraceptive coverage from the
Guidelines entirely. They contended that fertility and pregnancy are
generally healthy conditions, not diseases that are appropriately the
target of a preventive health service; that contraceptives can pose
medical risks for women; and that studies do not show that
contraceptive programs reduce abortion rates or unintended pregnancies.
Some commented that many women report that they sought an abortion
because their contraception failed. Some other commenters contended
that, to the extent the Guidelines require coverage of certain drugs
and devices that may prevent implantation of an embryo after
fertilization, they require coverage of items that are abortifacient
and, therefore, violate federal conscience protections such as the
Weldon Amendment, Consolidated Appropriations Act, 2017, Public Law
115-31, Div. H, Sec. 507(d).
Other commenters contended that the exemptions in the Moral IFC
were too broad. Some of these commenters expressed concern about the
prospect of publicly traded for-profit entities also being afforded a
moral exemption. One such commenter commented that allowing publicly
traded for-profit entities a moral exemption could cause instability
and confusion, as leadership changes at such a corporation may
effectively change the corporation's eligibility for a moral exemption.
Still others stated that the Departments should not exempt various
kinds of entities such as businesses, issuers, or nonprofit entities,
arguing that only individuals, not entities, can possess moral
convictions. Some commenters were concerned that providing moral
exemptions would contribute to population growth and related societal
woes. Other commenters contended the exemptions and accommodation
should not be expanded, but should remain the same as they were in the
July 2015 final regulations (80 FR 41318), which did not encompass
moral convictions. Other commenters stated that the Departments should
not provide exemptions, but merely an accommodation process, to resolve
moral objections to the Mandate.
Some commenters objected to providing any exemption or
accommodation for moral objections at all. Some of these commenters
contended that even the previous regulations allowing an exemption and
accommodation were too broad and that no exemptions to the Mandate
should exist, in order that contraceptive coverage would be provided to
as many women as possible. Other commenters did not go that far, but
rejected the idea of exemptions or an accommodation based on moral
convictions, contending that such exemptions or accommodation would
contribute to population growth and related social woes. Some of these
commenters also contended that the exemption in the Moral IFC would
constitute an exemption covering every business and non-profit
organization.
After considering these comments, and although the previous
Administration declined to afford any exemption based on moral
convictions, the Departments have concluded that it is appropriate to
provide moral exemptions and access to the accommodation, as set forth
in these final rules. Congress did not mandate contraceptive coverage,
nor provide any explicit guidance about incorporating conscience
exemptions into the Guidelines. But as noted above, it is a long-
standing Congressional practice to provide consistent exemptions for
both religious beliefs and moral convictions in many federal statutes
in the health care context, and specifically concerning issues such as
abortion, sterilization, and contraception. It is not clear to the
Departments that, if Congress had expressly mandated contraceptive
coverage in the ACA, it would have done so without providing for
similar exemptions. Therefore, the Departments consider it appropriate,
to the extent we impose a contraceptive Mandate by the exercise of
agency discretion, that we also include an exemption for the protection
of moral convictions in certain cases. The exemptions finalized in
these final rules are generally consistent with the scope of exemptions
that Congress has established in similar contexts. As noted above, the
Departments consider the exemptions in these final rules consistent
with the intent of Executive Order 13535. The Departments also wish to
avoid the stark disparity that may result from respecting religious
objections to providing contraceptive coverage among certain entities
and individuals, but not respecting parallel objections for moral
convictions possessed by any entities and
[[Page 57604]]
individuals at all because those objections are not specifically
religious.
In addition, the Departments note that a significant majority of
states either impose no contraceptive coverage requirement or offer
broader exemptions than the exemption contained in the July 2015 final
regulations.\25\ Although the practice of states is by no means a limit
on the discretion delegated to HRSA by the ACA, nor a statement about
what the Federal Government may do consistent with other limitations in
federal law, such state practices can inform the Departments' view that
it is appropriate to provide conscience protections when exercising
agency discretion.
---------------------------------------------------------------------------
\25\ See ``Insurance Coverage of Contraceptives,'' The
Guttmacher Institute (June 11, 2018), https://www.guttmacher.org/state-policy/explore/insurance-coverage-contraceptives.
---------------------------------------------------------------------------
The Departments decline to use these final rules to remove the
contraceptive Mandate altogether, such as by declaring that HHS acting
through HRSA shall not include contraceptives in the list of women's
preventive services in Guidelines issued under section 2713(a)(4).
HRSA's Guidelines were not issued, ratified, or updated through the
regulations that preceded the Moral IFC and these final rules. Those
Guidelines were issued in separate processes in 2011 and 2016, directly
by HRSA, after consultation with external organizations that operated
under cooperative agreements with HRSA to consider the issue, solicit
public comment, and provide recommendations. The regulations preceding
these final rules attempted only to restate the statutory language of
section 2713 in regulatory form, and delineate what exemptions and
accommodations would apply if HRSA listed contraceptives in its
Guidelines. We decline to use these final rules to direct the separate
process that HRSA uses to determine what specific services are listed
in the Guidelines generally. Some commenters stated that if
contraceptives are not removed from the Guidelines entirely, entities
or individuals with moral objections might not qualify for the
exemptions or accommodation. As discussed below, however, the
exemptions in these rules include a broad range of entities and
individuals of whom we have notice may object based on moral
convictions. The Departments are not aware of specific employers or
individuals whose moral convictions would still be violated by
compliance with the Mandate after the issuance of the Moral IFC and
these final rules.
Some commenters stated that HRSA should remove contraceptives from
the Guidelines because the Guidelines have not been subject to the
notice and comment process under the Administrative Procedure Act. Some
commenters also contended that the Guidelines should be amended to omit
items that may prevent (or possibly dislodge) the implantation of a
human embryo after fertilization, in order to ensure consistency with
conscience provisions that prohibit requiring plans to pay for or cover
abortions. Whether and to what extent the Guidelines continue to list
contraceptives, or items considered to prevent implantation of an
embryo, for entities not subject to exemptions and an accommodation,
and what process is used to include those items in the Guidelines, is
outside the scope of these final rules. These final rules focus on what
moral exemptions and accommodation shall apply if Guidelines issued
under section 2713(a)(4) include contraceptives or items considered to
be abortifacient.
Members of the public that support or oppose the inclusion of some
or all contraceptives in the Guidelines, or wish to comment concerning
the content and process of developing and updating the Guidelines, are
welcome to communicate their views to HRSA, at [email protected].
The Departments also conclude that it would be inadequate to merely
attempt to amend or expand the accommodation process to account for
moral objectors, instead of providing the exemptions. In the past, the
Departments stated in our regulations and court briefs that the
previous accommodation required contraceptive coverage in a way that is
``seamless'' with the coverage provided by the objecting employer. As a
result, in significant respects, the accommodation process did not
actually accommodate the objections of many entities, as indicated by
many entities with religious objections. The Departments have attempted
to identify an accommodation that would eliminate the religious
plaintiffs' objections, including seeking public comment through a
Request For Information, 81 FR 47741 (July 26, 2016), but stated in
January 2017 that we were unable to develop such an approach at that
time.\26\ Just as the Departments continue to believe merely amending
the accommodation process would not adequately address religious
objections to compliance with the Mandate, we do not believe doing so
would adequately address similar moral objections. Furthermore, the few
litigants raising non-religious moral objections have been non-profit
organizations that assert they only hire persons who share the
employers' objection to contraceptive coverage. Consequently, the
Departments conclude that the most appropriate approach to resolve
these concerns is to provide the exemptions set forth in the Moral IFC
and these final rules. These final rules also finalize the
modifications to the accommodation process to make it available to
entities with moral objections, without forcing such entities to choose
between compliance with either the Mandate or the accommodation.
---------------------------------------------------------------------------
\26\ See Departments of Labor, Health and Human Services, and
the Treasury, FAQs About Affordable Care Act Implementation Part 36,
(Jan. 9, 2017), https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/ACA-FAQs-Part36_1-9-17-Final.pdf (``the comments reviewed by the
Departments in response to the RFI indicate that no feasible
approach has been identified at this time that would resolve the
concerns of religious objectors, while still ensuring that the
affected women receive full and equal health coverage, including
contraceptive coverage'').
---------------------------------------------------------------------------
Some commenters expressed concern over the lack of a definition of
``moral convictions'' in the Moral IFC, arguing that, without a
definition, any objection could be encompassed by the exemptions even
if it is not based on moral convictions. The Departments did not adopt
a regulatory definition of ``moral convictions'' in the Moral IFC, and
have decided not to adopt such a definition in response to public
comments at this time. Nevertheless, the Departments look to the
description of moral convictions in Welsh to help explain the scope of
the protection provided in the Moral IFC and these final rules. Neither
these final rules or the Moral IFC, nor the Church Amendments or other
Federal health care conscience statutes, define ``moral convictions''
(nor do they define ``religious beliefs''). But in issuing these final
rules, we adopt the same background understanding of that term that is
reflected in the Congressional Record in 1973, in which legislators
referenced cases such as Welsh to support the addition of language
protecting moral convictions. In protecting moral convictions in
parallel to religious beliefs, Welsh describes moral convictions
warranting such protection as ones: (1) That the ``individual deeply
and sincerely holds''; (2) ``that are purely ethical or moral in source
and content''; (3) ``but that nevertheless impose upon him a duty'';
(4) and that ``certainly occupy in the life of that individual a place
parallel to that filled by . . . God' in traditionally religious
persons,'' such
[[Page 57605]]
that one could say ``his beliefs function as a religion in his life.''
398 U.S. at 339-40. As recited above, Senators Church and Nelson agreed
that protections for such moral convictions would not encompass an
objection that an individual or entity raises ``capriciously.''
Instead, along with the requirement that protected moral convictions
must be ``sincerely held,'' this understanding cabins the protection of
moral convictions in contexts where they occupy a place parallel to
that filled by sincerely held religious beliefs in religious persons
and organizations.
While moral convictions are the sort of principles that, in the
life of an individual, occupy a place parallel to religion, sincerely
held moral convictions can also be adopted by corporate bodies, not
merely by individuals. Senators Church and Nelson, while discussing the
fact that opposition to abortion or sterilization on the basis of
``moral questions'' does not include capricious opposition to abortion
for no reason at all, were specifically talking about opposition to
abortion by corporate entities: A ``hospital board, or whatever the
ruling agency for the hospital was, a governing agency or otherwise.''
\27\ Corporate bodies operate by the decision-making actions of
individuals. Thus, if individuals act in the governance of a corporate
body so as to adopt a position for that body of adopting moral
convictions against coverage of contraceptives, such an entity can be
considered to have an objection to contraceptive coverage on the basis
of sincerely held moral convictions.
---------------------------------------------------------------------------
\27\ Nor was this recognition of the need to protect
organizations that object to performance of certain health care
procedures on the basis of moral conviction limited to the Church
Amendments' legislative history. The first of the Church Amendments
provides, in part, that the receipt of certain federal funds ``by
any individual or entity does not authorize any court or any public
official or other public authority to require-- . . . (2) such
entity to--(A) make its facilities available for the performance of
any sterilization procedure or abortion if the performance of such
procedure or abortion in such facilities is prohibited by the entity
on the basis of religious beliefs or moral convictions, or (B)
provide any personnel for the performance or assistance in the
performance of any sterilization procedure or abortion if the
performance or assistance in the performance of such procedures or
abortion by such personnel would be contrary to the religious
beliefs or moral convictions of such personnel.'' 42 U.S.C. 300a-
7(b).
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4. The Departments' Rebalancing of Government Interests
The Departments also received comments on their rebalancing of
interests as expressed and referenced in the Moral IFC. Some public
commenters agreed with the Departments' conclusion that our interest in
ensuring contraceptive coverage does not preclude the Departments from
offering exemptions and an accommodation for entities, plans, and
individuals with a qualifying objection to contraceptive coverage based
on moral convictions. Some public commenters pointed out that
protecting moral convictions serves to respect not only the interests
of certain persons to access contraceptives, but also the interests of
other persons to participate in a health coverage market consistent
with their moral convictions. Other commenters disagreed with this
rebalancing, and contended that the interest of women in receiving
contraceptive coverage without cost-sharing is so great that it
overrides private interests to the contrary, such that the government
should or must force private entities to provide this coverage to other
private citizens.
The Departments agree with the commenters who stated that the
governmental interest in requiring contraceptive coverage does not
override the interest in protecting moral convictions and does not make
these expanded exemptions inappropriate. For additional discussion of
the Government's balance of interests as applicable to religious
beliefs, see section II.C.2.b. of the companion final rules concerning
religious exemptions published by the Departments contemporaneously
with these final rules elsewhere in today's Federal Register. There,
and in the Religious and Moral IFCs, the Departments acknowledged the
reasons why the Departments have changed the policies and
interpretations previously adopted with respect to the Mandate and the
governmental interests underlying it. For parallel reasons, the
Departments believe the Government's legitimate interests in providing
for contraceptive coverage do not require the Departments to violate
sincerely held moral convictions while implementing the Guidelines. The
Departments likewise believe Congress did not set forth interests that
require us to violate sincerely held moral convictions if we otherwise
require contraceptive coverage in our discretionary implementation of
the women's preventive services Guidelines under section 2713(a)(4).
The Departments acknowledge that coverage of contraception is an
important and highly controversial issue, implicating many different
views, as reflected for example in the public comments received on
multiple rulemakings over the course of implementation of section
2713(a)(4), added to the PHS Act in 2010. The Departments' expansion of
conscience protections for moral convictions, similar to protections
contained in numerous statutes governing health care regulation, is not
taken lightly. However, after considering public comments on various
sides of the issue, and reconsidering the interests served by the
Mandate in this particular context, the objections raised, and the
relevant federal law, the Departments have determined that affording
the exemptions to protect moral convictions is a more appropriate
administrative response than continuing to refuse to extend the
exemptions and accommodations to certain entities and individuals for
whom the Mandate violates their sincerely held moral convictions.
Although the number of organizations and individuals that may seek to
invoke these exemptions and accommodation may be small, the Departments
believe that it is important to provide such protection, given the
long-standing recognition of such protections in law and regulation in
the health care and health insurance contexts. The Moral IFC and these
final rules leave unchanged HRSA's authority to decide whether to
include contraceptives in the women's preventive services Guidelines
for entities that are not exempted by law, regulation, or the
Guidelines. These rules also do not change the many other mechanisms by
which the Government advances contraceptive coverage, particularly for
low-income women, including through such programs as Medicaid and Title
X. The Departments also note that the exemptions created here, like the
exemptions created by the previous Administration, do not burden third
parties to a degree that counsels against providing the exemptions, as
discussed below.
5. Burdens on Third Parties
The Department received a variety of comments about the effect that
the exemptions and accommodation based on moral convictions would have
on third parties. Some commenters stated that the exemptions and
accommodation do not impose an impermissible or unjustified burden on
third parties, including on women who might otherwise receive
contraceptive coverage with no cost sharing. Other commenters
disagreed, asserting that the exemptions unacceptably burden women who
might lose contraceptive coverage as a result. They contended the
exemptions may remove contraceptive coverage, causing women to have
higher contraceptive costs, fewer contraceptive options, less ability
to use contraceptives more consistently, more
[[Page 57606]]
unintended pregnancies,\28\ births spaced more closely, and workplace,
economic, or societal inequality. Still other commenters took the view
that other laws or protections, such as in the First or Fifth
Amendments, prohibit the expanded exemptions, which those commenters
view as prioritizing conscientious objection of exempted entities over
the conscience, choices, or religious liberty of women who would not
receive contraceptive coverage where an exemption is used. Some
commenters disagreed and said the exemptions do not violate laws and
constitutional protections, nor do they inappropriately prioritize the
conscience of exempted entities over those of third parties.
---------------------------------------------------------------------------
\28\ Some commenters attempted to quantify the costs of
unintended pregnancy, but were unable to provide estimates with
regard to the number of women that this exemption may affect.
---------------------------------------------------------------------------
The Departments note that the exemptions in the Moral IFC and these
final rules, like the exemptions created by the previous
Administration, do not impermissibly burden third parties. Initially,
the Departments observe that these rules do not create a governmental
burden; rather, they relieve a governmental burden. The ACA did not
impose a contraceptive coverage requirement. Agency discretion was
exercised to include contraceptives in the Guidelines issued under
section 2713(a)(4). That decision is what created and imposed a
governmental burden. These rules simply relieve part of that
governmental burden. If some third parties do not receive contraceptive
coverage from private parties whom the government chooses not to
coerce, that result exists in the absence of governmental action--it is
not a result the government has imposed. Calling that result a
governmental burden rests on an incorrect presumption: That the
government has an obligation to force private parties to benefit those
third parties, and that the third parties have a right to those
benefits. Congress did not create a right to receive contraceptive
coverage from other private citizens through section 2713 of the PHS
Act, other portions of the ACA, or any other statutes it has enacted.
Although some commenters also contended such a right might exist under
treaties the Senate has ratified or the Constitution, the Departments
are not aware of any source demonstrating that the Constitution or a
treaty ratified by the Senate creates a right to receive contraceptive
coverage from other private citizens.
The fact that the government at one time exercised its
administrative discretion to require private parties to provide
coverage to which they morally object, to benefit other private
parties, does not prevent the government from relieving some or all of
the burden of that Mandate. Otherwise, any governmental coverage
requirement would be a one-way ratchet. In the Moral IFC and these
final rules, the government has simply restored a zone of freedom where
it once existed. There is no statutory or constitutional obstacle to
the government doing so, and the doctrine of third party burdens should
not be interpreted to impose such an obstacle. Such an interpretation
would be especially problematic given the millions of women, in a
variety of contexts, whom the Mandate does not ultimately benefit,
notwithstanding any expanded exemptions--including through the
grandfathering of plans, the previous religious exemptions, and the
failure of the accommodation to require delivery of contraceptive
coverage in various self-insured church plan contexts.
In addition, the Government is under no constitutional obligation
to fund contraception. Cf. Harris v. McRae, 448 U.S. 297 (1980)
(holding that, although the Supreme Court has recognized a
constitutional right to abortion, there is no constitutional obligation
for government to pay for abortions). Even more so may the government
refrain from requiring private citizens, in violation of their moral
convictions, to cover contraception for other citizens. Cf. Rust v.
Sullivan, 500 U.S. 173, 192-93 (1991) (``A refusal to fund protected
activity, without more, cannot be equated with the imposition of a
`penalty' on that activity.''). The constitutional rights of liberty
and privacy do not require the government to force private parties to
provide contraception to other citizens and do not prohibit the
government from protecting moral objections to such governmental
mandates, especially where, as here, the Mandate is not an explicit
statutory requirement.\29\ The Departments do not believe that the
Constitution prohibits offering the expanded exemptions in these rules.
---------------------------------------------------------------------------
\29\ See, for example, Planned Parenthood Ariz., Inc. v. Am.
Ass'n of Pro-Life Obstetricians & Gynecologists, 257 P.3d 181, 196
(Ariz. Ct. App. 2011) (``[A] woman's right to an abortion or to
contraception does not compel a private person or entity to
facilitate either.'').
---------------------------------------------------------------------------
Some commenters objected that the exemptions would violate the
Establishment Clause of the First Amendment. The Moral IFC and these
final rules create exemptions for moral convictions, not religious
beliefs, and they do so for the same neutral purposes for which
Congress has created similar exemptions for over four decades. Not only
do these final rules not violate the Establishment Clause, but the
Departments' decision to provide the exemptions and accommodation for
moral convictions, instead of limiting the exemptions to identical
objections based on religious beliefs, further demonstrates that
neither the purpose nor the effect of these exemptions is to establish
religion. The Establishment Clause does not force the Department to
impose a contraceptive Mandate in violation of the moral convictions of
entities and individuals protected by these rules.
American governmental bodies have, in many instances, refrained
from requiring certain private parties to cover contraceptive services
for other private parties. From 1789 through 2012 (when HRSA's
Guidelines went into effect), there was no federal women's preventive
services coverage mandate imposed nationally on health insurance and
group health plans. The ACA did not require contraceptives to be
included in HRSA's Guidelines, and it did not require any preventive
services required under section 2713 of the PHS Act to be covered by
grandfathered plans. Many states do not impose contraceptive coverage
mandates, or they offer religious, and in some cases moral, exemptions
to the requirements of such coverage mandates--exemptions that have not
been invalidated by federal or state courts. The Departments, in
previous regulations, exempted houses of worship and integrated
auxiliaries from the Mandate. The Departments then issued a temporary
enforcement safe harbor allowing religious nonprofit groups to not
provide contraceptive coverage under the Mandate for almost two
additional years. The Departments further expanded the houses of
worship and integrated auxiliaries exemption through definitional
changes. And the Departments created an accommodation process under
which many women in self-insured church plans may not ultimately
receive contraceptive coverage. The Departments are not aware of
federal courts declaring that the exemptions, safe harbor, or
accommodations gave rise to third party burdens that required the
government to mandate contraceptive coverage by entities eligible for
an exemption or accommodation. In addition, many organizations have not
been subject to the Mandate in practice because of injunctions they
received through litigation, protecting them from federal imposition of
the Mandate, including
[[Page 57607]]
under several recently entered permanent injunctions that will apply
regardless of the issuance of these final rules.
