Proposed Rule2023-01981
Coverage of Certain Preventive Services Under the Affordable Care Act
Primary source
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Published
February 2, 2023
Issuing agencies
Treasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
These proposed rules would amend regulations regarding coverage of certain preventive services under the Patient Protection and Affordable Care Act, which requires non-grandfathered group health plans and non-grandfathered group or individual health insurance coverage to cover certain contraceptive services without cost sharing. Current regulations include exemptions and optional accommodations for entities and individuals with religious or moral objections to coverage of contraceptive services. These rules propose rescinding the moral exemption rule. These proposed rules also would establish a new individual contraceptive arrangement that individuals enrolled in plans or coverage sponsored, arranged, or provided by objecting entities may use to obtain contraceptive services at no cost directly from a provider or facility that furnishes contraceptive services. Contraceptive services would be available through the proposed individual contraceptive arrangement without any involvement on the part of an objecting entity. Under these proposed rules, a provider or facility that furnishes contraceptive services in accordance with the individual contraceptive arrangement for eligible individuals would be able to be reimbursed for its costs by entering into an arrangement with an issuer on a Federally-facilitated Exchange or State Exchange on the Federal platform, which in turn may seek a user fee adjustment.
Full Text
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<title>Federal Register, Volume 88 Issue 22 (Thursday, February 2, 2023)</title>
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[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Proposed Rules]
[Pages 7236-7281]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01981]
[[Page 7235]]
Vol. 88
Thursday,
No. 22
February 2, 2023
Part IV
Department of the Treasury
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Internal Revenue Service
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26 CFR Part 54
Department of Labor
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Employee Benefits Security Administration
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29 CFR Part 2590
Department of Health and Human Services
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45 CFR Parts 147 and 156
Coverage of Certain Preventive Services Under the Affordable Care Act;
Proposed Rule
Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 /
Proposed Rules
[[Page 7236]]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG 124930-21]
RIN 1545-BQ35
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC13
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Parts 147 and 156
[CMS-9903-P]
RIN 0938-AU94
Coverage of Certain Preventive Services Under the Affordable Care
Act
AGENCY: Internal Revenue Service, Department of the Treasury; Employee
Benefits Security Administration, Department of Labor; Centers for
Medicare & Medicaid Services, Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
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SUMMARY: These proposed rules would amend regulations regarding
coverage of certain preventive services under the Patient Protection
and Affordable Care Act, which requires non-grandfathered group health
plans and non-grandfathered group or individual health insurance
coverage to cover certain contraceptive services without cost sharing.
Current regulations include exemptions and optional accommodations for
entities and individuals with religious or moral objections to coverage
of contraceptive services. These rules propose rescinding the moral
exemption rule. These proposed rules also would establish a new
individual contraceptive arrangement that individuals enrolled in plans
or coverage sponsored, arranged, or provided by objecting entities may
use to obtain contraceptive services at no cost directly from a
provider or facility that furnishes contraceptive services.
Contraceptive services would be available through the proposed
individual contraceptive arrangement without any involvement on the
part of an objecting entity. Under these proposed rules, a provider or
facility that furnishes contraceptive services in accordance with the
individual contraceptive arrangement for eligible individuals would be
able to be reimbursed for its costs by entering into an arrangement
with an issuer on a Federally-facilitated Exchange or State Exchange on
the Federal platform, which in turn may seek a user fee adjustment.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by April 3, 2023.
ADDRESSES: In commenting, please refer to file code CMS-9903-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-9903-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-9903-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Jason Sandoval, Internal Revenue
Service, Department of the Treasury, at (202) 317-5500; Beth Baum or
Matthew Meidell, Employee Benefits Security Administration, Department
of Labor, at (202) 693-8335; David Mlawsky, Centers for Medicare &
Medicaid Services, Department of Health and Human Services, at (410)
786-6851; for matters related to financial support, Allison Yadsko,
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, at (410) 786-1740.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor (DOL) concerning employment-
based health coverage laws may call the Employee Benefits Security
Administration (EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or
visit the DOL's website (<a href="http://www.dol.gov/ebsa">www.dol.gov/ebsa</a>). In addition, information
from the Department of Health and Human Services (HHS) on private
health insurance coverage and coverage provided by non-Federal
Governmental group health plans can be found on the Centers for
Medicare & Medicaid Services (CMS) website (<a href="http://www.cms.gov/cciio">www.cms.gov/cciio</a>), and
information on health care reform can be found at <a href="http://www.HealthCare.gov">www.HealthCare.gov</a>.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: Comments received before the close
of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post comments received
before the close of the comment period on the following website as soon
as possible after they have been received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the search instructions on that website to view public comments.
CMS will not post on <a href="http://regulations.gov">regulations.gov</a> public comments that make threats
to individuals or institutions or suggest that the commenter will take
actions to harm another individual. CMS continues to encourage
individuals not to submit duplicative comments. We will post acceptable
comments from multiple unique commenters even if the content is
identical or nearly identical to other comments.
I. Background
A. Legislative, Regulatory and Judicial History
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010. The Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30,
2010. These statutes are collectively known as the Affordable Care Act
(ACA). The ACA reorganized, amended, and added to the provisions of
part A of title XXVII of the Public Health Service Act (PHS Act)
relating to group health plans and health insurance issuers in the
group and individual markets. The ACA added section 715(a)(1) to the
Employee Retirement Income Security Act of 1974 (ERISA) and section
9815(a)(1) to the Internal Revenue Code (Code) to incorporate the
provisions of part A of title XXVII of the PHS Act into ERISA and the
Code, and to make them applicable to group health plans and health
insurance issuers providing health insurance coverage in connection
with group health plans. The sections of the PHS Act incorporated into
ERISA and the Code are sections 2701 through 2728.
[[Page 7237]]
Section 2713 of the PHS Act, as added by the ACA and incorporated
into ERISA and the Code, requires non-grandfathered group health plans
and health insurance issuers offering non-grandfathered group or
individual health insurance coverage to provide coverage of certain
specified preventive services without cost sharing, including, under
section 2713(a)(4) of the PHS Act, benefits for certain women's
preventive health services as provided for in comprehensive guidelines
supported by the Health Resources and Services Administration
(HRSA).<SUP>1 2</SUP> On August 1, 2011, HRSA adopted guidelines for
women's preventive health services (2011 HRSA-Supported Guidelines)
based on recommendations of the independent Institute of Medicine
(IOM), now known as the National Academy of Medicine.\3\ As relevant
here, the 2011 HRSA-Supported Guidelines included sterilization
procedures, patient education and counseling for women with
reproductive capacity, and all Food and Drug Administration (FDA)-
approved, cleared, or granted contraceptives, as prescribed by a health
care provider (collectively, contraceptive services).\4\ Except as
discussed later in this section, non-grandfathered group health plans
and health insurance issuers offering non-grandfathered group or
individual health insurance coverage were required to provide coverage
consistent with the 2011 HRSA-Supported Guidelines, without cost
sharing, for plan years (or, in the individual market, policy years)
beginning on or after August 1, 2012. As fully discussed in footnote 4
of this preamble, the 2011 HRSA-Supported Guidelines have been updated
several times; plans and issuers are currently required to provide
coverage without cost sharing consistent with the HRSA-Supported
Guidelines as amended in 2019.
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\1\ In addition to the specified preventive services addressed
in section 2713 of the PHS Act, section 3203 of the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act), enacted on March 27,
2020, requires non-grandfathered group health plans and health
insurance issuers offering non-grandfathered group or individual
health insurance to cover any qualifying coronavirus preventive
service without cost sharing, pursuant to section 2713(a) of the PHS
Act (including the regulations under 26 CFR 54.9815-2713, 29 CFR
2590.715-2713, and 45 CFR 147.130 (or any successor regulations)).
\2\ The final regulations generally provide that plans and
issuers must cover a preventive service pursuant to a new or changed
recommendation starting with the first plan year (or, in the
individual market, policy year) that begins on or after the date
that is one year after the date on which the new recommendation is
issued. 26 CFR 54.9815-2713(b)(1); 29 CFR 2590.715-2713(b)(1); 45
CFR 147.130(b)(1). Coverage of qualifying coronavirus preventive
services must begin on an expedited timeline. Public Law 116-136,
3203, 134 Stat. 367 (2020); 26 CFR 54.9815-2713T(b)(3); 29 CFR
2590.715-2713(b)(3); 45 CFR 147.130(b)(3).
\3\ The references to ``women'' in these proposed rules should
be considered to include any individual potentially capable of
becoming pregnant, including cisgender women, transgender men, and
non-binary individuals. Plans and issuers are required to cover
contraceptive services for all such individuals consistent with the
requirements in 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45
CFR 147.130. See FAQs About Affordable Care Act Implementation (Part
XXVI) (May 11, 2015), Q5, available at <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>.
\4\ The references in this document to ``contraception,''
``contraceptive,'' ``contraceptive coverage,'' or ``contraceptive
services'' generally include all contraceptives, sterilization, and
related patient education and counseling recommended by the HRSA-
Supported Women's Preventive Services Guidelines, unless otherwise
indicated. The Guidelines issued in 2011 referred to ``Contraceptive
Methods and Counseling'' as ``[a]ll Food and Drug Administration
approved contraceptive methods, sterilization procedures, and
patient education and counseling for all women with reproductive
capacity.'' The Guidelines, as amended in December 2016 refer, under
the header ``Contraception,'' to: ``the full range of female-
controlled U.S. Food and Drug Administration-approved contraceptive
methods, effective family planning practices, and sterilization
procedures,'' ``contraceptive counseling, initiation of
contraceptive use, and follow-up care (e.g., management, and
evaluation as well as changes to and removal or discontinuation of
the contraceptive method),'' and ``instruction in fertility
awareness-based methods, including the lactation amenorrhea
method.'' See <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>-2016/
index.html. The Guidelines as amended in 2019 maintain the
contraception guideline, and note, under the header
``Contraception'', the applicability of the Religious Exemptions and
Accommodations for Coverage of Certain Preventive Services. See
<a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>-2019. The Guidelines as
amended in December 2021, which are effective for plan years and
policy years beginning on or after December 30, 2022, refer, under
the header ``Contraception,'' to ``the full range of contraceptives
and contraceptive care to prevent unintended pregnancies and improve
birth outcomes.'' Unlike in previous versions of the Guidelines, the
term ``methods'' no longer appears in that phrase, as the FDA does
not and never has approved, granted, or cleared contraceptive
methods, only contraceptive products. With the removal of the phrase
``female-controlled'', all condoms are included in the December 2021
guidelines, which include ``screening, education, counseling, and
provision of contraceptives (including in the immediate postpartum
period)'' including ``follow-up care (e.g., management, evaluation
and changes, including the removal, continuation, and
discontinuation of contraceptives).'' The 2021 Guidelines include
``the full range of U.S. Food and Drug Administration (FDA)-
approved, -granted, or -cleared contraceptives, effective family
planning practices, and sterilization procedures be available as
part of contraceptive care.'' The 2021 Guidelines do not include
sterilization surgery for men. See <a href="https://www.hrsa.gov/womens-guidelines/index.html">https://www.hrsa.gov/womens-guidelines/index.html</a>. The following sentence appears in the
December 2016 Guidelines: ``Additionally, instruction in fertility
awareness-based methods, including the lactation amenorrhea method,
although less effective, should be provided for women desiring an
alternative method.'' Although that specific sentence does not
appear in the December 2021 Guidelines, HRSA maintains that other
language in the December 2021 Guidelines establishes that such
instruction is included in those Guidelines. Additionally, the U.S.
District Court for the Eastern District of Texas has issued a
temporary restraining order and preliminary injunction that the
effective date of the deletion of that sentence from the December
2021 Guidelines is delayed until further order of the Court, and as
a consequence the sentence remains in those Guidelines. The Court
enjoined HRSA and all persons in active concert or participation
with them from using or applying the December 2021 Guidelines to
delete the above language, thereby maintaining that current language
unless and until it is changed through a final rule issued after
notice to the public and an opportunity to comment. Tice-Harouff v.
Johnson, 6:22-cv-201-JDK (E.D. Tex. Aug. 12, 2022).
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HHS, DOL, and the Department of the Treasury (collectively, the
Departments) previously issued rules and guidance implementing section
2713 of the PHS Act, including guidance specific to coverage of
contraceptive services.\5\ The Departments also previously issued rules
providing exemptions from the contraceptive coverage requirement for
entities and individuals with moral or religious objections to
contraceptive coverage, and accommodations through which objecting
entities are not required to contract, arrange, pay, or provide a
referral for contraceptive coverage while at the same time ensuring
that participants, beneficiaries, and enrollees enrolled in coverage
sponsored or arranged by an objecting entity could separately obtain
contraceptive services at no cost. Specifically, the Departments have
issued:
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\5\ See section II.B of the preamble for a description of the
applicable guidance.
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<bullet> Interim final rules on July 19, 2010, at 75 FR 41726 (July
2010 interim final rules), which implemented the preventive services
requirements of section 2713 of the PHS Act;
<bullet> Interim final rules amending the July 2010 interim final
rules on August 3, 2011, at 76 FR 46621 (August 2011 interim final
rules), which provided HRSA with the authority to exempt group health
plans established or maintained by certain religious employers (and
group health insurance coverage provided in connection with those
plans) from the requirement to cover contraceptive services consistent
with the HRSA-Supported Guidelines;
<bullet> Final rules on February 15, 2012, at 77 FR 8725 (February
2012 final rules), which finalized the definition of ``religious
employer'' in the August 2011 interim final rules without modification;
<bullet> An advanced notice of proposed rulemaking on March 21,
2012, at 77 FR 16501 (March 2012 ANPRM), soliciting comments on how to
provide for coverage of recommended preventive services, including
contraceptive services, without cost sharing, while
[[Page 7238]]
simultaneously ensuring that certain nonprofit organizations with
religious objections to contraceptive coverage would not be required to
contract, arrange, pay, or provide a referral for that coverage;
<bullet> Proposed rules on February 6, 2013, at 78 FR 8456
(February 2013 proposed rules), which proposed to simplify and clarify
the definition of ``religious employer'' for purposes of the religious
employer exemption, and proposed accommodations for group health plans
established or maintained by certain nonprofit religious organizations
with religious objections to contraceptive coverage (and group health
insurance coverage provided in connection with those plans) and for
insured student health plans arranged by certain nonprofit religious
organizations that are institutions of higher education with religious
objections to contraceptive coverage;
<bullet> Final rules on July 2, 2013, at 78 FR 39870 (July 2013
final rules), which simplified and clarified the definition of
``religious employer'' for purposes of the religious employer
exemption, established an accommodation process for health coverage
established or maintained or arranged by eligible organizations,\6\ and
established the process for participating issuers to seek a user fee
adjustment under the applicable accommodations;
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\6\ That accommodation process, which was the only process by
which certain employers could avoid the contraceptive coverage
requirement under the July 2013 final rules, now forms the basis for
what is instead an optional accommodation process under final rules
published on November 15, 2018, at 83 FR 57536 (November 2018
Religious Exemption final rules).
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<bullet> Interim final rules on August 27, 2014, at 79 FR 51092
(August 2014 interim final rules), which amended the July 2013 final
rules in light of the United States Supreme Court's interim order in
connection with an application for an injunction in Wheaton College v.
Burwell \7\ (Wheaton interim order), and provided an alternative
process that an eligible organization may use to provide notice of its
religious objection to the coverage of contraceptive services;
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\7\ Wheaton College v. Burwell, 134 S. Ct. 2806, 573 U.S. 958,
189 L. Ed. 2d 856 (2014).
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<bullet> Proposed rules on August 27, 2014, at 79 FR 51118 (August
2014 proposed rules), which proposed potential changes to the
definition of ``eligible organization'' for purposes of the
accommodation process in light of the Supreme Court's decision in
Burwell v. Hobby Lobby Stores, Inc.; \8\
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\8\ Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 573
U.S. 682, 189 L. Ed. 2d 675 (2014).
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<bullet> Final rules on July 14, 2015, at 80 FR 41317 (July 2015
final rules), which finalized the July 2010 interim final rules, the
August 2014 interim final rules related to the process an eligible
organization uses to provide notice of its religious objection to the
coverage of contraceptive services, as well as the August 2014 proposed
rules, which had proposed expanding the definition of ``eligible
organization'' to allow closely held for-profit entities to access an
accommodation with respect to the coverage of contraceptive services;
<bullet> A request for information on July 26, 2016, at 81 FR 47741
(July 2016 RFI), which requested public comments on alternative ways
for objecting organizations to obtain an accommodation in light of the
Supreme Court's decision in Zubik v. Burwell; \9\
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\9\ Zubik v. Burwell, 136 S. Ct. 1557 (2016).
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<bullet> Frequently Asked Questions on January 9, 2017 (FAQs Part
36), which summarized alternative potential accommodations and stated
that the Departments were not modifying the existing accommodations
because the Departments continued to be of the view that the existing
accommodations were consistent with the Religious Freedom Restoration
Act (RFRA) \10\ and that alternative accommodations were not feasible;
\11\
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\10\ 42 U.S.C. 2000bb-1, et seq.
\11\ FAQs About Affordable Care Act Implementation Part 36 (Jan.
17, 2017), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf</a> and
<a href="https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/aca-faqs-part36_1-9-17-final.pdf">https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/aca-faqs-part36_1-9-17-final.pdf</a>.
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<bullet> Interim final rules on October 13, 2017, at 82 FR 47792
(October 2017 Religious Exemption interim final rules), which expanded
existing religious exemptions from the contraceptive coverage
requirement to objecting entities and individuals and made the existing
accommodation process optional;
<bullet> Interim final rules on October 13, 2017, at 82 FR 47838
(October 2017 Moral Exemption interim final rules), which created
exemptions for entities and individuals that object to the
contraceptive coverage requirement based on moral convictions, and
provided objecting entities access to the optional accommodation
process;
<bullet> Final rules on November 15, 2018, at 83 FR 57536 (November
2018 Religious Exemption final rules), which finalized the expanded
religious exemptions and optional accommodation process in the October
2017 Religious Exemption interim final rules;
<bullet> Final rules on November 15, 2018, at 83 FR 57592 (November
2018 Moral Exemption final rules), which finalized the new moral
exemptions and optional accommodation process in the October 2017 Moral
Exemption interim final rules;
<bullet> Frequently Asked Questions on August 16, 2021 (FAQs Part
48), which announced the Departments would initiate rulemaking to amend
the November 2018 Religious and Moral Exemption final rules in light of
recent litigation; \12\
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\12\ FAQs About Affordable Care Act Implementation Part 48 (Aug.
