47792 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, 

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 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD–9827] 

RIN 1545–BN92 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB83 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 147 

[CMS–9940–IFC] 

RIN 0938–AT20 

Religious 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 and 

moral convictions. These interim final 

rules expand exemptions to protect 

religious beliefs for certain entities and 

individuals whose health plans are 

subject to a mandate of contraceptive 

coverage through guidance issued 

pursuant to the Patient Protection and 

Affordable Care Act. These rules do not 

alter the discretion of the Health 

Resources and Services Administration 

(HRSA), a component of the United 

States Department of Health and Human 

Services (HHS), to maintain the 

guidelines requiring contraceptive 

coverage where no regulatorily 

recognized objection exists. These rules 

also leave the ‘‘accommodation’’ process 

in place as an optional process for 

certain exempt entities that wish to use 

it voluntarily. These rules do not alter 

multiple other Federal programs that 

provide free or subsidized 

contraceptives for women at risk of 

unintended pregnancy. 

DATES: Effective date: These interim 

final rules and temporary regulations 

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–9940–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–9940–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 

Congress has consistently sought to 

protect religious beliefs in the context of 

health care and human services, 

including health insurance, even as it 

has sought 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 47793 

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. 290kk–1 (protecting the religious character of 

organizations participating in certain programs and 

the religious freedom of beneficiaries of the 

programs); 42 U.S.C. 300x–65 (protecting the 

religious character of organizations and the 

religious freedom of individuals involved in the use 

of government funds to provide substance abuse 

services); 42 U.S.C. 604a (protecting the religious 

character of organizations and the religious freedom 

of beneficiaries involved in the use of government 

assistance to needy families); 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. 5106i (prohibiting 

certain Federal statutes from being construed to 

require that a parent or legal guardian provide a 

child any medical service or treatment against the 

religious beliefs of the parent or legal guardian); 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); also, see 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 document, 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’’ 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 the same discretion to allow 

exemptions to those requirements. 

Through rulemaking, including three 

interim final rules, the Departments 

allowed exemptions and 

accommodations for certain religious 

objectors where the Guidelines require 

coverage of contraceptive services. 

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, including the Religious 

Freedom Restoration Act, 42 U.S.C. 

2000bb–1. Much of that litigation 

continues to this day. 

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); protection of the free exercise of 

religion in the First Amendment and by 

Congress in the Religious Freedom 

Restoration Act of 1993; Congress’ 

history of providing protections for 

religious beliefs regarding certain health 

services (including contraception, 

sterilization, and items or services 

believed to involve abortion); the 

discretion afforded under section 

2713(a)(4) of the PHS Act; the structure 

and intent of that provision in the 

broader context of section 2713 and the 

Patient Protection and Affordable Care 

Act; the regulatory process and 

comments submitted in various requests 

for public comments (including in the 

Departments’ 2016 Request for 

Information). 

In light of these factors, the 

Departments issue these new interim 

final rules to better balance the 

Government’s interest in ensuring 

coverage for contraceptive and 

sterilization services in relation to the 

Government’s interests, including as 

reflected throughout Federal law, to 

provide conscience protections for 

individuals and entities with sincerely 

held religious beliefs in certain health 

care contexts, and to minimize burdens 

in 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 

HHS.’’ 

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 

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. 


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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. 

The Departments have consistently 

interpreted section 2714(a)(4) PHS Act’s 

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’s reference to 

‘‘comprehensive guidelines supported 

by HRSA for purposes of this 

paragraph’’ to grant HRSA authority to 

develop such Guidelines. And because 

the text refers to Guidelines ‘‘supported 

by HRSA 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) 

of the PHS Act, 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) of the 

PHS Act, the Departments have 

previously promulgated regulations 

defining the scope of permissible 

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 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 interpretation of section 

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

by the Affordable Care Act’s statutory 

structure. 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 of the PHS 

Act for grandfathered plans. In contrast, 

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 

of the PHS Act, which prohibits 

preexisting condition exclusions or 

other discrimination based on health 

status in group health coverage; section 

2708 of the PHS Act, which prohibits 

excessive waiting periods (as of January 

1, 2014); section 2711 of the PHS Act, 

which relates to lifetime limits; section 

2712 of the PHS Act, which prohibits 

rescission of health insurance coverage; 

section 2714 of the PHS Act, which 

extends dependent coverage until age 

26; and section 2718 of the PHS Act, 

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. While 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 religious beliefs 

regarding certain health matters, and are 

consistent with the intent that the 

Affordable Care Act would be 

implemented in accordance with 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. 

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 (ASPE), 

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 

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 


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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, Comments of the United 

States Conference of Catholic Bishops on Interim 

Final Rules on Preventive Services, File Code CMS– 

9992–IFC2 (Aug. 31, 2011). 

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). 

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 argued 

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 the United States 

Preventive Services Task Force 

(USPSTF), HRSA’s Bright Futures 

Project, and the Advisory Committee on 

Immunization Practices (ACIP) leads to 

lower rates of disability or disease and 

increased rates of well-being. He further 

argued 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.’’ Dr. 

LoSasso 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. 

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 specify 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 defined an exempt 

‘‘religious employer’’ narrowly as one 

that: (1) Had the inculcation of religious 

values as its purpose; (2) primarily 

employed persons who shared its 

religious tenets; (3) primarily served 

persons who shared its religious tenets; 

and (4) was a nonprofit organization, as 

described in section 6033(a)(1) and 

(a)(3)(A)(i) or (iii) of the Code. Those 

relevant sections of the Code include 

only churches, their integrated 

auxiliaries, conventions or associations 

of churches, and the exclusively 

religious activities of a religious order. 

The practical effect of the rules’ 

definition of ‘‘religious employer’’ was 

to create potential uncertainty about 

whether employers, including many of 

those houses of worship or their 

integrated auxiliaries, would fail to 

qualify for the exemption if they 

engaged in outreach activities toward 

persons who did not share their 

religious tenets.10 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). That same day, HRSA exercised 

the discretion described in the 2011 

interim final rules to provide the 

exemption. 

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 religious 

employers to file any certification form 

or comply with any other information 

collection process. 

Contemporaneous 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 

guidance provided that the temporary 

safe harbor would remain in effect until 

the first plan year beginning on or after 

August 1, 2013. The temporary safe 

harbor did not apply to for-profit 

entities. 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 


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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 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. 

15 ‘‘[P]roviding payments for contraceptive 

services is cost neutral for issuers.’’ (78 FR 39877). 

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 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 religious 

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. 

On August 15, 2012, the Departments 

also 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). But, 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 regulations also 

finalized an accommodation for eligible 

organizations. Under the 

accommodation, an eligible organization 

was required to submit a selfcertification 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 Secretary of the Department of 

Health and Human Services requests 

and an authorizing exception under 

OMB Circular No. A–25R is in effect.14

With respect to fully insured group 

health plans, the issuer was expected to 

bear the cost of such payments,15 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. 

With respect to self-insured group 

health plans, the July 2013 final 

regulations specified that the selfcertification was an instrument under 

which the plan was operated and that it 

obligated the third party administrator 

to provide or arrange for contraceptive 

coverage by operation of section 3(16) of 

ERISA. The regulations stated that, by 

submitting the self-certification form, 

the eligible organization ‘‘complies’’ 

with the contraceptive coverage 

requirement and does not have to 

contract, arrange, pay, or refer for 

contraceptive coverage. See, for 

example, Id. at 39874, 39896. Consistent 

with these statements, the Departments, 

through the Department of Labor, issued 

a self-certification form, EBSA Form 

700. The form stated, in indented text 

labeled as a ‘‘Notice to Third Party 

Administrators of Self-Insured Health 

Plans,’’ that ‘‘[t]he obligations of the 

third party administrator are set forth in 

26 CFR 54.9815–2713A, 29 CFR 2510.3– 

16, and 29 CFR 2590.715–2713A’’ and 

concluded, in unindented text, that 

‘‘[t]his form is an instrument under 

which the plan is operated.’’ 

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. The 

guidance extending the safe harbor 

included a form to be used by an 

organization during this temporary 

period to self-certify that its plan 

qualified for the temporary safe harbor 

if no prior form had been submitted. 

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. Religious plaintiffs principally 

argued that the Mandate violated the 

Religious Freedom Restoration Act of 

1993 (RFRA) by forcing them to provide 

coverage or payments for sterilization 

and contraceptive services, including 

what they viewed as early abortifacient 

items, contrary to their religious beliefs. 

Based on this claim, in July 2012 a 


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16The Supreme Court did not decide whether 

RFRA would apply to publicly traded for-profit 

corporations. See 134 S. Ct. at 2774. 

Federal district court issued a 

preliminary injunction barring the 

Departments from enforcing the 

Mandate against a family-owned 

business. Newland v. Sebelius, 881 F. 

Supp. 2d. 1287 (D. Colo. 2012). Multiple 

other courts proceeded to issue similar 

injunctions against the Mandate, 

although a minority of courts ruled in 

the Departments’ favor. Compare 

Tyndale House Publishers, Inc. v. 

Sebelius, 904 F. Supp. 2d 106 (D.D.C. 

2012), and The Seneca Hardwood 

Lumber Company, Inc. v. Sebelius (sub 

nom Geneva Coll. v. Sebelius), 941 F. 

Supp. 2d 672 (W.D. Pa. 2013), with 

O’Brien v. U.S. Dep’t of Health & 

Human Servs., 894 F. Supp. 2d 1149 

(E.D. Mo. 2012). 

A circuit split swiftly developed in 

cases filed by religiously motivated forprofit businesses, to which neither the 

religious employer exemption nor the 

eligible organization accommodation (as 

then promulgated) applied. Several forprofit businesses won rulings against 

the Mandate before the Unites States 

Court of Appeals for the Tenth Circuit, 

sitting en banc, while similar rulings 

against the Departments were issued by 

the Seventh and District of Columbia 

(DC) Circuits. Hobby Lobby Stores, Inc. 

v. Sebelius, 723 F.3d 1114 (10th Cir. 

2013); Korte v. Sebelius, 735 F.3d 654 

(7th Cir. 2013); Gilardi v. U.S. Dep’t of 

Health & Human Servs., 733 F.3d 1208 

(D.C. Cir. 2013). The Third and Sixth 

Circuits disagreed with similar 

plaintiffs, and in November 2013 the 

U.S. Supreme Court granted certiorari in 

Hobby Lobby and Conestoga Wood 

Specialties Corp. v. Secretary of U.S. 

Department of Health & Human 

Services, 724 F.3d 377 (3d Cir. 2013), to 

resolve the circuit split. 

On June 30, 2014, the Supreme Court 

ruled against the Departments and held 

that, under RFRA, the Mandate could 

not be applied to the closely held forprofit corporations before the Court 

because their owners had religious 

objections to providing such 

coverage.16 Burwell v. Hobby Lobby 

Stores, Inc. 134 S. Ct. 2751 (2014). The 

Court held that the ‘‘contraceptive 

mandate ‘substantially burdens’ the 

exercise of religion’’ as applied to 

employers that object to providing 

contraceptive coverage on religious 

grounds, and that the plaintiffs were 

therefore entitled to an exemption 

unless the Mandate was the least 

restrictive means of furthering a 

compelling governmental interest. Id. at 

2775. The Court observed that, under 

the compelling interest test of RFRA, the 

Departments could not rely on interests 

‘‘couched in very broad terms, such as 

promoting ‘public health’ and ‘gender 

equality,’ but rather, had to demonstrate 

that a compelling interest was served by 

refusing an exemption to the ‘‘particular 

claimant[s]’’ seeking an exemption. Id. 

at 2779. Assuming without deciding 

that a compelling interest existed, the 

Court held that the Government’s goal of 

guaranteeing coverage for contraceptive 

methods without cost sharing could be 

achieved in a less restrictive manner. 

The Court observed that ‘‘[t]he most 

straightforward way of doing this would 

be for the Government to assume the 

cost of providing the four contraceptives 

at issue to any women who are unable 

to obtain them under their healthinsurance policies due to their 

employers’ religious objections.’’ Id. at 

2780. The Court also observed that the 

Departments had ‘‘not provided any 

estimate of the average cost per 

employee of providing access to these 

contraceptives,’’ nor ‘‘any statistics 

regarding the number of employees who 

might be affected because they work for 

corporations like Hobby Lobby, 

Conestoga, and Mardel’’. Id. at 2780–81. 

But the Court ultimately concluded that 

it ‘‘need not rely on the option of a new, 

government-funded program in order to 

conclude that the HHS regulations fail 

the least-restrictive means test’’ because 

‘‘HHS itself ha[d] demonstrated that it 

ha[d] at its disposal an approach that is 

less restrictive than requiring employers 

to fund contraceptive methods that 

violate their religious beliefs.’’ Id. at 

2781–82. The Court explained that the 

‘‘already established’’ accommodation 

process available to nonprofit 

organizations was a less-restrictive 

alternative that ‘‘serve[d] HHS’s stated 

interests equally well,’’ although the 

Court emphasized that its ruling did not 

decide whether the accommodation 

process ‘‘complie[d] with RFRA for 

purposes of all religious claims’’. Id. at 

2788–82. 

Meanwhile, another plaintiff obtained 

temporary relief from the Supreme 

Court in a case challenging the 

accommodation under RFRA. Wheaton 

College, a Christian liberal arts college 

in Illinois, objected that the 

accommodation was a compliance 

process that rendered it complicit in 

delivering payments for abortifacient 

contraceptive services to its employees. 

Wheaton College refused to execute the 

EBSA Form 700 required under the July 

2013 final regulations. It was denied a 

preliminary injunction in the Federal 

district and appellate courts, and sought 

an emergency injunction pending 

appeal from the Unites States Supreme 

Court on June 30, 2014. On July 3, 2014, 

the Supreme Court issued an interim 

order in favor of the College, stating 

that, ‘‘[i]f the [plaintiff] informs the 

Secretary of Health and Human Services 

in writing that it is a nonprofit 

organization that holds itself out as 

religious and has religious objections to 

providing coverage for contraceptive 

services, the [Departments of Labor, 

Health and Human Services, and the 

Treasury] are enjoined from enforcing 

[the Mandate] against the [plaintiff] . . . 

pending final disposition of appellate 

review.’’ Wheaton College v. Burwell. 

134 S. Ct. 2806, 2807 (2014). The order 

stated that Wheaton College did not 

need to use EBSA Form 700 or send a 

copy of the executed form to its health 

insurance issuers or third party 

administrators to meet the condition for 

injunctive relief. Id. 

In response to this litigation, 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 the Department of Health and Human 

Services 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, 

and neither added a certification 

requirement for exempt entities. 

In October 2014, based on an 

interpretation of the Supreme Court’s 

interim order, HHS deemed Wheaton 

College as having submitted a sufficient 

notice to HHS. HHS conveyed that 

interpretation to the DOL, so as to 

trigger the accommodation process. 

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 preamble to the 

July 2015 final regulations stated that, 

through the accommodation, payments 


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17Available 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. 

for contraceptives and sterilization 

would be provided in a way that is 

‘‘seamless’’ with the coverage that 

eligible employers provide to their plan 

participants and beneficiaries. Id. at 

41328. 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. 

When an eligible organization 

maintains an insured group health plan 

or student health plan and provides the 

alternative notice, the July 2015 final 

regulations provide that HHS will 

inform the health insurance issuer of its 

obligations to cover contraceptive 

services to which the eligible 

organization objects. Where an eligible 

organization maintains a self-insured 

plan under ERISA and provides the 

alternative notice, the regulations 

provide that DOL will work with HHS 

to send a separate notification to the 

self-insured plan’s third party 

administrator(s). The regulations further 

provide that such notification is an 

instrument under which the plan is 

operated for the purposes of section 

3(16) of ERISA, and the instrument 

would designate the third party 

administrator as the entity obligated to 

provide or arrange for payments for 

contraceptives to which the eligible 

organization objects. The July 2015 final 

regulations continue to apply the 

amended notice requirement to eligible 

organizations that sponsor church plans 

exempt from ERISA pursuant to section 

4(b)(2) of ERISA, but acknowledge that, 

with respect to the operation of the 

accommodation process, section 3(16) of 

ERISA does not provide a mechanism to 

impose an obligation to provide 

contraceptive coverage as a plan 

administrator on those eligible 

organizations’ third party 

administrators. (80 FR 41323). 

Meanwhile, a second split among 

Federal appeals courts had developed 

involving challenges to the Mandate’s 

accommodation. Many religious 

nonprofit organizations argued that the 

accommodation impermissibly 

burdened their religious beliefs because 

it utilized the plans the organizations 

themselves sponsored to provide 

services to which they objected on 

religious grounds. They objected to the 

self-certification requirement on the 

same basis. Federal district courts split 

in the cases, granting preliminary 

injunction motions to religious groups 

in the majority of cases, but denying 

them to others. In most appellate cases, 

religious nonprofit organizations lost 

their challenges, where the courts often 

concluded that the accommodation 

imposed no substantial burden on their 

religious exercise under RFRA. For 

example, Priests for Life v. U.S. Dep’t of 

Health and Human Servs., 772 F. 3d 229 

(D.C. Cir. 2014); Little Sisters of the Poor 

Home for the Aged v. Burwell, 794 F.3d 

1151 (10th Cir. 2015); Geneva Coll. v. 

Sec’y U.S. Dep’t of Health & Human 

Servs., 778 F.3d 422 (3d Cir. 2015). But 

the Eighth Circuit disagreed and ruled 

in favor of religious nonprofit 

employers. Dordt College v. Burwell, 

801 F.3d 946, 949–50 (8th Cir. 2015) 

(relying on Sharpe Holdings, Inc. v. U.S. 

Dep’t of Health & Human Servs., 801 

F.3d 927 (8th Cir. 2015)). 

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. The Court held oral argument 

on March 23, 2016, and, after the 

argument, asked the parties to submit 

supplemental briefs addressing 

‘‘whether and how contraceptive 

coverage may be obtained by 

petitioners’ employees through 

petitioners’ insurance companies, but in 

a way that does not require any 

involvement of petitioners beyond their 

own decision to provide health 

insurance without contraceptive 

coverage to their employees’’. In a brief 

filed with the Supreme Court on April 

12, 2016, the Government stated on 

behalf of the Departments that the 

accommodation process for eligible 

organizations with insured plans could 

operate without any self-certification or 

written notice being submitted by 

eligible organizations. 

On May 16, 2016, the Supreme Court 

issued a per curiam opinion in Zubik, 

vacating the judgments of the Courts of 

Appeals and remanding the cases ‘‘in 

light of the substantial clarification and 

refinement in the positions of the 

parties’’ in their 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, some 

meetings were held between attorneys 

for the Government and for the plaintiffs 

in those cases. Separately, at various 

times after the Supreme Court’s remand 

order, HHS and DOL sent letters to the 

issuers and third party administrators of 

certain plaintiffs in Zubik and other 

pending cases, directing the issuers and 

third party administrators to provide 

contraceptive coverage for participants 

in those plaintiffs’ group health plans 

under the accommodation. 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. 

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 

contraceptive method). They also 

specified 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. 

On January 9, 2017, the Departments 

issued a document entitled, ‘‘FAQs 

About Affordable Care Act 

Implementation Part 36’’ (FAQ).17 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. Thus, the 


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litigation on remand from the Supreme 

Court remains unresolved. 

A separate category of unresolved 

litigation involved religious employees 

as plaintiffs. For example, in two cases, 

the plaintiff-employees work for a 

nonprofit organization that agrees with 

the employees (on moral grounds) in 

opposing coverage of certain 

contraceptives they believe to be 

abortifacient, and that is willing to offer 

them insurance coverage that omits 

such services. See March for Life v. 

Burwell, 128 F. Supp. 3d 116 (D.D.C. 

2015); Real Alternatives, 150 F. Supp. 

3d 419, affirmed by 867 F.3d 338 (3d 

Cir. 2017). In another case, the plaintiffemployees work for a State government 

entity that the employees claim is 

willing, under State law, to provide a 

plan omitting contraception consistent 

with the employees’ religious beliefs. 

See Wieland v. HHS, 196 F. Supp. 3d 

1010 (E.D. Mo. 2016). Those and similar 

employee-plaintiffs generally contend 

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 their willing employer or in 

the individual market, because the 

Departments offer no exemptions 

encompassing either circumstance. 

Such challenges have seen mixed 

success. Compare, for example, 

Wieland, 196 F. Supp. 3d at 1020 

(concluding that the Mandate violates 

the employee plaintiffs’ rights under 

RFRA and permanently enjoining the 

Departments) and March for Life, 128 F. 

Supp. 3d at 133–34 (same), with Real 

Alternatives, 2017 WL 3324690 at *18 

(affirming dismissal of employee 

plaintiffs’ RFRA claim). 

On May 4, 2017, the President issued 

an ‘‘Executive Order Promoting Free 

Speech and Religious Liberty.’’ 

Regarding ‘‘Conscience Protections with 

Respect to Preventive-Care Mandate,’’ 

that order instructs ‘‘[t]he Secretary of 

the Treasury, the Secretary of Labor, and 

the Secretary of Health and Human 

Services [to] 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. RFRA and Government Interests 

Underlying the Mandate 

RFRA provides that the Government 

‘‘shall not substantially burden a 

person’s exercise of religion even if the 

burden results from a rule of general 

applicability’’ unless the Government 

‘‘demonstrates that application of the 

burden to the person—(1) is in 

furtherance of a compelling 

governmental interest; and (2) is the 

least restrictive means of furthering that 

compelling governmental interest.’’ 42 

U.S.C. 2000bb–1(a) and (b). In Hobby 

Lobby, the Supreme Court had ‘‘little 

trouble concluding’’ that, in the absence 

of an accommodation or exemption, 

‘‘the HHS contraceptive mandate 

‘substantially burden[s]’ the exercise of 

religion. 42 U.S.C. 2000bb–1(a).’’ 134 S. 

Ct. at 2775. And although the Supreme 

Court did not resolve the RFRA claims 

presented in Zubik on their merits, it 

instructed the parties to consider 

alternative accommodations for the 

objecting plaintiffs, after the 

Government suggested that such 

alternatives might be possible. 

Despite multiple rounds of 

rulemaking, however, the Departments 

have not assuaged the sincere religious 

objections to contraceptive coverage of 

numerous organizations, nor have we 

resolved the pending litigation. To the 

contrary, the Departments have been 

litigating RFRA challenges to the 

Mandate and related regulations for 

more than 5 years, and dozens of those 

challenges remain pending today. That 

litigation, and the related modifications 

to the accommodation, have consumed 

substantial governmental resources 

while creating uncertainty for objecting 

organizations, issuers, third party 

administrators, employees, and 

beneficiaries. Consistent with the 

President’s Executive Order and the 

Government’s desire to resolve the 

pending litigation and prevent future 

litigation from similar plaintiffs, the 

Departments have concluded that it is 

appropriate to reexamine the exemption 

and accommodation scheme currently 

in place for the Mandate. 

These interim final rules (and the 

companion interim final rules published 

elsewhere in this Federal Register) are 

the result of that reexamination. The 

Departments acknowledge that coverage 

of contraception is an important and 

highly sensitive issue, implicating many 

different views, as reflected in the 

comments received on multiple 

rulemakings over the course of 

implementation of section 2713(a)(4) of 

the PHS Act. After reconsidering the 

interests served by the Mandate in this 

particular context, the objections raised, 

and the applicable Federal law, the 

Departments have determined that an 

expanded exemption, rather than the 

existing accommodation, is the most 

appropriate administrative response to 

the religious objections raised by certain 

entities and organizations concerning 

the Mandate. The Departments have 

accordingly decided to revise the 

regulations channeling HRSA authority 

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

provide an exemption from the Mandate 

to a broader range of entities and 

individuals that object to contraceptive 

coverage on religious grounds, while 

continuing to offer the existing 

accommodation as an optional 

alternative. The Departments have also 

decided to create a process by which a 

willing employer and issuer may allow 

an objecting individual employee to 

obtain health coverage without 

contraceptive coverage. 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. 

In addition to relying on the text of 

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

the Departments’ discretion to 

promulgate rules to carry out the 

provisions of the PHS Act, the 

Departments also draw on Congress’ 

decision in the Affordable Care Act 

neither to specify that contraception 

must be covered nor to require 

inflexible across-the-board application 

of section 2713 of the PHS Act. The 

Departments further consider Congress’ 

extensive history of protecting religious 

objections when certain matters in 

health care are specifically regulated— 

often specifically with respect to 

contraception, sterilization, abortion, 

and activities connected to abortion. 

Notable among the many statutes 

(listed in footnote 1 in Section IBackground) that include protections for 

religious beliefs are, not only the 

Church Amendments, but also 

protections for health plans or health 

care organizations in Medicaid or 

Medicare Advantage to object ‘‘on moral 

or religious grounds’’ to providing 

coverage of certain counseling or 

referral services. (42 U.S.C. 1395w– 

22(j)(3)(B); 42 U.S.C. 1396u–2(b)(3)). In 

addition, Congress has protected 

individuals who object to prescribing or 

providing contraceptives contrary to 

their religious beliefs. Consolidated 

Appropriations Act of 2017, Division C, 

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

and General Government 

Appropriations Act), Public Law 115–31 

(May 5, 2017). Congress likewise 

provided that, if the District of 

Columbia requires ‘‘the provision of 

contraceptive coverage by health 

insurance plans,’’ ‘‘it is the intent of 

Congress that any legislation enacted on 

such issue should include a ‘conscience 

clause’ which provides exceptions for 


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religious beliefs and moral convictions’’. 

Id. at Division C, Title VIII, Sec. 808. In 

light of the fact that Congress did not 

require HRSA to include contraception 

in Guidelines issued under section 2713 

of the PHS Act, we consider it 

significant, in support of the 

implementation of those Guidelines by 

the expanded exemption in these 

interim final rules, that Congress’ most 

recent statement on the prospect of 

Government mandated contraceptive 

coverage was to express the specific 

intent that a conscience clause be 

provided and that it should protect 

religious beliefs. 

The Departments’ authority to guide 

HRSA’s discretion in determining the 

scope of any contraceptive coverage 

requirement under section 2713(a)(4) of 

the PHS Act includes the authority to 

provide exemptions and independently 

justifies this rulemaking. The 

Departments have also determined that 

requiring certain objecting entities or 

individuals to choose between the 

Mandate, the accommodation, or 

penalties for noncompliance violates 

their rights under RFRA. 

A. Elements of RFRA 

1. Substantial Burden 

The Departments believe that agencies 

charged with administering a statute or 

associated regulations or guidance that 

imposes a substantial burden on the 

exercise of religion under RFRA have 

discretion in determining how to avoid 

the imposition of such burden. The 

Departments have previously contended 

that the Mandate does not impose a 

substantial burden on entities and 

individuals. With respect to the 

coverage Mandate itself, apart from the 

accommodation, and as applied to 

entities with religious objections, our 

argument was rejected in Hobby Lobby, 

which held that the Mandate imposes a 

substantial burden. (134 S. Ct. at 2775– 

79.) With respect to whether the 

Mandate imposes a substantial burden 

on entities that may choose the 

accommodation, but must choose 

between the accommodation, the 

Mandate, or penalties for 

noncompliance, a majority of Federal 

appeals courts have held that the 

accommodation does not impose a 

substantial burden on such entities 

(mostly religious nonprofit entities). 

The Departments have reevaluated 

our position on this question, however, 

in light of all the arguments made in 

various cases, public comments that 

have been submitted, and the concerns 

discussed throughout these rules. We 

have concluded that requiring certain 

objecting entities or individuals to 

choose between the Mandate, the 

accommodation, or penalties for 

noncompliance imposes a substantial 

burden on religious exercise under 

RFRA. We believe that the Court’s 

analysis in Hobby Lobby extends, for the 

purposes of analyzing a substantial 

burden, to the burdens that an entity 

faces when it religiously opposes 

participating in the accommodation 

process or the straightforward Mandate, 

and is subject to penalties or 

disadvantages that apply in this context 

if it chooses neither. As the Eighth 

Circuit stated in Sharpe Holdings, ‘‘[i]n 

light of [nonprofit religious 

organizations’] sincerely held religious 

beliefs, we conclude that compelling 

their participation in the 

accommodation process by threat of 

severe monetary penalty is a substantial 

burden on their exercise of religion. . . . 

That they themselves do not have to 

arrange or pay for objectionable 

contraceptive coverage is not 

determinative of whether the required 

or forbidden act is or is not religiously 

offensive’’. (801 F.3d at 942.) 

Our reconsideration of these issues 

has also led us to conclude, consistent 

with the rulings in favor of religious 

employee plaintiffs in Wieland and 

March for Life cited above, that the 

Mandate imposes a substantial burden 

on the religious beliefs of individual 

employees who oppose contraceptive 

coverage and would be able to obtain a 

plan that omits contraception from a 

willing employer or issuer (as 

applicable), but cannot obtain one solely 

because of the Mandate’s prohibition on 

that employer and/or issuer providing 

them with such a plan. 

