47838 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

1See, 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 of 2017, Div. H, 

Title V, Sec. 507(d) (Departments of Labor, HHS, 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD–9828] 

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–IFC] 

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: Interim final rules with request 

for comments. 

SUMMARY: The United States has a long 

history of providing conscience 

protections in the regulation of health 

care for entities and individuals with 

objections based on religious beliefs or 

moral convictions. These interim final 

rules expand exemptions to protect 

moral convictions 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 United States 

Department of Health and Human 

Services, to maintain the guidelines 

requiring contraceptive coverage where 

no regulatorily recognized objection 

exists. These rules also provide certain 

morally objecting entities access to the 

voluntary ‘‘accommodation’’ process 

regarding such coverage. 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 interim final 

rules are effective on October 6, 2017. 

Comment date: Written comments on 

these interim final rules are invited and 

must be received by December 5, 2017. 

ADDRESSES: Written comments may be 

submitted to the Department of Health 

and Human Services as specified below. 

Any comment that is submitted will be 

shared with the Department of Labor 

and the Department of the Treasury, and 

will also be made available to the 

public. 

Warning: Do not include any 

personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments may 

be posted on the Internet and can be 

retrieved by most Internet search 

engines. No deletions, modifications, or 

redactions will be made to the 

comments received, as they are public 

records. Comments may be submitted 

anonymously. Comments, identified by 

‘‘Preventive Services,’’ may be 

submitted one of four ways (please 

choose only one of the ways listed) 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9925–IFC, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9925–IFC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

Comments received will be posted 

without change to www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Jeff 

Wu (310) 492–4305 or 

marketreform@cms.hhs.gov for Centers 

for Medicare & Medicaid Services 

(CMS), Department of Health and 

Human Services (HHS), Amber Rivers or 

Matthew Litton, Employee Benefits 

Security Administration (EBSA), 

Department of Labor, at (202) 693–8335; 

Karen Levin, Internal Revenue Service, 

Department of the Treasury, at (202) 

317–5500. 

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 the Department of Labor’s 

Web site (www.dol.gov/ebsa). 

Information from HHS on private health 

insurance coverage can be found on 

CMS’s Web site (www.cms.gov/cciio), 

and information on health care reform 

can be found at www.HealthCare.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the context of legal requirements 

touching on certain sensitive health care 

issues—including health coverage of 

contraceptives—Congress has a 

consistent history of supporting 

conscience protections for moral 

convictions alongside protections for 

religious beliefs, including as part of its 

efforts to promote access to health 

services.1 Against that backdrop, 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47839 

and Education, and Related Agencies 

Appropriations Act), Public Law 115–31 (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. C, Title VIII, 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. C, Title VII, 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. I, 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’’). 

2This document’s references to ‘‘contraception,’’ 

‘‘contraceptive,’’ ‘‘contraceptive coverage,’’ or 

‘‘contraceptive services’’ generally includes 

contraceptives, sterilization, and related patient 

education and counseling, unless otherwise 

indicated. 

3Note, 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 In this IFR, we generally use ‘‘accommodation’’ 

and ‘‘accommodation process’’ interchangeably. 

Congress granted the Health Resources 

and Services Administration (HRSA), a 

component of the United States 

Department of Health and Human 

Services (HHS), discretion under the 

Patient Protection and Affordable Care 

Act to specify that certain group health 

plans and health insurance issuers shall 

cover, ‘‘with respect to women, such 

additional preventive care and 

screenings . . . as provided for in 

comprehensive guidelines supported 

by’’ HRSA (the ‘‘Guidelines’’). Public 

Health Service Act section 2713(a)(4). 

HRSA exercised that discretion under 

the last Administration to require health 

coverage for, among other things, certain 

contraceptive services,2 while the 

administering agencies—the 

Departments of Health and Human 

Services, Labor, and the Treasury 

(collectively, ‘‘the Departments’’),3

exercised both the discretion granted to 

HHS through HRSA, its component, in 

PHS Act section 2713(a)(4), and the 

authority granted to the Departments as 

administering agencies (26 U.S.C. 9833; 

29 U.S.C. 1191c; 42 U.S.C. 300gg–92) to 

issue regulations to guide HRSA in 

carrying out that provision. Through 

rulemaking, including three interim 

final rules, the Departments exempted 

and accommodated certain religious 

objectors, but did not offer an 

exemption or accommodation to any 

group possessing non-religious moral 

objections to providing coverage for 

some or all contraceptives. Many 

individuals and entities challenged the 

contraceptive coverage requirement and 

regulations (hereinafter, the 

‘‘contraceptive Mandate,’’ or the 

‘‘Mandate’’) as being inconsistent with 

various legal protections. These 

challenges included lawsuits brought by 

some non-religious organizations with 

sincerely held moral convictions 

inconsistent with providing coverage for 

some or all contraceptive services, and 

those cases continue to this day. Various 

public comments were also submitted 

asking the Departments to protect 

objections based on moral convictions. 

The Departments have recently 

exercised our discretion to reevaluate 

these exemptions and accommodations. 

This evaluation includes consideration 

of various factors, such as: The interests 

served by the existing Guidelines, 

regulations, and accommodation 

process; 4 the extensive litigation; 

Executive Order 13798, ‘‘Promoting Free 

Speech and Religious Liberty’’ (May 4, 

2017); Congress’ history of providing 

protections for moral convictions 

alongside religious beliefs regarding 

certain health services (including 

contraception, sterilization, and items or 

services believed to involve abortion); 

the discretion afforded under PHS Act 

section 2713(a)(4); the structure and 

intent of that provision in the broader 

context of section 2713 and the Patient 

Protection and Affordable Care Act; and 

the history of the regulatory process and 

comments submitted in various requests 

for public comments (including in the 

Departments’ 2016 Request for 

Information). Elsewhere in this issue of 

the Federal Register, the Departments 

published, contemporaneously with 

these interim final rules, companion 

interim final rules expanding 

exemptions to protect sincerely held 

religious beliefs in the context of the 

contraceptive Mandate. 

In light of these considerations, the 

Departments issue these interim final 

rules to better balance the Government’s 

interest in promoting coverage for 

contraceptive and sterilization services 

with the Government’s interests in 

providing conscience protections for 

individuals and entities with sincerely 

held moral convictions in certain health 

care contexts, and in minimizing 

burdens imposed by our regulation of 

the health insurance market. 

A. The Affordable Care Act 

Collectively, the Patient Protection 

and Affordable Care Act (Pub. L. 111– 

148), enacted on March 23, 2010, and 

the Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152), enacted on March 30, 2010, are 

known as the Affordable Care Act. In 

signing the Affordable Care Act, 

President Obama issued Executive 

Order 13535 (March 24, 2010), which 

declared that, ‘‘[u]nder the Act, 

longstanding Federal laws to protect 

conscience (such as the Church 

Amendment, 42 U.S.C. 300a–7, and the 

Weldon Amendment, section 508(d)(1) 

of Pub. L. 111–8) remain intact’’ and 

that ‘‘[n]umerous executive agencies 

have a role in ensuring that these 

restrictions are enforced, including the 

Department of Health and Human 

Services (HHS).’’ Those laws protect 

objections based on moral convictions 

in addition to religious beliefs. 

The Affordable Care Act reorganizes, 

amends, and adds 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. In addition, the Affordable 

Care Act adds 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) to incorporate the provisions of 

part A of title XXVII of the PHS Act into 

ERISA and the Code, and thereby make 

them applicable to certain group health 

plans regulated under ERISA or the 

Code. The sections of the PHS Act 

incorporated into ERISA and the Code 

are sections 2701 through 2728 of the 

PHS Act. 

These interim final rules concern 

section 2713 of the PHS Act. Where it 

applies, section 2713(a)(4) of the PHS 


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5 Kaiser Family Foundation & Health Research & 

Educational Trust, ‘‘Employer Health Benefits, 2017 

Annual Survey,’’ available at http://files.kff.org/ 

attachment/Report-Employer-Health-BenefitsAnnual-Survey-2017. 

6Because section 2713(a)(4) of the PHS Act 

specifies that the HRSA Guidelines shall include 

preventive care and screenings ‘‘with respect to 

women,’’ the Guidelines exclude services relating to 

a man’s reproductive capacity, such as vasectomies 

and condoms. 

7FDA’s guide ‘‘Birth Control: Medicines To Help 

You,’’ 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. 

Act requires coverage without cost 

sharing for ‘‘such additional’’ women’s 

preventive care and screenings ‘‘as 

provided for’’ and ‘‘supported by’’ 

guidelines developed by HRSA/HHS. 

The Congress did not specify any 

particular additional preventive care 

and screenings with respect to women 

that HRSA could or should include in 

its Guidelines, nor did Congress 

indicate whether the Guidelines should 

include contraception and sterilization. 

The Departments have consistently 

interpreted section 2713(a)(4)’s of the 

PHS Act grant of authority to include 

broad discretion to decide the extent to 

which HRSA will provide for and 

support the coverage of additional 

women’s preventive care and screenings 

in the Guidelines. In turn, the 

Departments have interpreted that 

discretion to include the ability to 

exempt entities from coverage 

requirements announced in HRSA’s 

Guidelines. That interpretation is rooted 

in the text of section 2713(a)(4) of the 

PHS Act, which allows HRSA to decide 

the extent to which the Guidelines will 

provide for and support the coverage of 

additional women’s preventive care and 

screenings. 

Accordingly, the Departments have 

consistently interpreted section 

2713(a)(4) of the PHS Act reference to 

‘‘comprehensive guidelines supported 

by the Health Resources and Services 

Administration for purposes of this 

paragraph’’ to grant HRSA authority to 

develop such Guidelines. And because 

the text refers to Guidelines ‘‘supported 

by the Health Resources and Services 

Administration for purposes of this 

paragraph,’’ the Departments have 

consistently interpreted that authority to 

afford HRSA broad discretion to 

consider the requirements of coverage 

and cost-sharing in determining the 

nature and extent of preventive care and 

screenings recommended in the 

guidelines. (76 FR 46623). As the 

Departments have noted, these 

Guidelines are different from ‘‘the other 

guidelines referenced in section 2713(a), 

which pre-dated the Affordable Care Act 

and were originally issued for purposes 

of identifying the non-binding 

recommended care that providers 

should provide to patients.’’ Id. 

Guidelines developed as nonbinding 

recommendations for care implicate 

significantly different legal and policy 

concerns than guidelines developed for 

a mandatory coverage requirement. To 

guide HRSA in exercising the discretion 

afforded to it in section 2713(a)(4), the 

Departments have previously 

promulgated regulations defining the 

scope of permissible religious 

exemptions and accommodations for 

such guidelines. (45 CFR 147.131). The 

interim final rules set forth herein are a 

necessary and appropriate exercise of 

the authority delegated to the 

Departments as administrators of the 

statutes. (26 U.S.C. 9833; 29 U.S.C. 

1191c; 42 U.S.C. 300gg–92). 

Our interpretation of section 

2713(a)(4) of the PHS Act is confirmed 

by the Affordable Care Act’s statutory 

structure. The Congress did not intend 

to require entirely uniform coverage of 

preventive services. (76 FR 46623). To 

the contrary, Congress carved out an 

exemption from section 2713 for 

grandfathered plans. This exemption is 

not applicable to many of the other 

provisions in Title I of the Affordable 

Care Act—provisions previously 

referred to by the Departments as 

providing ‘‘particularly significant 

protections.’’ (75 FR 34540). Those 

provisions include: 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 limits; section 2712, which 

prohibits rescissions of health insurance 

coverage; section 2714, which extends 

dependent coverage until age 26; and 

section 2718, which imposes a medical 

loss ratio on health insurance issuers in 

the individual and group markets (for 

insured coverage), or requires them to 

provide rebates to policyholders. (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 of the PHS Act.5 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). 

The Departments’ interpretation of 

section 2713(a)(4) of the PHS Act to 

permit HRSA to establish exemptions 

from the Guidelines, and of the 

Departments’ own authority as 

administering agencies to guide HRSA 

in establishing such exemptions, is also 

consistent with Executive Order 13535. 

That order, issued upon the signing of 

the Affordable Care Act, specified that 

‘‘longstanding Federal laws to protect 

conscience . . . remain intact,’’ 

including laws that protect religious 

beliefs and moral convictions from 

certain requirements in the health care 

context. Although the text of Executive 

Order 13535 does not require the 

expanded exemptions issued in these 

interim final rules, the expanded 

exemptions are, as explained below, 

consistent with longstanding Federal 

laws to protect conscience regarding 

certain health matters, and are 

consistent with the intent that the 

Affordable Care Act would be 

implemented in consideration of the 

protections set forth in those laws. 

B. The Regulations Concerning 

Women’s Preventive Services 

On July 19, 2010, the Departments 

issued interim final rules implementing 

section 2713 of the PHS Act (75 FR 

41726). Those interim final rules 

charged HRSA with developing the 

Guidelines authorized by section 

2713(a)(4) of the PHS Act. 

1. The Institute of Medicine Report 

In developing the Guidelines, HRSA 

relied on an independent report from 

the Institute of Medicine (IOM, now 

known as the National Academy of 

Medicine) on women’s preventive 

services, issued on July 19, 2011, 

‘‘Clinical Preventive Services for 

Women, Closing the Gaps’’ (IOM 2011). 