16, 2021), available at <a href="https://www.cms.gov/files/document/faqs-part-48.pdf">https://www.cms.gov/files/document/faqs-part-48.pdf</a> and <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-48.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-48.pdf</a>.
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<bullet> Frequently Asked Questions on January 10, 2022 (FAQs Part
51), which acknowledged complaints received about compliance with the
contraceptive coverage requirement and clarified currently applicable
guidance; \13\ and
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\13\ FAQs About Affordable Care Act Implementation Part 51,
Families First Coronavirus Response Act and Coronavirus Aid, Relief,
and Economic Security Act Implementations (Jan. 10, 2022), available
at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a>.
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<bullet> Frequently Asked Questions on July 28, 2022 (FAQs Part
54), which further clarified the contraceptive coverage requirement and
currently applicable guidance.\14\
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\14\ FAQs About Affordable Care Act Implementation Part 54 (July
28, 2022), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and
<a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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During the period in which the Departments issued these rules and
guidance, organizations and individuals filed lawsuits challenging the
contraceptive coverage requirement and regulations as being
inconsistent with various legal protections, including RFRA. Plaintiffs
included religious nonprofit organizations, for-profit businesses
controlled by religious individuals, and others, including several non-
religious organizations that opposed the required coverage of certain
contraceptives on the basis of non-religious moral convictions. These
lawsuits first led to the Supreme Court's ruling in Burwell v. Hobby
Lobby Stores, Inc.\15\ The Supreme Court ruled in Hobby Lobby that,
under RFRA, the contraceptive coverage requirement could not be applied
to closely held for-profit corporations because doing so imposed a
substantial burden on the owners' exercise of religion and was not the
least restrictive means of advancing
[[Page 7239]]
a compelling governmental interest.\16\ In response to Hobby Lobby, the
July 2015 final rules allowed closely held for-profit companies to
access the existing accommodation process.
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\15\ Burwell v. Hobby Lobby Stores, Inc, 134 S. Ct. 2751 (2014).
\16\ Id. at 2775-79.
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Later, a second series of legal challenges were filed by religious
nonprofit organizations that argued that the accommodation itself
impermissibly burdened their religious beliefs. On May 16, 2016, the
Supreme Court issued a per curiam decision in Zubik v. Burwell,
vacating the judgments of the Courts of Appeals--most of which had
ruled in the Departments' favor--and remanding the cases ``in light of
the substantial clarification and refinement in the positions of the
parties'' that had been supplied in supplemental briefs.\17\ The Court
anticipated that, on remand, the Courts of Appeals would ``allow the
parties sufficient time to resolve any outstanding issues between
them.'' \18\ The Departments issued the July 2016 RFI to gather public
comments in response to the Zubik decision.
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\17\ Zubik v. Burwell, 136 S. Ct. 1557, 1560 (2016).
\18\ Id.
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FAQs Part 36 summarized the public comments and suggestions
regarding the accommodation process. In Zubik, the Court suggested that
the parties submit to the court information about whether cost-free
contraceptive coverage could be provided to employees, through the
objecting employers' health insurance issuers, without the employers
having to provide any notice to the issuers or the Government.\19\ Some
comments received in response to the July 2016 RFI suggested that such
an accommodation process would not be acceptable to some employers with
religious objections, and some comments suggested that it would create
significant administrative and operational challenges that would
potentially undermine individuals' seamless access to full and equal
health coverage, including contraceptive coverage. Commenters also
noted that the process would not work for self-insured plans for which
there is no issuer with a duty to provide coverage. The Zubik
plaintiffs alternatively suggested creating contraceptive-only
insurance policies in which women would affirmatively enroll. Comments
received in response to the July 2016 RFI expressed, among other
concerns, that these policies might not be authorized under State
contract and insurance law.
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\19\ 578 U.S. 901.
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Beginning in 2015, lawsuits challenging the contraceptive coverage
requirement were also filed by non-religious organizations with moral
objections to contraceptive coverage. In one case, March for Life v.
Burwell, a nonprofit, non-religious organization and two of the
organization's individual employees filed a complaint claiming that the
contraceptive coverage requirement (1) violated the equal protection
component of the Due Process Clause of the Fifth Amendment, (2)
violated the individual employees' rights under RFRA, (3) violated the
individuals' rights under the First Amendment's Free Exercise Clause,
and (4) was arbitrary and capricious under the Administrative Procedure
Act (APA).\20\ Challenges by non-religious, nonprofit organizations led
to conflicting opinions among Federal courts. On August 31, 2015, the
District Court for the District of Columbia agreed with the March for
Life plaintiffs on the organization's equal protection claim and the
employees' RFRA claims, and while not ruling on the APA claim, issued a
permanent injunction against the Departments.\21\ That injunction
remains in place. Conversely, in another case, the U.S. Court of
Appeals for the Third Circuit (Third Circuit) on August 4, 2017 held
that Real Alternatives--a non-religious section 501(c)(3) nonprofit
organization and a moral objector--was not similarly situated to a
religious organization and was therefore not entitled to an
exemption.\22\ The Third Circuit concluded that ``a secular
antiabortion group mirrors a single-issue interest group and not a
religious organization that takes advantage of the Exemption.'' \23\ In
refusing to extend the exemption to a secular nonprofit organization,
the Third Circuit recognized the ``vast history of legislative
protections that single out and safeguard religious freedom but not
moral philosophy.'' \24\
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\20\ March for Life v. Burwell, 128 F. Supp. 3d 116 (D.D.C.
2015).
\21\ Id. at 134.
\22\ Real Alternatives v. Sec'y of HHS, 150 F. Supp. 3d 419,
affirmed 867 F. 3d 338 (3d Cir. 2017).
\23\ Id. at 349.
\24\ Id. at 350.
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In October 2017, the Departments issued the October 2017 Moral
Exemption interim final rules and the October 2017 Religious Exemption
interim final rules (together, the October 2017 interim final rules),
each of which went into effect immediately upon release. Those rules
expanded exemptions and accommodations to include employers that object
to contraceptive coverage on nonreligious moral grounds, along with
expanding the available religious exemptions. As stated in the October
2017 Moral Exemption interim final rules, with respect to the new
exemption for non-religious nonprofit organizations, the Departments
were aware of two small nonprofit organizations that had filed lawsuits
raising non-religious moral objections to coverage of some
contraceptives. HHS noted in the 2017 Moral Exemption interim final
rules that both of those entities had fewer than five employees
enrolled in health coverage, and both required all of their employees
to agree with their opposition to the coverage as a condition of
employment.\25\ In the November 2018 Moral Exemption final rules,
without data available to estimate the actual number of entities that
would make use of the expanded exemption for for-profit entities
without publicly traded ownership interests and that object to the
contraceptive coverage requirement based on sincerely held moral
convictions, the Departments estimated that fewer than 10 entities, if
any, would do so.\26\
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\25\ 82 FR 47856-47857.
\26\ 83 FR 57627.
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Numerous states filed lawsuits challenging the October 2017 interim
final rules, contending that the October 2017 interim final rules were
both procedurally invalid and arbitrary and capricious, and thus
violated the APA. Pennsylvania and New Jersey sued in the Eastern
District of Pennsylvania, while Massachusetts sued in the District of
Massachusetts, and California, Delaware, Maryland, New York, and
Virginia sued in the Northern District of California.\27\ They all
asked the courts to enjoin the interim final rules.
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\27\ Nine other states later joined the California litigation:
Connecticut, Hawaii, Illinois, Minnesota, North Carolina, Rhode
Island, Vermont, Washington, and Oregon, along with the District of
Columbia, and an additional three states (Colorado, Michigan, and
Nevada) moved to intervene in June 2019.
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Two Federal district courts issued preliminary injunctions blocking
the October 2017 interim final rules nationwide. The Northern District
of California did so based on the states' likelihood of success on
their procedural APA claim--that the interim final rules were invalid
for failing to follow notice and comment rulemaking.\28\ On appeal, the
Ninth Circuit affirmed the district court decision though it limited
the geographic scope of the injunction to the five states that were
then plaintiffs in the case. The Eastern District of Pennsylvania
enjoined the interim final rules nationwide, holding that plaintiffs
were likely to succeed on their claims
[[Page 7240]]
that the Departments did not follow proper procedures in issuing the
interim final rules, and that the interim final rules contradict the
statute.\29\ While the preliminary injunctions were on appeal, the
Departments issued the November 2018 Religious Exemption final rules
and the November 2018 Moral Exemption final rules (together, the
November 2018 final rules). The district courts in California and
Pennsylvania both enjoined enforcement of the November 2018 final
rules, and the courts of appeals upheld those injunctions.\30\
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\28\ California v. Azar, 281 F. Supp. 3d 806 (N.D. Cal. 2017),
affirmed, 911 F.3d 558 (9th Cir. 2018).
\29\ See Pennsylvania v. Trump, 281 F. Supp. 3d 553 (E.D. Pa.
2017), affirmed, 930 F.3d 543 (3d Cir. 2019).
\30\ See Pennsylvania v. Trump, 351 F. Supp. 3d 791 (E.D. Pa.
2019), affirmed, 930 F.3d 543 (3d Cir. 2019); and California v.
Azar, 351 F. Supp. 3d 1267 (N.D. Cal. 2019) (enjoining the final
rules with respect to 14 plaintiff states and the District of
Columbia); affirmed, 941 F.3d 410 (9th Cir. 2019).
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The November 2018 Religious Exemption final rules ultimately
expanded existing exemptions for individuals and entities with
religious objections to coverage of contraceptive services. All
nonprofit and for-profit employers with sincerely held religious
objections to contraceptive coverage became eligible for religious
exemptions, as did private universities and colleges with religious
objections with respect to student health insurance coverage. Those
rules retained the existing accommodation process but made it
optional.\31\
---------------------------------------------------------------------------
\31\ 83 FR 57536, 57537-38.
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In January 2020, the Supreme Court granted petitions for writ of
certiorari in the Trump v. Pennsylvania and Little Sisters of the Poor
Saints Peter and Paul Home v. Pennsylvania cases and consolidated them,
to review whether the Departments had the authority to promulgate rules
exempting employers with religious or moral objections from the
requirement to cover contraceptive services.\32\ The Court held that
the Departments have broad authority to identify and create both moral
and religious exemptions and that the final rules were not procedurally
invalid.\33\ The Court indicated that it was proper for the Departments
to take RFRA into account when considering religious exemptions, but
the Court did not decide whether the rules violated the APA's
arbitrary-and-capricious standard.\34\ In litigation following the
Supreme Court's decision, some plaintiffs continue to argue that the
Departments did not sufficiently weigh the benefits of expanded
employer exemptions against the harms of depriving more women of
contraceptive coverage.\35\
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\32\ Little Sisters of the Poor Saints Peter & Paul Home v.
Pennsylvania, 140 S. Ct. 918 (2020).
\33\ Little Sisters of the Poor Saints Peter & Paul Home v.
Pennsylvania, 140 S. Ct. 2367, 2386 (2020).
\34\ Id. at 2383-84.
\35\ See appellees supplemental brief, State of California v.
Azar, Nos. 19-15072, 19-15118, 19-15150 (9th Cir., Aug. 28, 2020).
(``For example, the court will have to determine . . . whether
defendants' justifications are implausible because the Exemption
Rules are not tailored to address the purported problems that the
Rules identify . . .'')
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Individuals also filed lawsuits claiming that the contraceptive
coverage requirement forced them to choose between (1) purchasing
health insurance that forces them to subsidize abortion or (2) forgoing
health insurance. The District Court for the Northern District of Texas
agreed with the plaintiffs in a class action lawsuit, DeOtte v. Azar,
and issued a permanent injunction covering a class of individuals and a
class of employers, which was ultimately vacated by the Fifth
Circuit.\36\
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\36\ DeOtte v. Azar, 393 F. Supp. 3d 490 (N.D. Tex. 2019),
DeOtte v. Nevada, No. 19-10754 (5th Cir. Dec. 17, 2021).
---------------------------------------------------------------------------
The states continue to challenge the November 2018 final rules as
arbitrary and capricious in three lawsuits. In Massachusetts v. Dept.
of Health & Human Services, Massachusetts argued that the moral
exemption is overbroad, and that the Departments failed to consider the
reliance interests of women who stand to lose contraceptive coverage
due to either of the exemptions.\37\ The U.S. District Court for the
District of Massachusetts ruled that the November 2018 final rules were
neither arbitrary and capricious nor unconstitutional.\38\ The
Massachusetts litigation (now on appeal) is currently being held in
abeyance, while California v. Becerra and Pennsylvania v. Biden are
stayed.\39\
---------------------------------------------------------------------------
\37\ See Mem. & Order (Op.), Massachusetts v. Dept. of Health &
Human Services, No. 17-cv-11930 (D. Mass. Jan. 15, 2021), ECF No.
139.
\38\ Id.
\39\ See Stay Order, Massachusetts v. Dept. of Health & Human
Services, No. 21-1076 (1st Cir. Mar. 12, 2021); Joint Status Report,
California v. Becerra, No. 4:17 cv 5783-HSG (N.D. Cal. Oct. 29,
2021); and Stay Order, Pennsylvania v. Biden, No. 2:17-cv-04540-WB
(E.D. Pa. March 8, 2021).
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B. Basis for Rulemaking
Section 2713(a)(4) of the PHS Act, also known as the Women's Health
Amendment, was enacted as part of the ACA to ensure that plans and
health insurance issuers cover women's preventive health needs. Access
to contraception is an essential component of women's health care in
part because contraception is effective at reducing unintended
pregnancy. Studies report that 99 percent of sexually-active women have
used at least one method of contraception at some point during their
lifetime,\40\ regardless of religious affiliation.\41\ The Centers for
Disease Control and Prevention (CDC) found that 65.3 percent of
American women aged 15 to 49 years were using contraception from 2017
to 2019.\42\ The contraceptive coverage requirement has resulted in
more women using contraception, especially long-acting reversible
contraceptives (LARCs), such as intrauterine devices (IUDs) and
implants.\43\ Without health insurance or other health coverage,
contraception can be prohibitively expensive,\44\ and the cost may
deter women from obtaining needed care.\45\ Unintended pregnancies have
negative health consequences for both women and children.\46\ Poor and
low-income women are most likely to have an unintended pregnancy \47\
and are also more likely to be unable to afford contraception. Further,
the U.S. Supreme Court's decision in Dobbs v. Jackson Women's Health
Organization, \48\ which allows for Federal and State laws that
significantly limit access to abortion and thus removes one key option
for women in making health care decisions, has placed a heightened
importance on access to contraceptive services nationwide. Ensuring
access to
[[Page 7241]]
contraception at no cost (other than the premium or contribution paid
for health coverage \49\) is a national public health imperative, as it
is a means to prevent unintended pregnancies and help provide better
health and economic outcomes for women, so that they can exercise
control over their reproductive health and family planning decisions,
particularly in states with prohibitions or tight restrictions on
abortion.
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\40\ Daniels, K., Mosher, W., & Jones, J. (2013). Contraceptive
Methods Women Have Ever Used: United States, 1982-2010. National
Health Statistics Reports, 62: 1-15.
\41\ Jones, R.K. (2020). People of all Religions Use Birth
Control and Have Abortions. Guttmacher Institute. <a href="https://www.guttmacher.org/print/article/2020/10/people-all-religions-use-birth-control-and-have-abortions">https://www.guttmacher.org/print/article/2020/10/people-all-religions-use-birth-control-and-have-abortions</a>.
\42\ National Center for Health Statistics, Current
Contraceptive Status Among Women Aged 15-49: United States, 2017-
2019. Daniels, K., & Abma, J.C. (2020) Current contraceptive status
among women aged 15-49: United States, 2017-2019. NCHS Data Brief,
no 388. Hyattsville, MD: National Center for Health Statistics.
Available at <a href="https://www.cdc.gov/nchs/products/databriefs/db388.htm">https://www.cdc.gov/nchs/products/databriefs/db388.htm</a>.
\43\ Snyder, A. H., Weisman, C. S., Liu, G., Leslie, D., &
Chuang, C. H. (2018). The Impact of the Affordable Care Act on
Contraceptive Use and Costs among Privately Insured Women. Women's
health issues: official publication of the Jacobs Institute of
Women's Health, 28(3), 219-223. <a href="https://doi.org/10.1016/j.whi.2018.01.005">https://doi.org/10.1016/j.whi.2018.01.005</a>.
\44\ Becker, N.V. & Polsky, D. (2015). Women Saw Large Decrease
in Out-Of-Pocket Spending for Contraceptives After ACA Mandate
Removed Cost Sharing. Health Affairs, 34(7): 1204-1208. Available at
<a href="https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.0127">https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.0127</a>.
\45\ Sonfield, A. (2011). ``The Case for Insurance Coverage of
Contraceptive Services and Supplies Without Cost-Sharing.''
Guttmacher Policy Review, 14(1): 7-15.
\46\ ``Preventing Unplanned Pregnancy.'' National Conference of
State Legislatures (2021). Available at: <a href="https://www.ncsl.org/research/health/preventing-unplanned-pregnancy.aspx">https://www.ncsl.org/research/health/preventing-unplanned-pregnancy.aspx</a>.
\47\ Guttmacher Institute (2019). ``Unintended Pregnancy in the
United States.'' Available at <a href="https://www.guttmacher.org/sites/default/files/factsheet/fb-unintended-pregnancy-us.pdf">https://www.guttmacher.org/sites/default/files/factsheet/fb-unintended-pregnancy-us.pdf</a>.
\48\ Dobbs v. Jackson Women's Health Organization, No. 19-1392,
597 U.S. __(2022).
\49\ For ease of reference, this preamble describes the proposed
individual contraceptive arrangement as providing access to
contraceptive services ``at no cost.'' However, individuals eligible
for the individual contraceptive arrangement would typically have to
pay a premium or contribution to enroll in the group health plan or
health insurance coverage sponsored, arranged, or provided by an
objecting entity.
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In previous rulemakings, the Departments established exemptions and
accommodations for a variety of entities. Although the November 2018
final rules expanded religious exemptions, the Departments have
concluded that these rulemakings did not give sufficient consideration
to women's significant interests in access to contraceptive services.
Requiring individuals with low incomes to pay out-of-pocket for
contraceptive services creates a disproportionate financial burden and
unnecessary barrier to care for those individuals who must spend a
greater percentage of their income on contraceptive services.\50\ The
exemptions also ignore the government interest in promoting coverage
for contraceptive services and assuring access to contraception.
Furthermore, section 1 of Executive Order 13985, ``Executive Order on
Advancing Racial Equity and Support for Underserved Communities Through
the Federal Government'' (E.O. 13985), instructs the Federal Government
to consider ways to affirmatively advance equity, civil rights, racial
justice, and equal opportunity, with an emphasis on including
historically marginalized communities and individuals. As noted
previously, requiring individuals to pay out-of-pocket for
contraceptive services will disproportionately burden low-wage workers.
