First Circuit Brief About Final Rule Next Steps

Case: 18-1514 Document: 00117368181 Page: 1 Date Filed: 11/20/2018 Entry ID: 6214393
IN THE UNITED STATES COURT OF APPEALS

FOR THE FIRST CIRCUIT
COMMONWEALTH OF MASSACHUSETTS,
Plaintiff-Appellant,
v.
No. 18-1514
UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES et al.,
Defendants-Appellees.
MOTION TO GOVERN FURTHER PROCEEDINGS
The federal defendants file this motion to govern further
proceedings to address the appropriate disposition of this appeal in
light of the issuance of final rules superseding the interim final rules
challenged in this case. As we explain below, this Court should allow
the appeal to continue and should decide the only issue in this appeal—
namely, whether Massachusetts has standing to challenge the rules.
STATEMENT
1. In October 2017, in an attempt to resolve ongoing litigation
over the contraceptive-coverage mandate adopted pursuant to the
Patient Protection and Affordable Care Act, the Departments of Health
and Human Services, Labor, and the Treasury issued interim final
rules expanding the regulatory exemption to the mandate. The interim
rules expanded the existing religious exemption to a broader range of
entities with sincere religious exemptions to providing contraceptive
coverage, see 82 Fed. Reg. 47,792 (Oct. 13, 2017) (JA 836), and created a
new exemption for entities with moral objections to providing such
coverage, see 82 Fed. Reg. 47,838 (Oct. 13, 2017) (JA 880).
Invoking agency-specific statutory authority to issue interim final
rules, 26 U.S.C. § 9833; 29 U.S.C. § 1191c; 42 U.S.C. § 300gg-92, as well
as the Administrative Procedure Act’s (APA’s) general “good cause”
exception to notice-and-comment requirements, 5 U.S.C. § 553(b), the
agencies issued the rules without prior notice and comment. The
agencies did, however, solicit comments for 60 days post-promulgation.
See 82 Fed. Reg. at 47,792; 82 Fed. Reg. at 47,838.
2. Massachusetts brought suit, challenging the interim rules.
Massachusetts claimed that the rules (1) failed to comply with the
APA’s notice-and-comment requirements; (2) are not in accordance with
law and exceed the agencies’ authority; (3) violate the Establishment
Clause; and (4) violate the Equal Protection Clause. See JA 31-35.
Massachusetts requested that the district court declare the interim
2
rules unlawful and permanently enjoin their implementation on a
nationwide basis.
The district court concluded that Massachusetts “lacks standing to
prosecute this action” and granted the federal government’s motion for
summary judgment. JA 1383. The court explained that “the
Commonwealth has failed to set forth specific facts establishing that it
will likely suffer future injury from the [interim rules].” Id. In
particular, the court explained, Massachusetts “has not established that
it is likely that any Massachusetts employers will avail themselves of
the [interim rules’] expanded exemptions,” JA 1408, and has not
“identif[ied] any particular woman who is likely to lose contraceptive
coverage because of the [interim rules],” JA 1420. The court found
Massachusetts’s reliance on the agencies’ estimate of the number of
women who could be affected by the interim rules and its “back-of-the-
envelope reckoning” that the interim rules would affect a proportionate
number of its residents to be “tenuous” and “unsupported by facts
sufficient to satisfy its burden” to demonstrate standing. JA 1403, 1405,
1406.
3
Massachusetts appealed, and filed its opening brief on September
17, 2018. The federal defendants have not yet filed their response brief.
3. After reviewing all the comments received on the interim rules,
the agencies promulgated final rules superseding the interim rules. The
final rules were made publicly available on the Federal Register’s
website on November 7, 2018, and were published in the Federal
Register on November 15, 2018. See 83 Fed. Reg. 57,536 (Nov. 15, 2018)
(religious exemption) (attached as Exhibit A); 83 Fed. Reg. 57,592 (Nov.
15, 2018) (moral exemption) (attached as Exhibit B).
The final rules finalize the exemptions provided in the interim
rules. In response to public comments, the agencies made certain
changes in the final rules to clarify the intended scope of the
exemptions. See 83 Fed. Reg. at 57,537; 83 Fed. Reg. at 57,593. But the
substance of the rules remains largely the same, and none of the
changes is material to Massachusetts’s substantive claims in this case
or the Commonwealth’s standing to bring those claims.
The final rules take effect on January 14, 2019. See 83 Fed. Reg.
at 57,536; 83 Fed. Reg. at 57,592.
4
4. On November 8, 2018, the federal government submitted a
letter notifying the Court that the agencies had promulgated final rules
and proposing that the government file a motion to govern further
proceedings by November 20, 2018, and that Massachusetts file any
response by December 7, 2018 (a schedule to which Massachusetts had
agreed).
ARGUMENT
Although the agencies have now issued final rules superseding the
interim rules challenged by Massachusetts, this Court should allow the
appeal to continue and should decide the only issue decided by the
district court and presented in this appeal—namely, whether
Massachusetts has Article III standing to bring this action.
1. The only issue raised by Massachusetts on appeal is whether
the district court erred in holding that Massachusetts lacks standing to
challenge the interim rules. Standing is a “core component” and an
“essential and unchanging part of the case-or-controversy requirement
of Article III.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992).
Because standing is a threshold jurisdictional issue, see Steel Co. v.
Citizens for a Better Env’t, 523 U.S. 83, 102 (1998), a court may
5
conclude that a case should be dismissed for lack of standing without
first addressing whether the case has become moot. As the Supreme
Court has made clear, while a federal court generally may not rule on
the merits without first determining that it has subject-matter and
personal jurisdiction, “there is no mandatory sequencing of
jurisdictional issues.” Sinochem Int’l Co. v. Malaysia Int’l Shipping
Corp., 549 U.S. 422, 431 (2007) (internal quotation marks omitted).
Instead, a court “has leeway to choose among threshold grounds for
denying audience to a case on the merits.” Id. (internal quotation marks
omitted).
Courts of appeals have thus dismissed cases or appeals on the
basis of standing without considering mootness. See Nicklaw v.
CitiMortgage, Inc., 839 F.3d 998, 1000 (11th Cir. 2016); Staker v. Wells
Fargo Bank, N.A. (In re Staker), 550 F. App’x 580, 582 (10th Cir. 2013);
Common Cause of Pa. v. Pennsylvania, 558 F.3d 249, 256 n.2 (3d Cir.
2009); National Comm. for the New River, Inc. v. FERC, 433 F.3d 830,
832 n.1 (D.C. Cir. 2005); Myers Investigative & Sec. Servs., Inc. v.
United States, 275 F.3d 1366, 1369 (Fed. Cir. 2002); In re VMS Ltd.
P’ship Sec. Litig., 976 F.2d 362, 366 n.7 (7th Cir. 1992).
6
Considerations of judicial economy counsel in favor of that
approach here. Massachusetts’s lawsuit challenges on various grounds
the expanded exemptions in the interim rules, alleging, for example,
that these exemptions “are not in accordance with the law and exceed
the [agencies’] authority under the ACA [Affordable Care Act].” JA 32
¶ 89; see also JA 33-35 (alleging Establishment Clause and Equal
Protection violations). And Massachusetts contends that the
Commonwealth and its residents will be injured because Massachusetts
employers “are likely to use the . . . expanded exemptions, causing
Massachusetts women to lose contraceptive coverage.” Mass. Br. 27
(asserting fiscal injury to the Commonwealth); see also id. at 50-53
(asserting quasi-sovereign interest in protecting citizens’ well-being).
The final rules finalize those exemptions in substantially the same
form. Accordingly, unless this Court reaches the arguments raised by
Massachusetts on appeal and affirms the district court’s ruling that
Massachusetts lacks standing to challenge the rules, we anticipate that
Massachusetts will seek to amend its complaint in district court (or file
a new complaint) to challenge the final rules. The likely outcome will
again be dismissal for lack of standing, as the district court’s reasoning
7
in holding that Massachusetts lacks standing to challenge the interim
rules applies with equal force to the final rules. And presumably in that
event, Massachusetts will appeal again and the issue of standing will
once again be presented to this Court.
We see no reason to engage in such an exercise and believe that
the more prudent and efficient approach would be for the Court to allow
the appeal to continue and to decide the question of standing now. Cf.
Maryland Highways Contractors Ass’n v. Maryland, 933 F.2d 1246,
1250 (4th Cir. 1991) (holding that case was moot in light of new statute,
but in anticipation of a “new attack” on the statute, “elect[ing] to
address the issue of standing in order to guide subsequent litigation.”).
To dismiss this appeal as moot without addressing standing would
“prove more wasteful than frugal.” Friends of the Earth, Inc. v. Laidlaw
Envtl. Servs. (TOC), Inc., 528 U.S. 167, 192 (2000).
2. Indeed, for much the same reasons that this Court should
decide the standing question, the case is not moot at all. A case does not
become moot when, as here, a challenged regulation is altered in an
“insignificant respect” given the scope of the challenge. Northeast Fla.
Chapter of the Associated Gen. Contractors of Am. v. City of
8
Jacksonville, 508 U.S. 656, 661-62 & n.3 (1993) (holding that case was
not moot where challenged ordinance was replaced by “sufficiently
similar” ordinance after Court granted certiorari); see also Conservation
Law Found. v. Evans, 360 F.3d 21, 25-27 (1st Cir. 2004) (holding that
substantive challenge to framework was not moot where superseding
framework was “largely an extension” of challenged framework). “[A]
superseding statute or regulation moots a case only to the extent that it
removes challenged features of the prior law.” Naturist Soc’y, Inc. v.
Fillyaw, 958 F.2d 1515, 1520 (11th Cir. 1992); cf. Gulf of Maine
Fishermen’s Alliance v. Daley, 292 F.3d 84, 88-90 (1st Cir. 2002)
(holding that substantive challenge to framework was moot where
similar provision in new framework was “based on new circumstances
and data” and “d[id] not subject the [plaintiff] to the same action
because [it] involved an entirely new analysis”).
As explained above, the final rules do not remove the “challenged
features” of the interim rules, Naturist Soc’y, 958 F.2d at 1520, and
presumably, Massachusetts will contend that the final rules harm the
Commonwealth “in the same fundamental way” as the interim rules,
American Freedom Def. Initiative v. Washington Metro. Area Transit
9
Auth., 901 F.3d 356, 362 (D.C. Cir. 2018) (holding that case was not
moot where challenged moratorium was replaced by “fundamentally
similar” guidelines); see also Associated Gen. Contractors of Am. v.
California Dep’t of Transp., 713 F.3d 1187, 1193-94 (9th Cir. 2013);
Nextel West Corp. v. Unity Township, 282 F.3d 257, 261-64 (3d Cir.
2002). Massachusetts’s substantive challenges to the rules thus are
not moot.1
3. To the extent the Court allows the appeal to continue, we have
no objection if Massachusetts wishes the opportunity to file a new or
supplemental opening brief before the federal government files its
response brief. Although, as explained, the substance of the rules
1The final rules, when they take effect, will moot Massachusetts’s
procedural challenge to the interim rules (i.e., the Commonwealth’s
claim that the agencies improperly issued the interim rules without
prior notice and comment). See Gulf of Maine, 292 F.3d at 88-90; see
also Safari Aviation Inc. v. Garvey, 300 F.3d 1144, 1150 (9th Cir. 2002)
(Because “the life of the interim rule is over, no purpose is served by
reviewing its rulemaking procedures.”); cf. Conservation Law Found.,
360 F.3d at 23 n.2, 26-27 (holding that procedural challenge was not
moot where statute contemplated periodic issuance of “framework
adjustments,” and where “alleged procedural deficiency” was likely to
recur with subsequent frameworks, especially given that notice was
provided in promulgating new framework only “in light of this appeal”).
That Massachusetts’s procedural claim is moot, however, does not mean
that the entire case is moot.
10
remains largely unchanged, and none of the changes is material to
Massachusetts’s standing to bring those claims, we have no objection if
Massachusetts wishes to revise its brief or file a supplemental brief to
refer to the final rules rather than the interim rules.
CONCLUSION
For the foregoing reasons, the Court should allow the appeal to
continue and should decide the only issue presented in the appeal—
namely, whether Massachusetts has Article III standing to bring this
action.
Respectfully submitted,
SHARON SWINGLE
LOWELL V. STURGILL JR.
/s/ Karen Schoen
KAREN SCHOEN
Attorneys, Appellate Staff
Civil Division, Room 7533
U.S. Department of Justice
950 Pennsylvania Avenue N.W.
Washington, D.C. 20530
(202) 514-3159
karen.a.schoen@usdoj.gov
NOVEMBER 2018
11
CERTIFICATE OF COMPLIANCE
Pursuant to Federal Rule of Appellate Procedure 32(g), I hereby
certify that this motion complies with the requirements of Rule
27(d)(1)(E) because it has been prepared in 14-point Century
Schoolbook, a proportionally spaced font, and that it complies with the
type-volume limitation of Rule 27(d)(2)(A), because it contains 1,985
words, according to the count of Microsoft Word.
/s/ Karen Schoen

Karen Schoen
CERTIFICATE OF SERVICE
I hereby certify that on November 20, 2018, I electronically filed
the foregoing motion with the Clerk of the Court for the United States
Court of Appeals for the First Circuit by using the appellate CM/ECF
system. Participants in the case are registered CM/ECF users, and
service will be accomplished by the appellate CM/ECF system.
/s/ Karen Schoen

Karen Schoen
EXHIBIT A
57536 Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Rules and Regulations
DEPARTMENT OF THE TREASURY DATES: Effective date: These regulations C. Scope of Religious Exemptions and
are effective on January 14, 2019. Requirements for Exempt Entities (45
Internal Revenue Service CFR 147.132)
FOR FURTHER INFORMATION CONTACT: Jeff
D. Plan Sponsors in General (45 CFR
Wu, at (301) 492–4305 or 147.132(a)(1)(i) prefatory text)
26 CFR Part 54 marketreform@cms.hhs.gov for the E. Houses of Worship and Integrated
Centers for Medicare & Medicaid Auxiliaries (45 CFR 147.132(a)(1)(i)(A))
[TD–9840]
Services (CMS), Department of Health F. Nonprofit Organizations (45 CFR
RIN 1545–BN92 and Human Services (HHS); Amber 147.132(a)(1)(i)(B))
Rivers or Matthew Litton, Employee G. Closely Held For-Profit Entities (45 CFR
DEPARTMENT OF LABOR Benefits Security Administration 147.132(a)(1)(i)(C))
(EBSA), Department of Labor, at (202) H. For-Profit Entities That Are Not Closely
Employee Benefits Security 693–8335; William Fischer, Internal Held (45 CFR 147.132(a)(1)(i)(D))
Administration I. Other Non-Governmental Employers (45
Revenue Service, Department of the
CFR 147.132(a)(1)(i)(E))
Treasury, at (202) 317–5500. J. Plans Established or Maintained by
29 CFR Part 2590 Customer Service Information: Objecting Nonprofit Entities (45 CFR
Individuals interested in obtaining 147.132(a)(1)(ii))
RIN 1210–AB83 information from the Department of K. Institutions of Higher Education (45 CFR
Labor concerning employment-based 147.132(a)(1)(iii))
DEPARTMENT OF HEALTH AND
health coverage laws may call the EBSA L. Health Insurance Issuers (45 CFR
HUMAN SERVICES
Toll-Free Hotline, 1–866–444–EBSA 147.132(a)(1)(iv))
(3272) or visit the Department of Labor’s M. Description of the Religious Objection
45 CFR Part 147 (45 CFR 147.132(a)(2))
website (www.dol.gov/ebsa).
Information from HHS on private health N. Individuals (45 CFR 147.132(b))
[CMS–9940–F2]
O. Accommodation (45 CFR 147.131, 26
insurance coverage can be found on
RIN 0938–AT54 CFR 54.9815–2713A, 29 CFR 2590.715–
CMS’s website (www.cms.gov/cciio), 2713A)
and information on health care reform P. Definition of Contraceptives for the
Religious Exemptions and can be found at www.HealthCare.gov. Purpose of These Final Rules
Accommodations for Coverage of
SUPPLEMENTARY INFORMATION: Q. Severability
Certain Preventive Services Under the R. Other Public Comments
Affordable Care Act Table of Contents 1. Items Approved as Contraceptives But
AGENCY: Internal Revenue Service, I. Executive Summary and Background Used To Treat Existing Conditions
A. Executive Summary 2. Comments Concerning Regulatory
Department of the Treasury; Employee
1. Purpose Impact
Benefits Security Administration, 2. Summary of the Major Provisions 3. Interaction With State Laws
Department of Labor; and Centers for a. Expanded Religious Exemptions to the IV. Economic Impact and Paperwork Burden
Medicare & Medicaid Services, Contraceptive Coverage Requirement A. Executive Orders 12866 and 13563—
Department of Health and Human b. Optional Accommodation Department of HHS and Department of
Services. 3. Summary of Costs, Savings and Benefits Labor
of the Major Provisions 1. Need for Regulatory Action
ACTION: Final rules.
B. Background 2. Anticipated Effects
SUMMARY: These rules finalize, with II. Overview, Analysis, and Response to a. Removal of Burdens on Religious
Public Comments Exercise
changes based on public comments, A. The Departments’ Authority To
interim final rules concerning religious b. Notices When Revoking Accommodated
Mandate Coverage and Provide Religious Status
exemptions and accommodations Exemptions c. Impacts on Third Party Administrators
regarding coverage of certain preventive B. Availability and Scope of Religious and Issuers
services issued in the Federal Register Exemptions d. Impacts on Persons Covered by Newly
on October 13, 2017. These rules C. The First Amendment and the Religious Exempt Plans
expand exemptions to protect religious Freedom Restoration Act
i. Unknown Factors Concerning Impact on
1. Discretion To Provide Religious
beliefs for certain entities and Exemptions
Persons in Newly Exempt Plans
individuals whose health plans are ii. Public Comments Concerning Estimates
2. Requiring Entities To Choose Between
subject to a mandate of contraceptive Compliance With the Contraceptive in Religious IFC
coverage through guidance issued Mandate or the Accommodation Violated iii. Possible Sources of Information for
pursuant to the Patient Protection and RFRA in Many Instances Estimating Impact
a. Substantial Burden iv. Estimates Based on Litigating Entities
Affordable Care Act. These rules do not That May Use Expanded Exemptions
alter the discretion of the Health b. Compelling Interest
D. Burdens on Third Parties v. Estimates of Accommodated Entities
Resources and Services Administration, That May Use Expanded Exemptions
E. Interim Final Rulemaking
a component of the U.S. Department of F. Health Effects of Contraception and vi. Combined Estimates of Litigating and
Health and Human Services, to maintain Pregnancy Accommodated Entities
the guidelines requiring contraceptive G. Health and Equality Effects of vii. Alternate Estimates Based on
coverage where no regulatorily Contraceptive Coverage Mandates Consideration of Pre-ACA Plans
recognized objection exists. These rules III. Description of the Text of the Regulations viii. Final Estimates of Persons Affected by
also leave in place an ‘‘accommodation’’ and Response to Additional Public Expanded Exemptions
khammond on DSK30JT082PROD with RULES2
process as an optional process for Comments B. Special Analyses—Department of the

A. Restatement of Statutory Requirements Treasury
certain exempt entities that wish to use
of PHS Act Section 2713(a) and (a)(4) (26 C. Regulatory Flexibility Act
it voluntarily. These rules do not alter CFR 54.9815–2713(a)(1) and (a)(1)(iv), 29 D. Paperwork Reduction Act—Department
multiple other federal programs that CFR 2590.715–2713(a)(1) and (a)(1)(iv), of Health and Human Services
provide free or subsidized and 45 CFR 147.130(a)(1) and (a)(1)(iv)) 1. Wage Data
contraceptives for women at risk of B. Prefatory Language of Religious 2. ICRs Regarding Self-Certification or
unintended pregnancy. Exemptions (45 CFR 147.132(a)(1)) Notices to HHS (§ 147.131(c)(3))
VerDate Sep<11>2014 20:27 Nov 14, 2018 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Rules and Regulations 57537
3. ICRs Regarding Notice of Availability of 2. Summary of the Major Provisions provision describing the religious
Separate Payments for Contraceptive objection for entities. That provision
a. Expanded Religious Exemptions to
Services (§ 147.131(e)) specifies that the entity objects, based
the Contraceptive Coverage
4. ICRs Regarding Notice of Revocation of on its sincerely held religious beliefs, to
Accommodation (§ 147.131(c)(4))
Requirement
its establishing, maintaining, providing,
5. Submission of PRA-Related Comments These rules finalize exemptions offering, or arranging for either:
E. Paperwork Reduction Act—Department provided in the Religious IFC for the coverage or payments for some or all
of Labor group health plans and health insurance contraceptive services; or, a plan, issuer,
F. Regulatory Reform Executive Orders coverage of various entities and or third party administrator that
13765, 13771 and 13777 individuals with sincerely held provides or arranges such coverage or
G. Unfunded Mandates Reform Act religious beliefs opposed to coverage of payments.
H. Federalism some or all contraceptive or sterilization The Departments also clarify language
V. Statutory Authority methods encompassed by HRSA’s in the exemption applicable to plans of
Guidelines. The rules finalize objecting individuals. The final rule
I. Executive Summary and Background exemptions to the same types of specifies that the individual exemption
A. Executive Summary organizatons and individuals for which ensures that the HRSA Guidelines do
exemptions were provided in the not prevent a willing health insurance
1. Purpose Religious IFC: Non-governmental plan issuer offering group or individual
sponsors including a church, an health insurance coverage, and as
The primary purpose of this rule is to integrated auxiliary of a church, a
finalize, with changes in response to applicable, a willing plan sponsor of a
convention or association of churches, group health plan, from offering a
public comments, the interim final or a religious order; a nonprofit separate policy, certificate or contract of
regulations with requests for comments organization; for-profit entities; an insurance or a separate group health
(IFCs) published in the Federal Register institution of higher education in plan or benefit package option, to any
on October 13, 2017 (82 FR 47792), arranging student health insurance group health plan sponsor (with respect
‘‘Religious Exemptions and coverage; and, in certain circumstances, to an individual) or individual, as
Accommodations for Coverage of issuers and individuals. The rules also applicable, who objects to coverage or
Certain Preventive Services Under the finalize the regulatory restatement in the payments for some or all contraceptive
Affordable Care Act’’ (the Religious Religious IFC of language from section services based on sincerely held
IFC). The rules are necessary to expand 2713(a) and (a)(4) of the Public Health religious beliefs. The exemption adds
the protections for the sincerely held Service Act. that, if an individual objects to some but
religious objections of certain entities In response to public comments, not all contraceptive services, but the
and individuals. The rules, thus, various changes are made to clarify the issuer, and as applicable, plan sponsor,
minimize the burdens imposed on their intended scope of the language in the are willing to provide the plan sponsor
exercise of religious beliefs, with regard Religious IFC. The prefatory language to or individual, as applicable, with a
to the discretionary requirement that the exemptions is clarified to ensure separate policy, certificate or contract of
exemptions apply to a group health plan insurance or a separate group health
health plans cover certain contraceptive
established or maintained by an plan or benefit package option that
services with no cost-sharing, a
objecting organization, or health omits all contraceptives, and the
requirement that was created by HHS insurance coverage offered or arranged
through guidance promulgated by the individual agrees, then the exemption
by an objecting organization, to the applies as if the individual objects to all
Health Resources and Services extent of the objections. The contraceptive services.
Administration (HRSA) (hereinafter Departments add language to clarify
‘‘Guidelines’’), pursuant to authority that, where an exemption encompasses b. Optional Accommodation
granted by the ACA in section a plan or coverage established or These rules also finalize provisions
2713(a)(4) of the Public Health Service maintained by a church, an integrated from the Religious IFC that maintain the
Act. In addition, the rules maintain a auxiliary of a church, a convention or accommodation process as an optional
previously created accommodation association of churches, a religious process for entities that qualify for the
process that permits entities with order, a nonprofit organization, or other exemption. Under that process, entities
certain religious objections voluntarily non-governmental organization or can choose to use the accommodation
to continue to object while the persons association, the exemption applies to process so that contraceptive coverage
covered in their plans receive each employer, organization, or plan to which they object is omitted from
contraceptive coverage or payments sponsor that adopts the plan. Language their plan, but their issuer or third party
arranged by their health insurance is also added to clarify that the administrator, as applicable, will
issuers or third party administrators. exemptions apply to non-governmental arrange for the persons covered by their
The rules do not remove the entities, including as the exemptions plan to receive contraceptive coverage
contraceptive coverage requirement apply to institutions of higher or payments.
generally from HRSA’s Guidelines. The education. The Departments revise the In response to public comments, these
changes being finalized to these rules exemption applicable to health final rules make technical changes to
insurance issuers to make clear that the the accommodation regulations
will ensure that proper respect is
group health plan established or maintained in parallel by HHS, the
afforded to sincerely held religious
maintained by the plan sponsor with Department of Labor, and the
objections in rules governing this area of which the health insurance issuer Department of the Treasury. The
health insurance and coverage, with contracts remains subject to any Departments modify the regulations
minimal impact on HRSA’s decision to requirement to provide coverage for governing when an entity, that was
otherwise require contraceptive contraceptive services under Guidelines using or will use the accommodation,
coverage. issued under § 147.130(a)(1)(iv) unless it can revoke the accommodation and
is also exempt from that requirement. operate under the exemption. The
The Departments also restructure the modifications set forth a transitional
rule as to when entities currently using sooner than the first day of the first plan issuer. Likewise, the rule adds pre-
the accommodation may revoke it and year that begins on or after 30 days after existing ‘‘reliance’’ language deeming an
use the exemption by giving 60-days the date of the revocation. issuer serving an accommodated
notice pursuant to Public Health Service The Departments also modify the organization compliant with the
Act section 2715(d)(4) and 45 Religious IFC by adding a provision that contraceptive coverage requirement if
CFR 147.200(b), 26 CFR 54.9815– existed in rules prior to the Religious the issuer relies reasonably and in good
2715(b), and 29 CFR 2590.715–2715(b). IFC, namely, that if an issuer relies faith on a representation by an
The modifications also express a general reasonably and in good faith on a organization as to its eligibility for the
rule that, in plan years that begin after representation by the eligible accommodation and the issuer
the date on which these final rules go organization as to its eligibility for the otherwise complies with the
into effect, if contraceptive coverage is accommodation, and the representation accommodation regulation, and likewise
being offered by an issuer or third party is later determined to be incorrect, the deeming a group health plan compliant
administrator through the with the contraceptive coverage
issuer is considered to comply with any
accommodation process, an requirement if it complies with the
applicable contraceptive coverage
organization eligible for the accommodation regulation.
requirement from HRSA’s Guidelines if
accommodation may revoke its use of the issuer complies with the obligations 3. Summary of Costs, Savings and
the accommodation process effective no under this section applicable to such Benefits of the Major Provisions
Provision Savings and benefits Costs
Restatement of statutory lan- The purpose of this provision is to ensure that the regu- We estimate no costs from finalizing this part of the
guage from section latory language that restates section 2713(a) and rule.
2713(a) and (a)(4) of the (a)(4) of the Public Health Service Act mirrors the
Public Health Service Act. language of the statute. We estimate no economic
savings or benefit from finalizing this part of the rule,
but consider it a deregulatory action to minimize the
regulatory impact beyond the scope set forth in the
statute.
Expanded religious exemp- Expanding religious exemptions to the contraceptive We estimate there will be transfer costs where women
tions. coverage requirement will relieve burdens that some previously receiving contraceptive coverage from em-
entities and individuals experience from being forced ployers will no longer receive that coverage where
to choose between, on the one hand, complying with the employers use the expanded exemptions. Even
their religious beliefs and facing penalties from failing after the public comment period, we have very limited
to comply with the contraceptive coverage require- data on what the scale of those transfer costs will be.
ment, and on the other hand, providing (or, for indi- We estimate that in no event will they be more than
viduals, obtaining) contraceptive coverage or using $68.9 million.
the accommodation in violation of their sincerely held We estimate that, where entities using the accommoda-
religious beliefs. tion revoke it to use the exemption, the cost to indus-
try of sending notices of revocation to their policy
holders will be $112,163.
Optional accommodation Maintaining the accommodation as an optional process We estimate that, by expanding the types of organiza-
regulations. will ensure that contraceptive coverage is made tions that may use the accommodation, some entities
available to many women covered by plans of em- not currently using it will opt into it. When doing so
ployers that object to contraceptive coverage but not they will incur costs of $677 to send a self-certifi-
to their issuers or third party administrators arranging cation or notice to their issuer or third party adminis-
for such coverage to be provided to their plan partici- trator, or to HHS, to commence operation of the ac-
pants. commodation.
We estimate that entities that newly make use of the
accommodation as the result of these rules, or their
issuers or third party administrators, will incur costs
of $311,304 in providing their policy holders with no-
tices indicating that contraceptive coverage or pay-
ments are available to them under the accommoda-
tion process.
B. Background individuals and entities that object to abortion);

Consolidated Appropriations Act of 2018, Div. H,
Over many decades, Congress has Sec. 507(d) (Departments of Labor, HHS, and legislation enacted on such issue should include a
protected conscientious objections, Education, and Related Agencies Appropriations ‘conscience clause’ which provides exceptions for
including those based on religious Act), Public Law 115–141, 132 Stat. 348, 764 (Mar. religious beliefs and moral convictions.’’); id. at Div.
23, 2018) (protecting any ‘‘health care professional, I, (Department of State, Foreign Operations, and
beliefs, in the context of health care and Related Programs Appropriations Act) (protecting
a hospital, a provider-sponsored organization, a
human services including health health maintenance organization, a health applicants for family planning funds based on their
coverage, even as it has sought to insurance plan, or any other kind of health care ‘‘religious or conscientious commitment to offer
promote and expand access to health facility, organization, or plan’’ in objecting to only natural family planning’’); 42 U.S.C. 290bb–36
abortion for any reason); id. at Div. E, Sec. 726(c) (prohibiting the statutory section from being
services.1 In 2010, Congress enacted the construed to require suicide-related treatment
(Financial Services and General Government
Appropriations Act) (protecting individuals who services for youth where the parents or legal
1 See, for example, 42 U.S.C. 300a–7 (protecting guardians object based on ‘‘religious beliefs or
object to prescribing or providing contraceptives
individuals and health care entities from being contrary to their ‘‘religious beliefs or moral moral objections’’); 42 U.S.C. 290kk–1 (protecting
required to provide or assist sterilizations, convictions’’); id. at Div. E, Sec. 808 (regarding any the religious character of organizations participating
abortions, or other lawful health services if it would requirement for ‘‘the provision of contraceptive in certain programs and the religious freedom of
violate their ‘‘religious beliefs or moral coverage by health insurance plans’’ in the District beneficiaries of the programs); 42 U.S.C. 300x–65
convictions’’); 42 U.S.C. 238n (protecting of Columbia, ‘‘it is the intent of Congress that any (protecting the religious character of organizations
Patient Protection and Affordable Care discretion to require that certain group regulations, the Departments defined
Act (PPACA) (Pub. L. 111–148) (March health plans and health insurance the scope of permissible exemptions
23, 2010). Congress enacted the Health issuers cover certain women’s and accommodations for certain
Care and Education Reconciliation Act preventive services, in addition to other religious objectors where the Guidelines
of 2010 (HCERA) (Pub. L. 111–152) on preventive services required to be require coverage of contraceptive
March 30, 2010, which, among other covered in section 2713. Congress services, changed the scope of those
things, amended the PPACA. As granted that discretion to the Health exemptions and accommodations, and
amended by HCERA, the PPACA is Resources and Services Administration solicited public comments on a number
known as the Affordable Care Act (HRSA), a component of the U.S. of occasions. Many individuals and
(ACA). Department of Health and Human entities brought legal challenges to the
The ACA reorganizes, amends, and Services (HHS). Specifically, section contraceptive coverage requirement and
adds to the provisions of part A of title 2713(a)(4) allows HRSA discretion to regulations (hereinafter, the
XXVII of the Public Health Service Act specify coverage requirements, ‘‘with ‘‘contraceptive Mandate,’’ or the
(PHS Act) relating to group health plans respect to women, such additional ‘‘Mandate’’) as being inconsistent with
and health insurance issuers in the preventive care and screenings . . . as various legal protections, including the
group and individual markets. The ACA provided for in comprehensive Religious Freedom Restoration Act, 42
adds section 715(a)(1) to the Employee guidelines supported by’’ HRSA’s U.S.C. 2000bb–1 (‘‘RFRA’’). Several of
Retirement Income Security Act of 1974 Guidelines. those cases went to the Supreme Court.
(ERISA) and section 9815(a)(1) to the Since 2011, HRSA has exercised that See, for example, Burwell v. Hobby
Internal Revenue Code (Code), in order discretion to require coverage for, Lobby Stores, Inc., 134 S. Ct. 2751
to incorporate the provisions of part A among other things, certain (2014); Zubik v. Burwell, 136 S. Ct. 1557
of title XXVII of the PHS Act into ERISA contraceptive services.2 In the same (2016).
and the Code, and to make them time period, the Departments of Health
applicable to group health plans and The Departments most recently
and Human Services (HHS), Labor, and
health insurance issuers providing solicited public comments on these
the Treasury (collectively, ‘‘the
health insurance coverage in connection issues again in two interim final
Departments’’) 3 have promulgated
with group health plans. The sections of regulations with requests for comments
regulations to guide HRSA in exercising
the PHS Act incorporated into ERISA (IFCs) published in the Federal Register
its discretion to allow exemptions to
and the Code are sections 2701 through on October 13, 2017: the regulations (82
those requirements, including issuing
2728. FR 47792) that are being finalized with
and finalizing three interim final
In section 2713(a)(4) of the PHS Act changes here, and regulations (82 FR
regulations prior to 2017.4 In those
(hereinafter ‘‘section 2713(a)(4)’’), 47838) concerning moral objections (the
Congress provided administrative 2 The references in this document to
Moral IFC), which are being finalized
‘‘contraception,’’ ‘‘contraceptive,’’ ‘‘contraceptive with changes in companion final rules
and the religious freedom of individuals involved coverage,’’ or ‘‘contraceptive services’’ generally published elsewhere in today’s Federal
in the use of government funds to provide include all contraceptives, sterilization, and related Register.
substance abuse services); 42 U.S.C. 604a patient education and counseling, required by the
(protecting the religious character of organizations Women’s Preventive Guidelines, unless otherwise In the preamble to the Religious IFC,
and the religious freedom of beneficiaries involved indicated. The Guidelines issued in 2011 referred the Departments explained several
in the use of government assistance to needy to ‘‘Contraceptive Methods and Counseling’’ as reasons why it was appropriate to
families); 42 U.S.C. 1395w–22(j)(3)(B) (protecting ‘‘[a]ll Food and Drug Administration approved
contraceptive methods, sterilization procedures, reevaluate the religious exemptions and
against forced counseling or referrals in
Medicare+Choice (now Medicare Advantage) and patient education and counseling for all women accommodations for the contraceptive
managed care plans with respect to objections based with reproductive capacity.’’ https://www.hrsa.gov/ Mandate and to take into account the
on ‘‘moral or religious grounds’’); 42 U.S.C. womens-guidelines/index.html. The Guidelines as religious beliefs of certain employers
1396a(w)(3) (ensuring particular Federal law does amended in December 2016 refer, under the header
‘‘Contraception,’’ to: ‘‘the full range of female- concerning that Mandate. The
not infringe on ‘‘conscience’’ as protected in state
law concerning advance directives); 42 U.S.C. controlled U.S. Food and Drug Administration- Departments also sought public
1396u–2(b)(3) (protecting against forced counseling approved contraceptive methods, effective family comment on those modifications. The
or referrals in Medicaid managed care plans with planning practices, and sterilization procedures,’’ Departments considered, among other
respect to objections based on ‘‘moral or religious ‘‘contraceptive counseling, initiation of
contraceptive use, and follow-up care (for example, things, Congress’s history of providing
grounds’’); 42 U.S.C. 5106i (prohibiting certain
Federal statutes from being construed to require management, and evaluation as well as changes to protections for religious beliefs
that a parent or legal guardian provide a child any and removal or discontinuation of the contraceptive regarding certain health services
medical service or treatment against the religious method),’’ and ‘‘instruction in fertility awareness- (including contraception, sterilization,
beliefs of the parent or legal guardian); 42 U.S.C. based methods, including the lactation amenorrhea
method.’’ https://www.hrsa.gov/womens-guidelines- and items or services believed to
2996f(b) (protecting objection to abortion funding in
legal services assistance grants based on ‘‘religious 2016/index.html. involve abortion); the text, context, and
beliefs or moral convictions’’); 42 U.S.C. 14406 3 Note, however, that in sections under headings intent of section 2713(a)(4) and the
(protecting organizations and health providers from listing only two of the three Departments, the term ACA; protection of the free exercise of
being required to inform or counsel persons ‘‘Departments’’ generally refers only to the two
Departments listed in the heading.
religion in the First Amendment and, by
pertaining to assisted suicide); 42 U.S.C. 18023
(blocking any requirement that issuers or exchanges 4 Interim final regulations on July 19, 2010, at 75 Congress, in RFRA; Executive Order
must cover abortion); 42 U.S.C. 18113 (protecting FR 41726 (July 2010 interim final regulations); 13798, ‘‘Promoting Free Speech and
health plans or health providers from being interim final regulations amending the July 2010 Religious Liberty’’ (May 4, 2017);
required to provide an item or service that helps interim final regulations on August 3, 2011, at 76 previously submitted public comments;
cause assisted suicide); see also 8 U.S.C. 1182(g) FR 46621; final regulations on February 15, 2012,
(protecting vaccination objections by ‘‘aliens’’ due at 77 FR 8725 (2012 final regulations); an advance
to ‘‘religious beliefs or moral convictions’’); 18 notice of proposed rulemaking (ANPRM) on March 80 FR 41318 (July 2015 final regulations); and a
U.S.C. 3597 (protecting objectors to participation in 21, 2012, at 77 FR 16501; proposed regulations on request for information on July 26, 2016, at 81 FR
Federal executions based on ‘‘moral or religious February 6, 2013, at 78 FR 8456; final regulations 47741 (RFI), which was addressed in an FAQ
convictions’’); 20 U.S.C. 1688 (prohibiting sex on July 2, 2013, at 78 FR 39870 (July 2013 final document issued on January 9, 2017, available at:
discrimination law to be used to require assistance regulations); interim final regulations on August 27, https://www.dol.gov/sites/default/files/ebsa/about-
in abortion for any reason); 22 U.S.C. 7631(d) 2014, at 79 FR 51092 (August 2014 interim final ebsa/our-activities/resource-center/faqs/aca-part-
(protecting entities from being required to use HIV/ regulations); proposed regulations on August 27, 36.pdf and https://www.cms.gov/CCIIO/Resources/
AIDS funds contrary to their ‘‘religious or moral 2014, at 79 FR 51118 (August 2014 proposed Fact-Sheets-and-FAQs/Downloads/ACA-FAQs-
objection’’). regulations); final regulations on July 14, 2015, at Part36_1-9-17-Final.pdf.
and the extensive litigation over the A. The Departments’ Authority To collectively, to administer these
contraceptive Mandate. Mandate Coverage and Provide statutes.9
After consideration of the comments Religious Exemptions Where it applies, section 2713(a)(4)
and feedback received from requires coverage without cost sharing
stakeholders, the Departments are The Departments received conflicting for ‘‘such additional’’ women’s
finalizing the Religious IFC, with comments on their legal authority to preventive care and screenings ‘‘as
changes based on comments as provide the expanded exemptions and provided for’’ and ‘‘supported by’’
indicated herein.5 accommodation for religious beliefs. Guidelines developed by HHS through
Some commenters agreed that the HRSA. When Congress enacted this
II. Overview, Analysis, and Response to
Departments are legally authorized to provision, those Guidelines did not
Public Comments
provide the expanded exemptions and exist. And nothing in the statute
We provided a 60-day public accommodation, noting that there was mandated that the Guidelines had to
comment period for the Religious IFC, no requirement of contraceptive include contraception, let alone for all
which closed on December 5, 2017. The coverage in the ACA and no prohibition types of employers with covered plans.
Departments received over 56,000 on providing religious exemptions in Instead, section 2713(a)(4) provided a
public comment submissions, which are Guidelines issued under section positive grant of authority for HSRA to
posted at www.regulations.gov.6 Below, 2713(a)(4). Other commenters, however, develop those Guidelines, thus
the Departments provide an overview of asserted that the Departments have no delegating authority to HHS, as the
the general comments on the final legal authority to provide any administering agency of HRSA, and to
regulations, and address the issues exemptions to the contraceptive all three agencies, as the administering
raised by commenters. Mandate, contending, based on agencies of the statutes by which the
These rules expand exemptions to Guidelines are enforced, to shape that
statements in the ACA’s legislative
protect religious beliefs for certain development. See 26 U.S.C. 9834; 29
history, that the ACA requires
entities and individuals with religious U.S.C. 1191(c), 42 U.S.C. 300gg–92. That
contraceptive coverage. Still other
objections to contraception whose is especially true for HHS, as HRSA is
health plans are subject to a mandate of commenters contended that the
Departments are legally authorized to a component of HHS that was
contraceptive coverage through unilaterally created by the agency and
guidance issued pursuant to the ACA. provide the exemptions that existed
prior to the Religious IFC, but not to thus is subject to the agency’s general
These rules do not alter the discretion supervision, see 47 FR 38,409 (August
of HRSA, a component of HHS, to expand them.
31, 1982). Thus, nothing prevented
maintain the Guidelines requiring Some commenters who argued that HRSA from creating an exemption from
contraceptive coverage where no section 2713(a)(4) does not allow for otherwise-applicable Guidelines or
regulatorily recognized objection exists. exemptions said that the previous prevented HHS and the other agencies
These rules finalize the accommodation exemptions for houses of worship and from directing that HRSA create such an
process, which was previously integrated auxiliaries, and the previous exemption.
established in response to objections of accommodation process, were set forth Congress did not specify the extent to
religious organizations that were not in the ACA itself, and therefore were which HRSA must ‘‘provide for’’ and
protected by the original exemption, as acceptable while the expanded ‘‘support’’ the application of Guidelines
an optional process for any exempt exemptions in the Religious IFC were that it chooses to adopt. HRSA’s
entities. These rules do not alter not. This is incorrect. The ACA does not authority to support ‘‘comprehensive
multiple other federal programs that prescribe (or prohibit) the previous guidelines’’ involves determining both
provide free or subsidized exemptions for house of worship and the types of coverage and scope of that
contraceptives or related education and the accommodation processes that the coverage. Section 2714(a)(4) requires
counseling for women at risk of Departments issued through coverage for preventive services only
unintended pregnancy.7 regulations.8 The Departments, ‘‘as provided for in comprehensive
therefore, find it appropriate to use the guidelines supported by [HRSA].’’ That
5 The Department of the Treasury and the Internal
regulatory process to issue these is, services are required to be included
Revenue Service (IRS) published proposed and in coverage only to the extent that the
temporary regulations as part of the joint
expanded exemptions and
rulemaking of the Religious IFC. The Departments accommodation, to better address Guidelines supported by HRSA provide
of Labor and HHS published their respective rules concerns about religious exercise. for them. Through use of the word ‘‘as’’
as interim final rules with request for comments in the phrase ‘‘as provided for,’’ it
and are finalizing their interim final rules. The The Departments conclude that legal requires that HRSA support how those
Department of the Treasury and IRS are finalizing authority exists to provide the expanded services apply—that is, the manner in
their proposed regulations. exemptions and accommodation for
6 See Regulations.gov at https:// which the support will happen, such as
religious beliefs set forth in these final in the phrase ‘‘as you like it.’’ 10 When
www.regulations.gov/searchResults?rpp=25&so=
DESC&sb=postedDate&po=0&cmd=12%7C rules. These rules concern section 2713 Congress means to require certain
05%7C17-12%7C05%7C17&dktid=CMS-2014-0115 of the PHS Act, as also incorporated into activities to occur in a certain manner,
and https://www.regulations.gov/docket ERISA and the Code. Congress has instead of simply authorizing the agency
Browser?rpp=25&so=DESC&sb=commentDue granted the Departments legal authority,
Date&po=7525&dct=PS&D=IRS-2017-0016. Some of to decide the manner in which they will
those submissions included form letters or occur, Congress knows how to do so.
attachments that, while not separately tabulated at and Child Health Block Grants, 42 U.S.C. 703; 42 See, e.g., 42 U.S.C. 1395x (‘‘The
regulations.gov, together included comments from, U.S.C. 247b–12; Title XIX of the Social Security
Secretary shall establish procedures to
or were signed by, hundreds of thousands of Act, 42 U.S.C. 1396, et seq.; the Indian Health
separate persons. The Departments reviewed all of Service, 25 U.S.C. 13, 42 U.S.C. 2001(a), and 25 make beneficiaries and providers aware
the public comments and attachments. U.S.C. 1601, et seq.; Health center grants, 42 U.S.C.
7 See, for example, Family Planning grants in 42 254b(e), (g), (h), and (i); the NIH Clinical Center, 42 9 26 U.S.C. 9833; 29 U.S.C. 1191c; 42 U.S.C.
U.S.C. 300 et seq.; the Teenage Pregnancy U.S.C. 248; and the Personal Responsibility 300gg–92.
Prevention Program, Public Law 112–74 (125 Stat Education Program, 42 U.S.C. 713. 10 See As (usage 2), Oxford English Dictionary
786, 1080); the Healthy Start Program, 42 U.S.C. 8 The ACA also does not require that Online (Feb. 2018) (‘‘[u]sed to indicate by
254c–8; the Maternal, Infant, and Early Childhood contraceptives be covered under the preventive comparison the way something happens or is
Home Visiting Program, 42 U.S.C. 711; Maternal services provisions. done’’).
of the requirement that a beneficiary is appropriate that HRSA . . . takes into of employers since the Guidelines were
complete a health risk assessment prior account the effect on the religious adopted. During prior rulemakings, the
to or at the same time as receiving beliefs of [employers] if coverage of Departments also disagreed with
personalized prevention plan services.’’) contraceptive services were required in commenters who contended the
(emphasis added). Thus, the inclusion [their] group health plans.’’ Id. Departments had no authority to create
of ‘‘as’’ in section 300gg–13(a)(3), and its Consistent with that longstanding view, exemptions under section 2713 of the
absence in similar neighboring Congress’s grant of discretion in section PHS Act, or as incorporated into ERISA
provisions, shows that HRSA has been 2713(a)(4), and the lack of a specific and the Code, and who contended
granted discretion in supporting how statutory mandate that contraceptives instead that we must enforce the
the preventive coverage mandate must be covered or that they be covered Guidelines on the broadest spectrum of
applies—it does not refer to the timing without any exemptions or exceptions, group health plans as possible. See, e.g.,
of the promulgation of the Guidelines. supports the conclusion that the 2012 final regulations at 77 FR 8726.
Nor is it simply a textual aberration Departments are legally authorized to The Departments’ interpretation of
that the word ‘‘as’’ is missing from the exempt certain entities or plans from a section 2713(a)(4) is confirmed by the
other three provisions in PHS Act contraceptive Mandate if HRSA decides ACA’s statutory structure. Congress did
section 2713(a). Rather, this difference to otherwise include contraceptives in not intend to require coverage of
mirrors other distinctions within that its Guidelines. preventive services for every type of
section that demonstrate that Congress The conclusions on which these final plan that is subject to the ACA. See, e.g.,
intended HRSA to have the discretion 76 FR 46623. On the contrary, Congress
rules are based are consistent with the
the Agencies invoke. For example, carved out an exemption from PHS Act
Departments’ interpretation of section
sections (a)(1) and (a)(3) require section 2713 (and from several other
2713 of the PHS Act since 2010, when
‘‘evidence-based’’ or ‘‘evidence- provisions) for grandfathered plans. In
the ACA was enacted, and since the
informed’’ coverage, while section (a)(4) contrast, grandfathered plans do have to
Departments started to issue interim
does not. This difference suggests that comply with many of the other
final regulations implementing that
the Agencies have the leeway to provisions in Title I of the ACA—
section. The Departments have
incorporate policy-based concerns into provisions referred to by the previous
consistently interpreted section
their decision-making. This reading of Administration as providing
2713(a)(4)’s grant of authority to include
section 2713(a)(4) also prevents the ‘‘particularly significant protections.’’
broad discretion regarding the extent to (75 FR 34540). Those provisions include
statute from being interpreted in a
cramped way that allows no flexibility which HRSA will provide for, and (from the PHS Act) section 2704, which
or tailoring, and that would force the support, the coverage of additional prohibits preexisting condition
Departments to choose between ignoring women’s preventive care and exclusions or other discrimination
religious objections in violation of screenings, including the decision to based on health status in group health
RFRA or else eliminating the exempt certain entities and plans, and coverage; section 2708, which prohibits
contraceptive coverage requirement not to provide for or support the excessive waiting periods (as of January
from the Guidelines altogether. The application of the Guidelines with 1, 2014); section 2711, which relates to
Departments instead interpret section respect to those entities or plans. The lifetime and annual dollar limits;
2713(a)(4) as authorizing HRSA’s Departments defined the scope of the section 2712, which generally prohibits
Guidelines to set forth both the kinds of exemption to the contraceptive Mandate rescission of health coverage; section
items and services that will be covered, when HRSA issued its Guidelines for 2714, which extends dependent child
and the scope of entities to which the contraceptive coverage in 2011, and coverage until the child turns 26; and
contraceptive coverage requirement in then amended and expanded the section 2718, which imposes a
those Guidelines will apply. exemption and added an minimum medical loss ratio on health
The religious objections at issue here, accommodation process in multiple insurance issuers in the individual and
and in regulations providing rulemakings thereafter. The group health insurance markets, and
exemptions from the inception of the accommodation process requires the requires them to provide rebates to
Mandate in 2011, are considerations provision of coverage or payments for policyholders if that medical loss ratio
that, consistent with the statutory contraceptives to participants in an is not met. (75 FR 34538, 34540, 34542).
provision, permissibly inform what eligible organization’s health plan by Consequently, of the 150 million
HHS, through HRSA, decides to provide the organization’s insurer or third party nonelderly people in America with
for and support in the Guidelines. Since administrator. However, the employer-sponsored health coverage,
the first rulemaking on this subject in accommodation process itself, in some approximately 25.5 million are
2011, the Departments have consistently cases, failed to require contraceptive estimated to be enrolled in
interpreted the broad discretion granted coverage for many women, because—as grandfathered plans not subject to
to HRSA in section 2713(a)(4) as the Departments acknowledged at the section 2713.11 Some commenters assert
including the power to reconcile the time—the enforcement mechanism for the exemptions for grandfathered plans
ACA’s preventive-services requirement that process, section 3(16) of ERISA, are temporary, or were intended to be
with sincerely held views of conscience does not provide a means to impose an temporary, but as the Supreme Court
on the sensitive subject of contraceptive obligation to provide contraceptive observed, ‘‘there is no legal requirement
coverage—namely, by exempting coverage on the third party that grandfathered plans ever be phased
churches and their integrated auxiliaries administrators of self-insured church out.’’ Hobby Lobby, 134 S. Ct. at 2764
from the contraceptive Mandate. (See 76 plans. See 80 FR 41323. Non-exempt n.10.
FR at 46623.) As the Departments employers participate in many church Some commenters argue that
explained at that time, the HRSA plans. Therefore, in both the previous Executive Order 13535’s reference to
Guidelines ‘‘exist solely to bind non- exemption, and in the previous
grandfathered group health plans and accommodation’s application to self- 11 Kaiser Family Foundation & Health Research &
health insurance issuers with respect to insured church plans, the Departments Educational Trust, ‘‘Employer Health Benefits, 2017
Annual Survey,’’ Henry J Kaiser Family Foundation
the extent of their coverage of certain have been choosing not to require (Sept. 2017), http://files.kff.org/attachment/Report-
preventive services for women,’’ and ‘‘it contraceptive coverage for certain kinds Employer-Health-Benefits-Annual-Survey-2017.
implementing the ACA consistent with Several other commenters asserted appropriate to maintain the exemptions
certain conscience laws does not justify that the exemptions in the Religious IFC created by the Religious IFC to avoid
creating exemptions to contraceptive are too narrow and called for there to be instances where the Mandate is applied
coverage in the Guidelines, because no mandate of contraceptive coverage. in a way that violates the religious
those laws do not specifically require Some of them contended that HRSA beliefs of certain plan sponsors, issuers,
exemptions to the Mandate in the should not include contraceptives in or individuals. The Departments do not
Guidelines. The Departments, however, their women’s preventive services believe the previous exemptions are
believe these final regulations are Guidelines because fertility and adequate, because some religious
consistent with Executive Order 13535. pregnancy are generally healthy objections by plan sponsors and
Issued upon the signing of the ACA, conditions, not diseases that are individuals were favored with
Executive Order 13535 specified that appropriately the target of preventive exemptions, some were not subjected to
‘‘longstanding Federal laws to protect health services. They also contended contraceptive coverage if they fell under
conscience . . . remain intact,’’ including that contraceptives can pose medical the indirect exemption for certain self-
laws that protect holders of religious risks for women and that studies do not insured church plans, and others had to
beliefs from certain requirements in show that contraceptive programs choose between the Mandate and the
health care contexts. While the reduce abortion rates or rates of accommodation even though they
Executive Order 13535 does not require unintended pregnancies. Some objected to both. The Departments wish
the expanded exemptions in these rules, commenters contended that, to the to avoid inconsistency in respecting
the expanded exemptions are, as extent the Guidelines require coverage religious objections in connection with
explained below, consistent with of certain drugs and devices that may the provision of contraceptive coverage.
longstanding federal laws that protect prevent implantation of an embryo after The lack of a congressional mandate
religious beliefs, and are consistent with fertilization, they require coverage of that contraceptives be covered, much
the Executive Order’s intent that the items that are abortifacients and, less that they be covered without
ACA would be implemented in therefore, violate federal conscience religious exemptions, has also informed
accordance with the conscience protections such as the Weldon the Departments’ decision to expand the
protections set forth in those laws. Amendment, see section 507(d) of exemptions. And Congress’s decision
The extent to which RFRA provides Public Law 115–141. not to apply PHS Act section 2713 to
Other commenters contended that the grandfathered plans has likewise
authority for these final rules is
expanded exemptions are too broad. In informed the Departments’ decision
discussed below in section II.C., The
general, these commenters supported whether exemptions to the
First Amendment and the Religious
the inclusion of contraceptives in the contraceptive Mandate are appropriate.
Freedom Restoration Act.
Guidelines, contending they are a Congress has also established a
B. Availability and Scope of Religious necessary preventive service for women. background rule against substantially
Exemptions Some said that the Departments should burdening sincere religious beliefs
not exempt various kinds of entities except where consistent with the
Some commenters supported the such as businesses, health insurance stringent requirements of the Religious
expanded exemptions and issuers, or other plan sponsors that are Freedom Restoration Act. And Congress
accommodation in the Religious IFC, not nonprofit entities. Other has consistently provided additional,
and the entities and individuals to commenters contended the exemptions specific exemptions for religious beliefs
which they applied. They asserted the and accommodation should not be in statutes addressing federal
expanded exemptions and expanded, but should remain the same requirements in the context of health
accommodation are appropriate as they were in the July 2015 final care and specifically concerning issues
exercises of discretion and are regulations (80 FR 41318). Some such as abortion, sterilization, and
consistent with religious exemptions commenters said the Departments contraception. Therefore, the
Congress has provided in many similar should not expand the exemptions, but Departments consider it appropriate, to
contexts. Some further commented that simply expand or adjust the the extent we impose a contraceptive
the expanded exemptions are necessary accommodation process to resolve coverage Mandate by the exercise of
under the First Amendment or RFRA. religious objections to the Mandate and agency discretion, that we also include
Similarly, commenters stated that the accommodation. Some commenters exemptions for the protection of
accommodation was an inadequate contended that even the previous religious beliefs in certain cases. The
means to resolve religious objections, regulations allowing an exemption and expanded exemptions finalized in these
and that the expanded exemptions are accommodation were too broad, and rules are generally consistent with the
needed. They objected to the said that no exemptions to the Mandate scope of exemptions that Congress has
accommodation process because it was should exist, in order that contraceptive established in similar contexts. They are
another method to require compliance coverage would be provided to as many also consistent with the intent of
with the Mandate. They contended its women as possible. Executive Order 13535 (March 24,
self-certification or notice involved After consideration of the comments, 2010), which was issued upon the
triggering the very contraceptive the Departments are finalizing the signing of the ACA and declared that,
coverage that organizations objected to, provisions of the Religious IFC without ‘‘[u]nder the Act, longstanding federal
and that such coverage flowed in contracting the scope of the exemptions laws to protect conscience (such as the
connection with the objecting and accommodation set forth in the Church Amendment, 42 U.S.C. 300a–7,
organizations’ health plans. The Religious IFC. Since HRSA issued its and the Weldon Amendment, section
commenters contended that the Guidelines in 2011, the Departments 508(d)(1) of Public Law 111–8) remain
seamlessness cited by the Departments have recognized that religious intact’’ and that ‘‘[n]umerous executive
between contraceptive coverage and an exemptions from the contraceptive agencies have a role in ensuring that
accommodated plan gives rise to the Mandate are appropriate. The details of these restrictions are enforced,
religious objections that organizations the scope of such exemptions are including the HHS.’’
would not have with an expanded discussed in further detail below. In Some commenters argued that
exemption. general, the Departments conclude it is Congress’s failure to explicitly include
religious exemptions in PHS Act section entities, and should not be construed to these final rules to revoke the
2713 itself is indicative of an intent that prohibit procedures. But those contraceptive Mandate altogether, such
such exemptions not be included, but comments mistake the Departments’ as by declaring that HHS through HRSA
the Departments disagree. As noted position. The Departments are not shall not include contraceptives in the
above, Congress also failed to require construing the Church Amendments to list of women’s preventive services in
contraceptive coverage in PHS Act require these exemptions, nor do the Guidelines issued under section
section 2713. And the commenters’ exemptions prohibit any procedures. 2713(a)(4). Although previous
argument would negate not just these Instead, through longstanding federal regulations were used to authorize
expanded exemptions, but the previous conscience statutes, Congress has religious exemptions and
exemptions for houses of worship and established consistent principles accommodations to the imposition of
integrated auxiliaries, and the indirect concerning respect for religious beliefs the Guidelines’ coverage of
exemption for self-insured church plans in the context of certain Federal health contraception, the issuance of the
that use the accommodation. Where care requirements. Under those Guidelines themselves in 2011
Congress left so many matters principles, and absent any contrary describing what items constitute
concerning section 2713(a)(4) to agency requirement of law, the Departments are recommended women’s preventive
discretion, the Departments consider it offering exemptions for sincerely held services, and the update to those
appropriate to implement these religious beliefs to the extent the recommendations in December 2016,
expanded exemptions in light of Guidelines otherwise include did not occur through the regulations
Congress’s long history of respecting contraceptive coverage.12 These that preceded the 2017 Religious IFC
religious beliefs in the context of certain exemptions do not prohibit any and these final rules. The Guidelines’
federal health care requirements. services, nor do they authorize specification of which women’s
If there is to be a federal contraceptive employers to prohibit employees from preventive services were recommended
mandate that fails to include some—or, obtaining any services. The Religious were issued, not by regulation, but
in the views of some commenters, any— IFC and these final rules simply refrain directly by HRSA, after consultation
religious exemptions, the Departments from imposing the federal Mandate that with external organizations that
do not believe it is appropriate for us to employers and health insurance issuers operated under cooperative agreements
impose such a regime through cover contraceptives in their health with HRSA to consider the issue, solicit
discretionary administrative measures. plans where compliance with the public comment, and provide
Instead, such a serious imposition on Mandate would violate their sincerely recommendations. The Departments
religious liberty should be created, if at held religious beliefs. And though not decline to accept the invitation of some
all, by Congress, in response to citizens necessary to the Departments’ decision commenters to use these rules to specify
exercising their rights of political here, the Departments note that the whether HRSA includes contraceptives
participation. Congress did not prohibit Church Amendments explicitly protect in the Guidelines at all. Instead the
religious exemptions under this entities and that several subsequent Departments conclude it is appropriate
Mandate. It did not even require federal conscience statutes have for these rules to continue to focus on
contraceptive coverage under the ACA. protected against federal mandates in restating the statutory language of PHS
It left the ACA subject to RFRA, and it health coverage. Act section 2713 in regulatory form, and
specified that additional women’s The Departments note that their delineating what exemptions and
preventive services will only be decision is also consistent with state accommodations apply if HRSA lists
required coverage as provided for in practice. A significant majority of states contraceptives in its Guidelines. Some
Guidelines supported by HRSA. either impose no contraceptive coverage commenters said that if contraceptives
Moreover, Congress legislated in the requirement or offer broader exemptions are not removed from the Guidelines
context of the political consensus on than the exemption contained in the entirely, some entities or individuals
conscientious exemptions for health July 2015 final regulations.13 Although with religious objections might not
care that has long been in place. Since the practice of states is not a limit on the qualify for the exemptions or
Roe v. Wade in 1973, Congress and the discretion delegated to HRSA by the accommodation. As discussed below,
states have consistently offered religious ACA, nor is it a statement about what however, the exemptions in the
exemptions for health care providers the federal government may do Religious IFC and these final rules cover
and others concerning issues such as consistent with RFRA or other
sterilization and abortion, which a broad range of entities and
limitations or protections embodied in individuals. The Departments are not
implicate deep disagreements on federal law, such state practices can
scientific, ethical, and religious (and aware of specific groups or individuals
inform the Departments’ view that it is whose religious beliefs would still be
moral) concerns. Indeed over the last 44 appropriate to protect religious liberty
years, Congress has repeatedly substantially burdened by the Mandate
as an exercise of agency discretion. after the issuance of these final rules.
expanded religious exemptions in The Departments decline to adopt the
similar cases, including to contraceptive Some commenters asserted that HRSA
suggestion of some commenters to use should remove contraceptives from the
coverage. Congress did not purport to
deviate from that approach in the ACA. 12 The Departments note that the Church
Guidelines because the Guidelines have
Thus, we conclude it is appropriate to Amendments are the subject of another, ongoing not been subject to the notice and
specify in these final rules, that, if the rulemaking process. See Protecting Statutory comment process under the
Guidelines continue to maintain a Conscience Rights in Health Care; Delegations of Administrative Procedure Act. Some
Authority, 83 FR 3880 (NPRM Jan. 26, 2018). Since commenters also contended that the
contraceptive coverage requirement, the
the Departments are not construing the

expanded exemptions will apply to Amendments to require the religious exemptions, Guidelines should be amended to omit
those Guidelines and their enforcement. we defer issues regarding the scope, interpretation, items that may prevent (or possibly
Some commenters contended that, and protections of the Amendments to HHS in that dislodge) the implantation of a human
even though Executive Order 13535 rulemaking. embryo after fertilization, in order to
13 See Guttmacher Institute, ‘‘Insurance Coverage
refers to the Church Amendments, the of Contraceptives’’, The Guttmacher Institute (June
ensure consistency with conscience
intention of those statutes is narrow, 11, 2018), https://www.guttmacher.org/state-policy/ provisions that prohibit requiring plans
should not be construed to extend to explore/insurance-coverage-contraceptives. to pay for or cover abortions.
Whether and to what extent the most appropriate approach to resolve a compelling interest to deny religious
Guidelines continue to list these concerns is to expand the exemptions, that there is no less
contraceptives, or items considered to exemptions as set forth in the Religious restrictive means to achieve its goals, or
prevent implantation of an embryo, for IFC and these final rules, while that the Mandate or its accommodation
entities not subject to exemptions and maintaining the accommodation as an process do not impose a substantial
an accommodation, and what process is option for providing contraceptive burden on religious exercise.
used to include those items in the coverage, without forcing entities to For the reasons discussed below, the
Guidelines, is outside the scope of these choose between compliance with either Departments believe that agencies
final rules. These rules focus on what the Mandate or the accommodation and charged with administering a statute
religious exemptions and their religious beliefs. that imposes a substantial burden on the
accommodations shall apply if Comments considering the exercise of religion under RFRA have
Guidelines issued under section appropriateness of exempting certain discretion in determining whether the
2713(a)(4) include contraceptives or specific kinds of entities or individuals appropriate response is to provide an
items considered to be abortifacients. are discussed in more detail below. exemption from the burdensome
Members of the public that support or requirement, or to merely attempt to
C. The First Amendment and the
oppose the inclusion of some or all create an accommodation that would
Religious Freedom Restoration Act
contraceptives in the Guidelines, or mitigate the burden. Here, after further
wish to comment concerning the Some commenters said that the consideration of these issues and review
content of, and the process for Supreme Court ruled that the of the public comments, the
developing and updating, the exemptions to the contraceptive Departments have determined that a
Guidelines, are welcome to Mandate, which the Departments broader exemption, rather than a mere
communicate their views to HRSA, at previously provided to houses of accommodation, is the appropriate
wellwomancare@hrsa.gov. worship and integrated auxiliaries, were response.
The Departments conclude that it required by the First Amendment. From In addition, with respect to religious
would be inadequate to merely attempt this, commenters concluded that the employers, the Departments conclude
to amend or expand the accommodation exemptions for houses of worship and that, without finalizing the expanded
process instead of expanding the integrated auxiliaries are legally exemptions, and therefore requiring
exemption. In the past, the Departments authorized, but exemptions beyond certain religiously objecting entities to
had stated in our regulations and court those are not. But in Hobby Lobby and choose between the Mandate, the
briefs that the previous accommodation Zubik, the Supreme Court did not accommodation, or penalties for
process required contraceptive coverage decide whether the exemptions noncompliance—or requiring objecting
or payments in a way that is ‘‘seamless’’ previously provided to houses of individuals to choose between
with the coverage provided by the worship and integrated auxiliaries were purchasing insurance with coverage to
objecting employer. As a result, in required by the First Amendment, and which they object or going without
significant respects, that previous the Court did not say the Departments insurance—the Departments would
accommodation process did not actually must apply the contraceptive Mandate violate their rights under RFRA.
accommodate the objections of many to other organizations unless RFRA
prohibits the Departments from doing 1. Discretion To Provide Religious
entities, as many entities with religious
so. Moreover, the previous church Exemptions
objections have argued. The
Departments have attempted to identify exemption, which applied automatically In the Religious IFC, we explained
an accommodation process that would to all churches whether or not they had that even if RFRA does not compel the
eliminate the religious objections of all even asserted a religious objection to Departments to provide the religious
plaintiffs, including seeking public contraception, 45 CFR 147.141(a), is not exemptions set forth in the IFC, the
comment through a Request For tailored to any plausible free-exercise Departments believe the exemptions are
Information, 81 FR 47741 (July 26, concerns. The Departments decline to the most appropriate administrative
2016), but we stated in January 2017 adopt the view that RFRA does not response to the religious objections that
that we were unable to develop such an apply to other religious organizations, have been raised.
approach at that time.14 The and there is no logical explanation for The Departments received conflicting
Departments continue to believe that, how RFRA could require the church comments on this issue. Some
because of the nature of the exemption but not this expanded commenters agreed that the
accommodation process, merely religious exemption, given that the Departments have administrative
amending that accommodation process accommodation is no less an available discretion to address the religious
without expanding the exemptions alternative for the former than the latter. objections even if the Mandate and
would not adequately address religious Commenters disagreed about the accommodation did not violate RFRA.
objections to compliance with the scope of RFRA’s protection in this Other commenters expressed the view
Mandate. Instead, we conclude that the context. Some commenters said that the that RFRA does not provide such
expanded exemptions and discretion, but only allows exemptions
14 See Departments of Labor, Health and Human accommodation are consistent with when RFRA requires exemptions. They
Services, and the Treasury, ‘‘FAQs About RFRA. Some also said that they are contended that RFRA does not require
Affordable Care Act Implementation Part 36,’’ (Jan.
9, 2017), https://www.dol.gov/sites/default/files/
required by RFRA, as the Mandate exemptions for entities covered by the
ebsa/about-ebsa/our-activities/resource-center/faqs/ imposes substantial burdens on expanded exemptions of the Religious
aca-part-36.pdf and https://www.cms.gov/CCIIO/ religious exercise and fails to satisfy the IFC, but that subjecting those entities to
Resources/Fact-Sheets-and-FAQs/Downloads/ACA- compelling-interest and least-restrictive- the accommodation satisfies RFRA, and