Commenters offered various assessments of the impact these rules
might have on state or local governments. Some commenters stated that
the expanded exemptions will not burden state or local governments, or
that such burdens should not prevent the Departments from offering
those exemptions. Others commenters stated that if the Departments
provide expanded exemptions, states or local jurisdictions may face
higher costs in providing birth control to women through government
programs. The Departments consider it appropriate to offer expanded
exemptions, notwithstanding the objection of some state or local
governments. Until 2012, there was no federal mandate of contraceptive
coverage across health insurance and health plans nationwide. The ACA
did not require a contraceptive Mandate, and its discretionary creation
by means of HRSA's Guidelines does not translate to a benefit that the
federal government owes to state or local governments. The various
situations recited in the previous paragraph, in which the federal
government has not imposed contraceptive coverage, have not been deemed
to cause a cognizable injury to state or local governments. The
Departments find no legal prohibition on finalizing these final rules
based on the allegation of an impact on state or local governments, and
disagree with the suggestion that once having exercised our discretion
to deny exemptions--no matter how recently or incompletely--the
Departments cannot change course if some state and local governments
believe they are receiving indirect benefits from the previous
decision.
In addition, the exemptions at issue here are available only to a
tiny fraction of entities to which the Mandate would otherwise apply--
those with qualifying moral objections. Public comments did not provide
reliable data on how many entities would use these expanded moral
exemptions, in which states women in those plans would reside, how many
of those women would qualify for or use state and local government
subsidies of contraceptives as a result, or in which states such women,
if they are low income, would go without contraceptives and potentially
experience unintended pregnancies that state Medicaid programs would
potentially have to cover. As noted below, at least one study \30\ has
concluded the Mandate caused no clear increase in contraceptive use;
one explanation proposed by the authors of the study is that women
eligible for family planning from safety net programs were already
receiving free or subsidized contraceptive access through them,
notwithstanding the Mandate's effects on the overall market. Some
commenters who opposed the exemptions admitted that this information is
unclear at this stage; other commenters that estimated considerably
more individuals and entities would seek an exemption also admitted the
difficulty of quantifying estimates. In addition, the only entities
that have brought suit based on their moral objections to the Mandate
are non-profit entities that have said they only hire persons who share
their objections and do not use the contraceptives to which their
employers object, so it is unlikely that exemptions for those entities
would have any impact on safety net programs. Below, we predict that a
small number of additional nonprofit and closely held for-profit
entities will use the exemptions based on moral convictions. In light
of the limited evidence of third party or state and local government
impact of these final rules, the Departments consider it an appropriate
policy option to provide the exemptions.
---------------------------------------------------------------------------
\30\ M.L. Kavanaugh et al., ``Contraceptive method use in the
United States: trends and characteristics between 2008, 2012 and
2014,'', 97 Contraception 14, 14-21 (2018), available at https://www.contraceptionjournal.org/article/S0010-7824(17)30478-X/pdf.
---------------------------------------------------------------------------
Some commenters contended that the exemptions would constitute
unlawful sex discrimination, such as under section 1557 of the
Affordable Care Act, Title VII of the Civil Rights Act of 1964, Title
IX of the Education Amendments of 1972, or the Fifth Amendment. Some
commenters suggested the expanded exemptions would discriminate on
bases such as race, disability, or LGBT status, or that they would
disproportionately burden certain persons in such categories.
But these rules do not discriminate or draw any distinctions on the
basis of sex, pregnancy, race, disability, socio-economic class, LGBT
status, or otherwise, nor do they discriminate on any unlawful grounds.
The exemptions in these rules do not authorize entities to comply with
the Mandate for one person, but not for another person, based on that
person's status as a member of a protected class. Instead, they allow
entities that have sincerely held moral objections to providing some or
all contraceptives included in the Mandate to not be forced to provide
coverage of those items to anyone.
Those commenters' contentions about discrimination are unpersuasive
for still additional reasons. First, Title VII is applicable to
discrimination committed by employers, and these final rules have been
issued in the government's capacity as a regulator of group health
plans and group and individual health insurance, not in its capacity as
an employer. See also In Re Union Pac. R.R. Emp't Practices Litig., 479
F.3d 936, 940-42 & n.1 (8th Cir. 2007) (holding that Title VII ``does
not require coverage of contraception because contraception is not a
gender-specific term like potential pregnancy, but rather applies to
both men and women''). Second, these rules create no disparate impact.
The women's preventive service mandate under section 2713(a)(4), and
the contraceptive Mandate promulgated under such preventive services
mandate, already inure to the specific benefit of women--men are denied
any benefit from section 2713(a)(4). Both before and after these rules
are in effect, section 2713(a)(4) and the Guidelines issued under that
section treat women's preventive services in general, and female
contraceptives specifically, more favorably than they treat male
preventive services or contraceptives.
It is simply not the case that the government's implementation of
section 2713(a)(4) is discriminatory against women because exemptions
encompass moral objections. The previous rules, as discussed elsewhere
herein, do not require contraceptive coverage in a host of plans,
including grandfathered plans, plans of houses of worship and
integrated auxiliaries, and--through inability to enforce the
accommodation on certain third party administrators--plans of many
religious non-profits in self-insured church plans. Below, the
Departments estimate that nearly all women of childbearing age in the
country will be unaffected by these exemptions. In this context, the
Departments do not believe that an adjustment to discretionary
Guidelines for women's preventive services concerning contraceptives
constitutes unlawful sex discrimination. Otherwise, anytime the
government exercises its discretion to provide a benefit that is
specific to women (or specific to men), it would constitute sex
discrimination for the government to reconsider that benefit. Under
that theory, Hobby Lobby itself, and RFRA (on which Hobby Lobby's
holding was based), which provided a religious exemption to this
Mandate for many businesses, would be deemed discriminatory against
women
[[Page 57608]]
because the underlying women's preventive services requirement is a
benefit for women, not for men. Such conclusions are not consistent
with legal doctrines concerning sex discrimination.
It is not clear that these expanded exemptions will significantly
burden women most at risk of unintended pregnancies. Some commenters
stated that contraceptives are often readily accessible at relatively
low cost. Other commenters disagreed. Some commenters objected that the
Moral IFC's estimate of a $584 yearly cost of contraceptives for women
was too low. But some of those same commenters provided similar
estimates, citing sources claiming that birth control pills can cost up
to $600 per year, and stated that IUDs, which can last 3 to 6 years or
more,\31\ can cost $1,100 (that is, less than $50 per month over the
duration of use). Some commenters stated that, for lower income women,
contraceptives and related education and counseling can be available at
free or low cost through government programs (federal programs offering
such services include, for example, Medicaid, Title X, community health
center grants, and Temporary Assistance for Needy Families (TANF)).
Other commenters contended that many women in employer-sponsored
coverage might not qualify for those programs, although that sometimes
occurs because their incomes are above certain thresholds or because
the programs were not intended to absorb privately covered individuals.
Some commenters observed that contraceptives may be available through
other sources, such as a plan of another family member, and that the
expanded exemptions will not likely encompass a very large segment of
the population otherwise benefitting from the Mandate. Other commenters
disagreed, emphasizing that income and eligibility thresholds could
prevent some women from receiving contraceptives through certain
government programs if they were no longer covered in their group
health plans or health insurance plans.
---------------------------------------------------------------------------
\31\ See, for example, ``IUD,'' Planned Parenthood, https://www.plannedparenthood.org/learn/birth-control/iud.
---------------------------------------------------------------------------
The Departments do not believe that such differences make it
inappropriate to issue the expanded exemptions set forth in these
rules. As explained more fully below, the Departments estimate that
nearly all women of childbearing age in the country will be unaffected
by these exemptions. Moreover, the Departments note that the HHS Office
of Population Affairs, within the Office of the Assistant Secretary for
Health, has recently issued a proposed rule to amend the regulations
governing its Title X family planning program. The proposed rule would
amend the definition of ``low income family''--individuals eligible for
free or low cost contraceptive services--to include women who are
unable to obtain certain family planning services under their employer-
sponsored health coverage due to their employers' religious beliefs or
moral convictions. (83 FR 25502). If that rule is finalized as
proposed, it would further reduce any potential effect of these final
rules on women's access to contraceptives.
Some commenters stated that the expanded exemptions would violate
section 1554 of the ACA. That section says the Secretary of HHS ``shall
not promulgate any regulation'' that ``creates any unreasonable
barriers to the ability of individuals to obtain appropriate medical
care,'' ``impedes timely access to health care services,'' ``interferes
with communications regarding a full range of treatment options between
the patient and the provider,'' ``restricts the ability of health care
providers to provide full disclosure of all relevant information to
patients making health care decisions,'' ``violates the principles of
informed consent and the ethical standards of health care
professionals,'' or ``limits the availability of health care treatment
for the full duration of a patient's medical needs.'' 42 U.S.C. 18114.
Such commenters urged, for example, that the Moral IFC created
unreasonable barriers to the ability of individuals to obtain
appropriate medical care, particularly in areas they said may have a
disproportionately high number of entities likely to take advantage of
the exemption.
The Departments disagree with these comments about section 1554 of
the ACA. The Departments issued previous exemptions and accommodations
that allowed various plans to not provide contraceptive coverage on the
basis of religious objections; multiple courts considered those
regulations; and while many ruled that entities did not need to provide
contraceptive coverage, none ruled that the exemptions or
accommodations in the regulations violated section 1554 of the ACA.
Moreover, the decision not to impose a governmental mandate is not the
creation of a ``barrier,'' especially when that mandate requires
private citizens to provide services to other private citizens. This
would turn the assumptions of the United States' system of government
on its head. See, for example, U.S. Constitution, Ninth Amendment.
Section 1554 of the ACA likewise does not require the Departments to
require coverage of, or to keep in place a requirement to cover,
certain services, including contraceptives, that was issued pursuant to
HHS's exercise of discretion under section 2713(a)(4). Nor does section
1554 of the ACA prohibit the Departments from providing exemptions to
relieve burdens on moral convictions, or as is the case here, from
refraining to impose the Mandate in cases where moral convictions would
be burdened by the Mandate. Moral exemptions from federal mandates in
certain health contexts, including sterilization, contraception, or
items believed to be abortifacient, have existed in federal laws for
decades. Some of those laws were referenced by President Obama in
signing Executive Order 13535. In light of that Executive Order and
Congress's long history of providing exemptions for moral convictions
in the health context, providing moral exemptions is a reasonable
administrative response to this federally mandated burden, especially
since the burden itself is a subregulatory creation that does not apply
in various contexts.
In short, we do not believe sections 1554 or 1557 of the ACA, other
nondiscrimination statutes, or any constitutional doctrines, create an
affirmative obligation to create, maintain, or impose a Mandate that
forces covered entities to provide coverage of preventive contraceptive
services in health plans. The ACA's grant of authority to HRSA to
provide for, and support, the Guidelines is not transformed by any of
the laws cited by commenters into a requirement that, once those
Guidelines exist, they can never be reconsidered, or amended because
doing so would only affect women's coverage or would allegedly impact
particular populations disparately.
In summary, members of the public have widely divergent views on
whether the exemptions in the Moral IFC and these final rules are good
public policy. Some commenters stated that the exemptions would burden
workers, families, and the economic and social stability of the
country, and interfere with the physician-patient relationship. Other
commenters disagreed, favoring the public policy behind the exemption,
and arguing that the exemption would not interfere with the physician-
patient relationship. The Departments have determined that these final
rules are an appropriate exercise of public policy discretion. Because
of the importance of the moral convictions being accommodated, the
limited impact of these final rules, and uncertainty about
[[Page 57609]]
the impact of the Mandate overall according to some studies, the
Departments do not believe these final rules will have any of the
drastic negative consequences on third parties or society that some
opponents of these rules have suggested.
6. Interim Final Rulemaking
The Departments received several comments about the decision to
issue the Moral IFC as interim final rules with request for comments,
instead of as a notice of proposed rulemaking. Several commenters
asserted that the Departments had the authority to issue the Moral IFC
in that way, agreeing with the Departments that there was explicit
statutory authority to do so, good cause under the APA, or both. Other
commenters held the opposite view, contending that there was neither
statutory authority to issue the rules on an interim final basis, nor
good cause under the APA to make the rules immediately effective.
The Departments continue to believe authority existed to issue the
Moral IFC as interim final rules. Section 9833 of the Code, section 734
of ERISA, and section 2792 of the PHS Act authorize the Secretaries of
the Treasury, Labor, and HHS (collectively, the Secretaries) to
promulgate any interim final rules that they determine are appropriate
to carry out the provisions of chapter 100 of the Code, part 7 of
subtitle B of title I of ERISA, and part A of title XXVII of the PHS
Act, which include sections 2701 through 2728 of that Act, and the
incorporation of those sections into section 715 of ERISA and section
9815 of the Code. The Religious and Moral IFCs fall under those
statutory authorizations for the use of interim final rulemaking. Prior
to the Moral IFC, the Departments issued three interim final
regulations implementing this section of the PHS Act because of the
needs of covered entities for immediate guidance and the weighty
matters implicated by the HRSA Guidelines, including issuance of new or
revised exemptions or accommodations. (75 FR 41726; 76 FR 46621; 79 FR
51092). The Departments also had good cause to issue the Moral IFC as
interim final rules, for the reasons discussed therein.
In any event, the objections of some commenters to the issuance of
the Moral IFC as interim final rules with request for comments does not
prevent the issuance of these final rules. These final rules were
issued after receiving and thoroughly considering public comments as
requested in the Moral IFC. These final rules therefore comply with the
APA's notice and comment requirements.
7. Health Effects of Contraception and Pregnancy
The Departments received numerous comments on the health effects of
contraception and pregnancy. As noted above, some commenters supported
the expanded exemptions, and others urged that contraceptives be
removed from the Guidelines entirely, based on the view that pregnancy
and the unborn children resulting from conception are not diseases or
unhealthy conditions that are properly the subject of preventive care
coverage. Such commenters further contended that hormonal
contraceptives may present health risks to women. For example, they
contended that studies show certain contraceptives cause, or are
associated with, an increased risk of depression,\32\ venous
thromboembolic disease,\33\ fatal pulmonary embolism,\34\ thrombotic
stroke and myocardial infarction (particularly among women who smoke,
are hypertensive, or are older),\35\ hypertension,\36\ HIV-1
acquisition and transmission,\37\ and breast, cervical, and liver
cancers.\38\ Some commenters also stated that fertility awareness based
methods of birth spacing are free of similar health risks since they do
not involve ingestion of chemicals. Some commenters contended that it
is not the case that contraceptive access reduces unintended
pregnancies or abortions.
---------------------------------------------------------------------------
\32\ Commenters cited Charlotte Wessel Skovlund, et al.,
``Association of Hormonal Contraception with Depression,'' JAMA
Psychiatry 1154, 1154 (published online Sept. 28, 2016) (``Use of
hormonal contraception, especially among adolescents, was associated
with subsequent use of antidepressants and a first diagnosis of
depression, suggesting depression as a potential adverse effect of
hormonal contraceptive use.'').
\33\ Commenters cited the Practice Committee of the American
Society for Reproductive Medicine, ``Hormonal Contraception: Recent
Advances and Controversies,'' 82 Fertility and Sterility S26, S30
(2004); V.A. Van Hylckama et al., ``The Venous Thrombotic Risk of
Oral Contraceptives, Effects of Estrogen Dose and Progestogen Type:
Results of the MEGA Case-Control Study,'' 339 Brit. Med. J. b2921
(2009); Y. Vinogradova et al., ``Use of Combined Oral Contraceptives
and Risk of Venous Thromboembolism: Nested Case-Control Studies
Using the QResearch and CPRD Databases,'' 350 Brit. Med. J. h2135
(2015) (``Current exposure to any combined oral contraceptive was
associated with an increased risk of venous thromboembolism . . .
compared with no exposure in the previous year.''); [Oslash].
Lidegaard et al., ``Hormonal contraception and risk of venous
thromboembolism: national follow-up study,'' 339 Brit. Med. J. b2890
(2009): M. de Bastos et al., ``Combined oral contraceptives: venous
thrombosis,'' Cochrane Database Syst. Rev., Mar. 3, 2014. doi:
10.1002/14651858.CD010813.pub2, available at https://www.ncbi.nlm.nih.gov/pubmed?term=24590565; L.J. Havrilesky et al.,
``Oral Contraceptive User for the Primary Prevention of Ovarian
Cancer,'' Agency for Healthcare Research and Quality, Report No. 13-
E002-EF (June 2013), available at https://archive.ahrq.gov/research/findings/evidence-based-reports/ocusetp.html; and Robert A. Hatcher
et al., Contraceptive Technology, 405-07 (Ardent Media 18th rev. ed.
2004).
\34\ Commenters cited N.R. Poulter, ``Risk of Fatal Pulmonary
Embolism with Oral Contraceptives,'' 355 Lancet 2088 (2000).
\35\ Commenters cited [Oslash]. Lidegaard et al., ``Thrombotic
Stroke and Myocardial Infarction with Hormonal Contraception, 366 N.
Engl. J. Med. 2257, 2257 (2012) (risks ``increased by a factor of
0.9 to 1.7 with oral contraceptives that included ethinyl estradiol
at a dose of 20 [mu]g and by a factor of 1.3 to 2.3 with those that
included ethinyl estradiol at a dose of 30 to 40 [mu]g''); Practice
Committee of the American Society for Reproductive Medicine,
``Hormonal Contraception''; M. Vessey et al., ``Mortality in
Relation to Oral Contraceptive Use and Cigarette Smoking,'' 362
Lancet 185, 185-91 (2003); WHO Collaborative Study of Cardiovascular
Disease and Steroid Hormone Contraception, ``Acute Myocardial
Infarction and Combined Oral Contraceptives: Results of an
International Multicentre Case-Control Study,'' 349 Lancet 1202,
1202-09 (1997); K.M. Curtis et al., ``Combined Oral Contraceptive
Use Among Women With Hypertension: A Systematic Review,'' 73
Contraception 179, 179-188 (2006); L.A. Gillum et al., ``Ischemic
stroke risk with oral contraceptives: A meta analysis,'' 284 JAMA
72, 72-78 (2000), available at https://www.ncbi.nlm.nih.gov/pubmed/10872016; and Robert A. Hatcher et al., Contraceptive Technology,
404-05, 445 (Ardent Media 18th rev. ed. 2004).
\36\ Commenters cited Robert A. Hatcher et al., Contraceptive
Technology, 407, 445 (Ardent Media 18th rev. ed. 2004).
\37\ Commenters cited Renee Heffron et al., ``Use of Hormonal
Contraceptives and Risk of HIV-1 Transmission: A Prospective Cohort
Study,'' 12 Lancet Infectious Diseases 19, 24 (2012) (``Use of
hormonal contraceptives was associated with a two-times increase in
the risk of HIV-1 acquisition by women and HIV-1 transmission from
women to men.''); and ``Hormonal Contraception Doubles HIV Risk,
Study Suggests,'' Science Daily (Oct. 4, 2011), https://www.sciencedaily.com/releases/2011/10/111003195253.htm.
\38\ Commenters cited ``Oral Contraceptives and Cancer Risk,''
National Cancer Institute (Mar. 21, 2012), https://www.cancer.gov/about-cancer/causes-prevention/risk/hormones/oral-contraceptives-fact-sheet; L.J Havrilesky et al., ``Oral Contraceptive User for the
Primary Prevention of Ovarian Cancer,'' Agency for Healthcare
Research and Quality, Report No. 13-E002-EF (June 2013), available
at https://archive.ahrq.gov/research/findings/evidence-based-reports/ocusetp.html; S. N. Bhupathiraju et al., ``Exogenous hormone
use: Oral contraceptives, postmenopausal hormone therapy, and health
outcomes in the Nurses' Health Study,'' 106 Am. J. Pub. Health 1631,
1631-37 (2016); The World Health Organization Department of
Reproductive Health and Research, ``Carcinogenicity of Combined
Hormonal Contraceptives and Combined Menopausal Treatment,'' (Sept.
2005), available at https://www.who.int/reproductivehealth/topics/ageing/cocs_hrt_statement.pdf; and the American Cancer Society,
``Known and Probably Human Carcinogens,'' American Cancer Society
(rev. Nov. 3, 2016), https://www.cancer.org/cancer/cancer-causes/general-info/known-and-probable-human-carcinogens.html.
---------------------------------------------------------------------------
Other commenters disagreed, citing a variety of studies they
contend show health benefits caused by, or associated
[[Page 57610]]
with, contraceptive use or the prevention of unintended pregnancy.
Commenters cited, for example, the 2011 Report of the Institute of
Medicine (IOM), ``Clinical Preventive Services for Women: Closing the
Gaps,'' in its discussion of the negative effects associated with
unintended pregnancies, as well as other studies. Such commenters
contended that, by reducing unintended pregnancy, contraceptives reduce
the risk of unaddressed health complications, low birth weight, preterm
birth, infant mortality, and maternal mortality. Commenters also stated
that studies show contraceptives are associated with a reduced risk of
conditions such as ovarian cancer, colorectal cancer, and endometrial
cancer, and that contraceptives treat such conditions as endometriosis,
polycystic ovarian syndrome, migraines, pre-menstrual pain, menstrual
regulation, and pelvic inflammatory disease.\39\ Some commenters stated
that pregnancy presents various health risks, such as blood clots,
bleeding, anemia, high blood pressure, gestational diabetes, and death.