A considerable percentage of low-income women in the U.S. already rely
on safety-net clinics for contraception services.\51\ Low-income women
also have the least access to contraception through employer-sponsored
health insurance.\52\ Given that non-white women are overrepresented
among low-wage workers, exemptions for employers of low-wage workers
from requiring coverage for contraceptive services could further
disproportionately burden non-white women by limiting their access to
contraceptive coverage and reproductive care through employer-sponsored
coverage. This decrease in access to health care has also resulted in
an increase in the prevalence of unplanned pregnancies for non-white
and low-income individuals.\53\ In addition, historically marginalized
communities and individuals are disproportionately affected by racial
biases in health care. Racial bias has led to more skepticism about the
safety of women's health care and less knowledge about the efficacy of
various forms of birth control for family planning among non-white
women.\54\
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\50\ Although many women try and use multiple contraceptive
methods for various reasons, nearly one in five women (18 percent)
say they are not currently using their preferred method of birth
control. The primary reason women say they are not using their
preferred method of contraception is because they cannot afford it.
See Frederiksen, B., Ranji, U., Salganikoff, A., & Long, M., (2021),
Women's Sexual and Reproductive Health Services: Key Findings from
the 2020 KFF Women's Health Survey. <a href="https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey/">https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey/</a>.
\51\ Ranji, U., Salganicoff, A., Sobel, L., & Gomez, I. (2017).
Financing family planning services for low-income women: The role of
public programs. The Henry J. Kaiser Family Foundation. <a href="https://www.kff.org/wp-content/uploads/2019/10/Issue-Brief-Financing-Family-Planning-Services-for-Low-income-Women-1.pdf">https://www.kff.org/wp-content/uploads/2019/10/Issue-Brief-Financing-Family-Planning-Services-for-Low-income-Women-1.pdf</a>
\52\ Sawhill, I. & Guyot, K. (2019). ``Preventing unplanned
pregnancy: Lessons from the states.'' Brookings. <a href="https://www.brookings.edu/research/preventing-unplanned-pregnancy-lessons-from-the-states/">https://www.brookings.edu/research/preventing-unplanned-pregnancy-lessons-from-the-states/</a>.
\53\ Finer, L. & Zolna, M. (2016). ``Declines in Unintended
Pregnancy in the United States, 2008-2011.'' N Engl J Med,
374(9):843-52 and Behn, M., Pace, LE. et al.(2019). ``The Trump
Administration's Final Regulations Limit Insurance Coverage of
Contraception.'' Women's Health Issues, 29(2): 103-106.
\54\ Payne, C., & Fanarjian, N. (2014). Seeking causes for race-
related disparities in contraceptive use. Virtual Mentor, 16(10),
805-809. <a href="https://doi.org/10.1001/virtualmentor.2014.16.10.jdsc1-1410">https://doi.org/10.1001/virtualmentor.2014.16.10.jdsc1-1410</a>.
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The disparities in maternal health among women of different races
can be addressed in part by removing financial barriers to accessing
contraceptive services. Racial-ethnic disparities in access to
reproductive health care, including contraceptive services, are
widespread.\55\ Improving access to contraceptive services is critical
to narrowing disparities in reproductive health access and outcomes, as
well as longer-term outcomes. Access to postpartum contraception is
important to increase spacing between pregnancies, as short intervals
between pregnancies can be associated with adverse health outcomes.\56\
Access to contraceptive services without cost sharing increases
knowledge about safe and effective forms of birth control planning and
decreases financial constraints that prevent continuation of
appropriate contraception use for women in marginalized communities.
Additionally, access to contraceptive services has wide-ranging
economic effects for women, from increased educational attainment to
increases in labor force participation and lifetime earnings.\57\
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\55\ Sutton, M. Y., Anachebe, N. F. & Skanes H. (2021). ``Racial
and Ethnic Disparities in Reproductive Health Services and Outcomes,
2020.'' Obstetrics and gynecology, 137(2), 225-233. <a href="https://doi.org/10.1097/AOG.0000000000004224">https://doi.org/10.1097/AOG.0000000000004224</a>.
\56\ See The White House. (2022). White House Blueprint for
Addressing the Maternal Health Crisis. <a href="https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf</a>. See also
Schummers, L., Hutcheon, J.A., Hernandez-Diaz, S., Williams, P.L.,
Hacker, M.R., VanderWeele, T.J., & Norman, W.V. (2018). Association
of Short Interpregnancy Interval With Pregnancy Outcomes According
to Maternal Age. JAMA Internal Medicine, 178(12), 1661-1670. <a href="https://doi.org/10.1001/jamainternmed.2018.4696">https://doi.org/10.1001/jamainternmed.2018.4696</a>.
\57\ See Bernstein, Anna and Kelly M. Jones (2019). ``The
Economic Effects of Contraceptive Access: A Review of the
Evidence.'' Institute for Women's Policy Research. Available at
<a href="https://iwpr.org/wp-content/uploads/2020/07/B381_Contraception-Access_Final.pdf">https://iwpr.org/wp-content/uploads/2020/07/B381_Contraception-Access_Final.pdf</a>.
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In addition to addressing the policy objectives discussed
previously, these proposed rules are consistent with meeting the
objectives of several Executive Orders and a Presidential Memorandum
issued by President Biden. On January 28, 2021, President Biden issued
Executive Order 14009, ``Strengthening Medicaid and the Affordable Care
Act'' (E.O. 14009).\58\ Section 3 of E.O. 14009 directs HHS, and the
heads of all other executive departments and agencies with authorities
and responsibilities related to Medicaid and the ACA, to review all
existing regulations, orders, guidance documents, policies, and any
other similar agency actions to determine whether they are inconsistent
with policy priorities described in section 1 of E.O. 14009, to include
protecting and strengthening the ACA and making high-quality health
care accessible and affordable for all individuals.\59\ The ACA is
fundamentally ``designed to broaden access to healthcare and insurance
coverage.'' \60\ Further, the Women's Health Amendment was designed to
expand access to the preventive care and screenings that
[[Page 7242]]
women require.\61\ HHS issued the HRSA-Supported Guidelines pursuant to
the Women's Health Amendment that included contraceptives as a category
of preventive services recommended for women. If finalized, these
proposed rules would better align the preventive services regulations
with the policy priorities described in section 1 of E.O. 14009 by
expanding access to contraceptive services without cost sharing to
individuals whose health plans currently do not or would not offer such
coverage due to a religious or moral objection.
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\58\ 86 FR 7793 (February 2, 2021).
\59\ E.O. 14009 also revoked Executive Order 13765 of January
20, 2017 (Minimizing the Economic Burden of the Patient Protection
and Affordable Care Act Pending Repeal). The Departments adopted the
moral exemption and accommodation in part to further this now
revoked Executive Order by relieving a regulatory burden imposed on
entities with moral convictions opposed to providing certain
contraceptive coverage.
\60\ Religious Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113
(D.N.D. 2021).
\61\ To implement the Women's Health Amendment, HRSA
commissioned the independent Institute of Medicine, now known as the
National Academy of Medicine, to conduct a scientific review and
provide recommendations on specific preventive measures that meet
women's health needs.
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Also, on January 28, 2021, President Biden issued a Memorandum on
``Protecting Women's Health at Home and Abroad.'' \62\ Section 1 of the
Memorandum stated ``[w]omen should have access to the healthcare they
need. For too many women today, both at home and abroad, that is not
possible . . . The Federal Government must take action to ensure that
women at home and around the world are able to access complete medical
information, including with respect to their reproductive health.''
These proposed rules would, if finalized, help to support women's
access to reproductive health care services at home.
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\62\ 86 FR 33077.
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On April 5, 2022, President Biden issued Executive Order 14070,
``Continuing to Strengthen Americans' Access to Affordable, Quality
Health Coverage'' (E.O. 14070).\63\ Section 2 of E.O. 14070 requires
the heads of appropriate agencies to, in addition to taking the actions
directed pursuant to E.O. 14009, take several other actions, including
examine policies or practices that make it easier for all consumers to
enroll in and retain coverage, understand their coverage options, and
select appropriate coverage; that strengthen benefits and improve
access to health care providers; that improve the comprehensiveness of
coverage and protect consumers from low-quality coverage; that expand
eligibility and lower costs for coverage in the ACA Exchanges,
Medicaid, Medicare, and other programs; that help improve linkages
between the health care system and other stakeholders to address
health-related needs; and that help reduce the burden of medical debt
on households. These proposed rules would further the goals of E.O.
14070.
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\63\ 87 FR 20689.
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On July 8, 2022, President Biden issued Executive Order 14076,
``Protecting Access to Reproductive Healthcare Services (E.O. 14076).''
\64\ Section 3 of E.O. 14076 requires the Secretary of HHS to submit a
report to the President identifying potential actions to ``protect and
expand access to the full range of reproductive healthcare services,
including actions to enhance family planning services such as access to
emergency contraception'' and ``identifying ways to increase outreach
and education about access to reproductive healthcare services,
including by launching a public awareness initiative to provide timely
and accurate information about such access, which shall include
promoting awareness of and access to the full range of contraceptive
services.'' These proposed rules would take critical steps to further
the goals in E.O. 14076 by expanding access to the full range of
contraceptive services for women enrolled in coverage established or
maintained by an objecting entity, or in health insurance coverage
offered or arranged by an objecting entity.
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\64\ 87 FR 42053.
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In addition to addressing the directives in the Executive Orders
discussed above, these proposed rules also address the concerns about
limiting access to contraception that have been raised by litigants.
The Supreme Court remanded the Little Sisters cases to the U.S. Courts
of Appeals for the Third and Ninth Circuits, respectively, to consider
whether the November 2018 final rules adequately considered women's
health and access to contraceptives or were arbitrary and capricious.
Under the current exemptions, objectors are not required to inform
participants, beneficiaries, or enrollees that the plan or coverage
does not cover contraceptive services or invoke the optional
accommodation, and no alternative mechanisms provide contraceptive
coverage for affected women--leaving many women without coverage.\65\
Given that the November 2018 final rules allow, but do not require,
objecting entities to invoke the accommodation process, many women in
plans subject to an exemption may be unable to access contraceptive
services due to financial, logistical, or administrative barriers.
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\65\ In the November 2018 final rules, the Departments estimated
that between 70,500 and 126,400 women may have lost contraceptive
coverage as a result of the November 2018 Religious Exemption final
rules, and that approximately 15 women may have incurred
contraceptive costs due to use of the November 2018 Moral Exemption
final rules by for-profit entities.
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These proposed rules seek to ensure that women who are enrolled in
either a group health plan established or maintained by an objecting
entity, or in health insurance coverage offered or arranged by an
objecting entity, including an employer, institution of higher
education, or health insurance issuer, have access to cost-free
contraceptive coverage, even when the objecting entity claims the
regulatory exemption without voluntarily using the accommodation
process. This proposed approach would further the government's interest
in protecting women's health and their right to make reproductive
decisions.
In light of these considerations, the Departments are issuing these
proposed rules to further the government's interest in promoting
coverage for contraceptive services for all women,\66\ and in
eliminating barriers to access, while respecting the religious
objections of employers, health insurance issuers, and institutions of
higher education to coverage of contraceptive services.
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\66\ See Section VI.B.2. of this preamble, under the Benefits
heading.
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II. Overview of the Proposed Rules--Departments of HHS, Labor, and the
Treasury
A. Introduction
As discussed in section I.B of this preamble, the Departments have
engaged in several rounds of rulemaking and other initiatives that
solicited public input in an effort to address the claims of those
religious employers, institutions of higher education, and health
insurance issuers that object to providing coverage for contraceptive
services while also ensuring women's access to seamless coverage for
contraceptive services. Previously, under the July 2015 final rules,
many of the objecting entities that are now covered by the November
2018 Religious Exemption final rules could avoid the contraceptive
coverage requirement only by invoking an accommodation. The
accommodation was designed so that these entities were not required to
contract, arrange, pay, or provide a referral for contraceptive
coverage. At the same time, the accommodation was intended to generally
ensure that women enrolled in a health plan established, maintained, or
arranged by the eligible organization, similar to women enrolled in
health plans maintained by other employers, received contraceptive
coverage seamlessly--that is, through the same issuers or third party
administrators that
[[Page 7243]]
provided or administered the health coverage furnished by the eligible
organization, and without financial, logistical, or administrative
obstacles.
As explained in section I.A of this preamble, several employers
challenged the contraceptive coverage accommodation under RFRA. These
religious-objector employers alleged that the accommodation violated
RFRA by making them complicit in the provision of contraceptive
services and care. These employers also asserted that the public
interest of ensuring women have access to contraceptive coverage can be
accomplished in a way that complies with RFRA, that is, in a less
restrictive way than the accommodation. Ultimately, the Departments
issued the November 2018 final rules, which significantly expanded the
types of entities eligible for a religious exemption, created an
exemption for entities with a non-religious moral objection, and made
the aforementioned accommodation optional.
As noted previously, a number of states challenged the November
2018 final rules in court, arguing that these rules are unlawfully
arbitrary and capricious. In light of this litigation, and upon further
consideration, the Departments have determined that the November 2018
final rules failed to adequately account for women's legal entitlement
to access preventive care, critically including contraceptive services,
without cost sharing as Congress intended; the impact on the number of
unintended pregnancies; the costs to states and individuals of such
pregnancies; and the government's interest in ensuring women have
access to this coverage.
These proposed rules, if finalized, seek to resolve the long-
running litigation with respect to religious objections to providing
contraceptive coverage, by respecting the objecting entities' religious
objections while also ensuring that women enrolled in plans or coverage
sponsored, arranged, or provided by objecting entities have the
opportunity to obtain contraceptive services at no cost. These rules
propose to maintain the November 2018 final rules' religious exemption
for entities with sincerely held religious objections to providing
coverage for contraceptive services, under the preventive services
guidelines pursuant to 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-
2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv). Additionally, under these
proposed rules, entities that sponsor insured or self-insured group
health plans or arrange student health insurance coverage and that are
exempt based on their religious objections would continue to be able to
choose to invoke the optional accommodation set forth in the November
2018 Religious Exemption final rules at 26 CFR 54.9815-2713A, 29 CFR
2590.715-2713A, and 45 CFR 147.131 (as applicable). These proposed
rules would confirm that this optional accommodation for exempt
religious-objector entities is available to entities that are
institutions of higher education.
While these proposed rules would maintain the religious exemption
rule, they also would provide an independent pathway through which
women enrolled in plans or coverage sponsored, arranged, or provided by
objecting entities can access contraceptive services at no cost. With
respect to participants and beneficiaries in insured or self-insured
group health plans sponsored by an exempt entity, or enrollees in
individual health insurance coverage (including student health
insurance coverage) arranged or provided by an exempt entity, and that
does not invoke the optional accommodation (if eligible), these
proposed rules would create a pathway, independent from the employer,
group health plan, plan sponsor, or issuer, through which individuals
could obtain at no cost from a willing provider of contraceptive
services \67\ (that meets certain requirements), contraceptive services
for which their plan or issuer would otherwise be required to provide
coverage absent the religious exemption. These proposed rules refer to
this pathway as the individual contraceptive arrangement. This
individual contraceptive arrangement would be available to the
participant, beneficiary, or enrollee without the plan sponsor or
issuer having to take any action that would facilitate the coverage to
which it objects. Simply put, the action is undertaken by the
individual, for the individual. Through the individual contraceptive
arrangement, a provider of contraceptive services, who provides these
services at no cost to the women receiving them, would be able to seek
reimbursement from an issuer with whom it has a signed agreement for
the cost of providing contraceptive services to women covered under
these plans. These proposed rules also would amend 45 CFR 156.50(d) so
that a qualified health plan (QHP) issuer that has agreed to reimburse
an eligible provider of contraceptive services that participates in the
individual contraceptive arrangement would be eligible for an
adjustment to the issuer's Federally-facilitated Exchange (FFE) or
State Exchange on the Federal platform (SBE-FP) fee through the same
mechanism for the user fee adjustment previously established in 45 CFR
156.50(d).
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\67\ These proposed rules refer to providers, consistent with
the proposed definition of the term ``provider of contraceptive
services,'' as including both health care providers and facilities.
This definition is discussed later in this preamble.
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Finally, as discussed in section II.C.2 of this preamble, this
proposed rule would eliminate the exemption and the availability of the
optional accommodation for entities that object to contraceptive
coverage based on non-religious moral beliefs. As more fully explained
in that section, there have not been a large number of entities that
have expressed a desire for an exemption based on a non-religious moral
objection, the Departments are under no legal obligation to provide
such an exemption, and RFRA would never apply to require such an
exemption. Additionally, in light of the Supreme Court's decision in
Dobbs, the Departments have concluded that it is all the more critical
now to ensure women's access to reproductive health care and
contraceptive services without cost sharing, and have determined that
it is necessary to provide women enrolled in plans with respect to
which the sponsor or issuer has non-religious moral objections to
contraceptive coverage, with such coverage directly through their plan.
The Departments are of the view that these proposed rules would
respect the religious objections to contraceptive coverage of
employers, institutions of higher education, and health insurance
issuers, by allowing them to continue to rely upon the religious
exemptions, while also advancing the public interest of ensuring that
women enrolled in such plans and coverage have access to contraceptives
with no cost.
B. Coverage of Preventive Health Services (26 CFR 54.9815-2713, 29 CFR
2590.715-2713, and 45 CFR 147.130)
1. Background on Requirement To Cover Contraceptive Services
Pursuant to 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-
2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), a group health plan, or a
health insurance issuer offering group or individual health insurance
coverage, generally must provide coverage and must not impose any cost-
sharing requirements (such as a copayment, coinsurance, or a
deductible) for, with respect to women, such additional preventive care
and screenings not described in 26 CFR 54.9815-2713(a)(1)(i), 29 CFR
2590.715-2713(a)(1)(i), and 45 CFR 147.130(a)(1)(i), as provided for in
[[Page 7244]]
comprehensive guidelines supported by HRSA for purposes of section
2713(a)(4) of the PHS Act. The currently applicable \68\ HRSA-Supported
Guidelines, as updated on December 17, 2019, include a guideline that
adolescent and adult women have access to the full range of female-
controlled FDA-approved contraceptive methods,\69\ effective family
planning practices, and sterilization procedures to prevent unintended
pregnancy and improve birth outcomes.\70\ The currently applicable
HRSA-Supported Guidelines state that contraceptive care should include
contraceptive counseling, initiation of contraceptive use, and follow-
up care (for example, management and evaluation as well as changes to,
and removal or discontinuation of, the contraceptive method), and that
instruction in fertility awareness-based methods, including the
lactation amenorrhea method, should be provided for women desiring an
alternative method.