FAQs-Part36_1-9-17-Final.pdf (‘‘the comments
reviewed by the Departments in response to the RFI means tests imposed by RFRA. Other therefore RFRA provides the
indicate that no feasible approach has been commenters, however, contended that Departments with no additional
identified at this time that would resolve the the expanded exemptions and authority to exempt those entities.
concerns of religious objectors, while still ensuring
that the affected women receive full and equal
accommodation are neither required by, Those commenters further contended
health coverage, including contraceptive nor consistent with, RFRA. In this vein, that because, in their view, section
coverage’’). some argued that the Departments have 2713(a)(4) does not authorize the
expanded exemptions, no statutory Hobby Lobby—neither RFRA nor the litigation over the accommodation).15
authority exists for the Departments to ACA prescribes the remedy by which Some commenters agreed the religious
finalize the expanded exemptions. the government must eliminate that objections could not be satisfied by
As discussed above, the Departments burden, where any means of doing so amending the accommodation without
disagree with the suggestions of will require departing from the ACA to expanding the exemptions, because if
commenters that section 2713(a)(4) does some extent (on the view of some the accommodation requires an
not authorize the Departments to adopt commenters, with which the objecting entity’s issuer or third party
the expanded exemptions. Nevertheless, Departments disagree, that section administrator to provide or arrange
the Departments note that the expanded 2713(a)(4) does not itself authorize the contraceptive coverage for persons
exemptions for religious objectors also Departments to recognize exceptions). covered by the plan because they are
rest on an additional, independent The prior administration chose to do so covered by the plan, this implicates the
ground: The Departments have through the complex accommodation it objection of entities to the coverage
determined that, in light of RFRA, an created, but nothing in RFRA or the being provided through their own plan,
expanded exemption rather than the ACA compelled that novel choice or issuer, or third party administrator.
existing accommodation is the most prohibits the current administration Other commenters contended the
appropriate administrative response to from employing the more accommodation could be modified to
the substantial burden identified by the straightforward choice of an satisfy RFRA concerns without
Supreme Court in Hobby Lobby. Indeed, exemption—much like the existing and extending exemptions to objecting
with respect to at least some objecting entities, but they did not propose a
unchallenged exemption for churches.
entities, an expanded exemption, as method of modifying the
After all, on the theory that section
opposed to the existing accommodation, accommodation that would, in the view
2713(a)(4) allows for no exemptions, the
is required by RFRA. The Departments of the Departments, actually address the
accommodation also departed from
disagree with commenters who contend religious objections to the
section 2713(a)(4) in the sense that
RFRA does not give the Departments accommodation.
discretion to offer these expanded employers were not themselves offering In the Departments’ view, after
exemptions. contraceptive coverage, and the ACA considering all the comments and the
The Departments’ determination did not require the Departments to preceding years of contention over this
about their authority under RFRA rests choose that departure rather than the issue, it is appropriate to finalize the
in part on the Departments’ expanded exemptions as the exclusive expanded exemptions rather than
reassessment of the interests served by method to satisfy their obligations under merely attempt to change the
the application of the Mandate in this RFRA to eliminate the substantial accommodation to satisfy religious
specific context. Although the burden imposed by the Mandate. The objections. This is because if the
Departments previously took the agencies’ choice to adopt an exemption accommodation still delivers
position that the application of the in addition to the accommodation is contraceptive coverage through use of
Mandate to objecting employers was particularly reasonable given the the objecting employer’s plan, issuer, or
narrowly tailored to serve a compelling existing legal uncertainty as to whether third party administrator, it does not
governmental interest, as discussed the accommodation itself violates address the religious objections. If the
below the Departments have now RFRA. See 82 FR at 47798; see also accommodation could deliver
concluded, after reassessing the relevant Ricci v. DeStefano, 557 U.S. 586, 585 contraceptive coverage independent and
interests and for the reasons stated (2009) (holding that an employer need separate from the objecting employer’s
below, that it does not. Particularly only have a strong basis to believe that plan, issuer, and third party
under those circumstances, the an employment practice violates Title administrator, it could possibly address
Departments believe that agencies VII’s disparate impact ban in order to the religious objections, but there are
charged with administering a statute take certain types of remedial action two problems with such an approach.
that imposes a substantial burden on the that would otherwise violate Title VII’s First, it would effectively be an
exercise of religion under RFRA have disparate-treatment ban). Indeed, if the exemption, not the accommodation as it
discretion in determining whether the Departments had simply adopted an has existed, so it would not be a reason
appropriate response is to provide an expanded exemption from the outset— not to offer the expanded exemptions
exemption from the burdensome as they did for churches—no one could finalized in these rules. Second,
requirement or instead to attempt to reasonably have argued that doing so although (as explained above) the
create an accommodation that would was improper because they should have Departments have authority to provide
mitigate the burden. And here, the invented the accommodation instead. exemptions to the Mandate, the
Departments have determined that a Neither RFRA nor the ACA compels a Departments are not aware of the
broader exemption rather than the different result now based merely on authority, or of a practical mechanism,
existing accommodation is the path dependence. for using section 2713(a)(4) to require
appropriate response. That contraceptive coverage be provided
determination is informed by the Although the foregoing analysis is
Departments’ reassessment of the independently sufficient, additional 15 See RFI, 81 FR 47741 (July 26, 2016);
relevant interests, as well as by their support for this view is provided by the Departments of Labor, Health and Human Services,
desire to bring to a close the more than Departments’ conclusion, as explained and the Treasury, ‘‘FAQs, About Affordable Care
more fully below, that an expanded Act Implementation Part 36,’’ (Jan. 9, 2017), https://
five years of litigation over RFRA www.dol.gov/sites/default/files/ebsa/about-ebsa/
challenges to the Mandate. exemption is required by RFRA for at our-activities/resource-center/faqs/aca-part-36.pdf
Although RFRA prohibits the least some objectors. In the Religious and https://www.cms.gov/CCIIO/Resources/Fact-
IFC, the Departments reaffirmed their Sheets-and-FAQs/Downloads/ACA-FAQs-Part36_1-
government from substantially 9-17-Final.pdf (‘‘the comments reviewed by the
burdening a person’s religious exercise conclusion that there is not a way to Departments in response to the RFI indicate that no
where doing so is not the least satisfy all religious objections by feasible approach has been identified at this time
restrictive means of furthering a amending the accommodation, (82 FR at that would resolve the concerns of religious
47800), a conclusion that was confirmed objectors, while still ensuring that the affected
compelling interest—as is the case with women receive full and equal health coverage,
the contraceptive Mandate, pursuant to by some commenters (and the continued including contraceptive coverage’’).
specifically to persons covered by an interest, and was not the least restrictive certain non-exempt religious entities to
objecting employer, other than by using means of achieving such an interest. choose between complying with the
the employer’s plan, issuer, or third Other commenters contended that Mandate, complying with the
party administrator, which would likely requiring compliance either with the accommodation, or facing significant
violate some entities’ religious Mandate or the accommodation did not penalties. Various entities sincerely
objections. The Departments are aware violate RFRA, agreeing with some courts contended, in litigation or in public
of ways in which certain persons that have concluded the accommodation comments, that complying with either
covered by an objecting employer might does not substantially burden the the Mandate or the accommodation was
obtain contraceptive coverage through religious exercise of organizations since, inconsistent with their religious
other governmental programs or in their view, it does not require observance or practice. The
requirements, instead of through organizations to facilitate contraceptive Departments have concluded that
objecting employers’ plans, issuers, or coverage except by submitting a self- withholding an exemption from those
third party administrators, and we certification form or notice, and entities has imposed a substantial
mention those elsewhere in this rule. requiring compliance was the least burden on their exercise of religion,
But those approaches do not involve the restrictive means of advancing the either by compelling an act inconsistent
accommodation, they involve the compelling interest of providing with that observance or practice, or by
expanded exemptions, plus the access contraceptive access to women covered substantially pressuring the adherents to
to contraceptives through separate by objecting entities’ plans. modify such observance or practice. To
means. The Departments have examined this extent, the Departments believe that
further, including in light of public the Court’s analysis in Hobby Lobby
2. Requiring Entities To Choose
comments, the issue of whether extends, for the purposes of analyzing
Between Compliance With the
requiring compliance with the substantial burden, to the burdens that
Contraceptive Mandate or the
combination of the contraceptive an entity faces when it opposes, on the
Accommodation Violated RFRA in
Mandate and the accommodation basis of its religious beliefs, complying
Many Instances
process imposes a substantial burden on with the Mandate or participating in the
Before the Religious IFC, the entities that object to both, and is the accommodation process, and is subject
Departments had previously contended least restrictive means of advancing a to penalties or disadvantages that would
that the Mandate did not impose a compelling government interest. The have applied in this context if it chose
substantial burden on entities and Departments now reaffirm the neither. See also Sharpe Holdings, 801
individuals under RFRA; that it was F.3d at 942. Likewise, reconsideration of
conclusion set forth in the Religious
supported by a compelling government these issues has also led the
IFC, that requiring certain religiously
interest; and that it was, in combination Departments to conclude that the
objecting entities or individuals to
with the accommodation, the least Mandate imposes a substantial burden
choose between the Mandate, the
restrictive means of advancing that on the religious beliefs of an individual
accommodation, or incurring penalties
interest. With respect to the coverage employee who opposes coverage of
for noncompliance imposes a
Mandate itself, apart from the some (or all) contraceptives in his or her
substantial burden on religious exercise
accommodation, and as applied to plan on the basis of his or her religious
under RFRA.
entities with sincerely held religious beliefs, and would be able to obtain a
objections, that argument was rejected a. Substantial Burden plan that omits contraception from a
in Hobby Lobby, which held that the willing employer or issuer (as
The Departments concur with the
Mandate imposes a substantial burden applicable), but cannot obtain one solely
description of substantial burdens
and was not the least restrictive means because the Mandate requires that
expressed recently by the Department of
of achieving any compelling employer or issuer to provide a plan
Justice:
governmental interest. See 134 S. Ct. at that covers all FDA-approved
2775–79. In the Religious IFC, the A governmental action substantially contraceptives. The Departments
Departments revisited its earlier burdens an exercise of religion under RFRA
disagree with commenters that contend
conclusions and reached a different if it bans an aspect of an adherent’s religious
observance or practice, compels an act the accommodation did not impose a
view, concluding that requiring inconsistent with that observance or practice, substantial burden on religiously
compliance through the Mandate or or substantially pressures the adherent to objecting entities, and agree with other
accommodation constituted a modify such observance or practice. commenters and some courts and judges
substantial burden on the religious Because the government cannot second- that concluded the accommodation can
exercise of many entities or individuals guess the reasonableness of a religious belief be seen as imposing a substantial
with religious objections, did not serve or the adherent’s assessment of the burden on religious exercise in many
a compelling interest, and was not the connection between the government mandate instances.
least restrictive means of serving a and the underlying religious belief, the
compelling interest, so that requiring substantial burden test focuses on the extent b. Compelling Interest
such compliance led to the violation of of governmental compulsion involved. In Although the Departments previously
general, a government action that bans an
RFRA in many instances. (82 FR at aspect of an adherent’s religious observance
took the position that the application of
47806). or practice, compels an act inconsistent with the Mandate to certain objecting
In general, commenters disagreed that observance or practice, or substantially employers was necessary to serve a
about this issue. Some commenters pressures the adherent to modify such compelling governmental interest, the
agreed with the Departments, and with observance or practice, will qualify as a Departments have concluded, after
some courts, that requiring entities to substantial burden on the exercise of reassessing the relevant interests and, in
choose between the contraceptive religion.16 light of the public comments received,
Mandate and its accommodation The Mandate and accommodation that it does not. This is based on several
violated their rights under RFRA, under the previous regulation forced independent reasons.
because it imposed a substantial burden First, as discussed above, the
on their religious exercise, did not 16 See Federal Law Protections for Religious structure of section 2713(a)(4) and the
advance a compelling government Liberty, 82 FR 49668, 49669 (Oct. 26, 2017). ACA evince a desire by Congress to
grant a great amount of discretion on the plans, and HHS’s and DOL’s lack of Third, the Departments now believe
issue of whether, and to what extent, to authority under the PHS Act or ERISA the administrative record on which the
require contraceptive coverage in health to require TPAs of those plans to Mandate rested was—and remains—
plans pursuant to section 2713(a)(4). provide such coverage, led to significant insufficient to meet the high threshold
This informs the Departments’ disparity in the requirement to provide to establish a compelling governmental
assessment of whether the interest in contraceptive coverage among nonprofit interest in ensuring that women covered
mandating the coverage constitutes a organizations with religious objections by plans of objecting organizations
compelling interest, as doing so imposes to the coverage. receive cost-free contraceptive coverage
a substantial burden on religious Third party administrators for some, through those plans. The Mandate is not
exercise. As the Department of Justice but not all, religious nonprofit narrowly tailored to advance the
has explained, ‘‘[t]he strict scrutiny organizations were subject to government’s interests and appears both
standard applicable to RFRA is enforcement for failure to provide overinclusive and underinclusive. It
exceptionally demanding,’’ and ‘‘[o]nly contraceptive coverage under the includes some entities where a
those interests of the highest order can accommodation, depending on whether contraceptive coverage requirement
outweigh legitimate claims to the free they administer a self-insured church seems unlikely to be effective, such as
exercise of religion, and such interests plan. Notably, many of those nonprofit religious organizations of certain faiths,
must be evaluated not in broad organizations were not houses of which, according to commenters,
generalities but as applied to the worship or integrated auxiliaries. Under primarily hire persons who agree with
particular adherent.’’ 17 section 3(33)(C) of ERISA, organizations their religious views or make their
Second, since the day the whose employees participate in self- dedication to their religious views
contraceptive Mandate came into effect insured church plans need not be known to potential employees who are
in 2011, the Mandate has not applied in churches so long as they are controlled expected to respect those views. The
many circumstances. To begin, the ACA by or ‘‘share[ ] common religious bonds Mandate also does not apply to a
does not apply the Mandate, or any part and convictions with’’ a church or significant number of entities
of the preventive services coverage convention or association of churches. encompassing many employees and for-
requirements, to grandfathered plans. The effect is that many similar religious profit businesses, such as grandfathered
To continue, the Departments under the organizations were being treated plans. And it does not appear to target
last Administration provided differently with respect to their the population defined, at the time the
exemptions to the Mandate and employees receiving contraceptive Guidelines were developed, as being the
expanded those exemptions through coverage based solely on whether most at-risk of unintended pregnancy,
multiple rulemaking processes. Those organization employees participate in a that is, ‘‘women who are aged 18 to 24
rulemaking processes included an church plan. years and unmarried, who have a low
accommodation that effectively left This arrangement encompassed income, who are not high school
employees of many non-exempt potentially hundreds of religious non- graduates, and who are members of a
religious nonprofit entities without profit organizations that were not racial or ethnic minority.’’ 19 Rather
contraceptive coverage, in particular covered by the exemption for houses of than focusing on this group, the
with respect to self-insured church worship and integrated auxiliaries. For Mandate is a broad-sweeping
plans exempt from ERISA. Under the example, the Departments were sued by requirement across employer-provided
previous accommodation, once a self- two large self-insured church plans— coverage and the individual and group
insured church plan filed a self- health insurance markets.
Guidestone and Christian Brothers.18
certification or notice, the The Department received conflicting
Guidestone is a plan organized by the
accommodation relieved it of any comments on this issue. Some
Southern Baptist convention that covers
further obligation with respect to commenters agreed that the government
38,000 employers, some of which are
contraceptive services coverage. Having does not have a compelling interest in
exempt as churches or integrated
done so, the accommodation process applying the Mandate to objecting
auxiliaries, and some of which are not.
would generally have transferred the religious employers. They noted that the
Christian Brothers is a plan that covers
obligation to provide or arrange for expanded exemptions will impact only
Catholic churches and integrated
contraceptive coverage to a self-insured a small fraction of women otherwise
auxiliaries and has said in litigation that
plan’s third party administrator (TPA). affected by the Mandate and argued that
But the Departments recognized that it covers about 500 additional entities
that are not exempt as churches. In refusing to provide those exemptions
they lack authority to compel church would fail to satisfy the compelling
plan TPAs to provide contraceptive several other lawsuits challenging the
Mandate, the previous Administration interest test. Other commenters,
coverage or levy fines against those however, argued that the government
TPAs for failing to provide it. This is took the position that some plans
established and maintained by houses of has a broader interest in the Mandate
because church plans are exempt from because all women should be
ERISA pursuant to section 4(b)(2) of worship but that included entities that
were not integrated auxiliaries, were considered at-risk of unintended
ERISA. Section 2761(a) of the PHS Act pregnancy. But the Institute of Medicine
provides that States may enforce the church plans under section 3(33) of
ERISA and, thus, the Government ‘‘has (IOM), in discussing whether
provisions of title XXVII of the PHS Act contraceptive coverage is needed,
as they pertain to health insurance no authority to require the plaintiffs’
TPAs to provide contraceptive coverage provided a very specific definition of
issuers, but does not apply to church the population of women most at-risk of
plans that do not provide coverage at this time.’’ Roman Catholic
Archdiocese of N.Y. v. Sebelius, 987 F. unintended pregnancy.20 The

through a policy issued by a health Departments believe it is appropriate to
insurance issuer. The combined result Supp. 2d 232, 242 (E.D.N.Y. 2013).
consider the government’s interest in
of PHS Act section 2713’s authority to
18 The Departments take no view on the status of
remove contraceptive coverage 19 Institute of Medicine, ‘‘Clinical Preventive
particular plans under the Employee Retirement
obligations from self-insured church Income Security Act of 1974 (ERISA), but simply Services for Women: Closing the Gaps’’ at 102
make this observation for the purpose of seeking to (2011).
17 Id. at 49670. estimate the impact of these final rules. 20 Id.
the contraceptive coverage requirement implementation of the ACA, many employers’ religious objections to the
using the definition that formed the women were able to access contraceptive Mandate.
basis of that requirement and the contraceptive methods at low or no cost Some commenters contended that
justifications the Departments have through publicly funded family obtaining contraceptive coverage from
offered for it since 2011. The Mandate, planning centers and Medicaid; other sources could be more difficult or
by its own terms, applies not just to existence of these safety net programs more expensive for women than
women most at-risk of unintended may have dampened any impact that the obtaining it from their group health plan
pregnancy as identified by the IOM, but ACA could have had on contraceptive or health insurance plan. The
applies to any non-grandfathered use. In addition, cost is not the only Departments do not believe that such
‘‘group health plan and a health barrier to accessing a full range of differences rise to the level of a
insurance issuer offering group or method options,’’ and ‘‘[t]he fact that compelling interest or make it
individual health insurance coverage.’’ income is not associated with use of inappropriate for us to issue the
PHS Act section 2713(a). Similarly, the most other methods [besides male expanded exemptions set forth in these
exemptions and accommodation in sterilization and withdrawal] obtained final rules. Instead, after considering
previous rules, and the expanded through health care settings may reflect this issue, the Departments conclude
exemptions in these rules, do not apply broader access to affordable and/or free that the religious liberty interests that
only to coverage for women most at-risk would be infringed if we do not offer the
contraception made possible through
of unintended pregnancy, but to plans expanded exemptions are not
programs such as Title X.’’
where a qualifying objection exists overridden by the impact on those who
based on sincerely held religious beliefs Fifth, the Departments previously will no longer obtain contraceptives
without regard to the types of women created the accommodation, in part, as through their employer sponsored
covered in those plans. Seen in this a way to provide for payments of coverage as a result. This is discussed in
light, the Departments believe there is a contraceptives and sterilization in a way more detail in following section, II.D.,
serious question whether the that is ‘‘seamless’’ with the coverage Burdens on Third Parties.
administrative record supports the that eligible employers provide to their
conclusion that the Mandate, as applied plan participants and their beneficiaries. D. Burdens on Third Parties
to religious objectors encompassed by (80 FR 41318). As noted above, some The Departments received a number
the expanded exemptions, is narrowly commenters contended that of comments on the question of burdens
tailored to achieve the interests seamlessness between contraceptive that these rules might impose on third
previously identified by the coverage and employer sponsored parties. Some commenters asserted that
government. Whether and to what insurance is important and is a the expanded exemptions and
extent it is certain that an interest in compelling governmental interest, while accommodation do not impose an
health is advanced by refraining from other commenters disagreed. Neither impermissible or unjustified burden on
providing expanded religious Congress, nor the Departments in other third parties, including on women who
exemptions is discussed in more detail contexts, have concluded that might not otherwise receive
below in section II.F., Health Effects of seamlessness, as such, is a compelling contraceptive coverage with no cost-
Contraception and Pregnancy. interest in the federal government’s sharing. These included commenters
Fourth, the availability of delivery of contraceptive coverage. For agreeing with the Departments’
contraceptive coverage from other example, the preventive services explanations in the Religious IFC,
possible sources—including some Mandate itself does not require stating that unintended pregnancies
objecting entities that are willing to contraceptive coverage and does not were decreasing before the Mandate was
provide some (but not all) apply to grandfathered plans, thereby implemented, and asserting that any
contraceptives, or from other failing to guarantee seamless benefit that third parties might receive
governmental programs for low-income in getting contraceptive coverage does
contraceptive coverage. The exemption
women—detracts from the government’s not justify forcing religious persons to
for houses of worship and integrated
interest to refuse to expand exemptions provide such products in violation of
auxiliaries, and the application of the
to the Mandate. The Guttmacher their beliefs. Other commenters
accommodation to certain self-insured
Institute recently published a study that disagreed, asserting that the expanded
church plans, also represents a failure to
concluded, ‘‘[b]etween 2008 and 2014, exemptions unacceptably burden
there were no significant changes in the achieve seamless contraceptive
coverage. HHS’s Title X program women who might lose contraceptive
overall proportion of women who used
provides contraceptive coverage in a coverage as a result. They contended the
a contraceptive method both among all
way that is not necessarily seamless exemptions may remove contraceptive
women and among women at risk of
with beneficiaries’ employer sponsored coverage, causing women to have higher
unintended pregnancy,’’ and ‘‘there was
insurance plans. After reviewing the contraceptive costs, fewer contraceptive
no significant increase in the use of
public comments and reconsidering this options, less ability to use
methods that would have been covered
issue, the Departments no longer believe contraceptives more consistently, more
under the ACA (most or moderately
that if a woman working for an objecting unintended pregnancies,22 births spaced
effective methods) during the most
recent time period (2012–2014) religious employer receives more closely, and workplace, economic,
excepting small increases in implant contraceptive access in ways that are or societal inequality. Still other
use.’’ 21 In discussing why they did not not seamless to her employer sponsored commenters took the view that other
see such an effect from the Mandate, the insurance, a compelling government laws or protections, such as those found
authors suggested that ‘‘[p]rior to the interest has nevertheless been in the First or Fifth Amendments,
undermined. Therefore the Departments prohibit the expanded exemptions,
21 M.L. Kavanaugh et al., Contraceptive method conclude that guaranteeing which those commenters view as
use in the United States: trends and characteristics seamlessness between contraceptive
between 2008, 2012 and 2014, 97 Contraception 14, 22 Some commenters attempted to quantify the
14–21 (2018), available at http://

access and employer sponsored costs of unintended pregnancy, but failed to
www.contraceptionjournal.org/article/S0010- insurance does not constitute a persuasively estimate the population of women that
7824(17)30478-X/pdf. compelling interest that overrides this exemption may affect.
prioritizing religious liberty of ultimately benefit, notwithstanding any Government could decide that all
exempted entities over the religious expanded exemptions—including supermarkets must sell alcohol for the
liberty, conscience, or choices of women through grandfathering of plans, the convenience of customers (and thereby
who would not receive contraceptive previous religious exemptions, and the exclude Muslims with religious
coverage where an exemption is used. failure of the accommodation to require objections from owning supermarkets),
The Departments note that the delivery of contraceptive coverage in or it could decide that all restaurants
exemptions in the Religious IFC and various self-insured church plan must remain open on Saturdays to give
these final rules, like the exemptions contexts. employees an opportunity to earn tips
created by the previous Administration, In addition, the Government is under (and thereby exclude Jews with
do not impermissibly burden third no constitutional obligation to fund religious objections from owning
parties. Initially, the Departments contraception. Cf. Harris v. McRae, 448 restaurants).’’ Id.
observe that these final rules do not U.S. 297 (1980) (holding that, although When government relieves burdens
create a governmental burden; rather, the Supreme Court has recognized a on religious exercise, it does not violate
they relieve a governmental burden. The constitutional right to abortion, there is the Establishment Clause; rather, ‘‘it
ACA did not impose a contraceptive no constitutional obligation for follows the best of our traditions.’’
coverage requirement. HHS exercised government to pay for abortions). Even Zorach v. Clauson, 343 U.S. 306, 314
discretion granted to HRSA by the more so may the Government refrain (1952). The Supreme Court’s cases
Congress to include contraceptives in from requiring private citizens, in ‘‘leave no doubt that in commanding
the Guidelines issued under section violation of their religious beliefs, to neutrality the Religion Clauses do not
2713(a)(4). That decision is what created cover contraception for other citizens. require the government to be oblivious
and imposed a governmental burden. Cf. Rust v. Sullivan, 500 U.S. 173, 192– to impositions that legitimate exercises
These rules simply relieve part of that 93 (1991) (‘‘A refusal to fund protected of state power may place on religious
governmental burden. If some third activity, without more, cannot be belief and practice.’’ Board of Educ. of
parties do not receive contraceptive equated with the imposition of a Kiryas Joel Village Sch. Dist. v. Grumet,
coverage from private parties who the ‘penalty’ on that activity.’’). The 512 U.S. 687, 705 (1994). Rather, the
government chose not to coerce, that constitutional rights of liberty and Supreme Court ‘‘has long recognized
result exists in the absence of privacy do not require the government that the government may (and
governmental action—it is not a result to force private parties to provide sometimes must) accommodate religious
the government has imposed. Calling contraception to other citizens and do practices and that it may do so without
that result a governmental burden rests not prohibit the government from violating the Establishment Clause.’’
on an incorrect presumption: that the protecting religious objections to such Corporation of the Presiding Bishop of
government has an obligation to force governmental mandates, especially the Church of Jesus Christ of Latter-Day
private parties to benefit those third where, as here, the mandate is not an Saints v. Amos, 483 U.S. 327, 334 (1987)
parties and that the third parties have a explicit statutory requirement.23 The (quoting Hobbie v. Unemployment
right to those benefits. But Congress did Departments do not believe that the Appeals Comm’n of Fla., 480 U.S. 136,
not create a right to receive Constitution prohibits offering the 144–45 (1987)). ‘‘[T]here is room for
contraceptive coverage from other expanded exemptions in these final play in the joints between the Free
private citizens through PHS Act section rules. Exercise and Establishment Clauses,
2713, other portions of the ACA, or any As the Department of Justice has allowing the government to
other statutes it has enacted. Although observed, the fact that exemptions may accommodate religion beyond free
some commenters also contended such relieve a religious adherent from exercise requirements, without offense
a right might exist under treaties the conferring a benefit on a third party to the Establishment Clause.’’ Cutter v.
Senate has ratified or the Constitution, ‘‘does not categorically render an Wilkinson, 544 U.S. 709, 713 (2005)
the Departments are not aware of any exemption unavailable,’’ and RFRA still (internal quotation omitted). Thus, the
source demonstrating that the applies.24 The Departments conclusion Supreme Court has upheld a broad
Constitution or a treaty ratified by the on this matter is consistent with the range of accommodations against
Senate creates a right to receive Supreme Court’s observation that RFRA Establishment Clause challenges,
contraceptive coverage from other may require exemptions even from laws including the exemption of religious
private citizens. requiring claimants ‘‘to confer benefits organizations from Title VII’s
The fact that the government at one on third parties.’’ See Hobby Lobby, 134 prohibition against discrimination in
time exercised its administrative S. Ct. at 2781 n.37. Here, no law employment on the basis of religion, see
discretion to require private parties to contains such a requirement, but the Amos, 483 U.S. at 335–39; a state
provide coverage to benefit other private Mandate is derived from an property tax exemption for religious
parties, does not prevent the administrative exercise of discretion organizations, see Walz v. Tax Comm’n
government from relieving some or all that Congress charged HRSA and the of City of New York, 397 U.S. 664, 672–
of the burden of its Mandate. Otherwise, Departments with exercising. Burdens 80 (1970); and a state program releasing
any governmental coverage requirement that may affect third parties as a result public school children during the
would be a one-way ratchet. In the of revisiting the exercise of agency school day to receive religious
Religious IFC and these rules, the discretion may be relevant to the RFRA instruction at religious centers, see
government has simply restored a zone analysis, but they cannot be dispositive. Zorach, 343 U.S. at 315.
of freedom where it once existed. There ‘‘Otherwise, for example, the Before 2012 (when HRSA’s
is no statutory or constitutional obstacle Guidelines went into effect), there was
to the government doing so, and the 23 See, for example, Planned Parenthood Ariz., no federal women’s preventive services
doctrine of third-party burdens should Inc. v. Am. Ass’n of Pro-Life Obstetricians & coverage mandate imposed nationally
not be interpreted to impose such an Gynecologists, 257 P.3d 181, 196 (Ariz. Ct. App. on health insurance and group health
obstacle. Such an interpretation would 2011) (‘‘[A] woman’s right to an abortion or to plans. The ACA did not require
contraception does not compel a private person or
be especially problematic given the entity to facilitate either.’’). contraceptives to be included in HRSA’s
millions of women, in a variety of 24 See Federal Law Protections for Religious Guidelines, and it did not require any
contexts, whom the Mandate does not Liberty, 82 FR at 49670. preventive services required under PHS
Act section 2713 to be covered by from the expanded exemptions, but they Solely for the purposes of determining
grandfathered plans. Many States do not did not adequately demonstrate that whether the rules have a significant
impose contraceptive coverage such impacts would occur, and they did economic impact under Executive Order
mandates, or they offer religious not explain whether, or to what extent, 12,866, and in order to estimate the
exemptions to the requirements of such they were impacted by the other kinds broadest possible impact so as to
coverage mandates—exemptions that of instances mentioned above in which determine the applicability of the
have not been invalidated by federal or no federal mandate of contraceptive procedures set forth in that Executive
State courts. The Departments, in coverage has applied to certain plans. Order, the Departments propose that the
previous regulations, exempted houses The Departments find no legal rules will affect no more than 126,400
of worship and integrated auxiliaries prohibition on finalizing these rules women of childbearing age who use
from the Mandate. The Departments based on the speculative suggestion of contraceptives covered by the
then issued a temporary enforcement an impact on state or local governments, Guidelines, and conclude the economic
safe harbor allowing religious nonprofit and we disagree with the suggestion that impact falls well below $100 million. As
groups to not provide contraceptive once we have exercised our discretion explained below, that estimate assumes
coverage under the Mandate for almost to deny exemptions—no matter how that a certain percentage of employers
two additional years. The Departments recently or incompletely—we cannot which did not cover contraceptives
further expanded the houses of worship change course if some state and local before the ACA will use these
and integrated auxiliaries exemption governments believe they are receiving exemptions based on sincerely held
through definitional changes. And the indirect benefits from the previous religious beliefs. The Departments do
Departments created an accommodation decision. not actually know that such entities will
process under which many women in In addition, these expanded do so, however, or that they operate
self-insured church plans may not exemptions apply only to a small based on sincerely held religious beliefs
ultimately receive contraceptive fraction of entities to which the against contraceptive coverage. The
coverage. In addition, many Mandate would otherwise apply—those Departments also explain that other
organizations have not been subject to with qualifying religious objections. exemptions unaffected by these rules
the Mandate in practice because of Public comments did not provide may encompass many or most women
injunctions they received through reliable data on how many entities potentially affected by the expanded
litigation, protecting them from federal would use these expanded religious exemptions. In other words, the houses
imposition of the Mandate, including exemptions, in which states women in of worship and integrated auxiliaries
under several recently entered such plans would reside, how many of exemption, the accommodation’s failure
permanent injunctions that will apply those women would qualify for or use to require contraceptive coverage in
regardless of the issuance of these final state and local government subsidies of certain self-insured church plans, the
rules. contraceptives as a result, or in which non-applicability of PHS Act section
states such women, if they are low 2713 to grandfathered plans, and the
Commenters offered various income, would go without
assessments of the impact these rules permanent injunctive relief many
contraceptives and potentially religious litigants have received against
might have on state or local experience unintended pregnancies that
governments. Some commenters said section 2713(a)(4), may encompass a
state Medicaid programs would have to large percentage of women potentially
that the expanded exemptions will not cover. As mentioned above, at least one
burden state or local governments, or affected by religious objections, and
study, published by the Guttmacher
that such burdens should not prevent therefore many women in those plans
Institute, concluded the Mandate has
the Departments from offering those may not be impacted by these rules at
caused no clear increase in
exemptions. Others said that if the all. In addition, even if 126,400 women
contraceptive use; one explanation
Departments provide expanded might be affected by these rules, that
proposed by the authors of the study is
exemptions, states or local jurisdictions number constitutes less than 0.1% of all
that women eligible for family planning
may face higher costs in providing birth women in the United States.25 This
from safety net programs were already
control to women through government suggests that if these rules have any
receiving free or subsidized
programs. The Departments consider it impact on state or local governments, it
contraceptive access through them,
appropriate to offer expanded notwithstanding the Mandate’s effects will be statistically de minimus. The
exemptions, notwithstanding the on the overall market. Some Departments conclude that there is
objection of some state or local commenters who opposed the expanded insufficient evidence of a potential
governments. The ACA did not require exemptions admitted that this negative impact of these rules on state
a contraceptive Mandate, and its information is unclear at this stage; and local governments to override the
discretionary creation by means of other commenters that estimated appropriateness of deciding to finalize
HRSA’s Guidelines does not translate to considerably more individuals and these rules.
a benefit that the federal government entities would seek an exemption also Some commenters contended that the
owes to states or local governments. We admitted the difficulty of quantifying expanded exemptions would constitute
are not aware of instances where the estimates. unlawful sex discrimination, such as
various situations recited in the In the discussion below concerning under section 1557 of the Affordable
previous paragraph, in which the estimated economic impacts of these Care Act, Title VII of the Civil Rights
federal government has not imposed rules, the Departments explain there is Act of 1964, Title IX of the Education
contraceptive coverage (other than not reliable data available to accurately Amendments of 1972, or the Fifth
through the Religious and Moral IFCs), estimate the number of women who Amendment. Some commenters
have been determined to cause a may lose contraceptive coverage under suggested the expanded exemptions
cognizable injury to state or local these rules, and the Departments set
25 U.S. Census Bureau, ‘‘Quick Facts: Population
governments. Some states that were forth various reasons why it is difficult
Estimates, July 1, 2017’’ (estimating 325,719,178
opposed to the IFCs submitted to know how many entities will use persons in the U.S., 50.8% of which are female),
comments objecting to the potential these exemptions or how many women available at https://www.census.gov/quickfacts/fact/
impacts on their programs resulting will be impacted by those decisions. table/US/PST045217.
would discriminate on bases such as country will be affected by these because the programs were not intended
race, disability, or LGBT status, or that expanded exemptions.26 In this context, to absorb privately insured individuals.
they would disproportionately burden the Departments do not believe that an Some commenters observed that
certain persons in such categories. adjustment to discretionary Guidelines contraceptives may be available through
But these final rules do not for women’s preventive services other sources, such as a plan of another
discriminate or draw any distinctions concerning contraceptives constitutes family member and that the expanded
on the basis of sex, pregnancy, race, unlawful sex discrimination. Otherwise, exemptions will not likely encompass a
disability, socio-economic class, LGBT anytime the government exercises its very large segment of the population
status, or otherwise, nor do they discretion to provide a benefit that is otherwise benefitting from the Mandate.
discriminate on any unlawful grounds. specific to women (or specific to men), Other commenters disagreed, pointing
The expanded exemptions in these rules it would constitute sex discrimination out that some government programs that
do not authorize entities to comply with for the government to reconsider that provide family planning have income
the Mandate for one person, but not for benefit. Under that theory, Hobby Lobby and eligibility thresholds, so that
another person, based on that person’s itself, and RFRA (on which Hobby women earning certain amounts above
status as a member of a protected class. Lobby’s holding was based), which those levels would need to pay full cost
Instead they allow entities that have provided a religious exemption to this for contraceptives if they were no longer
sincerely held religious objections to Mandate for many businesses, would be covered in their health plans.
providing some or all contraceptives deemed discriminatory against women The Departments do not believe that
included in the Mandate to not be because the underlying women’s these general considerations make it
forced to provide coverage of those preventive services requirement is a inappropriate to issue the expanded
items to anyone. benefit for women, not for men. Such exemptions set forth in these rules. In
These commenters’ contentions about conclusions are not consistent with addition, the Departments note that the
discrimination are unpersuasive for still legal doctrines concerning sex HHS Office of Population Affairs,
additional reasons. First, Title VII is discrimination. within the Office of the Assistant
applicable to discrimination committed It is not clear that these expanded Secretary for Health, has recently issued
by employers, and these rules have been exemptions will significantly burden a proposed regulation to amend the
issued in the government’s capacity as women most at risk of unintended regulations governing its Title X family
a regulator of group health plans and pregnancies. Some commenters planning program. The proposed
group and individual health insurance, observed that contraceptives are often regulation would amend the definition
not an employer. See also In Re Union readily accessible at relatively low cost. of ‘‘low income family’’—individuals
Pac. R.R. Emp’t Practices Litig., 479 F.3d Other commenters disagreed. Some eligible for free or low cost
936, 940–42 & n.1 (8th Cir. 2007) objected to the suggestion in the contraceptive services—to include
(holding that Title VII ‘‘does not require Religious IFC that many forms of women who are unable to obtain certain
coverage of contraception because contraceptives are available for around family planning services under their
contraception is not a gender-specific $50 per month and other forms, though employer-sponsored health coverage
term like potential pregnancy, but rather they bear a higher one-time cost, cost a due to their employers’ religious beliefs
applies to both men and women’’). similar amount over the duration of use. or moral convictions (see 83 FR 25502).
Second, these rules create no disparate But some of those commenters cited If that regulation is finalized as
impact. The women’s preventive sources maintaining that birth control proposed, it could further reduce any
services mandate under section pills can cost up to $600 per year (that potential effect of these final rules on
2713(a)(4), and the contraceptive is, $50 per month), and said that IUDs, women’s access to contraceptives. That
Mandate promulgated under such which can last three to six years or proposal also demonstrates that the
preventive services mandate, already more,27 can cost $1,100 (that is, less government has other means available
inures to the specific benefit of than $50 per month over the duration of to it for increasing women’s access to
women—men are denied any benefit use). Some commenters said that, for contraception. Some of those means are
from that section. Both before and after lower income women, contraceptives less restrictive of religious exercise than
these final rules, section 2713(a)(4) and can be available at free or low cost imposition of the contraceptive Mandate
the Guidelines issued under that section through government programs (federal on employers with sincerely held
treat women’s preventive services in programs offering such services include, religious objections to providing such
general, and female contraceptives for example, Medicaid, Title X, coverage.
specifically, more favorably than they community health center grants, and Some commenters stated that the
treat male preventive services or male Temporary Assistance for Needy expanded exemptions would violate
contraceptives. Families (TANF)). Other commenters section 1554 of the ACA. That section
It is simply not the case that the contended that many women in says the Secretary of HHS ‘‘shall not
government’s implementation of section employer-sponsored coverage might not promulgate any regulation’’ that
2713(a)(4) is discriminatory against qualify for those programs, although ‘‘creates any unreasonable barriers to
women because exemptions are that sometimes occurs because their the ability of individuals to obtain
expanded to encompass religious incomes are above certain thresholds or appropriate medical care,’’ ‘‘impedes
objections. The previous regulations, as timely access to health care services,’’
discussed elsewhere herein, do not 26 Below, the Departments estimate that no more ‘‘interferes with communications
require contraceptive coverage in a host than 126,400 women of childbearing age will be regarding a full range of treatment
of plans, including grandfathered plans, affected by the expanded exemptions. As noted
options between the patient and the
above, this is less than 0.1% of the over 165 million

plans of houses of worship, and— women in the United States. The Departments provider,’’ ‘‘restricts the ability of health
through inability to enforce the previously estimated that, at most 120,000 women care providers to provide full disclosure
accommodation on certain third party of childbearing age would be affected by the of all relevant information to patients
administrators—plans of many religious expanded exemptions. See Religious IFC, 82 FR making health care decisions,’’ ‘‘violates
47,823–84.
non-profits in self-insured church plans. 27 See, for example, Planned Parenthood, ‘‘IUD,’’ the principles of informed consent and
Below, the Departments estimate that https://www.plannedparenthood.org/learn/birth- the ethical standards of health care
few women of childbearing age in the control/iud. professionals,’’ or ‘‘limits the
availability of health care treatment for below, consistent with longstanding Section 9833 of the Code, section 734 of
the full duration of a patient’s medical federal laws to protect religious beliefs. ERISA, and section 2792 of the PHS Act
needs.’’ 42 U.S.C. 18114. Such In short, the Departments do not authorize the Secretaries of the
commenters urged, for example, that the believe sections 1554 or 1557 of the Treasury, Labor, and HHS (collectively,
Religious IFC created unreasonable ACA, other nondiscrimination statutes, the Secretaries) to promulgate any
barriers to the ability of individuals to or any constitutional doctrines, create interim final rules that they determine
obtain appropriate medical care, an affirmative obligation to create, are appropriate to carry out the
particularly in areas they said may have maintain, or impose a Mandate that provisions of chapter 100 of the Code,
a disproportionately high number of forces covered entities to provide part 7 of subtitle B of title I of ERISA,
entities likely to take advantage of the coverage of preventive contraceptive and part A of title XXVII of the PHS Act,
exemption. services in health plans. The ACA’s which include sections 2701 through
The Departments disagree with these grant of authority to HRSA to provide 2728 of the PHS Act and the
comments about section 1554. The for, and support, the Guidelines is not incorporation of those sections into
Departments issued previous transformed by any of the laws cited by section 715 of ERISA and section 9815
exemptions and accommodations that commenters into a requirement that, of the Code. The Religious and Moral
allowed various plans to not provide once those Guidelines exist, they can IFCs fall under those statutory
contraceptive coverage on the basis of never be reconsidered or amended authorizations for the use of interim
religious objections. The Departments, because doing so would only affect final rulemaking. Prior to the Religious
women’s coverage or would allegedly IFC, the Departments issued three
which administer both ACA section
impact particular populations interim final rules implementing this
1554 and PHS Act section 2713, did not
disparately. section of the PHS Act because of the
conclude that the exemptions or Members of the public have widely
accommodations in those regulations needs of covered entities for immediate
divergent views on whether expanding guidance and the weighty matters
violated section 1554. Moreover, the the exemptions is good public policy.
decision not to impose a governmental implicated by the HRSA Guidelines,
Some commenters said the exemptions including issuance of new or revised
mandate is not the ‘‘creation’’ of a would burden workers, families, and the
‘‘barrier,’’ especially when that mandate exemptions or accommodations. (75 FR
economic and social stability of the 41726; 76 FR 46621; 79 FR 51092). The
requires private citizens to provide country, and interfere with the
services to other private citizens. Nor, in Departments also had good cause to
physician-patient relationship. Other issue the Religious IFC as interim final
any event, are the exemptions from the commenters disagreed, favoring the
Mandate unreasonable. Section 1554 of rules, for the reasons discussed therein.
public policy behind expanding the In any event, the objections of some
the ACA does not require the exemptions and arguing that the commenters to the issuance of the
Departments to require coverage of, or to exemptions would not interfere with the Religious IFC as interim final rules with
keep in place a requirement to cover, physician-patient relationship. For all request for comments does not prevent
certain services, including the reasons explained at length in this the issuance of these final rules. These
contraceptives, that was issued pursuant preamble, the Departments have final rules are being issued after
to HHS’s exercise of discretion under determined that these rules are good receiving and thoroughly considering
section 2713(a)(4). Nor does section policy. Because of the importance of the public comments as requested in the
1554 prohibit the Departments from religious liberty values being Religious IFC. These final rules
providing exemptions for burdens on accommodated, the limited impact of therefore comply with the APA’s notice
religious exercise, or, as is the case here, these rules, and uncertainty about the and comment requirements.
from refraining to impose the Mandate impact of the Mandate overall according
in cases where religious exercise would to some studies, the Departments do not F. Health Effects of Contraception and
be burdened by it. In light of RFRA and believe these rules will have any of the Pregnancy
the First Amendment, providing drastic negative consequences on third The Departments received numerous
religious exemptions is a reasonable parties or society that some opponents comments on the health effects of
administrative response in the context of these rules have suggested. contraception and pregnancy. As noted
of this federally mandated burden, above, some commenters supported the
especially since the burden itself is a E. Interim Final Rulemaking
expanded exemptions, and others urged
subregulatory creation that does not The Departments received several that contraceptives be removed from the
apply in various contexts. Religious comments about their decision to issue Guidelines entirely, based on the view
exemptions from federal mandates in the Religious IFC as interim final rules that pregnancy and the unborn children
sensitive health contexts have existed in with requests for comments, instead of resulting from conception are not
federal laws for decades, and President as a notice of proposed rulemaking. diseases or unhealthy conditions that
Obama referenced them when he issued Several commenters asserted that the are properly the subject of preventive
Executive Order 13535 (March 24, Departments had the authority to issue care coverage. Such commenters further
2010), declaring that, under the ACA, the Religious IFC in that way, agreeing contended that hormonal contraceptives
‘‘longstanding Federal laws to protect that the Departments had explicit may present health risks to women. For
conscience (such as the Church statutory authority to do so, good cause example, they contended that studies
Amendment, 42 U.S.C. 300a–7, and the under the Administrative Procedure Act show certain contraceptives cause or are
Weldon Amendment, section 508(d)(1) (APA), or both. Other commenters held associated with an increased risk of
of Pub. L. 111–8) remain intact,’’ and the opposite view, contending that there depression,28 venous thromboembolic
that ‘‘[n]umerous executive agencies was neither statutory authority to issue

have a role in ensuring that these the rules on an interim final basis, nor 28 Commenters cited Charlotte Wessel Skovlund
restrictions are enforced, including the good cause under the APA to make the et al., ‘‘Association of Hormonal Contraception with
HHS.’’ While the text of Executive Order rules immediately effective. Depression,’’ 73 JAMA Psychiatry 1154, 1154
(published online Sept. 28, 2016) (‘‘Use of
13535 does not require the expanded The Departments continue to believe hormonal contraception, especially among
exemptions issued in these rules, the legal authority existed to issue the adolescents, was associated with subsequent use of
expanded exemptions are, as explained Religious IFC as interim final rules. antidepressants and a first diagnosis of depression,
disease,29 fatal pulmonary embolism,30 breast, cervical, and liver cancers.34 disease.37 Some commenters said that
thrombotic stroke and myocardial Some commenters also observed that pregnancy presents various health risks,
infarction (particularly among women fertility awareness based methods of such as blood clots, bleeding, anemia,
who smoke, are hypertensive, or are birth spacing are free of similar health high blood pressure, gestational
older),31 hypertension,32 HIV–1 risks since they do not involve ingestion diabetes, and death. Some commenters
acquisition and transmission,33 and of chemicals. Some commenters also contended that increased access to
contended that contraceptive access contraception reduces abortions.
suggesting depression as a potential adverse effect does not reduce unintended pregnancies Some commenters said that, in the
of hormonal contraceptive use.’’). or abortions. Religious IFC, the Departments made
29 Commenters cited the Practice Committee of
Other commenters disagreed, citing a incorrect statements concerning
the American Society for Reproductive Medicine,
‘‘Hormonal Contraception: Recent Advances and variety of studies they contend show scientific studies. For example, some
Controversies,’’ 82 Fertility and Sterility S20, S26 health benefits caused by, or associated commenters argued there is no proven
(2004); V.A. Van Hylckama et al., ‘‘The Venous with, contraceptive use or the increased risk of breast cancer or other
Thrombotic Risk of Oral Contraceptives, Effects of
Estrogen Dose and Progestogen Type: Results of the prevention of unintended pregnancy. risks among contraceptive users. They
MEGA Case-Control Study,’’ 339 Brit. Med. J. Commenters cited, for example, the criticized the Religious IFC for citing
339b2921 (2009); Y. Vinogradova et al., ‘‘Use of 2011 IOM Report’s discussions of the studies, including one previewed in the
Combined Oral Contraceptives and Risk of Venous negative effects associated with 2011 IOM Report itself (Agency for
Thromboembolism: Nested Case-Control Studies
Using the QResearch and CPRD Databases,’’ 350 unintended pregnancies, as well as Healthcare Research and Quality Report
Brit. Med. J. 350h2135 (2015) (‘‘Current exposure to other studies. Such commenters No.: 13–E002–EF (June 2013) (cited
any combined oral contraceptive was associated contended that, by reducing unintended above)), discussing an association
with an increased risk of venous thromboembolism between contraceptive use and
. . . compared with no exposure in the previous
pregnancy, contraceptives reduce the
year.’’); ;. Lidegaard et al., ‘‘Hormonal risk of unaddressed health increased risks of breast and cervical
contraception and risk of venous thromboembolism: complications, low birth weight, cancer, and concluding there are no net
national follow-up study,’’ 339 Brit. Med. J. b2890 preterm birth, infant mortality, and cancer-reducing benefits of
(2009): M. de Bastos et al., ‘‘Combined oral contraceptive use. As described in the
contraceptives: venous thrombosis,’’ Cochrane
maternal mortality.35 Commenters also
Database Syst. Rev. (no. 3, 2014). CD010813. doi: said studies show contraceptives are Religious IFC, 82 FR at 47804, the 2013
10.1002/14651858.CD010813.pub2, available at associated with a reduced risk of Agency for Healthcare Research and
https://www.ncbi.nlm.nih.gov/ conditions such as ovarian cancer, Quality study, and others, reach
pubmed?term=24590565; L.J Havrilesky et al., ‘‘Oral conclusions with which these
Contraceptive User for the Primary Prevention of
colorectal cancer, and endometrial
Ovarian Cancer,’’ Agency for Healthcare Research cancer,36 and that contraceptives treat commenters appear to disagree. The
and Quality, Report No. 13–E002–EF (June 2013), such conditions as endometriosis, Departments consider it appropriate to
available at https://archive.ahrq.gov/research/ polycystic ovarian syndrome, migraines, take into account both of those studies,
findings/evidence-based-reports/ocusetp.html; and as well as the studies cited by
Robert A. Hatcher et al., Contraceptive Technology
pre-menstrual pain, menstrual
405–07 (Ardent Media 18th rev. ed. 2004). regulation, and pelvic inflammatory commenters who disagree with those
30 Commenters cited N.R. Poulter, ‘‘Risk of Fatal conclusions.
Pulmonary Embolism with Oral Contraceptives,’’ https://www.sciencedaily.com/releases/2011/10/ Some commenters further criticized
355 Lancet 2088 (2000). 111003195253.htm. the Departments for saying two studies
31 Commenters cited ;. Lidegaard et al., 34 Commenters cited ‘‘Oral Contraceptives and
cited by the 2011 IOM Report, which
‘‘Thrombotic Stroke and Myocardial Infarction with Cancer Risk’’ (Mar. 21, 2012, National Cancer
Hormonal Contraception,’’ 366 N. Eng. J. Med. 2257, Institute (reviewed Feb. 22, 2018), https://
asserted an associative relationship
2257 (2012) (risks ‘‘increased by a factor of 0.9 to www.cancer.gov/about-cancer/causes-prevention/ between contraceptive use and
1.7 with oral contraceptives that included ethinyl risk/hormones/oral-contraceptives-fact-sheet; L.J decreases in unintended pregnancy, did
estradiol at a dose of 20 mg and by a factor of 1.3 Havrilesky et al., ‘‘Oral Contraceptive User for the not on their face establish a causal
to 2.3 with those that included ethinyl estradiol at Primary Prevention of Ovarian Cancer,’’ Agency for
a dose of 30 to 40 mg’’); Practice Committee of the Healthcare Research and Quality, Report No. 13–
relationship between a broad coverage
American Society for Reproductive Medicine, E002–EF (June 2013), available at https:// mandate and decreases in unintended
‘‘Hormonal Contraception’’; M. Vessey et al., archive.ahrq.gov/research/findings/evidence-based- pregnancy. In this respect, as noted in
‘‘Mortality in Relation to Oral Contraceptive Use reports/ocusetp.html; S.N. Bhupathiraju et al., the Religious IFC,38 the purpose for the
and Cigarette Smoking,’’ 362 Lancet 185, 185–91 ‘‘Exogenous hormone use: Oral contraceptives,
(2003); WHO Collaborative Study of Cardiovascular postmenopausal hormone therapy, and health
Departments’ reference to such studies
Disease and Steroid Hormone Contraception, outcomes in the Nurses’ Health Study,’’ 106 Am. J. was to highlight the difference between
‘‘Acute Myocardial Infarction and Combined Oral Pub. Health 1631, 1631–37 (2016); The World a causal relationship and an associative
Contraceptives: Results of an International Health Organization Department of Reproductive one, as well as the difference between
Multicentre Case-Control Study,’’ 349 Lancet 1202, Health and Research, ‘‘The Carcinogenicity of
1202–09(1997); K.M. Curtis et al., Combined Oral Combined Hormonal Contraceptives and Combined
saying contraceptive use has a certain
Contraceptive Use Among Women With Menopausal Treatment’’, World Health effect and saying a contraceptive
Hypertension: A Systematic Review, 73 Organization (Sept. 2005), http://www.who.int/ coverage mandate (or, more specifically,
Contraception 73179, 179–88 (2006); L.A. Gillum et reproductivehealth/topics/ageing/cocs_hrt_ the part of that mandate affected by
al., ‘‘Ischemic stroke risk with oral contraceptives: statement.pdf; and the American Cancer Society,
A meta analysis,’’ 284 JAMA 72, 72–78 (2000), ‘‘Known and Probably Human Carcinogens,’’
certain exemptions) will necessarily
available at https://www.ncbi.nlm.nih.gov/pubmed/ American Cancer Society (rev. Nov. 3, 2016), have (or negate, respectively) such an
10872016; and Robert A. Hatcher et al., https://www.cancer.org/cancer/cancer-causes/ effect.
Contraceptive Technology 404–05, 445 (Ardent general-info/known-and-probable-human- Commenters disagreed about the
Media 18th rev. ed. 2004). carcinogens.html.
32 Commenters cited Robert A. Hatcher et al., 35 Citing, e.g., Conde-Agudelo A, Rosas-Bermudez
effects of some FDA-approved
Contraceptive Technology 407, 445 (Ardent Media A, Kafury-Goeta AC. Birth spacing and risk of contraceptives on embryos. Some
18th rev. ed. 2004). adverse perinatal outcomes: a meta-analysis. JAMA
33 Commenters cited Renee Heffron et al., ‘‘Use of 2006;295:1809–23, and John Hopkins Bloomberg 37 Citing, e.g., id., and American College of
Hormonal Contraceptives and Risk of HIV–1 Public Health School of Health, Contraception Use Obstetricians and Gynecologists, Committee on
Transmission: A Prospective Cohort Study,’’ 12 Averts 272,000 Maternal Deaths Worldwide, Health Care for Underserved Women. (2015,
Lancet Infectious Diseases 19, 24 (2012) (‘‘Use of https://www.jhsph.edu/news/news-releases/2012/ January). Committee Opinion Number 615: Access
hormonal contraceptives was associated with a two- ahmed-contraception.html. to Contraception. As discussed below, to the extent
times increase in the risk of HIV–1 acquisition by 36 Citing, e.g., Schindler, A.E. (2013). Non- that contraceptives are prescribed to treat existing
women and HIV–1 transmission from women to contraceptive benefits of oral hormonal health conditions, and not for preventive purposes,
men.’’); and ‘‘Hormonal Contraception Doubles HIV contraceptives. International Journal of the Mandate would not be applicable.
Risk, Study Suggests,’’ Science Daily (Oct. 4, 2011), Endocrinology and Metabolism, 11 (1), 41–47. 38 82 FR at 47803–04.
commenters agreed with the quotation, sincere religious objections to providing this discussion, while other commenters
in the Religious IFC, of FDA materials 39 contraception coverage on this basis. disagreed. Commenters who supported
that indicate that some items it has The Supreme Court has already the expanded exemptions cited these
approved as contraceptives may prevent recognized that such a view can form and similar sources suggesting that
the implantation of an embryo after the basis of a sincerely held religious denying expanded exemptions to the
fertilization. Some of those commenters belief under RFRA.40 Even though there Mandate is not a narrowly tailored way
cited additional scientific sources to is a plausible scientific argument against to advance the Government’s interests
argue that certain approved the view that certain contraceptives in reducing teen pregnancy, and
contraceptives may prevent have mechanisms of action that may suggesting there are means of doing so
implantation, and that, in some cases, prevent implantation, there is also a that are less restrictive of religious
some contraceptive items may even plausible scientific argument in favor of exercise.42 Some commenters opposing
dislodge an embryo shortly after it—as demonstrated, for example, by the expanded exemptions stated that
implantation. Other commenters FDA’s statement that some school-based health centers provide
disagreed with the sources cited in the contraceptives may prevent access to contraceptives, thus increasing
Religious IFC and cited additional implantation and by some scientific use of contraceptives by sexually active
studies on that issue. Some commenters studies cited by commenters. The students. They also cited studies
further criticized the Departments for Departments believe in this context we concluding that certain decreases in
asserting in the Religious IFC that some have a sufficient rationale to offer teen pregnancy are attributable to
persons believe those possible effects expanded religious exemptions with increased contraceptive use.43
are ‘‘abortifacient.’’ respect to this Mandate. Many commenters opposing the
The objection on this issue appears to The Departments also received Religious IFC misunderstood the
be partially one of semantics. People comments about their discussion of the Departments’ discussion of this issue.
disagree about whether to define uncertain effects of the expanded Teens are a significant part, though not
‘‘conception’’ or ‘‘pregnancy’’ to occur exemptions on teen sexual activity. In the entirety, of women the IOM
at fertilization, when the sperm and this respect, the Departments stated, identified as being most at risk of
ovum unite, or days later at ‘‘With respect to teens, the Santelli and unintended pregnancy. The
implantation, when that embryo has Melnikas study cited by IOM 2011 Departments do not take a position on
undergone further cellular development, observes that, between 1960 and 1990, the empirical question of whether
travelled down the fallopian tube, and as contraceptive use increased, teen contraception has caused certain
implanted in the uterine wall. This sexual activity outside of marriage reductions in teen pregnancy. Rather,
question is independent of the question likewise increased (although the study we note that studies suggesting various
of what mechanisms of action FDA- does not assert a causal relationship). causes of teen pregnancy and
approved or cleared contraceptives may Another study, which proposed an unintended pregnancy in general
have. It is also a separate question from economic model for the decision to support the Departments’ conclusion
whether members of the public assert, engage in sexual activity, stated that that it is difficult to establish causation
or believe, that it is appropriate to ‘[p]rograms that increase access to between granting religious exemptions
consider the items ‘‘abortifacient’’—that contraception are found to decrease teen to the contraceptive Mandate and either
is, a kind of abortion, or a medical pregnancies in the short run but an increase in teen pregnancies in
product that causes an abortion— increase teen pregnancies in the long particular, or unintended pregnancies in
because they believe abortion means to run.’ ’’ 41 Some commenters agreed with general. For example, a 2015 study
cause the demise of a post-fertilization investigating the decline in teen
embryo inside the mother’s body. 40 ‘‘Although many of the required, FDA- pregnancy since 1991 attributed it to
Commenters referenced scientific approved methods of contraception work by multiple factors (including but not
preventing the fertilization of an egg, four of those limited to reduced sexual activity,
studies and sources on both sides of the methods (those specifically at issue in these cases)
issue of whether certain contraceptives may have the effect of preventing an already
falling welfare benefit levels, and
prevent implantation. Commenters and fertilized egg from developing any further by expansion of family planning services in
litigants have positively stated that inhibiting its attachment to the uterus. See Brief for Medicaid, with the latter accounting for
HHS in No. 13–354, pp. 9–10, n. 4; FDA, Birth less than 13 percent of the decline), and
some of them view certain Control: Medicines to Help You.’’ Hobby Lobby, 134
contraceptives as abortifacients, for this S. Ct. at 2762–63. ‘‘The Hahns have accordingly
concluded ‘‘that none of the relatively
reason. See also Hobby Lobby, 134 U.S. excluded from the group-health-insurance plan they easy, policy-based explanations for the
at 2765 (‘‘The Hahns have accordingly offer to their employees certain contraceptive recent decline in teen childbearing in
methods that they consider to be the United States hold up very well to
excluded from the group-health- abortifacients. . . . Like the Hahns, the Greens
insurance plan they offer to their believe that life begins at conception and that it
careful empirical scrutiny.’’ 44 One
employees certain contraceptive would violate their religion to facilitate access to
42 See Helen Alvaré, ‘‘No Compelling Interest:
contraceptive drugs or devices that operate after
methods that they consider to be that point.’’ Id. at 2765–66. The ‘Birth Control’ Mandate and Religious
abortifacients.’’). 41 Citing J.S. Santelli & A.J. Melnikas, ‘‘Teen Freedom,’’ 58 Vill. L. Rev. 379, 400–02 (2013)
The Departments do not take a fertility in transition: recent and historic trends in (discussing the Santelli & Melnikas study and the
position on the scientific, religious, or the United States,’’ 31 Ann. Rev. Pub. Health 371, Arcidiacono study cited above, and other research
375–76 (2010), and Peter Arcidiacono et al., Habit that considers the extent to which reduction in teen
moral debates on this issue by pregnancy is attributable to sexual risk avoidance
Persistence and Teen Sex: Could Increased Access
recognizing that some people have to Contraception Have Unintended Consequences rather than to contraception access).
43 See, for example, Lindberg L., Santelli J.,
for Teen Pregnancies? (2005), available at http://
39 FDA’s guide ‘‘Birth Control: Medicines To Help public.econ.duke.edu/∼psarcidi/addicted13.pdf. ‘‘Understanding the Decline in Adolescent Fertility
You,’’ specifies that various approved See also K. Buckles & D. Hungerman, ‘‘The in the United States, 2007–2012,’’ 59 J. Adolescent
contraceptives, including Levonorgestrel, Ulipristal Incidental Fertility Effects of School Condom Health 577–83 (Nov. 2016), https://doi.org/10.1016/
Acetate, and IUDs, work mainly by preventing Distribution Programs,’’ Nat’l Bureau of Econ. j.jadohealth.2016.06.024; see also Comment of The
fertilization and ‘‘may also work . . . by preventing Research Working Paper No. 22322 (June 2016), Colorado Health Foundation, submission ID CMS–
attachment (implantation) to the womb (uterus)’’ of available at http://www.nber.org/papers/w22322 2014–0115–19635, www.regulations.gov (discussing
a human embryo after fertilization. Available at (‘‘access to condoms in schools increases teen teen pregnancy data from Colorado).
https://www.fda.gov/forconsumers/byaudience/ fertility by about 10 percent’’ and increased 44 Kearney MS and Levine PB, ‘‘Investigating
forwomen/freepublications/ucm313215.htm. sexually transmitted infections). recent trends in the U.S. birth rate,’’ 41 J. Health
study found that during the teen As the Departments stated in the effective to more effective methods, and
pregnancy decline between 2007–2012, Religious IFC, we do not take a position that it was ‘‘unclear’’ whether this
teen sexual activity was also on the variety of empirical questions Mandate impacted contraceptive use
decreasing.45 One study concluded that discussed above. Likewise, these rules because there was no significant
falling unemployment rates in the 1990s do not address the substantive question increase in the use of contraceptive
accounted for 85% of the decrease in of whether HRSA should include methods the Mandate covered.51 These
rates of first births among 18–19 year- contraceptives in the women’s commenters also noted that, in the 29
old African Americans.46 Another study preventive services Guidelines issued States where contraceptive coverage
found that the representation of African- under section 2713(a)(4). Rather, mandates have been imposed
American teachers was associated with reexamination of the record and review statewide,52 those mandates have not
a significant reduction in the African- of the public comments has reinforced necessarily lowered rates of unintended
American teen pregnancy rate.47 One the Departments’ conclusion that pregnancy (or abortion) overall.53 Other
study concluded that an ‘‘increase in the significantly more uncertainty and commenters, however, disputed the
price of the Pill on college campuses ambiguity exists on these issues than significance of these state statistics,
. . . did not increase the rates of the Departments previously noting that of the 29 states with
unintended pregnancy.’’ 48 Similarly, acknowledged when we declined to contraceptive coverage mandates, only
one study from England found that, extend the exemption to certain four states have laws that match the
where funding for teen pregnancy objecting organizations and individuals. federal requirements in scope. Some
prevention was reduced, there was no The uncertainty surrounding these also observed that, even in states with
evidence that the reduction led to an weighty and important issues makes it state contraceptive coverage mandates,
increase in teen pregnancies.49 Some appropriate to maintain the expanded self-insured group health plans might
commenters also cited studies, which exemptions and accommodation if and escape those requirements, and some
are not limited to the issue of teen for as long as HRSA continues to states do not mandate the contraceptives
pregnancy, that have found many include contraceptives in the to be covered at no out-of-pocket cost to
women who have abortions report that Guidelines. The federal government has the beneficiary.
they were using contraceptives when a long history, particularly in certain The Departments have considered
they became pregnant.50 sensitive and multi-faceted health these experiences as relevant to the
issues, of providing religious effect the expanded exemptions in these
Econ. 15–29 (2015), available at https:// exemptions from governmental rules might have on the Mandate more
www.sciencedirect.com/science/article/abs/pii/ mandates. These final rules are broadly. The state mandates apply to a
S0167629615000041.
45 See, for example, K. Ethier et al., ‘‘Sexual
consistent with that history and with very large number of plans and plan
Intercourse Among High School Students—29 the discretion Congress vested in the participants, notwithstanding ERISA
States and United States Overall, 2005–2015,’’ 66 Departments for implementing the ACA. preemption, and public commenters did
CDC Morb. Mortal. Wkly Report 1393, 1393–97 (Jan. not point to studies showing those state
5, 2018), available at http://dx.doi.org/10.15585/ G. Health and Equality Effects of mandates reduced unintended
mmwr.mm665152a1 (‘‘Nationwide, the proportion Contraceptive Coverage Mandates pregnancies. The federal contraceptive
of high school students who had ever had sexual
intercourse decreased significantly overall. . . .’’). The Departments also received Mandate, likewise, applies to a broad,
46 Colen CG, Geronimus AT, and Phipps MG, comments about the health and equality but not entirely comprehensive, number
‘‘Getting a piece of the pie? The economic boom of effects of the Mandate more broadly. of employers. For example, to the extent
the 1990s and declining teen birth rates in the Some commenters contended that the
United States,’’ 63 Social Science & Med. 1531–45
that houses of worship and integrated
(Sept. 2006), available at https:// contraceptive Mandate promotes the auxiliaries may have self-insured to
www.sciencedirect.com/science/article/pii/ health and equality of women, avoid state health insurance
S027795360600205X. especially low income women and contraceptive coverage mandates or for
47 Atkins DN and Wilkins VM, ‘‘Going Beyond
promotes female participation and other reasons, those groups are, and
Reading, Writing, and Arithmetic: The Effects of
Teacher Representation on Teen Pregnancy Rates,’’ equality in the workforce. Other have been, exempt from the federal
23 J. Pub. Admin. Research & Theory 771–90 (Oct. commenters contended that there was Mandate prior to the Religious IFC. The
1, 2013), available at https://academic.oup.com/ insufficient evidence that the expanded exemptions as set forth in the Religious
jpart/article-abstract/23/4/771/963674. exemptions would harm those interests. IFC and in these final rules leave the
48 E. Collins & B. Herchbein, ‘‘The Impact of
Subsidized Birth Control for College Women:

Some of those commenters further contraceptive Mandate in place for
Evidence from the Deficit Reduction Act,’’ U. Mich. questioned whether there was evidence nearly all entities and plans to which
Pop. Studies Ctr. Report 11–737 (May 2011), that broad health coverage mandates of the Mandate has applied. The
available at https://www.psc.isr.umich.edu/pubs/ contraception lead to increased Departments are not aware of data
pdf/rr11-737.pdf (‘‘[I]ncrease in the price of the Pill
on college campuses . . . did not increase the rates contraceptive use, reductions in showing that these expanded
of unintended pregnancy or sexually transmitted unintended pregnancies, or reductions exemptions would negate any reduction
infections for most women’’). in negative effects said to be associated in unintended pregnancies that might
49 See D. Paton & L. Wright, ‘‘The effect of
with unintended pregnancies. In
spending cuts on teen pregnancy,’’ 54 J. Health 51 Kavanaugh, 97 Contraception at 14–21.
Econ. 135, 135–46 (2017), available at https://
particular, some commenters discussed
52 See Guttmacher Institute, ‘‘Insurance Coverage
www.sciencedirect.com/science/article/abs/pii/ the study quoted above, published and
of Contraceptives’’ (June 11, 2018); Kaiser Family
S0167629617304551 (‘‘Contrary to predictions revised by the Guttmacher Institute in Foundation, ‘‘State Requirements for Insurance
made at the time of the cuts, panel data estimates October 2017, concluding that through Coverage of Contraceptives,’’ Henry J Kaiser Family
provide no evidence that areas which reduced Foundation (Jan. 1, 2018), https://www.kff.org/
expenditure the most have experienced relative
2014 there were no significant changes
other/state-indicator/state-requirements-for-
in the overall proportion of women who
increases in teenage pregnancy rates. Rather, insurance-coverage-of-contraceptives/?current