Consistent with our conclusion earlier 

this year after the remand of cases in 

Zubik and our reviewing of comments 

submitted in response to the 2016 RFI, 

the Departments believe there is not a 

way to satisfy all religious objections by 

amending the accommodation. 

Accordingly, the Departments have 

decided it is necessary and appropriate 

to provide the expanded exemptions set 

forth herein. 

2. Compelling Interest 

Although the Departments previously 

took the position that the application of 

the Mandate to certain objecting 

employers was necessary to serve a 

compelling governmental interest, the 

Departments have now concluded, after 

reassessing the relevant interests and for 

the reasons stated below, that it does 

not. Under such circumstances, the 

Departments are required by law to 

alleviate the substantial burden created 

by the Mandate. Here, informed by the 

Departments’ reassessment of the 

relevant interests, as well as by our 

desire to bring to a close the more than 

5 years of litigation over RFRA 

challenges to the Mandate, the 

Departments have determined that the 

appropriate administrative response is 

to create a broader exemption, rather 

than simply adjusting the 

accommodation process. 

RFRA requires the Government to 

respect religious beliefs under ‘‘the most 

demanding test known to constitutional 

law’’: Where the Government imposes a 

substantial burden on religious exercise, 

it must demonstrate a compelling 

governmental interest and show that the 

law or requirement is the least 

restrictive means of furthering that 

interest. City of Boerne v. Flores, 521 

U.S. 507, 534 (1997). For an interest to 

be compelling, its rank must be of the 

‘‘highest order’’. Church of the Lukumi 

Babalu Aye, Inc. v. City of Hialeah, 508 

U.S. 520, 546 (1993); see also Sherbert 

v. Verner, 374 U.S. 398, 406–09 (1963); 

Wisconsin v. Yoder, 406 U.S. 205, 221– 

29 (1972). In applying RFRA, the 

Supreme Court has ‘‘looked beyond 

broadly formulated interests justifying 

the general applicability of government 

mandates and scrutinized the asserted 

harm of granting specific exemptions to 

particular religious claimants.’’ 

Gonzales v. O Centro Espirita 

Beneficente Uniao do Vegetal, 546 U.S. 

418, 431 (2006). To justify a substantial 

burden on religious exercise under 

RFRA, the Government must show it 

has a compelling interest in applying 

the requirement to the ‘‘particular 

claimant[s] whose sincere exercise of 

religion is being substantially 

burdened.’’ Id. at 430–31. Moreover, the 

Government must meet the 

‘‘exceptionally demanding’’ leastrestrictive-means standard. Hobby 

Lobby, 134 S. Ct. at 2780. Under that 

standard, the Government must 

establish that ‘‘it lacks other means of 

achieving its desired goal without 

imposing a substantial burden on the 

exercise of religion by the objecting 

parties.’’ Id. 

Upon further examination of the 

relevant provisions of the Affordable 

Care Act and the administrative record 

on which the Mandate was based, the 

Departments have concluded that the 

application of the Mandate to entities 

with sincerely held religious objections 

to it does not serve a compelling 

governmental interest. The Departments 

have reached that conclusion for 

multiple reasons, no one of which is 

dispositive. 

First, Congress did not mandate that 

contraception be covered at all under 

the Affordable Care Act. Instead, 

Congress merely provided for coverage 


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of ‘‘such additional preventive care and 

screenings’’ for women ‘‘provided for in 

comprehensive guidelines supported by 

[HRSA].’’ Congress, thus, left the 

identification of any additional required 

preventive services for women to 

administrative discretion. The fact that 

Congress granted the Departments the 

authority to promulgate all rules 

appropriate and necessary for the 

administration of the relevant 

provisions of the Code, ERISA, and the 

PHS Act, including by channeling the 

discretion Congress afforded to HRSA to 

decide whether to require contraceptive 

coverage, indicates that the 

Departments’ judgment should carry 

particular weight in considering the 

relative importance of the Government’s 

interest in applying the Mandate to the 

narrow population of entities exempted 

in these rules. 

Second, while Congress specified that 

many health insurance requirements 

added by the Affordable Care Act— 

including provisions adjacent to section 

2713 of the PHS Act—were so important 

that they needed to be applied to all 

health plans immediately, the 

preventive services requirement in 

section 2713 of the PHS Act was not 

made applicable to ‘‘grandfathered 

plans.’’ That feature of the Affordable 

Care Act is significant: As cited above, 

seven years after the Affordable Care 

Act’s enactment, approximately 25.5 

million people are estimated to be 

enrolled in grandfathered plans not 

subject to section 2713 of the PHS Act. 

We do not suggest that a requirement 

that is inapplicable to grandfathered 

plans or otherwise subject to exceptions 

could never qualify as a serving a 

compelling interest under RFRA. For 

example, ‘‘[e]ven a compelling interest 

may be outweighed in some 

circumstances by another even 

weightier consideration.’’ Hobby Lobby, 

134 S. Ct. at 2780. But Congress’ 

decision not to apply section 2713 of the 

PHS Act to grandfathered plans, while 

deeming other requirements closely 

associated in the same statute as 

sufficiently important to impose 

immediately, is relevant to our 

assessment of the importance of the 

Government interests served by the 

Mandate. As the Departments observed 

in 2010, those immediately applicable 

requirements were ‘‘particularly 

significant.’’ (75 FR 34540). Congress’ 

decision to leave section 2713 out of 

that category informs the Departments’ 

assessment of the weight of the 

Government’s interest in applying the 

Guidelines issued pursuant to section 

2713 of the PHS Act to religious 

objectors. 

Third, various entities that brought 

legal challenges to the Mandate 

(including some of the largest 

employers) have been willing to provide 

coverage of some, though not all, 

contraceptives. For example, the 

plaintiffs in Hobby Lobby were willing 

to provide coverage with no cost sharing 

of 14 of 18 FDA-approved women’s 

contraceptive and sterilization methods. 

(134 S. Ct. at 2766.) With respect to 

organizations and entities holding those 

beliefs, the fact that they are willing to 

provide coverage for various 

contraceptive methods significantly 

detracts from the government interest in 

requiring that they provide coverage for 

other contraceptive methods to which 

they object. 

Fourth, the case for a compelling 

interest is undermined by the existing 

accommodation process, and how it 

applies to certain similarly situated 

entities based on whether or not they 

participate in certain self-insured group 

health plans, known as church plans, 

under applicable law. The Departments 

previously exempted eligible 

organizations from the contraceptive 

coverage requirement, and created an 

accommodation under which those 

organizations bore no obligation to 

provide for such coverage after 

submitting a self-certification or notice. 

Where a non-exempt religious 

organization uses an insured group 

health plan instead of a self-insured 

church plan, the health insurance issuer 

would be obliged to provide 

contraceptive coverage or payments to 

the plan’s participants under the 

accommodation. Even in a self-insured 

church plan context, the preventive 

services requirement in section 

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

plan, and through the Code, to the 

religious organization that sponsors the 

plan. But under the accommodation, 

once a self-insured church plan files a 

self-certification or notice, the 

accommodation relieves it of any further 

obligation with respect to contraceptive 

services coverage. Having done so, the 

accommodation process would 

normally transfer the obligation to 

provide or arrange for contraceptive 

coverage to a self-insured plan’s third 

party administrator (TPA). But the 

Departments lack authority to compel 

church plan TPAs to provide 

contraceptive coverage or levy fines 

against those TPAs for failing to provide 

it. This is because church plans are 

exempt from ERISA pursuant to section 

4(b)(2) of ERISA. Section 2761(a) of the 

PHS Act provides that States may 

enforce the provisions of title XXVII of 

the PHS Act as they pertain to issuers, 

but not as they pertain to church plans 

that do not provide coverage through a 

policy issued by a health insurance 

issuer. The combined result of PHS Act 

section 2713’s authority to remove 

contraceptive coverage obligations from 

self-insured church plans, and HHS’s 

and DOL’s lack of authority under the 

PHS Act or ERISA to require TPAs to 

become administrators of those plans to 

provide such coverage, has led to 

significant incongruity in the 

requirement to provide contraceptive 

coverage among nonprofit organizations 

with religious objections to the 

coverage. 

More specifically, issuers and third 

party administrators for some, but not 

all, religious nonprofit organizations are 

subject to enforcement for failure to 

provide contraceptive coverage under 

the accommodation, depending on 

whether they participate in a selfinsured church plan. Notably, many of 

those nonprofit organizations are not 

houses of worship or integrated 

auxiliaries. Under section 3(33)(C)(iv) of 

ERISA, many organizations in selfinsured church plans need not be 

churches, but can merely ‘‘share[] 

common religious bonds and 

convictions with [a] church or 

convention or association of churches’’. 

The effect is that many similar religious 

organizations are being treated very 

differently with respect to their 

employees receiving contraceptive 

coverage—depending on whether the 

organization is part of a church plan— 

even though the Departments claimed a 

compelling interest to deny exemptions 

to all such organizations. In this context, 

the fact that the Mandate and the 

Departments’ application thereof 

‘‘leaves appreciable damage to [their] 

supposedly vital interest unprohibited’’ 

is strong evidence that the Mandate 

‘‘cannot be regarded as protecting an 

interest ‘of the highest order.’ ’’ Lukumi, 

508 U.S. at 520 (citation and quotation 

marks omitted). 

Fifth, the Departments’ previous 

assertion that the exemption for houses 

of worship was offered to respect a 

certain sphere of church autonomy (80 

FR 41325) does not adequately explain 

some of the disparate results of the 

existing rules. And the desire to respect 

church autonomy is not grounds to 

prevent the Departments from 

expanding the exemption to other 

religious entities. The Departments 

previously treated religious 

organizations that operate in a similar 

fashion very differently for the purposes 

of the Mandate. For example, the 

Departments exempted houses of 

worship and integrated auxiliaries that 

may conduct activities, such as the 


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18 In changing its position, an agency ‘‘need not 

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.’’ FCC v. Fox Television 

Stations, Inc., 556 U.S. 502, 515 (2009). 

19See, for example, Geneva College v. Sebelius, 

929 F. Supp. 2d 402, 411 (W.D. Pa. 2013); Grace 

Schools v. Sebelius, 988 F. Supp. 2d 935, 943 (N.D. 

Ind. 2013); Comments of the Council for Christian 

Colleges & Universities, re: CMS–9968–P (filed Apr. 

8, 2013) (‘‘On behalf of [] 172 higher education 

institutions . . . a requirement for membership in 

the CCCU is that full-time administrators and 

faculty at our institutions share the Christian faith 

of the institution.’’). 

20Notably, ‘‘the First Amendment simply does 

not require that every member of a group agree on 

every issue in order for the group’s policy to be 

‘expressive association.’’’ Boy Scouts of America v. 

Dale, 530 U.S. 640, 655 (2000). 

operating of schools, that are also 

conducted by non-exempt religious 

nonprofit organizations. Likewise, 

among religious nonprofit groups that 

were not exempt as houses of worship 

or integrated auxiliaries, many operate 

their religious activities similarly even if 

they differ in whether they participate 

in self-insured church plans. As another 

example, two religious colleges might 

have the same level of religiosity and 

commitment to defined ideals, but one 

might identify with a specific large 

denomination and choose to be in a selfinsured church plan offered by that 

denomination, while another might not 

be so associated or might not have as 

ready access to a church plan and so 

might offer its employees a fully insured 

health plan. Under the accommodation, 

employees of the college using a fully 

insured plan (or a self-insured plan that 

is not a church plan) would receive 

coverage of contraceptive services 

without cost sharing, while employees 

of the college participating in the selfinsured church plan would not receive 

the coverage where that plan required 

its third party administrator to not offer 

the coverage. 

As the Supreme Court recently 

confirmed, a self-insured church plan 

exempt from ERISA through ERISA 

3(33) can include a plan that is not 

actually established or maintained by a 

church or by a convention or association 

of churches, but is maintained by ‘‘an 

organization . . . the principal purpose 

or function of which is the 

administration or funding of a plan or 

program for the provision of retirement 

benefits or welfare benefits, or both, for 

the employees of a church or a 

convention or association of churches, if 

such organization is controlled by or 

associated with a church or a 

convention or association of churches’’ 

(a so-called ‘‘principal-purpose 

organization’’). See Advocate Health 

Care Network v. Stapleton, 137 S. Ct. 

1652, 1656–57 (U.S. June 5, 2017); 

ERISA 3(33)(C). While the Departments 

take no view on the status of these 

particular plans, the Departments 

acknowledge that the church plan 

exemption not only includes some nonhouses-of-worship as organizations 

whose employees can be covered by the 

plan, but also, in certain circumstances, 

may include plans that are not 

themselves established and maintained 

by houses of worship. Yet, such entities 

and plans—if they file a selfcertification or notice through the 

existing accommodation—are relieved 

of obligations under the contraceptive 

Mandate and their third party 

administrators are not subject to a 

requirement that they provide 

contraceptive coverage to their plan 

participants and beneficiaries. 

After considering the differential 

treatment of various religious nonprofit 

organizations under the previous 

accommodation, the Departments 

conclude that it is appropriate to 

expand the exemption to other religious 

nonprofit organizations with sincerely 

held religious beliefs opposed to 

contraceptive coverage. We also 

conclude that it is not appropriate to 

limit the scope of a religious exemption 

by relying upon a small minority of 

State laws that contain narrow 

exemptions that focus on houses of 

worship and integrated auxiliaries. (76 

FR 46623.) 

Sixth, the Government’s interest in 

ensuring contraceptive coverage for 

employees of particular objecting 

employers is undermined by the 

characteristics of many of those 

employers, especially nonprofit 

employers. The plaintiffs challenging 

the existing accommodation include, 

among other organizations, religious 

colleges and universities, and religious 

orders that provide health care or other 

charitable services. Based in part on our 

experience litigating against such 

organizations, the Departments now 

disagree with our previous assertion 

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.’’ 18

(78 FR 39874.) Although empirical data 

was not required to reach our previous 

conclusion, we note that the conclusion 

was not supported by any specific data 

or other source, but instead was 

intended to be a reasonable assumption. 

Nevertheless, in the litigation and in 

numerous public comments submitted 

throughout the regulatory processes 

described above, many religious 

nonprofit organizations have indicated 

that they possess deep religious 

commitments even if they are not 

houses of worship or their integrated 

auxiliaries. Some of the religious 

nonprofit groups challenging the 

accommodation claim that their 

employees are required to adhere to a 

statement of faith which includes the 

entities’ views on certain contraceptive 

items.19 The Departments recognize, of 

course, that not all of the plaintiffs 

challenging the accommodation require 

all of their employees (or covered 

students) to share their religious 

objections to contraceptives. At the 

same time, it has become apparent from 

public comments and from court filings 

in dozens of cases—encompassing 

hundreds of organizations—that many 

religious nonprofit organizations 

express their beliefs publicly and hold 

themselves out as organizations for 

whom their religious beliefs are vitally 

important. Employees of such 

organizations, even if not required to 

sign a statement of faith, often have 

access to, and knowledge of, the views 

of their employers on contraceptive 

coverage, whether through the 

organization’s published mission 

statement or statement of beliefs, 

through employee benefits disclosures 

and other communications with 

employees and prospective employees, 

or through publicly filed lawsuits 

objecting to providing such coverage 

and attendant media coverage. In many 

cases, the employees of religious 

organizations will have chosen to work 

for those organizations with an 

understanding—explicit or implicit— 

that they were being employed to 

advance the organization’s goals and to 

be respectful of the organization’s 

beliefs even if they do not share all of 

those beliefs. Religious nonprofit 

organizations that engage in expressive 

activity generally have a First 

Amendment right of expressive 

association and religious free exercise to 

choose to hire persons (or, in the case 

of students, to admit them) based on 

whether they share, or at least will be 

respectful of, their beliefs.20

Given the sincerely held religious 

beliefs of many religious organizations, 

imposing the contraceptive-coverage 

requirement on those that object based 

on such beliefs might undermine the 

Government’s broader interests in 

ensuring health coverage by causing the 

entities to stop providing health 

coverage. For example, because the 

Affordable Care Act does not require 


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21See, for example, Manya Brachear Pashman, 

‘‘Wheaton College ends coverage amid fight against 

birth control mandate,’’ Chicago Tribune (July 29, 

2015); Laura Bassett, ‘‘Franciscan University Drops 

Entire Student Health Insurance Plan Over Birth 

Control Mandate,’’ HuffPost (May 15, 2012). 

22The Departments are not aware of any objectors 

to the contraceptive Mandate that are unwilling to 

cover any of the other preventive services without 

cost sharing as required by PHS Act section 2713. 

23 ‘‘Facts on Publicly Funded Contraceptive 

Services in the United States,’’ March 2016. 

24See, for example, Caroline Cunningham, ‘‘How 

Much Will Your Birth Control Cost Once the 

Affordable Care Act Is Repealed?’’ Washingtonian 

(Jan. 17, 2017), available at https://

www.washingtonian.com/2017/01/17/how-muchwill-your-birth-control-cost-once-the-affordablecare-act-is-repealed/; also, see https://www.planned

parenthood.org/learn/birth-control. 

25 Id. 

26Prior to the implementation of the Affordable 

Care Act approximately 6 percent of employer 

survey respondents did not offer contraceptive 

coverage, with 31 percent of respondents not 

knowing whether they offered such coverage Kaiser 

Family Foundation & Health Research & 

Educational Trust, ‘‘Employer Health Benefits, 2010 

Annual Survey’’ at 196, available at https://kaiser

familyfoundation.files.wordpress.com/2013/04/

8085.pdf. It is not clear whether the minority of 

employers who did not cover contraception 

refrained from doing so for conscientious reasons or 

for other reasons. Estimates of the number of 

women who might be impacted by the exemptions 

offered in these rules, as compared to the total 

number of women who will likely continue to 

receive contraceptive coverage, is discussed in more 

detail below. 

27 ‘‘Contraceptive Use in the United States,’’ 

September 2016. 

28The IOM 2011 Report reflected this when it 

cited the IOM’s own 1995 report on unintended 

pregnancy, ‘‘The Best Intentions’’ (IOM 1995). IOM 

1995 identifies various methodological difficulties 

in demonstrating the interest in reducing 

unintended pregnancies by means of a coverage 

mandate in employer plans. These include: The 

ambiguity of intent as an evidence-based measure 

(does it refer to mistimed pregnancy or unwanted 

pregnancy, and do studies make that distinction?); 

‘‘the problem of determining parental attitudes at 

conception’’ and inaccurate methods often used for 

that assessment, such as ‘‘to use the request for an 

abortion as a marker’’; and the overarching problem 

of ‘‘association versus causality,’’ that is, whether 

intent causes certain negative outcomes or is merely 

correlated with them. IOM 1995 at 64–66. See also 

IOM 1995 at 222 (‘‘the largest public sector funding 

efforts, Title X and Medicaid, have not been well 

evaluated in terms of their net effectiveness, 

including their precise impact on unintended 

pregnancy’’). 

institutions of higher education to 

arrange student coverage, some 

institutions of higher education that 

object to the Mandate appear to have 

chosen to stop arranging student plans 

rather than comply with the Mandate or 

be subject to the accommodation with 

respect to such populations.21

Seventh, we now believe the 

administrative record on which the 

Mandate rests is insufficient to meet the 

high threshold to establish a compelling 

governmental interest in ensuring that 

women covered by plans of objecting 

organizations receive cost-free 

contraceptive coverage through those 

plans. To begin, in support of the IOM’s 

recommendations, which HRSA 

adopted, the IOM identified several 

studies showing a preventive services 

gap because women require more 

preventive care than men. (IOM 2011 at 

19–21). Those studies did not identify 

contraceptives or sterilization as 

composing a specific portion of that gap, 

and the IOM did not consider or 

establish in the report whether any cost 

associated with that gap remains after 

all other women’s preventive services 

are covered without cost-sharing. Id. 

Even without knowing what the 

empirical data would show about that 

gap, the coverage of the other women’s 

preventive services required under both 

the HRSA Guidelines and throughout 

section 2713(a) of the PHS Act— 

including annual well-woman visits and 

a variety of tests, screenings, and 

counseling services—serves at a 

minimum to diminish the cost gap 

identified by IOM for women whose 

employers decline to cover some or all 

contraceptives on religious grounds.22

Moreover, there are multiple Federal, 

State, and local programs that provide 

free or subsidized contraceptives for 

low-income women. Such Federal 

programs include, among others, 

Medicaid (with a 90 percent Federal 

match for family planning services), 

Title X, community health center grants, 

and Temporary Assistance for Needy 

Families. According to the Guttmacher 

Institute, government-subsidized family 

planning services are provided at 8,409 

health centers overall.23 The Title X 

program, for example, administered by 

the HHS Office of Population Affairs 

(OPA), provides a wide variety of 

voluntary family planning information 

and services for clients based on their 

ability to pay, through a network that 

includes nearly 4,000 family planning 

centers. http://www.hhs.gov/opa/title-xfamily-planning/ Individuals with 

family incomes at or below the HHS 

poverty guideline (for 2017, $24,600 for 

a family of four in the 48 contiguous 

States and the District of Columbia) 

receive services at no charge unless a 

third party (governmental or private) is 

authorized or obligated to pay for these 

services. Individuals with incomes in 

excess of 100 percent up to 250 percent 

of the poverty guideline are charged for 

services using a sliding fee scale based 

on family size and income. 

Unemancipated minors seeking 

confidential services are assessed fees 

based on their own income level rather 

than their family’s income. The 

availability of such programs to serve 

the most at-risk women (as defined in 

the IOM report) diminishes the 

Government’s interest in applying the 

Mandate to objecting employers. Many 

forms of contraception are available for 

around $50 per month, including longacting methods such as the birth control 

shot and intrauterine devices (IUDs).24

Other, more permanent forms of 

contraception like implantables bear a 

higher one-time cost, but when 

calculated over the duration of use, cost 

a similar amount.25 Various State 

programs supplement the Federal 

programs referenced above, and 28 

States have their own mandates of 

contraceptive coverage as a matter of 

State law. This existing intergovernmental structure for obtaining 

contraceptives significantly diminishes 

the Government’s interest in applying 

the Mandate to employers over their 

sincerely held religious objections. 

The record also does not reflect that 

the Mandate is tailored to the women 

most likely to experience unintended 

pregnancy, identified by the 2011 IOM 

report as ‘‘women who are aged 18 to 24 

years and unmarried, who have a low 

income, who are not high school 

graduates, and who are members of a 

racial or ethnic minority’’. (IOM 2011 at 

102). For example, with respect to 

religiously objecting organizations, the 

Mandate applies in employer-based 

group health plans and student 

insurance at private colleges and 

universities. It is not clear that applying 

the Mandate among those objecting 

entities is a narrowly tailored way to 

benefit the most at-risk population. The 

entities appear to encompass some such 

women, but also appear to omit many of 

them and to include a significantly 

larger cross-section of women as 

employees or plan participants. At the 

same time, the Mandate as applied to 

objecting employers appears to 

encompass a relatively small percentage 

of the number of women impacted by 

the Mandate overall, since most 

employers do not appear to have 

conscientious objections to the 

Mandate.26 The Guttmacher Institute, 

on which the IOM relied, further 

reported that 89 percent of women who 

are at risk of unintended pregnancy and 

are living at 0 through 149 percent of 

the poverty line are already using 

contraceptives, as are 92 percent of 

those with incomes of 300 percent or 

more of the Federal poverty level.27

The rates of—and reasons for— 

unintended pregnancy are notoriously 

difficult to measure.28 In particular, 

association and causality can be hard to 

disentangle, and the studies referred to 

by the 2011 IOM Report speak more to 

association than causality. For example, 

IOM 2011 references Boonstra, et al. 


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29H. Boonstra, et al., ‘‘Abortion in Women’s 

Lives’’ at 18, Guttmacher Inst. (2006). 

30Citing John S. Santelli & Andrea J. Melnikas, 

‘‘Teen Fertility in Transition: Recent and Historic 

Trends in the United States,’’ 31 Ann. Rev. Pub. 

Health 371 (2010). 

31Bearak, J.M. and Jones, R.K., ‘‘Did 

Contraceptive Use Patterns Change after the 

Affordable Care Act? A Descriptive Analysis,’’ 27 

Women’s Health Issues 316 (Guttmacher Inst. May– 

June 2017), available at http://www.whijournal.

com/article/S1049-3867(17)30029-4/fulltext. 

32 31 Ann. Rev. Pub. Health at 375–76. 

33Peter Arcidiacono, et al., ‘‘Habit Persistence 

and Teen Sex: Could Increased Access to 

Contraception Have Unintended Consequences for 

Teen Pregnancies?’’ (2005), available at http://

public.econ.duke.edu/∼psarcidi/teensex.pdf. 

34 G. Raymond et al., ‘‘Population effect of 

increased access to emergency contraceptive pills: 

a systematic review,’’ 109 Obstet. Gynecol. 181 

(2007). 

35William D. Mosher & Jo Jones, U.S. Dep’t of 

HHS, CDC, National Center for Health Statistics, 

‘‘Use of Contraception in the United States: 1982– 

2008’’ at 5 fig. 1, 23 Vital and Health Statistics 29 

(Aug. 2010), available at https://www.cdc.gov/nchs/ 

data/series/sr_23/sr23_029.pdf. 

36Helen M. Alvare ́, ‘‘No Compelling Interest: The 

‘Birth Control’ Mandate and Religious Freedom,’’ 58 

Vill. L. Rev. 379, 404–05 & n.128 (2013), available 

at http://digitalcommons.law.villanova.edu/vlr/

vol58/iss3/2 (quoting Christopher Tietze, 

‘‘Unintended Pregnancies in the United States, 

1970–1972,’’ 11 Fam. Plan. Persp. 186, 186 n.* 

(1979) (‘‘in 1972, 35.4 percent percent of all U.S. 

pregnancies were ‘unwanted’ or ‘wanted later’’’)). 

37 Id. (citing Lawrence B. Finer & Stanley K. 

Henshaw, ‘‘Disparities in Rates of Unintended 

Pregnancy in the United States, 1994 and 2001’’ 38 

Persp. on Sexual Reprod. Health 90 (2006) (‘‘In 

2001, 49 percent of pregnancies in the United States 

were unintended’’)). 

38See, for example, J.L Duen ̃ as, et al., ‘‘Trends in 

the Use of Contraceptive Methods and Voluntary 

Interruption of Pregnancy in the Spanish 

Population during 1997–2007,’’ 83 Contraception 

82 (2011) (as use of contraceptives increased from 

49 percent to 80 percent, the elective abortion rate 

more than doubled); D. Paton, ‘‘The economics of 

family planning and underage conceptions,’’ 21 J. 

Health Econ. 207 (2002) (data from the UK confirms 

an economic model which suggests improved 

family planning access for females under 16 

increases underage sexual activity and has an 

ambiguous impact on underage conception rates); 

T. Raine et al., ‘‘Emergency contraception: advance 

provision in a young, high-risk clinic population,’’ 

96 Obstet. Gynecol. 1 (2000) (providing advance 

provision of emergency contraception at family 

planning clinics to women aged 16–24 was 

associated with the usage of less effective and less 

consistently used contraception by other methods); 

M. Belzer et al., ‘‘Advance supply of emergency 

contraception: a randomized trial in adolescent 

mothers,’’ 18 J. Pediatr. Adolesc. Gynecol. 347 

(2005) (advance provision of emergency 

contraception to mothers aged 13–20 was associated 

with increased unprotected sex at the 12-month 

follow up). 

39NIH, ‘‘Female Contraceptive Development 

Program (U01)’’ (Nov. 5, 2013), available at https:// 

grants.nih.gov/grants/guide/rfa-files/RFA-HD-14- 

024.html. Thirty six percent of women in the 

United States are obese. https://www.niddk.nih.gov/ 

health-information/health-statistics/overweightobesity. Also see ‘‘Does birth control raise my risk 

for health problems?’’ and ‘‘What are the health 

risks for smokers who use birth control?’’ HHS 

Office on Women’s Health, available at https://

www.womenshealth.gov/a-z-topics/birth-controlmethods; Skovlund, CW, ‘‘Association of Hormonal 

Contraception with Depression,’’ 73 JAMA 

Psychiatry 1154 (Nov. 1, 2016), available at https:// 

www.ncbi.nlm.nih.gov/pubmed/27680324. 

40Havrilesky, L.J, et al., ‘‘Oral Contraceptive User 

for the Primary Prevention of Ovarian Cancer,’’ 

Agency for Healthcare Research and Quality, Report 

No.: 13–E002–EF (June 2013), available at https:// 

archive.ahrq.gov/research/findings/evidence-basedreports/ocusetp.html. 

41 Id. 

(2006), as finding that, ‘‘as the rate of 

contraceptive use by unmarried women 

increased in the United States between 

1982 and 2002, rates of unintended 

pregnancy and abortion for unmarried 

women also declined,’’ 29 and Santelli 

and Melnikas as finding that ‘‘increased 

rates of contraceptive use by adolescents 

from the early 1990s to the early 2000s 

was associated with a decline in teen 

pregnancies and that periodic increases 

in the teen pregnancy rate are associated 

with lower rates of contraceptive use’’. 