Some commenters also contended that increased access to contraception
reduces abortions.
---------------------------------------------------------------------------
\39\ To the extent that contraceptives are prescribed to treat
health conditions, and not for preventive purposes, the Mandate
would not be applicable.
---------------------------------------------------------------------------
Some commenters stated that, in the Moral IFC, the Departments
relied on incorrect statements concerning scientific studies. For
example, some commenters stated that there is no proven increased risk
of breast cancer or other risks among contraceptive users. They
criticized the Departments for citing studies, including one previewed
in the 2011 IOM Report itself (Agency for Healthcare Research and
Quality, Report No. 13-E002-EF (June 2013) (cited above)), discussing
an association between contraceptive use and increased risks of breast
and cervical cancer, and concluding there are no net cancer-reducing
benefits of contraceptive use. As described in the Religious IFC, 82 FR
47804, the 2013 Agency for Healthcare Research and Quality study, and
other sources, reach conclusions with which these commenters appear to
disagree. The Departments consider it appropriate to consider these
studies, as well as the studies cited by commenters who disagree with
those conclusions.
Some commenters further criticized the Departments for saying two
studies cited by the 2011 IOM Report, which asserted an associative
relationship between contraceptive use and decreases in unintended
pregnancy, did not on their face establish a causal relationship
between a broad coverage mandate and decreases in unintended pregnancy.
In this respect, as noted in the Religious IFC,\40\ the purpose for the
Departments' reference to such studies was to highlight the difference
between a causal relationship and an associative one, as well as the
difference between saying contraceptive use has a certain effect and
saying a contraceptive coverage mandate (or part of that mandate
affected by certain exemptions) will necessarily have (or negate,
respectively) such an effect.
---------------------------------------------------------------------------
\40\ 82 FR at 47803-04.
---------------------------------------------------------------------------
Commenters disagreed about the effects of some FDA-approved
contraceptives on embryos. Some commenters agreed with the quotation,
in the Moral IFC, of FDA materials \41\ that indicate that some items
it has approved as contraceptives may prevent the implantation of an
embryo after fertilization. Some of those commenters cited additional
scientific sources to argue that certain approved contraceptives may
prevent implantation, and that, in some cases, some contraceptive items
may even dislodge an embryo shortly after implantation. Other
commenters disagreed with the sources cited in the Moral IFC and cited
additional studies on that issue. Some commenters further criticized
the Departments for asserting in the Moral IFC that some persons
believe those possible effects are ``abortifacient.''
---------------------------------------------------------------------------
\41\ FDA's guide ``Birth Control'' specifies that various
approved contraceptives, including Levonorgestrel, Ulipristal
Acetate, and IUDs, work mainly by preventing fertilization and ``may
also work . . . by preventing attachment (implantation) to the womb
(uterus)'' of a human embryo after fertilization. Available at
https://www.fda.gov/forconsumers/byaudience/forwomen/freepublications/ucm313215.htm.
---------------------------------------------------------------------------
This objection on this issue appears to be partially one of
semantics. People disagree about whether to define ``conception'' or
``pregnancy'' to occur at fertilization, when the sperm and ovum unite,
or days later at implantation, when that embryo has undergone further
cellular development, travelled down the fallopian tube, and implanted
in the uterine wall. This question is independent of the question of
what mechanisms of action FDA-approved or cleared contraceptives may
have. It is also a separate question from whether members of the public
assert, or believe, that it is appropriate to consider the items
``abortifacient''--that is, a kind of abortion, or a medical product
that causes an abortion--because they believe abortion means to cause
the demise of a post-fertilization embryo inside the mother's body.
Commenters referenced scientific studies and sources on both sides of
the issue of whether certain contraceptives prevent implantation.
Commenters and litigants have positively stated that some of them view
certain contraceptives as abortifacients, for this reason. See also
Hobby Lobby, 134 U.S. at 2765 (``The Hahns have accordingly excluded
from the group-health-insurance plan they offer to their employees
certain contraceptive methods that they consider to be
abortifacients.'').
The Departments do not take a position on the scientific,
religious, or moral debates on this issue by recognizing that some
people have sincere moral objections to providing contraception
coverage on this basis. The Supreme Court has already recognized that
such a view can form the basis of an objection based on sincerely held
religious belief under RFRA.\42\ Several litigants have separately
raised non-religious moral objections to contraceptive coverage based
on the same basic rationale. Even though there is a plausible
scientific argument against the view that certain contraceptives have
mechanisms of action that may prevent implantation, there is also a
plausible scientific argument in favor of it--as demonstrated, for
example, by FDA's statement that some contraceptives may prevent
implantation and by some scientific studies cited by commenters. The
Departments believe in this context we have a sufficient rationale to
offer moral exemptions with respect to this Mandate.
---------------------------------------------------------------------------
\42\ ``Although many of the required, FDA-approved methods of
contraception work by preventing the fertilization of an egg, four
of those methods (those specifically at issue in these cases) may
have the effect of preventing an already fertilized egg from
developing any further by inhibiting its attachment to the uterus.
See Brief for HHS in No. 13-354, pp. 9-10, n. 4; FDA, Birth Control:
Medicines to Help You.'' Hobby Lobby, 134 S. Ct. at 2762-63. ``The
Hahns have accordingly excluded from the group-health-insurance plan
they offer to their employees certain contraceptive methods that
they consider to be abortifacients. . . . Like the Hahns, the Greens
believe that life begins at conception and that it would violate
their religion to facilitate access to contraceptive drugs or
devices that operate after that point.'' Id. at 2765-66.
---------------------------------------------------------------------------
The Departments also received comments about their discussion,
located in the Religious IFC but partly relied upon in the Moral IFC,
concerning uncertainty about the effects the Mandate's expanded
exemptions might have on teen sexual activity. In this respect, the
Departments stated, ``With respect to teens, the Santelli and Melnikas
study cited by IOM 2011
[[Page 57611]]
observes that, between 1960 and 1990, as contraceptive use increased,
teen sexual activity outside of marriage likewise increased (although
the study does not assert a causal relationship). Another study, which
proposed an economic model for the decision to engage in sexual
activity, stated that `[p]rograms that increase access to contraception
are found to decrease teen pregnancies in the short run but increase
teen pregnancies in the long run.' '' \43\ Some commenters agreed with
this discussion, while other commenters disagreed. Commenters who
supported the expanded exemptions cited these and similar sources
suggesting that limiting the exemptions to the Mandate to those that
existed prior to the Religious and Moral IFCs is not tailored towards
advancing the Government's interests in reducing teen pregnancy.
Instead they suggested there are means of reducing teen pregnancy that
are less burdensome on conscientious objections.\44\ Some commenters
opposing the expanded exemptions stated that school-based health
centers provide access to contraceptives, thus increasing use of
contraceptives by sexually active students. They also cited studies
concluding that certain decreases in teen pregnancy are attributable to
increased contraceptive use.\45\
---------------------------------------------------------------------------
\43\ Citing J.S. Santelli & A.J. Melnikas, ``Teen fertility in
transition: recent and historic trends in the United States,'' 31
Ann. Rev. Pub. Health 371, 375-76 (2010), and Peter Arcidiacono et
al., Habit Persistence and Teen Sex: Could Increased Access to
Contraception Have Unintended Consequences for Teen Pregnancies?
(2005), available at https://public.econ.duke.edu/~psarcidi/
addicted13.pdf. See also K. Buckles & D. Hungerman, ``The Incidental
Fertility Effects of School Condom Distribution Programs,'' Nat'l
Bureau of Econ. Research Working Paper No. 22322 (June 2016),
available at https://www.nber.org/papers/w22322 (``access to condoms
in schools increases teen fertility by about 10 percent'' and
increased sexually transmitted infections).
\44\ See Helen Alvar[eacute], ``No Compelling Interest: The
`Birth Control' Mandate and Religious Freedom,'' 58 Vill. L. Rev.
379, 400-02 (2013) (discussing the Santelli & Melnikas study and the
Arcidiacono study cited above, and other research that considers the
extent to which reduction in teen pregnancy is attributable to
sexual risk avoidance rather than to contraception access).
\45\ See, e.g., Lindberg L., Santelli J., ``Understanding the
Decline in Adolescent Fertility in the United States, 2007-2012,''
59 J. Adolescent Health 577-83 (Nov. 2016), https://doi.org/10.1016/j.jadohealth.2016.06.024; see also Comment of The Colorado Health
Foundation, submission ID CMS-2014-0115-19635, www.regulations.gov
(discussing teen pregnancy data from Colorado).
---------------------------------------------------------------------------
Many commenters opposing the moral exemptions misunderstood the
Departments' discussion of this issue. Teens are a significant part,
though not the entirety, of women the IOM identified as being most at
risk of unintended pregnancy. The Departments do not take a position on
the empirical question of whether contraception has caused certain
reductions in teen pregnancy. Rather, the Departments note that studies
suggesting various causes of teen pregnancy and unintended pregnancy in
general make it difficult to establish causation between exemptions to
the contraceptive Mandate, and an increase in teen pregnancies in
particular, or unintended pregnancies in general. For example, a 2015
study investigating the decline in teen pregnancy since 1991 attributed
it to multiple factors (including, but not limited to, reduced sexual
activity, falling welfare benefit levels, and expansion of family
planning services in Medicaid, with the latter accounting for less than
13 percent of the decline). It concluded that ``that none of the
relatively easy, policy-based explanations for the recent decline in
teen childbearing in the United States hold up very well to careful
empirical scrutiny.'' \46\ One study found that, during the teen
pregnancy decline between 2007 through 2012, teen sexual activity was
also decreasing.\47\ One study concluded that falling unemployment
rates in the 1990s accounted for 85 percent of the decrease in rates of
first births among 18 to 19 year-old African Americans.\48\ Another
study found that the representation of African-American teachers was
associated with a significant reduction in the African-American teen
pregnancy rate.\49\ One study concluded that an ``increase in the price
of the Pill on college campuses . . . did not increase the rates of
unintended pregnancy.'' \50\ Similarly, one study from England found
that, where funding for teen pregnancy prevention was reduced, there
was no evidence that the reduction led to an increase in teen
pregnancies.\51\ Some commenters also cited studies--which are not
limited to the issue of teen pregnancy--that have found that many women
who have abortions report that they were using contraceptives when they
became pregnant.\52\
---------------------------------------------------------------------------
\46\ Kearney MS and Levine PB, ``Investigating recent trends in
the U.S. birth rate,'' 41 J. Health Econ. 15-29 (2015), available at
https://www.sciencedirect.com/science/article/abs/pii/S0167629615000041.
\47\ See, e.g., K. Ethier et al., ``Sexual Intercourse Among
High School Students--29 States and United States Overall, 2005-
2015,'' 66 CDC Morb. Mortal. Wkly Report 1393, 1393-97 (Jan. 5,
2018), available at https://dx.doi.org/10.15585/mmwr.mm665152a1
(``Nationwide, the proportion of high school students who had ever
had sexual intercourse decreased significantly overall . . . .'').
\48\ Colen CG, Geronimus AT, and Phipps MG, ``Getting a piece of
the pie? The economic boom of the 1990s and declining teen birth
rates in the United States,'' 63 Social Science & Med. 1531-45
(Sept. 2006), available at https://www.sciencedirect.com/science/article/pii/S027795360600205X.
\49\ Atkins DN and Wilkins VM, ``Going Beyond Reading, Writing,
and Arithmetic: The Effects of Teacher Representation on Teen
Pregnancy Rates,'' 23 J. Pub. Admin. Research & Theory 771-90 (Oct.
1, 2013), available at https://academic.oup.com/jpart/article-abstract/23/4/771/963674.
\50\ E. Collins & B. Herchbein, ``The Impact of Subsidized Birth
Control for College Women: Evidence from the Deficit Reduction
Act,'' U. Mich. Pop. Studies Ctr. Report 11-737 (May 2011),
available at https://www.psc.isr.umich.edu/pubs/pdf/rr11-737.pdf
(``[I]ncrease in the price of the Pill on college campuses . . . did
not increase the rates of unintended pregnancy or sexually
transmitted infections for most women'').
\51\ See D. Paton & L. Wright, ``The effect of spending cuts on
teen pregnancy,'' 54 J. Health Econ. 135, 135-46 (2017), available
at https://www.sciencedirect.com/science/article/abs/pii/S0167629617304551 (``Contrary to predictions made at the time of the
cuts, panel data estimates provide no evidence that areas which
reduced expenditure the most have experienced relative increases in
teenage pregnancy rates. Rather, expenditure cuts are associated
with small reductions in teen pregnancy rates'').
\52\ Commenters cited, for example, Guttmacher Institute, ``Fact
Sheet: Induced Abortion in the United States'' (Jan. 2018) (``Fifty-
one percent of abortion patients in 2014 were using a contraceptive
method in the month they became pregnant''), available at https://www.guttmacher.org/sites/default/files/factsheet/fb_induced_abortion.pdf.
---------------------------------------------------------------------------
As the Departments stated in the Religious IFC, we do not take a
position on the variety of empirical questions discussed above.
Likewise, these rules do not address the substantive question of
whether HRSA should include contraceptives in the women's preventive
services Guidelines issued under section 2713(a)(4). Rather,
reexamination of the record and review of public comments has
reinforced the Departments' view that the uncertainty surrounding these
weighty and important issues makes it appropriate to provide the moral
exemptions and accommodation if and for as long as HRSA continues to
include contraceptives in the Guidelines. The federal government has a
long history, particularly in certain sensitive and multi-faceted
health issues, of providing moral exemptions from governmental
mandates. These final rules are consistent with that history and with
the discretion Congress vested in the Departments to implement the ACA.
8. Health and Equality Effects of Contraceptive Coverage Mandates
The Departments also received comments about the health and
equality effects of the Mandate more broadly. Some commenters contended
that the contraceptive Mandate promoted the health and equality of
women, especially low income women, and promoted female participation
and
[[Page 57612]]
equality in the workforce. Other commenters contended there was
insufficient evidence showing that the expanded exemptions would harm
those interests. Some of those commenters further questioned whether
there was evidence to show that broad health coverage mandates of
contraception lead to increased contraceptive use, reductions in
unintended pregnancies, or reductions in negative effects said to be
associated with unintended pregnancies. In particular, some commenters
discussed a study published and revised by the Guttmacher Institute in
October 2017, concluding that ``[b]etween 2008 and 2014, there were no
significant changes in the overall proportion of women who used a
contraceptive method both among all women and among women at risk of
unintended pregnancy.'' \53\ This timeframe includes the first two
years of the contraceptive Mandate's implementation. Despite some
changes in the use of various methods of contraceptives, the study
concluded that, ``[f]or the most part, women are changing method type
within the group of most or moderately effective methods and not
shifting from less effective to more effective methods.'' Regarding the
effect of this Mandate in particular, the authors concluded that
``[t]he role that the contraceptive coverage guarantee played in
impacting use of contraception at the national level remains unclear,
as there was no significant increase in the use of methods that would
have been covered under the ACA (most or moderately effective methods)
during the most recent time period (2012-2014) excepting small
increases in implant use.'' The authors observed that other ``[s]tudies
have produced mixed evidence regarding the relationship between the
implementation of the ACA and contraceptive use patterns.'' In
explaining some possible reasons or no clear effect on contraceptive
use, the authors suggested that ``existence of these safety net
programs [publicly funded family planning centers and Medicaid] may
have dampened any impact that the ACA could have had on contraceptive
use,'' ``cost is not the only barrier to accessing a full range of
method options,'' and ``access to affordable and/or free contraception
made possible through programs such as Title X'' may have led to income
not being associated with the use of most contraceptive methods.\54\ In
addition, commenters noted that in the 29 states where contraceptive
coverage mandates have been imposed statewide,\55\ those mandates have
not necessarily lowered rates of unintended pregnancy (or abortion)
overall.\56\
---------------------------------------------------------------------------
\53\ M.L. Kavanaugh et al., ``Contraceptive method use in the
United States: trends and characteristics between 2008, 2012 and
2014,'' 97 Contraception 14, 14-21 (2018), available at https://www.contraceptionjournal.org/article/S0010-7824(17)30478-X/pdf.
\54\ Id.
\55\ See Guttmacher Institute, ``Insurance Coverage of
Contraceptives'' (June 11, 2018); ``State Requirements for Insurance
Coverage of Contraceptives,'' Henry J. Kaiser Family Foundation
(Jan. 1, 2018), https://www.kff.org/other/state-indicator/state-requirements-for-insurance-coverage-of-contraceptives/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.
\56\ See Michael J. New, ``Analyzing the Impact of State Level
Contraception Mandates on Public Health Outcomes,'' 13 Ave Maria L.
Rev. 345 (2015), available at https://avemarialaw-law-review.avemarialaw.edu/Content/articles/vXIII.i2.new.final.0809.pdf.
---------------------------------------------------------------------------
Other commenters, however, disputed the significance of these state
statistics, noting that, of the 29 states with contraceptive coverage
mandates, only four states have laws that match the federal
requirements in scope. Some also observed that, even in states with
state contraceptive coverage mandates, self-insured group health plans
might escape those requirements, and some states do not mandate the
contraceptives to be covered at no out-of-pocket cost to the
beneficiary.
The Departments have considered these experiences as relevant to
the effect the exemption in these rules might have on the Mandate more
broadly. The state mandates of contraceptive coverage still apply to a
very large number of plans and plan participants notwithstanding ERISA
preemption, and public commenters did not point to studies showing
those state mandates reduced unintended pregnancies. The federal
contraceptive Mandate, likewise, applies to a broad, but not entirely
comprehensive, number of employers. For example, to the extent that
houses of worship and integrated auxiliaries may have self-insured to
avoid state health insurance contraceptive coverage mandates or for
other reasons, those groups were already exempt from the federal
Mandate prior to the 2017 Religious and Moral IFCs. The exemptions as
set forth in the Moral IFC and in these final rules leave the
contraceptive Mandate in place for nearly all entities and plans to
which the Mandate has applied. The Departments are not aware of data
showing that these expanded exemptions would negate any reduction in
unintended pregnancies that might result from the contraceptive Mandate
here.
Some commenters took a view that appears to disagree with the
assertion in the 2017 Guttmacher study, that ``[t]he role that the
contraceptive coverage guarantee played in impacting use of
contraception at the national level remains unclear, as there was no
significant increase in the use of methods that would have been covered
under the ACA.'' These commenters instead observed that, under the
Mandate, more women have coverage of contraceptives and contraception
counseling and that more contraceptives are provided without co-pays
than before. Still others argued that the Mandate, or other expansions
of contraceptive coverage, have led women to increase their use of
contraception in general, or to change from less effective, less
expensive contraceptive methods to more effective, more expensive
contraceptive methods. Some commenters pointed to studies cited in the
2011 IOM Report recommending contraception be included in the
Guidelines and argued that certain women will go without certain health
care, or contraception specifically, because of cost. They contended
that a smaller percentage of women delay or forego health care overall
under the ACA \57\ and that, according to studies, coverage of
contraceptives without cost-sharing has increased use of contraceptives
in certain circumstances. Some commenters also stated that studies show
that decreases in unintended pregnancies are due to broader access to
contraceptives. Finally, some commenters also stated that birth control
access generally has led to social and economic equality for women.
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\57\ Citing, for example, Adelle Simmons et al., ``The
Affordable Care Act: Promoting Better Health for Women,'' Table 1,
ASPE (June 14, 2016), https://aspe.hhs.gov/system/files/pdf/205066/ACAWomenHealthIssueBrief.pdf.
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The Departments have reviewed the comments, including studies
submitted by commenters either supporting or opposing these expanded
exemptions. Based on that review, it is not clear that merely offering
the exemption in these rules will have a significant effect on
contraceptive use and health, or workplace equality, for the vast
majority of women benefitting from the Mandate. There is conflicting
evidence regarding whether the Mandate alone, as distinct from
contraceptive access more generally, has caused increased contraceptive
use, reduced unintended pregnancies, or eliminated workplace
disparities, where all other women's preventive services were covered
without cost sharing. Without taking a definitive position on those
evidentiary issues, however, the Departments
[[Page 57613]]
conclude that the Moral IFC and these final rules--which merely
withdraw the Mandate's requirement from what appears to be a small
number of newly exempt entities and plans--are not likely to have
negative effects on the health or equality of women nationwide. The
Departments also conclude that the expanded exemptions are an
appropriate policy choice left to the agencies under the relevant
statutes, and, thus, an appropriate exercise of the Departments'
discretion.
Moreover, the Departments conclude that the best way to balance the
various policy interests at stake in the Moral IFC and these final
rules is to provide the exemptions set forth herein, even if certain
effects may occur among the populations actually affected by the
employment of these exemptions. These rules provide tangible conscience
protections for moral convictions, and impose fewer governmental
burdens on various entities and individuals, some of whom have
contended for several years that denying them an exemption from the
contraceptive Mandate imposes a burden on their moral convictions. The
Departments view the provision of those protections to preserve
conscience in this health care context as an appropriate policy option,
notwithstanding the widely divergent effects that public commenters
have predicted based on different studies they cited. Providing the
protections for moral convictions set forth in the Moral IFC and these
final rules is not inconsistent with the ACA, and brings this Mandate
into better alignment with various other federal conscience protections
in health care, some of which have been in place for decades.