expenditure cuts are associated with small used a contraceptive method both Timeframe=0&sortModel=%7B%22colId%22:
reductions in teen pregnancy rates’’). among all women and among women at %22Location%22,%22sort%22:%22asc%22%7D.
50 Commenters cited, for example, Guttmacher 53 See Michael J. New, ‘‘Analyzing the Impact of
risk of unintended pregnancy, that there
Institute, ‘‘Fact Sheet: Induced Abortion in the State Level Contraception Mandates on Public
United States’’ (Jan. 2018) (‘‘Fifty-one percent of was no significant shift from less Health Outcomes,’’ 13 Ave Maria L. Rev. 345 (2015),
abortion patients in 2014 were using a available at http://avemarialaw-law-review.
contraceptive method in the month they became www.guttmacher.org/sites/default/files/factsheet/ avemarialaw.edu/Content/articles/
pregnant’’), available at https:// fb_induced_abortion.pdf. vXIII.i2.new.final.0809.pdf.
result from a broad contraceptive women delay or forego health care provision of those protections to
coverage mandate. overall under the ACA 54 and that, preserve religious exercise in this health
Some commenters expressed concern according to studies, coverage of care context as an appropriate policy
that providing exemptions to the contraceptives without cost-sharing has option, notwithstanding the widely
Mandate that private parties provide increased use of contraceptives in divergent effects that public
contraception may lead to exemptions certain circumstances. Some commenters have predicted based on
regarding other medications or services, commenters also argued that studies different studies they cited. Providing
like vaccines. The exemptions provided show that decreases in unintended the protections for religious exercise set
in these rules, however, do not apply pregnancies are due to broader access of forth in the Religious IFC and these final
beyond the contraceptive coverage contraceptives. Finally, some rules is not inconsistent with the ACA,
requirement implemented through commenters argued that birth control and brings this Mandate into better
section 2713(a)(4). Specifically, PHS Act access generally has led to social and alignment with various other federal
section 2713(a)(2) requires coverage of economic equality for women. conscience protections in health care,
‘‘immunizations,’’ and these exemptions The Departments have reviewed the some of which have been in place for
do not encompass that requirement. The comments, including studies submitted decades.
fact that the Departments have by commenters either supporting or
exempted houses of worship and opposing these expanded exemptions. III. Description of the Text of the
integrated auxiliaries from the Based on our review, it is not clear that Regulations and Response to
contraceptive Mandate since 2011 did merely expanding exemptions as done Additional Public Comments
not lead to those entities receiving in these rules will have a significant Here, the Departments describe the
exemptions under section 2713(a)(2) effect on contraceptive use and health, regulatory text set forth prior to the
concerning vaccines. In addition, or workplace equality, for the vast Religious IFC, the regulations from that
hundreds of entities have sued the majority of women benefitting from the IFC, public comments in response to the
Departments over the implementation of Mandate. There is conflicting evidence specific regulatory text set forth in the
section 2713(a)(4), leading to two regarding whether the Mandate alone, as IFC, the Departments’ response to those
decisions of the U.S. Supreme Court, distinct from birth control access more comments, and, in consideration of
but no similar wave of lawsuits has generally, has caused increased those comments, the regulatory text as
challenged section 2713(a)(2). The contraceptive use, reduced unintended finalized in this final rule. As noted
expanded exemptions in these final pregnancies, or eliminated workplace above, various members of the public
rules are consistent with a long history disparities, where all other women’s provided comments that were
of statutes protecting religious beliefs preventive services were covered supportive, or critical, of the Religious
from certain health care mandates without cost sharing. Without taking a IFC overall, or of significant policies
concerning issues such as sterilization, definitive position on those evidentiary pertaining to those regulations. To the
abortion and birth control. issues, however, we conclude that the extent those comments apply to the
Some commenters took issue with the Religious IFC and these final rules— following regulatory text, the
conclusion set forth in the Religious which merely withdraw the Mandate’s Departments have responded to them
IFC, which is similar to that asserted in requirement from what appears to be a above. This section of the preamble
the 2017 Guttmacher study, that ‘‘[t]he small group of newly exempt entities responds to comments that pertain more
role that the contraceptive coverage and plans—are not likely to have specifically to particular regulatory text.
guarantee played in impacting use of negative effects on the health or equality A. Restatement of Statutory
contraception at the national level of women nationwide. We also Requirements of PHS Act Section
remains unclear, as there was no conclude that the expanded exemptions 2713(a) and (a)(4) (26 CFR 54.9815–
significant increase in the use of are an appropriate policy choice left to 2713(a)(1) and (a)(1)(iv), 29 CFR
methods that would have been covered the agencies under the relevant statutes,
2590.715–2713(a)(1) and (a)(1)(iv), and
under the ACA.’’ They observed that and, thus, are an appropriate exercise of
45 CFR 147.130(a)(1) and (a)(1)(iv))
more women have coverage of the Departments’ discretion.
contraceptives and contraception Moreover, we conclude that the best The previous regulations restated the
counseling under the Mandate and that way to balance the various policy statutory requirements of section
more contraceptives are provided interests at stake in the Religious IFC 2713(a) of the PHS Act, at 26 CFR
without co-pays than before. Still other and these final rules is to provide the 54.9815–2713(a)(1) and (a)(1)(iv), 29
commenters argued that the Mandate, or expanded exemptions set forth herein, CFR 2590.715–2713(a)(1) and (a)(1)(iv),
other expansions of contraceptive even if certain effects may occur among and 45 CFR 147.130(a)(1) and (a)(1)(iv).
coverage, have led women to increase the populations actually affected by the The Religious IFC modified these
their use of contraception in general, or employment of these exemptions. These restatements to more closely align them
to change from less effective, less rules will provide tangible protections with the text of PHS Act section 2713(a)
expensive contraceptive methods to for religious liberty, and impose fewer and (a)(4).
more effective, more expensive governmental burdens on various Previous versions of these rules had
contraceptive methods. Some entities and individuals, some of whom varied from the statutory language. PHS
commenters lamented that exemptions have contended for several years that Act section 2713(a) and (a)(4) require
would include exemption from the denying them an exemption from the group health plans and health insurance
requirement to cover contraception contraceptive Mandate imposes a issuers offering coverage to provide
counseling. Some commenters pointed substantial burden on their religious coverage without cost sharing for ‘‘such
to studies cited in the 2011 IOM Report exercise. The Departments view the additional preventive care and
recommending contraception be screenings not described in paragraph
included in the Guidelines and argued 54 Citing, for example, Adelle Simmons et al., (1) as provided for in comprehensive
that certain women will go without ‘‘The Affordable Care Act: Promoting Better Health guidelines’’ supported by HRSA. In
for Women,’’ Table 1, Assistant Secretary for
certain health care, or contraception Planning and Evaluation (June 14, 2016), https://
comparison, the previous version of
specifically, because of cost. They aspe.hhs.gov/system/files/pdf/205066/ACAWomen regulatory restatements of this language
contended that a smaller percentage of HealthIssueBrief.pdf. (as drawn from 45 CFR 147.130(a)(1)
and (a)(1)(iv)) stated the coverage must acknowledges that the Departments paragraph (c) set forth a definition, and
include ‘‘evidence-informed preventive have decided Guidelines issued under paragraph (d) discussed severability.
care and screenings provided for in section 2713(a)(4) will not be provided The prefatory language to
binding comprehensive health plan for or supported to the extent they § 147.132(a)(1) stated that HRSA’s
coverage guidelines supported by’’ exceed the exemptions and Guidelines ‘‘must not provide for or
HRSA. The Religious IFC amended this accommodation set forth in 45 CFR support the requirement of coverage or
language to state, parallel to the 147.131 and 147.132. Previous versions payments for contraceptive services’’ for
language in section 2713(a)(4), that the of the regulation placed that limit in 45 the health plan or coverage of an
coverage must include ‘‘such additional CFR 147.130(a)(1), but did not reiterate ‘‘objecting organization,’’ and thus that
preventive care and screenings not it in § 147.130(a)(1)(iv). To clearly set HRSA ‘‘will exempt’’ such an
described in paragraph (a)(1)(i) of this forth the applicability of the exemptions organization from the contraceptive
section as provided for in and accommodation, the Departments coverage requirments of the Guidelines.
comprehensive guidelines supported adopt as final the Religious IFC The remainder of paragraph (a)(1),
by’’ HRSA. language, which included the language which is discussed in greater detail
These rules adopt as final, without ‘‘subject to §§ 147.131 and 147.132’’ in below, describes what entities are
change, the provisions in the Religious both § 147.130(a)(1) and included as objecting organizations.
IFC amending 26 CFR 54.9815– § 147.130(a)(1)(iv). Because these final This language not only specifies that
2713(a)(1) and (a)(1)(iv), 29 CFR rules adopt as final the Religious IFC certain entities are ‘‘exempt,’’ but also
2590.715–2713(a)(1) and (a)(1)(iv), and language which includes the explains that the Guidelines shall not
45 CFR 147.130(a)(1) and (a)(1)(iv). In exemptions and accommodation in both support or provide for an imposition of
this way, the regulatory text better §§ 147.131 and 147.132, and not just in the contraceptive coverage requirement
conforms to the statutory language. In § 147.131 as under the previous rules, to such exempt entities. This is an
paragraph (a)(1) of the final regulations, the Departments correspondingly acknowledgement that section
instead of saying ‘‘must provide included references to both sections in 2713(a)(4) requires women’s preventive
coverage for all of the following items this part. services coverage only ‘‘as provided for
and services, and may not impose any Some commenters supported in comprehensive guidelines supported
cost-sharing requirements . . . with restoring the statutory language from by the Health Resources and Services
respect to those items and services:’’, PHS Act section 2713(a) and (a)(4) in Administration.’’ To the extent the
the regulation now tracks the statutory the regulatory restatements of that HRSA Guidelines do not provide for, or
language by saying ‘‘must provide language. Other commenters opposed support, the application of such
coverage for and must not impose any doing so, asserting that Guidelines coverage to certain entities or plans, the
cost-sharing requirements . . . for—’’. issued pursuant to section 2713(a)(4) Affordable Care Act does not require the
By eliminating the language ‘‘coverage must be ‘‘evidence-informed’’ and coverage. Those entities or plans are
for all of the following items and ‘‘binding.’’ The Departments disagree ‘‘exempt’’ by not being subject to the
services,’’ and ‘‘with respect to those with the position that, even though requirements in the first instance.
items and services,’’ the Departments do Congress omitted those terms from Therefore, in describing the entities or
not intend that coverage for specified section 2713(a)(4), their regulatory plans as ‘‘exempt,’’ and in referring to
items and services will not be required, restatement of the statutory requirement the ‘‘exemption’’ encompassing those
but we simply intend to simplify the should include those terms. Instead, the entities or plans, the Departments also
text of the regulation to track the statute Departments conclude that it is more affirm the non-applicability of the
and avoid duplicative language. appropriate for the regulatory Guidelines to them.
By specifying that paragraph (a)(1)(iv) restatements of section 2713(a)(4) to The Departments wish to make clear
concerning the women’s preventive track the statutory language in this that the expanded exemption set forth
services Guidelines encompasses ‘‘such regard, namely, ‘‘as provided for in in § 147.132(a) applies to several
additional preventive care and comprehensive guidelines supported by distinct entities involved in the
screenings not described in paragraph [HRSA] for purposes of’’ that paragraph. provision of coverage to the objecting
(a)(1)(i) of this section as provided for in employer’s employees. This explanation
comprehensive guidelines supported by B. Prefatory Language of Religious is consistent with how prior regulations
the Health Resources and Services Exemptions (45 CFR 147.132(a)(1)) have worked by means of similar
Administration for purposes of section These final rules adopt as final, with language. When sections § 147.132(a)(1)
2713(a)(4) of the Public Health Service changes based on comments as set forth and (a)(1)(i) specify that ‘‘[a] group
Act, subject to §§ 147.131 and 147.132,’’ below, the regulatory provision in the health plan,’’ ‘‘health insurance
the regulatory text also better tracks the Religious IFC that moved the religious coverage provided in connection with a
statutory language that the Guidelines exemption from 45 CFR 147.131(a) to 45 group health plan,’’ and ‘‘health
are for ‘‘such additional’’ preventive CFR 147.132. insurance coverage offered or arranged
services as HRSA may ‘‘provide[ ] for’’ In the previous regulations, the by an objecting organization’’ are
and ‘‘support[ ].’’ This text also exemption stated, at § 147.131(a), that exempt ‘‘to the extent’’ of the objections
eliminates language, not found in the HRSA’s Guidelines ‘‘may establish an ‘‘as specified in paragraph (a)(2),’’ that
statute, that the Guidelines are exemption’’ for the health plan or language exempts the group health
‘‘evidence-informed’’ and ‘‘binding.’’ coverage of a ‘‘religious employer,’’ plans of the sponsors that object, and
Congress did not include the word defined as ‘‘an organization that is their health insurance issuers in
‘‘binding’’ in PHS Act section 2713, and organized and operates as a nonprofit providing the coverage in those plans
did include the words ‘‘evidence-based’’ entity and is referred to in section (whether or not the issuers have their
or ‘‘evidence-informed’’ in section 6033(a)(3)(A)(i) or (iii) of the Internal own objections). Consequently, with
2713(a)(1) and (a)(3), but omitted such Revenue Code.’’ The Religious IFC respect to Guidelines issued under
terms from section 2713(a)(4). In this moved the exemption to a new § 147.130(a)(1)(iv) (and as referenced by
way, the regulatory text better comports § 147.132, in which paragraph (a) the parallel provisions in 26 CFR
with the scope of the statutory text. This discussed objecting entities, paragraph 54.9815–2713(a)(1)(iv) and 29 CFR
text of paragraph (a)(1)(iv) also (b) discussed objecting individuals, 2590.715–2713(a)(1)(iv)), the plan
sponsor, issuer, and plan covered in the prior to the Religious IFC. Specific exempt entities could cause additional
exemption of § 147.132(a)(1) and entities to which the expanded operational burdens for plans that have
(a)(1)(i) would face no penalty as a exemptions apply are discussed below. existing processes in place to handle
result of omitting certain contraceptive The exemptions contained in exemptions. Other commenters,
coverage from the benefits of the plan previous regulations, at § 147.131(a), did however, favored including a self-
participants and beneficiaries. However, not require exempt entities to submit certification process for exempt entities.
while the objection of a plan sponsor (or any particular self-certification or They suggested that entities might abuse
entity that arranges coverage under the notice, either to the government or to the availability of an exemption or use
plan, as applicable) removes penalties their issuer or third party administrator, exempt status insincerely if no self-
from that plan’s issuer, it only does so in order to obtain or qualify for the certification process exists, and that the
for that plan—it does not affect the exemption. Similarly, under the Mandate might be difficult to enforce
issuer’s coverage for other group health expanded exemptions in § 147.132, the without a self-certification process.
plans where the plan sponsor has no Religious IFC did not require exempt Some commenters asked that the
qualifying objection. More information entities to comply with a self- government publish a list of entities that
on the effects of the objection of a health certification process. We finalize that claim the exemption.
insurance issuer in § 147.132(a)(1)(iii) is approach in this respect without The Departments believe it is
included below. change. Although exempt entities do not appropriate to not require exempt
The exemptions in § 147.132(a)(1) need to file notices or certifications of entities to submit a self-certification or
apply ‘‘to the extent’’ of the objecting their exemption, and these final rules do notice. The previous exemption did not
entities’ sincerely held religious not impose any new notice require a self-certification or notice, and
convictions. Thus, entities that hold a requirements on them, existing ERISA the Departments did not collect a list of
requisite objection to covering some, but rules governing group health plans all entities that used the exemption. The
not all, contraceptive items would be require that, with respect to plans Departments believe the approach under
exempt with respect to the items to subject to ERISA, a plan document must the previous exemption is appropriate
which they object, but not with respect include a comprehensive summary of for the expanded exemption. Adding a
to the items to which they do not object. the benefits covered by the plan and a self-certification or notice to the
Some commenters said it was unclear statement of the conditions for exemption process would impose an
whether the plans of entities or eligibility to receive benefits. Under additional paperwork burden on exempt
individuals that religiously object to ERISA, the plan document identifies entities that the previous regulations did
some but not all contraceptives would what benefits are provided to not impose, and would also involve
be exempt from being required to cover participants and beneficiaries under the additional public costs if those
just the contraceptive methods as to plan; if an objecting employer would certifications or notices were to be
which there is an objection, or whether like to exclude all or a subset of reviewed or kept on file by the
the objection to some contraceptives contraceptive services, it must ensure government.
leads to an exemption from that plan that the exclusion is clear in the plan The Departments are not aware of
being required to cover all document. Moreover, if there is a instances where the lack of a self-
contraceptives. The Departments intend reduction in a covered service or certification under the previous
that a requisite religious objection benefit, the plan has to disclose that exemption led to abuses or to an
against some but not all contraceptives change to plan participants.55 Thus, inability to engage in enforcement. The
would lead to an exemption only to the where an exemption applies and all (or Mandate is enforceable through various
extent of that objection: That is, the a subset of) contraceptive services are mechanisms in the PHS Act, the Code,
exemption would encompass only the omitted from a plan’s coverage, and ERISA. Entities that insincerely or
items to which the relevant entity or otherwise applicable ERISA disclosure otherwise improperly operate as if they
individual objects, and would not documents must reflect the omission of are exempt would do so at the risk of
encompass contraceptive methods to coverage in ERISA plans. These existing enforcement under such mechanisms.
which the objection does not apply. To disclosure requirements serve to help The Departments are not aware of
make this clearer, in these final rules, provide notice to participants and sufficient reasons to believe those
the Departments finalize the prefatory beneficiaries of what ERISA plans do measures and mechanisms would fail to
language of § 147.132(a) with the and do not cover. deter entities from improperly operating
following change, so that the final rules Some commenters supported the as if they are exempt. Moreover, as
state that an exemption shall be expanded exemption’s approach which noted above, ERISA and other plan
included, and the Guidelines must not maintained the policy of the previous disclosure requirements governing
provide for contraceptive coverage, ‘‘to exemption in not requiring exempt group health plans require provision of
the extent of the objections specified entities to comply with a self- a comprehensive summary of the
below.’’ certification process. They suggested benefits covered by the plan and
The Departments have made that self-certification forms for an disclosure of any reductions in covered
corresponding changes to language exemption are not necessary, could add services or benefits, so beneficiaries in
throughout the regulatory text, to burdens to exempt entities beyond those plans that reduce or eliminate
describe the exemptions as applying ‘‘to imposed by the previous exemption, contraceptive benefits as a result of the
the extent’’ of the objection(s). and could give rise to religious exemption will know whether their
objections to the self-certification health plan claims an exemption and
C. Scope of Religious Exemptions and process itself. Commenters also stated will be able to raise appropriate
Requirements for Exempt Entities (45 that requiring an exemption form for challenges to such claims. As a
CFR 147.132) consequence, the Departments believe it
In 45 CFR 147.132(a)(1)(i) through (iii) 55 See, for example, 29 U.S.C. 1022, 1024(b), 29 is an appropriate balance of various
and (b), the Religious IFC expands the CFR 2520.102–2, 102–3, & 104b–3(d), and 29 CFR concerns expressed by commenters for
2590.715–2715. See also 45 CFR 147.200 (requiring
exemption to plans of additional entities disclosure of the ‘‘exceptions, reductions, and
these rules to continue to not require
and individuals not encompassed by the limitations of the coverage,’’ including group health notices or self-certifications for using
exemption set forth in the regulations plans and group and individual issuers). the exemption.
Some commenters asked the between exempt entities and their flux, due to various rulemakings and
Departments to add language indicating issuers or third party administrators. court orders. Overall, concerns raised by
that an exemption cannot be invoked in Regarding the Religious IFC’s some public commenters have not led
the middle of a plan year, nor should it expansion of the exemption to other the Departments to consider it likely
be used to the extent inconsistent with kinds of entities and individuals in that offering these expanded exemptions
laws that apply to, or state approval of, general, commenters disagreed about will cause any injury to the uniformity
fully insured plans. None of the the likely effects of the exemptions on or operability of the health coverage
previous iterations of the exemption the health coverage market. Some market.
regulations included such provisions, commenters said that expanding the
exemptions would not cause D. Plan Sponsors in General (45 CFR
and the Departments do not consider 147.132(a)(1)(i) Prefatory Text)
them necessary in these rules. The complications in the market, while
expanded exemptions in these rules others said that it could, due to such With respect to employers and others
only purport to exempt plans and causes as a lack of uniformity among that sponsor group health plans, in
entities from the application of the plans or permitting multiple risk pools. § 147.132(a)(1)(i), the Religious IFC
federal contraceptive coverage The Departments note that the extent to provided exemptions for non-
requirement of the Guidelines issued which plans cover contraception under governmental plan sponsors that object
under section 2713(a)(4). They do not the prior regulations is already far from to coverage of all, or a subset of,
purport to exempt entities or plans from uniform. Congress did not require all contraceptives or sterilization and
state laws concerning contraceptive entities to comply with section 2713 of related patient education and
coverage, or laws governing whether an the PHS Act (under which the Mandate counseling based on sincerely held
entity can make a change (of whatever was promulgated)—most notably by religious beliefs. The Departments
kind) during a plan year. The rules exempting grandfathered plans. finalize the prefatory text of
governing the accommodation likewise Moreover, under the previous § 147.132(a)(1)(i) without change.
regulations, issuers were already able to The expanded exemptions covered
do not purport to obviate the need to
offer plans that omit contraceptives—or any kind of non-governmental employer
follow otherwise applicable rules about
offer only some contraceptives—to plan sponsor with the requisite
making changes during a plan year.
houses of worship and integrated objections, stating the exemption
(Below, these rules discuss in more
auxiliaries; some commenters and encompassed ‘‘[a] group health plan and
detail the accommodation and when an
litigants said that issuers were doing so. health insurance coverage provided in
entity seeking to revoke it would be able
These cases where plans did not need connection with a group health plan to
to do so or to notify plan participants of
to comply with the Mandate, and the the extent the non-governmental plan
the revocation.)
Departments’ previous accommodation sponsor objects as specified in
Commenters also asked that clauses process allowing coverage not to be paragraph (a)(2) of this section.’’ For the
be added to the regulatory text holding provided in certain self-insured church sake of clarity, the expanded
issuers harmless where exemptions are plans, together show that the exemptions also stated that ‘‘[s]uch non-
invoked by plan sponsors. As discussed importance of a uniform health coverage governmental plan sponsors include,
above, the exemption rules already system is not significantly harmed by but are not limited to, the following
specify that, where an exemption allowing plans to omit contraception in entities,’’ followed by an illustrative,
applies to a group health plan, it some contexts.56 non-exhaustive list of non-governmental
encompasses both the group health plan Concerning the prospect raised by organizations whose objections qualify
and health insurance coverage provided commenters of different risk pools the plans they sponsor for an
in connection with the group health between men and women, PHS Act exemption. Each type of such entities,
plan, and therefore encompasses any section 2713(a) itself provides for some and comments specifically concerning
impact on the issuer of the preventive services coverage that them, are discussed below.
contraceptive coverage requirement applies to both men and women, and The plans of governmental employers
with respect to that plan. In addition, as some that would apply only to women. are not covered by the plan sponsor
discussed below, the Departments are With respect to the latter, it does not exemption in § 147.132(a)(1)(i). Some
including, in these final rules, language specify what, if anything, HRSA’s commenters suggested that the
from the previous regulations protecting Guidelines for women’s preventives expanded religious exemptions should
issuers that act in reliance on certain services would cover, or if contraceptive include government entities. Others
representations made in the coverage would be required. These rules disagreed. The Departments are not
accommodation process. To the extent do not require issuers to offer products aware of reasons why it would be
that commenters seek language offering that satisfy religiously objecting entities appropriate or necessary to offer a
additional protections for other or individuals; they simply make it legal religious exemption to governmental
incidents that might occur in to do so. The Mandate has been employer plan sponsors with respect to
connection with the invocation of an imposed only relatively recently, and the contraceptive Mandate. We are
exemption, the previous exemption the contours of its application to unaware of government entities that
regulations did not include such religious entities has been in continual would attempt to assert a religious
provisions, and the Departments do not exemption to the Mandate, and it is not
consider them necessary in these final 56 See also Real Alternatives v. Sec’y, Dep’t of clear to us that a governmental entity
rules. As noted above, the expanded Health & Human Servs., 867 F.3d 338, 389 (3d Cir. could do so. Accordingly, we conclude
exemptions in these final rules simply 2017) (Jordan, J., concurring in part and dissenting that it is appropriate for us to not further
in part) (‘‘Because insurance companies would offer

remove or narrow the contraceptive such plans as a result of market forces, doing so expand the religious exemption to
Mandate contained in and derived from would not undermine the government’s interest in include governmental entities in the
the Guidelines for certain plans. The a sustainable and functioning market. . . . Because religious plan-sponsor exemption.
previous regulations included a reliance the government has failed to demonstrate why Nevertheless, as discussed below,
allowing such a system (not unlike the one that
clause in the accommodation allowed wider choice before the ACA) would be
governmental employers are permitted
provisions, but did not specify further unworkable, it has not satisfied strict scrutiny.’’ to respect an individual’s objection
details regarding the relationship (citation and internal quotation marks omitted)). under § 147.132(b) and, thus, to provide
health coverage without the objected-to Departments respond above. Notably, when this regulation text exempts a
contraceptive coverage to such this exemption exempts ‘‘a religious plan ‘‘established or maintained by’’ a
individual. Where that exemption is order,’’ and not merely ‘‘the exclusively house of worship or integrated
operative, the Guidelines may not be religious activities of any religious auxiliary, such exemption will no
construed to prevent a willing order.’’ In addition, section longer ‘‘be determined on an employer
governmental plan sponsor of a group 6033(a)(3)(A)(i) specifies that it covers by employer basis,’’ but will be
health plan from offering a separate churches, not merely ‘‘the exclusively determined on a plan basis—that is, by
benefit package option, or a separate religious activities’’ of a church. Some whether the plan is a ‘‘plan established
policy, certificate or contract of religious people might express their or maintained by’’ a house of worship
insurance, to any individual who beliefs through a church, others might or integrated auxiliary. This
objects to coverage or payments for do so through a religious order, and still interpretation better conforms to the text
some or all contraceptive services based others might do so through religious of the regulation setting forth the
on sincerely held religious beliefs. bodies that take a different form, exemption—in both the prior regulation
By the general extension of the structure, or nomenclature based on a and in the text set forth in these final
exemption to the plans of plan sponsors different cultural or historical tradition. rules. It also offers appropriate respect
in § 147.132(a)(1)(i), these final rules Cf. Hosanna-Tabor Evangelical to houses of worship and their
also exempt group health plans Lutheran Church and School v. integrated auxiliaries not only in their
sponsored by an entity other than an E.E.O.C., 565 U.S. 171, 198 (2012) (Alito internal employment practices, but in
employer (for example, a union, or a and Kagan, JJ., concurring) (‘‘The term their choice of organizational form and/
sponsor of a multiemployer plan) that ‘minister’ is commonly used by many or in their activity of establishing or
objects based on sincerely held religious Protestant denominations to refer to maintaining health plans for employees
beliefs to coverage of contraceptives or members of their clergy, but the term is of associated employers that do not
sterilization. Some commenters objected rarely if ever used in this way by meet the requirement of being integrated
to extending the exemption to such Catholics, Jews, Muslims, Hindus, or auxiliaries. Under this interpretation,
entities, arguing that they could not Buddhists.’’). For the purposes of houses of worship would not be faced
have the same kind of religious respecting the exercise of religious with the potential of having to include,
objection that a single employer might beliefs, which the expanded exemptions in the plans that they have established
have. Other commenters supported the in these rules concern, the Departments and maintained, coverage for services to
protection of any plan sponsor with the find it appropriate that this part of the which they have a religious objection
requisite religious objection. The exemption encompasses religious orders for employees of an affiliated employer
Departments conclude that it is and churches similarly, without limiting participating in the plans.
appropriate, where the plan sponsor of the scope of the protection to the The Departments do not believe there
a union, multiemployer, or similar plan exclusively religious activities of either is a sufficient factual basis to exclude
adopts a religious objection using the kind of entity. Based on all these from this part of the exemption entities
same procedures that such a plan considerations, the Departments finalize that are so closely associated with a
sponsor might use to make other § 147.132(a)(1)(i)(A) without change. house of worship or integrated auxiliary
decisions, that the expanded that they are permitted to participate in
exemptions should respect that decision Moreover, the Departments also its health plan but are not themselves
by providing an exemption from the finalize the regulatory text to exempt integrated auxiliaries. Additionally, this
Mandate. plans ‘‘established or maintained by’’ a interpretation is not inconsistent with
house of worship or integrated auxiliary the operation of the accommodation
E. Houses of Worship and Integrated on a plan, not employer, basis. Under under the prior regulation where with
Auxiliaries (45 CFR 147.132(a)(1)(i)(A)) previous regulations, the Departments respect to self-insured church plans,
As noted above, the exemption in the stated that ‘‘the availability of the hundreds of nonprofit religious entities
previous regulations, found at exemption or accommodation [was to] participating in those plans were
§ 147.131(a), included only ‘‘an be determined on an employer by provided a mechanism by which their
organization that is organized and employer basis, which the Departments plan participants would not receive
operates as a nonprofit entity and is . . . believe[d] best balance[d] the contraceptive coverage through the plan
referred to in section 6033(a)(3)(A)(i) or interests of religious employers and or third party administrator.57
(iii) of the Internal Revenue Code of eligible organizations and those of Therefore, the Departments believe it
1986, as amended.’’ Section employees and their dependents.’’ (78 is most appropriate to use a plan basis,
6033(a)(3)(A)(i) or (iii) of the Code FR 39886 (emphasis added)). Therefore, not an employer by employer basis, to
encompasses ‘‘churches, their integrated under the prior exemption, if an determine the scope of an exemption for
auxiliaries, and conventions or employer participated in a house of a group health plan established or
associations of churches,’’ and ‘‘the worship’s plan—perhaps because it was maintained by a house of worship or
exclusively religious activities of any affiliated with a house of worship—but integrated auxiliary.
religious order.’’ was not an integrated auxiliary or a
The Religious IFC expanded the house of worship itself, that employer F. Nonprofit Organizations (45 CFR
exemption to include, in was not covered by the exemption, even 147.132(a)(1)(i)(B))
§ 147.132(a)(1)(i)(A), plans sponsored by though it was, in the ordinary meaning The exemption under previous
‘‘[a] church, an integrated auxiliary of a of the text of the prior regulation, regulations did not encompass nonprofit
church, a convention or association of participating in a ‘‘plan established or religious organizations beyond one that
churches, or a religious order.’’ Most maintained by a [house of worship].’’ is organized and operates as a nonprofit
commenters did not oppose the Upon further consideration, in the entity and is referred to in section
exemptions continuing to include these Religious IFC, the Departments changed 6033(a)(3)(A)(i) or (iii) of the Code. The
entities, although some contended that their view on this issue and expanded Religious IFC expanded the exemption
the Departments have no authority to the exemption for houses of worship to include plans sponsored by any other
exempt any entity or plan from the and integrated auxiliaries. Under these
Mandate, an objection to which the rules, the Departments intend that, 57 See supra at II.A.3.
‘‘nonprofit organization,’’ grounds to refuse to extend the employers indicating that the
§ 147.132(a)(1)(i)(B), if it has the exemptions to other nonprofit entities accommodation satisfied their religious
requisite religious objection under with religious objections. Respect for objections. These final rules leave the
§ 147.132(a)(2) (see § 147.132(a)(1)(i) churches does not preclude respect for accommodation in place as an optional
introductory text). The Religious IFC other religious entities. Among religious process. Thus, it is not clear to the
also specified in § 147.132(a)(1)(i)(A), as nonprofit organizations, the Departments that all or most of such
under the prior exemption, that the Departments no longer adhere to our large nonprofit employers will choose to
exemption covers ‘‘a group health plan previous assertion that ‘‘[h]ouses of use the expanded exemption instead of
established or maintained by . . . [a] worship and their integrated auxiliaries the accommodation. If they continue to
church, the integrated auxiliary of a that object to contraceptive coverage on use the accommodation, their insurers
church, a convention or association of religious grounds are more likely than or third party administrators would
churches, or a religious order.’’ other employers to employ people of the continue to be required to provide
(Hereinafter ‘‘houses of worship and same faith who share the same contraceptive coverage to the plan
integrated auxiliaries.’’) These rules objection.’’ (78 FR 39874.) It is not clear sponsors’ employees through such
finalize, without change, the text of to the Departments that the percentage accommodation.
§ 147.132(a)(1)(i)(A) and (B). of women who work at churches that Given the sincerely held religious
The Departments received comments oppose contraception, but who support beliefs of many nonprofit religious
in support of, and in opposition to, this contraception, is lower than the organizations, some commenters also
expansion. Some commenters supported percentage of woman who work at contended that continuing to impose the
the expansion of the exemptions beyond nonprofit religious organizations that contraceptive Mandate on certain
houses of worship and integrated oppose contraception on religious nonprofit religious objectors might also
auxiliaries to other nonprofit grounds, but who support undermine the Government’s broader
organizations with religious objections contraception. In addition, public interests in ensuring health coverage by
(referred to herein as ‘‘religious comments and litigation reflect that causing some entities to stop providing
nonprofit’’ organizations, groups or many nonprofit religious organizations health coverage entirely.59 Although the
employers). They said that religious publicly describe their religiosity. Departments do not know the extent to
belief and exercise in American law has Government records and those groups’ which that effect would result from not
not been limited to worship, that websites also often reflect those groups’ extending exemptions, we wish to avoid
religious people engage in service and religious character. If a person who that potential obstacle to the general
social engagement as part of their desires contraceptive coverage works at expansion of health coverage.
religious exercise, and, therefore, that a nonprofit religious organization, the G. Closely Held For-Profit Entities (45
the Departments should respect the Departments believe it is sufficiently CFR 147.132(a)(1)(i)(C))
religiosity of nonprofit groups even likely that the person would know, or
when they are not houses of worship The previous regulations did not
would know to ask, whether the exempt plans sponsored by closely held
and integrated auxiliaries. Some public organization offers such coverage. The
commenters and litigants have indicated for-profit entities; however, the
Departments are not aware of federal Religious IFC included in its list of
that various religious nonprofit groups laws that would require a nonprofit
possess deep religious commitments exempt plan sponsors, at
religious organization that opposes § 147.132(a)(1)(i)(C), ‘‘[a] closely held
even if they are not houses of worship contraceptive coverage to hire a person
or their integrated auxiliaries. Other for-profit entity.’’ These rules finalize
who the organization knows disagrees § 147.132(a)(1)(i)(C) without change.
commenters did not support the
with the organization’s view on Some commenters supported
expansion of exemptions to nonprofit
contraceptive coverage. Instead, including these entities in the
organizations. Some of them described
nonprofit organizations generally have exemption, saying owners of such
churches as having a special status that
access to a First Amendment right of entities exercise their religious beliefs
should not be extended to religious
expressive association and religious free through their businesses and should not
nonprofit groups. Some others
exercise to choose to hire persons (or, in be burdened by a federal governmental
contended that women at nonprofit
the case of students, to admit them) contraceptive Mandate. Other
religious organizations may support or
based on whether they share, or at least commenters opposed extending the
wish to use contraceptives and that if
the exemptions are expanded, it would will be respectful of, their beliefs.58 exemption to closely held for-profit
deprive all or most of the employees of In addition, it is not at all clear to the entities, saying the entities cannot
various religious nonprofit Departments that expanding the exercise religion or should not have
organizations of contraceptive coverage. exemptions would, as some commenters their religious opposition to
After evaluating the comments, the asserted, remove contraceptive coverage contraceptive coverage protected by the
Departments continue to believe that an from employees of many large religious exemption. Some said the entities
expanded exemption is the appropriate nonprofit organizations. Many large should not be able to impose their
administrative response to the religious nonprofit employers, including beliefs about contraceptive coverage on
substantial burdens on sincere religious but not limited to some Catholic their employees, and that doing so
beliefs imposed by the contraceptive hospitals, notified the Department constitutes discrimination.
Mandate, as well as to the litigation under the last Administration that they As set forth in the Religious IFC, the
objecting to the same. We agree with the had opted into the accommodation and Departments believe it is appropriate to
comments that religious exercise in this expressed no objections to doing so. We expand the exemptions to include
country has long been understood to also received public comments from closely held for-profit employers in
encompass actions outside of houses of organizations of similar nonprofit
worship and their integrated auxiliaries. 59 See, e.g., Manya Brachear Pashman, ‘‘Wheaton
58 Notably, ‘‘the First Amendment simply does College ends coverage amid fight against birth
The Departments’ previous assertion
not require that every member of a group agree on control mandate,’’ Chicago Tribune, July 29, 2015;
that the exemptions were intended to every issue in order for the group’s policy to be Laura Bassett, ‘‘Franciscan University Drops Entire
respect a certain sphere of church ‘expressive association.’ ’’ Boy Scouts of America v. Student Health Insurance Plan Over Birth Control
autonomy (80 FR 41325) is not, in itself, Dale, 530 U.S. 640, 655 (2000). Mandate,’’ HuffPost, May 15, 2012.
order to protect the religious exercise of company’s own profits, and that nothing employers covered contraceptives.
those entities and their owners. The in principle would preclude them from Some commenters opposed to including
ACA did not apply the preventive using the same mechanisms of corporate publicly traded entities in these
services mandate to the many decision-making to exercise religious exemptions noted that there did not
grandfathered health plans among views against contraceptive coverage. appear to be any known religiously
closely held as well as publicly traded They also said that other protections for motivated objections to the Mandate
for-profit entities, encompassing tens of religious beliefs in federal health care from publicly traded for-profit
millions of women. As explained below, conscience statutes do not preclude the corporations. These comments support
we are not aware of evidence showing application of such protections to our estimates that including publicly
that the expanded exemptions finalized certain entities on the basis that they are traded entities in the exemptions will
here will impact such a large number of not closely held, and federal law defines have little, if any effect, on
women. And, in the Departments’ view, ‘‘persons,’’ protected under RFRA, to contraceptive coverage for women. We
the decision by Congress to not apply include corporations at 1 U.S.C. 1. Other likewise agree with the Supreme Court’s
the preventive services mandate to commenters opposed including publicly statement in Hobby Lobby that it is
grandfathered plans did not constitute traded companies in the expanded unlikely that many publicly traded
improper discrimination or an exemptions. Some of these commenters companies will adopt religious
imposition of beliefs. We also do not stated that such companies could not objections to offering women
believe RFRA or the large number of exercise religious beliefs, and opposed contraceptive coverage. See 134 S. Ct. at
other statutory exemptions Congress has the effects on women if they could. 2774. Some commenters contended that,
provided for religious beliefs (including These commenters also objected that because many closely held for-profit
those exercised for profit) in certain including such employers, along with businesses expressed religious
health contexts such as sterilization, closely held businesses, would extend objections to the Mandate, or took
contraception, or abortion have been the exemptions to all or virtually all advantage of the accommodation, it is
improper. employers. likely that many publicly traded
Including closely held for-profit The Departments conclude it is businesses will do so. The Departments
entities in the exemption is also appropriate to include entities that are agree it is possible that publicly traded
consistent with the Supreme Court’s not closely held within the expanded businesses may use the expanded
ruling in Hobby Lobby, which declared exemptions for entities with religious exemption. But while scores of closely
that a corporate entity is capable of objection. RFRA prohibits the federal held for-profit businesses filed suit
possessing and pursuing non-pecuniary government from ‘‘substantially against the Mandate, no publicly traded
goals (in Hobby Lobby, the pursuit of burden[ing] a person’s exercise of entities did so, even though they were
religious beliefs), regardless of whether religion . . . .’’ unless it demonstrates not authorized to seek the
the entity operates as a nonprofit that the application of the burden to the accommodation. Based on these data
organization, and rejected the previous person’’ is the least restrictive means to points, we believe the impact of the
Administration’s argument to the achieve a compelling governmental extension of the exemption to publicly
contrary. 134 S. Ct. at 2768–75. Some interest. 42 U.S.C. 2000bb–1(a) & (b). As traded for-profit organizations will not
reports and industry experts have commenters noted, the definition of be significant. Below, based on limited
indicated that few for-profit entities ‘‘person’’ applicable in RFRA is found at data, but on years of receiving public
beyond those that had originally 1 U.S.C. 1, which defines ‘‘person’’ as comments and defending litigation
challenged the Mandate have sought including ‘‘corporations, companies, brought by organizations challenging
relief from it after Hobby Lobby.60 associations, firms, partnerships, the Mandate on the basis of their
societies, and joint stock companies, as religious objections, our best estimate of
H. For-Profit Entities That Are Not
well as individuals.’’ Accordingly, the the anticipated effects of these rules is
Closely Held (45 CFR
Departments’ decision to extend the that no publicly traded employers will
147.132(a)(1)(i)(D))
religious exemption to publicly traded invoke the religious exemption.
The previous regulations did not for profit corporations is supported by In the Departments’ view, such
exempt for-profit entities that are not the text of RFRA. The mechanisms for estimate does not lead to the conclusion
closely held. However, the Religious IFC determining whether a company has that the religious exemption should not
included in its list of exempt plan adopted and holds certain principles or be extended to publicly traded
sponsors, at § 147.132(a)(1)(i)(D), ‘‘[a] views, such as sincerely held religious corporations. The Departments are
for-profit entity that is not closely held.’’ beliefs, is a matter of well-established generally aware that, in a country as
These rules finalize § 147.132(a)(1)(i)(D) State law with respect to corporate large as the U.S., comprised of a
without change. decision-making,61 and the Departments supermajority of religious persons,62
Under § 147.132(a)(1)(i)(D), the rules expect that application of such laws some publicly traded entities might
extend the exemption to the plans of would cabin the scope of this claim a religious character for their
for-profit entities that are not closely exemption. company, or the majority of shares (or
held. Some commenters supported As to the impact of so extending the voting shares) of some publicly traded
including such entities, including religious exemption, the Departments companies might be controlled by a
publicly traded businesses, in the scope are not aware of any publicly traded small group of religiously devout
of the exemption. Some of them said entities that have publicly objected to persons so as to set forth such a
that publicly traded entities have providing contraceptive coverage on the religious character.63 Thus we consider
historically taken various positions on basis of religious belief. As noted above,
important public concerns beyond before the ACA, a substantial majority of 62 For example, in 2017, 74 percent of Americans
merely (and exclusively) seeking the said that religion is fairly important or very
61 Although the Departments do not prescribe any important in their lives, and 87 percent of
60 See Jennifer Haberkorn, ‘‘Two years later, few form or notification, they would expect that such Americans said they believe in God. Gallup,
Hobby Lobby copycats emerge,’’ Politico (Oct. 11, principles or views would have been adopted and ‘‘Religion,’’ available at https://news.gallup.com/
2016), http://www.politico.com/story/2016/10/ documented in accordance with the laws of the poll/1690/religion.aspx.
obamacare-birth-control-mandate-employers- jurisdiction under which the organization is 63 See, for example, Kapitall, ‘‘4 Publicly Traded
229627. incorporated or organized. Religious Companies if You’re Looking to Invest in
it possible that a publicly traded making, generally apply to other that adopt or participate in such plans
company might have religious nongovernmental employers as well, if may not be the ‘‘plan sponsors.’’ They
objections to contraceptive coverage. they have sincerely held religious recommended, therefore, that the final
Moreover, as noted, there are many beliefs opposed to contraceptive rules specify that the exemption applies
closely held for-profit corporations that coverage and otherwise meet the on a plan basis when plans are
do have religious objections to covering requirements of these rules. We agree established or maintained by houses of
some or all contraceptives. The with commenters who contend there is worship, integrated auxiliaries, or
Departments do not want to preclude not a sufficient basis to exclude other religious nonprofits, so as to shield
such a closely held corporation from nongovernmental employers from the employers that adopt such plans from
having to decide between relinquishing exemption. penalties for noncompliance with the
the exemption or financing future Mandate.
J. Plans Established or Maintained by The text of the prefatory language of
growth by sales of stock, which would
Objecting Nonprofit Entities (45 CFR § 147.132(a)(1), as set forth in the
be the effect of denying it the exemption
147.132(a)(1)(ii)) Religious IFC, declared that the
if it changes its status and became a
publicly traded entity. The Departments Based on the expressed intent in the Guidelines would not apply ‘‘with
also find it relevant that other federal Religious IFC, as discussed above, to respect to a group health plan
conscience statutes, such as those expand the exemption to encompass established or maintained by an
applying to hospitals or insurance plans established or maintained by objecting organization, or health
companies, do not exclude publicly nonprofit organizations with religious insurance coverage offered or arranged
traded businesses from protection.64 As objections, and on public comments by an objecting organization.’’ We
a result, the Departments continue to received concerning those exemptions, intended this language to exempt a plan
consider it appropriate not to exclude these rules finalize new language in and/or coverage where the entity that
such entities from these expanded § 147.132(a)(1)(ii) to better clarify the established or maintained a plan was an
exemptions. scope and application of the objecting organization, and not just to
exemptions. look at the views or status of individual
I. Other Non-Governmental Employers The preamble to the Religious IFC employers (or other entities)
(45 CFR 147.132(a)(1)(i)(E)) contained several discussions about the participating in such plan. The
As noted above, the exemption in the Departments’ intent to exempt plans Departments agree with commenters
previous regulations, found at established or maintained by certain who stated that additional clarity is
§ 147.131(a), included only churches, religious organizations that have the needed and appropriate in these final
their integrated auxiliaries, conventions requisite objection to contraceptive rules, in order to ensure that such plans
or associations of churches, and the coverage, including instances in which are exempt on a plan basis, and that
exclusively religious activities of any the plans encompass multiple employers joining or adopting those
religious order. The Religious IFC employers. For example, as noted above, plans are exempt by virtue of the plan
included, in its list of exempt plan the Departments intended that the itself being exempt. Doing so will make
sponsors at § 147.132(a)(1)(i)(E), ‘‘[a]ny exemption for houses of worship and the application of the expanded
other non-governmental employer.’’ integrated auxiliaries be interpreted to exemption clearer, and protect
These rules finalize § 147.132(a)(1)(i)(E) apply on a plan basis, instead of on an employers (and other entities)
without change. employer-by-employer basis. In participating in such plans from
Some commenters objected to addition, the Departments discussed at penalties for noncompliance with the
extending the exemption to other length the fact that, under the prior Mandate. Clearer language will better
nongovernmental employers, asserting regulations, where an entity was realize the intent to exempt plans and
that it is not clear such employers enrolled in a self-insured church plan coverage ‘‘established or maintained by
should be protected, nor that they can exempt from ERISA under ERISA an objecting organization,’’ and make
assert religious objections. The section 3(33) and the accommodation in the operation of that exemption simpler
Departments, however, agree with other the previous regulations was used, that by specifying that the exemption applies
commenters that supported that accommodation process provided no based on the objection of the entity that
provision of the Religious IFC. The mechanism to impose, or enforce, the established or maintains the plan. Such
Departments believe it is appropriate accommodation requirement of language would also resolve the
that any nongovernmental employer contraceptive coverage against a third anomaly that, under the previous rules,
asserting the requisite religious party administrator of such a plan. As only self-insured church plans (not
objections should be protected from the a result, the prior accommodation insured church plans) under ERISA
Mandate in the same way as other plan served, in effect, as an exemption from section 3(33) were, in effect, exempt—
sponsors. Such other employers could requirements of contraceptive coverage but only indirectly through the
include, for example, association health for all organizations and employers Departments’ inability to impose, or
plans.65 The reasons discussed above covered under a self-insured church enforce, the accommodation process
for providing the exemption to various plan. against the third party administrators of
specific kinds of employers, and for In response to these discussions in the such plans, instead of being specifically
their ability to assert sincerely held Religious IFC, some commenters, exempt in the rules.
religious beliefs using ordinary including some church plans, supported We believe entities participating in
mechanisms of corporate decision- the apparent intent to exempt such plans established or maintained by an
plans on a plan basis, but suggested that objecting organization usually share the
Faith’’ (Feb. 7, 2014), http://www.nasdaq.com/ additional clarification is needed in the views of those organizations. Multiple
article/4-publicly-traded-religious-companies-if- text of the rule to effect this intent. They lawsuits were filed against the
youre-looking-to-invest-in-faith-cm324665. observed that some plans are Departments by churches that
64 See, for example, 42 U.S.C. 300a–7, 42 U.S.C.
established or maintained by religious established or maintained plans, or the
238n, Consolidated Appropriations Act of 2018,
Div. H, Sec. 507(d), Public Law 115–141, and id. at nonprofit entities that might not be church plans themselves, and they
Div. E, Sec. 808. houses of worship or integrated generally declared that the entities or
65 See 29 CFR 2510.3–5. auxiliaries, and that some employers individuals participating in their plans
are usually required to share their finalize this language with a change to an even smaller number receive such
religious affiliation or beliefs. In clarify their application, as discussed coverage from religious schools, and
addition, because, as we have stated below, and by redesignating the from religious or other private schools
before, ‘‘providing payments for paragraph as § 147.132(a)(1)(iii). that object to arranging contraceptive
contraceptive services is cost neutral for These rules treat the plans of coverage. Religious institutions of
issuers’’ (78 FR 39877), we do not institutions of higher education that higher education are private entities
believe this clarification would produce arrange student health insurance with religious missions. Various
any financial incentive for entities that coverage similarly to the way in which commenters asserted the importance, to
do not have religious objections to the rules treat the plans of employers. many of those institutions, of being able
contraceptive coverage to enter into These rules do so by making such to adhere to their religious tenets.
plans established or maintained by an student health plans eligible for the Indeed, many students who attend such
organization that does have such expanded exemptions, and by institutions do so because of the
objections. permitting them the option of electing to institutions’ religious tenets. No student
Therefore, the Departments finalize utilize the accommodation process. is required to attend such an institution.
the text of § 147.132(a)(1) of the Thus, these rules specify, in At a minimum, students who attend
Religious IFC with the following § 147.132(a)(1)(iii), that the exemption is private colleges and universities have
change: adding a provision that makes extended, in the case of institutions of the ability to ask those institutions in
explicit this understanding, in a new higher education (as defined in 20 advance what religious tenets they
paragraph at § 147.132(a)(1)(ii). This U.S.C. 1002) with objections to the follow, including whether the
language now specifies that the Mandate based on sincerely held institutions will provide contraceptives
exemptions encompassed by religious beliefs, to their arrangement of in insurance plans they arrange. Some
§ 147.132(a)(1) include: ‘‘[a] group student health insurance coverage in a students wish to receive contraceptive
health plan, and health insurance manner comparable to the applicability coverage from a health plan arranged by
coverage provided in connection with a of the exemption for group health an institution of higher education. But
group health plan, where the plan or insurance coverage provided in other students wish to attend an
coverage is established or maintained by connection with a group health plan institution of higher education that
a church, an integrated auxiliary of a established or maintained by a plan adheres to its religious mission about
church, a convention or association of sponsor that is an employer. contraceptives in health insurance. And
churches, a religious order, a nonprofit Some commenters supported still other students favor contraception,
organization, or other organization or including, in the expanded exemptions, but are willing to attend a religious
association, to the extent the plan institutions of higher education that university without forcing it to violate
sponsor responsible for establishing provide health coverage for students its beliefs about contraceptive coverage.
and/or maintaining the plan objects as through student health plans but have Exempting religious institutions that
specified in paragraph (a)(2) of this religious objections to providing certain object to contraceptive coverage still
section. The exemption in this contraceptive coverage. They said that allows contraceptive coverage to be
paragraph applies to each employer, religious exemptions allow freedom for provided by institutions of higher
organization, or plan sponsor that certain religious institutions of higher education more broadly. The exemption
adopts the plan[.]’’ education to exist, and this in turn gives simply makes it legal under federal law
students the choice of institutions that for institutions to adhere to religious
K. Institutions of Higher Education (45 hold different views on important issues
CFR 147.132(a)(1)(iii)) beliefs that oppose contraception,
such as contraceptives and
The previous regulations did not without facing penalties for non-
abortifacients. Other commenters
exempt student health plans arranged compliance that could threaten their
opposed including the exemption,
by institutions of higher education, existence. This removes a possible
asserting that expanding the exemptions
although it did, for purposes of the barrier to diversity in the nation’s higher
would negatively impact female
accommodation, treat plans arranged by education system, and makes it more
students because institutions of higher
institutions of higher education similar possible for students to attend
education might not cover
to the way in which the regulations institutions of higher education that
contraceptives in student health plans,
treated plans of nonprofit religious hold those views.
women enrolled in those plans would
employers. See 80 FR at 41347. The In addition, under the previous
not receive access to birth control, and
Religious IFC included in its list of exemption and accommodation, it was
an increased number of unintended
exemptions, at § 147.132(a)(1)(ii), ‘‘[a]n possible for self-insured church plans
pregnancies would result among those
institution of higher education as exempt from ERISA that have religious
women.
defined in 20 U.S.C. 1002 in its objection to certain contraceptives to
In the Departments’ view, the reasons
arrangement of student health insurance avoid any requirement that either they
for extending the exemptions to
coverage, to the extent that institution or their third party administrators
institutions of higher education are
objects as specified in paragraph (a)(2) provide contraceptive coverage. As seen
similar to the reasons, discussed above,
of this section. In the case of student for extending the exemption to other
documents/Networks/Coalitions/Why_SHIPs_
health insurance coverage, this section nonprofit organizations. Only a minority Matter.pdf. We assume for the purposes of this
is applicable in a manner comparable to of students in higher education receive estimate that those plans covered 2,100,000 million
its applicability to group health health insurance coverage from plans students. Data from the Department of Education
insurance coverage provided in arranged by their colleges or shows that in 2014, there were 20,207,000 students
enrolled in degree-granting postsecondary

connection with a group health plan universities.66 It is necessarily true that institutions. National Center for Education
established or maintained by a plan Statistics, Table 105.20, ‘‘Enrollment in elementary,
sponsor that is an employer, and 66 The American College Health Association secondary, and degree-granting postsecondary
references to ‘plan participants and estimates that, in 2014, student health insurance institutions, by level and control of institution,
plans at colleges and universities covered ‘‘more enrollment level, and attendance status and sex of
beneficiaries’ will be interpreted as than two million college students nationwide.’’ ‘‘Do student: Selected years, fall 1990 through fall
references to student enrollees and their You Know Why Student Health Insurance 2026,’’ available at https://nces.ed.gov/programs/
covered dependents.’’ These rules Matters?’’ available at https://www.acha.org/ digest/d16/tables/dt16_105.20.asp?current=yes.
in some public comments and litigation established or maintained by a plan that, where a health insurance issuer
statements, some such self-insured sponsor that is an employer.’’ providing group health insurance
church plans provide health coverage Consequently, the Religious IFC’s coverage is exempt under paragraph
for students at institutions of higher expanded exemptions only applied to (a)(1)(iii) of this section, the plan
education covered by those church non-governmental institutions of higher remains subject to any requirement to
plans. In order to avoid the situation education, including for student health provide coverage for contraceptive
where some student health plans insurance coverage, not to governmental services under Guidelines issued under
sponsored by institutions with religious institutions of higher education. § 147.130(a)(1)(iv), unless it is also
objections are effectively exempt from Nevertheless, the term ‘‘non- exempt from that requirement.
the contraceptive Mandate, and other governmental,’’ while appearing twice Under these rules, issuers that hold
student health plans sponsored by other in § 147.132(a)(1)(i) concerning plan their own objections, based on sincerely
institutions with similar religious sponsors, was not repeated in in held religious beliefs, could issue
objections are required to comply with § 147.132(a)(1)(ii). To more clearly policies that omit contraception to plan
the Mandate, the Departments consider specify that this limitation was intended sponsors or individuals that are
it appropriate to extend the exemption, to apply to § 147.132(a)(1)(ii), we otherwise exempt based on their
so that religious colleges and finalize this paragraph with a change by religious beliefs, or on their moral
universities with objections to the adding the phrase ‘‘which is non- convictions under the companion final
Mandate would not be treated governmental’’ after the phrase ‘‘An rules published elsewhere in today’s
differently in this regard. institution of higher education as Federal Register. Likewise, issuers with
The Departments also note that the defined in 20 U.S.C. 1002’’. sincerely held moral convictions, that
ACA does not require institutions of are exempt under those companion final
higher education to provide student L. Health Insurance Issuers (45 CFR rules, could issue policies that omit
health insurance coverage. As a result, 147.132(a)(1)(iv)) contraception to plan sponsors or
some institutions of higher education The previous regulations did not individuals that are otherwise exempt
that object to the Mandate appear to exempt health insurance issuers. based on either their religious beliefs or
have chosen to stop arranging student However, the Religious IFC included in their moral convictions.
health insurance plans, rather than its list of exemptions at In the separate companion IFC to the
comply with the Mandate or be subject § 147.132(a)(1)(iii), ‘‘[a] health insurance Religious IFC—the Moral IFC—the
to the accommodation.67 Extending the issuer offering group or individual Departments provided a similar
exemption in these rules removes an insurance coverage to the extent the exemption for issuers in the context of
obstacle to such entities deciding to issuer objects as specified in paragraph moral objections, but we used slightly
offer student health insurance plans, (a)(2) of this section. Where a health different operative language. There, in
thereby giving students another health insurance issuer providing group health the second sentence, instead of saying
insurance option. insurance coverage is exempt under this ‘‘the plan remains subject to any
As noted above, it is not clear that paragraph (a)(1)(iii), the plan remains requirement to provide coverage for
studies discussing various effects of subject to any requirement to provide contraceptive services,’’ the exemption
birth control access clearly and coverage for contraceptive services stated, ‘‘the group health plan
specifically demonstrate a negative under Guidelines issued under established or maintained by the plan
impact to students in higher education § 147.130(a)(1)(iv) unless it is also sponsor with which the health
because of the expanded exemption in exempt from that requirement[.]’’ These insurance issuer contracts remains
these final rules. The Departments rules finalize this exemption with subject to any requirement to provide
consider these expanded exemptions to technical changes to clarify the language coverage for contraceptive services.’’
be an appropriate and permissible based on public comments, and Some commenters took note of this
policy choice in light of various redesignate the paragraph as difference, and asked the Departments
interests at stake and the lack of a § 147.132(a)(1)(iv). to clarify which language applies, and
statutory requirement for the The Religious IFC extends the whether the Departments intended any
Departments to impose the Mandate on exemption to health insurance issuers difference in the operation of the two
entities and plans that qualify for these offering group or individual health paragraphs. The Departments did not
expanded exemptions. insurance coverage that sincerely hold intend the language to operate
Finally, the Religious IFC specified their own religious objections to differently. The language in the Moral
that the plan sponsor exemption applied providing coverage for contraceptive IFC accurately, and more clearly,
to ‘‘non-governmental’’ plan sponsors services. Under this exemption, the only expresses the intent set forth in the
(§ 147.132(a)(1)(i)), including ‘‘[a]ny plan sponsors—or in the case of Religious IFC about how the issuer
other non-governmental employer’’ individual insurance coverage, exemption applies. Consequently, these
(§ 147.132(a)(1)(i)(E)). Then, in individuals—who are eligible to rules finalize the issuer exemption
§ 147.132(a)(1)(ii), the rule specified that purchase or enroll in health insurance paragraph from the Religious IFC with
the institution of higher education coverage offered by an exempt issuer minor technical changes so that the final
exemption applicable to the that does not cover some or all language will mirror language from the
arrangement of student health insurance contraceptive services, are plan Moral IFC, stating that the exemption
coverage applied ‘‘in a manner sponsors or individuals who themselves encompasses: ‘‘[a] health insurance
comparable to its applicability to group object and whose plans are otherwise issuer offering group or individual
health insurance coverage provided in exempt based on their objection. An insurance coverage to the extent the
connection with a group health plan exempt issuer can then offer an exempt issuer objects as specified in paragraph
health insurance product to an entity or (a)(2) of this section. Where a health
67 See, e.g., Manya Brachear Pashman, ‘‘Wheaton individual that is exempt based on insurance issuer providing group health
College ends coverage amid fight against birth either the moral exemptions for entities insurance coverage is exempt under
control mandate,’’ Chicago Tribune, July 29, 2015;
Laura Bassett, ‘‘Franciscan University Drops Entire
and individuals, or the religious paragraph (a)(1)(iv) of this section, the
Student Health Insurance Plan Over Birth Control exemptions for entities and individuals. group health plan established or
Mandate,’’ HuffPost, May 15, 2012. Thus, the issuer exemption specifies maintained by the plan sponsor with
which the health insurance issuer subjecting the issuers to potential claims processors, are under no
contracts remains subject to any liability if those plans are not exempt obligation under section 2713(a)(4) to
requirement to provide coverage for from the Guidelines. provide benefits for contraceptive
contraceptive services under Guidelines The Departments reject the services, as that section applies only to
issued under § 147.130(a)(1)(iv) unless it proposition that issuers cannot exercise plans and issuers. In the case of ERISA-
is also exempt from that requirement[.]’’ religious beliefs. First, since RFRA covered plans, plan administrators are
Some commenters supported protects the religious exercise of obligated under ERISA to follow the
including this exemption for issuers in corporations as persons, the religious plan terms, but it is the Departments’
these rules, both to protect the religious exercise of health insurance issuers— understanding that third party
exercise of issuers, and so that in the which are generally organized as administrators are not typically
future religious issuers that may wish to corporations—is protected by RFRA. In designated as plan administrators, and,
specifically serve religious plan addition, many federal health care therefore, would not normally act as
sponsors would be free to organize. conscience laws and regulations plan administrators, under section 3(16)
Other commenters objected to including specifically protect issuers or plans. For of ERISA. Therefore, to the
an exemption for issuers. Some objected example, 42 U.S.C. 1395w–22(j)(3)(B) Departments’ knowledge, it is only
that issuers cannot exercise religious and 1396u–2(b)(3) protect plans or under the existing accommodation
beliefs, while others objected that managed care organizations in Medicaid process that third party administrators
exempting issuers would threaten or Medicare Advantage. The Weldon are required to undertake any
contraceptive coverage for women. Amendment specifically protects, obligations to provide or arrange for
Some commenters said that it was among other entities, provider- contraceptive coverage to which they
arbitrary and capricious for the sponsored organizations, health might object. These rules make the
Departments to provide an exemption maintenance organizations (HMOs), accommodation process optional for
for issuers if we do not know that health insurance plans, and ‘‘any other employers and other plan sponsors, and
issuers with qualifying religious kind of health care facilit[ies], specify that third party administrators
objections exist. organization[s], or plan[s]’’ as a ‘‘health that have their own objection to
The Departments consider it care entity’’ from being required to pay complying with the accommodation
appropriate to provide this exemption for, or provide coverage of, abortions. process may decline to enter into, or
for issuers. Because the issuer See for example, Consolidated decline to continue, contracts as third
exemption only applies where an Appropriations Act of 2018, Public Law party administrators of such plans.
independently exempt policyholder 115–141, Div. H, Sec. 507(d), 132 Stat.
(entity or individual) is involved, the 348, 764 (Mar. 23, 2018).68 Congress M. Description of the Religious
issuer exemption will not serve to also declared this year that ‘‘it is the Objection (45 CFR 147.132(a)(2))
remove contraceptive coverage intent of Congress’’ to include a The previous regulations did not
obligations from any plan or plan ‘‘conscience clause’’ which provides specify what, if any, religious objection
sponsor that is not also exempt, nor will exceptions for religious beliefs if the applied to its exemption; however, the
it prevent other issuers from being District of Columbia requires ‘‘the Religious IFC set forth the scope of the
required to provide contraceptive provision of contraceptive coverage by
coverage in individual or group religious objection of objecting entities
health insurance plans.’’ See id. at Div. in § 147.132(a)(2), as follows: ‘‘The
insurance coverage. The issuer E, Sec. 808, 132 Stat. at 603. In light of
exemption therefore serves several exemption of this paragraph (a) will
the clearly expressed intent of Congress apply to the extent that an entity
interests, even though the Departments
to protect religious liberty, particularly described in paragraph (a)(1) of this
are not currently aware of existing
in certain health care contexts, along section objects to its establishing,
issuers that would use it. As noted by
with the specific efforts to protect maintaining, providing, offering, or
some commenters, allowing issuers to
issuers, the Departments have arranging (as applicable) coverage,
be exempt, at least with respect to plan
concluded that an exemption for issuers payments, or a plan that provides
sponsors and plans that independently
is appropriate. coverage or payments for some or all
qualify for an exemption, will remove a The issuer exemption does not
possible obstacle to religious issuers contraceptive services, based on its
specifically include third party sincerely held religious beliefs.’’ These
being organized in the future to serve
administrators, although the optional rules finalize this description with
entities and individuals that want plans
accommodation process provided under technical changes to clarify the scope of
that respect their religious beliefs or
these final rules specifies that third the objection as intended in the
moral convictions. Furthermore,
party administrators cannot be required Religious IFC, and based on public
permitting issuers to object to offering
to contract with an entity that invokes comments.
contraceptive coverage based on
that process. Some religious third party Throughout the exemptions for
sincerely held religious beliefs will
administrators have brought suit in objecting entities, the rules specify that
allow issuers to continue to offer
conjunction with suits brought by they apply where the entities object as
coverage to plan sponsors and
individuals, without subjecting them to organizations enrolled in ERISA-exempt specified in § 147.132(a)(2) of the
liability under section 2713(a)(4), or church plans. Such plans are now Religious IFC. That paragraph describes
related provisions, for their failure to exempt under these final rules, and the religious objection by specifying that
provide contraceptive coverage. In this their third party administrators, as exemptions for objecting entities will
way, the issuer exemption serves to apply to the extent that an entity
68 ACA section 1553 protects an identically

protect objecting issuers from being defined group of ‘‘health care entities,’’ including
described in paragraph (a)(1) objects to
required to issue policies that cover provider-sponsored organizations, HMOs, health its establishing, maintaining, providing,
contraception in violation of the issuers’ insurance plans, and ‘‘any other kind of . . . plan,’’ offering, or arranging (as applicable)
sincerely held religious beliefs, and from being subject to discrimination on the basis coverage, payments, or a plan that
that it does not provide any health care item or
from being required to issue policies service furnishing for the purpose of assisted
provides coverage or payments for some
that omit contraceptive coverage to non- suicide, euthanasia, mercy killing, and the like. or all contraceptive services, based on
exempt entities or individuals, thus ACA section 1553, 42 U.S.C. 18113. its sincerely held religious beliefs.
In the separate companion IFC to the structure specifies that it includes an of a qualifying religious objection.
Religious IFC—the Moral IFC—the objection to establishing, maintaining, Similarly, under the previous
Departments, at § 147.133(a)(2), providing, offering, or arranging for (as exemption, the plans of houses of
provided a similar description of the applicable) coverage or payments for worship and integrated auxiliaries were
scope of the objection based on moral contraceptive services, and it includes exempt from offering some or all
convictions rather than religious beliefs, an objection to establishing, contraceptives, but the previous
but we used slightly different operative maintaining, providing, offering, or regulations did not require issuers and
language. There, instead of saying the arranging for (as applicable) a plan, third party administrators to contract
entity ‘‘objects to its establishing, issuer, or third party administrator that with those exempt entities if they chose
maintaining, providing, offering, or provides contraceptive coverage. This not to do so.
arranging (as applicable) coverage, more clearly encompasses objections to N. Individuals (45 CFR 147.132(b))
payments, or a plan that provides complying with either the Mandate or
coverage or payments for some or all the accommodation. Consequently, The previous regulations did not
contraceptive services,’’ the paragraph these rules finalize the paragraph provide an exemption for objecting
describing the religious objection in the individuals. However, the Religious IFC
stated the entity ‘‘objects to its
Religious IFC with minor technical expanded the exemptions to encompass
establishing, maintaining, providing,
changes so that the final language will objecting individuals (referred to here as
offering, or arranging (as applicable)
essentially mirror language from the the ‘‘individual exemption’’), at
coverage or payments for some or all
Moral IFC. The introductory phrase of § 147.132(b). These rules finalize the
contraceptive services, or for a plan, individual exemption from the
issuer, or third party administrator that the religious objection set forth in
paragraph (a)(2) is finalized to state the Religious IFC with changes, which
provides or arranges such coverage or reflect both non-substantial technical
payments.’’ Some commenters took note exemption ‘‘will apply to the extent that
an entity described in paragraph (a)(1) revisions, and changes based on public
of this difference, and asked the comments to more clearly express the
Departments to clarify which language of this section objects, based on its
sincerely held religious beliefs, to its intent of the Religious IFC.
applies, and whether the Departments In the separate companion IFC to the
intended any difference in the operation establishing, maintaining, providing,
Religious IFC—the Moral IFC—the
of the two paragraphs. The Departments offering, or arranging for (as
Departments, at § 147.133(b), provided a
did not intend the language to operate applicable)’’. The remainder of the
similar individual exemption, but we
differently. The language in the Moral paragraph is broken into two sub-
used slightly different operative
IFC accurately, and more clearly, paragraphs, regarding either ‘‘coverage
language. Where the Religious IFC
expresses the intent set forth in the or payments for some or all described what may be offered to
Religious IFC about how the issuer contraceptive services,’’ or ‘‘a plan, objecting individuals as ‘‘a separate
exemption applies. The Religious IFC issuer, or third party administrator that benefit package option, or a separate
explained that the intent of the provides or arranges such coverage or policy, certificate or contract of
expanded exemptions was to encompass payments.’’ insurance,’’ the Moral IFC said a willing
entities that objected to providing or Some commenters observed that by issuer and plan sponsor may offer ‘‘a
arranging for contraceptive coverage in allowing exempt groups to object to separate policy, certificate or contract of
their plans, and to encompass entities ‘‘some or all’’ contraceptives, this might insurance or a separate group health
that objected to the previous yield a cafeteria-style approach where plan or benefit package option, to any
accommodation process, by which their different plan sponsors choose various individual who objects’’ under the
issuers or third party administrators combinations of contraceptives that they individual exemption. Some
were required to provide contraceptive wish to cover. Some commenters further commenters observed this difference
coverage or payments in connection observed that this might create a burden and asked whether the language was
with their plans. In other words, an on issuers or third party administrators. intended to encompass the same
entity would be exempt from the The Departments have concluded, options. The Departments intended
Mandate if it objected to complying however, that, just as the exemption these descriptions to include the same
with the Mandate, or if it objected to under the previous regulations allowed scope of options. Some commenters
complying with the accommodation. entities to object to some or all suggested that the individual exemption
The language in the Religious IFC contraceptives, it is appropriate to should not allow the offering of ‘‘a
encompassed both circumstances by maintain that flexibility for entities separate group health plan,’’ as set forth
encompassing an objection to providing covered by the expanded exemption. in the version found in § 147.133(b),
‘‘coverage [or] payments’’ for Notably, even where an entity or because doing so could cause various
contraceptive services, and by individual qualifies for an exemption administrative burdens. The
encompassing an objection to ‘‘a plan under these rules, these rules do not Departments disagree, since group
that provides’’ coverage or payments for require the issuer or third party health plan sponsors and group and
contraceptive services. But the language administrator to contract with that individual health insurance issuers
describing the objection set forth in the entity or individual if the issuer or third would be free to decline to provide that
Moral IFC does so more clearly, and party administrator does not wish to do option, including because of
restructuring the sentence could make it so, including because the issuer or third administrative burdens. In addition, the
clearer still. Questions by commenters party administrator does not wish to Departments wish to clarify that, where
about the scope of the description offer an unusual variation of a plan. an employee claims the exemption, a
suggests that we should restructure the These rules simply remove the federal willing issuer and a willing employer
description, in a non-substantive way, Mandate that, in some cases, could have may, where otherwise permitted, offer
to provide more clarity. The led to penalties for an employer, issuer, the employee participation in a group
Departments do this by breaking some or third party administrator if they health insurance policy or benefit
of the text out into subparagraphs, and wished to sponsor, provide, or option that complies with the
rearranging clauses so that it is clearer administer a plan that omits employee’s objection. Consequently,
which words they modify. The new contraceptive coverage in the presence these rules finalize the individual
exemption by making a technical issuers are willing to offer particular objection if the institution did not wish
change to the language to adopt the options in individual cases. to do so.
formulation, ‘‘a separate policy, In addition, Congress has provided As an example, in one lawsuit
certificate or contract of insurance or a several protections for individuals who brought against the Departments, the
separate group health plan or benefit object to prescribing or providing State of Missouri enacted a law under
package option, to any group health contraceptives contrary to their religious which the State is not permitted to
plan sponsor (with respect to an beliefs. See for example, Consolidated discriminate against insurance issuers
individual) or individual, as applicable, Appropriations Act of 2018, Div. E, Sec. that offer group health insurance
who objects’’ under the individual 726(c) (Financial Services and General policies without coverage for
exemption. Government Appropriations Act), contraception based on employees’
Some commenters supported the Public Law 115–141, 132 Stat. 348, 593– religious beliefs, or against the
individual exemption as providing 94 (Mar. 23, 2018). While some individual employees who accept such
appropriate protections for the religious commenters proposed to construe this offers. See Wieland, 196 F. Supp. 3d at
beliefs of individuals who obtain their provision narrowly, Congress likewise 1015–16 (quoting Mo. Rev. Stat.
insurance coverage in such places as the provided that, if the District of 191.724). Under the individual
individual market or exchanges, or who Columbia requires ‘‘the provision of exemption of these final rules,
obtain coverage from a group health contraceptive coverage by health employers sponsoring governmental
plan sponsor that does not object to insurance plans,’’ ‘‘it is the intent of plans would be free to honor the
contraceptive coverage but is willing Congress that any legislation enacted on objections of individual employees by
(and, as applicable, the issuer is also such issue should include a ‘conscience offering them plans that omit
willing) to provide coverage that is clause’ which provides exceptions for contraceptive coverage, even if those
consistent with an individual’s religious religious beliefs and moral convictions’’. governmental entities do not object to
objections. Some commenters also Id. at Div. E, Sec. 808, 132 Stat. at 603. offering contraceptive coverage in
observed that, by specifying that the A religious exemption for individuals general.
individual exemption only operates would not be effective if the government This individual exemption cannot be
where the plan sponsor and issuer, as simultaneously made it illegal for used to force a plan (or its sponsor) or
applicable, are willing to provide issuers and group health plans to an issuer to provide coverage omitting
coverage that is consistent with the provide individuals with policies that contraception, or, with respect to health
objection, the exemption would not comply with the individual’s religious insurance coverage, to prevent the
impose burdens on the insurance beliefs. application of State law that requires
market because the possibility of such coverage of such contraceptives or
The individual exemption extends to
burdens would be factored into the sterilization. Nor can the individual
the coverage unit in which the plan
willingness of an employer or issuer to
participant, or subscriber in the exemption be construed to require the
offer such coverage. Other commenters
individual market, is enrolled (for guaranteed availability of coverage
disagreed and contended that allowing
instance, to family coverage covering omitting contraception to a plan sponsor
the individual exemption would cause
the participant and his or her or individual who does not have a
burden and confusion in the insurance
beneficiaries enrolled under the plan), sincerely held religious objection. This
market. Some commenters also
but does not relieve the plan’s or individual exemption is limited to the
suggested that the individual exemption
issuer’s obligation to comply with the requirement to provide contraceptive
should not allow the offering of a
Mandate with respect to the group coverage under section 2713(a)(4), and
separate group health plan because
health plan generally, or, as applicable, does not affect any other federal or State
doing so could cause various
to any other individual policies the law governing the plan or coverage.
administrative burdens.
The Departments agree with the issuer offers. Thus, if there are other applicable laws
commenters who suggested the This individual exemption allows or plan terms governing the benefits,
individual exemption will not burden plan sponsors and issuers that do not these final rules do not affect such other
the insurance market, and, therefore, specifically object to contraceptive laws or terms.
conclude that it is appropriate to coverage to offer religiously acceptable Some individuals commented that
provide the individual exemption where coverage to their participants or they welcomed the individual
a plan sponsor and, as applicable, issuer subscribers who do object, while exemption so that their religious beliefs
are willing to cooperate in doing so. As offering coverage that includes were not forced to be in tension with
discussed in the Religious IFC, the contraception to participants or their desire for health coverage. The
individual exemption only operates in subscribers who do not object. This Departments believe the individual
the case where the group health plan individual exemption can apply with exemption may help to meet the ACA’s
sponsor or group or individual market respect to individuals in plans goal of increasing health coverage
health insurance issuer is willing to sponsored by private employers or because it will reduce the incidence of
provide the separate option; in the case governmental employers. certain individuals choosing to forego
of coverage provided by a group health By its terms, the individual health coverage because the only
plan sponsor, where the plan sponsor is exemption would also apply with coverage available would violate their
willing; or in the case where both a plan respect to individuals in plans arranged sincerely held religious beliefs.69 At the
sponsor and issuer are involved, both by institutions of higher education, if same time, this individual exemption
are willing. The Departments conclude the issuers offering those plans were ‘‘does not undermine the governmental
that it is appropriate to provide the willing to provide plans complying with interests furthered by the contraceptive
individual exemption so that the the individuals’ objections. Because
Mandate will not serve as an obstacle federal law does not require institutions 69 See also, for example, Wieland, 196 F. Supp.
among these various options. Practical of higher education to arrange such 3d at 1017, and March for Life, 128 F. Supp. 3d at
130, where the courts noted that the individual
difficulties that may be implicated by plans, the institutions would not be employee plaintiffs indicated that they viewed the
one option or another will likely be required by these rules to arrange a plan Mandate as pressuring them to ‘‘forgo health
factored into whether plan sponsors and compliant with an individual’s insurance altogether.’’
coverage requirement,’’ 70 because, package option that omits all issuer or third party administrator.
when the exemption is applicable, the contraceptives, and the individual Upon doing so, the plan would not
individual does not want the coverage, agrees, then the exemption applies as if cover some or all contraceptive services,
and therefore would not use the the individual objects to all and the issuer or third party
objectionable items even if they were contraceptive services.’’ administrator would be responsible for
covered. Some commenters asked for plain providing or arranging for persons
Some commenters welcomed the language guidance and examples about covered by the plan to receive coverage
ability of individuals covered by the how the individual exemption might or payments of those services (except in
individual exemption to be able to apply in the context of employer- the case of self-insured church plans
assert an objection to either some or all sponsored insurance. Here is one such exempt from ERISA, in which case no
contraceptives. Other commenters example. An employee is enrolled in such obligation was imposed on the
expressed concern that there might be group health coverage through her third party administrator). The
multiple variations in the kinds of employer. The plan is fully insured. If accommodation was set forth in
contraceptive coverage to which the employee has sincerely held regulations of each of the Departments.
individuals object, and this might make religious beliefs objecting to her plan Based on each Department’s regulatory
it difficult for willing plan sponsors and including coverage for contraceptives, authority, HHS regulations applied to
issuers to provide coverage that she could raise this with her employer. insured group health plans, and DOL
complies with the religious beliefs of an If the employer is willing to offer her a and Treasury regulations applied to
exempt individual. As discussed above, plan that omits contraceptives, the both insured group health plans and
where the individual exemption employer could discuss this with the self-insured group health plans.
applies, it only affects the coverage of an insurance agent or issuer. If the issuer The Religious IFC maintained the
individual. If an individual only objects is also willing to offer the employer, accommodation process. Nevertheless,
to some contraceptives, and the with respect to this employee, a group by virtue of expanding the exemptions
individual’s issuer and, as applicable, health insurance policy that omits to encompass all entities that were
plan sponsor are willing to provide the contraceptive coverage, the individual eligible for the accommodation process
individual a package of benefits exemption would make it legal for the under the previous regulations, in
omitting such coverage, but for practical group health insurance issuer to omit addition to other newly exempt entities,
reasons they can only do so by contraceptives for her and her the Religious IFC rendered the
providing the individual with coverage beneficiaries under a policy, for her accommodation process optional.
that omits all—not just some— employer to sponsor that plan for her, Entities could choose not just between
contraceptives, the Departments believe and for the issuer to issue such a plan the Mandate and the accommodation,
that it favors individual freedom and to the employer, to cover that employee. but between the Mandate, the
market choice, and does not harm This would not affect other employees’ exemption, and the accommodation.
others, to allow the issuer and plan plans—those plans would still be These rules finalize the optional
sponsor to provide, in that case, a plan subject to the Mandate and would accommodation process and its location
omitting all contraceptives if the continue to cover contraceptives. But if in the Code of Federal Regulations at 45
individual is willing to enroll in that either the employer, or the issuer, is not CFR 147.131, 26 CFR 54.9815–2713A,
plan. The language of the individual willing (for whatever reason) to offer a and 29 CFR 2590.715–2713A, but the
exemption set forth in the Religious IFC plan or a policy for that employee that Departments do so with several changes
implied this conclusion, by specifying omits contraceptive coverage, these based on public comments.
that the Guidelines requirement of rules do not require them to. The Many commenters supported keeping
contraceptive coverage did not apply employee would have the choice of the accommodation as an optional
where the individual objected to some staying enrolled in a plan with its process, including some commenters
or all contraceptives. Notably, this was coverage of contraceptives, not enrolling who otherwise supported creating the
different than the language applicable to in that plan, seeking coverage expanded exemptions. Some
the exemptions under § 147.132(a), elsewhere, or seeking employment commenters opposed making the
which specifies that the exemptions elsewhere. accommodation optional, but asked the
apply ‘‘to the extent’’ of the religious For all these reasons, these rules Departments to return to the previous
objections, so that, as discussed above, adopt the individual exemption regulations in which entities that did
the exemptions include only those language from the Religious IFC with not meet the narrower exemption could
contraceptive methods to which the clarifying changes to reflect the only choose between the
objection applied. In response to Departments’ intent. accommodation process or direct
comments suggesting the language of compliance with the Mandate. Some
O. Accommodation (45 CFR 147.131, 26 commenters believed there should be no
the individual exemption was not
CFR 54.9815–2713A, 29 CFR 2590.715– exemptions and no accommodation
sufficiently clear on this distinction,
2713A) process.
however, the Departments in these rules
finalize the individual exemption at The previous regulations set forth an The Departments continue to consider
§ 147.133(b) with the following change, accommodation process at 45 CFR it appropriate to make the
by adding the following sentence at the 147.131, 26 CFR 54.9815–2713A, and 29 accommodation process optional for
end of the paragraph: ‘‘Under this CFR 2590.715–2713A, as an alternative entities that are otherwise also eligible
exemption, if an individual objects to method of compliance with the for the expanded exemptions—that is, to
some but not all contraceptive services, Mandate. Under the accommodation, if keep it in place as an option that exempt
but the issuer, and as applicable, plan a religious nonprofit entity, or a entities can choose. The accommodation
sponsor, are willing to provide the religious closely held for-profit provides contraceptive access, which is
individual with a separate policy, business, objected to coverage of some a result many opponents of the
certificate or contract of insurance or a or all contraceptive services in its health expanded exemptions said they desire.
separate group health plan or benefit plan, it could file a notice or fill out a The accommodation involves some
form expressing this objection and regulation of issuers and third party
70 78 FR 39874. describing its objection to its plan and administrators, but the previous
regulations had already put that find it necessary to add an additional guidance further stated that the notice
regulatory structure in place. These payment mechanism for the may be provided by the organization
rules for the most part merely keep it in accommodation process. itself, its group health plan, or its third
place and maintain the way it operates. If an eligible organization wishes to party administrator, as applicable. The
The Religious IFC adds some additional revoke its use of the accommodation, it guidance stated that, under the
paperwork burdens as a result of the can do so under these rules, and operate regulation at 45 CFR 147.200(b), ‘‘[t]he
new interaction between the under its exempt status. As part of its notice of modification must be provided
accommodation and the expanded revocation, the issuer or third party in a form that is consistent with the
exemptions; those are discussed below. administrator of the eligible rules of paragraph (a)(4) of this section,’’
Above, the Departments discussed organization must provide participants and (a)(4) has detailed rules on when
public comments concerning whether and beneficiaries written notice of such electronic notice is permitted. These
we should have merely expanded the revocation. Some commenters suggested guidelines still apply under the final
accommodation rather than expanding HHS has not yet issued guidance on the rules. These rules adopt those
the exemptions. The Religious IFC and revocation process, but CCIIO provided guidelines.
these final rules expand the kinds of guidance concerning this process on The guidance further specified that
entities that may use the optional November 30, 2017.71 These rules the revocation of the accommodation
accommodation, by expanding the supersede that guidance, and adopt or would be effective notice on the first
exemptions and allowing any exempt modify its specific guidelines as day of the first plan year that begins on
entities to opt to make use of the explained below. As a result, these rules or after 30 days after the date of the
accommodation. Consequently, under delete references, set forth in the revocation, or alternatively, whether or
these rules, objecting employers may Religious IFC’s accommodation not the objecting entity’s group health
make use of the exemption or may regulations, to ‘‘guidance issued by the plan or issuer listed the contraceptive
choose to utilize the optional Secretary of the Department of Health benefit in its Summary of Benefits of
accommodation process. If an eligible and Human Services.’’ Coverage (SBC), the group health plan
organization uses the optional The guidance stated that an entity that or issuer could revoke the
accommodation process through the was using the accommodation under the accommodation by giving at least 60-
EBSA Form 700 or other specified previous rules, or an entity that adopts days prior notice pursuant to section
notice to HHS, it voluntarily shifts an the accommodation maintained by the 2715(d)(4) of the PHS Act (incorporated
obligation to provide separate but IFCs, could revoke its use of the into ERISA and the Code) 72 and
seamless contraceptive coverage to its accommodation and use the exemption. applicable regulations thereunder to
issuer or third party administrator. This guideline applies under the final revoke the accommodation. The
Some commenters asked that these rules. This revocation process applies guidance noted that, unlike the SBC
final rules create an alternative payment both prospectively to eligible notification process, which can
mechanism to cover contraceptive organizations that decide at a later date effectuate a modification of benefits in
services for third party administrators to avail themselves of the optional the middle of a plan year, provided it
obligated to provide or arrange such accommodation and then decide to is allowed by State law and the contract
coverage under the accommodation. revoke that accommodation, as well as of the policy, the 30 day notification
These rules do not concern the payment to organizations that invoked the process under the guidance can only
mechanism, which is set forth in accommodation prior to the effective effectuate a benefit modification at the
separate rules at 45 CFR 156.50. The date of the Religious IFC either by their beginning of a plan year. This part of the
Departments do not view an alternative submission of an EBSA Form 700 or guidance is adopted in part and changed
payment mechanism as necessary. As notification, or by some other means in part by these final rules, as follows,
discussed below, although the under which their third party based on public comments on the issue.
Departments do not know how many administrator or issuer was notified by Some commenters asked that
entities will use the accommodation, it DOL or HHS that the accommodation revocations only be permitted to occur
is reasonably likely that some entities applies. on the first day of the next plan year, or
previously using it will continue to do The guidance stated that, when the no sooner than January 2019, to avoid
so, while others will choose the accommodation is revoked by an entity burdens on plans and because some
expanded exemption, leading to an using the exemption, the issuer of the states do not allow for mid-year plan
overall reduction in the use of the eligible organization must provide changes. The Departments believe that
accommodation. The Departments have participants and beneficiaries written providing 60-days notice pursuant to
reason to believe that these final rules notice of such revocation. These rules section 2715(d)(4) of the PHS Act,
will not lead to a significant expansion adopt that guideline. Consistent with where applicable, is a mechanism that
of entities using the accommodation, other applicable laws, the issuer or third already exists for making changes in
since nearly all of the entities of which party administrator of an eligible health benefits covered by a group
the Departments are aware that may be organization must promptly notify plan health plan during a plan year; that
interested in doing so were already able participants and beneficiaries of the process already takes into consideration
to do so prior to the Religious IFC. change of status to the extent such any applicable state laws. However, in
Moreover, it is still the case under these participants and beneficiaries are response to public comments, these
rules that if an entity serving as a third currently being offered contraceptive rules change the accommodation
party administrator does not wish to coverage at the time the accommodated provisions from the Religious IFC to
satisfy the obligations it would need to organization invokes its exemption. The indicate that, as a transitional rule,
satisfy under an accommodation, it providing 60-days notice for revoking an