IOM 2011 at 105.30 In this respect, the 

report does not show that access to 

contraception causes decreased 

incidents of unintended pregnancy, 

because both of the assertions rely on 

association rather than causation, and 

they associate reduction in unintended 

pregnancy with increased use of 

contraception, not merely with 

increased access to such contraceptives. 

Similarly, in a study involving over 

8,000 women between 2012 and 2015, 

conducted to determine whether 

contraceptive coverage under the 

Mandate changed contraceptive use 

patterns, the Guttmacher Institute 

concluded that ‘‘[w]e observed no 

changes in contraceptive use patterns 

among sexually active women.’’ 31 With 

respect to teens, the Santelli and 

Melnikas study cited by IOM 2011 

observes that, between 1960 and 1990, 

as contraceptive use increased, teen 

sexual activity outside of marriage 

likewise increased (although the study 

does not assert a causal relationship).32

Another study, which proposed an 

economic model for the decision to 

engage in sexual activity, stated that 

‘‘[p]rograms that increase access to 

contraception are found to decrease teen 

pregnancies in the short run but 

increase teen pregnancies in the long 

run.’’ 33 Regarding emergency 

contraception in particular, ‘‘[i]ncreased 

access to emergency contraceptive pills 

enhances use but has not been shown to 

reduce unintended pregnancy rates.’’34

In the longer term—from 1972 through 

2002—while the percentage of sexually 

experienced women who had ever used 

some form of contraception rose to 98 

percent,35 unintended pregnancy rates 

in the Unites States rose from 35.4 

percent36 to 49 percent.’’37 The 

Departments note these and other 

studies38 to observe the complexity and 

uncertainty in the relationship between 

contraceptive access, contraceptive use, 

and unintended pregnancy. 

Contraception’s association with 

positive health effects might also be 

partially offset by an association with 

negative health effects. In 2013 the 

National Institutes of Health indicated, 

in funding opportunity announcement 

for the development of new clinically 

useful female contraceptive products, 

that ‘‘hormonal contraceptives have the 

disadvantage of having many 

undesirable side effects[,] are associated 

with adverse events, and obese women 

are at higher risk for serious 

complications such as deep venous 

thrombosis.’’ 39 In addition, IOM 2011 

stated that ‘‘[l]ong-term use of oral 

contraceptives has been shown to 

reduce a woman’s risk of endometrial 

cancer, as well as protect against pelvic 

inflammatory disease and some benign 

breast diseases (PRB, 1998). The Agency 

for Healthcare Research and Quality 

(AHRQ) is currently undertaking a 

systematic evidence review to evaluate 

the effectiveness of oral contraceptives 

as primary prevention for ovarian 

cancer (AHRQ, 2011).’’ (IOM 2011 at 

107). However, after IOM 2011 made 

this statement, AHRQ (a component of 

HHS) completed its systematic evidence 

review.40 Based on its review, AHRQ 

stated that: ‘‘[o]varian cancer incidence 

was significantly reduced in OC [oral 

contraceptive] users’’; ‘‘[b]reast cancer 

incidence was slightly but significantly 

increased in OC users’’; ‘‘[t]he risk of 

cervical cancer was significantly 

increased in women with persistent 

human papillomavirus infection who 

used OCs, but heterogeneity prevented a 

formal meta-analysis’’; ‘‘[i]ncidences of 

both colorectal cancer [] and 

endometrial cancer [] were significantly 

reduced by OC use’’; ‘‘[t]he risk of 

vascular events was increased in current 

OC users compared with nonusers, 

although the increase in myocardial 

infarction was not statistically 

significant’’; ‘‘[t]he overall strength of 

evidence for ovarian cancer prevention 

was moderate to low’’; and ‘‘[t]he 

simulation model predicted that the 

combined increase in risk of breast and 

cervical cancers and vascular events 

was likely to be equivalent to or greater 

than the decreased risk in ovarian 

cancer.’’41 Based on these findings, 

AHRQ concluded that ‘‘[t]here is 

insufficient evidence to recommend for 

or against the use of OCs solely for the 

primary prevention of ovarian 

cancer.... the harm/benefit ratio for 

ovarian cancer prevention alone is 

uncertain, particularly when the 


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42 Id. Also, see Kelli Miller, ‘‘Birth Control & 

Cancer: Which Methods Raise, Lower Risk,’’ The 

Am. Cancer Society, (Jan. 21, 2016), available at 

http://www.cancer.org/cancer/news/features/birthcontrol-cancer-which-methods-raise-lower-risk. 

43For further discussion, see Alvare ́, 58 Vill. L. 

Rev. at 400–02 (discussing the Santelli & Melnikas 

study and the Arcidiacono study cited above, and 

other research that considers the extent to which 

reduction in teen pregnancy is attributable to sexual 

risk avoidance rather than to contraception access). 

44 ‘‘WPSI 2016 Recommendations: Evidence 

Summaries and Appendices,’’ at 54–64, available at 

https://www.womenspreventivehealth.org/wpcontent/uploads/2016/12/Evidence-Summariesand-Appendices.pdf. 

45Available at https://aspe.hhs.gov/pdf-report/

affordable-care-act-improving-access-preventiveservices-millions-americans; also, see Abridged 

Report, available at https://www.womenspreventive

health.org/wp-content/uploads/2017/01/WPSI_

2016AbridgedReport.pdf. 

46 In addition, as in IOM 2011, the WPSI report 

bases its evidentiary conclusions relating to 

contraceptive coverage, use, unintended pregnancy, 

and health benefits, on conclusions that the 

phenomena are ‘‘associated’’ with the intended 

outcomes, without showing there is a causal 

relationship. For example, the WPSI report states 

that ‘‘[c]ontraceptive counseling in primary care 

may increase the uptake of hormonal methods and 

[long-acting reversible contraceptives], although 

data on structured counseling in specialized 

reproductive health settings demonstrated no such 

effect.’’ Id. at 63. The WPSI report also 

acknowledges that a large-scale study evaluating the 

effects of providing no-cost contraception had ‘‘no 

randomization or control group.’’ Id. at 63. 

The WPSI report also identifies the at-risk 

population as young, low-income, and/or minority 

women: ‘‘[u]nintended pregnancies 

disproportionately occur in women age 18 to 24 

years, especially among those with low incomes or 

from racial/ethnic minorities.’’ Id. at 58. The WPSI 

report acknowledges that many in this population 

are already served by Title X programs, which 

provide family planning services to ‘‘approximately 

1 million teens each year.’’ Id. at 58. The WPSI 

report observes that between 2008 and 2011—before 

the contraceptive coverage requirement was 

implemented—unintended pregnancy decreased to 

the lowest rate in 30 years. Id. at 58. The WPSI 

report does not address how to balance 

contraceptive coverage interests with religious 

objections, nor does it specify the extent to which 

applying the Mandate among commercially insured 

at objecting entities serves to deliver contraceptive 

coverage to women most at risk of unintended 

pregnancy. 

47See Michael J. New, ‘‘Analyzing the Impact of 

State Level Contraception Mandates on Public 

Health Outcomes,’’ 13 Ave Maria L. Rev. 345 (2015), 

available at http://avemarialaw-lawreview.avemarialaw.edu/Content/articles/vXIII.i2.

new.final.0809.pdf. 

48The Departments previously cited the IOM’s 

listing of existing conditions that contraceptive 

drugs can be used to treat (menstrual disorders, 

acne, and pelvic pain), and said of those uses that 

‘‘there are demonstrated preventive health benefits 

Continued 

potential quality-of-life impact of breast 

cancer and vascular events are 

considered.’’42

In addition, in relation to several 

studies cited above, imposing a coverage 

Mandate on objecting entities whose 

plans cover many enrollee families who 

may share objections to contraception 

could, among some populations, affect 

risky sexual behavior in a negative way. 

For example, it may not be a narrowly 

tailored way to advance the Government 

interests identified here to mandate 

contraceptive access to teenagers and 

young adults who are not already 

sexually active and at significant risk of 

unintended pregnancy.43

Finally, evidence from studies that 

post-date the Mandate is not 

inconsistent with the observations the 

Departments make here. In 2016, HRSA 

awarded a 5-year cooperative agreement 

to the American College of Obstetricians 

and Gynecologists to develop 

recommendations for updated Women’s 

Preventive Services Guidelines. The 

awardee formed an expert panel called 

the Women’s Preventive Services 

Initiative that issued a report (the WPSI 

report).44 After observing that ‘‘[p]rivate 

companies are increasingly challenging 

the contraception provisions in the 

Affordable Care Act,’’ the WPSI report 

cited studies through 2013 stating that 

application of HRSA Guidelines had 

applied preventive services coverage to 

55.6 million women and had led to a 70 

percent decrease in out-of-pocket 

expenses for contraceptive services 

among commercially insured women. 

Id. at 57–58. The WPSI report relied on 

a 2015 report of the HHS Office of the 

Assistant Secretary for Planning and 

Evaluation (ASPE), ‘‘The Affordable 

Care Act Is Improving Access to 

Preventive Services for Millions of 

Americans,’’ which estimated that 

persons who have private insurance 

coverage of preventive services without 

cost sharing includes 55.6 million 

women.45

As discussed above and based on the 

Departments’ knowledge of litigation 

challenging the Mandate, during the 

time ASPE estimated the scope of 

preventive services coverage (2011– 

2013), houses of worship and integrated 

auxiliaries were exempt from the 

Mandate, other objecting religious 

nonprofit organizations were protected 

by the temporary safe harbor, and 

hundreds of accommodated self-insured 

church plan entities were not subject to 

enforcement of the Mandate through 

their third party administrators. In 

addition, dozens of for-profit entities 

that had filed lawsuits challenging the 

Mandate were protected by court orders 

pending the Supreme Court’s resolution 

of Hobby Lobby in June 2014. It would 

therefore appear that the benefits 

recorded by the report occurred even 

though most objecting entities were not 

in compliance.46 Additional data 

indicates that, in 28 States where 

contraceptive coverage mandates have 

been imposed statewide, those 

mandates have not necessarily lowered 

rates of unintended pregnancy (or 

abortion) overall.47

The Departments need not take a 

position on these empirical questions. 

Our review is sufficient to lead us to 

conclude that significantly more 

uncertainty and ambiguity exists in the 

record than the Departments previously 

acknowledged when we declined to 

extend the exemption to certain 

objecting organizations and individuals 

as set forth herein, and that no 

compelling interest exists to counsel 

against us extending the exemption. 

During public comment periods, some 

commenters noted that some drugs 

included in the preventive services 

contraceptive Mandate can also be 

useful for treating certain existing health 

conditions. The IOM similarly stated 

that ‘‘the non-contraceptive benefits of 

hormonal contraception include 

treatment of menstrual disorders, acne 

or hirsutism, and pelvic pain.’’ IOM 

2011 at 107. Consequently, some 

commenters suggested that religious 

objections to the Mandate should not be 

permitted in cases where such methods 

are used to treat such conditions, even 

if those methods can also be used for 

contraceptive purposes. Section 

2713(a)(4) of the PHS Act does not, 

however, apply to non-preventive care 

provided solely for treatment of an 

existing condition. It applies only to 

‘‘such additional preventive care and 

screenings . . . as provided for’’ by 

HRSA (Section 2713(a)(4) of the PHS 

Act). HRSA’s Guidelines implementing 

this section state repeatedly that they 

apply to ‘‘preventive’’ services or care, 

and with respect to the coverage of 

contraception specifically, they declare 

that the methods covered are 

‘‘contraceptive’’ methods as a ‘‘Type of 

Preventive Service,’’ and that they are to 

be covered only ‘‘[a]s prescribed’’ by a 

physician or other health care provider. 

https://www.hrsa.gov/womens

guidelines/ The contraceptive coverage 

requirement in the Guidelines also only 

applies for ‘‘women with reproductive 

capacity.’’ https://www.hrsa.gov/

womensguidelines/; (80 FR 40318). 

Therefore, the Guidelines’ inclusion of 

contraceptive services requires coverage 

of contraceptive methods as a type of 

preventive service only when a drug 

that the FDA has approved for 

contraceptive use is prescribed in whole 

or in part for such use. The Guidelines 

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

not require coverage of such drugs 

where they are prescribed exclusively 

for a non-contraceptive and nonpreventive use to treat an existing 

condition.48 As discussed above, the last 


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from contraceptives relating to conditions other 

than pregnancy.’’ 77 FR 8727 & n.7. This was not, 

however, an assertion that PHS Act section 

2713(a)(4) or the Guidelines require coverage of 

‘‘contraceptive’’ methods when prescribed for an 

exclusively non-contraceptive, non-preventive use. 

Instead it was an observation that such drugs— 

generally referred to as ‘‘contraceptives’’—also have 

some alternate beneficial uses to treat existing 

conditions. For the purposes of these interim final 

rules, the Departments clarify here that our 

previous reference to the benefits of using 

contraceptive drugs exclusively for some noncontraceptive and non-preventive uses to treat 

existing conditions did not mean that the 

Guidelines require coverage of such uses, and 

consequently is not a reason to refrain from offering 

the expanded exemptions provided here. Where a 

drug approved by the FDA for contraceptive use is 

prescribed for both a contraceptive use and a noncontraceptive use, the Guidelines (to the extent they 

apply) would require its coverage. Where a drug 

approved by the FDA for contraceptive use is 

prescribed exclusively for a non-contraceptive and 

non-preventive use to treat an existing condition, it 

would be outside the scope of the Guidelines. 

49Brief for the Respondents at 65, Zubik v. 

Burwell, 136 S. Ct. 1557 (2016) (No. 14–1418). 

Administration decided to exempt 

houses of worship and their integrated 

auxiliaries from the Mandate, and to 

relieve hundreds of religious nonprofit 

organizations of their obligations under 

the Mandate and not further require 

contraceptive coverage to their 

employees. In several of the lawsuits 

challenging the Mandate, some religious 

plaintiffs stated that they do not object 

and are willing to cover drugs 

prescribed for the treatment of an 

existing condition and not for 

contraceptive purposes—even if those 

drugs are also approved by the FDA for 

contraceptive uses. Therefore, the 

Departments conclude that the fact that 

some drugs that are approved for 

preventive contraceptive purposes can 

also be used for exclusively nonpreventive purposes to treat existing 

conditions is not a sufficient reason to 

refrain from expanding the exemption to 

the Mandate. 

An additional consideration 

supporting the Departments’ present 

view is that alternative approaches can 

further the interests the Departments 

previously identified behind the 

Mandate. As noted above, the 

Government already engages in dozens 

of programs that subsidize 

contraception for the low-income 

women identified by the IOM as the 

most at risk for unintended pregnancy. 

The Departments have also 

acknowledged in legal briefing that 

contraception access can be provided 

through means other than coverage 

offered by religious objectors, for 

example, through ‘‘a family member’s 

employer,’’ ‘‘an Exchange,’’ or ‘‘another 

government program.’’ 49

Many employer plan sponsors, 

institutions of education arranging 

student health coverage, and 

individuals enrolled in plans where 

their employers or issuers (as 

applicable) are willing to offer them a 

religiously acceptable plan, hold 

sincerely held religious beliefs against 

(respectively) providing, arranging, or 

participating in plans that comply with 

the Mandate either by providing 

contraceptive coverage or by using the 

accommodation. Because we have 

concluded that requiring such 

compliance through the Mandate or 

accommodation has constituted a 

substantial burden on the religious 

exercise of many such entities or 

individuals, and because we conclude 

requiring such compliance did not serve 

a compelling interest and was not the 

least restrictive means of serving a 

compelling interest, we now believe that 

requiring such compliance led to the 

violation of RFRA in many instances. 

We recognize that this is a change of 

position on this issue, and we make that 

change based on all the matters 

discussed in this preamble. 

B. Discretion To Provide Religious 

Exemptions 

Even if RFRA does not compel the 

religious exemptions provided in these 

interim final rules, the Departments 

believe they are the most appropriate 

administrative response to the religious 

objections that have been raised. RFRA 

identifies certain circumstance under 

which government must accommodate 

religious exercise-when a government 

action imposes a substantial burden on 

the religious exercise of an adherent and 

imposition of that burden is not the 

least restrictive means of achieving a 

compelling government interest. RFRA 

does not, however, prescribe the 

accommodation that the government 

must adopt. Rather, agencies have 

discretion to fashion an appropriate and 

administrable response to respect 

religious liberty interests implicated by 

their own regulations. We know from 

Hobby Lobby that, in the absence of any 

accommodation, the contraceptivecoverage requirement imposes a 

substantial burden on certain objecting 

employers. We know from other 

lawsuits and public comments that 

many religious entities have objections 

to complying with the accommodation 

based on their sincerely held religious 

beliefs. Previously, the Departments 

attempted to develop an 

accommodation that would either 

alleviate the substantial burden imposed 

on religious exercise or satisfy RFRA’s 

requirements for imposing that burden. 

Now, however, the Departments have 

reassessed the relevant interests and 

determined that, even if exemptions are 

not required by RFRA, they would 

exercise their discretion to address the 

substantial burden identified in Hobby 

Lobby by expanding the exemptions 

from the Mandate instead of revising 

accommodations previously offered. In 

the Departments’ view, a broader 

exemption is a more direct, effective 

means of satisfying all bona fide 

religious objectors. This view is 

informed by the fact that the 

Departments’ previous attempt to 

develop an appropriate accommodation 

did not satisfy all objectors. That 

previous accommodation consumed 

Departmental resources not only 

through the regulatory process, but in 

persistent litigation and negotiations. 

Offering exemptions as described in 

these interim final rules is a more 

workable way to respond to the 

substantial burden identified in Hobby 

Lobby and bring years of litigation 

concerning the Mandate to a close. 

C. General Scope of Expanded Religious 

Exemptions 

1. Exemption and Accommodation for 

Religious Employers, Plan Sponsors, 

and Institutions of Higher Education 

For all of these reasons, and as further 

explained below, the Departments now 

believe it is appropriate to modify the 

scope of the discretion afforded to 

HRSA in the July 2015 final regulations 

to direct HRSA to provide the expanded 

exemptions and change the 

accommodation to an optional process if 

HRSA continues to otherwise provide 

for contraceptive coverage in the 

Guidelines. As set forth below, the 

expanded exemption encompasses nongovernmental plan sponsors that object 

based on sincerely held religious beliefs, 

and institutions of higher education in 

their arrangement of student health 

plans. The accommodation is also 

maintained as an optional process for 

exempt employers, and will provide 

contraceptive availability for persons 

covered by the plans of entities that use 

it (a legitimate program purpose). 

The Departments believe this 

approach is sufficiently respectful of 

religious objections while still allowing 

the Government to advance other 

interests. Even with the expanded 

exemption, HRSA maintains the 

discretion to require contraceptive 

coverage for nearly all entities to which 

the Mandate previously applied (since 

most plan sponsors do not appear to 

possess the requisite religious 

objections), and to reconsider those 

interests in the future where no covered 

objection exists. Other Government 

subsidies of contraception are likewise 

not affected by this rule. 


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50 In this respect, the Government’s interest in 

contraceptive coverage is different than its interest 

in persons receiving some other kinds of health 

coverage or coverage in general, which can lead to 

important benefits that are not necessarily 

conditional on the recipient’s desire to use the 

coverage and the specific benefits that may result 

from their choice to use it. 

51Also, see 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 Affordable Care Act) would be 

unworkable, it has not satisfied strict scrutiny.’’ 

(citation and internal quotation marks omitted)). 

52Cf. also Planned Parenthood Ariz., Inc. v. Am. 

Ass’n of Pro-Life Obstetricians & Gynecologists, 257 

P.3d 181, 196 (Ariz. Ct. App. 2011) (‘‘a woman’s 

right to an abortion or to contraception does not 

compel a private person or entity to facilitate 

either.’’). 

2. Exemption for Objecting Individuals 

Covered by Willing Employers and 

Issuers 

As noted above, some individuals 

have brought suit objecting to being 

covered under an insurance policy that 

includes coverage for contraceptives. 

See, for example, Wieland v. HHS, 196 

F. Supp. 3d 1010 (E.D. Mo. 2016); Soda 

v. McGettigan, No. 15–cv–00898 (D. 

Md.). Just as the Departments have 

determined that the Government does 

not have a compelling interest in 

applying the Mandate to employers that 

object to contraceptive coverage on 

religious grounds, we have also 

concluded that the Government does 

not have a compelling interest in 

requiring individuals to be covered by 

policies that include contraceptive 

coverage when the individuals have 

sincerely held religious objections to 

that coverage. The Government does not 

have an interest in ensuring the 

provision of contraceptive coverage to 

individuals who do not wish to have 

such coverage. Especially relevant to 

this conclusion is the fact that the 

Departments have described their 

interests of health and gender equality 

as being advanced among women who 

‘‘want’’ the coverage so as to prevent 

‘‘unintended’’ pregnancy. (77 FR 

8727).50 No asserted interest is served 

by denying an exemption to individuals 

who object to it. No unintended 

pregnancies will be avoided or costs 

reduced by imposing the coverage on 

those individuals. 

Although the Departments previously 

took the position that allowing 

individual religious exemptions would 

undermine the workability of the 

insurance system, the Departments now 

agree with those district courts that have 

concluded that an exemption that 

allows—but does not require—issuers 

and employers to omit contraceptives 

from coverage provided to objecting 

individuals does not undermine any 

compelling interest. See Wieland, 196 F. 

Supp. 3d at 1019–20; March for Life, 

128 F. Supp. 3d at 132. The individual 

exemption will only apply where the 

employer and issuer (or, in the 

individual market, the issuer) are 

willing to offer a policy accommodating 

the objecting individual. As a result, the 

Departments consider it likely that 

where an individual exemption is 

invoked, it will impose no burdens on 

the insurance market because such 

burdens may be factored into the 

willingness of an employer or issuer to 

offer such coverage. At the level of plan 

offerings, the extent to which plans 

cover contraception under the prior 

rules is already far from uniform. 

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 lack of 

authority to enforce the accommodation 

with respect to 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.51 Furthermore, granting 

exemptions to individuals who do not 

wish to receive contraceptive coverage 

where the plan and, as applicable, 

issuer and plan sponsor are willing, 

does not undermine the Government’s 

interest in ensuring the provision of 

such coverage to other individuals who 

wish to receive it. Nor do such 

exemptions undermine the operation of 

the many other programs subsidizing 

contraception. Rather, such exemptions 

serve the Government’s interest in 

accommodating religious exercise. 

Accordingly, as further explained 

below, the Departments have provided 

an exemption to address the concerns of 

objecting individuals. 

D. Effects on Third Parties of 

Exemptions 

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. Congress did 

not create a right to receive 

contraceptive coverage, and Congress 

explicitly chose not to impose the 

section 2713 of the PHS Act 

requirements on grandfathered plans 

that cover 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 the various 

governmental programs discussed 

above. As the Government is under no 

constitutional obligation to fund 

contraception, cf. Harris v. McRae, 448 

United States 297 (1980), even more so 

may the Government refrain from 

requiring private citizens to cover 

contraception for other citizens in 

violation of their religious beliefs. 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.’’).52

That conclusion is consistent with the 

Supreme Court’s observation that RFRA 

may require exemptions even from laws 

requiring claimants ‘‘to confer benefits 

on third parties.’’ Hobby Lobby, 134 S. 

Ct. at 2781 n.37. The burdens imposed 

on such third parties may be relevant to 

the RFRA analysis, but they cannot be 

dispositive. ‘‘Otherwise, for example, 

the Government could decide that all 

supermarkets must sell alcohol for the 

convenience of customers (and thereby 

exclude Muslims with religious 

objections from owning supermarkets), 

or it could decide that all restaurants 

must remain open on Saturdays to give 

employees an opportunity to earn tips 

(and thereby exclude Jews with 

religious objections from owning 

restaurants).’’ Id. Where, as here, 

contraceptives are readily accessible 

and, for many low income persons, are 

available at reduced cost or for free 

through various governmental programs, 

and contraceptive coverage may be 

available through State sources or 

family plans obtained through nonobjecting employers, the Departments 

have determined that the expanded 

exemptions rather than 

accommodations are the appropriate 

response to the substantial burden that 

the Mandate has placed upon the 

religious exercise of many religious 

employers. 

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 prior interim final rules), 

public comments, and litigation 

throughout the Federal court system. 

The interim final rules seek to resolve 

this matter and the long-running 

litigation with respect to religious 


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53See https://www.hrsa.gov/womensguidelines/ 

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

index.html. 

54See, 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. Also, see 45 CFR 

147.200 (requiring disclosure of the ‘‘exceptions, 

reductions, and limitations of the coverage,’’ 

including group health plans and group & 

individual issuers). 

objections by extending the exemption 

under the HRSA Guidelines to 

encompass entities, and individuals, 

with sincerely held religious beliefs 

objecting to contraceptive or 

sterilization coverage, and by making 

the accommodation process optional for 

eligible organizations. 

The Departments acknowledge that 

the foregoing analysis represents a 

change from the policies and 

interpretations we previously adopted 

with respect to the Mandate and the 

governmental interests that underlie the 

Mandate. These changes in policy are 

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)); also, see 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’’). 

Here, for all of the reasons discussed 

above, the Departments have 

determined that the Government’s 

interest in the application of 

contraceptive coverage requirements in 

this specific context to the plans of 

certain entities and individuals does not 

outweigh the sincerely held religious 

objections of those entities and 

individuals based on the analyses set 

forth above. Thus, these interim final 

rules amend the Departments’ July 2015 

final regulations to expand the 

exemption to include additional entities 

and persons that object based on 

sincerely held religious beliefs. These 

rules leave in place HRSA’s discretion 

to continue to require contraceptive and 

sterilization coverage where no such 

objection exists, and to the extent that 

section 2713 of the PHS Act applies. 

These interim final rules also maintain 

the existence of an accommodation 

process, but consistent with our 

expansion of the exemption, we make 

the process optional for eligible 

organizations. HRSA is simultaneously 

updating its Guidelines to reflect the 

requirements of these interim final 

rules.53

A. Regulatory Restatements of Section 

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

These interim final rules modify the 

restatements of the requirements of 

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

Act, contained in 26 CFR 54.9815– 

2713(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) introductory text and 

(a)(1)(iv), so that they conform to the 

statutory text of section 2713 of the PHS 

Act. 

B. Prefatory Language of the Exemption 

in 45 CFR 147.132 

These interim final rules move the 

religious exemption from 45 CFR 

147.131 to a new § 147.132 and expand 

it as follows. In the prefatory language 

of § 147.132, these interim final rules 

specify that not only are certain entities 

‘‘exempt,’’ but the Guidelines shall not 

support or provide for an imposition of 

the contraceptive coverage requirement 

to such entities. This is an 

acknowledgement that section 

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

women’s preventive services coverage 

only ‘‘as provided for in comprehensive 

guidelines supported by the Health 

Resources and Services 

Administration.’’ To the extent the 

HRSA Guidelines do not provide for or 

support the application of such coverage 

to exempt entities, the Affordable Care 

Act does not require the coverage. 

Section 147.132 not only describes the 

exemption of certain entities and plans, 

but does so by specifying that the HRSA 

Guidelines do not provide for, or 

support the application of, such 

coverage to exempt entities and plans. 

C. General Scope of Exemption for 

Objecting Entities 

In the new 45 CFR 147.132 as created 

by these interim final rules, these rules 

expand the exemption that was 

previously located in § 147.131(a). With 

respect to employers that sponsor group 

health plans, the new language of 

§ 147.132(a)(1) introductory text and 

(a)(1)(i) provides exemptions for 

employers that object to coverage of all 

or a subset of contraceptives or 

sterilization and related patient 

education and counseling based on 

sincerely held religious beliefs. 

For avoidance of doubt, the 

Departments wish to make clear that the 

expanded exemption created in 

§ 147.132(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 147.132(a)(1) introductory text 

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 from 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– 

2713(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.54 Thus, 

where an exemption applies and all or 

a subset of contraceptive services are 

omitted from a plan’s coverage, 


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55 ‘‘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.’’ 

Chevron, U.S.A., Inc. v. Natural Resources Defense 

Council, Inc., 467 U.S. 837, 863–64 (1984). 

56See, 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. 

57See Guttmacher Institute, ‘‘Insurance Coverage 

of Contraceptives’’ available at https://

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

insurance-coverage-contraceptives. 

otherwise applicable ERISA disclosures 

must reflect the omission of coverage in 

ERISA plans. These existing disclosure 

requirements serve to help provide 

notice to participants and beneficiaries 

of what ERISA plans do and do not 

cover. 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 § 147.132(a) apply 

‘‘to the extent’’ of the objecting entities’ 

sincerely held religious beliefs. 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 

§ 147.132(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 sponsor has no qualifying 

objection. The objection of a health 

insurance issuer in § 147.132(a)(1)(iii) 

similarly operates only to the extent of 

its objection, and as otherwise limited 

as described below. 