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\68\ As explained in FN 4, in December 2021, HRSA approved
updates to the contraception guidelines that apply to plan years (in
the individual market, policy years) starting on and after December
30, 2022. See changes at <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
\69\ The Departments note that the FDA approves, clears, and
grants contraceptive products and not methods.
\70\ See <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>-2019.
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The Departments have clarified in guidance the obligation of a plan
or issuer to provide coverage of contraceptive services in accordance
with these HRSA-Supported Guidelines. On February 20, 2013, the
Departments issued FAQs about Affordable Care Act Implementation Part
XII (FAQs Part XII) stating that the HRSA-Supported Guidelines ensure
women's access to the full range of FDA-approved contraceptive methods
\71\ including, but not limited to, barrier methods, hormonal methods,
and implanted devices, as well as patient education and counseling, as
prescribed by a health care provider.\72\ The FAQs further clarified
that plans and issuers may use reasonable medical management techniques
to control costs and promote efficient delivery of care, such as
covering a generic drug without cost sharing and imposing cost sharing
for equivalent branded drugs. However, FAQs Part XII stated that, in
these instances, a plan or issuer must accommodate any individual for
whom a particular drug (generic or brand name) would be medically
inappropriate, as determined by the individual's health care provider,
by having a mechanism for waiving the otherwise applicable cost sharing
for the brand or non-preferred brand version. The FAQs also clarified
that contraceptive products that are generally available over-the-
counter are required to be covered only if they are both FDA-approved,
cleared, or granted and prescribed by a health care provider.\73\
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\71\ The FDA does not and never has approved, granted, or
cleared contraceptive methods, only contraceptive products. See FN
4, supra.
\72\ See Q14, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf</a> and <a href="http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html">www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html</a>. See also FN 61.
\73\ Id. at Q15.
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On May 11, 2015, the Departments issued FAQs about Affordable Care
Act Implementation Part XXVI (FAQs Part XXVI) clarifying that plans and
issuers must cover, without cost sharing, at least one form of
contraception in each category that is identified by the FDA in its
Birth Control Guide.\74\ The FAQs further clarified that, to the extent
plans and issuers use reasonable medical management techniques within a
specified category of contraception, plans and issuers must have an
easily accessible, transparent, and sufficiently expedient exceptions
process that is not unduly burdensome on the individual or provider (or
other individual acting as a patient's authorized representative) to
ensure coverage without cost sharing of any service or FDA-approved
item within the specified category of contraception. FAQs Part XXVI
stated that if an individual's attending provider recommends a
particular service or FDA-approved item based on a determination of
medical necessity with respect to that individual, the plan or issuer
must cover that service or item without cost sharing. The FAQs made
clear that a plan or issuer must defer to the determination of the
attending provider. FAQs Part XXVI stated that medical necessity may
include considerations such as severity of side effects, differences in
permanence and reversibility of contraceptives, and ability to adhere
to the appropriate use of the item or service, as determined by the
attending provider. The FAQs also clarified that the exceptions process
must provide for making a determination of the claim according to a
timeframe and in a manner that takes into account the nature of the
claim (for example, pre-service or post-service) and the medical
exigencies involved for a claim involving urgent care. FAQs Part XXVI
additionally clarified that a plan or issuer cannot limit sex-specific
recommended preventive services based on an individual's sex assigned
at birth, gender identity, or recorded gender.\75\
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\74\ See Q2 and Q3, available at https://www.dol.gov/sites/
dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/
aca-part-xxvi.pdf and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf</a>. In prior
FAQs related to contraceptive coverage such as FAQs Part XXVI, the
Departments referenced the FDA Birth Control Guide as the source for
categories of contraceptives that must be covered without cost
sharing. The Departments now cite the HRSA-Supported Guidelines for
the list of contraceptive categories to better align with the
language of the Affordable Care Act's preventive service coverage
requirements. Despite the change in wording, there is no substantive
difference and the requirements for plans and issuers remain the
same. The range of identified categories of contraception in the
currently applicable 2019 HRSA-Supported Guidelines include: (1)
sterilization surgery for women; (2) surgical sterilization via
implant for women; (3) implantable rods; (4) copper intrauterine
devices; (5) intrauterine devices with progestin (all durations and
doses); (6) the shot or injection; (7) oral contraceptives (combined
pill); (8) oral contraceptives (progestin only); (9) oral
contraceptives (extended or continuous use); (10) the contraceptive
patch; (11) vaginal contraceptive rings; (12) diaphragms; (13)
contraceptive sponges; (14) cervical caps; (15) female condoms; (16)
spermicides; (17) emergency contraception (levonorgestrel); and (18)
emergency contraception (ulipristal acetate), and additional methods
as identified by the FDA. The 2021 HRSA-Supported Guidelines
clarified that, in addition to the enumerated categories, the full
range of contraceptives includes any additional contraceptives
approved, granted, or cleared by the FDA. The 2021 HRSA-Supported
Guidelines also expanded the recommendation to encompass
contraceptives that are not female-controlled, such as male condoms
(which must be covered with a prescription by plans and issuers for
plan years (in the individual market, policy years) that begin on or
after December 30, 2022). The 2021 HRSA-Supported Guidelines do not
include male sterilization. See <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>. See also Preamble to Final Rules regarding coverage of
certain preventive services at 78 FR 39870 (July 2, 2013).
\75\ Id. at Q5.
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On April 20, 2016, the Departments issued FAQs about Affordable
Care Act Implementation Part 31, Mental Health Parity Act
Implementation, and Women's Health and Cancer Rights Act Implementation
(FAQs Part 31) stating that if a plan or issuer utilizes reasonable
medical management techniques within a specified method of
contraception, the plan or issuer may develop and utilize a standard
exception form and instructions as part of its steps to ensure that it
provides an easily accessible, transparent, and sufficiently expedient
exceptions process that is not unduly burdensome on the individual or a
provider (or other individual acting as a patient's authorized
representative).\76\ The FAQs suggested that the Medicare Part D
Coverage Determination Request Form may serve as a model for plans and
[[Page 7245]]
issuers when developing a standard exception form.\77\
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\76\ See Q2, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf</a>.
\77\ A copy of the Medicare Part D Coverage Determination
Request Form is available at <a href="https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-">https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-</a>.
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On January 10, 2022, the Departments issued FAQs about Affordable
Care Act Implementation Part 51, Families First Coronavirus Response
Act and Coronavirus Aid, Relief, and Economic Security Act
Implementation (FAQs Part 51) that reiterated previously issued
guidance related to coverage of contraceptive services and provided
examples of practices reported to the Departments that denied
contraceptive coverage to participants, beneficiaries, and
enrollees.\78\ The FAQ also clarified that if an individual's attending
provider determines that a particular service or FDA-approved, cleared,
or granted contraceptive product is medically appropriate for such
individual, a plan or issuer must cover that service or product without
cost sharing, whether or not the service or product is in a category of
contraception specifically identified in the current HRSA-Supported
Guidelines.
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\78\ See Q9, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf</a>.
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On July 28, 2022, the Departments issued FAQs about Affordable Care
Act Implementation Part 54 (FAQs Part 54) on additional aspects of
contraceptive coverage, reiterating and clarifying the types of items
and services required to be covered under PHS Act section 2713 and its
implementing regulations. Specifically, these FAQs explained that plans
and issuers are required to cover, without any cost sharing, items and
services that are integral to the furnishing of a recommended
preventive service, such as anesthesia necessary for a tubal ligation
procedure or pregnancy tests needed before provision of certain forms
of contraceptives, such as an intrauterine device (also known as an
IUD), regardless of whether the item or service is billed
separately.\79\ FAQs Part 54 also addressed contraceptive products and
services that are not included in a category of contraception described
in the HRSA-Supported Guidelines, reiterating that plans and issuers
must cover any contraceptive services and FDA-approved, cleared, or
granted contraceptive products that an individual and their attending
provider have determined to be medically appropriate for the
individual, whether or not those services or products are specifically
identified in the categories listed in the HRSA-Supported
Guidelines.\80\ Additionally, the FAQs reiterated the requirement to
cover FDA-approved emergency contraception, including emergency
contraception that is available over-the-counter (OTC), when
prescribed, and encouraged plans and issuers to cover OTC emergency
contraceptive products with no cost sharing when purchased without a
prescription. The FAQs also state that a health savings account, health
flexible spending arrangement, or health reimbursement arrangement can
reimburse expenses incurred for OTC contraception obtained without a
prescription.\81\ Further, the FAQs addressed instruction in fertility
awareness-based methods and encouraged plans and issuers to cover the
dispensing of a 12-month supply of contraception without cost
sharing.\82\
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\79\ See Q1, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and at <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
\80\ Id. at Q2.
\81\ Id. at Q5 and Q6.
\82\ Id. at Q4 and Q7.
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FAQs Part 54 also addressed the use of reasonable medical
management techniques as applied to contraceptive products or services,
including explaining that plans and issuers may use reasonable medical
management techniques for contraceptive products or services not
included in the categories described in the HRSA-Supported Guidelines
only if multiple, substantially similar services or products that are
not included in a category are available and are medically appropriate
for an individual.\83\ For contraceptive products or services included
in the categories described in the HRSA-Supported Guidelines, the FAQs
reiterate that plans and issuers may utilize reasonable medical
management techniques only within a specified category of contraception
and only to the extent the HRSA-Supported Guidelines do not specify the
frequency, method, treatment, or setting for the provision of a
recommended preventive service that is a contraceptive service or FDA-
approved, cleared, or granted product.\84\ The FAQs offered guidance on
how to determine whether a medical management technique is reasonable
for purposes of the requirements under PHS Act section 2713, including
examples of unreasonable medical management techniques, such as
imposing an age limit on contraceptive coverage instead of providing
these benefits to all individuals with reproductive capacity.\85\ In
addition, FAQs Part 54 offered guidance on what constitutes an easily
accessible, transparent, and sufficiently expedient exceptions process
that is not unduly burdensome on the individual or their provider and
explained that the Departments will consider an exceptions process to
be easily accessible if plan documentation includes relevant
information regarding the exceptions process under the plan or
coverage, including how to access the exceptions process without
initiating an appeal pursuant to the plan's or issuer's internal claims
and appeals procedures, the types of information the plan or issuer
requires as part of a request for an exception, and contact information
for a representative of the plan or issuer who can answer questions
related to the exceptions process.\86\ The FAQs state that a plan or
issuer may not require a participant, beneficiary, or enrollee to
appeal an adverse benefit determination using the plan or issuer's
internal claims and appeals process as the means for an individual to
obtain an exception.\87\
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\83\ Id. at Q3.
\84\ Id. at Q8.
\85\ Id.
\86\ Id. at Q9.
\87\ Id. at Q10.
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As explained in FAQs Part 51 and FAQs Part 54, the Departments have
received a number of complaints and reports regarding potential
violations of the contraceptive coverage requirement. The Departments
are committed to ensuring consumers have access to the contraceptive
benefits, without cost sharing, that they are entitled to under the ACA
and implementing regulations. In addition to previously issued
clarifications, the Departments are continuing to assess what changes
to existing regulations or guidance may be needed to better ensure
individuals receive the coverage to which they are entitled under the
law and will issue additional guidance, as warranted. The Departments
solicit comments regarding whether any other clarifications or
additional guidance is needed in these proposed rules to help ensure
that women covered under group health plans or health insurance
coverage have access to contraceptive services at no cost. Moreover,
stakeholders who have information regarding potential noncompliance
with these requirements should contact the Departments as the
Departments continue to consider what additional oversight and
enforcement actions could be taken to ensure health plans and issuers
are complying with the contraceptive benefits guaranteed under the
ACA.\88\
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\88\ As stated in FAQs Part 54, Q14, consumers who have fully-
insured coverage and who have concerns about their health insurance
issuer's compliance with these requirements may contact their State
Department of Insurance (for more information, visit <a href="https://content.naic.org/state_web_map.htm">https://content.naic.org/state_web_map.htm</a>). Consumers who are covered by a
private-sector, employer-sponsored group health plan and have
concerns about their plan's compliance with these requirements may
contact the Department of Labor at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/ask-a-question/ask-ebsa">https://www.dol.gov/agencies/ebsa/about-ebsa/ask-a-question/ask-ebsa</a> or by calling toll free at
1-866-444-3272. Consumers who are covered by a non-Federal public-
sector employer-sponsored plan (such as a State or local government
employee plan) and have concerns about their plan's compliance with
these requirements may contact the Center for Consumer Information
and Insurance Oversight at (888) 393-2789 or
<a href="/cdn-cgi/l/email-protection#a0c3cfced4d2c1c3c5d0d4c9cfceffc3cfcdd0ccc1c9ced4d3e0c3cdd38ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="12717d7c666073717762667b7d7c4d717d7f627e737b7c666152717f613c7a7a613c757d64">[email protected]</span></a> for further assistance with a
question or issue.
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[[Page 7246]]
However, these proposed rules would not alter these coverage
standards applicable to contraceptive services. Rather, these proposed
rules focus on the religious and moral objections of entities otherwise
subject to those coverage standards, and participants', beneficiaries',
and enrollees' access to contraceptive services without cost sharing
when their plan or coverage excludes coverage for these services based
on religious objections and does not adopt the existing optional
accommodation. No new Federal processes, resources, data systems, or
reporting mechanisms are anticipated for monitoring and tracking
entities' objections, or the identities of entities availing themselves
of these exemptions. Therefore, the Departments propose only minor
changes to 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR
147.130.
2. Addition of the Phrase ``Evidence-Informed''
The Departments propose to add the phrase ``evidence-informed''
immediately before ``comprehensive'' in 26 CFR 54.9815-2713(a)(1)(iv),
29 CFR 2590.715-2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), so that
the reference in the paragraph would be to evidence-informed
comprehensive guidelines supported by HRSA.
Section 2713(a) of the PHS Act specifies that the preventive
services that must be covered without cost sharing are: (1) evidence-
based items or services that have in effect a rating of ``A'' or ``B''
in the current recommendations of the United States Preventive Services
Task Force (USPSTF) with respect to the individual involved; (2)
immunizations that have in effect a recommendation from the Advisory
Committee on Immunization Practices of the CDC with respect to the
individual involved; (3) with respect to infants, children, and
adolescents, evidence-informed preventive care and screenings provided
for in the comprehensive guidelines supported by HRSA; and (4) with
respect to women, such additional preventive care and screenings not
described in the aforementioned recommendations by USPSTF as provided
for in comprehensive guidelines supported by HRSA for purposes of
section 2713(a)(4) of the PHS Act.\89\ The reference to ``evidence-
informed'' preventive care and screenings in comprehensive HRSA-
Supported Guidelines was removed in the October 2017 Religious
Exemption interim final rules to align with the statutory text.\90\
However, because the statute requires that the USPSTF recommendations
relate to ``evidence-based'' items and services, and because the
statute also requires that HRSA's guidelines for infants, children, and
adolescents be ``evidence-informed,'' the Departments are of the view
that it is consistent with the general purpose of section 2713 of the
PHS Act that, with respect to women, the additional preventive care and
screenings provided for in comprehensive guidelines supported by HRSA
be evidence-informed.\91\
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\89\ In addition, under section 3203 of the Coronavirus Aid,
Relief, and Economic Security (CARES) Act and its implementing
regulations, plans and issuers must cover, without cost-sharing
requirements, any qualifying coronavirus preventive service pursuant
to section 2713(a) of the PHS Act and its implementing regulations
(or any successor regulations). The term ``qualifying coronavirus
preventive service'' means an item, service, or immunization that is
intended to prevent or mitigate coronavirus disease 2019 (COVID-19)
and that is, with respect to the individual involved (1) an
evidence-based item or service that has in effect a rating of ``A''
or ``B'' in the current USPSTF recommendations; or (2) an
immunization that has in effect a recommendation from ACIP
(regardless of whether the immunization is recommended for routine
use). On November 6, 2020, the Departments published interim final
rules with a request for comment regarding this requirement,
Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency (85 FR 71142).
\90\ The explanation for why the reference to ``evidence-
informed'' was removed, that is, to align with the statutory text,
was provided in the November 2018 Religious Exemption final rules.
See 83 FR 57536, 57557 (November 15, 2018).
\91\ The Departments interpret ``evidence-based'' to require
that the standards be based solely on scientific ``evidence,''
while, as discussed later in this preamble, ``evidence-informed''
means that they are informed by a consideration of scientific
evidence, but such evidence need not be the only basis for its
standards. As the Court held in Little Sisters, HRSA is also
authorized to consider the propriety of including exemptions based
upon religious or moral objections. 140 S. Ct. at 2381.
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Furthermore, the Departments recognize that section 2713 of the PHS
Act establishes special coverage requirements for certain services that
have been shown by evidence to have benefits as preventive
services.\92\ Most studies suggest that removing cost-sharing barriers
to these items and services helps to increase access and utilization by
participants, beneficiaries, and enrollees who might otherwise delay or
skip care due to financial barriers.\93\ However, coverage, without
cost sharing, of recommended preventive items and services and the
resulting increases in utilization can increase costs to consumers in
the form of increased premiums, unless those costs are offset by
savings. By reinstating the requirement that the HRSA-Supported
Guidelines be evidence-informed, these proposed rules would help ensure
that plans and issuers are required to cover recommended preventive
items and services, without cost sharing, only when evidence supports
the items' or services' value as preventive care. Thus, this proposed
amendment would help to limit overutilization of services and promote
efficiencies in care delivery while ensuring that participants,
beneficiaries, and enrollees have access to critical women's preventive
services.
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\92\ See section 2713(a)(1) and (3) of the PHS Act.
\93\ Norris, HCH. C., Richardson, HM., et al. (2021). ``H. M.,
Benoit, M. C., Shrosbree, B., Smith, J. E., & Fendrick, A. M.
(2022). Utilization Impact of Cost-Sharing Elimination for
Preventive Care Services: A Rapid Review.'' Medical Care Research
and Review. Available at, 79(2), 175-197. <a href="https://journals.sagepub.com/doi/pdf.org/10.1177/10775587211027372">https://journals.sagepub.com/doi/pdf.org/10.1177/10775587211027372</a>.