could choose not to contract with an 71 See Randy Pate, ‘‘Notice by Issuer or Third
accommodation is only available, if
entity that opts into the accommodation. Party Administrator for Employer/Plan Sponsor of applicable, to plans that are using the
This conflict is even less likely now that Revocation of the Accommodation for Certain
Preventive Services,’’ CMS (Nov. 30, 2017), https:// accommodation at the time of the
entities eligible for the accommodation www.cms.gov/CCIIO/Resources/Regulations-and-
are also eligible for the exemption. For Guidance/Downloads/Notice-Issuer-Third-Party- 72 See also 26 CFR 54.9815–2715(b); 29 CFR
these reasons, the Departments do not Employer-Preventive.pdf. 2590.715–2715(b); 45 CFR 147.200(b).
publication of these final rules. As a Department of Health and Human which an issuer is deemed to have
general rule, for plans that use the Services.’’ On November 30, 2017, HHS complied with the Mandate where the
accommodation in future plan years, the issued the guidance regarding issuer relied reasonably and in good
Departments believe it is appropriate to revocation. These final rules incorporate faith on a representation by an eligible
allow revocation of an accommodation this guidance, with certain organization as to its eligibility for the
only on the first day of the next plan clarifications, and state that the accommodation, even if that
year. Based on the objections of various revocation notice must be provided ‘‘as representation was later determined to
litigants and public commenters, we specified herein.’’ The final rule be incorrect. The Departments omitted
believe that some entities already using incorporates the two sets of directions this provision from the Religious IFC,
the accommodation may have been for revoking the accommodation on the grounds that this provision was
doing so only because previous initially set forth in the interim less necessary where any organization
regulations denied them an exemption. guidance in the following manner. The eligible for the optional accommodation
For them, access to the transitional 60- first, designated as subparagprah (1) as is also exempt. Nevertheless, in order to
days notice procedure (if applicable) is a ‘‘[t]ransitional rule,’’ explains that if respond to concerns in public
appropriate in the period immediately contraceptive coverage is being offered comments, and to prevent any risk to
following the finalization of these rules. through the accommodation process on issuers of a mistake or
In future plan years, however—plan the date on which these final rules go misrepresentation by an organization
years that begin after the effective date into effect, 60-days notice may be seeking the accommodation process, the
of these final rules—plans and entities provided to revoke the accommodation Departments have finalized the
that qualify as exempt under these rules process, or they revocation may occur Religious IFC with an additional change
will have been on notice that they ‘‘on the first day of the first plan year that restores this clause. The clause uses
qualify for an exemption or the that begins on or after 30 days after the the same language that was in the
accommodation. If they have opted to date of the revocation’’ consistent with regulations prior to the Religious IFC,
enter or remain in the accommodation PHS Act section 2715(d)(4), 45 and it is inserted at 45 CFR 147.131(f),
in those future plan years, when they CFR 147.200(b), 26 CFR 54.9815– 26 CFR 54.9815–2713A(e), and 29 CFR
could have chosen the exemption, the 2715(b), or 29 CFR 2590.715–2715(b). 2590.715–2713A(e). As a result, these
Departments believe it is appropriate for The second direction, set forth in rules renumber the subsequent
them to wait until the first day of the subparagraph (ii), explains the paragraphs in each of those sections.
following plan year to change to exempt ‘‘[g]eneral rule’’ that, in plan years
P. Definition of Contraceptives for the
status.73 beginning after the date on which these
Purpose of These Final Rules
This change is implemented in the final rules go into effect, revocation of
the accommodation will be effective on The previous regulations did not
following manner. In the Religious IFC,
‘‘the first day of the first plan year that define contraceptive services. The
the accommodation provisions
begins on or after 30 days after the date Guidelines issued in 2011 included,
addressing revocation were found at 45
of the revocation.’’ under ‘‘Contraceptive methods and
CFR 147.131(c)(4), 26 CFR 54.9815–
The Religious IFC states that if an counseling,’’ ‘‘[a]ll Food and Drug
2713AT(a)(5),74 and 29 CFR 2590.715–
accommodated entity objects to some, Administration approved contraceptive
2713A(a)(5).
but not all, contraceptives, an issuer for methods, sterilization procedures, and
The provisions in the Religious IFC
an insured group health plan that covers patient education and counseling for all
(with technical variations among the
contraceptives under the women with reproductive capacity.’’
HHS, Labor, and Treasury rules) state
accommodation may, at the issuer’s The previous regulations concerning the
that a written notice of revocation must
option, choose to provide coverage or exemption and the accommodation used
be provided ‘‘as specified in guidance
payments for all contraceptive services, the terms contraceptive services and
issued by the Secretary of the
instead of just for the narrower set of contraceptive coverage as catch-all
73 These final rules go into effect 60 days after contraceptive services to which the terms to encompass all of those
they are published in the Federal Register. Some entities object. Some commenters Guidelines’ requirements. The 2016
entities currently using the accommodation may supported this provision, saying that it update to the Guidelines are similarly
have a plan year that begins less than 30 days after allows flexibility for issuers that might worded. Under ‘‘Contraception,’’ they
the effective date of these final rules. In such cases,
they may be unable, after the effective date of these
otherwise face unintended burdens from include the ‘‘full range of contraceptive
final rules, to provide a revocation notice 30 days providing coverage under the methods for women currently identified
prior to the start of their next plan year. However, accommodation for entities that object by the U.S. Food and Drug
these final rules will be published at least 60 days to only some contraceptive items. The Administration,’’ ‘‘instruction in
prior to the start of that plan year. Therefore, Departments have maintained this
entities exempt under these final rules that have
fertility awareness-based methods,’’ and
been subject to the accommodation on the date provision in these final rules. Note that ‘‘[c]ontraceptive care’’ to ‘‘include
these final rules are published, that wish to revoke this provision is consistent with the contraceptive counseling, initiation of
the accommodation, and whose next plan years other assertions in the rules saying that contraceptive use, and follow-up care
start after these final rules go into effect, but less an entity’s objection applies ‘‘to the
than 30 days thereafter, may submit their 30 day
(for example, management, and
revocation notices after these final rules are extent’’ of the entity’s religious beliefs, evaluation as well as changes to and
published, before these final rules are in effect, so because in this instance, under the removal or discontinuation of the
that they will have submitted the revocation at least accommodation, the plan participant or contraceptive method).’’ 75
30 days before their next plan year starts. In such beneficiary still receives coverage or
cases, even though the revocation notice will be
To more explicitly state that the
payments for all contraceptives, and this exemption encompasses any of the
submitted before these final rules are in effect, the

actual revocation will not occur until after these provision simply allows issuers more contraceptive or sterilization services,
final rules are in effect, and plan participants will flexibility in choosing how to help items, or information that have been
have been provided with 30 days’ notice of the provide that coverage.
revocation.
required under the Guidelines, the
74 The Department of the Treasury’s rule
Some commenters asked that the Religious IFC included a definition at 45
addressing the accommodation is being finalized at
Departments retain the ‘‘reliance’’
26 CFR 54.9815–2713A, superseding its temporary provision, contained in the previous 75 https://www.hrsa.gov/womens-guidelines-2016/
regulation at 26 CFR 54.9815–2713AT. accommodation regulations, under index.html.
CFR 147.131(f) and 147.132(c), 26 CFR of contraceptive methods as a type of prescribed for non-preventive, non-
54.9815–2713AT(e), and 29 CFR preventive service only when a drug contraceptive purposes. As discussed
2590.715–2713A(e). These rules finalize that FDA has approved for contraceptive above, these final rules also do not
those definitions without change, but use is prescribed in whole or in part for purport to delineate the items HRSA
renumber them as 45 CFR 147.131(f) such purpose or intended use. Section will include in the Guidelines, but only
and 147.132(c), 26 CFR 54.9815– 2713(a)(4) does not authorize the concern expanded exemptions and
2713A(e), and 29 CFR 2590.715– Departments to require coverage, accommodations that apply to the
2713A(e), respectively. without cost-sharing, of drugs extent the Guidelines require
prescribed exclusively for a non- contraceptive coverage. Therefore, the
Q. Severability contraceptive and non-preventive use to Departments do not consider it
The Departments finalize without treat an existing condition.77 The extent appropriate to specify in these final
change (except for certain paragraph to which contraceptives are covered to rules that under section 2713(a)(4),
redesignations), the severability clauses treat non-preventive conditions would exempt organizations must provide
in the interim final rules, namely, at be determined by application of the coverage for drugs prescribed
paragraph (g) of 26 CFR 54.9815–2713A, requirement section 1302(b)(1)(F) of the exclusively for a non-contraceptive and
the redesignated paragraph (g) of 29 CFR ACA to cover prescription drugs (where non-preventive use to treat an existing
2590.715–2713A, and 45 CFR applicable), implementing regulations at condition.
147.132(d). 45 CFR 156.122, and 156.125, and
2. Comments Concerning Regulatory
plans’ decisions about the basket of
R. Other Public Comments Impact
medicines to cover for these conditions.
1. Items Approved as Contraceptives Some commenters observed that Some commenters agreed with the
But Used To Treat Existing Conditions pharmacy claims do not include a Departments’ statement in the Religious
medical diagnosis code, so plans may be IFC that the expanded exemptions are
Some commenters noted that some unable to discern whether a drug likely to affect only a small percentage
drugs included in the preventive approved by FDA for contraceptive uses of women otherwise receiving coverage
services contraceptive Mandate can also is actually applied for a preventive or under the Mandate. Other commenters
be useful for treating certain existing contraceptive use, or for another use. disagreed, stating that the expanded
health conditions, and that women use Section 2713(a)(4), however, draws a exemptions could take contraceptive
them for non-contraceptive purposes. distinction between preventive care and coverage away from many or most
Certain commenters urged the screenings and other kinds of care and women. Still others opposed expanding
Departments to clarify that the final screenings. That subsection does not the exemptions and contended that
rules do not permit employers to authorize the Departments to impose a accurately determining the number of
exclude from coverage medically coverage mandate of services that are women affected by the expanded
necessary prescription drugs used for not at least partly applied for a exemptions is not possible.
non-preventive services. Some preventive use, and the Guidelines After reviewing the public comments,
commenters suggested that religious themselves do not require coverage of the Departments agree with commenters
objections to the Mandate should not be contraceptive methods or care unless who said that estimating the impact of
permitted in cases where such methods such methods or care is contraceptive in these final rules is difficult based on the
are used to treat such conditions, even purpose. These rules do not prohibit limited data available to us, and with
if those methods can also be used for issuers from covering drugs and devices commenters who agreed with the
contraceptive purposes. that are approved for contraceptive uses Religious IFC that the expanded
Section 2713(a)(4) only applies to even when those drugs and devices are exemptions are likely to affect only a
‘‘preventive’’ care and screenings. The small percentage of women. The
statute does not allow the Guidelines to 77 The Departments previously cited the IOM’s Departments do not find the estimates of
mandate coverage of services provided listing of existing conditions that contraceptive large impacts submitted by some
solely for a non-preventive use, such as drugs can be used to treat (menstrual disorders,
acne, and pelvic pain), and said of those uses that
commenters more reliable than the
the treatment of an existing condition. ‘‘there are demonstrated preventive health benefits estimates set forth in the Religious and
The Guidelines implementing this from contraceptives relating to conditions other Moral IFCs. Even certain commenters
section of the statute are consistent with than pregnancy.’’ 77 FR 8727 & n.7. This was not, that ‘‘strongly oppos[ed]’’ the Religious
that narrow authority. They state however, an assertion that PHS Act 2713(a)(4) or
the Guidelines require coverage of ‘‘contraceptive’’
IFC commented that merely
repeatedly that they apply to methods when prescribed for an exclusively non- ‘‘thousands’’ would be impacted, a
‘‘preventive’’ services or care.76 The contraceptive, non-preventive use. Instead, it was number consistent with the
requirement in the Guidelines an observation that such drugs—generally referred Departments’ estimate of the number of
concerning ‘‘contraception’’ specifies to as ‘‘contraceptives’’—also have some alternate
beneficial uses to treat existing conditions. For the
women who may be affected by the rule.
several times that it encompasses purposes of these final rules, the Departments The Departments’ estimates of the
‘‘contraceptives,’’ that is, medical clarify here that the reference prior to the Religious impact of these final rules are discussed
products, methods, and services applied IFC to the benefits of using contraceptive drugs in more detail in the following section.
for ‘‘contraceptive’’ uses. The exclusively for some non-contraceptive and non-
preventive uses to treat existing conditions did not
Therefore, the Departments conclude
Guidelines do not require coverage of mean that the Guidelines require coverage of such that the estimates of regulatory impact
care and screenings that are non- uses, and consequently is not a reason to refrain made in the Religious IFC are still the
preventive, and the contraception from offering the expanded exemptions provided best estimates available. Our estimates
portion of those Guidelines do not here. Where a drug approved by the FDA for
are discussed in more detail in the
contraceptive use is prescribed for both a

require coverage of medical products, contraceptive use and a non-contraceptive use, the following section.
methods, care, and screenings that are Guidelines (to the extent they apply) would require
non-contraceptive in purpose or use. its coverage for contraceptive use. Where a drug 3. Interaction With State Laws
The Guidelines’ inclusion of approved by the FDA for contraceptive use is Some commenters asked the
prescribed exclusively for a non-contraceptive and
contraceptive services requires coverage non-preventive use to treat an existing condition, it
Departments to discuss the interaction
would be outside the scope of the Guidelines and between these final rules and state laws
76 Id. the contraceptive Mandate. that either require contraceptive
coverage or provide religious contraceptives, nor that the Guidelines economically significant effects ($100
exemptions from those and other must force entities with religious million or more in any one year), and
requirements. Some commenters argued objections to cover contraceptives. an ‘‘economically significant’’
that providing expanded exemptions in regulatory action is subject to review by
IV. Economic Impact and Paperwork
these rules would negate state the Office of Management and Budget
Burden
contraceptive requirements or narrower (OMB). As discussed below regarding
state religious exemptions. Some The Departments have examined the their anticipated effects, the Religious
commenters asked that the Departments impacts of the Religious IFC and the IFC and these rules are not likely to
specify that these exemptions do not final rules as required by Executive have economic impacts of $100 million
apply to plans governed by state laws Order 12866 on Regulatory Planning or more in any one year, and therefore
that require contraceptive coverage. The and Review (September 30, 1993), do not meet the definition of
Department agrees that these rules Executive Order 13563 on Improving ‘‘economically significant’’ under
concern only the applicability of the Regulation and Regulatory Review Executive Order 12866. However, OMB
Federal contraceptive Mandate imposed (January 18, 2011), the Regulatory has determined that the actions are
pursuant to section 2713(a)(4). They do Flexibility Act (RFA) (September 19, significant within the meaning of
not regulate state contraceptive 1980, Pub. L. 96 354), section 1102(b) of section 3(f)(4) of the Executive Order.
mandates or state religious exemptions. the Social Security Act, section 202 of Therefore, OMB has reviewed these
If a plan is exempt under the Religious the Unfunded Mandates Reform Act of final rules, and the Departments have
IFC and these rules, that exemption 1995 (March 22, 1995; Pub. L. 104–4), provided the following assessment of
does not necessarily exempt the plan or Executive Order 13132 on Federalism their impact.
other insurance issuer from state laws (August 4, 1999), the Congressional
that may apply to it. The previous Review Act (5 U.S.C. 804(2)), and 1. Need for Regulatory Action
regulations, which offered exemptions Executive Order 13771 on Reducing These final rules adopt as final and
for houses of worship and integrated Regulation and Controlling Regulatory further change the amendments made
auxiliaries, did not include regulatory Costs (January 30, 2017). by the Religious IFC, which amended
language negating the exemptions in A. Executive Orders 12866 and 13563— the Departments’ July 2015 final
states that require contraceptive Department of HHS and Department of regulations. The Religious IFC and these
coverage, although the Departments Labor final rules expand the exemption from
discussed the issue to some degree in the requirement to provide coverage for
various preambles of those previous Executive Orders 12866 and 13563
contraceptives and sterilization,
regulations. The Departments do not direct agencies to assess all costs and
established under the HRSA Guidelines,
consider it appropriate or necessary in benefits of available regulatory
promulgated under section 2713(a)(4) of
the regulatory text of the religious alternatives and, if regulation is
the PHS Act, section 715(a)(1) of ERISA,
exemptions to declare that the Federal necessary, to select regulatory
and section 9815(a)(1) of the Code, to
contraceptive Mandate will still apply approaches that maximize net benefits
include certain entities and individuals
in states that have a state contraceptive (including potential economic,
with objections to compliance with the
mandate, since these rules do not environmental, and public health and
Mandate based on sincerely held
purport to regulate the applicability of safety effects; distributive impacts; and
religious beliefs, and they revise the
state contraceptive mandates.78 equity). Executive Order 13563
accommodation process to make it
Some commenters observed that, emphasizes the importance of
optional for eligible organizations. The
through ERISA, some entities may avoid quantifying both costs and benefits,
expanded exemption applies to certain
state laws that require contraceptive reducing costs, harmonizing rules, and
individuals and entities that have
coverage by self-insuring. This is a promoting flexibility.
Section 3(f) of Executive Order 12866 religious objections to some (or all) of
result of the application of the the contraceptive and/or sterilization
preemption and savings clauses defines a ‘‘significant regulatory action’’
as an action that is likely to result in a services that would be covered under
contained in ERISA to state insurance the Guidelines. Such action has been
regulation. See 29 U.S.C. 1144(a) & regulation: (1) Having an annual effect
on the economy of $100 million or more taken, among other reasons discussed
(b)(1). These rules cannot change above, to provide for participation in the
statutory ERISA provisions, and do not in any one year, or adversely and
materially affecting a sector of the health insurance market by certain
change the standards applicable to
economy, productivity, competition, entities or individuals, by freeing them
ERISA preemption. To the extent
jobs, the environment, public health or from penalties they could incur if they
Congress has decided that ERISA
safety, or State, local, or tribal follow their sincerely held religious
preemption includes preemption of
governments or communities (also beliefs against contraceptive coverage.
state laws requiring contraceptive
coverage, that decision occurred before referred to as ‘‘economically 2. Anticipated Effects
the ACA and was not negated by the significant’’); (2) creating a serious
a. Removal of Burdens on Religious
ACA. Congress did not mandate in the inconsistency or otherwise interfering
Exercise
ACA that any Guidelines issued under with an action taken or planned by
section 2713(a)(4) must include another agency; (3) materially altering Regarding entities and individuals
the budgetary impacts of entitlement that are extended an exemption by the
78 Some commenters also asked that these final grants, user fees, or loan programs or the Religious IFC and these final rules,
rules specify that exempt entities must comply with rights and obligations of recipients without that exemption the Guidelines
other applicable laws concerning such things as would require many of them to either
notice to plan participants or collective bargaining
thereof; or (4) raising novel legal or
agreements. These final rules relieve the application policy issues arising out of legal pay for coverage of contraceptive
of the Federal contraceptive Mandate under section mandates, the President’s priorities, or services that they find religiously
2713(a)(4) to qualified exempt entities; they do not the principles set forth in the Executive objectionable; submit self-certifications
affect the applicability of other laws. Elsewhere in
this preamble, the Departments provide guidance Order. that would result in their issuer or third
applicable to notices of revocation and changes that A regulatory impact analysis must be party administrator paying for such
an entity may seek to make during its plan year. prepared for major rules with services for their employees, which
some entities also believe entangles burdens for issuers and third party provided coverage for 14 of the 18 FDA-
them in the provision of such administrators due to reductions in use approved women’s contraceptive or
objectionable coverage; or pay tax of the accommodation will more than sterilization methods, 134 S. Ct. at
penalties, or be subject to other adverse offset increased obligations for serving 2766).
consequences, for non-compliance with the fewer number of entities that will • How many women will be covered
these requirements. These final rules now opt into the accommodation. This by plans of entities using their newly
remove certain associated burdens will lead to a net decrease in burdens exempt status.
imposed on these entities and and costs on issuers and third party • Which of the women covered by
individuals—that is, by recognizing administrators, who will no longer have those plans want and would have used
their religious objections to, and continuing obligations imposed on them contraceptive coverage or payments for
exempting them on the basis of such by the accommodation. While these contraceptive methods that are no
objections from, the contraceptive and/ rules make it legal for issuers to offer longer covered by such plans.
or sterilization coverage requirement of insurance coverage that omits • Whether, given the broad
the HRSA Guidelines and making the contraceptives to exempt entities and availability of contraceptives and their
accommodation process optional for individuals, these final rules do not relatively low cost, such women will
eligible organizations. require issuers to do so. obtain and use contraception even if it
The Departments anticipate that the is not covered.
b. Notices When Revoking • The degree to which such women
effect of these rules on adjustments
Accommodated Status are in the category of women identified
made to the federally facilitated
To the extent that entities choose to Exchange user fees under 45 CFR 156.50 by IOM as most at risk of unintended
revoke their accommodated status to will be that fewer overall adjustments pregnancy.
make use of the expanded exemption, a will be made using the accommodation • The degree to which unintended
notice will need to be sent to enrollees process, because there will be more pregnancies may result among those
(either by the objecting entity or by the entities who previously were reluctant women, which would be attributable as
issuer or third party administrator) that users of the accommodation that will an effect of these rules only if the
their contraceptive coverage is choose to operate under the newly women did not otherwise use
changing, and guidance will reflect that expanded exemption than there will be contraception or a particular
such a notice requirement is imposed no entities not previously eligible to use contraceptive method due to their plan
more than is already required by the accommodation that will opt into it. making use of its newly exempt status.
preexisting rules that require notices to The Departments’ estimates of each • The degree to which such
be sent to enrollees of changes to number of those entities is set forth in unintended pregnancies may be
coverage during a plan year. If the more detail below. associated with negative health effects,
entities wait until the start of their next or whether such effects may be offset by
plan year to change to exempt status, d. Impacts on Persons Covered by other factors, such as the fact that those
instead of doing so during the current Newly Exempt Plans women will be otherwise enrolled in
plan year, those entities generally will These final rules will result in some insurance coverage.
also be able to avoid sending any persons covered in plans of newly • The extent to which such women
supplementary notices in addition to exempt entities not receiving coverage will qualify for alternative sources of
what they would otherwise normally or payments for contraceptive services. contraceptive access, such as through a
send prior to the start of a new plan As discussed in the Religious IFC, the parent’s or spouse’s plan, or through
year. Additionally, these final rules Departments did not have sufficient one of the many governmental programs
provide such entities with an offsetting data on a variety of relevant factors to that subsidize contraceptive coverage to
regulatory benefit by the exemption precisely estimate how many women supplement their access.
itself and its relief of burdens on their would be impacted by the expanded ii. Public Comments Concerning
religious beliefs. As discussed below, exemptions or any related costs they Estimates in Religious IFC
assuming that more than half of the may incur for contraceptive coverage or
entities that have been using the the results associated with any In the public comments, some
previous accommodation will seek unintended pregnancies. commenters agreed with the
immediate revocation of their Departments’ estimate that, at most, the
accommodated status and notices will i. Unknown Factors Concerning Impact economic impact would lead to a
be sent to all their enrollees, the total on Persons in Newly Exempt Plans potential transfer cost, from employers
estimated cost of sending those notices As referenced above and for reasons (or other plan sponsors) to affected
will be $302,036. explained here, there are multiple levels women, of $63.8 million. Some
of uncertainty involved in measuring commenters said the impact would be
c. Impacts on Third Party much smaller. Other commenters
Administrators and Issuers the effect of the expanded exemption,
including but not limited to— disagreed, suggesting that the expanded
The Departments estimate that these • How many entities will make use of exemptions risked removing
final rules will not result in any their newly exempt status. contraceptive coverage from more than
additional burdens or costs on issuers or • How many entities will opt into the 55 million women receiving the benefits
third party administrators. As discussed accommodation maintained by these of the preventive services Guidelines, or
below, the Departments believe that 109 rules, under which their plan even risked removing contraceptive
of the 209 entities making use of the participants will continue receiving coverage from over 100 million women.
accommodation process will instead contraceptive coverage. Some commenters cited studies
make use of their new exempt status. In • Which contraceptive methods some indicating that, nationally, unintended
contrast, the Departments expect that a newly exempt entities will continue to pregnancies have large public costs, and
much smaller number (which we provide without cost-sharing despite the the Mandate overall led to large out-of-
assume to be 9) will make use of the entity objecting to other methods (for pocket savings for women.
accommodation to which they were not example, as reflected in Hobby Lobby, These general comments do not,
previously provided access. Reduced several objecting entities have still however, substantially assist us in
estimating how many women would be cases will cover 14 of 18 FDA-approved contraceptive user fees adjustments, in
affected by these expanded exemptions women’s contraceptive and sterilization the 2015 plan year, to obtain
specifically, or among them, how many methods.79 See Hobby Lobby, 134 S. Ct. reimbursement for contraceptive service
unintended pregnancies would result, at 2766. The effects of the expanded payments made for coverage of such
or how many of the affected women exemptions will be mitigated to that services for women covered by self-
would nevertheless use contraceptives extent. No publicly traded for-profit insured plans that were accommodated.
not covered under the health plans of entities sued challenging the Mandate, Overall, while recognizing the limited
their objecting employers and, thus, be and the public comments did not reveal data available, the Departments
subject to the transfer costs the any that specifically would seek to use assumed that, under an expanded
Departments estimate, or instead, how the expanded exemptions. exemption and accommodation,
many women might avoid unintended Consequently, the Departments agree approximately 109 previously
pregnancies by changing their activities with the estimate from the Religious IFC accommodated entities would use an
in other ways besides using that publicly traded companies would expanded exemption, and about 100
contraceptives. The Departments not likely make use of these expanded would continue their accommodated
conclude, therefore, that our estimates exemptions. status. We also estimated that another 9
of the anticipated effect in the Religious Fourth, HHS previously estimated entities would use the accommodation
IFC are still the best estimates we have that 209 entities would make use of the where the entities were not previously
based on the limited data available to accommodation process. To arrive at eligible to do so.
make those estimates. We do not believe this number, the Departments used, as These sources of information were
that the higher estimates submitted by a placeholder, the approximately 122 outlined in the Religious IFC. Some
various public commenters sufficiently nonprofit entities that brought litigation commenters agreed with the
took into consideration, or analyzed, the challenging the accommodation process, Departments’ estimates based on those
various factors that suggest the small and the approximately 87 closely held sources, and while others disagreed, the
percentage of entities that will now use for-profit entities that filed suit Departments conclude that commenters
the expanded exemptions out of the challenging the Mandate in general. The did not provide information that allows
large number of entities subject to the Departments’ records indicate, as noted us to make better estimates.
Mandate overall. Instead, the in the Religious IFC, that approximately iv. Estimates Based on Litigating
Departments agree with various public 63 entities affirmatively submitted Entities That May Use Expanded
commenters providing comment and notices to HHS to use the Exemptions
analysis that, for a variety of reasons, accommodation,80 and approximately
the best estimate of the impact of the Based on these and other factors, the
60 plans took advantage of the
expanded exemptions finalized in these Departments considered two approaches
rules is that most women receiving 79 By reference to the FDA Birth Control Guide’s
in the Religious IFC to estimate the
contraceptive coverage under the list of 18 birth control methods for women and 2 number of women affected among
Mandate will not be affected. We agree for men, https://www.fda.gov/downloads/ entities using the expanded exemptions.
with such commenters that the number forconsumers/byaudience/forwomen/ First, following the use in previous
freepublications/ucm517406.pdf, Hobby Lobby and regulations of litigating entities to
of women covered by entities likely to entities with similar beliefs were not willing to
make use of the expanded exemptions cover: IUD copper; IUD with progestin; emergency estimate the effect of the exemption and
in these rules is likely to be very small contraceptive (Levonorgestrel); and emergency accommodation, the Departments
in comparison to the overall number of contraceptive (Ulipristal Acetate). See 134 S. Ct. at attempted to estimate the number of
2765–66. Hobby Lobby was willing to cover: women covered by plans of litigating
women receiving contraceptive coverage sterilization surgery for women; sterilization
as a result of the Mandate. implant for women; implantable rod; shot/injection; entities that could be affected by
oral contraceptives (‘‘the Pill’’—combined pill); oral expanded exemptions. Based on papers
iii. Possible Sources of Information for contraceptives (‘‘the Pill’’—extended/continuous filed in litigation, and public sources,
Estimating Impact use/combined pill); oral contraceptives (‘‘the Mini the Departments estimated in the
Pill’’—progestin only); patch; vaginal contraceptive
The Departments have access to the ring; diaphragm with spermicide; sponge with
Religious IFC that approximately 8,700
following general sources of information spermicide; cervical cap with spermicide; female women of childbearing age could have
that are relevant to this issue, but these condom; spermicide alone. Id. Among women using their contraception costs affected by
sources do not provide a full picture of these 18 female contraceptive methods, 85 percent plans of litigating entities using these
use the 14 methods that Hobby Lobby and entities
the impact of these final rules. First, the with similar beliefs were willing to cover
expanded exemptions. The Departments
regulations prior to the Religious IFC (22,446,000 out of 26,436,000), and ‘‘[t]he pill and believe that number is lower based upon
already exempted certain houses of female sterilization have been the two most the receipt, by many of those litigating
worship and their integrated auxiliaries commonly used methods since 1982.’’ See entities, of permanent injunctions
Guttmacher Institute, ‘‘Contraceptive Use in the against the enforcement of section
and, as explained elsewhere, effectively United States’’ (Sept. 2016), https://
did not apply contraceptive coverage www.guttmacher.org/fact-sheet/contraceptive-use- 2713(a)(4) to the extent it supports a
requirements to various entities in self- united-states. contraceptive Mandate, which have
insured church plans. The effect of 80 This includes some fully insured and some been entered by federal district courts
those previous exemptions or self-insured plans, but it does not include entities since the issuance of the Religious
that may have used the accommodation by
limitations are not included as effects of submitting an EBSA form 700 self-certification
IFC.81 As a result, these final rules will
these rules, which leave those impacts directly to their issuer or third party administrator. not affect whether such entities will be
in place. Second, in the Departments’ In addition, the Departments have deemed some subject to the contraceptive Mandate.
previous regulations creating or other entities as being subject to the Subtracting those entities from the total,
accommodation through their litigation filings, but the Departments estimate that the
expanding exemptions and the that might not have led to contraceptive coverage
accommodation process we concluded being provided to persons covered in some of those remaining litigating entities employ
that no significant burden or costs plans, either because they are exempt as houses of
would result. 76 FR 46625; 78 FR 39889. worship or integrated auxiliaries, they are in self- 81 See, for example, Catholic Benefits Ass’n LCA
insured church plans, or the Departments were not v. Hargan, No. 5:14–cv–00240–R (W.D. Okla. order
Third, some entities, including some aware of their issuers or third party administrators filed Mar. 7, 2018), and Dordt Coll. v. Burwell, No.
for-profit entities, object to only some so as to send them letters obligating them to provide 5:13–cv–04100 (N.D. Iowa order filed June 12,
but not all contraceptives, and in some such coverage. 2018).
approximately 49,000 persons, male and referenced above, that 43.6 percent of adjustments. Where the issuers seeking
female. The average percent of workers such women use contraception covered adjustments are separate from the TPAs,
at firms offering health benefits that are by the Guidelines, the Departments the TPAs are asked to report the number
actually covered by those benefits is 60 estimate that 1,150 of those women of persons covered by those plans. Some
percent.82 This amounts to would be affected by these final rules. users do not enter all the requested data,
approximately 29,000 employees Together, this leads the Departments and not all the data for the 2017 plan
covered under those plans. EBSA to estimate that approximately 6,400 year is complete. Nevertheless, HHS has
estimates that for each employee women of childbearing age may have reviewed the user fees adjustment data
policyholder, there is approximately their contraception costs affected by received for the 2017 plan year. HHS’s
one dependent.83 This amounts to plans of litigating entities using these best estimate from the data is that there
approximately 58,000 covered persons. expanded exemptions. As noted were $38.4 million in contraception
Census data indicate that women of previously, the Departments do not have claims sought as the basis for user fees
childbearing age—that is, women aged data indicating how many of those adjustments for plans, and that these
15 to 44—compose 20.2 percent of the women agree with their employers’ or claims were for plans covering
general population.84 Furthermore, educational institutions’ opposition to approximately 1,823,000 plan
approximately 43.6 percent of women of contraception (so that fewer of them participants and beneficiaries of all
childbearing age use women’s than the national average might actually ages, male and female.
contraceptive methods covered by the use contraception). Nor do the This number fluctuates from year to
Guidelines.85 Therefore, the Departments know how many would year. It is larger than the estimate used
Departments estimate that have alternative contraceptive access in the Religious IFC because, on closer
approximately 5,200 women of from a parent’s or spouse’s plan, or from examination of the data, this number
childbearing age that use contraception federal, state, or local governmental better accounts for plans where TPAs
covered by the Guidelines are covered programs, nor how many of those were also issuers seeking user fees
by employer sponsored plans of entities women would fall in the category of adjustments, in addition to plans where
that might be affected by these final being most at risk of unintended the TPA is separate from the issuer
rules. The Departments also estimate pregnancy, nor how many of those seeking user fees adjustments. The
that, for the educational institutions that entities would provide some number of employers using the
brought litigation challenges objecting contraception in their plans while only accommodation where user fees
to the Mandate as applied to student objecting to certain contraceptives. adjustments were sought cannot be
coverage that they arranged—where (1) determined from HHS data, because not
the institutions were not exempt under v. Estimates of Accommodated Entities
all users are required to submit that
the prior rule, (2) their student plans That May Use Expanded Exemptions
information, and HHS does not
were not self-insured, and (3) they have In the Religious IFC, the Departments necessarily receive information about
not received permanent injunctions also examined data concerning user-fee fully insured plans using the
preventing the application of the reductions to estimate how many accommodation. Therefore, the
previous regulations—such student women might be affected by entities that Departments still consider our previous
plans likely covered approximately are using the accommodation and estimate of 209 entities using the
2,600 students. Thus, the Departments would use the expanded exemptions accommodation as the best estimate
estimate the female members of those under these final rules. Under the available.
plans is 2,600 women.86 Assuming, as accommodation, HHS has received As noted in the Religious IFC, HHS’s
information from issuers that seek user information indicates that religious
82 See Kaiser Family Foundation and Health
Research and Educational Trust, ‘‘Employer Health

fees adjustments under 45 CFR nonprofit hospitals or health systems
Benefits: 2018 Annual Survey’’ at 62, available at 156.50(d)(3)(ii), for providing sponsored a significant minority of the
http://files.kff.org/attachment/Report-Employer- contraceptive payments for self-insured accommodated self-insured plans that
Health-Benefits-Annual-Survey-2018. plans that make use of the were using contraceptive user fees
83 Employee Benefits Security Administration,
accommodation. HHS receives requests adjustments, yet those plans covered
‘‘Health Insurance Coverage Bulletin’’ Table 4, page
21. Using Data for the March 2016 Annual Social for fees adjustments both where Third more than 80 percent of the persons
and Economic Supplement to the Current Party Administrators (TPAs) for those covered in all plans using contraceptive
Population Survey. https://www.dol.gov/sites/ self-insured accommodated plans are user fees adjustments. Some of those
default/files/ebsa/researchers/data/health-and- themselves issuers, and where the TPAs
welfare/health-insurance-coverage-bulletin-
plans cover nearly tens of thousands of
2016.pdf. use separate issuers to provide the persons each and are proportionately
84 United States Census Bureau, ‘‘Age and Sex payments and those issuers seek fees much larger than the plans provided by
Composition: 2010’’ (May 2011), available at other entities using the contraceptive
https://www.census.gov/prod/cen2010/briefs/ female. For the purposes of this estimate, we also user fees adjustments.
c2010br-03.pdf. The Guidelines’ requirement of assume that female policyholders covered by plans
contraceptive coverage only applies ‘‘for all women The Departments continue to believe
arranged by institutions of higher education are
with reproductive capacity.’’ https://www.hrsa.gov/ women of childbearing age. The Departments that a significant fraction of the persons
womensguidelines/; also, see 80 FR 40318. In expect that they would have less than the average covered by previously accommodated
addition, studies commonly consider the 15–44 age number of dependents per policyholder than exists plans provided by religious nonprofit
range to assess contraceptive use by women of in standard plans, but for the purposes of providing
childbearing age. See, for example, Guttmacher hospitals or health systems may not be
an upper bound to this estimate, the Departments
Institute, ‘‘Contraceptive Use in the United States’’ assume that they would have an average of one affected by the expanded exemption. A
(Sept. 2016), available at https:// dependent per policyholder, thus bringing the broad range of religious hospitals or
www.guttmacher.org/fact-sheet/contraceptive-use- number of policyholders and dependents back up health systems have publicly indicated
united-states. to 2,6,00. Many of those dependents are likely not
85 See https://www.guttmacher.org/fact-sheet/ that they do not conscientiously oppose
to be women of childbearing age, but in order to
contraceptive-use-united-states (reporting that of provide an upper bound to this estimate, the participating in the accommodation.87
61,491,766 women aged 15–44, 26,809,5550 use Departments assume they are. Therefore, for the
women’s contraceptive methods covered by the purposes of this estimate, the Departments assume 87 See, e.g., https://www.chausa.org/newsroom/
Guidelines). that the effect of these expanded exemptions on women%27s-preventive-health-services-final-rule
86 On average, the Departments expect that student plans of litigating entities includes 2,600 (‘‘HHS has now established an accommodation that
approximately half of those students (1,300) are women. will allow our ministries to continue offering health
Of course, some of these religious vi. Combined Estimates of Litigating and plans using the accommodation under
hospitals or health systems may opt for Accommodated Entities the previous regulations.
the expanded exemption under these Considering all these data points and Although recognizing the limited data
final rules, but others might not. In limitations, the Departments offer the available for our estimates, the
addition, among plans of religious following estimate of the number of Departments estimate that 100 of the
nonprofit hospitals or health systems, women who will be impacted by the 209 entities that were using the
some have indicated that they might be expanded exemption in these final accommodation under the previous
eligible for status as a self-insured rules. In addition to the estimate of regulations will continue to opt into it
church plan.88 As discussed above, 6,400 women of childbearing age that under these final rules and that those
some litigants challenging the Mandate use contraception covered by the entities will cover the substantial
have appeared, after their complaints Guidelines, who will be affected by use majority of persons previously covered
were filed, to make use of self-insured of the expanded exemption among in accommodated plans. The data
church plan status.89 (The Departments litigating entities, the Departments concerning accommodated self-insured
take no view on the status of these calculate the following number of plans indicates that plans sponsored by
particular plans under the Employee women who we estimate to be affected religious hospitals and health systems
Retirement Income Security Act of 1974 by accommodated entities using the and other entities likely to continue
(ERISA), but simply make this expanded exemption. As noted above, using the accommodation constitute
observation for the purpose of seeking to approximately 1,823,000 plan over 60 percent of plans using the
estimate the impact of these final rules.) participants and beneficiaries were accommodation, and encompass more
Nevertheless, considering all these covered by self-insured plans that than 90 percent of the persons covered
factors, it generally seems likely that received contraceptive user fee in accommodated plans.91 In other
adjustments in 2017. Although words, plans sponsored by such entities
many of the remaining religious hospital
additional self-insured entities may appear to be a majority of plans using
or health systems plans previously
have participated in the accommodation the accommodation, and also have a
using the accommodation will continue
without making use of contraceptive proportionately larger number of
to opt into the voluntary user fees adjustments, the Departments covered persons than do plans
accommodation under these final rules, do not know what number of entities sponsored by other accommodated
under which their employees will still did so. We consider it likely that self- entities, which have smaller numbers of
receive contraceptive coverage. To the insured entities with relatively larger covered persons. Moreover, as cited
extent that plans of religious hospitals numbers of covered persons had above, many religious hospitals and
or health systems are able to make use sufficient financial incentive to make health systems have indicated that they
of self-insured church plan status, the use of the contraceptive user fees do not object to the accommodation,
previous accommodation rule would adjustments. Therefore, without better and some of those entities might also
already have allowed them to relieve data available, the Departments assume qualify as self-insured church plans, so
themselves and their third party that the number of persons covered by that these final rules would not impact
administrators of obligations to provide self-insured plans using contraceptive the contraceptive coverage their
contraceptive coverage or payments. user fees adjustments approximates the employees receive.
Therefore, in such situations, the number of persons covered by all self- The Departments do not have specific
Religious IFC and these final rules insured plans using the accommodation. data on which plans of which sizes will
would not have an anticipated effect on An additional but unknown number actually continue to opt into the
the contraceptive coverage of women in of persons were likely covered in fully accommodation, nor how many will
those plans. insured plans using the accommodation. make use of self-insured church plan
The Departments do not have data on status. The Departments assume that the
insurance plans for their employees as they have how many fully insured plans have proportions of covered persons in self-
always done. . . . We are pleased that our been using the accommodation, nor on insured plans using contraceptive user
members now have an accommodation that will not how many persons were covered by fees adjustments also apply in fully
require them to contract, provide, pay or refer for those plans. DOL estimates that, among insured plans, for which the
contraceptive coverage. . . . We will work with our persons covered by employer-sponsored
members to implement this accommodation.’’). In Departments lack representative data.
insurance in the private sector, 62.7 Based on these assumptions and
comments submitted in previous rules concerning
this Mandate, the Catholic Health Association has
percent are covered by self-insured without better data available, the
stated it ‘‘is the national leadership organization for plans and 37.3 percent are covered by Departments assume that the 100
the Catholic health ministry, consisting of more fully insured plans.90 Therefore, accommodated entities that will remain
than 2,000 Catholic health care sponsors, systems, corresponding to the approximately in the accommodation will account for
hospitals, long-term care facilities, and related 1,823,000 persons covered by self-
organizations. Our ministry is represented in all 50
75 percent of all the persons previously
insured plans using user fee covered in accommodated plans. In
states and the District of Columbia.’’ Comments on
CMS–9968–ANPRM (dated June 15, 2012).
adjustments, we estimate an additional comparison, the Departments assume
88 See, for example, Brief of the Catholic Health 1,084,000 persons were covered by fully the 109 accommodated entities that will
Association of the United States as Amicus Curiae insured plans using the accommodation. make use of the expanded exemption
in Support of Petitioners, Advocate Health Care This yields approximately 2,907,000 will encompass 25 percent of persons
Network, Nos. 16–74, 16–86, 16–258, 2017 WL persons of all ages and sexes whom the
371934 at *1 (U.S. filed Jan. 24, 2017) (‘‘CHA Departments estimate were covered in
91 The data also reflects a religious university

members have relied for decades that the ‘church
plan’ exemption contained in’’ ERISA.). using the accommodation that has publicly affirmed
90 ‘‘Health Insurance Coverage Bulletin’’ Table the accommodation is consistent with its religious
89 See https://www.franciscanhealth.org/sites/
3A, page 14. Using Data for the March 2016 Annual views, and two houses of worship that are using the
default/files/ Social and Economic Supplement to the Current accommodation despite already qualifying for the
2015%20employee%20benefit%20booklet.pdf; see, Population Survey. https://www.dol.gov/sites/ previous exemption. We assume for the purposes of
for example, Roman Catholic Archdiocese of N.Y. default/files/ebsa/researchers/data/health-and- this estimate these three entities will also continue
v. Sebelius, 987 F. Supp. 2d 232, 242 (E.D.N.Y. welfare/health-insurance-coverage-bulletin- using the accommodation instead of the expanded
2013). 2016.pdf. exemption.
previously covered in accommodated 1,823,000 persons. Among those preventive services coverage under the
plans. persons, as cited above, approximately Affordable Care Act.93 The Religious
Applying these percentages to the 20.2 percent on average were women of IFC used this estimate in this second
estimated 2,907,000 persons covered in childbearing age, and of those, analysis of the possible impact of the
previously accommodated plans, the approximately 43.6 percent use expanded exemptions in the interim
Departments estimate that women’s contraceptive methods final rules. ASPE has not issued an
approximately 727,000 persons will be covered by the Guidelines. This update to its report. Some commenters
covered in the 109 plans that use the amounts to approximately 161,000 noted that a private organization
expanded exemption, and 2,180,000 women. Therefore, entities using published a fact sheet in 2017 claiming
persons will be covered in the estimated contraceptive user fees adjustments to make similar estimates based on more
100 plans that continue to use the received approximately $239 per year recent data, in which it estimated that
accommodation. According to the per woman of childbearing age that used 62.4 million aged 15 to 64 were covered
Census data cited above, women of contraception covered by the Guidelines by private insurance had preventive
childbearing age comprise 20.2 percent and covered in their plans. But in the services coverage under the Affordable
of the population, which means that Religious IFC, we estimated that the Care Act.94 The primary difference
approximately 147,000 women of average annual cost of contraception per between these numbers appears to be a
childbearing age are covered in woman per year is $584. As noted change in the number of persons
previously accommodated plans that the above, public commenters cited similar covered by grandfathered plans.
Departments estimate will use the estimates of the annual cost of various The methodology of both reports do
expanded exemption. As noted above, contraceptive methods, if calculated for not fully correspond to the number the
approximately 43.6 percent of women of the life of the method’s effectiveness. Departments seek to estimate here for
childbearing age use women’s Therefore, to estimate the annual the purposes of Executive Orders 12866
contraceptive methods covered by the transfer effects of these final rules, the and 13563. These final rules will not
Guidelines, so that the Departments Departments will continue to use the affect all women aged 15 to 64 who are
expect approximately 64,000 women estimate of $584 per woman per year. covered by private insurance and have
that use contraception covered by the With an estimated impact of these final coverage of preventive services under
Guidelines will be affected by rules of 70,500 women per year, the the Affordable Care Act. This is partly
accommodated entities using the financial transfer effects attributable to because the Departments do not have
expanded exemption. these final rules on those women would evidence to suggest that most employers
It is not clear the extent to which this be approximately $41.2 million. will have sincerely held religious
number overlaps with the number Some commenters suggested that the objections to contraceptive coverage and
estimated above of 6,400 women in Departments’ estimate of women will use the expanded exemptions. In
plans of litigating entities that may be affected among litigating entities was addition, both reports include women
affected by these rules. In order to more too low, but they did not support their covered by plans that are not likely
broadly estimate the possible effects of proposed higher numbers with citations affected by the expanded exemptions for
these rules, the Departments assume or specific data that could be verified as other reasons. For example, even though
there is no overlap between the two more reliable than the estimates in the the estimates in those reports do not
numbers, and therefore that these final Religious IFC. Their estimates appeared include enrollees in public plans such
rules would affect the contraceptive to be overinclusive, for example, by as Medicare or Medicaid, they do
costs of approximately 70,500 women. counting all litigating entities and not
include enrollees in plans obtained on
Under the assumptions just discussed, just those that may be affected by these
the health insurance marketplaces,
the number of women whose rules because they are not in church
purchased in the individual market,
contraceptive costs will be impacted by plans, or by counting all plan
obtained by self-employed persons, or
the expanded exemption in these final participants and not just women of
offered by government employers.
rules is approximately 0.1 percent of the childbearing age that use contraception.
Women who purchase plans in the
55.6 million women in private plans Moreover, since the Religious IFC was
marketplaces, the individual market, or
that HHS’s Office of the Assistant issued, additional entities have received
as self-employed persons are not
Secretary for Planning and Evaluation permanent injunctions against
required to use the exemptions in these
(ASPE) estimated in 2015 received enforcement of any regulations
rules. Government employers are also
preventive services coverage under the implementing the contraceptive
not affected by the exemptions in these
Guidelines. Mandate and so will not be affected by
rules.
In order to estimate the cost of these final rules. Taking all of these
In response to public comments citing
contraception to women affected by the factors into account, the Departments
the more recent report, the Departments
expanded exemption, the Departments are not aware of a better method of
offer the following estimates based on
are aware that, under the previous estimating the number of women
more recent data than used in the
accommodation process, the total affected by these expanded exemptions.
Religious IFC. Data from the U.S.
amount of contraceptive claims sought vii. Alternate Estimates Based on Census Bureau indicates that 167.6
for self-insured plans for the 2017 Consideration of Pre-ACA Plans million individuals, male and female,
benefit year was $38.5 million.92 These To account for uncertainty in the under 65 years of age, were covered by
adjustments covered the cost of estimates above, the Departments
contraceptive coverage provided to conducted a second analysis using an
93 Available at https://aspe.hhs.gov/system/files/
women. As also discussed above, the pdf/139221/The%20Affordable

alternative framework, in order to %20Care%20Act%20is%20Improving%20
Departments estimate that amount thoroughly consider the possible upper Access%20to%20Preventive%20Services%20
corresponded to plans covering bound economic impact of these final for%20Millions%20of%20Americans.pdf.
94 The commenters cited the National Women’s
92 The amount of user fees adjustments provided
rules.
Law Center’s Fact Sheet from September 2017,
was higher than this, since an additional
In 2015, ASPE estimated that 55.6 available at https://nwlc-ciw49tixgw5lbab.
administrative amount was added to the amount of million women aged 15 to 64 were stackpathdns.com/wp-content/uploads/2017/09/
contraceptive costs claimed. covered by private insurance had New-Preventive-Services-Estimates-3.pdf.
employment-based insurance in 2017.95 from private sector insurance from a women of childbearing age that use
Of those, 50.1 percent were female, that third party employer plan sponsor. contraceptives covered by the
is, 84 million.96 The most recent Health The Kaiser Family Foundation’s Guidelines were covered by plans that
Insurance Coverage Bulletin from EBSA Employer Health Benefits Annual omitted contraceptive coverage prior to
states that, within employer-sponsored Survey 2018 states that 16% of covered the Affordable Care Act.103
insurance, 76.5% are covered by private workers at all firms are enrolled in a It is unknown what motivated those
sector employers.97 As noted above, plan grandfathered under the ACA (and employers to omit contraceptive
these expanded exemptions do not thus not subject to the preventive coverage—whether they did so for
apply to public sector employers. services coverage requirements), but religious or other reasons. Despite the
Assuming the same percentage applies that only 14% of workers receiving lack of information about their motives,
to the Census data for 2017, 64.2 million coverage from state and local the Departments attempt to make a
women under 65 years of age were government employer plans are in reasonable estimate of the upper bound
covered by private sector employment grandfathered plans.99 Using the data of the number of those employers that
based insurance. EBSA’s bulletin also cited above in EBSA’s bulletin omitted contraception before the
states that, among those covered by concerning the number of persons Affordable Care Act and that would
private sector employer sponsored covered in public and private sector make use of these expanded exemptions
insurance, 5% receive health insurance employer sponsored insurance, this based on sincerely held religious beliefs.
coverage from a different primary suggests 16.6% of persons covered by To begin, the Departments estimate
source.98 We assume for the purposes of private sector employer sponsored plans that publicly traded companies would
this estimate that an exemption claimed are in grandfathered plans, and 83.4% not likely make use of these expanded
by an employer under these rules need in non-grandfathered plans.100 Applying exemptions. Even though the rule does
not affect contraceptive coverage of a this percentage to the Census data, 49 not preclude publicly traded companies
person who receives health insurance million women under 65 years of age from dropping coverage based on a
coverage from a different primary received primary health insurance sincerely held religious belief, it is
source. Again assuming this percentage coverage from private sector, third party likely that attempts to object on
applies to the 2017 coverage year, we employment-based, non-grandfathered religious grounds by publicly traded
estimate that 61 million women under plans. Census data indicates that among companies would be rare. The
65 years of age received primary health women under age 65, 46.7% are of Departments take note of the Supreme
coverage from private sector, childbearing age (aged 15 to 44).101 Court’s decision in Hobby Lobby, where
employment-based insurance. In Therefore, we estimate that 22.9 million the Court observed that ‘‘HHS has not
conducting this analysis, the women aged 15–44 received primary pointed to any example of a publicly
Departments also observed that for 3.8 health insurance coverage from private traded corporation asserting RFRA
percent of those covered by private sector, third party employment based, rights, and numerous practical restraints
sector employment sponsored non-grandfathered insurance plans. would likely prevent that from
insurance, the plan was purchased by a Prior to the implementation of the occurring. For example, the idea that
self-employed person, not by a third Affordable Care Act, approximately 6 unrelated shareholders—including
party employer. Self-employed persons percent of employer survey respondents institutional investors with their own
who direct firms are not required to use did not offer contraceptive coverage, set of stakeholders—would agree to run
the exemptions in these final rules, but with 31 percent of respondents not a corporation under the same religious
if they do, they would not be losing knowing whether they offered such beliefs seems improbable.’’ 134 S. Ct. at
contraceptive coverage that they want to coverage.102 The 6 percent may have 2774. The Departments are aware of
have, since they would be using the included approximately 1.37 million of several federal health care conscience
exemption based on their sincerely held the women aged 15 to 44 primarily
religious beliefs. If those persons have covered by employer-sponsored 103 Some of the 31 percent of survey respondents
insurance plans in the private sector. that did not know about contraceptive coverage
employees, the employees would be may not have offered such coverage. If it were
included in this estimate in the number And as noted above, approximately 43.6 possible to account for this non-coverage, the
of people who receive employer percent of women of childbearing age estimate of potentially affected covered women
sponsored insurance from a third party. use women’s contraceptive methods could increase. On the other hand, these employers’
covered by the Guidelines. Therefore, lack of knowledge about contraceptive coverage
Assuming this percentage applies to the suggests that they lacked sincerely held religious
2017 coverage year, we estimate that the Departments estimate that 599,000 beliefs specifically objecting to such coverage—
58.7 million women under 65 years of beliefs without which they would not qualify for
99 ‘‘Employer Health Benefits: 2018 Annual
age received primary health coverage the expanded exemptions offered by these final
Survey’’ at 211, available at http://files.kff.org/ rules. In that case, omission of such employers and
attachment/Report-Employer-Health-Benefits- covered women from this estimation approach
95 See U.S. Census Bureau Current Population
Annual-Survey-2018. would be appropriate. Correspondingly, the 6
Survey Table HI–01, ‘‘Health Insurance Coverage in 100 EBSA’s bulletin shows 168.7 million persons percent of employers that had direct knowledge
2017: All Races,’’ available at https:// with primary coverage from employer sponsored about the absence of coverage may be more likely
www2.census.gov/programs-surveys/cps/tables/hi- insurance, with 131.6 million in the private sector to have omitted such coverage on the basis of
01/2018/hi01_1.xls. and 37.1 million in the public sector. 16% of 168.7 religious beliefs than were the 31 percent of survey
96 Id.
million is 26.9 million. 14% of 37.1 million is 5.2 respondents who did not know whether the
97 Table 1A, page 5 (stating that in coverage year million. 26.9 million ¥ 5.2 million is 21.8 million, coverage was offered. Yet an entity’s mere
2015, 177.5 million persons of all ages were covered which is 16.6% of the 131.6 million persons with knowledge about its coverage status does not itself
by employer sponsored insurance, with 135.7 primary coverage from private sector employer reflect its motive for omitting coverage. In
million of those being covered by private sector sponsored insurance. responding to the survey, the entity may have
employers), available at https://www.dol.gov/sites/ 101 U.S. Census Bureau, Table S0101 ‘‘Age and simply examined its plan document to determine
default/files/ebsa/researchers/data/health-and- Sex’’ (available at https://data.census.gov/cedsci/ whether or not contraceptive coverage was offered.
welfare/health-insurance-coverage-bulletin- results/tables?q=S0101:%20AGE%20 As will be relevant in a later portion of the analysis,
2016.pdf. AND%20SEX&ps=table*currentPage@1). we have no data indicating what portion of the
98 Id. at Table 1C, page 8 (168.7 million persons 102 Kaiser Family Foundation & Health Research entities that omitted contraceptive coverage pre-
received health insurance coverage from employer & Educational Trust, ‘‘Employer Health Benefits, Affordable Care Act did so on the basis of sincerely
sponsored insurance as their primary source, 2010 Annual Survey’’ at 196, available at https:// held religious beliefs, as opposed to doing so for
compared to 177.5 million persons covered by kaiserfamilyfoundation.files.wordpress.com/2013/ other reasons that would not qualify them for the
employer sponsored insurance overall). 04/8085.pdf. expanded exemption offered in these final rules.
laws 104 that in some cases have existed dioceses,107 5,224 Catholic elementary the private, non-publicly traded
for decades and that protect companies, schools, and 1,205 Catholic secondary employers that did not cover
including publicly traded companies, schools.108 Not all Catholic schools are contraception pre-Affordable Care Act,
from discrimination if, for example, integrated auxiliaries of Catholic and that were not exempt by the
they decline to facilitate abortion, but churches, but there are other Catholic previous regulations nor were
the Departments are not aware of entities that are integrated auxiliaries participants in self-insured church
examples where publicly traded that are not schools, so the Departments plans that oppose contraceptive
companies have made use of these use the number of schools as an coverage, covered approximately
exemptions. Thus, while the estimate of the number of integrated 379,000 women aged 15 to 44 that use
Departments consider it important to auxiliaries. Among self-insured church contraceptives covered by the
include publicly traded companies in plans that oppose the Mandate, the Guidelines. But to estimate the likely
the scope of these expanded exemptions Department has been sued by two— actual transfer impact of these final
for reasons similar to those reasons used Guidestone and Christian Brothers. rules, the Departments must estimate
by the Congress in RFRA and some Guidestone is a plan organized by the not just the number of such women
health care conscience laws, in Southern Baptist convention covering covered by those entities, but how many
estimating the anticipated effects of the 38,000 employers, some of which are of those entities would actually qualify
expanded exemptions, the Departments exempt as churches or integrated for, and use, the expanded exemptions.
agree with the Supreme Court that it is auxiliaries, and some of which are The Departments do not have data
improbable any will do so. not.109 Christian Brothers is a plan that indicating how many of the entities that
This assumption is significant covers Catholic organizations including omitted coverage of contraception pre-
because 31.3 percent of employees in Catholic churches and integrated Affordable Care Act did so on the basis
the private sector work for publicly auxiliaries, which are estimated above, of sincerely held religious beliefs that
traded companies.105 That means that but has also said in litigation that it might qualify them for exempt status
only approximately 411,000 women covers about 500 additional entities that under these final rules, as opposed to
aged 15 to 44 that use contraceptives are not exempt as churches.110 In total, having done so for other reasons.
covered by the Guidelines were covered therefore, without having certain data Besides the entities that filed lawsuits or
by plans of non-publicly traded on the number of entities exempt under submitted public comments concerning
companies that did not provide the previous rules, the Departments previous regulations on this matter, the
contraceptive coverage pre-Affordable estimate that approximately 62,000 Departments are not aware of entities
Care Act. employers among houses of worship, that omitted contraception pre-
Moreover, because these final rules integrated auxiliaries, and church plans, Affordable Care Act and then opposed
build on previous regulations that were exempt or relieved of the contraceptive coverage requirement
already exempted houses of worship contraceptive coverage obligations after it was imposed by the Guidelines.
and integrated auxiliaries and, as under the previous regulations. The For the following reasons, however, the
explained above, effectively eliminated Departments do not know how many Departments believe that a reasonable
obligations to provide contraceptive persons are covered in the plans of estimate is that no more than
coverage within objecting self-insured those employers. Guidestone reports approximately one third of the persons
church plans, the Departments attempt that among its 38,000 employers, its covered by relevant entities—that is, no
to estimate the number of such plan covers approximately 220,000 more than approximately 126,400
employers whose employees would not persons, and its employers include affected women—would likely be
be affected by these rules. In attempting ‘‘churches, mission-sending agencies, subject to potential transfer impacts
to estimate the number of such hospitals, educational institutions and under the expanded religious
employers, the Departments consider other related ministries.’’ Using that exemptions offered in these final rules.
the following information. Many ratio, the Departments estimate that the Consequently, as explained below, the
Catholic dioceses have litigated or filed 62,000 church and church plan Departments believe that the potential
public comments opposing the employers among Guidestone, Christian impact of these final rules falls
Mandate, representing to the Brothers, and Catholic churches would substantially below the $100 million
Departments and to courts around the include 359,000 persons. Among them, threshold for an economically
country that official Catholic Church as referenced above, 72,500 women significant major rule.
teaching opposes contraception. There First, as mentioned, the Departments
would be of childbearing age, and
are 17,651 Catholic parishes in the are not aware of information, or of data
32,100 may use contraceptives covered
United States,106 197 Catholic from public comments, that would lead
by the Guidelines.
us to estimate that all or most entities
Taking all of these factors into
104 For example, 42 U.S.C. 300a–7(b), 42 U.S.C. that omitted coverage of contraception
account, the Departments estimate that
238n, and Consolidated Appropriations Act of pre-Affordable Care Act did so on the
2017, Div. H, Title V, Sec. 507(d), Public Law basis of sincerely held conscientious
107 Wikipedia, ‘‘List of Catholic dioceses in the
115–31.
105 John Asker, et al., ‘‘Corporate Investment and United States,’’ available at https:// objections in general or, specifically,
Stock Market Listing: A Puzzle?’’ 28 Review of en.wikipedia.org/wiki/List_of_Catholic_dioceses_ religious beliefs, as opposed to having
Financial Studies Issue 2, at 342–390 (Oct. 7, 2014), in_the_United_States. done so for other reasons. It would seem
108 National Catholic Educational Association,
available at https://doi.org/10.1093/rfs/hhu077. reasonable to assume that many of those
This is true even though there are only about 4,300 ‘‘Catholic School Data,’’ available at http://
publicly traded companies in the U.S. See Rayhanul www.ncea.org/NCEA/Proclaim/Catholic_School_ entities did not do so based on sincerely
held religious beliefs. According to a
Ibrahim, ‘‘The number of publicly-traded US Data/Catholic_School_Data.aspx.

companies is down 46% in the past two decades,’’ 109 Guidestone Financial Resources, ‘‘Who We 2016 poll, only 4% of Americans
Yahoo! Finance (Aug. 8, 2016), available at https:// Serve,’’ available at https://www.guidestone.org/ believe that using contraceptives is
finance.yahoo.com/news/jp-startup-public- AboutUs/WhoWeServe.
companies-fewer-000000709.html. 110 The Departments take no view on the status
morally wrong (including from a
106 Roman Catholic Diocese of Reno, ‘‘Diocese of of particular plans under the Employee Retirement religious perspective).111 In addition,
Reno Directory: 2016–2017,’’ available at http:// Income Security Act of 1974 (ERISA), but simply
www.renodiocese.org/documents/2016/9/ make this observation for the purpose of seeking to 111 Pew Research Center, ‘‘Where the Public
2016%202017%20directory.pdf. estimate the impact of these final rules. Stands on Religious Liberty vs. Nondiscrimination’’
various reasons exist for some percent of those would be 185,000, and covered by the Guidelines, who
employers not to return to a pre-ACA one third of that number would be received primary coverage from plans of
situation in which they did not provide 62,000. The Departments consider it private, non-publicly traded, third party
contraceptive coverage, such as unlikely that tens or hundreds of employers that did not cover
avoiding negative publicity, the thousands of for-profit private sector contraception pre-Affordable Care Act,
difficulty of taking away a fringe benefit establishments omitted contraceptive and whose plans were neither exempt
that employees have become coverage pre-ACA specifically because nor omitted from mandatory
accustomed to having, and avoiding the of sincerely held religious beliefs, when, contraceptive coverage under the
administrative cost of renegotiating after six years of litigation and multiple previous regulations, we estimate that
insurance contracts. Additionally, as public comment periods, the no more than 126,400 women would be
discussed above, many employers with Departments are aware of less than 100 in plans that will use these expanded
objections to contraception, including such entities. The Departments do not exemptions.
several of the largest litigants, only know how many additional nonprofit
object to some contraceptives and cover viii. Final Estimates of Persons Affected
entities would use the expanded
as many as 14 of 18 of the contraceptive by Expanded Exemptions
exemptions, but as noted above, under
methods included in the Guidelines. the rules predating the Religious IFC, Based on the estimate of an average
This will reduce, and potentially tens of thousands were already exempt annual expenditure on contraceptive
eliminate, the contraceptive cost as churches or integrated auxiliaries, or products and services of $584 per user,
transfer for women covered in their were covered by self-insured church the effect of the expanded exemptions
plans.112 Moreover, as suggested by the plans that are not penalized if no on 126,400 women would give rise to
Guidestone data mentioned previously, contraceptive coverage is offered. approximately $73.8 million in
employers with conscientious Finally, among entities that omitted potential transfer impact. It is possible,
objections may tend to have relatively contraceptive coverage based on however, that premiums would adjust to
few employees and, among nonprofit sincerely held conscientious objections reflect changes in coverage, thus
entities that object to the Mandate, it is as opposed to other reasons, it is likely partially offsetting the transfer
possible that a greater share of their that some, albeit a minority, did so experienced by women who use the
employees oppose contraception than based on moral objections that are non- affected contraceptives. As referenced
among the general population, which religious, and therefore would not be elsewhere in this analysis, such women
should lead to a reduction in the compassed by the expanded exemptions may make up approximately 8.8 percent
estimate of how many women in those in these final rules.114 Among the of the covered population,116 in which
plans actually use contraception. general public, polls vary about case the offset would also be
It may not be the case that all entities religious beliefs, but one prominent poll approximately 8.8 percent, yielding a
that objected on religious grounds to shows that 13 percent of Americans say potential transfer of $67.3 million.
contraceptive coverage before the ACA they do not believe in God or have no Thus, in their most expansive
brought suit against the Mandate. opinion on the question.115 Therefore, estimate, the Departments conclude that
However, it is worth noting that, while the Departments estimate that, of the no more than approximately 126,400
less than 100 for-profit entities entities that omitted contraception pre- women would likely be subject to
challenged the Mandate in court (and an Affordable Care Act based on sincerely potential transfer impacts under the
unknown number joined two newly held conscientious objections as expanded religious exemptions offered
formed associational organizations opposed to other reasons, a small in these final rules. The Departments
bringing suit on their behalf), there are fraction did so based on sincerely held estimate this financial transfer to be
more than 3 million for-profit private non-religious moral convictions, and approximately $67.3 million. This falls
sector establishments in the United therefore would not be affected by the substantially below the $100 million
States that offer health insurance.113 Six expanded exemption provided by these threshold for an economically
final rules for religious beliefs. significant and major rule.
at page 26 (Sept. 28, 2016), available at http:// As noted above, the Departments view
assets.pewresearch.org/wp-content/uploads/sites/
For the reasons stated above, the
11/2016/09/Religious-Liberty-full-for-web.pdf. Departments believe it would be this alternative estimate as being the
112 On the other hand, a key input in the incorrect to assume that all or even most highest possible bound of the transfer
approach that generated the one third threshold of the plans that did not cover effects of these rules, but believe the
estimate was a survey indicating that six percent of contraceptives before the ACA did so on number of establishments that will
employers did not provide contraceptive coverage
pre-Affordable Care Act. Employers that covered the basis of religious objections. Instead, actually exempt their plans as the result
some contraceptives pre-Affordable Care Act may without data available on the reasons of these rules will be far fewer than
have answered ‘‘yes’’ or ‘‘don’t know’’ to the those plans omitted contraceptive contemplated by this estimate. The
survey. In such cases, the potential transfer estimate coverage before the ACA, we assume Departments make these estimates only
has a tendency toward underestimation because the
rule’s effects on such women—causing their that no more than one third of those for the purposes of determining whether
contraceptive coverage to be reduced from all 18 plans omitted contraceptive coverage the rules are economically significant
methods to some smaller subset—have been based on sincerely held religious beliefs. under Executive Orders 12866 and
omitted from the calculation. Thus, of the estimated 379,000 women 13563.
113 Tables I.A.1 and I.A.2, Medical Expenditure
aged 15 to 44 that use contraceptives After reviewing public comments,
Panel Survey, ‘‘Private-Sector Data by Firm Size,
Industry Group, Ownership, Age of Firm, and Other both those supporting and those
Characteristics: 2017,’’ HHS Agency for Healthcare 114 Such objections may be encompassed by disagreeing with these estimates and
Research and Quality (indicating total number of companion final rules published elsewhere in similar estimates from the Religious IFC,
for-profit incorporated, for-profit unincorporated, today’s Federal Register. Those final rules,
however, are narrower in scope than these final
and because the Departments do not
and non-profit establishments in the United States,
and the percentage of each that offer health rules. For example, in providing expanded have sufficient data to precisely
insurance), available at https://meps.ahrq.gov/data_ exemptions for plan sponsors, they do not
stats/summ_tables/insr/national/series_1/2017/ encompass companies with certain publicly traded 116 As cited above, women of childbearing age are
tia1.htm and https://meps.ahrq.gov/data_stats/ ownership interests. 20.2 percent of woman aged 15–65, and 43.6
summ_tables/insr/national/series_1/2017/tia2.htm. 115 Gallup, ‘‘Religion,’’ available at https:// percent of women of childbearing age use
2523. news.gallup.com/poll/1690/religion.aspx. contraceptives covered by the Guidelines.
estimate the amount by which these rules will have a significant economic that we solicit comment on the
factors render our estimate too high, or effect on a substantial number of small following issues:
too low, the Departments simply entities. These final rules will not result • The need for the information
conclude that the financial transfer falls in any additional costs to affected collection and its usefulness in carrying
substantially below the $100 million entities, and, in many cases, may relieve out the proper functions of our agency.
threshold for an economically burdens and costs from such entities. By • The accuracy of our estimate of the
significant rule based on the exempting from the Mandate small information collection burden.
calculations set forth above. businesses and nonprofit organizations • The quality, utility, and clarity of
B. Special Analyses—Department of the with religious objections to some (or all) the information to be collected.
Treasury contraceptives and/or sterilization— Recommendations to minimize the
businesses and organizations that would information collection burden on the
These regulations are not subject to otherwise be faced with the dilemma of
review under section 6(b) of Executive affected public, including automated
complying with the Mandate (and collection techniques. In the October 13,
Order 12866 pursuant to the violating their religious beliefs) or
Memorandum of Agreement (April 11, 2017 (82 FR 47792) interim final rules,
following their beliefs (and incurring we solicited public comment on each of
2018) between the Department of the potentially significant financial
Treasury and the Office of Management these issues for the following sections of
penalties for noncompliance)—the the rule containing information
and Budget regarding review of tax Departments have reduced regulatory
regulations. collection requirements (ICRs). A
burden on such small entities. Pursuant description of the information collection
C. Regulatory Flexibility Act to section 7805(f) of the Code, the notice provisions implicated in these final
of proposed rulemaking preceding these rules is given in the following section
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) imposes regulations was submitted to the Chief with an estimate of the annual burden.
certain requirements with respect to Counsel for Advocacy of the Small The burden related to these ICRs
federal rules that are subject to the Business Administration for comment received emergency review and
notice and comment requirements of on their impact on small business. approval under OMB control number
section 553(b) of the APA (5 U.S.C. 551 D. Paperwork Reduction Act— 0938–1344. They have been resubmitted
et seq.) and that are likely to have a Department of Health and Human to OMB in conjunction with these final
significant economic impact on a Services rules and are pending re-approval. The
substantial number of small entities. Departments sought public comments
The Religious IFC was an interim final Under the Paperwork Reduction Act on PRA estimates set forth in the
rule with comment period, and in these of 1995 (44 U.S.C. 3501 et seq.), we are Religious IFC, and are not aware of
final rules, the Departments adopt the required to provide 30-day notice in the significant comments submitted that
Religious IFC as final with certain Federal Register and solicit public suggest there is a better way to estimate
changes. These final rules are, thus, comment before a collection of these burdens.
being issued after a notice and comment information is submitted to the Office of
1. Wage Data
period. Management and Budget (OMB) for
The Departments also carefully review and approval. In order to fairly Average labor costs (including 100
considered the likely impact of the rule evaluate whether an information percent fringe benefits and overhead)
on small entities in connection with collection should be approved by OMB, used to estimate the costs are calculated
their assessment under Executive Order section 3506(c)(2)(A) of the Paperwork using data available derived from the
12866 and do not expect that these final Reduction Act of 1995 (PRA) requires Bureau of Labor Statistics.117
TABLE 1—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Mean hourly Fringe benefits Adjusted
Occupational
BLS occupation title wage and overhead hourly wage
code ($/hr) ($/hr) ($/hr)
Executive Secretaries and Executive Administrative Assistants ..................... 43–6011 $27.84 $27.84 $55.68
Compensation and Benefits Manager ............................................................. 11–3111 61.01 61.01 122.02
Legal Counsel .................................................................................................. 23–1011 67.25 67.25 134.50
Senior Executive .............................................................................................. 11–1011 93.44 93.44 186.88
General and Operations Managers ................................................................. 11–1021 58.70 58.70 117.40
2. ICRs Regarding Self-Certification or or a subset of contraceptive services. Notably, however, entities that are
Notices to HHS (§ 147.131(c)(3)) Specifically, these final rules continue participating in the previous
to allow eligible organizations to notify accommodation process, where a self-
Each organization seeking to be
treated as an eligible organization that an issuer or third party administrator certification or notice has already been
wishes to use the optional using EBSA Form 700, or to notify HHS, submitted, and where the entities
accommodation process offered under of their religious objection to coverage choose to continue their accommodated
of all or a subset of contraceptive status under these final rules, generally
these final rules must either use the