The IOM’s report was funded by the 

HHS Office of the Assistant Secretary 

for Planning and Evaluation, pursuant 

to a funding opportunity that charged 

the IOM to conduct a review of effective 

preventive services to ensure women’s 

health and well-being.6

The IOM made a number of 

recommendations with respect to 

women’s preventive services. As 

relevant here, the IOM recommended 

that the Guidelines cover the full range 

of Food and Drug Administration 

(FDA)-approved contraceptive methods, 

sterilization procedures, and patient 

education and counseling for women 

with reproductive capacity. Because 

FDA includes in the category of 

‘‘contraceptives’’ certain drugs and 

devices that may not only prevent 

conception (fertilization), but may also 

prevent implantation of an embryo,7 the 

IOM’s recommendation included 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47841 

8The Departments do not relay these dissenting 

remarks as an endorsement of the remarks, but to 

describe the history of the Guidelines, which 

includes this part of the report that IOM provided 

to HRSA. 

9The 2011 amended interim final rules were 

issued and effective on August 1, 2011, and 

published in the Federal Register on August 3, 

2011. (76 FR 46621). 

10See, for example, Americans United for Life 

(‘‘AUL’’) Comment on CMA–9992–IFC2 at 10 (Nov. 

1, 2011), available at http://www.regulations.gov/ 

#!documentDetail;D=HHS-OS-2011-0023-59496. 

11The 2012 final regulations were published on 

February 15, 2012 (77 FR 8725). 

12 Guidance on the Temporary Enforcement Safe 

Harbor for Certain Employers, Group Health Plans, 

and Group Health Insurance Issuers with Respect to 

the Requirement to Cover Contraceptive Services 

Without Cost Sharing Under section 2713 of the 

Public Health Service Act, Section 715(a)(1) of the 

Employee Retirement Income Security Act, and 

Section 9815(a)(1) of the Internal Revenue Code, 

issued on February 10, 2012, and reissued on 

August 15, 2012. Available at: http:// 

www.lb7.uscourts.gov/documents/12cv3932.pdf. 

The guidance, as reissued on August 15, 2012, 

clarified, among other things, that plans that took 

some action before February 10, 2012, to try, 

without success, to exclude or limit contraceptive 

coverage were not precluded from eligibility for the 

safe harbor. The temporary enforcement safe harbor 

was also available to insured student health 

insurance coverage arranged by nonprofit 

institutions of higher education with religious 

objections to contraceptive coverage that met the 

conditions set forth in the guidance. See final rule 

entitled ‘‘Student Health Insurance Coverage’’ 

published March 21, 2012 (77 FR 16457). 

several contraceptive methods that 

many persons and organizations believe 

are abortifacient—that is, as causing 

early abortion—and which they 

conscientiously oppose for that reason 

distinct from whether they also oppose 

contraception or sterilization. One of the 

16 members of the IOM committee, Dr. 

Anthony LoSasso, a Professor at the 

University of Illinois at Chicago School 

of Public Health, wrote a formal 

dissenting opinion. He stated that the 

IOM committee did not have sufficient 

time to evaluate fully the evidence on 

whether the use of preventive services 

beyond those encompassed by section 

2713(a)(1) through (3) of the PHS Act 

leads to lower rates of disability or 

disease and increased rates of wellbeing, such that the IOM should 

recommend additional services to be 

included under Guidelines issued under 

section 2713(a)(4) of the PHS Act. He 

further stated that ‘‘the 

recommendations were made without 

high quality, systematic evidence of the 

preventive nature of the services 

considered,’’ and that ‘‘the committee 

process for evaluation of the evidence 

lacked transparency and was largely 

subject to the preferences of the 

committee’s composition. Troublingly, 

the process tended to result in a mix of 

objective and subjective determinations 

filtered through a lens of advocacy.’’ He 

also raised concerns that the committee 

did not have time to develop a 

framework for determining whether 

coverage of any given preventive service 

leads to a reduction in healthcare 

expenditure.8 IOM 2011 at 231–32. In 

its response to Dr. LoSasso, the other 15 

committee members stated in part that 

‘‘At the first committee meeting, it was 

agreed that cost considerations were 

outside the scope of the charge, and that 

the committee should not attempt to 

duplicate the disparate review processes 

used by other bodies, such as the 

USPSTF, ACIP, and Bright Futures. 

HHS, with input from this committee, 

may consider other factors including 

cost in its development of coverage 

decisions.’’ 

2. HRSA’s 2011 Guidelines and the 

Departments’ Second Interim Final 

Rules 

On August 1, 2011, HRSA released 

onto its Web site its Guidelines for 

women’s preventive services, adopting 

the recommendations of the IOM. 

https://www.hrsa.gov/ 

womensguidelines/ The Guidelines 

included coverage for all FDA-approved 

contraceptives, sterilization procedures, 

and related patient education and 

counseling for women with 

reproductive capacity, as prescribed by 

a health care provider (hereinafter ‘‘the 

Mandate’’). 

In administering this Mandate, on 

August 1, 2011, the Departments 

promulgated interim final rules 

amending our 2010 interim final rules. 

(76 FR 46621) (2011 interim final rules). 

The 2011 interim final rules specified 

that HRSA has the authority to establish 

exemptions from the contraceptive 

coverage requirement for certain group 

health plans established or maintained 

by certain religious employers and for 

health insurance coverage provided in 

connection with such plans.9 The 2011 

interim final rules only offered the 

exemption to a narrow scope of 

employers, and only if they were 

religious. As the basis for adopting that 

limited definition of religious employer, 

the 2011 interim final rules stated that 

they relied on the laws of some ‘‘States 

that exempt certain religious employers 

from having to comply with State law 

requirements to cover contraceptive 

services.’’ (76 FR 46623). Several 

comments were submitted asking that 

the exemption include those who object 

to contraceptive coverage based on nonreligious moral convictions, including 

pro-life, non-profit advocacy 

organizations.10

3. The Departments’ Subsequent 

Rulemaking on the Accommodation and 

Third Interim Final Rules 

Final regulations issued on February 

10, 2012, adopted the definition of 

‘‘religious employer’’ in the 2011 

interim final rules without modification 

(2012 final regulations).11 (77 FR 8725). 

The exemption did not require exempt 

employers to file any certification form 

or comply with any other information 

collection process. 

Contemporaneously with the issuance 

of the 2012 final regulations, HHS— 

with the agreement of the Department of 

Labor (DOL) and the Department of the 

Treasury—issued guidance establishing 

a temporary safe harbor from 

enforcement of the contraceptive 

coverage requirement by the 

Departments with respect to group 

health plans established or maintained 

by certain nonprofit organizations with 

religious objections to contraceptive 

coverage (and the group health 

insurance coverage provided in 

connection with such plans).12 The 

temporary safe harbor did not include 

nonprofit organizations that had an 

objection to contraceptives based on 

moral convictions but not religious 

beliefs, nor did it include for-profit 

entities of any kind. The Departments 

stated that, during the temporary safe 

harbor, the Departments would engage 

in rulemaking to achieve ‘‘two goals— 

providing contraceptive coverage 

without cost-sharing to individuals who 

want it and accommodating nonexempted, nonprofit organizations’ 

religious objections to covering 

contraceptive services.’’ (77 FR 8727). 

On March 21, 2012, the Departments 

published an advance notice of 

proposed rulemaking (ANPRM) that 

described possible approaches to 

achieve those goals with respect to 

religious nonprofit organizations, and 

solicited public comments on the same. 

(77 FR 16501). Following review of the 

comments on the ANPRM, the 

Departments published proposed 

regulations on February 6, 2013 (2013 

NPRM) (78 FR 8456). 

The 2013 NPRM proposed to expand 

the definition of ‘‘religious employer’’ 

for purposes of the religious employer 

exemption. Specifically, it proposed to 

require only that the religious employer 

be organized and operate as a nonprofit 

entity and be referred to in section 

6033(a)(3)(A)(i) or (iii) of the Code, 

eliminating the requirements that a 

religious employer—(1) have the 

inculcation of religious values as its 

purpose; (2) primarily employ persons 

who share its religious tenets; and (3) 

primarily serve persons who share its 

religious tenets. The proposed expanded 


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13The NPRM proposed to treat student health 

insurance coverage arranged by eligible 

organizations that are institutions of higher 

education in a similar manner. 

14See,for example, AUL Comment on CMS– 

9968–P at 5 (Apr. 8, 2013), available at http:// 

www.regulations.gov/#!documentDetail;D=CMS2012-0031-79115. 

15See also 45 CFR 156.50. Under the regulations, 

if the third party administrator does not participate 

in a Federally-facilitated Exchange as an issuer, it 

is permitted to contract with an insurer which does 

so participate, in order to obtain such 

reimbursement. The total contraceptive user fee 

adjustment for the 2015 benefit year was $33 

million. 

16 ‘‘[P]roviding payments for contraceptive 

services is cost neutral for issuers.’’ (78 FR 39877). 17The Supreme Court did not decide whether 

RFRA would apply to publicly traded for-profit 

corporations. See 134 S. Ct. at 2774. 

definition still encompassed only 

religious entities. 

The 2013 NPRM also proposed to 

create a compliance process, which it 

called an accommodation, for group 

health plans established, maintained, or 

arranged by certain eligible nonprofit 

organizations that fell outside the 

houses of worship and integrated 

auxiliaries covered by section 

6033(a)(3)(A)(i) or (iii) of the Code (and, 

thus, outside of the religious employer 

exemption). The 2013 NPRM proposed 

to define such eligible organizations as 

nonprofit entities that hold themselves 

out as religious, oppose providing 

coverage for certain contraceptive items 

on account of religious objections, and 

maintain a certification to this effect in 

their records. The 2013 NPRM stated, 

without citing a supporting source, that 

employees of eligible organizations 

‘‘may be less likely than’’ employees of 

exempt houses of worship and 

integrated auxiliaries to share their 

employer’s faith and opposition to 

contraception on religious grounds. (78 

FR 8461). The 2013 NPRM therefore 

proposed that, in the case of an insured 

group health plan established or 

maintained by an eligible organization, 

the health insurance issuer providing 

group health insurance coverage in 

connection with the plan would provide 

contraceptive coverage to plan 

participants and beneficiaries without 

cost sharing, premium, fee, or other 

charge to plan participants or 

beneficiaries enrolled in the eligible 

organization’s plan—and without any 

cost to the eligible organization.13 In the 

case of a self-insured group health plan 

established or maintained by an eligible 

organization, the 2013 NPRM presented 

potential approaches under which the 

third party administrator of the plan 

would provide or arrange for 

contraceptive coverage to plan 

participants and beneficiaries. The 

proposed accommodation process was 

not to be offered to non-religious 

nonprofit organizations, nor to any forprofit entities. Public comments again 

included the request that exemptions 

encompass objections to contraceptive 

coverage based on moral convictions 

and not just based on religious beliefs.14

On August 15, 2012, the Departments 

extended our temporary safe harbor 

until the first plan year beginning on or 

after August 1, 2013. 

The Departments published final 

regulations on July 2, 2013 (July 2013 

final regulations) (78 FR 39869). The 

July 2013 final regulations finalized the 

expansion of the exemption for houses 

of worship and their integrated 

auxiliaries. Although some commenters 

had suggested that the exemption be 

further expanded, the Departments 

declined to adopt that approach. 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). However, like the 2013 

NPRM, the July 2013 regulations 

assumed that ‘‘[h]ouses of worship and 

their integrated auxiliaries that object to 

contraceptive coverage on religious 

grounds are more likely than other 

employers to employ people of the same 

faith who share the same objection’’ to 

contraceptives. Id. 

The July 2013 regulation also 

finalized an accommodation for eligible 

organizations, which were then defined 

to include solely organizations that are 

religious. Under the accommodation, an 

eligible organization was required to 

submit a self-certification to its group 

health insurance issuer or third party 

administrator, as applicable. Upon 

receiving that self-certification, the 

issuer or third party administrator 

would provide or arrange for payments 

for the contraceptive services to the plan 

participants and beneficiaries enrolled 

in the eligible organization’s plan, 

without requiring any cost sharing on 

the part of plan participants and 

beneficiaries and without cost to the 

eligible organization. With respect to 

self-insured plans, the third party 

administrators (or issuers they 

contracted with) could receive 

reimbursements by reducing user fee 

payments (to Federally facilitated 

Exchanges) by the amounts paid out for 

contraceptive services under the 

accommodation, plus an allowance for 

certain administrative costs, as long as 

the HHS Secretary requests and an 

authorizing exception under OMB 

Circular No. A–25R is in effect.15 With 

respect to fully insured group health 

plans, the issuer was expected to bear 

the cost of such payments,16 and HHS 

intended to clarify in guidance that the 

issuer could treat those payments as an 

adjustment to claims costs for purposes 

of medical loss ratio and risk corridor 

program calculations. The Departments 

extended the temporary safe harbor 

again on June 20, 2013, to encompass 

plan years beginning on or after August 

1, 2013, and before January 1, 2014. 