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Additionally, this proposed change would better reflect current
practice. HRSA's process for developing clinical guidelines for women's
preventive services is, and has historically been, evidence-based. In
establishing the HRSA-Supported Guidelines, HHS, acting through HRSA,
depends on the work of the Women's Preventive Services Initiative
(WPSI). According to WPSI, its recommendations are intended to guide
clinical practice and coverage of services for HRSA and other
stakeholders.\94\ The recommendation development process of the WPSI is
based on adaptation of the eight criteria for evidence-based clinical
practice guideline development as articulated in the 2011 report,
Clinical Practice Guidelines We Can Trust from the National Academy of
Medicine (formerly the Institute of Medicine [IOM]).\95\ The WPSI
clinical recommendations are based on reaching a threshold of
supportive evidence, similar to the 2011 IOM Panel.\96\ The WPSI bases
recommendations on evidence of both benefits and harms of an
intervention or service and an assessment of the balance between
[[Page 7247]]
them.\97\ As part of the WPSI process, an evidence report on an
approved topic is presented to its multidisciplinary steering committee
(MSC), and is used as the basis for recommendation development.\98\ The
MSC is then asked to consider the evidence in depth and to formulate a
recommendation.\99\ Recommendations, which include this evidence
review, that are approved by 75 percent of the MSC are submitted to
HRSA by December 1 of the given calendar year.\100\ If approved by HHS,
acting through the HRSA Administrator, the WPSI Clinical Recommendation
is added to the HRSA-Supported Guidelines.\101\ Thus, HRSA-Supported
Guidelines, as currently developed, are evidence-informed. The proposed
addition of the term ``evidence-informed'' in 26 CFR 54.9815-
2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), and 45 CFR
147.130(a)(1)(iv) would more precisely describe the process through
which the HRSA-Supported Guidelines are established and ensure the
Guidelines continue to be evidence-informed in the future.
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\94\ See WPSI's Methodology Summary at <a href="https://www.womenspreventivehealth.org/wp-content/uploads/WPSI-Methodology-1.pdf">https://www.womenspreventivehealth.org/wp-content/uploads/WPSI-Methodology-1.pdf</a>.
\95\ Id.
\96\ Id.
\97\ Id.
\98\ Id.
\99\ Id.
\100\ Id.
\101\ Id.
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For these reasons, the Departments propose to codify that standard.
The Departments do not anticipate that this proposed amendment would
alter the existing processes through which the HRSA-Supported
Guidelines are developed, as these processes, as stated previously,
already include a robust consideration of evidence.
The Departments seek comment on this proposal.
3. Conforming Edits
As discussed in section II.C.2 of this preamble, the Departments
also propose to eliminate the exemption for entities with moral
objections to contraceptive coverage at 45 CFR 147.133, and therefore
to also make conforming edits to remove references to 45 CFR 147.133
that appear in paragraph (a)(1) of 45 CFR 147.130 and paragraph
(a)(1)(iv) of 26 CFR 54.9815-2713, 29 CFR 2590.715-2713 and 45 CFR
147.130. Finally, HHS proposes to remove from 45 CFR 147.130(a)(1)
references to 45 CFR 147.131 and 45 CFR 147.132. Those references also
appear in paragraph (a)(1)(iv), for the same purpose, and therefore are
duplicative and unnecessary in 45 CFR 147.130(a)(1).
C. Exemptions in Connection With Coverage of Contraceptive Services (45
CFR 147.132 and 147.133)
1. Religious Exemptions
This proposed rule would maintain the religious exemption from the
November 2018 Religious Exemption final rules. Each of the proposed
changes made to the regulations with respect to religious objections is
either technical in nature or codifies the intent specified in the
preamble to the November 2018 Religious Exemption final rules. The
proposed changes in no way narrow the scope of the exemption or further
restrict the types of religious entities that may use the exemption.
Under the regulations at 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR
2590.715-2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), a non-
grandfathered group health plan, or a health insurance issuer offering
non-grandfathered group or individual health insurance coverage, must
provide coverage for, and must not impose any cost-sharing requirements
(such as a copayment, coinsurance, or a deductible) for, with respect
to women, such additional preventive care and screenings as provided
for in comprehensive guidelines supported by HRSA, subject to the
exemptions and accommodations related to contraceptive coverage. The
November 2018 Religious Exemption final rules at 45 CFR 147.132(a)(1)
state that guidelines issued under 45 CFR 147.130(a)(1)(iv) by HRSA
must not provide for or support the requirement of coverage or payments
for contraceptive services with respect to a group health plan
established or maintained by an objecting entity, to the extent of the
objections specified in the regulations.
The Departments note that the regulations require HRSA to include
an exemption in its guidelines. Although the Supreme Court held in
Little Sisters that the ACA ``gives HRSA broad discretion to define
preventive care and screenings and to create the religious and moral
exemptions,'' it also concluded that ``the plain language of the
statute clearly allows the Departments to create the preventive care
standards as well as the religious and moral exemptions''
<INF>102 103</INF> (emphasis added). This is understandable because the
HRSA Administrator exercises authority delegated from and subject to
the control of the Secretary of HHS.\104\
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\102\ Little Sisters of the Poor Saints Peter and Paul Home v.
Pennsylvania, 140 S. Ct. 2367, 2382 (2020); see also id. at 2374-75,
2377-78 (recounting the Departments' history of deciding what should
be included in the HRSA-Supported Guidelines).
\103\ Exempting the types of objecting entities listed in the
November 2018 final rules from any guideline requirements that
relate to the provision of contraceptive services is consistent with
the Departments' proposed requirement (discussed in section II.B of
this preamble) that the comprehensive guidelines supported by HRSA
be evidence-informed. The Departments interpret ``evidence-
informed'' to mean that the Guidelines must be informed by a
consideration of scientific evidence; however, the implementation of
the requirement with respect to group health plans or group or
individual health insurance coverage can also take into account the
Departments' decisions to provide religious exemptions.
\104\ See 42 U.S.C. 202 (``The Public Health Service in the
Department of Health and Human Services shall be administered by the
Assistant Secretary for Health under the supervision and direction
of the Secretary.''); Reorganization Plan No. 3 of 1966 Sec. 1, 5
U.S.C. app 1 (transferring to the Secretary ``all functions of the
Public Health Service, of the Surgeon General of the Public Health
Service, and of all other officers and employees of the Public
Health Service, and all functions of all agencies of or in the
Public Health Service.''); Health Resources and Services
Administration; Statement of Organization, Functions, and
Delegations of Authority, 47 F. R. 38,409 (Aug. 31, 1982). Note that
HHS is the successor of the U.S. Department of Health, Education,
and Welfare, the latter of which is referenced in Reorganization
Plan No. 3 of 1966 mentioned earlier in this footnote.
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Paragraph (a)(1)(i) through (iv) of 45 CFR 147.132 lists the types
of objecting entities that are exempted from the HRSA-Supported
Guideline requirements that relate to the provision of contraceptive
services. These proposed rules would make minor technical amendments to
45 CFR 147.132(a)(1)(i). That paragraph currently reads as follows: ``A
group health plan and health insurance coverage provided in connection
with a group health plan to the extent the non-governmental plan
sponsor objects as specified in paragraph (a)(2) of this section. Such
non-governmental plan sponsors include, but are not limited to, the
following entities -.'' These proposed rules would add the phrase ``of
the plan or coverage'' immediately following ``sponsor'' solely for
purposes of precision and clarity. Additionally, these proposed rules
would delete the phrase ``, but are not limited to,''. This change is
not intended to limit the types of non-governmental plan sponsors that
may avail themselves of the religious exemption as compared to the
November 2018 Religious Exemption final rules, but is rather intended
as a stylistic, grammatical change that is consistent with other
regulations issued by the Departments.
In addition, the proposed rules would add language in 45 CFR
147.132(a)(1)(iv) clarifying that, notwithstanding the guaranteed
availability requirements in 45 CFR 146.150 and 45 CFR 147.104, a
health insurance issuer may not offer coverage that excludes some or
all contraceptive services to any entity or individual that
[[Page 7248]]
is not an objecting entity or objecting individual. The preamble to the
November 2018 final rules specified this prohibition with respect to
exempt entities,\105\ but the provision was not included in the
regulatory text. This prohibition would apply to all health insurance
issuers, whether or not the issuer is an exempt or non-exempt entity.
The Departments have identified no reason to treat exempt and non-
exempt issuers differently in this regard. This prohibition is
important to ensure that entities and individuals that are not
objecting entities or individuals are not offered coverage that
excludes some or all contraceptive services from being provided without
cost sharing. In addition, the Departments are of the view that this
prohibition properly respects both the interests of ensuring that women
have the opportunity to obtain coverage for contraceptive services
without cost sharing and the interests of entities that have religious
objections to offering contraceptive coverage. By allowing health
insurance issuers to offer coverage that excludes some or all such
contraceptive services to entities or individuals that have religious
objections to involvement with contraceptive services, the November
2018 final rules provided important protections to objecting entities
and individuals. On the other hand, by limiting the individuals and
entities to whom an objecting health insurance issuer can offer the
coverage, the November 2018 final rules took critical steps to ensure
that women employed by or who are students of entities that do not have
an objection to coverage of contraceptive services (or women purchasing
coverage in the individual market who do not have such an objection)
continue to have access to contraceptive services as required under 26
CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130. These
proposed regulations would codify this limitation in regulatory text.
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\105\ 83 FR 57536, 57565.
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These proposed rules include amendments to reorganize the
regulatory text of 45 CFR 147.132(b) for clarity. These proposed
amendments do not affect the exemption in the HRSA-Supported Guidelines
and in the November 2018 Religious Exemption final rules for
individuals who have a religious objection to contraception coverage.
Paragraph (b) of 45 CFR 147.132 of the November 2018 Religious
Exemption final rules provided that HRSA-Supported Guidelines under 45
CFR 147.130(a)(1)(iv) must not provide for or support the requirement
of coverage or payments for contraceptive services with respect to
individuals who so object. The paragraph also states that nothing in 26
CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), or 45 CFR
147.130(a)(1)(iv) may be construed to prevent a willing health
insurance issuer offering group or individual health insurance coverage
and, as applicable, a willing plan sponsor of a group health plan, from
offering a separate policy, certificate or contract of insurance, or a
separate group health plan or benefit-package option, to any group
health plan sponsor (with respect to an individual) or individual, as
applicable, who objects to coverage or payments for some or all
contraceptive services based on sincerely held religious beliefs. Under
this exemption, if an individual objects to some but not all
contraceptive services, but the issuer (and, as applicable, the plan
sponsor) is willing to provide the plan sponsor or individual, as
applicable, with a separate policy, certificate or contract of
insurance or a separate group health plan or benefit package option
that omits all contraceptives, and the individual agrees, then the
exemption applies as if the individual objects to all contraceptive
services.
In addition to the proposed amendments to reorganize the regulatory
text of 45 CFR 147.132(b) for clarity, these proposed rules would also
make clear that the ability of a willing issuer to offer a separate
policy, certificate, or contract of insurance that omits some or all
contraceptive services to an objecting individual is permitted under
these proposed rules only to the extent permitted by applicable State
law.
The Departments note that section 2713 of the PHS Act applies to a
group health plan and a health insurance issuer offering group or
individual health insurance coverage. Because group health plans and
health insurance issuers are separate legal entities, in the case of an
insured group health plan, the requirements under section 2713 of the
PHS Act apply directly to both the group health plan that provides
benefits through a group health insurance policy and the health
insurance issuer. In the case of an insured student health plan,
although the institution of higher education is not directly subject to
section 2713 of the PHS Act, the institution arranges student health
insurance coverage for students and their dependents, similar to the
sponsor of a group health plan purchasing coverage in the group market.
In recognition of the statute's applicability, the November 2018 final
rules exempt a group health insurance issuer and an issuer of student
health insurance coverage from complying with the requirement to cover
contraceptive services under section 2713 of the PHS Act, if the
sponsor of the plan or institution of higher education that arranges
student health insurance coverage is an exempt entity, even when the
issuer itself is not an exempt entity. The Departments seek comment on
what challenges or concerns would exist under an approach in which, if
an entity that is a group health plan sponsor, group health plan, or
institution of higher education is an objecting entity and sponsors or
arranges for an insured group health plan or student health insurance
coverage, the contraceptive coverage requirement would continue to
apply directly to the health insurance issuer (that is, whether the
exemption should no longer extend to the issuer).
Notwithstanding that the group health plan sponsor, group health
plan, or institution of higher education is an exempt entity, under
this alternative approach, the health insurance issuer would still be
required to fulfill its separate and independent obligation to provide
contraceptive coverage, unless the issuer itself has a religious
objection to contraceptive services. Requiring the health insurance
issuer to independently provide coverage for contraceptive services,
unless it has its own religious objection to doing so, would ensure
that women who are in fully-insured plans sponsored or arranged by
objecting entities (and who thus otherwise might not have access to
contraceptive services under the existing optional accommodation or
might be limited in their ability to access contraceptive services
through the individual contraceptive arrangement proposed in these
rules) would have seamless access to contraceptive coverage. Under the
current regulations, an issuer may exclude coverage of contraceptive
services if the coverage is sponsored or arranged for by an objecting
entity. In order for the issuer to instead provide the coverage
directly to participants, beneficiaries, and enrollees, the Departments
expect that the objecting entity would have to communicate its
religious objections to the issuer in some manner.
The Departments seek comment on all aspects of this alternative
approach. Specifically, the Departments seek comment on whether and how
an objecting entity that is a group health plan sponsor, group health
plan, or institution of higher education generally communicates to the
health insurance issuer its religious objection to providing
contraceptive coverage, and
[[Page 7249]]
whether this form of communication would be sufficient for an issuer to
understand that it must fulfill its separate and independent obligation
to provide coverage of contraceptive services. The Departments also
seek comment on whether and how the health insurance issuer, in
instances in which it does not have its own religious objection to
covering contraceptive services, should be required to provide the
contraceptive coverage, and what guardrails should be in place to
separate the issuer's coverage of contraceptive services from the
coverage provided under the insured group health plan or student health
insurance coverage.
2. Moral Exemptions
Under 45 CFR 147.133, the HRSA-Supported Guidelines must not
provide for or support the requirement of coverage or payments for
contraceptive services with respect to a group health plan established
or maintained by an objecting organization, or health insurance
coverage offered or arranged by an objecting organization, to the
extent of the entity's objections, based on its sincerely held moral
convictions, to its establishing, maintaining, providing, offering, or
arranging for (as applicable) coverage or payments for some or all
contraceptive services; or a plan, issuer, or third party administrator
that provides or arranges such coverage or payments. Similarly, under
45 CFR 147.133, the HRSA-Supported Guidelines must not provide for, or
support, the requirement of coverage or payments for contraceptive
services with respect to individuals who object to coverage or payments
for some or all contraceptive services based on sincerely held moral
convictions.
These proposed rules would remove the ability of entities to claim
an exemption to establishing, maintaining, providing, offering, or
arranging for contraceptive coverage based on a non-religious moral
objection, and would remove the exemption on the basis of moral
convictions applicable to objecting individuals.
As the Departments explained in the November 2018 Moral Exemption
final rule, and as pointed out in section I.A of this preamble, the
Departments' adoption of the moral exemptions was not legally required
but rather an exercise of the Departments' discretion to protect moral
convictions.\106\ Additionally, as noted in the November 2018 Moral
Exemption final rules, the moral exemption likely affects very few
individuals.\107\ In Little Sisters, the Supreme Court concluded that
it was appropriate for HRSA to consider the prevalence of RFRA claims,
and the possibility of required exemptions under RFRA, as a reason for
establishing the religious exemption.\108\ The Departments have done
so, and these proposed rules continue to provide exemptions for
religious organizations, employers and institutions of higher
education, and health insurance issuers with sincerely held religious
objections to providing, sponsoring, or arranging coverage of
contraceptive services.
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\106\ 83 FR 57592, 57598.
\107\ 83 FR 57592, 57627. The November 2018 Moral Exemption
final rules assumed that nine nonprofit entities and nine for-profit
entities would avail themselves of the moral exemption, and
estimated that approximately 15 women may incur contraceptive costs
due to use of the moral exemption by for-profit entities.
\108\ Little Sisters of the Poor Saints Peter and Paul Home v.
Pennsylvania, 140 S. Ct. 2367 (2020).
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However, there is no such justification for treating non-religious
moral objectors in the same manner as religious objectors. RFRA does
not require any exemption for non-religious moral objections that do
not result in a substantial burden on someone's exercise of religion;
therefore, there is no prospect of successful RFRA claims for those
entities that might have only non-religious moral objections to
contraception. Nor does the existence of the religious exemption compel
the conferral of corresponding exemptions based on non-religious moral
objections. The Supreme Court has held that where ``government acts
with the proper purpose of lifting a regulation that burdens the
exercise of religion, we see no reason to require that the exemption
come packaged with benefits to secular entities.'' \109\
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\109\ Corporation of Presiding Bishop of Jesus Christ of Latter-
Day Saints v. Amos, 483 U.S. 327, 339, 107 S. Ct. 2862 (1987).
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In considering whether to propose removing the moral exemption, the
Departments considered past litigation and settlements related to non-
religious moral objections to the requirement that plans and issuers
provide coverage of certain preventive services. The Departments are
aware that one entity, March for Life, has obtained a permanent
injunction preventing the enforcement of the contraceptive coverage
requirement against it because of its non-religious moral objections.
The District Court for the District of Columbia in that case reasoned
that there was no rational basis for the Departments to distinguish
between religious and moral objections.\110\ The Departments
respectfully disagree with that conclusion: as noted previously, the
reason for the distinction is that the Departments can account for the
prospect of numerous RFRA claims with respect to a religious exemption,
some of which might be meritorious, but there is no analogous need to
heed the possibility of successful claims to a non-religious moral
exemption, because there is no moral-exemption statute similar to RFRA.
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\110\ March for Life v. Burwell, 128 F. Supp. 3d 116 (D.D.C.
2015).
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The Departments are of the view that few entities make use of the
moral exemption at this time. In the November 2018 Moral Exemption
final rules, without data available to estimate the actual number of
entities that would make use of the exemption for entities with sincere
moral objections, the Departments assumed that the moral exemption
would be used by nine nonprofit entities and nine for-profit
entities.\111\ These assumptions were made in the absence of data.
Thus, the Departments seek comment on how many women lost contraceptive
coverage without cost sharing based on the moral exemption rule, and
how many would regain access to such coverage by rescinding the
availability of the moral exemption. The Departments seek evidence of
the quantitative harms from the moral exemption rule. The Departments
note, however, that eliminating the moral exemption is likely justified
even if more entities than previously estimated make use of the moral
exemption.
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\111\ 83 FR 57592, 57625 (November 15, 2018).