D. Exemption of Employers and 

Institutions of Higher Education 

The scope of the exemption is 

expanded for non-governmental plan 

sponsors and certain entities that 

arrange health coverage under these 

interim final rules. The Departments 

have consistently taken the position that 

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

HRSA authority to issue Guidelines that 

provide for and support exemptions 

from a contraceptive coverage 

requirement. Since the beginning of 

rulemaking concerning the Mandate, 

HRSA and the Departments have 

repeatedly exercised their discretion to 

create and modify various exemptions 

within the Guidelines.55

The Departments believe the 

approach of these interim final rules 

better aligns our implementation of 

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

Congress’ intent in the Affordable Care 

Act and throughout other Federal health 

care laws. As discussed above, many 

Federal health care laws and regulations 

provide exemptions for objections based 

on religious beliefs, and RFRA applies 

to the Affordable Care Act. Expanding 

the exemption removes religious 

obstacles that entities and certain 

individuals may face when they 

otherwise wish to participate in the 

health care market. This advances the 

Affordable Care Acts goal of expanding 

health coverage among entities and 

individuals that might otherwise be 

reluctant to participate. These rules also 

leave in place many Federal programs 

that subsidize contraceptives for women 

who are most at risk of unintended 

pregnancy and who may have more 

limited access to contraceptives.56

These interim final rules achieve greater 

uniformity and simplicity in the 

regulation of health insurance by 

expanding the exemptions to include 

entities that object to the Mandate based 

on their sincerely held religious beliefs. 

The Departments further conclude 

that it would be inadequate to merely 

attempt to amend the accommodation 

process instead of expand the 

exemption. The Departments have 

stated in our regulations and court 

briefings that the existing 

accommodation with respect to selfinsured 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. The 

Departments have engaged in an effort 

to attempt to identify an 

accommodation that would eliminate 

the plaintiffs’ religious objections, 

including seeking public comment 

through an RFI, but we stated in January 

2017 that we were unable to develop 

such an approach at that time. 

1. Plan Sponsors Generally 

The expanded exemptions in these 

interim final rules cover any kind of 

non-governmental employer plan 

sponsor with the requisite objections 

but, for the sake of clarity, they include 

an illustrative, non-exhaustive list of 

employers whose objections qualify the 

plans they sponsor for an exemption. 

Under these interim final rules, the 

Departments do not limit the Guidelines 

exemption with reference to nonprofit 

status or to sections 6033(a)(3)(A)(i) or 

(iii) of the Code, as previous rules have 

done. 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.57 Although 

the practice of States is by no means a 

limit on the discretion delegated to 

HRSA by the Affordable Care Act, nor 

a statement about what the Federal 

Government may do consistent with 

RFRA or other limitations in federal 

law, such State practice can be 

informative as to the viability of broad 

protections for religious liberty. In this 

case, such practice supports the 

Departments’ decision to expand the 

federal exemption, bringing the Federal 

Government’s practice into greater 

alignment with the practices of the 

majority of the States. 

2. Section 147.132(a)(1)(i)(A) 

Despite not limiting the exemption to 

certain organizations referred to in 

section 6033(a)(3)(A)(i) or (iii) of the 

Code, the exemption in these rules 

includes such organizations. Section 

147.132(a)(1)(i)(A) specifies, as under 

the prior exemption, that the exemption 

covers ‘‘a group health plan established 

or maintained by . . . [a] church, the 

integrated auxiliary of a church, a 

convention or association of churches, 

or a religious order.’’ In the preamble to 

rules setting forth the prior exemption at 

§ 147.132(a), the Departments 

interpreted this same language used in 

those rules by declaring that ‘‘[t]he final 

regulations continue to provide that the 

availability of the exemption or 

accommodation be determined on an 

employer by employer basis, which the 

Departments continue to believe best 

balances the interests of religious 

employers and eligible organizations 

and those of employees and their 

dependents.’’ (78 FR 39886). Therefore, 

under the prior exemption, if an 

employer participated in a house of 

worship’s plan—perhaps because it was 

affiliated with a house of worship—but 

was not an integrated auxiliary or a 

house of worship itself, that employer 

was not considered to be covered by the 


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58See 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. 

59 In the companion interim final rules published 

elsewhere in this Federal Register, the Departments 

provide an exemption on an interim final basis to 

closely held entities by using a negative definition: 

entities that do not have publicly traded ownership 

interests as defined by certain securities required to 

be registered under section 12 of the Securities 

Exchange Act of 1934. Although this is a more 

workable definition than set forth in our previous 

rules, we have determined that it is appropriate to 

offer the expanded religious exemptions to certain 

entities whether or not they have publicly traded 

ownership interests. 

60Although 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. 

61See, e.g., Nasdaq.com, ‘‘4 Publicly Traded 

Religious Companies if You’re Looking to Invest in 

Faith’’ (Feb. 7, 2014), available at http://

www.nasdaq.com/article/4-publicly-tradedreligious-companies-if-youre-looking-to-invest-infaith-cm324665. 

exemption, even though it was, in the 

ordinary meaning of the text of the prior 

regulation, participating in a ‘‘plan 

established or maintained by a [house of 

worship].’’ 

Under these interim final rules, 

however, the Departments intend that, 

when this regulation text exempts a 

plan ‘‘established or maintained by’’ a 

house of worship or integrated 

auxiliary, such exemption will no 

longer ‘‘be determined on an employer 

by employer basis,’’ but will be 

determined on a plan basis—that is, by 

whether the plan is a ‘‘plan established 

or maintained by’’ a house of worship 

or integrated auxiliary. This 

interpretation better conforms to the text 

of the regulation setting forth the 

exemption—in both the prior regulation 

and in the text set forth in these interim 

final rules. It also offers appropriate 

respect to houses of worship and their 

integrated auxiliaries not only in their 

internal employment practices but in 

their choice of organizational form and/ 

or in their activity of establishing or 

maintaining health plans for employees 

of associated employers that do not 

meet the threshold of being integrated 

auxiliaries. Moreover, under this 

interpretation, houses of worship would 

not be faced with the potential prospect 

of services to which they have a 

religious objection being covered for 

employees of an associated employer 

participating in a plan they have 

established and maintain. 

The Departments do not believe there 

is a sufficient factual basis to exclude 

from this part of the exemption entities 

that are so closely associated with a 

house of worship or integrated auxiliary 

that they are permitted participation in 

its health plan, but are not themselves 

integrated auxiliaries. Additionally, this 

interpretation is not inconsistent with 

the operation of the accommodation 

under the prior rule, to the extent that, 

in practice and as discussed elsewhere 

herein, it does not force contraceptive 

coverage to be provided on behalf of the 

plan participants of many religious 

organizations in a self-insured church 

plan exempt from ERISA—which are 

exempt in part because the plans are 

established and maintained by a church. 

(Section 3(33)(A) of ERISA) In several 

lawsuits challenging the Mandate, the 

Departments took the position that some 

plans established and maintained by 

houses of worship, but that included 

entities that were not integrated 

auxiliaries, were church plans under 

section 3(33) of ERISA and, thus, the 

Government ‘‘has no authority to 

require the plaintiffs’ TPAs to provide 

contraceptive coverage at this time.’’ 

Roman Catholic Archdiocese of N.Y. v. 

Sebelius, 987 F. Supp. 2d 232, 242 

(E.D.N.Y. 2013). Therefore the 

Departments believe it is most 

appropriate to use a plan basis, not an 

employer by employer basis, to 

determine the scope of an exemption for 

a group health plan established or 

maintained by a house of worship or 

integrated auxiliary. 

3. Section 147.132(a)(1)(i)(B) 

Section 147.132(a)(1)(i)(B) of the rules 

specifies that the exemption includes 

the plans of plan sponsors that are 

nonprofit organizations. 

4. Section 147.132(a)(1)(i)(C) 

Under § 147.132(a)(1)(i)(C), the rules 

extend the exemption to the plans of 

closely held for-profit entities. This is 

consistent with the Supreme Court’s 

ruling in Hobby Lobby, which declared 

that a corporate entity is capable of 

possessing and pursuing non-pecuniary 

goals (in Hobby Lobby, religion), 

regardless of whether the entity operates 

as a nonprofit organization, and 

rejecting the 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.58

5. Section 147.132(a)(1)(i)(D) 

Under § 147.132(a)(1)(i)(D), the rules 

extend the exemption to the plans of 

for-profit entities that are not closely 

held. 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. The 

Departments implicitly recognized the 

difficulty of providing an affirmative 

definition of 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. The 

exemptions in these interim final rules 

do not need to address this difficulty 

because they include both for-profit 

entities that are closely held and forprofit entities that are not closely held.59

The mechanisms for determining 

whether a company has adopted and 

holds such principles or views is a 

matter of well-established State law 

with respect to corporate decisionmaking,60 and the Departments expect 

that application of such laws would 

cabin the scope of this exemption. 

In including entities in the exemption 

that are not closely held, these interim 

final rules provide for the possibility 

that some publicly traded entities may 

use the exemption. Even though the 

Supreme Court did not extend its 

holding in Hobby Lobby to publicly 

traded corporations (the matter could be 

resolved without deciding that 

question), the Court did instruct that 

RFRA applies to corporations because 

they are ‘‘persons’’ as that term is 

defined in 1 U.S.C. 1. Given that the 

definition under 1 U.S.C. 1 applies to 

any corporation, the Departments 

consider it appropriate to extend the 

exemption set forth in these interim 

final rules to for-profit corporations 

whether or not they are closely held. 

The Departments are generally aware 

that in a country as large as America 

comprised of a supermajority of 

religious persons, some publicly traded 

entities might claim a religious 

character for their company, or that the 

majority of shares (or voting shares) of 

some publicly traded companies might 

be controlled by a small group of 

religiously devout persons so as to set 

forth such a religious character.61 The 

fact that such a company is religious 

does not mean that it will have an 

objection to contraceptive coverage, and 

there are many fewer publicly traded 

companies than there are closely held 

ones. But our experience with closely 

held companies is that some, albeit a 

small minority, do have religious 

objections to contraceptive coverage. 

Thus we consider it possible, though 

very unlikely, that a religious publicly 


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traded company might have objections 

to contraceptive coverage. At the same 

time, we are not aware of any publicly 

traded entities that challenged the 

Mandate specifically either publicly or 

in court. The Departments 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’’ and thereby qualify for the 

exemption. (134 S. Ct. at 2774) 

6. Section 147.132(a)(1)(i)(E) 

Under § 147.132(a)(1)(i)(E), the rules 

extend the exemption to the plans of 

any other non-governmental employer. 

The plans of governmental employers 

are not covered by the plan sponsor 

exemption of § 147.132(a)(1)(i). The 

Departments are not aware of reasons 

why it would be appropriate or 

necessary to offer religious exemptions 

to governmental employer plan 

sponsors in the United States with 

respect to the contraceptive Mandate. 

But, as discussed below, governmental 

employers are permitted to respect an 

individual’s objection under 

§ 147.132(b) and thus to provide health 

insurance coverage without the 

objected-to contraceptive coverage to 

such individual. Where that exemption 

is operative, the Guidelines may not be 

construed to prevent a willing 

governmental plan sponsor of a group 

health plan 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 sincerely held religious beliefs. 

By the general extension of the 

exemption to the plans of plan sponsors 

in § 147.132(a)(1)(i), these interim final 

rules also exempt group health plans 

sponsored by an entity other than an 

employer (for example, a union) that 

objects based on sincerely held religious 

beliefs to coverage of contraceptives or 

sterilization. 

7. Section 147.132(a)(1)(ii) 

As in the previous rules, the plans of 

institutions of higher education that 

arrange student health insurance 

coverage will continue to be treated 

similarly to the way in which the plans 

of employers are treated, but for the 

purposes of such plans being exempt or 

electing the optional accommodation, 

rather than merely being eligible for the 

accommodation as in the previous rule. 

These interim final rules specify, in 

§ 147.132(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. As mentioned above, because 

the Affordable Care Act does not require 

institutions of higher education to 

arrange student coverage, some 

institutions of higher education that 

object to the Mandate appear to have 

chosen to stop arranging student plans 

rather than comply with the Mandate or 

use the accommodation. Extending the 

exemption in these interim final rules 

may remove an obstacle to such entities 

deciding to offer student plans, thereby 

giving students another health 

insurance option. 

E. Exemption for Issuers 

These interim final rules extend the 

exemption, in § 147.132(a)(1)(iii), to 

health insurance issuers offering group 

or individual health insurance coverage 

that sincerely hold their own religious 

objections to providing coverage for 

contraceptive services. 

The Departments are not currently 

aware of health insurance issuers that 

possess their own religious objections to 

offering contraceptive coverage. 

Nevertheless, many Federal health care 

conscience laws and regulations protect 

issuers or plans specifically. For 

example, 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 are protected from 

being required to provide coverage or 

pay for abortions. See, for example, 

Consolidated Appropriations Act of 

2017, Public Law 115–31, Div. H, Title 

V, Sec. 507(d). Congress also declared 

this year that ‘‘it is the intent of 

Congress’’ to include a ‘‘conscience 

clause’’ which provides exceptions for 

religious beliefs if the District of 

Columbia requires ‘‘the provision of 

contraceptive coverage by health 

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

VIII, Sec. 808. In light of the clearly 

expressed intent of Congress to protect 

religious liberty, particularly in certain 

health care contexts, along with the 

specific efforts to protect issuers, the 

Departments have concluded that an 

exemption for issuers is appropriate. 

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 

§ 147.132(a)(1)(iii) adds to that 

protection, but the additional protection 

operates in a different way than the plan 

sponsor exemption operates. As set 

forth in these interim final rules, 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. 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 42 CFR 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 coverage for some 

or all contraceptive services are plan 

sponsors or individuals who themselves 

object and are exempt. Issuers that hold 

religious objections should identify to 

plan sponsors the 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 

religious beliefs, 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. Permitting issuers 

to object to offering contraceptive 

coverage based on sincerely held 

religious beliefs will allow issuers to 


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62See, for example, Wieland, 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.’’ 

63 78 FR 39874. 

continue to offer coverage to plan 

sponsors and individuals, without 

subjecting them to liability under 

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

related provisions for their failure to 

provide contraceptive coverage. 

The issuer exemption does not 

specifically include third party 

administrators, although the optional 

accommodation process provided under 

these interim final rules specifies that 

third party administrators cannot be 

required to contract with an entity that 

invokes that process. Some religious 

third party administrators have brought 

suit in conjunction with suits brought 

by organizations enrolled in ERISAexempt church plans. Such plans are 

now exempt under these interim final 

rules, and their third party 

administrators, as claims processors, are 

under no obligation under section 

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

benefits for contraceptive services, as 

that section applies only to plans and 

issuers. In the case of ERISA-covered 

plans, plan administrators are obligated 

under ERISA to follow the plan terms, 

but it is the Departments’ understanding 

that third party administrators are not 

typically designated as plan 

administrators under section 3(16) of 

ERISA and, therefore, would not 

normally act as plan administrators 

under section 3(16) of ERISA. Therefore, 

to the Departments’ knowledge, it is 

only under the existing accommodation 

process that third party administrators 

are required to undertake any 

obligations to provide or arrange for 

contraceptive coverage to which they 

might object. These interim final rules 

make the accommodation process 

optional for employers and other plan 

sponsors, and specify that third party 

administrators that have their own 

objection to complying with the 

accommodation process may decline to 

enter into, or continue, contracts as 

third party administrators of such plans. 

For these reasons, these interim final 

rules do not otherwise exempt third 

party administrators. 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 religious 

beliefs implicated by the Mandate. 

F. Scope of Objections Needed for the 

Objecting Entity Exemption 

Exemptions for objecting entities 

specify that they apply where the 

entities object as specified in 

§ 147.132(a)(2). That paragraph specifies 

that exemptions for objecting entities 

will apply to the extent that an entity 

described in § 147.132(a)(1) objects to its 

establishing, maintaining, providing, 

offering, or arranging (as applicable) 

coverage, payments, or a plan that 

provides coverage or payments for some 

or all contraceptive services, based on 

its sincerely held religious beliefs. 

G. Individual Exemption 

These interim final rules include a 

special rule pertaining to individuals 

(referred to here as the ‘‘individual 

exemption’’). Section 147.132(b) 

provides that 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 plan sponsor of a 

group health plan 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 religious beliefs. 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 religiously 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’ religious beliefs, 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 

objections of individual employees by 

offering them plans that omit 

contraceptive coverage, even if those 

governmental entities do not object to 

offering contraceptive coverage in 

general. 

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 religious 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 religious beliefs.62 At the same 

time, this individual exemption ‘‘does 

not undermine the governmental 

interests furthered by the contraceptive 

coverage requirement,’’ 63 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. 

H. Optional Accommodation 

Despite expanding the scope of the 

exemption, these rules also keep the 

accommodation process, but revise it so 

as to make it optional. In this way, 

objecting employers are no longer 

required to choose between direct 

compliance or compliance through the 

accommodation. These rules maintain 

the location of the accommodation 

process in the Code of Federal 

Regulations at 45 CFR 147.131, 26 CFR 

54.9815–2713A, and 29 CFR 2590.715– 

2713A. These rules, by virtue of 

expanding the plan sponsor exemption 

beyond houses of worship and 

integrated auxiliaries that were 


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64See also 26 CFR 54.9815–2715(b); 29 CFR 

2590.715–2715(b); 45 CFR 147.200(b). 

previously exempt, and beyond 

religious nonprofit groups that were 

previously accommodated, and by 

defining eligible organizations for the 

accommodation with reference to those 

covered by the exemption, likewise 

expand the kinds of entities that may 

use the optional accommodation. This 

includes plan sponsors with sincerely 

held religious beliefs for the reasons 

described above. Consequently, under 

these interim final rules, objecting 

employers may make use of the 

exemption, or may choose to pursue the 

optional accommodation process. If an 

eligible organization pursues the 

optional accommodation process 

through the EBSA Form 700 or other 

specified notice to HHS, it voluntarily 

shifts an obligation to provide separate 

but seamless contraceptive coverage to 

its issuer or third party administrator. 

The fees adjustment process for 

qualifying health issuers or third party 

administrators pursuant to 45 CFR 

156.50 is not modified, and (as specified 

therein) requires for its applicability 

that an exception under OMB Circular 

No. A–25R be in effect as the Secretary 

of the Department of Health and Human 

Services requests. 

If an eligible organization wishes to 

revoke its use of the accommodation, it 

can do so under these interim final rules 

and operate under its exempt status. As 

part of its revocation, the issuer or third 

party administrator of the eligible 

organization must provide participants 

and beneficiaries written notice of such 

revocation as specified in guidance 

issued by the Secretary of the 

Department of Health and Human 

Services. This revocation process 

applies both prospectively to eligible 

organizations who decide at a later date 

to avail themselves of the optional 

accommodation and then decide to 

revoke that accommodation, as well as 

to organizations that were included in 

the accommodation prior to the effective 

date of these interim final rules either 

by their submission of an EBSA Form 

700 or notification, or by some other 

means under which their third party 

administrator or issuer was notified by 

DOL or HHS that the accommodation 

applies. Consistent with other 

applicable laws, the issuer or third party 

administrator of an eligible organization 

must promptly notify plan participants 

and beneficiaries of the change of status 

to the extent such participants and 

beneficiaries are currently being offered 

contraceptive coverage at the time the 

accommodated organization invokes its 

exemption. If contraceptive coverage is 

being offered by an issuer or third party 

administrator through the 

accommodation process, the revocation 

will be effective on the 1st day of the 1st 

plan year that begins on or after 30 days 

after the date of the revocation (to allow 

for the provision of notice to plan 

participants in cases where 

contraceptive benefits will no longer be 

provided). Alternatively, an eligible 

organization may give 60-days notice 

pursuant to section 2715(d)(4) of the 

PHS Act,64 if applicable, to revoke its 

use of the accommodation process. 

The Departments have eliminated the 

provision in the previous 

accommodation under which an issuer 

is deemed to have complied with the 

Mandate where the issuer relied 

reasonably and in good faith on a 

representation by an eligible 

organization as to its eligibility for the 

accommodation, even if that 

representation was later determined to 

be incorrect. Because any organization 

with a sincerely held religious objection 

to contraceptive coverage is now eligible 

for the optional accommodation under 

these interim final rules and is also 

exempt, the Departments believe there 

is minimal opportunity for mistake or 

misrepresentation by the organization, 

and the reliance provision is no longer 

necessary. 

I. Definition of Contraceptive Services 

for the Purpose of These Rules 

The interim final rules specify that 

when the rules refer to ‘‘contraceptive’’ 

services, benefits, or coverage, such 

terms include contraceptive or 

sterilization items, services, or related 

patient education or counseling, to the 

extent specified for purposes of 

§ 147.130(a)(1)(iv). This was the case 

under the previous rules, as expressed 

in the preamble text of the various 

iterations of the regulations, but the 

Departments wish to make the scope 

clear by specifying it in the regulatory 

text. 

J. Conclusion 

The Departments believe that the 

Guidelines and the exemptions 

expanded herein will advance the 

limited purposes for which Congress 

imposed section 2713 of the PHS Act, 

while acting consistently with Congress’ 

well-established record of allowing for 

religious exemptions with respect to 

especially sensitive health care and 

health insurance requirements. These 

interim final rules 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. These 

interim final rules also maintain HRSA’s 

discretion to decide whether to continue 

to require contraceptive coverage under 

the Guidelines (in plans where Congress 

applied section 2713 of the PHS Act) if 

no objection exists. The Departments 

believe this array of programs and 

requirements better serves the interest of 

providing contraceptive coverage while 

protecting the conscience rights of 

entities that have sincerely held 

religious objections to some or all 

contraceptive or sterilization services. 

The Departments request and 

encourage public comments on all 

matters addressed in these interim final 

rules. 

V. 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; 

79 FR 51092). 

Section 553(b) of the Administrative 

Procedure Act (APA) requires notice 

and comment rulemaking, involving a 

notice of proposed rulemaking and a 

comment period prior 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 


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those Guidelines without engaging in 

the regulatory process (because doing so 

is not a legal requirement), and 

announced that it plans to continue to 

update the Guidelines. 

Dozens of lawsuits over the Mandate 

have been pending for nearly 5 years. 

The Supreme Court remanded several of 

those cases more than a year ago, stating 

that on remand ‘‘[w]e anticipate that the 

Courts of Appeals will allow the parties 

sufficient time to resolve any 

outstanding issues between them’’. 

Zubik, 136 S. Ct. at 1560. During that 

time, Courts of Appeals have been 

asking the parties in those cases to 

submit status reports every 30 through 

90 days. Those status reports have 

informed the courts that the parties 

were in discussions, and about the RFI 

issued in late 2016 and its subsequent 

comment process and the FAQ the 

Departments issued indicating that we 

could not find a way at that time to 

amend the accommodation process so as 

to satisfy objecting eligible organizations 

while pursuing the Departments’ policy 

goals. Since then, several courts have 

issued orders setting more pressing 

deadlines. For example, on March 10, 

2017, the United States Court of 

Appeals for the Seventh Circuit ordered 

that, by May 1, 2017, ‘‘the court expects 

to see either a report of an agreement to 

resolve the case or detailed reports on 

the parties’ respective positions. In the 

event no agreement is reported on or 

before May 1, 2017, the court will plan 

to schedule oral argument on the merits 

of the case on short notice after that 

date’’. The Departments submitted a 

status report but were unable to set forth 

their specific position because this 

interim final rule was not yet on public 

display. Instead, the Departments 

informed the Court that we ‘‘are now 

considering whether further 

administrative action would be 

appropriate’’. In response, the court 

extended the deadline to June 1, 2017, 

again declaring the court expected ‘‘to 

see either a report of an agreement to 

resolve the case or detailed reports on 

the parties’ respective positions’’. The 

Departments were again unable to set 

forth their position in that status report, 

but were able to state that the 

‘‘Departments of Health and Human 

Services, Labor, and the Treasury are 

engaged in rulemaking to reconsider the 

regulations at issue here,’’ citing https:// 

www.reginfo.gov/public/do/

eoDetails?rrid=127381. 

As discussed above, the Departments 

have concluded that, in many instances, 

requiring certain objecting entities or 

individuals to choose between the 

Mandate, the accommodation, or 

penalties for noncomplaince has 

violated RFRA. Good cause exists to 

issue the expanded exemption in these 

interim final rules in order to cure such 

violations (whether among litigants or 

among similarly situated parties that 

have not litigated), to help settle or 

resolve cases, and to ensure, moving 

forward, that our regulations are 

consistent with any approach we have 

taken in resolving certain litigation 

matters. 

The Departments have also been 

subject to temporary injunctions 

protecting many religious nonprofit 

organizations from being subject to the 

accommodation process against their 

wishes, while many other organizations 

are fully exempt, have permanent court 

orders blocking the contraceptive 

coverage requirement, or are not subject 

to section 2713 of the PHS Act and its 

enforcement due to Congress’ limited 

application of that requirement. Good 

cause exists to change the Departments’ 

previous rules to direct HRSA to bring 

its Guidelines in accord with the legal 

realities and remove the threat of a 

future violation of religious beliefs, 

including where such violations are 

contrary to Federal law. 

Other objecting entities similarly have 

not had the protection of court 

injunctions. This includes some 

nonprofit entities that have sued the 

Departments, but it also includes some 

organizations that do not have lawsuits 

pending against us. For example, many 

of the closely held for-profit companies 

that brought the array of lawsuits 

challenging the Mandate leading up to 

the decision in Hobby Lobby are not 

protected by injunctions from the 

current rules, including the requirement 

that they either fully comply with the 

Mandate or subject themselves to the 

accommodation. Continuing to apply 

the Mandate’s regulatory burden on 

individuals and organizations with 

religious beliefs against it could serve as 

a deterrent for citizens who might 

consider forming new entities— 

nonprofit or for-profit—and to offering 

health insurance in employer-sponsored 

plans or plans arranged by institutions 

of higher education. Delaying the 

protection afforded by these interim 

final rules would be contrary to the 

public interest because it would serve to 

extend for many months the harm 

caused to all entities and individuals 

with religious objections to the 

Mandate. Good cause exists to provide 

immediate resolution to this myriad of 

situations rather than leaving them to 

continued uncertainty, inconsistency, 

and cost during litigation challenging 

the previous rules. 

These interim final rules provide a 

specific policy resolution that courts 

have been waiting to receive from the 

Departments for more than a year. If the 

Departments were to publish a notice of 

proposed rulemaking instead of these 

interim final rules, many more months 

could pass before the current Mandate 

is lifted from the entities receiving the 

expanded exemption, during which 

time those entities would be deprived of 

the relief clearly set forth in these 

interim final rules. 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 by 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. 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. 

As the United States Court of Appeals 

for the D.C. Circuit stated with respect 

to an earlier interim final rule 

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 ‘‘delay in 

implementation of the rule would 

interfere with the prompt availability of 

contraceptive coverage and delay the 

implementation of the alternative optout for religious objectors’’. Id. at 277. 

Delaying the availability of the 

expanded exemption would delay the 

ability of those organizations and 

individuals to avail themselves of the 

relief afforded by these interim final 

rules. Good cause is supported by 


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providing relief for entities and 

individuals for whom the Mandate 

operates in violation of their sincerely 

held religious beliefs, but who would 

have to experience that burden for many 

more months under the prior 

regulations if these rules are not issued 

on an interim final basis. Good cause is 

also supported by the effect of these 

interim final rules in bringing to a close 

the uncertainty caused by years of 

litigation and regulatory changes made 

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

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. 

Delaying the availability of the 

expanded exemption would also 

increase the costs of health insurance. 

As reflected in litigation pertaining to 

the Mandate, some entities are in 

grandfathered health plans that do not 

cover contraception. They 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. They are refraining 

from making those changes—and 

therefore are continuing to incur and 

pass on higher insurance costs—to 

prevent the Mandate from applying to 

their plans in violation of their 

consciences. Issuing these rules on an 

interim final basis is necessary in order 

to help reduce the costs of health 

insurance for such entities and their 

plan participants. 

These interim final rules also set forth 

an optional accommodation process, 

and expand eligibility for that process to 

a broader category of entities. Delaying 

the availability of the optional 

accommodation process would delay 

the ability of organizations that do not 

now qualify for the accommodation, but 

wish to opt into it, to be able to do so 

and therefore to provide a mechanism 

for contraceptive coverage to be 

provided to their employees while the 

organization’s religious objections are 

accommodated. 

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 at the Office of the Federal 

Register. 

VI. 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 one 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 1 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 

to 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, and to revise the accommodation 

process to make it optional for eligible 

organizations. The expanded exemption 

would apply to individuals and entities 

that have religious objections to some 

(or all) of the contraceptive and/or 

sterilization services that would be 

covered under the Guidelines. Such 

action is taken, among other reasons, to 

provide for participation in the health 

insurance market by certain entities or 

individuals free from penalties for 

violating sincerely held religious beliefs 

opposed to providing or receiving 

coverage of contraceptive services, and 

to resolve many of the lawsuits that 

have been filed against the Departments. 