4. Litigation Over the Mandate and the 

Accommodation Process 

During the period when the 

Departments were publishing and 

modifying our regulations, organizations 

and individuals filed dozens of lawsuits 

challenging 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. Religious for-profit 

entities 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.17

On August 27, 2014, the Departments 

simultaneously issued a third set of 

interim final rules (August 2014 interim 

final rules) (79 FR 51092), and a notice 

of proposed rulemaking (August 2014 

proposed rules) (79 FR 51118). The 

August 2014 interim final rules changed 

the accommodation process so that it 

could be initiated either by selfcertification using EBSA Form 700 or 

through a notice informing the Secretary 

of HHS that an eligible organization had 

religious objections to coverage of all or 

a subset of contraceptive services (79 FR 

51092). In response to Hobby Lobby, the 

August 2014 proposed rules extended 

the accommodation process to closely 

held for-profit entities with religious 

objections to contraceptive coverage, by 

including them in the definition of 

eligible organizations (79 FR 51118). 

Neither the August 2014 interim final 

rules nor the August 2014 proposed 

rules extended the exemption; neither 

added a certification requirement for 


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18See, for example, https://www.regulations.gov/ 

document?D=CMS-2016-0123-54142; see also 

https://www.regulations.gov/document?D=CMS2016-0123-54218 and https://www.regulations.gov/ 

document?D=CMS-2016-0123-46220. 

exempt entities; and neither 

encompassed objections based on nonreligious moral convictions. 

On July 14, 2015, the Departments 

finalized both the August 2014 interim 

final rules and the August 2014 

proposed rules in a set of final 

regulations (the July 2015 final 

regulations) (80 FR 41318). (The July 

2015 final regulations also encompassed 

issues related to other preventive 

services coverage.) The July 2015 final 

regulations allowed eligible 

organizations to submit a notice to HHS 

as an alternative to submitting the EBSA 

Form 700, but specified that such notice 

must include the eligible organization’s 

name and an expression of its religious 

objection, along with the plan name, 

plan type, and name and contact 

information for any of the plan’s third 

party administrators or health insurance 

issuers. The Departments indicated that 

such information represents the 

minimum information necessary for us 

to administer the accommodation 

process. 

Meanwhile, 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 November 6, 2015, the U.S. Supreme 

Court granted certiorari in seven similar 

cases under the title of a filing from the 

Third Circuit, Zubik v. Burwell. On May 

16, 2016, the Supreme Court issued a 

per curiam opinion in Zubik, 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. 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. 

The Court also specified that ‘‘the 

Government may not impose taxes or 

penalties on petitioners for failure to 

provide the relevant notice’’ while the 

cases remained pending. Id. at 1561. 

After remand, as indicated by the 

Departments in court filings, meetings 

were held between attorneys for the 

Government and for the plaintiffs in 

those cases. The Departments also 

issued a Request for Information (‘‘RFI’’) 

on July 26, 2016, seeking public 

comment on options for modifying the 

accommodation process in light of the 

supplemental briefing in Zubik and the 

Supreme Court’s remand order. (81 FR 

47741). Public comments were 

submitted in response to the RFI, during 

a comment period that closed on 

September 20, 2016. Those comments 

included the request that the exemption 

be expanded to include those who 

oppose the 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.18

Beginning in 2015, lawsuits 

challenging the Mandate were also filed 

by various non-religious organizations 

with moral objections to contraceptive 

coverage. These organizations asserted 

that they believe some methods 

classified by FDA as contraceptives may 

have an abortifacient effect and 

therefore, in their view, are morally 

equivalent to abortion. These 

organizations have neither received an 

exemption from the Mandate nor do 

they qualify for the accommodation. For 

example, the organization that since 

1974 has sponsored the annual March 

for Life in Washington, DC (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 

doing so 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 our assumption that such 

entities are relatively more likely than 

other religious nonprofits to have 

employees that share their views against 

contraception), 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 violates their rights 

under RFRA by making it impossible for 

them to obtain health insurance 

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 

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 (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 from 

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 

dissented in part, stating he would have 

ruled in favor of the individual 

employee plaintiffs under RFRA. Id. at 

*18. 

On December 20, 2016, HRSA 

updated the Guidelines via its Web site, 

https://www.hrsa.gov/ 

womensguidelines2016/index.html. 

HRSA announced that, for plans subject 

to the Guidelines, the updated 

Guidelines would apply to the first plan 

year beginning after December 20, 2017. 

Among other changes, the updated 

Guidelines specified that the required 

contraceptive coverage includes followup care (for example, management and 

evaluation, as well as changes to, and 

removal or discontinuation of, the 


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19Available 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. 

contraceptive method). They also 

specified, for the first time, that 

coverage should include instruction in 

fertility awareness-based methods for 

women desiring an alternative method 

of family planning. HRSA stated that, 

with the input of a committee operating 

under a cooperative agreement, HRSA 

would review and periodically update 

the Women’s Preventive Services’ 

Guidelines. The updated Guidelines did 

not alter the religious employer 

exemption or accommodation process, 

nor did they extend the exemption or 

accommodation process to organizations 

or individuals that oppose certain forms 

of contraception (and coverage thereof) 

on moral grounds. 

On January 9, 2017, the Departments 

issued a document entitled, ‘‘FAQs 

About Affordable Care Act 

Implementation Part 36.’’ 19 The FAQ 

stated that, after reviewing comments 

submitted in response to the 2016 RFI 

and considering various options, the 

Departments could not find a way at 

that time to amend the accommodation 

so as to satisfy objecting eligible 

organizations while pursuing the 

Departments’ policy goals. The 

Departments did not adopt the approach 

requested by certain commenters, cited 

above, to expand the exemption to 

include those who oppose the Mandate 

for moral reasons. 

On May 4, 2017, the President issued 

Executive Order 13798, ‘‘Promoting Free 

Speech and Religious Liberty.’’ Section 

3 of that order declares, ‘‘Conscience 

Protections with Respect to PreventiveCare Mandate. The Secretary of the 

Treasury, the Secretary of Labor, and the 

Secretary of Health and Human Services 

shall consider issuing amended 

regulations, consistent with applicable 

law, to address conscience-based 

objections to the preventive-care 

mandate promulgated under section 

300gg–13(a)(4) of title 42, United States 

Code.’’ 

II. Expanded Exemptions and 

Accommodations for Moral Convictions 

These interim final rules incorporate 

conscience protections into the 

contraceptive Mandate. They do so in 

part to bring the Mandate into 

conformity with Congress’s long history 

of providing or supporting conscience 

protections in the regulation of sensitive 

health-care issues, cognizant that 

Congress neither required the 

Departments to impose the Mandate nor 

prohibited them from providing 

conscience protections if they did so. 

Specifically, these interim final rules 

expand exemptions to the contraceptive 

Mandate to protect certain entities and 

individuals that object to coverage of 

some or all contraceptives based on 

sincerely held moral convictions but not 

religious beliefs, and these rules make 

those exempt entities eligible for 

accommodations concerning the same 

Mandate. 

A. Discretion To Provide Exemptions 

Under Section 2713(a)(4) of the PHS Act 

and the Affordable Care Act 

The Departments have consistently 

interpreted HRSA’s authority under 

section 2713(a)(4) of the PHS Act to 

allow for exemptions and 

accommodations to the contraceptive 

Mandate for certain objecting 

organizations. Section 2713(a)(4) of the 

PHS Act gives HRSA discretion to 

decide whether and in what 

circumstances it will support 

Guidelines providing for additional 

women’s preventive services coverage. 

That authority includes HRSA’s 

discretion to include contraceptive 

coverage in those Guidelines, but the 

Congress did not specify whether or to 

what extent HRSA should do so. 

Therefore, section 2713(a)(4) of the PHS 

Act allows HRSA to not apply the 

Guidelines to certain plans of entities or 

individuals with religious or moral 

objections to contraceptive coverage, 

and by not applying the Guidelines to 

them, to exempt those entities from the 

Mandate. These rules are a necessary 

and appropriate exercise of the 

authority of HHS, of which HRSA is a 

component, and of the authority 

delegated to the Departments 

collectively as administrators of the 

statutes. (26 U.S.C. 9833; 29 U.S.C. 

1191c; 42 U.S.C. 300gg–92). 

Our protection of conscience in these 

interim final rules is consistent with the 

structure and intent of the Affordable 

Care Act. The Affordable Care Act 

refrains from applying section 

2713(a)(4) of the PHS Act to millions of 

women in grandfathered plans. In 

contrast, we anticipate that 

conscientious exemptions to the 

Mandate will impact a much smaller 

number of women. President Obama 

emphasized in signing the Affordable 

Care Act that ‘‘longstanding Federal law 

to protect conscience’’—laws with 

conscience protections encompassing 

moral (as well as religious) objections— 

specifically including (but not limited 

to) the Church Amendments (42 U.S.C. 

300a–7), ‘‘remain intact.’’ Executive 

Order 13535. Nothing in the Affordable 

Care Act suggests Congress’ intent to 

deviate from its long history, discussed 

below, of protecting moral convictions 

in particular health care contexts. The 

Departments’ implementation of section 

2713(a)(4) of the PHS Act with respect 

to contraceptive coverage is a context 

similar to those encompassed by many 

other health care conscience protections 

provided or supported by Congress. 

This Mandate concerns contraception 

and sterilization services, including 

items believed by some citizens to have 

an abortifacient effect—that is, to cause 

the destruction of a human life at an 

early stage of embryonic development. 

These are highly sensitive issues in the 

history of health care regulation and 

have long been shielded by conscience 

protections in the laws of the United 

States. 

B. Congress’ History of Providing 

Exemptions for Moral Convictions 

In deciding the most appropriate way 

to exercise our discretion in this 

context, the Departments draw on 

nearly 50 years of statutory law and 

Supreme Court precedent discussing the 

protection of moral convictions in 

certain circumstances—particularly in 

the context of health care and health 

insurance coverage. Congress very 

recently 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 of 2017, Division C, 

Title VIII, Sec. 808, Public Law 115–31 

(May 5, 2017). In support of these 

interim final rules, we consider it 

significant that Congress’ most recent 

statement on the prospect of 

Government mandated contraceptive 

coverage specifically intends that a 

conscience clause be included to protect 

moral convictions. 

The many statutes listed in Section IBackground under footnote 1, which 

show Congress’ consistent protection of 

moral convictions alongside religious 

beliefs in the Federal regulation of 

health care, includes laws such as the 

1973 Church Amendments, which we 

discuss at length below, all the way to 

the 2017 Consolidated Appropriations 

Act discussed above. Notably among 

those laws, the 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– 


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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’’). The 

Congress has also protected individuals 

who object to prescribing or providing 

contraceptives contrary to their 

‘‘religious beliefs or moral convictions.’’ 

Consolidated Appropriations Act of 

2017, Division C, Title VII, Sec. 726(c) 

(Financial Services and General 

Government Appropriations Act), 

Public Law 115–31. 

C. 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. 

These sections of the United States 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. 

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). Even though the Court 

in Roe required abortion to be legal in 

certain circumstances, Roe did not 

include, within that right, the 

requirement that other citizens must 

facilitate its exercise. Thus, 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 

relevant 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 is particularly 

relevant to 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 

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. at 

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. at 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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20The Senator might have meant ‘‘[forced] . . . 

against his will.’’ 

21Rep. Heckler later served as the 15th Secretary 

of HHS, from March 1983 to December 1985. 

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] 20 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. at S5723. 

In support of the same protections 

when they were debated in the U.S. 

House, Representative Margaret Heckler 

(R–MA) 21 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 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. 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); and Consolidated 

Appropriations Act of 2017, Div. H, 

Title V, Sec. 507(d), Public Law 115–31; 

• Protections for entities and 

individuals that object to providing or 

covering contraceptives: See id. at Div. 

C, Title VIII, Sec. 808; id. at Div. C, Title 

VII, Sec. 726(c) (Financial Services and 

General Government Appropriations 

Act); and id. at Div. I, Title III; and 

• 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. 14406; 42 U.S.C. 

18113; and 42 U.S.C. 1396a(w)(3). 

The Departments believe that the 

intent behind Congress’ protection of 

moral convictions in certain health care 

contexts, especially to protect entities 

and individuals from governmental 

coercion, supports our decision in these 

interim final rules to protect sincerely 

held moral convictions from 

governmental compulsion threatened by 

the contraceptive Mandate. 

D. Court Precedents Relevant to These 

Expanded Exemptions 

The legislative history of the 

protection of moral convictions in the 

first Church Amendments shows that 

Members of Congress saw the protection 

as being consistent with Supreme Court 

decisions. Not only did Senator Church 

cite the abortion case Doe v. Bolton as 

a parallel instance of conscience 

protection, but he also 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 

decided just 3 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. 

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.’’ 

The Departments look to the 

description of moral convictions in 

Welsh to help explain the scope of the 

protection provided in these interim 

final rules. Neither these interim final 

rules, nor the Church Amendments or 

other Federal health care conscience 

statutes, define ‘‘moral convictions’’ 

(nor do they define ‘‘religious beliefs’’). 

But in issuing these interim final rules, 

we seek to use 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 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 

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. 

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 


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22See, 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). 

23See 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’’). 