9. Other General Comments
Some commenters expressed the view that the exemptions afforded in
the Moral IFC and herein violate the RFRA rights of women who might not
receive contraceptive coverage as the result of these final rules, by
allowing their employers to impose their moral convictions on them by
removing contraceptive coverage through use of the exemption. Still
other commenters stated that employer payment of insurance premiums is
part of any employee's compensation package, the benefits of which
employers should not be able to limit. In the Departments' view, the
expanded exemptions in these final rules do not prohibit employers from
providing contraceptive coverage. Instead, they lift a government
burden that was imposed on some employers to provide contraceptive
coverage to their employees in violation of those employers' moral
convictions. The Departments do not believe RFRA requires, or has ever
required, the federal government to force employers to provide
contraceptive coverage. The federal government's decision to exempt
some entities from a requirement to provide no-cost-sharing services to
private citizens does not constitute a federal government-imposed
burden on the latter under RFRA.
Some commenters asked the Departments to discuss the interaction
between these rules and state laws that either require contraceptive
coverage or provide exemptions from those and other requirements. Some
commenters argue that providing the exemptions in these rules would
negate state contraceptive requirements or narrower state exemptions.
Some commenters asked that the Departments specify that these
exemptions do not apply to plans governed by state laws that require
contraceptive coverage.
The Departments agree that these rules only concern the
applicability of the federal contraceptive Mandate imposed pursuant to
section 2713(a)(4). They do not regulate state contraceptive mandates
or state exemptions. If a plan is exempt under the Moral IFC and these
final rules, that exemption does not necessarily exempt the plan or
other insurance issuer from state laws that may apply to it. The
previous regulations, which offered exemptions for houses of worship
and integrated auxiliaries, did not include regulatory language
negating the exemptions in states that require contraceptive coverage,
although the Departments discussed the issue to some degree in various
preambles of those previous regulations. The Departments do not
consider it appropriate or necessary in the regulatory text of the
moral exemption rules to declare whether the federal contraceptive
Mandate would still apply in states that have a state contraceptive
mandate, since these rules do not purport to regulate the applicability
of state contraceptive mandates.\58\
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\58\ Some commenters also asked that these final rules specify
that exempt entities must comply with other applicable laws
concerning such things as notice to plan participants or collective
bargaining agreements. These final rules relieve the application of
the federal contraceptive Mandate under section 2713(a)(4) to
qualified exempt entities; they do not affect the applicability of
other laws. In the preamble to the companion final rules concerning
religious exemptions published elsewhere in today's Federal
Register, the Departments provide guidance applicable to notices of
revocation and changes that an entity may seek to make during its
plan year.
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Some commenters observed that, through ERISA, some entities may
avoid state laws that require contraceptive coverage by self-insuring.
This is a result of the application of the preemption and savings
clauses contained in ERISA to state insurance regulation. See 29 U.S.C.
1144(a) & (b)(1).
These final rules cannot change statutory ERISA provisions, and do
not change the standards applicable to ERISA preemption. To the extent
Congress has decided that ERISA preemption includes preemption of state
laws requiring contraceptive coverage, that decision occurred before
the ACA and was not negated by the ACA. Congress did not mandate in the
ACA that any Guidelines issued under section 2713(a)(4) must include
contraceptives, nor that the Guidelines must force entities with moral
objections to cover contraceptives.
Finally, some commenters expressed concern that providing moral
exemptions to the mandate that private parties provide contraception
may lead to exemptions regarding other medications or services, like
vaccines. The exemptions provided in these rules, however, do not apply
beyond the contraceptive coverage requirement implemented through
section 2713(a)(4). Specifically, section 2713(a)(2) of the PHS Act
requires coverage of ``immunizations,'' and these exemptions do not
encompass that requirement. The fact that the Departments have exempted
houses of worship and integrated auxiliaries from the contraceptive
Mandate since 2011 did not lead to those entities receiving exemptions
under section 2713(a)(2) concerning vaccines. In addition, hundreds of
entities have sued the Departments over the implementation of section
2713(a)(4), leading to two decisions of the U.S. Supreme Court, but no
similar wave of lawsuits has challenged section 2713(a)(2). The
expanded exemptions in these final rules are consistent with a long
history of statutes protecting moral convictions from certain health
care mandates concerning issues such as sterilization, abortion and
birth control.
B. Text of the Final Rules
In this section, the Departments describe the regulations from the
Moral IFC, public comments in response to the specific regulatory text
set forth in the IFC, the Departments' response to those comments, and,
in consideration of those comments, the regulatory text as finalized in
this final rule. We also note the regulatory text as it existed prior
to the Religious and Moral IFCs, as appropriate. The Departments
consider the exemptions finalized here to be an appropriate and
permissible policy
[[Page 57614]]
choice in light of various interests at stake and the lack of a
statutory requirement for the Departments to impose the Mandate on
entities and plans that qualify for these exemptions.
As noted above, various members of the public provided comments
that were supportive, or critical, of the regulations overall, or of
significant policies pertaining to the regulations. To the extent those
comments apply to the following regulatory text, the Departments have
responded to them above. This section of the preamble responds to
comments that pertain more specifically to particular regulatory text.
1. Restatement of Statutory Requirements of Section 2713(a) and (a)(4)
of the PHS Act (26 CFR 54.9815-2713(a)(1) and (a)(1)(iv), 29 CFR
2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR 147.130(a)(1) and
(a)(1)(iv))
The previous regulations restated the statutory requirements of
section 2713(a) and (a)(4) of the PHS Act, at 26 CFR 54.9815-2713(a)(1)
and (a)(1)(iv), 29 CFR 2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR
147.130(a)(1) and (a)(1)(iv). The Religious IFC modified those
restatements to more closely align them with the text of section
2713(a) and (a)(4) of the PHS Act. Those sections cross-reference the
other sections of the Departments' rules that provide exemptions to the
contraceptive Mandate. After the Religious IFC changed those sections,
the Moral IFC inserted, within those cross-references, references to
the new Sec. 147.133, which contains the text of the moral exemptions.
The insertions correspond to the cross-references to the religious
exemptions added by the Religious IFC. The Departments finalize these
parts of the Moral IFC without change.
2. Exemption for Objecting Entities Based on Moral Convictions (45 CFR
147.133(a))
The previous regulations contained no exemption concerning moral
convictions, as distinct from religious beliefs. Instead, at 45 CFR
147.131(a), they offered an exemption for houses of worship and
integrated auxiliaries. In the remaining part of Sec. 147.131, the
previous regulations described the accommodation process for
organizations with religious objections. The Religious IFC moved the
religious exemption to a new section 45 CFR 147.132, and expanded its
scope. The Moral IFC created a new section 45 CFR 147.133, providing
exemptions for moral convictions similar to, but not exactly the same
as, the exemptions for religious beliefs set forth in Sec. 147.132.
The prefatory language of Sec. 147.133(a) not only specifies that
certain entities are ``exempt,'' but also explains that the Guidelines
shall not support or provide for an imposition of the contraceptive
coverage requirement to such exempt entities. This is an
acknowledgement that section 2713(a)(4) requires women's preventive
services coverage only ``as provided for in comprehensive guidelines
supported by the Health Resources and Services Administration.'' To the
extent the HRSA Guidelines do not provide for, or support, the
application of such coverage to certain entities or plans, the
Affordable Care Act does not require the coverage. Those entities or
plans are ``exempt'' by not being subject to the requirements in the
first instance. Therefore, in describing the entities or plans as
``exempt,'' and in referring to the ``exemption'' encompassing those
entities or plans, the Departments also affirm the non-applicability of
the Guidelines to them.
The Departments wish to make clear that the expanded exemption set
forth in Sec. 147.133(a) applies to several distinct entities involved
in the provision of coverage to an objecting employer's employees. This
explanation is consistent with how prior regulations have worked by
means of similar language. When Sec. 147.133(a)(1) and (a)(1)(i)
specify that ``[a] group health plan,'' ``health insurance coverage
provided in connection with a group health plan,'' and ``health
insurance coverage offered or arranged by an objecting organization''
are exempt ``to the extent'' of the objections ``as specified in
paragraph (a)(2),'' that language exempts the group health plans of the
sponsors that object, and their health insurance issuers in providing
the coverage in those plans (whether or not the issuers have their own
objections). Consequently, with respect to Guidelines issued under
Sec. 147.130(a)(1)(iv) (and as referenced by the parallel provisions
in 26 CFR 54.9815 through 2713(a)(1)(iv) and 29 CFR 2590.715 through
2713(a)(1)(v)), the plan sponsor, issuer, and plan covered in the
exemption of that paragraph would face no penalty as a result of
omitting contraceptive coverage from the benefits of the plan
participants and beneficiaries. However, while a plan sponsor's or
arranger's objection removes penalties from that group health plan's
issuer, it only does so with respect to that group health plan--it does
not affect the issuer's coverage for other group health plans where the
plan sponsor has no qualifying objection. More information on the
effects of the objection of a health insurance issuer in Sec.
147.133(a)(1)(iii) is included below.
The exemptions in Sec. 147.133(a)(1) apply ``to the extent'' of
the objecting entities' sincerely held moral convictions. Thus,
entities that hold a requisite objection to covering some, but not all,
contraceptive items would be exempt with respect to the items to which
they object, but not with respect to the items to which they do not
object. Some commenters stated it was unclear whether the plans of
entities or individuals that morally object to some but not all
contraceptives would be exempt from being required to cover just the
contraceptive methods as to which there is an objection, or whether the
objection to some contraceptives leads to an exemption from that plan
being required to cover all contraceptives. The Departments intend that
a requisite moral objection to some, but not all, contraceptives would
lead to an exemption only to the extent of that objection: That is, the
exemption would encompass only the items to which the relevant entity
or individual objects and would not encompass contraceptive methods to
which the objection does not apply. To make this clearer, in these
final rules the Departments finalize the prefatory language of Sec.
147.133(a) so that the first sentence of that paragraph states that an
exemption shall be included, and the Guidelines must not provide for
contraceptive coverage, ``to the extent of the objections specified
below.'' The Departments have made corresponding changes to language
throughout the regulatory text, to describe the exemptions as applying
``to the extent'' of the objection(s).
The exemptions contained in previous regulations, at Sec.
147.131(a), did not require an exempt entity to submit any particular
self-certification or notice, either to the government or to the
entity's issuer or third party administrator, in order to obtain or
qualify for their exemption. Similarly, under the expanded exemptions
in Sec. 147.133, the Moral IFC did not require exempt entities to
comply with a self-certification process. We finalize that approach
without change. Although exempt entities do not need to file notices or
certifications of their exemption, and these final rules do not impose
any new notice requirements on them, existing ERISA rules governing
group health plans require that, with respect to plans subject to
ERISA, a plan document must include a comprehensive summary of the
benefits covered by the plan and a statement of the conditions for
eligibility to receive benefits. Under ERISA, the plan
[[Page 57615]]
document identifies what benefits are provided to participants and
beneficiaries under the plan; if an objecting employer would like to
exclude all or a subset of contraceptive services, it must ensure that
the exclusion is clear in the plan document. Moreover, if there is a
reduction in a covered service or benefit, the plan has to disclose
that change to plan participants.\59\ Thus, where an exemption applies
and all (or a subset of) contraceptive services are omitted from a
plan's coverage, otherwise applicable ERISA disclosures must reflect
the omission of coverage in ERISA plans. These existing disclosure
requirements serve to help provide notice to participants and
beneficiaries of what ERISA plans do and do not cover.
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\59\ See, for example, 29 U.S.C. 1022, 1024(b), 29 CFR 2520.102-
2, 2520.102-3, & 2520.104b-3(d), and 29 CFR 2590.715-2715. See also
45 CFR 147.200 (requiring disclosure of the ``exceptions,
reductions, and limitations of the coverage,'' including group
health plans and group & individual issuers).
---------------------------------------------------------------------------
Some commenters supported this approach, while others did not.
Those in favor suggested that self-certification forms for an exemption
are not necessary, could add burdens to exempt entities beyond those
imposed by the previous exemption, and could give rise to objections to
the self-certification process itself. Commenters also stated that
requiring an exemption form for exempt entities could cause additional
operational burdens for plans that have existing processes in place to
handle exemptions. Other commenters favored including a self-
certification process for exempt entities. They suggested that entities
might abuse the availability of an exemption or use their exempt status
insincerely if no self-certification process exists, and that the
Mandate might be difficult to enforce without a self-certification
process.
After considering the comments, the Departments continue to believe
it is appropriate to not require exempt entities to submit a self-
certification or notice. The previous exemption did not require a self-
certification or notice, and the Departments did not collect a list of
all entities that used the exemption, although there may have been
thousands of houses of worship and integrated auxiliaries covered by
the previous exemption and the Departments think it likely that only a
small number of entities will use the moral exemption. Adding a self-
certification or notice to the exemption would impose an additional
paperwork burden on exempt entities that the previous regulations did
not impose, and would also involve additional public costs if those
certifications or notices are to be reviewed or kept on file by the
government.
The Departments are not aware of instances where the lack of a
self-certification under the previous exemption led to abuses or to an
inability to engage in enforcement. The Mandate is enforceable through
various mechanisms in the PHS Act, the Code, and ERISA. Entities that
insincerely or otherwise improperly operate as if they are exempt would
do so at the risk of enforcement and accountability under such
mechanisms. The Departments are not aware of sufficient reasons to
believe those measures and mechanisms would fail to deter entities from
improperly operating as if they are exempt. Moreover, as noted above,
ERISA and other plan disclosure requirements governing group health
plans require provision of a comprehensive summary of the benefits
covered by the plan and disclosure of any reductions in covered
services or benefits, so beneficiaries will know whether their health
plan claims a contraceptive Mandate exemption and will be able to raise
appropriate challenges to such claims. As a consequence, the
Departments believe it is an appropriate balance of various concerns
expressed by commenters for these final rules to continue to not
require notices or self-certifications for using the exemption.
Some commenters asked the Departments to add language indicating
that an exemption cannot be invoked in the middle of a plan year, nor
should it be used to the extent inconsistent with laws that apply to,
or state approval of, fully insured plans. None of the previous
iterations of the exemption regulations included such provisions, and
the Departments do not consider them necessary in these final rules.
The exemptions in these final rules only purport to exempt plans and
entities from the application of the federal contraceptive coverage
requirement of the Guidelines issued under section 2713(a)(4). They do
not purport to exempt entities or plans from state laws concerning
contraceptive coverage, or laws governing whether an entity can make a
change (of whatever kind) during a plan year. Final rules governing the
accommodation likewise do not purport to obviate the need to follow
otherwise applicable rules about making changes during a plan year. (In
the companion rules concerning religious beliefs published elsewhere in
today's Federal Register, the Departments discuss in more detail the
accommodation and when an entity seeking to revoke it would be able to
do so or to notify plan participants of the revocation.)
Commenters also asked that clauses be added to the regulatory text
holding issuers harmless where exemptions are invoked by plan sponsors.
As discussed above, the exemption rules already specify that where an
exemption applies to a group health plan, it encompasses both the group
health plan and health insurance coverage provided in connection with
the group health plan, and therefore encompasses any impact on the
issuer of the contraceptive coverage requirement with respect to that
plan. In addition, as discussed in the companion religious final rule
published elsewhere in today's Federal Register, the Departments have
added language from the previous regulations, in Sec. 147.131(f), to
protect issuers that act in reliance on certain representations made in
the accommodation process. To the extent that commenters seek language
offering additional protections for other incidents that might occur in
connection with the invocation of an exemption, the previous exemption
regulations did not include such provisions, and the Departments do not
consider them necessary in these final rules. As noted above, the
expanded exemptions in these final rules simply remove or narrow the
contraceptive Mandate contained in, and derived from, the Guidelines
for certain plans. The previous regulations included a reliance clause
in the accommodation provisions, but did not specify further details
regarding the relationship between exempt entities and their issuers or
third party administrators. The Departments do not believe it necessary
to do so in these final rules.
Commenters disagreed about the likely effects of the moral
exemptions on the health coverage market. Some commenters stated that
expanding the exemptions to encompass moral convictions would not cause
complications in the market, while others said that it could, due to
such causes as a lack of uniformity among plans, or permitting multiple
risk pools. The Departments note that the extent to which plans cover
contraception under the prior regulations is already far from uniform.
Congress did not require all entities to comply with section 2713 of
the PHS Act (under which the Mandate was promulgated)--most notably by
exempting grandfathered plans. Moreover, under the previous
regulations, issuers were already able to offer plans that omit
contraceptives--or only some contraceptives--to houses of worship and
integrated auxiliaries, and some commenters and litigants said that
issuers were doing so. These cases
[[Page 57616]]
where plans did not need to comply with the Mandate, and the
Departments' previous accommodation process which had the effect of
allowing coverage not to be provided in certain self-insured church
plans, together show that the importance of a uniform health coverage
system is not significantly harmed by allowing plans to omit
contraception in some contexts.\60\
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\60\ See also Real Alternatives, 867 F.3d 338, 389 (3d Cir.
2017) (Jordan, J., concurring in part and dissenting in part)
(``Because insurance companies would offer such plans as a result of
market forces, doing so would not undermine the government's
interest in a sustainable and functioning market. . . . Because the
government has failed to demonstrate why allowing such a system (not
unlike the one that allowed wider choice before the ACA) would be
unworkable, it has not satisfied strict scrutiny.'' (citation and
internal quotation marks omitted)).
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Concerning the prospect raised by some commenters of different risk
pools between men and women, section 2713(a) of the PHS Act itself
provides for some preventive services coverage that applies to both men
and women, and some that would apply only to women. With respect to the
latter, it does not specify what, if anything, HRSA's Guidelines for
women's preventives services would cover, or if contraceptive coverage
will be required. The Moral IFC and these final rules do not require
issuers to offer health insurance products that satisfy morally
objecting entities, they simply make it legal to do so. The Mandate has
been imposed only relatively recently, and the contours of its
application to objecting entities has been in continual flux, due to
various rulemakings and court orders. Overall, concerns raised by some
public commenters have not led the Departments to consider it likely
that offering these expanded exemptions will cause any injury to the
uniformity or operability of the health coverage market.
3. Exemption for Certain Plan Sponsors (45 CFR 147.133(a)(1)(i))
The exemption in Sec. 147.133(a)(1)(i) of the Moral IFC covers a
group health plan and health insurance coverage for non-governmental
plan sponsors that object as specified in paragraph (a)(2), and that
are either nonprofit organizations, or are for-profit entities that
have no publicly traded ownership interests (defined as any class of
common equity securities required to be registered under section 12 of
the Securities Exchange Act of 1934). The Departments finalize this
paragraph without change, and discuss each part of the paragraph in
turn.
a. Plan Sponsors in General (45 CFR 147.133(a)(1)(i) Prefatory Text)
Under the plan sponsor exemption in Sec. 147.132(a)(1)(i), the
prefatory text in that paragraph specifies that it encompasses group
health plans, and health insurance coverage provided in connection with
such group health plans, that are sponsored by certain kinds of
entities, namely, nonprofit organizations or for-profit entities that
have no publicly traded ownership interests.
Such plan sponsors, if they are otherwise nonprofit organizations
or for-profit entities that have no publicly traded ownership
interests, can include entities that are not employers (for example, a
union, or a sponsor of a multiemployer plan), where the plan sponsor
objects based on sincerely held moral convictions to coverage of
contraceptives or sterilization. Plan sponsors encompassed by the
exemption can also include employers, and consistent with the
definition of ``employer'' in 29 CFR 2510.3-5, can include association
health plans, where the plan sponsor is a nonprofit organization or a
for-profit entity that has no publicly traded ownership interests.
Some commenters objected to extending the exemption to plan
sponsors that are not single employers, arguing that they could not
have the same kind of moral objection that a single employer might
have. Other commenters supported the protection of any plan sponsor
with the requisite moral objection. The Departments conclude that it is
appropriate, where a plan sponsor of a multiemployer plan or multiple
employer plan adopts a moral objection using the same procedures that
such a plan sponsor might use to make other decisions, to respect that
decision by providing an exemption from the Mandate.
The plans of governmental employers are not covered by the plan
sponsor exemption in Sec. 147.133(a)(1)(i), which instead limits the
moral exemptions to ``non-governmental plan sponsors.'' As noted above,
the Departments sought public comment on whether to extend the
exemptions to non-federal governmental plan sponsors. Some commenters
suggested that the moral exemptions should include government entities
because other conscience laws can include government entities, such as
when they oppose offering abortions. Others disagreed, contending that
governmental entities should not or cannot object based on moral
convictions, or that it would be unlawful for them to do so.