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In the November 2018 Moral Exemption final rules, the Departments
noted that the organizations that have sued seeking a moral exemption
have adopted longstanding moral tenets opposed to certain FDA-approved
contraceptives and hire only employees who share this view. Commenters
on the October 2017 Moral Exemption interim final rules made similar
points and also suggested that therefore requiring coverage of
contraceptive services by a group health plan or coverage sponsored,
arranged, or provided by an objecting entity subject to a moral
exemption would yield no benefits, because that entity's employees
would neither want nor use contraception. At the time, the Departments
concluded that employees of these organizations would not benefit from
the requirement to provide contraceptive services coverage.\112\ Yet,
although employees of these organizations may typically share the views
of the organizations, it is not necessarily true that all employees of
these organizations share all of these
[[Page 7250]]
views, and employees may share these views in general while wishing to
make personal benefits elections that arguably conflict with certain
organizational views. This is true regardless of how many, or how few,
entities object to covering contraceptives based on a moral exemption.
Furthermore, dependents covered under plans sponsored by these
organizations may not share the views of these organizations and could
not be required to share these views as a condition of employment,
unless they are also employees of the organizations. It is now the
Departments' view that the potential harm to these individuals was not
adequately considered when the Departments adopted the November 2018
Moral Exemption final rules. The Departments seek comment on the
potential impact to these individuals.
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\112\ 83 FR 57536, 57602.
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In the preamble to the November 2018 Moral Exemption final rules,
the Departments referred to a number of Federal statutes demonstrating
Congress' historical desire and intent to protect non-religious moral
objections to abortion and other activities. For example, the
Departments referred at length to the Church Amendments. The preamble
to the November 2018 Moral Exemption final rules stated:
The Church Amendments specifically provide conscience
protections based on sincerely held moral convictions, not just
religious beliefs. Among other things, the amendments protect the
recipients of certain federal health funds [under the Public Health
Service Act (42 U.S.C.A. 201 et seq.), the Community Mental Health
Centers Act (42 U.S.C.A. 2689 et seq.), the Developmental
Disabilities Assistance, or the Bill of Rights Act of 2000 (42
U.S.C.A. 15001 et seq.)] from being required to perform, assist, or
make their facilities available for abortions or sterilizations if
they object `on the basis of religious beliefs or moral
convictions,' and they prohibit recipients of certain federal health
funds from discriminating against any personnel `because he refused
to perform or assist in the performance of such a procedure or
abortion on the grounds that his performance or assistance in the
performance of the procedure or abortion would be contrary to his
religious beliefs or moral convictions.' Later additions to the
Church Amendments protect other conscientious objections, including
some objections on the basis of moral conviction to `any lawful
health service,' or to `any part of a health service program.' In
contexts covered by those sections of the Church Amendments, the
provision or coverage of certain contraceptives, depending on the
circumstances, could constitute `any lawful health service' or a
`part of a health service program.' \113\
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\113\ 83 FR 57592, 57599 (internal citations removed).
However, the Departments now find it significant that Congress
chose not to apply those statutory provisions to private entities that
typically do not accept funds from or do business with the government,
that is, entities that are, in that respect, similar to sponsors of
private group health plans.\114\ The Departments also note that the
Church Amendments primarily address the imposition of employment
responsibilities or personal service requirements that would infringe
upon an individual's moral beliefs, which is not directly relevant to
an employer's, college's or university's, or health insurance issuer's
moral objections to contraceptive coverage. The Departments also find
it significant that those statutory provisions were enacted before the
Supreme Court's opinion in Dobbs. Given that decision and the
consequent threat to women's access to abortion and their ability to
exercise control over their reproductive health care decisions, it is
now all the more critical that women have access to contraceptive
coverage. In fact, the Departments noted in the November 2018 Moral
Exemption final rules that ``[t]he Church Amendments were enacted in
the wake of the Supreme Court's decision in Roe v. Wade.'' \115\ At
that time, Congress was acting in an environment in which there were,
or were about to be, fewer restrictions on reproductive health.
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\114\ As noted, the Departments also observe that the Church
Amendments apply only to recipients of certain types of Federal
funds, further narrowing the Church Amendments' application.
\115\ Id.
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The Departments are of the view that non-religious moral objections
to contraceptives are outweighed by the strong public interest in
making contraceptive coverage as accessible to women as possible. As a
result, and for the reasons stated above, these proposed rules would
eliminate the moral exemption from the requirement to provide
contraceptive coverage without cost sharing.
The Departments considered proposing to retain the moral exemption,
and apply the individual contraceptive arrangement with respect to
women enrolled in plans or coverage that are sponsored, arranged, or
provided by non-religious moral objectors, in instances where the
sponsor of the coverage was eligible for but did not avail itself of
the optional accommodation, but decided against such a proposal. As
explained more fully in section VI.B.2 of this preamble, it is possible
that through the individual contraceptive arrangement, an eligible
individual would need to seek care from a provider of contraceptive
services who is not one of their regular providers, which not only adds
inconvenience, but also could lead to disruptions in care.
Additionally, eligible individuals that participate in the individual
contraceptive arrangement would have to confirm eligibility to their
provider of contraceptive services. The Departments are of the view
that these additional burdens are not justified when weighed against a
moral as opposed to a religious objection.
However, given the larger number of entities that have religious
objections to contraceptive coverage, and the fact that RFRA in some
circumstances could require religious exemptions from such coverage,
the Departments are retaining the religious exemption.
Correspondingly, the Departments propose to make conforming edits
to remove references to 45 CFR 147.133 (which is where the moral
exemption is codified in the current rules) that appear in paragraph
(a)(1) of 45 CFR 147.130 and paragraph (a)(1)(iv) of 26 CFR 54.9815-
2713, 29 CFR 2590.715-2713, and 45 CFR 147.130. The Departments seek
comments on these proposals.
The Departments acknowledge that some objecting entities have
relied on the moral exemption, and that removing that exemption, if
finalized, would disrupt that reliance by requiring such entities to
begin covering contraceptive services without cost sharing. However,
the Departments are of the view that newly applying the contraceptive
coverage requirement on non-religious moral objectors is no different
from requiring a plan or issuer to newly provide coverage without cost
sharing for a preventive service after an applicable recommendation or
guideline is first established. The Departments seek comment on how,
and the degree to which, reliance on the moral exemption would be
disrupted by requiring such entities to begin covering contraceptive
services without cost sharing, and the type and magnitude of burden
that such disruption would cause such entities.
Although the Departments are proposing to eliminate the exemptions
for entities with non-religious moral objections to providing coverage
of contraceptive services, the Departments respect non-religious moral
objections and also seek comment on alternatives to fully rescinding
the moral exemption that would balance the interests of entities with
non-religious moral objections against the strong public interest of
ensuring women have access to contraceptive services without cost
[[Page 7251]]
sharing.\116\ The Departments also seek comment on whether such an
approach would introduce unwarranted barriers for women to access
contraceptive services, as compared to simply eliminating the moral
exemption.
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\116\ While no other Federal law may require the Departments to
provide for an across-the-board moral exemption via regulation,
Federal law continues to protect the exercise of convictions in
certain specific contexts covered by the respective statutory text.
See, for example, the Church Amendments at 42 U.S.C. 300a-7(c)(2)
and (d) (requiring certain covered entities to provide for persons'
lawful exercise of conscience with respect to certain services or
programs, which may include contraceptive services or coverage).
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D. Alternate Availability of Certain Preventive Health Services (26 CFR
54.9815-2713A, 29 CFR 2590.715-2713A, and 45 CFR 147.131)
1. Optional Accommodation for Exempt Entities
The Departments propose several amendments to the existing
regulatory text in 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, and 45
CFR 147.131 regarding the optional accommodation for exempt entities.
The Departments propose to amend the language describing which entities
are eligible for the optional accommodation to align with the scope of
entities eligible for an exemption under these proposed rules. The
Departments also propose changes to reflect needed updates and several
minor additional changes.
In the list of organizations eligible for the optional
accommodation (26 CFR 54.9815-2713A(a)(1), 29 CFR 2590.715-2713A(a)(1),
and 45 CFR 147.131(c)(1) \117\), the Departments propose to remove the
cross-reference to 45 CFR 147.133(a)(1)(i) or (ii) because, as
discussed in section II.C.2 of this preamble, these proposed rules
would eliminate the moral exemption and entities that object to
coverage of contraceptive services based on non-religious moral
objections would no longer be exempt entities. Thus, if finalized,
these proposed rules would not allow these entities to avail themselves
of the optional accommodation.
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\117\ In 45 CFR 147.131, these proposed rules would eliminate
reserved paragraphs (a) and (b), and redesignate paragraph (c) as
paragraph (a).
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In the same paragraph, the Departments propose to add a cross-
reference to 45 CFR 147.132(a)(1)(iii), in addition to the existing
cross-references to 45 CFR 147.132(a)(1)(i) and (ii), to clarify that
the existing optional accommodation for objecting entities is available
to objecting entities that are institutions of higher education. The
preamble to the November 2018 Religious Exemption final rules stated
that the optional accommodation is available to objecting entities that
are institutions of higher education,\118\ but the text of the November
2018 Religious Exemption final rules inadvertently did not specify that
the optional accommodation is available to these entities. These
proposed rules would also add a rule of construction to the HHS
regulation at 45 CFR 147.131 as redesignated paragraph (f) to clarify
that in the case of student health insurance coverage, 45 CFR 147.131
would be applicable in the same manner as to group health insurance
coverage provided in connection with a group health plan established or
maintained by a plan sponsor that is an employer, and references to
``plan participants and beneficiaries'' would be interpreted as
references to student enrollees and their covered dependents.
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\118\ See 83 FR 57536, 57564. (``These rules treat the plans of
institutions of higher education that arrange student health
insurance coverage similarly to the way in which the rules treat the
plans of employers. These rules do so by making such student health
plans eligible for the expanded exemptions, and by permitting them
the option of electing to utilize the accommodation process.'')
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The Departments also propose technical amendments to the regulatory
text to remove the transitional rule provision, which was added in the
November 2018 Religious Exemption final rules. In instances where an
issuer or third party administrator makes separate payments for
contraceptive services through the optional accommodation process on
January 14, 2019, this transitional rule permitted the eligible
organization to give accelerated notice of revocation of the
accommodation. The period during which this accelerated notice process
was permitted has expired. In addition, the Departments do not see a
reason to create a new opportunity for such an accelerated notice,
since all entities currently availing themselves of the optional
accommodation are doing so voluntarily. Therefore, the Departments
propose technical amendments to remove the transitional rule. The
Departments do not propose to modify the generally applicable rule of
revocation, which requires an eligible organization's revocation of use
of the optional accommodation process to be effective no sooner than
the first day of the first plan year that begins on or after 30 days
after the date of the revocation.
Additionally, the Departments propose to replace the cross-
reference to section 2719A of the PHS Act with a cross-reference to
section 9822 of the Code, section 722 of ERISA, and section 2799A-7 of
the PHS Act, in 26 CFR 54.9815-2713A(c)(2)(ii), 29 CFR 2590.715-
2713A(c)(2)(ii), and redesignated 45 CFR 147.131(b)(2)(ii). The current
cross-reference establishes that, when an insured group health plan
avails itself of the optional accommodation, its health insurance
issuer must provide separate payments for contraceptive services in a
manner that is consistent with, among others, the patient protection
requirements under section 2719A of the PHS Act. Section 2719A of the
PHS Act provided that if a plan or issuer requires or provides for
designation by a participant, beneficiary, or enrollee of a
participating primary care provider, individuals may designate any
participating primary care providers available to accept them,
including pediatricians, and prohibits the plan or issuer from
requiring authorization or referral for obstetrical or gynecological
care. Section 102 of title I of Division BB of the Consolidated
Appropriations Act, 2021 (CAA) \119\ amended section 2719A of the PHS
Act to include a sunset provision effective for plan years beginning on
or after January 1, 2022, when the new protections under the No
Surprises Act took effect. Additionally, the No Surprises Act
recodified the patient protections regarding choice of health care
professional from section 2719A(a), (c), and (d) of the PHS Act at new
section 9822 of the Code, section 722 of ERISA, and section 2799A-7 of
the PHS Act.\120\ The Departments are of the view that it would be
appropriate to continue to require that, when making separate payments
for contraceptive services through the optional accommodation for
insured plans, an issuer must make those payments in a manner that is
consistent with these patient protections. The Departments seek comment
on the circumstances under which contraceptive services would
constitute emergency services,\121\ as well as whether to continue to
apply the protections for emergency services, which were set forth
under section 2719A of the PHS Act, and subsequent to that provision
sunsetting, are now set
[[Page 7252]]
forth in section 2799A-1 of the PHS Act but include different such
protections, to issuers making separate payments for contraceptive
services through the optional accommodation for insured plans.
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\119\ Title I of Division BB of the CAA is also known as the No
Surprises Act.
\120\ Section 2719A(b) of the PHS Act and the Departments'
implementing regulations established requirements applicable to
group health plans and health insurance issuers offering group or
individual health insurance related to the coverage of emergency
services, which are also covered under the CAA's sunset provision.
The No Surprises Act added section 9816 of the Code, section 716 of
ERISA, and section 2799A-1 of the PHS Act, which expand the patient
protections related to emergency services under section 2719A of the
PHS Act, in part, by providing additional consumer protections
related to balance billing.
\121\ The term emergency services is defined in regulations at
26 CFR 54.9816-4T(c)(2), 29 CFR 2590.716-4(c)(2), and 45 CFR
149.110(c)(2).
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Redesignated paragraphs 26 CFR 54.9815-2713A(d), 29 CFR 2590.715-
2713A(d), and 45 CFR 147.131(c) set forth model language for the
written notice of the availability of separate payments for
contraceptive services with respect to eligible organizations
exercising the optional accommodations set forth in 26 CFR 54.9815-
2713A(b) and (c), 29 CFR 2590.715-2713A(b) and (c), and 45 CFR
147.131(b). Under current paragraphs 26 CFR 54.9815-2713A(d), 29 CFR
2590.715-2713A(d), and 45 CFR 147.131(e), the language explains to a
participant or beneficiary that a plan sponsor has certified that the
plan or coverage qualifies for an accommodation with respect to the
requirement to cover all FDA-approved contraceptive services for women,
as prescribed by a health care provider, without cost sharing. The
Departments propose to redesignate those paragraphs and amend the
language that refers to FDA-approved contraceptive services to refer to
all FDA-approved, cleared, or granted contraceptives. This proposed
change is consistent with the fact that FDA does not approve
contraceptive ``services,'' but rather contraceptive products, which
may be approved, cleared, or granted, depending on the product type.
The Departments also propose several minor additional grammatical,
conforming, and technical changes. In 26 CFR 54.9815-2713A(b)(1)(ii)(B)
and (c)(1)(ii)(B), 29 CFR 2590.715-2713A(b)(1)(ii)(B) and
(c)(1)(ii)(B), and 45 CFR 147.131(d)(1)(ii)(B) of the current rules,
which are redesignated as 26 CFR 54.9815-2713A(b)(1)(ii)(B) and
(c)(1)(ii)(C), 29 CFR 2590.715-2713A(b)(1)(ii)(B) and (c)(1)(ii)(C),
and 45 CFR 147.131(b)(1)(ii)(B) in these proposed rules, the
Departments propose to update the reference to a student health
insurance plan to refer to student health insurance coverage, to be
consistent with the terminology used in 45 CFR 147.145(a). The
Departments also propose to add a reference to section 414(e) of the
Code when referring to church plans, to fully account for the fact that
the Internal Revenue Service and the Department of the Treasury
regulate such plans. In addition, in what is proposed to be
redesignated as 26 CFR 54.9815-2713A(f), 29 CFR 2590.715-2713A(f), and
45 CFR 147.131(e) (which are paragraphs 26 CFR 54.9815-2713A(e), 29 CFR
2590.715-2713A(e), and 45 CFR 147.131(f) in current regulations), the
Departments propose non-substantive amendments for clarity.
These proposed rules retain the optional accommodation process for
self-insured group health plans under 26 CFR 54.9815-2713A(b) and 29
CFR 2590.715-2713A(b). Under that optional accommodation, an eligible
organization is not required to contract, arrange, pay, or provide a
referral for the delivery of contraceptive benefits in cases where the
organization objects to providing contraception coverage, but does not
object to having third parties (such as a third party administrator)
provide for the benefits. The Department of the Treasury and DOL
propose to make minor amendments to the existing regulatory text in 26
CFR 54.9815-2713A(b) and 29 CFR 2590.715-2713A(b) regarding the
optional accommodation for exempt entities that provide benefits on a
self-insured basis. The proposed amendments make conforming edits to
paragraphs (b)(1)(ii) and (b)(1)(ii)(B) that remove references to 45
CFR 147.133 and add language to paragraph (b)(1)(ii) noting that third
party administrators provide administrative services in connection with
the plan consistent with the parallel optional accommodation for
insured plans. The proposed rules would also add a reference to State
Exchange on the Federal platform user fees to paragraph (b)(3) to be
consistent with amendments made to the user fee provisions in 45 CFR
156.50(d).\122\
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\122\ In 2021, HHS amended 45 CFR 156.50(d) to clarify that
issuers participating through SBE-FPs are eligible to receive
adjustment to their Federal user fee amounts that reflect the value
of contraceptive claims they have reimbursed to third-party
administrators (TPAs) that have provided contraceptive coverage on
behalf of an eligible employer. 86 FR 24140, 24229 (May 5, 2021).
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The Departments seek comment on all aspects of these proposed
amendments.
2. Individual Contraceptive Arrangement for Eligible Individuals
By making the accommodations in 26 CFR 54.9815-2713A, 29 CFR
2590.715-2713A, and 45 CFR 147.131 optional in the November 2018 final
rules, the Departments responded to litigants' concerns that some
objecting entities believed the accommodations under the prior rules
left the objecting entity complicit in contracting, arranging, paying,
or providing a referral for the contraceptive coverage. Those rules
left the accommodation process intact as a voluntary option that
objecting entities could avail themselves of if they did not object to
the accommodation. However, the November 2018 final rules had the
adverse effect of failing to provide women enrolled in a health plan
established or maintained or arranged by an objecting entity with an
alternative mechanism for obtaining contraceptive services with no cost
sharing if the entity did not choose to use the accommodation.