24According 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’’ 

(June 1, 2017), available at https:// 

www.guttmacher.org/state-policy/explore/refusingprovide-health-services. 

25From 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. 26Letter 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. 27 James Madison, ‘‘Essay on Property’’ (March 

29, 1792); First draft of the First Amendment, 1 

Annals of Congress 434 (June 8, 1789). 

beliefs constitute an illegitimate 

‘‘separat[ion]’’ of moral convictions, nor 

do we 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’ 

intent in the Church Amendments and 

in later Federal conscience statutes that 

provide protections for moral 

convictions alongside religious beliefs 

in other health care contexts. 

E. Conscience Protections in Regulations 

and Among the States 

The tradition of protecting moral 

convictions in certain health contexts is 

not limited to Congress. Multiple federal 

regulations protect objections based on 

moral convictions in such contexts.22

Other federal regulations have also 

applied the principle of respecting 

moral convictions alongside religious 

beliefs when they have determined that 

it is appropriate to do so 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).23

Forty-five States have health care 

conscience protections covering 

objections to abortion, and several of 

those also cover sterilization or 

contraception.24 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). 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 this 

Mandate in part because they consider 

some forms of FDA-approved 

contraceptives to be abortifacients and 

morally equivalent to abortion due to 

the possibility that some of the items 

may have the effect of preventing the 

implantation of a human embryo after 

fertilization. Based on our knowledge 

from the litigation, all of the current 

litigants asserting purely non-religious 

objections share this view, and most of 

the religious litigants do as well. 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. 

Outside of the context of abortion, as 

cited above, Congress has also provided 

health care conscience protections 

pertaining to sterilization, 

contraception, and other health care 

services and practices. 

F. Founding Principles 

The Departments also look to 

guidance 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. As quoted above, in 

supporting protecting 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.’’ 

Rep. 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 

citizenship.’’ 25 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.’’ 26 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.’’ 27

These Founding Era statements of 

general principle do not specify how 

they would be applied in a particular 

health care context. We do not suggest 

that the specific protections offered in 

this rule would also be required or 

necessarily appropriate in any other 

context that does not raise the specific 

concerns implicated by this Mandate. 

These interim final rules do not address 

in any way how the Government would 

balance its interests with respect to 


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28As 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. 

other health services not encompassed 

by the contraceptive Mandate.28 Instead 

we highlight this tradition of respect for 

conscience from our Founding Era to 

provide background support for the 

Departments’ decision to implement 

section 2713(a)(4) of the PHS Act, while 

protecting conscience in the exercise of 

moral convictions. We believe that these 

interim final rules are consistent both 

with the American tradition of respect 

for conscience and with Congress’ 

history of providing conscience 

protections in the kinds of health care 

matters involved in this Mandate. 

G. Executive Orders Relevant to These 

Expanded Exemptions 

Protecting moral convictions, as set 

forth in the expanded exemptions and 

accommodations of these 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 moral convictions and not just 

religious beliefs. Likewise, President 

Trump’s first Executive Order, EO 

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.’’ This 

Mandate imposes both a cost, fee, tax, 

or penalty, and a regulatory burden, on 

individuals and purchasers of health 

insurance that have moral convictions 

opposed to providing contraceptive 

coverage. These interim final rules 

exercise the Departments’ discretion to 

grant exemptions from the Mandate to 

reduce and relieve regulatory burdens 

and promote freedom in the health care 

market. 

H. Litigation Concerning the Mandate 

The sensitivity of certain health care 

matters makes it particularly important 

for the Government to tread carefully 

when engaging in regulation concerning 

those areas, and to respect individuals 

and organizations whose moral 

convictions are burdened by 

Government regulations. Providing 

conscience protections advances the 

Affordable Care Act’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 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 would 

be a serious outcome. As demonstrated 

by litigation and 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 some of 

those items may cause early abortions. 

The Departments wish to implement the 

contraceptive coverage Guidelines 

issued under section 2713(a)(4) of the 

PHS Act in a way that respects the 

moral convictions of our citizens so that 

they are more free to engage in ‘‘full 

participation in the economic life of the 

Nation.’’ These expanded exemptions 

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. 

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 recently affirmed a district 

court ruling that allows the previous 

regulations to be imposed in a way that 

violates the moral convictions of a small 

nonprofit pro-life organization and its 

employees. See Real Alternatives, 2017 

WL 3324690. Our litigation of these 

cases has 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 all adopted moral 

tenets opposed to contraception and 

hire only employees who share this 

view. It is reasonable to conclude that 

employees of these organizations would 

therefore not benefit from the Mandate. 

As a result, 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, 

and our 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 interim final rules. Even though, 

as discussed below, we 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, we 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, we consider it appropriate to issue 

the protections set forth in these interim 

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 we, 

too, believe that ‘‘our moral convictions 

as well as our religious beliefs, warrant 

protection from this intrusion by the 

Government’’ in this situation. 

I. The Departments’ Rebalancing of 

Government Interests 

For additional discussion of the 

Government’s balance of interests 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules, see the related document 

published by the Department elsewhere 

in this issue of the Federal Register. 

There, we acknowledge that the 

Departments have changed the policies 

and interpretations we previously 

adopted with respect to the Mandate 

and the governmental interests that 

underlying it, and we assert that we 

now believe the Government’s 

legitimate interests in providing for 

contraceptive coverage do not require us 

to violate sincerely held religious beliefs 

while implementing the Guidelines. For 

parallel reasons, the Departments 

believe Congress did not set forth—and 

we do not possess—interests that 

require us to violate sincerely held 

moral convictions in the course of 

generally requiring contraceptive 

coverage. These changes in policy are 


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29See also Chevron, U.S.A., Inc. v. Natural 

Resources Defense Council, Inc., 467 U.S. 837, 863– 

64 (1984) (‘‘The fact that the agency has adopted 

different definitions in different contexts adds force 

to the argument that the definition itself is flexible, 

particularly since Congress has never indicated any 

disapproval of a flexible reading of the statute.’’) 

30See, 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. 

31See https://www.hrsa.gov/womensguidelines/ 

and https://www.hrsa.gov/womensguidelines2016/ 

index.html. 

within the Departments’ authority. As 

the Supreme Court has acknowledged, 

‘‘[a]gencies are free to change their 

existing policies as long as they provide 

a reasoned explanation for the change.’’ 

Encino Motorcars, LLC v. Navarro, 136 

S. Ct. 2117, 2125 (2016). This ‘‘reasoned 

analysis’’ requirement does not demand 

that an agency ‘‘demonstrate to a court’s 

satisfaction that the reasons for the new 

policy are better than the reasons for the 

old one; it suffices that the new policy 

is permissible under the statute, that 

there are good reasons for it, and that 

the agency believes it to be better, which 

the conscious change of course 

adequately indicates.’’ United Student 

Aid Funds, Inc. v. King, 200 F. Supp. 3d 

163, 169–70 (D.D.C. 2016) (citing FCC v. 

Fox Television Stations, Inc., 556 U.S. 

502, 515 (2009)); see also New Edge 

Network, Inc. v. FCC, 461 F.3d 1105, 

1112–13 (9th Cir. 2006) (rejecting an 

argument that ‘‘an agency changing its 

course by rescinding a rule is obligated 

to supply a reasoned analysis for the 

change beyond that which may be 

required when an agency does not act in 

the first instance’’).29

The Departments note that the 

exemptions created here, like the 

exemptions created by the last 

Administration, do not burden third 

parties to a degree that counsels against 

providing the exemptions. In addition to 

the apparent fact that many entities with 

non-religious moral objections to the 

Mandate appear to only hire persons 

that share those objections, Congress did 

not create a right to receive 

contraceptive coverage, and Congress 

explicitly chose not to impose the 

section 2713 requirements on 

grandfathered plans benefitting millions 

of people. Individuals who are unable to 

obtain contraceptive coverage through 

their employer-sponsored health plans 

because of the exemptions created in 

these interim final rules, or because of 

other exemptions to the Mandate, have 

other avenues for obtaining 

contraception, including through 

various other mechanisms by which the 

Government advances contraceptive 

coverage, particularly for low-income 

women, and which these interim final 

rules leave unchanged.30 As the 

Government is under no constitutional 

obligation to fund contraception, cf. 

Harris v. McRae, 448 U.S. 297 (1980), 

even more so may the Government 

refrain from requiring private citizens to 

cover contraception for other citizens in 

violation of their moral convictions. 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 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) of 

the PHS Act. Our expansion of 

conscience protections for moral 

convictions, similar to protections 

contained in numerous statutes 

governing health care regulation, is not 

taken lightly. However, after 

reconsidering the interests served by the 

Mandate in this particular context, the 

objections raised, and the relevant 

Federal law, the Departments have 

determined that expanding the 

exemptions to include protections for 

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 take advantage of these 

exemptions and accommodations may 

be small, we believe that it is important 

formally to codify such protections for 

objections based on moral conviction, 

given the long-standing recognition of 

such protections in health care and 

health insurance context in law and 

regulation and the particularly sensitive 

nature of these issues in the health care 

context. These interim 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. 

III. Provisions of the Interim Final 

Rules With Comment Period 

The Departments are issuing these 

interim final rules in light of the full 

history of relevant rulemaking 

(including 3 previous interim final 

rules), public comments, and the longrunning litigation from non-religious 

moral objectors to the Mandate, as well 

as the information contained in the 

companion interim final rules issued 

elsewhere in this issue of the Federal 

Register. These interim final rules seek 

to resolve these matters by directing 

HRSA, to the extent it requires coverage 

for certain contraceptive services in its 

Guidelines, to afford an exemption to 

certain entities and individuals with 

sincerely held moral convictions by 

which they object to contraceptive or 

sterilization coverage, and by making 

the accommodation process available 

for certain organizations with such 

convictions. 

For all of the reasons discussed and 

referenced above, the Departments have 

determined that the Government’s 

interest in applying contraceptive 

coverage requirements to the plans of 

certain entities and individuals does not 

outweigh the sincerely held moral 

objections of those entities and 

individuals. Thus, these interim final 

rules amend the regulations amended in 

both the Departments’ July 2015 final 

regulations and in the companion 

interim final rules concerning religious 

beliefs issued contemporaneously with 

these interim final rules and published 

elsewhere in this issue of the Federal 

Register. 

These interim final rules expand 

those exemptions to include additional 

entities and persons that object based on 

sincerely held moral convictions. These 

rules leave in place HRSA’s discretion 

to continue to require contraceptive and 

sterilization coverage where no 

objection specified in the regulations 

exists, and if section 2713 of the PHS 

Act otherwise applies. These interim 

final rules also maintain the existence of 

an accommodation process as a 

voluntary option for organizations with 

moral objections to contraceptive 

coverage, but consistent with our 

expansion of the exemption, we expand 

eligibility for the accommodation to 

include organizations with sincerely 

held moral convictions concerning 

contraceptive coverage. HRSA is 

simultaneously updating its Guidelines 

to reflect the requirements of these 

interim final rules.31


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32See, 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). 

33See Guttmacher Institute, ‘‘Insurance Coverage 

of Contraceptives’’ (Aug. 1, 2017), available at 

https://www.guttmacher.org/state-policy/explore/ 

insurance-coverage-contraceptives. 

34See, for example, Guttmacher Institute, 

‘‘Refusing to Provide Health Services’’ (Aug. 1, 

2017), available at https://www.guttmacher.org/ 

state-policy/explore/refusing-provide-healthservices. 

1. Exemption for Objecting Entities 

Based on Moral Convictions 

In the new 45 CFR 147.133 as created 

by these interim final rules, we expand 

the exemption that was previously 

located in § 147.131(a), and that was 

expanded in § 147.132 by the 

companion interim final rules 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules and published elsewhere in 

this issue of the Federal Register. 

With respect to employers that 

sponsor group health plans, 

§ 147.133(a)(1) and (a)(1)(i) provide 

exemptions for certain employers that 

object to coverage of all or a subset of 

contraceptives or sterilization and 

related patient education and 

counseling based on sincerely held 

moral convictions. 

For avoidance of doubt, the 

Departments wish to make clear that the 

expanded exemption in § 147.133(a) 

applies to several distinct entities 

involved in the provision of coverage to 

the objecting employer’s employees. 

This explanation is consistent with how 

prior rules have worked by means of 

similar language. Section 147.133(a)(1) 

and (a)(1)(i), by specifying that ‘‘[a] 

group health plan and health insurance 

coverage provided in connection with a 

group health plan’’ is exempt ‘‘to the 

extent the plan sponsor objects as 

specified in paragraph (a)(2),’’ exempt 

the group health plans the sponsors of 

which object, and exempt 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), or the parallel 

provisions in 26 CFR 54.9815– 

2713T(a)(1)(iv) and 29 CFR 2590.715– 

2713(a)(1)(iv), 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. 

Consistent with the restated 

exemption, exempt entities will not be 

required to comply with a selfcertification process. Although exempt 

entities do not need to file notices or 

certifications of their exemption, and 

these interim 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 

document provides what benefits are 

provided to participants and 

beneficiaries under the plan and, 

therefore, 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.32 Thus, 

where an exemption applies and all or 

a subset of contraceptive services are 

omitted from a plan’s coverage, 

otherwise applicable ERISA disclosures 

should 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. The Departments 

invite public comment on whether 

exempt entities, or others, would find 

value either in being able to maintain or 

submit a specific form of certification to 

claim their exemption, or in otherwise 

receiving guidance on a way to 

document their exemption. 