The Departments are sympathetic to the arguments of commenters that
favor including government entities in the exemption for moral
convictions. The protections outlined in the first paragraph of the
Church Amendments for entities that object based on moral convictions
to making their facilities or personnel available to assist in the
performance of abortions or sterilizations do not turn on the nature of
the entity, whether public, private, nonprofit, for-profit, or
governmental. (42 U.S.C. 300a-7(b)). Both the Weldon and Coats-Snowe
Amendments also protect state and local government entities from
providing, promoting, or paying for abortions in particular ways.\61\
Congress has generally not limited protections for conscience based on
the nature of an entity--even in the case of governmental entities.
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\61\ Consolidated Appropriations Act, 2018, Div. H, Sec. 507(d),
132 Stat. at 764 (protecting any ``hospital, a provider-sponsored
organization, a health maintenance organization, a health insurance
plan, or any other kind of health care facility, organization, or
plan'' in objecting to abortion); 42 U.S.C. 238n (protecting
entities that object to abortion, including, but not limited to, any
``postgraduate physician training program'').
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At the same time, the Departments do not at this time have
information suggesting that an exemption for governmental entities is
needed or desired. The Departments have not been sued by any
governmental entities raising objections to the Mandate based on non-
religious moral convictions. Although the Departments sought public
comment on the issue, the Departments received no public comments
identifying governmental entities that need or desire such an
exemption. Rather, the Departments are aware of governmental entities
that, despite not possessing their own objections to contraceptive
coverage, have acted to protect their employees who have conscientious
objections to receiving contraceptive coverage in their employer-
provided health insurance plans. See Wieland v. U.S. Dep't of Health &
Human Servs., 196 F. Supp. 1010, 1015-16 (E.D. Mo. 2016) (quoting Mo.
Rev. Stat. 191.724). The individual exemption adopted in these rules
will ensure the Mandate is not an obstacle to those efforts.
Thus, in light of the balance of public comments, the Departments
decline to extend the moral convictions exemption to governmental
entities. As is the case with the Departments' decision not to extend
the moral exemption to publicly traded for-profit entities, this
decision does not reflect a disagreement with the various conscience
statutes that provide exemptions for moral convictions
[[Page 57617]]
without categorically excluding governmental entities. The Departments
remain open to the possibility of future rulemaking on this issue if
the Departments become aware of a governmental entity seeking to be
exempt from the contraceptive Mandate.
b. Nonprofit Organizations (45 CFR 147.133(a)(1)(i)(A))
As discussed above, some commenters opposed offering exemptions
based on moral convictions to any plan sponsors, and/or objected to
doing so for nonprofit organizations, on various grounds, including but
not limited to arguments that the benefits of contraception access
should override moral objections, entities cannot assert moral
objections, and moral objections burden third parties. Other commenters
supported the exemptions, generally defending the interest of nonprofit
organizations not to be forced to violate their moral convictions,
supporting the history of government protection of moral convictions in
similar contexts, and disputing the claims of opponents of the
exemptions.
The Departments are aware, through litigation, of only two non-
religious nonprofit organizations with moral objections to the
contraceptive Mandate. Many more nonprofit religious organizations have
sued suggesting--as discussed below--that the effect of this exemption
for non-religious nonprofit objections to the Mandate will be far less
significant than commenters who oppose the exemption believe it will.
The two non-religious nonprofit organizations that challenged the
Mandate in court provide a good illustration of the reasons why the
Department has decided to provide this exemption to nonprofit
organizations. Both organizations have said in court they oppose
certain contraceptives on non-religious moral grounds as being
abortifacient and state that they only hire employees who share that
view. Public comments and litigation reflect that many nonprofit
organizations publicly describe their beliefs and convictions.
Government records and many of those groups' websites also often
reflect those groups' religious or moral character, as the case may be.
If a person who desires contraceptive coverage works at a nonprofit
organization, the Departments view it as sufficiently likely that the
person would know, or would know to ask, whether the organization
offers such coverage. The Departments are not aware of federal laws
that would require a nonprofit organization that opposes contraceptive
coverage to hire a person who disagrees with the organization's view on
contraceptive coverage. Instead, nonprofit organizations generally have
access to a First Amendment right of expressive association to choose
to hire persons (or, in the case of students, to admit them) based on
whether they share, or at least will be respectful of, their
beliefs.\62\
---------------------------------------------------------------------------
\62\ Notably, ``the First Amendment simply does not require that
every member of a group agree on every issue in order for the
group's policy to be `expressive association.' '' Boy Scouts of
America v. Dale, 530 U.S. 640, 655 (2000).
---------------------------------------------------------------------------
The Departments agree with commenters who support offering the
exemption to nonprofit organizations and believe that doing so is an
appropriate protection and is not likely to have a significant impact
on women who want contraceptive coverage.
c. For-Profit Entities (45 CFR 147.133(a)(1)(i)(B))
With respect to for-profit organizations addressed in Sec.
147.133(a)(1)(i)(B), in the Moral IFC, the Departments did not limit
the exemption to nonprofit organizations, but also included some for-
profit entities. Some commenters supported including for-profit
entities in the exemption, saying owners of such entities exercise
their moral convictions through their businesses, and that such owners
should not be burdened by a federal governmental contraceptive Mandate.
Other commenters opposed extending the exemption to closely held for-
profit entities, saying the entities cannot exercise moral convictions
or should not have their moral opposition to contraceptive coverage
protected by the exemption. Some commenters stated that the entities
should not be able to impose their beliefs about contraceptive coverage
on their employees and that doing so constitutes discrimination.
The Departments agree with commenters who support including some
for-profit entities in the exemption. Many of the federal health care
conscience statutes cited above offer protections for the moral
convictions of entities, without regard to whether they operate as
nonprofit organizations or for-profit entities. In addition, nearly
half of the states either impose no contraceptive coverage requirement
or offer ``an almost unlimited'' exemption encompassing both
``religious and secular organizations.'' \63\ States also generally
protect moral convictions in other health care conscience laws whether
or not an entity operates as a nonprofit.\64\
---------------------------------------------------------------------------
\63\ ``Insurance Coverage of Contraceptives,'' The Guttmacher
Institute (June 11, 2018), https://www.guttmacher.org/state-policy/explore/insurance-coverage-contraceptives.
\64\ See, e.g., ``Refusing to Provide Health Services,'' The
Guttmacher Institute (June 1, 2018), https://www.guttmacher.org/state-policy/explore/refusing-provide-health-services.
---------------------------------------------------------------------------
Extending the exemption to certain for-profit entities is also
consistent with the Supreme Court's ruling in Hobby Lobby, which
declared that a corporate entity is capable of possessing and pursuing
non-pecuniary goals (in Hobby Lobby, the pursuit of religious beliefs),
regardless of whether the entity operates as a nonprofit organization
and rejected the Departments' argument to the contrary. 134 S. Ct. at
2768-75. The mechanisms by which a for-profit company makes decisions
of conscience, or resolves disputes on those issues among their owners,
are problems that ``state corporate law provides a ready means'' of
solving. Id. at 2774-75. Some reports and industry experts have
indicated that few for-profit entities beyond those that had originally
challenged the Mandate have sought relief from it after Hobby
Lobby.\65\ Because all of those appear to be informed by religious
beliefs, extending the exemption to entities with non-religious moral
convictions would seem to have an even smaller impact on access to
contraceptive coverage.
---------------------------------------------------------------------------
\65\ See Jennifer Haberkorn, ``Two years later, few Hobby Lobby
copycats emerge,'' Politico (Oct. 11, 2016), https://www.politico.com/story/2016/10/obamacare-birth-control-mandate-employers-229627.
---------------------------------------------------------------------------
The Moral IFC only extended the exemption covering for-profit
entities to those that are closely held, not to for-profit entities
that are publicly traded, but asked for comment on whether publicly
traded entities should be included in the moral exemption. In this way
the Moral IFC differed from the exemption provided to plan sponsors
with objections based on sincerely held religious beliefs set forth in
the Religious IFC, at Sec. 147.132(a)(1), finalized in companion rules
published elsewhere in today's Federal Register.
Some commenters supported including publicly traded entities in the
moral exemption, contending that publicly traded entities have
historically taken various positions on important public concerns
beyond merely seeking the company's own profits, and that nothing in
principle would preclude them from using the same mechanisms of
corporate decision-making to establish and exercise moral convictions
against contraceptive coverage. They observed that large publicly
traded entities are exempt from the contraceptive Mandate by means of
the grandfathering provision of the ACA, so
[[Page 57618]]
that it is inappropriate to refuse to exempt publicly traded entities
that actually have sincerely held moral convictions against compliance
with the Mandate. They further argued that in some instances there are
closely held companies that are as large as publicly traded companies
of significant size. They also stated that other protections for moral
convictions in certain federal health care conscience statutes do not
preclude the application of such protections to certain entities on the
basis that they are not closely held, and federal law defines
``persons'' to include all forms of corporations, not just closely held
corporations, at 1 U.S.C. 1. Additionally, some commenters were
concerned that not providing a moral exemption for publicly traded for-
profit entities but allowing a religious exemption for publicly traded
for-profit entities (as was allowed in the Religious IFC, and as is
allowed in the companion religious final rules published elsewhere in
today's Federal Register), may raise Establishment Clause questions,
may cause confusion to the public, and may make the exemptions more
difficult for the Departments and enforcing agencies to administer.
They stated that it is incongruous to include publicly traded entities
in the exemption for religious beliefs, but exclude them from the
exemption for moral convictions.
Other commenters opposed including publicly traded companies in
these moral exemptions. Some stated that such companies could not
exercise moral convictions and opposed the effects on women if they
would. They also objected that including such companies, along with
closely held businesses, would extend the exemptions to all or
virtually all companies. Some commenters stated that many publicly
traded companies would use a moral exemption if available to them,
because many closely held for-profit businesses expressed religious
objections to the Mandate, or availed themselves of the religious
accommodation.
As is the case for non-federal governmental employers, the
Departments are sympathetic to the arguments of commenters that favor
including publicly traded entities in the exemption for moral
convictions. In the case of particularly sensitive health care matters,
several significant federal health care conscience statutes protect
entities' moral objections without regard to their ownership status.
For example, the first paragraph of the Church Amendments provides
certain protections for entities that object based on moral convictions
to making their facilities or personnel available to assist in the
performance of abortions or sterilizations; the protections of the
Church Amendments do not turn on the nature of the entity, whether
public, private, nonprofit, for-profit, or governmental. (42 U.S.C.
300a-7(b)). Thus, under section 300a-7(b), a hospital in a publicly
traded health system, or a local governmental hospital, could adopt
sincerely held moral convictions by which it objects to providing
facilities or personnel for abortions or sterilizations, and if the
entity receives relevant funds from HHS specified by section 300a-7(b),
the protections of that section would apply. Other federal conscience
protections in the health sector apply in the same manner:
The Coats-Snowe Amendment (42 U.S.C. 238n) provides
certain protections for health care entities and postgraduate physician
training programs that, among other things, choose not to perform,
refer for, or provide training for, abortions.
The Weldon Amendment \66\ provides certain protections for
health care entities, hospitals, provider-sponsored organizations,
health maintenance organizations, and health insurance plans that do
not provide, pay for, provide coverage of, or refer for abortions.
---------------------------------------------------------------------------
\66\ See Consolidated Appropriations Act, 2018, Public Law 115-
141, Div. H, Sec. 507(d) (Mar. 2018).
---------------------------------------------------------------------------
The ACA provides certain protections for any institutional
health care entity, hospital, provider-sponsored organization, health
maintenance organization, health insurance plan, or any other kind of
health care facility, that does not provide any health care item or
service furnished for the purpose of causing or assisting in causing
assisted suicide, euthanasia, or mercy killing. (42 U.S.C. 18113).\67\
---------------------------------------------------------------------------
\67\ The lack of the limitation in this provision may be
particularly relevant since it was enacted in the same statute, the
ACA, as the provision under which the Mandate--and these exemptions
to the Mandate--were promulgated.
---------------------------------------------------------------------------
Social Security Act sections 1852(j)(3)(B) (Medicare) and
1932(b)(3)(B) (Medicaid), 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-
2(b)(3)(B), provide protections so that the statutes cannot be
construed to require organizations that offer Medicare Advantage and
Medicaid managed care plans in certain contexts to provide, reimburse
for, or provide coverage of a counseling or referral service if they
object to doing so on moral grounds.
Congress's most recent statement on contraceptive coverage
specified that, if the District of Columbia requires ``the provision of
contraceptive coverage by health insurance plans,'' ``it is the intent
of Congress that any legislation enacted on such issue should include a
`conscience clause' which provides exceptions for religious beliefs and
moral convictions.'' Consolidated Appropriations Act, 2018, Public Law
115-141, Div. E, Sec. 808.
In all of these instances, Congress did not limit the protection for
conscience based on the nature of the entity--and did not exclude
publicly traded entities from protection.
At the same time, as stated in the Moral IFC, the Departments
continue to lack significant information about whether there is a need
to extend the expanded exemption to publicly traded entities. The
Departments have been sued by nonprofit entities expressing objections
to the Mandate based on non-religious moral convictions, as well as by
closely held for-profit entities expressing religious objections, but
not by any publicly traded entities. In addition, the Departments
sought public comments on whether publicly traded entities might
benefit from extending the moral exemption to them. No such entities
were brought to the attention of the Department through the comment
process. The Supreme Court concluded it is improbable that publicly
traded companies with numerous ``unrelated shareholders--including
institutional investors with their own set of stakeholders--would agree
to run a corporation under the same religious beliefs.'' Hobby Lobby,
134 S. Ct. at 2774. It would appear to be even less probable that
publicly traded entities would adopt that view based on non-religious
moral convictions.
In light of the balance of public comments, the Departments decline
to extend the moral convictions exemption to publicly traded entities.
Because the Departments are aware of so many closely-held for-profit
entities with religious objections to contraceptive coverage, and of
some nonprofit entities with non-religious moral objections to
contraceptive coverage, the Departments believe it is reasonably
possible that closely held for-profit entities with non-religious moral
objections to contraceptive coverage might exist or come into being.
The Departments have also concluded that it is reasonably possible,
even if improbable, that publicly traded entities with religious
objections to contraceptive coverage might exist or come into being.
But the Departments conclude there is not a similar probability that
publicly traded for-profit entities with non-religious moral objections
to contraceptive
[[Page 57619]]
coverage may exist and need to be included in these expanded
exemptions. The decision to not extend the moral exemption to publicly
traded for-profit entities in these rules does not reflect a
disagreement with the various conscience statutes that provide
exemptions for moral convictions without categorically excluding
publicly traded entities. The Departments remain open to the
possibility of future rulemaking on this issue, if we become aware of
the need to expand the exemptions to publicly traded corporations with
non-religious moral objections to all (or a subset of) contraceptives.
In contrast, the Departments finalize, without change, the Moral
IFC's extension of the exemptions in these rules to closely held for-
profit entities with moral convictions opposed to offering coverage of
some or all contraceptives. The Departments conclude that it is
sufficiently likely that closely held for-profit entities exist or may
come into being and may maintain moral objections to certain
contraceptives, so as to support including them in these expanded
exemptions. The Departments seek to remove an obstacle that might
prevent individuals with moral objections from forming or maintaining
such small or closely held businesses and providing health coverage to
their employees in accordance with their moral convictions.
In defining what constitutes a closely held for-profit entity to
which these exemptions extend, the Moral IFC used language derived from
the July 2015 final regulations. Those regulations, in offering the
accommodation (not an exemption) to religious (not moral) closely held
for-profit entities, did so by attempting to positively define what
constitutes a closely held entity, formulating a multi-factor, and
partially open-ended, definition for that purpose. (80 FR 41313). Any
such positive definition runs up against the myriad state differences
in defining such entities and potentially intrudes into a traditional
area of state regulation of business organizations. Instead of
attempting to positively define closely held businesses in the Moral
IFC, however, the Departments considered it much clearer, effective,
and preferable to define the category negatively, by reference to one
element of the previous definition: that the entity has no publicly
traded ownership interest (that is, any class of common equity
securities required to be registered under section 12 of the Securities
Exchange Act of 1934).
4. Institutions of Higher Education (45 CFR 147.133(a)(1)(ii))
The previous regulations did not exempt plans arranged by
institutions of higher education, although they did include, in the
accommodation, plans arranged by institutions of higher education
similarly to the way in which the regulations provided the
accommodation to plans of nonprofit religious employers. (See 80 FR
41347). The Moral IFC provided an exemption, in Sec.
147.133(a)(1)(ii), encompassing institutions of higher education that
arrange student health insurance coverage, and stating the exemption
would operate in a manner comparable to the exemption for employers
with respect to plans they sponsor. In these final rules, the
Departments finalize Sec. 147.133(a)(1)(ii) with one change.
These rules treat the health plans of institutions of higher
education that arrange student health insurance coverage similarly to
the way in which the rules treat the plans of employers. The rules do
so by making such student health plans eligible for the expanded
exemptions, and by permitting them the option of electing to utilize
the accommodation process. Thus, these rules specify, in Sec.
147.133(a)(1)(ii), that the exemption is extended, in the case of
institutions of higher education (as defined in 20 U.S.C. 1002) with
objections to the Mandate based on sincerely held moral convictions, to
their arrangement of student health insurance coverage, in a manner
comparable to the exemption for group health insurance coverage
provided in connection with a group health plan established or
maintained by a plan sponsor.
Some commenters supported including, in the exemptions,
institutions of higher education that provide health coverage for
students through student health plans but have moral objections to
providing certain contraceptive coverage. They stated that moral
exemptions allow freedom for certain institutions of higher education
to exist, and this in turn gives students the choice of institutions
that hold different views on important issues such as contraceptives
and abortifacients. Other commenters opposed including the exemption,
asserting that expanding the exemption would negatively impact female
students because institutions of higher education might not cover
contraceptives in student health plans, women enrolled in those plans
would not receive access to birth control, and an increased number of
unintended pregnancies would result.
In the Departments' view, the reasons for extending the exemption
to institutions of higher education are similar to the reasons,
discussed above, for extending the exemption to other nonprofit
organizations. The Departments are not aware of any institutions of
higher education that arrange student health insurance coverage and
object to the Mandate based on non-religious moral convictions. But
because the Departments have been sued by several institutions of
higher education that arrange student health insurance coverage and
object to the Mandate based on religious beliefs and by several
nonprofit organizations with moral objections, the Departments believe
the existence of institutions of higher education with non-religious
moral objections, or the possible formation of such entities in the
future, is sufficiently possible to justify including protections for
such entities in these final rules.
The Departments conclude that this aspect of the exemption is
likely to have a minimal impact on contraceptive coverage for women at
institutions of higher education. As noted above, the Departments are
not aware of any institutions of higher education that would currently
qualify for the objection. In addition, only a minority of students in
higher education receive health insurance coverage from plans arranged
by their colleges or universities, as opposed to from other sources,
and an even smaller number receive such coverage from schools objecting
to contraceptive coverage. Exempting institutions of higher education
that object to contraceptive coverage based on moral convictions does
not affect student health insurance contraceptive coverage at the vast
majority of institutions of higher education. The exemption simply
makes it legal under federal law for institutions to adhere to moral
convictions that oppose contraception, without facing penalties for
non-compliance that could threaten their existence. This removes a
possible barrier to diversity in the nation's higher education system,
because it makes it easier for students to attend institutions of
higher education that hold those views, if the institutions exist or
come into being and students choose to attend them. Moreover, because
institutions of higher education have no legal obligation to sponsor
student health insurance coverage, providing this moral exemption
removes an obstacle to such institutions sponsoring student health
insurance coverage, thus possibly encouraging
[[Page 57620]]
more widespread health insurance coverage.
As noted above, after seeking public comment on whether the final
moral exemptions rules should be extended to include non-federal
governmental entities, the Departments have concluded they should only
include non-governmental entities. For the same reasons, the
Departments are inserting a reference into Sec. 147.133(a)(1)(ii)
specifying that it includes an institution of higher education ``which
is non-governmental.'' This language is parallel to the same limiting
phrase used in the religious exemptions rule governing institutions of
higher education, at Sec. 147.132(a)(1)(ii). Thus, the first sentence
of Sec. 147.133(a)(1)(ii) is finalized to read: ``An institution of
higher education as defined in 20 U.S.C. 1002, which is non-
governmental, in its arrangement of student health insurance coverage,
to the extent that institution objects as specified in paragraph (a)(2)
of this section.'' The remaining text of Sec. 147.133(a)(1)(ii) is
finalized without change.
5. Health Insurance Issuers (45 CFR 147.133(a)(1)(iii))
The Moral IFC extended the exemption, in Sec. 147.133(a)(1)(iii),
to health insurance issuers offering group or individual health
insurance coverage that sincerely hold their own moral convictions
opposed to providing coverage for contraceptive services. The issuer
exemption only applied to the group health plan if the plan itself was
also exempt under an exemption for the plan sponsor or individuals. In
these final rules, the Departments finalize Sec. 147.133(a)(1)(iii)
without change.