2. Anticipated Effects 

The Departments assess this interim 

final rule together with a companion 

interim final rule concerning moral but 

non-religious conscientious objections 

to contraception, published elsewhere 

in this Federal Register. Regarding 

entities that are extended an exemption, 

absent expansion of the exemption the 

Guidelines would require many of these 

entities and individuals to either: Pay 

for coverage of contraceptive services 

that they find religiously objectionable; 

submit self-certifications that would 

result in their issuer or third party 

administrator paying for such services 

for their employees, which some entities 

also believe entangles them in the 

provision of such objectionable 

coverage; or, pay tax penalties or be 


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65See, for example, Brief in Opp. To Pls.’ Mot. 

for Prelim. Inj., Brandt v. Burwell, No. 2:14–cv– 

681–AJS, doc. #23 (W.D. Pa. filed June 10, 2014) 

(arguing that ‘‘plaintiffs have not established an 

injury in fact to the degree plaintiffs have a selfinsured church plan,’’ based on the fact that ‘‘the 

same law firm representing the plaintiffs here has 

suggested in another similar case that all ‘Catholic 

entities like the Archdiocese participate in ‘‘church 

plans.’’ ’); Roman Catholic Archdiocese of N.Y. v. 

Sebelius, 987 F. Supp. 2d 232, 242 (E.D.N.Y. 2013) 

(‘‘because plaintiffs’ self-insured plans are church 

plans, their third party administrators would not be 

required to provide contraceptive coverage’’). 

subject to other adverse consequences 

for non-compliance with these 

requirements. These interim final rules 

remove certain associated burdens 

imposed on these entities and 

individuals—that is, by recognizing 

their religious objections and exempting 

them—on the basis of such objections— 

from the contraceptive and/or 

sterilization coverage requirement of the 

HRSA Guidelines and making the 

accommodation process optional for 

eligible organizations. 

To the extent that entities choose to 

revoke their accommodated status to 

make use of the expanded exemption 

immediately, a notice will need to be 

sent to enrollees (either by the entity or 

by the issuer or third party 

administrator) that their contraceptive 

coverage is changing, and guidance will 

reflect that such a notice requirement is 

imposed no more than is already 

required by preexisting rules that 

require notices to be sent to enrollees of 

changes to coverage during a plan year. 

If the entities wait until the start of their 

next plan year to change to exempt 

status, instead of doing so during a plan 

year, those entities generally will also be 

able to avoid sending any 

supplementary notices in addition to 

what they would otherwise normally 

send prior to the start of a new plan 

year. Additionally, these interim final 

rules provide such entities with an 

offsetting regulatory benefit by the 

exemption itself and its relief of burdens 

on their religious beliefs. As discussed 

below, assuming that more than half of 

entities that have been using the 

previous accommodation will seek 

immediate revocation of their 

accommodated status and notices will 

be sent to all their enrollees, the total 

estimated cost of sending those notices 

will be $51,990. 

The Departments estimate that these 

interim final rules will not result in any 

additional burdens or costs on issuers or 

third party administrators. As discussed 

below, the Departments believe that 109 

of the 209 entities making use of the 

accommodation process will instead 

make use of their newly exempt status. 

In contrast, the Departments expect that 

a much smaller number (which we 

assume to be 9) will make use of the 

accommodation that were not provided 

access to it previously. Reduced 

burdens for issuers and third party 

administrators due to reductions in use 

of the accommodation will more than 

offset increased obligations on issuers 

and third party administrators serving 

the fewer number of entities that will 

newly opt into the accommodation. This 

will lead to a net decrease in burdens 

and costs on issuers and third party 

administrators, who will no longer have 

continuing obligations imposed on them 

by the accommodation. 

These interim final rules will result in 

some persons covered in plans of newly 

exempt entities not receiving coverage 

or payments for contraceptive services. 

The Departments do not have sufficient 

data to determine the actual effect of 

these rules on plan participants and 

beneficiaries, including for costs they 

may incur for contraceptive coverage, 

nor of unintended pregnancies that may 

occur. As discussed above and for 

reasons explained here, there are 

multiple levels of uncertainty involved 

in measuring the effect of the expanded 

exemption, including but not limited 

to— 

• How many entities will make use of 

their newly exempt status. 

• how many entities will opt into the 

accommodation maintained by these 

rules, under which their plan 

participants will continue receiving 

contraceptive coverage. 

• which contraceptive methods some 

newly exempt entities will continue to 

provide without cost-sharing despite the 

entity objecting to other methods (for 

example, as reflected in Hobby Lobby, 

several objecting entities still provide 

coverage for 14 of the 18 women’s 

contraceptive or sterilization methods, 

134 S. Ct. at 2766). 

• how many women will be covered 

by plans of entities using their newly 

exempt status. 

• which of the women covered by 

those plans want and would have used 

contraceptive coverage or payments for 

contraceptive methods that are no 

longer covered by such plans. 

• whether, given the broad 

availability of contraceptives and their 

relatively low cost, such women will 

obtain and use contraception even if it 

is not covered. 

• the degree to which such women 

are in the category of women identified 

by IOM as most at risk of unintended 

pregnancy. 

• the degree to which unintended 

pregnancies may result among those 

women, which would be attributable as 

an effect of these rules only if the 

women did not otherwise use 

contraception or a particular 

contraceptive method due to their plan 

making use of its newly exempt status. 

• the degree to which such 

unintended pregnancies may be 

associated with negative health effects, 

or whether such effects may be offset by 

other factors, such as the fact that those 

women will be otherwise enrolled in 

insurance coverage. 

• the extent to which such women 

will qualify for alternative sources of 

contraceptive access, such as through a 

parent’s or spouse’s plan, or through 

one of the many governmental programs 

that subsidize contraceptive coverage to 

supplement their access. 

The Departments have access to 

sources of information discussed in the 

following paragraphs that are relevant to 

this issue, but those sources do not 

provide a full picture of the impact of 

these interim final rules. 

First, the prior rules already exempted 

certain houses of worship and their 

integrated auxiliaries. Further, as 

discussed above, the prior 

accommodation process allows 

hundreds of additional religious 

nonprofit organizations in self-insured 

church plans that are exempt from 

ERISA to file a self-certification or 

notice that relieves not only themselves 

but, in effect, their third party 

administrators of any obligation to 

provide contraceptive coverage or 

payments. Although in the latter case, 

third party administrators are legally 

permitted to provide the coverage, 

several self-insured church plans 

themselves have expressed an objection 

in litigation to allowing such 

contraceptive coverage to be provided, 

and according to information received 

during litigation, it appears that such 

contraceptive coverage has not been 

provided. In addition, a significant 

portion of the lawsuits challenging the 

Mandate were brought by a single firm 

representing Catholic dioceses and 

related entities covered by their diocesesponsored plans. In that litigation, the 

Departments took the position that, 

where those diocese-sponsored plans 

are self-insured, those plans are likely 

church plans exempt from ERISA.65 For 

the purposes of considering whether the 

expanded exemption in these rules 

affects the persons covered by such 

diocese-sponsored plans, the 

Departments continue to assume that 

such plans are similar to other objecting 

entities using self-insured church plans 

with respect to their third party 

administrators being unlikely to provide 

contraceptive coverage to plan 

participants and beneficiaries under the 

previous rule. Therefore the 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47817 

66See https://www.franciscanhealth.org/sites/

default/files/

2015%20employee%20benefit%20booklet.pdf.; see, 

for example, Roman Catholic Archdiocese of N.Y. 

v. Sebelius, 987 F. Supp. 2d 232, 242 (E.D.N.Y. 

2013). 

67 Verified Complaint ¶ 34, Hobby Lobby Stores, 

Inc., et al. v. Sebelius, No. 5:12–cv–01000–HE (Sept. 

12, 2012 W.D. Okla.) (13,240 employees). 

68By reference to the FDA Birth Control Guide’s 

list of 18 birth control methods for women and 2 

for men, https://www.fda.gov/downloads/

forconsumers/byaudience/forwomen/

freepublications/ucm517406.pdf, Hobby Lobby and 

entities with similar beliefs were not willing to 

cover: IUD copper; IUD with progestin; emergency 

contraceptive (Levonorgestrel); and emergency 

contraceptive (Ulipristal Acetate). See 134 S. Ct. at 

2765–66. Hobby Lobby was willing to cover: 

Sterilization surgery for women; sterilization 

implant for women; implantable rod; shot/injection; 

oral contraceptives (‘‘the Pill’’—combined pill); oral 

contraceptives (‘‘the Pill’’—extended/continuous 

use/combined pill); oral contraceptives (‘‘the Mini 

Pill’’—progestin only); patch; vaginal contraceptive 

ring; diaphragm with spermicide; sponge with 

spermicide; cervical cap with spermicide; female 

condom; spermicide alone. Id. Among women using 

these 18 female contraceptive methods, 85 percent 

use the 14 methods that Hobby Lobby and entities 

with similar beliefs were willing to cover 

(22,446,000 out of 26,436,000), and ‘‘[t]he pill and 

female sterilization have been the two most 

commonly used methods since 1982.’’ See 

Guttmacher Institute, ‘‘Contraceptive Use in the 

United States’’ (Sept. 2016), available at https://

www.guttmacher.org/fact-sheet/contraceptive-useunited-states. 

Departments estimate that these interim 

final rules have no significant effect on 

the contraceptive coverage of women 

covered by plans of houses of worship 

and their integrated auxiliaries, entities 

using a self-insured church plan, or 

church dioceses sponsoring self-insured 

plans. 

It is possible that an even greater 

number of litigating or accommodated 

plans might have made use of selfinsured church plan status under the 

previous accommodation. Notably, one 

of the largest nonprofit employers that 

had filed suit challenging the Mandate 

had, under these prior rules, shifted 

most of their employees into selfinsured church plans, and the 

Departments have taken the position 

that various other employers that filed 

suit were eligible to assume self-insured 

church plan status.66 The Supreme 

Court’s recent decision in Advocate 

Health Care Network, while not 

involving this Mandate, also clarifies 

certain circumstances under which 

religious hospitals may be eligible for 

self-insured church plan status. See 137 

S. Ct. at 1656–57, 1663 (holding that a 

church plan under ERISA can be a plan 

not established and maintained by a 

church, if it is maintained by a 

principal-purpose organization). 

Second, when the Departments 

previously created the exemption, 

expanded its application, and provided 

an accommodation (which, as 

mentioned, can lift obligations on selfinsured church plans for hundreds of 

nonprofit organizations), we concluded 

that no significant burden or costs 

would result at all. (76 FR 46625; 78 FR 

39889.) We reached this conclusion 

despite the impact, just described, 

whereby the previous rule apparently 

lead to women not receiving 

contraceptive coverage through 

hundreds of nonprofit entities using 

self-insured church plans. We also 

reached this conclusion without 

counting any significant burden or cost 

to some women covered in the plans of 

houses of worship or integrated 

auxiliaries that might want 

contraceptive coverage. This conclusion 

was based in part on the assertion, set 

forth in previous regulations, that 

employees of houses of worship and 

integrated auxiliaries likely share their 

employers’ opposition to contraception. 

Many other religious nonprofit entities, 

however, both adopt and implement 

religious principles with similar 

fervency. For the reasons discussed 

above, the Departments no longer 

believe we can distinguish many of the 

women covered in the plans of religious 

nonprofit entities from the women 

covered in the plans of houses of 

worship and integrated auxiliaries 

regarding which the Departments 

assumed share their employers’ 

objection to contraception, nor from 

women covered in the plans of religious 

entities using self-insured church plans 

regarding which we chose not to 

calculate any anticipated effect even 

though we conceded we were not 

requiring their third party 

administrators to provide contraceptive 

coverage. In the estimates and 

assumptions below, we include the 

potential effect of these interim rules on 

women covered by such entities, in 

order to capture all of the anticipated 

effects of these rules. 

Third, these interim final rules extend 

the exemption to for-profit entities. 

Among the for-profit employers that 

filed suit challenging the Mandate, the 

one with the most employees was 

Hobby Lobby.67 As noted above, and 

like some similar entities, the plaintiffs 

in Hobby Lobby were willing to provide 

coverage with no cost sharing of various 

contraceptive services: 14 of 18 FDAapproved women’s contraceptive and 

sterilization methods.68 (134 S. Ct. at 

2766.) The effect of expanding the 

exemption to for-profit entities is 

therefore mitigated to the extent many 

of the persons covered by such entities’ 

plans may receive coverage for at least 

some contraceptive services. No 

publicly traded for-profit entities have 

filed lawsuits challenging the Mandate. 

The Departments agree with the 

Supreme Court’s expectation in this 

regard: ‘‘it seems unlikely that the sort 

of corporate giants to which HHS refers 

will often assert RFRA claims. HHS has 

not pointed to any example of a publicly 

traded corporation asserting RFRA 

rights, and numerous practical restraints 

would likely prevent that from 

occurring. For example, the idea that 

unrelated shareholders—including 

institutional investors with their own 

set of stakeholders—would agree to run 

a corporation under the same religious 

beliefs seems improbable’’. Hobby 

Lobby, 134 S. Ct. at 2774. Therefore, 

although publicly traded entities could 

make use of exempt status under these 

interim final rules, the Departments do 

not expect that very many will do so, as 

compared to the 87 religious closely 

held for-profit entities that brought 

litigation challenging the Mandate 

(some of which might be content with 

the accommodation). 

Fourth, the Departments have a 

limited amount of information about 

entities that have made use of the 

accommodation process as set forth in 

the previous rules. HHS previously 

estimated that 209 entities would make 

use of the accommodation process. That 

estimate was based on HHS’s 

observation in its August 2014 interim 

final rules and July 2015 final 

regulations that there were 122 eligible 

entities that had filed litigation 

challenging the accommodation process, 

and 87 closely held for-profit entities 

that had filed suit challenging the 

Mandate in general. (79 FR 51096; 80 FR 

41336). The Departments acknowledged 

that entities that had not litigated might 

make use of the accommodation, but we 

stated we did not have better data to 

estimate how many might use the 

accommodation overall. 

After issuing those rules, the 

Departments have not received 

complete data on the number of entities 

actually using the accommodation, 

because the accommodation does not 

require many accommodated entities to 

submit information to us. Our limited 

records indicate that approximately 63 

entities have affirmatively submitted 

notices to HHS to use the 

accommodation. This includes some 

fully insured and some self-insured 

plans, but it does not include entities 

that may have used the accommodation 

by submitting an EBSA form 700 selfcertification directly to their issuer or 

third party administrator. We have 

deemed some other entities as being 

subject to the accommodation through 

their litigation filings, but that might not 

have led to contraceptive coverage being 


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47818 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

69See, for example, Catholic Diocese of 

Pittsburgh, ‘‘Award-winning attorney ‘humbled’ by 

recognition,’’ Pittsburgh Catholic (‘‘Jones Day is 

doing the cases ‘pro bono,’ or voluntarily and 

without payment.’’) (quoting Paul M. Pohl, Partner, 

Jones Day), available at http://diopitt.org/

pittsburgh-catholic/award-winning-attorneyhumbled-recognition; ‘‘Little Sisters Fight for 

Religious Freedom,’’ National Review (Oct. 2, 2013) 

(‘‘the Becket Fund for Religious Liberty is 

representing us pro bono, as they do all their 

clients.’’) (quoting Sister Constance Veit, L.S.P., 

communications director for the Little Sisters of the 

Poor), available at http://www.nationalreview.com/ 

article/360103/little-sisters-fight-religious-freedominterview; Suzanne Cassidy, ‘‘Meet the major legal 

players in the Conestoga Wood Specialties Supreme 

Court case,’’ LancasterOnline (Mar. 25, 2014) 

(‘‘Cortman and the other lawyers arguing on behalf 

of Conestoga Wood Specialties and Hobby Lobby 

are offering their services pro bono.’’), available at 

http://lancasteronline.com/news/local/meet-themajor-legal-players-in-the-conestoga-woodspecialties/article_302bc8e2-b379-11e3-b669- 

001a4bcf6878.html. 

provided to persons covered in some of 

those plans, either because they are 

exempt as houses of worship or 

integrated auxiliaries, they are in selfinsured church plans, or we were not 

aware of their issuers or third party 

administrators so as to send them letters 

obligating them to provide such 

coverage. Our records also indicate that 

60 plans used the contraceptive user 

fees adjustments in the 2015 plan year, 

the last year for which we have data. 

This includes only self-insured plans, 

and it includes some plans that selfcertified through submitting notices and 

other plans that, presumably, selfcertified through the EBSA form 700. 

These sets of data are not inconsistent 

with our previous estimate that 209 

entities would use the accommodation, 

but they indicate that some nonlitigating entities used the 

accommodation, and some litigating 

entities did not, possibly amounting to 

a similar number. For this reason, and 

because we do not have more complete 

data available, we believe the previous 

estimate of 209 accommodated entities 

is still the best estimate available for 

how many entities have used the 

accommodation under the previous 

rule. This assumes that the number of 

litigating entities that did not use the 

accommodation is approximately the 

same as the number of non-litigating 

entities that did use it. 

In considering how many entities will 

use the voluntary accommodation 

moving forward—and how many will 

use the expanded exemption—we also 

do not have specific data. We expect the 

122 nonprofit entities that specifically 

challenged the accommodation in court 

to use the expanded exemption. But, as 

noted above, we believe a significant 

number of them are not presently 

participating in the accommodation, 

and that some nonprofit entities in selfinsured church plans are not providing 

contraceptive coverage through their 

third party administrators even if they 

are using the accommodation. Among 

the 87 for-profit entities that filed suit 

challenging the Mandate in general, few 

if any filed suit challenging the 

accommodation. We do not know how 

many of those entities are using the 

accommodation, how many may be 

complying with the Mandate fully, how 

many may be relying on court 

injunctions to do neither, or how many 

will use the expanded exemption 

moving forward. Among entities that 

never litigated but used the 

accommodation, we expect many but 

not all of them to continue using the 

accommodation, and we do not have 

data to estimate how many such entities 

there are or how many will choose 

either option. 

Overall, therefore, without sufficient 

data to estimate what the estimated 209 

previously accommodated entities will 

do under these interim final rules, we 

assume that just over half of them will 

use the expanded exemption, and just 

under half will continue their 

accommodated status under the 

voluntary process set forth in these 

rules. Specifically, we assume that 109 

previously accommodated entities will 

make use of their exempt status, and 

100 will continue using the 

accommodation. This estimate is based 

in part on our view that most litigating 

nonprofit entities would prefer the 

exemption to the accommodation, but 

that many of either have not been using 

the accommodation or, if they have been 

using it, it is not providing 

contraceptive coverage for women in 

their plans where they participate in 

self-insured church plans. This estimate 

is also consistent with our lack of 

knowledge of how many for-profit 

entities were using the accommodation 

and will choose the exemption or the 

accommodation, given that many of 

them did not bring legal challenges 

against the accommodation after Hobby 

Lobby. This estimate is further 

consistent with our view, explained in 

more detail below, that some entities 

that are using the accommodation and 

did not bring litigation will use the 

exemption, but many accommodated, 

non-litigating entities—including the 

ones with the largest relative workforces 

among accommodated entities—will 

continue using the accommodation. The 

Departments recognize that we do not 

have better data to estimate the effects 

of these interim final rules on such 

entities. 

In addition to these factors, we 

recognize that the expanded exemption 

and accommodation are newly available 

to religious for-profit entities that are 

not closely held and some other plan 

sponsors. As explained above, the 

Departments believe religious for-profit 

entities that are not closely held may 

exist, or may wish to come into being. 

HHS does not anticipate that there will 

be significant number of such entities, 

and among those, we believe that very 

few if any will use the accommodation. 

All of the for-profit entities that have 

challenged the Mandate have been 

religious closely held entities. 

It is also possible that religious 

nonprofit or closely held for-profit 

entities that were already eligible for the 

accommodation but did not previously 

use it will opt into it moving forward, 

but because they could have done so 

under the previous rules, their opting 

into the accommodation is not caused 

by these rules. 

Without any data to estimate how 

many of any entities newly eligible for 

and interested in using the 

accommodation might exist, HHS 

assumes for the purposes of estimating 

the anticipated effect of these rules that 

less than 10 entities (9) will do so. 

Therefore, we estimate that 109 entities 

will use the voluntary accommodation 

moving forward, 100 of which were 

already using the previous 

accommodation, and that 109 entities 

that have been using the previous 

accommodation will use the expanded 

exemption instead. 

Fifth, in attempting to estimate the 

anticipated effect of these interim final 

rules on women receiving contraceptive 

coverage, the Departments have limited 

information about the entities that have 

filed suit challenging the Mandate. 

Approximately 209 entities have 

brought suit challenging the Mandate 

over more than 5 years. They have 

included a broad range of nonprofit 

entities and closely held for-profit 

entities. We discuss a number of 

potentially relevant points: 

First, the Departments do not believe 

that out-of-pocket litigation costs have 

been a significant barrier to entities 

choosing to file suit. Based on the 

Departments’ knowledge of these cases 

through public sources and litigation, 

nearly all the entities were represented 

pro bono and were subject to little or no 

discovery during the cases, and multiple 

public interest law firms publicly 

provided legal services for entities 

willing to challenge the Mandate.69 (It is 

noteworthy, however, that such pro 

bono arrangements and minimization of 

discovery do not eliminate 100 percent 

of the time costs of participating in 

litigation or, as discussed in more detail 

below, the potential for negative 


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70Where complaints, affidavits, or other 

documents filed in court did not indicate the 

number of employees that work for an entity, and 

that entity was not apparently exempt as a house 

of worship or integrated auxiliary, and it was not 

using the kind of plan that we have stated in 

litigation qualifies for self-insured church plan 

status (see, for example, Roman Catholic 

Archdiocese of N.Y. v. Sebelius, 987 F. Supp. 2d 

232, 242 (E.D.N.Y. 2013)), we examined 

employment data contained in some IRS form 

W–3’s that are publicly available online for certain 

nonprofit groups, and looked at other Web sites 

discussing the number of people employed at 

certain entities. 

71 In a small number of lawsuits, named plaintiffs 

include organizations claiming to have members 

that seek an exemption. We have very little 

information about the number, size, and types of 

entities those members. Based on limited 

information from those cases, however, their 

membership appears to consist mainly, although 

not entirely, of houses of worship, integrated 

auxiliaries, and participants in self-insured plans of 

churches. As explained above, the contraceptive 

coverage of women covered by such plans is not 

likely to be affected by the expanded exemption in 

these rules. However, to account for plans subject 

to contraceptive coverage obligations among those 

members we have added 10,000 to our estimate of 

the number of persons among litigants that may be 

impacted by these rules. 

72See Kaiser Family Foundation and Health 

Research and Educational Trust, ‘‘Employer Health 

Benefits: 2017 Annual Survey’’ at 57, available at 

http://files.kff.org/attachment/Report-EmployerHealth-Benefits-Annual-Survey-2017. 

73 ‘‘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. 

74United States 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/; also, see 80 FR 40318. In 

addition, studies commonly consider the 15–44 age 

range to assess contraceptive use by women of 

childbearing age. See, for example, Guttmacher 

Institute, ‘‘Contraceptive Use in the United States’’ 

(Sept. 2016), available at https://

www.guttmacher.org/fact-sheet/contraceptive-useunited-states. 

75See https://www.guttmacher.org/fact-sheet/

contraceptive-use-united-states (reporting that of 

60,877,000 women aged 15–44, 26,945,000 use 

women’s contraceptive methods covered by the 

Guidelines). 

76 It would appear that a smaller percentage of 

college-aged women use contraception—and use 

more expensive methods such as long acting 

methods or sterilization—than among other women 

of childbearing age. See NCHS Data Brief, ‘‘Current 

Contraceptive Status Among Women Aged 15–44: 

United States, 2011–2013’’ (Dec. 2014), available at 

Continued 

publicity. Both concerns could have 

dissuaded participation in lawsuits, and 

the potential for negative publicity may 

also dissuade participation in the 

expanded exemptions.) 

Second, prior to the Affordable Care 

Act, the vast majority of entities already 

covered contraception, albeit not always 

without cost-sharing The Departments 

do not have data to indicate why 

entities that did not cover contraception 

prior to the Affordable Care Act chose 

not to cover it. As noted above, 

however, the Departments have 

maintained that compliance with the 

contraceptive Mandate is cost-neutral to 

issuers, which indicates that no 

significant financial incentive exists to 

omit contraceptive coverage. As 

indicated by the report by HHS ASPE 

discussed above, we have assumed that 

millions of women received preventive 

services after the Mandate went into 

effect because nearly all entities 

complied with the Guidelines. We are 

not aware of expressions from most of 

those entities indicating that they would 

have sincerely held religious objections 

to complying with the Mandate, and 

therefore that they would make use of 

the expanded exemption provided here. 

Third, omitting contraceptive 

coverage has subjected some entities to 

serious public criticism and in some 

cases organized boycotts or opposition 

campaigns that have been reported in 

various media and online outlets 

regarding entities that have filed suit. 

The Departments expect that even if 

some entities might not receive such 

criticism, many entities will be reluctant 

to use the expanded exemption unless 

they are committed to their views to a 

significant degree. 

Overall, the Departments do not know 

how many entities will use the 

expanded exemption. We expect that 

some non-litigating entities will use it, 

but given the aforementioned 

considerations, we believe it might not 

be very many more. Moreover, many 

litigating entities are already exempt or 

are not providing contraceptive 

coverage to women in their plans due to 

their participating in self-insured 

church plans, so the effect of the 

expanded exemption among litigating 

entities is significantly lower than it 

would be if all the women in their plans 

were already receiving the coverage. 

To calculate the anticipated effects of 

this rule on contraceptive coverage 

among women covered by plans 

provided by litigating entities, we start 

by examining court documents and 

other public sources.70 These sources 

provide some information, albeit 

incomplete, about how many people are 

employed by these entities. As noted 

above, however, contraceptive coverage 

among the employees of many litigating 

entities will not be affected by these 

rules because some litigating entities 

were exempt under the prior rule, while 

others were or appeared to be in selfinsured church plans so that women 

covered in their plans were already not 

receiving contraceptive coverage. 

Among litigating entities that were 

neither exempt nor likely using selfinsured church plans, our best estimate 

based on court documents and public 

sources is that such entities employed 

approximately 65,000 persons, male and 

female.71 The average number of 

workers at firms offering health benefits 

that are actually covered by those 

benefits is 62 percent.72 This amounts to 

approximately 34,000 employees 

covered under those plans. DOL 

estimates that for each employee 

policyholder, there is approximately 

one dependent.73 This amounts to 

approximately 68,000 covered persons. 

Census data indicate that women of 

childbearing age—that is, women aged 

15–44—compose 20.2 percent of the 

general population.74 In addition, 

approximately 44.3 percent of women of 

childbearing age use women’s 

contraceptive methods covered by the 

Guidelines.75 Therefore, we estimate 

that approximately 7,221 women of 

childbearing age that use contraception 

covered by the Guidelines are covered 

by employer sponsored plans of entities 

that have filed lawsuits challenging the 

Mandate, where those plans are neither 

exempt under the prior rule nor are selfinsured church plans. 

We also estimate that for the 

educational institutions objecting to the 

Mandate as applied to student coverage 

that they arranged, where the entities 

were neither exempt under the prior 

rule nor were their student plans selfinsured, such student plans likely 

covered approximately 3,300 students. 

On average, we expect that 

approximately half of those students 

(1,650) are female. For the purposes of 

this estimate, we also assume that 

female policyholders covered by plans 

arranged by institutions of higher 

education are women of childbearing 

age. We expect that they would have 

less than the average number of 

dependents per policyholder than exists 

in standard plans, but for the purposes 

of providing an upper bound to this 

estimate, we assume that they would 

have an average of one dependent per 

policyholder, thus bringing the number 

of policyholders and dependents back 

up to 3,300. Many of those dependents 

are likely not to be women of 

childbearing age, but in order to provide 

an upper bound to this estimate, we 

assume they are. Therefore, for the 

purposes of this estimate, we assume 

that the effect of these expanded 

exemptions on student plans of 

litigating entities includes 3,300 

women. Assuming that 44.3 perecent of 

such women use contraception covered 

by the Guidelines,76 we estimate that 


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https://www.cdc.gov/nchs/data/databriefs/

db173.pdf. 

77Brief of Respondents at 18–19 & n.7, Zubik v. 

Burwell, No. 14–1418, et al. (U.S. filed Feb. 10, 

2016). The actual number is 612,487. 

78See, for example, https://www.chausa.org/

newsroom/women%27s-preventive-health-servicesfinal-rule (‘‘HHS has now established an 

accommodation that will allow our ministries to 

continue offering health insurance plans for their 

employees as they have always done. . . . We are 

pleased that our members now have an 

accommodation that will not require them to 

contract, provide, pay or refer for contraceptive 

coverage. . . . We will work with our members to 

implement this accommodation.’’) In comments 

submitted in previous rules concerning this 

Mandate, the Catholic Health Association has stated 

it ‘‘is the national leadership organization for the 

Catholic health ministry, consisting of more than 

2,000 Catholic health care sponsors, systems, 

hospitals, long-term care facilities, and related 

organizations. Our ministry is represented in all 50 

states and the District of Columbia.’’ Comments on 

CMS–9968–ANPRM (dated June 15, 2012). 