EBSA Form 700 method of self- services, as set forth in the July 2015 do not need to file a new self-
certification or provide notice to HHS of final regulations (80 FR 41318). certification or notice (unless they
its religious objection to coverage of all change their issuer or third party
117 May 2016 National Occupational Employment
and Wage Estimates United States found at https://

www.bls.gov/oes/current/oes_nat.htm.
administrator). As explained above, sending the self-certifications or notices covered in the plans of the 100 entities
HHS assumes that, among the 209 to HHS by mail is approximately $2.75 that previously used the
entities the Departments estimated are for 5 entities. As DOL and HHS share accommodation and will continue doing
using the previous accommodation, 109 jurisdiction they are splitting the cost so, and that an additional 9 entities will
will use the expanded exemption and burden so that each will account for newly opt into the accommodation. We
100 will continue under the voluntary $1.38 of the cost burden. reach this estimate using calculations
accommodation. Those 100 entities will 3. ICRs Regarding Notice of Availability set forth above, in which we used 2017
not need to file additional self- of Separate Payments for Contraceptive data available to HHS for contraceptive
certifications or notices. HHS also Services (§ 147.131(e)) user fees adjustments to estimate that
assumes that an additional 9 entities approximately 2,907,000 plan
that were not using the previous As required by the July 2015 final participants and beneficiaries were
accommodation will opt into it. Those regulations (80 FR 41318), a health covered by plans using the
entities will be subject to the self- insurance issuer or third party accommodation. We further estimated
certification or notice requirement. administrator providing or arranging that the 100 entities that previously
In order to estimate the cost for an separate payments for contraceptive used the accommodation and will
entity that chooses to opt into the services for participants and continue doing so will cover
accommodation process, HHS assumes beneficiaries in insured or self-insured approximately 75 percent of the persons
that clerical staff for each eligible group health plans (or student enrollees in all accommodated plans, based on
organization will gather and enter the and covered dependents in student HHS data concerning accommodated
necessary information and send the self- health insurance coverage) of eligible self-insured plans that indicates plans
certification to the issuer or third party organizations is required to provide a sponsored by religious hospitals and
administrator as appropriate, or send written notice to plan participants and health systems encompass more than 80
the notice to HHS.118 HHS assumes that beneficiaries (or student enrollees and percent of the persons covered in such
a compensation and benefits manager covered dependents) informing them of plans. In other words, plans sponsored
and inside legal counsel will review the the availability of such payments. The by such entities have a proportionately
self-certification or notice to HHS and a notice must be separate from, but larger number of covered persons than
senior executive would execute it. HHS contemporaneous with (to the extent do plans sponsored by other
estimates that an eligible organization possible), any application materials accommodated entities, which have
would spend approximately 50 minutes distributed in connection with smaller numbers of covered persons. As
(30 minutes of clerical labor at a cost of enrollment (or re-enrollment) in group
noted above, many religious hospitals
$55.68 per hour, 10 minutes for a or student coverage of the eligible
and health systems have indicated that
compensation and benefits manager at a organization in any plan year to which
they do not object to the
cost of $122.02 per hour, 5 minutes for the accommodation is to apply and will
accommodation, and some of those
legal counsel at a cost of $134.50 per be provided annually. To satisfy the
entities might also qualify as self-
hour, and 5 minutes by a senior notice requirement, issuers and third
insured church plans. The Departments
executive at a cost of $186.88 per hour) party administrators may, but are not
do not have specific data on which
required to, use the model language
preparing and sending the self- plans of which employer sizes will
previously provided by HHS or
certification or notice to HHS and filing actually continue to opt into the
substantially similar language.
it to meet the recordkeeping As mentioned, HHS is anticipating accommodation, nor how many will
requirement. Therefore, the total annual that approximately 109 entities will use make use of self-insured church plan
burden for preparing and providing the the optional accommodation (100 that status. The Departments assume that the
information in the self-certification or used it previously, and 9 that will newly proportions of covered persons in self-
notice to HHS will require opt into it). It is unknown how many insured plans using contraceptive user
approximately 50 minutes for each issuers or third party administrators fees adjustments also apply in fully
eligible organization with an equivalent provide health insurance coverage or insured plans, for which we lack
cost of approximately $74.96 for a total services in connection with health plans representative data.
hour burden of approximately 7.5 hours of eligible organizations, but HHS will Based on these assumptions and
and an associated equivalent cost of assume at least 109. It is estimated that without better data available, the
approximately $675 for 9 entities. As each issuer or third party administrator Departments estimate that previously
DOL and HHS share jurisdiction, they will need approximately 1 hour of accommodated entities encompassed
are splitting the hour burden so that clerical labor (at $55.68 per hour) and approximately 2,907,000 persons; the
each will account for approximately 15 minutes of management review (at estimated 100 entities that previously
3.75 burden hours with an equivalent $117.40 per hour) to prepare the notices. used the accommodation and continue
cost of approximately $337. The total burden for each issuer or third to use it will account for 75 percent of
HHS estimates that each self- party administrator to prepare notices those persons (that is, approximately
certification or notice to HHS will will be 1.25 hours with an associated 2,180,000 persons); and the estimated
require $0.50 in postage and $0.05 in cost of approximately $85.03. The total 109 entities that previously used the
materials cost (paper and ink) and the burden for all 109 issuers or third party accommodation and will now use their
total postage and materials cost for each administrators will be 136 hours, with exempt status will account for 25
self-certification or notice sent via mail an associated cost of approximately percent of those persons (that is,
will be $0.55. For purposes of this $9,268. As DOL and HHS share approximately 727,000 persons). It is
analysis, HHS assumes that 50 percent jurisdiction, they are splitting the not known how many persons will be
of self-certifications or notices to HHS burden each will account for 68 burden covered in the plans of the 9 entities we
will be mailed. The total cost for hours with an associated cost of $4,634, estimate will newly use the
118 For purposes of this analysis, the Department
with approximately 55 respondents. accommodation. Assuming that those 9
assumes that the same amount of time will be
The Departments estimate that entities will have a similar number of
required to prepare the self-certification and the approximately 2,180,000 plan covered persons per entity as the 100
notice to HHS. participants and beneficiaries will be entities encompassing 2,180,000
persons, the Departments estimate that expanded exemption may revoke its use of approximately $182; for 109 entities,
all 109 accommodated entities will of the accommodation process; its issuer the total hour burden will be 218 hours
encompass approximately 2,376,000 or third party administrator must with an associated cost of
covered persons. provide written notice of such approximately $19,798. As DOL and
The Departments assume that sending revocation to participants and HHS share jurisdiction, they are
one notice to each policyholder will beneficiaries as soon as practicable. As splitting the hour burden so each will
satisfy the need to send the notices to discussed above, HHS estimates that account for 109 burden hours with an
all participants and dependents. Among 109 entities that are using the associated cost of approximately $9,899.
persons covered by insurance plans accommodation process will revoke
As discussed above, HHS estimates
sponsored by large employers in the their use of the accommodation, and
that there are approximately 727,000
private sector, approximately 50.1 will therefore be required to send the
percent are participants and 49.9 covered persons in accommodated plans
notification; the issuer or third party
percent are dependents.119 For 109 that will revoke their accommodated
administrator can send the notice on
entities, the total number of notices will behalf of the entity. For the purpose of status and use the expanded
be 1,190,613. For purposes of this calculating the ICRs associated with exemption.121 As before, the
analysis, the Departments also assume revocations of the accommodation, and Departments use the average of 50.1
that 53.7 percent of notices will be sent for various reasons discussed above, percent of covered persons who are
electronically, and 46.3 percent will be HHS assumes that litigating entities that policyholders, and estimate that an
mailed.120 Therefore, approximately were previously using the average of 53.7 percent of notices will
551,254 notices will be mailed. HHS accommodation and that will revoke be sent electronically and 46.3 percent
estimates that each notice will require their use of the accommodation fall by mail. Therefore, approximately
$0.50 in postage and $0.05 in materials within the estimated 109 entities that 364,102 notices will be distributed, of
cost (paper and ink) and the total will revoke the accommodation overall. which 168,579 notices will be mailed.
postage and materials cost for each As before, HHS assumes that, for each HHS estimates that each mailed notice
notice sent via mail will be $0.55. The issuer or third party administrator, a will require $0.50 in postage and $0.05
total cost for sending approximately manager and inside legal counsel and in materials cost (paper and ink) and the
551,254 notices by mail will be clerical staff will need approximately 2 total postage and materials cost for each
approximately $303,190. As DOL and hours to prepare and send the notice sent via mail will be $0.55. The
HHS share jurisdiction, they are notification to participants and total cost for sending approximately
splitting the cost burden so each will beneficiaries and maintain records (30 168,579 notices by mail is
account for $151,595 of the cost burden. minutes for a manager at a cost of approximately $93,545. As DOL and
$117.40 per hour, 30 minutes for legal HHS share jurisdiction, they are
4. ICRs Regarding Notice of Revocation counsel at a cost of $134.50 per hour, 1 splitting the hour burden so each will
of Accommodation (§ 147.131(c)(4)) hour for clerical staff at a cost of $55.68 account for 182,051 notices, with an
An eligible organization that now per hour). The burden per respondent associated cost of approximately
wishes to take advantage of the will be 2 hours with an associated cost $46,772.
TABLE 1—SUMMARY OF INFORMATION COLLECTION BURDENS
Hourly labor Total labor
Burden per Total annual
OMB Number of cost of cost of Total cost
Regulation section Responses respondent burden
Control No. respondents reporting reporting ($)
(hours) (hours) ($) ($)
Self-Certification or Notices to HHS ......... 0938–1344 *5 5 0.83 3.75 $89.95 $337 $339
Notice of Availability of Separate Pay-
ments for Contraceptive Services ......... 0938–1344 * 55 595,307 1.25 68.13 68.02 4,634 156,229
Notice of Revocation of Accommodation .. 0938–1344 *55 182,051 2.00 109 90.82 9,899 56,671
Total ................................................... .................... *115 777,363 .................... 180.88 ........................ 14,870 213,239
* 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.
119 ‘‘Health Insurance Coverage Bulletin’’ Table 4, disclosure at work). Additionally, the NTIA reports number of women in accommodated plans affected
page 21. Using Data for the March 2016 Annual that 38.5 percent of individuals age 25 and over by these final rules overlap with the number of
Social and Economic Supplement to the Current have access to the internet outside of work. women in plans offered by litigating entities that
Population Survey. https://www.dol.gov/sites/ According to a Pew Research Center survey, 61 will be affected by these final rules, though we
default/files/ebsa/researchers/data/health-and- percent of internet users use online banking, which
assume there is significant overlap. That
welfare/health-insurance-coverage-bulletin- is used as the proxy for the number of internet users
2016.pdf. who will opt in for electronic disclosure (for a total uncertainty should not affect the calculation of the
120 According to data from the National of 23.5 percent receiving electronic disclosure ICRs for revocation notices, however. If the two
Telecommunications and Information Agency outside of work). Combining the 30.2 percent who numbers overlap, the estimates of plans revoking
(NTIA), 36.0 percent of individuals age 25 and over receive electronic disclosure at work with the 23.5 the accommodation and policyholders covered in
have access to the internet at work. According to percent who receive electronic disclosure outside of those plans would already include plans and
a Greenwald & Associates survey, 84 percent of work produces a total of 53.7 percent who will policyholders of litigating entities. If the numbers
plan participants find it acceptable to make receive electronic disclosure overall. do not overlap, those litigating entity plans would
electronic delivery the default option, which is 121 In estimating the number of women that might
not presently be enrolled in the accommodation,
used as the proxy for the number of participants have their contraceptive coverage affected by the
and therefore would not need to send notices
who will not opt out that are automatically enrolled expanded exemption, the Departments indicated
(for a total of 30.2 percent receiving electronic that we do not know the extent to which the concerning revocation of accommodated status.
5. Submission of PRA-Related These issuers and third party exercise all authority and discretion
Comments administrators will spend available to them to waive, defer, grant
We have submitted a copy of this rule approximately 1.25 hours in preparation exemptions from, or delay the
to OMB for its review of the rule’s time and incur $0.54 cost per mailed implementation of any provision or
information collection and notice. Notices of Availability of requirement of the Act that would
recordkeeping requirements. These Separate Payments for Contraceptive impose a fiscal burden on any state or
requirements are not effective until they Services will need to be sent to a cost, fee, tax, penalty, or regulatory
have been approved by OMB. 1,190,613 policyholders, and 53.7 burden on individuals, families,
percent of the notices will be sent healthcare providers, health insurers,
E. Paperwork Reduction Act— electronically, while 46.3 percent will patients, recipients of healthcare
Department of Labor be mailed. Finally, 109 entities using services, purchasers of health insurance,
Under the Paperwork Reduction Act, the previous accommodation process
or makers of medical devices, products,
an agency may not conduct or sponsor, will revoke their use of the
or medications.’’ In addition, agencies
and an individual is not required to accommodation (in favor of the
are directed to ‘‘take all actions
respond to, a collection of information expanded exemption) and will therefore
be required to cause the Notice of consistent with law to minimize the
unless it displays a valid OMB control unwarranted economic and regulatory
number. In accordance with the Revocation of Accommodation to be
sent, with the issuer or third party burdens of the [Affordable Care Act],
requirements of the PRA, the ICR for the
administrator able to send the notice on and prepare to afford the states more
EBSA Form 700 and alternative notice
behalf of the entity. These entities will flexibility and control to create a freer
have previously been approved by OMB
spend approximately two hours in and open healthcare market.’’ These
under control numbers 1210–0150 and
1210–0152. A copy of the ICR may be preparation time and incur $0.54 cost final rules exercise the discretion
obtained by contacting the PRA per mailed notice. Notice of Revocation provided to the Departments under the
addressee shown below or at http:// of Accommodation will need to be sent Affordable Care Act, RFRA, and other
www.RegInfo.gov. PRA ADDRESSEE: G. to an average of 364,102 policyholders laws to grant exemptions and thereby
Christopher Cosby, Office of Policy and and 53.7 percent of the notices will be minimize regulatory burdens of the
Research, U.S. Department of Labor, sent electronically. The DOL Affordable Care Act on the affected
Employee Benefits Security information collections in this rule are entities and recipients of health care
Administration, 200 Constitution found in 29 CFR 2510.3–16 and services.
Avenue NW, Room N–5718, 2590.715–2713A and are summarized as Consistent with Executive Order
Washington, DC 20210. Telephone: follows: 13771 (82 FR 9339, February 3, 2017),
202–693–8410; Fax: 202–219–4745. Type of Review: Revised Collection. the Departments have estimated the
These are not toll-free numbers. Agency: DOL–EBSA. costs and cost savings attributable to
The Religious final rules amended the Title: Coverage of Certain Preventive these final rules. As discussed in more
ICR by changing the accommodation Services under the Affordable Care
detail in the preceding analysis, these
process to an optional process for Act—Private Sector.
final rules lessen incremental reporting
exempt organizations and requiring a OMB Numbers: 1210–0150.
costs.123 However, in order to avoid
notice of revocation to be sent by the Affected Public: Private Sector—Not
for profit and religious organizations; double-counting with the Religious IFC,
issuer or third party administrator to which has already been tallied as an
participants and beneficiaries in plans businesses or other for-profits.
Total Respondents: 114 122 (combined Executive Order 13771 deregulatory
whose employer revokes their action, this finalization of the IFC’s
accommodation; these final rules with HHS total is 227).
Total Responses: 777,362 (combined policy is not considered a deregulatory
confirm as final the Religious IFC
with HHS total is 1,554,724). action under the Executive Order.
provisions on the accommodation
process. DOL submitted the ICRs to Frequency of Response: On occasion. 123 Other noteworthy potential impacts
OMB in order to obtain OMB approval Estimated Total Annual Burden encompass potential changes in medical
under the PRA for the regulatory Hours: 181 (combined with HHS total is expenditures, including potential decreased
revision. In an effort to consolidate the 362 hours). expenditures on contraceptive devices and drugs
Estimated Total Annual Burden Cost: and potential increased expenditures on pregnancy-
number of information collection related medical services. OMB’s guidance on E.O.
requests, DOL is combining the ICR $197,955 (combined with HHS total is 13771 implementation (Dominic J. Mancini,
related to the OMB control number $395,911). ‘‘Guidance Implementing Executive Order 13771,
1210–0152 with the ICR related to the Type of Review: Revised Collection. Titled ‘‘Reducing Regulation and Controlling
Agency: DOL–EBSA. Regulatory Costs,’’ Office of Mgmt. & Budget (Apr.
OMB control number 1210–0150 and 5, 2017), https://www.whitehouse.gov/sites/
discontinuing OMB control number F. Regulatory Reform Executive Orders whitehouse.gov/files/omb/memoranda/2017/M-17-
1210–0152. Consistent with the analysis 13765, 13771 and 13777 21-OMB.pdf) states that impacts should be
in the HHS PRA section above, the categorized as consistently as possible within
Departments expect that each of the Executive Order 13765 (January 20, Departments. The Food and Drug Administration,
2017) directs that, ‘‘[t]o the maximum within HHS, and the Occupational Safety and
estimated 9 eligible organizations newly Health Administration (OSHA) and Mine Safety
opting into the accommodation will extent permitted by law, the Secretary of and Health Administration (MSHA), within DOL,
spend approximately 50 minutes in the Department of Health and Human regularly estimate medical expenditure impacts in
preparation time and incur $0.54 Services and the heads of all other the analyses that accompany their regulations, with
executive departments and agencies the results being categorized as benefits (positive
mailing cost to self-certify or notify benefits if expenditures are reduced, negative
HHS. Each of the 109 issuers or third (agencies) with authorities and benefits if expenditures are raised). Following the
party administrators for the 109 eligible responsibilities under the Act shall FDA, OSHA and MSHA accounting convention
organizations that make use of the leads to this final rule’s medical expenditure
122 Denotes that there is an overlap between impacts being categorized as (positive or negative)
accommodation overall will distribute jurisdiction shared by HHS and DOL over these benefits, rather than as costs, thus placing them
Notices of Availability of Separate respondents and therefore they are included only outside of consideration for E.O. 13771 designation
Payments for Contraceptive Services. once in the total. purposes.
G. Unfunded Mandates Reform Act 200, 112 Stat. 645 (42 U.S.C. 651 note); DEPARTMENT OF THE TREASURY
The Unfunded Mandates Reform Act sec. 512(d), Public Law 110–343, 122
Internal Revenue Service
of 1995 (section 202(a) of Pub. L. 104– Stat. 3881; sec. 1001, 1201, and 1562(e),
Public Law 111–148, 124 Stat. 119, as Accordingly, 26 CFR part 54 is
4), requires the Departments to prepare amended as follows:
a written statement, which includes an amended by Public Law 111–152, 124
assessment of anticipated costs and Stat. 1029; Pub. L. 103–141, 107 Stat.
1488 (42 U.S.C. 2000bb–2000bb–4); PART 54—PENSION EXCISE TAXES
benefits, before issuing ‘‘any rule that
includes any federal mandate that may Secretary of Labor’s Order 1–2011, 77 ■ 1. The authority citation for part 54
result in the expenditure by state, local, FR 1088 (Jan. 9, 2012). continues to read, in part, as follows:
and tribal governments, in the aggregate, The Department of Health and Human Authority: 26 U.S.C. 7805. * * *
or by the private sector, of $100 million Services regulations are adopted
■ 2. Section 54.9815–2713 is amended
or more (adjusted annually for inflation) pursuant to the authority contained in
by revising paragraphs (a)(1)
in any one year.’’ In 2018, that threshold sections 2701 through 2763, 2791, and
introductory text and (a)(1)(iv) to read as
after adjustment for inflation is $150 2792 of the PHS Act (42 U.S.C. 300gg
follows:
million. For purposes of the Unfunded through 300gg–63, 300gg–91, and
Mandates Reform Act, the Religious IFC 300gg–92), as amended; and Title I of § 54.9815–2713 Coverage of preventive
and these final rules do not include any the Affordable Care Act, sections 1301– health services.
federal mandate that may result in 1304, 1311–1312, 1321–1322, 1324, (a) * * *
expenditures by state, local, or tribal 1334, 1342–1343, 1401–1402, 1412, (1) In general. Beginning at the time
governments, nor do they include any Public Law 111–148, 124 Stat. 119 (42 described in paragraph (b) of this
federal mandates that may impose an U.S.C. 18021–18024, 18031–18032, section and subject to § 54.9815–2713A,
annual burden of $150 million, adjusted 18041–18042, 18044, 18054, 18061, a group health plan, or a health
for inflation, or more on the private 18063, 18071, 18082, 26 U.S.C. 36B, and insurance issuer offering group health
sector. 31 U.S.C. 9701); and Public Law 103– insurance coverage, must provide
141, 107 Stat. 1488 (42 U.S.C. 2000bb– coverage for and must not impose any
H. Federalism 2000bb–4). cost-sharing requirements (such as a
Executive Order 13132 outlines copayment, coinsurance, or a
fundamental principles of federalism, List of Subjects deductible) for—
and requires the adherence to specific 26 CFR Part 54 * * * * *
criteria by federal agencies in the (iv) With respect to women, such
process of their formulation and Excise taxes, Health care, Health additional preventive care and
implementation of policies that have insurance, Pensions, Reporting and screenings not described in paragraph
‘‘substantial direct effects’’ on states, the recordkeeping requirements. (a)(1)(i) of this section as provided for in
relationship between the federal comprehensive guidelines supported by
29 CFR Part 2590
government and states, or the the Health Resources and Services
distribution of power and Continuation coverage, Disclosure, Administration for purposes of section
responsibilities among the various Employee benefit plans, Group health 2713(a)(4) of the Public Health Service
levels of government. Federal agencies plans, Health care, Health insurance, Act, subject to 45 CFR 147.131 and
promulgating regulations that have Medical child support, Reporting and 147.132.
these federalism implications must recordkeeping requirements. * * * * *
consult with state and local officials, ■ 3. Section 54.9815–2713A is revised
and describe the extent of their 45 CFR Part 147
to read as follows:
consultation and the nature of the
Health care, Health insurance, § 54.9815–2713A Accommodations in
concerns of state and local officials in
Reporting and recordkeeping connection with coverage of preventive
the preamble to the regulation.
requirements, State regulation of health health services.
These final rules do not have any
insurance. (a) Eligible organizations for optional
federalism implications, since they only
provide exemptions from the Kirsten Wielobob, accommodation. An eligible
contraceptive and sterilization coverage organization is an organization that
Deputy Commissioner for Services and
requirement in HRSA Guidelines Enforcement.
meets the criteria of paragraphs (a)(1)
supplied under section 2713 of the PHS through (4) of this section.
Approved: October 30, 2018. (1) The organization is an objecting
Act.
David J. Kautter, entity described in 45 CFR
V. Statutory Authority Assistant Secretary for Tax Policy. 147.132(a)(1)(i) or (ii);
The Department of the Treasury Signed this 29th day of October 2018. (2) Notwithstanding its status under
regulations are adopted pursuant to the paragraph (a)(1) of this section and
Preston Rutledge,
authority contained in sections 7805 under 45 CFR 147.132(a), the
Assistant Secretary, Employee Benefits organization voluntarily seeks to be
and 9833 of the Code, and Public Law Security Administration, Department of
103–141, 107 Stat. 1488 (42 U.S.C. considered an eligible organization to
Labor.
2000bb–2000bb–4). invoke the optional accommodation
Dated: October 17, 2018. under paragraph (b) or (c) of this section
The Department of Labor regulations
Seema Verma, as applicable; and

are adopted pursuant to the authority
contained in 29 U.S.C. 1002(16), 1027, Administrator, Centers for Medicare & (3) [Reserved]
Medicaid Services. (4) The organization self-certifies in
1059, 1135, 1161–1168, 1169, 1181–
Dated: October 18, 2018. the form and manner specified by the
1183, 1181 note, 1185, 1185a, 1185b,
1185d, 1191, 1191a, 1191b, and 1191c; Alex M. Azar II,
sec. 101(g), Public Law 104–191, 110 Secretary, Department of Health and Human
Stat. 1936; sec. 401(b), Public Law 105– Services.
Secretary of Labor or provides notice to (i) The eligible organization or its plan administrative services for the plan,
the Secretary of the Department of must contract with one or more third then the third party administrator will
Health and Human Services as party administrators. provide or arrange payments for
described in paragraph (b) or (c) of this (ii) The eligible organization must contraceptive services, using one of the
section. To qualify as an eligible provide either a copy of the self- following methods—
organization, the organization must certification to each third party (i) Provide payments for the
make such self-certification or notice administrator or a notice to the contraceptive services for plan
available for examination upon request Secretary of the Department of Health participants and beneficiaries without
by the first day of the first plan year to and Human Services that it is an eligible imposing any cost-sharing requirements
which the accommodation in paragraph organization and of its objection as (such as a copayment, coinsurance, or a
(b) or (c) of this section applies. The described in 45 CFR 147.132 to coverage deductible), premium, fee, or other
self-certification or notice must be of all or a subset of contraceptive charge, or any portion thereof, directly
executed by a person authorized to services. or indirectly, on the eligible
make the certification or provide the (A) When a copy of the self- organization, the group health plan, or
notice on behalf of the organization, and certification is provided directly to a plan participants or beneficiaries; or
must be maintained in a manner third party administrator, such self- (ii) Arrange for an issuer or other
consistent with the record retention certification must include notice that entity to provide payments for the
requirements under section 107 of obligations of the third party contraceptive services for plan
ERISA. administrator are set forth in 29 CFR participants and beneficiaries without
2510.3–16 and this section. imposing any cost-sharing requirements
(5) An eligible organization may (B) When a notice is provided to the (such as a copayment, coinsurance, or a
revoke its use of the accommodation Secretary of Health and Human deductible), premium, fee, or other
process, and its issuer or third party Services, the notice must include the charge, or any portion thereof, directly
administrator must provide participants name of the eligible organization; a or indirectly, on the eligible
and beneficiaries written notice of such statement that it objects as described in organization, the group health plan, or
revocation, as specified herein. 45 CFR 147.132 to coverage of some or plan participants or beneficiaries.
(i) Transitional rule—If contraceptive all contraceptive services (including an (3) If a third party administrator
coverage is being offered on the date on identification of the subset of provides or arranges payments for
which these final rules go into effect, by contraceptive services to which contraceptive services in accordance
an issuer or third party administrator coverage the eligible organization with either paragraph (b)(2)(i) or (ii) of
through the accommodation process, an objects, if applicable), but that it would this section, the costs of providing or
eligible organization may give 60-days like to elect the optional arranging such payments may be
notice pursuant to section 2715(d)(4) of accommodation process; the plan name reimbursed through an adjustment to
the PHS Act and § 54.9815–2715(b), if and type (that is, whether it is a student the federally facilitated Exchange user
applicable, to revoke its use of the health insurance plan within the fee for a participating issuer pursuant to
accommodation process (to allow for the meaning of 45 CFR 147.145(a) or a 45 CFR 156.50(d).
provision of notice to plan participants church plan within the meaning of (4) A third party administrator may
in cases where contraceptive benefits section 3(33) of ERISA); and the name not require any documentation other
will no longer be provided). and contact information for any of the than a copy of the self-certification from
Alternatively, such eligible organization plan’s third party administrators. If the eligible organization or notification
may revoke its use of the there is a change in any of the from the Department of Labor described
accommodation process effective on the information required to be included in in paragraph (b)(1)(ii) of this section.
first day of the first plan year that begins the notice, the eligible organization (5) Where an otherwise eligible
on or after 30 days after the date of the must provide updated information to organization does not contract with a
revocation. the Secretary of the Department of third party administrator and files a self-
Health and Human Services for the certification or notice under paragraph
(ii) General rule—In plan years that optional accommodation process to (b)(1)(ii) of this section, the obligations
begin after the date on which these final remain in effect. The Department of under paragraph (b)(2) of this section do
rules go into effect, if contraceptive Labor (working with the Department of not apply, and the otherwise eligible
coverage is being offered by an issuer or Health and Human Services) will send organization is under no requirement to
third party administrator through the a separate notification to each of the provide coverage or payments for
accommodation process, an eligible plan’s third party administrators contraceptive services to which it
organization’s revocation of use of the informing the third party administrator objects. The plan administrator for that
accommodation process will be effective that the Secretary of the Department of otherwise eligible organization may, if it
no sooner than the first day of the first Health and Human Services has and the otherwise eligible organization
plan year that begins on or after 30 days received a notice under paragraph choose, arrange for payments for
after the date of the revocation. (b)(1)(ii) of this section and describing contraceptive services from an issuer or
(b) Optional accommodation—self- the obligations of the third party other entity in accordance with
insured group health plans—(1) A group administrator under 29 CFR 2510.3–16 paragraph (b)(2)(ii) of this section, and
health plan established or maintained and this section. such issuer or other entity may receive
by an eligible organization that provides (2) If a third party administrator reimbursements in accordance with
benefits on a self-insured basis may receives a copy of the self-certification paragraph (b)(3) of this section.
voluntarily elect an optional from an eligible organization or a (6) Where an otherwise eligible
accommodation under which its third notification from the Department of organization is an ERISA-exempt church
party administrator(s) will provide or Labor, as described in paragraph plan within the meaning of section 3(33)
arrange payments for all or a subset of (b)(1)(ii) of this section, and is willing of ERISA and it files a self-certification
contraceptive services for one or more to enter into or remain in a contractual or notice under paragraph (b)(1)(ii) of
plan years. To invoke the optional relationship with the eligible this section, the obligations under
accommodation process: organization or its plan to provide paragraph (b)(2) of this section do not
apply, and the otherwise eligible Department of Health and Human eligible organization or the notification
organization is under no requirement to Services for the optional from the Department of Health and
provide coverage or payments for accommodation process to remain in Human Services described in paragraph
contraceptive services to which it effect. The Department of Health and (c)(1)(ii) of this section.
objects. The third party administrator Human Services will send a separate (d) Notice of availability of separate
for that otherwise eligible organization notification to each of the plan’s health payments for contraceptive services—
may, if it and the otherwise eligible insurance issuers informing the issuer self-insured and insured group health
organization choose, provide or arrange that the Secretary of the Department plans. For each plan year to which the
payments for contraceptive services in Health and Human Services has optional accommodation in paragraph
accordance with paragraphs (b)(2)(i) or received a notice under paragraph (b) or (c) of this section is to apply, a
(ii) of this section, and receive (c)(2)(ii) of this section and describing third party administrator required to
reimbursements in accordance with the obligations of the issuer under this provide or arrange payments for
paragraph (b)(3) of this section. section. contraceptive services pursuant to
(c) Optional accommodation— (2) If an issuer receives a copy of the paragraph (b) of this section, and an
insured group health plans—(1) General self-certification from an eligible issuer required to provide payments for
rule. A group health plan established or organization or the notification from the contraceptive services pursuant to
maintained by an eligible organization Department of Health and Human paragraph (c) of this section, must
that provides benefits through one or Services as described in paragraph provide to plan participants and
more group health insurance issuers (c)(2)(ii) of this section and does not beneficiaries written notice of the
may voluntarily elect an optional have its own objection as described in availability of separate payments for
accommodation under which its health 45 CFR 147.132 to providing the contraceptive services contemporaneous
insurance issuer(s) will provide contraceptive services to which the with (to the extent possible), but
payments for all or a subset of eligible organization objects, then the separate from, any application materials
contraceptive services for one or more issuer will provide payments for distributed in connection with
plan years. To invoke the optional contraceptive services as follows— enrollment (or re-enrollment) in group
accommodation process— (i) The issuer must expressly exclude health coverage that is effective
(i) The eligible organization or its plan contraceptive coverage from the group beginning on the first day of each
must contract with one or more health health insurance coverage provided in applicable plan year. The notice must
insurance issuers. connection with the group health plan specify that the eligible organization
(ii) The eligible organization must and provide separate payments for any does not administer or fund
provide either a copy of the self- contraceptive services required to be contraceptive benefits, but that the third
certification to each issuer providing covered under § 54.9815–2713(a)(1)(iv) party administrator or issuer, as
coverage in connection with the plan or for plan participants and beneficiaries applicable, provides or arranges
a notice to the Secretary of the for so long as they remain enrolled in separate payments for contraceptive
Department of Health and Human the plan. services, and must provide contact
Services that it is an eligible (ii) With respect to payments for information for questions and
organization and of its objection as contraceptive services, the issuer may complaints. The following model
described in 45 CFR 147.132 to coverage not impose any cost-sharing language, or substantially similar
for all or a subset of contraceptive requirements (such as a copayment, language, may be used to satisfy the
services. coinsurance, or a deductible), or impose notice requirement of this paragraph (d):
(A) When a self-certification is any premium, fee, or other charge, or ‘‘Your employer has certified that your
provided directly to an issuer, the issuer any portion thereof, directly or group health plan qualifies for an
has sole responsibility for providing indirectly, on the eligible organization, accommodation with respect to the
such coverage in accordance with the group health plan, or plan federal requirement to cover all Food
§ 54.9815–2713. participants or beneficiaries. The issuer and Drug Administration-approved
(B) When a notice is provided to the must segregate premium revenue contraceptive services for women, as
Secretary of the Department Health and collected from the eligible organization prescribed by a health care provider,
Human Services, the notice must from the monies used to provide without cost sharing. This means that
include the name of the eligible payments for contraceptive services. your employer will not contract,
organization; a statement that it objects The issuer must provide payments for arrange, pay, or refer for contraceptive
as described in 45 CFR 147.132 to contraceptive services in a manner that coverage. Instead, [name of third party
coverage of some or all contraceptive is consistent with the requirements administrator/health insurance issuer]
services (including an identification of under sections 2706, 2709, 2711, 2713, will provide or arrange separate
the subset of contraceptive services to 2719, and 2719A of the PHS Act, as payments for contraceptive services that
which coverage the eligible organization incorporated into section 9815 of the you use, without cost sharing and at no
objects, if applicable) but that it would PHS Act. If the group health plan of the other cost, for so long as you are
like to elect the optional eligible organization provides coverage enrolled in your group health plan.
accommodation process; the plan name for some but not all of any contraceptive Your employer will not administer or
and type (that is, whether it is a student services required to be covered under fund these payments. If you have any
health insurance plan within the § 54.9815–2713(a)(1)(iv), the issuer is questions about this notice, contact
meaning of 45 CFR 147.145(a) or a required to provide payments only for [contact information for third party
church plan within the meaning of those contraceptive services for which administrator/health insurance issuer].’’
section 3(33) of ERISA); and the name the group health plan does not provide (e) Reliance—insured group health
and contact information for any of the coverage. However, the issuer may plans—(1) If an issuer relies reasonably
plan’s health insurance issuers. If there provide payments for all contraceptive and in good faith on a representation by
is a change in any of the information services, at the issuer’s option. the eligible organization as to its
required to be included in the notice, (3) A health insurance issuer may not eligibility for the accommodation in
the eligible organization must provide require any documentation other than a paragraph (c) of this section, and the
updated information to the Secretary of copy of the self-certification from the representation is later determined to be
incorrect, the issuer is considered to 110–343, 122 Stat. 3881; sec. 1001, 1201, and (2) A group health plan is considered
comply with any applicable 1562(e), Pub. L. 111–148, 124 Stat. 119, as to comply with any applicable
requirement under § 54.9815– amended by Pub. L. 111–152, 124 Stat. 1029; requirement under § 2590.715–
Division M, Pub. L. 113–235, 128 Stat. 2130;
2713(a)(1)(iv) to provide contraceptive Secretary of Labor’s Order 1–2011, 77 FR
2713(a)(1)(iv) to provide contraceptive
coverage if the issuer complies with the 1088 (Jan. 9, 2012). coverage if the plan complies with its
obligations under this section applicable obligations under paragraph (c) of this
to such issuer. ■ 7. Section 2590.715–2713A is section, without regard to whether the
(2) A group health plan is considered amended by: issuer complies with the obligations
■ a. Revising paragraph (a)(5);
to comply with any applicable under this section applicable to such
■ b. Redesignating paragraphs (e) and (f)
requirement under § 54.9815– issuer.
as paragraphs (f) and (g); and
2713(a)(1)(iv) to provide contraceptive ■ c. Adding new paragraph (e). * * * * *
coverage if the plan complies with its The revision and addition read as
obligations under paragraph (c) of this DEPARTMENT OF HEALTH AND
follows: HUMAN SERVICES
section, without regard to whether the
issuer complies with the obligations § 2590.715–2713A Accommodations in For the reasons set forth in the
under this section applicable to such connection with coverage of preventive preamble, the Department of Health and
issuer. health services. Human Services adopts as final the
(f) Definition. For the purposes of this (a) * * * interim final rules amending 45 CFR
section, reference to ‘‘contraceptive’’ (5) An eligible organization may part 147 published on October 13, 2017
services, benefits, or coverage includes revoke its use of the accommodation (82 FR 47792) with the following
contraceptive or sterilization items, process, and its issuer or third party changes:
procedures, or services, or related administrator must provide participants
patient education or counseling, to the and beneficiaries written notice of such PART 147—HEALTH INSURANCE
extent specified for purposes of revocation, as specified herein. REFORM REQUIREMENTS FOR THE
§ 54.9815–2713(a)(1)(iv). (i) Transitional rule—If contraceptive GROUP AND INDIVIDUAL HEALTH
(g) Severability. Any provision of this coverage is being offered on the date on INSURANCE MARKETS
section held to be invalid or which these final rules go into effect, by
unenforceable by its terms, or as applied an issuer or third party administrator ■ 8. The authority citation for part 147
to any person or circumstance, shall be through the accommodation process, an is revised to read as follows:
construed so as to continue to give eligible organization may give 60-days Authority: 42 U.S.C. 300gg through 300gg–
maximum effect to the provision notice pursuant to PHS Act section 63, 300gg–91, and 300gg–92, as amended.
permitted by law, unless such holding 2715(d)(4) and § 2590.715–2715(b), if
applicable, to revoke its use of the ■ 9. Section 147.131 is amended by:
shall be one of utter invalidity or ■ a. Revising paragraph (c)(4);
unenforceability, in which event the accommodation process (to allow for the
■ b. Redesignating paragraphs (f) and (g)
provision shall be severable from this provision of notice to plan participants
as (g) and (h); and
section and shall not affect the in cases where contraceptive benefits
■ c. Adding new paragraph (f).
remainder thereof or the application of will no longer be provided). The revision and addition read as
the provision to persons not similarly Alternatively, such eligible organization follows:
situated or to dissimilar circumstances. may revoke its use of the
accommodation process effective on the § 147.131 Accommodations in connection
§ 54.9815–2713T [Removed] first day of the first plan year that begins with coverage of certain preventive health
on or after 30 days after the date of the services.
■ 4. Section 54.9815–2713T is removed.
revocation. * * * * *
§ 54.9815–2713AT [Removed] (ii) General rule—In plan years that (c) * * *
■ 5. Section 54.9815–2713AT is begin after the date on which these final (4) An eligible organization may
removed. rules go into effect, if contraceptive revoke its use of the accommodation
coverage is being offered by an issuer or process, and its issuer must provide
DEPARTMENT OF LABOR third party administrator through the participants and beneficiaries written
Employee Benefits Security accommodation process, an eligible notice of such revocation, as specified
Administration organization’s revocation of use of the herein.
accommodation process will be effective (i) Transitional rule—If contraceptive
For the reasons set forth in the no sooner than the first day of the first coverage is being offered on January 14,
preamble, the Department of Labor plan year that begins on or after 30 days 2019, by an issuer through the
adopts as final the interim final rules after the date of the revocation. accommodation process, an eligible
amending 29 CFR part 2590 published organization may give 60-days notice
* * * * *
on October 13, 2017 (82 FR 47792) with (e) Reliance—insured group health pursuant to section 2715(d)(4) of the
the following changes: plans—(1) If an issuer relies reasonably PHS Act and § 147.200(b), if applicable,
PART 2590—RULES AND and in good faith on a representation by to revoke its use of the accommodation
REGULATIONS FOR GROUP HEALTH the eligible organization as to its process (to allow for the provision of
PLANS eligibility for the accommodation in notice to plan participants in cases
paragraph (c) of this section, and the where contraceptive benefits will no
■ 6. The authority citation for part 2590 representation is later determined to be longer be provided). Alternatively, such
continues to read, as follows: incorrect, the issuer is considered to eligible organization may revoke its use
comply with any applicable of the accommodation process effective
Authority: 29 U.S.C. 1027, 1059, 1135,
1161–1168, 1169, 1181–1183, 1181 note,
requirement under § 2590.715– on the first day of the first plan year that
1185, 1185a, 1185b, 1191, 1191a, 1191b, and 2713(a)(1)(iv) to provide contraceptive begins on or after 30 days after the date
1191c; sec. 101(g), Pub. L. 104–191, 110 Stat. coverage if the issuer complies with the of the revocation.
1936; sec. 401(b), Pub. L. 105–200, 112 Stat. obligations under this section applicable (ii) General rule—In plan years that
645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. to such issuer. begin after January 14, 2019, if
contraceptive coverage is being offered maintained by an objecting coverage for contraceptive services
by an issuer through the organization, or health insurance under Guidelines issued under
accommodation process, an eligible coverage offered or arranged by an § 147.130(a)(1)(iv) unless it is also
organization’s revocation of use of the objecting organization, to the extent of exempt from that requirement.
accommodation process will be effective the objections specified below. Thus the (2) The exemption of this paragraph
no sooner than the first day of the first Health Resources and Service (a) will apply to the extent that an entity
plan year that begins on or after 30 days Administration will exempt from any described in paragraph (a)(1) of this
after the date of the revocation. guidelines’ requirements that relate to section objects, based on its sincerely
* * * * * the provision of contraceptive services: held religious beliefs, to its establishing,
(f) Reliance—(1) If an issuer relies * * * * * maintaining, providing, offering, or
reasonably and in good faith on a (ii) A group health plan, and health arranging for (as applicable):
representation by the eligible insurance coverage provided in (i) Coverage or payments for some or
organization as to its eligibility for the connection with a group health plan, all contraceptive services; or
accommodation in paragraph (d) of this where the plan or coverage is (ii) A plan, issuer, or third party
section, and the representation is later established or maintained by a church, administrator that provides or arranges
determined to be incorrect, the issuer is an integrated auxiliary of a church, a such coverage or payments.
considered to comply with any convention or association of churches, a (b) Objecting individuals. Guidelines
applicable requirement under religious order, a nonprofit organization, issued under § 147.130(a)(1)(iv) by the
§ 147.130(a)(1)(iv) to provide or other non-governmental organization Health Resources and Services
contraceptive coverage if the issuer or association, to the extent the plan Administration must not provide for or
complies with the obligations under this sponsor responsible for establishing support the requirement of coverage or
section applicable to such issuer. and/or maintaining the plan objects as payments for contraceptive services
(2) A group health plan is considered specified in paragraph (a)(2) of this with respect to individuals who object
to comply with any applicable section. The exemption in this as specified in this paragraph (b), and
requirement under § 147.130(a)(1)(iv) to paragraph applies to each employer, nothing in § 147.130(a)(1)(iv), 26 CFR
provide contraceptive coverage if the organization, or plan sponsor that 54.9815–2713(a)(1)(iv), or 29 CFR
plan complies with its obligations under adopts the plan; 2590.715–2713(a)(1)(iv) may be
paragraph (d) of this section, without (iii) An institution of higher education construed to prevent a willing health
regard to whether the issuer complies as defined in 20 U.S.C. 1002, which is insurance issuer offering group or
with the obligations under this section non-governmental, in its arrangement of individual health insurance coverage,
applicable to such issuer. student health insurance coverage, to and as applicable, a willing plan
* * * * * the extent that institution objects as sponsor of a group health plan, from
specified in paragraph (a)(2) of this offering a separate policy, certificate or
■ 10. Section 147.132 is amended by:
section. In the case of student health contract of insurance or a separate group
■ a. Revising paragraph (a)(1)
insurance coverage, this section is health plan or benefit package option, to
introductory text;
applicable in a manner comparable to any group health plan sponsor (with
■ b. Redesignating paragraphs (a)(1)(ii)
its applicability to group health respect to an individual) or individual,
and (iii) as paragraphs (iii) and (iv);
■ c. Adding new paragraph (a)(1)(ii);
insurance coverage provided in as applicable, who objects to coverage or
■ d. Revising newly designated
connection with a group health plan payments for some or all contraceptive
paragraph (a)(1)(iii); established or maintained by a plan services based on sincerely held
■ e. Revising newly designated
sponsor that is an employer, and religious beliefs. Under this exemption,
paragraph (a)(1)(iv); and references to ‘‘plan participants and if an individual objects to some but not
■ f. Revising paragraphs (a)(2) and (b).
beneficiaries’’ will be interpreted as all contraceptive services, but the issuer,
The revisions and addition read as references to student enrollees and their and as applicable, plan sponsor, are
follows: covered dependents; and willing to provide the plan sponsor or
(iv) A health insurance issuer offering
individual, as applicable, with a
§ 147.132 Religious exemptions in group or individual insurance coverage
separate policy, certificate or contract of
connection with coverage of certain to the extent the issuer objects as
preventive health services. insurance or a separate group health
specified in paragraph (a)(2) of this
plan or benefit package option that
(a) * * * section. Where a health insurance issuer
omits all contraceptives, and the
(1) Guidelines issued under providing group health insurance
individual agrees, then the exemption
§ 147.130(a)(1)(iv) by the Health coverage is exempt under this
applies as if the individual objects to all
Resources and Services Administration subparagraph (iv), the group health plan
contraceptive services.
must not provide for or support the established or maintained by the plan
requirement of coverage or payments for sponsor with which the health * * * * *
contraceptive services with respect to a insurance issuer contracts remains [FR Doc. 2018–24512 Filed 11–7–18; 4:15 pm]
group health plan established or subject to any requirement to provide BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P
EXHIBIT B
DEPARTMENT OF THE TREASURY FOR FURTHER INFORMATION CONTACT: 2. Exemption for Objecting Entities Based
Jeff Wu at (301) 492–4305 or on Moral Convictions (45 CFR
Internal Revenue Service marketreform@cms.hhs.gov for the 147.133(a))
3. Exemption for Certain Plan Sponsors (45
Centers for Medicare & Medicaid CFR 147.133(a)(1)(i))
26 CFR Part 54 Services (CMS), Department of Health a. Plan sponsors in general (45 CFR
[TD–9841] and Human Services (HHS). 147.133(a)(1)(i) prefatory text)
Amber Rivers or Matthew Litton at (202) b. Nonprofit organizations (45 CFR
RIN 1545–BN91 693–8335 for Employee Benefits 147.133(a)(1)(i)(A))
Security Administration (EBSA), c. For-Profit Entities (45 CFR
DEPARTMENT OF LABOR 147.133(a)(1)(i)(B))
Department of Labor (DOL).
William Fischer at (202) 317–5500 for 4. Institutions of Higher Education (45 CFR
Employee Benefits Security 147.133(a)(1)(ii))
Administration Internal Revenue Service, Department 5. Health Insurance Issuers (45 CFR
of the Treasury. 147.133(a)(1)(iii))
29 CFR Part 2590 Customer Service Information: 6. Description of the Moral Objection (45
Individuals interested in obtaining CFR 147.133(a)(2))
RIN 1210–AB84 information from the Department of 7. Individuals (45 CFR 147.133(b))
Labor concerning employment-based 8. Accommodation (45 CFR 147.131, 26
DEPARTMENT OF HEALTH AND health coverage laws may call the EBSA CFR 54.9815–2713A, 29 CFR 2590.715–
HUMAN SERVICES Toll-Free Hotline at 1–866–444–EBSA 2713A)
9. Definition of Contraceptives for the
(3272) or visit DOL’s website
45 CFR Part 147 Purpose of These Final Rules
(www.dol.gov/ebsa). Information from 10. Severability
[CMS–9925–F] HHS on private health insurance C. Other Public Comments
coverage can be found on CMS’s website 1. Items Approved as Contraceptives But
RIN 0938–AT46
(www.cms.gov/cciio), and information Used to Treat Existing Conditions
Moral Exemptions and on health care reform can be found at 2. Comments Concerning Regulatory
Accommodations for Coverage of www.HealthCare.gov. Impact
III. Economic Impact and Paperwork Burden
Certain Preventive Services Under the SUPPLEMENTARY INFORMATION:
A. Executive Orders 12866 and 13563—
Affordable Care Act Department of HHS and Department of
Table of Contents
AGENCY: Internal Revenue Service, Labor
I. Executive Summary and Background 1. Need for Regulatory Action
Department of the Treasury; Employee A. Executive Summary 2. Anticipated Effects
Benefits Security Administration, 1. Purpose B. Special Analyses—Department of the
Department of Labor; and Centers for 2. Summary of the Major Provisions Treasury
Medicare & Medicaid Services, 3. Summary of Costs, Savings and Benefits C. Regulatory Flexibility Act
Department of Health and Human of the Major Provisions D. Paperwork Reduction Act—Department
Services. B. Background of Health and Human Services
II. Overview of the Final Rules and Public E. Paperwork Reduction Act—Department
ACTION: Final rules. Comments of Labor
A. Moral Exemptions and Accommodation F. Regulatory Reform Executive Orders
SUMMARY: These rules finalize, with in General
changes based on public comments, the 13765, 13771 and 13777
1. The Departments’ Authority to Mandate G. Unfunded Mandates Reform Act
interim final rules issued in the Federal Coverage or Provide Exemptions H. Federalism
Register on October 13, 2017 concerning 2. Congress’s History of Protecting Moral IV. Statutory Authority
moral exemptions and accommodations Convictions
regarding coverage of certain preventive a. The Church Amendments’ Protection of I. Executive Summary and Background
services. These rules finalize expanded Moral Convictions
b. Court Precedents Relevant to These A. Executive Summary
exemptions to protect moral beliefs for
certain entities and individuals whose Expanded Exemptions 1. Purpose
c. Conscience Protections in Other Federal
health plans are subject to a mandate of and State Contexts The primary purpose of these final
contraceptive coverage through d. Founding Principles rules is to finalize, with changes in
guidance issued pursuant to the Patient e. Executive Orders Relevant to These response to public comments, the
Protection and Affordable Care Act. Expanded Exemptions interim final regulations with requests
These rules do not alter the discretion f. Litigation Concerning the Mandate for comments (IFCs) published in the
of the Health Resources and Services 3. Whether Moral Exemptions Should Federal Register on October 13, 2017
Administration, a component of the U.S. Exist, and Whom They Should Cover
(82 FR 47838), ‘‘Moral Exemptions and
Department of Health and Human 4. The Departments’ Rebalancing of
Government Interests Accommodations for Coverage of
Services, to maintain the guidelines Certain Preventive Services Under the
5. Burdens on Third Parties
requiring contraceptive coverage where 6. Interim Final Rulemaking Affordable Care Act’’ (the Moral IFC).
no regulatorily recognized objection 7. Health Effects of Contraception and The rules are necessary to protect
exists. These rules also leave in place an Pregnancy sincerely held moral objections of
optional ‘‘accommodation’’ process for 8. Health and Equality Effects of certain entities and individuals. The
certain exempt entities that wish to use Contraceptive Coverage Mandates rules, thus, minimize the burdens
it voluntarily. These rules do not alter 9. Other General Comments imposed on their moral beliefs, with
multiple other federal programs that B. Text of the Final Rules regard to the discretionary requirement
provide free or subsidized 1. Restatement of Statutory Requirements
of Section 2713(a) and (a)(4) of the PHS
that health plans cover certain
contraceptives for women at risk of contraceptive services with no cost-
Act (26 CFR 54.9815–2713(a)(1) and
unintended pregnancy. (a)(1)(iv), 29 CFR 2590.715–2713(a)(1) sharing, which was created by HHS
DATES: Effective date: These regulations and (a)(1)(iv), and 45 CFR 147.130(a)(1) through guidance promulgated by the
are effective on January 14, 2019. and (a)(1)(iv)). Health Resources and Services
Administration (HRSA), pursuant to individuals with respect to their own individual health insurance coverage,
authority granted by the ACA in section coverage, where their health insurance and as applicable, a willing plan
2713(a)(4) of the Public Health Service issuer and plan sponsor, as applicable, sponsor of a group health plan, from
Act. In addition, the rules finalize are willing to provide coverage offering a separate policy, certificate or
references to these moral exemptions in complying with the individual’s moral contract of insurance or a separate group
the previously created accommodation objection. After considering public health plan or benefit package option, to
process that permit entities with certain comments, the Departments have any group health plan sponsor (with
objections voluntarily to continue to decided not to extend the moral respect to an individual) or individual,
object while the persons covered in exemptions to non-federal governmental as applicable, who objects to coverage or
their plans receive contraceptive entities at this time, although payments for some or all contraceptive
coverage or payments arranged by their individuals receiving employer- services based on sincerely held moral
issuers or third party administrators. sponsored insurance from a convictions. The exemption adds that, if
The rules do not remove the governmental entity may use the an individual objects to some but not all
contraceptive coverage requirement individual exemption if the other terms contraceptive services, but the issuer,
generally from HRSA’s guidelines. The of the individual exemption apply, and as applicable, plan sponsor, are
changes to the rules being finalized will including that their employer is willing willing to provide the plan sponsor or
ensure clarity in implementation of the to offer them a plan consistent with individual, as applicable, with a
moral exemptions so that proper respect their moral objection. separate policy, certificate or contract of
is afforded to sincerely held moral In response to public comments, insurance or a separate group health
convictions in rules governing this area various changes are made to clarify the plan or benefit package option that
of health insurance and coverage, with intended scope of the language in the omits all contraceptives, and the
minimal impact on HRSA’s decision to Moral IFC’s exemptions. The prefatory individual agrees, then the exemption
otherwise require contraceptive exemption language is clarified to applies as if the individual objects to all
coverage. ensure exemptions apply to a group contraceptive services.
health plan established or maintained
2. Summary of the Major Provisions by an objecting organization, or health b. References to Moral Exemptions in
a. Moral Exemptions insurance coverage offered or arranged Accommodation Regulations and in
by an objecting organization, to the Regulatory Restatement of Statutory
These rules finalize exemptions extent of the objections. The Language
provided in the Moral IFC for the group Departments add language to specify These rules finalize without change
health plans and health insurance that the exemption for institutions of the references to the moral exemptions
coverage of various entities and higher education applies to non- that were inserted by the Moral IFC into
individuals with sincerely held moral governmental entities. The Departments the rules that regulatorily restate the
convictions opposed to coverage of also modified language describing the statutory language from section 2713(a)
some or all contraceptive or sterilization moral objection applicable to the and (a)(4) of the Public Health Service
methods encompassed by HRSA’s exemptions, to specify that the entity Act. Similarly, these rules finalize
guidelines. As in the Moral IFC, the objects, based on its sincerely held without change from the Moral IFC
exemptions include plan sponsors that moral convictions, to its establishing, references to the moral exemptions that
are nonprofit organization plan sponsors maintaining, providing, offering, or were inserted into the regulations
or for-profit entities that have no arranging for (as applicable) either: governing the optional accommodation
publicly traded ownership interests Coverage or payments for some or all process. These references operationalize
(defined as any class of common equity contraceptive services; or a plan, issuer, the effect of the moral exemptions rule,
securities required to be registered or third party administrator that and they allow contraceptive services to
under section 12 of the Securities provides or arranges such coverage or be made available to women if any
Exchange Act of 1934). The exemptions payments. employers with non-religious moral
also continue to include institutions of The Departments also clarify language
objections to contraceptive coverage
higher education in their arrangement of in the exemption applicable to plans of
choose to use the optional
student health insurance coverage; objecting individuals. The clarification
accommodation process.
health insurance issuers (but only with is made to ensure that the HRSA
respect to plans that are otherwise also guidelines do not prevent a willing 3. Summary of Costs, Savings and
exempt under the rules); and objecting health insurance issuer offering group or Benefits of the Major Provisions
Provision Savings and Benefits Costs
Finalizing insertion of ref- These provisions, finalized without change, are for the We estimate no costs from finalizing this part of the
erences to moral exemp- purpose of inserting references to the moral exemp- rule.
tions into restatement of tions into the regulatory restatement of section
statutory language from 2713(a) and (a)(4) of the Public Health Service Act,
section 2713(a) and (a)(4) which already references the religious exemptions.
of the Public Health Serv- This operationalizes the moral exemptions in each of
ice Act. the tri-agencies’ rules. We estimate no economic
savings or benefit from finalizing this part of the rule,
but consider it a deregulatory action to minimize the

regulatory impact beyond the scope set forth in the
statute.
Provision Savings and Benefits Costs
Finalized moral exemptions The moral exemptions to the contraceptive coverage We estimate there will be only a small amount of costs
requirement are finalized with technical changes. for these exemptions, because they will primarily be
Their purpose is to relieve burdens that some entities used by organizations and individuals that do not
and individuals experience from being forced to want contraceptive coverage. To the extent some
choose between, on the one hand, complying with other employers will use the exemption where there
their moral beliefs and facing penalties from failing to will be transfer costs for women previously receiving
comply with the contraceptive coverage requirement, contraceptive coverage who will no longer receive
and on the other hand, providing (or, for individuals, that coverage, we expect those costs to be minimal
obtaining) contraceptive coverage in violation of their due to the small number of entities expected to use
sincerely held moral beliefs. the exemptions with non-religious moral objections.
We estimate the transfer costs will amount to $8,760.
Finalizing insertion of ref- These provisions, finalized without change, will allow We do not estimate any entities with non-religious
erences to moral exemp- organizations with moral objections to contraceptive moral objections to use the accommodation process
tions into optional accom- coverage on the basis of sincerely held moral convic- at this time.
modation regulations. tions to use the accommodation as an optional proc-
ess. These provisions will allow contraceptive cov-
erage to be made available to women covered by
plans of employers that object to contraceptive cov-
erage but do not object to their issuers or third party
administrators arranging for such coverage to be pro-
vided to persons covered by their plans.
B. Background enacted the Patient Protection and health insurance issuers providing
Over many decades, Congress has Affordable Care Act (PPACA) (Pub. L. health insurance coverage in connection
protected conscientious objections 111–148) (March 23, 2010). Congress with group health plans. The sections of
including based on moral convictions in enacted the Health Care and Education the PHS Act incorporated into ERISA
the context of health care and human Reconciliation Act of 2010 (HCERA) and the Code are sections 2701 through
services, and including health coverage, (Pub. L. 111–152) on March 30, 2010, 2728.
even as it has sought to promote access which, among other things, amended In section 2713(a)(4) of the PHS Act
to health services.1 In 2010, Congress PPACA. As amended by HCERA, (hereinafter ‘‘section 2713(a)(4)’’),
PPACA is known as the Affordable Care Congress provided administrative
1 See, for example, 42 U.S.C. 300a–7 (protecting Act (ACA). discretion to require that certain group
individuals and health care entities from being The ACA reorganized, amended, and health plans and health insurance
required to provide or assist sterilizations, added to the provisions of part A of title issuers cover certain women’s
abortions, or other lawful health services if it would XXVII of the Public Health Service Act preventive services, in addition to other
violate their ‘‘religious beliefs or moral
convictions’’); 42 U.S.C. 238n (protecting (PHS Act) relating to group health plans preventive services required to be
individuals and entities that object to abortion); and health insurance issuers in the covered in section 2713. Congress
Consolidated Appropriations Act, 2018, Div. H, Sec. group and individual markets. The ACA granted that discretion to the Health
507(d) (Departments of Labor, HHS, and Education, added section 715(a)(1) to the Employee Resources and Services Administration
and Related Agencies Appropriations Act), Public
Law 115–141, 132 Stat. 348, 764 (Mar. 23, 2018) Retirement Income Security Act of 1974 (HRSA), a component of the U.S.
(protecting any ‘‘health care professional, a (ERISA) and section 9815(a)(1) to the Department of Health and Human
hospital, a provider-sponsored organization, a Internal Revenue Code (Code), in order Services (HHS). Specifically, section
health maintenance organization, a health 2713(a)(4) allows HRSA discretion to
insurance plan, or any other kind of health care
to incorporate the provisions of part A
facility, organization, or plan’’ in objecting to of title XXVII of the PHS Act into ERISA specify coverage requirements, ‘‘with
abortion for any reason); Id. at Div. E, Sec. 726(c) and the Code, and to make them respect to women, such additional
(Financial Services and General Government applicable to group health plans and preventive care and screenings as
Appropriations Act) (protecting individuals who provided for in comprehensive
object to prescribing or providing contraceptives
contrary to their ‘‘religious beliefs or moral advance directives); 42 U.S.C. 1396u–2(b)(3) guidelines supported’’ by HRSA (the
convictions’’); Id. at Div. E, Sec. 808 (regarding any (protecting against forced counseling or referrals in ‘‘Guidelines’’).
requirement of ‘‘the provision of contraceptive Medicaid managed care plans with respect to Since 2011, HRSA has exercised that
coverage by health insurance plans’’ in the District objections based on ‘‘moral or religious grounds’’);
42 U.S.C. 2996f(b) (protecting objection to abortion
discretion to require coverage for,
of Columbia, ‘‘it is the intent of Congress that any
legislation enacted on such issue should include a funding in legal services assistance grants based on among other things, certain
‘conscience clause’ which provides exceptions for ‘‘religious beliefs or moral convictions’’); 42 U.S.C. contraceptive services.2 In the same
religious beliefs and moral convictions.’’); Id. at 14406 (protecting organizations and health
Div. K, Title III (Department of State, Foreign providers from being required to inform or counsel 2 The references in this document to
Operations, and Related Programs Appropriations persons pertaining to assisted suicide); 42 U.S.C. ‘‘contraception,’’ ‘‘contraceptive,’’ ‘‘contraceptive
Act) (protecting applicants for family planning 18023 (blocking any requirement that issuers or coverage,’’ or ‘‘contraceptive services’’ generally
funds based on their ‘‘religious or conscientious exchanges must cover abortion); 42 U.S.C. 18113 include all contraceptives, sterilization, and related
commitment to offer only natural family (protecting health plans or health providers from patient education and counseling, required by the
planning’’); 42 U.S.C. 290bb–36 (prohibiting the being required to provide an item or service that Women’s Preventive Guidelines, unless otherwise
statutory section from being construed to require helps cause assisted suicide); see also 8 U.S.C. indicated. The Guidelines issued in 2011 referred
suicide related treatment services for youth where 1182(g) (protecting vaccination objections by to ‘‘Contraceptive Methods and Counseling’’ as
the parents or legal guardians object based on ‘‘aliens’’ due to ‘‘religious beliefs or moral ‘‘[a]ll Food and Drug Administration approved
‘‘religious beliefs or moral objections’’); 42 U.S.C. convictions’’); 18 U.S.C. 3597 (protecting objectors contraceptive methods, sterilization procedures,
1395w–22(j)(3)(B) (protecting against forced to participation in Federal executions based on and patient education and counseling for all women
counseling or referrals in Medicare+Choice, now ‘‘moral or religious convictions’’); 20 U.S.C. 1688 with reproductive capacity.’’ https://www.hrsa.gov/
Medicare Advantage, managed care plans with (prohibiting sex discrimination law to be used to womens-guidelines/index.html. The Guidelines as
respect to objections based on ‘‘moral or religious require assistance in abortion for any reason); 22 amended in December 2016 refer, under the header
grounds’’); 42 U.S.C. 1396a(w)(3) (ensuring U.S.C. 7631(d) (protecting entities from being ‘‘Contraception,’’ to: ‘‘the full range of female-
particular Federal law does not infringe on required to use HIV/AIDS funds contrary to their controlled U.S. Food and Drug Administration-
‘‘conscience’’ as protected in State law concerning ‘‘religious or moral objection’’). approved contraceptive methods, effective family
time period, the administering During the period when the have a moral objection. Under
agencies—HHS, the Department of Departments were publishing and regulations preceding October 2017,
Labor, and the Department of the modifying the regulations, organizations these organizations neither received an
Treasury (collectively, ‘‘the and individuals filed dozens of lawsuits exemption from the Mandate nor
Departments’’ 3)—exercised discretion challenging the contraceptive coverage qualified for the accommodation. For
to allow exemptions to those requirement and regulations example, March for Life filed a
requirements by issuing rulemaking (hereinafter, the ‘‘contraceptive complaint claiming that the Mandate
various times, including issuing and Mandate,’’ or the ‘‘Mandate’’). Plaintiffs violated the equal protection component
finalizing three interim final regulations included religious nonprofit of the Due Process Clause of the Fifth
prior to 2017.4 In those regulations, the organizations, businesses run by Amendment, and was arbitrary and
Departments crafted exemptions and religious families, individuals, and capricious under the Administrative
accommodations for certain religious others, including several non-religious Procedure Act (APA). Citing, for
objectors where the Guidelines require organizations that opposed coverage of example, 77 FR 8727, March for Life
coverage of contraceptive services, certain contraceptives under the argued that the Departments’ stated
changed the scope of those exemptions Mandate on the basis of non-religious interests behind the Mandate were only
and accommodations, and solicited moral convictions. For-profit entities advanced among women who ‘‘want’’
public comments on a number of with religious objections won various the coverage so as to prevent
occasions. Public comments were court decisions leading to the Supreme ‘‘unintended’’ pregnancy. March for Life
submitted on various iterations of the Court’s ruling in Burwell v. Hobby contended that, because it only hires
regulations issued before 2017, and Lobby Stores, Inc. 134 S. Ct. 2751 employees who publicly advocate
some of those comments supported (2014). The Supreme Court ruled against against abortion, including what they
expanding the exemptions to include the Departments and held that, under regard as abortifacient contraceptive
those who oppose the contraceptive the Religious Freedom Restoration Act items, the Departments’ interests were
coverage mandate for either religious of 1993 (RFRA), the Mandate could not not rationally advanced by imposing the
‘‘or moral’’ reasons, consistent with be applied to the closely held for-profit Mandate upon it and its employees.
various state laws (such as in corporations before the Court because Accordingly, March for Life contended
Connecticut or Missouri) that protect their owners had religious objections to that applying the Mandate to it (and
objections to contraceptive coverage providing such coverage.6 Later, a other similarly situated organizations)
based on moral convictions.5 second series of legal challenges were lacked a rational basis and, therefore,
filed by religious nonprofit was arbitrary and capricious in violation
planning practices, and sterilization procedures,’’ organizations that stated the of the APA. March for Life further
‘‘contraceptive counseling, initiation of
contraceptive use, and follow-up care (e.g., accommodation impermissibly contended that, because the
management, and evaluation as well as changes to burdened their religious beliefs because Departments concluded the
and removal or discontinuation of the contraceptive it utilized their health plans to provide government’s interests were not
method),’’ and ‘‘instruction in fertility awareness-
based methods, including the lactation amenorrhea
services to which they objected on undermined by exempting houses of
method.’’ https://www.hrsa.gov/womens-guidelines- religious grounds, and it required them worship and integrated auxiliaries
2016/index.html. to submit a self-certification or notice. (based on the assumption that such
3 Note, however, that in sections under headings
On May 16, 2016, the Supreme Court entities are relatively more likely than
listing only two of the three Departments, the term issued a per curiam decision, vacating other nonprofits with religious
‘‘Departments’’ generally refers only to the two
Departments listed in the heading. the judgments of the Courts of objections to have employees that share
4 Interim final regulations on July 19, 2010, at 75 Appeals—most of which had ruled in their views against certain
FR 41726 (July 2010 interim final regulations); the Departments’ favor—and remanding contraceptives), applying the Mandate
interim final regulations amending the July 2010 the cases ‘‘in light of the substantial to March for Life or similar
interim final regulations on August 3, 2011, at 76
FR 46621; final regulations on February 15, 2012, clarification and refinement in the organizations that definitively hire only
at 77 FR 8725 (2012 final regulations); an advance positions of the parties’’ that had been employees who oppose certain
notice of proposed rulemaking (ANPRM) on March filed in supplemental briefs. Zubik v. contraceptives lacked a rational basis
21, 2012, at 77 FR 16501; proposed regulations on Burwell, 136 S. Ct. 1557, 1560 (2016). and, therefore, violated their right of
February 6, 2013, at 78 FR 8456; final regulations
on July 2, 2013, at 78 FR 39870 (July 2013 final The Court stated that it anticipated that, equal protection under the Due Process
regulations); interim final regulations on August 27, on remand, the Courts of Appeals would Clause.
2014, at 79 FR 51092 (August 2014 interim final ‘‘allow the parties sufficient time to
regulations); proposed regulations on August 27,
March for Life’s employees, who
2014, at 79 FR 51118 (August 2014 proposed
resolve any outstanding issues between stated they were personally religious
regulations); final regulations on July 14, 2015, at them.’’ Id. (although personal religiosity was not a
80 FR 41318 (July 2015 final regulations); and a Beginning in 2015, lawsuits condition of their employment), also
request for information on July 26, 2016, at 81 FR challenging the Mandate were also filed
47741 (RFI), which was addressed in an FAQ
sued as co-plaintiffs. They contended
document issued on January 9, 2017, available at:
by various non-religious organizations that the Mandate violated their rights
https://www.dol.gov/sites/default/files/ebsa/about- with moral objections to contraceptive under RFRA by making it impossible for
ebsa/our-activities/resource-center/faqs/aca-part- coverage. These organizations stated them to obtain health coverage
36.pdf and https://www.cms.gov/CCIIO/Resources/ that they believe some methods
Fact-Sheets-and-FAQs/Downloads/ACA-FAQs- consistent with their religious beliefs,
Part36_1-9-17-Final.pdf. classified by the Food and Drug either from the plan March for Life
5 See, for example, Denise M. Burke, Re: file code Administration (FDA) as contraceptives wanted to offer them, or in the
CMS–9968–P, Regulations.gov (posted May 5, may have an abortifacient effect and, individual market, because the
2013), http://www.regulations.gov/ therefore, in their view, are morally