As discussed above, where the exemption for plan sponsors or
institutions of higher education applies, issuers are exempt under
those sections with respect to providing contraceptive coverage in
those plans. The issuer exemption in Sec. 147.133(a)(1)(iii) adds to
that protection, but the additional protection operates in a different
way than the plan sponsor exemption operates. The only plan sponsors--
or in the case of individual insurance coverage, individuals--who are
eligible to purchase or enroll in health insurance coverage offered by
an exempt issuer that does not cover some or all contraceptive
services, are plan sponsors or individuals who themselves object and
whose plans are otherwise exempt based on that objection. An exempt
issuer can then offer an exempt product to an entity or individual that
is exempt based on either the moral exemptions for entities and
individuals, or the religious exemptions for entities and individuals.
Thus, the issuer exemption specifies that, where a health insurance
issuer providing group health insurance coverage is exempt under
paragraph (a)(1)(iii), the plan remains subject to any requirement to
provide coverage for contraceptive services under Guidelines issued
under Sec. 147.130(a)(1)(iv), unless the plan is otherwise exempt from
that requirement. Accordingly, the only plan sponsors, or in the case
of individual insurance coverage, individuals, who are eligible to
purchase or enroll in health insurance coverage offered by an exempt
issuer under this paragraph (a)(1)(iii) that does not include some or
all contraceptive services, are plan sponsors or individuals who
themselves object and are exempt.
Under these rules, issuers that hold their own objections based on
sincerely held moral convictions could issue policies that omit
contraception to plan sponsors or individuals that are otherwise exempt
based on their moral convictions, or if they are exempt based on their
religious beliefs under the companion final rules published elsewhere
in today's Federal Register. Likewise, issuers with sincerely held
religious beliefs, that are exempt under those companion final rules,
could likewise issue policies that omit contraception to plan sponsors
or individuals that are otherwise exempt based on either their
religious beliefs or their moral convictions.
Some commenters supported including this exemption for issuers in
these rules, both to protect the moral convictions of issuers, and so
that, in the future, issuers would be free to organize that may wish to
specifically serve plan sponsors and individuals that object to
contraception based on religious or moral reasons. Other commenters
objected to including an exemption for issuers. Some commenters stated
that issuers cannot exercise moral convictions, while others stated
that exempting issuers would threaten contraceptive coverage for women.
Some commenters stated that it was arbitrary and capricious for the
Departments to provide an exemption for issuers if they do not know
that issuers with qualifying moral objections exist.
The Departments consider it appropriate to provide this exemption
for issuers. Because the issuer exemption only applies where an
independently exempt policyholder (entity or individual) is involved,
the issuer exemption will not serve to remove contraceptive coverage
obligations from any plan or plan sponsor that is not also exempt, nor
will it prevent other issuers from being required to provide
contraceptive coverage in individual or group insurance coverage.
The issuer exemption serves several interests, even though the
Departments are not currently aware of existing issuers that would use
it. As noted by some commenters, allowing issuers to be exempt, at
least with respect to plan sponsors, plans, and individuals that
independently qualify for an exemption, will remove a possible obstacle
to issuers with moral convictions being organized in the future to
serve entities and individuals that want plans that respect their
religious beliefs or moral convictions. Furthermore, permitting issuers
to object to offering contraceptive coverage based on sincerely held
moral convictions will allow issuers to continue to offer coverage to
plan sponsors and individuals, without subjecting them to liability
under section 2713(a)(4), or related provisions, for their failure to
provide contraceptive coverage. In this way, the issuer exemption
serves to protect objecting issuers both from being required to issue
policies that cover contraception in violation of the issuers'
sincerely held moral convictions and from being asked or required to
issue policies that omit contraceptive coverage to non-exempt entities
or individuals, thus subjecting the issuers to potential liability if
those plans are not exempt from the Guidelines.
The Departments reject the proposition that issuers cannot exercise
moral convictions. Many federal health care conscience laws and
regulations protect issuers or plans specifically. For example, as
discussed above, 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3) protect
plans or managed care organizations in Medicare Advantage or Medicaid.
The Weldon Amendment specifically protects, among other entities, HMOs,
health insurance plans, and ``any other kind of health care
facility[ies], organization[s] or plan[s]'' as a ``health care entity''
from being required to provide coverage of, or pay for, abortions. See,
for example, Consolidated Appropriations Act, 2018, Public Law 115-141,
Div. H, Sec. 507(d).\68\ The most recently enacted Consolidated
Appropriations Act declares that Congress supports a
[[Page 57621]]
``conscience clause'' to protect moral convictions concerning ``the
provision of contraceptive coverage by health insurance plans.'' See
id. at Div. E, Sec. 808.
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\68\ ACA section 1553 protects an identically defined group of
``health care entities,'' including provider-sponsored
organizations, HMOs, health insurance plans, and ``any other kind of
. . . plan,'' from being subject to discrimination on the basis that
it does not provide any health care item or service furnishing for
the purpose of assisted suicide, euthanasia, mercy killing, and the
like. ACA section 1553, 42 U.S.C. 18113.
---------------------------------------------------------------------------
The issuer exemption does not specifically include third party
administrators, for the reasons discussed in the companion Religious
IFC and final rules concerning religious beliefs issued
contemporaneously with these final rules and published elsewhere in
today's Federal Register.\69\
---------------------------------------------------------------------------
\69\ The exemption for issuers, as outlined here, does not make
a distinction among issuers based on whether they are publicly
traded, unlike the plan sponsor exemption for employers. Because the
issuer exemption operates more narrowly than the exemption for plan
sponsors operates, in the ways described here (i.e., the issuer
exemption does not operate unless the plan sponsor or individual, as
applicable, is also exempt), and exists in part to help preserve
market options for objecting plan sponsors and individuals, the
Departments consider it appropriate to not draw such a distinction
among issuers.
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6. Description of the Moral Objection (45 CFR 147.133(a)(2))
The Moral IFC set forth the scope of the moral objection of
objecting entities in Sec. 147.133(a)(2), so that it applies to the
extent an entity described in paragraph (a)(1), based on sincerely held
moral convictions, objects to ``establishing, maintaining, providing,
offering, or arranging'' either ``coverage or payments'' for
contraceptives, or ``for a plan, issuer, or third party administrator
that provides or arranges such coverage or payments.'' The Departments
are finalizing this exemption with structural changes separating the
second half of the sentence into separate subparagraphs, so as to more
clearly specify, as set forth in the Moral IFC text, that the objection
may pertain either to coverage or payments for contraceptives, or to a
plan, issuer, or third party administrator that provides or arranges
such coverage or payments.
Some commenters observed that, by allowing exempt plan sponsors to
object to ``some or all'' contraceptives, this might yield a cafeteria-
style approach where different plan sponsors choose various
combinations of contraceptives that they wish to cover. Some commenters
further observed that this might create a burden on issuers or third
party administrators.
The Departments have concluded, however, that just as the previous
exemption rules allowed certain religious plan sponsors to object to
some or all contraceptives, it is appropriate to maintain that
flexibility for entities covered by the expanded exemption. These rules
do not require any issuer or third party administrator to contract with
an exempt entity or individual if the issuer or third party
administrator does not wish to do so, including because the issuer or
third party administrator does not wish to offer an unusual plan
variation. These rules simply remove the federal Mandate, in some
cases, where it could have led to penalties on an employer, issuer, or
third party administrator if they wished to sponsor, provide, or
administer a plan that omits contraceptive coverage in the presence of
a qualifying moral objection. That approach is consistent with the
approach under the previous regulations, which did not require issuers
and third party administrators to contract with exempt plans of houses
of worship or integrated auxiliaries if they did not wish to do so.
The definition does not specify that the moral convictions that can
support an exemption need to be non-religious moral convictions. We
find it unnecessary to limit the definition in that way. Even though
moral convictions need not be based on religious beliefs, religious
beliefs can have a moral component. It is not always clear whether a
moral conviction is based on religious tenets. As noted in Welsh, a
moral conviction can be ``purely ethical or moral in source and content
but that nevertheless . . . occupy in the life of that individual a
place parallel to that filled by God [and] function as a religion in
his life.'' 398 U.S at 340. One reason for providing exemptions for
moral convictions is so that the government need not engage in the
potentially difficult task of parsing which convictions are religious
and which are not. If sincerely held moral convictions supporting an
exemption are religious, they will be encompassed by the exemption for
sincerely held religious beliefs. If the moral convictions are not also
religious, or if their religious quality is unclear but they are
ethical or moral, they can qualify as sincerely held moral convictions
under these rules if the other requirements of these rules are met.
The Departments are not aware of any entities that qualify for an
exemption under the religious exemptions finalized elsewhere in today's
Federal Register, but not under the moral exemptions finalized here,
such as publicly traded entities. If publicly traded entities object to
the Mandate, it seems unlikely their objection is based on moral
convictions and not religious beliefs, given that many more objections
to the Mandate have been based on religious beliefs. Thus, the
Departments find it unlikely that they would be faced with a situation
where a publicly traded entity, for example, has an objection to the
contraceptive Mandate, but it is not clear whether that objection is
based on sincerely held religious beliefs or merely based on sincerely
held moral convictions.
7. Individuals (45 CFR 147.133(b))
The previous regulations did not provide an exemption for objecting
individuals. The Moral IFC provided such an exemption for objecting
individuals (referred to here as the ``individual exemption''), using
the following language at Sec. 147.133(b): ``Objecting individuals''.
Guidelines issued under Sec. 147.130(a)(1)(iv) by the Health Resources
and Services Administration must not provide for or support the
requirement of coverage or payments for contraceptive services with
respect to individuals who object as specified in this paragraph (b),
and nothing in Sec. 147.130(a)(1)(iv), 26 CFR 54.9815-2713(a)(1)(iv),
or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing
health insurance issuer offering group or individual health insurance
coverage, and as applicable, a willing plan sponsor of a group health
plan, from offering a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option, to
any individual who objects to coverage or payments for some or all
contraceptive services based on sincerely held moral convictions.''
The Departments finalize this language, with changes in response to
public comments in some of the text and in a new sentence at the end of
the paragraph that clarify how the exemption applies.
Section 147.133(b) sets forth a special rule pertaining to
individuals (referred to here as the ``individual exemption''). This
rule exempts plans of certain individuals with moral objections to
contraceptive coverage where the plan sponsor and, as applicable,
issuer is willing to provide a plan compliant with the individuals'
objections to such plan sponsors or individuals, as applicable.
Some commenters supported this exemption as providing appropriate
protections for the moral convictions of individuals who obtain their
insurance coverage in such places as the individual market or
exchanges, or who obtain coverage from a group health plan sponsor that
does not object to coverage of contraceptives but is willing (and, as
applicable, the issuer is also willing) to provide coverage consistent
with an individual's moral objections. They commented that this
exemption
[[Page 57622]]
would free individuals from having their moral convictions placed in
tension with their desire for health coverage. They also contended that
the individual exemption would not undermine any government interests
behind the contraceptive Mandate, since the individuals would be
choosing not to have the coverage. Some commenters also observed that,
by specifying that the individual exemption only operates where the
plan sponsor and issuer, as applicable, are willing to provide coverage
that is consistent with the objection, the exemption would not impose
burdens on the insurance market because the possibility of such burdens
would be factored into the willingness of an employer or issuer to
offer such coverage.
Other commenters disagreed and contended that allowing the
individual exemption would cause burden and confusion in the insurance
market. Some commenters also suggested that the individual exemption
should not allow the offering of a separate group health plan because
doing so could cause various administrative burdens.
The Departments agree with the commenters who suggested the
individual exemption will not burden the insurance market, and,
therefore, conclude that it is appropriate to provide the individual
exemption where a plan sponsor and, as applicable, issuer are willing
to cooperate in doing so. The Departments note that this individual
exemption only operates in the case where the issuer is willing to
provide the separate option; in the case of coverage provided by a
group health plan sponsor, where the plan sponsor is willing; or in the
case where both a plan sponsor and issuer are involved, both are
willing. The Departments conclude that it is appropriate to provide the
individual exemption so that the Mandate will not serve as an obstacle
among these various options. Practical difficulties that may be
implicated by one option or another will likely be factored into
whether plan sponsors and issuers are willing to offer particular
options in individual cases. But the Departments do not wish to pose an
obstacle to the offering of such coverage.
The Departments note that their decision is consistent with the
decision by Congress to provide protections in certain contexts for
individuals who object to prescribing or providing contraceptives
contrary to their moral convictions. See, for example, Consolidated
Appropriations Act of 2018, Div. E, Sec. 726(c) (Mar. 23, 2018). While
some commenters argued that such express protections are narrow,
Congress likewise provided that, if the District of Columbia requires
``the provision of contraceptive coverage by health insurance plans,''
``it is the intent of Congress that any legislation enacted on such
issue should include a `conscience clause' which provides exceptions
for religious beliefs and moral convictions''. Id. at Div. E, Sec. 808.
A moral exemption for individuals would not be effective if the
government did not, at the same time, permit issuers and group health
plans to provide individuals with policies that comply with their moral
convictions.
The individual exemption extends to the coverage unit in which the
plan participant, or subscriber in the individual market, is enrolled
(for instance, to family coverage covering the participant and his or
her beneficiaries enrolled under the plan), but does not relieve the
plan's or issuer's obligation to comply with the Mandate with respect
to the group health plan generally, or, as applicable, to any other
individual policies the issuer offers. Thus, this individual exemption
allows plan sponsors and issuers that do not specifically object to
contraceptive coverage to offer morally acceptable coverage to their
participants or subscribers who do object, while offering coverage that
includes contraception to participants or subscribers who do not
object. The July 2013 regulations stated that, because employees of
objecting houses of worship and integrated auxiliaries are relatively
likely to oppose contraception, exempting those organizations ``does
not undermine the governmental interests furthered by the contraceptive
coverage requirement.'' (78 FR 39874). For parallel reasons, as the
Departments stated in the Moral IFC (83 FR at 47853 through 47854),
this individual exemption does not undermine the governmental interests
furthered by the contraceptive coverage requirement, because, when the
exemption is applicable, the individual does not want the coverage, and
therefore would not use the objectionable items even if they were
covered.
This individual exemption can apply with respect to individuals in
plans sponsored by private employers or governmental employers. For
example, in one case brought against the Departments, the State of
Missouri enacted a law under which the state is not permitted to
discriminate against insurance issuers that offer group health
insurance policies without coverage for contraception based on
employees' religious beliefs ``or moral convictions,'' or against the
individual employees who accept such offers. See Wieland, 196 F. Supp.
3d at 1015-16 (quoting Mo. Rev. Stat. 191.724). Under the individual
exemption in these rules, employers sponsoring governmental plans would
be free to honor the moral objections of individual employees by
offering them plans that omit contraceptive coverage, even if those
governmental entities do not object to offering contraceptive coverage
in general.
In the separate companion IFC to the Moral IFC--the Religious IFC--
the Departments, at Sec. 147.133(b), provided a similar individual
exemption, but we used slightly different operative language. Where the
Moral IFC said a willing issuer and plan sponsor may offer ``a separate
policy, certificate or contract of insurance or a separate group health
plan or benefit package option, to any individual who objects'' under
the individual exemption, the Religious IFC described what may be
offered to objecting individuals as ``a separate benefit package
option, or a separate policy, certificate or contract of insurance.''
Some commenters observed this difference and asked whether the language
was intended to encompass the same options. The Departments intended
these descriptions to include the same scope of options. Some
commenters suggested that the individual exemption should not allow the
offering of ``a separate group health plan,'' because doing so could
cause various administrative burdens. The Departments disagree, since
group health plan sponsors and group and individual health insurance
issuers would be free to decline to provide that option, including
because of administrative burdens. In addition, the Departments wish to
clarify that, where an employee claims the exemption, a willing issuer
and a willing employer may, where otherwise permitted, offer the
employee participation in a group health insurance policy or benefit
option that complies with the employee's objection. Consequently, these
rules finalize the individual exemption by making a technical change to
the language to adopt the formulation, ``a separate policy, certificate
or contract of insurance or a separate group health plan or benefit
package option, to any group health plan sponsor (with respect to an
individual) or individual, as applicable, who objects.''
This individual exemption cannot be used to force a plan (or its
sponsor) or an issuer to provide coverage omitting contraception, or,
with respect to health insurance coverage, to prevent the application
of state law that requires coverage of such contraceptives or
[[Page 57623]]
sterilization. Nor can the individual exemption be construed to require
the guaranteed availability of coverage omitting contraception to a
plan sponsor or individual who does not have a sincerely held moral
objection. This individual exemption is limited to the requirement to
provide contraceptive coverage under section 2713(a)(4), and does not
affect any other federal or state law governing the plan or coverage.
Thus, if there are other applicable laws or plan terms governing the
benefits, these rules do not affect such other laws or terms.
The Departments received numerous comments about the administrative
burden from the potential variations in moral convictions held by
individuals. Some commenters welcomed the ability of individuals
covered by the individual exemption to be able to assert an objection
to either some or all contraceptives, while others expressed concern
that the variations in the kinds of contraceptive coverage to which
individuals object might make it difficult for willing plan sponsors
and issuers to provide coverage that complies with the moral
convictions of an exempt individual.
If an individual only objects to some contraceptives, and the
individual's issuer and, as applicable, plan sponsor are willing to
provide the individual a package of benefits omitting such coverage,
but for practical reasons can only do so by providing the individual
with coverage that omits all--not just some--contraceptives, the
Departments believe that it favors individual freedom and market
choice, and does not harm others, to allow the issuer and plan sponsor
to provide, in that case, a plan omitting all contraceptives if the
individual is willing to enroll in that plan. The language of the
individual exemption set forth in the Moral IFC implied this conclusion
by specifying that the Guidelines requirement of contraceptive coverage
did not apply where the individual objected to some or all
contraceptives. Notably, that language differed from the language
applicable to the exemptions under Sec. 147.133(a), which specifies
that those exemptions apply ``to the extent'' of the moral objections,
so that, as discussed above, they include only those contraceptive
methods to which the objection applied. In response to comments
suggesting the language of the individual exemption was not
sufficiently clear on this distinction, however, the Departments in
these rules finalize the individual exemption at Sec. 147.133(b), with
the following change, by adding the following sentence at the end of
the paragraph: ``Under this exemption, if an individual objects to some
but not all contraceptive services, but the issuer, and as applicable,
plan sponsor, are willing to provide the plan sponsor or individual, as
applicable, with a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option
that omits all contraceptives, and the individual agrees, then the
exemption applies as if the individual objects to all contraceptive
services.''
Some commenters asked for plain language guidance and examples
about how the individual exemption might apply in the context of
employer-sponsored insurance. Here is one such example. An employee is
enrolled in group health coverage through her employer. The plan is
fully insured. If the employee has sincerely held moral convictions
objecting to her plan including coverage for contraceptives, she could
raise this with her employer. If the employer is willing to offer her a
plan that omits contraceptives, the employer could discuss this with
the insurance agent or issuer. If the issuer is also willing to offer
the employer, with respect to the employee, a group health insurance
policy that omits contraceptive coverage, the individual exemption
would make it legal for the group health insurance issuer to omit
contraceptives for her and her beneficiaries under her policy, for her
employer to sponsor that plan for her, and for the issuer to issue such
a plan to the employer, to cover that employee. This would not affect
other employees' plans--those plans would still be subject to the
Mandate and would continue to cover contraceptives. But if either the
employer, or the issuer, is not willing (for whatever reason) to offer
a plan or a policy for that employee that omits contraceptive coverage,
these rules do not require them to do so. The employee would have the
choice of staying enrolled in a plan with its coverage of
contraceptives, not enrolling in that plan, seeking coverage elsewhere,
or seeking employment elsewhere.
For all these reasons, these rules adopt the individual exemption
language from the Religious IFC with changes, to read as follows: ``(b)
Objecting individuals. Guidelines issued under Sec. 147.130(a)(1)(iv)
by the Health Resources and Services Administration must not provide
for or support the requirement of coverage or payments for
contraceptive services with respect to individuals who object as
specified in this paragraph (b), and nothing in Sec.
147.130(a)(1)(iv), 26 CFR 54.9815-2713(a)(1)(iv), or 29 CFR 2590.715-
2713(a)(1)(iv) may be construed to prevent a willing health insurance
issuer offering group or individual health insurance coverage, and as
applicable, a willing plan sponsor of a group health plan, from
offering a separate policy, certificate or contract of insurance or a
separate group health plan or benefit package option, to any group
health plan sponsor (with respect to an individual) or individual, as
applicable, who objects to coverage or payments for some or all
contraceptive services based on sincerely held moral convictions. Under
this exemption, if an individual objects to some but not all
contraceptive services, but the issuer, and as applicable, plan
sponsor, are willing to provide the plan sponsor or individual, as
applicable, with a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option
that omits all contraceptives, and the individual agrees, then the
exemption applies as if the individual objects to all contraceptive
services.''
8. Accommodation (45 CFR 147.131, 26 CFR 54.9815-2713A, 29 CFR
2590.715-2713A)
The previous regulations did not offer the accommodation process to
entities with moral non-religious objections. The Religious IFC amended
the accommodation regulations to offer it to all entities that are
exempt on the basis of religious beliefs under Sec. 147.132, as an
optional process in which such entities could participate voluntarily.
The Moral IFC did not change that accommodation process, but inserted
references in it to the new section Sec. 147.133, alongside the
references to section Sec. 147.132. These changes made entities
eligible for the voluntary accommodation process if they are exempt on
the basis of moral convictions. The references were inserted in 45 CFR
147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A.