The exemptions in § 147.133(a) 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. Likewise, the requisite 

objection of a plan sponsor or 

institution of higher education in 

§ 147.133(a)(1)(i) and (ii) exempts its 

group health plan, health insurance 

coverage offered by a health insurance 

issuer in connection with such plan, 

and its issuer in its offering of such 

coverage, but that exemption does not 

extend to coverage provided by that 

issuer to other group health plans where 

the plan sponsors have no qualifying 

objection. The objection of a health 

insurance issuer in § 147.133(a)(1)(iii) 

similarly operates only to the extent of 

its objection, and as otherwise limited 

as described below. 

2. Exemption of Certain Plan Sponsors 

The rules cover certain kinds of nongovernmental employer plan sponsors 

with the requisite objections, and the 

rules specify which kinds of entities 

qualify for the exemption. 

Under these interim final rules, the 

Departments do not limit the exemption 

with reference to nonprofit status as 

previous rules have done. 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 

nonprofits or for-profit entities. In 

addition, 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.33 States also generally 

protect moral convictions in health care 

conscience laws, and they often offer 

those protections whether or not an 

entity operates as a nonprofit.34

Although the practice of states is by no 

means a limit on the discretion 

delegated to HRSA by the Affordable 

Care Act, nor is it a statement about 

what the Federal Government may do 

consistent with other protections or 

limitations in federal law, such state 

practice can be informative as to the 

viability of offering protections for 

conscientious objections in particularly 

sensitive health care contexts. In this 

case, the existence of many instances 

where conscience protections are 

offered, or no underlying mandate of 

this kind exists that could violate moral 

convictions, supports the Departments’ 

decision to expand the Federal 

exemption concerning this Mandate as 

set forth in these interim final rules. 

Section 147.133(a)(1)(i)(A) of the rules 

specifies that the exemption includes 

the plans of a plan sponsor that is a 

nonprofit organization with sincerely 

held moral convictions. 

Section 147.133(a)(1)(i)(B) of the rules 

specifies that the exemption includes 

the plans of a plan sponsor that is a forprofit entity that has no publicly traded 

ownership interests (for this purpose, a 

publicly traded ownership interest is 

any class of common equity securities 

required to be registered under section 

12 of the Securities Exchange Act of 

1934). 

Extending the exemption to certain 

for-profit entities is consistent with the 

Supreme Court’s ruling in Hobby Lobby, 

which declared that a corporate entity is 

capable of possessing and pursuing nonpecuniary goals (in Hobby Lobby, 

religion), regardless of whether the 

entity operates as a nonprofit 

organization, and rejecting the 


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35See Jennifer Haberkorn, ‘‘Two years later, few 

Hobby Lobby copycats emerge,’’ Politico (Oct. 11, 

2016), available at http://www.politico.com/story/ 

2016/10/obamacare-birth-control-mandateemployers-229627. 

36Although the Departments do not prescribe any 

form or notification, they would expect that such 

principles or views would have been adopted and 

documented in accordance with the laws of the 

jurisdiction under which they are incorporated or 

organized. 

37Consolidated Appropriations Act of 2017, Div. 

H, Title V, Sec. 507(d), Pub. L. 115–31. 

38The lack of the limitation in this provision may 

be particularly relevant since it is contained in the 

same statute, the ACA, as the provision under 

which the Mandate—and these exemptions to the 

Mandate—are promulgated. 

Departments’ argument to the contrary. 

134 S. Ct. 2768–75. Some reports and 

industry experts have indicated that not 

many for-profit entities beyond those 

that had originally brought suit have 

sought relief from the Mandate after 

Hobby Lobby.35 The mechanisms for 

determining whether a company has 

adopted and holds certain principles or 

views, such as sincerely held moral 

convictions, is a matter of wellestablished State law with respect to 

corporate decision-making,36 and the 

Departments expect that application of 

such laws would cabin the scope of this 

exemption. 

The July 2015 final regulations 

extended the accommodation to forprofit entities only if they are closely 

held, by positively defining what 

constitutes a closely held entity. 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. The 

Departments implicitly recognized the 

difficulty of defining closely held 

entities in the July 2015 final 

regulations when we adopted a 

definition that included entities that are 

merely ‘‘substantially similar’’ to certain 

specified parameters, and we allowed 

entities that were not sure if they met 

the definition to inquire with HHS; HHS 

was permitted to decline to answer the 

inquiry, at which time the entity would 

be deemed to qualify as an eligible 

organization. Instead of attempting to 

positively define closely held 

businesses for the purpose of this rule, 

the Departments consider it much more 

clear, effective, and preferable to define 

the category negatively by reference to 

one element of our previous definition, 

namely, 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). 

In this way, these interim final rules 

differ from the exemption provided to 

plan sponsors with objections based on 

sincerely held religious beliefs set forth 

in § 147.132(a)(1)—those extend to forprofit entities whether or not they are 

closely held or publicly traded. The 

Departments seek public comment on 

whether the exemption in 

§ 147.133(a)(1)(i) for plan sponsors with 

moral objections to the Mandate should 

be finalized to encompass all of the 

types of plan sponsors covered by 

§ 147.132(a)(1)(i), including publicly 

traded corporations with objections 

based on sincerely held moral 

convictions, and also non-federal 

governmental plan sponsors that may 

have objections based on sincerely held 

moral convictions. 

In the case of particularly sensitive 

health care matters, several significant 

federal health care conscience statutes 

protect entities’ moral objections 

without precluding publicly traded and 

governmental entities from using those 

protections. 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, and the 

statute does not limit those protections 

based on whether the entities are 

publicly traded 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. The Coats-Snowe 

Amendment likewise provides certain 

protections for health care entities and 

postgraduate physician training 

programs that choose not to perform, 

refer for, or provide training for 

abortions, and the statute does not limit 

those protections based on whether the 

entities are publicly traded or 

governmental. (42 U.S.C. 238n). 

The Weldon Amendment 37 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, and the statute does not limit 

those protections based on whether the 

entity is publicly traded or 

governmental. The Affordable Care Act 

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, and the 

statute similarly does not limit those 

protections based on whether the entity 

is publicly traded or governmental. (42 

U.S.C. 18113).38

Sections 1395w–22(j)(3)(B) and 

1396u–2(b)(3) of 42 U.S.C. protect 

organizations that offer Medicaid and 

Medicare Advantage managed care 

plans from being required to provide, 

reimburse for, or provide coverage of a 

counseling or referral service if they 

object to doing so on moral grounds, 

and those paragraphs do not further 

specify that publicly traded entities do 

not qualify for the protections. Congress’ 

most recent statement on Government 

requirements of 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 of 

2017, Division C, Title VIII, Sec. 808. 

Congress expressed no intent that such 

a conscience should be limited based on 

whether the entity is publicly traded. 

At the same time, the Departments 

lack significant information about the 

need to extend the expanded exemption 

further. We have been subjected to 

litigation by nonprofit entities 

expressing objections to the Mandate 

based on non-religious moral 

convictions, and we have been sued by 

closely held for-profit entities 

expressing religious objections. This 

combination of different types of 

plaintiffs leads us to believe that there 

may be a small number of closely held 

for-profit entities that would seek to use 

an exemption to the contraceptive 

Mandate based on moral convictions. 

The fact that many closely held forprofit entities brought challenges to the 

Mandate has led us to offer protections 

that would include publicly traded 

entities with religious objections to the 

Mandate if such entities exist. But the 

combined lack of any lawsuits 

challenging the Mandate by for-profit 

entities with non-religious moral 

convictions, and of any lawsuits by any 

kind of publicly traded entity, leads us 

to not extend the expanded exemption 

in these interim final rules to publicly 

traded entities, but rather to invite 

public comment on whether to do so in 


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47852 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

a way parallel to the protections set 

forth in § 147.132(a)(1)(i). We agree with 

the Supreme Court that it is improbable 

that many 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’’ (or moral convictions) and 

thereby qualify for the exemption. 

Hobby Lobby, 134 S. Ct. at 2774. We are 

also not aware of other types of plan 

sponsors (such as non-Federal 

governmental entities) that might 

possess moral objections to compliance 

with the Mandate, including whether 

some might consider certain 

contraceptive methods as having a 

possible abortifacient effect. 

Nevertheless, we would welcome any 

comments on whether such 

corporations or other plan sponsors 

exist and would benefit from such an 

exemption. 

Despite our a lack of complete 

information, the Departments know that 

nonprofit entities have challenged the 

Mandate, and we assume that a closely 

held business might wish to assert nonreligious moral convictions in objecting 

to the Mandate (although we anticipate 

very few if any will do so). Thus we 

have chosen in these interim final rules 

to include them in the expanded 

exemption and thereby remove an 

obstacle preventing such entities from 

claiming an exemption based on nonreligious moral convictions. But we are 

less certain that we need to use these 

interim final rules to extend the 

expanded exemption for moral 

convictions to encompass other kinds of 

plan sponsors not included in the 

protections of these interim final rules. 

Therefore, with respect to plan sponsors 

not included in the expanded 

exemptions of § 147.133(a)(1)(i), and 

non-federal governmental plan sponsors 

that might have moral objections to the 

Mandate, we invite public comment on 

whether to include such entities when 

we finalize these rules at a later date. 

The Departments further conclude 

that it would be inadequate to merely 

provide entities access to the 

accommodation process instead of to 

the exemption where those entities 

object to the Mandate based on sincerely 

held moral convictions. The 

Departments have stated in our 

regulations and court briefings that the 

existing accommodation with respect to 

self-insured plans requires 

contraceptive coverage as part of the 

same plan as the coverage provided by 

the employer, and operates in a way 

‘‘seamless’’ to those plans. As a result, 

in significant respects, the 

accommodation process does not 

actually accommodate the objections of 

many entities. This has led many 

religious groups to challenge the 

accommodation in court, and we expect 

similar challenges would come from 

organizations objecting to the 

accommodation based on moral 

convictions if we offered them the 

accommodation but not an exemption. 

When we took that narrow approach 

with religious nonprofit entities it led to 

multiple cases in many courts that we 

needed to litigate to the Supreme Court 

various times. Although objections to 

the accommodation were not 

specifically litigated in the two cases 

brought by nonprofit non-religious 

organizations (because we have not even 

made them eligible for the 

accommodation), those organizations 

made it clear that they and their 

employees strongly oppose coverage of 

certain contraceptives in their plans and 

in connection with their plans. 

3. Exemption for Institutions of Higher 

Education 

The plans of institutions of higher 

education that arrange student health 

insurance coverage will be treated 

similarly to the way that plans of 

employers are treated for the purposes 

of such plans being exempt or 

accommodated based on moral 

convictions. These interim final 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), to their 

arrangement of student health insurance 

coverage, in a manner comparable to the 

applicability of the exemption for group 

health insurance coverage provided in 

connection with a group health plan 

established or maintained by a plan 

sponsor. 

The Departments are not aware of 

institutions of higher education that 

arrange student coverage and object to 

the Mandate based on non-religious 

moral convictions. We have been sued 

by several institutions of higher 

education that arrange student coverage 

and object to the Mandate based on 

religious beliefs. We believe the 

existence of such entities with nonreligious moral objections, or the 

possible formation of such entities in 

the future, is sufficiently possible so 

that we should provide protections for 

them in these interim final rules. But 

based on a lack of information about 

such entities, we assume that none will 

use the exemption concerning student 

coverage at this time. 

4. Exemption for Issuers 

These interim final rules extend 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. 

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 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 are otherwise exempt based on their 

objection (whether the objection is 

based on moral convictions, as set forth 

in these rules, or on religious beliefs, as 

set forth in exemptions created by the 

companion interim final rules published 

elsewhere in this issue of the Federal 

Register). 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 

issuer that is exempt 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 the rules as amended, issuers 

with objections based on sincerely held 

moral convictions could issue policies 

that omit contraception to plan sponsors 

or individuals that are otherwise exempt 

based on either their religious beliefs or 

their moral convictions, and issuers 

with sincerely held religious beliefs 

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. 

Issuers that hold moral objections 

should identify to plan sponsors the 


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39The 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 business entities. Because 

the issuer exemption operates more narrowly than 

the exemption for business plan sponsors operates, 

in the ways described here, and exists in part to 

help preserve market options for objecting plan 

sponsors, the Departments consider it appropriate 

to not draw such a distinction among issuers. 

40This prospect has been raised in cases of 

religious individuals—see, for example, Wieland, 

Continued 

lack of contraceptive coverage in any 

health insurance coverage being offered 

that is based on the issuer’s exemption, 

and communicate the group health 

plan’s independent obligation to 

provide contraceptive coverage, unless 

the group health plan itself is exempt 

under regulations governing the 

Mandate. 

In this way, the issuer exemption 

serves to protect objecting issuers both 

from being asked or 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. At the same time, 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 

insurance coverage. Protecting issuers 

that object to offering contraceptive 

coverage based on sincerely held moral 

convictions will help preserve space in 

the health insurance market for certain 

issuers so that exempt plan sponsors 

and individuals will be able to obtain 

coverage. 