79See, for example, Brief of the Catholic Health 

Association of the United States as Amicus Curiae 

in Support of Petitioners, Advocate Health Care 

Network, Nos. 16–74, 16–86, 16–258, 2017 WL 

371934 at *1 (U.S. filed Jan. 24, 2017) (‘‘CHA 

members have relied for decades that the ‘church 

plan’ exemption contained in’’ ERISA.). 

80See supra note 66. 

81 ‘‘Health Insurance Coverage Bulletin’’ Table 

3A, page 15. 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. 

1,462 of those women would be affected 

by these rules. 

Together, this leads the Departments 

to estimate that approximately 8,700 

women of childbearing age may have 

their contraception costs affected by 

plans of litigating entities using these 

expanded exemptions. As noted above, 

the Departments do not have data 

indicating how many of those women 

agree with their employers’ or 

educational institutions’ opposition to 

contraception (so that fewer of them 

than the national average might actually 

use contraception). Nor do we know 

how many would have alternative 

contraceptive access from a parent’s or 

spouse’s plan, or from Federal, State, or 

local governmental programs, nor how 

many of those women would fall in the 

category of being most at risk of 

unintended pregnancy, nor how many 

of those entities would provide some 

contraception in their plans while only 

objecting to certain contraceptives. 

Sixth, in a brief filed in the Zubik 

litigation, the Departments stated that 

‘‘in 2014, [HHS] provided user-fee 

reductions to compensate TPAs for 

making contraceptive coverage available 

to more than 600,000 employees and 

beneficiaries,’’ and that ‘‘[t]hat figure 

includes both men and women covered 

under the relevant plans.’’ 77 HHS has 

reviewed the information giving rise to 

that estimate, and has received updated 

information for 2015. In 2014, 612,000 

persons were covered by plans claiming 

contraceptive user fees adjustments, and 

in 2015, 576,000 persons were covered 

by such plans. These numbers include 

all persons in such plans, not just 

women of childbearing age. 

HHS’s information indicates that 

religious nonprofit hospitals or health 

systems sponsored a significant 

minority of the accommodated selfinsured plans that were using 

contraceptive user fees adjustments, yet 

those plans covered more than 80 

percent of the persons covered in all 

plans using contraceptive user fees 

adjustments. Some of those plans cover 

nearly 100,000 persons each, and 

several others cover approximately 

40,000 persons each. In other words, 

these plans were proportionately much 

larger than the plans provided by other 

entities using the contraceptive user fees 

adjustments. 

There are two reasons to believe that 

a significant fraction of the persons 

covered by previously accommodated 

plans provided by religious nonprofit 

hospitals or health systems may not be 

affected by the expanded exemption. A 

broad range of religious hospitals or 

health systems have publicly indicated 

that they do not conscientiously oppose 

participating in the accommodation.78

Of course, some of these religious 

hospitals or health systems may opt for 

the expanded exemption under these 

interim final rules, but others might not. 

In addition, among plans of religious 

nonprofit hospitals or health systems, 

some have indicated that they might be 

eligible for status as a self-insured 

church plan.79 As discussed above, 

some litigants challenging the Mandate 

have appeared, after their complaints 

were filed, to make use of self-insured 

church plan status.80 (The Departments 

take no view on the status of these 

particular plans under ERISA, but 

simply make this observation for the 

purpose of seeking to estimate the 

impact of these interim final rules.) 

Nevertheless, overall it seems likely that 

many of the remaining religious hospital 

or health systems plans previously 

using the accommodation will continue 

to opt into the voluntary 

accommodation under these interim 

final rules, under which their 

employees will still receive 

contraceptive coverage. To the extent 

that plans of religious hospitals or 

health systems are able to make use of 

self-insured church plan status, the 

previous accommodation rule would 

already have allowed them to relieve 

themselves and their third party 

administrators of obligations to provide 

contraceptive coverage or payments. 

Therefore, in such situations these 

interim final rules would not have an 

anticipated effect on the contraceptive 

coverage of women in those plans. 

Considering all these data points and 

limitations, the Departments offer the 

following estimate of the number of 

women who will be impacted by the 

expanded exemption in these interim 

final rules. The Departments begin with 

the 8,700 women of childbearing age 

that use contraception who we estimate 

will be affected by use of the expanded 

exemption among litigating entities. In 

addition to that number, we calculate 

the following number of women affected 

by accommodated entities using the 

expanded exemption. As noted above, 

approximately 576,000 plan participants 

and beneficiaries were covered by selfinsured plans that received 

contraceptive user fee adjustments in 

2014. Although additional self-insured 

entities may have participated in the 

accommodation without making use of 

contraceptive user fees adjustments, we 

do not know what number of entities 

did so. We consider it likely that selfinsured entities with relatively larger 

numbers of covered persons had 

sufficient financial incentive to make 

use of the contraceptive user fees 

adjustments. Therefore, without better 

data available, we assume that the 

number of persons covered by selfinsured plans using contraceptive user 

fees adjustments approximates the 

number of persons covered by all selfinsured plans using the accommodation. 

An additional but unknown number 

of persons were likely covered in fully 

insured plans using the accommodation. 

The Departments do not have data on 

how many fully insured plans have 

been using the accommodation, nor on 

how many persons were covered by 

those plans. DOL estimates that, among 

persons covered by employer sponsored 

insurance, 56.1 percent are covered by 

self-insured plans and 43.9 percent are 

covered by fully insured plans.81

Therefore, corresponding to the 576,000 

persons covered by self-insured plans 

using user fee adjustments, we estimate 

an additional 451,000 persons were 

covered by fully insured plans using the 

accommodation. This yields an estimate 

of 1,027,000 covered persons of all ages 

and sexes in plans using the previous 

accommodation. 

As discussed below, and recognizing 

the limited data available for our 

estimates, the Departments estimate that 

100 of the 209 entities that were using 

the accommodation under the prior rule 


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82Available at https://aspe.hhs.gov/pdf-report/

affordable-care-act-improving-access-preventiveservices-millions-americans; also, see Abridged 

Report, available at https://www.womenspreventive

health.org/wp-content/uploads/2017/01/WPSI_

2016AbridgedReport.pdf. 

83As noted above, the Departments have taken 

the position that providing contraceptive coverage 

is cost neutral to issuers. (78 FR 39877). At the same 

time, because of the up-front costs of some 

contraceptive or sterilization methods, and because 

some entities did not cover contraception prior to 

the Affordable Care Act, premiums may be expected 

to adjust to reflect changes in coverage, thus 

partially offsetting the transfer experienced by 

women who use the affected contraceptives. As 

discussed elsewhere in this analysis, such women 

may make up approximately 8.9 percent (= 20.2 

percent × 44.3 percent) of the covered population, 

in which case the offset would also be 

approximately 8.9 percent. 

84 Describing this impact as a transfer reflects an 

implicit assumption that the same products and 

services would be used with or without the rule. 

Such an assumption is somewhat oversimplified 

because the interim final rules shift cost burden to 

consumption decision-makers (that is, the women 

who choose whether or not to use the relevant 

contraceptives) and thus can be expected to lead to 

some decrease in use of the affected drugs and 

devices and a potential increase in pregnancy—thus 

leading to a decrease and an increase, respectively, 

in medical expenditures. 

85Available at https://aspe.hhs.gov/system/files/

pdf/139221/The%20Affordable%20Care%20

Act%20is%20Improving%20Access%20to%20

Preventive%20Services%20for%20

Millions%20of%20Americans.pdf. 

86The ASPE study relied on Census data of 

private health insurance plans, which included 

plans sponsored by either private or public sector 

Continued 

will continue to opt into it under these 

interim final rules. Notably, however, 

the data concerning accommodated selfinsured plans indicates that plans 

sponsored by religious hospitals and 

health systems encompass more than 80 

percent of the persons covered in such 

plans. In other words, plans sponsored 

by such entities have a proportionately 

larger number of covered persons than 

do plans sponsored by other 

accommodated entities, which have 

smaller numbers of covered persons. As 

also cited above, many religious 

hospitals and health systems have 

indicated that they do not object to the 

accommodation, and some of those 

entities might also qualify as selfinsured church plans, so that these 

interim final rules would not impact the 

contraceptive coverage their employees 

receive. We do not have specific data on 

which plans of which sizes will actually 

continue to opt into the 

accommodation, nor how many will 

make use of self-insured church plan 

status. We assume that the proportions 

of covered persons in self-insured plans 

using contraceptive user fees 

adjustments also apply in fully insured 

plans, for which we lack representative 

data. Based on these assumptions and 

without better data available, we assume 

that the 100 accommodated entities that 

will remain in the accommodation will 

account for 75 percent of all the persons 

previously covered in accommodated 

plans. In comparison, we assume the 

109 accommodated entities that will 

make use of the expanded exemption 

will encompass 25 percent of persons 

previously covered in accommodated 

plans. 

Applying these percentages to the 

total number of 1,027,000 persons we 

estimate are covered in accommodated 

plans, we estimate that approximately 

257,000 persons previously covered in 

accommodated plans will be covered in 

the 109 plans that use the expanded 

exemption, and 770,000 persons will be 

covered in the estimated 100 plans that 

continue to use the accommodation. 

According to the Census data cited 

above, 20.2 percent of these persons are 

women of childbearing age, which 

amounts to approximately 51,900 

women of childbearing age in 

previously accommodated plans that we 

estimate will use the expanded 

exemption. As noted above, 

approximately 44.3 percent of women of 

childbearing age use women’s 

contraceptive methods covered by the 

Guidelines, so that we expect 

approximately 23,000 women that use 

contraception covered by the Guidelines 

to be affected by accommodated entities 

using the expanded exemption. 

It is not clear the extent to which this 

number overlaps with the number 

estimated above of 8,700 women in 

plans of litigating entities that may be 

affected by these rules. Based on our 

limited information from the litigation 

and accommodation notices, we expect 

that the overlap is significant. 

Nevertheless, in order to estimate the 

possible effects of these rules, we 

assume there is no overlap between 

these two numbers, and therefore that 

these interim final rules would affect 

the contraceptive costs of approximately 

31,700 women. 

Under the assumptions just discussed, 

the number of women whose 

contraceptive costs will be impacted by 

the expanded exemption in these 

interim final rules is less than 0.1 

percent of the 55.6 million women in 

private plans that HHS ASPE 

estimated 82 receive preventive services 

coverage under the Guidelines. 

In order to estimate the cost of 

contraception to women affected by the 

expanded exemption, the Departments 

are aware that, under the prior 

accommodation process, the total user 

fee adjustment amount for self-insured 

plans for the 2015 benefit year was $33 

million. These adjustments covered the 

cost of contraceptive coverage provided 

to women participants and beneficiaries 

in self-insured plans where the 

employer objected and made use of the 

accommodation, and where an 

authorizing exception under OMB 

Circular No. A–25R was in effect as the 

Secretary of the Department of Health 

and Human Services requests. Nine 

percent of that amount was attributable 

to administrative costs and margin, 

according to the provisions of 45 CFR 

156.50(d)(3)(ii). Thus the amount of the 

adjustments attributable to the cost of 

contraceptive services was about $30 

million. As discussed above, in 2015 

that amount corresponded to 576,000 

persons covered by such plans. Among 

those persons, as cited above, 

approximately 20.2 percent on average 

were women of childbearing age—that 

is, approximately 116,000 women. As 

noted above, approximately 44.3 

percent of women of childbearing age 

use women’s contraceptive methods 

covered by the Guidelines, which 

includes 51,400 women in those plans. 

Therefore, entities using contraceptive 

user fees adjustments received 

approximately $584 per year per woman 

of childbearing age that use 

contraception covered by the Guidelines 

and are covered in their plans. 

As discussed above, the Departments 

estimate that the expanded exemptions 

will impact the contraceptive costs of 

approximately 31,700 women of 

childbearing age that use contraception 

covered by the Guidelines. At an 

average of $584 per year, the financial 

transfer effects attributable to the 

interim final rules on those women 

would be approximately $18.5 

million.83 84

To account for uncertainty in the 

estimate, we conducted a second 

analysis using an alternative framework, 

in order to thoroughly consider the 

possible upper bound economic impact 

of these interim final rules. 

As noted above, the HHS ASPE report 

estimated that 55.6 million women aged 

15 to 64 and covered by private 

insurance had preventive services 

coverage under the Affordable Care Act. 

Approximately 16.2 percent of those 

women were enrolled in plans on 

exchanges or were otherwise not 

covered by employer sponsored 

insurance, so only 46.6 million women 

aged 15 to 64 received the coverage 

through employer sponsored private 

insurance plans.85 In addition, some of 

those private insurance plans were 

offered by government employers, 

encompassing approximately 10.5 

million of those women aged 15 to 64.86


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employers. See Table 2, notes 2 & 3 (explaining the 

scope of private plans and government plans for 

purposes of Table 2), available at https://

www.census.gov/content/dam/Census/library/

publications/2014/demo/p60-250.pdf. 

According to data tables from the Medical 

Expenditure Panel Survey (MEPS) of the Agency for 

Healthcare Research and Quality of HHS (https://

meps.ahrq.gov/mepsweb/), State and local 

governments employ 19,297,960 persons; 99.2 

percent of those employers offer health insurance; 

and 67.4 percent of employees that work at such 

entities where insurance is offered are enrolled in 

those plans, amounting to 12.9 million persons 

enrolled. DOL estimates that in the public sector, 

for each policyholder there is an average of slightly 

less than one dependent. ‘‘Health Insurance 

Coverage Bulletin’’ Table 4, page 21. https://

www.dol.gov/sites/default/files/ebsa/researchers/

data/health-and-welfare/health-insurancecoverage-bulletin-2015.pdf. Therefore, State and 

local government employer plans cover 

approximately 24.8 million persons of all ages. 

Census data indicates that on average, 12 percent 

of persons covered by private insurance plans are 

aged 65 and older. Using these numbers, we 

estimate that State and local government employer 

plans cover approximately 21.9 million persons 

under age 65. 

The Federal Government has approximately 8.2 

million persons covered in its employee health 

plans. According to information we received from 

the Office of Personnel Management, this includes 

2.1 million employees having 3.2 million 

dependents, and 1.9 million retirees (annuitants) 

having 1 million dependents. We do not have 

information about the ages of these policyholders 

and dependents, but for the purposes of this 

estimate we assume the annuitants and their 

dependents are aged 65 or older and the employees 

and their dependents are under age 65, so that the 

Federal Government’s employee health plans cover 

5.3 million persons under age 65. 

Thus, overall we estimate there are 27.2 million 

persons under age 65 enrolled in private health 

insurance sponsored by government employers. Of 

those, 38.3 percent are women aged 15–64, that is, 

10.5 million. 

87 Kaiser Family Foundation & Health Research & 

Educational Trust, ‘‘Employer Health Benefits, 2010 

Annual Survey’’ at 196, available at https://kaiser

familyfoundation.files.wordpress.com/2013/04/

8085.pdf. 

88Some of the 31 percent of survey respondents 

that did not know about contraceptive coverage 

may not have offered such coverage. If it were 

possible to account for this non-coverage, the 

estimate of potentially affected covered women 

could increase. On the other hand, these employers’ 

lack of knowledge about contraceptive coverage 

suggests that they lacked sincerely held religious 

beliefs specifically objecting to such coverage— 

beliefs without which they would not qualify for 

the expanded exemptions offered by these rules. In 

that case, omission of such employers and covered 

women from this estimation approach would be 

appropriate. Correspondingly, the 6 percent of 

employers that had direct knowledge about the 

absence of coverage may be more likely to have 

omitted such coverage on the basis of religious 

beliefs than were the 31 percent of survey 

respondents who did not know whether the 

coverage was offered. Yet an entity’s mere 

knowledge about its coverage status does not itself 

reflect its motive for omitting coverage. In 

responding to the survey, the entity may have 

simply examined its plan document to determine 

whether or not contraceptive coverage was offered. 

As will be relevant in a later portion of the analysis, 

we have no data indicating what portion of the 

entities that omitted contraceptive coverage preAffordable Care Act did so on the basis of sincerely 

held religious beliefs, as opposed to doing so for 

other reasons that would not qualify them for the 

expanded exemption offered in these interim final 

rules. 

89For example, 42 U.S.C. 300a–7(b), 42 U.S.C. 

238n, and Consolidated Appropriations Act of 

2017, Div. H, Title V, Sec. 507(d), Public Law 115– 

31. 

90 John Asker, et al., ‘‘Corporate Investment and 

Stock Market Listing: A Puzzle?’’ 28 Review of 

Financial Studies Issue 2, at 342–390 (Oct. 7, 2014), 

available at https://doi.org/10.1093/rfs/hhu077. 

This is true even though there are only about 4,300 

publicly traded companies in the U.S. See Rayhanul 

Ibrahim, ‘‘The number of publicly-traded US 

companies is down 46% in the past two decades,’’ 

Yahoo! Finance (Aug. 8, 2016), available at https:// 

finance.yahoo.com/news/jp-startup-publiccompanies-fewer-000000709.html. 

The expanded exemption in these 

interim final rules does not apply to 

government plan sponsors. Thus we 

estimate that the number of women aged 

15 to 64 covered by private sector 

employer sponsored insurance who 

receive preventive services coverage 

under the Affordable Care Act is 

approximately 36 million. 

Prior to the implementation of the 

Affordable Care Act, approximately 6 

percent of employer survey respondents 

did not offer contraceptive coverage, 

with 31 percent of respondents not 

knowing whether they offered such 

coverage.87 The 6 percent may have 

included approximately 2.16 million of 

the women aged 15–64 covered by 

employer sponsored insurance plans in 

the private sector. According to Census 

data, 59.9 percent of women aged 15 to 

64 are of childbearing age (aged 15 to 

44), in this case, 1.3 million. And as 

noted above, approximately 44.3 

percent of women of childbearing age 

use women’s contraceptive methods 

covered by the Guidelines. Therefore we 

estimate that 574,000 women of 

childbearing age that use contraceptives 

covered by the Guidelines were covered 

by plans that omitted contraceptive 

coverage prior to the Affordable Care 

Act.88

It is unknown what motivated those 

employers to omit contraceptive 

coverage—whether they did so for 

conscientious reasons, or for other 

reasons. Despite our lack of information 

about their motives, we attempt to make 

a reasonable estimate of the upper 

bound of the number of those employers 

that omitted contraception before the 

Affordable Care Act and that would 

make use of these expanded exemptions 

based on sincerely held religious beliefs. 

To begin, we estimate that publicly 

traded companies would not likely 

make use of these expanded 

exemptions. Even though the rule does 

not preclude publicly traded companies 

from dropping coverage based on a 

sincerely held religious belief, it is 

likely that attempts to object on 

religious grounds by publicly traded 

companies would be rare. The 

Departments take note of the Supreme 

Court’s decision in Hobby Lobby, where 

the Court observed that ‘‘HHS has not 

pointed to any example of a publicly 

traded corporation asserting RFRA 

rights, and numerous practical restraints 

would likely prevent that from 

occurring. For example, the idea that 

unrelated shareholders—including 

institutional investors with their own 

set of stakeholders—would agree to run 

a corporation under the same religious 

beliefs seems improbable’’. 134 S. Ct. at 

2774. The Departments are aware of 

several Federal health care conscience 

laws 89 that in some cases have existed 

for decades and that protect companies, 

including publicly traded companies, 

from discrimination if, for example, 

they decline to facilitate abortion, but 

we are not aware of examples where 

publicly traded companies have made 

use of these exemptions. Thus, while we 

consider it important to include 

publicly traded companies in the scope 

of these expanded exemptions for 

reasons similar to those used by the 

Congress in RFRA and some health care 

conscience laws, in estimating the 

anticipated effects of the expanded 

exemptions we agree with the Supreme 

Court that it is improbable any will do 

so. 

This assumption is significant 

because 31.3 percent of employees in 

the private sector work for publicly 

traded companies.90 That means that 

only approximately 394,000 women 

aged 15 to 44 that use contraceptives 

covered by the Guidelines were covered 

by plans of non-publicly traded 

companies that did not provide 

contraceptive coverage pre-Affordable 

Care Act. 

Moreover, these interim final rules 

build on existing rules that already 

exempt houses of worship and 

integrated auxiliaries and, as explained 

above, effectively remove obligations to 

provide contraceptive coverage within 

objecting self-insured church plans. 

These rules will therefore not effect 

transfers to women in the plans of such 

employers. In attempting to estimate the 

number of such employers, we consider 

the following information. Many 

Catholic dioceses have litigated or filed 

public comments opposing the 

Mandate, representing to the 

Departments and to courts around the 

country that official Catholic Church 

teaching opposes contraception. There 

are 17,651 Catholic parishes in the 


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91Roman Catholic Diocese of Reno, ‘‘Diocese of 

Reno Directory: 2016–2017,’’ available at http://

www.renodiocese.org/documents/2016/9/

2016%202017%20directory.pdf. 

92Wikipedia, ‘‘List of Catholic dioceses in the 

United States,’’ available at https://

en.wikipedia.org/wiki/List_of_Catholic_dioceses_

in_the_United_States. 

93National Catholic Educational Association, 

‘‘Catholic School Data,’’ available at http://

www.ncea.org/NCEA/Proclaim/Catholic_School_

Data/Catholic_School_Data.aspx. 

94 Guidestone Financial Resources, ‘‘Who We 

Serve,’’ available at https://www.guidestone.org/

AboutUs/WhoWeServe. 

95On the other hand, a key input in the approach 

that generated the one third threshold estimate was 

a survey indicating that six percent of employers 

did not provide contraceptive coverage preAffordable Care Act. Employers that covered some 

contraceptives pre-Affordable Care Act may have 

answered ‘‘yes’’ or ‘‘don’t know’’ to the survey. In 

such cases, the potential transfer estimate has a 

tendency toward underestimation because the rule’s 

effects on such women—causing their contraceptive 

coverage to be reduced from all 18 methods to some 

smaller subset—have been omitted from the 

calculation. 

96Such objections may be encompassed by 

companion interim final rules published elsewhere 

in this Federal Register. Those rules, however, as 

an interim final matter, are more narrow in scope 

than these rules. For example, in providing 

expanded exemptions for plan sponsors, they do 

not encompass companies with certain publicly 

traded ownership interests. 

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

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

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

United States,91 197 Catholic dioceses,92

5,224 Catholic elementary schools, and 

1,205 Catholic secondary schools.93 Not 

all Catholic schools are integrated 

auxiliaries of Catholic churches, but 

there are other Catholic entities that are 

integrated auxiliaries that are not 

schools, so we use the number of 

schools to estimate of the number of 

integrated auxiliaries. Among selfinsured church plans that oppose the 

Mandate, the Department has been sued 

by two—Guidestone and Christian 

Brothers. Guidestone is a plan organized 

by the Southern Baptist convention. It 

covers 38,000 employers, some of which 

are exempt as churches or integrated 

auxiliaries, and some of which are not.94

Christian Brothers is a plan that covers 

Catholic organizations. It covers 

Catholic churches and integrated 

auxiliaries, which are estimated above, 

but also it has said in litigation that it 

also covers about 500 additional entities 

that are not exempt as churches. In total, 

therefore, we estimate that 

approximately 62,000 employers among 

houses of worship, integrated 

auxiliaries, and church plans, were 

exempt or relieved of contraceptive 

coverage obligations under the previous 

rules. We do not know how many 

persons are covered in the plans of 

those employers. Guidestone reports 

that among its 38,000 employers, its 

plan covers approximately 220,000 

persons, and its employers include 

‘‘churches, mission-sending agencies, 

hospitals, educational institutions and 

other related ministries.’’ Using that 

ratio, we estimate that the 62,000 

church and church plan employers 

among Guidestone, Christian Brothers, 

and Catholic churches would include 

359,000 persons. Among them, as 

referenced above, 72,500 would be of 

childbearing age, and 32,100 would use 

contraceptives covered by the 

Guidelines. Therefore, we estimate that 

the private, non-publicly traded 

employers that did not cover 

contraception pre-Affordable Care Act, 

and that were not exempt by the 

previous rules nor were participants in 

self-insured church plans that oppose 

contraceptive coverage, covered 362,100 

women aged 15 to 44 that use 

contraceptives covered by the 

Guidelines. As noted above, we estimate 

an average annual expenditure on 

contraceptive products and services of 

$584 per user. That would amount to 

$211.5 million in potential transfer 

impact among entities that did not cover 

contraception pre- Affordable Care Act 

for any reason. 

We do not have data indicating how 

many of the entities that omitted 

coverage of contraception preAffordable Care Act did so on the basis 

of sincerely held religious beliefs that 

might qualify them for exempt status 

under these interim final rules, as 

opposed to having done so for other 

reasons. Besides the entities that filed 

lawsuits or submitted public comments 

concerning previous rules on this 

matter, we are not aware of entities that 

omitted contraception pre-Affordable 

Care Act and then opposed the 

contraceptive coverage requirement 

after it was imposed by the Guidelines. 

For the following reasons, however, we 

believe that a reasonable estimate is that 

no more than approximately one third 

of the persons covered by relevant 

entities—that is, no more than 

approximately 120,000 affected 

women—would likely be subject to 

potential transfer impacts under the 

expanded religious exemptions offered 

in these interim final rules. 

Consequently, as explained below, we 

believe that the potential impact of 

these interim final rules falls 

substantially below the $100 million 

threshold for economically significant 

and major rules. 

First, as mentioned, we are not aware 

of information that would lead us to 

estimate that all or most entities that 

omitted coverage of contraception preAffordable Care Act did so on the basis 

of sincerely held conscientious 

objections in general or religious beliefs 

specifically, as opposed to having done 

so for other reasons. Moreover, as 

suggested by the Guidestone data 

mentioned previously, employers with 

conscientious objections may tend to 

have relatively few employees. Also, 

avoiding negative publicity, the 

difficulty of taking away a fringe benefit 

that employees have become 

accustomed to having, and avoiding the 

administrative cost of renegotiating 

insurance contracts, all provide reasons 

for some employers not to return to preAffordable Care Act lack of 

contraceptive coverage. Additionally, as 

discussed above, many employers with 

objections to contraception, including 

several of the largest litigants, only 

object to some contraceptives and cover 

as many as 14 of 18 of the contraceptive 

methods included in the Guidelines. 

This will reduce, and potentially 

eliminate, the contraceptive cost 

transfer for women covered in their 

plans.95 Furthermore, among nonprofit 

entities that object to the Mandate, it is 

possible that a greater share of their 

employees oppose contraception than 

among the general population, which 

should lead to a reduction in the 

estimate of how many women in those 

plans actually use contraception. 

In addition, not all sincerely held 

conscientious objections to 

contraceptive coverage are likely to be 

held by persons with religious beliefs as 

distinct from persons with sincerely 

held non-religious moral convictions, 

whose objections would not be 

encompassed by these interim final 

rules.96 We do not have data to indicate, 

among entities that did not cover 

contraception pre-Affordable Care Act 

based on sincerely held conscientious 

objections as opposed to other reasons, 

which ones did so based on religious 

beliefs and which ones did so instead 

based on non-religious moral 

convictions. Among the general public, 

polls vary about religious beliefs but one 

prominent poll shows that 89 percent of 

Americans say they believe in God, 

while 11 percent say they do not or are 

agnostic.97 Therefore, we estimate that 

for every ten entities that omitted 

contraception pre-Affordable Care Act 

based on sincerely held conscientious 

objections as opposed to other reasons, 

one did so based on sincerely held nonreligious moral convictions, and 

therefore are not affected by the 

expanded exemption provided by these 

interim final rules for religious beliefs. 

Based on our estimate of an average 

annual expenditure on contraceptive 

products and services of $584 per user, 


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98May 2016 National Occupational Employment 

and Wage Estimates United States found at https:// 

www.bls.gov/oes/current/oes_nat.htm. 

the effect of the expanded exemptions 

on 120,000 women would give rise to 

approximately $70.1 million in 

potential transfer impact. This falls 

substantially below the $100 million 

threshold for economically significant 

and major rules. In addition, as noted 

above, premiums may be expected to 

adjust to reflect changes in coverage, 

thus partially offsetting the transfer 

experienced by women who use the 

affected contraceptives. As discussed 

elsewhere in this analysis, such women 

may make up approximately 8.9 percent 

(= 20.2 percent × 44.3 percent) of the 

covered population, in which case the 

offset would also be approximately 8.9 

percent, yielding a potential transfer of 

$63.8 million. 

We request comment on all aspects of 

the preceding regulatory impact 

analysis, as well as on how to attribute 

impacts to this interim final rule and the 

companion interim final rule 

concerning exemptions provided based 

on sincerely held (non-religious) moral 

convictions published elsewhere in this 

Federal Register. 