Additionally, the November 2018 final rules did not require objecting
entities or their health plans to notify eligible individuals that the
coverage offered excludes contraceptive services. The Departments have
determined that it is necessary to provide these women with an
alternative pathway to obtaining contraceptive services at no cost
(other than the premium or contribution paid for health coverage)
because of the public health interest in ensuring women's access to
reproductive health care and contraceptive services without cost
sharing, particularly in light of the Supreme Court's opinion in Dobbs
v. Jackson Women's Health Organization. Specifically, the Departments
propose to amend 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, and 45
CFR 147.131 to create an individual contraceptive arrangement for women
enrolled in a group health plan or health insurance coverage sponsored,
offered, or arranged by an objecting entity that does not provide
contraceptive coverage and that elects not to use the existing optional
accommodations with respect to some or all contraceptive services. By
enabling individuals to directly receive contraceptive services at no
cost, this proposal would provide them with access to all contraceptive
services the plan or coverage would otherwise be required to cover,
absent the exemption. Critically, this would be accomplished
independent of any action by the objecting entity, which would not be
required to take any steps to facilitate this provision of
contraceptive services.
Under these proposed rules, an eligible individual may voluntarily,
and independent of any actions by the objecting entity, elect this
individual contraceptive arrangement. Under proposed 26 CFR 54.9815-
2713A(e), 29 CFR 2590.715-2713A(e), and 45 CFR 147.131(d), a provider
of contraceptive services would furnish contraceptive services to the
eligible individual without imposing any fee or charge of any kind,
directly or indirectly, on the eligible individual or any other entity
for the cost of the items and services or any portion thereof.\123\ The
provider of
[[Page 7253]]
contraceptive services would be permitted to seek reimbursement from a
participating issuer as defined under 45 CFR 156.50,\124\ with which
the provider has a signed agreement for the costs of providing these
contraceptive services. The Departments expect that administrative
costs incurred by participating providers of contraceptive services
would be included in the amounts they submit to issuers for
reimbursement. The issuer in turn would be able to receive a reduction
equal to this amount (plus an administrative allowance for costs and
margin) to the issuer's FFE or SBE-FP user fees pursuant to 45 CFR
156.50(d). See section III of this preamble for a discussion of how a
provider of contraceptive services would be reimbursed through such an
adjustment.
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\123\ Under these proposed rules, the provider of contraceptive
services would furnish contraceptive services to the eligible
individual in a manner that is totally independent of any costs that
are associated with a group health plan or health insurance coverage
sponsored, arranged, or provided by an objecting entity. The
Departments note that, because the individual contraceptive
arrangement would be completely separate from a plan or coverage
sponsored, arranged, or provided by an objecting entity, the
provision of the proposed rules that would require a provider of
contraceptive services to furnish contraceptive services to eligible
individuals without imposing any fee or charge of any kind would
mean that the provider of contraceptive services would not collect
any amounts that would typically be associated with an eligible
individual's plan or coverage, such as any premiums, cost-sharing
requirements, or other similar amounts.
\124\ 45 CFR 156.50 defines participating issuer as any issuer
offering a plan that participates in the specific function that is
funded by user fees. This term may include: health insurance
issuers, QHP issuers, issuers of multi-State plans (as defined in 45
CFR 155.1000(a), issuers of stand-alone dental plans (as described
in 45 CFR 155.1065), or other issuers identified by an Exchange.
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Participation in an individual contraceptive arrangement would be
entirely voluntary for the provider of contraceptive services. A
willing provider of contraceptive services would also be reimbursed for
items and services that are integral to the furnishing of the
contraceptive service, for an amount agreed to by the provider and
eligible issuer, regardless of whether the provider would typically
bill for the item or service separately. Reimbursing for the items and
services that are integral to the furnishing of the contraceptive
service, regardless of whether the provider would typically bill for
the item or service separately, is consistent with how the Departments
have interpreted section 2713 of the PHS Act as applied to group health
plans and health insurance issuers offering group or individual health
insurance coverage.\125\
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\125\ 85 FR 71142, 71174. See also FAQs about Affordable Care
Act Implementation Part 54 (July 28, 2022), Q1, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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For purposes of this individual contraceptive arrangement, these
proposed rules would define an eligible individual under 26 CFR
54.9815-2713A(a)(3), 29 CFR 2590.715-2713A(a)(3), and 45 CFR
147.131(a)(3) as a participant or beneficiary enrolled in a group
health plan established or maintained, or an enrollee in individual
health insurance coverage offered or arranged, by an objecting entity
described in 45 CFR 147.132(a) that, to the extent eligible, has not
invoked the accommodation, and who confirms to a provider of
contraceptive services (that agrees to meet certain criteria) that the
individual is enrolled in a group health plan or group or individual
health insurance coverage sponsored, provided, or arranged by an
objecting entity that does not provide coverage for all or a subset of
contraceptive services as generally required for non-objecting entities
under 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv),
and 45 CFR 147.130(a)(1)(iv).
The individual may make this confirmation by producing any
documentation that may include the relevant information, such as a
summary of benefits (for example, a summary of benefits and coverage
(SBC) that includes the relevant information), or through other
methods, such as by providing an attestation.\126\ The provider of
contraceptive services would have discretion on choosing what
confirmation method to accept. The Departments seek comment on
additional sources of information that participants, beneficiaries, and
enrollees could provide for this confirmation, including what
documentation plans and issuers may already be providing to
participants, beneficiaries, and enrollees independent of any Federal
requirements.
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\126\ The Departments are proposing to add sample attestation
language for this purpose to the regulations at 26 CFR 54.9815-
2713A(e)(2), 29 CFR 2590.715-2713A(e)(2), and 45 CFR 147.131(d)(2).
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Excluded from the proposed definition of eligible individual are a
participant or beneficiary enrolled in a group health plan established
or maintained, or an enrollee in individual health insurance coverage
offered or arranged, by an objecting entity that has invoked the
optional accommodation. The Departments do not expect many such
participants, beneficiaries, or enrollees would avail themselves of the
individual contraceptive arrangement, even if they were eligible, as it
would likely be easier for them to obtain contraceptive services
through the accommodation. However, the Departments recognize that it
may be challenging for an individual or a provider of contraceptive
services to distinguish between an eligible individual, as defined
under these proposed rules, and a participant or beneficiary enrolled
in a group health plan established or maintained, or an enrollee in
individual health insurance coverage offered or arranged, by an
objecting entity that has invoked the optional accommodation.
Therefore, the Departments seek comment on whether these individuals
should be included within the definition of eligible individual.
The Departments acknowledge that grandfathered health plans are not
required to comply with section 2713 of the PHS Act, including the
implementing regulations. However, because there are relatively few
grandfathered plans and coverage still in existence,\127\ and these
plans and issuers providing grandfathered coverage may voluntarily, or
as required by State law, provide contraceptive coverage, the
Departments are not proposing to apply the proposed individual
contraceptive arrangement to women enrolled in grandfathered plans.
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\127\ In 2020, the Departments estimated that there are 2.5
million ERISA-covered plans offered by private employers that cover
an estimated 136.2 million participants and beneficiaries in those
private employer-sponsored plans. Similarly, the Departments
estimated that there were 84,087 State and local governments that
offer health coverage to their employees, with an estimated 32.8
million participants and beneficiaries in those employer-sponsored
plans. The Departments estimated that, of firms offering health
benefits, 400,000 sponsor ERISA-covered plans that are grandfathered
(or include a grandfathered benefit package option) and cover 19.1
million participants and beneficiaries. The Departments further
estimated there are 13,454 State and local governments offering at
least one grandfathered health plan and 4.6 million participants and
beneficiaries covered by a grandfathered State or local government
plan. See 85 FR 81097, 81108. The Departments expect that those
numbers are now somewhat lower.
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These proposed rules, if finalized, would not place any additional
obligations on a plan or health insurance issuer. Under this individual
contraceptive arrangement, an exempt entity would not have to provide
any verbal or written documentation to an eligible individual, a
provider of contraceptive services, a health insurance issuer, a third
party administrator, a government agency, or any other person or
entity, that an exempt entity would not already be required to provide
by virtue of sponsoring, arranging, or offering health coverage in
general.\128\ Under these
[[Page 7254]]
proposed rules, an eligible individual may voluntarily, without the
objecting entity's knowledge, and independent of any actions by the
objecting entity, elect this individual contraceptive arrangement. The
individual contraceptive arrangement option would therefore operate
independently of any health plan or health insurance arrangement that
involves or implicates an objecting entity. The Departments seek
comment on adequate ways to ensure individuals are aware of the
individual contraceptive arrangement, can learn if they are eligible,
and can find participating providers to access contraceptive services
at no cost.
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\128\ However, these proposed rules would not prohibit an
eligible individual from requesting that the plan or coverage
provide documentation showing the plan or coverage does not cover
all or a subset of contraceptive services as generally required
under 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv),
or 45 CFR 147.130(a)(1)(iv). The Departments note that a plan or
coverage would be required to comply with generally applicable
disclosure requirements. For example, if an individual requests that
the plan or coverage provide them with a copy of their SBC, the plan
or coverage would be required to furnish the SBC in accordance with
existing regulations. See 26 CFR 54.9815-2715(a)(1), 29 CFR
2590.715-2715(a)(1), and 45 CFR 147.200(a)(1). Additionally, group
health plans covered by ERISA are required to provide a summary plan
description to participants and beneficiaries that describe, in
terms understandable to the average plan participant, the rights,
benefits, and responsibilities of participants and beneficiaries.
See ERISA section 102 and 29 CFR 2520.104b-2.
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These proposed rules would also add a definition of provider of
contraceptive services for purposes of 26 CFR 54.9815-2713A, 29 CFR
2590.715-2713A, and 45 CFR 147.131 in new paragraphs 26 CFR 54.9815-
2713A(g)(2), 29 CFR 2590.715-2713A(g)(2), and 45 CFR 147.131(g)(2). The
term ``provider of contraceptive services'' would mean any health care
provider (including a clinician, pharmacy, or other facility) acting
within the scope of that provider's license, certification, or
authority under applicable law to provide contraceptive services. This
definition is intended to be interpreted broadly to encompass any
provider or facility authorized to provide any contraceptive services,
including when provided via telehealth or mail. The Departments
specifically seek comment on whether there are any entities that would
be equipped to facilitate the individual contraceptive arrangement that
would not be included within this definition.
The Departments acknowledge that this proposal would not achieve
the Women's Health Amendment's goal of ensuring that women have
seamless cost-free coverage of contraceptives, because the individual
contraceptive arrangement would require some additional action by the
affected women and could require them to obtain contraceptive care from
providers other than those from whom they typically receive women's
health care. As the Departments have explained, however, they have been
unable to identify a mechanism that would achieve seamless coverage
while addressing the religious objections to the contraceptive coverage
requirement and the existing accommodations as well as resolving the
long-running litigation.\129\ Nonetheless, the proposed individual
contraceptive arrangement would be more effective than the existing
regulations at advancing the goals of the Women's Health Amendment,
because the current regulations provide no pathway to obtain
contraceptive services at no cost for women whose employers,
institutions of higher education, or health insurance issuers exercise
a religious exemption and either opt not to or are not eligible to
invoke the accommodation.
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\129\ See FAQs Part 36, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf</a> and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-
and-FAQs/Downloads/ACA-FAQs-Part36_1-9-17-Final.pdf.
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The Departments propose to codify the proposed individual
contraceptive arrangement in the same section of the regulations as the
existing optional accommodation for exempt entities, as both would
operate to ensure that women enrolled in coverage sponsored or offered
or arranged by an exempt entity have access to contraceptive services
otherwise required to be covered, without cost sharing. Therefore, the
Departments propose to change the titles of 26 CFR 54.9815-2713A, 29
CFR 2590.715-2713A, and 45 CFR 147.131 from ``Accommodations in
connection with coverage of certain preventive health services,'' to
``Alternate availability of certain preventive health services.''
The Departments seek comment on all aspects of these proposed
amendments.
III. Overview of Proposed Rules--Department of Health and Human
Services
Financial Support (45 CFR 156.50)
To facilitate the proposed individual contraceptive arrangement,
HHS proposes to amend 45 CFR 156.50(d) to allow a participating issuer
\130\ on the FFE or an SBE-FP to receive an FFE or SBE-FP user fee
adjustment for reimbursing a provider of contraceptive services for the
costs of providing contraceptive services pursuant to the individual
contraceptive arrangement.\131\ Additionally, for purposes of 45 CFR
156.50(a), HHS proposes that ``provider of contraceptive services''
would have the same meaning as ``provider of contraceptive services''
under proposed 45 CFR 147.131(g)(2). Under this definition, a provider
of contraceptive services would not be required to be located in an FFE
or SBE-FP State, but a participating issuer would need to be subject to
FFE or SBE-FP user fees to be eligible to receive a user fee
adjustment. In other words, a provider of contraceptive services would
be able to seek reimbursement from a participating issuer in another
State.
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\130\ Under 45 CFR 156.50(a), a participating issuer means any
issuer offering a plan that participates in the specific function
that is funded by user fees. This term may include: health insurance
issuers, QHP issuers, issuers of multi-State plans (as defined in 45
CFR 155.1000(a)), issuers of stand-alone dental plans (as described
in 45 CFR 155.1065), or other issuers identified by an Exchange. The
references to ``participating issuer'' in this section would mean a
participating issuer on the FFE or an SBE-FP.
\131\ HHS notes it is not proposing to change the substantive
requirements on participating issuers and third party administrators
when participating issuers make payments to third party
administrators, nor is HHS proposing to make substantive changes
related to information and documentation requirements on third party
administrators and participating issuers that have made arrangements
with each other. To conform with proposed changes for the individual
contraceptive arrangement, HHS would amend 45 CFR 156.50 to include
references to the individual contraceptive arrangement and re-
designate paragraphs to include references to the individual
contraceptive arrangement provisions. These changes are discussed in
more detail in the following paragraphs.
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To summarize, a provider of contraceptive services that incurs
costs for furnishing contraceptive services pursuant to the individual
contraceptive arrangement would be able to seek reimbursement of these
costs from a participating issuer, with the issuer in turn receiving a
reduction equal to this amount, plus an administrative allowance for
costs and margin, of the issuer's FFE or SBE-FFP user fees as discussed
in detail in this section of the preamble:
<bullet> In order to receive reimbursement for contraceptive
services provided pursuant to the individual contraceptive arrangement,
a provider of contraceptive services would be required to enter into a
signed agreement with a participating issuer to reimburse the provider
for the cost of furnishing contraceptive services.
<bullet> For the participating issuer to receive the user fee
adjustment and for the provider of contraceptive services to receive
reimbursement from the participating issuer as a result of the
participating issuer's user fee adjustment, the participating issuer
would be required to submit to HHS: (1) a copy of the signed agreement
it entered into with the provider of
[[Page 7255]]
contraceptive services; (2) information that identifies the provider of
contraceptive services it reimbursed or will reimburse; and (3) the
total dollar amount of the payments it made or will make to reimburse
the provider of contraceptive services for the costs of furnishing
contraceptive services to eligible individuals pursuant to the
individual contraceptive arrangement.
<bullet> If the necessary conditions are met, the participating
issuer would receive an adjustment to its user fee obligation equal to
the total amount of costs of furnishing contraceptive services for each
provider of contraceptive services in accordance with the individual
contraceptive arrangement, plus an allowance for administrative costs
and margin.\132\ If the adjustment exceeds the user fees owed in the
month of the initial adjustment or in any later month, any excess
adjustment would be carried over to later months.
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\132\ The allowance for administrative costs and margin is
intended to cover a participating issuer's administrative costs
associated with reimbursing providers of contraceptive services,
such as the costs associated with entering into arrangements with
such providers and submitting documentation to seek a reduction in
the user fee obligation, as well as provide a margin to ensure that
participating issuers receive appropriate compensation for providing
such reimbursements. See 78 FR 39870, 39884.
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<bullet> Under these proposed rules and the current regulation, the
administrative allowance--which would be at least 10 percent of the
total dollar amount of the costs of furnishing contraceptive services
pursuant to the individual contraceptive arrangement \133\--would be
specified by HHS in the annual HHS notice of benefit and payment
parameters or other rulemaking. If the administrative allowance for an
applicable year is not specified in that year's HHS notice of benefit
and payment parameters or other rulemaking, then the administrative
allowance would be the amount last specified in rulemaking.
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\133\ Pursuant to 45 CFR 156.50(d)(3)(ii), the minimum
administrative allowance permitted for the existing third party
administrator optional accommodation is also at least 10 percent of
the total dollar amount of payments for contraceptive services. See
78 FR 39870, 39885. Per the HHS Notice of Benefit and Payment
Parameters for 2015 (``2015 Payment Notice''), HHS set the
administrative allowance for the existing third party administrator
optional accommodation at 15 percent. See 79 FR 13743, 13809 (March
11, 2014).
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<bullet> The participating issuer may pay the provider of
contraceptive services as soon as the contraceptive services are
delivered pursuant to the individual contraceptive arrangement, but the
participating issuer would be required to pay the provider, no later
than within 60 days of receipt of any adjustment of a user fee. No
payment would be required with respect to the allowance for
administrative costs and margin. This proposal sets the latest date on
which the participating issuer must reimburse the provider of
contraceptive services. This proposal would not preclude the
participating issuer and provider of contraceptive services from
agreeing that the participating issuer would reimburse the provider at
more frequent intervals, such as on a monthly or quarterly basis, or
upfront for the full cost of services provided during the applicable
benefit year rather than in the following benefit year in which the
issuer receives the monthly user fee adjustment.
Each of the items from the preceding list laying out this proposed
user fee adjustment is discussed in more detail in the following
paragraphs.
HHS proposes to add paragraph (d)(1)(iii) to 45 CFR 156.50 to
require that a provider of contraceptive services and a participating
issuer enter into an agreement for that issuer to seek a user fee
adjustment as a result of reimbursing the provider's costs pursuant to
the individual contraceptive arrangement. An agreement between the
participating issuer and the provider of contraceptive services would
be a condition of participation in the individual contraceptive
arrangement and required to receive reimbursement for the costs of
furnishing contraceptive services.
HHS proposes to amend 45 CFR 156.50(d)(2)(i) to establish the
information and documentation a participating issuer that is eligible
for a user fee adjustment must provide to HHS to receive a user fee
adjustment as a result of reimbursement of (or intention to reimburse
pursuant to proposed 45 CFR 156.50(d)(5)) the cost of furnishing
contraceptive services incurred by a provider of contraceptive
services. HHS proposes to amend 45 CFR 156.50(d)(2)(i)(A) to require
that, to receive a user fee adjustment under the individual
contraceptive arrangement, a participating issuer must submit to HHS
identifying information on each provider of contraceptive services it
reimbursed (or will reimburse pursuant to proposed 45 CFR
156.50(d)(5)). Additionally, HHS proposes to add 45 CFR
156.50(d)(2)(i)(D) and (E) to require the participating issuer offering
a plan through the FFE or an SBE-FP to submit: (1) documentation that
demonstrates that the participating issuer and the provider of
contraceptive services have entered into an agreement through which the
participating issuer would reimburse the provider for the costs of
contraceptive services furnished under the individual contraceptive
arrangement; and (2) the total dollar amount of the payments the
participating issuer made (or will make) to reimburse the provider for
the costs of furnishing those contraceptive services already provided
under the individual contraceptive arrangement.