The Departments are not currently 

aware of health insurance issuers that 

possess their own religious or moral 

objections to offering contraceptive 

coverage. Nevertheless, 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 Medicaid or 

Medicare Advantage. The Weldon 

Amendment protects HMOs, health 

insurance plans, and any other health 

care organizations from being required 

to provide coverage or pay for abortions. 

See, for example, Consolidated 

Appropriations Act of 2017, Div. H, 

Title V, Sec. 507(d), Public Law 115–31. 

The most recently enacted Consolidated 

Appropriations Act declares that 

Congress supports a ‘‘conscience 

clause’’ to protect moral convictions 

concerning ‘‘the provision of 

contraceptive coverage by health 

insurance plans.’’ See id. at Div. C, Title 

VIII, Sec. 808. 

The issuer exemption does not 

specifically include third party 

administrators, for the reasons 

discussed in the companion interim 

final rules concerning religious beliefs 

issued contemporaneously with these 

interim final rules and published 

elsewhere in this issue of the Federal 

Register. The Departments solicit public 

comment; however, on whether there 

are situations where there may be an 

additional need to provide distinct 

protections for third party 

administrators that may have moral 

convictions implicated by the 

Mandate.39

5. Scope of Objections Needed for the 

Objecting Entity Exemption 

Exemptions for objecting entities 

specify that they apply where the 

entities object as specified in 

§ 147.133(a)(2). That section specifies 

that exemptions for objecting entities 

will apply to the extent that an entity 

described in § 147.133(a)(1) objects to its 

establishing, maintaining, providing, 

offering, or arranging (as applicable) for 

coverage, payments, or a plan that 

provides coverage or payments for some 

or all contraceptive services, based on 

its sincerely held moral convictions. 

6. Individual Exemption 

These interim final rules include a 

special rule pertaining to individuals 

(referred to here as the ‘‘individual 

exemption’’). Section 147.133(b) 

provides that nothing in 

§ 147.130(a)(1)(iv), 26 CFR 54.9815– 

2713T(a)(1)(iv) and 29 CFR 2590.715– 

2713(a)(1)(iv), may be construed to 

prevent a willing plan sponsor of a 

group health plan and/or a willing 

health insurance issuer offering group or 

individual health insurance coverage, 

from offering a separate benefit package 

option, or a separate policy, certificate, 

or contract of insurance, to any 

individual who objects to coverage or 

payments for some or all contraceptive 

services based on the individual’s 

sincerely held 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 at large or, as applicable, to 

any other individual policies the issuer 

offers. 

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. 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 health plans 

without coverage for contraception 

based on employees’ 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 of these interim 

final rules, employers sponsoring 

governmental plans would be free to 

honor the sincerely held moral 

objections of individual employees by 

offering them plans that omit 

contraception, even if those 

governmental entities do not object to 

offering contraceptive coverage in 

general. 

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 

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) of the 

PHS Act, 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 interim final rules do 

not affect such other laws or terms. 

The Departments believe the 

individual exemption will help to meet 

the Affordable Care Act’s goal of 

increasing health coverage because it 

will reduce the incidence of certain 

individuals choosing to forego health 

coverage because the only coverage 

available would violate their sincerely 

held moral convictions.40 At the same 


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196 F. Supp. 3d at 1017, and March for Life, 128 

F. Supp. 3d at 130—where the courts noted that the 

individual employee plaintiffs indicated that they 

viewed the Mandate as pressuring them to ‘‘forgo 

health insurance altogether.’’ 

41 78 FR 39874. 

42See also Real Alternatives, 2017 WL 3324690 

at *36 (3d Cir. Aug. 4, 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)). 

time, this individual exemption ‘‘does 

not undermine the governmental 

interests furthered by the contraceptive 

coverage requirement,’’ 41 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. In addition, because the 

individual exemption only operates 

when the employer and/or issuer, as 

applicable, are willing, the exemption 

will not undermine any governmental 

interest in the workability of the 

insurance market, because we expect 

that any workability concerns will be 

taken into account in the decision of 

whether to be willing to offer the 

individual morally acceptable coverage. 

For similar reasons, we have changed 

our position and now believe the 

individual exemption will not 

undermine any Government interest in 

uniformity in the health insurance 

market. At the level of plan offerings, 

the extent to which plans cover 

contraception under the prior rules is 

already far from uniform. The Congress 

did not require compliance with section 

2713 of the PHS Act by all entities—in 

particular by grandfathered plans. The 

Departments’ previous exemption for 

houses of worship and integrated 

auxiliaries, and our accommodation of 

self-insured church plans, show that the 

importance of a uniform health 

insurance system is not significantly 

harmed by allowing plans to omit 

contraception in many contexts.42

With respect to operationalizing this 

provision of these rules, as well as the 

similar provision protecting individuals 

with religious objections to purchasing 

insurance that covers some or all 

contraceptives, in the interim final rules 

published elsewhere in this issue of the 

Federal Register, the Departments note 

that a plan sponsor or health insurance 

issuer is not required to offer separate 

and different benefit package options, or 

separate and different forms of policy, 

certificate, or contract of insurance with 

respect to those individuals who object 

on moral bases from those who object 

on religious bases. That is, a willing 

employer or issuer may offer the same 

benefit package option or policy, 

certificate, or contract of insurance— 

which excludes the same scope of some 

or all contraceptive coverage—to 

individuals who are exempt from the 

Mandate because of their moral 

convictions (under these rules) or their 

religious beliefs (under the regulations 

as amended by the interim final rules 

pertaining to religious beliefs). 

7. Optional Accommodation 

In addition to expanding the 

exemption to those with sincerely held 

moral convictions, these rules also 

expand eligibility for the optional 

accommodation process to include 

employers with objections based on 

sincerely held moral convictions. This 

is accomplished by inserting references 

to the newly added exemption for moral 

convictions, 45 CFR 147.133, into the 

regulatory sections where the 

accommodation process is codified, 45 

CFR 147.131, 26 CFR 54.9815–2713AT, 

and 29 CFR 2590.715–2713A. In all 

other respects the accommodation 

process works the same as it does for 

entities with objections based on 

sincerely held religious beliefs, as 

described in the companion interim 

final rules concerning religious beliefs 

issued contemporaneously with these 

interim final rules and published 

elsewhere in this issue of the Federal 

Register. 

The Departments are not aware of 

entities with objections to the Mandate 

based on sincerely held moral 

convictions that wish to make use of the 

optional accommodation, and our 

present assumption is that no such 

entities will seek to use the 

accommodation rather than the 

exemption. But if such entities do wish 

to use the accommodation, making it 

available to them will both provide 

contraceptive coverage to their plan 

participants and respect those entities’ 

objections. Because entities with 

objections to the Mandate based on 

sincerely held non-religious moral 

convictions have not previously had 

access to the accommodation, they 

would not be in a position to revoke 

their use of the accommodation at the 

time these interim final rules are issued, 

but could do so in the future under the 

same parameters set forth in the 

accommodation regulations. 

8. Regulatory Restatements of Section 

2713(a) and (a)(4) of the PHS Act 

These interim final rules insert 

references to 45 CFR 147.133 into the 

restatements of the requirements of 

section 2713(a) and (a)(4) of the PHS 

Act, contained in 26 CFR 54.9815– 

2713T(a)(1) introductory text and 

(a)(1)(iv), 29 CFR 2590.715–2713(a)(1) 

introductory text and (a)(1)(iv), and 45 

CFR 147.130(a)(1) and (a)(1)(iv). 

9. Conclusion 

The Departments believe that the 

Guidelines, and the expanded 

exemptions and accommodations set 

forth in these interim final rules, will 

advance the legitimate but limited 

purposes for which Congress imposed 

section 2713 of the PHS Act, while 

acting consistently with Congress’ wellestablished record of allowing for moral 

exemptions with respect to various 

health care matters. These interim final 

rules maintain HRSA’s discretion to 

decide whether to continue to require 

contraceptive coverage under the 

Guidelines if no regulatorily recognized 

exemption exists (and in plans where 

Congress applied section 2713 of the 

PHS Act). As cited above, these interim 

final rules also leave fully in place over 

a dozen Federal programs that provide, 

or subsidize, contraceptives for women, 

including for low income women based 

on financial need. The Departments 

believe this array of programs and 

requirements better serves the interests 

of providing contraceptive coverage 

while protecting the moral convictions 

of entities and individuals concerning 

coverage of some or all contraceptive or 

sterilization services. 

The Departments request and 

encourage public comments on all 

matters addressed in these interim final 

rules. 

IV. Interim Final Rules, Request for 

Comments and Waiver of Delay of 

Effective Date 

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 the PHS Act and the 

incorporation of those sections into 

section 715 of ERISA and section 9815 

of the Code. These interim final rules 

fall under those statutory authorized 

justifications, as did previous rules on 

this matter (75 FR 41726; 76 FR 46621; 

and 79 FR 51092). 

Section 553(b) of the APA requires 

notice and comment rulemaking, 

involving a notice of proposed 

rulemaking and a comment period prior 


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43 March for Life, 128 F. Supp. 3d 116; Real 

Alternatives, 867 F.3d 338. 

44See, for example, Americans United for Life 

(‘‘AUL’’) Comment on CMA–9992–IFC2 at 10 (Nov. 

1, 2011), available at http://www.regulations.gov/ 

#!documentDetail;D=HHS-OS-2011-0023-59496, 

and AUL Comment on CMS–9968–P at 5 (Apr. 8, 

2013), available at http://www.regulations.gov/ 

#!documentDetail;D=CMS-2012-0031-79115. 

45See, for example, http://www.regulations.gov/ 

#!documentDetail;D=HHS-OS-2011-0023-59496, 

http://www.regulations.gov/ 

#!documentDetail;D=CMS-2012-0031-79115, 

https://www.regulations.gov/document?D=CMS2016-0123-54142, https://www.regulations.gov/ 

document?D=CMS-2016-0123-54218, and https:// 

www.regulations.gov/document?D=CMS-2016-0123- 

46220. 

to finalization of regulatory 

requirements—except when an agency, 

for good cause, finds that notice and 

public comment thereon are 

impracticable, unnecessary, or contrary 

to the public interest. These provisions 

of the APA do not apply here because 

of the specific authority granted to the 

Secretaries by section 9833 of the Code, 

section 734 of ERISA, and section 2792 

of the PHS Act. 

Even if these provisions of the APA 

applied, they would be satisfied: The 

Departments have determined that it 

would be impracticable and contrary to 

the public interest to delay putting these 

provisions in place until a full public 

notice-and-comment process is 

completed. As discussed earlier, the 

Departments have issued three interim 

final rules implementing this section of 

the PHS Act because of the immediate 

needs of covered entities and the 

weighty matters implicated by the 

HRSA Guidelines. As recently as 

December 20, 2016, HRSA updated 

those Guidelines without engaging in 

the regulatory process (because doing so 

is not a legal requirement), and 

announced that it plans to so continue 

to update the Guidelines. 

Two lawsuits have been pending for 

several years by entities raising nonreligious moral objections to the 

Mandate.43 In one of those cases, the 

Departments are subject to a permanent 

injunction and the appeal of that case 

has been stayed since February 2016. In 

the other case, Federal district and 

appeals courts ruled in favor of the 

Departments, denying injunctive relief 

to the plaintiffs, and that case is also 

still pending. Based on the public 

comments the Departments have 

received, we have reason to believe that 

some similar nonprofit entities might 

exist, even if it is likely a small 

number.44

For entities and individuals facing a 

burden on their sincerely held moral 

convictions, providing them relief from 

Government regulations that impose 

such a burden is an important and 

urgent matter, and delay in doing so 

injures those entities in ways that 

cannot be repaired retroactively. The 

burdens of the existing rules undermine 

these entities’ and individuals’ 

participation in the health care market 

because they provide them with a 

serious disincentive—indeed a crisis of 

conscience—between participating in or 

providing quality and affordable health 

insurance coverage and being forced to 

violate their sincerely held moral 

convictions. The existence of 

inconsistent court rulings in multiple 

proceedings has also caused confusion 

and uncertainty that has extended for 

several years, with different federal 

courts taking different positions on 

whether entities with moral objections 

are entitled to relief from the Mandate. 

Delaying the availability of the 

expanded exemption would require 

entities to bear these burdens for many 

more months. Continuing to apply the 

Mandate’s regulatory burden on 

individuals and organizations with 

moral convictions objecting to 

compliance with the Mandate also 

serves as a deterrent for citizens who 

might consider forming new entities 

consistent with their moral convictions 

and offering health insurance through 

those entities. 

Moreover, we separately expanded 

exemptions to protect religious beliefs 

in the companion interim final rules 

issued contemporaneously with these 

interim final rules and published 

elsewhere in this issue of the Federal 

Register. Because Congress has 

provided many statutes that protect 

religious beliefs and moral convictions 

similarly in certain health care contexts, 

it is important not to delay the 

expansion of exemptions for moral 

convictions set forth in these rules, 

since the companion rules provide 

protections for religious beliefs on an 

interim final basis. Otherwise, our 

regulations would simultaneously 

provide and deny relief to entities and 

individuals that are, in the Departments’ 

view, similarly deserving of exemptions 

and accommodations consistent, with 

similar protections in other federal laws. 