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 anticipate that 

there will be more entities reluctantly 

using the existing accommodation that 

will choose to operate under the newly 

expanded exemption, than entities that 

are not currently eligible to use the 

accommodation that will opt into it. The 

effect of this rule will therefore be that 

fewer overall adjustments are made to 

the Federally facilitated Exchange user 

fees for entities using the 

accommodation process, as long as the 

Secretary of the Department of Health 

and Human Services requests and an 

authorizing exception under OMB 

Circular No. A–25R is in effect, than 

would have occurred under the 

previous rule if this rule were not 

finalized. 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 

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, and 

in many cases will relieve burdens and 

costs from such entities. By exempting 

from the Mandate small businesses and 

nonprofit organizations with religious 

objections to some (or all) 

contraceptives and/or sterilization, the 

Departments have reduced regulatory 

burden on such 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. 

However, we are requesting an 

emergency review of the information 

collection referenced later in this 

section. In compliance with the 

requirement of section 3506(c)(2)(A) of 

the PRA, we have submitted the 

following for emergency review to the 

Office of Management and Budget 

(OMB). We are requesting an emergency 

review and approval under both 5 CFR 

1320.13(a)(2)(i) and (iii) of the 

implementing regulations of the PRA in 

order to implement 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)). In 

accordance with 5 CFR 1320.13(a)(2)(i), 

we believe public harm is reasonably 

likely to ensue if the normal clearance 

procedures are followed. The use of 

normal clearance procedures is 

reasonably likely to prevent or disrupt 

the collection of information. Similarly, 

in accordance with 5 CFR 

1320.13(a)(2)(iii), we believe the use of 

normal clearance procedures is 

reasonably likely to cause a statutory or 

court ordered deadline to be missed. 

Many cases have been on remand for 

over a year from the Supreme Court, 

asking the Departments and the parties 

to resolve this matter. These interim 

final rules extend exemptions to 

entities, which involves no collection of 

information and which the Departments 

have statutory authority to do by the use 

of interim final rules. If the information 

collection involved in the amended 

accommodation process is not approved 

on an emergency basis, newly exempt 

entities that wish to opt into the 

amended accommodation process might 

not be able to do so until normal 

clearance procedures are completed. 

A description of the information 

collection provisions implicated in 

these interim final rules is given in the 

following section with an estimate of 

the annual burden. Average labor costs 

(including 100 percent fringe benefits) 

used to estimate the costs are calculated 

using data available from the Bureau of 

Labor Statistics.98

a. ICRs Regarding Self-Certification or 

Notices to HHS (§ 147.131(c)(3)) 

Each organization seeking to be 

treated as an eligible organization that 

wishes to use the optional 

accommodation process offered under 


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99For purposes of this analysis, the Department 

assumes that the same amount of time will be 

required to prepare the self-certification and the 

notice to HHS. 

100Occupation code 43–6011 for Executive 

Secretaries and Executive Administrative Assistants 

with mean hourly wage $27.84, https://

www.bls.gov/oes/current/oes436011.htm. 

101Occupation code 11–3111 for Compensation 

and Benefits Managers with mean hourly wage 

$61.01, https://www.bls.gov/oes/current/

oes113111.htm. 

102Occupation code 23–1011 for Lawyers with 

mean hourly wage $67.25, https://www.bls.gov/oes/ 

current/oes231011.htm. 

103Occupation code11–1011 for Chief Executives 

with mean hourly wage $93.44, https://

www.bls.gov/oes/current/oes111011.htm. 

104Occupation code 43–6011 for Executive 

Secretaries and Executive Administrative Assistants 

with mean hourly wage $27.84. 105Occupation code 11–1021 General and 

Operations Managers with mean hourly wage 

$58.70. 

these interim final rules must either use 

the EBSA Form 700 method of selfcertification or provide notice to HHS of 

its religious objection to coverage of all 

or a subset of contraceptive services. 

Specifically, these interim final rules 

continue to allow eligible organizations 

to notify an issuer or third party 

administrator using EBSA Form 700, or 

to notify HHS, of their religious 

objection to coverage of all or a subset 

of contraceptive services, as set forth in 

the July 2015 final regulations. The 

burden related to the notice to HHS is 

currently approved under OMB Control 

Number 0938–1248 and the burden 

related to the self-certification (EBSA 

Form 700) is currently approved under 

OMB control number 0938–1292. 

Notably, however, entities that are 

participating in the previous 

accommodation process, where a selfcertification or notice has already been 

submitted, and where the entities 

choose to continue their accommodated 

status under these interim final rules, 

generally do not need to file a new selfcertification or notice (unless they 

change their issuer or third party 

administrator). As explained above, 

HHS assumes that, among the 209 

entities we estimated are using the 

previous accommodation, 109 will use 

the expanded exemption and 100 will 

continue under the voluntary 

accommodation. Those 100 entities will 

not need to file additional selfcertifications or notices. HHS also 

assumes that an additional 9 entities 

that were not using the previous 

accommodation will opt into it. Those 

entities will be subject to the selfcertification or notice requirement. 

In order to estimate the cost for an 

entity that chooses to opt into the 

accommodation process, HHS assumes, 

as it did in its August 2014 interim final 

rules, that clerical staff for each eligible 

organization will gather and enter the 

necessary information and send the selfcertification to the issuer or third party 

administrator as appropriate, or send 

the notice to HHS.99 HHS assumes that 

a compensation and benefits manager 

and inside legal counsel will review the 

self-certification or notice to HHS and a 

senior executive would execute it. HHS 

estimates that an eligible organization 

would spend approximately 50 minutes 

(30 minutes of clerical labor at a cost of 

$55.68 per hour,100 10 minutes for a 

compensation and benefits manager at a 

cost of $122.02 per hour,101 5 minutes 

for legal counsel at a cost of $134.50 per 

hour,102 and 5 minutes by a senior 

executive at a cost of $186.88 per 

hour 103) preparing and sending the selfcertification or notice to HHS and filing 

it to meet the recordkeeping 

requirement. Therefore, the total annual 

burden for preparing and providing the 

information in the self-certification or 

notice to HHS will require 

approximately 50 minutes for each 

eligible organization with an equivalent 

cost burden of approximately $74.96 for 

a total hour burden of approximately 7.5 

hours with an equivalent cost of 

approximately $675 for 9 entities. As 

DOL and HHS share jurisdiction, they 

are splitting the hour burden so each 

will account for approximately 3.75 

burden hours with an equivalent cost of 

approximately $337. 

HHS estimates that each selfcertification or notice to HHS will 

require $0.49 in postage and $0.05 in 

materials cost (paper and ink) and the 

total postage and materials cost for each 

self-certification or notice sent via mail 

will be $0.54. For purposes of this 

analysis, HHS assumes that 50 percent 

of self-certifications or notices to HHS 

will be mailed. The total cost for 

sending the self-certifications or notices 

to HHS by mail is approximately $2.70 

for 5 entities. As DOL and HHS share 

jurisdiction they are splitting the cost 

burden so each will account for $1.35 of 

the cost burden. 

b. ICRs Regarding Notice of Availability 

of Separate Payments for Contraceptive 

Services (§ 147.131(e)) 

As required by the July 2015 final 

regulations, a health insurance issuer or 

third party administrator providing or 

arranging separate payments for 

contraceptive services for participants 

and beneficiaries in insured or selfinsured group health plans (or student 

enrollees and covered dependents in 

student health insurance coverage) of 

eligible organizations is required to 

provide a written notice to plan 

participants and beneficiaries (or 

student enrollees and covered 

dependents) informing them of the 

availability of such payments. The 

notice must be separate from, but 

contemporaneous with (to the extent 

possible), any application materials 

distributed in connection with 

enrollment (or re-enrollment) in group 

or student coverage of the eligible 

organization in any plan year to which 

the accommodation is to apply and will 

be provided annually. To satisfy the 

notice requirement, issuers and third 

party administrators may, but are not 

required to, use the model language set 

forth previously by HHS or substantially 

similar language. The burden for this 

ICR is currently approved under OMB 

control number 0938–1292. 

As mentioned, HHS is anticipating 

that approximately 109 entities will use 

the optional accommodation (100 that 

used it previously, and 9 that will newly 

opt into it). It is unknown how many 

issuers or third party administrators 

provide health insurance coverage or 

services in connection with health plans 

of eligible organizations, but HHS will 

assume at least 109. It is estimated that 

each issuer or third party administrator 

will need approximately 1 hour of 

clerical labor (at $55.68 per hour) 104

and 15 minutes of management review 

(at $117.40 per hour) 105 to prepare the 

notices. The total burden for each issuer 

or third party administrator to prepare 

notices will be 1.25 hours with an 

equivalent cost of approximately $85.03. 

The total burden for all issuers or third 

party administrators will be 136 hours, 

with an equivalent cost of $9,268. As 

DOL and HHS share jurisdiction, they 

are splitting the hour burden so each 

will account for 68 burden hours with 

an equivalent cost of $4,634, with 

approximately 55 respondents. 

As discussed above, the Departments 

estimate that 770,000 persons will be 

covered in the plans of the 100 entities 

that previously used the 

accommodation and will continue doing 

so, and that an additional 9 entities will 

newly opt into the accommodation. It is 

not known how many persons will be 

covered in the plans of the 9 entities 

newly using the accommodation. 

Assuming that those 9 entities will have 

a similar number of covered persons per 

entity, we estimate that all 109 

accommodated entities will encompass 

839,300 covered persons. We assume 

that sending one notice to each 

participant will satisfy the need to send 

the notices to all participants and 

dependents. Among persons covered by 

plans, approximately 50.1 percent are 

participants and 49.9 percent are 


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106 ‘‘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. 

107According to data from the National 

Telecommunications and Information Agency 

(NTIA), 36.0 percent of individuals age 25 and over 

have access to the Internet at work. According to 

a Greenwald & Associates survey, 84 percent of 

plan participants find it acceptable to make 

electronic delivery the default option, which is 

used as the proxy for the number of participants 

who will not opt out that are automatically enrolled 

(for a total of 30.2 percent receiving electronic 

disclosure at work). Additionally, the NTIA reports 

that 38.5 percent of individuals age 25 and over 

have access to the Internet outside of work. 

According to a Pew Research Center survey, 61 

percent of Internet users use online banking, which 

is used as the proxy for the number of Internet users 

who will opt in for electronic disclosure (for a total 

of 23.5 percent receiving electronic disclosure 

outside of work). Combining the 30.2 percent who 

receive electronic disclosure at work with the 23.5 

percent who receive electronic disclosure outside of 

work produces a total of 53.7 percent who will 

receive electronic disclosure overall. 

108Occupation code 11–1021 for General and 

Operations Managers with mean hourly wage 

$58.70, https://www.bls.gov/oes/current/

oes111021.htm. 109Occupation code 23–1011 for Lawyers with 

mean hourly wage $67.25, https://www.bls.gov/oes/ 

current/oes231011.htm. 

110Occupation code 43–6011 for Executive 

Secretaries and Executive Administrative Assistants 

with mean hourly wage $27.84, https://

www.bls.gov/oes/current/oes436011.htm. 

111 In estimating the number of women that might 

have their contraceptive coverage affected by the 

expanded exemption, we indicated that we do not 

know the extent to which the number of women in 

accommodated plans affected by these rules overlap 

with the number of women in plans offered by 

litigating entities that will be affected by these 

rules, though we assume there is significant 

overlap. That uncertainty should not affect the 

calculation of the ICRs for revocation notices, 

however. If the two numbers overlap, the estimates 

of plans revoking the accommodation and 

policyholders covered in those plans would already 

include plans and policyholders of litigating 

entities. If the numbers do not overlap, those 

litigating entity plans would not presently be 

enrolled in the accommodation, and therefore 

would not need to send notices concerning 

revocation of accommodated status. 

dependents.106 For 109 entities, the total 

number of notices will be 420,490. For 

purposes of this analysis, the 

Departments also assume that 53.7 

percent of notices will be sent 

electronically, and 46.3 percent will be 

mailed.107 Therefore, approximately 

194,687 notices will be mailed. HHS 

estimates that each notice will require 

$0.49 in postage and $0.05 in materials 

cost (paper and ink) and the total 

postage and materials cost for each 

notice sent via mail will be $0.54. The 

total cost for sending approximately 

194,687 notices by mail is 

approximately $105,131. As DOL and 

HHS share jurisdiction, they are 

splitting the cost burden so each will 

account for $52,565 of the cost burden. 

c. ICRs Regarding Notice of Revocation 

of Accommodation (§ 147.131(c)(4)) 

An eligible organization may revoke 

its use of the accommodation process; 

its issuer or third party administrator 

must provide written notice of such 

revocation to participants and 

beneficiaries as soon as practicable. As 

discussed above, HHS estimates that 

109 entities that are using the 

accommodation process will revoke 

their use of the accommodation, and 

will therefore be required to cause the 

notification to be sent (the issuer or 

third party administrator can send the 

notice on behalf of the entity). For the 

purpose of calculating ICRs associated 

with revocations of the accommodation, 

and for various reasons discussed above, 

HHS assumes that litigating entities that 

were previously using the 

accommodation and that will revoke it 

fall within the estimated 109 entities 

that will revoke the accommodation 

overall. 

As before, HHS assumes that, for each 

issuer or third party administrator, a 

manager and inside legal counsel and 

clerical staff will need approximately 2 

hours to prepare and send the 

notification to participants and 

beneficiaries and maintain records (30 

minutes for a manager at a cost of 

$117.40 per hour,108 30 minutes for 

legal counsel at a cost of $134.50 per 

hour 109, 1 hour for clerical labor at a 

cost of $55.68 per hour 110). The burden 

per respondent will be 2 hours with an 

equivalent cost of $181.63; for 109 

entities, the total burden will be 218 

hours with an equivalent cost of 

approximately $19,798. As DOL and 

HHS share jurisdiction, they are 

splitting the hour burden so each will 

account for 109 burden hours with an 

equivalent cost of approximately $9,899. 

As discussed above, HHS estimates 

that there are 257,000 covered persons 

in accommodated plans that will revoke 

their accommodated status and use the 

expanded exemption.111 As before, we 

use the average of 50.1 percent of 

covered persons who are policyholders, 

and estimate that an average of 53.7 

percent of notices will be sent 

electronically and 46.3 percent by mail. 

Therefore, approximately 128,757 

notices will be sent, of which 59,615 

notices will be mailed. HHS estimates 

that each notice will require $0.49 in 

postage and $0.05 in materials cost 

(paper and ink) and the total postage 

and materials cost for each notice sent 

via mail will be $0.54. The total cost for 

sending approximately 59,615 notices 

by mail is approximately $32,192. As 

DOL and HHS share jurisdiction, they 

are splitting the hour burden so each 

will account for 64,379 notices, with an 

equivalent cost of approximately 

$16,096. 

TABLE 1—SUMMARY OF INFORMATION COLLECTION BURDENS

Regulation section OMB 

control No. 

Number of 

respondents Responses 

Burden per 

respondent 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

($) 

Total labor 

cost of 

reporting 

($) 

Total cost 

($) 

Self-Certification or Notices to HHS ....... 0938—NEW ... *5 5 0.83 3.75 $89.95 $337.31 $338.66 

Notice of Availability of Separate Payments for Contraceptive Services.0938—NEW ... *55 210,245 1.25 68.13 68.02 4,634.14 57,199.59 

Notice of Revocation of Accommodation 0938—NEW ... *55 64,379 2.00 109 90.82 9,898.84 25,994.75 

Total ................................................ ........................ *115 274,629 4.08 180.88 ...................... 14,870.29 83,533.00 

* The total number of respondents is 227 (= 9+109+109) for both HHS and DOL, but the summaries here and below exceed that total because of rounding up that 

occurs when sharing the burden between HHS and DOL. 

Note: There are no capital/maintenance costs associated with the ICRs contained in this rule; therefore, we have removed the associated column from Table 1. 

Postage and material costs are included in Total Cost. 

We are soliciting comments on all of 

the information collection requirements 

contained in these interim final rules. In 

addition, we are also soliciting 

comments on all of the related 

information collection requirements 

currently approved under 0938–1292 

and 0938–1248. HHS is requesting a 

new OMB control number that will 

ultimately contain the approval for the 

new information collection 

requirements contained in these interim 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47827 

112 Denotes that there is an overlap between 

jurisdiction shared by HHS and DOL over these 

respondents and therefore they are included only 

once in the total. 

final rules as well as the related 

requirements currently approved under 

0938–1292 and 0938–1248. In an effort 

to consolidate the number of 

information collection requests, we will 

formally discontinue the control 

numbers 0938–1292 and 0938–1248 

once the new information collection 

request associated with these interim 

final rules is approved. 

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. 

These interim final rules amend the 

ICR by changing the accommodation 

process to an optional process for 

exempt organizations and requiring a 

notice of revocation to be sent by the 

issuer or third party administrator to 

participants and beneficiaries in plans 

whose employer who revokes their 

accommodation. DOL submitted the 

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. In an effort to consolidate the 

number of information collection 

requests, DOL will combine the ICR 

related to the OMB control number 

1210–0152 with the ICR related to the 

OMB control number 1210–0150. Once 

the ICR is approved DOL will 

discontinue 1210–0152. 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 will allow respondents to 

temporarily utilize the additional 

flexibility these interim final regulations 

provide, while DOL seeks public 

comment on the collection methods— 

including their utility and burden. 

Consistent with the analysis in the 

HHS PRA section above, the 

Departments expect that each of the 

estimated 9 eligible organizations newly 

opting into the accommodation will 

spend approximately 50 minutes in 

preparation time and incur $0.54 

mailing cost to self-certify or notify 

HHS. Each of the 109 issuers or third 

party administrators for the 109 eligible 

organizations that make use of the 

accommodation overall will distribute 

Notices of Availability of Separate 

Payments for Contraceptive Services. 

These issuers and third party 

administrators will spend 

approximately 1.25 hours in preparation 

time and incur $0.54 cost per mailed 

notice. Notices of Availability of 

Separate Payments for Contraceptive 

Services will need to be sent to 420,489 

policyholders, and 53.7 percent of the 

notices will be sent electronically, while 

46.3 percent will be mailed. Finally, 109 

entities using the previous 

accommodation process will revoke its 

use and will therefore be required to 

cause the Notice of Revocation of 

Accommodation to be sent (the issuer or 

third party administrator can send the 

notice on behalf of the entity). These 

entities will spend approximately two 

hours in preparation time and incur 

$0.54 cost per mailed notice. Notice of 

Revocation of Accommodation will 

need to be sent to an average of 128,757 

policyholders and 53.7 percent of the 

notices will be sent electronically. The 

DOL information collections in this rule 

are found in 29 CFR 2510.3–16 and 

2590.715–2713A and are summarized as 

follows: 

Type of Review: Revised Collection. 

Agency: DOL–EBSA. 

Title: Coverage of Certain Preventive 

Services under the Affordable Care 

Act—Private Sector. 

OMB Numbers: 1210–0150. 

Affected Public: Private Sector—Not 

for profit and religious organizations; 

businesses or other for-profits. 

Total Respondents: 114 112 (combined 

with HHS total is 227). 

Total Responses: 274,628 (combined 

with HHS total is 549,255). 

Frequency of Response: On occasion. 

Estimated Total Annual Burden 

Hours: 181 (combined with HHS total is 

362 hours). 

Estimated Total Annual Burden Cost: 

$68,662 (combined with HHS total is 

$137,325). 

Type of Review: Revised Collection. 

Agency: DOL–EBSA. 

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 

the Department of Health and Human 

Services 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, RFRA, 

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 


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47828 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

113Other noteworthy potential impacts 

encompass potential changes in medical 

expenditures, including potential decreased 

expenditures on contraceptive devices and drugs 

and potential increased expenditures on pregnancyrelated medical services. OMB’s guidance on E.O. 

13771 implementation (https://

www.whitehouse.gov/the-press-office/2017/04/05/

memorandum-implementing-executive-order13771-titled-reducing-regulation) states that impacts 

should be categorized as consistently as possible 

within Departments. The Food and Drug 

Administration, within HHS, and the Occupational 

Safety and Health Administration (OSHA) and 

Mine Safety and Health Administration (MSHA), 

within DOL, regularly estimate medical expenditure 

impacts in the analyses that accompany their 

regulations, with the results being categorized as 

benefits (positive benefits if expenditures are 

reduced, negative benefits if expenditures are 

raised). Following the FDA, OSHA and MSHA 

accounting convention leads to 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. 

costs.113 Therefore, this interim final 

rule is considered an Executive Order 

13771 deregulatory action. 

F. 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 Deflater 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. 

G. 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. 

VII. 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, 

Public Law 111–148, 124 Stat. 119 (42 

U.S.C. 18021–18024, 18031–18032, 

18041–18042, 18044, 18054, 18061, 

18063, 18071, 18082, 26 U.S.C. 36B, and 

31 U.S.C. 9701). 

List of Subjects 

26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 2590 

Continuation coverage, Disclosure, 

Employee benefit plans, Group health 

plans, Health care, Health insurance, 

Medical child support, Reporting and 

recordkeeping requirements. 

45 CFR Part 147 

Health care, Health insurance, 

Reporting and recordkeeping 

requirements, State regulation of health 

insurance. 

Kirsten 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 * * * 

■ 2. Section 54.9815–2713 is amended 

by revising paragraphs (a)(1) 

introductory text and (a)(1)(iv) to read as 

follows: 

§ 54.9815–2713 Coverage of preventive 

health services. 

(a) * * * 

(1) In general. [Reserved]. For further 

guidance, see § 54.9815–2713T(a)(1) 

introductory text. 

* * * * * 

(iv) [Reserved]. For further guidance, 

see § 54.9815–2713T(a)(1)(iv). 

* * * * * 

■ 3. Section 54.9815–2713T is added to 

read as follows: 

§ 54.9815–2713T Coverage of preventive 

health services (temporary). 

(a) Services—(1) In general. Beginning 

at the time described in paragraph (b) of 

§ 54.9815–2713 and subject to 

§ 54.9815–2713A, a group health plan, 

or a health insurance issuer offering 

group health insurance coverage, must 

provide coverage for and must not 

impose any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible) for— 

(i)–(iii) [Reserved]. For further 

guidance, see § 54.9815–2713(a)(1)(i) 

through (iii). 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47829 

(iv) With respect to women, such 

additional preventive care and 

screenings not described in paragraph 

(a)(1)(i) of § 54.9815–2713 as provided 

for in comprehensive guidelines 

supported by the Health Resources and 

Services Administration for purposes of 

section 2713(a)(4) of the Public Health 

Service Act, subject to 45 CFR 147.131 

and 147.132. 

(2)–(c) [Reserved]. For further 

guidance, see § 54.9815–2713(a)(2) 

through (c). 

(d) Effective/Applicability date. (1) 

Paragraphs (a) through (c) of this section 

are applicable beginning on April 16, 

2012, except— 

(2) Paragraphs (a)(1) introductory text 

and (a)(1)(iv) of this section are effective 

on October 6, 2017. 

(e) Expiration date. This section 

expires on October 6, 2020. 

■ 4. Section 54.9815–2713A is revised 

to read as follows: 

§ 54.9815–2713A Accommodations in 

connection with coverage of preventive 

health services. 

(a) through (f) [Reserved]. For further 

guidance, see § 54.9815–2713AT. 

(b) 

■ 5. Section 54.9815–2713AT is added 

to read as follows: 

§ 54.9815–2713AT Accommodations in 

connection with coverage of preventive 

health services (temporary). 

(a) Eligible organizations for optional 

accommodation. An eligible 

organization is an organization that 

meets the criteria of paragraphs (a)(1) 

through (4) of this section. 

(1) The organization is an objecting 

entity described in 45 CFR 

147.132(a)(1)(i) or (ii); 

(2) Notwithstanding its status under 

paragraph (a)(1) of this section and 

under 45 CFR 147.132(a), the 

organization voluntarily seeks to be 

considered an eligible organization to 

invoke the optional accommodation 

under paragraph (b) or (c) of this section 

as applicable; and 

(3) [Reserved] 

(4) The organization self-certifies in 

the form and manner specified by the 

Secretary of Labor or provides notice to 

the Secretary of the Department of 

Health and Human Services as 

described in paragraph (b) or (c) of this 

section. To qualify as an eligible 

organization, the organization must 

make such self-certification or notice 

available for examination upon request 

by the first day of the first plan year to 

which the accommodation in paragraph 

(b) or (c) of this section applies. The 

self-certification or notice must be 

executed by a person authorized to 

make the certification or provide the 

notice on behalf of the organization, and 

must be maintained in a manner 

consistent with the record retention 

requirements under section 107 of 

ERISA. 

(5) An eligible organization may 

revoke its use of the accommodation 

process, and its issuer or third party 

administrator must provide participants 

and beneficiaries written notice of such 

revocation as specified in guidance 

issued by the Secretary of the 

Department of Health and Human 

Services. If contraceptive coverage is 

currently being offered by an issuer or 

third party administrator through the 

accommodation process, the revocation 

will be effective on the first day of the 

first plan year that begins on or after 30 

days after the date of the revocation (to 

allow for the provision of notice to plan 

participants in cases where 

contraceptive benefits will no longer be 

provided). Alternatively, an eligible 

organization may give sixty-days notice 

pursuant to section 2715(d)(4) of the 

PHS Act and § 54.9815–2715(b), if 

applicable, to revoke its use of the 

accommodation process. 

(b) Optional accommodation—selfinsured group health plans. (1) A group 

health plan established or maintained 

by an eligible organization that provides 

benefits on a self-insured basis may 

voluntarily elect an optional 

accommodation under which its third 

party administrator(s) will provide or 

arrange payments for all or a subset of 

contraceptive services for one or more 

plan years. To invoke the optional 

accommodation process: 

(i) The eligible organization or its plan 

must contract with one or more third 

party administrators. 

(ii) The eligible organization must 

provide either a copy of the selfcertification to each third party 

administrator or a notice to the 

Secretary of the Department of Health 

and Human Services that it is an eligible 

organization and of its objection as 

described in 45 CFR 147.132 to coverage 

of all or a subset of contraceptive 

services. 

(A) When a copy of the selfcertification is provided directly to a 

third party administrator, such selfcertification must include notice that 

obligations of the third party 

administrator are set forth in 29 CFR 

2510.3–16 and this section. 

(B) When a notice is provided to the 

Secretary of Health and Human 

Services, the notice must include the 

name of the eligible organization; a 

statement that it objects as described in 

45 CFR 147.132 to coverage of some or 

all contraceptive services (including an 

identification of the subset of 

contraceptive services to which 

coverage the eligible organization 

objects, if applicable), but that it would 

like to elect the optional 

accommodation process; the plan name 

and type (that is, whether it is a student 

health insurance plan within the 

meaning of 45 CFR 147.145(a) or a 

church plan within the meaning of 

section 3(33) of ERISA); and the name 

and contact information for any of the 

plan’s third party administrators. If 

there is a change in any of the 

information required to be included in 

the notice, the eligible organization 

must provide updated information to 

the Secretary of the Department of 

Health and Human Services for the 

optional accommodation process to 

remain in effect. The Department of 

Labor (working with the Department of 

Health and Human Services), will send 

a separate notification to each of the 

plan’s third party administrators 

informing the third party administrator 

that the Secretary of the Department of 

Health and Human Services has 

received a notice under paragraph 

(b)(1)(ii) of this section and describing 

the obligations of the third party 

administrator under 29 CFR 2510.3–16 

and this section. 

(2) If a third party administrator 

receives a copy of the self-certification 

from an eligible organization or a 

notification from the Department of 

Labor, as described in paragraph 

(b)(1)(ii) of this section, and is willing 

to enter into or remain in a contractual 

relationship with the eligible 

organization or its plan to provide 

administrative services for the plan, 

then the third party administrator will 

provide or arrange payments for 

contraceptive services, using one of the 

following methods— 

(i) Provide payments for the 

contraceptive services for plan 

participants and beneficiaries without 

imposing any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible), premium, fee, or other 

charge, or any portion thereof, directly 

or indirectly, on the eligible 

organization, the group health plan, or 

plan participants or beneficiaries; or 

(ii) Arrange for an issuer or other 

entity to provide payments for the 

contraceptive services for plan 

participants and beneficiaries without 

imposing any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible), premium, fee, or other 

charge, or any portion thereof, directly 

or indirectly, on the eligible 

organization, the group health plan, or 

plan participants or beneficiaries. 


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47830 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

(3) If a third party administrator 

provides or arranges payments for 

contraceptive services in accordance 

with either paragraph (b)(2)(i) or (ii) of 

this section, the costs of providing or 

arranging such payments may be 

reimbursed through an adjustment to 

the Federally facilitated Exchange user 

fee for a participating issuer pursuant to 

45 CFR 156.50(d). 

(4) A third party administrator may 

not require any documentation other 

than a copy of the self-certification from 

the eligible organization or notification 

from the Department of Labor described 

in paragraph (b)(1)(ii) of this section. 

(5) Where an otherwise eligible 

organization does not contract with a 

third party administrator and files a selfcertification or notice under paragraph 

(b)(1)(ii) of this section, the obligations 

under paragraph (b)(2) of this section do 

not apply, and the otherwise eligible 

organization is under no requirement to 

provide coverage or payments for 

contraceptive services to which it 

objects. The plan administrator for that 

otherwise eligible organization may, if it 

and the otherwise eligible organization 

choose, arrange for payments for 

contraceptive services from an issuer or 

other entity in accordance with 

paragraph (b)(2)(ii) of this section, and 

such issuer or other entity may receive 

reimbursements in accordance with 

paragraph (b)(3) of this section. 