In these rules, the Departments finalize, without change, the Moral
IFC's revisions of 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR
2590.715-2713A. The operation of the accommodation process, changes
made in the Religious IFC, and public comments concerning the
accommodation, are more fully described in the Religious IFC, and in
the companion final rules concerning the religious exemptions and
accommodation, published elsewhere in today's Federal Register. Those
descriptions are incorporated here by reference to the extent they
apply to these rules.
[[Page 57624]]
Many commenters supported extending the accommodation process to
entities with objections based on moral convictions. Others objected to
doing so, raising arguments parallel to their objections to creating
exemptions for group health plan sponsors with moral convictions. For
much the same reasons discussed above concerning why the Departments
find it appropriate to exempt entities with moral objections to
contraceptive coverage, the Departments find it appropriate to extend
the optional accommodation process to these entities. The Departments
observe that, to the extent such entities wish to use the process, it
will not be an obstacle to contraceptive coverage, but will instead
help deliver contraceptive coverage to women who receive health
coverage from such entities while respecting the moral convictions of
the entities. The Departments are not aware of entities with non-
religious moral convictions against contraceptive coverage that also
consider the accommodation acceptable and would opt into it, but we are
aware of a small number of entities with non-religious moral objections
to the Mandate. The Departments, therefore, continue to consider it
appropriate to extend the optional accommodation to such entities in
case any wish to use it. Below, albeit based on very limited data, the
Departments estimate that a small number of entities with non-religious
moral objections may use the accommodation process.
9. Definition of Contraceptives for the Purpose of These Final Rules
The previous regulations did not define contraceptive services. The
Guidelines issued in 2011 included, under ``Contraceptive methods and
counseling,'' ``[a]ll Food and Drug Administration approved
contraceptive methods, sterilization procedures, and patient education
and counseling for all women with reproductive capacity.'' The previous
regulations concerning the exemption and the accommodation used the
terms ``contraceptive services'' and ``contraceptive coverage'' as
catch-all terms to encompass all of those Guidelines requirements. The
2016 update to the Guidelines are similarly worded. Under
``Contraception,'' they include the ``full range of contraceptive
methods for women currently identified by the U.S. Food and Drug
Administration,'' ``instruction in fertility awareness-based methods,''
and ``[c]ontraceptive care'' to ``include contraceptive counseling,
initiation of contraceptive use, and follow-up care (e.g., management,
and evaluation as well as changes to and removal or discontinuation of
the contraceptive method).'' \70\
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\70\ ``Women's Preventive Services Guidelines,'' HRSA (last
reviewed Oct. 2017), https://www.hrsa.gov/womens-guidelines-2016/.
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To more explicitly state that the expanded exemptions encompass any
of the contraceptive or sterilization services, items, procedures, or
related patient education or information that have been required under
the Guidelines, the Moral IFC included a definition of contraceptive
services, benefits or coverage, at 45 CFR 147.133(c). These rules
finalize that definition without change.
10. Severability
The Departments finalize, without change, the severability clause
set forth at Sec. 147.133(d).
C. Other Public Comments
1. Items Approved as Contraceptives But Used To Treat Existing
Conditions
Some commenters noted that some drugs included in the preventive
services contraceptive Mandate can also be useful for treating certain
existing health conditions, and that women use them for non-
contraceptive purposes. Certain commenters urged the Departments to
clarify that the final rules do not permit employers to exclude from
coverage medically necessary prescription drugs used for non-preventive
services. Some commenters suggested that moral objections to the
Mandate should not be permitted in cases where contraceptive methods
are used to treat such existing medical conditions and not for
preventive purposes, even if those contraceptive methods can also be
used for contraceptive purposes.
Section 2713(a)(4) only applies to ``preventive'' care and
screenings. The statute does not allow the Guidelines to mandate
coverage of services provided solely for a non-preventive use, such as
the treatment of an existing condition. The Guidelines implementing
this section of the statute are consistent with that narrow authority.
They state repeatedly that they apply to ``preventive'' services or
care.\71\ The requirement in the Guidelines concerning
``contraception'' specifies several times that it encompasses
``contraceptives,'' that is, medical products, methods, and services
applied for ``contraceptive'' uses. The Guidelines do not require
coverage of care and screenings that are non-preventive, and the
contraception portion of those Guidelines do not require coverage of
medical products, methods, care, and screenings that are non-
contraceptive in purpose or use. The Guidelines' inclusion of
contraceptive services requires coverage of contraceptive methods as a
type of preventive service only when a drug that FDA has approved for
contraceptive use is prescribed in whole or in part for such purpose or
intended use. Section 2713(a)(4) does not authorize the Departments to
require coverage of drugs prescribed exclusively for a non-
contraceptive and non-preventive use to treat an existing
condition.\72\ The extent to which contraceptives are covered to treat
non-preventive conditions would be determined by application of the
requirement section 1302(b)(1)(F) of the ACA to cover prescription
drugs (where applicable), implementing regulations at 45 CFR 156.122,
and 156.125, and plans' decisions about the basket of medicines to
cover for these conditions.
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\71\ Id.
\72\ The Departments previously cited the IOM's listing of
existing conditions that contraceptive drugs can be used to treat
(menstrual disorders, acne, and pelvic pain), and said of those uses
that ``there are demonstrated preventive health benefits from
contraceptives relating to conditions other than pregnancy.'' 77 FR
8727 & n.7. This was not, however, an assertion that section
2713(a)(4) or the Guidelines require coverage of ``contraceptive''
methods when prescribed for an exclusively non-contraceptive, non-
preventive use. Instead, it was an observation that such drugs--
generally referred to as ``contraceptives''--also have some
alternate beneficial uses to treat existing conditions. For the
purposes of these final rules, the Departments clarify here that the
previous reference to the benefits of using contraceptive drugs
exclusively for some non-contraceptive and non-preventive uses to
treat existing conditions did not mean that the Guidelines require
coverage of such uses, and consequently is not a reason to refrain
from offering the exemptions provided here. Where a drug approved by
the FDA for contraceptive use is prescribed for both a contraceptive
use and a non-contraceptive use, the Guidelines (to the extent they
apply) would require its coverage. Where a drug approved by the FDA
for contraceptive use is prescribed exclusively for a non-
contraceptive and non-preventive use to treat an existing condition,
it would be outside the scope of the Guidelines and the
contraceptive Mandate.
---------------------------------------------------------------------------
Some commenters observed that pharmacy claims do not include a
medical diagnosis code, so that plans may be unable to discern whether
a drug approved by FDA for contraceptive uses is actually applied for a
preventive or contraceptive use. Section 2713(a)(4), however, draws a
distinction between preventive and other kinds of care and screenings.
That subsection does not authorize the Departments to impose a coverage
mandate of services that are not at least partly applied for a
preventive use, and the Guidelines themselves do not require coverage
of care unless it is contraceptive in purpose. These rules do not
prohibit issuers from covering drugs and devices that are approved for
contraceptive uses even when those drugs and devices are
[[Page 57625]]
prescribed for non-preventive, non-contraceptive purposes. As discussed
above, these final rules do not purport to delineate the items HRSA
will include in the Guidelines, but only concern expanded exemptions
and accommodations that apply if the Guidelines require contraceptive
coverage. Therefore, the Departments do not consider it appropriate to
specify in these final rules that, under section 2713(a)(4), exempt
organizations must provide coverage for drugs or items prescribed
exclusively for a non-contraceptive and non-preventive use to treat an
existing condition.
2. Comments Concerning Regulatory Impact
Some commenters agreed with the Departments' statement in the Moral
IFC that the moral exemptions are likely to affect only a very small
number of women otherwise receiving coverage under the Mandate. Other
commenters disagreed, stating that the exemptions could take
contraceptive coverage away from many or most women. Still others
opposed establishing the exemptions, but contended that accurately
determining the number of women affected by the exemptions is not
possible. Public comments included various statements that these
exemptions would impact coverage for a large number of women, while
others stated they would affect only a very small number. But few, if
any, public commenters provided data predicting a precise number of
entities that would make use of the exemptions for moral convictions
nor a precise number of employees that would potentially be affected.
After reviewing the public comments, the Departments do not find
the suggestions of commenters who predicted a very large impact any
more reliable than the estimates set forth in the Religious and Moral
IFCs. Therefore, the Departments conclude that the estimates of
regulatory impact made in the Religious and Moral IFCs are still the
best estimates available. The Departments' estimates are discussed in
more detail in the following section.
III. Economic Impact and Paperwork Burden
The Departments have examined the impacts of these final rules as
required by Executive Order 12866 on Regulatory Planning and Review
(September 30, 1993), Executive Order 13563 on Improving Regulation and
Regulatory Review (January 18, 2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96-354, section1102(b) of the Social
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and
Executive Order 13771 on Reducing Regulation and Controlling Regulatory
Costs (January 30, 2017).
A. Executive Orders 12866 and 13563--Department of HHS and Department
of Labor
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, and public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a
regulation: (1) Having an annual effect on the economy of $100 million
or more in any 1 year, or adversely and materially affecting a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or state, local, or tribal governments or
communities (also referred to as ``economically significant''); (2)
creating a serious inconsistency or otherwise interfering with an
action taken or planned by another agency; (3) materially altering the
budgetary impacts of entitlement grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year),
and an ``economically significant'' regulatory action is subject to
review by OMB. As discussed below regarding their anticipated effects,
the these final rules are not likely to have economic impacts of $100
million or more in any one year, and therefore do not meet the
definition of ``economically significant'' under Executive Order 12866.
However, OMB has determined that the actions are significant within the
meaning of section 3(f)(4) of the Executive Order. Therefore, OMB has
reviewed these final rules and the Departments have provided the
following assessment of their impact.
1. Need for Regulatory Action
The Religious IFC amended the Departments' July 2015 final
regulations. The Moral IFC amended those regulations further, and added
an additional rule at 45 CFR part 147.133. These final rules adopt as
final, and further amend, the amendments made by the Moral IFC. The
Departments do so in conjunction with the amendments made in the
companion final rules concerning religious beliefs published elsewhere
in today's Federal Register. These rules provide an exemption from the
requirement to provide coverage for contraceptives and sterilization,
established under the HRSA Guidelines, promulgated under section
2713(a)(4), section 715(a)(1) of the ERISA, and section 9815(a)(1) of
the Code, for certain entities and individuals with objections to
compliance with the Mandate based on sincerely held moral convictions,
and they revise the accommodation process by making the accommodation
applicable to organizations with such convictions as an option. The
exemption applies to certain individuals, nonprofit entities,
institutions of higher education, issuers, and for-profit entities that
do not have publicly traded ownership interests, that have a moral
objection to some (or all) of the contraceptive and/or sterilization
services covered by the Guidelines. Such action has been taken to
provide for participation in the health insurance market by certain
entities or individuals in a manner free from penalties for violating
sincerely held moral convictions opposed to providing or receiving
coverage of contraceptive services, to ensure the preventive services
coverage requirement is implemented in a way consistent with
longstanding federal conscience statutes, to prevent lawsuits of the
kind that were filed against the Departments when the expanded
exemption in these final rules was not offered, and for the other
reasons discussed above.
2. Anticipated Effects
The Departments acknowledge that expanding the exemption to include
objections based on moral convictions might result in less insurance
coverage of contraception for some women who may want the coverage.
Although the Departments do not know the exact scope of that effect
attributable to the moral exemption in these final rules, we believe it
to be small.
With respect to the exemption for nonprofit organizations with
objections based on moral convictions, as noted
[[Page 57626]]
above, the Departments are aware of two small nonprofit organizations
that have filed lawsuits raising non-religious moral objections to
coverage of some contraceptives. Both of those entities have fewer than
five employees enrolled in health coverage, and both require all of
their employees to agree with their opposition to the nature of certain
contraceptives subject to coverage under the Mandate.\73\ One of them
has obtained a permanent injunction against any regulations
implementing the contraceptive Mandate, and so will not be affected by
these final rules. Based on comments submitted in response to
rulemakings prior to the Moral and Religious IFCs, the Departments
believe that at least one other similar entity exists.\74\ However, the
Departments do not know how many similar entities exist and are
currently unable to estimate the number of such entities. Lacking other
information, we assume that the number is small. The Departments
estimate it to be less than 10 and assume the exemption will be used by
nine nonprofit entities.
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\73\ Non-religious nonprofit organizations that engage in
expressive activity generally have a First Amendment right to hire
only people who share their moral convictions or will be respectful
of them--including their convictions on whether the organization or
others provide health coverage of contraception, or of certain items
they view as being abortifacient.
\74\ See, for example, Americans United for Life (``AUL'')
Comment on CMA-9992-IFC2 at 10 (Nov. 1, 2011), available at https://www.regulations.gov/#!documentDetail;D=HHS-OS-2011-0023-59496, and
AUL Comment on CMS-9968-P at 5 (Apr. 8, 2013), available at https://www.regulations.gov/#!documentDetail;D=CMS-2012-0031-79115.
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The Departments also assume that those nine entities will operate
in a fashion similar to the two similar entities of which we are aware,
so that their employees will likely share their views against coverage
of certain contraceptives. This is consistent with the conclusion in
previous regulations that no significant burden or costs would result
from exempting houses of worship and integrated auxiliaries. (See 76 FR
46625 and 78 FR 39889). The Departments reached that conclusion without
ultimately requiring that houses of worship and integrated auxiliaries
only hire persons who agree with their views against contraception and
without requiring that such entities actually oppose contraception in
order to be exempt (in contrast, the exemption here requires the exempt
entity to actually possess sincerely held moral convictions objecting
to contraceptive coverage). In concluding that the exemption for houses
of worship and integrated auxiliaries would result in no significant
burden or costs, the Departments relied on the assumption that the
employees of exempt houses of worship and integrated auxiliaries likely
share their employers' opposition to contraceptive coverage.
A similar assumption is appropriate with respect to the expanded
exemption for nonprofit organizations with objections based on moral
convictions. To the knowledge of the Departments, the vast majority of
organizations objecting to the Mandate assert objections based on
religious beliefs. The only nonprofit organizations of which they are
aware that possess non-religious moral convictions against some or all
contraceptive methods only hire persons who share their convictions. It
is possible that the exemption for nonprofit organizations with moral
convictions in these final rules could be used by a nonprofit
organization that employs persons who do not share the organization's
views on contraception, but it was also possible under the Departments'
previous regulations that a house of worship or integrated auxiliary
could employ persons who do not share their views on contraception.\75\
Although the Departments are unable to find sufficient data on this
issue, we believe that there are far fewer nonprofit organizations
opposed to contraceptive coverage on the basis of moral convictions
than there are houses of worship or integrated auxiliaries with
religious objections to such coverage. Based on the limited data
available, the Departments believe the most likely effect of the
expanded exemption for nonprofit entities is that it will be used by
entities similar to the two entities that have sought an exemption
through litigation, and whose employees also oppose certain
contraceptive coverage. Therefore, the Departments expect that the
moral exemption for nonprofit entities will have a minimal effect of
reducing contraceptive coverage with respect to employees who want such
coverage.
---------------------------------------------------------------------------
\75\ Cf., for example, Frank Newport, ``Americans, Including
Catholics, Say Birth Control Is Morally OK,'' Gallup, (May 22,
2012), https://www.gallup.com/poll/154799/americans-including-catholics-say-birth-control-morally.aspx (``Eighty-two percent of
U.S. Catholics say birth control is morally acceptable'').
---------------------------------------------------------------------------
These rules extend the exemption to include institutions of higher
education that arrange student coverage and have non-religious moral
objections to the Mandate, and make exempt entities with moral
objections eligible to avail themselves of the accommodation. The
Departments are not aware of any institutions of higher education with
this kind of non-religious moral convictions. Moreover, the Departments
believe the overall number of entities that would object to the Mandate
based on non-religious moral convictions is already very small. The
only entities of which we are aware that have raised such objections
are not institutions of higher education. Public comments did not
reveal the existence of any institutions of higher education with such
moral convictions. Therefore, for the purposes of estimating the
anticipated effect of these final rules on contraceptive coverage of
women who wish to receive such coverage, the Departments assume that--
at this time--no entities with non-religious moral objections to the
Mandate will be institutions of higher education that arrange student
coverage, and no other entities with non-religious moral objections
will opt into the accommodation. We wish to make the expanded exemption
and accommodation available to such entities in case they do exist or
might come into existence, based on reasons similar to those given
above for why the exemptions and accommodations are extended to other
entities.
The Departments believe that the exemption for issuers with
objections based on moral convictions will not result in a distinct
effect on contraceptive coverage for women who wish to receive it,
because that exemption only applies in cases where plan sponsors or
individuals are also otherwise exempt, and the effect of those
exemptions is discussed elsewhere herein, or in the companion final
rules concerning religious beliefs published elsewhere in today's
Federal Register. The exemption for individuals that oppose
contraceptive coverage based on sincerely held moral convictions will
provide coverage that omits contraception for individuals that object
to contraceptive coverage.
The moral exemption will also cover for-profit entities that do not
have publicly traded ownership interests and that have non-religious
moral objections to the Mandate, if such entities exist. Some
commenters agreed that the impact of these final rules would be no more
than the Departments estimated in the Moral IFC, and some commenters
stated the impact would be much smaller. Other commenters disagreed,
suggesting that the expanded exemptions risked removing contraceptive
coverage from more than 55 million women receiving the benefits of the
preventive services Guidelines, or even risked removing contraceptive
coverage from over 100 million women. Some commenters cited studies
indicating that, nationally, unintended
[[Page 57627]]
pregnancies have large public costs, and the Mandate overall led to
large out-of-pocket savings for women. These general comments did not,
however, substantially assist the Departments in estimating the number
of women that would potentially be affected by these exemptions for
moral convictions specifically, or among them, how many unintended
pregnancies would result, how many of the affected women would
nevertheless use contraceptives not covered under the health plans of
their objecting employers and, thus, be subject to the estimated
transfer costs, or instead, how many women might avoid unintended
pregnancies by changing their activities in other ways besides using
contraceptives.
Some of the comments opposing these exemptions assert that they
will lead to a large number of entities dropping contraceptive
coverage. The Departments disagree; they are aware of only two entities
that hold non-religious moral convictions against contraceptive
coverage. Both only hire employees that share their beliefs, and one
will not be affected by these final rules because it is protected by an
injunction from any regulations implementing the contraceptive Mandate.
Commenters cited no other specific entities that might assert these
moral convictions, and did not provide better data to estimate how many
entities might exist. Likewise, the Departments find it unlikely that
any of the vast majority of entities that covered contraceptives before
this Mandate was announced in 2011 would terminate such coverage
because of these exemptions based on moral convictions. The Departments
also find it unlikely that a significant number of for-profit entities,
whose plans include a significant number of women, omitted
contraceptive coverage before the ACA on the basis of objections
grounded in non-religious moral convictions, and would claim an
exemption under these final rules. No such entities, or data concerning
such entities, were identified by public commenters, nor are the
Departments aware of any involved in litigation over the Mandate.
Numerous for-profit entities claiming religious objections have
filed suit challenging the Mandate. Among the over 200 entities that
brought legal challenges, only two entities (less than 1 percent)
raised non-religious moral objections--and both were nonprofit
organizations. Among the general public, polls vary about religious
beliefs, but one prominent poll shows that 89 percent of Americans say
they believe in God.\76\ Among non-religious persons, only a very small
percentage of the population appears to hold moral objections to
contraception. A recent study found that only 2 percent of religiously
unaffiliated persons believed using contraceptives is morally
wrong.\77\ Combined, this suggests that 0.2 percent of Americans at
most \78\ might believe contraceptives are morally wrong based on moral
convictions but not religious beliefs. The Departments have no
information about how many of those persons run closely held
businesses, offer employer sponsored health insurance, and would make
use of the expanded exemption for moral convictions set forth in these
final rules. Given the large number of closely held entities that
challenged the Mandate based on religious objections, the Departments
assume that some similar for-profit entities with non-religious moral
objections exist. But the Departments expect that it will be a
comparatively small number of entities, since among the nonprofit
litigants, only two were non-religious. Without data available to
estimate the actual number of entities that will make use of the
expanded exemption for for-profit entities without publicly traded
ownership interests and with sincere moral objections to the Mandate,
the Departments expect that fewer than 10 entities, if any, will do
so--so the Departments assume nine for-profit entities will use the
exemption in these final rules.
---------------------------------------------------------------------------
\76\ Frank Newport, ``Most Americans Still Believe in God,''
Gallup (June 29, 2016), https://www.gallup.com/poll/193271/americans-believe-god.aspx.
\77\ Pew Research Center, ``Where the Public Stands on Religious
Liberty vs. Nondiscrimination,'' Pew Research Center, 26 (Sept. 28,
2016), https://assets.pewresearch.org/wp-content/uploads/sites/11/2016/09/Religious-Liberty-full-for-web.pdf.
\78\ The study defined religiously ``unaffiliated'' as agnostic,
atheist or ``nothing in particular'', id. at 8, as distinct from
several versions of Protestants, or Catholics. ``Nothing in
particular'' might have included some theists.