This could cause similarly situated 

entities and individuals to be burdened 

unequally. 

In response to several of the previous 

rules on this issue—including three 

issued as interim final rules under the 

statutory authority cited above—the 

Departments received more than 

100,000 public comments on multiple 

occasions. Those comments included 

extensive discussion about whether and 

to what extent to expand the exemption. 

Most recently, on July 26, 2016, the 

Departments issued a request for 

information (81 FR 47741) and received 

over 54,000 public comments about 

different possible ways to resolve these 

issues. As noted above, the public 

comments in response to both the RFI 

and various prior rulemaking 

proceedings included specific requests 

that the exemptions be expanded to 

include those who oppose the Mandate 

for either religious or ‘‘moral’’ reasons.45

In connection with past regulations, the 

Departments have offered or expanded a 

temporary safe harbor allowing 

organizations that were not exempt from 

the HRSA Guidelines to operate out of 

compliance with the Guidelines. The 

Departments will fully consider 

comments submitted in response to 

these interim final rules, but believe that 

good cause exists to issue the rules on 

an interim final basis before the 

comments are submitted and reviewed. 

Issuing interim final rules with a 

comment period provides the public 

with an opportunity to comment on 

whether these regulations expanding the 

exemption should be made permanent 

or subject to modification without 

delaying the effective date of the 

regulations. 

As the U.S. Court of Appeals for the 

D.C. Circuit stated with respect to an 

earlier IFR promulgated with respect to 

this issue in Priests for Life v. U.S. 

Department of Health and Human 

Services, 772 F.3d 229, 276 (D.C. Cir. 

2014), vacated on other grounds, Zubik 

v. Burwell, 136 S. Ct. 1557 (2016), 

‘‘[S]everal reasons support HHS’s 

decision not to engage in notice and 

comment here.’’ Among other things, 

the Court noted that ‘‘the agency made 

a good cause finding in the rule it 

issued’’; that ‘‘the regulations the 

interim final rule modifies were recently 

enacted pursuant to notice and 

comment rulemaking, and presented 

virtually identical issues’’; that ‘‘HHS 

will expose its interim rule to notice 

and comment before its permanent 

implementation’’; and that not 

proceeding under interim final rules 

would ‘‘delay the implementation of the 

alternative opt-out for religious 

objectors.’’ Id. at 277. Similarly, not 

proceeding with exemptions and 

accommodations for moral objectors 

here would delay the implementation of 

those alternative opt-outs for moral 

objectors. 

Delaying the availability of the 

expanded exemption could also 

increase the costs of health insurance 

for some entities. As reflected in 

litigation pertaining to the Mandate, 

some entities are in grandfathered 

health plans that do not cover 


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46 Kaiser Family Foundation & Health Research & 

Educational Trust, ‘‘Employer Health Benefits, 2017 

Annual Survey,’’ available at http://files.kff.org/ 

attachment/Report-Employer-Health-BenefitsAnnual-Survey-2017. 

contraception. As such, they may wish 

to make changes to their health plans 

that will reduce the costs of insurance 

coverage for their beneficiaries or 

policyholders, but which would cause 

the plans to lose grandfathered status. 

To the extent that entities with 

objections to the Mandate based on 

moral convictions but not religious 

beliefs fall into this category, they may 

be refraining from making those 

changes—and therefore may be 

continuing to incur and pass on higher 

insurance costs—to prevent the 

Mandate from applying to their plans in 

violation of their consciences. We are 

not aware of the extent to which such 

entities exist, but 17 percent of all 

covered workers are in grandfathered 

health plans, encompassing tens of 

millions of people.46 Issuing these rules 

on an interim final basis reduces the 

costs of health insurance and regulatory 

burdens for such entities and their plan 

participants. 

These interim final rules also expand 

access to the optional accommodation 

process for certain entities with 

objections to the Mandate based on 

moral convictions. If entities exist that 

wish to use that process, the 

Departments believe they should be able 

to do so without the delay that would 

be involved by not offering them the 

optional accommodation process by use 

of interim final rules. Proceeding 

otherwise could delay the provision of 

contraceptive coverage to those entities’ 

employees. 

For the foregoing reasons, the 

Departments have determined that it 

would be impracticable and contrary to 

the public interest to engage in full 

notice and comment rulemaking before 

putting these interim final rules into 

effect, and that it is in the public interest 

to promulgate interim final rules. For 

the same reasons, the Departments have 

determined, consistent with section 

553(d) of the APA (5 U.S.C. 553(d)), that 

there is good cause to make these 

interim final rules effective immediately 

upon filing for public inspection at the 

Office of the Federal Register. 

V. Economic Impact and Paperwork 

Burden 

We have examined the impacts of the 

interim 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, 

section 1102(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 one year), and 

an ‘‘economically significant’’ 

regulatory action is subject to review by 

the Office of Management and Budget 

(OMB). As discussed below regarding 

anticipated effects of these rules and the 

Paperwork Reduction Act, these interim 

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 regulations and the Departments 

have provided the following assessment 

of their impact. 

1. Need for Regulatory Action 

These interim final rules amend the 

Departments’ July 2015 final regulations 

and do so in conjunction with the 

amendments made in the companion 

interim final rules concerning religious 

beliefs issued contemporaneously with 

these interim final rules and published 

elsewhere in this issue of the Federal 

Register. These interim final rules 

expand the exemption from the 

requirement to provide coverage for 

contraceptives and sterilization, 

established under the HRSA Guidelines, 

promulgated under section 2713(a)(4) of 

the PHS Act, section 715(a)(1) of the 

ERISA, and section 9815(a)(1) of the 

Code, to include certain entities and 

individuals with objections to 

compliance with the Mandate based on 

sincerely held moral convictions, and 

they revise the accommodation process 

to make entities with such convictions 

eligible to use it. The expanded 

exemption would apply 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 providing 

coverage for some (or all) of the 

contraceptive and/or sterilization 

services covered by the Guidelines. 

Such action is taken, among other 

reasons, to provide for conscientious 

participation in the health insurance 

market free from penalties for violating 

sincerely held moral convictions 

opposed to providing or receiving 

coverage of contraceptive services, to 

resolve lawsuits that have been filed 

against the Departments by some such 

entities, and to avoid similar legal 

challenges. 

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 interim final 

rules, they believe it to be small. 

With respect to the expanded 

exemption for nonprofit organizations, 

as noted above the Departments are 

aware of two small nonprofit 


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47Non-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. 

48Cf., for example, Gallup, ‘‘Americans, 

Including Catholics, Say Birth Control Is Morally 

OK,’’ (May 22, 2012) (‘‘Eighty-two percent of U.S. 

Catholics say birth control is morally acceptable’’), 

available at http://www.gallup.com/poll/154799/ 

americans-including-catholics-say-birth-controlmorally.aspx. 

49 Gallup, ‘‘Most Americans Still Believe in God’’ 

(June 14–23, 2016), available at http:// 

www.gallup.com/poll/193271/americans-believegod.aspx. 

50Pew Research Center, ‘‘Where the Public 

Stands on Religious Liberty vs. Nondiscrimination’’ 

at page 26 (Sept. 28, 2016), available at http:// 

assets.pewresearch.org/wp-content/uploads/sites/ 

11/2016/09/Religious-Liberty-full-for-web.pdf. 

51The 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. 

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 

coverage.47 Based on comments 

submitted in response to prior 

rulemakings on this subject, we believe 

that at least one other similar entity 

exists. However, we do not know how 

many similar entities exist. Lacking 

other information we assume that the 

number is small. Without data to 

estimate the number of such entities, we 

believe it to be less than 10, and assume 

the exemption will be used by nine 

nonprofit entities. 

We 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 our conclusion in 

previous rules that no significant 

burden or costs would result from 

exempting houses of worship and 

integrated auxiliaries. (See 76 FR 46625 

and 78 FR 39889). We 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 even requiring that such 

entities actually oppose contraception 

in order to be exempt (in contrast, the 

expanded exemption here requires the 

exempt entity to actually possess 

sincerely held moral convictions 

objecting to the coverage). In concluding 

that the exemption for houses of 

worship and integrated auxiliaries 

would result in no significant burden or 

costs, we relied on our assumption that 

the employees of exempt houses of 

worship and integrated auxiliaries likely 

share their employers’ opposition to 

contraceptive coverage. 

A similar assumption is supported 

with respect to the expanded exemption 

for nonprofit organizations. To our 

knowledge, the vast majority of 

organizations objecting to the Mandate 

assert religious beliefs. The only 

nonprofit organizations of which we 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 interim 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 our previous rules that a house of 

worship or integrated auxiliary could 

employ persons who do not share their 

views on contraception.48 Although we 

are unable to find sufficient data on this 

issue, we believe that there are far fewer 

non-religious moral nonprofit 

organizations opposed to contraceptive 

coverage than there are churches with 

religious objections to such coverage. 

Based on our limited data, we 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 the 

coverage. Therefore, we expect that the 

expanded exemption for nonprofit 

entities will have no effect of reducing 

contraceptive coverage to employees 

who want that coverage. 

These interim final rules expand the 

exemption to include institutions of 

higher education that arrange student 

coverage and have non-religious moral 

objections to the Mandate, and they 

make exempt entities with moral 

objections eligible to use the 

accommodation. The Departments are 

not aware of either kind of entity. We 

believe the number of entities that 

object to the Mandate based on nonreligious 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, and appear to hold 

objections that we assume would likely 

lead them to reject the accommodation 

process. Therefore, for the purposes of 

estimating the anticipated effect of these 

interim final rules on contraceptive 

coverage of women who wish to receive 

such coverage, we 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 

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 similar 

reasons to those given above for why the 

exemptions and accommodations are 

extended to other entities. We invite 

public comment on whether and how 

many such entities will make use of 

these interim final rules. 

The expanded exemption for issuers 

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. The expanded 

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 expanded moral exemption 

would also cover for-profit entities that 

do not have publicly traded ownership 

interests, and that have non-religious 

moral objections to the Mandate. The 

Departments are not aware of any forprofit entities that possess non-religious 

moral objections to the Mandate. 

However, scores of for-profit entities 

have filed suit challenging the Mandate. 

Among the over 200 entities that 

brought legal challenges, only two 

entities (less than 1 percent) raised nonreligious moral objections—both were 

nonprofit. Among the general public 

polls vary about religious beliefs, but 

one prominent poll shows that 89 

percent of Americans say they believe in 

God.49 Among non-religious persons, 

only a very small percentage 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.50 Combined, this suggests that 

0.2 percent of Americans at most 51

might believe contraceptives are morally 

wrong based on moral convictions but 

not religious beliefs. We 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 


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52 ‘‘Health Insurance Coverage Bulletin’’ 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.pdfEstimates of 

the number of ERISA Plans based on 2015 Medical 

Expenditure Survey—Insurance 

53 ‘‘Health Insurance Coverage Bulletin’’ 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. 

54U.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.’’ 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, Guttmacher Institute, 

‘‘Contraceptive Use in the United States’’ (Sept. 

2016), available at https://www.guttmacher.org/factsheet/contraceptive-use-united-states. 

55See https://www.guttmacher.org/fact-sheet/ 

contraceptive-use-united-states. 

56We 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-ofpocket expenses in order to obtain contraceptives, 

and that those who might do so would bear lower 

costs due to many contraceptive items being 

covered. 

convictions set forth in these interim 

final rules. Given the large number of 

closely held entities that challenged the 

Mandate based on religious objections, 

we assume that some similar for-profit 

entities with non-religious moral 

objections exist. But we 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 forprofit entities that do not have publicly 

traded ownership interests and that 

have objections to the Mandate based on 

sincerely held moral convictions, we 

expect that fewer than 10 entities, if 

any, will do so—we assume nine forprofit entities will use the exemption in 

these interim final rules. 

The expanded 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.52 The average 

number of policyholders (9) in plans 

with under 100 employees was 

obtained. It is not known what size the 

for-profit employers will be that might 

claim this exemption, but as discussed 

above these interim final rules do not 

include publicly traded companies (and 

we invite public comments on whether 

to do so in the final rules), and both of 

the two nonprofit entities that 

challenged the Mandate included fewer 

than five policyholders in each entity. 

Therefore we assume the for-profit 

entities that may claim this expanded 

exemption will have fewer than 100 

employees and an average of 9 

policyholders. For nine entities, the 

total number of policyholders would be 

81. DOL estimates that for each 

policyholder, there is approximately 

one dependent.53 This amounts to 162 

covered persons. Census data indicate 

that women of childbearing age—that is, 

women aged 15–44—comprise 20.2 

percent of the general population.54

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.55 Thus we 

estimate that 15 women may incur 

contraceptive costs due to for-profit 

entities using the expanded exemption 

provided in these interim final rules.56

In the companion interim final rules 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules and published elsewhere in 

this issue of the Federal Register, we 

estimate that the average cost of 

contraception per year per woman of 

childbearing age that use contraception 

covered by the Guidelines, within 

health plans that cover contraception, is 

$584. Consequently, we estimate that 

the anticipated effects attributable to the 

cost of contraception from for-profit 

entities using the expanded exemption 

in these interim final rules is 

approximately $8,760. 