#!documentDetail;D=CMS-2012-0031-79115;
Departments offered no exemptions in
Comment, Regulations.gov (posted Oct. 26, 2016),
equivalent to abortion to which they either circumstance. Another non-
https://www.regulations.gov/document?D=CMS- religious nonprofit organization that
2016-0123-54142; David Sater, Re: CMS–9931–NC: www.regulations.gov/document?D=CMS-2016-0123- opposed the Mandate’s requirement to
Request for Information, Regulations.gov (posted 46220.
Oct. 26, 2016), https://www.regulations.gov/ 6 The Supreme Court did not decide whether provide certain contraceptive coverage
document?D=CMS-2016-0123-54218; Comment, RFRA would apply to publicly traded for-profit on moral grounds also filed a lawsuit
Regulations.gov (posted Oct. 26, 2016), https:// corporations. See 134 S. Ct. at 2774. challenging the Mandate. Real
Alternatives, Inc. v. Burwell, 150 F. the moral convictions of certain counseling for women at risk of
Supp. 3d 419 (M.D. Pa. 2015). employers, individuals and health unintended pregnancy.9
Challenges by non-religious nonprofit insurance issuers where the coverage of
organizations led to conflicting opinions 1. The Departments’ Authority To
contraceptive services is concerned.
among the federal courts. A district Mandate Coverage or Provide
Comments were requested on the
court agreed with the March for Life Exemptions
interim final regulations.
plaintiffs on the organization’s equal After consideration of the comments The Departments received conflicting
protection claim and the employees’ and feedback received from comments on their legal authority to
RFRA claims, while not specifically stakeholders, the Departments are provide exemptions and
ruling on the APA claim, and issued a finalizing the Moral IFC, with changes accommodations to the Mandate. Some
permanent injunction against the based on comments as indicated commenters agreed that the
Departments that is still in place. March herein.7 Departments are legally authorized to
for Life v. Burwell, 128 F. Supp. 3d 116 provide expanded exemptions and an
(D.D.C. 2015). The appeal in March for II. Overview of the Final Rules and
accommodation for moral convictions,
Life is pending and has been stayed Public Comments
noting that there was no requirement of
since early 2016. In another case, federal During the 60-day comment period for contraceptive coverage in the ACA and
district and appellate courts in the Moral IFC, which closed on no prohibition on providing moral
Pennsylvania disagreed with the December 5, 2017, the Departments exemptions in Guidelines issued under
reasoning in March for Life, and ruled received over 54,000 public comment section 2713(a)(4). Other commenters,
against claims brought by a similarly submissions, which are posted to however, asserted that the Departments
non-religious nonprofit employer and www.regulations.gov.8 Below, the have no legal authority to provide any
its religious employees. Real Departments provide an overview of the exemptions to the contraceptive
Alternatives, 150 F. Supp. 3d 419, final rules and address the issues raised Mandate, contending, based on
affirmed by 867 F.3d 338 (3d Cir. 2017). in the comments we received. statements in the ACA’s legislative
One member of the appeals court panel history, that the ACA requires
in Real Alternatives v. Sec’y of HHS A. Moral Exemptions and
Accommodation in General contraceptive coverage. Still other
dissented in part, stating he would have commenters contended that the
ruled in favor of the individual These rules expand exemptions to Departments are legally authorized to
employee plaintiffs under RFRA. 867 protect certain entities and individuals provide the religious exemptions that
F.3d 338, 367 (3d Cir. 2017) (Jordan, J., with moral convictions that oppose existed prior to the 2017 IFCs, but not
dissenting). contraception whose health plans are to protect moral convictions.
The Departments most recently subject to a mandate of contraceptive The Departments conclude that we
solicited public comments on these coverage through guidance issued are legally authorized to provide the
issues again in two interim final pursuant to the ACA. These rules do not exemption and accommodation for
regulations with request for comments alter the discretion of HRSA, a moral convictions set forth in the Moral
published in the Federal Register on component of HHS, to maintain the IFC and these final rules. These rules
October 13, 2017: The regulations (82 Guidelines requiring contraceptive concern section 2713 of the PHS Act, as
FR 47838) (the Moral IFC) that are being coverage where no regulatorily incorporated into ERISA and the Code.
finalized with changes here, and the recognized objection exists. These rules Congress has granted the Departments
regulations (82 FR 47792) (the Religious also make available to exempt legal authority, collectively, to
IFC) published on the same day as the organizations the accommodation administer these statutes. (26 U.S.C.
Moral IFC, which are being finalized process, which was previously 9833; 29 U.S.C. 1191c; 42 U.S.C. 300gg–
with changes in the companion final established in response to some 92).
rules published elsewhere in today’s objections of religious organizations, as Where it applies, section 2713(a)(4)
Federal Register. an optional process for exempt entities
In the preamble to the Moral IFC, the requires coverage without cost sharing
that wish to use it voluntarily. These for ‘‘such additional’’ women’s
Departments explained several reasons rules do not alter multiple other federal
why, after exercising our discretion to preventive care and screenings ‘‘as
programs that provide free or subsidized provided for’’ and ‘‘supported by’’
reevaluate the exemptions and contraceptives or related education and
accommodations for the contraceptive guidelines developed by HHS acting
Mandate, we sought public comment on 7 The Department of the Treasury and Internal
through HRSA. When Congress enacted
whether to protect moral convictions in Revenue Service published proposed and
this provision, those Guidelines did not
the Moral IFC and these final rules. The temporary regulations as part of the joint exist. And nothing in the statute
Departments noted that we considered, rulemaking of the Moral IFC. The Departments of mandated that the Guidelines had to
Labor and HHS published their respective rules as include contraception, let alone for all
among other things, Congress’s history interim final rules with request for comments and
of providing protections for moral are finalizing their interim final rules in these final
types of employers with covered plans.
convictions regarding certain health rules. The Department of the Treasury and Internal Instead, section 2713(a)(4) provided a
services (including contraception, Revenue Service are finalizing their regulations.
8 See Regulations.gov at https:// 9 See, for example, Family Planning grants in 42
sterilization, and items or services www.regulations.gov/searchResults?rpp=25&so= U.S.C. 300, et seq.; the Teenage Pregnancy
believed to involve abortion); the text, DESC&sb=postedDate&po=0&cmd= Prevention Program, Public Law 112–74 (125 Stat
context, and intent of section 2713(a)(4) 12%7C05%7C17-12%7C05%7C17&dktid=CMS- 786, 1080); the Healthy Start Program, 42 U.S.C.
and the ACA; Executive Order 13798, 2017-0133 and https://www.regulations.gov/ 254c–8; the Maternal, Infant, and Early Childhood
docketBrowser?rpp=25&so=ASC&sb=posted Home Visiting Program, 42 U.S.C. 711; Maternal

‘‘Promoting Free Speech and Religious Date&po=100&D=IRS-2017-0015. Some of those and Child Health Block Grants, 42 U.S.C. 703; 42
Liberty’’ (May 4, 2017); previously submissions included form letters or attachments U.S.C. 247b–12; Title XIX of the Social Security
submitted public comments; and the that, while not separately tabulated at Act, 42 U.S.C. 1396, et seq.; the Indian Health
extensive litigation over the regulations.gov, together included comments from, Service, 25 U.S.C. 13, 42 U.S.C. 2001(a), & 25 U.S.C.
or were signed by, possibly over a hundred 1601, et seq.; Health center grants, 42 U.S.C.
contraceptive Mandate. The thousand separate persons. The Departments 254b(e), (g), (h), & (i); the NIH Clinical Center, 42
Departments concluded that it was reviewed all of the public comments and U.S.C. 248; and the Personal Responsibility
appropriate that HRSA take into account attachments. Education Program, 42 U.S.C. 713.
positive grant of authority for HSRA to mirrors other distinctions within that Mandate if HRSA decides to otherwise
develop those Guidelines, thus section that demonstrate that Congress include contraceptives in its Guidelines.
delegating authority to HHS to shape intended HRSA to have the discretion The Departments’ conclusions are
that development, as the administering the Agencies invoke. For example, consistent with our interpretation of
agency of HRSA, and to all three sections (a)(1) and (a)(3) require section 2713 of the PHS Act since 2010,
agencies as the administering agencies ‘‘evidence-based’’ or ‘‘evidence- when the ACA was enacted, and since
of the statutes by which the Guidelines informed’’ coverage, while section (a)(4) the Departments started to issue interim
are enforced. See 26 U.S.C. 9833; 29 does not. This difference suggests that final regulations implementing that
U.S.C. 1191(c), 42 U.S.C. 300gg–92. That the Agencies have the leeway to section. The Departments have
is especially true for HHS, as HRSA is incorporate policy-based concerns into consistently interpreted section
a component of HHS that was their decision-making. This reading of 2713(a)(4) to grant broad discretion to
unilaterally created by the agency and section 2713(a)(4) also prevents the decide the extent to which HRSA will
thus is subject to the agency’s general statute from being interpreted in a provide for, and support, the coverage of
supervision, see 47 FR 38409 (August additional women’s preventive care and
cramped way that allows no flexibility
31, 1982). Thus, nothing prevented screenings, including the decision to
or tailoring, and that would force the
HRSA from creating an exemption from exempt certain entities and plans, and
Departments to choose between ignoring
otherwise-applicable guidelines or not to provide for or support the
religious objections in violation of application of the Guidelines with
prevented HHS and the other agencies RFRA or else eliminating the
from directing that HRSA create such an respect to those entities or plans. The
contraceptive coverage requirement Departments created an exemption to
exemption. from the Guidelines altogether. The
Congress did not specify the extent to the contraceptive Mandate when that
Departments instead interpret section Mandate was announced in 2011, and
which HRSA must ‘‘provide for’’ and
2713(a)(4) as authorizing HRSA’s then amended and expanded the
‘‘support’’ the application of Guidelines
Guidelines to set forth both the kinds of exemption and added an
that it chooses to adopt. HRSA’s
items and services that will be covered, accommodation process in multiple
authority to support ‘‘comprehensive
and the scope of entities to which the rulemakings thereafter. The
guidelines’’ involves determining both
the types of coverage and scope of that contraceptive coverage requirement in accommodation process requires the
coverage. Section 2714(a)(4) requires those Guidelines will apply. provision of coverage or payments for
coverage for preventive services only The moral objections at issue here, contraceptives to plan participants in an
‘‘as provided for in comprehensive like the religious objections prompting eligible organization’s health plan by
guidelines supported by [HRSA].’’ That exemptions dating back to the inception the organization’s insurer or third party
is, services are required to be included of the Mandate in 2011, may, consistent administrator. However, the
in coverage only to the extent that the with the statutory provision, accommodation process itself, in some
Guidelines supported by HRSA provide permissibly inform what HHS, through cases, failed to require contraceptive
for them. Through use of the word ‘‘as’’ HRSA, decides to provide for and coverage for many women, because—as
in the phrase ‘‘as provided for,’’ it support in the Guidelines. Since the the Departments acknowledged at the
requires that HRSA support how those first rulemaking on this subject in 2011, time—the enforcement mechanism for
services apply—that is, the manner in the Departments have consistently that process, section 3(16) of ERISA,
which the support will happen, such as interpreted the broad discretion granted does not provide a means to impose an
in the phrase ‘‘as you like it.’’ 10 When to HRSA in section 2713(a)(4) as obligation to provide contraceptive
Congress means to require certain including the power to reconcile the coverage on the third party
activities to occur in a certain manner, ACA’s preventive-services requirement administrator of self-insured church
instead of simply authorizing the agency with sincerely held views of conscience plans (see 80 FR 41323). Non-exempt
to decide the manner in which they will employers participate in many church
on the sensitive subject of contraceptive
occur, Congress knows how to do so. plans. Therefore, in both the previous
coverage—namely, by exempting
exemption, and in the previous
See for example, 42 U.S.C. 1395x (‘‘The churches and their integrated auxiliaries
accommodation’s application to self-
Secretary shall establish procedures to from the contraceptive-coverage
insured church plans, the Departments
make beneficiaries and providers aware Mandate. (See 76 FR at 46623.) As the have been choosing not to require
of the requirement that a beneficiary Departments explained at that time, the contraceptive coverage for certain kinds
complete a health risk assessment prior HRSA Guidelines ‘‘exist solely to bind of employers since the Guidelines were
to or at the same time as receiving non-grandfathered group health plans adopted. In doing so, the Departments
personalized prevention plan services.’’) and health insurance issuers with have been acting contrary to
(emphasis added). Thus, the inclusion respect to the extent of their coverage of commenters who contended the
of ‘‘as’’ in section 300gg–13(a)(3), and its certain preventive services for women,’’ Departments had no authority to create
absence in similar neighboring and ‘‘it is appropriate that HRSA . . . exemptions under section 2713 of the
provisions, shows that HRSA has takes into account the effect on the PHS Act, or its incorporation into
discretion whether to support how the religious beliefs of [employers] if ERISA and the Code, and who
preventive coverage mandate applies—it coverage of contraceptive services were contended instead that the Departments
does not refer to the timing of the required in [their] group health plans.’’ must enforce Guidelines on the broadest
promulgation of the Guidelines. Id. Consistent with that longstanding spectrum of group health plans as
Nor is it simply a textual aberration view, Congress’s grant of discretion in possible, even including churches (see,
that the word ‘‘as’’ is missing from the section 2713(a)(4), and the lack of a for example, 2012 final regulations at 77
other three provisions in section 2713(a) mandate that contraceptives be covered FR 8726).
of the PHS Act. Rather, this difference or that they be covered without any The Departments’ interpretation of
exemptions or exceptions, lead the section 2713(a)(4) is confirmed by the
10 See As (usage 2), Oxford English Dictionary
Online (Feb. 2018) (‘‘[u]sed to indicate by

Departments to conclude that we are ACA’s statutory structure. Congress did
comparison the way something happens or is legally authorized to exempt certain not intend to require entirely uniform
done’’). entities or plans from a contraceptive coverage of preventive services (see for
example, 76 FR 46623). On the contrary, including laws that protect holders of exemptions provided for houses of
Congress carved out an exemption from religious beliefs or moral convictions worship and integrated auxiliaries were
section 2713 of the PHS Act (and from from certain requirements in health care required by the First Amendment, and
several other provisions) for contexts. Although the text of Executive the Court did not say the Departments
grandfathered plans. In contrast, the Order 13535 does not require the must apply the contraceptive Mandate
grandfathering exemption is not expanded exemptions confirmed in unless RFRA prohibits us from doing so.
applicable to many of the other these final rules, the expanded The appropriateness of including
provisions in Title I of the ACA— exemptions are, as explained below, exemptions to protect moral convictions
provisions previously referred to by the consistent with longstanding federal is informed by Congress’s long history
Departments as providing ‘‘particularly laws to protect conscience objections, of providing exemptions for moral
significant protections.’’ (75 FR 34540). based on religious beliefs or moral convictions, especially in certain health
Those provisions include (from the PHS convictions regarding certain health care contexts.
Act) section 2704, which prohibits matters, and are consistent with the 2. Congress’s History of Protecting
preexisting condition exclusions or intent that the ACA be implemented in Moral Convictions
other discrimination based on health accordance with the conscience
status in group health coverage; section protections set forth in those laws. The Department received numerous
2708, which prohibits excessive waiting Some commenters contended that, comments about its decision in the
periods (as of January 1, 2014); section even though Executive Order 13535 Moral IFC to exercise its discretion to
2711, which relates to lifetime dollar refers to the Church Amendments, the provide moral exemptions to, and an
limits; section 2712, which generally intention of those statutes is narrow, accommodation under, the
prohibits rescission of health coverage; should not be construed to extend to contraceptive Mandate. Some
section 2714, which extends dependent entities instead of to individuals, and commenters agreed with the
child coverage until the child turns 26; should not be construed to prohibit Departments’ decision in the Moral IFC,
and section 2718, which imposes a procedures. But those comments arguing that it is appropriate to exercise
minimum medical loss ratio on health mistake the Departments’ position. The the Departments’ discretion to protect
insurance issuers in the individual and Departments are not construing the moral convictions in light of Congress’s
group markets (for insured coverage), Church Amendments to require these history of protecting moral convictions
and requires them to provide rebates to exemptions, nor do the exemptions in various contexts, especially
policyholders if that medical loss ratio prohibit any procedures. Instead, concerning health care. Other
is not met. (75 FR 34538, 34540, 34542). through longstanding federal conscience commenters disagreed, saying that
Consequently, of the 150 million statutes, Congress has established existing conscience statutes protecting
nonelderly people in America with consistent principles concerning respect moral convictions do not require these
employer-sponsored health coverage, for sincerely held moral convictions in exemptions and, therefore, the
approximately 25.5 million are sensitive healthcare contexts.12 Under exemptions should not be offered. Some
estimated to be enrolled in those principles, and absent any commenters stated that because
grandfathered plans not subject to contrary requirement of law, the Congress has provided conscience
section 2713.11 Some commenters assert Departments are offering exemptions for protections, but did not specifically
the exemptions for grandfathered plans sincerely held moral convictions to the provide them in section 2713(a)(4),
are temporary, or were intended to be extent the Departments otherwise conscience protections are
temporary, but as the Supreme Court impose a contraceptive Mandate. These inappropriate in the implementation of
observed, ‘‘there is no legal requirement exemptions do not prohibit any that section. Still other commenters
that grandfathered plans ever be phased services, nor authorize employers to went further, disagreeing with
out.’’ Burwell v. Hobby Lobby Stores, prohibit employees from obtaining any conscience protections regarding
Inc., 134 S. Ct. 2751, 2764 n.10 (2014). services. The exemptions in the Moral contraceptives, abortions, or health care
Some commenters argue that IFC and these final rules simply refrain in general.
Executive Order 13535’s reference to from imposing a federal mandate that In deciding the most appropriate way
implementing the ACA consistent with employers cover contraceptives in their to exercise our discretion in this
certain conscience laws does not justify health plans even if they have sincerely context, the Departments draw on the
creating exemptions to contraceptive held moral convictions against doing so. most recent statements of Congress,
coverage in the Guidelines, because Some commenters stated that the along with nearly 50 years of statutes
those laws do not specifically require Supreme Court ruled that the and Supreme Court precedent
exemptions in the Guidelines. The exemptions provided for houses of discussing the protection of moral
Departments, however, believe that they worship and integrated auxiliaries were convictions in certain circumstances—
are acting consistent with Executive required by the First Amendment. From particularly in the context of health care
Order 13535 by creating exemptions this, commenters concluded that the and health coverage. Most recently,
using HRSA’s authority under section exemptions for houses of worship and Congress expressed its intent on the
2713(a)(4), and the Departments’ integrated auxiliaries are legally matter of Government-mandated
administrative authority over the authorized, but that exemptions beyond contraceptive coverage when it
implementation of section 2713(a) of the those are not. But the Supreme Court declared, with respect to the possibility
PHS Act. Executive Order 13535, issued did not rule on the question whether the that the District of Columbia would
upon the signing of the ACA, specified require contraceptive coverage, that ‘‘it
that ‘‘longstanding Federal laws to 12 The Departments note that the Church is the intent of Congress that any
Amendments are the subject of another, ongoing legislation enacted on such issue should
protect conscience . . . remain intact,’’ rulemaking process. See Protecting Statutory
Conscience Rights in Health Care; Delegations of include a ‘conscience clause’ which
11 Kaiser Family Foundation & Health Research & Authority, 83 FR 3880 (NPRM Jan. 26, 2018). Since provides exceptions for religious beliefs
Educational Trust, ‘‘Employer Health Benefits, 2017 the Departments are not construing the and moral convictions.’’ Consolidated
Annual Survey,’’ Henry J Kaiser Family Foundation Amendments to require the religious exemptions,
(Sept. 19, 2017), http://files.kff.org/attachment/ we defer issues regarding the scope, interpretation,
Appropriations Act, 2018, Div. E,
Report-Employer-Health-Benefits-Annual-Survey- and protections of the Amendments to HHS in that section 808, Public Law 115–141, 132
2017. rulemaking. Stat. 348, 603 (Mar. 23, 2018); see also
Consolidated Appropriations Act, 2017, specifically require contraceptive protections provided by those
Div. C, section 808, Public Law 115–31 coverage in section 2713 of the PHS Act. provisions of the Church Amendments
(May 5, 2017). The Departments This argument would also negate not would encompass moral objections to
consider it significant that Congress’s just these expanded exemptions, but the contraceptive services or coverage.
most recent statements on the prospect previous exemptions provided for The Church Amendments were
of Government-mandated contraceptive houses of worship and integrated enacted in the wake of the Supreme
coverage specifically intend that a auxiliaries, and the indirect exemption Court’s decision in Roe v. Wade, 410
conscience clause be included to protect for self-insured church plans that use U.S. 113 (1973). Although the Court in
moral convictions. the accommodation. Where Congress Roe required abortion to be legal in
The Departments also consider left so many matters concerning section certain circumstances, Roe did not
significant the many statutes listed 2713(a)(4) to agency discretion, the include, within that right, the
above, in section I—Background Departments consider it appropriate to requirement that other citizens facilitate
footnote 1, that show Congress’s implement these expanded exemptions its exercise. Indeed, Roe favorably
consistent protection of moral in light of Congress’s long history of quoted the proceedings of the American
convictions alongside religious beliefs respecting moral convictions in the Medical Association House of Delegates
in the federal regulation of health care. context of certain federal health care 220 (June 1970), which declared,
These include laws such as the Church requirements. ‘‘Neither physician, hospital, nor
Amendments (dating back to 1973), hospital personnel shall be required to
which we discuss at length below, to the a. The Church Amendments’ Protection
of Moral Convictions perform any act violative of personally-
2018 Consolidated Appropriations Act held moral principles.’’ 410 U.S. at 144
discussed above. Notably among those One of the most important and well- & n.38 (1973). Likewise, in Roe’s
laws, and in addition to the Church established federal statutes respecting companion case, Doe v. Bolton, the
Amendments, Congress has enacted conscientious objections in specific Court observed that, under state law, ‘‘a
protections for health plans or health health care contexts was enacted over physician or any other employee has the
care organizations in Medicaid or the course of several years beginning in right to refrain, for moral or religious
Medicare Advantage to object ‘‘on moral 1973, initially as a response to court reasons, from participating in the
or religious grounds’’ to providing decisions raising the prospect that abortion procedure.’’ 410 U.S. 179, 197–
coverage of certain counseling or entities or individuals might be required 98 (1973). The Court said that these
referral services. 42 U.S.C. 1395w– to facilitate abortions or sterilizations conscience provisions ‘‘obviously . . .
22(j)(3)(B) (protecting against forced because they had received federal funds. afford appropriate protection.’’ Id. at
counseling or referrals in Medicare + These sections of the U.S. Code are 198. As an Arizona court later put it, ‘‘a
Choice (now Medicare Advantage) known as the Church Amendments, woman’s right to an abortion or to
managed care plans with respect to named after their primary sponsor, contraception does not compel a private
objections based on ‘‘moral or religious Senator Frank Church (D-Idaho). The person or entity to facilitate either.’’
grounds’’); 42 U.S.C. 1396u–2(b)(3) Church Amendments specifically Planned Parenthood Ariz., Inc. v. Am.
(protecting against forced counseling or provide conscience protections based on Ass’n of Pro-Life Obstetricians &
referrals in Medicaid managed care sincerely held moral convictions, not Gynecologists, 257 P.3d 181, 196 (Ariz.
plans with respect to objections based just religious beliefs. Among other
Ct. App. 2011).
on ‘‘moral or religious grounds’’). things, the amendments protect the The Congressional Record contains
Congress has also protected individuals recipients of certain federal health funds discussions that occurred when the
who object to prescribing or providing from being required to perform, assist, protection for moral convictions was
contraceptives contrary to their or make their facilities available for first proposed in the Church
‘‘religious beliefs or moral convictions.’’ abortions or sterilizations if they object Amendments. When Senator Church
Consolidated Appropriations Act, 2018, ‘‘on the basis of religious beliefs or introduced the first of those
Public Law 115–141, Division E, section moral convictions,’’ and they prohibit amendments in 1973, he cited not only
726(c); see also Consolidated recipients of certain federal health funds
Roe v. Wade, but also an instance where
Appropriations Act of 2017, Division C, from discriminating against any
a federal court had ordered a Catholic
Title VII, Sec. 726(c) (Financial Services personnel ‘‘because he refused to
hospital to perform sterilizations. 119
and General Government perform or assist in the performance of
Congr. Rec. S5717–18 (Mar. 27, 1973).
Appropriations Act), Public Law 115– such a procedure or abortion on the
After his opening remarks, Senator
31.13 grounds that his performance or
Adlai Stevenson III (D–IL) rose to ask
The Departments disagree with assistance in the performance of the
that the amendment be changed to
commenters that suggested we should procedure or abortion would be contrary
specify that it also protects objections to
not consider Congress’s history of to his religious beliefs or moral
abortion and sterilization based on
protecting moral objections in certain convictions’’ (42 U.S.C. 300a–7(b),
(c)(1)). Later additions to the Church moral convictions on the same terms as
health care contexts due to Congress’s
Amendments protect other it protects objections based on religious
failure to explicitly include exemptions
conscientious objections, including beliefs. The following excerpt of the
in section 2713(a)(4) itself. The
argument by these commenters proves some objections on the basis of moral Congressional Record records this
too much, since Congress also did not conviction to ‘‘any lawful health discussion:
service,’’ or to ‘‘any part of a health Mr. STEVENSON. Mr. President, first of all
13 The Departments also note that, in protecting service program.’’ (42 U.S.C. 300a– I commend the Senator from Idaho for
those individual and institutional health care 7(c)(2), (d)). In contexts covered by bringing this matter to the attention of the
entities that object to certain abortion-related Senate. I ask the Senator a question.
services and activities regardless of the basis for those sections of the Church
One need not be of the Catholic faith or
such objection, the Coats-Snowe Amendment, PHS Amendments, the provision or coverage any other religious faith to feel deeply about
Act section 245 (42 U.S.C. 238n), and the Weldon of certain contraceptives, depending on the worth of human life. The protections
Amendment, Consolidated Appropriations Act,
2018, Div. H, Sec. 507(d), Public Law 115–141,
the circumstances, could constitute afforded by this amendment run only to
protect those whose objection is based on moral ‘‘any lawful health service’’ or a ‘‘part of those whose religious beliefs would be
conviction. a health service program.’’ As such, the offended by the necessity of performing or
participating in the performance of certain recent Supreme Court decisions will likely to such services on the basis of religious
medical procedures; others, for moral unleash a series of court actions across the beliefs. And, as noted above, subsequent
reasons, not necessarily for any religious United States to try to impose the personal statutes add protections for moral
belief, can feel equally as strong about human preferences of the majority of the Supreme objections in many other situations.
life. They too can revere human life. Court on the totality of the Nation.
As mortals, we cannot with confidence say, I believe it is ironic that we should have
These include, for example:
when life begins. But whether it is life, or the this debate at all. Who would have predicted
• Protections for individuals and
potentiality of life, our moral convictions as a year or two ago that we would have to entities that object to abortion. See 42
well as our religious beliefs, warrant guard against even the possibility that U.S.C. 238n; 42 U.S.C. 18023; 42 U.S.C.
protection from this intrusion by the someone might be free [sic] 14 to participate 2996f(b); Consolidated Appropriations
Government. Would, therefore, the Senator in an abortion or sterilization against his Act, 2018, Div. H, Sec. 507(d), Public
include moral convictions? will? Such an idea is repugnant to our Law 115–141.
Would the Senator consider an amendment political tradition. This is a Nation which has • Protections for entities and
on page 2, line 18 which would add to always been concerned with the right of individuals that object to providing or
religious beliefs, the words ‘‘or moral’’? conscience. It is the right of conscience covering contraceptives. See id. at Div.
Mr. CHURCH. I would suggest to the which is protected in our draft laws. It is the E, Sec. 808; id. at Div. E, Sec. 726(c)
Senator that perhaps his objective could be right of conscience which the Supreme Court
(Financial Services and General
more clearly stated if the words ‘‘or moral has quite properly expanded not only to
conviction’’ were added after ‘‘religious embrace those young men who, because of
Government Appropriations Act); id. at
belief.’’ I think that the Supreme Court in the tenets of a particular faith, believe they Div. K, Title III.
considering the protection we give religious cannot kill another man, but also those who • Protections for entities and
beliefs has given comparable treatment to because of their own deepest moral individuals that object to performing,
deeply held moral convictions. I would not convictions are so persuaded. assisting, counseling, or referring as
be averse to amending the language of the I am delighted that the Senator from Idaho pertains to suicide, assisted suicide, or
amendment in such a manner. It is consistent has amended his language to include the advance directives. See 42 U.S.C.
with the general purpose. I see no reason words ‘‘moral conviction,’’ because, of 290bb–36; 42 U.S.C. 1396a(w)(3); 42
why a deeply held moral conviction ought course, we know that this is not a matter of U.S.C. 14406; 42 U.S.C. 18113 (adopted
not be given the same treatment as a religious concern to any one religious body to the as part of the ACA).
belief. exclusion of all others, or even to men who The Departments believe that the
Mr. STEVENSON. The Senator’s suggestion believe in a God to the exclusion of all
is well taken. I thank him. others. It has been a traditional concept in
intent behind Congress’s protection of
our society from the earliest times that the moral convictions in certain health care
119 Congr. Rec. S5717–18 right of conscience, like the paramount right contexts, especially to protect entities
As the debate proceeded, Senator to life from which it is derived, is sacred. and individuals from governmental
Church went on to quote Doe v. Bolton’s coercion, supports the Departments’
reliance on a Georgia statute that stated 119 Congr. Rec. S5723 decision in the Moral IFC and these
‘‘a physician or any other employee has In support of the same protections final rules to protect sincerely held
the right to refrain, for moral or religious when they were debated in the U.S. moral convictions from governmental
reasons, from participating in the House, Representative Margaret Heckler compulsion threatened by the
abortion procedure.’’ 119 Congr. Rec. (R–MA) 15 likewise observed that ‘‘the contraceptive Mandate.
S5722 (quoting 410 U.S. at 197–98). right of conscience has long been b. Court Precedents Relevant to These
Senator Church added, ‘‘I see no reason recognized in the parallel situation in Expanded Exemptions
why the amendment ought not also to which the individual’s right to
As reflected in the legislative history
cover doctors and nurses who have conscientious objector status in our
of the first Church Amendments, the
strong moral convictions against these selective service system has been
Supreme Court has long afforded
particular operations.’’ Id. Considering protected’’ and ‘‘expanded by the
protection to moral convictions
the scope of the protections, Senator Supreme Court to include moral
alongside religious beliefs. Indeed,
Gaylord Nelson (D–WI) asked whether, conviction as well as formal religious
Senator Church cited Doe v. Bolton, 410
‘‘if a hospital board, or whatever the belief.’’ 119 Congr. Rec. H4148–49 (May
U.S. 179, as a parallel instance of
ruling agency for the hospital was, a 31, 1973). Rep. Heckler added, ‘‘We are
conscience protection and spoke of the
governing agency or otherwise, just concerned here only with the right of
Supreme Court generally giving
capriciously—and not upon the moral conscience, which has always
‘‘comparable treatment to deeply held
religious or moral questions at all— been a part of our national tradition.’’
moral convictions.’’ Both Senator
simply said, ‘We are not going to bother Id. at 4149.
Buckley and Rep. Heckler specifically
with this kind of procedure in this These first sections of the Church
cited the Supreme Court’s protection of
hospital,’ would the pending Amendments, codified at 42 U.S.C.
moral convictions in laws governing
amendment permit that?’’ 119 Congr. 300a–7(b) and (c)(1), passed the House
military service. Those legislators
Rec. S5723. Senator Church responded 372–1, and were approved by the Senate
appear to have been referencing cases
that the amendment would not 94–0. 119 Congr. Rec. at H4149; 119
such as Welsh v. United States, 398 U.S.
encompass such an objection. Id. Congr. Rec. S10405 (June 5, 1973). The
Senator James L. Buckley (C–NY), 333 (1970), which the Supreme Court
subsequently adopted provisions that
speaking in support of the amendment, had decided just three years earlier.
comprise the Church Amendments Welsh involved what is perhaps the
added the following perspective: similarly extend protection to those Government’s paradigmatic compelling
Mr. BUCKLEY. Mr. President, I organizations and individuals who interest—the need to defend the nation
compliment the Senator from Idaho for object to the provision of certain by military force. The Court stated that,
proposing this most important and timely services on the basis of their moral where the Government protects
amendment. It is timely in the first instance convictions, as well as those who object objections to military service based on
because the attempt has already been made
to compel the performance of abortion and 14 The Senator might have meant ‘‘[forced] . . .
‘‘religious training and belief,’’ that
sterilization operations on the part of those against his will.’’ protection would also extend to
who are fundamentally opposed to such 15 Rep. Heckler later served as the 15th Secretary avowedly non-religious objections to
procedures. And it is timely also because the of HHS, from March 1983 to December 1985. war held with the same moral strength.
Id. at 343. The Court declared, ‘‘[i]f an regulations have also applied the morally equivalent to abortion due to
individual deeply and sincerely holds principle of respecting moral the possibility that such items may
beliefs that are purely ethical or moral convictions alongside religious beliefs prevent the implantation of a human
in source and content but that in particular circumstances. The Equal embryo after fertilization.19 The
nevertheless impose upon him a duty of Employment Opportunity Commission Supreme Court, in describing family
conscience to refrain from participating has consistently protected ‘‘moral or business owners with religious
in any war at any time, those beliefs ethical beliefs as to what is right and objections, explained that ‘‘[t]he owners
certainly occupy in the life of that wrong which are sincerely held with the of the businesses have religious
individual ‘a place parallel to that filled strength of traditional religious views’’ objections to abortion, and according to
by . . . God’ in traditionally religious alongside religious views under the their religious beliefs the four
persons. Because his beliefs function as ‘‘standard [ ] developed in United States contraceptive methods at issue are
a religion in his life, such an individual v. Seeger, 380 U.S. 163 (1965) and abortifacients. If the owners comply
is as much entitled to a ‘religious’ [Welsh].’’ 29 CFR 1605.1. The
with the HHS mandate, they believe
conscientious objector exemption . . . Department of Justice has declared that,
they will be facilitating abortions.’’
as is someone who derives his in cases of capital punishment, no
officer or employee may be required to Hobby Lobby, 134 S. Ct. at 2751. Based
conscientious opposition to war from on pleadings in the litigation, all of the
traditional religious convictions.’’ attend or participate if doing so ‘‘is
contrary to the moral or religious litigants challenging the Mandate and
In the context of this particular
convictions of the officer or employee, asserting purely non-religious objections
Mandate, it is also worth noting that, in
or if the employee is a medical share this view. And as Congress has
Hobby Lobby, Justice Ginsburg (joined,
in this part of the opinion, by Justices professional who considers such implicitly recognized in providing
Breyer, Kagan, and Sotomayor), cited participation or attendance contrary to health care conscience protections
Justice Harlan’s opinion in Welsh, 398 medical ethics.’’ 28 CFR 26.5.17 pertaining to sterilization,
U.S. at 357–58, in support of her Forty-five states have health care contraception, and other health care
statement that ‘‘[s]eparating moral conscience protections covering services and practices, individuals or
convictions from religious beliefs would objections to abortion; several of these entities may have additional moral
be of questionable legitimacy.’’ 134 S. also cover sterilization or objections to contraception.20
Ct. at 2789 n.6. In quoting this passage, contraception.18 Most of those state laws
protect objections based on ‘‘moral,’’ d. Founding Principles
the Departments do not mean to suggest
that all laws protecting only religious ‘‘ethical,’’ or ‘‘conscientious’’ grounds in The Departments also look to
beliefs constitute an illegitimate addition to ‘‘religious’’ grounds. guidance from, and draw support for the
‘‘separat[ion]’’ of moral convictions, nor Particularly in the case of abortion,
Moral IFC and these final rules from, the
do the Departments assert that moral some federal and state conscience laws
broader history of respect for conscience
convictions must always be protected do not require any specified motive for
the objection. 42 U.S.C. 238n; in the laws and founding principles of
alongside religious beliefs; we also do the United States. Members of Congress
not agree with Justice Harlan that Consolidated Appropriations, 2018,
Public Law 115–141, Div. H, section specifically relied on the American
distinguishing between religious and tradition of respect for conscience when
moral objections would violate the 507(d).
These various statutes and regulations they decided to protect moral
Establishment Clause. Instead, the convictions in health care. In supporting
reflect an important governmental
Departments believe that, in the specific the protection of conscience based on
interest in protecting moral convictions
health care context implicated here, non-religious moral convictions,
in appropriate health contexts. The
providing respect for moral convictions contraceptive Mandate implicates that Senator Buckley declared ‘‘[i]t has been
parallel to the respect afforded to governmental interest. Many persons a traditional concept in our society from
religious beliefs is appropriate, draws and entities object to the Mandate in the earliest times that the right of
from long-standing Federal Government part because they consider some forms conscience, like the paramount right to
practice, and shares common ground of FDA-approved contraceptives to be life from which it is derived, is sacred.’’
with Congress’s intent in the Church
Amendments and in later federal Representative Heckler similarly stated
moral or religious grounds’’); 48 CFR 1609.7001 that ‘‘the right of moral conscience . . .
statutes that provide protections for (‘‘health plan sponsoring organizations are not
moral convictions alongside religious required to discuss treatment options that they has always been a part of our national
beliefs in other health care contexts. would not ordinarily discuss in their customary tradition.’’ This tradition is reflected, for
course of practice because such options are example, in a letter President George
c. Conscience Protections in Other inconsistent with their professional judgment or
ethical, moral or religious beliefs.’’); 48 CFR Washington wrote saying that ‘‘[t]he
Federal and State Contexts 352.270–9 (‘‘Non-Discrimination for Conscience’’ Citizens of the United States of America
The tradition of protecting moral clause for organizations receiving HIV or Malaria have a right to applaud themselves for
relief funds).
convictions in certain health contexts is 17 See also 18 CFR 214.11 (where a law
having given to mankind examples of an
not limited to laws passed by Congress. enforcement agency (LEA) seeks assistance in the enlarged and liberal policy: A policy
Multiple federal regulations protect investigation or prosecution of trafficking of worthy of imitation. All possess alike
objections based on moral convictions persons, the reasonableness of the LEA’s request liberty of conscience and immunities of
will depend in part on ‘‘[c]ultural, religious, or
in such contexts.16 Other federal moral objections to the request’’). 19 FDA, ‘‘Birth Control,’’ U.S. Food and Drug
18 According to the Guttmacher Institute, 45 states
Administration (Mar. 6, 2018), https://www.fda.gov/
16 See, for example, 42 CFR 422.206 (declaring

have conscience statutes pertaining to abortion (43 forconsumers/byaudience/forwomen/
that the general Medicare Advantage rule ‘‘does not of which cover institutions), 18 have conscience freepublications/ucm313215.htm (various approved
require the MA plan to cover, furnish, or pay for statutes pertaining to sterilization (16 of which
contraceptives, including Levonorgestrel, Ulipristal
a particular counseling or referral service if the MA cover institutions), and 12 have conscience statutes
organization that offers the plan—(1) Objects to the pertaining to contraception (8 of which cover Acetate, and IUDs, work mainly by preventing
provision of that service on moral or religious institutions). ‘‘Refusing to Provide Health Services,’’ fertilization, but ‘‘may also work . . . by preventing
grounds.’’); 42 CFR 438.102 (declaring that The Guttmacher Institute (June 1, 2017), https:// attachment (implantation) to the womb (uterus)’’ of
information requirements do not apply ‘‘if the www.guttmacher.org/state-policy/explore/refusing- a human embryo after fertilization).
MCO, PIHP, or PAHP objects to the service on provide-health-services. 20 See supra note 1.
citizenship.’’ 21 Thomas Jefferson e. Executive Orders Relevant to These issuers, third party administrators, and
similarly declared that ‘‘[n]o provision Expanded Exemptions employees and beneficiaries. The
in our Constitution ought to be dearer to Protecting moral convictions, as set organizations that have sued seeking a
man than that which protects the rights forth in these expanded exemptions and moral exemption have adopted
of conscience against the enterprises of accommodation in these final rules, is longstanding moral tenets opposed to
the civil authority.’’ 22 Although these consistent with recent executive orders. certain FDA-approved contraceptives,
statements by Presidents Washington President Trump’s Executive Order and hire only employees who share this
and Jefferson were spoken to religious concerning this Mandate directed the view. As a result, it is reasonable to
congregations, and although religious Departments to consider providing conclude that employees of these
and moral conscience were tightly protections, not specifically for organizations would not benefit from
intertwined for the Founders, they both ‘‘religious’’ beliefs, but for the Mandate. Thus, subjecting this
reflect a broad principle of respect for ‘‘conscience.’’ We interpret that term to subset of organizations to the Mandate
conscience against government include both religious beliefs and moral does not advance any governmental
coercion. James Madison likewise called convictions. Moreover, President interest. The need to resolve this
conscience ‘‘the most sacred of all Trump’s first Executive Order, E.O. litigation and the potential concerns of
property,’’ and proposed that the Bill of 13765, declared that ‘‘the Secretary of similar entities, as well as the legal
Rights should guarantee, in addition to Health and Human Services (Secretary) requirement to comply with permanent
protecting religious belief and worship, and the heads of all other executive injunctive relief currently imposed in
that ‘‘the full and equal rights of departments and agencies (agencies) March for Life, provide substantial
conscience [shall not] be in any manner, with authorities and responsibilities reasons for the Departments to protect
or on any pretext infringed.’’ 23 under the [ACA] shall exercise all moral convictions through these final
These Founding Era statements of authority and discretion available to rules. Although, as discussed below, the
general principle do not specify how them to waive, defer, grant exemptions Departments assume the number of
they would be applied in a particular from, or delay the implementation of entities and individuals that may seek
health care context, and the any provision or requirement of the Act exemption from the Mandate on the
Departments do not suggest that the that would impose a fiscal burden on basis of moral convictions, as these two
specific protections offered in the Moral any state or a cost, fee, tax, penalty, or sets of litigants did, will be small, the
IFC and these final rules would be regulatory burden on individuals, Departments know from the litigation
required or necessarily appropriate in families, healthcare providers, health that it will not be zero. As a result, the
any other context that does not raise the insurers, patients, recipients of Departments have taken these types of
specific concerns implicated by this healthcare services, purchasers of health objections into consideration in
Mandate. These final rules do not insurance, or makers of medical devices, reviewing our regulations. Having done
address in any way how the products, or medications.’’ The so, the Departments consider it
Government would balance its interests exemption and accommodation adopted appropriate to issue the protections set
with respect to other health services not in these final rules relieves a regulatory forth in these final rules. Just as
encompassed by the contraceptive burden imposed on entities with moral Congress, in adopting the early
Mandate.24 Instead, the Departments convictions opposed to providing provisions of the Church Amendments,
highlight this tradition of respect for certain contraceptive coverage and is viewed it as necessary and appropriate
conscience from the Nation’s Founding therefore consistent with both Executive to protect those organizations and
Era to provide background support for Orders. individuals with objections to certain
the Departments’ decision to implement health care services on the basis of
section 2713(a)(4), while protecting f. Litigation Concerning the Mandate moral convictions, so the Departments,
conscience in the exercise of moral The Departments have further taken too, believe that ‘‘our moral convictions
convictions. The Departments believe into consideration the litigation as well as our religious beliefs, warrant
that these final rules are consistent both surrounding the Mandate in exercising protection from this intrusion by the
with the American tradition of respect their discretion to adopt the exemption Government’’ in this situation. See 119
for conscience and with Congress’s in these final rules. Among the lawsuits Congr. Rec. S5717–18.
history of providing conscience challenging the Mandate, two have been The litigation concerning the Mandate
protections in the kinds of health care filed based in part on non-religious has also underscored how important it
matters involved in this Mandate. moral convictions. In one case, the is for the Government to tread carefully
Departments are subject to a permanent when engaging in regulation concerning
21 Letter from George Washington to the Hebrew
injunction requiring us to respect the sensitive health care areas. As
Congregation in Newport, Rhode Island (Aug. 18,
1790) (available at https://founders.archives.gov/ non-religious moral objections of an demonstrated by the litigation, as well
documents/Washington/05-06-02-0135). employer. See March for Life v. Burwell, as the public comments, various citizens
22 Letter to the Society of the Methodist Episcopal 128 F. Supp. 3d 116 (D.D.C. 2015). In sincerely hold moral convictions, which
Church at New London, Connecticut (February 4, the other case, an appeals court affirmed are not necessarily religious, against
1809) (available at https://founders.archives.gov/
documents/Jefferson/99-01-02-9714).
a district court ruling that allows the providing or participating in coverage of
23 James Madison, ‘‘Essay on Property’’ (March previous regulations to be imposed in a contraceptive items included in the
29, 1792); First draft of the First Amendment, 1 way that affects the moral convictions of Mandate, and some believe that certain
Annals of Congress 434 (June 8, 1789). a small nonprofit pro-life organization contraceptive items may cause early
24 As the Supreme Court stated in Hobby Lobby,
and its employees. See Real Alternatives abortions. Providing conscience
the Court’s decision concerns only the

contraceptive Mandate, and should not be
v. Sec’y, Dep’t of Health & Human protections advances the ACA’s goal of
understood to hold that all insurance-coverage Servs., 867 F.3d 338 (3d Cir. 2017). The expanding health coverage among
mandates, for example, for vaccinations or blood Departments’ litigation of these cases entities and individuals that might
transfusions, must necessarily fail if they conflict has thus led to inconsistent court otherwise be reluctant to participate in
with an employer’s religious beliefs. Nor does the
Court’s opinion provide a shield for employers who
rulings, consumed substantial the market. For example, the Supreme
might cloak illegal discrimination as a religious (or governmental resources, and created Court in Hobby Lobby declared that, if
moral) practice. 134 S. Ct. at 2783. uncertainty for objecting organizations, HHS requires owners of businesses to
cover procedures that the owners yield no benefits—it would only Some commenters objected to
‘‘could not in good conscience’’ cover, suppress the existence of non-profit providing any exemption or
such as abortion, ‘‘HHS would organizations holding those views. accommodation for moral objections at
effectively exclude these people from Several other commenters stated that all. Some of these commenters
full participation in the economic life of the exemptions were still too narrow. contended that even the previous
the Nation.’’ 134 S. Ct. at 2783. That sort They asked that the exemptions set forth regulations allowing an exemption and
of outcome is one the Departments wish in these final rules be as broad as the accommodation were too broad and that
to avoid. The Departments wish to exemptions set forth in the Religious no exemptions to the Mandate should
implement the contraceptive coverage IFC concerning sincerely held religious exist, in order that contraceptive
Guidelines issued under section beliefs. Some of these commenters also coverage would be provided to as many
2713(a)(4) in a way that respects the asked that HHS withdraw its Mandate of women as possible. Other commenters
moral convictions of Americans so that contraceptive coverage from the did not go that far, but rejected the idea
they are freer to engage in ‘‘full Guidelines entirely. They contended of exemptions or an accommodation
participation in the economic life of the that fertility and pregnancy are based on moral convictions, contending
Nation.’’ The exemptions in these final generally healthy conditions, not that such exemptions or accommodation
rules do so by removing an obstacle that diseases that are appropriately the target would contribute to population growth
might otherwise lead entities or of a preventive health service; that and related social woes. Some of these
individuals with moral objections to contraceptives can pose medical risks commenters also contended that the
contraceptive coverage to choose not to for women; and that studies do not exemption in the Moral IFC would
sponsor or participate in health plans if show that contraceptive programs
they include such coverage. constitute an exemption covering every
reduce abortion rates or unintended business and non-profit organization.
3. Whether Moral Exemptions Should pregnancies. Some commented that
many women report that they sought an After considering these comments,
Exist, and Whom They Should Cover
abortion because their contraception and although the previous
As noted above, the Department Administration declined to afford any
failed. Some other commenters
received comments expressing diverse exemption based on moral convictions,
contended that, to the extent the
views as to whether exemptions based the Departments have concluded that it
Guidelines require coverage of certain
on moral convictions should exist and, is appropriate to provide moral
drugs and devices that may prevent
if so, whom they should cover. exemptions and access to the
Some commenters supported the implantation of an embryo after
fertilization, they require coverage of accommodation, as set forth in these
expanded exemptions and final rules. Congress did not mandate
accommodation in the Moral IFC, and items that are abortifacient and,
therefore, violate federal conscience contraceptive coverage, nor provide any
the choice of entities and individuals to explicit guidance about incorporating
which they applied. They stated the protections such as the Weldon
Amendment, Consolidated conscience exemptions into the
expanded exemptions and Guidelines. But as noted above, it is a
accommodation would be an Appropriations Act, 2017, Public Law
115–31, Div. H, § 507(d). long-standing Congressional practice to
appropriate exercise of discretion and
Other commenters contended that the provide consistent exemptions for both
would be consistent with moral
exemptions in the Moral IFC were too religious beliefs and moral convictions
exemptions Congress has provided in
broad. Some of these commenters in many federal statutes in the health
many similar contexts. Similarly,
expressed concern about the prospect of care context, and specifically
commenters stated that the
accommodation would be an inadequate publicly traded for-profit entities also concerning issues such as abortion,
means to resolve moral objections and being afforded a moral exemption. One sterilization, and contraception. It is not
that the expanded exemptions are such commenter commented that clear to the Departments that, if
needed. They contended that the allowing publicly traded for-profit Congress had expressly mandated
accommodation process was entities a moral exemption could cause contraceptive coverage in the ACA, it
objectionable because it was another instability and confusion, as leadership would have done so without providing
method of complying with the Mandate, changes at such a corporation may for similar exemptions. Therefore, the
its self-certification or notice involved effectively change the corporation’s Departments consider it appropriate, to
triggering the very contraceptive eligibility for a moral exemption. Still the extent we impose a contraceptive
coverage that organizations objected to, others stated that the Departments Mandate by the exercise of agency
and the coverage for contraceptive should not exempt various kinds of discretion, that we also include an
services ‘‘hijacked’’ or flowed in entities such as businesses, issuers, or exemption for the protection of moral
connection with the objecting nonprofit entities, arguing that only convictions in certain cases. The
organizations’ health plans. The individuals, not entities, can possess exemptions finalized in these final rules
commenters contended that the moral convictions. Some commenters are generally consistent with the scope
seamlessness cited by the Departments were concerned that providing moral of exemptions that Congress has
between contraceptive coverage and an exemptions would contribute to established in similar contexts. As noted
accommodated plan gives rise to moral population growth and related societal above, the Departments consider the
objections that organizations would not woes. Other commenters contended the exemptions in these final rules
have with an expanded exemption. exemptions and accommodation should consistent with the intent of Executive
Commenters also stated that, with not be expanded, but should remain the Order 13535. The Departments also
respect to non-profit organizations that same as they were in the July 2015 final wish to avoid the stark disparity that
have moral objections and only hire regulations (80 FR 41318), which did may result from respecting religious
persons who agree with those not encompass moral convictions. Other objections to providing contraceptive
objections, the Mandate serves no commenters stated that the Departments coverage among certain entities and
legitimate government interest because should not provide exemptions, but individuals, but not respecting parallel
the mandated coverage is neither merely an accommodation process, to objections for moral convictions
wanted nor used and, therefore, would resolve moral objections to the Mandate. possessed by any entities and
individuals at all because those Some commenters stated that HRSA Just as the Departments continue to
objections are not specifically religious. should remove contraceptives from the believe merely amending the
In addition, the Departments note that Guidelines because the Guidelines have accommodation process would not
a significant majority of states either not been subject to the notice and adequately address religious objections
impose no contraceptive coverage comment process under the to compliance with the Mandate, we do
requirement or offer broader exemptions Administrative Procedure Act. Some not believe doing so would adequately
than the exemption contained in the commenters also contended that the address similar moral objections.
Guidelines should be amended to omit Furthermore, the few litigants raising
July 2015 final regulations.25 Although
items that may prevent (or possibly non-religious moral objections have
the practice of states is by no means a
dislodge) the implantation of a human been non-profit organizations that assert
limit on the discretion delegated to
embryo after fertilization, in order to they only hire persons who share the
HRSA by the ACA, nor a statement
ensure consistency with conscience employers’ objection to contraceptive
about what the Federal Government
provisions that prohibit requiring plans coverage. Consequently, the
may do consistent with other limitations
to pay for or cover abortions. Whether Departments conclude that the most
in federal law, such state practices can
and to what extent the Guidelines appropriate approach to resolve these
inform the Departments’ view that it is
continue to list contraceptives, or items concerns is to provide the exemptions
appropriate to provide conscience
considered to prevent implantation of set forth in the Moral IFC and these final
protections when exercising agency an embryo, for entities not subject to rules. These final rules also finalize the
discretion. exemptions and an accommodation, and modifications to the accommodation
The Departments decline to use these what process is used to include those process to make it available to entities
final rules to remove the contraceptive items in the Guidelines, is outside the with moral objections, without forcing
Mandate altogether, such as by scope of these final rules. These final such entities to choose between
declaring that HHS acting through rules focus on what moral exemptions compliance with either the Mandate or
HRSA shall not include contraceptives and accommodation shall apply if the accommodation.
in the list of women’s preventive Guidelines issued under section Some commenters expressed concern
services in Guidelines issued under 2713(a)(4) include contraceptives or over the lack of a definition of ‘‘moral
section 2713(a)(4). HRSA’s Guidelines items considered to be abortifacient. convictions’’ in the Moral IFC, arguing
were not issued, ratified, or updated Members of the public that support or that, without a definition, any objection
through the regulations that preceded oppose the inclusion of some or all could be encompassed by the
the Moral IFC and these final rules. contraceptives in the Guidelines, or exemptions even if it is not based on
Those Guidelines were issued in wish to comment concerning the moral convictions. The Departments did
separate processes in 2011 and 2016, content and process of developing and not adopt a regulatory definition of
directly by HRSA, after consultation updating the Guidelines, are welcome to ‘‘moral convictions’’ in the Moral IFC,
with external organizations that communicate their views to HRSA, at and have decided not to adopt such a
operated under cooperative agreements wellwomancare@hrsa.gov. definition in response to public
with HRSA to consider the issue, solicit The Departments also conclude that it comments at this time. Nevertheless, the
public comment, and provide would be inadequate to merely attempt Departments look to the description of
recommendations. The regulations to amend or expand the accommodation moral convictions in Welsh to help
preceding these final rules attempted process to account for moral objectors, explain the scope of the protection
only to restate the statutory language of instead of providing the exemptions. In provided in the Moral IFC and these
section 2713 in regulatory form, and the past, the Departments stated in our final rules. Neither these final rules or
delineate what exemptions and regulations and court briefs that the the Moral IFC, nor the Church
accommodations would apply if HRSA previous accommodation required Amendments or other Federal health
listed contraceptives in its Guidelines. contraceptive coverage in a way that is care conscience statutes, define ‘‘moral
We decline to use these final rules to ‘‘seamless’’ with the coverage provided convictions’’ (nor do they define
direct the separate process that HRSA by the objecting employer. As a result, ‘‘religious beliefs’’). But in issuing these
uses to determine what specific services in significant respects, the final rules, we adopt the same
are listed in the Guidelines generally. accommodation process did not actually background understanding of that term
Some commenters stated that if accommodate the objections of many that is reflected in the Congressional
contraceptives are not removed from the entities, as indicated by many entities Record in 1973, in which legislators
Guidelines entirely, entities or with religious objections. The referenced cases such as Welsh to
individuals with moral objections might Departments have attempted to identify support the addition of language
not qualify for the exemptions or an accommodation that would eliminate protecting moral convictions. In
accommodation. As discussed below, the religious plaintiffs’ objections, protecting moral convictions in parallel
however, the exemptions in these rules including seeking public comment to religious beliefs, Welsh describes
include a broad range of entities and through a Request For Information, 81 moral convictions warranting such
individuals of whom we have notice FR 47741 (July 26, 2016), but stated in protection as ones: (1) That the
may object based on moral convictions. January 2017 that we were unable to ‘‘individual deeply and sincerely
The Departments are not aware of develop such an approach at that time.26 holds’’; (2) ‘‘that are purely ethical or
specific employers or individuals whose 26 See Departments of Labor, Health and Human
moral in source and content’’; (3) ‘‘but
moral convictions would still be Services, and the Treasury, FAQs About Affordable
that nevertheless impose upon him a
violated by compliance with the Care Act Implementation Part 36, (Jan. 9, 2017), duty’’; (4) and that ‘‘certainly occupy in
Mandate after the issuance of the Moral https://www.dol.gov/sites/default/files/ebsa/about- the life of that individual a place
IFC and these final rules. ebsa/our-activities/resource-center/faqs/aca-part- parallel to that filled by . . . God’ in
36.pdf and https://www.cms.gov/CCIIO/Resources/
Fact-Sheets-and-FAQs/Downloads/ACA-FAQs- traditionally religious persons,’’ such
25 See ‘‘Insurance Coverage of Contraceptives,’’ Part36_1-9-17-Final.pdf (‘‘the comments reviewed
The Guttmacher Institute (June 11, 2018), https:// by the Departments in response to the RFI indicate objectors, while still ensuring that the affected
www.guttmacher.org/state-policy/explore/ that no feasible approach has been identified at this women receive full and equal health coverage,
insurance-coverage-contraceptives. time that would resolve the concerns of religious including contraceptive coverage’’).
that one could say ‘‘his beliefs function conclusion that our interest in ensuring Departments’ expansion of conscience
as a religion in his life.’’ 398 U.S. at contraceptive coverage does not protections for moral convictions,
339–40. As recited above, Senators preclude the Departments from offering similar to protections contained in
Church and Nelson agreed that exemptions and an accommodation for numerous statutes governing health care
protections for such moral convictions entities, plans, and individuals with a regulation, is not taken lightly.
would not encompass an objection that qualifying objection to contraceptive However, after considering public
an individual or entity raises coverage based on moral convictions. comments on various sides of the issue,
‘‘capriciously.’’ Instead, along with the Some public commenters pointed out and reconsidering the interests served
requirement that protected moral that protecting moral convictions serves by the Mandate in this particular
convictions must be ‘‘sincerely held,’’ to respect not only the interests of context, the objections raised, and the
this understanding cabins the protection certain persons to access contraceptives, relevant federal law, the Departments
of moral convictions in contexts where but also the interests of other persons to have determined that affording the
they occupy a place parallel to that participate in a health coverage market exemptions to protect moral convictions
filled by sincerely held religious beliefs consistent with their moral convictions. is a more appropriate administrative
in religious persons and organizations. Other commenters disagreed with this response than continuing to refuse to
While moral convictions are the sort rebalancing, and contended that the extend the exemptions and
of principles that, in the life of an interest of women in receiving accommodations to certain entities and
individual, occupy a place parallel to contraceptive coverage without cost- individuals for whom the Mandate
religion, sincerely held moral sharing is so great that it overrides violates their sincerely held moral
convictions can also be adopted by private interests to the contrary, such convictions. Although the number of
corporate bodies, not merely by that the government should or must organizations and individuals that may
individuals. Senators Church and force private entities to provide this seek to invoke these exemptions and
Nelson, while discussing the fact that coverage to other private citizens. accommodation may be small, the
opposition to abortion or sterilization on The Departments agree with the Departments believe that it is important
the basis of ‘‘moral questions’’ does not commenters who stated that the to provide such protection, given the
include capricious opposition to governmental interest in requiring long-standing recognition of such
abortion for no reason at all, were contraceptive coverage does not protections in law and regulation in the
specifically talking about opposition to override the interest in protecting moral health care and health insurance
abortion by corporate entities: A convictions and does not make these contexts. The Moral IFC and these final
‘‘hospital board, or whatever the ruling expanded exemptions inappropriate. rules leave unchanged HRSA’s authority
agency for the hospital was, a governing For additional discussion of the to decide whether to include
agency or otherwise.’’ 27 Corporate Government’s balance of interests as contraceptives in the women’s
bodies operate by the decision-making applicable to religious beliefs, see preventive services Guidelines for
actions of individuals. Thus, if section II.C.2.b. of the companion final entities that are not exempted by law,
individuals act in the governance of a rules concerning religious exemptions regulation, or the Guidelines. These
corporate body so as to adopt a position published by the Departments rules also do not change the many other
for that body of adopting moral contemporaneously with these final mechanisms by which the Government
convictions against coverage of rules elsewhere in today’s Federal advances contraceptive coverage,
contraceptives, such an entity can be Register. There, and in the Religious particularly for low-income women,
considered to have an objection to and Moral IFCs, the Departments including through such programs as
contraceptive coverage on the basis of acknowledged the reasons why the Medicaid and Title X. The Departments
sincerely held moral convictions. Departments have changed the policies also note that the exemptions created
and interpretations previously adopted here, like the exemptions created by the
4. The Departments’ Rebalancing of with respect to the Mandate and the previous Administration, do not burden
Government Interests governmental interests underlying it. third parties to a degree that counsels
The Departments also received For parallel reasons, the Departments against providing the exemptions, as
comments on their rebalancing of believe the Government’s legitimate discussed below.
interests as expressed and referenced in interests in providing for contraceptive
the Moral IFC. Some public commenters coverage do not require the Departments 5. Burdens on Third Parties
agreed with the Departments’ to violate sincerely held moral The Department received a variety of
convictions while implementing the comments about the effect that the
27 Nor was this recognition of the need to protect Guidelines. The Departments likewise exemptions and accommodation based
organizations that object to performance of certain believe Congress did not set forth on moral convictions would have on
health care procedures on the basis of moral third parties. Some commenters stated
conviction limited to the Church Amendments’
interests that require us to violate
legislative history. The first of the Church sincerely held moral convictions if we that the exemptions and
Amendments provides, in part, that the receipt of otherwise require contraceptive accommodation do not impose an
certain federal funds ‘‘by any individual or entity coverage in our discretionary impermissible or unjustified burden on
does not authorize any court or any public official third parties, including on women who
or other public authority to require— . . . (2) such
implementation of the women’s
entity to—(A) make its facilities available for the preventive services Guidelines under might otherwise receive contraceptive
performance of any sterilization procedure or section 2713(a)(4). coverage with no cost sharing. Other
abortion if the performance of such procedure or The Departments acknowledge that commenters disagreed, asserting that the
abortion in such facilities is prohibited by the entity coverage of contraception is an exemptions unacceptably burden
on the basis of religious beliefs or moral

convictions, or (B) provide any personnel for the
important and highly controversial women who might lose contraceptive
performance or assistance in the performance of any issue, implicating many different views, coverage as a result. They contended the
sterilization procedure or abortion if the as reflected for example in the public exemptions may remove contraceptive
performance or assistance in the performance of comments received on multiple coverage, causing women to have higher
such procedures or abortion by such personnel
would be contrary to the religious beliefs or moral
rulemakings over the course of contraceptive costs, fewer contraceptive
convictions of such personnel.’’ 42 U.S.C. 300a– implementation of section 2713(a)(4), options, less ability to use
7(b). added to the PHS Act in 2010. The contraceptives more consistently, more
unintended pregnancies,28 births spaced discretion to require private parties to for which Congress has created similar
more closely, and workplace, economic, provide coverage to which they morally exemptions for over four decades. Not
or societal inequality. Still other object, to benefit other private parties, only do these final rules not violate the
commenters took the view that other does not prevent the government from Establishment Clause, but the
laws or protections, such as in the First relieving some or all of the burden of Departments’ decision to provide the
or Fifth Amendments, prohibit the that Mandate. Otherwise, any exemptions and accommodation for
expanded exemptions, which those governmental coverage requirement moral convictions, instead of limiting
commenters view as prioritizing would be a one-way ratchet. In the the exemptions to identical objections
conscientious objection of exempted Moral IFC and these final rules, the based on religious beliefs, further
entities over the conscience, choices, or government has simply restored a zone demonstrates that neither the purpose
religious liberty of women who would of freedom where it once existed. There nor the effect of these exemptions is to
not receive contraceptive coverage is no statutory or constitutional obstacle establish religion. The Establishment
where an exemption is used. Some to the government doing so, and the Clause does not force the Department to
commenters disagreed and said the doctrine of third party burdens should impose a contraceptive Mandate in
exemptions do not violate laws and not be interpreted to impose such an violation of the moral convictions of
constitutional protections, nor do they obstacle. Such an interpretation would entities and individuals protected by
inappropriately prioritize the be especially problematic given the these rules.
conscience of exempted entities over millions of women, in a variety of American governmental bodies have,
those of third parties. contexts, whom the Mandate does not in many instances, refrained from
The Departments note that the ultimately benefit, notwithstanding any requiring certain private parties to cover
exemptions in the Moral IFC and these expanded exemptions—including contraceptive services for other private
final rules, like the exemptions created through the grandfathering of plans, the parties. From 1789 through 2012 (when
by the previous Administration, do not previous religious exemptions, and the HRSA’s Guidelines went into effect),
impermissibly burden third parties. failure of the accommodation to require there was no federal women’s
Initially, the Departments observe that delivery of contraceptive coverage in preventive services coverage mandate
these rules do not create a governmental various self-insured church plan
imposed nationally on health insurance
burden; rather, they relieve a contexts.
and group health plans. The ACA did
governmental burden. The ACA did not In addition, the Government is under
no constitutional obligation to fund not require contraceptives to be
impose a contraceptive coverage included in HRSA’s Guidelines, and it
requirement. Agency discretion was contraception. Cf. Harris v. McRae, 448
U.S. 297 (1980) (holding that, although did not require any preventive services
exercised to include contraceptives in required under section 2713 of the PHS
the Guidelines issued under section the Supreme Court has recognized a
constitutional right to abortion, there is Act to be covered by grandfathered
2713(a)(4). That decision is what created plans. Many states do not impose
and imposed a governmental burden. no constitutional obligation for
government to pay for abortions). Even contraceptive coverage mandates, or
These rules simply relieve part of that they offer religious, and in some cases
governmental burden. If some third more so may the government refrain
from requiring private citizens, in moral, exemptions to the requirements
parties do not receive contraceptive of such coverage mandates—exemptions
coverage from private parties whom the violation of their moral convictions, to
cover contraception for other citizens. that have not been invalidated by
government chooses not to coerce, that federal or state courts. The Departments,
result exists in the absence of Cf. Rust v. Sullivan, 500 U.S. 173, 192–
93 (1991) (‘‘A refusal to fund protected in previous regulations, exempted
governmental action—it is not a result houses of worship and integrated
the government has imposed. Calling activity, without more, cannot be
equated with the imposition of a auxiliaries from the Mandate. The
that result a governmental burden rests Departments then issued a temporary
on an incorrect presumption: That the ‘penalty’ on that activity.’’). The
constitutional rights of liberty and enforcement safe harbor allowing
government has an obligation to force religious nonprofit groups to not
private parties to benefit those third privacy do not require the government
to force private parties to provide provide contraceptive coverage under
parties, and that the third parties have the Mandate for almost two additional
contraception to other citizens and do
a right to those benefits. Congress did years. The Departments further
not prohibit the government from
not create a right to receive expanded the houses of worship and
protecting moral objections to such
contraceptive coverage from other integrated auxiliaries exemption
governmental mandates, especially
private citizens through section 2713 of through definitional changes. And the
where, as here, the Mandate is not an
the PHS Act, other portions of the ACA, Departments created an accommodation
explicit statutory requirement.29 The
or any other statutes it has enacted. process under which many women in
Departments do not believe that the
Although some commenters also self-insured church plans may not
Constitution prohibits offering the
contended such a right might exist ultimately receive contraceptive
expanded exemptions in these rules.
under treaties the Senate has ratified or Some commenters objected that the coverage. The Departments are not
the Constitution, the Departments are exemptions would violate the aware of federal courts declaring that
not aware of any source demonstrating Establishment Clause of the First the exemptions, safe harbor, or
that the Constitution or a treaty ratified Amendment. The Moral IFC and these accommodations gave rise to third party
by the Senate creates a right to receive final rules create exemptions for moral burdens that required the government to
contraceptive coverage from other convictions, not religious beliefs, and mandate contraceptive coverage by
private citizens. they do so for the same neutral purposes entities eligible for an exemption or
The fact that the government at one accommodation. In addition, many
time exercised its administrative 29 See, for example, Planned Parenthood Ariz., organizations have not been subject to
Inc. v. Am. Ass’n of Pro-Life Obstetricians & the Mandate in practice because of
28 Some commenters attempted to quantify the Gynecologists, 257 P.3d 181, 196 (Ariz. Ct. App.
costs of unintended pregnancy, but were unable to 2011) (‘‘[A] woman’s right to an abortion or to
injunctions they received through
provide estimates with regard to the number of contraception does not compel a private person or litigation, protecting them from federal
women that this exemption may affect. entity to facilitate either.’’). imposition of the Mandate, including
under several recently entered study 30 has concluded the Mandate or all contraceptives included in the
permanent injunctions that will apply caused no clear increase in Mandate to not be forced to provide
regardless of the issuance of these final contraceptive use; one explanation coverage of those items to anyone.
rules. proposed by the authors of the study is Those commenters’ contentions about
Commenters offered various that women eligible for family planning discrimination are unpersuasive for still
assessments of the impact these rules from safety net programs were already additional reasons. First, Title VII is
might have on state or local receiving free or subsidized applicable to discrimination committed
governments. Some commenters stated contraceptive access through them, by employers, and these final rules have
that the expanded exemptions will not notwithstanding the Mandate’s effects been issued in the government’s
burden state or local governments, or on the overall market. Some capacity as a regulator of group health
that such burdens should not prevent commenters who opposed the plans and group and individual health
the Departments from offering those exemptions admitted that this insurance, not in its capacity as an
exemptions. Others commenters stated information is unclear at this stage; employer. See also In Re Union Pac.
that if the Departments provide other commenters that estimated R.R. Emp’t Practices Litig., 479 F.3d 936,
expanded exemptions, states or local considerably more individuals and 940–42 & n.1 (8th Cir. 2007) (holding
jurisdictions may face higher costs in entities would seek an exemption also that Title VII ‘‘does not require coverage
providing birth control to women admitted the difficulty of quantifying of contraception because contraception
through government programs. The estimates. In addition, the only entities is not a gender-specific term like
Departments consider it appropriate to that have brought suit based on their potential pregnancy, but rather applies
offer expanded exemptions, moral objections to the Mandate are to both men and women’’). Second,
notwithstanding the objection of some non-profit entities that have said they these rules create no disparate impact.
state or local governments. Until 2012, only hire persons who share their The women’s preventive service
there was no federal mandate of objections and do not use the mandate under section 2713(a)(4), and
contraceptive coverage across health contraceptives to which their employers the contraceptive Mandate promulgated
insurance and health plans nationwide. object, so it is unlikely that exemptions under such preventive services
The ACA did not require a for those entities would have any mandate, already inure to the specific
contraceptive Mandate, and its impact on safety net programs. Below, benefit of women—men are denied any
discretionary creation by means of we predict that a small number of benefit from section 2713(a)(4). Both
HRSA’s Guidelines does not translate to additional nonprofit and closely held before and after these rules are in effect,
a benefit that the federal government for-profit entities will use the section 2713(a)(4) and the Guidelines
owes to state or local governments. The exemptions based on moral convictions. issued under that section treat women’s
various situations recited in the In light of the limited evidence of third preventive services in general, and
previous paragraph, in which the party or state and local government female contraceptives specifically, more
federal government has not imposed impact of these final rules, the favorably than they treat male
contraceptive coverage, have not been Departments consider it an appropriate preventive services or contraceptives.
policy option to provide the It is simply not the case that the
deemed to cause a cognizable injury to
exemptions. government’s implementation of section
state or local governments. The
Some commenters contended that the 2713(a)(4) is discriminatory against
Departments find no legal prohibition
exemptions would constitute unlawful women because exemptions encompass
on finalizing these final rules based on
sex discrimination, such as under moral objections. The previous rules, as
the allegation of an impact on state or
section 1557 of the Affordable Care Act, discussed elsewhere herein, do not
local governments, and disagree with
Title VII of the Civil Rights Act of 1964, require contraceptive coverage in a host
the suggestion that once having of plans, including grandfathered plans,
Title IX of the Education Amendments
exercised our discretion to deny plans of houses of worship and
of 1972, or the Fifth Amendment. Some
exemptions—no matter how recently or integrated auxiliaries, and—through
commenters suggested the expanded
incompletely—the Departments cannot inability to enforce the accommodation
exemptions would discriminate on
change course if some state and local on certain third party administrators—
bases such as race, disability, or LGBT
governments believe they are receiving plans of many religious non-profits in
status, or that they would
indirect benefits from the previous self-insured church plans. Below, the
disproportionately burden certain
decision. persons in such categories. Departments estimate that nearly all
In addition, the exemptions at issue But these rules do not discriminate or women of childbearing age in the
here are available only to a tiny fraction draw any distinctions on the basis of country will be unaffected by these
of entities to which the Mandate would sex, pregnancy, race, disability, socio- exemptions. In this context, the
otherwise apply—those with qualifying economic class, LGBT status, or Departments do not believe that an
moral objections. Public comments did otherwise, nor do they discriminate on adjustment to discretionary Guidelines
not provide reliable data on how many any unlawful grounds. The exemptions for women’s preventive services
entities would use these expanded in these rules do not authorize entities concerning contraceptives constitutes
moral exemptions, in which states to comply with the Mandate for one unlawful sex discrimination. Otherwise,
women in those plans would reside, person, but not for another person, anytime the government exercises its
how many of those women would based on that person’s status as a discretion to provide a benefit that is
qualify for or use state and local member of a protected class. Instead, specific to women (or specific to men),
government subsidies of contraceptives they allow entities that have sincerely it would constitute sex discrimination
as a result, or in which states such held moral objections to providing some for the government to reconsider that
women, if they are low income, would benefit. Under that theory, Hobby Lobby
go without contraceptives and 30 M.L. Kavanaugh et al., ‘‘Contraceptive method itself, and RFRA (on which Hobby
potentially experience unintended use in the United States: trends and characteristics Lobby’s holding was based), which
pregnancies that state Medicaid between 2008, 2012 and 2014,’’, 97 Contraception
14, 14–21 (2018), available at http://
provided a religious exemption to this
programs would potentially have to www.contraceptionjournal.org/article/S0010- Mandate for many businesses, would be
cover. As noted below, at least one 7824(17)30478-X/pdf. deemed discriminatory against women
because the underlying women’s recently issued a proposed rule to likewise does not require the
preventive services requirement is a amend the regulations governing its Departments to require coverage of, or to
benefit for women, not for men. Such Title X family planning program. The keep in place a requirement to cover,
conclusions are not consistent with proposed rule would amend the certain services, including
legal doctrines concerning sex definition of ‘‘low income family’’— contraceptives, that was issued pursuant
discrimination. individuals eligible for free or low cost to HHS’s exercise of discretion under
It is not clear that these expanded contraceptive services—to include section 2713(a)(4). Nor does section
exemptions will significantly burden women who are unable to obtain certain 1554 of the ACA prohibit the
women most at risk of unintended family planning services under their Departments from providing exemptions
pregnancies. Some commenters stated employer-sponsored health coverage to relieve burdens on moral convictions,
that contraceptives are often readily due to their employers’ religious beliefs or as is the case here, from refraining to
accessible at relatively low cost. Other or moral convictions. (83 FR 25502). If impose the Mandate in cases where
commenters disagreed. Some that rule is finalized as proposed, it moral convictions would be burdened
commenters objected that the Moral would further reduce any potential by the Mandate. Moral exemptions from
IFC’s estimate of a $584 yearly cost of effect of these final rules on women’s federal mandates in certain health
contraceptives for women was too low. access to contraceptives. contexts, including sterilization,
But some of those same commenters Some commenters stated that the contraception, or items believed to be
provided similar estimates, citing expanded exemptions would violate abortifacient, have existed in federal
sources claiming that birth control pills section 1554 of the ACA. That section laws for decades. Some of those laws
can cost up to $600 per year, and stated says the Secretary of HHS ‘‘shall not were referenced by President Obama in
that IUDs, which can last 3 to 6 years promulgate any regulation’’ that signing Executive Order 13535. In light
or more,31 can cost $1,100 (that is, less ‘‘creates any unreasonable barriers to of that Executive Order and Congress’s
than $50 per month over the duration of the ability of individuals to obtain long history of providing exemptions for
use). Some commenters stated that, for appropriate medical care,’’ ‘‘impedes moral convictions in the health context,
lower income women, contraceptives timely access to health care services,’’ providing moral exemptions is a
and related education and counseling ‘‘interferes with communications reasonable administrative response to
can be available at free or low cost regarding a full range of treatment this federally mandated burden,
through government programs (federal options between the patient and the especially since the burden itself is a
programs offering such services include, provider,’’ ‘‘restricts the ability of health subregulatory creation that does not
for example, Medicaid, Title X, care providers to provide full disclosure apply in various contexts.
community health center grants, and of all relevant information to patients In short, we do not believe sections
Temporary Assistance for Needy making health care decisions,’’ ‘‘violates 1554 or 1557 of the ACA, other
Families (TANF)). Other commenters the principles of informed consent and nondiscrimination statutes, or any
contended that many women in the ethical standards of health care constitutional doctrines, create an
employer-sponsored coverage might not professionals,’’ or ‘‘limits the affirmative obligation to create,
qualify for those programs, although availability of health care treatment for maintain, or impose a Mandate that
that sometimes occurs because their the full duration of a patient’s medical forces covered entities to provide
incomes are above certain thresholds or needs.’’ 42 U.S.C. 18114. Such coverage of preventive contraceptive
because the programs were not intended commenters urged, for example, that the services in health plans. The ACA’s
to absorb privately covered individuals. Moral IFC created unreasonable barriers grant of authority to HRSA to provide
Some commenters observed that to the ability of individuals to obtain for, and support, the Guidelines is not
contraceptives may be available through appropriate medical care, particularly in transformed by any of the laws cited by
other sources, such as a plan of another areas they said may have a commenters into a requirement that,
family member, and that the expanded disproportionately high number of once those Guidelines exist, they can
exemptions will not likely encompass a entities likely to take advantage of the never be reconsidered, or amended
very large segment of the population exemption. because doing so would only affect
otherwise benefitting from the Mandate. The Departments disagree with these women’s coverage or would allegedly
Other commenters disagreed, comments about section 1554 of the impact particular populations
emphasizing that income and eligibility ACA. The Departments issued previous disparately.
thresholds could prevent some women exemptions and accommodations that In summary, members of the public
from receiving contraceptives through allowed various plans to not provide have widely divergent views on whether
certain government programs if they contraceptive coverage on the basis of the exemptions in the Moral IFC and
were no longer covered in their group religious objections; multiple courts these final rules are good public policy.
health plans or health insurance plans. considered those regulations; and while Some commenters stated that the
The Departments do not believe that many ruled that entities did not need to exemptions would burden workers,
such differences make it inappropriate provide contraceptive coverage, none families, and the economic and social
to issue the expanded exemptions set ruled that the exemptions or stability of the country, and interfere
forth in these rules. As explained more accommodations in the regulations with the physician-patient relationship.
fully below, the Departments estimate violated section 1554 of the ACA. Other commenters disagreed, favoring
that nearly all women of childbearing Moreover, the decision not to impose a the public policy behind the exemption,
age in the country will be unaffected by governmental mandate is not the and arguing that the exemption would
creation of a ‘‘barrier,’’ especially when not interfere with the physician-patient
these exemptions. Moreover, the