---------------------------------------------------------------------------
The moral exemption encompassing certain for-profit entities could
result in the removal of contraceptive coverage from women who do not
share their employers' views. The Departments used data from the
Current Population Survey (CPS) and the Medical Expenditure Panel
Survey-Insurance Component (MEPS-IC) to obtain an estimate of the
number of policyholders that will be covered by the plans of the nine
for-profit entities we assume may make use of these expanded
exemptions.\79\ The average number of policyholders (9) in plans with
under 100 employees was obtained. It is not known how many employees
would be employed by the for-profit employers that might claim this
exemption, but as discussed above these final rules do not include
publicly traded companies, and both of the two nonprofit entities that
challenged the Mandate based on moral objections included fewer than
five policyholders in their group plans. Therefore, the Departments
assume that the for-profit entities that may claim this expanded
exemption will have fewer than 100 employees and an average of 9
policyholders. For 9 entities, the total number of policyholders would
be approximately 81. DOL estimates that for each policyholder, there is
approximately one dependent.\80\ This amounts to approximately 162
covered persons. Census data indicate that women of childbearing age,
i.e., women aged 15 to 44, comprise 20.2 percent of the general
population.\81\ This amounts to approximately 33 women of childbearing
age for this group of individuals covered by group plans sponsored by
for-profit moral objectors. Approximately 44.3 percent of women
currently use contraceptives covered by the Guidelines.\82\ Thus, the
Departments estimate that approximately 15 women may incur
contraceptive costs due to for-profit entities using the expanded moral
exemption provided for in these final rules.\83\ In the companion final
[[Page 57628]]
rules concerning religious beliefs issued contemporaneously with these
final rules and published elsewhere in today's Federal Register, we
estimate that the average cost of contraception per year per woman of
childbearing age that use contraception covered by the Guidelines, in
health plans that cover contraception, is $584. Consequently, the
Departments estimate that the anticipated effects attributable to the
cost of contraception from for-profit entities using the expanded moral
exemption in these final rules is approximately $8,760.
---------------------------------------------------------------------------
\79\ ``Health Insurance Coverage Bulletin,'' Dept. of Labor
(June 28, 2016), Table 4, page 21. Using March 2015 Annual Social
and Economic Supplement to the Current Population Survey. https://www.dol.gov/sites/default/files/ebsa/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2015.pdf. Estimates of
the number of ERISA Plans based on 2015 Medical Expenditure Survey--
Insurance.
\80\ ``Health Insurance Coverage Bulletin'' Dept. of Labor''
(June 28, 2016), Table 4, page 21. Using March 2015 Annual Social
and Economic Supplement to the Current Population Survey. https://www.dol.gov/sites/default/files/ebsa/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2015.pdf.
\81\ U.S. Census Bureau, ``Age and Sex Composition: 2010'' (May
2011), available at https://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf. The Guidelines' requirement of contraceptive
coverage only applies ``for all women with reproductive capacity.''
Women's Preventive Services Guidelines, HRSA (last reviewed Oct.
2017), https://www.hrsa.gov/womensguidelines/; see also 80 FR 40318.
In addition, studies commonly consider the 15-44 age range to assess
contraceptive use by women of childbearing age. See, e.g.,
``Contraceptive Use in the United States,'' The Guttmacher Institute
(Sept. 2016), https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states.
\82\ See ``Contraceptive Use in the United States,'' The
Guttmacher Institute (Sept. 2016), https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states.
\83\ The Departments note that many non-religious for-profit
entities which sued the Departments challenging the Mandate,
including some of the largest employers, only objected to coverage
of 4 of the 18 types of contraceptives required to be covered by the
Mandate--namely, those contraceptives which they viewed as
abortifacients, and akin to abortion --and they were willing to
provide coverage for other types of contraception. It is reasonable
to assume that this would also be the case with respect to some for-
profits that object to the Mandate on the basis of sincerely held
moral convictions. Accordingly, it is possible that even fewer women
beneficiaries under such plans would bear out-of-pocket expenses in
order to obtain contraceptives, and that those who might do so would
bear lower costs due to many contraceptive items being covered.
---------------------------------------------------------------------------
The Departments estimate that these final rules will not result in
any additional burden or costs on issuers or third party
administrators. As discussed above, we assume that no entities with
non-religious moral convictions will avail themselves of the
accommodation, although the Departments wish to make it available in
case an entity voluntarily opts into it in order to allow contraceptive
coverage to be provided to its plan participants and beneficiaries.
While these final rules make it legal for issuers to offer insurance
coverage that omits contraceptives to/for exempt entities and
individuals, these final rules do not require issuers to do so.
Finally, because the accommodation process was not previously available
to entities that possess non-religious moral objections to the Mandate,
the Departments do not anticipate that these final rules will result in
any burden from such entities acting to revoke their accommodated
status.
The Departments believe the foregoing analysis represents a
reasonable estimate of the likely impact under the exemptions finalized
in these final rules. The Departments acknowledge uncertainty in the
estimate and, therefore, conducted a second analysis using an
alternative framework, which is set forth in the companion final rules
concerning religious beliefs issued contemporaneously with these final
rules and published elsewhere in today's Federal Register, with
reference to the analysis conducted in the Religious IFC. Under either
estimate, these final rules are not deemed to be economically
significant.
The Departments reiterate the rareness of instances in which we are
aware that employers assert non-religious objections to contraceptive
coverage based on sincerely held moral convictions, as discussed above,
and also that in the few instances where such an objection has been
raised, employees of such employers also opposed contraception.
B. Special Analyses--Department of the Treasury
These regulations are not subject to review under section 6(b) of
Executive Order 12866 pursuant to the Memorandum of Agreement (April
11, 2018) between the Department of the Treasury and the Office of
Management and Budget regarding review of tax regulations.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) imposes
certain requirements with respect to federal regulations that are
subject to the notice and comment requirements of section 553(b) of the
APA (5 U.S.C. 551 et seq.) and that are likely to have a significant
economic impact on a substantial number of small entities. Under
section 553(b) of the APA, a general notice of proposed rulemaking is
not required when an agency, for good cause, finds that notice and
public comment thereon are impracticable, unnecessary, or contrary to
the public interest. The Moral IFC was a set of interim final rules
with comment, and in these final rules, the Departments finalize the
Moral IFC with certain changes based on public comments. The Moral IFC
was exempt from the notice and comment requirements of the APA, both
because the PHS Act, ERISA, and the Code contain specific provisions
under which the Secretaries may adopt regulations by interim final rule
and because the Departments have made a good cause finding that a
general notice of proposed rulemaking is not necessary earlier in this
preamble. Therefore, the RFA did not apply to the Moral IFC. These
final rules are, however, issued after a notice and comment period.
The Departments carefully considered the likely impact of the rules
on small entities in connection with their assessment under Executive
Order 12866. The Departments do not expect that these final rules will
have a significant economic effect on a substantial number of small
entities, because they will not result in any additional costs to
affected entities. Instead, by exempting from the Mandate small
businesses and nonprofit organizations with moral objections to some or
all contraceptives and/or sterilization--businesses and organizations
which would otherwise be faced with the dilemma of complying with the
Mandate (and violating their moral convictions), or of following their
moral convictions and incurring potentially significant financial
penalties for noncompliance--the Departments have reduced regulatory
burden on small entities. Pursuant to section 7805(f) of the Code, the
notice of proposed rulemaking preceding these regulations was submitted
to the Chief Counsel for Advocacy of the Small Business Administration
for comment on their impact on small business.
D. Paperwork Reduction Act--Department of Health and Human Services
Under the Paperwork Reduction Act of 1995 (the PRA), federal
agencies are required to publish notice in the Federal Register and
solicit public comment before a collection of information is submitted
to the Office of Management and Budget (OMB) for review and approval.
Interested persons are invited to send comments regarding our burden
estimates or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
The Departments estimate that these final rules will not result in
additional burdens not accounted for as set forth in companion final
rules concerning religious beliefs issued contemporaneously with these
final rules and published elsewhere in today's Federal Register. As
discussed there, rules covering the accommodation include provisions
regarding self-certification or notices to HHS from eligible
organizations (Sec. 147.131(c)(3)), notice of availability of separate
payments for contraceptive services (Sec. 147.131(e)), and notice of
revocation of accommodation (Sec. 147.131(c)(4)). The burden related
to these information collection requirements (ICRs) received emergency
review and approval under OMB Control Number 0938-1344. They have been
resubmitted to OMB in conjunction with this final rule and are pending
re-approval.
[[Page 57629]]
As discussed above, however, the Departments assume that no
entities with non-religious moral objections to the Mandate will use
the accommodation. The Departments know that no such entities were
eligible for it until now, so that no entity possesses an accommodated
status that would need to be revoked. Therefore, the Departments
believe that the burden for these ICRs is accounted for in the
collection approved under OMB Control Numbers 0938-1344, as described
in the final rules concerning religious beliefs issued
contemporaneously with these final rules.
E. Paperwork Reduction Act--Department of Labor
Under the Paperwork Reduction Act, an agency may not conduct or
sponsor, and an individual is not required to respond to, a collection
of information unless it displays a valid OMB control number. In
accordance with the requirements of the PRA, the ICR for the EBSA Form
700 and alternative notice have previously been approved by OMB under
control numbers 1210-0150 and 1210-0152. In an effort to consolidate
the number of information collections the Department is combining OMB
control numbers 1210-0150 and 1210-0152 under OMB control number 1210-
0150 and discontinuing OMB control number 1210-0152.
A copy of the ICR may be obtained by contacting the PRA addressee
shown below or at https://www.RegInfo.gov. PRA ADDRESSEE: G. Christopher
Cosby, Office of Policy and Research, U.S. Department of Labor,
Employee Benefits Security Administration, 200 Constitution Avenue NW,
Room N-5718, Washington, DC 20210. Telephone: (202) 693-8410; Fax:
(202) 219-4745. These are not toll-free numbers.
Consistent with the analysis in the HHS PRA section above, although
these final rules make entities with certain moral convictions eligible
for the accommodation, the Department assumes (1) that no entities will
use the accommodation rather than the exemption, and (2) entities using
the moral exemption would not have to revoke an accommodation, because
they previously were not eligible for it. Therefore, the Department
believes these final rules do not involve additional burden not
accounted for under OMB control number 1210-0150, which is published
elsewhere in today's issue of the Federal Register in connection with
the companion Religious Exemption and Accommodation Preventive Health
Service final rule. The Department will publish a notice informing the
public of OMB's action with respect to the Department's submission of
the ICRs under OMB control number 1210-0150.
F. Regulatory Reform Executive Orders 13765, 13771 and 13777
Executive Order 13765 (January 20, 2017) directs that, ``[t]o the
maximum extent permitted by law, the Secretary of Health and Human
Services (Secretary) and the heads of all other executive departments
and agencies (agencies) with authorities and responsibilities under the
[Affordable Care] Act shall exercise all authority and discretion
available to them to waive, defer, grant exemptions from, or delay the
implementation of any provision or requirement of the Act that would
impose a fiscal burden on any state or a cost, fee, tax, penalty, or
regulatory burden on individuals, families, healthcare providers,
health insurers, patients, recipients of healthcare services,
purchasers of health insurance, or makers of medical devices, products,
or medications.'' In addition, agencies are directed to ``take all
actions consistent with law to minimize the unwarranted economic and
regulatory burdens of the [Affordable Care Act], and prepare to afford
the States more flexibility and control to create a more free and open
healthcare market.'' The Moral IFC and these final rules exercise the
discretion provided to the Departments under the Affordable Care Act
and other laws to grant exemptions and thereby minimize regulatory
burdens of the Affordable Care Act on the affected entities and
recipients of health care services.
Consistent with Executive Order 13771 (82 FR 9339, February 3,
2017), the Departments have estimated the costs and cost savings
attributable to these rules. As discussed in more detail in the
preceding analysis, these final rules lessen incremental reporting
costs.\84\ However, in order to avoid double-counting with the Moral
IFC, which has already been tallied as an E.O. 13771 deregulatory
action, this finalization of the IFC's policy is not considered a
deregulatory action under the Executive Order.
---------------------------------------------------------------------------
\84\ Other noteworthy potential impacts encompass potential
changes in medical expenditures, including potential decreased
expenditures on contraceptive devices and drugs and potential
increased expenditures on pregnancy-related medical services. OMB's
guidance on E.O. 13771 implementation (https://www.whitehouse.gov/the-press-office/2017/04/05/memorandum-implementing-executive-order-13771-titled-reducing-regulation) states that impacts should be
categorized as consistently as possible within Departments. The Food
and Drug Administration, within HHS, and the Occupational Safety and
Health Administration (OSHA) and Mine Safety and Health
Administration (MSHA), within DOL, regularly estimate medical
expenditure impacts in the analyses that accompany their
regulations, with the results being categorized as benefits
(positive benefits if expenditures are reduced, negative benefits if
expenditures are raised). Following the FDA, OSHA and MSHA
accounting convention leads to these final rules' medical
expenditure impacts being categorized as (positive or negative)
benefits, rather than as costs, thus placing them outside of
consideration for E.O. 13771 designation purposes.
---------------------------------------------------------------------------
G. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (section 202(a) (Pub. L.
104-4), requires the Departments to prepare a written statement, which
includes an assessment of anticipated costs and benefits, before
issuing ``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 million or more (adjusted
annually for inflation) in any 1 year.'' In 2018, that threshold is
approximately $150 million. For purposes of the Unfunded Mandates
Reform Act, the Moral IFC and these final rules do not include any
federal mandate that may result in expenditures by state, local, or
tribal governments, nor do they include any federal mandates that may
impose an annual burden of $150 million or more on the private sector.
H. Federalism
Executive Order 13132 outlines fundamental principles of
federalism, and requires the adherence to specific criteria by federal
agencies in the process of their formulation and implementation of
policies that have ``substantial direct effects'' on states, the
relationship between the federal government and states, or the
distribution of power and responsibilities among the various levels of
government. Federal agencies promulgating regulations that have these
federalism implications must consult with state and local officials,
and describe the extent of their consultation and the nature of the
concerns of state and local officials in the preamble to the
regulation.
These rules do not have any Federalism implications, since they
only provide exemptions from the contraceptive and sterilization
coverage requirement in HRSA Guidelines supplied under section 2713 of
the PHS Act.
IV. Statutory Authority
The Department of the Treasury regulations are adopted pursuant to
the authority contained in sections 7805 and 9833 of the Code.
[[Page 57630]]
The Department of Labor regulations are adopted pursuant to the
authority contained in 29 U.S.C. 1002(16), 1027, 1059, 1135, 1161-1168,
1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a,
1191b, and 1191c; sec. 101(g), Public Law 104-191, 110 Stat. 1936; sec.
401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec.
512(d), Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and
1562(e), Public Law 111-148, 124 Stat. 119, as amended by Public Law
111-152, 124 Stat. 1029; Secretary of Labor's Order 1-2011, 77 FR 1088
(Jan. 9, 2012).
The Department of Health and Human Services regulations are adopted
pursuant to the authority contained in sections 2701 through 2763,
2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-
91, and 300gg-92), as amended; and Title I of the Affordable Care Act,
sections 1301-1304, 1311-1312, 1321-1322, 1324, 1334, 1342-1343, 1401-
1402, and 1412, Public Law 111-148, 124 Stat. 119 (42 U.S.C. 18021-
18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071,
18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).
List of Subjects
26 CFR Part 54
Excise taxes, Health care, Health insurance, Pensions, Reporting
and recordkeeping requirements.
29 CFR Part 2590
Continuation coverage, Disclosure, Employee benefit plans, Group
health plans, Health care, Health insurance, Medical child support,
Reporting and recordkeeping requirements.
45 CFR Part 147
Health care, Health insurance, Reporting and recordkeeping
requirements, State regulation of health insurance.
Kirsten Wielobob,
Deputy Commissioner for Services and Enforcement.
Approved: October 30, 2018.
David J. Kautter,
Assistant Secretary for Tax Policy.
Signed this 29th day of October, 2018.
Preston Rutledge,
Assistant Secretary, Employee Benefits Security Administration,
Department of Labor.
Dated: October 17, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: October 18, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
For the reasons set forth in this preamble, 26 CFR part 54 is
amended as follows:
PART 54--PENSION EXCISE TAXES
0
1. The authority citation for part 54 continues to read, in part, as
follows:
Authority: 26 U.S.C. 7805. * * *
Sec. 54.9815-2713 [Amended]
0
2. Section 54.9815-2713, as amended elsewhere in this issue of the
Federal Register, is further amended in paragraph (a)(1)(iv) by
removing the reference ``147.131 and 147.132'' and adding in its place
the reference ``147.131, 147.132, and 147.133''.
Sec. 54.9815-2713A [Amended]
0
3. Section 54.9815-2713A, as amended elsewhere in this issue of the
Federal Register, is further amended--
0
a. In paragraph (a)(1) by removing ``or (ii)'' and adding in its place
``or (ii), or 45 CFR 147.133(a)(1)(i) or (ii)'';
0
b. In paragraph (a)(2) by removing the reference ``147.132(a)'' and
adding in its place the reference ``147.132(a) or 147.133(a)'';
0
c. In paragraph (b)(1)(ii) introductory text by removing the reference
``147.132'' and adding in its place the reference ``147.132 or
147.133'';
0
d. In paragraph (b)(1)(ii)(B) by removing the reference ``147.132'' and
adding in its place the reference ``147.132 or 147.133'';
0
e. In paragraph (c)(1)(ii) introductory text by removing the reference
``147.132'' and adding in its place the reference ``147.132 or
147.133'';
0
f. In paragraph (c)(1)(ii)(B) by removing the reference ``147.132'' and
adding in its place the reference ``147.132 or 147.133''; and
0
g. In paragraph (c)(2) by removing the reference ``147.132'' and adding
in its place the reference ``147.132 or 147.133''.
DEPARTMENT OF LABOR
Employee Benefits Security Administration
PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS
0
For the reasons set forth in the preamble, the Department of Labor
adopts, as final, the interim final rules amending 29 CFR part 2590,
published October 13, 2017 (82 FR 47838), without change.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
0
For the reasons set forth in the preamble, the Department of Health and
Human Services adopts as final the interim final rules amending 45 CFR
part 147 published on October 13, 2017 (82 FR 47838) with the following
changes:
PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND
INDIVIDUAL HEALTH INSURANCE MARKETS
0
4. The authority citation for part 147, as revised elsewhere in this
issue of the Federal Register, continues to read as follows:
Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, and
300gg-92, as amended.
0
5. Section 147.133 is amended by revising paragraph (a)(1) introductory
text, (a)(1)(ii), (a)(2), and (b) to read as follow:
Sec. 147.133 Moral exemptions in connection with coverage of certain
preventive health services.
(a) * * *
(1) Guidelines issued under Sec. 147.130(a)(1)(iv) by the Health
Resources and Services Administration must not provide for or support
the requirement of coverage or payments for contraceptive services with
respect to a group health plan established or maintained by an
objecting organization, or health insurance coverage offered or
arranged by an objecting organization, to the extent of the objections
specified below. Thus the Health Resources and Service Administration
will exempt from any guidelines' requirements that relate to the
provision of contraceptive services:
* * * * *
(ii) An institution of higher education as defined in 20 U.S.C.
1002, which is non-governmental, in its arrangement of student health
insurance coverage, to the extent that institution objects as specified
in paragraph (a)(2) of this section. In the case of student health
[[Page 57631]]
insurance coverage, this section is applicable in a manner comparable
to its applicability to group health insurance coverage provided in
connection with a group health plan established or maintained by a plan
sponsor that is an employer, and references to ``plan participants and
beneficiaries'' will be interpreted as references to student enrollees
and their covered dependents; and
* * * * *
(2) The exemption of this paragraph (a) will apply to the extent
that an entity described in paragraph (a)(1) of this section objects,
based on its sincerely held moral convictions, to its establishing,
maintaining, providing, offering, or arranging for (as applicable):
(i) Coverage or payments for some or all contraceptive services; or
(ii) A plan, issuer, or third party administrator that provides or
arranges such coverage or payments.
(b) Objecting individuals. Guidelines issued under Sec.
147.130(a)(1)(iv) by the Health Resources and Services Administration
must not provide for or support the requirement of coverage or payments
for contraceptive services with respect to individuals who object as
specified in this paragraph (b), and nothing in Sec.
147.130(a)(1)(iv), 26 CFR 54.9815-2713(a)(1)(iv), or 29 CFR 2590.715-
2713(a)(1)(iv) may be construed to prevent a willing health insurance
issuer offering group or individual health insurance coverage, and as
applicable, a willing plan sponsor of a group health plan, from
offering a separate policy, certificate or contract of insurance or a
separate group health plan or benefit package option, to any group
health plan sponsor (with respect to an individual) or individual, as
applicable, who objects to coverage or payments for some or all
contraceptive services based on sincerely held moral convictions. Under
this exemption, if an individual objects to some but not all
contraceptive services, but the issuer, and as applicable, plan
sponsor, are willing to provide the plan sponsor or individual, as
applicable, with a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option
that omits all contraceptives, and the individual agrees, then the
exemption applies as if the individual objects to all contraceptive
services.
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[FR Doc. 2018-24514 Filed 11-7-18; 4:15 pm]
BILLING CODE 4830-01-P; 4510-29-P; 4120-01-P