The Departments estimate that these 

interim 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 use 

the accommodation, although we 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. 

Finally, because the accommodation 

process was not previously available to 

entities that possess non-religious moral 

objections to the Mandate, we do not 

anticipate that these interim final rules 

will result in any burden from such 

entities revoking their accommodated 

status. 

The Departments believe the 

foregoing analysis represents a 

reasonable estimate of the likely impact 

under the rules expanded exemptions. 

The Departments acknowledge 

uncertainty in the estimate and 

therefore conducted a second analysis 

using an alternative framework, which 

is set forth in the companion interim 

final rule concerning religious beliefs 

issued contemporaneously with this 

interim final rule and published 

elsewhere in this issue of the Federal 

Register. Under either estimate, this 

interim final rule is not economically 

significant. 

We 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. 

We request comment on all aspects of 

the preceding regulatory impact 

analysis. 

B. Special Analyses—Department of the 

Treasury 

For purposes of the Department of the 

Treasury, certain Internal Revenue 

Service (IRS) regulations, including this 

one, are exempt from the requirements 

in Executive Order 12866, as 

supplemented by Executive Order 

13563. The Departments estimate that 

the likely effect of these interim final 

rules will be that entities will use the 

exemption and not the accommodation. 

Therefore, a regulatory assessment is not 

required. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) imposes 

certain requirements with respect to 

Federal rules 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 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47859 

interest. The interim final rules are 

exempt from 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 does 

not apply and the Departments are not 

required to either certify that the 

regulations or this amendment would 

not have a significant economic impact 

on a substantial number of small entities 

or conduct a regulatory flexibility 

analysis. 

Nevertheless, the Departments 

carefully considered the likely impact of 

the rule on small entities in connection 

with their assessment under Executive 

Order 12866. The Departments do not 

expect that these interim 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, the Departments have 

reduced regulatory burden on small 

entities. Pursuant to section 7805(f) of 

the Code, these regulations have been 

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 concerning each 

proposed collection of information. 

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. 

We estimate that these interim final 

rules will not result in additional 

burdens not accounted for as set forth in 

the companion interim final rules 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules and published elsewhere in 

this issue of the Federal Register. As 

discussed there, regulations 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(f)), and notice of 

revocation of accommodation 

(§ 147.131(c)(4)). The burdens related to 

those ICRs are currently approved under 

OMB Control Numbers 0938–1248 and 

0938–1292. These interim final rules 

amend the accommodation regulations 

to make entities with moral objections 

to the Mandate eligible to use the same 

accommodation processes. The 

Departments will update the forms and 

model notices regarding these processes 

to reflect that entities with sincerely 

held moral convictions are eligible 

organizations. 

As discussed above, however, we 

assume that no entities with nonreligious moral objections to the 

Mandate will use the accommodation, 

and we know that no such entities were 

eligible for it until now, so that they do 

not possess accommodated status to 

revoke. Therefore we believe that the 

burden for these ICRs is accounted for 

in the collection approved under OMB 

Control Numbers 0938–1248 and 0938– 

1292, as described in the interim final 

rules concerning religious beliefs issued 

contemporaneously with these interim 

final rules. 

We are soliciting comments on all of 

the possible information collection 

requirements contained in these interim 

final rules, including those discussed in 

the companion interim final rules 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules and published elsewhere in 

this issue of the Federal Register, for 

which these interim final rules provide 

eligibility to entities with objections 

based on moral convictions. In addition, 

we are also soliciting comments on all 

of the related information collection 

requirements currently approved under 

0938–1292 and 0938–1248. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

If you comment on these information 

collections, that is, reporting, 

recordkeeping or third-party disclosure 

requirements, please submit your 

comments electronically as specified in 

the ADDRESSES section of these interim 

final rules with comment period. 

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. A copy of the ICR may be 

obtained by contacting the PRA 

addressee shown below or at http:// 

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 

interim final rules make entities with 

certain moral convictions eligible for the 

accommodation, we assume that no 

entities will use it rather than the 

exemption, and such entities were not 

previously eligible for the 

accommodation so as to revoke it. 

Therefore we believe these interim final 

rules do not involve additional burden 

not accounted for under OMB control 

number 1210–0150. 

Regarding the ICRs discussed in the 

companion interim final rules 

concerning religious beliefs issued 

contemporaneously with these interim 

final rules and published elsewhere in 

this issue of the Federal Register, the 

forms for which would be used if any 

entities with moral objections used the 

accommodation process in the future, 

DOL submitted those ICRs in order to 

obtain OMB approval under the PRA for 

the regulatory revision. The request was 

made under emergency clearance 

procedures specified in regulations at 5 

CFR 1320.13. OMB approved the ICRs 

under the emergency clearance process. 

In an effort to consolidate the number of 

information collection requests, DOL 

indicated it will combine the ICR 

related to the OMB control number 

1210–0152 with the ICR related to the 

OMB control number 1210–0150. Once 


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57Other 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 

leads to this interim final rule’s 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. 

the ICR is approved, DOL indicated it 

will discontinue 1210–0152. OMB 

approved the ICR under control number 

1210–0150 through [DATE]. A copy of 

the information collection request may 

be obtained free of charge on the 

RegInfo.gov Web site at http:// 

www.reginfo.gov/public/do/ 

PRAViewICR?ref_nbr=201705-1210-001. 

This approval allows respondents 

temporarily to utilize the additional 

flexibility these interim final regulations 

provide, while DOL seeks public 

comment on the collection methods— 

including their utility and burden. 

Contemporaneously with the 

publication of these interim final rules, 

DOL will publish a notice in the Federal 

Register informing the public of its 

intention to extend the OMB approval. 

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 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.’’ These 

interim 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), 

we have estimated the costs and cost 

savings attributable to this interim final 

rule. As discussed in more detail in the 

preceding analysis, this interim final 

rule lessens incremental reporting 

costs.57 Therefore, this interim final rule 

is considered an EO 13771 deregulatory 

action. 

G. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a) of 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 $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $148 

million, using the most current (2016) 

Implicit Price Deflator for the Gross 

Domestic Product. For purposes of the 

Unfunded Mandates Reform Act, these 

interim 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 $100 million, adjusted 

for inflation, 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 interim final 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. 

VI. Statutory Authority 

The Department of the Treasury 

temporary regulations are adopted 

pursuant to the authority contained in 

sections 7805 and 9833 of the Code. 

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, 

Pub. L. 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 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47861 

requirements, State regulation of health 

insurance. 

Kirsten B. Wielobob, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: October 2, 2017. 

David J. Kautter, 

Assistant Secretary for Tax Policy. 

Signed this 4th day of October, 2017. 

Timothy D. Hauser, 

Deputy Assistant Secretary for Program 

Operations, Employee Benefits Security 

Administration, Department of Labor. 

Dated: October 4, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 4, 2017. 

Donald Wright, 

Acting 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 

■ 1. The authority citation for part 54 

continues to read, in part, as follows: 

Authority: 26 U.S.C. 7805. * * * 

§ 54.9815–2713T [Amended] 

■ 2. Section 54.9815–2713T, as added 

elsewhere in this issue of the Federal 

Register, is 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’’. 

§ 54.9815–2713AT [Amended] 

■ 3. Section 54.9815–2713AT, as added 

elsewhere in this issue of the Federal 

Register], is 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) introductory text 

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 

For the reasons set forth in the 

preamble, the Department of Labor 

amends 29 CFR part 2590 as follows: 

PART 2590—RULES AND 

REGULATIONS FOR GROUP HEALTH 

PLANS 

■ 3. The authority citation for part 2590 

continues to read as follows: 

Authority: 29 U.S.C. 1027, 1059, 1135, 

1161–1168, 1169, 1181–1183, 1181 note, 

1185, 1185a, 1185b, 1191, 1191a, 1191b, and 

1191c; sec. 101(g), Pub. L. 104–191, 110 Stat. 

1936; sec. 401(b), Pub. L. 105–200, 112 Stat. 

645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 

110–343, 122 Stat. 3881; sec. 1001, 1201, and 

1562(e), Pub. L. 111–148, 124 Stat. 119, as 

amended by Pub. L. 111–152, 124 Stat. 1029; 

Division M, Pub. L. 113–235, 128 Stat. 2130; 

Secretary of Labor’s Order 1–2011, 77 FR 

1088 (Jan. 9, 2012). 

§ 2590.715–2713 [Amended] 

■ 4. Section 2590.715–2713, 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’’. 

§ 2590.715–2713A [Amended] 

■ 5. Section 2590.715–2713A, as revised 

elsewhere in this issue of the Federal 

Register], is further amended— 

■ a. In paragraph (a)(1) by removing 

‘‘(ii)’’ and adding in its place ‘‘(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) introductory text 

by removing the reference ‘‘147.132’’ 

and adding in its place the reference 

‘‘147.132 or 147.133’’. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

For the reasons set forth in the 

preamble, the Department of Health and 

Human Services amends 45 CFR part 

147 as follows: 

PART 147—HEALTH INSURANCE 

REFORM REQUIREMENTS FOR THE 

GROUP AND INDIVIDUAL HEALTH 

INSURANCE MARKETS 

■ 6. The authority citation for part 147 

continues to read as follows: 

Authority: Secs 2701 through 2763, 2791, 

and 2792 of the Public Health Service Act (42 

U.S.C. 300gg through 300gg–63, 300gg–91, 

and 300gg–92), as amended. 

§ 147.130 [Amended] 

■ 7. Section 147.130, as amended 

elsewhere in this issue of the Federal 

Register, is further amended in 

paragraphs (a)(1) introductory text and 

(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’’. 

§ 147.131 [Amended] 

■ 8. Section 147.131, as revised 

elsewhere in this issue of the Federal 

Register, is further amended— 

■ a. In paragraph (c)(1) by removing the 

reference ‘‘(ii)’’ and adding in its place 

the reference ‘‘(ii), or 45 CFR 

147.133(a)(1)(i) or (ii)’’. 

■ b. In paragraph (c)(2) by removing the 

reference ‘‘§ 147.132(a)’’ and adding in 

its place the reference ‘‘§ 147.132(a) or 

147.133’’; and 

■ c. In paragraphs (d)(1)(ii) introductory 

text, (d)(1)(ii)(B) and (d)(2) by removing 

the reference ‘‘§ 147.132’’ and to adding 

in its place the reference ‘‘§ 147.132 or 

147.133’’. 

■ 9. Add § 147.133 to read as follows: 

§ 147.133 Moral exemptions in connection 

with coverage of certain preventive health 

services. 

(a) Objecting entities. (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, and thus 


asabaliauskas on DSKBBXCHB2PROD with RULES
47862 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

the Health Resources and Service 

Administration will exempt from any 

guidelines’ requirements that relate to 

the provision of contraceptive services: 

(i) A group health plan and health 

insurance coverage provided in 

connection with a group health plan to 

the extent one of the following nongovernmental plan sponsors object as 

specified in paragraph (a)(2) of this 

section: 

(A) A nonprofit organization; or 

(B) A for-profit entity that has no 

publicly traded ownership interests (for 

this purpose, a publicly traded 

ownership interest is any class of 

common equity securities required to be 

registered under section 12 of the 

Securities Exchange Act of 1934); 

(ii) An institution of higher education 

as defined in 20 U.S.C. 1002 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 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 

(iii) A health insurance issuer offering 

group or individual insurance coverage 

to the extent the issuer objects as 

specified in paragraph (a)(2) of this 

section. Where a health insurance issuer 

providing group health insurance 

coverage is exempt under paragraph 

(a)(1)(iii) of this section, the group 

health plan established or maintained 

by the plan sponsor with which the 

health insurance issuer contracts 

remains subject to any requirement to 

provide coverage for contraceptive 

services under Guidelines issued under 

§ 147.130(a)(1)(iv) unless it is also 

exempt from that requirement. 

(2) The exemption of this paragraph 

(a) will apply to the extent that an entity 

described in paragraph (a)(1) of this 

section objects to its establishing, 

maintaining, providing, offering, or 

arranging (as applicable) coverage or 

payments for some or all contraceptive 

services, or for a plan, issuer, or third 

party administrator that provides or 

arranges such coverage or payments, 

based on its sincerely held moral 

convictions. 

(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. 

(c) Definition. For the purposes of this 

section, reference to ‘‘contraceptive’’ 

services, benefits, or coverage includes 

contraceptive or sterilization items, 

procedures, or services, or related 

patient education or counseling, to the 

extent specified for purposes of 

§ 147.130(a)(1)(iv). 

(d) Severability. Any provision of this 

section held to be invalid or 

unenforceable by its terms, or as applied 

to any person or circumstance, shall be 

construed so as to continue to give 

maximum effect to the provision 

permitted by law, unless such holding 

shall be one of utter invalidity or 

unenforceability, in which event the 

provision shall be severable from this 

section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

[FR Doc. 2017–21852 Filed 10–6–17; 11:15 am] 

BILLING CODE 4830–01–P; 4510–029–P; 4120–01–P; 

6325–64–P 


asabaliauskas on DSKBBXCHB2PROD with RULES