Departments note that the HHS Office of that mandate requires private citizens to relationship. The Departments have
Population Affairs, within the Office of provide services to other private determined that these final rules are an
the Assistant Secretary for Health, has citizens. This would turn the appropriate exercise of public policy
assumptions of the United States’ discretion. Because of the importance of
31 See, for example, ‘‘IUD,’’ Planned Parenthood, system of government on its head. See, the moral convictions being
https://www.plannedparenthood.org/learn/birth- for example, U.S. Constitution, Ninth accommodated, the limited impact of
control/iud. Amendment. Section 1554 of the ACA these final rules, and uncertainty about
the impact of the Mandate overall 7. Health Effects of Contraception and older),35 hypertension,36 HIV–1
according to some studies, the Pregnancy acquisition and transmission,37 and
Departments do not believe these final breast, cervical, and liver cancers.38
rules will have any of the drastic The Departments received numerous Some commenters also stated that
negative consequences on third parties comments on the health effects of fertility awareness based methods of
or society that some opponents of these contraception and pregnancy. As noted birth spacing are free of similar health
rules have suggested. above, some commenters supported the risks since they do not involve ingestion
expanded exemptions, and others urged of chemicals. Some commenters
6. Interim Final Rulemaking
that contraceptives be removed from the contended that it is not the case that
The Departments received several Guidelines entirely, based on the view contraceptive access reduces
comments about the decision to issue that pregnancy and the unborn children unintended pregnancies or abortions.
the Moral IFC as interim final rules with resulting from conception are not Other commenters disagreed, citing a
request for comments, instead of as a diseases or unhealthy conditions that variety of studies they contend show
notice of proposed rulemaking. Several health benefits caused by, or associated
are properly the subject of preventive
commenters asserted that the
care coverage. Such commenters further
Departments had the authority to issue 35 Commenters cited ;. Lidegaard et al.,
the Moral IFC in that way, agreeing with contended that hormonal contraceptives ‘‘Thrombotic Stroke and Myocardial Infarction with
the Departments that there was explicit may present health risks to women. For Hormonal Contraception, 366 N. Engl. J. Med. 2257,
example, they contended that studies 2257 (2012) (risks ‘‘increased by a factor of 0.9 to
statutory authority to do so, good cause 1.7 with oral contraceptives that included ethinyl
under the APA, or both. Other show certain contraceptives cause, or estradiol at a dose of 20 mg and by a factor of 1.3
commenters held the opposite view, are associated with, an increased risk of to 2.3 with those that included ethinyl estradiol at
contending that there was neither depression,32 venous thromboembolic a dose of 30 to 40 mg’’); Practice Committee of the
American Society for Reproductive Medicine,
statutory authority to issue the rules on disease,33 fatal pulmonary embolism,34 ‘‘Hormonal Contraception’’; M. Vessey et al.,
an interim final basis, nor good cause thrombotic stroke and myocardial ‘‘Mortality in Relation to Oral Contraceptive Use
under the APA to make the rules infarction (particularly among women and Cigarette Smoking,’’ 362 Lancet 185, 185–91
(2003); WHO Collaborative Study of Cardiovascular
immediately effective. who smoke, are hypertensive, or are Disease and Steroid Hormone Contraception,
The Departments continue to believe ‘‘Acute Myocardial Infarction and Combined Oral
authority existed to issue the Moral IFC Contraceptives: Results of an International
as interim final rules. Section 9833 of Multicentre Case-Control Study,’’ 349 Lancet 1202,
the Code, section 734 of ERISA, and 1202–09 (1997); K.M. Curtis et al., ‘‘Combined Oral
32 Commenters cited Charlotte Wessel Skovlund, Contraceptive Use Among Women With
section 2792 of the PHS Act authorize Hypertension: A Systematic Review,’’ 73
et al., ‘‘Association of Hormonal Contraception with
the Secretaries of the Treasury, Labor, Contraception 179, 179–188 (2006); L.A. Gillum et
Depression,’’ JAMA Psychiatry 1154, 1154
and HHS (collectively, the Secretaries) (published online Sept. 28, 2016) (‘‘Use of
al., ‘‘Ischemic stroke risk with oral contraceptives:
to promulgate any interim final rules A meta analysis,’’ 284 JAMA 72, 72–78 (2000),
hormonal contraception, especially among available at https://www.ncbi.nlm.nih.gov/pubmed/
that they determine are appropriate to adolescents, was associated with subsequent use of 10872016; and Robert A. Hatcher et al.,
carry out the provisions of chapter 100 antidepressants and a first diagnosis of depression, Contraceptive Technology, 404–05, 445 (Ardent
of the Code, part 7 of subtitle B of title suggesting depression as a potential adverse effect Media 18th rev. ed. 2004).
of hormonal contraceptive use.’’). 36 Commenters cited Robert A. Hatcher et al.,
I of ERISA, and part A of title XXVII of
33 Commenters cited the Practice Committee of Contraceptive Technology, 407, 445 (Ardent Media
the PHS Act, which include sections 18th rev. ed. 2004).
2701 through 2728 of that Act, and the the American Society for Reproductive Medicine,
37 Commenters cited Renee Heffron et al., ‘‘Use of
‘‘Hormonal Contraception: Recent Advances and
incorporation of those sections into Controversies,’’ 82 Fertility and Sterility S26, S30
Hormonal Contraceptives and Risk of HIV–1
section 715 of ERISA and section 9815 (2004); V.A. Van Hylckama et al., ‘‘The Venous
Transmission: A Prospective Cohort Study,’’ 12
of the Code. The Religious and Moral Lancet Infectious Diseases 19, 24 (2012) (‘‘Use of
Thrombotic Risk of Oral Contraceptives, Effects of hormonal contraceptives was associated with a two-
IFCs fall under those statutory Estrogen Dose and Progestogen Type: Results of the times increase in the risk of HIV–1 acquisition by
authorizations for the use of interim MEGA Case-Control Study,’’ 339 Brit. Med. J. b2921 women and HIV–1 transmission from women to
final rulemaking. Prior to the Moral IFC, (2009); Y. Vinogradova et al., ‘‘Use of Combined men.’’); and ‘‘Hormonal Contraception Doubles HIV
the Departments issued three interim Oral Contraceptives and Risk of Venous Risk, Study Suggests,’’ Science Daily (Oct. 4, 2011),
Thromboembolism: Nested Case-Control Studies https://www.sciencedaily.com/releases/2011/10/
final regulations implementing this 111003195253.htm.
Using the QResearch and CPRD Databases,’’ 350
section of the PHS Act because of the Brit. Med. J. h2135 (2015) (‘‘Current exposure to any
38 Commenters cited ‘‘Oral Contraceptives and
needs of covered entities for immediate combined oral contraceptive was associated with an
Cancer Risk,’’ National Cancer Institute (Mar. 21,
guidance and the weighty matters 2012), https://www.cancer.gov/about-cancer/
increased risk of venous thromboembolism . . . causes-prevention/risk/hormones/oral-
implicated by the HRSA Guidelines, compared with no exposure in the previous year.’’); contraceptives-fact-sheet; L.J Havrilesky et al.,
including issuance of new or revised ;. Lidegaard et al., ‘‘Hormonal contraception and ‘‘Oral Contraceptive User for the Primary
exemptions or accommodations. (75 FR risk of venous thromboembolism: national follow- Prevention of Ovarian Cancer,’’ Agency for
41726; 76 FR 46621; 79 FR 51092). The up study,’’ 339 Brit. Med. J. b2890 (2009): M. de Healthcare Research and Quality, Report No. 13–
Bastos et al., ‘‘Combined oral contraceptives: E002–EF (June 2013), available at https://
Departments also had good cause to archive.ahrq.gov/research/findings/evidence-based-
venous thrombosis,’’ Cochrane Database Syst. Rev.,
issue the Moral IFC as interim final Mar. 3, 2014. doi: 10.1002/ reports/ocusetp.html; S. N. Bhupathiraju et al.,
rules, for the reasons discussed therein. ‘‘Exogenous hormone use: Oral contraceptives,
14651858.CD010813.pub2, available at https://
In any event, the objections of some postmenopausal hormone therapy, and health
www.ncbi.nlm.nih.gov/pubmed?term=24590565; outcomes in the Nurses’ Health Study,’’ 106 Am. J.
commenters to the issuance of the Moral L.J. Havrilesky et al., ‘‘Oral Contraceptive User for Pub. Health 1631, 1631–37 (2016); The World
IFC as interim final rules with request the Primary Prevention of Ovarian Cancer,’’ Agency Health Organization Department of Reproductive
for comments does not prevent the for Healthcare Research and Quality, Report No. Health and Research, ‘‘Carcinogenicity of Combined
issuance of these final rules. These final 13–E002–EF (June 2013), available at https:// Hormonal Contraceptives and Combined
archive.ahrq.gov/research/findings/evidence-based- Menopausal Treatment,’’ (Sept. 2005), available at
rules were issued after receiving and http://www.who.int/reproductivehealth/topics/
reports/ocusetp.html; and Robert A. Hatcher et al.,
thoroughly considering public Contraceptive Technology, 405–07 (Ardent Media ageing/cocs_hrt_statement.pdf; and the American
comments as requested in the Moral Cancer Society, ‘‘Known and Probably Human
18th rev. ed. 2004).
Carcinogens,’’ American Cancer Society (rev. Nov.
IFC. These final rules therefore comply 34 Commenters cited N.R. Poulter, ‘‘Risk of Fatal
3, 2016), https://www.cancer.org/cancer/cancer-
with the APA’s notice and comment Pulmonary Embolism with Oral Contraceptives,’’ causes/general-info/known-and-probable-human-
requirements. 355 Lancet 2088 (2000). carcinogens.html.
with, contraceptive use or the not on their face establish a causal embryo inside the mother’s body.
prevention of unintended pregnancy. relationship between a broad coverage Commenters referenced scientific
Commenters cited, for example, the mandate and decreases in unintended studies and sources on both sides of the
2011 Report of the Institute of Medicine pregnancy. In this respect, as noted in issue of whether certain contraceptives
(IOM), ‘‘Clinical Preventive Services for the Religious IFC,40 the purpose for the prevent implantation. Commenters and
Women: Closing the Gaps,’’ in its Departments’ reference to such studies litigants have positively stated that
discussion of the negative effects was to highlight the difference between some of them view certain
associated with unintended a causal relationship and an associative contraceptives as abortifacients, for this
pregnancies, as well as other studies. one, as well as the difference between reason. See also Hobby Lobby, 134 U.S.
Such commenters contended that, by saying contraceptive use has a certain at 2765 (‘‘The Hahns have accordingly
reducing unintended pregnancy, effect and saying a contraceptive excluded from the group-health-
contraceptives reduce the risk of coverage mandate (or part of that insurance plan they offer to their
unaddressed health complications, low mandate affected by certain exemptions) employees certain contraceptive
birth weight, preterm birth, infant will necessarily have (or negate, methods that they consider to be
mortality, and maternal mortality. respectively) such an effect. abortifacients.’’).
Commenters also stated that studies Commenters disagreed about the The Departments do not take a
show contraceptives are associated with effects of some FDA-approved position on the scientific, religious, or
a reduced risk of conditions such as contraceptives on embryos. Some moral debates on this issue by
ovarian cancer, colorectal cancer, and commenters agreed with the quotation, recognizing that some people have
endometrial cancer, and that in the Moral IFC, of FDA materials 41 sincere moral objections to providing
contraceptives treat such conditions as that indicate that some items it has contraception coverage on this basis.
endometriosis, polycystic ovarian approved as contraceptives may prevent The Supreme Court has already
syndrome, migraines, pre-menstrual the implantation of an embryo after recognized that such a view can form
pain, menstrual regulation, and pelvic fertilization. Some of those commenters the basis of an objection based on
inflammatory disease.39 Some cited additional scientific sources to sincerely held religious belief under
commenters stated that pregnancy argue that certain approved RFRA.42 Several litigants have
presents various health risks, such as contraceptives may prevent separately raised non-religious moral
blood clots, bleeding, anemia, high implantation, and that, in some cases, objections to contraceptive coverage
blood pressure, gestational diabetes, and some contraceptive items may even based on the same basic rationale. Even
death. Some commenters also dislodge an embryo shortly after though there is a plausible scientific
contended that increased access to implantation. Other commenters argument against the view that certain
contraception reduces abortions. disagreed with the sources cited in the contraceptives have mechanisms of
Some commenters stated that, in the Moral IFC and cited additional studies action that may prevent implantation,
Moral IFC, the Departments relied on on that issue. Some commenters further there is also a plausible scientific
incorrect statements concerning criticized the Departments for asserting argument in favor of it—as
scientific studies. For example, some in the Moral IFC that some persons demonstrated, for example, by FDA’s
commenters stated that there is no believe those possible effects are statement that some contraceptives may
proven increased risk of breast cancer or ‘‘abortifacient.’’ prevent implantation and by some
other risks among contraceptive users. This objection on this issue appears to scientific studies cited by commenters.
They criticized the Departments for be partially one of semantics. People The Departments believe in this context
citing studies, including one previewed disagree about whether to define we have a sufficient rationale to offer
in the 2011 IOM Report itself (Agency ‘‘conception’’ or ‘‘pregnancy’’ to occur moral exemptions with respect to this
for Healthcare Research and Quality, at fertilization, when the sperm and Mandate.
Report No. 13–E002–EF (June 2013) ovum unite, or days later at The Departments also received
(cited above)), discussing an association implantation, when that embryo has comments about their discussion,
between contraceptive use and undergone further cellular development, located in the Religious IFC but partly
increased risks of breast and cervical travelled down the fallopian tube, and relied upon in the Moral IFC,
cancer, and concluding there are no net implanted in the uterine wall. This concerning uncertainty about the effects
cancer-reducing benefits of question is independent of the question the Mandate’s expanded exemptions
contraceptive use. As described in the of what mechanisms of action FDA- might have on teen sexual activity. In
Religious IFC, 82 FR 47804, the 2013 approved or cleared contraceptives may this respect, the Departments stated,
Agency for Healthcare Research and have. It is also a separate question from ‘‘With respect to teens, the Santelli and
Quality study, and other sources, reach whether members of the public assert, Melnikas study cited by IOM 2011
conclusions with which these or believe, that it is appropriate to
commenters appear to disagree. The consider the items ‘‘abortifacient’’—that
42 ‘‘Although many of the required, FDA-
Departments consider it appropriate to approved methods of contraception work by

is, a kind of abortion, or a medical preventing the fertilization of an egg, four of those
consider these studies, as well as the product that causes an abortion— methods (those specifically at issue in these cases)
studies cited by commenters who because they believe abortion means to may have the effect of preventing an already
disagree with those conclusions. cause the demise of a post-fertilization fertilized egg from developing any further by
Some commenters further criticized inhibiting its attachment to the uterus. See Brief for
HHS in No. 13–354, pp. 9–10, n. 4; FDA, Birth
the Departments for saying two studies 40 82 FR at 47803–04. Control: Medicines to Help You.’’ Hobby Lobby, 134
cited by the 2011 IOM Report, which 41 FDA’s guide ‘‘Birth Control’’ specifies that S. Ct. at 2762–63. ‘‘The Hahns have accordingly
asserted an associative relationship various approved contraceptives, including excluded from the group-health-insurance plan they
between contraceptive use and Levonorgestrel, Ulipristal Acetate, and IUDs, work offer to their employees certain contraceptive
mainly by preventing fertilization and ‘‘may also methods that they consider to be
decreases in unintended pregnancy, did work . . . by preventing attachment (implantation) abortifacients. . . . Like the Hahns, the Greens
to the womb (uterus)’’ of a human embryo after believe that life begins at conception and that it
39 To the extent that contraceptives are prescribed fertilization. Available at https://www.fda.gov/ would violate their religion to facilitate access to
to treat health conditions, and not for preventive forconsumers/byaudience/forwomen/ contraceptive drugs or devices that operate after
purposes, the Mandate would not be applicable. freepublications/ucm313215.htm. that point.’’ Id. at 2765–66.
observes that, between 1960 and 1990, Departments do not take a position on one study from England found that,
as contraceptive use increased, teen the empirical question of whether where funding for teen pregnancy
sexual activity outside of marriage contraception has caused certain prevention was reduced, there was no
likewise increased (although the study reductions in teen pregnancy. Rather, evidence that the reduction led to an
does not assert a causal relationship). the Departments note that studies increase in teen pregnancies.51 Some
Another study, which proposed an suggesting various causes of teen commenters also cited studies—which
economic model for the decision to pregnancy and unintended pregnancy in are not limited to the issue of teen
engage in sexual activity, stated that general make it difficult to establish pregnancy—that have found that many
‘[p]rograms that increase access to causation between exemptions to the women who have abortions report that
contraception are found to decrease teen contraceptive Mandate, and an increase they were using contraceptives when
pregnancies in the short run but in teen pregnancies in particular, or they became pregnant.52
increase teen pregnancies in the long unintended pregnancies in general. For As the Departments stated in the
run.’ ’’ 43 Some commenters agreed with example, a 2015 study investigating the Religious IFC, we do not take a position
this discussion, while other commenters decline in teen pregnancy since 1991 on the variety of empirical questions
disagreed. Commenters who supported attributed it to multiple factors discussed above. Likewise, these rules
the expanded exemptions cited these (including, but not limited to, reduced do not address the substantive question
and similar sources suggesting that sexual activity, falling welfare benefit of whether HRSA should include
limiting the exemptions to the Mandate levels, and expansion of family contraceptives in the women’s
to those that existed prior to the planning services in Medicaid, with the preventive services Guidelines issued
Religious and Moral IFCs is not tailored latter accounting for less than 13 under section 2713(a)(4). Rather,
towards advancing the Government’s percent of the decline). It concluded reexamination of the record and review
interests in reducing teen pregnancy. that ‘‘that none of the relatively easy, of public comments has reinforced the
Instead they suggested there are means policy-based explanations for the recent Departments’ view that the uncertainty
of reducing teen pregnancy that are less decline in teen childbearing in the surrounding these weighty and
burdensome on conscientious United States hold up very well to important issues makes it appropriate to
objections.44 Some commenters careful empirical scrutiny.’’ 46 One provide the moral exemptions and
opposing the expanded exemptions study found that, during the teen accommodation if and for as long as
stated that school-based health centers pregnancy decline between 2007 HRSA continues to include
provide access to contraceptives, thus through 2012, teen sexual activity was contraceptives in the Guidelines. The
increasing use of contraceptives by also decreasing.47 One study concluded federal government has a long history,
sexually active students. They also cited that falling unemployment rates in the particularly in certain sensitive and
studies concluding that certain 1990s accounted for 85 percent of the multi-faceted health issues, of providing
decreases in teen pregnancy are decrease in rates of first births among 18 moral exemptions from governmental
attributable to increased contraceptive to 19 year-old African Americans.48 mandates. These final rules are
use.45 Another study found that the consistent with that history and with
Many commenters opposing the moral representation of African-American the discretion Congress vested in the
exemptions misunderstood the teachers was associated with a Departments to implement the ACA.
Departments’ discussion of this issue. significant reduction in the African-
Teens are a significant part, though not American teen pregnancy rate.49 One 8. Health and Equality Effects of
the entirety, of women the IOM study concluded that an ‘‘increase in the Contraceptive Coverage Mandates
identified as being most at risk of price of the Pill on college campuses The Departments also received
unintended pregnancy. The . . . did not increase the rates of comments about the health and equality
unintended pregnancy.’’ 50 Similarly, effects of the Mandate more broadly.
43 Citing J.S. Santelli & A.J. Melnikas, ‘‘Teen
Some commenters contended that the
fertility in transition: recent and historic trends in
the United States,’’ 31 Ann. Rev. Pub. Health 371,
46 Kearney MS and Levine PB, ‘‘Investigating
contraceptive Mandate promoted the
recent trends in the U.S. birth rate,’’ 41 J. Health health and equality of women,
375–76 (2010), and Peter Arcidiacono et al., Habit
Econ. 15–29 (2015), available at https://
Persistence and Teen Sex: Could Increased Access
www.sciencedirect.com/science/article/abs/pii/ especially low income women, and
to Contraception Have Unintended Consequences promoted female participation and
S0167629615000041.
for Teen Pregnancies? (2005), available at http:// 47 See, e.g., K. Ethier et al., ‘‘Sexual Intercourse
public.econ.duke.edu/∼psarcidi/addicted13.pdf.
See also K. Buckles & D. Hungerman, ‘‘The Among High School Students—29 States and available at https://www.psc.isr.umich.edu/pubs/
Incidental Fertility Effects of School Condom United States Overall, 2005–2015,’’ 66 CDC Morb. pdf/rr11-737.pdf (‘‘[I]ncrease in the price of the Pill
Distribution Programs,’’ Nat’l Bureau of Econ. Mortal. Wkly Report 1393, 1393–97 (Jan. 5, 2018), on college campuses . . . did not increase the rates
Research Working Paper No. 22322 (June 2016), available at http://dx.doi.org/10.15585/ of unintended pregnancy or sexually transmitted
available at http://www.nber.org/papers/w22322 mmwr.mm665152a1 (‘‘Nationwide, the proportion infections for most women’’).
(‘‘access to condoms in schools increases teen of high school students who had ever had sexual 51 See D. Paton & L. Wright, ‘‘The effect of
fertility by about 10 percent’’ and increased intercourse decreased significantly overall . . . .’’). spending cuts on teen pregnancy,’’ 54 J. Health
48 Colen CG, Geronimus AT, and Phipps MG,
sexually transmitted infections). Econ. 135, 135–46 (2017), available at https://
44 See Helen Alvaré, ‘‘No Compelling Interest: ‘‘Getting a piece of the pie? The economic boom of www.sciencedirect.com/science/article/abs/pii/
The ‘Birth Control’ Mandate and Religious the 1990s and declining teen birth rates in the S0167629617304551 (‘‘Contrary to predictions
Freedom,’’ 58 Vill. L. Rev. 379, 400–02 (2013) United States,’’ 63 Social Science & Med. 1531–45 made at the time of the cuts, panel data estimates
(discussing the Santelli & Melnikas study and the (Sept. 2006), available at https:// provide no evidence that areas which reduced
Arcidiacono study cited above, and other research www.sciencedirect.com/science/article/pii/ expenditure the most have experienced relative
that considers the extent to which reduction in teen S027795360600205X. increases in teenage pregnancy rates. Rather,
49 Atkins DN and Wilkins VM, ‘‘Going Beyond expenditure cuts are associated with small
pregnancy is attributable to sexual risk avoidance
rather than to contraception access). Reading, Writing, and Arithmetic: The Effects of reductions in teen pregnancy rates’’).
45 See, e.g., Lindberg L., Santelli J., Teacher Representation on Teen Pregnancy Rates,’’ 52 Commenters cited, for example, Guttmacher
‘‘Understanding the Decline in Adolescent Fertility 23 J. Pub. Admin. Research & Theory 771–90 (Oct. Institute, ‘‘Fact Sheet: Induced Abortion in the
in the United States, 2007–2012,’’ 59 J. Adolescent 1, 2013), available at https://academic.oup.com/ United States’’ (Jan. 2018) (‘‘Fifty-one percent of
Health 577–83 (Nov. 2016), https://doi.org/10.1016/ jpart/article-abstract/23/4/771/963674. abortion patients in 2014 were using a
j.jadohealth.2016.06.024; see also Comment of The 50 E. Collins & B. Herchbein, ‘‘The Impact of contraceptive method in the month they became
Colorado Health Foundation, submission ID CMS– Subsidized Birth Control for College Women: pregnant’’), available at https://
2014–0115–19635, www.regulations.gov (discussing Evidence from the Deficit Reduction Act,’’ U. Mich. www.guttmacher.org/sites/default/files/factsheet/
teen pregnancy data from Colorado). Pop. Studies Ctr. Report 11–737 (May 2011), fb_induced_abortion.pdf.
equality in the workforce. Other contraceptive methods.54 In addition, the 2017 Guttmacher study, that ‘‘[t]he
commenters contended there was commenters noted that in the 29 states role that the contraceptive coverage
insufficient evidence showing that the where contraceptive coverage mandates guarantee played in impacting use of
expanded exemptions would harm have been imposed statewide,55 those contraception at the national level
those interests. Some of those mandates have not necessarily lowered remains unclear, as there was no
commenters further questioned whether rates of unintended pregnancy (or significant increase in the use of
there was evidence to show that broad abortion) overall.56 methods that would have been covered
health coverage mandates of Other commenters, however, disputed under the ACA.’’ These commenters
contraception lead to increased the significance of these state statistics, instead observed that, under the
contraceptive use, reductions in noting that, of the 29 states with Mandate, more women have coverage of
unintended pregnancies, or reductions contraceptive coverage mandates, only contraceptives and contraception
in negative effects said to be associated four states have laws that match the counseling and that more contraceptives
with unintended pregnancies. In federal requirements in scope. Some are provided without co-pays than
particular, some commenters discussed also observed that, even in states with before. Still others argued that the
a study published and revised by the state contraceptive coverage mandates, Mandate, or other expansions of
Guttmacher Institute in October 2017, self-insured group health plans might contraceptive coverage, have led women
concluding that ‘‘[b]etween 2008 and escape those requirements, and some to increase their use of contraception in
2014, there were no significant changes states do not mandate the contraceptives general, or to change from less effective,
in the overall proportion of women who to be covered at no out-of-pocket cost to less expensive contraceptive methods to
used a contraceptive method both the beneficiary. more effective, more expensive
among all women and among women at The Departments have considered contraceptive methods. Some
risk of unintended pregnancy.’’ 53 This these experiences as relevant to the commenters pointed to studies cited in
timeframe includes the first two years of effect the exemption in these rules the 2011 IOM Report recommending
the contraceptive Mandate’s might have on the Mandate more contraception be included in the
implementation. Despite some changes broadly. The state mandates of Guidelines and argued that certain
in the use of various methods of contraceptive coverage still apply to a women will go without certain health
contraceptives, the study concluded very large number of plans and plan care, or contraception specifically,
that, ‘‘[f]or the most part, women are participants notwithstanding ERISA because of cost. They contended that a
changing method type within the group preemption, and public commenters did smaller percentage of women delay or
of most or moderately effective methods not point to studies showing those state forego health care overall under the
and not shifting from less effective to mandates reduced unintended ACA 57 and that, according to studies,
more effective methods.’’ Regarding the pregnancies. The federal contraceptive
coverage of contraceptives without cost-
effect of this Mandate in particular, the Mandate, likewise, applies to a broad,
sharing has increased use of
authors concluded that ‘‘[t]he role that but not entirely comprehensive, number
contraceptives in certain circumstances.
the contraceptive coverage guarantee of employers. For example, to the extent
Some commenters also stated that
played in impacting use of that houses of worship and integrated
studies show that decreases in
contraception at the national level auxiliaries may have self-insured to
unintended pregnancies are due to
remains unclear, as there was no avoid state health insurance
broader access to contraceptives.
significant increase in the use of contraceptive coverage mandates or for
Finally, some commenters also stated
methods that would have been covered other reasons, those groups were already
that birth control access generally has
under the ACA (most or moderately exempt from the federal Mandate prior
led to social and economic equality for
effective methods) during the most to the 2017 Religious and Moral IFCs.
The exemptions as set forth in the Moral women.
recent time period (2012–2014) The Departments have reviewed the
excepting small increases in implant IFC and in these final rules leave the
contraceptive Mandate in place for comments, including studies submitted
use.’’ The authors observed that other by commenters either supporting or
‘‘[s]tudies have produced mixed nearly all entities and plans to which
the Mandate has applied. The opposing these expanded exemptions.
evidence regarding the relationship
Departments are not aware of data Based on that review, it is not clear that
between the implementation of the ACA
showing that these expanded merely offering the exemption in these
and contraceptive use patterns.’’ In
exemptions would negate any reduction rules will have a significant effect on
explaining some possible reasons or no
in unintended pregnancies that might contraceptive use and health, or
clear effect on contraceptive use, the
result from the contraceptive Mandate workplace equality, for the vast majority
authors suggested that ‘‘existence of
here. of women benefitting from the Mandate.
these safety net programs [publicly
Some commenters took a view that There is conflicting evidence regarding
funded family planning centers and
appears to disagree with the assertion in whether the Mandate alone, as distinct
Medicaid] may have dampened any
from contraceptive access more
impact that the ACA could have had on
contraceptive use,’’ ‘‘cost is not the only 54 Id. generally, has caused increased
barrier to accessing a full range of
55 See Guttmacher Institute, ‘‘Insurance Coverage contraceptive use, reduced unintended
method options,’’ and ‘‘access to
of Contraceptives’’ (June 11, 2018); ‘‘State pregnancies, or eliminated workplace
Requirements for Insurance Coverage of
affordable and/or free contraception Contraceptives,’’ Henry J. Kaiser Family Foundation
disparities, where all other women’s
made possible through programs such as (Jan. 1, 2018), https://www.kff.org/other/state- preventive services were covered
Title X’’ may have led to income not indicator/state-requirements-for-insurance- without cost sharing. Without taking a
coverage-of-contraceptives/?currentTimeframe= definitive position on those evidentiary

being associated with the use of most 0&sortModel=%7B%22colId%22:%22Location%22,
%22sort%22:%22asc%22%7D.
issues, however, the Departments
53 M.L. Kavanaugh et al., ‘‘Contraceptive method 56 See Michael J. New, ‘‘Analyzing the Impact of
State Level Contraception Mandates on Public 57 Citing, for example, Adelle Simmons et al.,
use in the United States: trends and characteristics
between 2008, 2012 and 2014,’’ 97 Contraception Health Outcomes,’’ 13 Ave Maria L. Rev. 345 (2015), ‘‘The Affordable Care Act: Promoting Better Health
14, 14–21 (2018), available at http:// available at http://avemarialaw-law- for Women,’’ Table 1, ASPE (June 14, 2016), https://
www.contraceptionjournal.org/article/S0010- review.avemarialaw.edu/Content/articles/ aspe.hhs.gov/system/files/pdf/205066/
7824(17)30478-X/pdf. vXIII.i2.new.final.0809.pdf. ACAWomenHealthIssueBrief.pdf.
conclude that the Moral IFC and these Departments do not believe RFRA coverage by self-insuring. This is a
final rules—which merely withdraw the requires, or has ever required, the result of the application of the
Mandate’s requirement from what federal government to force employers preemption and savings clauses
appears to be a small number of newly to provide contraceptive coverage. The contained in ERISA to state insurance
exempt entities and plans—are not federal government’s decision to exempt regulation. See 29 U.S.C. 1144(a) &
likely to have negative effects on the some entities from a requirement to (b)(1).
health or equality of women provide no-cost-sharing services to These final rules cannot change
nationwide. The Departments also private citizens does not constitute a statutory ERISA provisions, and do not
conclude that the expanded exemptions federal government-imposed burden on change the standards applicable to
are an appropriate policy choice left to the latter under RFRA. ERISA preemption. To the extent
the agencies under the relevant statutes, Some commenters asked the Congress has decided that ERISA
and, thus, an appropriate exercise of the Departments to discuss the interaction preemption includes preemption of
Departments’ discretion. between these rules and state laws that state laws requiring contraceptive
Moreover, the Departments conclude either require contraceptive coverage or coverage, that decision occurred before
that the best way to balance the various provide exemptions from those and the ACA and was not negated by the
policy interests at stake in the Moral IFC other requirements. Some commenters ACA. Congress did not mandate in the
and these final rules is to provide the argue that providing the exemptions in ACA that any Guidelines issued under
exemptions set forth herein, even if these rules would negate state section 2713(a)(4) must include
certain effects may occur among the contraceptive requirements or narrower contraceptives, nor that the Guidelines
populations actually affected by the state exemptions. Some commenters must force entities with moral
employment of these exemptions. These asked that the Departments specify that objections to cover contraceptives.
rules provide tangible conscience these exemptions do not apply to plans Finally, some commenters expressed
protections for moral convictions, and governed by state laws that require concern that providing moral
impose fewer governmental burdens on contraceptive coverage. exemptions to the mandate that private
various entities and individuals, some The Departments agree that these parties provide contraception may lead
of whom have contended for several rules only concern the applicability of to exemptions regarding other
years that denying them an exemption the federal contraceptive Mandate medications or services, like vaccines.
from the contraceptive Mandate imposed pursuant to section 2713(a)(4). The exemptions provided in these rules,
imposes a burden on their moral They do not regulate state contraceptive however, do not apply beyond the
convictions. The Departments view the mandates or state exemptions. If a plan contraceptive coverage requirement
provision of those protections to is exempt under the Moral IFC and implemented through section
preserve conscience in this health care these final rules, that exemption does 2713(a)(4). Specifically, section
context as an appropriate policy option, not necessarily exempt the plan or other 2713(a)(2) of the PHS Act requires
notwithstanding the widely divergent insurance issuer from state laws that coverage of ‘‘immunizations,’’ and these
effects that public commenters have may apply to it. The previous exemptions do not encompass that
predicted based on different studies regulations, which offered exemptions requirement. The fact that the
they cited. Providing the protections for for houses of worship and integrated Departments have exempted houses of
moral convictions set forth in the Moral auxiliaries, did not include regulatory worship and integrated auxiliaries from
IFC and these final rules is not language negating the exemptions in the contraceptive Mandate since 2011
inconsistent with the ACA, and brings states that require contraceptive did not lead to those entities receiving
this Mandate into better alignment with coverage, although the Departments exemptions under section 2713(a)(2)
various other federal conscience discussed the issue to some degree in concerning vaccines. In addition,
protections in health care, some of hundreds of entities have sued the
various preambles of those previous
which have been in place for decades. Departments over the implementation of
regulations. The Departments do not
section 2713(a)(4), leading to two
9. Other General Comments consider it appropriate or necessary in
decisions of the U.S. Supreme Court,
Some commenters expressed the view the regulatory text of the moral
but no similar wave of lawsuits has
that the exemptions afforded in the exemption rules to declare whether the
challenged section 2713(a)(2). The
Moral IFC and herein violate the RFRA federal contraceptive Mandate would
expanded exemptions in these final
rights of women who might not receive still apply in states that have a state
rules are consistent with a long history
contraceptive coverage as the result of contraceptive mandate, since these rules
of statutes protecting moral convictions
these final rules, by allowing their do not purport to regulate the
from certain health care mandates
employers to impose their moral applicability of state contraceptive
concerning issues such as sterilization,
convictions on them by removing mandates.58
abortion and birth control.
contraceptive coverage through use of Some commenters observed that,
the exemption. Still other commenters through ERISA, some entities may avoid B. Text of the Final Rules
stated that employer payment of state laws that require contraceptive In this section, the Departments
insurance premiums is part of any 58 Some commenters also asked that these final
describe the regulations from the Moral
employee’s compensation package, the rules specify that exempt entities must comply with
IFC, public comments in response to the
benefits of which employers should not other applicable laws concerning such things as specific regulatory text set forth in the
be able to limit. In the Departments’ notice to plan participants or collective bargaining IFC, the Departments’ response to those
view, the expanded exemptions in these agreements. These final rules relieve the application comments, and, in consideration of
of the federal contraceptive Mandate under section

final rules do not prohibit employers 2713(a)(4) to qualified exempt entities; they do not
those comments, the regulatory text as
from providing contraceptive coverage. affect the applicability of other laws. In the finalized in this final rule. We also note
Instead, they lift a government burden preamble to the companion final rules concerning the regulatory text as it existed prior to
that was imposed on some employers to religious exemptions published elsewhere in the Religious and Moral IFCs, as
today’s Federal Register, the Departments provide
provide contraceptive coverage to their guidance applicable to notices of revocation and
appropriate. The Departments consider
employees in violation of those changes that an entity may seek to make during its the exemptions finalized here to be an
employers’ moral convictions. The plan year. appropriate and permissible policy
choice in light of various interests at The prefatory language of § 147.133(a) on the effects of the objection of a health
stake and the lack of a statutory not only specifies that certain entities insurance issuer in § 147.133(a)(1)(iii) is
requirement for the Departments to are ‘‘exempt,’’ but also explains that the included below.
impose the Mandate on entities and Guidelines shall not support or provide The exemptions in § 147.133(a)(1)
plans that qualify for these exemptions. for an imposition of the contraceptive apply ‘‘to the extent’’ of the objecting
As noted above, various members of coverage requirement to such exempt entities’ sincerely held moral
the public provided comments that were entities. This is an acknowledgement convictions. Thus, entities that hold a
supportive, or critical, of the regulations that section 2713(a)(4) requires women’s requisite objection to covering some, but
overall, or of significant policies preventive services coverage only ‘‘as not all, contraceptive items would be
pertaining to the regulations. To the provided for in comprehensive exempt with respect to the items to
extent those comments apply to the guidelines supported by the Health which they object, but not with respect
following regulatory text, the Resources and Services to the items to which they do not object.
Departments have responded to them Administration.’’ To the extent the Some commenters stated it was unclear
above. This section of the preamble HRSA Guidelines do not provide for, or whether the plans of entities or
responds to comments that pertain more support, the application of such individuals that morally object to some
specifically to particular regulatory text. coverage to certain entities or plans, the but not all contraceptives would be
Affordable Care Act does not require the exempt from being required to cover just
1. Restatement of Statutory coverage. Those entities or plans are the contraceptive methods as to which
Requirements of Section 2713(a) and ‘‘exempt’’ by not being subject to the there is an objection, or whether the
(a)(4) of the PHS Act (26 CFR 54.9815– requirements in the first instance. objection to some contraceptives leads
2713(a)(1) and (a)(1)(iv), 29 CFR Therefore, in describing the entities or to an exemption from that plan being
2590.715–2713(a)(1) and (a)(1)(iv), and plans as ‘‘exempt,’’ and in referring to required to cover all contraceptives. The
45 CFR 147.130(a)(1) and (a)(1)(iv)) the ‘‘exemption’’ encompassing those Departments intend that a requisite
entities or plans, the Departments also moral objection to some, but not all,
The previous regulations restated the
affirm the non-applicability of the contraceptives would lead to an
statutory requirements of section
Guidelines to them. exemption only to the extent of that
2713(a) and (a)(4) of the PHS Act, at 26
objection: That is, the exemption would
CFR 54.9815–2713(a)(1) and (a)(1)(iv), The Departments wish to make clear
encompass only the items to which the
29 CFR 2590.715–2713(a)(1) and that the expanded exemption set forth relevant entity or individual objects and
(a)(1)(iv), and 45 CFR 147.130(a)(1) and in § 147.133(a) applies to several would not encompass contraceptive
(a)(1)(iv). The Religious IFC modified distinct entities involved in the methods to which the objection does not
those restatements to more closely align provision of coverage to an objecting apply. To make this clearer, in these
them with the text of section 2713(a) employer’s employees. This explanation final rules the Departments finalize the
and (a)(4) of the PHS Act. Those is consistent with how prior regulations prefatory language of § 147.133(a) so
sections cross-reference the other have worked by means of similar that the first sentence of that paragraph
sections of the Departments’ rules that language. When § 147.133(a)(1) and states that an exemption shall be
provide exemptions to the contraceptive (a)(1)(i) specify that ‘‘[a] group health included, and the Guidelines must not
Mandate. After the Religious IFC plan,’’ ‘‘health insurance coverage provide for contraceptive coverage, ‘‘to
changed those sections, the Moral IFC provided in connection with a group the extent of the objections specified
inserted, within those cross-references, health plan,’’ and ‘‘health insurance below.’’ The Departments have made
references to the new § 147.133, which coverage offered or arranged by an corresponding changes to language
contains the text of the moral objecting organization’’ are exempt ‘‘to throughout the regulatory text, to
exemptions. The insertions correspond the extent’’ of the objections ‘‘as describe the exemptions as applying ‘‘to
to the cross-references to the religious specified in paragraph (a)(2),’’ that the extent’’ of the objection(s).
exemptions added by the Religious IFC. language exempts the group health The exemptions contained in
The Departments finalize these parts of plans of the sponsors that object, and previous regulations, at § 147.131(a), did
the Moral IFC without change. their health insurance issuers in not require an exempt entity to submit
providing the coverage in those plans any particular self-certification or
2. Exemption for Objecting Entities
(whether or not the issuers have their notice, either to the government or to
Based on Moral Convictions (45 CFR
own objections). Consequently, with the entity’s issuer or third party
147.133(a))
respect to Guidelines issued under administrator, in order to obtain or
The previous regulations contained § 147.130(a)(1)(iv) (and as referenced by qualify for their exemption. Similarly,
no exemption concerning moral the parallel provisions in 26 CFR under the expanded exemptions in
convictions, as distinct from religious 54.9815 through 2713(a)(1)(iv) and 29 § 147.133, the Moral IFC did not require
beliefs. Instead, at 45 CFR 147.131(a), CFR 2590.715 through 2713(a)(1)(v)), exempt entities to comply with a self-
they offered an exemption for houses of the plan sponsor, issuer, and plan certification process. We finalize that
worship and integrated auxiliaries. In covered in the exemption of that approach without change. Although
the remaining part of § 147.131, the paragraph would face no penalty as a exempt entities do not need to file
previous regulations described the result of omitting contraceptive notices or certifications of their
accommodation process for coverage from the benefits of the plan exemption, and these final rules do not
organizations with religious objections. participants and beneficiaries. However, impose any new notice requirements on
The Religious IFC moved the religious while a plan sponsor’s or arranger’s them, existing ERISA rules governing
exemption to a new section 45 CFR objection removes penalties from that group health plans require that, with
147.132, and expanded its scope. The group health plan’s issuer, it only does respect to plans subject to ERISA, a plan
Moral IFC created a new section 45 CFR so with respect to that group health document must include a
147.133, providing exemptions for plan—it does not affect the issuer’s comprehensive summary of the benefits
moral convictions similar to, but not coverage for other group health plans covered by the plan and a statement of
exactly the same as, the exemptions for where the plan sponsor has no the conditions for eligibility to receive
religious beliefs set forth in § 147.132. qualifying objection. More information benefits. Under ERISA, the plan
document identifies what benefits are public costs if those certifications or so or to notify plan participants of the
provided to participants and notices are to be reviewed or kept on file revocation.)
beneficiaries under the plan; if an by the government. Commenters also asked that clauses
objecting employer would like to The Departments are not aware of be added to the regulatory text holding
exclude all or a subset of contraceptive instances where the lack of a self- issuers harmless where exemptions are
services, it must ensure that the certification under the previous invoked by plan sponsors. As discussed
exclusion is clear in the plan document. exemption led to abuses or to an above, the exemption rules already
Moreover, if there is a reduction in a inability to engage in enforcement. The specify that where an exemption applies
covered service or benefit, the plan has Mandate is enforceable through various to a group health plan, it encompasses
to disclose that change to plan mechanisms in the PHS Act, the Code, both the group health plan and health
participants.59 Thus, where an and ERISA. Entities that insincerely or insurance coverage provided in
exemption applies and all (or a subset otherwise improperly operate as if they connection with the group health plan,
of) contraceptive services are omitted are exempt would do so at the risk of and therefore encompasses any impact
from a plan’s coverage, otherwise enforcement and accountability under on the issuer of the contraceptive
applicable ERISA disclosures must such mechanisms. The Departments are coverage requirement with respect to
reflect the omission of coverage in not aware of sufficient reasons to that plan. In addition, as discussed in
ERISA plans. These existing disclosure believe those measures and mechanisms the companion religious final rule
requirements serve to help provide would fail to deter entities from published elsewhere in today’s Federal
notice to participants and beneficiaries improperly operating as if they are Register, the Departments have added
of what ERISA plans do and do not exempt. Moreover, as noted above, language from the previous regulations,
cover. ERISA and other plan disclosure in § 147.131(f), to protect issuers that act
Some commenters supported this requirements governing group health in reliance on certain representations
approach, while others did not. Those plans require provision of a made in the accommodation process. To
in favor suggested that self-certification comprehensive summary of the benefits the extent that commenters seek
forms for an exemption are not covered by the plan and disclosure of language offering additional protections
necessary, could add burdens to exempt any reductions in covered services or for other incidents that might occur in
entities beyond those imposed by the benefits, so beneficiaries will know connection with the invocation of an
previous exemption, and could give rise whether their health plan claims a exemption, the previous exemption
to objections to the self-certification contraceptive Mandate exemption and regulations did not include such
process itself. Commenters also stated will be able to raise appropriate provisions, and the Departments do not
that requiring an exemption form for challenges to such claims. As a consider them necessary in these final
exempt entities could cause additional consequence, the Departments believe it rules. As noted above, the expanded
operational burdens for plans that have is an appropriate balance of various exemptions in these final rules simply
existing processes in place to handle concerns expressed by commenters for remove or narrow the contraceptive
exemptions. Other commenters favored these final rules to continue to not Mandate contained in, and derived
including a self-certification process for require notices or self-certifications for from, the Guidelines for certain plans.
exempt entities. They suggested that using the exemption. The previous regulations included a
entities might abuse the availability of Some commenters asked the reliance clause in the accommodation
an exemption or use their exempt status Departments to add language indicating provisions, but did not specify further
insincerely if no self-certification that an exemption cannot be invoked in details regarding the relationship
process exists, and that the Mandate the middle of a plan year, nor should it between exempt entities and their
might be difficult to enforce without a be used to the extent inconsistent with issuers or third party administrators.
self-certification process. laws that apply to, or state approval of, The Departments do not believe it
After considering the comments, the fully insured plans. None of the necessary to do so in these final rules.
Departments continue to believe it is previous iterations of the exemption Commenters disagreed about the
appropriate to not require exempt regulations included such provisions, likely effects of the moral exemptions
entities to submit a self-certification or and the Departments do not consider on the health coverage market. Some
notice. The previous exemption did not them necessary in these final rules. The commenters stated that expanding the
require a self-certification or notice, and exemptions in these final rules only exemptions to encompass moral
the Departments did not collect a list of purport to exempt plans and entities convictions would not cause
all entities that used the exemption, from the application of the federal complications in the market, while
although there may have been contraceptive coverage requirement of others said that it could, due to such
thousands of houses of worship and the Guidelines issued under section causes as a lack of uniformity among
integrated auxiliaries covered by the 2713(a)(4). They do not purport to plans, or permitting multiple risk pools.
previous exemption and the exempt entities or plans from state laws The Departments note that the extent to
Departments think it likely that only a concerning contraceptive coverage, or which plans cover contraception under
small number of entities will use the laws governing whether an entity can the prior regulations is already far from
moral exemption. Adding a self- make a change (of whatever kind) uniform. Congress did not require all
certification or notice to the exemption during a plan year. Final rules entities to comply with section 2713 of
would impose an additional paperwork governing the accommodation likewise the PHS Act (under which the Mandate
burden on exempt entities that the do not purport to obviate the need to was promulgated)—most notably by
previous regulations did not impose, follow otherwise applicable rules about exempting grandfathered plans.
and would also involve additional making changes during a plan year. (In Moreover, under the previous
the companion rules concerning regulations, issuers were already able to
59 See, for example, 29 U.S.C. 1022, 1024(b), 29 religious beliefs published elsewhere in offer plans that omit contraceptives—or
CFR 2520.102–2, 2520.102–3, & 2520.104b-3(d), and today’s Federal Register, the only some contraceptives—to houses of
29 CFR 2590.715–2715. See also 45 CFR 147.200
(requiring disclosure of the ‘‘exceptions, reductions,
Departments discuss in more detail the worship and integrated auxiliaries, and
and limitations of the coverage,’’ including group accommodation and when an entity some commenters and litigants said that
health plans and group & individual issuers). seeking to revoke it would be able to do issuers were doing so. These cases
where plans did not need to comply a. Plan Sponsors in General (45 CFR The Departments are sympathetic to
with the Mandate, and the Departments’ 147.133(a)(1)(i) Prefatory Text) the arguments of commenters that favor
previous accommodation process which Under the plan sponsor exemption in including government entities in the
had the effect of allowing coverage not § 147.132(a)(1)(i), the prefatory text in exemption for moral convictions. The
to be provided in certain self-insured that paragraph specifies that it protections outlined in the first
church plans, together show that the encompasses group health plans, and paragraph of the Church Amendments
importance of a uniform health coverage health insurance coverage provided in for entities that object based on moral
system is not significantly harmed by connection with such group health convictions to making their facilities or
allowing plans to omit contraception in plans, that are sponsored by certain personnel available to assist in the
some contexts.60 kinds of entities, namely, nonprofit performance of abortions or
organizations or for-profit entities that sterilizations do not turn on the nature
Concerning the prospect raised by
have no publicly traded ownership of the entity, whether public, private,
some commenters of different risk pools
interests. nonprofit, for-profit, or governmental.
between men and women, section (42 U.S.C. 300a–7(b)). Both the Weldon
2713(a) of the PHS Act itself provides Such plan sponsors, if they are
otherwise nonprofit organizations or for- and Coats-Snowe Amendments also
for some preventive services coverage protect state and local government
that applies to both men and women, profit entities that have no publicly
traded ownership interests, can include entities from providing, promoting, or
and some that would apply only to paying for abortions in particular
women. With respect to the latter, it entities that are not employers (for
example, a union, or a sponsor of a ways.61 Congress has generally not
does not specify what, if anything, limited protections for conscience based
HRSA’s Guidelines for women’s multiemployer plan), where the plan
sponsor objects based on sincerely held on the nature of an entity—even in the
preventives services would cover, or if case of governmental entities.
contraceptive coverage will be required. moral convictions to coverage of
contraceptives or sterilization. Plan At the same time, the Departments do
The Moral IFC and these final rules do not at this time have information
not require issuers to offer health sponsors encompassed by the
exemption can also include employers, suggesting that an exemption for
insurance products that satisfy morally governmental entities is needed or
objecting entities, they simply make it and consistent with the definition of
‘‘employer’’ in 29 CFR 2510.3–5, can desired. The Departments have not been
legal to do so. The Mandate has been sued by any governmental entities
include association health plans, where
imposed only relatively recently, and raising objections to the Mandate based
the plan sponsor is a nonprofit
the contours of its application to on non-religious moral convictions.
organization or a for-profit entity that
objecting entities has been in continual Although the Departments sought
has no publicly traded ownership
flux, due to various rulemakings and public comment on the issue, the
interests.
court orders. Overall, concerns raised by Departments received no public
Some commenters objected to
some public commenters have not led extending the exemption to plan comments identifying governmental
the Departments to consider it likely sponsors that are not single employers, entities that need or desire such an
that offering these expanded exemptions arguing that they could not have the exemption. Rather, the Departments are
will cause any injury to the uniformity same kind of moral objection that a aware of governmental entities that,
or operability of the health coverage single employer might have. Other despite not possessing their own
market. commenters supported the protection of objections to contraceptive coverage,
any plan sponsor with the requisite have acted to protect their employees
3. Exemption for Certain Plan Sponsors
moral objection. The Departments who have conscientious objections to
(45 CFR 147.133(a)(1)(i))
conclude that it is appropriate, where a receiving contraceptive coverage in their
The exemption in § 147.133(a)(1)(i) of plan sponsor of a multiemployer plan or employer-provided health insurance
the Moral IFC covers a group health multiple employer plan adopts a moral plans. See Wieland v. U.S. Dep’t of
plan and health insurance coverage for objection using the same procedures Health & Human Servs., 196 F. Supp.
non-governmental plan sponsors that that such a plan sponsor might use to 1010, 1015–16 (E.D. Mo. 2016) (quoting
object as specified in paragraph (a)(2), make other decisions, to respect that Mo. Rev. Stat. 191.724). The individual
and that are either nonprofit decision by providing an exemption exemption adopted in these rules will
organizations, or are for-profit entities from the Mandate. ensure the Mandate is not an obstacle to
that have no publicly traded ownership The plans of governmental employers those efforts.
interests (defined as any class of are not covered by the plan sponsor Thus, in light of the balance of public
common equity securities required to be exemption in § 147.133(a)(1)(i), which comments, the Departments decline to
registered under section 12 of the instead limits the moral exemptions to extend the moral convictions exemption
Securities Exchange Act of 1934). The ‘‘non-governmental plan sponsors.’’ As to governmental entities. As is the case
Departments finalize this paragraph noted above, the Departments sought with the Departments’ decision not to
without change, and discuss each part public comment on whether to extend extend the moral exemption to publicly
of the paragraph in turn. the exemptions to non-federal traded for-profit entities, this decision
governmental plan sponsors. Some does not reflect a disagreement with the
60 See also Real Alternatives, 867 F.3d 338, 389 commenters suggested that the moral various conscience statutes that provide
(3d Cir. 2017) (Jordan, J., concurring in part and exemptions should include government exemptions for moral convictions
dissenting in part) (‘‘Because insurance companies entities because other conscience laws
would offer such plans as a result of market forces, 61 Consolidated Appropriations Act, 2018, Div. H,
doing so would not undermine the government’s

can include government entities, such Sec. 507(d), 132 Stat. at 764 (protecting any
interest in a sustainable and functioning market. as when they oppose offering abortions. ‘‘hospital, a provider-sponsored organization, a
. . . Because the government has failed to Others disagreed, contending that health maintenance organization, a health
demonstrate why allowing such a system (not governmental entities should not or insurance plan, or any other kind of health care
unlike the one that allowed wider choice before the facility, organization, or plan’’ in objecting to
ACA) would be unworkable, it has not satisfied
cannot object based on moral abortion); 42 U.S.C. 238n (protecting entities that
strict scrutiny.’’ (citation and internal quotation convictions, or that it would be object to abortion, including, but not limited to, any
marks omitted)). unlawful for them to do so. ‘‘postgraduate physician training program’’).
without categorically excluding view on contraceptive coverage. Instead, health care conscience laws whether or
governmental entities. The Departments nonprofit organizations generally have not an entity operates as a nonprofit.64
remain open to the possibility of future access to a First Amendment right of Extending the exemption to certain
rulemaking on this issue if the expressive association to choose to hire for-profit entities is also consistent with
Departments become aware of a persons (or, in the case of students, to the Supreme Court’s ruling in Hobby
governmental entity seeking to be admit them) based on whether they Lobby, which declared that a corporate
exempt from the contraceptive Mandate. share, or at least will be respectful of, entity is capable of possessing and
their beliefs.62 pursuing non-pecuniary goals (in Hobby
b. Nonprofit Organizations (45 CFR
Lobby, the pursuit of religious beliefs),
147.133(a)(1)(i)(A)) The Departments agree with regardless of whether the entity operates
As discussed above, some commenters who support offering the as a nonprofit organization and rejected
commenters opposed offering exemption to nonprofit organizations the Departments’ argument to the
exemptions based on moral convictions and believe that doing so is an contrary. 134 S. Ct. at 2768–75. The
to any plan sponsors, and/or objected to appropriate protection and is not likely mechanisms by which a for-profit
doing so for nonprofit organizations, on to have a significant impact on women company makes decisions of
various grounds, including but not who want contraceptive coverage. conscience, or resolves disputes on
limited to arguments that the benefits of those issues among their owners, are
c. For-Profit Entities (45 CFR
contraception access should override problems that ‘‘state corporate law
147.133(a)(1)(i)(B))
moral objections, entities cannot assert provides a ready means’’ of solving. Id.
moral objections, and moral objections With respect to for-profit at 2774–75. Some reports and industry
burden third parties. Other commenters organizations addressed in experts have indicated that few for-
supported the exemptions, generally § 147.133(a)(1)(i)(B), in the Moral IFC, profit entities beyond those that had
defending the interest of nonprofit the Departments did not limit the originally challenged the Mandate have
organizations not to be forced to violate exemption to nonprofit organizations, sought relief from it after Hobby
their moral convictions, supporting the but also included some for-profit Lobby.65 Because all of those appear to
history of government protection of entities. Some commenters supported be informed by religious beliefs,
moral convictions in similar contexts, including for-profit entities in the extending the exemption to entities with
and disputing the claims of opponents exemption, saying owners of such non-religious moral convictions would
of the exemptions. entities exercise their moral convictions seem to have an even smaller impact on
The Departments are aware, through access to contraceptive coverage.
through their businesses, and that such
litigation, of only two non-religious The Moral IFC only extended the
nonprofit organizations with moral owners should not be burdened by a
federal governmental contraceptive exemption covering for-profit entities to
objections to the contraceptive Mandate. those that are closely held, not to for-
Many more nonprofit religious Mandate. Other commenters opposed
extending the exemption to closely held profit entities that are publicly traded,
organizations have sued suggesting—as but asked for comment on whether
discussed below—that the effect of this for-profit entities, saying the entities
cannot exercise moral convictions or publicly traded entities should be
exemption for non-religious nonprofit included in the moral exemption. In this
objections to the Mandate will be far should not have their moral opposition
to contraceptive coverage protected by way the Moral IFC differed from the
less significant than commenters who exemption provided to plan sponsors
oppose the exemption believe it will. the exemption. Some commenters stated
that the entities should not be able to with objections based on sincerely held
The two non-religious nonprofit
impose their beliefs about contraceptive religious beliefs set forth in the
organizations that challenged the
coverage on their employees and that Religious IFC, at § 147.132(a)(1),
Mandate in court provide a good
doing so constitutes discrimination. finalized in companion rules published
illustration of the reasons why the
elsewhere in today’s Federal Register.
Department has decided to provide this The Departments agree with Some commenters supported
exemption to nonprofit organizations. commenters who support including including publicly traded entities in the
Both organizations have said in court some for-profit entities in the moral exemption, contending that
they oppose certain contraceptives on exemption. Many of the federal health publicly traded entities have historically
non-religious moral grounds as being care conscience statutes cited above taken various positions on important
abortifacient and state that they only offer protections for the moral public concerns beyond merely seeking
hire employees who share that view. convictions of entities, without regard to the company’s own profits, and that
Public comments and litigation reflect whether they operate as nonprofit nothing in principle would preclude
that many nonprofit organizations organizations or for-profit entities. In them from using the same mechanisms
publicly describe their beliefs and addition, nearly half of the states either of corporate decision-making to
convictions. Government records and impose no contraceptive coverage establish and exercise moral convictions
many of those groups’ websites also requirement or offer ‘‘an almost against contraceptive coverage. They
often reflect those groups’ religious or unlimited’’ exemption encompassing observed that large publicly traded
moral character, as the case may be. If both ‘‘religious and secular entities are exempt from the
a person who desires contraceptive organizations.’’ 63 States also generally contraceptive Mandate by means of the
coverage works at a nonprofit protect moral convictions in other grandfathering provision of the ACA, so
organization, the Departments view it as
sufficiently likely that the person would
62 Notably, ‘‘the First Amendment simply does 64 See, e.g., ‘‘Refusing to Provide Health
know, or would know to ask, whether not require that every member of a group agree on Services,’’ The Guttmacher Institute (June 1, 2018),
the organization offers such coverage. every issue in order for the group’s policy to be https://www.guttmacher.org/state-policy/explore/
The Departments are not aware of ‘expressive association.’ ’’ Boy Scouts of America v. refusing-provide-health-services.
federal laws that would require a Dale, 530 U.S. 640, 655 (2000). 65 See Jennifer Haberkorn, ‘‘Two years later, few
63 ‘‘Insurance Coverage of Contraceptives,’’ The Hobby Lobby copycats emerge,’’ Politico (Oct. 11,
nonprofit organization that opposes Guttmacher Institute (June 11, 2018), https:// 2016), http://www.politico.com/story/2016/10/
contraceptive coverage to hire a person www.guttmacher.org/state-policy/explore/ obamacare-birth-control-mandate-employers-
who disagrees with the organization’s insurance-coverage-contraceptives. 229627.
that it is inappropriate to refuse to facilities or personnel available to assist provision of contraceptive coverage by
exempt publicly traded entities that in the performance of abortions or health insurance plans,’’ ‘‘it is the intent
actually have sincerely held moral sterilizations; the protections of the of Congress that any legislation enacted
convictions against compliance with the Church Amendments do not turn on the on such issue should include a
Mandate. They further argued that in nature of the entity, whether public, ‘conscience clause’ which provides
some instances there are closely held private, nonprofit, for-profit, or exceptions for religious beliefs and
companies that are as large as publicly governmental. (42 U.S.C. 300a–7(b)). moral convictions.’’ Consolidated
traded companies of significant size. Thus, under section 300a–7(b), a Appropriations Act, 2018, Public Law
They also stated that other protections hospital in a publicly traded health 115–141, Div. E, Sec. 808.
for moral convictions in certain federal system, or a local governmental In all of these instances, Congress did
health care conscience statutes do not hospital, could adopt sincerely held not limit the protection for conscience
preclude the application of such moral convictions by which it objects to based on the nature of the entity—and
protections to certain entities on the providing facilities or personnel for did not exclude publicly traded entities
basis that they are not closely held, and abortions or sterilizations, and if the from protection.
federal law defines ‘‘persons’’ to include entity receives relevant funds from HHS At the same time, as stated in the
all forms of corporations, not just specified by section 300a–7(b), the Moral IFC, the Departments continue to
closely held corporations, at 1 U.S.C. 1. protections of that section would apply. lack significant information about
Additionally, some commenters were Other federal conscience protections in whether there is a need to extend the
concerned that not providing a moral the health sector apply in the same expanded exemption to publicly traded
exemption for publicly traded for-profit manner: entities. The Departments have been
entities but allowing a religious • The Coats-Snowe Amendment (42 sued by nonprofit entities expressing
exemption for publicly traded for-profit U.S.C. 238n) provides certain objections to the Mandate based on non-
entities (as was allowed in the Religious protections for health care entities and religious moral convictions, as well as
IFC, and as is allowed in the companion postgraduate physician training by closely held for-profit entities
religious final rules published programs that, among other things, expressing religious objections, but not
elsewhere in today’s Federal Register), choose not to perform, refer for, or by any publicly traded entities. In
may raise Establishment Clause provide training for, abortions. addition, the Departments sought public
questions, may cause confusion to the • The Weldon Amendment 66 comments on whether publicly traded
public, and may make the exemptions provides certain protections for health entities might benefit from extending
more difficult for the Departments and care entities, hospitals, provider- the moral exemption to them. No such
enforcing agencies to administer. They sponsored organizations, health entities were brought to the attention of
stated that it is incongruous to include maintenance organizations, and health the Department through the comment
publicly traded entities in the insurance plans that do not provide, pay process. The Supreme Court concluded
exemption for religious beliefs, but for, provide coverage of, or refer for it is improbable that publicly traded
exclude them from the exemption for abortions. companies with numerous ‘‘unrelated
moral convictions. • The ACA provides certain
Other commenters opposed including shareholders—including institutional
protections for any institutional health
publicly traded companies in these investors with their own set of
care entity, hospital, provider-sponsored
moral exemptions. Some stated that stakeholders—would agree to run a
organization, health maintenance
such companies could not exercise corporation under the same religious
organization, health insurance plan, or
moral convictions and opposed the beliefs.’’ Hobby Lobby, 134 S. Ct. at
any other kind of health care facility,
effects on women if they would. They 2774. It would appear to be even less
that does not provide any health care
also objected that including such probable that publicly traded entities
item or service furnished for the
companies, along with closely held would adopt that view based on non-
purpose of causing or assisting in
businesses, would extend the religious moral convictions.
causing assisted suicide, euthanasia, or
exemptions to all or virtually all In light of the balance of public
mercy killing. (42 U.S.C. 18113).67
companies. Some commenters stated • Social Security Act sections comments, the Departments decline to
that many publicly traded companies 1852(j)(3)(B) (Medicare) and extend the moral convictions exemption
would use a moral exemption if 1932(b)(3)(B) (Medicaid), 42 U.S.C. to publicly traded entities. Because the
available to them, because many closely 1395w–22(j)(3)(B) and 1396u–2(b)(3)(B), Departments are aware of so many
held for-profit businesses expressed provide protections so that the statutes closely-held for-profit entities with
religious objections to the Mandate, or cannot be construed to require religious objections to contraceptive
availed themselves of the religious organizations that offer Medicare coverage, and of some nonprofit entities
accommodation. Advantage and Medicaid managed care with non-religious moral objections to
As is the case for non-federal plans in certain contexts to provide, contraceptive coverage, the Departments
governmental employers, the reimburse for, or provide coverage of a believe it is reasonably possible that
Departments are sympathetic to the counseling or referral service if they closely held for-profit entities with non-
arguments of commenters that favor object to doing so on moral grounds. religious moral objections to
including publicly traded entities in the • Congress’s most recent statement on contraceptive coverage might exist or
exemption for moral convictions. In the contraceptive coverage specified that, if come into being. The Departments have
case of particularly sensitive health care the District of Columbia requires ‘‘the also concluded that it is reasonably
matters, several significant federal possible, even if improbable, that
health care conscience statutes protect 66 See Consolidated Appropriations Act, 2018, publicly traded entities with religious
entities’ moral objections without regard Public Law 115–141, Div. H, Sec. 507(d) (Mar. objections to contraceptive coverage
to their ownership status. For example, 2018). might exist or come into being. But the
67 The lack of the limitation in this provision may
the first paragraph of the Church Departments conclude there is not a
be particularly relevant since it was enacted in the
Amendments provides certain same statute, the ACA, as the provision under
similar probability that publicly traded
protections for entities that object based which the Mandate—and these exemptions to the for-profit entities with non-religious
on moral convictions to making their Mandate—were promulgated. moral objections to contraceptive
coverage may exist and need to be 4. Institutions of Higher Education (45 In the Departments’ view, the reasons
included in these expanded exemptions. CFR 147.133(a)(1)(ii)) for extending the exemption to
The decision to not extend the moral institutions of higher education are
exemption to publicly traded for-profit The previous regulations did not similar to the reasons, discussed above,
entities in these rules does not reflect a exempt plans arranged by institutions of for extending the exemption to other
disagreement with the various higher education, although they did nonprofit organizations. The
conscience statutes that provide include, in the accommodation, plans Departments are not aware of any
exemptions for moral convictions arranged by institutions of higher
institutions of higher education that
without categorically excluding publicly education similarly to the way in which
arrange student health insurance
traded entities. The Departments remain the regulations provided the
coverage and object to the Mandate
open to the possibility of future accommodation to plans of nonprofit
based on non-religious moral
rulemaking on this issue, if we become religious employers. (See 80 FR 41347).
convictions. But because the
aware of the need to expand the The Moral IFC provided an exemption,
in § 147.133(a)(1)(ii), encompassing Departments have been sued by several
exemptions to publicly traded institutions of higher education that
corporations with non-religious moral institutions of higher education that
arrange student health insurance arrange student health insurance
objections to all (or a subset of) coverage and object to the Mandate
contraceptives. coverage, and stating the exemption
would operate in a manner comparable based on religious beliefs and by several
In contrast, the Departments finalize, nonprofit organizations with moral
without change, the Moral IFC’s to the exemption for employers with
respect to plans they sponsor. In these objections, the Departments believe the
extension of the exemptions in these existence of institutions of higher
rules to closely held for-profit entities final rules, the Departments finalize
§ 147.133(a)(1)(ii) with one change. education with non-religious moral
with moral convictions opposed to objections, or the possible formation of
offering coverage of some or all These rules treat the health plans of
such entities in the future, is sufficiently
contraceptives. The Departments institutions of higher education that
possible to justify including protections
conclude that it is sufficiently likely arrange student health insurance
for such entities in these final rules.
that closely held for-profit entities exist coverage similarly to the way in which
or may come into being and may the rules treat the plans of employers. The Departments conclude that this
maintain moral objections to certain The rules do so by making such student aspect of the exemption is likely to have
contraceptives, so as to support health plans eligible for the expanded a minimal impact on contraceptive
including them in these expanded exemptions, and by permitting them the coverage for women at institutions of
exemptions. The Departments seek to option of electing to utilize the higher education. As noted above, the
remove an obstacle that might prevent accommodation process. Thus, these Departments are not aware of any
individuals with moral objections from rules specify, in § 147.133(a)(1)(ii), that institutions of higher education that
forming or maintaining such small or the exemption is extended, in the case would currently qualify for the
closely held businesses and providing of institutions of higher education (as objection. In addition, only a minority
health coverage to their employees in defined in 20 U.S.C. 1002) with of students in higher education receive
accordance with their moral objections to the Mandate based on health insurance coverage from plans
convictions. sincerely held moral convictions, to arranged by their colleges or
In defining what constitutes a closely their arrangement of student health universities, as opposed to from other
held for-profit entity to which these insurance coverage, in a manner sources, and an even smaller number
exemptions extend, the Moral IFC used comparable to the exemption for group receive such coverage from schools
language derived from the July 2015 health insurance coverage provided in objecting to contraceptive coverage.
final regulations. Those regulations, in connection with a group health plan Exempting institutions of higher
offering the accommodation (not an established or maintained by a plan education that object to contraceptive
exemption) to religious (not moral) sponsor. coverage based on moral convictions
closely held for-profit entities, did so by Some commenters supported does not affect student health insurance
attempting to positively define what including, in the exemptions, contraceptive coverage at the vast
constitutes a closely held entity, institutions of higher education that majority of institutions of higher
formulating a multi-factor, and partially provide health coverage for students education. The exemption simply makes
open-ended, definition for that purpose. through student health plans but have it legal under federal law for institutions
(80 FR 41313). Any such positive moral objections to providing certain to adhere to moral convictions that
definition runs up against the myriad contraceptive coverage. They stated that oppose contraception, without facing
state differences in defining such moral exemptions allow freedom for penalties for non-compliance that could
entities and potentially intrudes into a certain institutions of higher education threaten their existence. This removes a
traditional area of state regulation of to exist, and this in turn gives students possible barrier to diversity in the
business organizations. Instead of the choice of institutions that hold nation’s higher education system,
attempting to positively define closely different views on important issues such because it makes it easier for students to
held businesses in the Moral IFC, as contraceptives and abortifacients. attend institutions of higher education
however, the Departments considered it Other commenters opposed including that hold those views, if the institutions
much clearer, effective, and preferable the exemption, asserting that expanding exist or come into being and students
to define the category negatively, by the exemption would negatively impact choose to attend them. Moreover,
reference to one element of the previous female students because institutions of because institutions of higher education
definition: that the entity has no higher education might not cover have no legal obligation to sponsor
publicly traded ownership interest (that contraceptives in student health plans, student health insurance coverage,
is, any class of common equity women enrolled in those plans would providing this moral exemption
securities required to be registered not receive access to birth control, and removes an obstacle to such institutions
under section 12 of the Securities an increased number of unintended sponsoring student health insurance
Exchange Act of 1934). pregnancies would result. coverage, thus possibly encouraging
more widespread health insurance and individuals. Thus, the issuer it prevent other issuers from being
coverage. exemption specifies that, where a health required to provide contraceptive
As noted above, after seeking public insurance issuer providing group health coverage in individual or group
comment on whether the final moral insurance coverage is exempt under insurance coverage.
exemptions rules should be extended to paragraph (a)(1)(iii), the plan remains The issuer exemption serves several
include non-federal governmental subject to any requirement to provide interests, even though the Departments
entities, the Departments have coverage for contraceptive services are not currently aware of existing
concluded they should only include under Guidelines issued under issuers that would use it. As noted by
non-governmental entities. For the same § 147.130(a)(1)(iv), unless the plan is some commenters, allowing issuers to
reasons, the Departments are inserting a otherwise exempt from that be exempt, at least with respect to plan
reference into § 147.133(a)(1)(ii) requirement. Accordingly, the only plan sponsors, plans, and individuals that
specifying that it includes an institution sponsors, or in the case of individual independently qualify for an exemption,
of higher education ‘‘which is non- insurance coverage, individuals, who will remove a possible obstacle to
governmental.’’ This language is parallel are eligible to purchase or enroll in issuers with moral convictions being
to the same limiting phrase used in the health insurance coverage offered by an organized in the future to serve entities
religious exemptions rule governing exempt issuer under this paragraph and individuals that want plans that
institutions of higher education, at (a)(1)(iii) that does not include some or respect their religious beliefs or moral
§ 147.132(a)(1)(ii). Thus, the first all contraceptive services, are plan convictions. Furthermore, permitting
sentence of § 147.133(a)(1)(ii) is sponsors or individuals who themselves issuers to object to offering
finalized to read: ‘‘An institution of object and are exempt. contraceptive coverage based on
higher education as defined in 20 U.S.C. Under these rules, issuers that hold sincerely held moral convictions will
1002, which is non-governmental, in its their own objections based on sincerely allow issuers to continue to offer
arrangement of student health insurance held moral convictions could issue coverage to plan sponsors and
coverage, to the extent that institution policies that omit contraception to plan individuals, without subjecting them to
objects as specified in paragraph (a)(2) sponsors or individuals that are liability under section 2713(a)(4), or
of this section.’’ The remaining text of otherwise exempt based on their moral related provisions, for their failure to
§ 147.133(a)(1)(ii) is finalized without convictions, or if they are exempt based provide contraceptive coverage. In this
change. on their religious beliefs under the way, the issuer exemption serves to
companion final rules published protect objecting issuers both from being
5. Health Insurance Issuers (45 CFR
elsewhere in today’s Federal Register. required to issue policies that cover
147.133(a)(1)(iii))
Likewise, issuers with sincerely held contraception in violation of the issuers’
The Moral IFC extended the religious beliefs, that are exempt under sincerely held moral convictions and
exemption, in § 147.133(a)(1)(iii), to those companion final rules, could from being asked or required to issue
health insurance issuers offering group likewise issue policies that omit policies that omit contraceptive
or individual health insurance coverage contraception to plan sponsors or coverage to non-exempt entities or
that sincerely hold their own moral individuals that are otherwise exempt individuals, thus subjecting the issuers
convictions opposed to providing based on either their religious beliefs or to potential liability if those plans are
coverage for contraceptive services. The their moral convictions. not exempt from the Guidelines.
issuer exemption only applied to the Some commenters supported The Departments reject the
group health plan if the plan itself was including this exemption for issuers in proposition that issuers cannot exercise
also exempt under an exemption for the these rules, both to protect the moral moral convictions. Many federal health
plan sponsor or individuals. In these convictions of issuers, and so that, in care conscience laws and regulations
final rules, the Departments finalize the future, issuers would be free to protect issuers or plans specifically. For
§ 147.133(a)(1)(iii) without change. organize that may wish to specifically
As discussed above, where the example, as discussed above, 42 U.S.C.
serve plan sponsors and individuals that 1395w–22(j)(3)(B) and 1396u–2(b)(3)
exemption for plan sponsors or object to contraception based on
institutions of higher education applies, protect plans or managed care
religious or moral reasons. Other organizations in Medicare Advantage or
issuers are exempt under those sections commenters objected to including an
with respect to providing contraceptive Medicaid. The Weldon Amendment
exemption for issuers. Some
coverage in those plans. The issuer specifically protects, among other
commenters stated that issuers cannot
exemption in § 147.133(a)(1)(iii) adds to entities, HMOs, health insurance plans,
exercise moral convictions, while others
that protection, but the additional and ‘‘any other kind of health care
stated that exempting issuers would
protection operates in a different way facility[ies], organization[s] or plan[s]’’
threaten contraceptive coverage for
than the plan sponsor exemption as a ‘‘health care entity’’ from being
women. Some commenters stated that it
operates. The only plan sponsors—or in required to provide coverage of, or pay
was arbitrary and capricious for the
the case of individual insurance for, abortions. See, for example,
Departments to provide an exemption
coverage, individuals—who are eligible Consolidated Appropriations Act, 2018,
for issuers if they do not know that
to purchase or enroll in health issuers with qualifying moral objections Public Law 115–141, Div. H, Sec.
insurance coverage offered by an exist. 507(d).68 The most recently enacted
exempt issuer that does not cover some The Departments consider it Consolidated Appropriations Act
or all contraceptive services, are plan appropriate to provide this exemption declares that Congress supports a
sponsors or individuals who themselves for issuers. Because the issuer
68 ACA section 1553 protects an identically