(6) Where an otherwise eligible 

organization is an ERISA-exempt church 

plan within the meaning of section 3(33) 

of ERISA and it files a self-certification 

or notice under paragraph (b)(1)(ii) of 

this section, the obligations under 

paragraph (b)(2) of this section do not 

apply, and the otherwise eligible 

organization is under no requirement to 

provide coverage or payments for 

contraceptive services to which it 

objects. The third party administrator 

for that otherwise eligible organization 

may, if it and the otherwise eligible 

organization choose, provide or arrange 

payments for contraceptive services in 

accordance with paragraphs (b)(2)(i) or 

(ii) of this section, and receive 

reimbursements in accordance with 

paragraph (b)(3) of this section. 

(c) Optional accommodation— 

insured group health plans—(1) General 

rule. A group health plan established or 

maintained by an eligible organization 

that provides benefits through one or 

more group health insurance issuers 

may voluntarily elect an optional 

accommodation under which its health 

insurance issuer(s) will provide 

payments for all or a subset of 

contraceptive services for one or more 

plan years. To invoke the optional 

accommodation process— 

(i) The eligible organization or its plan 

must contract with one or more health 

insurance issuers. 

(ii) The eligible organization must 

provide either a copy of the selfcertification to each issuer providing 

coverage in connection with the plan or 

a notice to the Secretary of the 

Department of Health and Human 

Services that it is an eligible 

organization and of its objection as 

described in 45 CFR 147.132 to coverage 

for all or a subset of contraceptive 

services. 

(A) When a self-certification is 

provided directly to an issuer, the issuer 

has sole responsibility for providing 

such coverage in accordance with 

§ 54.9815–2713. 

(B) When a notice is provided to the 

Secretary of the Department Health and 

Human Services, the notice must 

include the name of the eligible 

organization; a statement that it objects 

as described in 45 CFR 147.132 to 

coverage of some or all contraceptive 

services (including an identification of 

the subset of contraceptive services to 

which coverage the eligible organization 

objects, if applicable) but that it would 

like to elect the optional 

accommodation process; the plan name 

and type (that is, whether it is a student 

health insurance plan within the 

meaning of 45 CFR 147.145(a) or a 

church plan within the meaning of 

section 3(33) of ERISA); and the name 

and contact information for any of the 

plan’s health insurance issuers. If there 

is a change in any of the information 

required to be included in the notice, 

the eligible organization must provide 

updated information to the Secretary of 

Department of Health and Human 

Services for the optional 

accommodation process to remain in 

effect. The Department of Health and 

Human Services will send a separate 

notification to each of the plan’s health 

insurance issuers informing the issuer 

that the Secretary of the Department 

Health and Human Services has 

received a notice under paragraph 

(c)(2)(ii) of this section and describing 

the obligations of the issuer under this 

section. 

(2) If an issuer receives a copy of the 

self-certification from an eligible 

organization or the notification from the 

Department of Health and Human 

Services as described in paragraph 

(c)(2)(ii) of this section and does not 

have its own objection as described in 

45 CFR 147.132 to providing the 

contraceptive services to which the 

eligible organization objects, then the 

issuer will provide payments for 

contraceptive services as follows— 

(i) The issuer must expressly exclude 

contraceptive coverage from the group 

health insurance coverage provided in 

connection with the group health plan 

and provide separate payments for any 

contraceptive services required to be 

covered under § 54.9815–2713(a)(1)(iv) 

for plan participants and beneficiaries 

for so long as they remain enrolled in 

the plan. 

(ii) With respect to payments for 

contraceptive services, the issuer may 

not impose any cost-sharing 

requirements (such as a copayment, 

coinsurance, or a deductible), or impose 

any premium, fee, or other charge, or 

any portion thereof, directly or 

indirectly, on the eligible organization, 

the group health plan, or plan 

participants or beneficiaries. The issuer 

must segregate premium revenue 

collected from the eligible organization 

from the monies used to provide 

payments for contraceptive services. 

The issuer must provide payments for 

contraceptive services in a manner that 

is consistent with the requirements 

under sections 2706, 2709, 2711, 2713, 

2719, and 2719A of the PHS Act, as 

incorporated into section 9815 of the 

PHS Act. If the group health plan of the 

eligible organization provides coverage 

for some but not all of any contraceptive 

services required to be covered under 

§ 54.9815–2713(a)(1)(iv), the issuer is 

required to provide payments only for 

those contraceptive services for which 

the group health plan does not provide 

coverage. However, the issuer may 

provide payments for all contraceptive 

services, at the issuer’s option. 

(3) A health insurance issuer may not 

require any documentation other than a 

copy of the self-certification from the 

eligible organization or the notification 

from the Department of Health and 

Human Services described in paragraph 

(c)(1)(ii) of this section. 

(d) Notice of availability of separate 

payments for contraceptive services— 

self-insured and insured group health 

plans. For each plan year to which the 

optional accommodation in paragraph 

(b) or (c) of this section is to apply, a 

third party administrator required to 

provide or arrange payments for 

contraceptive services pursuant to 

paragraph (b) of this section, and an 

issuer required to provide payments for 

contraceptive services pursuant to 

paragraph (c) of this section, must 

provide to plan participants and 

beneficiaries written notice of the 

availability of separate payments for 

contraceptive services contemporaneous 

with (to the extent possible), but 

separate from, any application materials 

distributed in connection with 

enrollment (or re-enrollment) in group 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47831 

health coverage that is effective 

beginning on the first day of each 

applicable plan year. The notice must 

specify that the eligible organization 

does not administer or fund 

contraceptive benefits, but that the third 

party administrator or issuer, as 

applicable, provides or arranges 

separate payments for contraceptive 

services, and must provide contact 

information for questions and 

complaints. The following model 

language, or substantially similar 

language, may be used to satisfy the 

notice requirement of this paragraph (d): 

‘‘Your employer has certified that your 

group health plan qualifies for an 

accommodation with respect to the 

Federal requirement to cover all Food 

and Drug Administration-approved 

contraceptive services for women, as 

prescribed by a health care provider, 

without cost sharing. This means that 

your employer will not contract, 

arrange, pay, or refer for contraceptive 

coverage. Instead, [name of third party 

administrator/health insurance issuer] 

will provide or arrange separate 

payments for contraceptive services that 

you use, without cost sharing and at no 

other cost, for so long as you are 

enrolled in your group health plan. 

Your employer will not administer or 

fund these payments. If you have any 

questions about this notice, contact 

[contact information for third party 

administrator/health insurance issuer].’’ 

(e) 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 

§ 54.9815–2713(a)(1)(iv). 

(f) 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. 

(g) Expiration date. This section 

expires on October 6, 2020. 

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 

■ 6. 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). 

■ 7. Section 2590.715–2713 is amended 

by revising paragraphs (a)(1) 

introductory text and (a)(1)(iv) to read as 

follows: 

§ 2590.715–2713 Coverage of preventive 

health services. 

(a) Services—(1) In general. Beginning 

at the time described in paragraph (b) of 

this section and subject to § 2590.715– 

2713A, a group health plan, or a health 

insurance issuer offering group health 

insurance coverage, must provide 

coverage for and must not impose any 

cost-sharing requirements (such as a 

copayment, coinsurance, or a 

deductible) for— 

* * * * * 

(iv) With respect to women, such 

additional preventive care and 

screenings not described in paragraph 

(a)(1)(i) of this section as provided for in 

comprehensive guidelines supported by 

the Health Resources and Services 

Administration for purposes of section 

2713(a)(4) of the Public Health Service 

Act, subject to 45 CFR 147.131 and 

147.132. 

* * * * * 

■ 8. Section 2590.715–2713A is revised 

to read as follows: 

§ 2590.715–2713A Accommodations in 

connection with coverage of preventive 

health services. 

(a) Eligible organizations for optional 

accommodation. An eligible 

organization is an organization that 

meets the criteria of paragraphs (a)(1) 

through (4) of this section. 

(1) The organization is an objecting 

entity described in 45 CFR 

147.132(a)(1)(i) or (ii); 

(2) Notwithstanding its exempt status 

under 45 CFR 147.132(a), the 

organization voluntarily seeks to be 

considered an eligible organization to 

invoke the optional accommodation 

under paragraph (b) or (c) of this section 

as applicable; and 

(3) [Reserved] 

(4) The organization self-certifies in 

the form and manner specified by the 

Secretary or provides notice to the 

Secretary of the Department of Health 

and Human Services as described in 

paragraph (b) or (c) of this section. To 

qualify as an eligible organization, the 

organization must make such selfcertification or notice available for 

examination upon request by the first 

day of the first plan year to which the 

accommodation in paragraph (b) or (c) 

of this section applies. The selfcertification or notice must be executed 

by a person authorized to make the 

certification or provide the notice on 

behalf of the organization, and must be 

maintained in a manner consistent with 

the record retention requirements under 

section 107 of ERISA. 

(5) An eligible organization may 

revoke its use of the accommodation 

process, and its issuer or third party 

administrator must provide participants 

and beneficiaries written notice of such 

revocation as specified in guidance 

issued by the Secretary of the 

Department of Health and Human 

Services. If contraceptive coverage is 

currently being offered by an issuer or 

third party administrator through the 

accommodation process, the revocation 

will be effective on the first day of the 

first plan year that begins on or after 30 

days after the date of the revocation (to 

allow for the provision of notice to plan 

participants in cases where 

contraceptive benefits will no longer be 

provided). Alternatively, an eligible 

organization may give 60-days notice 

pursuant to PHS Act section 2715(d)(4) 

and § 2590.715–2715(b), if applicable, to 

revoke its use of the accommodation 

process. 

(b) Optional accommodation—selfinsured group health plans. (1) A group 

health plan established or maintained 

by an eligible organization that provides 

benefits on a self-insured basis may 

voluntarily elect an optional 

accommodation under which its third 

party administrator(s) will provide or 

arrange payments for all or a subset of 

contraceptive services for one or more 

plan years. To invoke the optional 

accommodation process: 

(i) The eligible organization or its plan 

must contract with one or more third 

party administrators. 

(ii) The eligible organization must 

provide either a copy of the selfcertification to each third party 

administrator or a notice to the 

Secretary of the Department of Health 

and Human Services that it is an eligible 

organization and of its objection as 

described in 45 CFR 147.132 to coverage 

of all or a subset of contraceptive 

services. 


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47832 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

(A) When a copy of the selfcertification is provided directly to a 

third party administrator, such selfcertification must include notice that 

obligations of the third party 

administrator are set forth in § 2510.3– 

16 of this chapter and this section. 

(B) When a notice is provided to the 

Secretary of Health and Human 

Services, the notice must include the 

name of the eligible organization; a 

statement that it objects as described in 

45 CFR 147.132 to coverage of some or 

all contraceptive services (including an 

identification of the subset of 

contraceptive services to which 

coverage the eligible organization 

objects, if applicable), but that it would 

like to elect the optional 

accommodation process; the plan name 

and type (that is, whether it is a student 

health insurance plan within the 

meaning of 45 CFR 147.145(a) or a 

church plan within the meaning of 

section 3(33) of ERISA); and the name 

and contact information for any of the 

plan’s third party administrators. If 

there is a change in any of the 

information required to be included in 

the notice, the eligible organization 

must provide updated information to 

the Secretary of the Department of 

Health and Human Services for the 

optional accommodation process to 

remain in effect. The Department of 

Labor (working with the Department of 

Health and Human Services), will send 

a separate notification to each of the 

plan’s third party administrators 

informing the third party administrator 

that the Secretary of the Department of 

Health and Human Services has 

received a notice under paragraph 

(b)(1)(ii) of this section and describing 

the obligations of the third party 

administrator under § 2510.3–16 of this 

chapter and this section. 

(2) If a third party administrator 

receives a copy of the self-certification 

from an eligible organization or a 

notification from the Department of 

Labor, as described in paragraph 

(b)(1)(ii) of this section, and is willing 

to enter into or remain in a contractual 

relationship with the eligible 

organization or its plan to provide 

administrative services for the plan, 

then the third party administrator will 

provide or arrange payments for 

contraceptive services, using one of the 

following methods— 

(i) Provide payments for the 

contraceptive services for plan 

participants and beneficiaries without 

imposing any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible), premium, fee, or other 

charge, or any portion thereof, directly 

or indirectly, on the eligible 

organization, the group health plan, or 

plan participants or beneficiaries; or 

(ii) Arrange for an issuer or other 

entity to provide payments for 

contraceptive services for plan 

participants and beneficiaries without 

imposing any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible), premium, fee, or other 

charge, or any portion thereof, directly 

or indirectly, on the eligible 

organization, the group health plan, or 

plan participants or beneficiaries. 

(3) If a third party administrator 

provides or arranges payments for 

contraceptive services in accordance 

with either paragraph (b)(2)(i) or (ii) of 

this section, the costs of providing or 

arranging such payments may be 

reimbursed through an adjustment to 

the Federally facilitated Exchange user 

fee for a participating issuer pursuant to 

45 CFR 156.50(d). 

(4) A third party administrator may 

not require any documentation other 

than a copy of the self-certification from 

the eligible organization or notification 

from the Department of Labor described 

in paragraph (b)(1)(ii) of this section. 

(5) Where an otherwise eligible 

organization does not contract with a 

third party administrator and it files a 

self-certification or notice under 

paragraph (b)(1)(ii) of this section, the 

obligations under paragraph (b)(2) of 

this section do not apply, and the 

otherwise eligible organization is under 

no requirement to provide coverage or 

payments for contraceptive services to 

which it objects. The plan administrator 

for that otherwise eligible organization 

may, if it and the otherwise eligible 

organization choose, arrange for 

payments for contraceptive services 

from an issuer or other entity in 

accordance with paragraph (b)(2)(ii) of 

this section, and such issuer or other 

entity may receive reimbursements in 

accordance with paragraph (b)(3) of this 

section. 

(c) Optional accommodation— 

insured group health plans—(1) General 

rule. A group health plan established or 

maintained by an eligible organization 

that provides benefits through one or 

more group health insurance issuers 

may voluntarily elect an optional 

accommodation under which its health 

insurance issuer(s) will provide 

payments for all or a subset of 

contraceptive services for one or more 

plan years. To invoke the optional 

accommodation process: 

(i) The eligible organization or its plan 

must contract with one or more health 

insurance issuers. 

(ii) The eligible organization must 

provide either a copy of the selfcertification to each issuer providing 

coverage in connection with the plan or 

a notice to the Secretary of the 

Department of Health and Human 

Services that it is an eligible 

organization and of its objection as 

described in 45 CFR 147.132 to coverage 

for all or a subset of contraceptive 

services. 

(A) When a self-certification is 

provided directly to an issuer, the issuer 

has sole responsibility for providing 

such coverage in accordance with 

§ 2590.715–2713. 

(B) When a notice is provided to the 

Secretary of the Department of Health 

and Human Services, the notice must 

include the name of the eligible 

organization; a statement that it objects 

as described in 45 CFR 147.132 to 

coverage of some or all contraceptive 

services (including an identification of 

the subset of contraceptive services to 

which coverage the eligible organization 

objects, if applicable) but that it would 

like to elect the optional 

accommodation process; the plan name 

and type (that is, whether it is a student 

health insurance plan within the 

meaning of 45 CFR 147.145(a) or a 

church plan within the meaning of 

section 3(33) of ERISA); and the name 

and contact information for any of the 

plan’s health insurance issuers. If there 

is a change in any of the information 

required to be included in the notice, 

the eligible organization must provide 

updated information to the Secretary of 

Department Health and Human Services 

for the optional accommodation process 

to remain in effect. The Department of 

Health and Human Services will send a 

separate notification to each of the 

plan’s health insurance issuers 

informing the issuer that the Secretary 

of Health and Human Services has 

received a notice under paragraph 

(c)(2)(ii) of this section and describing 

the obligations of the issuer under this 

section. 

(2) If an issuer receives a copy of the 

self-certification from an eligible 

organization or the notification from the 

Department of Health and Human 

Services as described in paragraph 

(c)(2)(ii) of this section and does not 

have its own objection as described in 

45 CFR 147.132 to providing the 

contraceptive services to which the 

eligible organization objects, then the 

issuer will provide payments for 

contraceptive services as follows— 

(i) The issuer must expressly exclude 

contraceptive coverage from the group 

health insurance coverage provided in 

connection with the group health plan 

and provide separate payments for any 

contraceptive services required to be 

covered under § 2590.715–2713(a)(1)(iv) 

for plan participants and beneficiaries 


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Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47833 

for so long as they remain enrolled in 

the plan. 

(ii) With respect to payments for 

contraceptive services, the issuer may 

not impose any cost-sharing 

requirements (such as a copayment, 

coinsurance, or a deductible), or impose 

any premium, fee, or other charge, or 

any portion thereof, directly or 

indirectly, on the eligible organization, 

the group health plan, or plan 

participants or beneficiaries. The issuer 

must segregate premium revenue 

collected from the eligible organization 

from the monies used to provide 

payments for contraceptive services. 

The issuer must provide payments for 

contraceptive services in a manner that 

is consistent with the requirements 

under sections 2706, 2709, 2711, 2713, 

2719, and 2719A of the PHS Act, as 

incorporated into section 715 of ERISA. 

If the group health plan of the eligible 

organization provides coverage for some 

but not all of any contraceptive services 

required to be covered under 

§ 2590.715–2713(a)(1)(iv), the issuer is 

required to provide payments only for 

those contraceptive services for which 

the group health plan does not provide 

coverage. However, the issuer may 

provide payments for all contraceptive 

services, at the issuer’s option. 

(3) A health insurance issuer may not 

require any documentation other than a 

copy of the self-certification from the 

eligible organization or the notification 

from the Department of Health and 

Human Services described in paragraph 

(c)(1)(ii) of this section. 

(d) Notice of availability of separate 

payments for contraceptive services— 

self-insured and insured group health 

plans. For each plan year to which the 

optional accommodation in paragraph 

(b) or (c) of this section is to apply, a 

third party administrator required to 

provide or arrange payments for 

contraceptive services pursuant to 

paragraph (b) of this section, and an 

issuer required to provide payments for 

contraceptive services pursuant to 

paragraph (c) of this section, must 

provide to plan participants and 

beneficiaries written notice of the 

availability of separate payments for 

contraceptive services contemporaneous 

with (to the extent possible), but 

separate from, any application materials 

distributed in connection with 

enrollment (or re-enrollment) in group 

health coverage that is effective 

beginning on the first day of each 

applicable plan year. The notice must 

specify that the eligible organization 

does not administer or fund 

contraceptive benefits, but that the third 

party administrator or issuer, as 

applicable, provides or arranges 

separate payments for contraceptive 

services, and must provide contact 

information for questions and 

complaints. The following model 

language, or substantially similar 

language, may be used to satisfy the 

notice requirement of this paragraph (d): 

‘‘Your employer has certified that your 

group health plan qualifies for an 

accommodation with respect to the 

Federal requirement to cover all Food 

and Drug Administration-approved 

contraceptive services for women, as 

prescribed by a health care provider, 

without cost sharing. This means that 

your employer will not contract, 

arrange, pay, or refer for contraceptive 

coverage. Instead, [name of third party 

administrator/health insurance issuer] 

will provide or arrange separate 

payments for contraceptive services that 

you use, without cost sharing and at no 

other cost, for so long as you are 

enrolled in your group health plan. 

Your employer will not administer or 

fund these payments. If you have any 

questions about this notice, contact 

[contact information for third party 

administrator/health insurance issuer].’’ 

(e) 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 

§ 2590.715–2713(a)(1)(iv). 

(f) 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. 

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 

■ 9. 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. 

■ 10. Section 147.130 is amended by 

revising paragraphs (a)(1) introductory 

text and (a)(1)(iv) to read as follows: 

§ 147.130 Coverage of preventive health 

services. 

(a) * * * 

(1) In general. Beginning at the time 

described in paragraph (b) of this 

section and subject to §§ 147.131 and 

147.132, a group health plan, or a health 

insurance issuer offering group or 

individual health insurance coverage, 

must provide coverage for and must not 

impose any cost-sharing requirements 

(such as a copayment, coinsurance, or a 

deductible) for— 

* * * * * 

(iv) With respect to women, such 

additional preventive care and 

screenings not described in paragraph 

(a)(1)(i) of this section as provided for in 

comprehensive guidelines supported by 

the Health Resources and Services 

Administration for purposes of section 

2713(a)(4) of the Public Health Service 

Act, subject to §§ 147.131 and 147.132. 

* * * * * 

■ 11. Section 147.131 is revised to read 

as follows: 

§ 147.131 Accommodations in connection 

with coverage of certain preventive health 

services. 

(a)–(b) [Reserved] 

(c) Eligible organizations for optional 

accommodation. An eligible 

organization is an organization that 

meets the criteria of paragraphs (c)(1) 

through (3) of this section. 

(1) The organization is an objecting 

entity described in § 147.132(a)(1)(i) or 

(ii). 

(2) Notwithstanding its exempt status 

under § 147.132(a), the organization 

voluntarily seeks to be considered an 

eligible organization to invoke the 

optional accommodation under 

paragraph (d) of this section; and 

(3) The organization self-certifies in 

the form and manner specified by the 

Secretary or provides notice to the 

Secretary as described in paragraph (d) 

of this section. To qualify as an eligible 

organization, the organization must 

make such self-certification or notice 

available for examination upon request 

by the first day of the first plan year to 

which the accommodation in paragraph 

(d) of this section applies. The selfcertification or notice must be executed 

by a person authorized to make the 

certification or provide the notice on 

behalf of the organization, and must be 

maintained in a manner consistent with 

the record retention requirements under 

section 107 of ERISA. 


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47834 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 

(4) An eligible organization may 

revoke its use of the accommodation 

process, and its issuer must provide 

participants and beneficiaries written 

notice of such revocation as specified in 

guidance issued by the Secretary of the 

Department of Health and Human 

Services. If contraceptive coverage is 

currently being offered by an issuer 

through the accommodation process, the 

revocation will be effective on the first 

day of the first plan year that begins on 

or after 30 days after the date of the 

revocation (to allow for the provision of 

notice to plan participants in cases 

where contraceptive benefits will no 

longer be provided). Alternatively, an 

eligible organization may give 60-days 

notice pursuant to section 2715(d)(4) of 

the PHS Act and § 147.200(b), if 

applicable, to revoke its use of the 

accommodation process. 

(d) Optional accommodation— 

insured group health plans—(1) General 

rule. A group health plan established or 

maintained by an eligible organization 

that provides benefits through one or 

more group health insurance issuers 

may voluntarily elect an optional 

accommodation under which its health 

insurance issuer(s) will provide 

payments for all or a subset of 

contraceptive services for one or more 

plan years. To invoke the optional 

accommodation process: 

(i) The eligible organization or its plan 

must contract with one or more health 

insurance issuers. 

(ii) The eligible organization must 

provide either a copy of the selfcertification to each issuer providing 

coverage in connection with the plan or 

a notice to the Secretary of the 

Department of Health and Human 

Services that it is an eligible 

organization and of its objection as 

described in § 147.132 to coverage for 

all or a subset of contraceptive services. 

(A) When a self-certification is 

provided directly to an issuer, the issuer 

has sole responsibility for providing 

such coverage in accordance with 

§ 147.130(a)(iv). 

(B) When a notice is provided to the 

Secretary of the Department of Health 

and Human Services, the notice must 

include the name of the eligible 

organization; a statement that it objects 

as described in § 147.132 to coverage of 

some or all contraceptive services 

(including an identification of the 

subset of contraceptive services to 

which coverage the eligible organization 

objects, if applicable) but that it would 

like to elect the optional 

accommodation process; the plan name 

and type (that is, whether it is a student 

health insurance plan within the 

meaning of § 147.145(a) or a church 

plan within the meaning of section 3(33) 

of ERISA); and the name and contact 

information for any of the plan’s health 

insurance issuers. If there is a change in 

any of the information required to be 

included in the notice, the eligible 

organization must provide updated 

information to the Secretary of the 

Department of Health and Human 

Services for the optional 

accommodation to remain in effect. The 

Department of Health and Human 

Services will send a separate 

notification to each of the plan’s health 

insurance issuers informing the issuer 

that the Secretary of the Deparement of 

Health and Human Services has 

received a notice under paragraph 

(d)(1)(ii) of this section and describing 

the obligations of the issuer under this 

section. 

(2) If an issuer receives a copy of the 

self-certification from an eligible 

organization or the notification from the 

Department of Health and Human 

Services as described in paragraph 

(d)(1)(ii) of this section and does not 

have an objection as described in 

§ 147.132 to providing the contraceptive 

services identified in the selfcertification or the notification from the 

Department of Health and Human 

Services, then the issuer will provide 

payments for contraceptive services as 

follows— 

(i) The issuer must expressly exclude 

contraceptive coverage from the group 

health insurance coverage provided in 

connection with the group health plan 

and provide separate payments for any 

contraceptive services required to be 

covered under § 141.130(a)(1)(iv) for 

plan participants and beneficiaries for 

so long as they remain enrolled in the 

plan. 

(ii) With respect to payments for 

contraceptive services, the issuer may 

not impose any cost-sharing 

requirements (such as a copayment, 

coinsurance, or a deductible), premium, 

fee, or other charge, or any portion 

thereof, directly or indirectly, on the 

eligible organization, the group health 

plan, or plan participants or 

beneficiaries. The issuer must segregate 

premium revenue collected from the 

eligible organization from the monies 

used to provide payments for 

contraceptive services. The issuer must 

provide payments for contraceptive 

services in a manner that is consistent 

with the requirements under sections 

2706, 2709, 2711, 2713, 2719, and 

2719A of the PHS Act. If the group 

health plan of the eligible organization 

provides coverage for some but not all 

of any contraceptive services required to 

be covered under § 147.130(a)(1)(iv), the 

issuer is required to provide payments 

only for those contraceptive services for 

which the group health plan does not 

provide coverage. However, the issuer 

may provide payments for all 

contraceptive services, at the issuer’s 

option. 

(3) A health insurance issuer may not 

require any documentation other than a 

copy of the self-certification from the 

eligible organization or the notification 

from the Department of Health and 

Human Services described in paragraph 

(d)(1)(ii) of this section. 

(e) Notice of availability of separate 

payments for contraceptive services— 

insured group health plans and student 

health insurance coverage. For each 

plan year to which the optional 

accommodation in paragraph (d) of this 

section is to apply, an issuer required to 

provide payments for contraceptive 

services pursuant to paragraph (d) of 

this section must provide to plan 

participants and beneficiaries written 

notice of the availability of separate 

payments for contraceptive services 

contemporaneous with (to the extent 

possible), but separate from, any 

application materials distributed in 

connection with enrollment (or reenrollment) in group health coverage 

that is effective beginning on the first 

day of each applicable plan year. The 

notice must specify that the eligible 

organization does not administer or 

fund contraceptive benefits, but that the 

issuer provides separate payments for 

contraceptive services, and must 

provide contact information for 

questions and complaints. The 

following model language, or 

substantially similar language, may be 

used to satisfy the notice requirement of 

this paragraph (e) ‘‘Your [employer/

institution of higher education] has 

certified that your [group health plan/

student health insurance coverage] 

qualifies for an accommodation with 

respect to the Federal requirement to 

cover all Food and Drug 

Administration-approved contraceptive 

services for women, as prescribed by a 

health care provider, without cost 

sharing. This means that your 

[employer/institution of higher 

education] will not contract, arrange, 

pay, or refer for contraceptive coverage. 

Instead, [name of health insurance 

issuer] will provide separate payments 

for contraceptive services that you use, 

without cost sharing and at no other 

cost, for so long as you are enrolled in 

your [group health plan/student health 

insurance coverage]. Your [employer/

institution of higher education] will not 

administer or fund these payments . If 

you have any questions about this 

notice, contact [contact information for 

health insurance issuer].’’ 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Rules and Regulations 47835 

(f) 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). 

(g) 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. 

■ 12. Add § 147.132 to read as follows: 

§ 147.132 Religious 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 

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 the non-governmental plan 

sponsor objects as specified in 

paragraph (a)(2) of this section. Such 

non-governmental plan sponsors 

include, but are not limited to, the 

following entities— 

(A) A church, an integrated auxiliary 

of a church, a convention or association 

of churches, or a religious order. 

(B) A nonprofit organization. 

(C) A closely held for-profit entity. 

(D) A for-profit entity that is not 

closely held. 

(E) Any other non-governmental 

employer. 

(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 this 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 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, 

payments, or a plan that provides 

coverage or payments for some or all 

contraceptive services, based on its 

sincerely held religious beliefs. 

(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 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 sincerely held 

religious beliefs. 

(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. 2017–21851 Filed 10–6–17; 11:15 am] 

BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P; 

6325–64–P 


asabaliauskas on DSKBBXCHB2PROD with RULES