To facilitate the individual contraceptive arrangement, HHS
proposes that providers of contraceptive services and participating
issuers, as a condition for participating in this individual
contraceptive arrangement, must enter into a signed agreement and that
the participating issuer must submit a copy of this agreement to HHS to
satisfy the proposed submission requirements at 45 CFR
156.50(d)(2)(i)(A) and (D). HHS proposes that this signed agreement
must include identifying information of the provider of contraceptive
services, such as the name and contact information for the provider's
practice or facility or, if applicable, the provider's National
Provider Identifier.\134\ In addition, the agreement would need to
include the signatures of individuals with the authority to legally and
financially bind the provider of contraceptive services and the
participating issuer. The agreement would need to demonstrate that the
provider of contraceptive services and participating issuer have
entered into an arrangement through which the participating issuer will
reimburse the provider for the costs of furnishing contraceptive
services in accordance with the individual contraceptive arrangement at
proposed 26 CFR 54.9815-2713A(e), 29 CFR 2590.715-2713A(e), and 45 CFR
147.131(d), and that the participating issuer will seek a user fee
adjustment for the amount of those eligible costs (plus an
administrative allowance as specified at proposed 45 CFR
156.50(d)(3)(iii)). HHS notes that other terms of the agreement between
a provider of contraceptive services and a participating issuer, such
as the period of time over which the agreement is effective, are at the
discretion of the participating issuer and provider. HHS also notes
that, to facilitate the individual contraceptive arrangement, a single
participating issuer may enter into separate agreements with more than
one provider of contraceptive services. Additionally, providers of
contraceptive services may enter into separate agreements with more
than one participating issuer. HHS recognizes that there may be
additional
[[Page 7256]]
forms of documentation that could satisfy these proposed submission
requirements; thus, HHS seeks comment on the types of documentation HHS
should accept. HHS also seeks comment on the types of information
participating issuers must submit to adequately identify the providers
of contraceptive services with which the participating issuers have
entered into such arrangements.
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\134\ See ``NPI: What You Need to Know'' (March 2021), available
at <a href="https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/NPI-What-You-Need-To-Know.pdf">https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/NPI-What-You-Need-To-Know.pdf</a>.
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HHS proposes to add 45 CFR 156.50(d)(2)(i)(E) to require a
participating issuer to submit the total dollar amount of the
provider's costs of furnishing contraceptive services under the
individual contraceptive arrangement and for which a participating
issuer would be able to receive a user fee adjustment (plus an
administrative allowance as specified at proposed 45 CFR
156.50(d)(3)(iii)). HHS recognizes that the costs of furnishing
contraceptive services under the individual contraceptive arrangement
would vary based on the specific contraceptive service provided and the
time it takes to provide that service. Because of this cost variance,
HHS proposes to allow a provider of contraceptive services to calculate
its actual costs of furnishing these contraceptive services and to
provide that calculation of actual costs to the participating issuer
offering a plan through the FFE or an SBE-FP with which the provider
has entered into an arrangement for reimbursement of these costs.
Consistent with how the Departments have interpreted section 2713 of
the PHS Act as applied to group health plans, and health insurance
issuers offering group or individual health insurance coverage,\135\
HHS proposes that the actual costs of the provider of contraceptive
services would include items and services that are integral to the
furnishing of the contraceptive service, for an amount agreed to by the
provider and eligible issuer, regardless of whether the provider would
typically bill for the item or service separately. This would include
the administrative costs incurred by participating providers of
contraceptive services to deliver the contraceptive services. HHS seeks
comment on the costs a provider of contraceptive services could include
in its calculation of actual costs provided to the participating issuer
with which it has entered into an arrangement for reimbursement of
these costs. In determining how a provider's costs should be calculated
for reimbursement under the individual contraceptive arrangement, HHS
considered whether costs should be calculated using a standard
methodology. However, due to the wide variation in costs depending on
the specific contraceptive services provided and how the service is
delivered, HHS determined that permitting a provider of contraceptive
services to calculate its actual costs would allow the provider to
receive a more accurate cost reimbursement. HHS seeks comment on
whether the reimbursement should be equal to the provider's actual
costs of furnishing contraceptive services to eligible individuals or
whether HHS should instead establish a standard methodology to
calculate costs. HHS seeks comment on benchmarks HHS could use to
establish a reimbursement rate.
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\135\ 85 FR 71142, 71174. See also FAQs Part 54, Q1, available
at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf</a> and <a href="https://www.cms.gov/files/document/faqs-part-54.pdf">https://www.cms.gov/files/document/faqs-part-54.pdf</a>.
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Additionally, HHS proposes to revise 45 CFR 156.50(d)(3)(ii) to
permit a participating issuer that satisfies the requirements as
proposed in 45 CFR 156.50(d)(2) to receive a user fee adjustment equal
to the total dollar amount of a provider's costs of furnishing
contraceptive services plus the administrative allowance. HHS proposes
to re-designate the administrative allowance provision at existing 45
CFR 156.50(d)(3)(ii) to new paragraph (d)(3)(iii), and amend it to
establish that the allowance should be calculated as a percentage of
the sum of the total dollar amount of the payments for contraceptive
services provided to a third party administrator as calculated at 45
CFR 156.50(d)(3)(i) and the provider's costs of furnishing
contraceptive services as calculated at proposed 45 CFR
156.50(d)(3)(ii). HHS is of the view that it is appropriate to provide
an administrative allowance because participating issuers will incur
additional administrative costs to providers of contraceptive services
for the actual cost of furnishing contraceptive services. As
established in the 2015 Payment Notice,\136\ the current administrative
allowance is 15 percent for issuers that have entered into agreements
with third party administrators to reimburse the cost of contraceptive
services with respect to women getting non-contraceptive coverage
through eligible organizations.\137\ Consistent with the 2015 Payment
Notice administrative allowance for third party administrators, HHS
proposes an administrative allowance of at least 10 percent for issuers
that enter into agreements with providers of contraceptive services
pursuant to the individual contraceptive arrangement. HHS proposes a 15
percent administrative allowance for this adjustment, similar to the
administrative allowance set in the 2015 Payment Notice for third party
administrators.
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\136\ 79 FR 13743.
\137\ 79 FR 13743 at 13809.
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Additionally, for clarification and consistency with current
practice, HHS proposes to clarify at 45 CFR 156.50(d)(3)(iii) that,
unless a new allowance for administrative costs and margin is specified
in the applicable year's HHS notice of benefit and payment parameters
or other rulemaking, HHS will, for a particular calendar year, maintain
the allowance that was last specified in rulemaking. HHS believes this
proposal makes clear the allowance and the mechanism HHS would use to
propose any changes to the allowance. While HHS is proposing to
maintain that the administrative allowance must be at least 10 percent,
as set forth in the 2015 Payment Notice, the current, applicable
administrative allowance is 15 percent.\138\ HHS is not proposing
making changes to this percentage in this rulemaking.
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\138\ 79 FR 13743 at 13809.
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HHS also proposes to amend 45 CFR 156.50(d)(5) to provide that a
participating issuer may provide payments for contraceptive services as
soon as they are delivered, but must provide payments within 60 days to
a third party administrator or a provider of contraceptive services.
Such payments must be made within 60 days of receipt of any adjustment
of a user fee in an amount that is no less than the portion of the
adjustment attributable to the total dollar amount of the payments for
contraceptive services submitted by the third party administrator or
provider of contraceptive services. This proposed amendment to 45 CFR
156.50(d)(5) is intended to clarify and codify in regulation the
current policy as applied to the existing optional accommodation with
respect to a third party administrator, as well as to extend this
policy to providers of contraceptive services pursuant to the
individual contraceptive arrangement. The adjustments to a
participating issuer's user fee through the FFE or an SBE-FP for a
given year are based on data submitted by third party administrators to
HHS regarding the prior benefit year, and adjustments to a
participating issuer's current user fee charges are made on a monthly
basis based on the data received to date regarding the payments for
contraceptive services from the prior year. For example, a
[[Page 7257]]
participating issuer and a provider of contraceptive services could
agree that, prior to and in anticipation of receiving a user fee
adjustment as specified at 45 CFR 156.50(d)(3), the participating
issuer would reimburse the provider on a monthly or quarterly basis in
an amount equal to the provider's costs of furnishing contraceptive
services in accordance with the individual contraceptive arrangement.
However, HHS notes that if any monthly user fee adjustment that a
participating issuer receives does not cover the full costs of
contraceptive services provided by the provider of contraceptive
services or the full payment for contraceptive services made or
arranged for by the third party administrator for the applicable
benefit year, then the provider may not receive full reimbursement for
all contraceptive services furnished during the applicable calendar
year within 60 days of when the participating issuer has first received
an adjustment to its FFE or SBE-FP user fee. Thus, HHS proposes that
the signed agreement between a participating issuer and a provider of
contraceptive services must define the terms for payment to the
provider.
Next, HHS proposes to amend 45 CFR 156.50(d)(6) to establish that,
for 10 years following the calendar year for which the user fee
adjustment is received, a participating issuer must retain
documentation demonstrating that it timely paid each provider of
contraceptive services for which it received any user fee adjustment.
These proposals align with the existing recordkeeping requirements for
a participating issuer under the third party administrator
contraceptive user fee adjustment process.
In addition, HHS proposes to add 45 CFR 156.50(d)(8) to establish
recordkeeping requirements with which providers must comply as a
condition of participating in the individual contraceptive arrangement.
HHS proposes to require that, for 10 years following the contraceptive
service being provided, providers of contraceptive services must
maintain documentation showing the actual costs of furnishing
contraceptive services in compliance with the requirements of the
individual contraceptive arrangement and documentation supporting the
total dollar amount of those costs, and must make this documentation
available upon request to HHS, the HHS Office of the Inspector General,
the Comptroller General, and their designees. This timeframe is similar
to the standard used for third party administrators under the existing
optional accommodation and the standards used for other Exchange
programs. We solicit comment on this timeframe and whether the
timeframe should be tied to the issuer payment instead of the timeframe
from when the contraceptive service is being provided.
As explained previously, an eligible individual would be able to
access the individual contraceptive arrangement without the exempt
entity providing any documentation to an issuer, third party
administrator, or HHS. Nevertheless, a provider of contraceptive
services seeking to furnish contraceptive services pursuant to the
individual contraceptive arrangement would be required to confirm an
individual's eligibility for the individual contraceptive arrangement.
As explained earlier in this preamble, the individual may make this
confirmation by producing a summary of benefits, such as an SBC that
includes the relevant information or through other methods, such as by
providing an attestation. The provider of contraceptive services would
have discretion on choosing what confirmation method to accept. HHS
expects that providers would choose to document receiving this
representation in a variety of ways, such as by making a notation in a
specific eligible individual's medical chart. HHS is of the view that
allowing providers of contraceptive services to choose how they
document an eligible individual's representation would decrease
operational barriers related to these recordkeeping requirements and
would thereby allow a greater number of interested providers to furnish
contraceptive services under the individual contraceptive arrangement.
Recognizing the various types of representations a provider of
contraceptive services could receive from or on behalf of an individual
to demonstrate that individual's eligibility for the individual
contraceptive arrangement, HHS proposes to add 45 CFR 156.50(d)(9) and
(10). These proposals would preserve, if certain reliance requirements
are met, a provider's ability to receive reimbursement for
contraceptive services furnished, as well as a participating issuer's
ability to receive a user fee adjustment, if the representation as to
the individual's eligibility for the individual contraceptive
arrangement is later determined to be incorrect. Specifically, proposed
45 CFR 156.50(d)(9) would establish that if a provider of contraceptive
services relies reasonably and in good faith on a representation that
the individual is eligible to receive contraceptive services pursuant
to the individual contraceptive arrangement, and the representation is
later determined to be incorrect, then the provider of contraceptive
services would be considered to have received a representation by an
eligible individual for purposes of receiving a reimbursement for
contraceptive services furnished by a participating issuer, and would
meet any requirements related to maintaining documentation of this
representation. Similarly, 45 CFR 156.50(d)(10), if finalized, would
establish that if a participating issuer relies reasonably and in good
faith on the provider's representation that the provider of
contraceptive services furnished contraceptive services for an eligible
individual, and the representation the provider received from or on
behalf of the individual is later determined to be incorrect, then the
participating issuer would meet any requirements that involve the
provider's receipt of such representation.
HHS also proposes to add 45 CFR 156.50(d)(11) to preserve, if
certain requirements are met, the ability of a participating issuer to
receive a user fee adjustment if the provider's representation to the
participating issuer that the provider furnished contraceptive services
in accordance with the individual contraceptive arrangement is later
determined to be incorrect. First, proposed 45 CFR 156.50(d)(11) would
establish that if a participating issuer relies reasonably and in good
faith on a provider's representation that the provider furnished
contraceptive services in accordance with the individual contraceptive
arrangement, and the representation by the provider of contraceptive
services is later determined to be incorrect, then the participating
issuer's good faith reliance on that incorrect representation would
meet any requirements that involve that representation. Second, the
proposal at 45 CFR 156.50(d)(11) would apply only when a participating
issuer has already reimbursed a provider of contraceptive services for
any amount of its costs of furnishing contraceptive services as
specified in proposed 45 CFR 156.50(d)(2)(i)(E). HHS is of the view
that it is appropriate to limit this proposal to instances in which the
participating issuer has already paid the provider of contraceptive
services. If the participating issuer has not yet paid the provider of
contraceptive services at the time the provider's representation is
determined to be incorrect, the participating issuer will not have
incurred a financial loss by no longer having the ability to receive a
user fee adjustment.
[[Page 7258]]
To participate in the individual contraceptive arrangement,
proposed 45 CFR 147.131(d)(1) would require that a provider of
contraceptive services furnish contraceptive services to the eligible
individual without imposing a fee or charge of any kind, directly or
indirectly, on the eligible individual or any other entity for the cost
of the items and services or any portion thereof. Consistent with this
requirement, HHS proposes to include in new 45 CFR 156.50(d)(1)(iii),
(d)(10), and (d)(11) that a provider of contraceptive services must
furnish contraceptive services to the eligible individual ``without
imposing a fee or charge of any kind, directly or indirectly, on the
eligible individual or any other entity for the cost of the items and
services or any portion thereof.''
Finally, HHS proposes technical corrections to 45 CFR
156.50(d)(1)(ii), (d)(2)(i)(A) and (B), (d)(2)(ii), (d)(2)(iii)(B), and
(d)(7)(i) to align with these proposed changes. First, HHS proposes a
technical correction to 45 CFR 156.50(d)(1)(ii), (d)(2)(i)(A) and (B),
(d)(2)(ii), (d)(2)(iii)(B), and (d)(7)(i) to update cross-references to
26 CFR 54.9815-2713A(a)(4) and 29 CFR 2590.715-2713A(a)(4), which have
been re-designated to 26 CFR 54.9815-2713A(a)(1)(iii) and 29 CFR
2590.715-2713A(a)(1)(iii), respectively. Second, HHS proposes a
technical correction to 45 CFR 156.50(d)(1)(ii) to clarify that a
participating issuer participating on an SBE-FP is eligible to receive
an adjustment to its Federal user fee amounts that reflect the value of
contraceptive services it has agreed to reimburse to third party
administrators or has agreed to reimburse to providers for the
providers' actual costs of furnishing contraceptive services consistent
with this individual contraceptive arrangement. In the HHS Notice of
Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager
Standards final rule,\139\ HHS explained that issuers participating
through an SBE-FP have been able to qualify for user fee adjustments as
provided for in the HHS Notice of Benefit and Payment Parameters for
2017,\140\ and amended 45 CFR 156.50 to make explicit that issuers are
eligible to receive SBE-FP user fee adjustments.\141\ Thus, HHS
proposes to make a conforming amendment to 45 CFR 156.50(d)(1)(ii).
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\139\ 86 FR 24140 at 24229 (May 5, 2021).
\140\ 81 FR 12203 at 12293 (March 8, 2016).
\141\ 86 FR 24229.
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HHS notes that it is not proposing to raise the FFE or SBE-FP user
fee rates finalized in the HHS Notice of Benefit and Payment Parameters
for 2023 \142\ to offset the FFE and SBE-FP user fee adjustments, and
HHS estimates reimbursements for contraceptive services will represent
only a small portion of total FFE user fees.
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\142\ See 87 FR 27208 at 27288. In part 3 of the HHS Notice of
Benefit and Payment Parameters 2022 final rule, HHS finalized the
repeal of the Exchange Direct Enrollment (DE) option and the removal
of 45 CFR 155.221(j). See 86 FR 53412 at 53429 (September 27, 2021).
To align with these actions, HHS finalized in the 2023 Payment
Notice conforming amendments to 45 CFR 156.50(c) and (d) to remove
references to 45 CFR 155.221(j) and the Exchange DE option.
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HHS is of the view that the proposed amendment to 45 CFR
156.50(d)(2)(i)(A) and the proposed addition of 45 CFR
156.50(d)(2)(i)(D), which would require participating issuers, but not
providers of contraceptive services, to submit documentation
demonstrating the agreement, would mitigate the operational burden on
providers of providing contraceptive services through the individual
contraceptive arrangement, without materially increasing the burden for
participating issuers that are already familiar with the process of
submitting information to HHS as part of the existing conditions for
receiving a user fee adjustment through an arrangement with a third
party administrator, pursuant to the requirements of 45 CFR 156.50(d).
To facilitate the individual contraceptive arrangement, HHS proposes to
make available to providers of contraceptive services a list of
participating issuers that have previously participated in the third
party administrator optional contraceptive user fee adjustment process
under current 45 CFR 156.50(d). HHS seeks comment on this proposal,
including whether prior participating issuers or issuers that intend to
participate in these arrangements in future years would have concerns
with HHS making this public disclosure. HHS seeks comment on the
proposed amendments to 45 CFR 156.50(d).
As mentioned in section I.B of this preamble, section 3 of E.O.
14009 directs HHS and other heads of agencies to review all agency
actions, such as the FFE or SBE-FP user fees, to determine whether they
are inconsistent with policy priorities described in section 1 of E.O.
14009, to include protecting and strengthening the ACA and making high-
quality health care accessible and affordable for all individuals.\143\
Collectively, these proposed rules on the user fee adjustment would
further the goals of E.O. 14009 by making high-quality health care that
is inclusive of contraceptive services accessible and affordable for
more individuals. U
[…truncated; see source link]Indexed from Federal Register on February 2, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.