object and whose plans are otherwise exemption only applies where an defined group of ‘‘health care entities,’’ including
exempt based on that objection. An independently exempt policyholder provider-sponsored organizations, HMOs, health
exempt issuer can then offer an exempt (entity or individual) is involved, the insurance plans, and ‘‘any other kind of . . . plan,’’
product to an entity or individual that issuer exemption will not serve to from being subject to discrimination on the basis
that it does not provide any health care item or
is exempt based on either the moral remove contraceptive coverage service furnishing for the purpose of assisted
exemptions for entities and individuals, obligations from any plan or plan suicide, euthanasia, mercy killing, and the like.
or the religious exemptions for entities sponsor that is not also exempt, nor will ACA section 1553, 42 U.S.C. 18113.
‘‘conscience clause’’ to protect moral third party administrator to contract situation where a publicly traded entity,
convictions concerning ‘‘the provision with an exempt entity or individual if for example, has an objection to the
of contraceptive coverage by health the issuer or third party administrator contraceptive Mandate, but it is not
insurance plans.’’ See id. at Div. E, Sec. does not wish to do so, including clear whether that objection is based on
808. because the issuer or third party sincerely held religious beliefs or
The issuer exemption does not administrator does not wish to offer an merely based on sincerely held moral
specifically include third party unusual plan variation. These rules convictions.
administrators, for the reasons simply remove the federal Mandate, in
7. Individuals (45 CFR 147.133(b))
discussed in the companion Religious some cases, where it could have led to
IFC and final rules concerning religious penalties on an employer, issuer, or The previous regulations did not
beliefs issued contemporaneously with third party administrator if they wished provide an exemption for objecting
these final rules and published to sponsor, provide, or administer a individuals. The Moral IFC provided
elsewhere in today’s Federal Register.69 plan that omits contraceptive coverage such an exemption for objecting
in the presence of a qualifying moral individuals (referred to here as the
6. Description of the Moral Objection objection. That approach is consistent ‘‘individual exemption’’), using the
(45 CFR 147.133(a)(2)) with the approach under the previous following language at § 147.133(b):
The Moral IFC set forth the scope of regulations, which did not require ‘‘Objecting individuals’’. Guidelines
the moral objection of objecting entities issuers and third party administrators to issued under § 147.130(a)(1)(iv) by the
in § 147.133(a)(2), so that it applies to contract with exempt plans of houses of Health Resources and Services
the extent an entity described in worship or integrated auxiliaries if they Administration must not provide for or
paragraph (a)(1), based on sincerely held did not wish to do so. support the requirement of coverage or
moral convictions, objects to The definition does not specify that payments for contraceptive services
‘‘establishing, maintaining, providing, the moral convictions that can support with respect to individuals who object
offering, or arranging’’ either ‘‘coverage an exemption need to be non-religious as specified in this paragraph (b), and
or payments’’ for contraceptives, or ‘‘for moral convictions. We find it nothing in § 147.130(a)(1)(iv), 26 CFR
a plan, issuer, or third party unnecessary to limit the definition in 54.9815–2713(a)(1)(iv), or 29 CFR
administrator that provides or arranges that way. Even though moral 2590.715–2713(a)(1)(iv) may be
such coverage or payments.’’ The convictions need not be based on construed to prevent a willing health
Departments are finalizing this religious beliefs, religious beliefs can insurance issuer offering group or
exemption with structural changes have a moral component. It is not individual health insurance coverage,
separating the second half of the always clear whether a moral conviction and as applicable, a willing plan
sentence into separate subparagraphs, so is based on religious tenets. As noted in sponsor of a group health plan, from
as to more clearly specify, as set forth Welsh, a moral conviction can be offering a separate policy, certificate or
in the Moral IFC text, that the objection ‘‘purely ethical or moral in source and contract of insurance or a separate group
may pertain either to coverage or content but that nevertheless . . . health plan or benefit package option, to
payments for contraceptives, or to a occupy in the life of that individual a any individual who objects to coverage
plan, issuer, or third party administrator place parallel to that filled by God [and] or payments for some or all
that provides or arranges such coverage function as a religion in his life.’’ 398 contraceptive services based on
or payments. U.S at 340. One reason for providing sincerely held moral convictions.’’
Some commenters observed that, by exemptions for moral convictions is so The Departments finalize this
allowing exempt plan sponsors to object that the government need not engage in language, with changes in response to
to ‘‘some or all’’ contraceptives, this the potentially difficult task of parsing public comments in some of the text
might yield a cafeteria-style approach which convictions are religious and and in a new sentence at the end of the
where different plan sponsors choose which are not. If sincerely held moral paragraph that clarify how the
various combinations of contraceptives convictions supporting an exemption exemption applies.
that they wish to cover. Some are religious, they will be encompassed Section 147.133(b) sets forth a special
commenters further observed that this by the exemption for sincerely held rule pertaining to individuals (referred
might create a burden on issuers or third religious beliefs. If the moral to here as the ‘‘individual exemption’’).
party administrators. convictions are not also religious, or if This rule exempts plans of certain
The Departments have concluded, their religious quality is unclear but individuals with moral objections to
however, that just as the previous they are ethical or moral, they can contraceptive coverage where the plan
exemption rules allowed certain qualify as sincerely held moral sponsor and, as applicable, issuer is
religious plan sponsors to object to some convictions under these rules if the willing to provide a plan compliant
or all contraceptives, it is appropriate to other requirements of these rules are with the individuals’ objections to such
maintain that flexibility for entities met. plan sponsors or individuals, as
covered by the expanded exemption. The Departments are not aware of any applicable.
entities that qualify for an exemption Some commenters supported this
These rules do not require any issuer or
under the religious exemptions finalized exemption as providing appropriate
69 The exemption for issuers, as outlined here, elsewhere in today’s Federal Register, protections for the moral convictions of
does not make a distinction among issuers based on but not under the moral exemptions individuals who obtain their insurance
whether they are publicly traded, unlike the plan finalized here, such as publicly traded coverage in such places as the
sponsor exemption for employers. Because the entities. If publicly traded entities object individual market or exchanges, or who
issuer exemption operates more narrowly than the

exemption for plan sponsors operates, in the ways
to the Mandate, it seems unlikely their obtain coverage from a group health
described here (i.e., the issuer exemption does not objection is based on moral convictions plan sponsor that does not object to
operate unless the plan sponsor or individual, as and not religious beliefs, given that coverage of contraceptives but is willing
applicable, is also exempt), and exists in part to many more objections to the Mandate (and, as applicable, the issuer is also
help preserve market options for objecting plan
sponsors and individuals, the Departments consider
have been based on religious beliefs. willing) to provide coverage consistent
it appropriate to not draw such a distinction among Thus, the Departments find it unlikely with an individual’s moral objections.
issuers. that they would be faced with a They commented that this exemption
would free individuals from having District of Columbia requires ‘‘the 196 F. Supp. 3d at 1015–16 (quoting
their moral convictions placed in provision of contraceptive coverage by Mo. Rev. Stat. 191.724). Under the
tension with their desire for health health insurance plans,’’ ‘‘it is the intent individual exemption in these rules,
coverage. They also contended that the of Congress that any legislation enacted employers sponsoring governmental
individual exemption would not on such issue should include a plans would be free to honor the moral
undermine any government interests ‘conscience clause’ which provides objections of individual employees by
behind the contraceptive Mandate, since exceptions for religious beliefs and offering them plans that omit
the individuals would be choosing not moral convictions’’. Id. at Div. E, Sec. contraceptive coverage, even if those
to have the coverage. Some commenters 808. A moral exemption for individuals governmental entities do not object to
also observed that, by specifying that would not be effective if the government offering contraceptive coverage in
the individual exemption only operates did not, at the same time, permit issuers general.
where the plan sponsor and issuer, as and group health plans to provide In the separate companion IFC to the
applicable, are willing to provide individuals with policies that comply Moral IFC—the Religious IFC—the
coverage that is consistent with the with their moral convictions. Departments, at § 147.133(b), provided a
objection, the exemption would not The individual exemption extends to similar individual exemption, but we
impose burdens on the insurance the coverage unit in which the plan used slightly different operative
market because the possibility of such participant, or subscriber in the language. Where the Moral IFC said a
burdens would be factored into the individual market, is enrolled (for willing issuer and plan sponsor may
willingness of an employer or issuer to instance, to family coverage covering offer ‘‘a separate policy, certificate or
offer such coverage. the participant and his or her contract of insurance or a separate group
Other commenters disagreed and beneficiaries enrolled under the plan), health plan or benefit package option, to
contended that allowing the individual but does not relieve the plan’s or any individual who objects’’ under the
exemption would cause burden and issuer’s obligation to comply with the individual exemption, the Religious IFC
confusion in the insurance market. Mandate with respect to the group described what may be offered to
Some commenters also suggested that health plan generally, or, as applicable, objecting individuals as ‘‘a separate
the individual exemption should not to any other individual policies the benefit package option, or a separate
allow the offering of a separate group issuer offers. Thus, this individual policy, certificate or contract of
health plan because doing so could exemption allows plan sponsors and insurance.’’ Some commenters observed
cause various administrative burdens. issuers that do not specifically object to this difference and asked whether the
The Departments agree with the contraceptive coverage to offer morally language was intended to encompass
commenters who suggested the acceptable coverage to their participants the same options. The Departments
individual exemption will not burden or subscribers who do object, while intended these descriptions to include
the insurance market, and, therefore, offering coverage that includes the same scope of options. Some
conclude that it is appropriate to contraception to participants or commenters suggested that the
provide the individual exemption where subscribers who do not object. The July individual exemption should not allow
a plan sponsor and, as applicable, issuer 2013 regulations stated that, because the offering of ‘‘a separate group health
are willing to cooperate in doing so. The employees of objecting houses of plan,’’ because doing so could cause
Departments note that this individual worship and integrated auxiliaries are various administrative burdens. The
exemption only operates in the case relatively likely to oppose Departments disagree, since group
where the issuer is willing to provide contraception, exempting those health plan sponsors and group and
the separate option; in the case of organizations ‘‘does not undermine the individual health insurance issuers
coverage provided by a group health governmental interests furthered by the would be free to decline to provide that
plan sponsor, where the plan sponsor is contraceptive coverage requirement.’’ option, including because of
willing; or in the case where both a plan (78 FR 39874). For parallel reasons, as administrative burdens. In addition, the
sponsor and issuer are involved, both the Departments stated in the Moral IFC Departments wish to clarify that, where
are willing. The Departments conclude (83 FR at 47853 through 47854), this an employee claims the exemption, a
that it is appropriate to provide the individual exemption does not willing issuer and a willing employer
individual exemption so that the undermine the governmental interests may, where otherwise permitted, offer
Mandate will not serve as an obstacle furthered by the contraceptive coverage the employee participation in a group
among these various options. Practical requirement, because, when the health insurance policy or benefit
difficulties that may be implicated by exemption is applicable, the individual option that complies with the
one option or another will likely be does not want the coverage, and employee’s objection. Consequently,
factored into whether plan sponsors and therefore would not use the these rules finalize the individual
issuers are willing to offer particular objectionable items even if they were exemption by making a technical
options in individual cases. But the covered. change to the language to adopt the
Departments do not wish to pose an This individual exemption can apply formulation, ‘‘a separate policy,
obstacle to the offering of such coverage. with respect to individuals in plans certificate or contract of insurance or a
The Departments note that their sponsored by private employers or separate group health plan or benefit
decision is consistent with the decision governmental employers. For example, package option, to any group health
by Congress to provide protections in in one case brought against the plan sponsor (with respect to an
certain contexts for individuals who Departments, the State of Missouri individual) or individual, as applicable,
object to prescribing or providing enacted a law under which the state is who objects.’’
contraceptives contrary to their moral not permitted to discriminate against This individual exemption cannot be
convictions. See, for example, insurance issuers that offer group health used to force a plan (or its sponsor) or
Consolidated Appropriations Act of insurance policies without coverage for an issuer to provide coverage omitting
2018, Div. E, Sec. 726(c) (Mar. 23, 2018). contraception based on employees’ contraception, or, with respect to health
While some commenters argued that religious beliefs ‘‘or moral convictions,’’ insurance coverage, to prevent the
such express protections are narrow, or against the individual employees application of state law that requires
Congress likewise provided that, if the who accept such offers. See Wieland, coverage of such contraceptives or
sterilization. Nor can the individual exemption, if an individual objects to prevent a willing health insurance
exemption be construed to require the some but not all contraceptive services, issuer offering group or individual
guaranteed availability of coverage but the issuer, and as applicable, plan health insurance coverage, and as
omitting contraception to a plan sponsor sponsor, are willing to provide the plan applicable, a willing plan sponsor of a
or individual who does not have a sponsor or individual, as applicable, group health plan, from offering a
sincerely held moral objection. This with a separate policy, certificate or separate policy, certificate or contract of
individual exemption is limited to the contract of insurance or a separate group insurance or a separate group health
requirement to provide contraceptive health plan or benefit package option plan or benefit package option, to any
coverage under section 2713(a)(4), and that omits all contraceptives, and the group health plan sponsor (with respect
does not affect any other federal or state individual agrees, then the exemption to an individual) or individual, as
law governing the plan or coverage. applies as if the individual objects to all applicable, who objects to coverage or
Thus, if there are other applicable laws contraceptive services.’’ payments for some or all contraceptive
or plan terms governing the benefits, Some commenters asked for plain services based on sincerely held moral
these rules do not affect such other laws language guidance and examples about convictions. Under this exemption, if an
or terms. how the individual exemption might individual objects to some but not all
The Departments received numerous apply in the context of employer- contraceptive services, but the issuer,
comments about the administrative sponsored insurance. Here is one such and as applicable, plan sponsor, are
burden from the potential variations in example. An employee is enrolled in willing to provide the plan sponsor or
moral convictions held by individuals. group health coverage through her individual, as applicable, with a
Some commenters welcomed the ability employer. The plan is fully insured. If separate policy, certificate or contract of
of individuals covered by the individual the employee has sincerely held moral insurance or a separate group health
exemption to be able to assert an convictions objecting to her plan plan or benefit package option that
objection to either some or all including coverage for contraceptives, omits all contraceptives, and the
contraceptives, while others expressed she could raise this with her employer. individual agrees, then the exemption
concern that the variations in the kinds If the employer is willing to offer her a applies as if the individual objects to all
of contraceptive coverage to which plan that omits contraceptives, the contraceptive services.’’
individuals object might make it employer could discuss this with the
difficult for willing plan sponsors and insurance agent or issuer. If the issuer 8. Accommodation (45 CFR 147.131, 26
issuers to provide coverage that is also willing to offer the employer, CFR 54.9815–2713A, 29 CFR 2590.715–
complies with the moral convictions of with respect to the employee, a group 2713A)
an exempt individual. health insurance policy that omits The previous regulations did not offer
If an individual only objects to some contraceptive coverage, the individual the accommodation process to entities
contraceptives, and the individual’s exemption would make it legal for the with moral non-religious objections.
issuer and, as applicable, plan sponsor group health insurance issuer to omit The Religious IFC amended the
are willing to provide the individual a contraceptives for her and her
accommodation regulations to offer it to
package of benefits omitting such beneficiaries under her policy, for her
all entities that are exempt on the basis
coverage, but for practical reasons can employer to sponsor that plan for her,
only do so by providing the individual of religious beliefs under § 147.132, as
and for the issuer to issue such a plan
with coverage that omits all—not just an optional process in which such
to the employer, to cover that employee.
some—contraceptives, the Departments entities could participate voluntarily.
This would not affect other employees’
believe that it favors individual freedom The Moral IFC did not change that
plans—those plans would still be
and market choice, and does not harm accommodation process, but inserted
subject to the Mandate and would
others, to allow the issuer and plan references in it to the new section
continue to cover contraceptives. But if
sponsor to provide, in that case, a plan § 147.133, alongside the references to
either the employer, or the issuer, is not
omitting all contraceptives if the willing (for whatever reason) to offer a section § 147.132. These changes made
individual is willing to enroll in that plan or a policy for that employee that entities eligible for the voluntary
plan. The language of the individual omits contraceptive coverage, these accommodation process if they are
exemption set forth in the Moral IFC rules do not require them to do so. The exempt on the basis of moral
implied this conclusion by specifying employee would have the choice of convictions. The references were
that the Guidelines requirement of staying enrolled in a plan with its inserted in 45 CFR 147.131, 26 CFR
contraceptive coverage did not apply coverage of contraceptives, not enrolling 54.9815–2713A, and 29 CFR 2590.715–
where the individual objected to some in that plan, seeking coverage 2713A.
or all contraceptives. Notably, that elsewhere, or seeking employment In these rules, the Departments
language differed from the language elsewhere. finalize, without change, the Moral
applicable to the exemptions under For all these reasons, these rules IFC’s revisions of 45 CFR 147.131, 26
§ 147.133(a), which specifies that those adopt the individual exemption CFR 54.9815–2713A, and 29 CFR
exemptions apply ‘‘to the extent’’ of the language from the Religious IFC with 2590.715–2713A. The operation of the
moral objections, so that, as discussed changes, to read as follows: ‘‘(b) accommodation process, changes made
above, they include only those Objecting individuals. Guidelines issued in the Religious IFC, and public
contraceptive methods to which the under § 147.130(a)(1)(iv) by the Health comments concerning the
objection applied. In response to Resources and Services Administration accommodation, are more fully
comments suggesting the language of must not provide for or support the described in the Religious IFC, and in
the individual exemption was not requirement of coverage or payments for the companion final rules concerning
sufficiently clear on this distinction, contraceptive services with respect to the religious exemptions and
however, the Departments in these rules individuals who object as specified in accommodation, published elsewhere in
finalize the individual exemption at this paragraph (b), and nothing in today’s Federal Register. Those
§ 147.133(b), with the following change, § 147.130(a)(1)(iv), 26 CFR 54.9815– descriptions are incorporated here by
by adding the following sentence at the 2713(a)(1)(iv), or 29 CFR 2590.715– reference to the extent they apply to
end of the paragraph: ‘‘Under this 2713(a)(1)(iv) may be construed to these rules.
Many commenters supported discontinuation of the contraceptive methods, care, and screenings that are
extending the accommodation process method).’’ 70 non-contraceptive in purpose or use.
to entities with objections based on To more explicitly state that the The Guidelines’ inclusion of
moral convictions. Others objected to expanded exemptions encompass any of contraceptive services requires coverage
doing so, raising arguments parallel to the contraceptive or sterilization of contraceptive methods as a type of
their objections to creating exemptions services, items, procedures, or related preventive service only when a drug
for group health plan sponsors with patient education or information that that FDA has approved for contraceptive
moral convictions. For much the same have been required under the use is prescribed in whole or in part for
reasons discussed above concerning Guidelines, the Moral IFC included a such purpose or intended use. Section
why the Departments find it appropriate definition of contraceptive services, 2713(a)(4) does not authorize the
to exempt entities with moral objections benefits or coverage, at 45 CFR Departments to require coverage of
to contraceptive coverage, the 147.133(c). These rules finalize that drugs prescribed exclusively for a non-
Departments find it appropriate to definition without change. contraceptive and non-preventive use to
extend the optional accommodation 10. Severability treat an existing condition.72 The extent
process to these entities. The to which contraceptives are covered to
Departments observe that, to the extent The Departments finalize, without treat non-preventive conditions would
such entities wish to use the process, it change, the severability clause set forth be determined by application of the
will not be an obstacle to contraceptive at § 147.133(d). requirement section 1302(b)(1)(F) of the
coverage, but will instead help deliver C. Other Public Comments ACA to cover prescription drugs (where
contraceptive coverage to women who applicable), implementing regulations at
receive health coverage from such 1. Items Approved as Contraceptives 45 CFR 156.122, and 156.125, and
entities while respecting the moral But Used To Treat Existing Conditions plans’ decisions about the basket of
convictions of the entities. The Some commenters noted that some medicines to cover for these conditions.
Departments are not aware of entities drugs included in the preventive Some commenters observed that
with non-religious moral convictions services contraceptive Mandate can also pharmacy claims do not include a
against contraceptive coverage that also be useful for treating certain existing medical diagnosis code, so that plans
consider the accommodation acceptable health conditions, and that women use may be unable to discern whether a
and would opt into it, but we are aware them for non-contraceptive purposes. drug approved by FDA for contraceptive
of a small number of entities with non- Certain commenters urged the uses is actually applied for a preventive
religious moral objections to the Departments to clarify that the final or contraceptive use. Section 2713(a)(4),
Mandate. The Departments, therefore, rules do not permit employers to however, draws a distinction between
continue to consider it appropriate to exclude from coverage medically preventive and other kinds of care and
extend the optional accommodation to necessary prescription drugs used for screenings. That subsection does not
such entities in case any wish to use it. non-preventive services. Some authorize the Departments to impose a
Below, albeit based on very limited commenters suggested that moral coverage mandate of services that are
data, the Departments estimate that a objections to the Mandate should not be not at least partly applied for a
small number of entities with non- permitted in cases where contraceptive preventive use, and the Guidelines
religious moral objections may use the methods are used to treat such existing themselves do not require coverage of
accommodation process. medical conditions and not for care unless it is contraceptive in
preventive purposes, even if those purpose. These rules do not prohibit
9. Definition of Contraceptives for the issuers from covering drugs and devices
Purpose of These Final Rules contraceptive methods can also be used
for contraceptive purposes. that are approved for contraceptive uses
The previous regulations did not Section 2713(a)(4) only applies to even when those drugs and devices are
define contraceptive services. The ‘‘preventive’’ care and screenings. The
Guidelines issued in 2011 included, statute does not allow the Guidelines to
72 The Departments previously cited the IOM’s
under ‘‘Contraceptive methods and mandate coverage of services provided

listing of existing conditions that contraceptive
counseling,’’ ‘‘[a]ll Food and Drug drugs can be used to treat (menstrual disorders,
solely for a non-preventive use, such as acne, and pelvic pain), and said of those uses that
Administration approved contraceptive the treatment of an existing condition. ‘‘there are demonstrated preventive health benefits
methods, sterilization procedures, and The Guidelines implementing this from contraceptives relating to conditions other
patient education and counseling for all section of the statute are consistent with
than pregnancy.’’ 77 FR 8727 & n.7. This was not,
women with reproductive capacity.’’ however, an assertion that section 2713(a)(4) or the
that narrow authority. They state Guidelines require coverage of ‘‘contraceptive’’
The previous regulations concerning the repeatedly that they apply to methods when prescribed for an exclusively non-
exemption and the accommodation used ‘‘preventive’’ services or care.71 The contraceptive, non-preventive use. Instead, it was
the terms ‘‘contraceptive services’’ and an observation that such drugs—generally referred
requirement in the Guidelines to as ‘‘contraceptives’’—also have some alternate
‘‘contraceptive coverage’’ as catch-all
concerning ‘‘contraception’’ specifies beneficial uses to treat existing conditions. For the
terms to encompass all of those purposes of these final rules, the Departments
several times that it encompasses
Guidelines requirements. The 2016 clarify here that the previous reference to the
‘‘contraceptives,’’ that is, medical benefits of using contraceptive drugs exclusively for
update to the Guidelines are similarly
products, methods, and services applied some non-contraceptive and non-preventive uses to
worded. Under ‘‘Contraception,’’ they
for ‘‘contraceptive’’ uses. The treat existing conditions did not mean that the
include the ‘‘full range of contraceptive Guidelines require coverage of such uses, and
Guidelines do not require coverage of
methods for women currently identified consequently is not a reason to refrain from offering
care and screenings that are non- the exemptions provided here. Where a drug
by the U.S. Food and Drug
preventive, and the contraception approved by the FDA for contraceptive use is
Administration,’’ ‘‘instruction in
portion of those Guidelines do not prescribed for both a contraceptive use and a non-
fertility awareness-based methods,’’ and contraceptive use, the Guidelines (to the extent they
require coverage of medical products,
‘‘[c]ontraceptive care’’ to ‘‘include apply) would require its coverage. Where a drug
contraceptive counseling, initiation of approved by the FDA for contraceptive use is
70 ‘‘Women’s Preventive Services Guidelines,’’
prescribed exclusively for a non-contraceptive and
contraceptive use, and follow-up care HRSA (last reviewed Oct. 2017), https:// non-preventive use to treat an existing condition, it
(e.g., management, and evaluation as www.hrsa.gov/womens-guidelines-2016/index.html. would be outside the scope of the Guidelines and
well as changes to and removal or 71 Id. the contraceptive Mandate.
prescribed for non-preventive, non- Act, section 202 of the Unfunded provided the following assessment of
contraceptive purposes. As discussed Mandates Reform Act of 1995 (March their impact.
above, these final rules do not purport 22, 1995; Pub. L. 104–4), Executive
1. Need for Regulatory Action
to delineate the items HRSA will Order 13132 on Federalism (August 4,
include in the Guidelines, but only 1999), the Congressional Review Act (5 The Religious IFC amended the
concern expanded exemptions and U.S.C. 804(2)) and Executive Order Departments’ July 2015 final
accommodations that apply if the 13771 on Reducing Regulation and regulations. The Moral IFC amended
Guidelines require contraceptive Controlling Regulatory Costs (January those regulations further, and added an
coverage. Therefore, the Departments do 30, 2017). additional rule at 45 CFR part 147.133.
not consider it appropriate to specify in These final rules adopt as final, and
A. Executive Orders 12866 and 13563— further amend, the amendments made
these final rules that, under section
Department of HHS and Department of by the Moral IFC. The Departments do
2713(a)(4), exempt organizations must
Labor so in conjunction with the amendments
provide coverage for drugs or items
prescribed exclusively for a non- Executive Orders 12866 and 13563 made in the companion final rules
contraceptive and non-preventive use to direct agencies to assess all costs and concerning religious beliefs published
treat an existing condition. benefits of available regulatory elsewhere in today’s Federal Register.
alternatives and, if regulation is These rules provide an exemption from
2. Comments Concerning Regulatory necessary, to select regulatory the requirement to provide coverage for
Impact approaches that maximize net benefits contraceptives and sterilization,
Some commenters agreed with the (including potential economic, established under the HRSA Guidelines,
Departments’ statement in the Moral IFC environmental, and public health and promulgated under section 2713(a)(4),
that the moral exemptions are likely to safety effects; distributive impacts; and section 715(a)(1) of the ERISA, and
affect only a very small number of equity). Executive Order 13563 section 9815(a)(1) of the Code, for
women otherwise receiving coverage emphasizes the importance of certain entities and individuals with
under the Mandate. Other commenters quantifying both costs and benefits, objections to compliance with the
disagreed, stating that the exemptions reducing costs, harmonizing rules, and Mandate based on sincerely held moral
could take contraceptive coverage away promoting flexibility. convictions, and they revise the
from many or most women. Still others Section 3(f) of Executive Order 12866 accommodation process by making the
opposed establishing the exemptions, defines a ‘‘significant regulatory action’’ accommodation applicable to
but contended that accurately as an action that is likely to result in a organizations with such convictions as
determining the number of women regulation: (1) Having an annual effect an option. The exemption applies to
affected by the exemptions is not on the economy of $100 million or more certain individuals, nonprofit entities,
possible. Public comments included in any 1 year, or adversely and institutions of higher education, issuers,
various statements that these materially affecting a sector of the and for-profit entities that do not have
exemptions would impact coverage for economy, productivity, competition, publicly traded ownership interests,
a large number of women, while others jobs, the environment, public health or that have a moral objection to some (or
stated they would affect only a very safety, or state, local, or tribal all) of the contraceptive and/or
small number. But few, if any, public governments or communities (also sterilization services covered by the
commenters provided data predicting a referred to as ‘‘economically Guidelines. Such action has been taken
precise number of entities that would significant’’); (2) creating a serious to provide for participation in the health
make use of the exemptions for moral inconsistency or otherwise interfering insurance market by certain entities or
convictions nor a precise number of with an action taken or planned by individuals in a manner free from
employees that would potentially be another agency; (3) materially altering penalties for violating sincerely held
affected. the budgetary impacts of entitlement moral convictions opposed to providing
After reviewing the public comments, grants, user fees, or loan programs or the or receiving coverage of contraceptive
the Departments do not find the rights and obligations of recipients services, to ensure the preventive
suggestions of commenters who thereof; or (4) raising novel legal or services coverage requirement is
predicted a very large impact any more policy issues arising out of legal implemented in a way consistent with
reliable than the estimates set forth in mandates, the President’s priorities, or longstanding federal conscience
the Religious and Moral IFCs. Therefore, the principles set forth in the Executive statutes, to prevent lawsuits of the kind
the Departments conclude that the Order. that were filed against the Departments
estimates of regulatory impact made in A regulatory impact analysis must be when the expanded exemption in these
the Religious and Moral IFCs are still prepared for major rules with final rules was not offered, and for the
the best estimates available. The economically significant effects ($100 other reasons discussed above.
Departments’ estimates are discussed in million or more in any 1 year), and an
more detail in the following section. ‘‘economically significant’’ regulatory 2. Anticipated Effects
action is subject to review by OMB. As The Departments acknowledge that
III. Economic Impact and Paperwork discussed below regarding their expanding the exemption to include
Burden anticipated effects, the these final rules objections based on moral convictions
The Departments have examined the are not likely to have economic impacts might result in less insurance coverage
impacts of these final rules as required of $100 million or more in any one year, of contraception for some women who
by Executive Order 12866 on Regulatory and therefore do not meet the definition may want the coverage. Although the
Planning and Review (September 30, of ‘‘economically significant’’ under Departments do not know the exact
1993), Executive Order 13563 on Executive Order 12866. However, OMB scope of that effect attributable to the
Improving Regulation and Regulatory has determined that the actions are moral exemption in these final rules, we
Review (January 18, 2011), the significant within the meaning of believe it to be small.
Regulatory Flexibility Act (RFA) section 3(f)(4) of the Executive Order. With respect to the exemption for
(September 19, 1980, Pub. L. 96–354, Therefore, OMB has reviewed these nonprofit organizations with objections
section1102(b) of the Social Security final rules and the Departments have based on moral convictions, as noted
above, the Departments are aware of two Departments relied on the assumption convictions. Moreover, the Departments
small nonprofit organizations that have that the employees of exempt houses of believe the overall number of entities
filed lawsuits raising non-religious worship and integrated auxiliaries likely that would object to the Mandate based
moral objections to coverage of some share their employers’ opposition to on non-religious moral convictions is
contraceptives. Both of those entities contraceptive coverage. already very small. The only entities of
have fewer than five employees enrolled A similar assumption is appropriate which we are aware that have raised
in health coverage, and both require all with respect to the expanded exemption such objections are not institutions of
of their employees to agree with their for nonprofit organizations with higher education. Public comments did
opposition to the nature of certain objections based on moral convictions. not reveal the existence of any
contraceptives subject to coverage under To the knowledge of the Departments, institutions of higher education with
the Mandate.73 One of them has the vast majority of organizations such moral convictions. Therefore, for
obtained a permanent injunction against objecting to the Mandate assert the purposes of estimating the
any regulations implementing the objections based on religious beliefs. anticipated effect of these final rules on
contraceptive Mandate, and so will not The only nonprofit organizations of contraceptive coverage of women who
be affected by these final rules. Based on which they are aware that possess non- wish to receive such coverage, the
comments submitted in response to religious moral convictions against Departments assume that—at this
rulemakings prior to the Moral and some or all contraceptive methods only time—no entities with non-religious
Religious IFCs, the Departments believe hire persons who share their moral objections to the Mandate will be
that at least one other similar entity convictions. It is possible that the institutions of higher education that
exists.74 However, the Departments do exemption for nonprofit organizations arrange student coverage, and no other
not know how many similar entities with moral convictions in these final entities with non-religious moral
exist and are currently unable to rules could be used by a nonprofit objections will opt into the
estimate the number of such entities. organization that employs persons who accommodation. We wish to make the
Lacking other information, we assume do not share the organization’s views on expanded exemption and
that the number is small. The contraception, but it was also possible accommodation available to such
Departments estimate it to be less than under the Departments’ previous entities in case they do exist or might
10 and assume the exemption will be regulations that a house of worship or come into existence, based on reasons
used by nine nonprofit entities. integrated auxiliary could employ similar to those given above for why the
The Departments also assume that persons who do not share their views on exemptions and accommodations are
those nine entities will operate in a contraception.75 Although the extended to other entities.
fashion similar to the two similar Departments are unable to find The Departments believe that the
entities of which we are aware, so that sufficient data on this issue, we believe exemption for issuers with objections
their employees will likely share their that there are far fewer nonprofit based on moral convictions will not
views against coverage of certain organizations opposed to contraceptive result in a distinct effect on
contraceptives. This is consistent with coverage on the basis of moral contraceptive coverage for women who
the conclusion in previous regulations convictions than there are houses of wish to receive it, because that
that no significant burden or costs worship or integrated auxiliaries with exemption only applies in cases where
would result from exempting houses of religious objections to such coverage. plan sponsors or individuals are also
Based on the limited data available, the otherwise exempt, and the effect of
worship and integrated auxiliaries. (See
Departments believe the most likely those exemptions is discussed
76 FR 46625 and 78 FR 39889). The
effect of the expanded exemption for elsewhere herein, or in the companion
Departments reached that conclusion
nonprofit entities is that it will be used final rules concerning religious beliefs
without ultimately requiring that houses
by entities similar to the two entities published elsewhere in today’s Federal
of worship and integrated auxiliaries
that have sought an exemption through Register. The exemption for individuals
only hire persons who agree with their
litigation, and whose employees also that oppose contraceptive coverage
views against contraception and without
oppose certain contraceptive coverage. based on sincerely held moral
requiring that such entities actually
Therefore, the Departments expect that convictions will provide coverage that
oppose contraception in order to be
the moral exemption for nonprofit omits contraception for individuals that
exempt (in contrast, the exemption here
entities will have a minimal effect of object to contraceptive coverage.
requires the exempt entity to actually The moral exemption will also cover
reducing contraceptive coverage with
possess sincerely held moral for-profit entities that do not have
respect to employees who want such
convictions objecting to contraceptive publicly traded ownership interests and
coverage.
coverage). In concluding that the that have non-religious moral objections
These rules extend the exemption to
exemption for houses of worship and to the Mandate, if such entities exist.
include institutions of higher education
integrated auxiliaries would result in no Some commenters agreed that the
that arrange student coverage and have
significant burden or costs, the impact of these final rules would be no
non-religious moral objections to the
73 Non-religious nonprofit organizations that
Mandate, and make exempt entities more than the Departments estimated in
engage in expressive activity generally have a First with moral objections eligible to avail the Moral IFC, and some commenters
Amendment right to hire only people who share themselves of the accommodation. The stated the impact would be much
their moral convictions or will be respectful of Departments are not aware of any smaller. Other commenters disagreed,
them—including their convictions on whether the suggesting that the expanded
organization or others provide health coverage of
institutions of higher education with
this kind of non-religious moral exemptions risked removing
contraception, or of certain items they view as being

abortifacient. contraceptive coverage from more than
74 See, for example, Americans United for Life 75 Cf., for example, Frank Newport, ‘‘Americans, 55 million women receiving the benefits
(‘‘AUL’’) Comment on CMA-9992-IFC2 at 10 (Nov. Including Catholics, Say Birth Control Is Morally of the preventive services Guidelines, or
1, 2011), available at http://www.regulations.gov/ OK,’’ Gallup, (May 22, 2012), http:// even risked removing contraceptive
#!documentDetail;D=HHS-OS-2011-0023-59496, www.gallup.com/poll/154799/americans-including-
and AUL Comment on CMS-9968-P at 5 (Apr. 8, catholics-say-birth-control-morally.aspx (‘‘Eighty-
coverage from over 100 million women.
2013), available at http://www.regulations.gov/ two percent of U.S. Catholics say birth control is Some commenters cited studies
#!documentDetail;D=CMS-2012-0031-79115. morally acceptable’’). indicating that, nationally, unintended
pregnancies have large public costs, and believe in God.76 Among non-religious policyholders (9) in plans with under
the Mandate overall led to large out-of- persons, only a very small percentage of 100 employees was obtained. It is not
pocket savings for women. These the population appears to hold moral known how many employees would be
general comments did not, however, objections to contraception. A recent employed by the for-profit employers
substantially assist the Departments in study found that only 2 percent of that might claim this exemption, but as
estimating the number of women that religiously unaffiliated persons believed discussed above these final rules do not
would potentially be affected by these using contraceptives is morally wrong.77 include publicly traded companies, and
exemptions for moral convictions Combined, this suggests that 0.2 percent both of the two nonprofit entities that
specifically, or among them, how many of Americans at most 78 might believe challenged the Mandate based on moral
unintended pregnancies would result, contraceptives are morally wrong based objections included fewer than five
how many of the affected women would on moral convictions but not religious policyholders in their group plans.
nevertheless use contraceptives not beliefs. The Departments have no Therefore, the Departments assume that
covered under the health plans of their information about how many of those the for-profit entities that may claim this
objecting employers and, thus, be persons run closely held businesses, expanded exemption will have fewer
subject to the estimated transfer costs, or offer employer sponsored health than 100 employees and an average of
instead, how many women might avoid insurance, and would make use of the 9 policyholders. For 9 entities, the total
unintended pregnancies by changing expanded exemption for moral number of policyholders would be
their activities in other ways besides convictions set forth in these final rules. approximately 81. DOL estimates that
using contraceptives. Given the large number of closely held for each policyholder, there is
entities that challenged the Mandate approximately one dependent.80 This
Some of the comments opposing these based on religious objections, the amounts to approximately 162 covered
exemptions assert that they will lead to Departments assume that some similar persons. Census data indicate that
a large number of entities dropping for-profit entities with non-religious women of childbearing age, i.e., women
contraceptive coverage. The moral objections exist. But the aged 15 to 44, comprise 20.2 percent of
Departments disagree; they are aware of Departments expect that it will be a the general population.81 This amounts
only two entities that hold non-religious comparatively small number of entities, to approximately 33 women of
moral convictions against contraceptive since among the nonprofit litigants, only childbearing age for this group of
coverage. Both only hire employees that two were non-religious. Without data individuals covered by group plans
share their beliefs, and one will not be available to estimate the actual number sponsored by for-profit moral objectors.
affected by these final rules because it of entities that will make use of the Approximately 44.3 percent of women
is protected by an injunction from any expanded exemption for for-profit currently use contraceptives covered by
regulations implementing the entities without publicly traded the Guidelines.82 Thus, the Departments
contraceptive Mandate. Commenters ownership interests and with sincere estimate that approximately 15 women
cited no other specific entities that moral objections to the Mandate, the may incur contraceptive costs due to
might assert these moral convictions, Departments expect that fewer than 10 for-profit entities using the expanded
and did not provide better data to entities, if any, will do so—so the moral exemption provided for in these
estimate how many entities might exist. Departments assume nine for-profit final rules.83 In the companion final
Likewise, the Departments find it entities will use the exemption in these
unlikely that any of the vast majority of final rules. Supplement to the Current Population Survey.
entities that covered contraceptives The moral exemption encompassing https://www.dol.gov/sites/default/files/ebsa/
researchers/data/health-and-welfare/health-
before this Mandate was announced in certain for-profit entities could result in insurance-coverage-bulletin-2015.pdf. Estimates of
2011 would terminate such coverage the removal of contraceptive coverage the number of ERISA Plans based on 2015 Medical
because of these exemptions based on from women who do not share their Expenditure Survey—Insurance.
moral convictions. The Departments employers’ views. The Departments 80 ‘‘Health Insurance Coverage Bulletin’’ Dept. of
used data from the Current Population Labor’’ (June 28, 2016), Table 4, page 21. Using
also find it unlikely that a significant March 2015 Annual Social and Economic
number of for-profit entities, whose Survey (CPS) and the Medical Supplement to the Current Population Survey.
plans include a significant number of Expenditure Panel Survey-Insurance https://www.dol.gov/sites/default/files/ebsa/
women, omitted contraceptive coverage Component (MEPS–IC) to obtain an researchers/data/health-and-welfare/health-
estimate of the number of policyholders insurance-coverage-bulletin-2015.pdf.
before the ACA on the basis of 81 U.S. Census Bureau, ‘‘Age and Sex
objections grounded in non-religious that will be covered by the plans of the Composition: 2010’’ (May 2011), available at
moral convictions, and would claim an nine for-profit entities we assume may https://www.census.gov/prod/cen2010/briefs/
exemption under these final rules. No make use of these expanded c2010br-03.pdf. The Guidelines’ requirement of
exemptions.79 The average number of contraceptive coverage only applies ‘‘for all women
such entities, or data concerning such with reproductive capacity.’’ Women’s Preventive
entities, were identified by public Services Guidelines, HRSA (last reviewed Oct.
76 Frank Newport, ‘‘Most Americans Still Believe
commenters, nor are the Departments 2017), https://www.hrsa.gov/womensguidelines/;
in God,’’ Gallup (June 29, 2016), http:// see also 80 FR 40318. In addition, studies
aware of any involved in litigation over www.gallup.com/poll/193271/americans-believe- commonly consider the 15–44 age range to assess
the Mandate. god.aspx. contraceptive use by women of childbearing age.
77 Pew Research Center, ‘‘Where the Public
Numerous for-profit entities claiming See, e.g., ‘‘Contraceptive Use in the United States,’’
Stands on Religious Liberty vs. The Guttmacher Institute (Sept. 2016), https://
religious objections have filed suit Nondiscrimination,’’ Pew Research Center, 26 www.guttmacher.org/fact-sheet/contraceptive-use-
challenging the Mandate. Among the (Sept. 28, 2016), http://assets.pewresearch.org/wp- united-states.
over 200 entities that brought legal content/uploads/sites/11/2016/09/Religious- 82 See ‘‘Contraceptive Use in the United States,’’
Liberty-full-for-web.pdf. The Guttmacher Institute (Sept. 2016), https://

challenges, only two entities (less than 78 The study defined religiously ‘‘unaffiliated’’ as
www.guttmacher.org/fact-sheet/contraceptive-use-
1 percent) raised non-religious moral agnostic, atheist or ‘‘nothing in particular’’, id. at 8, united-states.
objections—and both were nonprofit as distinct from several versions of Protestants, or 83 The Departments note that many non-religious
organizations. Among the general Catholics. ‘‘Nothing in particular’’ might have for-profit entities which sued the Departments
public, polls vary about religious included some theists. challenging the Mandate, including some of the
79 ‘‘Health Insurance Coverage Bulletin,’’ Dept. of largest employers, only objected to coverage of 4 of
beliefs, but one prominent poll shows Labor (June 28, 2016), Table 4, page 21. Using the 18 types of contraceptives required to be
that 89 percent of Americans say they March 2015 Annual Social and Economic Continued
rules concerning religious beliefs issued The Departments reiterate the some or all contraceptives and/or
contemporaneously with these final rareness of instances in which we are sterilization—businesses and
rules and published elsewhere in aware that employers assert non- organizations which would otherwise be
today’s Federal Register, we estimate religious objections to contraceptive faced with the dilemma of complying
that the average cost of contraception coverage based on sincerely held moral with the Mandate (and violating their
per year per woman of childbearing age convictions, as discussed above, and moral convictions), or of following their
that use contraception covered by the also that in the few instances where moral convictions and incurring
Guidelines, in health plans that cover such an objection has been raised, potentially significant financial
contraception, is $584. Consequently, employees of such employers also penalties for noncompliance—the
the Departments estimate that the opposed contraception. Departments have reduced regulatory
anticipated effects attributable to the burden on small entities. Pursuant to
B. Special Analyses—Department of the
cost of contraception from for-profit section 7805(f) of the Code, the notice
Treasury
entities using the expanded moral of proposed rulemaking preceding these
exemption in these final rules is These regulations are not subject to regulations was submitted to the Chief
approximately $8,760. review under section 6(b) of Executive Counsel for Advocacy of the Small
The Departments estimate that these Order 12866 pursuant to the Business Administration for comment
final rules will not result in any Memorandum of Agreement (April 11, on their impact on small business.
additional burden or costs on issuers or 2018) between the Department of the
third party administrators. As discussed Treasury and the Office of Management D. Paperwork Reduction Act—
above, we assume that no entities with and Budget regarding review of tax Department of Health and Human
non-religious moral convictions will regulations. Services
avail themselves of the accommodation, C. Regulatory Flexibility Act Under the Paperwork Reduction Act
although the Departments wish to make of 1995 (the PRA), federal agencies are
it available in case an entity voluntarily The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) imposes certain required to publish notice in the
opts into it in order to allow Federal Register and solicit public
contraceptive coverage to be provided to requirements with respect to federal
regulations that are subject to the notice comment before a collection of
its plan participants and beneficiaries. information is submitted to the Office of
While these final rules make it legal for and comment requirements of section
553(b) of the APA (5 U.S.C. 551 et seq.) Management and Budget (OMB) for
issuers to offer insurance coverage that review and approval. Interested persons
omits contraceptives to/for exempt and that are likely to have a significant
economic impact on a substantial are invited to send comments regarding
entities and individuals, these final our burden estimates or any other aspect
rules do not require issuers to do so. number of small entities. Under section
553(b) of the APA, a general notice of of this collection of information,
Finally, because the accommodation including any of the following subjects:
process was not previously available to proposed rulemaking is not required
when an agency, for good cause, finds (1) The necessity and utility of the
entities that possess non-religious moral proposed information collection for the
objections to the Mandate, the that notice and public comment thereon
are impracticable, unnecessary, or proper performance of the agency’s
Departments do not anticipate that these functions; (2) the accuracy of the
final rules will result in any burden contrary to the public interest. The
Moral IFC was a set of interim final estimated burden; (3) ways to enhance
from such entities acting to revoke their the quality, utility, and clarity of the
rules with comment, and in these final
accommodated status. information to be collected; and (4) the
The Departments believe the rules, the Departments finalize the
Moral IFC with certain changes based use of automated collection techniques
foregoing analysis represents a or other forms of information
reasonable estimate of the likely impact on public comments. The Moral IFC was
exempt from the notice and comment technology to minimize the information
under the exemptions finalized in these collection burden.
final rules. The Departments requirements of the APA, both because
the PHS Act, ERISA, and the Code The Departments estimate that these
acknowledge uncertainty in the estimate
contain specific provisions under which final rules will not result in additional
and, therefore, conducted a second
the Secretaries may adopt regulations by burdens not accounted for as set forth in
analysis using an alternative framework,
interim final rule and because the companion final rules concerning
which is set forth in the companion
Departments have made a good cause religious beliefs issued
final rules concerning religious beliefs
finding that a general notice of proposed contemporaneously with these final
issued contemporaneously with these
rulemaking is not necessary earlier in rules and published elsewhere in
final rules and published elsewhere in
this preamble. Therefore, the RFA did today’s Federal Register. As discussed
today’s Federal Register, with reference
not apply to the Moral IFC. These final there, rules covering the
to the analysis conducted in the
rules are, however, issued after a notice accommodation include provisions
Religious IFC. Under either estimate,
and comment period. regarding self-certification or notices to
these final rules are not deemed to be
The Departments carefully considered HHS from eligible organizations
economically significant.
the likely impact of the rules on small (§ 147.131(c)(3)), notice of availability of
covered by the Mandate—namely, those
entities in connection with their separate payments for contraceptive
contraceptives which they viewed as abortifacients, assessment under Executive Order services (§ 147.131(e)), and notice of
and akin to abortion —and they were willing to 12866. The Departments do not expect revocation of accommodation
provide coverage for other types of contraception. that these final rules will have a (§ 147.131(c)(4)). The burden related to
It is reasonable to assume that this would also be

the case with respect to some for-profits that object
significant economic effect on a these information collection
to the Mandate on the basis of sincerely held moral substantial number of small entities, requirements (ICRs) received emergency
convictions. Accordingly, it is possible that even because they will not result in any review and approval under OMB
fewer women beneficiaries under such plans would additional costs to affected entities. Control Number 0938–1344. They have
bear out-of-pocket expenses in order to obtain
contraceptives, and that those who might do so
Instead, by exempting from the Mandate been resubmitted to OMB in
would bear lower costs due to many contraceptive small businesses and nonprofit conjunction with this final rule and are
items being covered. organizations with moral objections to pending re-approval.
As discussed above, however, the publish a notice informing the public of double-counting with the Moral IFC,
Departments assume that no entities OMB’s action with respect to the which has already been tallied as an
with non-religious moral objections to Department’s submission of the ICRs E.O. 13771 deregulatory action, this
the Mandate will use the under OMB control number 1210–0150. finalization of the IFC’s policy is not
accommodation. The Departments know considered a deregulatory action under
F. Regulatory Reform Executive Orders
that no such entities were eligible for it the Executive Order.
13765, 13771 and 13777
until now, so that no entity possesses an
Executive Order 13765 (January 20, G. Unfunded Mandates Reform Act
accommodated status that would need
to be revoked. Therefore, the 2017) directs that, ‘‘[t]o the maximum The Unfunded Mandates Reform Act
Departments believe that the burden for extent permitted by law, the Secretary of of 1995 (section 202(a) (Pub. L. 104–4),
these ICRs is accounted for in the Health and Human Services (Secretary) requires the Departments to prepare a
collection approved under OMB Control and the heads of all other executive written statement, which includes an
Numbers 0938–1344, as described in the departments and agencies (agencies) assessment of anticipated costs and
final rules concerning religious beliefs with authorities and responsibilities benefits, before issuing ‘‘any rule that
issued contemporaneously with these under the [Affordable Care] Act shall includes any federal mandate that may
final rules. exercise all authority and discretion result in the expenditure by state, local,
available to them to waive, defer, grant and tribal governments, in the aggregate,
E. Paperwork Reduction Act— exemptions from, or delay the or by the private sector, of $100 million
Department of Labor implementation of any provision or or more (adjusted annually for inflation)
Under the Paperwork Reduction Act, requirement of the Act that would in any 1 year.’’ In 2018, that threshold
an agency may not conduct or sponsor, impose a fiscal burden on any state or is approximately $150 million. For
and an individual is not required to a cost, fee, tax, penalty, or regulatory purposes of the Unfunded Mandates
respond to, a collection of information burden on individuals, families, Reform Act, the Moral IFC and these
unless it displays a valid OMB control healthcare providers, health insurers, final rules do not include any federal
number. In accordance with the patients, recipients of healthcare mandate that may result in expenditures
requirements of the PRA, the ICR for the services, purchasers of health insurance, by state, local, or tribal governments,
EBSA Form 700 and alternative notice or makers of medical devices, products, nor do they include any federal
have previously been approved by OMB or medications.’’ In addition, agencies mandates that may impose an annual
under control numbers 1210–0150 and are directed to ‘‘take all actions burden of $150 million or more on the
1210–0152. In an effort to consolidate consistent with law to minimize the private sector.
the number of information collections unwarranted economic and regulatory
H. Federalism
the Department is combining OMB burdens of the [Affordable Care Act],
control numbers 1210–0150 and 1210– and prepare to afford the States more Executive Order 13132 outlines
0152 under OMB control number 1210– flexibility and control to create a more fundamental principles of federalism,
0150 and discontinuing OMB control free and open healthcare market.’’ The and requires the adherence to specific
number 1210–0152. Moral IFC and these final rules exercise criteria by federal agencies in the
A copy of the ICR may be obtained by the discretion provided to the process of their formulation and
contacting the PRA addressee shown Departments under the Affordable Care implementation of policies that have
below or at http://www.RegInfo.gov. Act and other laws to grant exemptions ‘‘substantial direct effects’’ on states, the
PRA ADDRESSEE: G. Christopher and thereby minimize regulatory relationship between the federal
Cosby, Office of Policy and Research, burdens of the Affordable Care Act on government and states, or the
U.S. Department of Labor, Employee the affected entities and recipients of distribution of power and
Benefits Security Administration, 200 health care services. responsibilities among the various
Constitution Avenue NW, Room N– Consistent with Executive Order levels of government. Federal agencies
5718, Washington, DC 20210. 13771 (82 FR 9339, February 3, 2017), promulgating regulations that have
Telephone: (202) 693–8410; Fax: (202) the Departments have estimated the these federalism implications must
219–4745. These are not toll-free costs and cost savings attributable to consult with state and local officials,
numbers. these rules. As discussed in more detail and describe the extent of their
Consistent with the analysis in the in the preceding analysis, these final consultation and the nature of the
HHS PRA section above, although these rules lessen incremental reporting concerns of state and local officials in
final rules make entities with certain costs.84 However, in order to avoid the preamble to the regulation.
moral convictions eligible for the These rules do not have any
accommodation, the Department 84 Other noteworthy potential impacts encompass
Federalism implications, since they
assumes (1) that no entities will use the potential changes in medical expenditures, only provide exemptions from the
including potential decreased expenditures on
accommodation rather than the contraceptive devices and drugs and potential contraceptive and sterilization coverage
exemption, and (2) entities using the increased expenditures on pregnancy-related requirement in HRSA Guidelines
moral exemption would not have to medical services. OMB’s guidance on E.O. 13771 supplied under section 2713 of the PHS
revoke an accommodation, because they implementation (https://www.whitehouse.gov/the- Act.
press-office/2017/04/05/memorandum-
previously were not eligible for it. implementing-executive-order-13771-titled- IV. Statutory Authority
Therefore, the Department believes reducing-regulation) states that impacts should be
these final rules do not involve categorized as consistently as possible within The Department of the Treasury
additional burden not accounted for Departments. The Food and Drug Administration, regulations are adopted pursuant to the
within HHS, and the Occupational Safety and authority contained in sections 7805
under OMB control number 1210–0150, Health Administration (OSHA) and Mine Safety
which is published elsewhere in today’s and Health Administration (MSHA), within DOL, and 9833 of the Code.
issue of the Federal Register in regularly estimate medical expenditure impacts in
connection with the companion the analyses that accompany their regulations, with leads to these final rules’ medical expenditure
the results being categorized as benefits (positive impacts being categorized as (positive or negative)
Religious Exemption and benefits if expenditures are reduced, negative benefits, rather than as costs, thus placing them
Accommodation Preventive Health benefits if expenditures are raised). Following the outside of consideration for E.O. 13771 designation
Service final rule. The Department will FDA, OSHA and MSHA accounting convention purposes.
The Department of Labor regulations Dated: October 17, 2018. DEPARTMENT OF LABOR
are adopted pursuant to the authority Seema Verma, Employee Benefits Security
contained in 29 U.S.C. 1002(16), 1027, Administrator, Centers for Medicare & Administration
1059, 1135, 1161–1168, 1169, 1181– Medicaid Services.
1183, 1181 note, 1185, 1185a, 1185b, Dated: October 18, 2018. PART 2590—RULES AND
1185d, 1191, 1191a, 1191b, and 1191c; Alex M. Azar II,
REGULATIONS FOR GROUP HEALTH
sec. 101(g), Public Law 104–191, 110 PLANS
Secretary, Department of Health and Human
Stat. 1936; sec. 401(b), Public Law 105– Services. ■ For the reasons set forth in the
200, 112 Stat. 645 (42 U.S.C. 651 note);
DEPARTMENT OF THE TREASURY preamble, the Department of Labor
sec. 512(d), Public Law 110–343, 122
adopts, as final, the interim final rules
Stat. 3881; sec. 1001, 1201, and 1562(e), Internal Revenue Service amending 29 CFR part 2590, published
Public Law 111–148, 124 Stat. 119, as October 13, 2017 (82 FR 47838), without
amended by Public Law 111–152, 124 For the reasons set forth in this change.
Stat. 1029; Secretary of Labor’s Order 1– preamble, 26 CFR part 54 is amended as
2011, 77 FR 1088 (Jan. 9, 2012). follows: DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Department of Health and Human
PART 54—PENSION EXCISE TAXES ■ For the reasons set forth in the
Services regulations are adopted
pursuant to the authority contained in preamble, the Department of Health and
■ 1. The authority citation for part 54 Human Services adopts as final the
sections 2701 through 2763, 2791, and
continues to read, in part, as follows: interim final rules amending 45 CFR
2792 of the PHS Act (42 U.S.C. 300gg
through 300gg–63, 300gg–91, and Authority: 26 U.S.C. 7805. * * * part 147 published on October 13, 2017
300gg–92), as amended; and Title I of (82 FR 47838) with the following
the Affordable Care Act, sections 1301–
§ 54.9815–2713 [Amended] changes:
1304, 1311–1312, 1321–1322, 1324, ■ 2. Section 54.9815–2713, as amended PART 147—HEALTH INSURANCE
1334, 1342–1343, 1401–1402, and 1412, elsewhere in this issue of the Federal REFORM REQUIREMENTS FOR THE
Public Law 111–148, 124 Stat. 119 (42 Register, is further amended in GROUP AND INDIVIDUAL HEALTH
U.S.C. 18021–18024, 18031–18032, paragraph (a)(1)(iv) by removing the INSURANCE MARKETS
18041–18042, 18044, 18054, 18061, reference ‘‘147.131 and 147.132’’ and
18063, 18071, 18082, 26 U.S.C. 36B, and adding in its place the reference ■ 4. The authority citation for part 147,
31 U.S.C. 9701). ‘‘147.131, 147.132, and 147.133’’. as revised elsewhere in this issue of the
Federal Register, continues to read as
List of Subjects § 54.9815–2713A [Amended] follows:
26 CFR Part 54 Authority: 42 U.S.C. 300gg through 300gg–
■ 3. Section 54.9815–2713A, as 63, 300gg–91, and 300gg–92, as amended.
Excise taxes, Health care, Health amended elsewhere in this issue of the
Federal Register, is further amended— ■ 5. Section 147.133 is amended by
insurance, Pensions, Reporting and revising paragraph (a)(1) introductory
recordkeeping requirements. ■ a. In paragraph (a)(1) by removing ‘‘or text, (a)(1)(ii), (a)(2), and (b) to read as
(ii)’’ and adding in its place ‘‘or (ii), or follow:
29 CFR Part 2590
45 CFR 147.133(a)(1)(i) or (ii)’’;
§ 147.133 Moral exemptions in connection
Continuation coverage, Disclosure, ■ b. In paragraph (a)(2) by removing the
with coverage of certain preventive health
Employee benefit plans, Group health reference ‘‘147.132(a)’’ and adding in its services.
plans, Health care, Health insurance, place the reference ‘‘147.132(a) or (a) * * *
Medical child support, Reporting and 147.133(a)’’; (1) Guidelines issued under
recordkeeping requirements. ■ c. In paragraph (b)(1)(ii) introductory § 147.130(a)(1)(iv) by the Health
45 CFR Part 147 text by removing the reference Resources and Services Administration
‘‘147.132’’ and adding in its place the must not provide for or support the
Health care, Health insurance, reference ‘‘147.132 or 147.133’’; requirement of coverage or payments for
Reporting and recordkeeping contraceptive services with respect to a
■ d. In paragraph (b)(1)(ii)(B) by
requirements, State regulation of health group health plan established or
removing the reference ‘‘147.132’’ and maintained by an objecting
insurance.
adding in its place the reference organization, or health insurance
Kirsten Wielobob, ‘‘147.132 or 147.133’’; coverage offered or arranged by an
Deputy Commissioner for Services and ■ e. In paragraph (c)(1)(ii) introductory objecting organization, to the extent of
Enforcement. text by removing the reference the objections specified below. Thus the
Approved: October 30, 2018. ‘‘147.132’’ and adding in its place the Health Resources and Service
David J. Kautter, reference ‘‘147.132 or 147.133’’; Administration will exempt from any
guidelines’ requirements that relate to
Assistant Secretary for Tax Policy. ■ f. In paragraph (c)(1)(ii)(B) by
the provision of contraceptive services:
Signed this 29th day of October, 2018. removing the reference ‘‘147.132’’ and
* * * * *
Preston Rutledge, adding in its place the reference

(ii) An institution of higher education
Assistant Secretary, Employee Benefits ‘‘147.132 or 147.133’’; and
as defined in 20 U.S.C. 1002, which is
Security Administration, Department of ■ g. In paragraph (c)(2) by removing the non-governmental, in its arrangement of
Labor. reference ‘‘147.132’’ and adding in its student health insurance coverage, to
place the reference ‘‘147.132 or the extent that institution objects as
147.133’’. specified in paragraph (a)(2) of this
section. In the case of student health
insurance coverage, this section is (ii) A plan, issuer, or third party any group health plan sponsor (with
applicable in a manner comparable to administrator that provides or arranges respect to an individual) or individual,
its applicability to group health such coverage or payments. as applicable, who objects to coverage or
insurance coverage provided in (b) Objecting individuals. Guidelines payments for some or all contraceptive
connection with a group health plan issued under § 147.130(a)(1)(iv) by the services based on sincerely held moral
established or maintained by a plan Health Resources and Services convictions. Under this exemption, if an
sponsor that is an employer, and Administration must not provide for or individual objects to some but not all
references to ‘‘plan participants and support the requirement of coverage or contraceptive services, but the issuer,
beneficiaries’’ will be interpreted as payments for contraceptive services and as applicable, plan sponsor, are
references to student enrollees and their with respect to individuals who object willing to provide the plan sponsor or
covered dependents; and as specified in this paragraph (b), and individual, as applicable, with a
* * * * * nothing in § 147.130(a)(1)(iv), 26 CFR separate policy, certificate or contract of
54.9815–2713(a)(1)(iv), or 29 CFR
(2) The exemption of this paragraph insurance or a separate group health
2590.715–2713(a)(1)(iv) may be
(a) will apply to the extent that an entity plan or benefit package option that
construed to prevent a willing health
described in paragraph (a)(1) of this omits all contraceptives, and the
insurance issuer offering group or
section objects, based on its sincerely individual health insurance coverage, individual agrees, then the exemption
held moral convictions, to its and as applicable, a willing plan applies as if the individual objects to all
establishing, maintaining, providing, sponsor of a group health plan, from contraceptive services.
offering, or arranging for (as applicable): offering a separate policy, certificate or * * * * *
(i) Coverage or payments for some or contract of insurance or a separate group [FR Doc. 2018–24514 Filed 11–7–18; 4:15 pm]
all contraceptive services; or health plan or benefit package option, to BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P

First Circuit Brief About Final Rule Next Steps

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Case: 18-1514 Document: 00117368181 Page: 1 Date Filed: 11/20/2018 Entry ID: 6214393

IN THE UNITED STATES COURT OF APPEALS

MOTION TO GOVERN FURTHER PROCEEDINGS

The federal defendants file this motion to govern further

proceedings to address the appropriate disposition of this appeal in

challenged in this case. As we explain below, this Court should allow

namely, whether Massachusetts has standing to challenge the rules.

1. In October 2017, in an attempt to resolve ongoing litigation

over the contraceptive-coverage mandate adopted pursuant to the

Patient Protection and Affordable Care Act, the Departments of Health

rules expanding the regulatory exemption to the mandate. The interim

rules expanded the existing religious exemption to a broader range of

entities with sincere religious exemptions to providing contraceptive

new exemption for entities with moral objections to providing such

Invoking agency-specific statutory authority to issue interim final

rules, 26 U.S.C. § 9833; 29 U.S.C. § 1191c; 42 U.S.C. § 300gg-92, as well

as the Administrative Procedure Act’s (APA’s) general “good cause”

exception to notice-and-comment requirements, 5 U.S.C. § 553(b), the

agencies did, however, solicit comments for 60 days post-promulgation.

See 82 Fed. Reg. at 47,792; 82 Fed. Reg. at 47,838.

2. Massachusetts brought suit, challenging the interim rules.

APA’s notice-and-comment requirements; (2) are not in accordance with

Massachusetts requested that the district court declare the interim

rules unlawful and permanently enjoin their implementation on a

The district court concluded that Massachusetts “lacks standing to

summary judgment. JA 1383. The court explained that “the

Commonwealth has failed to set forth specific facts establishing that it

particular, the court explained, Massachusetts “has not established that

it is likely that any Massachusetts employers will avail themselves of

the [interim rules’] expanded exemptions,” JA 1408, and has not

“identif[ied] any particular woman who is likely to lose contraceptive

coverage because of the [interim rules],” JA 1420. The court found

Massachusetts’s reliance on the agencies’ estimate of the number of

envelope reckoning” that the interim rules would affect a proportionate

number of its residents to be “tenuous” and “unsupported by facts

sufficient to satisfy its burden” to demonstrate standing. JA 1403, 1405,

Massachusetts appealed, and filed its opening brief on September

3. After reviewing all the comments received on the interim rules,

final rules were made publicly available on the Federal Register’s

website on November 7, 2018, and were published in the Federal

(religious exemption) (attached as Exhibit A); 83 Fed. Reg. 57,592 (Nov.

15, 2018) (moral exemption) (attached as Exhibit B).

The final rules finalize the exemptions provided in the interim

rules. In response to public comments, the agencies made certain

changes in the final rules to clarify the intended scope of the

changes is material to Massachusetts’s substantive claims in this case

or the Commonwealth’s standing to bring those claims.

at 57,536; 83 Fed. Reg. at 57,592.

4. On November 8, 2018, the federal government submitted a

and proposing that the government file a motion to govern further

proceedings by November 20, 2018, and that Massachusetts file any

response by December 7, 2018 (a schedule to which Massachusetts had

interim rules challenged by Massachusetts, this Court should allow the

district court and presented in this appeal—namely, whether

Massachusetts has Article III standing to bring this action.

1. The only issue raised by Massachusetts on appeal is whether

the district court erred in holding that Massachusetts lacks standing to

challenge the interim rules. Standing is a “core component” and an

“essential and unchanging part of the case-or-controversy requirement

Because standing is a threshold jurisdictional issue, see Steel Co. v.

conclude that a case should be dismissed for lack of standing without

the merits without first determining that it has subject-matter and

personal jurisdiction, “there is no mandatory sequencing of

jurisdictional issues.” Sinochem Int’l Co. v. Malaysia Int’l Shipping